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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark one)
⌧ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
Or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission file number 001-36020
Traws Pharma, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
22-3627252
(I.R.S. Employer
Identification No.)
12 Penns Trail, Newtown, PA
(Address of principal executive offices)
18940
(Zip Code)
(267) 759-3680
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $.01 per share
TRAW
The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ⌧
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ⌧
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ⌧ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ⌧ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”, “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ⌧
Smaller reporting company ⌧
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under
Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes ☐ No ⌧
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an
error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive
officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Act). Yes ☐ No ⌧
As of June 30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s voting stock held by non-affiliates
was approximately $9.6 million, based on the last reported sale price of the registrant’s common stock on the Nasdaq Capital Market.
There were 5,073,790 shares of Common Stock outstanding as of March 26, 2025.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the definitive proxy statement for the registrant’s 2025 annual meeting of stockholders to be filed within 120 days after the end of the period covered by this annual report on
Form 10-K are incorporated by reference into Part III of this annual report on Form 10-K.
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i
TRAWS PHARMA, INC.
INDEX TO REPORT ON FORM 10-K
Page
PART I
3
Item 1:
Business
3
Item 1A: Risk Factors
32
Item 1B: Unresolved Staff Comments
56
Item 1C: Cybersecurity
56
Item 2:
Properties
57
Item 3:
Legal Proceedings
57
Item 4:
Mine Safety Disclosures
57
PART II
58
Item 5:
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
58
Item 6:
Reserved
58
Item 7:
Management’s Discussion and Analysis of Financial Condition and Results of Operations
58
Item 7A: Quantitative and Qualitative Disclosures About Market Risk
74
Item 8:
Financial Statements and Supplementary Data
74
Item 9:
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
74
Item 9A: Controls and Procedures
74
Item 9B: Other Information
76
Item 9C: Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
77
PART III
78
Item 10: Directors, Executive Officers and Corporate Governance
78
Item 11: Executive Compensation
78
Item 12: Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
78
Item 13: Certain Relationships and Related Transactions, and Director Independence
78
Item 14: Principal Accounting Fees and Services
78
PART IV
79
Item 15: Exhibits, Financial Statement Schedules
79
Item 16: Form 10-K Summary
79
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1
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This Annual Report on Form 10-K (“Annual Report”) includes forward-looking statements. We may, in some cases,
use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-
looking statements. Forward-looking statements appear in a number of places throughout this Annual Report and include
statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other
things, the implementation of our business model and strategic plans for our business, our ongoing and planned preclinical
development and clinical trials, our interactions with the U.S. Food and Drug Administration (“FDA”) and similar foreign
authorities, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our
product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products,
particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations
regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, growth and
strategies, the industry in which we operate and the trends that may affect the industry or us.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive
dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may
occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each
forward-looking statement contained in this Annual Report, we caution you that forward-looking statements are not
guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the
development of the industry in which we operate may differ materially from the forward-looking statements contained in
this Annual Report.
You should also read carefully the factors described in the “Risk Factors” section of this Annual Report and elsewhere
to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As
a result of these factors, actual results could differ materially and adversely from those anticipated or implied in the
forward-looking statements in this Annual Report and you should not place undue reliance on any forward-looking
statements. These factors include, without limitations, the risks related to:
●
our need for additional financing for our future clinical trials and other operations, our ability to obtain sufficient
funds on acceptable terms when needed, and our plans and future needs to scale back operations if adequate
financing is not obtained;
●
our ability to continue as a going concern;
●
unexpected expenses and/or problems that may arise in the continuing process of integrating the business of
Trawsfynydd, which may result in us not operating as effectively and efficiently as expected;
●
our ability to achieve the expected benefits or opportunities, and related timing thereof, with respect to the Merger
(as defined below) or to monetize any of our legacy assets;
●
any future payouts under the contingent value right (“CVR”) issued to our holders of record as of the close of
business on April 15, 2024;
●
our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
●
the success and timing of our preclinical studies and clinical trials, including without limitation site initiation and
patient enrollment, and regulatory approval of protocols for future clinical trials;
●
our ability to enter into, maintain and perform collaboration agreements with other biotechnology or
pharmaceutical companies, for funding and commercialization of our clinical drug product candidates or
preclinical compounds, and our ability to achieve certain milestones under those agreements;
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2
●
the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under
any approval we may obtain;
●
our plans and ability to develop, manufacture and commercialize our product candidates;
●
our failure to recruit or retain key scientific or management personnel or to retain our executive officers;
●
the size and growth of the potential markets for our product candidates and our ability to serve those markets;
●
regulatory developments in the United States and foreign countries;
●
the rate and degree of market acceptance of any of our product candidates;
●
obtaining and maintaining intellectual property protection for our product candidates and our proprietary
technology;
●
the successful development of our commercialization capabilities, including sales and marketing capabilities;
●
recently implemented, and the potential for additional, cuts in federal funding and related budget cuts;
●
recently enacted and future legislation and regulation regarding the healthcare system;
●
the success of competing therapies and products that are or may become available;
●
our ability to maintain the listing of our securities on a national securities exchange;
●
the potential for third party disputes and litigation;
●
the performance of third parties, including contract research organizations (CROs) and third-party manufacturers;
and
●
the effects of a market volatility and macroeconomic factors on our business, our partners and our suppliers.
Any forward-looking statements that we make in this Annual Report speak only as of the date of such statement, and
we undertake no obligation to update such statements to reflect events or circumstances after the date of this Annual Report
or to reflect the occurrence of unanticipated events.
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3
PART I
ITEM 1. BUSINESS
Overview
Traws Pharma, Inc. (“Traws,” “we,” or the “Company”) is a clinical stage biopharmaceutical company dedicated to
developing novel therapies to target critical threats to human health in respiratory viral diseases. We are advancing novel
investigational antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten
human health. Our product candidates are intended to be safe, with simple dosing regimens. We strive to utilize accelerated
clinical trial strategies with a commitment to patients who are especially vulnerable.
On April 1, 2024, the Company (then known as Onconova Therapeutics, Inc.) consummated a merger (the “Merger”)
with Trawsfynydd Therapeutics, Inc. (“Trawsfynydd”), a privately-held biotechnology company developing next-
generation, best-in-class antivirals for influenza, COVID and other infectious diseases. Prior to the Merger, the focus of our
business was the discovery and development of novel products for patients with cancer. After completion of the Merger,
the focus of our business expanded to include the development of novel therapies to target critical threats to human health
in respiratory viral diseases. Following the Merger, we have four clinical programs: (i) tivoxavir marboxil, an
investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose
for the treatment of bird flu and seasonal influenza; (ii) ratutrelvir, an inhibitor of the main protease (also known as 3CL
protease) of the SAR-CoV-2 virus, the causative agent in COVID19; (iii) narazaciclib (ON 123300), a multi-targeted
kinase inhibitor in solid tumors and hematological malignancies as a single agent or in combination with other anti-cancer
therapies; and (iv) rigosertib, administered alone or in combination for investigation in various cancers. Each of these
programs is discussed in additional detail, below.
Product Candidates / Compounds
Tivoxavir marboxil — Small Molecule Cap- Dependent Endonuclease Inhibitor
Tivoxavir marboxil, is a small molecule cap-dependent endonuclease inhibitor. Cap-dependent endonuclease (“CEN”) is an
enzyme that is important for influenza virus replication. Tivoxavir marboxil is intended to inhibit CEN and, thus, is
intended to impede influenza virus replication including, the influenza A or B viral strains and bird flu viral strains. It is
our intention to develop tivoxavir marboxil as an oral dose given only once for potential treatment and prophylaxis of bird
flu and seasonal influenza.
The first-in-man clinical study of tivoxavir marboxil (designated AV5124 in a previous study) was performed from May to
September of 2023 in Russia. The study sponsor was Pharmasyntez, JSC. We have the right to use the data resulting from
the study outside of Russia and the Eurasian Economic Community countries. The trial was a single ascending dose study,
and, as such, each study participant only received one dose of tivoxavir marboxil. The study consisted of four dose cohorts
that received 20, 40, 80 or 120 mg tivoxavir marboxil delivered as 20 mg strength tablets, or placebo. The study enrolled
28 healthy males ages 18-45 years who received either the study drug or placebo. The primary study endpoint was
measurement of the safety and tolerability of single drug doses in healthy volunteers. The secondary endpoint was the
measurement of pharmacokinetic parameters of single drug doses in healthy volunteers on an empty stomach or after a
meal. In the study, one subject who received a single 40 mg dose of the study drug, experienced two adverse events
(“AEs”). This subject experienced hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir
marboxil, and erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered to
be a serious adverse event (“SAE”) believed unlikely to be related (doubtful per the protocol) to the study drug. There were
no other AEs in the trial, including at higher doses. The pharmacokinetic measurements indicated a small food effect for
tivoxavir marboxil, with increased exposure when drug was taken after a meal but otherwise showed increasing exposure
with increasing dose.
We further advanced the development of tivoxavir marboxil with a Traws Pharma sponsored Phase 1 randomized,
blinded, and placebo-controlled study in Australia that was approved by the Human Research Ethics Committee. The
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study enrolled four cohorts of 8 participants, with 6 participants randomized to receive study drug and 2 participants
assigned to receive placebo in each cohort. Participants were required to be healthy males or females ages 18-64 years.
Participants took either one dose of the study drug or one dose of placebo, depending on the assigned group. The dose
levels that were evaluated included 80, 120, 240, and 480 mg, taken once via oral capsules. The primary endpoint of the
study was the measurement of safety and tolerability, and the secondary and other endpoints included the determination of
the drug pharmacokinetic profile. Topline data showed good overall tolerability and a pharmacokinetic profile that appears
to support the potential use of tivoxavir marboxil as a one-time treatment for influenza. Sixteen AEs were recorded, of
which three were reported as possibly related to study drug during the study; all were mild headaches. Topline data from
this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels consistently above the EC90 and
within the predicted therapeutic window for more than 23 days.
We plan to meet with the FDA in the first half of 2025 to align on a path forward, including to seek guidance regarding
the potential for accelerated approval utilizing the “Animal Rule” for further development of tivoxavir marboxil in the
treatment of H5N1 bird flu. The FDA “Animal Rule” allows approval of therapeutic interventions in cases where there is a
risk of severe disease and a controlled human trial would be unethical or infeasible.
To date, extensive preliminary data has been obtained through pre-clinical studies regarding the impact of tivoxavir
marboxil on bird flu. Three animal models of influenza were employed: mice, ferrets and nonhuman primates. The virus
used to challenge these animals was A/Texas/37/2024 H5N1, a virus isolated from a Texas dairy worker who was infected
after direct contact with virus-positive cattle. The A/Texas/37/2024 virus demonstrated extreme virulence in several animal
species and is considered a stringent challenge for evaluating antiviral drug effects. The tivoxavir marboxil was delivered
by oral route in all studies, to maintain comparability to human disease as much as possible.
In mice infected with A/Texas/37/2024 via intranasal inoculation (15 animals per group), a single 50 mg/kg oral dose of
tivoxavir marboxil, given 8 hours after the virus, was sufficient to protect 100% of mice from virus lethality (study interval
was 10 days). Untreated mice showed substantial body weight loss starting 2 days after virus inoculation and all were
deceased by 6 days after infection. Measurements of virus levels in lungs, from mice sacrificed 3 days after infection (5 per
group), showed high levels of approximately 108 to 109 infectious virus per gram of lung tissue in untreated animals, while
all treated animals had virus below the lower limit of quantitation. Importantly, the 50 mg/kg murine dose is directly
comparable, by allometric scaling, to a human dose of 240 mg, which was evaluated and seen to be safe in our Australian
Phase I clinical trial.
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The A/Texas/37 2024 virus was also highly lethal in ferrets after intranasal inoculation (10 animals per group). Among
untreated animals, rapid body weight loss was seen as early as 2 days after virus infection, and all control animals were
deceased by day 4 of the study. Treated animals received doses of tivoxavir marboxil equivalent to 240 mg/kg (high dose),
or the equivalent of 120 mg human dose (low dose).
Animals treated with the higher dose were 100% surviving until day 8 and overall survival of that group was 50% at the
end of study (14 days). The group receiving a lower dose of tivoxavir marboxil demonstrated 100% survival until day 7
and an overall survival rate of 30% by the end of study. Body weight losses were delayed by treatment and also showed a
dose dependent pattern of response to treatment.
Evaluations of lung virus burden in animals sacrificed 3 days after infection (4 per group) showed highly significant
decreases among treated animals compared to the untreated control group; the high and low dose groups showed similar
patterns of reduced lung virus burden compared to untreated animals.
A third study was initiated in nonhuman primates (Rhesus macaques). The study utilized adult, female macaques (5 per
group), and treatment was an oral dose of tivoxavir marboxil, equivalent to 480 mg dose in a human, delivered 8 hours
after virus inoculation. The viral inoculum (1x106 tissue culture infection doses per animal, intranasal) resulted in a non-
lethal infection. Treatment had a significant effect on body weight loss, which was prevented in the treatment
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group. Bronchoalveolar lavage sampling of the lungs demonstrated significant difference in lung virus burden with 5 of 5
untreated animals having infectious virus levels between 5.6 and 3.7 log10 infectious doses per mL, while 5 of 5 treated
animals had infectious virus levels below the lower limit of quantitation on study day 3. Despite not observing deaths
among the untreated group, these data demonstrate a potent impact of tivoxavir marboxil on disease in the Rhesus macaque
model of bird flu.
Overall, data obtained from the three animal models of bird flu showed that the virus isolated from a dairy worker is highly
lethal in mice and ferrets, and that drug levels required for effective treatment may be concomitantly higher than drug
levels required to combat seasonal influenza. The drug dose used in Rhesus macaques was sufficient to mitigate the
symptoms of weight loss and lung viremia that are known to be associated with severity of influenza virus infections. The
infectious dose used and routed for delivery, may have reduced the disease severity and allowed all animals, including
those in the untreated group, to survive for the 10-day duration of this study. A higher virus dose, different route for virus
delivery, a longer observation period, or the use of younger animals may have resulted in deaths among the untreated
group, although this does not diminish the value of data obtained regarding tivoxavir marboxil impacts on body weight loss
and lung virus burden. Oral tivoxavir marboxil treatment subsequent to virus infection in three animal species,
demonstrated consistent impacts on markers of disease progression.
Ratutrelvir — Small Molecule - 3CL Protease Inhibitor
Ratutrelvir (TRX01) is an inhibitor of the main protease (also known as 3CL protease) of the SAR-CoV-2 virus, the
causative agent in COVID19. The main protease is an essential component in the mechanism for SARS-CoV-2 replication.
Ratutrelvir is intended to inhibit this protease and reduce SARS-CoV-2 virus replication. In vitro laboratory tests that
measured the impact of ratutrelvir on SARS-CoV-2 replication, demonstrated that ratutrelvir inhibited the replication of
viral isolates of the original SARS-CoV-2 isolates, and viral variants in the delta and omicron types. An animal study using
the widely adopted K18 transgenic mouse model, demonstrated non-inferiority between ratutrelvir and the combination of
nirmatrelvir + ritonavir, in terms of time to death and lung virus burden in this highly lethal model with neurological
manifestations. Based on preclinical pharmacokinetic studies in multiple animal species, we intend to develop ratutrelvir
for use without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir.
Ratutrelvir was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases. Participants
were required to be healthy males or females ages 18-64 years. The primary endpoint of the study was the measurement of
safety and tolerability, and the secondary endpoint included the determination of the drug pharmacokinetic and
pharmacodynamic profiles. The Phase 1 trial was conducted in Australia. It was sponsored by the Company and was
approved by the Human Research Ethics Committee. The trial administered either the study drug or placebo to 40
participants in the single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received
study drug and two received placebo). Subjects in the single ascending dose phase received one oral dose of the study drug
or placebo, depending on their assigned group. The single ascending dose portion of the study assessed oral ratutrelvir at
15, 50, 150, 300 and 600 mg doses. Subjects in the multiple ascending dose phase received a daily single oral dose of 150
mg or 600 mg (6 active and 2 placebo) for 10 consecutive days. The study was completed in September 2024. There were
few recorded adverse events reported up to the highest dose, and none were determined to be related to study drug.
Topline data also showed that once-daily administration of ratutrelvir for 10 consecutive days, maintained plasma drug
levels within the predicted therapeutic window for 12 days. In the cohort receiving a single, daily oral dose of 600 mg, the
maximum drug levels were approximately 20 times below the exposure limits established during GLP toxicology studies in
rats and Beagle dogs. The toxicology studies did not reach the no adverse event limit (NOAEL) after treating animals with
up to 1,000 mg/kg. The 24-hour Ctrough levels were constant for 10 days, at roughly 110 nM total blood drug
concentration, which is 13 times the EC50 measured in vitro for a collection of omicron strains of SARS-CoV-2.
Pharmacodynamic studies confirmed a direct correlation between drug levels in blood and inhibition of the main protease
enzyme in vitro.
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Narazaciclib (ON 123300) — Differentiated Multi-Kinase Inhibitor Targeting CDK4/6
Pursuant to a license agreement with Temple University, dated January 1, 1999, as amended March 21, 2013 (the
“Temple Licensing Agreement”), we licensed compounds from Temple University, including our product candidate
narazaciclib. Narazaciclib is a multi-targeted kinase inhibitor targeting multiple cyclin-dependent kinases (“CDK's”),
AMP-activated protein kinase (“AMPK”) related protein kinase 5 (“ARK5”), and colony-stimulating factor 1 receptor
(“CSF1R”) at low nM concentrations as well as other tyrosine kinases believed to drive tumor cell proliferation, survival
and metastasis. As an apoptotic and antiproliferative agent, narazaciclib modulates the levels and activities of regulatory
proteins of the cell cycle, including cyclin D1 and inhibits retinoblastoma (“Rb”) protein binding. Narazaciclib is believed
to inhibit cancer cell growth and suppresses deoxyribonucleic acid (“DNA”) synthesis by preventing CDK-mediated G1-S
phase transition, followed by tumor cell death by induction of mitochondria-mediated apoptosis. We believe, based on data
from preclinical studies, that narazaciclib has the potential to overcome the limitations of the current generation of
approved cyclin dependent kinase (CDK) 4/6 inhibitors. The table below depicts the half-maximal in vitro inhibitory
concentration (IC50) of narazaciclib palbociclib, ribociclib and abemaciclib. IC50 is a quantitative measure indicating the
concentration of each drug needed to inhibit, in vitro, these listed kinases by 50%. We believe our CDK inhibitor is
differentiated from other agents in the market or in development due to its multi-targeted kinase inhibition profile.
Narazaciclib
Palbociclib
Ribociclib
Abemaciclib
Sponsor
Traws
Pfizer
Novartis
Lilly
CDK Family
CDK4/cyclin D1
2
2
3
0.8
CDK6/cyclin D1
0.6
0.8
6.0
0.6
CDK1/cyclin A
2190
>10,000
>10,000
270
CDK2/cyclin E
69
2300
>10,000
130
CDK9/T1
48
630
390
7
Other Kinases
CSF1R
0.7
>10,000
>10,000
>10,000
ARK 5/NUAK 1
5
1,400
1,540
773
FLT3
6.0
496
753
72
Source: Reaction Biology 2021
Narazaciclib also inhibits ARK5 (“NUAK1”) with a 50% inhibitory concentration (IC50) of 4.95 nM (Report EPR-
123300-001 and Reddy 2014) while palbociclib, ribociclib, and abemaciclib do not. ARK5 has been shown to be important
in a number of cancer cell regulated survival pathways such as regulating AKT dependent cell survival, cell metabolism
through c-MYC activity, tumor cell survival under oxidative stress and tumor cell migration (Faisal, 2020, Lui, 2012, Port,
2018). The combination of CDK and ARK5 inhibitors in the same molecular entity is proposed to have a differentiated
effect on cancer cells by simultaneously inhibiting both cell cycle (cytostatic) and cellular metabolism (cytotoxic) pathways
through CDK and ARK5, respectively.
Narazaciclib also inhibits CSF1R with IC50 values between 0.7 to 10 nM (Unpublished data and Reddy 2014). The
ability of narazaciclib to bind and inhibit CSF1R at low nanomolar values, in both in vitro and cell-based assays suggests
that this compound may have an impact in cancers with a dependence on CSF1R signaling.
Unfortunately, several mechanisms of acquired resistance are emerging with the approved CDK4/6 inhibitors leading
to progression in patients with HR+/HER2- mBC (Spring, 2019; Knudsen, 2020). Therefore, the unmet medical need
supports development of the next (third) generation CDK4/6 inhibitors in advanced HR+/HER- mBC. The inhibitory effect
of narazaciclib may provide a therapeutic strategy to optimize efficacy of CDK 4/6 inhibition and reduce the emergence of
resistance and/or provide clinical benefit for patients with progression on palbociclib, ribociclib and/or abemaciclib.
Another established driver of resistance to CDK4/6 inhibitors in breast cancer is FGFR1-3.
Cancer cells can also lose Rb function through mutation and become resistant or insensitive to palbociclib. Generally,
second generation CDK 4/6 inhibitors agents have not been shown to be suitable for single agent therapy and
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must typically be used in combination with hormonal therapy in the treatment of HR+/HER2- mBC. In addition, the rate of
disease progression that occurs, especially in patients with visceral disease (Hortobagyi 2018), may benefit from the novel
inhibitory effects of narazaciclib. This hypothesis needs to be proven in a clinical trial.
We believe narazaciclib has a favorable kinase inhibitory profile in comparison to the approved CDK4/6 inhibitors
(palbociclib, ribociclib, and abemaciclib) and may result in both tumorigenic and safety benefits (Perumal, 2016, Divakar,
2016). In addition, the added inhibitory effects of narazaciclib on CSF-1R, and ARK5 is expected to increase the potential
of narazaciclib to treat a broader array of cancers such as triple negative breast cancer in combination with chemotherapy
and immunotherapy, mantle cell lymphoma in combination with Bruton Tyrosine Kinase (“BTK”) inhibitors, relapsed
refractory multiple myeloma, and colorectal cancer among others.
In December 2017, we entered into a license and collaboration agreement with HanX Biopharmaceuticals, Inc.
(“HanX”), a company focused on development of novel oncology products, for the manufacturing, clinical development,
registration and commercialization in China of narazaciclib (the “HanX License Agreement”). Under the terms of the
HanX License Agreement, we received an upfront payment, and will receive regulatory and commercial milestone
payments, as well as royalties on any future Chinese sales if the drug is approved. The key feature of the 2017
collaboration was that HanX provided all funding required for the Chinese Investigational New Drug Application (“IND”),
thereby enabling the studies necessary in order to seek IND approval by the National Medical Products Administration (the
“NMPA”), the Chinese equivalent of the FDA. In the fourth quarter of 2019, HanX filed an IND with the NMPA, which
was approved on January 6, 2020. We and HanX also intended for these studies underlying the Chinese IND approval, to
meet the FDA standards for IND approval. Accordingly, such studies were used by us for an IND filing with the US FDA.
In September 2020, a Phase 1 Study with narazaciclib in cancer patients was initiated in China. We maintain global rights
to the manufacturing, clinical development, and commercialization of narazaciclib outside of China.
In partnership with HanX, a Phase 1 dose escalation study (Study HX301-I-01) for patients with advanced
relapsed/refractory cancer has been initiated in China at three sites and the first patient was enrolled on September 15,
2020. In this study HX301 (narazaciclib) was dosed daily for 21 days followed by 7 days off therapy in each 28-day cycle.
This monotherapy study, which is now complete, enrolled a total of 20 patients with solid tumors at doses starting at 40mg
daily for 21 of 28 days, which were escalated from 40mg in increments of 40mg up to 200mg. The study is now complete,
and the results were presented in abstract form as ASCO in 2024. According to the report, the median age of the patients
was 55 years, ranging from 30 to 71. Notably, 15 patients (75%) had metastatic breast cancers. Dose-limiting toxicities
(“DLTs”) were observed in 2 patients in the 200 mg group. These included a Grade 4 increase in alanine aminotransferase
(“ALT”) and a Grade 3 decrease in platelet counts with associated epistaxis, both of which resolved after discontinuation of
treatment. The most common treatment-related AEs observed were elevated aspartate aminotransferase (“AST”) (65.0%),
decreased white blood cell count (50%), decreased neutrophil count (50%), elevated ALT (45%), elevated creatine kinase
(45%), and elevated creatinine (35%). Additionally, 4 patients experienced Grade 3 or higher treatment-related AEs,
including 1 patient in the 160 mg group with Grade 3 elevated γ-glutamyl transferase and alkaline phosphatase, and 3
patients in the 200 mg group with Grade 4 elevated ALT and Grade 3 elevated AST and Dyspepsia, Grade 3 decreased
neutrophil and platelet counts, and Grade 3 hyperglycemia. Notably, no AEs led to death. Among the 20 patients evaluable
for tumor assessment using RECIST 1.1 by investigators, 4 obtained stable disease, including 2 patients in the 200 mg
group, 1 in the 120 mg group, and 1 in the 80 mg group. Furthermore, 1 patient with HR+ breast cancer in the 200 mg
group received study drug for over a year (>400 days) and achieved prolonged stable disease for more than 12 months.
Another breast cancer patient dosed at 200mg had stable disease lasting more than 6 months. In total, 2 of 3 patients treated
with monotherapy at the 200mg dose had stable disease. These are noteworthy early clinical observations, considering that
narazaciclib was being administered as a monotherapy in breast cancer patients when in clinical practice this would be
combined with anti-estrogen therapy.
Our IND submission to the US FDA was submitted in November 2020 and the FDA Study May Proceed letter was
issued in December 2020. Enrollment into the complementary US phase 1 study (Study 19-01) with narazaciclib
commenced in May 2021. Study 19-01 was an exploratory Phase 1 clinical trial, conducted in the US, to assess the safety,
tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally as escalating daily doses in
patients with advanced cancer relapsed or refractory to at least 1 prior line of therapy. In Study 19-01 in the US,
narazaciclib was dosed on a continuous daily schedule in 28-day cycles. The study assessed the safety, tolerability,
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pharmacokinetics and pharmacodynamics of narazaciclib administered orally at increasing doses starting at 40 mg daily for
consecutive 28-day cycles in patients with relapsed/refractory advanced cancer. Enrollment in the sixth dose cohort (240
mg orally each day) of the Phase 1 solid tumor study of narazaciclib was completed with one dose limiting toxicity (DLT)
observed. The seventh dose cohort (280 mg daily) enrolled 3 patients. In this study, the highest dose tested was 280mg
once daily given continuously. This study is now closed to accrual and data analysis is ongoing in preparation for database
lock, data analysis and a clinical study report. Based on experience from study 19-01, there were no emergent safety
concerns.
The Company initiated a multi-center Phase 1/2a trial evaluating its multi-kinase inhibitor, narazaciclib, in
combination with letrozole for the treatment of recurrent metastatic endometrial cancer and other gynecologic malignancies
(Study 19-02). Both narazaciclib and letrozole were administered orally in the Phase 1 dose escalation phase. The first
patient in this trial was dosed in May 2023 and the initial cohort (160mg) was completed and no DLTs were observed. The
200mg cohort enrolled 6 evaluable subjects but two patients experienced dose limiting toxicities. As a result, the dose of
narazaciclib of 160mg once daily in combination with letrozole 2.5mg QD was declared to be the maximum tolerated dose
and the recommended Phase 2 dose for women with low grade endometrioid endometrial cancer. This study is now closed
to accrual. The database has been locked, and a clinical study report is currently under review.
We believe that the emerging safety profile of narazaciclib is promising and is consistent with what is expected of
CDK 4/6 inhibitors, except that the rates of severe neutropenia and diarrhea appear to be lower with narazaciclib in
general.
Narazaciclib is also being studied in China by HanX in clinical trials of patients with High-Grade Glioma (Grade III
and IV). Four patients have been enrolled to date.
Our strategic objective for narazaciclib is to carefully evaluate clinical trial results and potentially establish additional
partnerships for further development of the compound.
Rigosertib as Monotherapy
Recessive dystrophic epidermolysis bullosa (“RDEB”) is an ultra-rare condition with high unmet medical need caused
by a lack of type VII collagen protein expression. Type VII collagen protein is responsible for anchoring the skin’s inner
layer to its outer layer, and its absence leads to extreme skin fragility and chronic wound formation in RDEB patients. Over
time, many of these patients develop squamous cell carcinomas (SCCs) that typically arise in areas of chronic skin
wounding and inflammation. Preclinical investigations demonstrated overexpression of polo like kinase 1 (“PLK1”) in
RDEB-associated SCC tumor cells. These tumors show a highly aggressive, early metastasizing course, making them the
primary cause of death for these patients, with a cumulative risk of death of 70% and 78.7% by age 45 and 55, respectively
(Mellerio, 2016), (Fine, 2016). These neoplasms show limited response rates of mostly short duration to conventional
chemo- and radiotherapy as well as targeted therapy with epidermal growth factor and tyrosine kinase inhibitors (Mellerio,
2016), (Stratigos, 2020).
Based on rigosertib’s activity as a potent PLK-1 pathway inhibitor (Atanasova, 2019), a Phase 2 open label investigator-
initiated program was commenced in patients with advanced/metastatic squamous cell carcinoma associated with recessive
dystrophic epidermolysis bullosa (“RDEB-SCC”). The current clinical experience in RDEB SCC is based on the two small
phase II, open-label Investigator Sponsored Studies (“ISS”) evaluating the anti-tumor activity and safety of oral or IV
rigosertib in RDEB patients diagnosed with locally advanced/metastatic SCCs that have failed prior standard of care.
These studies were conducted at EB House, Salzburg, Austria (SALK) (EudraCT No.: 2016-003832-19; NCT03786237)
and at Thomas Jefferson University, Philadelphia, USA (NCT04177498). Both studies included the use of either IV or oral
rigosertib, depending on the clinical need of the patient. This is due to GI obstruction arising as a result of the presence of
esophageal strictures complicating oral administration or extreme skin fragility complicating IV administration. It is,
therefore, important in these patients that the investigator has both dosing options for the appropriate dosing of their
patients. The data presented here are preliminary and may be subject to change.
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A total of 5 patients with SCC in the setting of RDEB have been treated with rigosertib to date. These patients had
multiple surgical sections and treatments with systemic therapies such as cemiplimab, pembrolizumab and cetuximab,
which all failed. Following treatment with rigosertib, there have been 2 complete cutaneous responses in 4 evaluable
patients out of the 5 total patients with SCC in the setting of RDEB that were treated with rigosertib. The responses in these
patients were durable, lasting 15 months and 16 months, respectively. The third patient had significant tumor shrinkage of
the primary lesion, facilitating a successful amputation. Patient four demonstrated some initial tumor shrinkage and stayed
on treatment for 6 cycles before being withdrawn due to logistical complications prior to the next scheduled tumor
assessment. One patient was not evaluable, and this patient initially completed 2 weeks of oral rigosertib therapy before
stopping due to severe stool impaction, likely from opioid-induced constipation, and COVID infection. The patient finished
cycle 1 three weeks later, but eventually withdrew during cycle 2 due to inability to take oral medications, abdominal pain
from stool impaction, and unwillingness to take IV medication. Results showed that overall rigosertib had an acceptable
safety profile.
Although the trial’s currently available safety and efficacy data are from only four patients, which may not be
representative of a broader patient population, the investigators believe they represent encouraging findings. This is in the
backdrop of a well of > 1300 patients who have been treated in other diseases settings to support safety of the product in
rigosertib. In addition, the investigators, and we, believe the data generated in preclinical models that suggest rigosertib’s
activity against PLK1 have now been preliminarily supported in the clinic and suggest that rigosertib may play a role in
other more common cancers driven by PLK1.
As we disclosed in December 2021, early preliminary data from this study were presented at the Austrian Society of
Dermatology and Venerology Annual Conference 2021, which took place from November 25–27, 2021, and at the World
Congress on Rare Skin Diseases which took place in Paris, from June 7-9, 2022. More recently, data was presented at the
International Society of Investigative Dermatology (“ISID”) International Epidermolysis Bullosa Symposium in Osaka,
Japan on May 9, 2023, at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago on June 3,
2023, and at the European Academy of Dermatology and Venereology (“EADV”) in Berlin, Germany on October 12, 2023,
as well as the SID Society of Investigative Dermatology (“SID”) in Dallas, Texas in May 2024, where a poster was
presented. There was also a poster presentation and a plenary presentation given by Professor Andrew South at the World
Congress of Rare Skin Diseases (“WCRSD”) in Paris in June 2024.
Rare Disease Program in “RASopathies”
Preclinical studies with rigosertib are also being conducted in cardiomyopathies which are seen in children with
RASopathies such as Noonan Syndrome. Rigosertib normalized and reversed RASopathy-associated hypertrophic
cardiomyopathy (“HCM”) as well as other syndromic features in Raf1L613V/+ mice. A manuscript has been submitted for
publication.
At this point, our objective for rigosertib is to establish additional partnerships for further development of the compound in
RDEB SCC or other indications.
Research and Development
Since commencing operations, we have dedicated a significant portion of our resources to the development of our
clinical-stage product candidates, particularly rigosertib, narazaciclib and, more recently, tivoxavir marboxil and ratutrelvir.
We incurred research and development expenses of $12.8 million and $11.4 million during the years ended December 31,
2024 and 2023, respectively. We anticipate that a significant portion of our operating expenses will continue to be related to
research and development.
Collaboration and License Agreements
HanX Biopharmaceuticals, Inc. (narazaciclib Agreement)
Under the terms of the HanX License Agreement, we received an upfront payment, and will receive regulatory and
commercial milestone payments, as well as royalties on Chinese sales. The key feature of the collaboration is that HanX
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provides all funding required for Chinese IND enabling studies performed for Chinese health authority IND approval. The
Chinese IND was approved in January 2020. We maintain global rights to narazaciclib outside of China.
SymBio Pharmaceuticals Limited
In July 2011, we entered into a license agreement (the “Symbio License Agreement”) with SymBio Pharmaceuticals
Limited (“Symbio”), as subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development
and commercialization of rigosertib in Japan and Korea.
Under the terms of the SymBio License Agreement, we received an upfront payment of $7,500,000. In addition, we
could receive regulatory, development and sales-based milestone payments, as well as royalty payments at percentage rates
ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio.
Pint International SA
In March 2018, we entered into a License, Development and Commercialization Agreement (the “Pint License
Agreement”) with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to
as “Pint”). Under the terms of the Pint License Agreement, we granted Pint an exclusive, royalty-bearing license, with the
right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical
product (the “Pint Licensed Product”) containing rigosertib in all uses of the Pint Licensed Product in humans in Latin
American countries (including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican
Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico,
Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela).
Under the terms of the Securities Purchase Agreement (the “Pint SPA”) entered into by and between the Company and
Pint in connection with the Pint License Agreement, Pint agreed to make an upfront equity investment in the Company at a
specified premium to the Company’s share price. Pursuant to the Pint SPA, closing of the upfront equity investment
occurred on April 4, 2018 and Pint purchased 2,179 shares of common stock for $1,250,000. The total amount of the
premium was $319,000 and this amount was allocated to the license.
Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written
notice. The Pint License Agreement also contains customary provisions for termination by either party in the event of
breach of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
Knight Therapeutics, Inc.
In November 2019, we entered into a Distribution, License and Supply Agreement (the “Knight License Agreement”)
with Knight Therapeutics Inc. (“Knight”). Under the terms of the Knight License Agreement, we granted Knight (i) a non-
exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to
develop and manufacture any product (the “Knight Licensed Product”) containing rigosertib for Canada (and Israel, should
Knight exercise its option under the agreement) (the “Knight Territory”) and in human uses (the “Knight Licensed Field”),
and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-
how to commercialize the Knight Licensed Product in the Knight Territory and in the Knight Licensed Field.
Knight has also agreed to obtain from us all of Knight’s requirements of the Knight Licensed Products for the Knight
Territory, and we have agreed to supply Knight with all of its requirements of the Knight Licensed Products. We may, at
our discretion, use the services of a contract manufacturer to manufacture and package the Knight Licensed Products.
In addition, we have granted Knight an exclusive right of first refusal with respect to all or any part of the Knight
Territory, to store, market, promote, sell, offer for sale and/or distribute any ROFR Products. As used in the Knight License
Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed, or
controlled by us as of the effective date of the Knight License Agreement and all improvements thereto.
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We are eligible to receive clinical, regulatory, and sale-based milestone payments as well as tiered, double-digit
royalties based on net sales in the Knight Territory.
The License Agreement has a term of 15 years from the launch, on a country-by-country basis in the Knight Territory,
and contains customary provisions for termination by either party in the event of breach of the Knight License Agreement
by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee
or assignee.
Specialised Therapeutics Asia Pte. Ltd.
In December 2019, we entered into a Distribution, License and Supply Agreement (the “STA License Agreement”)
with Specialised Therapeutics Asia Pte. Ltd. (“STA”). Under the terms of the STA License Agreement, we granted STA (i)
a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how
to develop and manufacture any product (the “STA Licensed Product”) containing rigosertib for Australia and New
Zealand (the “STA Territory”) and in human uses (the “STA Licensed Field”), and (ii) an exclusive, royalty-bearing
license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the STA
Licensed Product in the STA Territory and in the STA Licensed Field.
STA has also agreed to obtain from us all of its requirements of the STA Licensed Products for the STA Territory, and
we have agreed to supply STA with all of its requirements of the STA Licensed Products. We may, at our discretion, use the
services of a contract manufacturer to manufacture and package the STA Licensed Products.
We are eligible to receive clinical, regulatory, and sale-based milestone payments as well as tiered, double-digit
royalties based on net sales in the STA Territory.
The STA License Agreement has a term of 15 years from the launch, on a country-by-country basis, in the STA
Territory and contains customary provisions for termination by either party in the event of breach of the STA License
Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any
sublicensee or assignee.
Intellectual Property
Patents and Proprietary Rights
Virology
License Agreement with Viriom, Inc. regarding Influenza Asset
In January 2023, Trawsfynydd entered into a License Agreement (the “Viriom License Agreement”) with Viriom, Inc.
(“Viriom”), pursuant to which Trawsfynydd obtained an exclusive, royalty-free, sublicensable, world-wide license to
certain Viriom patents, applications, and technical information (collectively, the “Viriom Licensed IP”) to make, have
made, use, sell, offer for sale and import several classes of novel compounds related to the treatment and prevention of
viral diseases, specifically for use of the Viriom Licensed IP in the development of treatment and methods to prevent viral
disease in Canada, China, the European Union, Hong Kong, Japan, the United States and all areas covered by PCT
applications for the Viriom Licensed IP. As consideration for the license, Trawsfynydd issued Viriom a SAFE for the
purchase amount of approximately $13 million, which SAFE was converted into shares of Trawsfynydd stock prior to the
Merger. No annual license fees, royalties, or milestone payments are required. Additionally, pursuant to the Viriom
License Agreement, Trawsfynydd obtained the right to control prosecution, defense of infringement and enforcement. As a
result of the Merger, the rights and obligations of Trawsfynydd under the Viriom License Agreement were transferred to
the Company (through its subsidiaries).
Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and effect for
the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application
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licensed under the agreement, whichever is later. The Viriom License Agreement can be terminated by either party due to
the material breach of either party (subject to a cure period).
As of March 2025, pursuant to the Viriom License Agreement, we exclusively licensed patents and patent applications
covering compounds, pharmaceutical compositions, methods of producing such compounds and pharmaceutical
compositions, methods and uses of such compounds and pharmaceutical compositions in the prophylaxis or treatment of
viral infections in, for example, the United States, Europe, Japan, and China, among others. These licensed patents and
patents that may result from currently pending patent applications expire in 2040 before any possible patent term
extensions. Patent term extensions may be available, depending on various provisions in the law.
Virology COVID Asset
In addition to the Viriom Licensed IP that we have rights to pursuant to the Viriom License Agreement, we own several
patent applications covering compounds, pharmaceutical compositions, methods of producing such compounds and
pharmaceutical compositions, methods and uses of such compounds and pharmaceutical compositions for the prevention or
treatment of a disease, disorder, or condition associated with coronavirus in, for example, Australia, Eurasia, Europe,
Mexico, and the United States, among others. These Company-owned patent applications and patents that may result from
currently pending patent applications expire in 2043 before any possible patent term extensions. Patent term extensions
may be available, depending on various provisions in the law.
Oncology
Our intellectual property in oncology is derived through our internal research, the Temple Licensing Agreement with
Temple University (“Temple”) and research agreements with the Mount Sinai School of Medicine (“Mount Sinai”).
License Agreement with Temple University
In January 1999, we entered into the Temple Licensing Agreement to obtain an exclusive, world-wide license to certain
Temple patents and technical information to make, have made, use, sell, offer for sale and import several classes of novel
compounds.
Under the terms of the Temple Licensing Agreement, we paid Temple a non-refundable up-front payment, and are
required to pay annual license maintenance fees, as well as a low single-digit percentage of net sales as a royalty. In
addition, we agreed to pay Temple 25% of any consideration received from any sublicensee of the licensed Temple patents
and technical information, which does not include any royalties on sales, funds received for research and development or
proceeds from any equity or debt investment.
The Temple Licensing Agreement can be terminated by mutual agreement or due to the material breach or bankruptcy of
either party. We may terminate the license agreement for any reason by giving Temple prior written notice.
Narazaciclib Patents
As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering
composition of matter, formulation and various indications for method-of-use for narazaciclib filed worldwide, including in
the United States. The U.S. composition-of-matter patent for narazaciclib expires in 2031. We have also filed new patent
applications covering methods of treatment in target indications that are projected to extend to 2042-2043 before any
possible patent term extensions. Patent term extensions may be available, depending on various provisions in the law.
Rigosertib Patents
As of March 2024, we owned or exclusively licensed issued patents and pending patent applications covering
composition-of-matter, process, formulation and various indications for method-of-use for rigosertib filed worldwide,
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including in the United States. The U.S. composition-of-matter patent for rigosertib, which we in-licensed pursuant to the
license agreement with Temple, currently expires in 2026. The novel formulation patent for rigosertib expires in 2037. We
have recently filed new patent applications covering methods of treatment in target indications that are projected to extend
to 2042-2044 before any possible patent term extensions. Patent term extensions may be available, depending on various
provisions in the law.
General Considerations
As with other biotechnology and pharmaceutical companies, our ability to maintain and solidify a proprietary position
for our product candidates will depend upon our success in obtaining effective patent claims and enforcing those claims
once granted.
Our commercial success will depend in part upon not infringing upon the proprietary rights of third parties. It is
uncertain whether the issuance of any third-party patent would require us to alter our development or commercial
strategies, or our product candidates or processes, obtain licenses or cease certain activities. The biotechnology and
pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.
If a third party commences a patent infringement action against us, or our collaborators, it could consume significant
financial and management resources, regardless of the merit of the claims or the outcome of the litigation.
If an application is timely filed with the Patent and Trademark Office, the term of a patent that covers an FDA-
approved drug may be eligible for additional patent term extension, which provides patent term restoration to account for
the patent term lost during product development and the FDA regulatory review process. The Drug Price Competition and
Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”) permits a patent term extension of up to five years beyond
the expiration of the patent. The length of the patent term extension is determined based upon the time from the IND
effective date to the full NDA submission date, and the time from NDA submission date and the eventual application
approval, as further described below. Patent extension cannot extend the remaining term of a patent beyond a total of
14 years from the date of product approval and only one patent applicable to an approved drug may be extended. Similar
provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved
drug. In the future, if and when our product candidates receive FDA approval, we expect to apply for patent term
extensions on patents covering those products.
Furthermore, we may be able to obtain extension of patent term by adjustment of the said term under the provisions of
35 U.S.C. § 154 if the issue of an original patent is delayed due to the failure of the U.S. Patent and Trademark Office. For
example, we have received adjustments of 1,139 days extension to the patent term for the rigosertib composition of matter
patent (US 7,598,232), 1,155 days extension for the patent covering the process for making rigosertib (US 8,143,453) and
751 days extension for rigosertib formulation patent (US 8,063,109) under the provisions of 35 U.S.C. §154.
In addition to patents and other licensed intellectual property rights, we rely upon unpatented trade secrets, know-how
and continuing technological innovation to develop and maintain a competitive position. We seek to protect our proprietary
information, in part, through confidentiality agreements with our employees, collaborators, contractors and consultants, and
invention assignment agreements with our employees. We also have agreements requiring assignment of inventions with
selected consultants and collaborators. The confidentiality agreements are designed to protect our proprietary information
and, in the case of agreements or clauses requiring invention assignment, to grant us ownership of technologies that are
developed through a relationship with a third party.
Competition
The biotechnology and pharmaceutical industries are highly competitive and subject to rapid and significant
technological change. While we believe that our development experience and scientific knowledge provide us with
competitive advantages, we face competition from both large and small pharmaceutical and biotechnology companies.
There are a number of pharmaceutical companies, biotechnology companies, public and private universities and research
organizations actively engaged in the research and development of products that may compete with our products. Many of
these companies are multinational pharmaceutical or biotechnology organizations, which are pursuing the
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development of, or are currently marketing, pharmaceuticals that target the key viruses, oncology indications or cellular
pathways on which we are focused.
Many of our competitors have significantly greater financial, technical and human resources than we have. Many of
our competitors also have a significant advantage with respect to experience in the discovery and development of product
candidates, as well as obtaining FDA and other regulatory approvals of products and the commercialization of those
products. We anticipate intense and increasing competition as new drugs enter the market and as more advanced
technologies become available. Our success will be based in part on our ability to identify, develop and manage a portfolio
of drugs that are safer and more effective than competing products.
There are currently various drugs approved for the treatment of influenza, including without limitation the
neuraminidase inhibitors oseltamivir phosphate (Tamiflu), zanamivir (Relenza), and peramivir (Rapivab) anti-influenza
drugs, which are sold by Gilead, Glaxo SmithKline (GSK), and BioCryst partners, respectively. Additionally, there is
currently one cap-dependent endonuclease (“CEN”) inhibitor, baloxavir marboxil (Xofluza), sold by Roche, currently
approved for use in the treatment of influenza. In addition, M2 channel inhibitors, generic drugs include amantadine and
rimantadine, both oral tablets that only inhibit the replication of the influenza virus have generally become ineffective
because of significant viral resistance to the approved M2 channel inhibitors, especially in the US. Several companies are
developing anti-influenza drugs, including for the treatment of bird flu, at present, including, for example, Cidara and
Eradivir. Small chemical classes include neuraminidase inhibitors, M2-channel inhibitors, and RDRP inhibitors, among
others. There are also monoclonal, polyclonal, and mixed antibodies, as well as enzymes as drugs in development.
Several companies have advanced drug candidates for the management of COVID-19. For example, remdesivir (sold
by Gilead), an antiviral drug, and oral Paxlovid (sold by Pfizer), a combination of nirmatrelvir and ritonavir tablets taken
together, have both received full FDA approval for the treatment of COVID-19 in certain populations. The FDA has
authorized emergency use (“EUA”) of oral molnupiravir (sold by Merck and Ridgeback). Several antibodies previously
received EUAs, but all of these have been revoked due to loss of efficacy as new variants emerged.
There are several ongoing clinical trials aimed at expanding the use of approved chemotherapeutic and
immunomodulatory agents in the diseases we are studying, as well as several new clinical programs testing novel
technologies. Companies with marketed CDK 4/6 inhibitors in the HR+/ HER2- metastatic breast cancer space include
Pfizer (palbociclib), Novartis (ribociclib) and Eli Lilly (abemaciclib).
Manufacturing
Our product candidates are synthetic small molecules. Manufacturing activities must comply with FDA current good
manufacturing practices (“cGMP”), regulations commensurate with the product candidates’ stage of development. We
conduct our manufacturing activities under individual purchase orders with third-party contract manufacturers (“CMOs”).
We have quality agreements in place with our key CMOs. We have also established an internal quality management
organization, which audits and qualifies CMOs in the United States and abroad.
We believe that the manufacturing processes for the active biopharmaceutical ingredients and finished drug products
for our product candidates are being developed to adequately support future development and commercial demands. If
manufacturing challenges occur, they are thoroughly reviewed and, as may be required, reported to health authorities to
determine whether the product can be used for clinical trials.
The FDA regulates and inspects or conducts remote regulatory assessments of equipment, facilities and processes used
in manufacturing biopharmaceutical products prior to approval. If we or our CMOs fail to comply with applicable cGMP
requirements and conditions of product approval, the FDA may seek sanctions, including fines, civil penalties, injunctions,
suspension of manufacturing operations, operating restrictions, withdrawal of FDA approval, refusal to approve
applications, seizure or recall of products and criminal prosecution. Although we periodically monitor the FDA compliance
of our third-party CMOs, we cannot be certain that our present or future third-party CMOs will consistently comply with
cGMP and other applicable FDA regulatory requirements.
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Commercial Operations
We do not currently have any relationships with organizations for the sale, marketing and distribution of
biopharmaceutical products. In the future, we may rely on licensing and co-promotion agreements with strategic partners
for the commercialization of our products in the United States and other territories. If we choose to build a commercial
infrastructure to support marketing in the United States, such commercial infrastructure could be expected to include a
targeted, sales force supported by sales management, internal sales support, an internal marketing group and distribution
support. To develop the appropriate commercial infrastructure internally, we would have to invest significant financial and
management resources.
Government Regulation
As a biopharmaceutical company that operates in the United States, we are subject to extensive regulation by the FDA,
and other federal, state, and local regulatory agencies. The Federal Food, Drug and Cosmetic Act (the “FDC Act”), and its
implementing regulations, as well as various other federal and state statutes and regulations, set forth, among other things,
requirements for the research, testing, development, manufacture, quality control, safety, effectiveness, approval, labeling,
storage, record keeping, reporting, distribution, import, export, advertising, marketing, and promotion of our product
candidates. The FDA also has issued a growing body of guidance documents that provide the agency’s interpretation of
regulatory requirements. As a result of these regulations, product development and the product approval process is very
expensive and time consuming.
Regulation by governmental authorities in the United States and other countries is a significant factor in our research
and development activities and strategy and will be a significant factor in the manufacture and marketing of our product
candidates. Although the discussion below focuses on regulation in the United States, we and/or our partners anticipate
seeking approval for, and marketing of, our products in other countries. Additionally, we are conducting certain of our
clinical trials outside of the United States, including in Australia. Generally, our activities in other countries are and will be
subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be
important differences. Additionally, some significant aspects of approval and regulation in Europe are addressed in a
centralized way through the EMA, but country-specific regulation remains essential in many respects and enforcement is
generally through EU member state authorities. The nature and extent to which such regulation applies to us will vary
depending on the nature of any products we may develop.
The process of obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal,
state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources and may
not be successful. In addition, approval in a foreign country does not automatically result in approval in the United States,
nor does approval in the United States automatically result in approval in the European Union or elsewhere.
United States Government Regulation
The FDA is the main regulatory body that controls biopharmaceuticals and pharmaceuticals in the United States, and
its regulatory authority is based in the FDC Act. Biopharmaceuticals and pharmaceutical products are also subject to other
federal, state and local statutes. A failure to comply explicitly with any requirements during the product development,
approval, or post-approval periods, may lead to administrative or judicial sanctions. These sanctions could include the
imposition by the FDA , an institutional review board (“IRB”), or Independent Ethics Committee (“IEC”) of a hold on
clinical trials, refusal to approve pending marketing applications or supplements, withdrawal of approval, warning letters,
untitled letters, cyber letters, product recalls, product seizures or detention, prohibition on importing or exporting, total or
partial suspension of production or distribution, injunctions, fines, civil penalties, adverse publicity, disgorgement,
restitution, FDA debarment, debarment from government contracting or refusal of future orders under existing contracts,
exclusion from Federal healthcare programs, corporate integrity agreements, consent decrees, or criminal prosecution.
The steps required before a new drug may be marketed in the United States generally include:
●
Completion of preclinical or nonclinical laboratory tests, animal studies and formulation studies in compliance
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with the FDA’s good laboratory practice (“GLP”), regulations and other applicable laws and regulations;
●
Submission to the FDA of an IND to support human clinical testing;
●
Approval by an IRB at each clinical site or centrally before each trial may be initiated;
●
Performance of adequate and well-controlled clinical trials in accordance with federal regulations and with
current good clinical practices (“GCPs”) to establish the safety and efficacy of the investigational drug product
for each targeted indication;
●
Submission of an NDA to the FDA;
●
Satisfactory completion of an FDA Advisory Committee review, if applicable;
●
Satisfactory completion of an FDA inspection of the manufacturing facilities at which the investigational product
is produced to assess compliance with cGMPs, and to assure that the facilities, methods and controls are
adequate, as well as satisfactory completion of FDA inspections of selected clinical trial sites to ensure that
clinical trials were conducted in accordance with GCPs; and
●
FDA review and approval of the NDA.
Preclinical and Clinical Trials
The testing and approval process of product candidates requires substantial time, effort, and financial resources.
Satisfaction of FDA pre-market approval requirements typically takes many years, and the actual time required may vary
substantially based upon the type, complexity, and novelty of the product or disease. Product development typically begins
with preclinical or nonclinical studies. Preclinical studies include laboratory evaluation of chemistry, pharmacology,
toxicity, and product formulation, as well as animal studies to assess potential safety and efficacy. Such studies must
generally be conducted in accordance with the FDA’s GLPs.
Prior to commencing the first clinical trial with a product candidate, an IND sponsor must submit the results of the
preclinical tests and preclinical literature, together with manufacturing information, analytical data, any available clinical
data or literature, and proposed clinical study protocols, among other things, to the FDA as part of an IND. Sponsors will
also be required to provide FDA with diversity action plans. An IND is a request for authorization from the FDA to
administer an investigational drug product to humans. This authorization is required before interstate shipping and
administration of any new drug product to humans that is not the subject of an approved NDA. A 30-day waiting period
after the submission of each IND is required prior to the commencement of clinical testing in humans. During its review,
the FDA may determine that study subjects would be exposed to an unacceptable level of risk of harm or injury, and may
raise questions or issues related to one or more components of the IND, resulting in the IND being placed on clinical hold.
If the FDA has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the
IND may begin. Clinical trials involve the administration of the investigational drug to patients under the supervision of
qualified investigators following GCPs, an international standard meant to protect the rights and health of patients and to
define the roles of clinical trial sponsors, administrators and monitors. Clinical trials are conducted under protocols that
detail the parameters to be used in monitoring safety, and the efficacy criteria to be evaluated. Each protocol involving
testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND. The
informed written consent of each participating subject is required. Special clinical trial ethical considerations also must be
taken into account if a study involves children. The clinical investigation of an investigational drug is generally divided
into three phases. Although the phases are usually conducted sequentially, they may overlap or be combined. The three
phases of an investigation are as follows:
●
Phase 1. Phase 1 includes the initial introduction of an investigational drug into humans. Phase 1 clinical trials
may be conducted in patients with the target disease or condition or healthy volunteers. These studies are
designed to evaluate the safety, metabolism, pharmacokinetics and pharmacologic actions of the investigational
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drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on
effectiveness. During Phase 1 clinical trials, sufficient information about the investigational product’s
pharmacokinetics and pharmacological effects may be obtained to permit the design of Phase 2 clinical trials. The
total number of participants included in Phase 1 clinical trials varies, but is generally in the range of 20 to 80.
●
Phase 2. Phase 2 includes the controlled clinical trials conducted to evaluate the effectiveness of the
investigational product for a particular indication(s) in patients with the disease or condition under study, to
determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risks
associated with the drug. Phase 2 clinical trials are typically well-controlled, closely monitored, and conducted in
a limited patient population, usually involving no more than several hundred participants.
●
Phase 3. Phase 3 clinical trials are controlled clinical trials conducted in an expanded patient population at
geographically dispersed clinical trial sites. They are performed after preliminary evidence suggesting
effectiveness of the investigational product has been obtained, and are intended to further evaluate dosage,
clinical effectiveness and safety, to establish the overall benefit-risk relationship of the product, and to provide an
adequate basis for product approval. Phase 3 clinical trials usually involve several hundred to several thousand
participants. In most cases, the FDA requires two adequate and well controlled Phase 3 clinical trials to
demonstrate the efficacy of the drug.
Additional kinds of data may also help support an NDA, such as patient experience data and real world evidence. Real
world evidence may be used to assist in clinical trial design or support an NDA for already approved products.
The decision to terminate development of an investigational drug product may be made by either a health authority
body, such as the FDA or IRB/independent ethics committees (“IECs”), or by a company for various reasons. An IRB
approves the initiation of a clinical trial and supervises the conduct of the trial to ensure that the risks to human subjects are
reasonable in relation to the anticipated benefits and that there are adequate human subject protections in place. The FDA
may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it
believes that the clinical trial either is not being conducted in accordance with FDA requirements or presents an
unacceptable risk to the clinical trial patients. In some cases, clinical trials are overseen by an independent group of
qualified experts organized by the trial sponsor. This group provides guidance on whether or not a trial may or should move
forward at designated check points. These decisions are based on the limited access to data from the ongoing trial. The
suspension or termination of development can occur during any phase of clinical trials if it is determined that the
participants or patients are being exposed to an unacceptable health risk, if the product candidate does not show sufficient
evidence of efficacy, if the development program does not comply with applicable regulatory requirements, or due to
changing sponsor business objectives.
In addition, there are various reporting requirements that clinical trial sponsors and investigators must comply with
during the course of a clinical trial. For instance, there are requirements for the registration of ongoing clinical trials of
drugs on public registries and the disclosure of certain information pertaining to the trials as well as clinical trial results
after completion. Sponsors must also make annual reports to the FDA concerning the progress of their clinical trial
programs as well as more frequent reports for certain serious adverse events. Sponsors must submit a protocol for each
clinical trial, and any subsequent protocol amendments to the FDA and the applicable IRBs. IRBs must also receive
information concerning unanticipated problems involving risks to subjects. Investigators must further provide certain
information to the clinical trial sponsors to allow the sponsors to make certain financial disclosures to the FDA. Moreover,
under the 21st Century Cures Act, manufacturers or distributors of investigational drugs for the diagnosis, monitoring, or
treatment of one or more serious diseases or conditions must have a publicly available policy concerning expanded access
to investigational drugs.
Further, the manufacture of investigational drugs for the conduct of human clinical trials is subject to cGMP
requirements. Investigational drugs and active pharmaceutical ingredients imported into the United States are also subject
to regulation by the FDA relating to their labeling and distribution. Further, the export of investigational drug products
outside of the United States is subject to regulatory requirements of the receiving country as well as U.S. export
requirements under the FDC Act.
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Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional
information about the chemistry and physical characteristics of the product candidate as well as finalize a process for
manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process
must be capable of consistently producing quality batches of the product candidate and, among other things, must develop
methods for testing the identity, strength, quality, potency, and purity of the final product. Additionally, appropriate
packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate
does not undergo unacceptable deterioration over its shelf life.
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements,
detailed investigational drug product information is submitted to the FDA in the form of an NDA to request market
approval for the product in specified indications.
New Drug Applications
In order to obtain approval to market a drug in the United States, a marketing application must be submitted to the
FDA, which provides data establishing the safety and effectiveness of the drug product for the proposed indication. The
application includes all relevant data available from pertinent preclinical and clinical trials, including negative or
ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry,
manufacturing, controls and proposed labeling, among other things. Data can come from company-sponsored clinical trials
intended to test the safety and effectiveness of a product, or from a number of alternative sources, including studies
initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to
establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA.
In most cases, the NDA must be accompanied by a substantial user fee; there may be some instances in which the user
fee is waived. The FDA will initially review the NDA for completeness before it accepts the NDA for filing. The FDA has
60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency’s
threshold determination that it is sufficiently complete to permit substantive review. After the NDA submission is accepted
for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance goals in the review of NDAs.
For new molecular entities (“NMEs”), the FDA has the goal of completing its review within 10 months of the application’s
acceptance for filing. This, however, is just a goal, and the review time may take longer. For instance, the FDA can extend
this review by three months to consider certain late-submitted information or information intended to clarify information
already provided in the submission.
The FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for
its intended use, and whether the product is being manufactured in accordance with cGMP. The FDA may refer
applications for novel drug products which present difficult questions of safety or efficacy to an advisory committee,
typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the
application should be approved and under what conditions. For drugs for which no active ingredient (including any ester or
salt of active ingredients) has previously been approved by the FDA, the FDA must refer the drug to an advisory
committee or provide in an action letter, a summary of the reasons why the FDA did not refer the product candidate to an
advisory committee. Product candidates may also be referred to advisory committees for other reasons. The FDA is not
bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making
decisions.
Before approving an NDA, the FDA will inspect or conduct a remote regulatory assessment of the facilities at which
the product is manufactured. The FDA will not approve the product unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product
within required specifications. Additionally, before approving an NDA, the FDA will typically inspect or conduct a remote
regulatory assessment of one or more clinical sites to assure compliance with GCP. After the FDA evaluates the NDA and
the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete response letter
indicates that the review cycle of the application is complete and the application is not ready for approval. A complete
response letter generally outlines the deficiencies in the submission and may require substantial additional testing or
information in order for the FDA to reconsider the application, including additional clinical trials. If a complete response
letter is issued, the applicant may either: resubmit the NDA, addressing all of the deficiencies
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identified in the letter; withdraw the application; or request an opportunity for a hearing. If, or when, those deficiencies
have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The
FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included.
Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the
application does not satisfy the regulatory criteria for approval.
An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific
indications. As a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to
help ensure that the benefits of the drug outweigh the potential risks. REMS can include medication guides,
communication plans for healthcare professionals, and elements to assure safe use, or ETASU. ETASU can include, but are
not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances,
special monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market
and profitability of the drug. Moreover, product approval may require substantial post-approval testing, clinical trials, and
surveillance to monitor the drug’s safety or efficacy, or to establish the product’s safety and efficacy in a more diverse or
representative population. Once granted, product approvals may be withdrawn if compliance with regulatory standards is
not maintained or if problems are identified following initial marketing.
Changes to some of the conditions established in an approved application, including changes in indications, labeling,
or manufacturing processes or facilities, require submission and FDA approval of a new NDA or NDA supplement before
the change can be implemented. An NDA supplement for a new indication typically requires clinical data similar to that in
the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in
reviewing NDAs, including the imposition of user fees for certain supplements.
Advertising and Promotion
The FDA and other federal regulatory agencies closely regulate the marketing and promotion of drugs through, among
other things, standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses,
industry-sponsored scientific and educational activities, and promotional activities involving the Internet. A product cannot
be commercially promoted before it is approved. After approval, product promotion can include only those claims relating
to safety and effectiveness that are consistent with the labeling approved by the FDA. Healthcare providers are permitted to
prescribe drugs for “off-label” uses — that is, uses not approved by the FDA and therefore not described in the drug’s
labeling — because the FDA does not regulate the practice of medicine. However, FDA regulations impose stringent
restrictions on manufacturers’ communications regarding off-label uses. Broadly speaking, a manufacturer may not
promote a drug for off-label use, but may engage in non-promotional, balanced scientific communications regarding off-
label use under specified conditions. All statements regarding products must be consistent with the FDA approved label,
must be truthful and non-misleading, and must be adequately substantiated with a fair balance between product benefit
claims and risks, among other requirements. This means, for example, that we cannot make claims about the superiority of
or otherwise compare our products to other treatments without substantiation, which typically are head-to-head clinical
studies. FDA’s promotional standards are an evolving space. For instance, in 2023, the FDA took a few actions with
respect to advertising and promotion, including issuing a final rule and a guidance on risk and efficacy disclosures in
direct-to-consumer advertising, and a guidance on communication of off-label scientific information about approved
products. Failure to comply with applicable FDA requirements and restrictions in this area may subject a company to
adverse publicity and enforcement action by the FDA, the Department of Justice (the “DOJ”), or the Office of the Inspector
General of the Department of Health and Human Services (“HHS”), as well as state authorities. This could subject a
company to a range of penalties that could have a significant commercial impact, including civil and criminal fines and
agreements that materially restrict the manner in which a company promotes or distributes drug products.
Post-Approval Regulations
After regulatory approval of a drug is obtained, a company is required to comply with a number of post-approval
requirements. For example, as a condition of approval of an NDA, the FDA may require post-marketing testing, including
Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after
commercialization. Regulatory approval of oncology products often requires that patients in clinical trials be
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followed for long periods to determine the overall survival benefit of the drug. In addition, as a holder of an approved
NDA, a company would be required to report adverse reactions and production problems to the FDA, to provide updated
safety and efficacy information, and to comply with requirements concerning advertising and promotional labeling for any
of its products. Further, under the Drug Quality and Security Act, manufacturers, repackagers, wholesale distributors,
dispensers, and third-party logistics providers have obligations concerning the tracking and tracing of drug products, as
well as the investigation and reporting of suspect and illegitimate products. Also, quality control and manufacturing
procedures must continue to conform to cGMP after approval to assure and preserve the long-term stability of the drug
product. Manufacturing facilities must be registered with FDA and marketed drug products must be listed. Sponsors are
also subject to annual program fees, though there may be some exemptions. The FDA periodically inspects or conducts
remote regulatory assessments of manufacturing facilities to assess compliance with cGMP, which imposes extensive
procedural and substantive record keeping requirements. In addition, changes to the manufacturing process are strictly
regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented.
FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting and
documentation requirements upon a company and any third-party manufacturers that a company may decide to use.
Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control
to maintain compliance with cGMP and other aspects of regulatory compliance.
We rely, and expect to continue to rely, on third parties for the production of clinical and commercial quantities of our
product candidates. Future FDA and state inspections may identify compliance issues at our facilities or at the facilities of
our contract manufacturers that may disrupt production or distribution, or require substantial resources to correct. In
addition, discovery of previously unknown problems with a product or the failure to comply with applicable requirements
may result in restrictions on a product, manufacturer or holder of an approved NDA, including withdrawal or recall of the
product from the market or other voluntary, FDA-initiated or judicial action that could delay or prohibit further marketing.
Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling,
including the addition of new warnings and contraindications, and also may require the implementation of other risk
management measures, such as risk evaluation and mitigation strategies and phase 4 studies. Also, new government
requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which
could delay or prevent regulatory approval of our products under development or result in additional post-approval
requirements.
After a product is approved for commercial sale, in addition to marketing and promotion restrictions, manufacturers
are subject to federal and state laws and regulations requiring them to report certain pricing data, transactions with medical
professionals, and similar information. Manufacturers participating in federal health care programs are also required to
provide statutorily mandated discounts and rebates.
FDA post-approval requirements are continually evolving. For example, in March 2020, the U.S. Congress passed the
Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which includes various provisions regarding
FDA drug shortage and manufacturing volume reporting requirements, as well as provisions regarding supply chain
security, such as risk management plan requirements, and the promotion of supply chain redundancy and domestic
manufacturing. As part of the CARES Act implementation, the FDA issued a guidance on the reporting of the volume of
drugs produced, which reporting requires additional administrative efforts by drug manufacturers. The executive branch
has also taken steps to promote domestic manufacturing, and the Consolidated Appropriations Act of 2023, and the
reauthorization of the Prescription Drug User Fee Act, which were passed in 2022, included several changes to the FDC
Act.
The Hatch-Waxman Amendments to the FDC Act
Orange Book Listing
In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims
cover the applicant’s product or method of using the product. Upon approval of a drug, each of the patents listed in the
application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence
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Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential
competitors in support of approval of an abbreviated new drug application (“ANDA”) or 505(b)(2) application. In an effort
to clarify which patents must be listed in the Orange Book, in January 2021, Congress passed the Orange Book
Transparency Act of 2020, which largely codified the FDA’s existing practices into the FDCA. Listing patents in the
Orange Book that do not qualify for listing can be considered to be anticompetitive conduct and, in 2023, the Federal Trade
Commission sent letters to a number of companies with respect to certain patents that agency asserted were improperly
listed or inaccurate.
An ANDA provides for marketing of a generic drug product that has the same active ingredients in the same strengths
and dosage form as the listed drug and has been shown through bioequivalence testing to be therapeutically equivalent to
the listed drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct, or
submit results of, pre-clinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in
this way are commonly referred to as “generic equivalents” to the listed drug, and can often be substituted by pharmacists
under prescriptions written for the original listed drug. 505(b)(2) applications provide for marketing of a drug product that
may have the same active ingredients as the listed drug and contain the same full safety and effectiveness data as an NDA,
but at least some of the information comes from studies not conducted by or for the applicant. 505(b)(2) applicants may
rely on published literature or the FDA’s prior finding of safety and effectiveness for an NDA approved drug product. The
ANDA or 505(b)(2) applicant is required to certify to the FDA concerning any patents listed for the approved product
referenced in the marketing application in the FDA’s Orange Book. Specifically, the applicant must certify that: (i) the
required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but
will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not
be infringed by the new product. The ANDA or 505(b)(2) applicant may also elect to submit a statement certifying that its
proposed label does not contain (or carves out) any language regarding the patented method-of-use rather than certify to a
listed method-of-use patent. If the applicant does not challenge or carve out the listed patents, the ANDA or 505(b)(2)
application approval will not be made effective until all the listed patents claiming the referenced product have expired.
A certification that the new product will not infringe the already approved product’s listed patents, or that such patents
are invalid, is called a Paragraph IV certification. If the ANDA or 505(b)(2) applicant has provided a Paragraph IV
certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent
holders. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the
Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV
certification automatically prevents the FDA from making an approval of the ANDA or 505(b)(2) application effective
until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that
is favorable to the ANDA or 505(b)(2) applicant, or such shorter or longer period as may be determined by a court.
The ANDA or 505(b)(2) application also will not be approved until any applicable non-patent exclusivity has expired.
Congress, the Administration, and administrative agencies have taken certain measures to increase drug competition
and thus, decrease drug prices. For example, measures have been proposed and implemented to facilitate product
importation. FDA recently approved a plan for the state of Florida to import drug products from Canada. Congress also
passed a bill requiring sponsors of NDA approved products to provide sufficient quantities of drug product on
commercially reasonable market-based terms to entities developing generic and similar drug products. This bill also
included provisions on shared and individual REMS for generic drug products.
Exclusivity
Upon NDA approval of a new chemical entity (“NCE”), which is a drug that contains no active moiety that has been
approved by the FDA in any other NDA, that drug receives five years of marketing exclusivity during which the FDA
cannot receive any ANDA or a 505(b)(2) application for the same active moiety. Certain changes to a drug, such as the
addition of a new indication to the package insert, may be associated with a three-year period of exclusivity during which
the FDA cannot approve an ANDA for a generic drug or a 505(b)(2) application that includes the change, if the applicant
conducted clinical trials essential to the approval of the application, which are not bioavailability or
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bioequivalence studies. Such exclusivity in the EU under a broadly equivalent regime is 10 years, though this may be
decreased in the future pending current European Commission review.
An ANDA or a 505(b)(2) application may be submitted one year before NCE exclusivity expires if a Paragraph IV
certification is filed.
Patent Term Extension
After NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension of a single
unexpired patent, that has not previously been extended. The allowable patent term extension is calculated as half of the
drug’s testing phase — the time between IND application and full NDA submission — and all of the review phase — the
time between full NDA submission and approval up to a maximum of five years. The time can be shortened if the FDA
determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not
exceed 14 years from the date of approval. Similar extension rules apply in the EU, though the specific calculations are
different.
The Foreign Corrupt Practices Act
The Foreign Corrupt Practices Act (the “FCPA”), prohibits any U.S. individual or business from paying, offering, or
authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or
candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business
in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to
comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect
all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of
internal accounting controls for international operations.
International Government Regulation
In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions
governing, among other things, clinical trials and any commercial sales and distribution of our products. Whether or not we
obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries
prior to the commencement of clinical trials or marketing of the product in those countries. Some countries outside of the
United States have a similar process that requires the submission of a clinical trial application (“CTA”), much like the IND
prior to the commencement of human clinical trials. In Europe, for example, a CTA must be submitted to each country’s
national health authority and an IEC, much like the FDA and IRB, respectively. Once the CTA is approved in accordance
with a country’s requirements, clinical trial development may proceed. With the Clinical Trials Regulation (EC) 536/2014
in force since January 31, 2022, it is now possible to make a single application for a cross-border trial within the EU
through an EU clinical trial portal. With the departure of the United Kingdom (“UK”) from the EU, trials in the UK have to
be approved through the portal and a separate application will need to be made to the UK Medicines and Healthcare
products Regulatory Agency. Additionally, in the EU there is an increasing move to transparency of trial summary reports
and the above Clinical Trial Regulation will include a publicly accessible database of data and information submitted in
accordance with this regulation. Companies submitting data will need to justify why it should be kept confidential.
To obtain regulatory approval to commercialize a new drug under European Union regulatory systems, we must
submit a marketing authorization application (“MAA”). The MAA is comparable to the NDA.
For other countries outside of the European Union, such as countries in Eastern Europe, Latin America or Asia, the
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to
country. In all cases, again, the clinical trials are conducted in accordance with GCP and the applicable regulatory
requirements and the ethical principles that have their origin in the Declaration of Helsinki.
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Expanded Access
Under certain circumstances, regulators may permit unapproved drugs to be used by patients outside of clinical trials.
In the U.S., with FDA approval, manufacturers may provide investigational drugs to patients with serious or immediately
life-threatening diseases for which there are no comparable or satisfactory alternative therapies. To qualify for U.S.
expanded access, the potential benefit must justify the potential risks, and the potential risks must not be unreasonable.
Providing the investigational drug must also not interfere with product development. There are additional qualifying
criteria depending on the number of patients in the expanded access program, and the expanded access sponsor and
investigator must comply with FDA’s regulations. U.S. law also permits treatment access to certain investigational drugs
under the federal Right to Try law, which permits manufacturers to provide investigational drugs to patients with a life-
threatening disease or condition, who have exhausted all approved treatment options, who cannot participate in a clinical
trial of the drug, and who provides informed consent, provided that certain conditions are met. Certain reports must be
submitted to FDA under the federal Right to Try law. There are also state level Right to Try statutes.
In the European Union, early access programs are authorized by EU legislation and, through national laws, EU
member states have implemented regulatory requirements related to these programs. National competent authorities may
authorize early access program use. In both the European Union and United States unapproved drug products may not be
promoted or marketed.
Compliance
During all phases of development (pre- and post-marketing), failure to comply with applicable regulatory requirements
may result in administrative or judicial sanctions. These sanctions could include the imposition by the FDA or an IRB of a
hold on clinical trials, refusal to approve pending marketing applications or supplements, withdrawal of approval, warning
letters, untitled letters, cyber letters, product recalls, product seizures or detention, prohibition on importing or exporting,
total or partial suspension of production or distribution, injunctions, fines, civil penalties, adverse publicity, disgorgement,
restitution, FDA debarment, debarment from government contracting or refusal of future orders under existing contracts,
exclusion from Federal healthcare programs, corporate integrity agreements, consent decrees, or criminal prosecution. Any
agency or judicial enforcement action could have a material adverse effect on us.
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Other Special Regulatory Procedures
Animal Rule
In 2002, the FDA amended its requirements applicable to NDAs to permit the approval of certain drugs and
biologics that are intended to reduce or prevent serious or life-threatening conditions based on evidence of safety from
clinical trial(s) in healthy subjects and effectiveness from appropriate animal studies when human efficacy studies are not
ethical or feasible. These regulations, which are known as the “Animal Rule,” authorize the FDA to rely on animal studies
to provide evidence of a product’s effectiveness under circumstances where there is a reasonably well-understood
mechanism for the activity of the agent. Under these requirements, and with the FDA’s prior agreement, drugs used to
reduce or prevent the toxicity of chemical, biological, radiological, or nuclear agents not otherwise naturally present may
be approved for use in humans based on evidence of effectiveness derived from appropriate animal studies and any
additional supporting data. Products evaluated under this rule must demonstrate effectiveness through pivotal animal
studies, which are generally equivalent in design and robustness to Phase 3 clinical studies. Additionally, the Animal Rule
requires post-marketing studies, such as field studies, to verify and describe the product’s clinical benefit and assess its
safety should an exigency exist that leads to the product being used in humans. Products approved under the Animal Rule
are subject to additional requirements, such as restrictions imposed on distribution or labeling requirements to inform
patients that the product’s approval was based on efficacy studies conducted in animals alone.
Other countries may not at this time have established criteria for review and approval of these types of products
outside their normal review process, i.e. there is no “Animal Rule” equivalent in countries other than the U.S., but some
may have similar policy objectives in place.
Orphan Drug Designation
The FDA may grant Orphan Drug Designation to drugs intended to treat a rare disease or condition that affects fewer
than 200,000 individuals in the United States, or, if the disease or condition affects more than 200,000 individuals in the
United States, there is no reasonable expectation that the cost of developing and making the drug would be recovered from
sales in the United States. Additionally, sponsors must present a plausible hypothesis for clinical superiority to obtain
orphan designation if there is a product already approved by the FDA that is intended for the same indication and that is
considered by the FDA to be the same as the already approved product. This hypothesis must be demonstrated to obtain
orphan exclusivity. In the European Union, the EMA’s Committee for Orphan Medicinal Products (“COMP”) grants
Orphan Drug Designation to promote the development of products that are intended for the diagnosis, prevention or
treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the
European Union. Additionally, designation is granted for products intended for the diagnosis, prevention or treatment of a
life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that
sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug.
In the United States, Orphan Drug Designation entitles a party to financial incentives, such as opportunities for grant
funding towards clinical trial costs for certain kinds of studies, tax credits for certain research and user fee waivers under
certain circumstances. Under the 21st Century Cures Act, Congress expanded the potential opportunities for grant funding
to include additional kinds of studies. The 2017 Tax Cuts and Jobs Act, however, reduced the available tax credits for
orphan products.
The FDA’s regulations, provide flexibility in meeting approval standards for new therapies intended to treat persons
with life-threatening and severely-debilitating illnesses, especially where no satisfactory alternative therapy exists, such
that FDA may exercise scientific judgment in determining the kind and quantity of data required for approval and during
development programs. Per guidance issued by FDA in 2023 with respect to rare diseases, “[t]his flexibility extends from
the early stages of development to the design of adequate and well-controlled clinical investigations required to
demonstrate effectiveness to support marketing approval and to establish safety data needed for the intended use.” FDA
states that it “is committed to helping sponsors create successful drug development programs that address the particular
challenges posed by each disease….”
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If a product receives the first FDA approval for the indication for which it has orphan designation, the product is
entitled to seven years of market exclusivity, which means the FDA may not approve any other application for the same
drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical
superiority over the product with orphan exclusivity. Orphan drug exclusivity does not prevent the FDA from approving a
different drug for the same disease or condition, or the same drug for a different disease or condition.
Notably, the exact scope of orphan drug exclusivity is currently in flux. A 2021 judicial decision, Catalyst Pharms.,
Inc. v. Becerra, challenged and reversed an FDA decision on the scope of orphan product exclusivity for the drug Firdapse.
Under this decision, orphan drug exclusivity for Firdapse blocked approval of another company’s application for the same
drug for the entire disease or condition that for which orphan drug designation was granted even though the approved
product indication was narrower. This decision was contrary to FDA’s interpretation of the FDC Act, which took the
position that orphan drug exclusivity only protected a product’s approved indication. In January 2023, the FDA published a
notice in the Federal Register stating that it interprets the Catalyst Pharms., decision narrowly and intends to continue tying
the scope of orphan drug exclusivity to the uses or indications that a drug is approved for. The scope of orphan drug
exclusivity will likely be an evolving area.
In the European Union, Orphan Drug Designation also entitles a party to financial incentives such as reduction of fees
or fee waivers and 10 years of market exclusivity is granted following drug approval. This period may be reduced to
six years if the Orphan Drug Designation criteria are no longer met, including where it is shown that the product is
sufficiently profitable not to justify maintenance of market exclusivity or where the holder of the marketing authorization
for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product. As with the
FDA, orphan drug exclusivity does not prevent the EMA from approving a second medicinal product where such second
medicinal product, although similar to the orphan medicinal product already authorized, is safer, more effective or
otherwise clinically superior. The European Commission has been reviewing the protection periods and proposes
shortening the standard market exclusivity period from 10 to 9 years except for products addressing high unmet medical
needs which would remain at 10 years.
Orphan drug designation must be requested before submission of an application for marketing approval. Orphan drug
designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
Priority Review (United States), Accelerated Review (European Union) and other Expedited Programs
The FDA has various programs, including Fast Track designation, accelerated approval, priority review and
breakthrough designation, that are intended to expedite or simplify the process for the development and FDA review of
certain drug products that are intended for the treatment of serious or life-threatening diseases or conditions, and
demonstrate the potential to address unmet medical needs or present a significant improvement over existing therapy. The
purpose of these programs is to provide important new drugs to patients earlier than under standard FDA review
procedures.
To be eligible for a Fast Track designation, the FDA must determine, based on the request of a sponsor, that a product
is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address an unmet
medical need. The FDA will determine that a product will fill an unmet medical need if the product will provide a therapy
where none exists or provide a therapy that may be potentially superior to existing therapy based on efficacy, safety, or
public health factors. If Fast Track designation is obtained, drug sponsors may be eligible for more frequent development
meetings and correspondence with the FDA. In addition, the FDA may initiate review of sections of an NDA before the
application is complete. This “rolling review” is available if the applicant provides and the FDA approves a schedule for
the remaining information.
Based on results of one or more Phase 3 clinical trials submitted in an NDA, upon the request of an applicant, a
priority review designation may be granted to a product by the FDA, which sets the target date for FDA action on the
application at six months from FDA filing, or eight months from the sponsor’s submission. Priority review is given to
drugs intended to treat serious conditions and which, if approved would provide significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of the serious condition. If criteria are not met for priority
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review, the standard FDA review period is 10 months from FDA filing, or 12 months from sponsor submission. Priority
review designation does not change the scientific/medical standard for approval or the quality of evidence necessary to
support approval.
Moreover, under the provisions of the Food and Drug Administration Safety and Innovation Act (“FDASIA”) enacted
in 2012, a sponsor can request designation of a product candidate as a “breakthrough therapy.” A breakthrough therapy is
defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-
threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects
observed early in clinical development. Drugs designated as breakthrough therapies are eligible for the Fast Track
designation features as described above, intensive guidance on an efficient drug development program beginning as early
as Phase 1 trials, and a commitment from the FDA to involve senior managers and experienced review staff in a proactive
collaborative, cross-disciplinary review.
In addition, products for treating serious or life threatening conditions and that provide a meaningful advantage over
available therapies may be eligible for accelerated approval and may be approved on the basis of adequate and well-
controlled clinical trials establishing that the drug product has an effect on a surrogate endpoint that is reasonably likely to
predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is
reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the
severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a condition of
approval, the FDA will require a sponsor of a drug receiving accelerated approval to perform post-marketing studies,
including completion of Phase 4 clinical trials to demonstrate clinical benefit, and to verify and describe the predicted
effect on irreversible morbidity or mortality or other clinical endpoints. By the date of approval of an accelerated approval
product, the FDA must specify the conditions for the required post approval studies, including enrollment targets, the study
protocol, milestones, and target completion dates. The FDA may also require that the confirmatory Phase 4 studies be
commenced prior to the FDA granting a product accelerate approval. Reports on the progress of the required Phase 4
confirmatory studies must be submitted to the FDA every 180 days after approval. The drug may be subject to accelerated
withdrawal procedures if such studies do not verify the product’s clinical benefit or other evidence shows a lack of safety
or efficacy pursuant to a streamlined process that is outlined in the FDC Act. Promotional materials for products approved
via the accelerated approval pathway must be submitted to the FDA prior to initial distribution. Such products may also be
subject to distribution or use restrictions, if the FDA determines that restrictions are needed to assure safe use. In recent
years, the accelerated approval pathway has come under significant FDA and public scrutiny. Accordingly, depending on
the results of our studies, the FDA may be more conservative in granting accelerated approval or, if granted, may be more
apt to withdrawal approval if clinical benefit is not confirmed.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer
meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
Sponsors availing themselves of these programs must also be prepared to potentially work on accelerated timelines with
respect to other areas of product development, including manufacturing.
Under the Centralized Procedure in the European Union, the maximum timeframe for the evaluation of a marketing
authorization application is 210 days (excluding clock stops, when additional written or oral information is to be provided
by the applicant in response to questions asked by the EMA’s Committee for Medicinal Products of Human Use
(“CHMP”)). On average, an approval is provided by the European Commission after approximately 15 months.
Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of
a major public health interest, defined by three cumulative criteria: the seriousness of the disease (e.g., heavy disabling or
life-threatening diseases) to be treated; the absence or insufficiency of an appropriate alternative therapeutic approach; and
anticipation of high therapeutic benefit. In this circumstance, EMA ensures that the opinion of the CHMP is given within
150 days. There is also a conditional marketing authorization which allows for the early approval of a medicine on the
basis of less complete clinical data than normally required, if the medicine addresses an unmet medical need and targets a
seriously debilitating or life-threatening disease, a rare disease or is intended for use in emergency situations in response to
a public health threat. The benefit to public health must outweigh the risk due to the limited availability of clinical data at
the time of marketing authorization.
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The EMA has recently been conducting a pilot on ‘adaptive pathways’ — an iterative process building on existing
regulatory processes involving gathering evidence through real-life use to supplement clinical trial data.
Pediatric Information
Under the Pediatric Research Equity Act (the “PREA”), NDAs or certain supplements to NDAs must contain data to
assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to
support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. Unless
otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has
been granted.
Also, under the FDA Reauthorization Act of 2017, sponsors submitting applications for product candidates intended
for the treatment of adult cancer which are directed at molecular targets that the FDA determines to be substantially
relevant to the growth or progression of pediatric cancer must submit, with the application, reports from molecularly
targeted pediatric cancer investigations designed to yield clinically meaningful pediatric study data, using appropriate
formulations, to inform potential pediatric labeling. The FDA may grant full or partial waivers, or deferrals, for submission
of data under PREA and this requirement.
The Best Pharmaceuticals for Children Act (“BPCA”) provides NDA holders a six-month extension of any exclusivity
— Orange Book listed patent or non-patent exclusivity — for a drug if certain conditions are met. Conditions for
exclusivity include the FDA’s determination that information relating to the use of a new drug in the pediatric population
may produce health benefits in that population, the FDA making a written request for pediatric studies, and the applicant
agreeing to perform, and reporting on, the requested studies within the required timeframe. The data do not need to show
the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the
FDA’s request, the additional protection is granted. This is not a patent term extension, but it effectively extends the
regulatory exclusivity period. Moreover, pediatric exclusivity attaches to all formulations, dosage forms, and indications
for products with existing marketing exclusivity or Orange Book listed patent life that contain the same active moiety as
that which was studied. Applications under the BPCA for labeling changes receive priority review designation, with all of
the benefits that designation confers.
In the European Union all applications for marketing authorization for new medicines have to include the results of
studies as described in an agreed pediatric investigation plan, unless the medicine receives a deferral or waiver. Medicines
authorized across the EU with the results of studies from a pediatric investigation plan included in the product information
are eligible for an extension of their supplementary protection certificate by six months. This is the case even when the
studies’ results are negative. For orphan medicines, the incentive is an additional two years of market exclusivity.
Healthcare Regulation
Following approval of any product candidate, the product would be subject to a comprehensive system of laws and
regulations on the state and federal level that govern how drug products are reimbursed, healthcare financing, and drug
manufacturers’ relationships and interactions with healthcare professionals, including potential prescribers. These
requirements include permissible fees, rebates, discounts and payment reductions, required price reporting and pricing
transparency, caps on price increases, requirements around price negotiation, and requirements to enter into agreements
with government agencies and certain healthcare entities that may result in significant limits on the prices we may charge
for our products. Failure to comply with these laws, regulations, and/or restrictions could result in a loss of our ability to
continue selling our drugs to the federal and state governments or receiving reimbursement for our drugs once approved. It
could also result in enforcement actions.
The government is increasingly focused on measures to contain program costs for prescription drugs and there have
been a number of U.S. Congressional inquiries, proposed bills, and enacted legislation focused on decreasing prescription
drug spending and bringing more transparency to drug pricing. These efforts may result in a decrease in the amount of
reimbursement we receive for our drugs from Medicare or other government programs for our drugs, once approved, and
any reduction in reimbursement from Medicare and other government programs may result in a similar
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reduction in payments from private payors. These and any additional healthcare reform measures could further constrain
our business or limit the amounts that federal and state governments will pay for healthcare products and services, which
could result in additional pricing pressures. The implementation of cost containment measures or other healthcare reforms
may prevent us from being able to generate revenue, attain profitability, or commercialize our products. In addition, it is
possible that there will be further legislation or regulation that could harm our business, financial condition, and results of
operations. Because of the significant governmental focus on drug prices, at this time we cannot determine how or if our
product candidates will be reimbursed, following approval, or if any reimbursement levels will be sufficient to allow us to
attain profitability. Changes in the law may result in additional downward pressure on coverage and the price that we
receive for any approved product, or may require increased manufacturer rebates, and could seriously harm our business.
Different pricing and reimbursement schemes exist in other countries. In the European Community, governments
influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health
care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and
negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain
reimbursement or pricing approval, some of these countries may require the completion of clinical trials that compare the
cost-effectiveness of a particular drug candidate to currently available therapies. Other member states allow companies to
fix their own prices for medicines, but monitor and control company profits. The downward pressure on health care costs
in general, particularly prescription drugs, has become very intense. As a result, increasingly high barriers are being erected
to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a
commercial pressure on pricing within a country. There can be no assurance that any country that has price controls or
reimbursement limitations for dug products will allow favorable reimbursement and pricing arrangements of our products.
Other Healthcare Laws and Compliance Requirements
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting
or receiving remuneration, directly or indirectly, to induce or in return for purchasing, leasing, ordering or arranging for the
purchase, lease or order of any healthcare item or service reimbursable in whole or in part under Medicare, Medicaid or
other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on one hand and prescribers, purchasers, and formulary managers on the other. The
Beneficiary Inducement Civil Monetary Penalties Law imposes similar restrictions on interactions between the
pharmaceutical industry and federal healthcare program beneficiaries. Although there are a number of statutory exceptions
and regulatory safe harbors protecting some business arrangements from prosecution, the exceptions and safe harbors are
drawn narrowly and practices that involve remuneration intended to induce prescribing, purchasing or recommending may
be subject to scrutiny if they do not qualify for an exception or safe harbor, as well as if they do. Failure to meet all the
requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se
illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis
based on a cumulative review of all its facts and circumstances.
With respect to the safe harbors, the Office of Inspector General of HHS recently promulgated two additional safe
harbor regulations. One safe harbor regulation excludes from the definition of “remuneration” limited categories of
manufacturer rebates or other price reductions to a plan sponsor under Medicare Part D or a Medicaid Managed Care
Organization plan reflected in point-of sale reductions in price. The second safe harbor regulation excludes from the
definition of “remuneration” PBM service fees paid by a manufacturer to a PBM. In addition, the Office of Inspector
General of HHS revised the discount safe harbor regulation to exclude from the definition of “discount” a reduction in
price by a manufacturer to plan sponsors under Medicare Part D either directly to the plan sponsor, or indirectly through a
PBM. The effective date of the two new safe harbors and the revision to the discount safe harbor was delayed by court
order until January 1, 2023. Recent legislation further delayed implementation of the new safe harbors and the revision to
the discount safe harbor until January 1, 2032. Our practices may not in all cases meet all of the criteria for safe harbor
protection from federal Anti-Kickback Statute liability. The reach of the Anti-Kickback Statute was broadened by the
Affordable Care Act, which, among other things, amends the intent requirement of the federal Anti-Kickback Statute.
Pursuant to the statutory amendment, a person or entity no longer needs to have actual knowledge of this statute or specific
intent to violate it in order to have committed a violation. In addition, the Affordable Care Act provides that the
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government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback
Statute constitutes a per se false or fraudulent claim for purposes of the civil False Claims Act (discussed below), which
imposes penalties against any person who is determined to have presented or caused to be presented a claim to a federal
healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is
false or fraudulent. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an
arrangement involving remuneration is to induce or reward referrals of federal healthcare program business, including
purchases of products paid by federal healthcare programs, the statute has been violated.
The federal civil False Claims Act prohibits any person from knowingly presenting, or causing to be presented, a false
claim for payment to the federal government, knowingly making, using, or causing to be made or used a false record or
statement material to a false or fraudulent claim to the federal government or avoiding, decreasing, or concealing an
obligation to pay money to the federal government. A claim includes “any request or demand” for money or property
presented to the U.S. government. Claims under the civil False Claims Act may be brought by the government or private
parties on behalf of the government, called “qui tam” actions, which may proceed even if the government does not join as a
party.
The civil False Claims Act has been used to assert liability on the basis of kickbacks and other improper referrals,
improperly reported government pricing metrics such as Best Price or Average Manufacturer Price, improper use of
Medicare provider or supplier numbers when detailing a provider of services, improper promotion of off-label uses not
expressly approved by the FDA in a product’s label, and allegations as to misrepresentations with respect to products,
contract requirements, and services rendered, in addition to other allegations. In addition, private payers have been filing
follow-on lawsuits alleging fraudulent misrepresentation. Intent to deceive is not required to establish liability under the
civil False Claims Act. Rather, a claim may be false for deliberate ignorance of the truth or falsity of the information
provided or for acts in reckless disregard of the truth or falsity of that information. If the government decides to intervene
in a qui tam action and prevails in the lawsuit, the individual will share in the proceeds from any damages, penalties or
settlement funds. If the government declines to intervene, the individual may pursue the case alone. The civil False Claims
Act provides for treble damages and a civil penalty for each false claim, such as an invoice or pharmacy claim for
reimbursement, which can aggregate into tens and even hundreds of millions of dollars. For these reasons, since 2004,
False Claims Act lawsuits against biopharmaceutical companies have increased significantly in volume and breadth,
leading to several substantial civil and criminal settlements, as much as $3.0 billion, regarding certain sales practices and
promoting off label uses. Civil False Claims Act liability may further be imposed for known Medicare or Medicaid
overpayments, for example, overpayments caused by understated rebate amounts, that are not refunded within 60 days of
identifying the overpayment, even if the overpayment was not caused by a false or fraudulent act.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) created new federal criminal statutes that
prohibit, among other things, knowingly and willfully executing a scheme to defraud any healthcare benefit program,
including private third-party payors, and knowingly and willfully falsifying, concealing or covering up a material fact or
making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare
benefits, items or services. The Affordable Care Act amended the intent requirement of certain of these criminal statutes
under HIPAA so that a person or entity no longer needs to have actual knowledge of the statute, or the specific intent to
violate it, to have committed a violation. Further, the government may prosecute conduct constituting a false claim under
the criminal False Claims Act. The criminal False Claims Act prohibits the making or presenting of a claim to the
government knowing such claim to be false, fictitious, or fraudulent and, unlike the civil False Claims Act, requires proof
of intent to submit a false claim. Also, many states have fraud and abuse statutes or regulations that are similar to the
federal Anti-Kickback Statute and False Claims Act that apply to items and services reimbursed under Medicaid and other
state programs, or, in several states, apply regardless of the payor.
The Affordable Care Act further created new federal requirements for reporting, by applicable manufacturers of
covered drugs, of information related to payments and other transfers of value made to or at the request of covered
recipients, namely US-licensed physicians and teaching hospitals, as well as ownership and investment interests held by
physicians and members of their immediate family. The categories of covered recipients later was expanded to include
physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives and certified registered nurse
anesthetists. Payments made to physicians, other principal investigators, and certain research institutions for clinical trials
are included within the ambit of this law.
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In addition, we may be subject to data privacy and security regulation by both the federal government and the states in
which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical
Health (HITECH) Act, and their implementing regulations, impose requirements relating to the privacy, security, breach
notification, and transmission of protected health information. HIPAA’s security and certain privacy standards are directly
applicable to “business associates” — persons or organizations, other than a member of a covered entity’s workforce, that
create, receive, maintain, or transmit protected health information on behalf of a covered entity for a function or activity
regulated by HIPAA. HIPAA authorizes the imposition of civil and criminal penalties against covered entities and business
associates. HIPAA permits state attorneys general to file civil actions for damages or injunctions in federal courts to
enforce the HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions. HIPAA also imposes
requirements with respect to disclosures of protected health information for research purposes, such as clinical trials. In
addition, state laws, such as the California Consumer Privacy Act, govern the privacy and security of health information in
specified circumstances, many of which differ from each other in significant ways and may not be preempted by HIPAA.
In 2023, new state privacy laws became effective in California, Colorado Connecticut, Utah, and Virginia, further
complicating privacy compliance efforts. Other states have passed similar consumer privacy laws that will become
effective in the coming years. In addition, more onerous foreign data privacy provisions may apply. For instance, the EU
General Data Protection Regulation imposes stricter rules on the processing of personal data than apply in the United States
and its provisions exclude the export of data relating to identifiable individuals to most countries, including the United
States, unless certain safeguards are in place.
In the United States, our activities are potentially subject to additional regulation by various federal, state and local
authorities in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of HHS (e.g.,
the Office of Inspector General), the DOJ and individual U.S. Attorney offices within the DOJ, and state and local
governments. If a drug product is reimbursed by Medicare or Medicaid, pricing and rebate programs must comply with, as
applicable, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 as well as the Medicaid rebate
requirements of the Omnibus Budget Reconciliation Act of 1990, or the OBRA, the Veterans Health Care Act of 1992,
Deficit Reduction Act of 2005, Patient Protection and Affordable Care Act, and the Inflation Reduction Act of 2022, each
as amended. Among other things, the OBRA requires drug manufacturers to calculate and report complex pricing metrics
used to determine rebates paid on prescription drugs to state Medicaid programs. Under the Veterans Health Care Act, or
VHCA, drug companies are required to offer “covered drugs” (including all drugs approved under an NDA) at no more
than a statutory ceiling price, calculated based on a manufacturer’s required price calculations, to four federal agencies
including the U.S. Department of Veterans Affairs, Indian Health Service, DoD, and the Public Health Service. Also,
under the VHCA, manufacturers are required to offer drugs for sale at no more than a separate statutory ceiling price
calculated by the manufacturer to Public Health Service designated entities in order to participate in other federal funding
programs including Medicaid. Legislation subsequent to the VHCA has required that certain discounted prices under the
VHCA also be offered for specified DoD purchases for its TRICARE program via a rebate system. Participation under the
VHCA requires submission of pricing data and calculation of discounts and rebates pursuant to complex statutory
formulas, as well as the entry into government procurement contracts governed by the Federal Acquisition Regulation.
Because of the breadth of these laws and the narrowness of available statutory and regulatory exemptions, it is possible
that some of our business activities could be subject to challenge under one or more of such laws. If our operations are
found to be in violation of any of the federal and state laws described above or any other governmental regulations that
apply to us, we may be subject to penalties, including criminal and significant civil monetary penalties, damages, fines,
imprisonment, exclusion from participation in government healthcare programs, injunctions, recall or seizure of products,
total or partial suspension of production, denial or withdrawal of pre-marketing product approvals, private “qui tam”
actions brought by individual whistleblowers in the name of the government, suspension or debarment prohibiting us from
participating in federal procurement and non-procurement transactions, including government contracts, and the
curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and
our results of operations. To the extent that any of our products are sold in a foreign country, we may be subject to similar
foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety
surveillance, anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments
or transfers of value to healthcare professionals.
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In order to distribute products commercially, we must comply with state laws that require the registration of
manufacturers and wholesale distributors of pharmaceutical products in a state, including, in some states, manufacturers
and distributors who ship products into the state even if such manufacturers or distributors have no place of business within
the state. Several states have enacted legislation requiring pharmaceutical companies to, among other things, establish
marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing,
pricing, clinical trials and other activities, and/ or register their sales representatives, as well as to prohibit pharmacies and
other healthcare entities from providing specified physician prescribing data to pharmaceutical companies for use in sales
and marketing, and to prohibit other specified sales and marketing practices. Additionally, some states have enacted laws
that cap increases in prices charged for drugs in that state. All of our activities are potentially subject to federal and state
consumer protection and unfair competition laws.
In Europe, most countries have laws or (more commonly) codes of practice which broadly emulate US ‘sunshine laws’
and require companies to maintain and publish a record of transfers of value to healthcare professionals. These are in
addition to national anti-corruption laws similar to the FCPA — for instance the UK Bribery Act 2010 which has a wider
scope than the FCPA in many respects including in that it covers relevant decision makers in both the private and public
sectors and applies both domestically and internationally.
Human Capital
We believe that our success is largely dependent upon our ability to attract and retain qualified employees. As of
December 31, 2024, we had 7 employees (6 of which were full-time employees), in addition to various independent
contractors working for us. We are not party to any collective bargaining arrangements and consider our relations with our
employees to be good. Although we believe that the size of our current workforce is appropriate to achieve our objectives,
we may hire additional employees with specialized expertise as we continue to grow our business. We believe that we have
been successful to date in attracting skilled and experienced scientific and business professionals.
Our compensation philosophy is to pay for performance, which supports the Company’s business strategies, and offer
competitive compensation arrangements to attract and retain key individuals. The Company has established a
Compensation Committee of the Board of Directors, which considers the impact of our corporate performance in
determining compensation for named executive officers, as well as each named executive officer’s individual performance,
macroeconomic conditions generally, and data from peer group companies.
Corporate Information
We were incorporated in Delaware in December 1998. Our principal executive offices are located at 12 Penns Trail,
Newtown, PA 18940 and our telephone number is (267) 759-3680. Our website address is www.trawspharma.com. The
information contained in, or that can be accessed through, our website is not part of this Annual Report.
ITEM 1A. RISK FACTORS
You should carefully consider the following risk factors together with the other information contained in this Annual
Report, including our financial statements, the related notes and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” appearing in this Annual Report. The occurrence of any of the following risks, or of
additional risks and uncertainties not presently known to us or that we currently believe to be immaterial, could materially
and adversely affect our business and our financial condition and results of operations. In this event, the market price of
our securities could decline and your investment could be lost. You should understand that it is not possible to predict or
identify all such risks. Consequently, you should not consider the following to be a complete discussion of all potential
risks or uncertainties.
Summary of Principal Risk Factors
●
Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial
doubt about our ability to continue as a going concern absent obtaining adequate new financings.
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●
The report of our independent registered accounting firm on our audited financial statements for the fiscal year
ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going
concern.
●
We have identified material weaknesses in our internal control over financial reporting; if we fail to develop and
maintain an effective system of disclosure controls and internal control over financial reporting, our ability to
produce timely and accurate financial statements or comply with applicable laws and regulations could be
impaired.
●
We need to obtain additional funding to continue as a going concern; if we are unable to meet our needs for
additional funding in the future, we will be required to limit, scale back or cease operations.
●
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to
relinquish rights to our technologies or product candidates.
●
Our product development efforts may not be successful.
●
Our future success is dependent primarily on the regulatory approval and commercialization of our product
candidates.
●
The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results. Any
product candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or
receive regulatory approval.
●
Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
●
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent
their regulatory approval, limit the commercial profile of an approved label, or result in significant negative
consequences following any marketing approval.
●
Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action.
●
Changes in product candidate manufacturing or formulation may result in additional costs or delay.
●
Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives,
may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product
candidates and affect the prices we may obtain.
●
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements, which could cause significant liability for us and harm our reputation.
●
We face substantial competition, which may result in others discovering, developing or commercializing products
before or more successfully than we do.
●
If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we
could lose the ability to continue the development and potential commercialization of these product candidates.
●
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization
of any products that we may develop.
●
There is no guarantee that the Merger will increase stockholder value, and stockholders may not realize a benefit
from the Merger commensurate with the ownership dilution they will experience in connection with the Merger,
including the issuance of our common stock upon conversion of the shares of Series C Preferred issued in the
Merger and the concurrent financing.
●
We expect to incur substantial expenses related to the integration of Trawsfynydd.
●
We may engage in future business combinations or collaborations that could disrupt our business, cause dilution
to our stockholders and harm our financial condition and operating results.
●
We depend on information technology and computer systems to operate our business; our business and operations
would suffer in the event of any failures or interruptions of our computer system, such as a data breach or
cybersecurity incident.
●
Climate change, environmental, social and governance and sustainability initiatives may result in regulatory or
structural industry changes that could require significant operational changes and expenditures, reduce demand
for the Company’s products and adversely affect our business, financial condition, and results of operations.
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34
●
Business disruptions could seriously harm our future revenues and financial condition and increase our costs and
expenses.
●
Our future success depends on our ability to retain our executive officers and to attract, retain and motivate
qualified personnel.
●
Our business, financial condition and results of operations could be materially adversely affected by any negative
impact on the global economy and capital markets resulting from international conflicts, international trade
disputes and geopolitical tensions.
●
Changes in United States and China relations, as well as relations with other countries, and/or regulations may
adversely impact our business, our operating results, our ability to raise capital and the market price of our shares.
●
We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our
product candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign
locations.
●
Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or
global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or
otherwise prevent new or modified products from being developed, approved or commercialized in a timely
manner or at all, which could negatively impact our business.
●
We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully
carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for
or commercialize our product candidates.
●
If we lose our relationships with CROs, our drug development efforts could be delayed.
●
We have limited experience manufacturing our product candidates on a large clinical or commercial scale and
have no manufacturing facility. We are dependent on third-party manufacturers for the manufacture of our
product candidates for clinical trials as well as on third parties for our supply chain, and if we experience
problems with any third parties, the manufacturing of our product candidates or products could be delayed.
●
We have entered into certain related party transactions and may continue to rely on related parties for certain
development and support activities.
●
We could be required to incur significant expenses to perfect our intellectual property rights, and our intellectual
property rights may be inadequate to protect our competitive position. If we are unable to protect our intellectual
property rights, our competitive position could be harmed.
●
We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive,
time consuming and unsuccessful.
●
Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the
outcome of which would be uncertain and could harm our business.
●
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their
former employers.
●
If we are unable to maintain compliance with the continued listing requirements of the Nasdaq Capital Market,
our common stock could be delisted, which could affect our common stock's market price and liquidity and
reduce our ability to raise capital.
●
Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders.
●
We may be subject to securities litigation, which is expensive and could divert management attention.
●
Some provisions of our charter documents and Delaware law may have anti-takeover effects that could
discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may
prevent attempts by our stockholders to replace or remove our current management.
Risks Related to Our Financial Position and Capital Needs
Our recurring operating losses, negative cash flows from operations, and accumulated deficit raise substantial doubt
about our ability to continue as a going concern absent obtaining adequate new financings.
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Management has concluded that substantial doubt exists about our ability to continue as a going concern for the next
twelve months from the date of the financial statements included in this Annual Report. As of December 31, 2024, we had
cash and cash equivalents of $21.3 million and current liabilities of $11.5 million. Based on current projections, we do not
have sufficient cash and cash equivalents as of the date of this Annual Report to support our operations for more than one
year following the date that the financial statements are issued.
We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue to
execute our strategy. To alleviate the conditions that raise substantial doubt about our ability to continue as a going
concern, we plan to explore various dilutive and non-dilutive opportunities, including equity financings, strategic alliances,
business development and/or combinations, and other transactions. The future success of the Company is dependent upon
our ability to obtain additional funding. There can be no assurance, however, that we will be successful in obtaining such
funding in sufficient amounts, on terms acceptable to us, or at all. The failure to obtain sufficient capital on acceptable
terms when needed would have a material adverse effect on our business, results of operations, and financial condition.
Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern
within one year after the date that these financial statements are issued.
The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended
December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern.
The auditor’s opinion on our audited financial statements for the year ended December 31, 2024 includes an
explanatory paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our
ability to continue as a going concern for the next twelve months from the date of the financial statements included in this
Annual Report. While we believe that we will be able to raise the capital we need to continue our operations, there can be
no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or eliminate our
operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our operating plans
and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition, and results of
operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we seek
additional financing to fund our business activities in the future and there remains substantial doubt about our ability to
continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on
commercially reasonable terms or at all.
We need to obtain additional funding to execute our business plans; if we are unable to meet our needs for additional
funding in the future, we will be required to limit, scale back or cease operations.
We do not currently have the funding resources necessary to carry out all of our proposed operating activities. We will
need to obtain additional financing in the future in order to fully fund tivoxavir marboxil, ratutrelvir, narazaciclib,
rigosertib or any other product candidates through the regulatory approval process. Accordingly, we may be required to
delay or pause our planned clinical trials until we secure adequate additional funding. If we seek to proceed with a clinical
trial without additional funding, we may receive questions or comments from the FDA, fail to obtain IRB approval, or find
it more difficult to enroll patients in the trial. We have scaled down our operations in order to reduce spending on general
and administrative functions, research and development, and other clinical trials, but by themselves, those measures may
not be sufficient to address our funding needs.
Our future capital requirements will depend on many factors, including:
●
timing and success of our clinical trials;
●
continued progress of, and increased spending related to, our research and development activities;
●
conditions in the capital markets and the biopharmaceutical industry, particularly with respect to raising capital or
entering into strategic arrangements;
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●
progress with preclinical experiments and clinical trials, including regulatory approvals necessary for
advancement and continuation of our development programs;
●
changes in regulatory requirements and guidance of the FDA and other regulatory authorities, which may require
additional clinical trials to evaluate safety and/or efficacy, and thus have significant impacts on our timelines, cost
projections, and financial requirements;
●
ongoing general and administrative expenses related to our reporting obligations under the Exchange Act;
●
cost, timing, and results of regulatory reviews and approvals;
●
costs of any legal proceedings, claims, lawsuits and investigations;
●
success, timing, and financial consequences of any existing or future collaborative, licensing and other
arrangements that we may establish, including potential granting of licenses to one or more of our programs in
various territories, or otherwise monetizing one or more of our programs;
●
cost of filing, prosecuting, defending and enforcing any patent
●
claims and other intellectual property rights;
●
costs of commercializing any of our product candidates;
●
technological and market developments;
●
compliance with Nasdaq's continued listing requirements;
●
cost of manufacturing development; and
●
timing and volume of sales of products for which we obtain marketing approval.
These factors could result in variations from our projected operating and liquidity requirements. Additional funds may
not be available when needed, or, if available, we may not be able to obtain such funds on terms acceptable to us. If
adequate funds are unavailable, we may be required, among other things, to:
●
delay, reduce the scope of or eliminate one or more of our research or development programs;
●
license rights to technologies, product candidates or products at an earlier stage or for indications or territories
than otherwise would be desirable, or on terms that are less favorable to us than might otherwise be available;
●
obtain funds through arrangements that may require us to relinquish rights to product candidates or products that
we would otherwise seek to develop or commercialize by ourselves; or
●
further reduce or cease operations.
We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.
We are a clinical-stage biopharmaceutical company. Investment in biopharmaceutical product development is highly
speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate could fail
to gain regulatory approval or become commercially viable. We do not have any products approved by regulatory
authorities for marketing and have not generated any revenue from product sales to date, and we continue to
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incur significant research, development and other expenses related to our ongoing operations. As a result, we are not
profitable and have incurred losses in every reporting period since our inception in 1998. For the years ended December
31, 2024, and 2023, we reported net losses of $166.5 million and $18.9 million, respectively, and we had an accumulated
deficit of $649.2 million as of December 31, 2024.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. These losses may
increase as we continue the research and development of, and seek regulatory approvals for, our product candidates, and
potentially begin to commercialize any products that may achieve regulatory approval. We may encounter unforeseen
expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of
our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues.
If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if approved, fail to achieve
market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to
sustain profitability in subsequent periods.
We are obligated to develop and maintain proper and effective internal control over financial reporting. If we fail to
develop and maintain an effective system of disclosure controls and internal control over financial reporting, our ability
to produce timely and accurate financial statements or comply with applicable laws and regulations could be impaired.
In addition, the presence of material weaknesses increases the risk of material misstatement of the consolidated
financial statements.
We are a public company and are required, pursuant to Section 404(a) of the Sarbanes-Oxley Act, to furnish a
report by management on, among other things, the effectiveness of its internal control over financial reporting on our
annual report on Form 10-K. Effective internal control over financial reporting is necessary for reliable financial reports
and, together with adequate disclosure controls and procedures, such internal controls are designed to prevent fraud.
Undetected material weaknesses in internal controls could lead to financial statement restatements and require us to incur
the expense of remediation. We are required to disclose changes made in internal control and procedures on a quarterly
basis.
As discussed elsewhere in this Annual Report, we completed the Merger in April 2024. Prior to the Merger,
Trawsfynydd was a private company and, therefore, its controls were not required to be designed or maintained in
accordance with Rules 13a-15 and 15d-15 under the Exchange Act. The design and implementation of internal control over
financial reporting post-Merger has required, and will continue to require, significant time and resources from management
and other personnel. Although we had internal controls in place prior to the Merger, and our management has determined
in recent years that such internal controls over financial reporting were effective, during its assessment of our internal
controls over financial reporting as of December 31, 2024 it was determined that our controls were not effectively updated
and implemented to reflect the changes in processes and staffing during the period between completion of the Merger and
December 31, 2024. Additionally, it was determined that there was an inadequate segregation of duties over the
preparation, review and posting of manual journal entries, which is the result of not having a sufficient risk assessment
process in place post-Merger to identify and analyze risk of misstatement due to fraud and/or error.
In connection with the audit of our financial statements for the year ended December 31, 2024, we identified
material weaknesses in our internal control over financial reporting, which relate to the determinations of management
discussed above. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial
reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial
statements will not be prevented or detected on a timely basis. Although we intend to update our controls and implement
additional controls, no assurance can be provided that we will be able to remediate the material weaknesses identified on a
timely basis, or at all. If we are unable to remedy our material weaknesses, or if we generally fail to establish and maintain
effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial
statements, and we may continue to conclude that our internal control over financial reporting is not effective, which could
adversely impact our investors’ confidence and our stock price.
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38
We currently have no source of product revenue and may never become profitable.
To date, we have not generated any revenues from commercial product sales. Our ability to generate revenue from
product sales and achieve profitability will depend upon our ability to successfully commercialize products, including any
of our current product candidates, or other product candidates that we may in-license or acquire in the future. Even if we
are able to successfully achieve regulatory approval for these product candidates, we do not know when any of these
products will generate revenue from product sales for us, if at all.
In addition, because of the numerous risks and uncertainties associated with product development, including that our
product candidates may not advance through development or achieve the endpoints of applicable clinical trials, we are
unable to predict the timing or amount of increased expenses, or when or if we will be able to achieve or maintain
profitability. Even if we are able to complete the development and regulatory process for any product candidates, we
anticipate incurring significant costs associated with commercializing these products. Additionally, even if we are able to
generate revenues from the sale of our products, we may not become profitable and may need to obtain additional funding
to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we
may be unable to continue our operations at planned levels and be forced to reduce or suspend our operations.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to
relinquish rights to our technologies or product candidates.
Until we can generate substantial revenue from product sales, if ever, we expect to continue to seek additional capital
through a combination of private and public equity offerings, debt financings, strategic collaborations and alliances and
licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, the ownership interests of existing stockholders will be diluted, and the terms may include liquidation or other
preferences that adversely affect the rights of existing stockholders. Debt financing, if available, may involve agreements
that include restrictive covenants limiting our ability to take important actions, such as incurring additional debt, making
capital expenditures or declaring dividends. If we raise additional funds through strategic collaborations and alliances or
licensing arrangements with third parties, which may include existing collaboration partners, we may have to relinquish
valuable rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. If we are
unable to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, reduce
or terminate our product development or commercialization efforts or grant rights to develop and market product
candidates or formulations that we would otherwise prefer to develop and market ourselves.
We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
The majority of our cash is held in accounts at U.S. banking institutions. Cash held in depository accounts may
exceed the Federal Deposit Insurance Corporation (“FDIC”) standard deposit insurance limit of $250,000. If such banking
institutions were to fail, such as Silicon Valley Bank when the FDIC took control in March 2023, we could lose all or a
portion of those amounts held in excess of such insured amounts. In the future, our access to our cash in amounts adequate
to finance our operations could be significantly impaired if the financial institutions with which we have arrangements
encounter liquidity constraints or failures. Any future limitation on timely access to our funds or any material loss that we
may experience in the future could have a material adverse effect on our financial condition and could materially impact
our ability to pay our operating expenses or make other payments.
We are currently operating in a period of economic uncertainty and capital markets disruption, which has been
significantly impacted by geopolitical instability and the ongoing military conflicts between Russia and Ukraine and
Israel and Hamas. Our business, financial condition and results of operations could be materially adversely affected by
any negative impact on the global economy and capital markets resulting from the conflict in Ukraine and the Middle
East and/or geopolitical tensions.
U.S. and global markets are experiencing volatility and disruption, and the global economy has been, and may
continue to be, negatively impacted by Russia’s ongoing military conflict with Ukraine. As a result of Russia’s invasion of
Ukraine in February 2022, the U.S., the European Union, the United Kingdom, other G7 countries, as well as various
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other countries, have imposed substantial financial and economic sanctions on certain industry sectors and parties in
Russia. Broad restrictions on exports to Russia have also been imposed. These measures include: (i) comprehensive
financial sanctions against major Russian banks; (ii) additional designations of Russian individuals with significant
business interests and government connections; (iii) designations of individuals and entities involved in Russian military
activities; and (iv) enhanced export controls and trade sanctions limiting Russia’s ability to import various goods. Russian
military actions and the resulting sanctions could continue to adversely affect the global economy and financial markets
and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional
funds.
Addition, in October 2023, Hamas militants and members of certain other organizations infiltrated Israel’s
southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Shortly thereafter,
Israel’s security cabinet declared war against Hamas and launched an aerial bombardment of various targets within the
Gaza Strip. It is possible that other countries and/or regional organizations will join the hostilities as well, including
without limitation Hezbollah in Lebanon, and Palestinian military organizations in the West Bank, resulting in further
expansion of the conflict. The conflict between Israel and Hamas is ongoing, and the length and impact of the ongoing
military conflict is highly unpredictable.
Although our business has not been materially impacted by the ongoing military conflicts between Russia and
Ukraine or Israel and Hamas or geopolitical tensions to date, it is impossible to predict the extent to which our operations,
or those of our suppliers and manufacturers, will be impacted in the short and long term, or the ways in which the conflict
may impact our business. The extent and duration of the conflicts in Ukraine and the Middle East, geopolitical tensions,
sanctions and resulting market disruptions are impossible to predict, but could be substantial. Any such disruptions may
also magnify the impact of other risks described herein.
International trade disputes could result in tariffs and other protectionist measures that could have a material adverse
effect on our business, financial condition and results of operations.
In recent years, including after the most recent presidential election, the U.S. has instituted or proposed changes in
trade policies that include the negotiation or termination of trade agreements, the imposition of higher tariffs on imports
into the U.S., economic sanctions on individuals, corporations or countries, and other government regulations affecting
trade between the U.S. and other countries where we conduct our business, in particular China, Mexico and Canada. A
number of other nations have proposed or instituted similar measures directed at trade with the United States in response.
As a result of these developments, there may be greater restrictions and economic disincentives on international trade that
could adversely affect our business. Additionally, tariffs could increase our costs, which could have a negative impact on
our financial condition and results of operations. As additional trade-related policies are instituted, we may need to modify
our business operations to comply and adapt to such developments, which may be time-consuming and expensive.
Changes in United States and China relations, as well as relations with other countries, and/or regulations may
adversely impact our business, our operating results, our ability to raise capital and the market price of our shares.
The US government, including the SEC, has made statements and taken certain actions that led to changes to US and
international relations, and will impact companies with connections to the United States or China, including imposing
several rounds of tariffs affecting certain products manufactured in China, imposing certain sanctions and restrictions in
relation to China and issuing statements indicating enhanced review of companies with significant China-based operations.
It is unknown whether and to what extent new legislation, executive orders, tariffs, laws or regulations will be adopted, or
the effect that any such actions would have on companies with significant connections to the U.S. or to China, our industry
or on us. Any unfavorable government policies on cross-border relations and/or international trade, including increased
scrutiny on companies with significant China-based operations, capital controls or tariffs, may affect our ability to raise
capital and the market price of our shares.
If any new legislation, executive orders, tariffs, laws and/or regulations are implemented, if existing trade agreements
are renegotiated or if the U.S. or Chinese governments take retaliatory actions due to the recent U.S.-China
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tension, such changes could have an adverse effect on our business, financial condition and results of operations, our ability
to raise capital and the market price of our shares.
We may be adversely affected by the effects of inflation.
Inflation has the potential to adversely affect our liquidity, business, financial condition and results of operations by
increasing our overall cost structure. The existence of inflation in the economy has resulted in, and may continue to result
in, higher interest rates and capital costs, supply shortages, increased costs of labor, components, manufacturing and
shipping, as well as weakening exchange rates and other similar effects. As a result of inflation, we have experienced and
may continue to experience cost increases. Although we may take measures to mitigate the effects of inflation, if these
measures are not effective, our business, financial condition, results of operations and liquidity could be materially
adversely affected. Even if such measures are effective, there could be a difference between the timing of when these
beneficial actions impact our results of operations and when the costs of inflation are incurred.
Risks Related to Our Business and Industry
Our product development efforts may not be successful.
Clinical and non-clinical development is expensive, time-consuming, and uncertain as to the outcome. The focus of
our development efforts is currently on tivoxavir marboxil and ratutrelvir, while we consider strategic options for
narazaciclib and rigosertib. Although we believe that there are opportunities for us to develop our drug candidates in
various indications, clinical drug development is expensive, can take many years to complete, and its outcome is inherently
uncertain. Even if our clinical development programs are successful, we may not be able to successfully commercialize any
product. There can be no assurance that our focus on tivoxavir marboxil and ratutrelvir and the strategic options available
for narazaciclib and rigosertib will be successful, and that we will be able to successfully develop a product candidate or,
even if we do, that we will be able to successfully commercialize such candidate.
Our future success is dependent primarily on the regulatory approval and commercialization of our product candidates.
Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we
must demonstrate with substantial evidence gathered in preclinical and well-controlled clinical studies and, with respect to
approval in the United States, to the satisfaction of the FDA, that the product candidate is safe and effective for use for that
target indication and that the manufacturing facilities, processes and controls are adequate. A failure of one or more
preclinical tests or clinical trials can occur at any stage of testing. Changes to product candidates may also impact their
performance in subsequent studies.
If we are unable to obtain regulatory approval or designations we may seek, such as orphan designation, for our
product candidates in one or more jurisdictions, we may not be able to obtain sufficient funding or generate sufficient
revenue to continue the development of our product candidates.
The results of preclinical testing or earlier clinical studies are not necessarily predictive of future results. Any product
candidate we advance into clinical trials may not have favorable results in later-stage clinical trials or receive
regulatory approval.
Encouraging results in preclinical testing and earlier clinical studies do not ensure that later clinical trials will generate
adequate data to demonstrate the efficacy and safety of an investigational drug. Additionally, mechanisms of action, studies
in small or single patient populations, and interim study results may not be predictive of later stage studies. The
development of a product candidate for one indication may further impact its development for other indications. If our
clinical trials do not produce favorable results for our product candidates, our ability to achieve regulatory approval for any
of our product candidates may be adversely impacted.
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Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
We may experience delays in our ongoing or future clinical trials, and we do not know whether planned clinical trials
will begin or enroll subjects on time, need to be redesigned or be completed on schedule, if at all. Regulatory authorities
may also find that our development programs do not support product approval. There can be no assurance that the FDA, an
IRB, or a comparable foreign regulatory authority will permit our clinical trials to commence and will not put clinical trials
of any of our product candidates on clinical hold in the future. Study results may also cause us to discontinue trials.
Clinical trials may be delayed, suspended or prematurely terminated and development programs may not be successful for
a variety of reasons, including:
●
delay or failure in reaching identifying, contracting with, and retaining contract research organizations (“CROs”)
and clinical trial sites;
●
delay or failure in recruiting and enrolling suitable subjects to participate in a trial and/or retaining subjects;
●
failure to follow the study procedures or applicable regulatory requirements;
●
change in standards of care, which may necessitate the modification of our clinical trials or the conduct of new
trials;
●
negative or ambiguous study results;
●
manufacturing or product quality issues;
●
the need to conduct additional development work, including clinical trials;
●
unanticipated clinical trial costs or insufficient funding, including paying substantial application user fees;
●
changes in governmental laws, regulations, policies, or administrative actions; and
●
regulatory authority disagreements regarding the design or implementation of our clinical trials.
If we experience delays in the completion or termination of, any clinical trial of our product candidates, the
commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of
these product candidates will be delayed. In addition, any delays in completing our clinical trials will increase our costs,
slow down our product candidate development and approval process and jeopardize our ability to commence product sales
and generate revenues. In addition, many of the factors that could cause a delay in the commencement or completion of
clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their
regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences
following any marketing approval.
Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or
halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or
other comparable foreign regulatory authority.
As a result of undesirable side effects or safety or toxicity issues that we may experience in our clinical trials, we may
not receive approval to market any product candidates, which could prevent us from ever generating revenues or achieving
profitability. Results of our trials could reveal an unacceptably high severity and prevalence of side effects. In such an
event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order
us to cease further development or deny approval of our product candidates for any or all targeted
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indications. These side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial or
result in potential product liability claims. They could also result in restrictive labeling for any approved products.
Failure to follow the FDA’s applicable regulatory requirements may result in enforcement action.
If we or our third-party contractors are not able to follow the FDA’s or comparable foreign regulatory authorities’
regulatory requirements, we or they may face enforcement actions that may materially harm our business, including, but
not limited to:
●
warning letters, untitled letters, cyber letters or otherwise unacceptable inspectional findings;
●
injunctions, penalties, fines, restitution, consent decrees, corporate integrity agreements, suspension or
debarment;
●
suspension or termination of any ongoing clinical studies, imposition of a clinical hold, or regulatory
authority refusal to approve pending marketing applications;
●
modification of promotional materials or labeling, provision of corrective information, imposition of post-
market requirements including the need for additional testing;
●
restrictions on operations, product seizure or detention, refusal to permit the import or export of products, or
product recalls; or
●
adverse publicity.
Changes in product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates are developed through preclinical studies to later-stage clinical trials towards approval and
commercialization, it is common that various aspects of the development program, such as manufacturing methods and
formulation, are altered along the way in an effort to optimize processes and results. During the course of a development
program, sponsors may also change the contract manufacturers used to produce the product candidates. Such changes carry
the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to
perform differently and affect the results of clinical trials. Such changes may also require additional testing, notification to,
or approval from the FDA or comparable foreign regulatory authority. This could delay completion of clinical trials;
require the conduct of bridging clinical trials or studies, or the repetition of one or more clinical trials; increase clinical trial
costs; delay approval of our product candidates; and jeopardize our ability to commence product sales and generate
revenue.
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We currently conduct clinical trials, and may in the future choose to conduct additional clinical trials, of our product
candidates in sites outside the US, and the FDA may not accept data from trials conducted in foreign locations.
We currently conduct, and expect in the future to conduct, clinical trials outside the US for our product candidates.
The acceptance of study data from clinical trials conducted outside the US or another jurisdiction by the FDA or
comparable foreign regulatory authorities may be subject to certain conditions or may not be accepted at all. In cases where
data from foreign clinical trials are intended to serve as the sole basis for marketing approval in the US, the FDA will
generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the US
population and US medical practice; (ii) the trials were performed by clinical investigators of recognized competence and
pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the
FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site
inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole
basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an
application for marketing approval unless the study was conducted in accordance with GCP requirements and the FDA is
able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory
authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws
of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any comparable
foreign regulatory authority will accept data from trials conducted outside of the US or the applicable jurisdiction. If the
FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional
trials, which could be costly and time-consuming, and which may result in current or future product candidates that we
may develop not receiving approval for commercialization in the applicable jurisdiction.
In addition, there are risks inherent in conducting clinical trials in multiple jurisdictions, inside and outside of the US,
such as:
●
regulatory and administrative requirements of the jurisdiction where the trial is conducted that could burden or
limit our ability to conduct our clinical trials;
●
foreign exchange fluctuations;
●
manufacturing, customs, shipment and storage requirements for clinical trial materials and supplies as well as
shipment and storage of biological samples;
●
cultural differences in medical practice and clinical research; and
●
the risk that the patient populations in such trials are not considered representative as compared to the patient
population in the target markets where approval is being sought.
Disruptions at the FDA and foreign regulatory authorities caused by funding shortages, staffing limitations or global
health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise
prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which
could negatively impact our business.
The ability of the FDA and foreign regulatory authorities to review or approve new products can be affected by a
variety of factors, including government budget and funding levels, statutory, regulatory, and policy changes, the FDA’s or
foreign regulatory authorities’ ability to hire and retain key personnel and accept the payment of user fees, and other events
that may otherwise affect the FDA’s or foreign regulatory authorities’ ability to perform routine functions including a rapid
substantial influx of applications from numerous sponsors, as occurred with COVID-19. Average review times at the FDA
and foreign regulatory authorities have fluctuated in recent years as a result. In addition, government funding of other
government agencies that fund research and development activities is subject to the political process, which is inherently
fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be
reviewed and/or approved by necessary government agencies, which would adversely affect our business. For example, in
recent years, the US government has shut down several times and certain regulatory agencies, such as the FDA, have had
to furlough critical FDA employees and stop critical activities.
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Separately, in response to the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign
manufacturing facilities at various points. If a prolonged government shutdown occurs, or funding shortages, staffing
limitations, or renewed global health concerns prevent the FDA or other regulatory authorities from conducting their
regular inspections, reviews, or other regulatory activities on a timely basis, it could significantly impact the ability of the
FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material
adverse effect on our business.
Healthcare legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may
increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and
affect the prices we may obtain.
The regulations that govern, among other things, marketing approvals, coverage, pricing and reimbursement for new
drug products vary widely from country to country and our ability to commercialize any products will depend, in part, on
the extent to which coverage and adequate reimbursement for our products is available. In the United States and some
foreign jurisdictions, including the European Union, there have been a number of legislative and regulatory changes and
proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product
candidates, restrict or regulate post-approval activities, limit coverage and reimbursement or restrict the prices we may
charge including through payments of increased manufacturer rebates and penalties, and affect our ability to successfully
sell any product candidates for which we obtain marketing approval. Furthermore, in the United States private payors often
follow Medicare coverage policies and payment limitations in setting their own reimbursement rates. These and any
additional healthcare reform measures in the United States, the European Union and other potentially significant markets
could further constrain our business or limit the amounts that governments will pay for healthcare products and services,
which could result in additional pricing pressures.
Certain states, in the US, have also enacted laws requiring pharmaceutical companies to, among other things, establish
marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing,
pricing, clinical trials and other activities, cap or regulate price increases, negotiate or pay increased supplemental rebates
and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing
specified physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit other
specified sales and marketing practices.
Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing
review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription
pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a
result, we might obtain marketing approval for a product candidate in a particular country, but then be subject to price
regulations that delay our commercial launch of the product, possibly for lengthy time periods, which could negatively
impact the revenues we are able to generate from the sale of the product in that particular country.
Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates even if
our product candidates obtain marketing approval. We cannot be sure that timely coverage and adequate reimbursement
will be available for any product that we commercialize and, if reimbursement is available, what the level of coverage and
reimbursement will be.
Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory
standards and requirements, which could cause significant liability for us and harm our reputation.
We are exposed to the risk of employee fraud or other misconduct, including intentional failures to comply with FDA
regulations or similar regulations of comparable foreign regulatory authorities, provide accurate information to the FDA,
Centers for Medicare & Medicaid Services, or comparable foreign regulatory authorities, comply with manufacturing
standards we have established, comply with federal and state healthcare fraud and abuse laws and regulations and similar
laws and regulations established and enforced by comparable foreign regulatory authorities, comply with the FDA’s laws
and regulations, report financial information or data accurately or disclose unauthorized activities to us. Employee
misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result
in regulatory sanctions and serious harm to our reputation. We have adopted a code of
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conduct for our directors, officers and employees, but it is not always possible to identify and deter employee misconduct,
and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged
risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to
be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in
defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of
operations, including the imposition of significant fines or other sanctions.
We face substantial competition, which may result in others discovering, developing or commercializing products before
or more successfully than we do.
The development and commercialization of new drug products is highly competitive. We face competition with respect
to our current product candidates and will face competition with respect to any product candidate that we may seek to
develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and
biotechnology companies worldwide. There are a number of large pharmaceutical and biotechnology companies that
currently market and sell products or are pursuing the development of products for the treatment of certain disease
indications for which we are developing our product candidates.
For example, large pharmaceutical companies such as Roche, GSK and BioCryst Partners successfully market the
commercialized anti-influenza drugs neuraminidase inhibitors oseltamivir phosphate (Tamiflu), zanamivir (Relenza), and
peramivir (Rapivab) anti-influenza drugs, respectively. Additionally, Roche’s antiviral, baloxavir marboxil (Xofluza), a
CEN inhibitor, is also approved for the treatment of influenza. Gilead, Pfizer and Merck have commercialized drugs for the
management of COVID-19 in certain populations, including remdesivir and, nirmatrelvir + ritonavir, or molnupiravir,
respectively.
Furthermore, other companies such as Pfizer, Novartis, Eli Lilly successfully market commercialized CDK 4/6
inhibitors palbociclib, ribociclib and abemaciclib and have done so for a number of years. More recently, G1 Therapeutics
secured FDA approval of the CDK 4/6 triaciclib for the prevention of myelosuppression following chemotherapy.
The approved antiviral drugs baloxavir marboxil, oseltamivir and CDK 4/6 inhibitor drugs palbociclib, ribociclib and
abemaciclib are well established therapies or products and are widely accepted by physicians, patients and third-party
payors. By the time our drug candidates are possibly approved in the future, insurers and other third-party payors may also
encourage the use of generic products. This may make it difficult for us to achieve market acceptance at desired levels in a
timely manner to ensure viability of our business.
More established companies may have a competitive advantage over us due to their greater size, cash flows and
institutional experience. Compared to us, many of our competitors may have significantly greater financial, technical and
human resources.
If we breach our license agreements or fail to negotiate new agreements pertaining to our product candidates, we could
lose the ability to continue the development and potential commercialization of these product candidates.
If we fail to meet our obligations under our current license agreements or if we fail to negotiate future license
agreements, our rights under the licenses could be terminated, and upon the effective date of such termination, our right to
use the licensed technology would terminate. While we would expect to exercise all rights and remedies available to us,
including attempting to cure any breach by us, and otherwise seek to preserve our rights under the patents and other
technology licensed to us, we may not be able to do so in a timely manner, at an acceptable cost or at all. Any uncured,
material breach under the license agreement could result in our loss of exclusive rights and may lead to a complete
termination of our product development and any commercialization efforts for the applicable product candidates.
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Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any
products that we may develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical
trials and will face an even greater risk if we commercially sell any products that we may develop. Product liability claims
may be brought against us by subjects enrolled in our clinical trials, and patients, healthcare providers or others using,
administering or selling our products in third party studies, expanded access programs, or commercially, if we receive
product approval. If we cannot successfully defend ourselves against claims that our product candidates or products caused
injuries, the clinical development and commercialization of our product candidates could be adversely affected or
terminated, and we could incur substantial liabilities.
We may engage in future business combinations or collaborations that could disrupt our business, cause dilution to our
stockholders and harm our financial condition and operating results.
While we currently have no specific plans to acquire any other specific business, we may, in the future, make
acquisitions of, or investments in, or otherwise engage in business combinations or collaborations with companies that we
believe have products or capabilities that are a strategic or commercial fit with our current product candidates and business
or otherwise offer opportunities for our company. In connection with these acquisitions or investments, we may: issue stock
that would dilute our existing stockholders’ percentage of ownership; incur debt and assume liabilities; and incur
amortization expenses related to intangible assets or incur large and immediate write-offs.
We may not be able to complete any future business combination or collaborations on favorable terms, if at all. If we
do complete a business combination or collaboration, we cannot assure you that it will ultimately strengthen our
competitive position or that it will be viewed positively by customers, financial markets or investors. Furthermore, future
business combinations could pose numerous additional risks to our operations, including, but not limited to problems
integrating the businesses, products or technologies, increases to our expenses, the failure to discover undisclosed liabilities
of an acquired asset or transaction partner, diversion of management’s attention from their day-to-day responsibilities, and
harm to our operating results or financial condition.
We may not be able to complete any collaboration or business combination or effectively integrate the operations,
products or personnel gained through any such business combination.
We depend on information technology and computer systems to operate our business; our business and operations
would suffer in the event of any failures or interruptions of our computer system, such as a data breach or cybersecurity
incident.
Despite the implementation of security measures, our internal computer systems, and those of third parties on
which we rely, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, fire, terrorism, war
and telecommunication and electrical failures. Cybersecurity attacks are evolving and include, but are not limited to,
malicious software, attempts to gain unauthorized access to data and other electronic security breaches that could lead to
disruptions in systems, misappropriation of our confidential or otherwise protected information, and corruption of data.
While we have not experienced any such material system failure, accident or security breach to date, if such an event were
to occur and cause interruptions in our operations, it could result in a material disruption of our drug development
programs. For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in
delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent
that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure
of confidential or proprietary information, we could incur liability or damage to our reputation, and the further
development of our product candidates could be delayed.
Likewise, data privacy or security breaches by employees or others may pose a risk that sensitive data, including
our intellectual property, trade secrets or personal information of our employees, patients or other business partners, may be
exposed to unauthorized persons or to the public. There can be no assurance that our efforts, or the efforts of our partners
and vendors, will prevent service interruptions, or identify breaches in our systems, that could adversely affect our business
and operations and/or result in the loss of critical or sensitive information, which could
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result in financial, legal, business or reputational harm to us. In addition, our liability insurance may not be sufficient in
type or amount to cover us against claims related to security breaches, cyberattacks and other related breaches.
Climate change, environmental, social and governance and sustainability initiatives may result in regulatory or
structural industry changes that could require significant operational changes and expenditures, reduce demand for the
Company’s products and adversely affect our business, financial condition, and results of operations.
Climate change, environmental, social and governance (“ESG”) and sustainability are a growing global movement.
Continuing political and social attention to these issues has resulted in both existing and pending international agreements
and national, regional and local legislation, regulatory measures, reporting obligations and policy changes. Also, there is
increasing societal pressure in some of the areas where we operate, to limit greenhouse gas emissions as well as other
global initiatives. These agreements and measures may require, or could result in future legislation, regulatory measures or
policy changes that would require operational changes or increase expenses.
Furthermore, increasing attention to climate change, ESG and sustainability has resulted in governmental
investigations, and public and private litigation, which could increase our costs or otherwise adversely affect our business
or results of operations. In addition, organizations that provide information to investors on corporate governance and
related matters have developed ratings processes for evaluating companies on their approach to ESG matters. Such ratings
are used by some investors to inform their investment and voting decisions. Unfavorable ESG ratings may lead to
increased negative investor sentiment toward us, which could have a negative impact on the price of our securities and our
access to and costs of capital.
Any or all of these ESG and sustainability initiatives may result in significant operational changes and expenditures,
cause us reputational harm, and could materially adversely affect our business, financial condition, and results of
operations.
Business disruptions could seriously harm our future revenues and financial condition and increase our costs and
expenses.
Our operations could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods,
hurricanes, typhoons, fires, extreme weather conditions, medical epidemics and other natural or manmade disasters or
business interruptions, for which we are predominantly self-insured. The occurrence of any of these business disruptions
could seriously harm our operations and financial condition and increase our costs and expenses. We rely on third-party
manufacturers to produce our product candidates. Our ability to obtain clinical supplies of product candidates could be
disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.
The ultimate impact on us, our significant suppliers and our general infrastructure of being consolidated in certain
geographical areas is unknown, but our operations and financial condition could suffer in the event of a major earthquake,
fire or other natural disaster.
Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified
personnel.
We are highly dependent upon members of our executive management team and other employees. As discussed
elsewhere in this Annual Report, Nora Brennan was appointed to serve as our Interim Chief Financial Officer in February
2025 and Iain Dukes, our Executive Chairman, will step in to serve as our Interim Chief Executive Officer, effective as of
close of business on the date of this Annual Report, in connection with Dr. Cautreels’ retirement from such role. Both Ms.
Brennan and Dr. Dukes have provided services to the Company prior to these changes, which we believe will help
minimize the transition period inherent in changes to executive management; however, no assurances can be provided.
Although we have employment agreements with our executive officers, these agreements are at-will and do not prevent
such persons from terminating their employment with us at any time. We do not maintain "key person" insurance for any of
our executives or other employees. The loss of the services of any of these persons could impede the achievement of our
research, development and commercialization objectives.
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The widespread outbreak of a communicable disease, such as the recent COVID-19 pandemic, could adversely impact
our business, including our clinical trials, drug manufacturing and nonclinical activities.
We face risks related to epidemics and other outbreaks of communicable diseases, such as the recent COVID-19
pandemic, which could adversely impact our business, including our clinical trials and clinical trial operations. These
potential disruptions may include but are not limited to delays or difficulties in clinical site initiation and patient
recruitment, patient withdrawals, postponement of planned clinical or preclinical studies, redirection of site resources from
studies, study modification, suspension, or termination, the introduction of remote study procedures and modified informed
consent procedures, study site changes, direct delivery of investigational products to patient homes requiring state
licensing, study deviations or noncompliance, diversion of healthcare resources away from the conduct of clinical trials,
including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical
trials, delays in receiving approval from local regulatory authorities to initiate our planned clinical trials, delays in
obtaining supplies of our product candidate or other materials that may be necessary for the conduct of our development
program, delays in obtaining necessary inspections from the FDA or other regulatory authorities, changing laws and
regulations, and changes or delays in site monitoring. The foregoing may require that we consult with relevant review and
ethics committees, IRBs, and the FDA or foreign regulatory authorities. The foregoing may also impact the integrity of our
study data, which may not become evident until later in our development programs. The effects of a health crisis may also
increase the need for clinical trial patient monitoring and regulatory reporting of adverse effects.
Risk Factors Relating to the Merger
There is no guarantee that the Merger will increase stockholder value.
As discussed elsewhere in this Annual Report, in April 2024, we merged with Trawsfynydd. We cannot guarantee
that implementing the Merger and related transactions will not impair stockholder value or otherwise adversely affect our
business. The Merger continues to pose integration challenges between our businesses and management teams, which
could result in management and business disruptions, any of which could harm our results of operation, business prospects,
and impair the value of the Merger to our stockholders.
Stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience
in connection with the Merger, including the issuance of our common stock upon conversion of all outstanding shares
of our Series C Preferred issued in the Merger and Financing.
If we are unable to realize the full strategic and financial benefits currently anticipated from the Merger,
stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate
benefit, or only receiving part of the commensurate benefit to the extent we are able to realize only part of the strategic and
financial benefits currently anticipated from the Merger.
The failure to successfully integrate the businesses of Onconova and Trawsfynydd in the expected timeframe would
adversely affect Traws Pharma’s future results.
Our ability to successfully integrate the operations of Onconova and Trawsfynydd will depend, in part, on our
ability to realize the anticipated benefits from the Merger. If we are not able to achieve these objectives within the
anticipated time frame, or at all, the anticipated benefits of the Merger may not be realized fully, or at all, or may take
longer to realize than expected, and the value of our common shares may be adversely affected. In addition, the integration
of the Company’s and Trawsfynydd’s respective businesses has been, and will likely continue to be, a time-consuming and
expensive process. Proper planning and effective and timely implementation will be critical to avoid any significant
disruption to Traws Pharma’s operations. It is possible that the continuing integration process could result in the loss of key
employees, the disruption of our ongoing business or the identification of inconsistencies in standards, controls, procedures
and policies that adversely affect our ability to maintain relationships with suppliers, distributors, creditors, lessors, clinical
trial investigators or managers or to achieve the anticipated benefits of the Merger. Delays encountered in the integration
process could have a material adverse effect on Traws Pharma’s revenues, expenses, operating results and financial
condition, including the value of its common shares.
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Our future results will suffer if we do not effectively manage our expanded operations.
As a result of the Merger, we have become a more diversified company and our business has become more
complex. There can be no assurance that we will effectively manage the increased complexity without experiencing
operating inefficiencies or control deficiencies. Significant management time and effort is required to effectively manage
our increased complexity and our failure to successfully do so could have a material adverse effect on our business,
financial condition, results of operations and growth prospects.
We expect to incur substantial expenses related to the integration of Trawsfynydd.
We have incurred, and expect to continue to incur, substantial expenses in connection with the Merger and the
integration of Trawsfynydd. There are a large number of processes, policies, procedures, operations, technologies and
systems that must be integrated, including purchasing, accounting and finance, billing, payroll, research and development,
marketing and benefits. Both the Company and Trawsfynydd incurred significant transaction expenses in connection with
the drafting and negotiation of the Merger Agreement, the Stock Purchase Agreement and the related ancillary agreements
and significant severance expenses in connection with the reduction of employees in April 2024. While we have assumed
that a certain level of expenses will be incurred, there are many factors beyond our control that could affect the total
amount or the timing of the integration expenses. Moreover, many of the expenses that will be incurred are, by their nature,
difficult to estimate accurately. These integration expenses likely will result in our taking significant charges against
earnings following the completion of the Merger, and the amount and timing of such charges are uncertain at present.
Risks Related to Our Dependence on Third Parties
We rely on third parties to conduct our preclinical and clinical trials. If these third parties do not successfully carry out
their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or
commercialize our product candidates.
We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data for our ongoing
preclinical and clinical programs, as well as clinical trial sites for the conduct of our clinical trials. There is no guarantee
that we will be able to maintain the relationships with these third parties, that we will be able to enter into additional
relationships, or that we will be able to find replacement sites or CROs should any of our agreements terminate. We rely on
these parties for execution of our preclinical and clinical trials, and we control only some aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable
protocol and legal, regulatory and scientific standards, and our reliance on the CROs and sites does not relieve us of our
regulatory responsibilities. We also rely on third parties to assist in conducting our preclinical studies in accordance with
Good Laboratory Practices (“GLP”) and the Animal Welfare Act requirements. We, our clinical trial sites, and our CROs
are required to comply with federal regulations and current GCPs, which are international standards meant to protect the
rights and health of patients that are enforced by the FDA, the Competent Authorities of the Member States of the
European Economic Area, the Australian Human Research Ethics Committee and comparable foreign regulatory
authorities for all of our products in clinical development. Regulatory authorities enforce GCPs through periodic
inspections of trial sponsors, principal investigators and trial sites. If we or any of our sites or CROs fail to comply with
applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable
foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing
applications. We or they may also face regulatory enforcement. We cannot assure you that upon inspection by a given
regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP requirements.
In addition, our clinical trials must be conducted with product produced under cGMP requirements. Failure to comply with
these regulations may require us to repeat preclinical and clinical trials, which would delay the regulatory approval process.
We may also face liability and/or regulatory enforcement action should any of the third parties that we rely upon fail to
comply with legal and/or regulatory requirements.
Our CROs and the employees at clinical sites are not our employees, and except for remedies available to us under our
agreements with such CROs and sites, we cannot control whether or not they devote sufficient time and resources to our
ongoing clinical, nonclinical and preclinical programs. If CROs or sites do not successfully carry out their
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contractual duties or obligations or meet expected deadlines or if the quality or accuracy of the clinical data they obtain is
compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical
trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully
commercialize our product candidates. Moreover, while we are required to monitor the activities of third parties providing
services on our behalf, there is no guarantee that we will be able to detect activities that do not comply with the applicable
regulatory requirements or our study plans and protocols. As a result, our results of operations and the commercial
prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could
be delayed.
Because we have relied on third parties, our internal capacity to perform these functions is limited. Outsourcing these
functions involves risk that third parties may not perform to our standards, may not produce results in a timely manner or
may fail to perform at all. In addition, the use of third-party service providers requires us to disclose our proprietary
information to these parties, which could increase the risk that this information will be misappropriated. We currently have
a small number of employees, which limits the internal resources we have available to identify and monitor our third-party
providers. To the extent we are unable to identify and successfully manage the performance of third-party service providers
in the future, our business may be adversely affected. Though we carefully manage our relationships with our CROs and
clinical trial sites, there can be no assurance that we will not encounter challenges or delays in the future or that these
delays or challenges will not have a material adverse impact on our business, financial condition and prospects.
If we lose our relationships with CROs, our drug development efforts could be delayed.
We rely on third-party vendors and CROs for preclinical studies and clinical trials related to our drug development
efforts. Switching or adding additional CROs would involve additional cost and requires management time and focus. Our
CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of
our CROs have an ability to terminate their respective agreements with us if it can be reasonably demonstrated that the
safety of the subjects participating in our clinical trials warrants such termination, if we make a general assignment for the
benefit of our creditors or if we are liquidated. We may also terminate a CRO for a number of reasons. Identifying,
qualifying and managing performance of third-party service providers can be difficult, time consuming and cause delays in
our development programs. In addition, there is a natural transition period when a new CRO commences work and the new
CRO may not provide the same type or level of services as the original provider. If any of our relationships with our third-
party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially
reasonable terms.
We have limited experience manufacturing our product candidates on a large clinical or commercial scale and have no
manufacturing facility. We are dependent on third-party manufacturers for the manufacture of our product candidates
for clinical trials as well as on third parties for our supply chain, and if we experience problems with any third parties,
the manufacturing of our product candidates or products could be delayed.
We do not own or operate facilities for the manufacture of our product candidates. We currently have no plans to build
our own clinical or commercial scale manufacturing capabilities. We currently rely on a single source CMO, for the
chemical manufacture of active pharmaceutical ingredient for each of our product candidates. To meet our projected needs
for clinical supplies to support our activities through regulatory approval and commercial manufacturing, the CMOs with
whom we currently work will need to increase the scale of production. We may need to identify additional CMOs for
continued production of supply for our product candidates. In addition, regulatory authorities enforce cGMP through
periodic inspections and remote regulatory assessments of active pharmaceutical ingredient (“API”) and drug product
manufacturing sites, quality control contract laboratories and distribution centers. If we or our CMO fail to comply with
applicable cGMPs, the manufacturing data generated and subsequent API lots and drug product batches in our supply chain
may be deemed unreliable. Clinical trials using the product candidate may also be deemed to be unreliable. As such, the
FDA or comparable foreign regulatory authorities may require us to perform additional API and drug product
manufacturing and manufacturing development before continuing clinical trials or approving our marketing applications,
may require us to conduct additional studies, and any such deficient product we supply to any collaboration partner may
subject us to certain obligations under relevant agreements. We or our contractors may also face enforcement actions. We
have not yet qualified alternate suppliers in the event the current CMO we utilize is unable to
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scale production, or if we otherwise experience any problems with them. By example, our third-party manufacturers may
not be able to obtain sufficient quantities of any necessary supplies such as due to changing trade policies or supply
shortages. Although alternative third-party suppliers with the necessary manufacturing and regulatory expertise and
facilities exist, as we have experienced with respect to our existing CMOs, it could be expensive and take a significant
amount of time to arrange for alternative suppliers. If we are unable to arrange for alternative third-party manufacturing
sources, or to do so on commercially reasonable terms or in a timely manner, we may not be able to complete development
of our product candidates, or market or distribute them.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured product
candidates or products ourselves, including reliance on the third party for regulatory compliance and quality assurance, the
possibility of breach of the manufacturing agreement by the third party because of factors beyond our control, including a
failure to synthesize and manufacture our product candidates or any products we may eventually commercialize in
accordance with our specifications, and the possibility of termination or nonrenewal of the agreement by the third party,
based on its own business priorities, at a time that is costly or damaging to us. In addition, the FDA and other regulatory
authorities require that our product candidates and any products that we may eventually commercialize be manufactured
according to cGMPs and similar foreign standards. Any failure by our third-party manufacturers to comply with cGMPs or
failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of product candidates in a
timely manner, could lead to a delay in, or failure to obtain, regulatory approval of any of our product candidates. In
addition, such failure could be the basis for the FDA to issue a warning letter, withdraw approvals for product candidates
previously granted to us, or take other regulatory or legal action, including recall or seizure of outside supplies of the
product candidate, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve
pending applications or supplemental applications, detention of product, refusal to permit the import or export of products,
injunction, or imposing civil and criminal penalties. Noncompliance with the applicable manufacturing requirements may
also require costly corrective and preventative actions. The manufacturing facilities that we use must also be approved by
the FDA under a pre-approval inspection. If the facilities cannot pass these inspections, the FDA will not approve our
marketing application. These manufacturing facilities will further be subject to continuing regulatory oversight and
inspection, and, thus, they must continue to expend time and resources to maintain regulatory compliance.
We have entered into certain related party transactions and may continue to rely on related parties for certain
development and support activities.
We have entered into, and may continue to enter into, transactions with related parties for certain development and
support activities. For example, we have entered into master research and development agreements with ChemDiv, Inc. and
Viriom, Inc., both of which are related parties, to provide certain research and development related services for virology
product candidates. For additional information related to these and other related party transactions, please see Note 12,
Research and Development Arrangements and Related Party Transactions, to our consolidated financial statements
included in Part IV in this Annual Report. Such related party transactions may not have been entered into on an arm’s-
length basis, and we may have achieved more favorable terms because such transactions were entered into with our related
parties. We rely on, and will continue to rely on, our related parties to maintain these services. If the pricing for these
services changes, or if our related parties cease to provide these services, including by terminating agreements with us, we
may be unable to obtain replacements for these services on the same terms without disruption to our business. This could
have a material effect on our business, results of operations and financial condition.
Risks Related to Our Intellectual Property
We could be required to incur significant expenses to perfect our intellectual property rights, and our intellectual
property rights may be inadequate to protect our competitive position. If we are unable to protect our intellectual
property rights, our competitive position could be harmed.
We depend on our ability to protect our proprietary technology. We rely on trade secret, patent, copyright and
trademark laws, and confidentiality, licensing and other agreements with employees and third parties, all of which offer
only limited protection. Our commercial success will depend in large part on our ability to obtain and maintain patent
protection in the United States and other countries with respect to our proprietary technology and products. Where we
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have the right to do so under our license agreements, we seek to protect our proprietary position by filing patent
applications in the United States and abroad related to our novel technologies and products that are important to our
business. The patent positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve
complex legal and factual questions and have in recent years been the subject of much litigation. As a result, the issuance,
scope, validity, enforceability and commercial value of our patents, including those patent rights licensed to us by third
parties, are highly uncertain.
The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our
proprietary information or infringement of our intellectual property rights, both inside and outside the United States. The
rights already granted under any of our currently issued patents and those that may be granted under future issued patents
may not provide us with the proprietary protection or competitive advantages we are seeking. If we are unable to obtain
and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not
sufficient, our competitors could develop and commercialize technology and products similar or superior to ours, and our
ability to successfully commercialize our technology and products may be adversely affected.
With respect to patent rights, we do not know whether any of the pending patent applications for any of our licensed
compounds will result in the issuance of patents that protect our technology or products, or if any of our issued patents will
effectively prevent others from commercializing competitive technologies and products. Our pending applications cannot
be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues
from such applications. Further, the examination process may require us or our licensor to narrow the claims for our
pending patent applications, which may limit the scope of patent protection that may be obtained if these applications issue.
Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that
we own or have licensed from third parties may be challenged in the courts or patent offices in the United States and
abroad. Such challenges may result in the loss of patent protection, the narrowing of claims in such patents or the invalidity
or unenforceability of such patents, which could limit our ability to stop others from using or commercializing similar or
identical technology and products or limit the duration of the patent protection for our technology and products. Protecting
against the unauthorized use of our patented technology, trademarks and other intellectual property rights is expensive,
difficult and may in some cases not be possible. In some cases, it may be difficult or impossible to detect third-party
infringement or misappropriation of our intellectual property rights, even in relation to issued patent claims, and proving
any such infringement may be even more difficult.
Even if patents are granted that cover commercially valuable molecules or compounds, we may decide to allow such
patents to lapse, or if in-licensed, return the patents to the licensor. The effects of doing so are uncertain. In the case of
returning granted patents to a licensor, we may encounter a scenario in which we need the patents in the future and are
unable to obtain a new license to such patents on commercially reasonable terms or at all. The licensor may license the
returned patents to a competitor, who may then enforce the patents against us.
We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time
consuming and unsuccessful.
Competitors may infringe our patents or misappropriate or otherwise violate our intellectual property rights. To
counter infringement or unauthorized use, litigation may be necessary in the future to enforce or defend our intellectual
property rights, to protect our trade secrets or to determine the validity and scope of our own intellectual property rights or
the proprietary rights of others. This can be expensive and time consuming. Many of our current and potential competitors
have the ability to dedicate substantially greater resources to defend their intellectual property rights than we can.
Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our
intellectual property. Litigation could result in substantial costs and diversion of management resources. In addition, in an
infringement proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable, or a court
may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the
technology in question. An adverse result in any litigation proceeding could put one or more of our patents at risk of being
invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery
required in connection with intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation.
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Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the
outcome of which would be uncertain and could harm our business.
Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market
and sell our product candidates, and to use our proprietary technologies without infringing the proprietary rights of third
parties. We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual
property rights with respect to our products and technology, including interference or derivation proceedings before the
USPTO. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in
the future. If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license
from such third party to continue developing and commercializing our products and technology. However, we may not be
able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it
may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced,
including by court order, to cease commercializing the infringing technology or product. In addition, in any such
proceeding or litigation, we could be found liable for monetary damages. A finding of infringement could prevent us from
commercializing our product candidates or force us to cease some of our business operations, which could materially harm
our business. Any claims by third parties that we have misappropriated their confidential information or trade secrets could
have a similar negative impact on our business.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former
employers.
Many of our employees, including our senior management, were previously employed at other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Some of these employees, including each
member of our senior management, executed proprietary rights, non-disclosure and non-competition agreements in
connection with such previous employment. Although we try to ensure that our employees do not use the proprietary
information or know-how of others in their work for us, we may be subject to claims that we or these employees have used
or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former
employer.
Risks Related to Ownership of Our Securities
We may be required to raise additional financing by issuing new securities with terms or rights superior to those of our
existing securityholders, which could adversely affect the market price of shares of common stock and our business.
We will require additional financing to fund future operations, including for research and development, clinical
trials, expansion in current and new markets, development and acquisition, capital costs and the costs of any necessary
implementation of technological innovations or alternative technologies. We may not be able to obtain financing on
favorable terms, if at all. If we raise additional funds by issuing equity securities, the percentage ownership of our current
stockholders will be reduced, and the holders of the new equity securities may have rights superior to those of our existing
securityholders, which could adversely affect the market price of our common stock and the voting power of shares of our
common stock. If we raise additional funds by issuing debt securities, the holders of these debt securities would similarly
have some rights senior to those of our existing securityholders, and the terms of these debt securities could impose
restrictions on operations and create a significant interest expense for us which could have a materially adverse effect on
our business.
If we are unable to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock
could be delisted, which could affect our common stock's market price and liquidity and reduce our ability to raise
capital.
Our common stock is listed on the Nasdaq Capital Market (“Nasdaq”), a national securities exchange, which imposes
continued listing requirements with respect to issuers whose securities are listed on Nasdaq. If we fail to satisfy the
continued listing standards, such as, for example, Nasdaq’s minimum bid price requirement or stockholders equity
requirements, Nasdaq may issue a non-compliance letter or initiate delisting proceedings.
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As previously disclosed, on November 20, 2024, we received a letter from the staff (the “Staff”) of the Listing
Qualifications Department of Nasdaq notifying us that the Company was no longer in compliance with the minimum $2.5
million stockholders’ equity requirement for continued listing on Nasdaq as set forth in Listing Rule 5550(b)(1) (the
“Rule”). After a hearing, the Nasdaq Hearings Panel granted the Company an exception until February 18, 2025 to
demonstrate compliance with the Nasdaq listing rules. On February 25, 2025, we received a letter from Nasdaq confirming
that the Company had regained compliance with the Rule. Pursuant to Listing Rule 5815(d)(4)(B), the Company will be
subject to a mandatory panel monitor for a period of one year from the date of such letter. If, within that one-year
monitoring period, the Staff finds that the Company is no longer in compliance with the Rule, then, notwithstanding Rule
5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to such deficiency and the
Staff will not be permitted to grant additional time for us to regain compliance with respect to such deficiency, nor will we
be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, the Staff will issue a Delist
Determination Letter and we will have an opportunity to request a new hearing with the initial Hearings Panel or a newly
convened Hearings Panel if the initial Hearings Panel is unavailable.
If we are unable to maintain compliance with the continued listing requirements of Nasdaq, our common stock could
be delisted, making it could be more difficult to buy or sell our securities and to obtain accurate quotations, and the price of
our securities could suffer a material decline. Delisting could also impair our ability to raise capital.
If we are unable to implement and maintain effective internal control over financial reporting in the future, investors
may lose confidence in the accuracy and completeness of our financial reports and the market price of our common
stock may decline.
As a public company, we are required to maintain internal control over financial reporting and to report any
material weaknesses in such internal controls. In addition, we are required to furnish a report by management on the
effectiveness of our internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act. As
discussed elsewhere in this Annual Report, as of December 31, 2024, based on an analysis completed by management, our
internal controls were not effective due to the existence of material weaknesses. The process of designing, implementing
and testing the internal control over financial reporting required to comply with this obligation is time-consuming, costly
and complicated. If we identify material weaknesses in our internal control over financial reporting (as we have for the
period covered by this Annual Report), if we are unable to comply with the requirements of Section 404 of the Sarbanes-
Oxley Act in a timely manner, or if we are unable to assert that our internal control over financial reporting is effective,
investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our
common stock could decline, and we could also become subject to investigations by the stock exchange on which our
common stock is listed, the Commission or other regulatory authorities, which could require additional financial and
management resources.
Future issuances of stock or other securities could dilute the holdings of stockholders and could materially affect the
price of the shares of our common stock.
As discussed elsewhere in this Annual Report, we will need to obtain additional financing in the future to carry
out our business objectives. We may do so through the sale and issuance of shares of our common stock or securities
convertible or exercisable for shares of our common stock. Additionally, there are currently warrants to purchase an
aggregate of 5,848,082 shares of our common stock outstanding and shares of Series C Preferred Stock convertible into an
aggregate of 2,959,158 shares of our common stock outstanding. Any issuance of shares of our common stock, including
upon the exercise or conversion of outstanding warrants and shares of Series C Preferred, respectively, or issuance of
securities exercisable for or convertible into shares of our common stock, will result in the dilution of the ownership
interests of our existing stockholders. Additionally, the issuance of a significant number of shares of our common stock
could result in a decrease in the price of our common stock.
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We have used and intend to continue to use equity incentives for employees, advisors, directors, key consultants
and select affiliates. Any issuance of stock upon the conversion of options, restricted stock units and/or other incentive
rights will result in the dilution of the ownership interests of our existing stockholders.
Our share price and the liquidity of our stock may be volatile and result in substantial losses to our stockholders.
The trading price of our common stock is highly volatile and could be subject to wide fluctuations in response to
various factors, some of which are beyond our control. In addition, the stock market in general, and pharmaceutical and
biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been
unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may
negatively affect the market price of our common stock, regardless of our actual operating performance. The realization of
any of these risks or any of a broad range of other risks could have a dramatic and material adverse impact on the market
price of our common stock.
We may be subject to securities litigation, which is expensive and could divert management attention.
In the past companies that have experienced volatility in the market price of their stock have been subject to securities
class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could
result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm
our business.
We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders
must rely on capital appreciation, if any, for any return on their investment.
We have never declared or paid cash dividends on our capital stock. We currently intend to retain all of our future
earnings, if any, to finance the growth and development of our business. As a result, capital appreciation, if any, of our
common stock will be your sole source of gain for the foreseeable future.
Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an
acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by
our stockholders to replace or remove our current management.
Provisions in our Tenth Amended and Restated Certificate of Incorporation, as amended (“Certificate of Incorporation”)
and Amended and Restated Bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to
acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders, or remove our current
management. These include provisions that will:
●
permit our board of directors to issue up to 5,000,000 shares of preferred stock, with any rights, preferences and
privileges as they may designate (as of March 26, 2025, we had 7,397.893 shares of Series C Preferred stock
issued and outstanding);
●
provide that all vacancies on our board of directors, including as a result of newly created directorships, may,
except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even
if less than a quorum;
●
require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting
of stockholders and not be taken by written consent;
●
provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates
for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify
requirements as to the form and content of a stockholder’s notice;
●
not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of common
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stock entitled to vote in any election of directors to elect all of the directors standing for election; and
●
provide that special meetings of our stockholders may be called only by the board of directors or by such person
or persons requested by a majority of the board of directors to call such meetings.
These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace members of our board of directors, who are responsible
for appointing the members of our management. Because we are incorporated in Delaware, we are governed by the
provisions of Section 203 of the Delaware General Corporation Law, which may discourage, delay or prevent someone
from acquiring us or merging with us whether or not it is desired by or beneficial to our stockholders. Under Delaware law,
a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock
unless the holder has held the stock for three years or, among other things, the board of directors has approved the
transaction. Any provision of our Certificate of Incorporation or Amended and Restated Bylaws or Delaware law that has
the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium
for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common
stock.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 1C. CYBERSECURITY
Risk Management and Strategy
Due to the size of our company, we have not yet developed robust policies and processes for assessing, identifying,
and managing material risk from cybersecurity threats. We have implemented access controls with respect to our systems,
which we monitor regularly. We currently rely heavily on products and services provided by third-party suppliers to
operate certain critical business systems, including without limitation, cloud-based infrastructure, encryption and
authentication technology, email, and other functions. We rely on third party providers and outsourced IT services to
protect, detect, monitor, mitigate and address cybersecurity related risks, including installing software for threat protection
and malware. Such third party providers are tasked with notifying management of any material risks or cybersecurity
concerns that they identify, which management then assesses and may bring to our audit committee or board of directors to
discuss if deemed necessary or appropriate. We also alert employees to significant new cybersecurity issues on a regular
basis.
We rely heavily on third party service providers for our clinical development activities and cloud-based documentation
and communications. A cybersecurity incident at a vendor or other third-party service provider could have a material and
adverse impact on our business, results of operations and financial condition. We do not currently have a formal process in
place for evaluating or reviewing third party vendor cybersecurity risks and procedures and rely on such third parties to
implement adequate protectionary and detection measures.
We do not specifically utilize assessors, consultants, auditors, or other third parties to evaluate or enhance our
cybersecurity programs. On an annual basis, our information technology risks, controls and procedures are reviewed by
third-party experts as part of our Sarbanes-Oxley review and testing.
Board Governance and Management
Our management team is primarily responsible for assessing and managing our strategic risk exposures, including
material risks from cybersecurity threats, with assistance from third-party service providers. Management oversees our
cybersecurity process on a day-to-day basis, including those described in “Risk Management and Strategy,” above.
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Our board of directors has oversight responsibility for risk management, which it administers directly and with
assistance from its committees, primarily the audit committee. Throughout the year, the board and its committees engage
with management to discuss a wide range of enterprise risks, including cybersecurity.
The audit committee assists the board of directors by overseeing the steps management has taken to monitor and
mitigate cybersecurity threats and risks. The audit committee receives reports annually from management on our
cybersecurity strategy and program. Significant changes are reported to the audit committee from time to time.
Cybersecurity incidents which are determined by management to be material will be reported immediately to the audit
committee.
To date, we are not aware of any cybersecurity incident that has had or is reasonably likely to have a material impact
on our business or operations; however, because of the frequently changing attack techniques, along with the increased
volume and sophistication of the attacks, there is the potential for us to be adversely impacted. This impact could result in
reputational, competitive, operational or other business harm as well as financial costs and regulatory action. See “Part I —
Item 1A. Risk Factors” for further discussion of these risks.
ITEM 2. PROPERTIES
Our corporate headquarters is located in Newtown, Pennsylvania, where we lease short-term flexible office space. We
believe that suitable additional or alternative space would be available on commercially reasonable terms if required in the
future.
ITEM 3. LEGAL PROCEEDINGS
For a description of our material pending legal proceedings, please see Note 5, Commitments and Contingencies, to
our consolidated financial statements included in Part IV in this Annual Report. We may, in the ordinary course of
business, face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to
assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or
efficacy of our products. Any of these claims could subject us to costly litigation. If this were to happen, the payment of
any such awards could have a material adverse effect on our business, financial condition and results of operations.
Additionally, any such claims, whether or not successful, could damage our reputation and business.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND
ISSUER PURCHASES OF EQUITY SECURITIES
Market Information
Our common stock is listed under the symbol TRAW on the Nasdaq Capital Market.
Stockholders
As of March 26, 2025, there were approximately 105 holders of record for shares of our common stock. This does not
reflect beneficial stockholders who held their common stock in “street” or nominee name through brokerage firms.
Securities Authorized for Issuance Under Equity Compensation Plans
Information regarding securities authorized for issuance under the Company’s equity compensation plans is contained
in Part III, Item 11 of this Annual Report, and incorporated by reference herein.
Dividend Policy
We have never declared or paid any cash dividends on our capital stock. We currently intend to retain all available
funds and any future earnings to support our operations and finance the growth and development of our business. We do
not intend to pay cash dividends on our common stock for the foreseeable future.
Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities
During the fiscal year ended December 31, 2024, there were no unregistered sales of our securities that were not
reported in a Current Report on Form 8-K or our Quarterly Reports on Form 10-Q.
Issuer Repurchases of Equity Securities
There were no repurchases of our capital stock during the fourth quarter of 2024.
ITEM 6. RESERVED
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together
with our consolidated financial statements and the related notes and other financial information included elsewhere in this
Annual Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual
Report, including information with respect to our plans and strategy for our business and related financing, includes
forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” section of this
Annual Report for a discussion of important factors that could cause actual results to differ materially from the results
described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
The Company’s net losses were $166.5 million and $18.9 million for the years ended December 31, 2024 and
2023, respectively. As of December 31, 2024, the Company had an accumulated deficit of $649.2 million. We expect
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to incur significant expenses and operating losses for the foreseeable future as we continue the development of, and
seek regulatory approval for, our product candidates, even if milestones under our license and collaboration agreements
may be met.
As of December 31, 2024, the Company had $21.3 million in cash and cash equivalents. On December 29,
2024, the Company entered into the Securities Purchase Agreement described below (the “December 2024 Purchase
Agreement”), for the sale of shares of Company common stock, pre-funded warrants, and Series A Warrants and raised
gross proceeds of $20.0 million at closing on December 31, 2024. In addition, on April 1, 2024, in connection with the
Merger, the Company entered into a Securities Purchase Agreement (the “April 2024 Securities Purchase Agreement”)
for the sale of common and preferred stock to TPAV, LLC (“TPAV”), an affiliate of Torrey Pines, and OrbiMed Private
Investments VIII, LP (“OrbiMed”), an affiliate of OrbiMed Advisors (together, the “Investors”) and raised gross
proceeds of $14.0 million. Based on current projections, we believe that we do not have sufficient cash and cash
equivalents to support our operations for more than one year following the date that these financial statements are
issued.
We are exploring various sources of funding for development and applying for regulatory approval of our
research compounds as well as for our ongoing operations. If we raise additional funds through strategic collaborations
and alliances or licensing arrangements with third parties, which may include existing collaboration partners, we may
have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that are not
favorable to us. There can be no assurance, however, that we will be successful in obtaining such financing in sufficient
amounts, on terms acceptable to us, or at all. In addition, there can be no assurance that we will obtain approvals
necessary to market our product candidates or achieve profitability or sustainable, positive cash flow. If we are unable
to successfully raise sufficient additional capital, through future financings or through strategic and collaborative
arrangements, we will not have sufficient cash to fund our ongoing trials and operations.
Our Portfolio/ Product Candidates/ Compounds
We are a clinical-stage biopharmaceutical company aiming to address unmet medical needs in respiratory viral
diseases and cancer. Following the closing of the Merger in which we acquired Trawsfynydd Therapeutics, Inc. on April
1, 2024, we are advancing the development of four clinical programs:
●
Tivoxavir marboxil, which we acquired as part of the Merger, is a small molecule cap-dependent
endonuclease inhibitor. Cap-dependent endonuclease (“CEN”) is an enzyme that is important for
influenza virus replication. Tivoxavir marboxil is intended to inhibit CEN and, thus, is intended to
impede influenza virus replication including, the influenza A or B viral strains and bird flu viral
strains. It is our intention to develop tivoxavir marboxil as an oral dose given only once for potential
treatment and prophylaxis of bird flu and seasonal influenza.
The first-in-man clinical study of tivoxavir marboxil (designated AV5124 in a previous study) was
performed from May to September of 2023 in Russia. The study sponsor was Pharmasyntez, JSC. We
have the right to use the data resulting from the study outside of Russia and the Eurasian Economic
Community countries. The trial was a single ascending dose study, and, as such, each study participant
only received one dose of tivoxavir marboxil. The study consisted of four dose cohorts that received 20,
40, 80 or 120 mg tivoxavir marboxil delivered as 20 mg strength tablets, or placebo. The study enrolled
28 healthy males ages 18-45 years who received either the study drug or placebo. The primary study
endpoint was measurement of the safety and tolerability of single drug doses in healthy volunteers. The
secondary endpoint was the measurement of pharmacokinetic parameters of single drug doses in healthy
volunteers on an empty stomach or after a meal. In the study, one subject who received a single 40 mg
dose of the study drug, experienced two adverse events (“AEs”). This subject experienced
hyperglycemia, which was deemed to be mild and believed probably related to tivoxavir marboxil, and
erosive gastritis with complications in the form of severe iron deficiency anemia, which was considered
to be a serious adverse event (“SAE”) believed unlikely to be related (doubtful per the protocol) to the
study drug.
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There were no other AEs in the trial, including at higher doses. The pharmacokinetic measurements
indicated a small food effect for tivoxavir marboxil, with increased exposure when drug was taken after a
meal but otherwise showed increasing exposure with increasing dose.
We are further advancing the development of tivoxavir marboxil with a Traws Pharma sponsored Phase
1 randomized, blinded, and placebo-controlled study in Australia that was approved by the Human
Research Ethics Committee. To date, this study enrolled four cohorts of 8 participants, with 6
participants randomized to receive study drug and 2 participants assigned to receive placebo in each
cohort. Participants were required to be healthy males or females ages 18-64 years. Participants took
either one dose of the study drug or one dose of placebo, depending on the group they were assigned
to. The dose levels that were evaluated included 80, 120, 240 mg, and 480 mg taken, via oral capsules.
The primary endpoint of the study was the measurement of safety and tolerability, and the secondary
and other endpoints included the determination of the drug pharmacokinetic profile. Topline data
showed good overall tolerability and a pharmacokinetic profile that appears to support the potential use
of tivoxavir marboxil as a one-time treatment for influenza. Sixteen AEs were recorded, of which three
were reported as possibly related to study drug during the study; all were mild headaches. Topline data
from this study showed that a single dose of tivoxavir marboxil maintained plasma drug levels
consistently above the EC90 and within the predicted therapeutic window for more than 23 days. We
plan to meet with the FDA in the first half of 2025 to align on a path forward, including to seek
guidance regarding the potential for accelerated approval utilizing the “Animal Rule” for further
development of tivoxavir marboxil in the treatment of H5N1 bird flu. The FDA “Animal Rule” allows
approval of therapeutic interventions in cases where there is a risk of severe disease and a controlled
human trial would be unethical or infeasible.
●
Ratutrelvir (“TRX01”), which we acquired as part of the Merger, is an inhibitor of the main protease
(also known as 3CL protease) of the SAR-CoV-2 virus, the causative agent in COVID19. The main
protease is an essential component in the mechanism for SARS-CoV-2 replication. TRX01 is intended
to inhibit this protease and reduce SARS-CoV-2 virus replication. In vitro laboratory tests that
measured the impact of TXR01 on SARS-CoV-2 replication, demonstrated that TRX01 inhibited the
replication of viral isolates of the original SARS-CoV-2 isolates, and viral variants in the delta and
omicron types. An animal study using the widely adopted K18 transgenic mouse model, demonstrated
non-inferiority between TRX01 and the combination of nirmatrelvir + ritonavir, in terms of time to
death and lung virus burden in this highly lethal model with neurological manifestations. Based on
preclinical pharmacokinetic studies in multiple animal species, we intend to develop TRX01 for use
without co-administration of a human cytochrome P450 (“CYP”) inhibitor such as ritonavir.
TRX01 was studied in a Phase 1 clinical trial that included single and multiple ascending dose phases.
Participants were required to be healthy males or females ages 18-64 years. The primary endpoint of
the study was the measurement of safety and tolerability, and the secondary endpoint included the
determination of the drug pharmacokinetic and pharmacodynamic profiles. The Phase 1 trial was
conducted in Australia. It was sponsored by the Company and was approved by the Human Research
Ethics Committee. The trial administered either the study drug or placebo to 40 participants in the
single ascending dose phase, which included 5 cohorts with 8 participants in each cohort (6 received
study drug and two received placebo). Subjects in the single ascending dose phase received one oral
dose of the study drug or placebo, depending on their assigned group. The single ascending dose
portion of the study assessed TRX01 at 15, 50, 150, 300 and 600 mg doses. Subjects in the multiple
ascending dose phase received a daily single oral dose of 150 mg or 600 mg (6 active and 2 placebo)
for 10 consecutive days. The study was completed in September 2024. There were few recorded
adverse events reported up to the highest dose, and none were determined to be related to study drug.
Topline data from the study showed no treatment related adverse events reported up to the highest dose.
Topline data also showed that once-daily administration of TRX01 for 10 consecutive days maintained
plasma drug levels within the predicted therapeutic window for 12 days.
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●
Narazaciclib is our oral CDK4-plus inhibitor intended initially to treat low grade endometrioid
endometrial cancer and other cancers. Narazaciclib is a multi-targeted kinase inhibitor targeting
multiple CDK’s, AMP-activated protein kinase (“AMPK”), related protein kinase 5 (“ARK5”), and
colony-stimulating factor 1 receptor (“CSF1R”) at low nM concentrations, as well as other tyrosine
kinases believed to drive tumor cell proliferation, survival and metastasis. We initiated a multi-center
Phase 1/2a trial evaluating narazaciclib in combination with letrozole as a second or third-line therapy
for recurrent metastatic low-grade endometrioid endometrial cancer in the first calendar quarter of
2023. In this study, both narazaciclib and letrozole were administered orally in the Phase 1 dose
escalation phase. The first patient in this trial was dosed in May 2023 and the initial cohort (160mg)
was completed and no DLTs were observed. The 200mg cohort enrolled 6 evaluable subjects but two
patients experienced dose limiting toxicities. As a result, the dose of narazaciclib of 160mg once daily
in combination with letrozole 2.5mg QD was declared to be the maximum tolerated dose and the
recommended Phase 2 dose for women with low grade endometrioid endometrial cancer. This study is
now closed to accrual. The database has been locked, and a clinical study report is currently under
review.
Another Phase 1 study of narazaciclib as a monotherapy has also been conducted in patients with
relapsed and/or refractory advanced cancer. The objectives of this study were to assess the safety,
tolerability, pharmacokinetics and pharmacodynamics of narazaciclib administered orally as escalating
daily doses in patients with advanced cancer relapsed or refractory to at least 1 prior line of therapy.
Narazaciclib was dosed on a continuous daily schedule in 28-day cycles. In this study, the highest dose
tested was 280mg once daily given continuously. This study is now closed to accrual and data analysis
is ongoing in preparation for database lock, data analysis and a clinical study report.
Narazaciclib is also being developed in greater China, under a 2017 license agreement between our
company and HanX. The development in greater China is entirely sponsored by HanX. The compound
is being studied in China in a clinical trial of patients with Grade III and IV glioma.
Our objective for narazaciclib is to establish additional partnerships for further development of the
compound.
●
Rigosertib is our second asset in oncology. Rigosertib is currently being studied in investigator
initiated trials for epidermolysis bullosa-associated squamous cell carcinoma. Both studies included
the use of either IV or oral rigosertib, depending on the clinical need of the patient. This is due to GI
obstruction arising as a result of the presence of esophageal strictures complicating oral administration
or extreme skin fragility complicating IV administration. It is, therefore, important in these patients
that the investigator has both dosing options for the appropriate dosing of their patients. The data
presented here are preliminary and may be subject to change. Our objective for this program is to
establish partnerships for the development of rigosertib in this indication.
Recent Developments
Reverse Stock Split
In September 2024, our board of directors (the “Board”) approved a one-for-25 reverse stock split of the
Company’s outstanding shares of common stock (the “Reverse Stock Split”). Each 25 shares of the common stock of the
Company, par value of $0.01 per share, issued and outstanding immediately prior to the Reverse Stock Split automatically
reclassified, combined, converted and changed into one fully paid and non-assessable share of common stock. In addition,
a proportionate adjustment was made to the per share exercise price and the number of shares issuable upon the exercise of
all outstanding options, warrants and convertible preferred stock entitling the holders to purchase shares of the Company’s
common stock, and the number of shares reserved for issuance pursuant to the Company’s 2021 Incentive Compensation
Plan (as amended and restated, the “2021 Plan”), including pursuant to outstanding restricted stock units outstanding
thereunder, was reduced proportionately. No fractional shares were issued as a result of the Reverse Stock Split. Instead,
the Company’s stockholders who otherwise would have been entitled to a fraction of a share received a full
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share of common stock. All common stock, per share and related information presented in this Annual Report for periods
prior to the date of the Reverse Stock Split, including the financial statements and accompanying notes, have been
retroactively adjusted to reflect the Reverse Stock Split.
At the Market Offering Agreement
On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”)
with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common
stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement),
from time to time, to or through Citizens, acting as sales agent and/or principal. Sales of shares of common stock, if any,
pursuant to the ATM Agreement will be made by any method permitted that is deemed an “at the market” offering as
defined in Rule 415(a)(4) under the Securities Act of 1933, as amended (the “Securities Act”), including sales made
directly on or through the Nasdaq Capital Market or any other existing trading market in the United States for the
Company’s common stock, directly to Citizens as principal, in privately negotiated transactions, in block transactions
and/or in any other method permitted by law. Subject to the terms and conditions of the ATM Agreement, Citizens will use
commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law,
rules and regulations and the rules of the Nasdaq Capital Market to sell shares, from time to time, based upon the
Company’s instructions, including any price, time or size limits specified by the Company.
The Company is not obligated to make any sales of common stock under the ATM Agreement and no assurance
can be given that the Company will sell any shares under the ATM Agreement, or, if it does, as to the price or amount of
shares that the Company will sell, or the dates on which any such sales will take place. The ATM Agreement may be
terminated by the Company at any time with five business days’ notice to Citizens, by Citizens at their discretion, or as
otherwise permitted in the ATM Agreement.
The shares of Company common stock will be sold pursuant to the Company’s effective shelf registration
statement on Form S-3 and an accompanying prospectus (Registration Statement No. 333-273081), filed with the
Securities and Exchange Commission (the “Commission”) on June 30, 2023, and declared effective by the Commission on
July 11, 2023, including the base prospectus contained therein, as supplemented by a prospectus supplement dated March
10, 2025 (the “Prospectus Supplement”) and filed with the Commission pursuant to Rule 424(b) under the Securities Act,
or subsequently filed prospectus supplements as applicable. In accordance with the terms of the ATM Agreement, the
Company may offer and sell shares of its common stock having an aggregate offering price of up to $5,514,200, from time
to time, to or through Citizens, which was the Company’s current “baby shelf” limitation under General Instruction I.B.6.
of Form S-3 as of the date of filing the Prospectus Supplement.
The Company will pay Citizens a commission at a fixed rate of 3.0% of the gross proceeds of each sale of shares
of Company common stock sold through or to Citizens under the ATM Agreement and will reimburse Citizens for the fees
and disbursements of its legal counsel incurred in connection with entering into the transactions contemplated by the ATM
Agreement in an amount not to exceed $50,000 in the aggregate, in addition to up to $5,000 per “Representation Date” (as
defined in the ATM Agreement) in connection with ongoing diligence arising from the transactions contemplated by the
ATM Agreement.
The Company made certain customary representations, warranties and covenants in the ATM Agreement
concerning the Company and its subsidiaries and the registration statement and base prospectus contained therein,
prospectus supplement and other documents and filings relating to the offering of the shares. In addition, the Company has
also provided Citizens with customary indemnification rights.
Nasdaq Compliance
The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in
2024 regarding non-compliance with continued listing requirements. On February 25, 2025, the Company received a letter
from Nasdaq confirming that the Company has regained compliance with Listing Rule 5550(b)(1) related to minimum
stockholders’ equity requirements, as required by the Hearings Panel of Nasdaq’s decision dated December 13, 2024.
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Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year
from the date of such letter.
December 2024 Purchase Agreement
On December 29, 2024, the Company entered into the December 2024 Purchase Agreement with several investors
for the sale of (i) up to 3,630,205 Class A Units (“Class A Units”), each Class A Unit consisting of (a) one share of
common stock or one pre-funded warrant to initially purchase one share of common stock, and (b) one Series A Warrant to
purchase one share of common stock and (ii) 289,044 Class B Units (“Class B Units” and, together with the Class A Units,
the “Units”), each Class B Unit consisting of one pre-funded warrant and one Series A Warrant. The purchase price per
Class A Unit was $5.103 and the purchase price per Class B Unit was $5.093. The Units sold pursuant to the December
2024 Purchase Agreement were issued to the purchasers thereunder on December 31, 2024.
The Series A Warrants have an exercise price of $13.42 per share of common stock, and, subject to certain
beneficial ownership limitations described in the Series A Warrants, will be exercisable six months after issuance and will
expire on the earlier of (a) subject to the fulfilment of the Equity Conditions (as defined in the December 2024 Purchase
Agreement), thirty Trading Days (as defined in the Purchase Agreement) after the last of the following data readouts to
occur, as announced by the Company: (i) Ferret animal model Bird Flu data, (ii) non-human primate Bird Flu data, or (iii)
Phase 2a Influenza A human clinical data and (b) the 5-year anniversary of the closing date of the December 2024
Purchase Agreement. The pre-funded warrants have an exercise price of $0.01 per share, and subject to certain beneficial
ownership limitations described in the pre-funded warrants, are exercisable and do not expire. The exercise price of the
Series A Warrants and pre-funded warrants will be subject to adjustment for stock splits, reverse splits, and similar capital
transactions, as described in the Series A Warrants and pre-funded warrants.
The Company also entered into an agreement with Tungsten Advisors (through its Broker-Dealer, Finalis
Securities LLC) (“Tungsten”), pursuant to which Tungsten agreed to serve as exclusive placement agent for the offering.
The Company has agreed to pay Tungsten a cash fee equal to 8.25% of the aggregate gross proceeds raised in this offering
from certain investors who are not affiliated with the Company and a cash fee equal to 4.125% of the aggregate gross
proceeds raised in this offering with respect to certain investors that are affiliates of the Company.
The net proceeds to the Company from the offering were approximately $18.1 million, after deducting placement
agent’s fees and other estimated offering expenses, with approximately $20 million gross proceeds at closing through the
sale of shares of common stock and pre-funded warrants and up to another $52.6 million upon exercise of Series A
Warrants issued with the offering if exercised in full prior to expiration thereof.
All of the securities in the offering were sold by the Company. The offering of common stock was made pursuant
to the Company’s effective registration statement on Form S-3 (File No. 333-273081). The Series A Warrants, pre-funded
warrants, and the shares of common stock underlying such warrants were offered in a concurrent private placement
pursuant to an exemption from the registration requirements of Section 5 of the Securities Act of 1933, as amended,
contained in Section 4(2) thereof and/or Regulation D thereunder. On January 14, 2025, as required by the December 2024
Purchase Agreement, the Company filed a registration statement on Form S-3 to register the shares of common stock
issuable upon exercise of the Series A Warrants and the pre-funded warrants for resale by the holders thereof, which
registration statement was declared effective by the SEC on January 22, 2205.
As required by the December 2024 Purchase Agreement, the Company obtained stockholder approval of the
exercise of the Series A Warrants and pre-funded warrants, as required by Nasdaq rules, at that special meeting of
stockholders held on February 17, 2025. Thereafter, certain investors exercised their pre-funded warrants for an aggregate
of 1,382,559 shares of common stock.
On February 18, 2025, the Company and certain of the purchasers entered into amendments to the Series A
Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants issued to such purchasers were
amended to (i) increase the threshold for a change of control, for purposes of determining whether a Fundamental
Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding common stock of the
Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the expected volatility rate to
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be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be utilized for calculating
consideration payable to the holders of the Series A Warrants in connection with a Fundamental Transaction that is not
within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under certain circumstances,
provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse stock split, stock
consolidation, or a recapitalization or similar event involving the Company’s common stock based on the volume weighted
average price of the Company’s common stock over the eleven trading day period commencing five trading days
immediately preceding such event and the five trading days immediately following such event.
On March 27, 2025, the Company and certain of the purchasers entered into amendments to the pre-funded
warrants (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to
increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined
in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50%
of the outstanding common stock of the Company.
Merger
On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of
Merger, dated April 1, 2024 (the “Merger Agreement”), by and among the Company, Traws Merger Sub I, Inc., a Delaware
corporation (“First Merger Sub”), Traws Merger Sub II, LLC, a Delaware limited liability company (“Second Merger
Sub”), and Trawsfynydd. Pursuant to the Merger Agreement, First Merger Sub merged with and into Trawsfynydd,
pursuant to which Trawsfynydd was the surviving corporation (the “First Merger”). Immediately following the First
Merger, Trawsfynydd merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving
entity and a wholly owned subsidiary of the Company (the “Second Merger” and together with the First Merger, the
“Merger”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Under the terms of the Merger Agreement, upon the consummation of the Merger on April 1, 2024 (the
“Closing”), in exchange for the outstanding shares of capital stock of Trawsfynydd immediately prior to the effective time
of the First Merger, the Company issued to the stockholders of Trawsfynydd an aggregate of (A) 141,982 shares of
Common Stock and (B) 10,359.0916 shares of Series C Preferred (as defined and described below). Each share of Series C
Preferred converts into shares of common stock, subject to certain conditions and the Beneficial Ownership Limitation
(defined below) as set forth in the Certificate of Designation. In addition, the Company assumed all Trawsfynydd stock
options immediately outstanding prior to the First Merger, each becoming an option to purchase common stock subject to
adjustment pursuant to the terms of the Merger Agreement (the “Assumed Options”). The Assumed Options are
exercisable for an aggregate of 365,547 shares of common stock. Following the effective time of the Second Merger, the
Company changed its name to “Traws Pharma, Inc.”
The Board approved the Merger Agreement and the related transactions, and the consummation of the Merger was
not subject to approval of Company stockholders.
In accordance with the Merger Agreement, each of Werner Cautreels, Iain Dukes, and Nikolay Savchuk were
appointed to the Board effective as of the Closing. In accordance with the Merger Agreement, Werner Cautreels was
appointed as Chief Executive Officer of the Company, Iain Dukes was appointed as Executive Chairman of the Company,
and Nikolay Savchuk was appointed as Chief Operating Officer of the Company effective as of the Closing.
Pursuant to the Merger Agreement, the Company agreed to hold a stockholders’ meeting to submit, among other
proposals, the following proposals to its stockholders for their consideration: (i) the approval of the conversion of shares of
Series C Preferred into shares of Common Stock in accordance with the rules of the Nasdaq Stock Market LLC, the Merger
Agreement and the Certificate of Designation (the “Conversion Proposal”) and (ii) the approval of an amendment to the
Company’s Certificate of Incorporation (as amended to date, the “Charter”), to increase the authorized shares of common
stock from 125,000,000 to 250,000,000 (the “Share Increase Proposal” and together with the Conversion Proposal, the
“Meeting Proposals”). In connection with these matters, the Company agreed to file a proxy statement on Schedule 14A
with the Securities and Exchange Commission (the “SEC”). Such proxy statement was filed on August 9, 2024. At a
special meeting of the stockholders held on September 16, 2024, the stockholders approved the Meeting Proposals and,
subject to the Beneficial Ownership Limitation, the outstanding shares of Series C Preferred, automatically
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converted to shares of common stock. After the automatic conversion, there were 7,440 shares of Series C Preferred
outstanding. In connection with the increase in common shares outstanding due to the December 2024 Purchase
Agreement, certain investors converted an additional 42.45 Series C Preferred shares into an aggregate of 16,980 shares of
the Company’s common stock to maintain the Beneficial Ownership Limitation. As of December 31, 2024, 7,398 shares of
Series C remained outstanding.
Support Agreements
In connection with the execution of the Merger Agreement, the Company and Trawsfynydd entered into
stockholder support agreements (the “Company Stockholder Support Agreements”) with certain of the Company’s
stockholders (solely in their capacity as stockholders of the Company). Pursuant to the Support Agreements, among other
things, each of the Company stockholder parties thereto agreed to vote or cause to be voted all of the shares of common
stock owned by such stockholder in favor of the Meeting Proposals.
In connection with the execution of the Merger Agreement, the Company and Trawsfynydd entered into
stockholder support agreements (the “Trawsfynydd Stockholder Support Agreements”) with all of Trawsfynydd’s
stockholders (solely in their capacity as stockholders of the Company). Pursuant to the Trawsfynydd Stockholder Support
Agreements, among other things, each of the Trawsfynydd stockholders agreed to the terms and conditions of the Merger
Agreement, to waive any dissenters’ rights and to release claims such stockholder may have against the Company and
Trawsfynydd.
Lock-up Agreements
Concurrently and in connection with the execution of the Merger Agreement, certain Trawsfynydd stockholders as
of immediately prior to the Closing, and certain directors, officers, and stockholders of the Company as of immediately
prior to the Closing entered into lock-up agreements with the Company and Trawsfynydd, pursuant to which each such
stockholder agreed to be subject to a 180-day lockup on the sale or transfer of shares of the Company held by each such
stockholder at the Closing, including those shares of Common Stock received by each such stockholder in the Merger and
Common Stock received upon conversion of Series C Preferred upon Board approval (the “Lock-up Agreements”).
Contingent Value Rights Agreement
Concurrently with the Closing of the Merger, the Company entered into a contingent value rights agreement (the
“CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of common stock as of the
applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the
Merger, is entitled to one contractual contingent value right (each, a “CVR”), subject to and in accordance with the terms
and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record
time (5:00 p.m. ET on April 15, 2024).
When issued, each contingent value right will entitle the holder (the “Holder”) thereof to distributions of the
following, pro-rated on a per-CVR basis, during the CVR Term (as defined in the CVR Agreement):
●
43.7% of the Net Proceeds (as defined in the CVR Agreement) received by us in a given calendar quarter in
the event of the sale, license, transfer or disposition of rights to our two leading cancer drug candidates,
Narazaciclib and Rigosertib (including any such sale or disposition of equity securities in any subsidiary
established by us to hold any right, title or interest in or to Rigosertib or Narazaciclib); or
●
6.24% of any Net Sales (as defined in the CVR Agreement) for our two leading cancer drug candidates,
Narazaciclib and Rigosertib, by us or any of our affiliates in a given calendar quarter.
The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of
deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-
pocket expenses incurred by us.
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Under the CVR Agreement, the Rights Agent has, and Holders of at least 30% of the CVRs then-outstanding
have, certain rights to audit and enforcement on behalf of all Holders of the CVRs.
Private Placement and Securities Purchase Agreement
On April 1, 2024, the Company entered into the April 2024 Securities Purchase Agreement with TPAV and
OrbiMed. Pursuant to the April 2024 Purchase Agreement, the Company issued and sold an aggregate of (i) 19,879 shares
of common stock and (ii) 1,578.2120 shares of Series C Preferred (the “Private Investment in Public Equity” or “PIPE
Securities”) for an aggregate purchase price of approximately $14 million (collectively, the “Financing”). The closing of
the Financing occurred concurrently with the closing of the Merger on April 1, 2024 (the “Financing Closing Date”).
Subject to the Beneficial Ownership Limitation (defined below), each share of Series C Preferred converts into shares of
common stock, as provided in the Certificate of Designation.
Registration Rights Agreement
On April 1, 2024, in connection with the April 2024 Purchase Agreement, the Company entered into a
Registration Rights Agreement (the “Registration Rights Agreement”) with the holders of common stock and Series C
Preferred signatory thereto. Pursuant to the Registration Rights Agreement, we are required to prepare and file a resale
registration statement with the SEC within 90 calendar days following the Financing Closing Date (the “Filing Deadline”),
with respect to the shares of common stock underlying the PIPE Securities and the common stock and Series C Preferred
issued to the signatories to the Registration Rights Agreement in the Merger. The Company filed such registration
statement on July 1, 2024, which was declared effective on August 28, 2024.
Certificate of Designation
On April 1, 2024, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the
Series C Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State
of Delaware in connection with the Merger. The Certificate of Designation provides for the designation of shares of the
Series C Preferred. Holders of Series C Preferred are entitled to receive dividends on shares of Series C Preferred equal to,
on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common
stock.
Except as otherwise required by law, the Series C Preferred does not have voting rights. However, as long as any
shares of Series C Preferred are outstanding, we will not, without the affirmative vote of the holders of a majority of the
then-outstanding shares of the Series C Preferred, (i) alter or change adversely the powers, preferences or rights given to
the Series C Preferred or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any
provision to, the Charter or our bylaws, or file any articles of amendment, certificate of designations, preferences,
limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or
change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series C Preferred,
regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger,
consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series C Preferred,
(iii) prior to the earlier of stockholder approval of the Conversion Proposal or the six-month anniversary of the Closing,
consummate either: (A) any Fundamental Transaction (as in the Certificate of Designation) or (B) any stock sale to, or any
merger, consolidation or other business combination with or into, another entity in which our stockholders immediately
before such transaction do not hold at least a majority of the capital stock immediately after such transaction, or (iv) enter
into any agreement with respect to any of the foregoing.
The Series C Preferred does not have a preference upon any liquidation, dissolution or winding-up of Traws
Pharma. Following stockholder approval of the Conversion Proposal, each share of Series C Preferred automatically
converted into 400 shares of common stock (on a post-split basis), subject to certain limitations, including that a holder of
Series C Preferred was prohibited from converting shares of Series C Preferred into shares of common stock if, as a result
of such conversion, such holder, together with its affiliates, would beneficially own more than 19.9% of the total number of
shares of Common Stock issued and outstanding immediately after giving effect to such conversion (the “Beneficial
Ownership Limitation”). The Series C Preferred is redeemable for cash at the option of the holder thereof at any time
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following the date that is nine months after the initial issuance of the Series C Preferred or following any failure to deliver
shares of common stock in accordance with the terms of the Series C Preferred, at a price per share equal to the then-
current fair value of the Series C Preferred on an as-converted basis, as described in the Certificate of Designation.
Certificate of Amendment
On April 2, 2024, the Company changed its name to “Traws Pharma, Inc.” pursuant to a certificate of amendment
to the Charter filed with the Secretary of State of the State of Delaware (the “Name Change”). Pursuant to the Delaware
General Corporation Law, a stockholder vote was not necessary to effectuate the Name Change and it does not affect the
rights of the Company’s stockholders. In addition, effective at the open of market trading on April 3, 2024, our common
stock ceased trading under the ticker symbol “ONTX” and began trading on the Nasdaq Stock Market under the ticker
symbol “TRAW”.
Transaction Costs
In connection with the Merger, the Company incurred transaction costs of approximately $8.7 million during the
year ended December 31, 2024. The transaction costs were included in the consideration paid to acquire Trawsfynydd and
immediately expensed as a component of in-process research and development expense in the statement of operations for
the year ended December 31, 2024.
Tungsten acted as financial advisor to the Company in connection with the Merger. As compensation for services
rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 6,747 shares of
Common Stock and 535 shares of Series C Preferred with an aggregated estimated fair value of $5.0 million and paid
approximately $1.0 million in cash in April 2024. The 535 shares of Series C Preferred were subsequently converted into
220,932 shares of common stock in connection with the Board’s approval of the Series C Preferred conversion. All of the
compensation to Tungsten was contingent on the closing of the Merger and therefore was expensed in the second quarter of
2024.
Employment and Severance Agreements
In accordance with the Merger Agreement, three directors were appointed to the Board of the Company and there
were several changes to management, each effective as of the Closing.
On April 8, 2024, the Company terminated 11 of its 17 employees, some of whom have been retained as
consultants. Severance costs of $0.9 million were expensed as a result of the termination. All severance costs were paid as
of December 31, 2024.
Changes in Management
Effective February 5, 2025, Mark Guerin resigned from his role as Chief Financial Officer of the Company and
Nora Brennan was appointed as Interim Chief Financial Officer.
On March 28, 2025, Werner Cautreels notified the Company of his decision to retire and resign from his role as
Chief Executive Officer of the Company, effective as of the close of business on the day that this Annual Report is filed
with the SEC (the “Termination Date”). Dr. Cautreels will continue to serve as a director on the Board after the
Termination Date, and will also continue to provide certain consulting services to the Company for a period of time after
the Termination Date.
Iain Dukes, the Company’s Executive Chairman, has been appointed as Interim Chief Executive Officer, effective
as of the Termination Date.
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Financial Overview
Revenue
During the years ended December 31, 2024 and 2023, our revenues were derived exclusively from activities conducted
in accordance with our collaboration arrangement with SymBio.
We have not generated any revenue from commercial product sales. In the future, if any of our product candidates
currently under development are approved for commercial sale in the United States or other territories where we have
retained commercialization rights, we may generate revenue from product sales, or alternatively, we may choose to select a
collaborator to commercialize our product candidates in these markets.
We are recognizing the $7.5 million upfront payment received in 2011 under the SymBio collaboration agreement as
revenue on a straight-line basis through December 2037, reflecting our estimate of when we will complete our obligations
under the agreement. For the years ended December 31, 2024 and 2023, we recognized revenues of $226,000, under the
SymBio collaboration agreement.
Operating Expenses
In-Process Research and Development
Research and development costs incurred in obtaining technology licenses are charged to research and
development expense if the technology licensed has not reached technological feasibility which includes manufacturing,
clinical, intellectual property and/or regulatory success which has no alternative future use. The licenses purchased by us
require substantial completion of research and development and regulatory and marketing approval efforts in order to reach
technological feasibility. As such, and since our inception, the purchase price of licenses acquired is classified as acquired
in-process research and development expenses in the statements of operations.
Research and Development Expenses
Our research and development expenses consist primarily of costs incurred for the development of our product
candidates, which include:
●
employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
●
expenses incurred under agreements with CROs and investigative sites that conduct our clinical trials and
preclinical studies;
●
the cost of acquiring, developing and manufacturing clinical trial materials;
●
direct expenses for maintenance of research equipment, clinical trial insurance and other supplies; and
●
costs associated with preclinical activities and regulatory operations.
Research and development costs are expensed as incurred. License fees and milestone payments we make related to in-
licensed products and technology are expensed if it is determined that they have no alternative future use. We record costs
for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific
tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors.
Research and development activities are central to our business model. Product candidates in later stages of clinical
development generally have higher development costs than those in earlier stages of clinical development, primarily due to
the increased size and duration of later-stage clinical trials.
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Our research and development expenses are related to tivoxavir marboxil, ratutrelvir, narazaciclib, rigosertib, and
potentially in-licensed products. We do not currently utilize a formal time allocation system to capture expenses on a
project-by-project basis because we are organized and record expense by functional department and our employees may
allocate time to more than one development project. Accordingly, we do not allocate expenses to individual projects or
product candidates, although we do allocate some portion of our research and development expenses by functional area and
by compound.
It is difficult to determine with certainty the duration and completion costs of our current or future preclinical
programs and clinical trials of our product candidates, or if, when or to what extent we will generate revenues from the
commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in
achieving regulatory approval for any of our product candidates. The duration, costs and timing of clinical trials and
development of our product candidates will depend on a variety of factors, including the uncertainties of future clinical and
preclinical studies, uncertainties in clinical trial enrollment rate and significant and changing government regulation. In
addition, the probability of success for each product candidate will depend on numerous factors, including competition,
manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund
each program in response to the scientific and clinical success of each product candidate, an assessment of each product
candidate’s commercial potential and our available funds.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for executive and other
administrative personnel, including stock-based compensation and travel expenses. Other general and administrative
expenses include facility-related costs, communication expenses, insurance, board of directors expenses and professional
fees for legal, patent review, consulting and accounting services.
We anticipate that our general and administrative expenses will remain consistent in the short-term, but would increase
in the future with the continued research and development and potential commercialization of our product candidates.
These increases will likely include increased costs for insurance, costs related to the hiring of additional personnel and
payments to outside consultants among other expenses. Additionally, if and when we believe a regulatory approval of a
product candidate appears likely, we anticipate an increase in payroll and expense as a result of our preparation for
commercial operations, especially as it relates to the sales and marketing of our product candidates.
Series A Warrant and pre-funded warrant expense
Series A Warrant and pre-funded warrant expense represents the excess of the warrant liability compared to the net
proceeds received as part of the December 2024 Purchase Agreement.
Other Income, Net
Other income, net consists principally of interest income earned on cash and cash equivalent balances and foreign
exchange gains and losses.
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Results of Operations
Comparison of the Years Ended December 31, 2024 and 2023
Year ended December 31,
2024
2023
Change
Revenue
$
226,000
$
226,000
$
—
Operating expenses:
Acquired in-process research and development
117,464,000
—
117,464,000
Research and development
12,847,000
11,430,000
1,417,000
General and administrative
12,289,000
9,094,000
3,195,000
Total operating expenses
142,600,000
20,524,000
122,076,000
Loss from operations
(142,374,000)
(20,298,000)
(122,076,000)
Series A warrant and prefunded warrant expense
(24,438,000)
—
(24,438,000)
Other income, net
289,000
1,350,000
(1,061,000)
Net loss
$ (166,523,000)
$ (18,948,000)
$ (147,575,000)
Revenues
Revenues for the years ended December 31, 2024 were consistent with the year ended December 31, 2023 and were
due to the recognition of deferred revenue from our collaboration with SymBio.
Acquired in-process research and development
In connection with the Merger, we recognized a non-cash in-process research and development expense of $117.5
million related to the acquired virology programs that had no alternative future use at the time of acquisition which requires
immediate expense recognition.
Research and development expenses
The details of our research and development expenses are:
Year ended December 31,
2024
2023
Virology
$
4,589,000
$
-
Oncology
5,290,000
8,444,000
Personnel related
2,787,000
2,400,000
Stock based compensation
181,000
586,000
$
12,847,000
$
11,430,000
Research and development expenses increased by $1.4 million, or 12.4%, to $12.8 million for the year ended
December 31, 2024, from $11.4 million for the year ended December 31, 2023. The increase was primarily attributable to
costs incurred in connection with our acquired virology programs of $4.6 million and a $0.4 million increase in personnel
related expenses attributable to our restructuring activities. In connection with the Merger, we initiated and completed our
Phase 1 study for tivoxavir marboxil in Australia. The increases were partially offset by a $3.2 million decrease in
oncology costs and a $0.4 million decrease in stock based compensation.
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General and administrative expenses
The details of our general and administrative expenses are:
Year Ended December 31,
2024
2023
Professional & consulting fees
$
5,954,000
$
2,162,000
Stock based compensation
1,209,000
715,000
Personnel related
3,035,000
3,264,000
Public company costs
1,231,000
1,968,000
Insurance & other
860,000
985,000
$
12,289,000
$
9,094,000
General and administrative expenses increased by $3.2 million, or 35.1%, to $12.3 million for the year ended
December 31, 2024, from $9.1 million for the year ended December 31, 2023. The increase was primarily attributable to a
$3.8 million increase in consulting fees in connection with seeking strategic alternatives for our investors and a $0.5
million increase in stock based compensation as a result of the options assumed in connection with the Merger. These
increases were partially offset by a decrease of $0.7 million in public company costs and a decrease in personnel related
costs of $0.2 million due to a decrease in headcount.
Series A Warrant and pre-funded warrant expense
Series A Warrant and pre-funded warrant expense of $24.4 million during the year ended December 31, 2024
represents the excess fair value of the warrant liabilities of $42.5 million over the $18.1 million in net proceeds in
connection with the December 2024 Purchase Agreement.
Other income, net
Other income, net, decreased by $1.1 million for the year ended December 31, 2024 compared to the year ended
December 31, 2023. The change was caused by lower interest income due to lower cash balances.
Liquidity and Capital Resources
Since our inception, we have incurred net losses and experienced negative cash flows from our operations. We
incurred net losses of $166.5 million and $18.9 million for the years ended December 31, 2024 and 2023, respectively. Our
operating activities used $29.8 million and $17.9 million of net cash during the year ended December 31, 2024 and 2023,
respectively. As of December 31, 2024, we had an accumulated deficit of $649.2 million, working capital of $13.4 million,
and cash and cash equivalents of $21.3 million. Based on current projections, we believe that we do not have sufficient
cash and cash equivalents to support our operations for more than one year following the date that these financial
statements are issued. As a result of these conditions, substantial doubt exists about our ability to continue as a going
concern. Due to the inherent uncertainty involved in making estimates and the risks associated with the research,
development, and commercialization of biotechnology products, we may have based this estimate on assumptions that may
prove to be wrong, and our operating plan may change as a result of many factors currently unknown to us.
We will require substantial additional financing to fund our ongoing clinical trials and operations, and to continue
to execute our strategy. To alleviate the conditions that raise substantial doubt about our ability to continue as a going
concern, we plan to explore various dilutive and non-dilutive sources of funding, including debt and equity financings
(including pursuant to the ATM Agreement), strategic alliances, business development and/or combinations, and other
sources. The future success of the Company is dependent upon our ability to obtain additional funding. There can be no
assurance, however, that we will be successful in obtaining such funding in sufficient amounts, on terms acceptable to us,
or at all. The failure to obtain sufficient capital on acceptable terms when needed would have a material adverse effect on
our business, results of operations, and financial condition. Accordingly, we have concluded that substantial doubt exists
with respect to our ability to continue as a going concern within one year after the date that these financial statements are
issued.
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The accompanying financial statements have been prepared on a going concern basis, which contemplates the
realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments
relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that
might be necessary should we be unable to continue as a going concern.
Cash Flows
The following table summarizes our cash flows for the year ended December 31, 2024 and 2023:
Year Ended December 31,
2024
2023
Net cash (used in) provided by:
Operating activities
$
(29,792,000)
$
(17,932,000)
Investing activities
(3,648,000)
(14,000)
Financing activities
33,976,000
—
Effect of foreign currency translation
(19,000)
10,000
Net increase (decrease) in cash and cash equivalents
$
517,000
$
(17,936,000)
Net cash used in operating activities
Net cash used in operating activities was $29.8 million for the year ended December 31, 2024 and consisted primarily
of a net loss of $166.5 million and a $6.5 million change in operating assets and liabilities. Significant changes in operating
assets and liabilities included a net decrease in accounts payable and accrued expenses of $4.5 million due to timing of
invoices and payments to our vendors. These operating uses of cash were offset by $143.3 million in non-cash charges
primarily attributable to the immediate expensing of in-process research and development acquired in connection with the
Merger of $117.5 million, immediate expensing of the Series A warrant and pre-funded warrant expense of $24.4 million,
and $1.4 million related to stock-based compensation expense.
Net cash used in operating activities was $17.9 million for the year ended December 31, 2023 and consisted primarily
of a net loss of $18.9 million, including $1.3 million of noncash stock-based compensation and depreciation expense.
Changes in operating assets and liabilities resulted in a net decrease in cash of $0.3 million. Significant changes in
operating assets and liabilities included a $1.3 million increase in prepaid assets and other current assets related to our
agreements with clinical and manufacturing vendors, partially offset by $1.2 million higher accounts payable and accrued
liabilities as a result of the timing of clinical trial and other accruals, and receipt and payment of vendor invoices. Deferred
revenue decreased $0.2 million due to recognition of the unamortized portion of the upfront payment under our
collaboration agreement with SymBio.
Net cash used in investing activities
Net cash used in investing activities was $3.6 million for the year ended December 31, 2024 and primarily related to
the transaction costs of $3.6 million in connection with the Merger.
Net cash used in investing activities was $14,000 for the year ended December 31, 2023 and primarily attributable to
the purchase of property and equipment.
Net cash provided by financing activities
Net cash provided by financing activities was $34.0 million for the year ended December 31, 2024 and primarily
attributable to the net proceeds received from the sale of our preferred and common stock in connection with the securities
offerings in April and December 2024. There were no financing activities during the year ended December 31, 2023.
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Material Cash Requirements
We have not achieved profitability since our inception and we expect to continue to incur net losses for the foreseeable
future. We expect net cash expended in 2025 to be higher than 2024 due to clinical trials and increased headcount in our
clinical and regulatory groups. We also expect an increase in costs for potential in-licensing, the timing of which will be
determined by the timing of any potential in-licensing. We enter into contracts in the normal course of business with third-
party contract organizations for clinical trials, preclinical studies, manufacturing and other services and products for
operating purposes. These contracts generally provide for termination following a certain period after notice and therefore
we believe that, currently, our non-cancelable obligations under these agreements are not material. Based on current
projections, we believe that we do not have sufficient cash and cash equivalents to support our operations for more than
one year following the date that these financial statements from our Annual Report on Form 10-K are issued. These
conditions raise substantial doubt about our ability to continue as a going concern through the one-year period after the
date that the financial statements are issued.
We are exploring various sources of funding for continued development and any potential in-licensed compounds as
well as our ongoing operations. We expect to incur significant expenses and operating losses for the foreseeable future as
we continue the development and clinical trials of, and seek regulatory approval for, our product candidates, even if
milestones under our license and collaboration agreements may be met. If we obtain regulatory approval for any of our
product candidates, we expect to incur significant NDA preparation and commercialization expenses. We do not currently
have a relationship with an organization for the sales, marketing and distribution of pharmaceutical products. In the future,
we may rely on licensing and co-promotion agreements with strategic or collaborative partners for the commercialization
of our products in the United States and other territories. If we choose to build a commercial infrastructure to support
marketing in the United States for any of our product candidates that achieve regulatory approval, such commercial
infrastructure could be expected to include a targeted, oncology sales force supported by sales management, internal sales
support, an internal marketing group and distribution support. To develop the appropriate commercial infrastructure
internally, we would have to invest financial and management resources, some of which would have to be deployed prior to
having any certainty about marketing approval. Furthermore, we have and expect to continue to incur additional costs
associated with operating as a public company.
Please see “Risk Factors” for additional risks associated with our substantial capital requirements.
Critical Accounting Policies and Estimates
This management’s discussion and analysis of our financial condition and results of operations is based on our
consolidated financial statements, which have been prepared in accordance with US generally accepted accounting
principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect
the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in
our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments. We base our
estimates on historical experience, known trends and events and various other factors that we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and
liabilities that are not readily apparent from other sources. Actual results may differ materially from these estimates under
different assumptions or conditions.
We believe the following accounting policies may involve a higher degree of judgment and complexity in their
application than our other accounting policies and represent the most critical judgments and estimates used in the
preparation of our consolidated financial statements. Our significant accounting policies are presented within Note 2 to our
Financial Statements.
Clinical Trial Expense
As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued
expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under
contracts with vendors, consultants and CROs and clinical site agreements in connection with conducting clinical trials.
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in
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payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our
objective is to reflect the appropriate clinical trial expenses in our consolidated financial statements by matching the
appropriate expenses with the period in which services are provided and efforts are expended. We account for these
expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the
trial. We determine accrual estimates through financial models that take into account discussion with applicable personnel
and outside service providers as to the progress or state of completion of trials, or the services completed. During the
course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make
estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on the facts
and circumstances known to us at that time. Our clinical trial accrual and prepaid assets are dependent, in part, upon the
receipt of timely and accurate reporting from CROs and other third-party vendors. Although we do not expect our
estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services
performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts
that are too high or too low for any particular period.
Recent Accounting Pronouncements
See Note 2 to our consolidated financial statements found in this Annual Report on Form 10-K for a description of
recent accounting pronouncements applicable to our consolidated financial statements.
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a smaller reporting company, the Company is not required to provide the information otherwise required by this
Item.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements and supplementary data required by this item are listed in Item 15 — “Exhibits and Financial
Statement Schedules” of this Annual Report.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer (our principal executive officer) and
Interim Chief Financial Officer (our principal financial officer), has evaluated, as of the end of the period covered by this
Annual Report, the effectiveness of our “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e)
under the Exchange Act). Based on such evaluation, and due to the identification of material weaknesses in our internal
controls over financial reporting as of December 31, 2024, which is discussed in additional detail below, our Chief
Executive Officer and Interim Chief Financial Officer concluded that, as of December 31, 2024, our disclosure controls and
procedures were not effective to ensure that information we are required to disclose in reports that we file or submit under
the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and
Exchange Commission rules and forms, and to ensure that information required to be disclosed by us in such reports is
accumulated and communicated to our management, including our Chief Executive Officer and our Interim Chief Financial
Officer, where appropriate, to allow timely decisions regarding required disclosure.
Management’s Annual Report on Internal Control Over Financial Reporting
As required by SEC rules and regulations implementing Section 404 of the Sarbanes-Oxley Act, our management
is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-
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15(f) and 15d-15(f) under the Exchange Act). Our internal control over financial reporting was designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for
external reporting purposes in accordance with GAAP. Our internal control over financial reporting includes those policies
and procedures that:
(1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and
dispositions of the assets of our company,
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance
with authorizations of our management and directors, and
(3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the financial statements.
Management assessed our internal control over financial reporting as of December 31, 2024, the end of our fiscal
year. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based
on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in “Internal
Control — Integrated Framework (2013).” Management’s assessment included evaluation of elements such as the design
and operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall
control environment.
Although we had internal controls in place prior to the Merger, and our management has determined in recent
years that such internal controls over financial reporting were effective, based on its assessment of our internal controls
over financial reporting as of December 31, 2024, management determined that there were material weaknesses in our
internal controls over financial reporting due to the fact that our controls were not effectively updated and implemented to
reflect the changes in processes and staffing as a result of the Merger. This is the result of not having a sufficient risk
assessment process in place post-Merger to identify and analyze risks of misstatement due to fraud and/or error.
Additionally, management determined that there was an inadequate segregation of duties over the preparation, review and
posting of manual journal entries. Due to the material weaknesses, management concluded that as of December 31, 2024,
the Company’s internal control over financial reporting was not effective.
As a result of the enactment of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, and the
resulting amendment of Section 404 of the Sarbanes-Oxley Act of 2002, as a smaller reporting company, the Company is
not required to provide an attestation report by our independent registered public accounting firm regarding internal control
over financial reporting for the fiscal year ended December 31, 2024 or thereafter, until such time as we are no longer
eligible for the exemption for smaller issuers set forth within the Sarbanes-Oxley Act.
Inherent Limitations on Effectiveness of Controls
Our management does not expect that our disclosure controls and procedures or our internal control over financial
reporting will prevent or detect all errors and all fraud. A control system, no matter how well-designed and operated, can
provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to
their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide
absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if
any, have been detected. The design of any system of controls is based in part on certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential
future conditions. Projections of any evaluation of the effectiveness of controls to future periods are subject to risks. Over
time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with
policies or procedures.
Changes in Internal Control Over Financial Reporting
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There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-
15(f) under the Exchange Act) during the quarter ended December 31, 2024, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Management’s goal is to improve upon our internal control environment as we continue integration efforts for the
Trawsfynydd business and continue to refine our processes and procedures to address changes in our staffing, processes
and activities in new geographical regions post-Merger. As we continue to evaluate and take actions to improve our internal
control over financial reporting, we may determine to take additional actions to address control deficiencies or determine to
modify certain of the remediation measurements that we are anticipating to make.
For a discussion of our internal controls, see the information provided in Item 1A under the risk factor captioned
“If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and
timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading
price of our common stock may decline.”
ITEM 9B. OTHER INFORMATION
Pre-Funded Warrant Amendment
As discussed elsewhere in this Annual Report, on December 29, 2024, the Company entered into the December
2024 Purchase Agreement with certain purchasers named therein, pursuant to which, on December 31, 2024, the Company
sold and issued to such purchasers an aggregate of (i) 3,630,205 Class A Units, each Class A Unit consisting of (a) one
share of common stock or one pre-funded warrant to purchase one share of common stock and (b) one Series A Warrant to
purchase one share of common stock, and (ii) 289,044 Class B Units, each Class B Unit consisting of one pre-funded
warrant to purchase one share of common stock and one Series A Warrant to purchase one share of common stock.
On March 27, 2025, the Company and certain of the purchasers entered into amendments to the pre-funded
warrants (the “PFW Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to
increase the threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined
in the pre-funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50%
of the outstanding common stock of the Company.
The foregoing description of the PFW Amendment does not purport to be complete and is qualified in its entirety
by reference to the full text of the PFW Amendment, the form of which is filed as Exhibit 4.7 to this Annual Report and is
incorporated herein by reference.
Securities Trading Plans of Directors and Executive Officers
During the three months ended December 31, 2024, none of our directors or officers entered into, modified or
terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” that were intended to satisfy
the affirmative defense conditions of Rule 10b5-1, in each case as defined in Item 408 of Regulation S-K.
Werner Cautreels Separation Agreement and Consulting Agreement
As previously disclosed in that Current Report on Form 8-K filed by the Company with the SEC on March 28,
2025, Werner Cautreels, the Company’s Chief Executive Officer, notified the Company of his decision to retire and resign
from his role as Chief Executive Officer of the Company, effective as of the close of business on the day that the Company
files this Annual Report with the SEC (the “Termination Date”). Iain Dukes, Executive Chairman of the Company, has
been appointed to serve as Interim Chief Executive Officer upon the effectiveness of Dr. Cautreels’ resignation.
On March 31, 2025, in connection with Dr. Cautreels’ resignation and retirement, the Company and Dr. Cautreels
entered into a Separation Agreement and Release of all Claims (the “Separation Agreement”), pursuant to which the
Company agreed to pay Dr. Cautreels $10,000 (less standard deductions and withholdings), payable in a single lump sum,
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which amount includes all amounts due and payable to Mr. Cautreels through the Termination Date. In exchange for such
payment, Dr. Cautreels has (i) provided the Company with a general release and waiver of claims, and (ii) agreed to be
bound by certain restrictive covenants, including those relating to non-disparagement and confidentiality.
Additionally, on March 31, 2025, the Company and Dr. Cautreels entered into a Consulting Services Agreement
(the “Consulting Agreement”), pursuant to which Dr. Cautreels agreed to provide certain consultancy services to the
Company for the period from April 1, 2025 to December 31, 2025, subject to earlier termination or extension pursuant to
the Consulting Agreement. Pursuant to the Consulting Agreement, the Company shall pay Dr. Cautreels $10,000 per month
as compensation for services to be rendered during the term of the Consulting Agreement.
The foregoing summaries of the terms of the Separation Agreement and the Consulting Agreement do not purport
to be complete, and are, respectively, qualified in their entirety by reference to the complete text of the Separation
Agreement and Consulting Agreement, copies of which are attached as Exhibits 10.46 and 10.47, respectively, to this
Annual Report and incorporated herein by reference.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Information with respect to this item will be set forth in the Proxy Statement for the 2025 Annual Meeting of
Stockholders (the “Proxy Statement”) under the headings “Election of Directors,” “Executive Officers,” “Section 16(a)
Beneficial Ownership Reporting Compliance,” “Code of Ethics” and “Corporate Governance” and is incorporated herein
by reference.
ITEM 11. EXECUTIVE COMPENSATION
Information with respect to this item will be set forth in the Proxy Statement under the headings “Executive
Compensation” and “Director Compensation,” and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
Information with respect to this item will be set forth in the Proxy Statement under the headings “Security Ownership
of Certain Beneficial Owners and Management” and “Executive Compensation,” and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Information with respect to this item will be set forth in the Proxy Statement under the headings “Certain
Relationships and Related Party Transactions” and “Corporate Governance” and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Information with respect to this item will be set forth in the Proxy Statement under the heading “Ratification of the
Selection of Independent Registered Public Accounting Firm,” and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) (1) Financial Statements: See Index to Consolidated Financial Statements on page F-1.
(3) Exhibits: See Exhibits Index on page 83
ITEM 16. FORM 10-K SUMMARY
Information with respect to this item is not required and has been omitted at the Company’s option.
Exhibit
Number
Exhibit Description
2.1
Agreement and Plan of Merger, dated April 1, 2024, by and among the Onconova Therapeutics, Inc., Traws
Merger Sub I, Inc., Traws Merger Sub II, LLC, and Trawsfynydd Therapeutics, Inc (Incorporated by
reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed on April 3, 2024).
3.1
Tenth Amended and Restated Certificate of Incorporation of Onconova Therapeutics, Inc. (Incorporated by
reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on July 25, 2013).
3.2
Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc. (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K
filed on May 31, 2016).
3.3
Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on
Form 8-K filed on March 22, 2018).
3.4
Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on
Form 8-K filed on June 8, 2018).
3.5
Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on
Form 8-K filed on September 25, 2018).
3.6
Certificate of Designation of Series A Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1
to the Company’s Current Report on Form 8-K filed on February 8, 2018).
3.7
Certificate of Designation of Series B Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 to
the Company’s Current Report on Form 8-K filed on April 30, 2018).
3.8
Certificate of Amendment to the Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on
Form 8-K filed on May 20, 2021).
3.9
Certificate of Amendment to the Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended (Incorporated by reference to Exhibit 3.2 to the Company’s Current Report on
Form 8-K filed on May 20, 2021).
3.10
Certificate of Designation of Series C Non-Voting Convertible Preferred Stock of Onconova Therapeutics,
Inc., dated April 1, 2024 (Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form
8-K filed on April 3, 2024).
3.11
Certificate of Amendment to Tenth Amended and Restated Certificate of Incorporation of Onconova
Therapeutics, Inc., as amended, dated April 2, 2024 (Incorporated by reference to Exhibit 3.2 to the
Company’s Current Report on Form 8-K filed on April 3, 2024).
3.12
Certificate of Amendment to the Tenth Amended and Restated Certificate of Incorporation of Traws
Pharma, Inc., as amended (the Reverse Stock Split Certificate of Amendment) (Incorporated by reference to
Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on September 17, 2024).
3.13
Certificate of Amendment to the Tenth Amended and Restated Certificate of Incorporation of Traws
Pharma, Inc., as amended (the Authorized Shares Increase Certificate of Amendment) (Incorporated by
reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed on September 17, 2024).
Table of Contents
80
Exhibit
Number
Exhibit Description
3.14
Amended and Restated Bylaws of Onconova Therapeutics, Inc. (Incorporated by reference to Exhibit 3.2 to
Pre-Effective Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed on July 11, 2013).
3.15
Amendment to Amended and Restated Bylaws of Traws Pharma, Inc., effective as of June 26, 2024
(Incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed on June 28,
2024).
4.1
Form of Certificate of Common Stock (Incorporated by reference to Exhibit 4.1 to Pre-Effective Amendment
No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).
4.2
Form of Pre-Funded Warrant, issued as of February 12, 2018 (Incorporated by reference to Exhibit 4.3 to the
Company’s Current Report on Form 8-K filed on February 8, 2018).
4.3
Form of Pre-Funded Warrant, issued as of May 1, 2018 (Incorporated by reference to Exhibit 4.2 to the
Company’s Current Report on Form 8-K filed on April 30, 2018).
4.4
Form of Series A Warrant, dated December 31, 2024 (Incorporated by reference to Exhibit 4.1 to the
Company’s Current Report on Form 8-K filed on December 31, 2024).
4.5
Form of Pre-Funded Warrant, dated December 31, 2024 (Incorporated by reference to Exhibit 4.2 to the
Company’s Current Report on Form 8-K filed on December 31, 2024).
4.6
Form of Amendment to Series A Common Stock Purchase Warrant, by and between Traws Pharma, Inc. and
certain holders, dated February 18, 2025 (Incorporated by reference to Exhibit 4.1 to the Company’s Current
Report on Form 8-K filed on February 18, 2025).
4.7#
Form of Amendment to Pre-Funded Warrant, by and between Traws Pharma, Inc. and certain holders, dated
March 27, 2025.
4.8#
Description of the Company’s Securities Registered under Section 12 of the Securities Exchange Act of 1934,
as amended.
10.1*
License Agreement, effective as of July 5, 2011, by and between Onconova Therapeutics, Inc. and SymBio
Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.2 to Pre-Effective Amendment No. 2 the
Company’s Registration Statement on Form S-1 filed on July 18, 2013).
10.2*
First Amendment to License Agreement, effective as of September 2, 2011, by and between Onconova
Therapeutics, Inc. and SymBio Pharmaceuticals Limited (Incorporated by reference to Exhibit 10.3 to the
Company’s Registration Statement on Form S-1 filed on June 14, 2013).
10.3*
License Agreement, effective as of January 1, 1999, by and between Onconova Therapeutics, Inc. and Temple
University — Of The Commonwealth System of Higher Education (Incorporated by reference to Exhibit 10.4
to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).
10.4*
Amendment to License Agreement, effective as of September 1, 2000, by and between Temple University —
Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc. (Incorporated by
reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).
10.5*
Amendment #1 to Exclusive License Agreement, effective as of March 21, 2013, by and between Temple
University — Of The Commonwealth System of Higher Education and Onconova Therapeutics, Inc.
(Incorporated by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 filed on June
14, 2013).
10.6+
Onconova Therapeutics, Inc. 2007 Equity Compensation Plan, and forms of agreement thereunder
(Incorporated by reference to Exhibit 10.13 to Pre-Effective Amendment No. 1 the Company’s Registration
Statement on Form S-1 filed on July 11, 2013).
10.7+
Consulting Agreement, effective as of January 1, 2012, by and between Onconova Therapeutics, Inc. and E.
Premkumar Reddy, Ph.D., including Consultant Agreement Renewal, dated February 27, 2013 (Incorporated
by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1 filed on June 14, 2013).
10.8+
Form of Indemnification Agreement entered into by and between Onconova Therapeutics, Inc. and each
director and executive officer (Incorporated by reference to Exhibit 10.24 to Pre-Effective Amendment No. 1
the Company’s Registration Statement on Form S-1 filed on July 11, 2013).
10.9+
Onconova Therapeutics, Inc. 2013 Equity Compensation Plan, and forms of agreement thereunder
(Incorporated by reference to Exhibit 10.25 to Pre-Effective Amendment No. 1 the Company’s Registration
Statement on Form S-1 filed on July 11, 2013).
Table of Contents
81
Exhibit
Number
Exhibit Description
10.10+
Onconova Therapeutics, Inc. 2013 Performance Bonus Plan (Incorporated by reference to Exhibit 10.26 to
Pre-Effective Amendment No. 1 the Company’s Registration Statement on Form S-1 filed on July 11, 2013).
10.11+
Employment Agreement, effective as of July 1, 2015, by and between Onconova Therapeutics, Inc. and Mark
Guerin (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on
February 17, 2016).
10.12+
Amended and Restated Employment Agreement, effective as of July 1, 2015, by and between Onconova
Therapeutics, Inc. and Steven M. Fruchtman, M.D. (Incorporated by reference to Exhibit 10.5 to the
Company’s Quarterly Report on Form 10-Q filed on August 13, 2015).
10.13*
License, Development and Commercialization Agreement, dated as of March 2, 2018, by and between
Onconova Therapeutics, Inc. and Pint International SA (Incorporated by reference to Exhibit 10.1 to the
Company’s Quarterly Report on Form 10-Q filed on May 15, 2018).
10.14
Securities Purchase Agreement, dated as of March 2, 2018, by and between Onconova Therapeutics, Inc. and
Pint Pharma GmbH (Incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form
10-Q filed on May 15, 2018).
10.15+
Amended and Restated Employment Agreement, effective as of June 19, 2018, by and between Onconova
Therapeutics, Inc. and Steven M. Fruchtman, M.D. (Incorporated by reference to Exhibit 10.2 to the
Company’s Quarterly Report on Form 10-Q filed on August 14, 2018).
10.16+
Onconova Therapeutics, Inc. 2018 Omnibus Incentive Compensation Plan, as approved by the stockholders
(Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 29,
2018).
10.17+
Form of Nonqualified Stock Option Award Agreement under the Onconova Therapeutics, Inc. 2018 Omnibus
Incentive Compensation Plan (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed on July 30, 2018).
10.18
License and Collaboration Agreement, effective as of May 10, 2019, by and between Onconova Therapeutics,
Inc. and HanX Biopharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.1 to the Company’s
Quarterly Report on Form 10-Q filed on August 14, 2019).
10.19
Securities Purchase Agreement, effective as of May 10, 2019, by and between Onconova Therapeutics, Inc.
and HanX Biopharmaceuticals, Inc. (Incorporated by reference to Exhibit 10.2 to the Company’s Quarterly
Report on Form 10-Q filed on August 14, 2019).
10.20
Securities Purchase Agreement, effective as of May 10, 2019, by and between Onconova Therapeutics, Inc.
and Abundant New Investments Ltd. (Incorporated by reference to Exhibit 10.3 to the Company’s Quarterly
Report on Form 10-Q filed on August 14, 2019).
10.21**
Distribution, License and Supply Agreement, effective as of November 20, 2019, by and between Onconova
Therapeutics, Inc. and Knight Therapeutics, Inc. (Incorporated by reference to Exhibit 10.1 to the Company’s
Current Report on Form 8-K filed on November 21, 2019).
10.22**
Distribution, License and Supply Agreement, by and between Onconova Therapeutics, Inc. and Specialised
Therapeutics Asia Pte. Ltd., effective as of December 18, 2019 (Incorporated by reference to Exhibit 10.1 to
the Company’s Current Report on Form 8-K filed on December 19, 2019).
10.23+
Form of Stock Appreciation Right Award Agreement (for Employees) (Incorporated by reference to Exhibit
10.1 to the Company’s Current Report on Form 8-K filed on July 10, 2020).
10.24+
Form of Stock Appreciation Right Award Agreement (for Non-Employee Directors) (Incorporated by
reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on November 16, 2020).
10.25+
Form of Performance Stock Unit Award Agreement (Incorporated by reference to Exhibit 10.2 to the
Company’s Current Report on Form 8-K filed on July 10, 2020).
10.26+
Employment Agreement, dated June 14, 2021, by and between Onconova Therapeutics, Inc. and Mark
Stephen Gelder, M.D. (Incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form
10-Q filed on August 16, 2021).
10.27+
Employment Agreement, dated March 9, 2021, by and between Onconova Therapeutics, Inc. and Abraham N.
Oler (Incorporated by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed on
August 16, 2021).
10.28+
Amendment to Employment Agreement, dated as of March 18, 2021, by and between Onconova
Therapeutics, Inc. and Steven M. Fruchtman, M.D. (Incorporated by reference to Exhibit 10.15.2 to the
Company’s Annual Report on Form 10-K filed on March 18, 2021).
Table of Contents
82
Exhibit
Number
Exhibit Description
10.29+
Form of Restricted Stock Unit Agreement (Incorporated by reference to Exhibit 10.1 to the Company’s
Quarterly Report on Form 10-Q filed on November 15, 2021).
10.30+
Form of Non-Qualified Stock Option Agreement (Incorporated by reference to Exhibit 10.2 to the Company’s
Quarterly Report on Form 10-Q filed on November 15, 2021).
10.31#
Master Research and Development Agreement dated January 5, 2022, by and between Viriom, Inc and
Trawsfynydd Therapeutics, Inc.
10.32+
Amendment to Employment Agreement, effective as of June 10, 2022, by and between Onconova
Therapeutics, Inc. and Mark Guerin (Incorporated by reference to Exhibit 10.1 to the Company’s Current
Report on Form 8-K filed on June 13, 2022).
10.33#
Master Research and Development Agreement dated September 23, 2022, by and between ChemDiv, Inc. and
Trawsfynydd Therapeutics, Inc.
10.34#
Master Research and Development Agreement dated September 1, 2022, by and between Expert Systems,
Inc. and Trawsfynydd Therapeutics, Inc.
10.35+
Onconova Therapeutics, Inc. 2021 Incentive Compensation Plan (Incorporated by reference to Exhibit 10.1 to
the Company’s Quarterly Report on Form 10-Q filed on November 14, 2022).
10.36#
License Agreement, dated January 20, 2023, by and between Trawsfynydd Therapeutics, Inc. and Viriom,
Inc.
10.37+
Employment Agreement, dated as of October 2, 2023, by and between Onconova Therapeutics, Inc. and
Victor Mandia Moyo, MBChB (Incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report
on Form 10-Q filed on November 14, 2023).
10.38**
Securities Purchase Agreement, dated April 1, 2024, by and among the Onconova Therapeutics,
Inc., OrbiMed and TorreyPines (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed on April 3, 2024).
10.39
Registration Rights Agreement, dated April 1, 2024, by and among the Onconova Therapeutics,
Inc., OrbiMed and TorreyPines (Incorporated by reference to Exhibit 10.2 to the Company’s Current Report
on Form 8-K filed on April 3, 2024).
10.40+
Employment Agreement, dated April 1, 2024, by and between Onconova Therpeutics, Inc. and Werner
Cautreels (Incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on
April 3, 2024).
10.41+
Form of Offer Letter for Ian Dukes and Nikolay Savchuck, dated April 1, 2024 (Incorporated by reference to
Exhibit 10.4 to the Company’s Current Report on Form 8-K filed on April 3, 2024).
10.42
Form of Securities Purchase Agreement, dated December 31, 2024 (Incorporated by reference to Exhibit 10.1
to the Company’s Current Report on Form 8-K filed on December 31, 2024).
10.43+
Separation Agreement and Release of all Claims, by and between Traws Pharma, Inc. and Mark Guerin, dated
February 5, 2025 (Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed on February 7, 2025).
10.44+
Offer Letter, by and between Traws Pharma, Inc. and Nora Brennan, dated February 5, 2025 (Incorporated by
reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on February 7, 2025).
10.45
At the Market Offering Agreement, by and between Traws Pharma, Inc. and Citizens JMP Securities, LLC
(Incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 10,
2025).
10.46#+
Separation Agreement and Release of all Claims, by and between Traws Pharma, Inc. and Werner Cautreels,
dated March 31, 2025.
10.47#
Consulting Services Agreement, by and between Traws Pharma, Inc. and Werner Cautreels, dated March 31,
2025.
21.1#
Subsidiaries of Traws Pharma, Inc.
23.1#
Consent of KPMG LLP
23.2#
Consent of Ernst & Young, LLP.
31.1#
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2#
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1##
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
Table of Contents
83
Exhibit
Number
Exhibit Description
32.2##
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002.
97.1
Compensation Recoupment Policy of Onconova Therapeutics, Inc., dated as of December 1, 2023
(Incorporated by reference to Exhibit 97 to the Company’s Annual Report on Form 10-K filed on April 1,
2024).
101.INS †
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File
because its XBRL tags are embedded within the Inline XBRL document.
101.SCH†
Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents.
104 †
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101 attachments)
EXHIBITS INDEX
+
Indicates management contract or compensatory plan.
*
Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been
filed separately with the Securities and Exchange Commission.
**
Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The
registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon
request.
# Filed herewith.
## Furnished herewith.
† The XBRL related information in Exhibit 101 shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to liability of that section and shall not be incorporated by
reference into any filing or other document pursuant to the Securities Act of 1933, as amended, except as shall be
expressly set forth by specific reference in such filing or document.
Table of Contents
84
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 31, 2025
Traws Pharma, Inc.
By:
/s/ Werner Cautreels, Ph.D.
Werner Cautreels, Ph.D.
Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the dates indicated:
Signature
Title
Date
/s/ Werner Cautreels, Ph.D.
Chief Executive Officer and Director
(Principal Executive Officer)
March 31, 2025
Werner Cautreels, Ph.D.
/s/ Nora Brennan
Interim Chief Financial Officer (Principal Financial
Officer and Principal Accounting Officer)
March 31, 2025
Nora Brennan
/s/ Iain Dukes, D. PHIL.
Executive Chairman, Board of Directors
March 31, 2025
Iain Dukes, D. Phil
/s/ Nikolay Savchuk, PH.D.
Director
March 31, 2025
Nikolay Savchuk, Ph.D.
/s/ Trafford Clarke, PH.D.
Director
March 31, 2025
Trafford Clarke, Ph.D.
/s/ Mary Teresa Shoemaker
Director
March 31, 2025
Mary Teresa Shoemaker
/s/ Jack E. Stover
Director
March 31, 2025
Jack E. Stover
Table of Contents
F-1
TRAWS PHARMA, INC.
Index to Consolidated Financial Statements
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 185)
F-2
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42)
F-4
Consolidated Balance Sheets, December 31, 2024 and 2023
F-5
Consolidated Statements of Operations, Years ended December 31, 2024 and 2023
F-6
Consolidated Statements of Comprehensive Loss, Years ended December 31, 2024 and 2023
F-7
Consolidated Statements of Stockholders’ Equity, Years ended December 31, 2024 and 2023
F-8
Consolidated Statements of Cash Flows, Years ended December 31, 2024 and 2023
F-9
Notes to Consolidated Financial Statements
F-10
Table of Contents
F-2
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors
Traws Pharma, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheet of Traws Pharma, Inc. and subsidiaries (the Company) as of
December 31, 2024, the related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash
flows for the year then ended, and the related notes (collectively, the consolidated financial statements). In our opinion, the
consolidated financial statements present fairly, in all material respects, the financial position of the Company as of
December 31, 2024, and the results of its operations and its cash flows for the year then ended, in conformity with U.S.
generally accepted accounting principles.
Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a
going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring losses
from operations since inception that raise substantial doubt about its ability to continue as a going concern. Management’s
plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to
express an opinion on these consolidated financial statements based on our audit. We are a public accounting firm
registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be
independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material
misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an
audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial
statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included
examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our
audit also included evaluating the accounting principles used and significant estimates made by management, as well as
evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable
basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts
or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging,
subjective, or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on
the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below,
providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Table of Contents
F-3
Evaluation of prepaid research and development expenses
As discussed in Note 4 to the consolidated financial statements, the Company has $1,514,000 of prepaid research
and development expenses as of December 31, 2024. As discussed in Note 2, research and development costs are
charged to expense as incurred and consist primarily of expenses incurred under agreements with contract
research organizations (CRO) and investigative sites that conduct clinical trials and preclinical studies. Costs for
certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to
completion of specific tasks using data such as patient enrollment, clinical site activations, or information
provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities
are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are
reflected in the consolidated financial statements as prepaid or accrued expense.
We identified the evaluation of prepaid research and development expenses for a certain CRO as a critical audit
matter. Specifically, evaluating the sufficiency of audit evidence obtained over associated costs incurred for the
services provided by the selected CRO required especially subjective auditor judgment due to the nature of
evidence available regarding progress towards completion of underlying phases within the statements of work.
The following are the primary procedures we performed to address this critical audit matter. For the selected CRO,
we inspected the statements of work and a selection of payments made, and compared them to the Company’s
schedule of costs incurred as of year-end. We also confirmed the status of underlying phases within the statements
of work directly with the selected CRO. We assessed the sufficiency of audit evidence obtained related to prepaid
research and development expenses with the selected CRO by evaluating the cumulative results of the audit
procedures
/s/ KPMG LLP
We have served as the Company’s auditor since 2024.
Philadelphia, Pennsylvania
March 31, 2025
Table of Contents
F-4
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Traws Pharma, Inc. (formerly Onconova Therapeutics, Inc.)
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheet of Traws Pharma, Inc. (formerly Onconova Therapeutics, Inc.)
(the Company) as of December 31, 2023, the related consolidated statements of operations, comprehensive loss, stockholders’
equity and cash flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Company at December 31, 2023, and the results of its operations and its cash flows for the year then ended, in
conformity with U.S. generally accepted accounting principles.
The Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going
concern. As discussed in Note 1 to the consolidated financial statements, the Company has suffered recurring losses from
operations and has stated that substantial doubt exists about the Company’s ability to continue as a going concern.
Management’s evaluation of the events and conditions and management’s plans regarding these matters are also described in
Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to
error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over
financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting
but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis,
evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting
principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial
statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We have served as the Company’s auditor from 2013 to 2024.
Philadelphia, Pennsylvania
April 1, 2024
except for the second paragraph of Note 1, and Note 10, as to which the date is March 31, 2025.
Table of Contents
F-5
TRAWS PHARMA, INC.
Consolidated Balance Sheets
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
21,338,000
$
20,821,000
Tax incentive and other receivables
1,765,000
18,000
Prepaid expenses and other assets
1,848,000
1,821,000
Total current assets
24,951,000
22,660,000
Property and equipment, net
10,000
22,000
Other assets
1,000
1,000
Total assets
$
24,962,000
$
22,683,000
Liabilities and stockholders’ (deficit) equity
Current liabilities:
Accounts payable
$
8,186,000
$
5,619,000
Accrued expenses and other liabilities
3,121,000
3,375,000
Deferred revenue
226,000
226,000
Total current liabilities
11,533,000
9,220,000
Deferred revenue, non-current
2,565,000
2,791,000
Warrant liabilities
42,494,000
—
Total liabilities
56,592,000
12,011,000
Commitments and contingencies (Note 5)
Stockholders’ (deficit) equity:
Series C Preferred stock, $0.01 par value, 5,000,000 shares authorized, 7,440 shares
issued and 7,398 shares outstanding at December 31, 2024 and no shares issued and
outstanding at December 31, 2023
—
—
Common stock, $0.01 par value, 250,000,000 shares authorized, 3,650,731 and
840,251 shares issued and outstanding at December 31, 2024 and
December 31, 2023, respectively
36,000
9,000
Additional paid in capital
617,530,000
493,317,000
Accumulated deficit
(649,154,000)
(482,631,000)
Accumulated other comprehensive loss
(42,000)
(23,000)
Total stockholders’ (deficit) equity
(31,630,000)
10,672,000
Total liabilities and stockholders’ (deficit) equity
$
24,962,000
$
22,683,000
See accompanying notes to consolidated financial statements.
Table of Contents
F-6
TRAWS PHARMA, INC.
Consolidated Statements of Operations
Years ended December 31,
2024
2023
Revenue
$
226,000
$
226,000
Operating expenses:
Acquired in-process research and development
117,464,000
—
Research and development
12,847,000
11,430,000
General and administrative
12,289,000
9,094,000
Total operating expenses
142,600,000
20,524,000
Loss from operations
(142,374,000)
(20,298,000)
Series A warrant and pre-funded warrant expense
(24,438,000)
—
Other income, net
289,000
1,350,000
Net loss
$ (166,523,000)
$ (18,948,000)
Net loss attributable to common stockholders, basic and diluted
$
(54,674,000)
$ (18,948,000)
Weighted-average shares of common stock outstanding, basic and diluted
1,552,685
839,554
Net loss per share of common stock, basic and diluted
$
(35.21)
$
(22.57)
Net loss attributable to Series C Preferred stockholders, basic and diluted
$ (111,849,000)
$
—
Weighted-average shares of Series C Preferred outstanding, basic and diluted
7,941
—
Net loss per share of Series C Preferred, basic and diluted
$
(14,085.00)
$
—
See accompanying notes to consolidated financial statements.
Table of Contents
F-7
TRAWS PHARMA, INC.
Consolidated Statements of Comprehensive Loss
Years ended December 31,
2024
2023
Net loss
$ (166,523,000)
$ (18,948,000)
Other comprehensive loss
Foreign currency translation adjustments
(19,000)
10,000
Other comprehensive loss (income)
(19,000)
10,000
Comprehensive loss
$ (166,542,000)
$ (18,938,000)
See accompanying notes to consolidated financial statements.
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F-8
TRAWS PHARMA, INC.
Consolidated Statements of Stockholders’ Equity
Stockholders’ Equity (Deficit)
Accumulated
Redeemable Convertible
Additional
other
Preferred Stock
Preferred Stock
Common Stock
Paid in
Accumulated
comprehensive
Shares
Amount
Shares Amount
Shares Amount
Capital
deficit
income (loss)
Total
Balance at
December 31, 2022
—
$
—
—
$
—
837,040
$
9,000
$
492,016,000
$
(463,683,000)
$
(33,000)
$
28,309,000
Stock-based
compensation
—
—
—
—
—
—
1,301,000
—
—
1,301,000
Shares issued for
vested restricted
stock units
—
—
—
—
3,211
—
—
—
—
—
Other
comprehensive
income
—
—
—
—
—
—
—
—
10,000
10,000
Net loss
—
—
—
—
—
—
—
(18,948,000)
—
(18,948,000)
Balance at
December 31, 2023
—
$
—
—
$
—
840,251
$
9,000
$
493,317,000
$
(482,631,000)
$
(23,000)
$
10,672,000
Issuance of stock
in connection with
the asset
acquisition of
Trawsfynydd
10,359
93,232,000
—
—
141,982
1,000
3,549,000
—
—
3,550,000
Transaction costs
paid through the
issuance of stock
535
4,815,000
—
—
6,747
—
169,000
—
—
169,000
Issuance of stock
in connection with
the private
placement, net of
expenses
1,578
13,572,000
—
—
19,879
—
427,000
—
—
427,000
Exchange of
Trawsfynydd stock
options for options
of the Company
—
—
—
—
—
—
7,085,000
—
—
7,085,000
Conversion of
redeemable
convertible
preferred stock
upon stockholder
approval
(12,472)
(111,619,000) 7,440
— 2,029,953
20,000
111,599,000
—
—
111,619,000
Issuance of
common stock in
connection with
the Securities
Purchase
Agreement
—
—
(42)
—
608,197
6,000
(6,000)
—
—
—
Stock-based
compensation
—
—
—
—
—
—
1,390,000
—
—
1,390,000
Shares issued for
vested restricted
stock units
—
—
—
—
3,722
—
—
—
—
—
Other
comprehensive loss
—
—
—
—
—
—
—
—
(19,000)
(19,000)
Net loss
—
—
—
—
—
—
—
(166,523,000)
—
(166,523,000)
Balance at
December 31, 2024
—
$
— 7,398
$
— 3,650,731
$
36,000
$
617,530,000
$
(649,154,000)
$
(42,000)
$
(31,630,000)
See accompanying notes to consolidated financial statements.
Table of Contents
F-9
TRAWS PHARMA, INC.
Consolidated Statements of Cash Flows
Year Ended December 31,
2024
2023
Operating activities:
Net loss
$
(166,523,000)
$
(18,948,000)
Adjustment to reconcile net loss to net cash used in operating activities:
Acquired in-process research and development
117,464,000
—
Series A warrant and pre-funded warrant expense
24,438,000
—
Depreciation and amortization
12,000
16,000
Stock-based compensation
1,390,000
1,301,000
Changes in assets and liabilities:
Receivables
(1,747,000)
11,000
Prepaid expenses and other current assets
(27,000)
(1,260,000)
Accounts payable
646,000
1,759,000
Accrued expenses and other current liabilities
(5,219,000)
(585,000)
Deferred revenue
(226,000)
(226,000)
Net cash used in operating activities
(29,792,000)
(17,932,000)
Investing activities:
Cash paid for acquisition, net of cash acquired
(3,648,000)
—
Payments for purchase of property and equipment
—
(14,000)
Net cash used in investing activities
(3,648,000)
(14,000)
Financing activities:
Proceeds from sale of common and preferred stock in connection with the
private placement, net of expenses
13,999,000
—
Proceeds from sale of common stock in connection with the Securities Purchase
Agreement, net of expenses
19,977,000
—
Net cash provided by financing activities
33,976,000
—
Effect of foreign currency translation on cash
(19,000)
10,000
Net increase (decrease) in cash and cash equivalents
517,000
(17,936,000)
Cash and cash equivalents at beginning of period
20,821,000
38,757,000
Cash and cash equivalents at end of period
$
21,338,000
$
20,821,000
Supplemental disclosure of cash flow information:
Preferred stock issued in connection with the reclassification and conversion of
redeemable convertible preferred stock
$
111,619,000
$
—
Common stock issued in connection with acquisition of Trawsfynydd
$
3,719,000
$
—
Preferred stock issued in connection with acquisition of Trawsfynydd
$
98,047,000
$
—
Offering costs included in accounts payable
$
1,921,000
$
—
See accompanying notes to consolidated financial statements.
Table of Contents
TRAWS PHARMA, INC.
Notes to Consolidated Financial Statements
F-10
1. Nature of Business
The Company
Traws Pharma, Inc. (“Traws Pharma” or the “Company”), formerly known as Onconova Therapeutics, Inc., was
incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The
Company's headquarters are located in Newtown, Pennsylvania. On April 1, 2024, the Company acquired Trawsfynydd
Therapeutics, Inc., a Delaware corporation (“Trawsfynydd”), through a merger and the name change to Traws Pharma was
effected. The Company accounted for the transaction as an asset acquisition as substantially all of the fair value of the gross
assets acquired was concentrated in two programs that were grouped as a single identifiable in-process research &
development (“IPR&D”) asset. Traws Pharma is a clinical stage biopharmaceutical company aiming to address unmet
medical needs in respiratory viral diseases and cancer. The viral respiratory disease program includes an oral antiviral drug
candidate for influenza and an oral inhibitor drug candidate of the SARS-CoV-2 Mpro (“3CL protease”). In the cancer
program, Traws Pharma is developing the novel, proprietary multi-kinase CDK2/4/6 inhibitor narazaciclib for refractory
endometrial cancer and potentially for other cancers.
Reverse Stock Split
In September 2024, the Board of Directors of the Company (the “Board”) approved a one-for-25 reverse stock
split of the Company’s outstanding shares of common stock (the “Reverse Stock Split”). Each 25 shares of the Company’s
common stock, par value of $0.01 per share, issued and outstanding immediately prior to the Reverse Stock Split
automatically reclassified, combined, converted and changed into one fully paid and nonassessable share of common stock,
par value of $0.01 per share. In addition, a proportionate adjustment was made to the per share exercise price and the
number of shares issuable upon the exercise of all outstanding options, warrants and convertible preferred stock entitling
the holders to purchase shares of the Company’s common stock, and the number of shares reserved for issuance pursuant to
the Company’s 2021 Incentive Compensation Plan (the “2021 Plan”), including pursuant to outstanding restricted stock
units outstanding thereunder, was reduced proportionately. No fractional shares were issued as a result of the Reverse Stock
Split. Instead, the Company’s stockholders who otherwise would have been entitled to a fraction of a share received a full
share of common stock. All common stock, per share and related information presented in the financial statements and
accompanying notes for periods prior to the date of the Reverse Stock Split have been retroactively adjusted to reflect the
Reverse Stock Split.
Liquidity
The Company has incurred recurring operating losses since inception. For the year ended December 31, 2024, the
Company incurred a net loss of $166,523,000 and as of December 31, 2024, the Company had generated an accumulated
deficit of $649,154,000. The Company anticipates operating losses to continue for the foreseeable future due to, among
other things, costs related to research, development of its product candidates and its preclinical programs, strategic
alliances and its administrative organization. At December 31, 2024, the Company had cash and cash equivalents of
$21,338,000. Based on current projections, the Company believes that it does not have sufficient cash and cash equivalents
to support its operations for more than one year following the date that these financial statements are issued. As a result of
these conditions, substantial doubt exists about the Company’s ability to continue as a going concern.
The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to
continue to execute its strategy. Management plans to explore various dilutive and non-dilutive sources of funding,
including equity financings, strategic alliances, business development and other sources. The future success of the
Company is dependent upon its ability to obtain additional funding. The failure to obtain sufficient capital on acceptable
terms when needed would have a material adverse effect on the Company’s business, results of operations and financial
condition. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient
amounts, on terms acceptable to the Company, or at all.
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F-11
Due to the inherent uncertainty involved in making estimates and the risks associated with the research, development,
and commercialization of biotechnology products, the Company may have based this estimate on assumptions that may
prove to be wrong, and the Company's operating plan may change as a result of many factors currently unknown to the
Company. The accompanying financial statements have been prepared on a going concern basis, which contemplates the
realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments
relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
The Company received multiple notifications from The Nasdaq Stock Market LLC (“Nasdaq”) staff (the “Staff”) in
2024 regarding non-compliance with continued listing requirements. On February 25, 2025, the Company received a letter
from Nasdaq confirming that the Company has regained compliance with Listing Rule 5550(b)(1) related to minimum
stockholders’ equity requirements, as required by the Hearings Panel of Nasdaq’s decision dated December 13, 2024.
Pursuant to Listing Rule 5815(d)(4)(B), the Company will be subject to a mandatory panel monitor for a period of one year
from the date of such letter.
2. Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the
United States (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned
subsidiaries, Trawsfynydd Therapeutics LLC, Trawsfynydd Therapeutics AU Ltd, Throxavir Therapeutics AU Pty Ltd, and
Onconova Europe GmbH. All significant intercompany transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes.
Management bases its estimates on historical experience and on various other market-specific and relevant assumptions
that management believes to be reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets, liabilities, and equity and the amount of revenues and expenses. Actual
results could differ significantly from those estimates. The most significant estimates and assumptions that management
considers in the preparation of the Company's financial statements relate to prepaid and accrued research and development
costs; the valuation of consideration transferred in acquiring the assets of Trawsfynydd; and inputs used in the Black-
Scholes model for stock-based compensation expense and Series A Warrant (as defined below) liability.
Segment Information
Operating segments are defined as components of an enterprise about which separate discrete information is available
for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in
assessing performance. The Company has one operating segment. The Company’s chief operating decision maker
(“CODM”) is the chief executive officer. The Company’s CODM manages the Company’s operations on a consolidated
basis for the purpose of allocating resources. All the Company’s long-lived assets are held in the United States.
Concentrations of Credit Risk and Off-Balance Sheet Risk
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash and cash
equivalents. The Company maintains a portion of its cash and cash equivalent balances in the form of money market
accounts with financial institutions that management believes are creditworthy. The Company has no financial instruments
with off-balance sheet risk of loss.
At December 31, 2024 the Company had $20,508,000 of its cash and cash equivalents in money market funds that
invest in a portfolio of liquid, high-quality debt securities issued by the U.S. government.
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F-12
Cash and Cash Equivalents
The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of
three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities
with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit,
commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair
value. During the years ended December 31, 2024 and 2023, the Company received $510,000 and $1,391,000, respectively,
of interest income primarily from a money market mutual fund that invests primarily in U.S. government obligations. The
interest income is included in Other income, net in the Statement of Operations.
Deferred Financing Costs
The Company capitalizes costs that are directly associated with in-process equity and debt financing until such
financings are consummated, at which time such costs are recorded against the gross proceeds from the applicable
financing. If a financing is abandoned, deferred financing costs are expensed.
Asset Acquisitions
Acquisitions of assets or a group of assets that do not meet the definition of a business are accounted for as asset
acquisitions, with a cost accumulation model used to determine the cost of the acquisition. Common stock issued as
consideration in an acquisition of assets is generally measured based on the acquisition date fair value of the equity
interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. Intangible assets that
are acquired in an asset acquisition for use in research and development activities that have an alternative future use are
capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use is
expensed immediately in the consolidated statements of operations and comprehensive loss.
Tax Incentive Receivable
The Company is eligible to receive a cash refund from the Australian Taxation Office for eligible research and
development (“R&D”) expenditures under the Australian Research and Development Tax Incentive Program (the
“Australian Tax Incentive”). The Australian Tax Incentive is recognized as a reduction to R&D expense when the relevant
expenditure has been incurred, the amount can be reliably measured and that the Australian Tax Incentive will be received.
The Company’s Australian subsidiaries began operations in the second quarter of 2024, and the Company has recognized
reductions to R&D expenses of $1,543,000 for the year ended December 31, 2024.
Redeemable Convertible Preferred Stock
The Company records shares of redeemable convertible preferred stock at their respective fair values on the dates
of issuance, net of issuance costs. The Company has historically applied the guidance from the Financial Accounting
Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) 480-10-S99-3A, SEC Staff Announcement:
Classification and Measurement of Redeemable Securities, and classified the redeemable convertible preferred stock
outside of stockholders’ equity because, if conversion to common stock is not approved by the stockholders, the
redeemable convertible preferred stock would have been redeemable at the option of the holders for cash equal to the
closing price of the common stock on the last trading day prior to the holder’s redemption request. The Company
determined that at the time, the conversion and redemption are outside of the Company’s control. Additionally, the
Company determined the conversion and redemption features did not require bifurcation as derivatives. In September
2024, and in connection with the Company’s stockholder approval to allow for the conversion of outstanding preferred
stock into common stock, the preferred stockholders right to request redemption expired. Immediately following the
stockholder approval and related conversions to common stock, the Company reclassified the remaining preferred stock
and related carrying value to permanent equity within the accompanying consolidated balance sheet as of December 31,
2024, and the preferred stock is no longer subject to temporary equity guidance within ASC 480-10-S99-3A.
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F-13
Fair Value of Financial Instruments
The Company accounts for financial instruments under ASC 820, Fair Value Measurements (“ASC 820”). This
statement defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles,
and expands disclosures about fair value measurements. To increase consistency and comparability in fair value
measurements, ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to
measure fair value into three levels as follows:
Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 — observable inputs other than Level 1, quoted prices for similar assets or liabilities in active markets,
quoted prices for identical or similar assets and liabilities in markets that are not active, and model-derived prices
whose inputs are observable or whose significant value drivers are observable; and
Level 3 — assets and liabilities whose significant value drivers are unobservable.
The carrying amounts reported in the accompanying consolidated financial statements for cash and cash
equivalents, accounts payable, and accrued liabilities approximate their respective fair values because of the short-term
nature of these accounts.
The following fair value hierarchy table presents information about the Company’s assets and liabilities measured
at fair value on a recurring basis:
Fair value measurement at reporting date using
December 31, 2024
(Level 1)
(Level 2)
(Level 3)
Assets:
Cash and cash equivalents - money market funds
$
20,508,000
$
-
$
-
Liabilities:
Warrant liabilities - Series A Warrants
$
-
$
-
$
13,125,000
Warrant liabilities - Pre-funded Warrants
-
29,369,000
-
Total warrant liabilities
$
-
$
29,369,000
$
13,125,000
December 31, 2023
Assets:
Cash and cash equivalents - money market funds
$
20,559,000
$
-
$
-
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F-14
On December 29, 2024, the Company entered into a Securities Purchase Agreement with several investors (the
“December 2024 Purchase Agreement”) for the sale of (i) up to 3,630,205 Class A Units (“Class A Units”), each Class A
Unit consisting of (a) one share of common stock or one pre-funded warrant to initially purchase one share of common
stock, and (b) one Series A Warrant to purchase one share of common stock (“Series A Warrants”) and (ii) 289,044 Class B
Units”, and together, with the Class A Units, the “Units”), each Class B Unit consisting of one pre-funded warrant and one
Series A Warrant. The fair value of the pre-funded warrants is the intrinsic value of the pre-funded warrants due to their
nominal exercise price. The fair value of the Series A Warrants was calculated using the Black-Scholes option pricing
model and is revalued to fair value at the end of each reporting period until the earlier of the exercise or expiration of the
Series A Warrants. The fair value of the Series A Warrant liability was estimated using the Black-Scholes option pricing
model using the following assumptions:
December 31,
2024
(Issuance date)
Expected term of warrants (years)
1 year
Risk-free interest rate
4.2%
Expected volatility
126.9%
Dividend yield
$ -
The warrant liabilities were initially measured at fair value at the day of issuance and on a recurring basis. The
changes in fair value of warrant liabilities will be recognized as part of the consolidated statements of operations. As the
warrants were issued on December 31, 2024, no change in warrant liability has been recorded during the year ended
December 31, 2024.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated
using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the
useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The
following estimated useful lives were used to depreciate the Company’s assets:
Estimated Useful Life
Lab equipment
5-6 years
Software
3 years
Computer and office equipment
5-6 years
Leasehold improvements
Shorter of the lease term or
estimated useful life
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the
accounts and any resulting gain or loss is recognized.
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the
carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets’ book value to
future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the
impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value,
which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses
have been recorded through December 31, 2024.
Warrant Accounting
The Company evaluates all of its financial instruments, including issued share purchase warrants, to determine if
such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC Topic 480,
Distinguishing Liabilities from Equity, ASC Topic 505, Equity, and ASC Topic 815, Derivatives and Hedging (“ASC
815”). The Company accounts for the Series A Warrants and pre-funded warrants issued in December 2024 in accordance
with the guidance contained in ASC 815 under which the warrants do not meet the criteria for equity treatment and must
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F-15
be recorded as liabilities. Accordingly, the Company classifies the Series A Warrants and pre-funded warrants as liabilities
at their fair value and adjust the liability to fair value at each reporting period. This liability is subject to re-measurement at
each balance sheet date until exercised, and any change in fair value is recognized in the Company’s consolidated
statements of operations. As the Series A Warrants and pre-funded warrants were issued on December 31, 2024, no change
in warrant liability has been recorded during the year ended December 31, 2024.
Foreign Currency
The reporting currency of the Company and its U.S. subsidiaries is the U.S. dollar. The functional currency of the
Company’s Australian subsidiary is the U.S. dollar. Transaction gains and losses resulting from exchange rate changes on
transactions denominated in currencies other than the U.S. dollar are included in operations in the period in which the
transaction occurs and reported within the other income, net in the consolidated statements of operations. The functional
currency for the Company’s German subsidiary is the euro. Translation adjustments are included as a component of
accumulated other comprehensive income and gains and losses resulting from exchange rate changes on such transactions
are reflected within the Company’s statements of comprehensive loss.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from
Contracts with Customers (“ASC 606”). The Company applies ASC 606 to all contracts with customers, except for
contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial
instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised
goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those
goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of
ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the
performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the
performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance
obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the
consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the
Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines
those that are performance obligations and assesses whether each promised good or service is distinct. The Company then
recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when
(or as) the performance obligation is satisfied.
The Company derives revenue from its collaboration and licensing agreements.
License, Collaboration and Other Revenues
The Company enters into licensing and collaboration agreements, under which it licenses certain of its product
candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC
606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-
refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales
of the licensed product.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its
agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the
Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include
forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical
and regulatory success.
Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct
from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-
refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able
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F-16
to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes
judgment to assess the nature of the combined performance obligation to determine whether the combined performance
obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for
purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each
reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition.
Milestone Payments: At the inception of each arrangement that includes development milestone payments, the
Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be
included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal
will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within
the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved
until those approvals are received. The transaction price is then allocated to each performance obligation on a relative
stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under
the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of
achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall
transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and
earnings in their period of adjustment.
Manufacturing supply service: Arrangements that include a promise for future supply of drug substance or drug
product for either clinical development or commercial supply at the customer’s discretion are generally considered as
options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as
separate performance obligations. If the Company is entitled to additional payments when the customer exercises these
options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of
sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes
revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the
royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty
revenue from its license agreements.
The Company recognized revenue under its license and collaboration agreement with SymBio as follows (Note 13):
Year ended December 31,
2024
2023
Symbio
Upfront license fee recognition over time
$ 226,000
$ 226,000
Deferred revenue is as follows:
Symbio
Upfront Payment
Deferred balance at December 31, 2023
$
3,017,000
Recognition to revenue
(226,000)
Deferred balance at December 31, 2024
$
2,791,000
Research and Development Expenses
R&D costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to
the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses
incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and
preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and
other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other
supplies; and costs associated with preclinical activities and regulatory operations.
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F-17
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress
to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to
the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms
of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated
financial statements as prepaid or accrued R&D expense, as the case may be.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are
recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the
differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit
carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain
research and patent costs, which have been charged to expense in the accompanying statements of operations but have been
recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a
tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been
established against all of the deferred tax assets (Note 11), as it is more likely than not that these assets will not be realized
given the Company’s history of operating losses. The Company recognizes the tax benefit from an uncertain tax position
only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The
amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability
basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position.
Stock-Based Compensation Expense
The Company applies the provisions of ASC Topic 718, Compensation—Stock Compensation (“ASC 718”), which
requires the measurement and recognition of compensation expense for all stock-based awards made to employees and
non-employees, including employee stock options, stock appreciation rights, performance stock units and restricted stock
units.
Share-based payment transactions with employees are recognized as compensation expense over the requisite service
period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates,
particularly surrounding Black-Scholes assumptions such as stock price volatility over the term and expected lives, to
estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock
compensation in the statement of operations.
Clinical Trial Expense Accruals
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting
from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site
agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations,
which vary from contract to contract and may result in payment flows that do not match the periods over which materials
or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its
financial statements by matching those expenses with the period in which services are performed and efforts are expended.
The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the
timing of various aspects of the trial. The Company determines accrual estimates through discussion with applicable
personnel and outside service providers as to the progress or state of consummation of trials, or the services completed.
During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its
estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and
circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate
reporting of contract research organizations and other third-party vendors. Although the Company does not expect its
estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services
performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts
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F-18
that are too high or too low for any particular period. For the years ended December 31, 2024 and 2023, there were no
material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials.
Net Loss Per Share
For purposes of net loss per share, the Series C Preferred shares have the same characteristics as common stock
and have no liquidation or other material preferential rights over common stock and accordingly, have been considered as a
second class of common stock in the computation of net loss per share regardless of their legal form. Losses are allocated
between the common shares and the Series C Preferred on a pro rata basis as they share equally in losses and residual net
assets on an as-converted basis.
Basic loss per share of common stock is computed by dividing net loss by the weighted-average number of shares
of common stock outstanding during each period, including pre-funded warrants. The pre-funded warrants to purchase
common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.01 per share
is non-substantive and is virtually assured.
Diluted loss per share of common stock includes the effect, if any, from the potential exercise or conversion of
securities, such as stock options, unvested restricted stock units, and common stock warrants, which would result in the
issuance of incremental shares of common stock. Basic and diluted net loss per share data is the same due to the fact that
when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive.
The following potentially dilutive securities have been excluded from the computation of diluted weighted-
average shares of common stock outstanding, as they would be anti-dilutive:
December 31,
2024
2023
Warrants
3,919,249
12,310
Stock Options
423,107
92,441
Unvested restricted stock units
22,421
9,888
4,364,777
114,639
Recently Adopted Accounting Pronouncements
The Company adopted the FASB’s Accounting Standards Update 2020-06, Accounting for Convertible
Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), effective as of January 1, 2024 using the modified
retrospective method. Among other amendments, ASU 2020-06 eliminates the cash conversion and beneficial conversion
feature models in ASC 470-20 that require an issuer of certain convertible debt and preferred stock to separately account
for embedded conversion features as a component of equity, as well as changed the accounting for diluted earnings-per-
share for convertible instruments and contracts that may be settled in cash or stock. Additionally, ASU 2020-06 requires
that the if-converted method, which is more dilutive than the treasury stock method, be used for all convertible instruments.
The Company applied ASU 2020-06 to all redeemable convertible preferred stock during 2024, accordingly the Company
did not apply the cash conversion or beneficial conversion feature models in its analysis of the redeemable convertible
preferred stock.
In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segment Disclosures (“ASU
2023-07”), which requires public companies to disclose for each reportable segment the significant expense categories and
amounts for such expenses. The Company incorporated the improved segment disclosures in the summary of significant
accounting policies, herein.
Recently Issued but not yet Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax
Disclosures (ASU 2023-09), which expands the disclosure required for income taxes. This ASU is effective for fiscal years
beginning after December 16, 2024, with early adoption permitted. The amendment should be applied on a prospective
Table of Contents
F-19
basis while retrospective application is permitted. The Company is currently evaluating the effect of this ASU on its
disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—
Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which is intended
to provide more detailed information about specified categories of expenses (purchases of inventory, employee
compensation, depreciation and amortization) included in certain expense captions presented on the consolidated statement
of operations. The guidance in this ASU is effective for fiscal years beginning after December 15, 2026, and interim
periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be
applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2)
retrospectively to all prior periods presented in the consolidated financial statements. The Company is currently evaluating
the impact that the adoption of ASU 2024-03 will have on its consolidated financial statements and disclosures.
3. Asset Acquisition
On April 1, 2024, the Company acquired Trawsfynydd, in accordance with the terms of an Agreement and Plan of
Merger, dated April 1, 2024 (the “Merger Agreement”), pursuant to which the Company acquired Trawsfynydd’s tivoxavir
marboxil and TRX01 programs and assumed certain liabilities associated with the acquired assets (the “Merger”). The
upfront consideration included (i) the issuance of 141,982 shares of common stock of the Company at an aggregate fair
value of $3,550,000, (ii) the issuance of 10,359 shares of Series C Convertible Preferred Stock (“Series C Preferred”) at an
aggregate fair value of $93,232,000, and (iii) the assumption of all Trawsfynydd stock options (the “assumed options”)
immediately outstanding prior to the transaction at an aggregated fair value of $7,085,000.
Each share of Series C Preferred was initially convertible into 10,000 shares of common stock, subject to the
Beneficial Ownership Limitation (defined below). Post Reverse Stock Split, each share of Series C Preferred converts into
400 shares of common stock, and is still subject to the Beneficial Ownership Limitation (defined below). The fair value of
the shares issued to Trawsfynydd and options assumed was based on the closing stock price of the Company’s common
stock on April 1, 2024 of $1.00, less a discount 10.0% related to unregistered share restrictions of the preferred shares.
The Company accounted for the transaction as an asset acquisition as the Company acquired inputs and no
substantive processes or outputs. The assets acquired in the transaction were measured based on the estimated fair value of
the consideration paid of $112,543,000, which included direct transactions costs of $8,676,000. Tungsten Partners LLC
(“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for
services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 6,747
shares of common stock and 535 shares of Series C Preferred.
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F-20
The consideration paid and the relative fair values of the assets acquired and liabilities assumed were as follows:
Consideration transferred:
Common stock
$
3,550,000
Series C Preferred
93,232,000
Assumed options
7,085,000
Company transaction costs settled in equity
4,984,000
Company transaction costs paid in cash
3,692,000
Total consideration transferred
$ 112,543,000
Assets acquired:
Cash and cash equivalents
$
44,000
Total assets acquired
$
44,000
Liabilities assumed:
Accrued expenses and other current liabilities
$
4,965,000
Total liabilities assumed
4,965,000
Net assets acquired
(4,921,000)
In-process research and development
117,464,000
Net assets acquired
$ 112,543,000
The Company elected to follow the asset acquisition approach and the Trawsfynydd IPR&D assets acquired have
no alternative future use to the Company. As a result, the Company charged $117,464,000 to expense within its
consolidated statement of operations for the year ended December 31, 2024.
The Company’s board of directors (“Board”) approved the Merger Agreement and the related transactions, and the
consummation of the Merger was not subject to approval of Company stockholders. In accordance with the Merger
Agreement, three directors were appointed to the Board, and there were several changes to management, each effective as
of the Closing.
Concurrently with the Closing of the Merger, the Company entered into a contingent value rights agreement (the
“CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of common stock as of the
applicable record date (April 15, 2024), including those holders receiving shares of common stock in connection with the
Merger, is entitled to one contractual contingent value right (each, a “CVR”) entitling the holder to certain distributions of
net proceeds and net sales of Traws Pharma’s two leading cancer candidates, subject to, and in accordance with, the terms
and conditions of the CVR Agreement, for each share of common stock held by such holder as of the applicable record
time.
The distributions in respect of the CVRs will be made on a quarterly basis, and will be subject to a number of
deductions, subject to certain exceptions or limitations, including but not limited to for certain taxes and certain out-of-
pocket expenses incurred by Traws Pharma. At the time of Merger and again at December 31, 2024, the value ascribed to
the CVR liability was de minimis given the uncertainty related to the success of the underlying oncology programs.
Pursuant to the Merger Agreement, the Company agreed to hold a stockholders’ meeting to submit, among other
proposals, the following proposals to its stockholders for their consideration: (i) the approval of the conversion of shares of
Series C Preferred into shares of common stock in accordance with the rules of the Nasdaq Stock Market LLC, the Merger
Agreement and the Certificate of Designation (the “Conversion Proposal”) and (ii) the approval of an amendment to the
Company’s Certificate of Incorporation (as amended, “Charter”), to increase the authorized shares of common stock from
125,000,000 to 250,000,000 (the “Share Increase Proposal” and together with the Conversion Proposal, the “Meeting
Proposals”). In connection with these matters, the Company agreed to file a proxy statement on Schedule 14A with the
SEC. Such proxy statement was filed on August 9, 2024. At a special meeting of the stockholders held on September 16,
2024, the Company’s stockholders approved the Meeting Proposals.
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F-21
4. Balance Sheet Detail
Prepaid expenses and other current assets:
December 31,
2024
2023
Research and development
$ 1,514,000
$ 1,060,000
Manufacturing
—
186,000
Insurance
156,000
174,000
Other
178,000
401,000
$ 1,848,000
$ 1,821,000
Property and Equipment:
December 31,
2024
2023
Computer and office equipment
$ 84,000
$ 84,000
Less accumulated depreciation
(74,000)
(62,000)
$ 10,000
$ 22,000
Depreciation and amortization expense was $12,000 and $16,000 for the years ended December 31, 2024 and
2023, respectively.
Accrued expenses and other current liabilities:
December 31,
2024
2023
Research and development
$ 2,331,000
$ 2,196,000
Employee compensation
265,000
1,002,000
Professional fees
525,000
177,000
$ 3,121,000
$ 3,375,000
5. Commitments and Contingencies
Litigation
In the normal course of business, the Company from time to time is named as a party to legal claims and actions.
The Company records a loss contingency reserve for a legal proceeding when the potential loss is considered probable and
can be reasonably estimated. The Company has not recorded any amounts for loss contingencies as of December 31, 2024.
On June 17, 2024, Steven M. Fruchtman informed the Board of his intent to resign from his positions of President
and Chief Scientific Officer, Oncology and indicated to the Company that Dr. Fruchtman believes his resignation to be for
"good reason" under the terms of his employment agreement and his expectation of compensation commensurate therewith
and in connection with a change in control. The Board accepted Dr. Fruchtman’s resignation effective immediately but
disagrees with the characterization of the events set forth in the letter. The Company believes that no severance payments
are due to Dr. Fruchtman under the terms of his employment agreement as it pertains to termination for good reason events.
At December 31, 2024, the Company determined a range of possible loss associated with Dr. Fruchtman’s claim to be zero
to $1.5 million. While the Company intends to defend itself against these claims, and believes it has strong arguments to
prevail in the litigation, there can be no assurance that the Company will prevail on its claims.
Contingent Value Rights
The Company issued CVRs to common stockholders as of April 15, 2024 and may be obligated to make future
distributions to such CVR holders in connection with entering into strategic arrangements related to its oncology programs
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F-22
and/or future royalty payments related to the successful commercialization of such programs. Refer to discussion of
Contingent Value Rights within Note 3.
6. Redeemable Convertible Preferred Stock and Stockholders’ (Deficit) Equity
As a result of the stockholder approval of the Meeting Proposals at the special meeting of the Company’s
stockholders held on September 16, 2024, certain of the Series C Preferred shares issued in connection with the acquisition
of Trawsfynydd and the concurrent private placement of securities were converted into 2,012,973 shares of the Company’s
common stock. In connection with the increase in common shares outstanding due to the December 2024 Purchase
Agreement (as defined below), certain investors converted an additional 42.45 Series C Preferred shares into 16,980 shares
of the Company’s common stock to maintain the Beneficial Ownership Limitation. As of December 31, 2024, 7,398 shares
of Series C Preferred remained outstanding.
Series C Preferred shares have no voting rights. Certain provisions of the Series C Preferred are as follows:
Dividends: Series C Preferred participates in any dividends with common stockholders on an as-converted basis
Liquidation: In the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary or
involuntary (a “Liquidation”), the holders of Series C Preferred shall rank on parity with common stockholders as to the
distributions of assets.
Redemption: In the event the Company is unable to obtain an affirmative stockholder vote to permit conversion within nine
months after the initial issuance of the Series C Preferred, each holder of Series C Preferred may elect, at the holder’s
option, to have the shares of Series C Preferred be redeemed by the Company at an amount equal to the last reported
closing trading price of the common stock at such time on an as-converted to common stock basis, as further described in
the Certificate of Designation relating to the Series C Preferred. The redemption right expired in connection with the
Company obtaining the affirmative stockholder vote on the Conversion Proposal in September 2024. Immediately
following the stockholder vote, any outstanding shares of Series C Preferred not converted were reclassified as permanent
equity within the Company’s consolidated balance sheet as of September 30, 2024.
Beneficial Ownership Limitation: A holder of Series C Preferred is prohibited from converting shares of Series C Preferred
into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially
own more than 19.9% of the total number of shares of common stock issued and outstanding immediately after giving
effect to such conversion (the “Beneficial Ownership Limitation”)
Securities Purchase Agreements
On December 29, 2024, the Company entered into the December 2024 Purchase Agreement for the sale of (i) up
to 3,630,205 Class A Units, each Class A Unit consisting of (a) one share of common stock or one pre-funded warrant to
initially purchase one share of common stock, and (b) one Series A Warrant and (ii) 289,044 Class B Units, each Class B
Unit consisting of one pre-funded warrant and one Series A Warrant. The purchase price per Class A Unit was $5.103 and
the purchase price per Class B Unit was $5.093. The Units sold pursuant to the December 2024 Purchase Agreement were
issued to the purchasers thereunder on December 31, 2024.
The Series A Warrants have an exercise price of $13.42 per share of common stock, and, subject to certain
beneficial ownership limitations described in the Series A Warrants, will be exercisable six months after issuance and will
expire on the earlier of (a) subject to the fulfilment of the Equity Conditions (as defined in the December 2024 Purchase
Agreement), thirty (30) Trading Days (as defined in the December 2024 Purchase Agreement) after the last of the
following data readouts to occur, as announced by the Company: (i) Ferret animal model Bird Flu data, (ii) non-human
primate Bird Flu data, or (iii) Phase 2a Influenza A human clinical data and (b) the 5-year anniversary of the closing date
of the December 2024 Purchase Agreement. The pre-funded warrants have an exercise price of $0.01 per share, and subject
to certain beneficial ownership limitations described in the pre-funded warrants, are exercisable and do not expire. The
exercise price of the Series A Warrants and pre-funded warrants will be subject to adjustment for stock splits, reverse splits,
and similar capital transactions as described in the Series A Warrants and pre-funded warrants.
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F-23
The Company also entered into an agreement with Tungsten (through its Broker-Dealer, Finalis Securities LLC),
pursuant to which Tungsten agreed to serve as exclusive placement agent for the offering. The Company has agreed to pay
Tungsten a cash fee equal to 8.25% of the aggregate gross proceeds raised in this offering from certain investors who are
not affiliated with the Company and a cash fee equal to 4.125% of the aggregate gross proceeds raised in this offering with
respect to certain investors that are affiliates of the Company.
The net proceeds to the Company from the offering was approximately $18.1 million, after deducting placement
agent’s fees and other estimated offering expenses with approximately $20.0 million gross proceeds at closing through the
sale of shares of common stock and pre-funded warrants and up to another $52.6 million upon exercise of Series A
Warrants issued with the offering if exercised in full prior to expiration thereof.
On April 1, 2024, the Company entered into a Securities Purchase Agreement (the “April 2024 Securities
Purchase Agreement”) with TPAV, LLC (“TPAV”), an affiliate of Torrey Pines, and OrbiMed Private Investments VIII, LP
(“OrbiMed”), an affiliate of OrbiMed Advisors (together, the “Investors”). Pursuant to the April 2024 Securities Purchase
Agreement, the Company issued and sold an aggregate of (i) 19,879 shares of common stock and (ii) 1,578 shares of Series
C Preferred (the “Private Investment in Public Equity” or “PIPE Securities”) for an aggregate purchase price of
approximately $14.0 million (collectively, the “Financing”). The closing of the Financing occurred concurrently with the
closing of the Merger on April 1, 2024 (the “Financing Closing Date”). Subject to the Beneficial Ownership Limitation,
each share of Series C Preferred was converted into 400 shares of common stock (on a post-split basis) upon Board
approval in September 2024.
Registration Rights Agreement
On April 1, 2024, in connection with the April 2024 Securities Purchase Agreement, the Company entered into a
Registration Rights Agreement (the “Registration Rights Agreement”) with the holders of common stock and Series C
Preferred signatory thereto. Pursuant to the Registration Rights Agreement, the Company was required to prepare and file a
resale registration statement with the SEC within 90 calendar days following the Financing Closing Date (the “Filing
Deadline”), with respect to the shares of common stock underlying the PIPE Securities and the common stock to be issued
upon conversion of the Series C Preferred issued to the signatories to the Registration Rights Agreement in the Merger,
subject to the Beneficial Ownership Limitation. The Company filed such registration statement within the Filing Deadline
on July 1, 2024 which was declared effective on August 28, 2024.
7.
7. Warrants
Common stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC
Topic 815, Derivatives and Hedging - Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or
as equity instruments depending on the specific terms of the warrant agreement. The conditions within ASC 815-40 are not
subject to a probability assessment. The equity classified warrants do not fall under the liability criteria within ASC 480
Distinguishing Liabilities from Equity as they are not puttable and do not represent an instrument that has a redeemable
underlying security. The equity classified warrants do meet the definition of a derivative instrument under ASC 815, but
are eligible for the scope exception as they are indexed to the Company’s own stock and would be classified in permanent
equity if freestanding. The Series A Warrants and pre-funded warrants issued in connection with the December 2024
Purchase Agreement do not meet the scope exception under ASC 815 and, therefore, are classified as liabilities. The
weighted average grant date fair value of the warrants issued during the year ended December 31, 2024 was $5.88. The fair
value of the Series A Warrant and pre-funded warrant liability exceeded the net proceeds received in connection with the
December 2024 Purchase Agreement, resulting in the recognition of Series A and pre-funded warrant expense of
$24,438,000 in the consolidated statements of operations.
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F-24
Warrants outstanding and warrant activity (reflects the number of common shares as if the warrants were
converted to common stock) for the year ended December 31, 2024 is as follows:
Balance
Balance
Exercise
Expiration
December 31,
Warrants
Warrants
Warrants
December 31,
Description
Classification
Price
Date
2023
Issued
Exercised Expired
2024
Non-tradable pre-funded warrants
Equity
$
56.25
none
141
—
—
—
141
Non-tradable pre-funded warrants
Equity
$
56.25
none
199
—
—
—
199
Non-tradable warrants
Equity
$
75.00
November 2024
9,780
—
—
(9,780)
—
Non-tradable warrants
Equity
$ 163.59375
December 2024
679
—
—
(679)
—
Non-tradable warrants
Equity
$ 168.86250
December 2024
1,851
—
—
(1,851)
—
Non-tradable pre-funded warrants
Liability
$
0.01
none
—
3,311,052
—
—
3,311,052
Series A Warrants
Liability
$
13.42
Variable
—
3,919,249
—
—
3,919,249
12,650
7,230,301
—
(12,310)
7,230,641
8. Stock-Based Compensation
In connection with the Merger in April 2024, the Company assumed all Trawsfynydd stock options outstanding,
each becoming an option to purchase shares of the Company’s common stock. The total number of Company shares
subject to such options is 365,547.
The Company’s 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”) was unanimously approved by the
Board on May 24, 2018 and was approved by the Company’s stockholders on June 27, 2018.
The 2018 Plan was amended and restated (as amended, the “Amended 2018 Plan”) following unanimous approval
of the Board on April 24, 2019 and was approved by the Company’s stockholders on June 17, 2019. The Amended 2018
Plan allowed for an additional 1,572 shares of the Company’s common stock to be issued under the Amended Plan with
respect to awards made on and after June 17, 2019. The maximum aggregate number of shares of the Company’s common
stock that may be issued pursuant to outstanding stock options granted under the Amended 2018 Plan is 1,073.
The 2021 Plan was unanimously approved by the Board on May 28, 2021 and was approved by the Company’s
stockholders on July 30, 2021. Upon stockholders’ approval of the 2021 Plan, no further awards have been or will be made
under the amended 2018 Plan. Under the 2021 Plan, the Company may grant incentive stock options, non-qualified stock
options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee
directors, consultants, and advisors.
The 2021 Plan was amended and restated (as so amended, the “First A&R 2021 Plan”) following unanimous
approval of the Board on May 23, 2022 and approval by the Company’s stockholders on August 18, 2022. The First A&R
2021 Plan allowed for the issuance of an additional 80,000 shares of the Company’s common stock with respect to awards
made under the First A&R 2021 Plan on and after August 18, 2022. The First A&R 2021 Plan was further amended and
restated (as so amended, the “Second A&R 2021 Plan”) following unanimous approval of the Board on October 10, 2024
and approval by the Company’s stockholders on October 31, 2024 to provide for the issuance of an additional 300,000
shares of the Company’s common stock.
In September 2024, the shares reserved for issuance under the First A&R 2021 Plan were proportionally reduced
in connection with the Reverse Stock Split. At December 31, 2024, there were 357,142 shares available for future issuance
with respect to new awards and outstanding awards under the Second A&R 2021 Plan.
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F-25
Stock-based compensation expense includes stock options granted to employees and non-employees and has been
reported in the Company’s statements of operations and comprehensive loss in either R&D expenses or general and
administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-
based compensation costs have been recognized since the Company’s inception. The Company recognized stock-based
compensation expense related to stock options and restricted stock units as follows for the years ended December 31, 2024
and 2023:
Year ended December 31,
2024
2023
Research and development
$
181,000
$
715,000
General and administrative
1,209,000
586,000
Total stock-based compensation expense
$ 1,390,000
$ 1,301,000
A summary of stock option activity for the twelve months ended December 31, 2024 is as follows:
Options Outstanding
Weighted
Weighted-
Average
Average
Remaining
Aggregate
Number
Exercise
Contractual
Intrinsic
of Shares
Price
Term (in years)
Value
Balance, December 31, 2023
92,441
$ 76.05
8.53
$
21,000
Trawsfynydd options exchanged in connection with acquisition
365,547
$
1.24
8.87
—
Granted
6,560
$
8.50
—
—
Forfeitures
(18,745)
$ 22.07
—
—
Expired
(22,696)
$ 327.10
—
—
Balance, December 31, 2024
423,107
$
11.89
8.75
$ 2,698,000
Exercisable at December 31, 2024
381,922
$ 13.01
8.74
$ 2,394,000
The Company accounts for all stock-based payments made to employees, non-employees and directors using an
option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the
estimated fair value of the awards on the date of grant. Compensation expense is recognized for the portion that is
ultimately expected to vest over the period during which the recipient renders the required services to the Company using
the straight-line single option method.
The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant
date. The Black-Scholes model requires the Company to make certain estimates and assumptions, assumptions related to
the expected price volatility of the common stock, the period during which the options will be outstanding, the rate of
return on risk-free investments and the expected dividend yield for the Company’s stock.
As of December 31, 2024, there was $126,000 of unrecognized compensation expense related to the unvested stock
options which is expected to be recognized over a weighted-average period of approximately 1.7 years.
The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the
following:
Year ended December 31,
2024
2023
Risk-free interest rate
3.46 %
4.0 %
Expected volatility
117.9 %
122.8 %
Expected term
6.00 years
5.74 years
Expected dividend yield
— %
— %
Weighted average grant date fair value
$ 7.36
$ 21.25
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F-26
The weighted-average valuation assumptions were determined as follows:
●
Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury
securities in effect at the time of grant for a period that is commensurate with the assumed expected option term.
●
Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected term of
its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin (SAB) No.
107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term
of the option.
●
Expected stock price volatility: Expected volatility is based on the historical volatility of the Company’s common
stock.
●
Expected annual dividend yield: The Company has never paid, and does not expect to pay, dividends in the
foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%.
On August 2, 2021, the compensation committee of the Board approved restricted stock unit grants to certain of
the Company’s employees (the “2021 RSUs”). An aggregate of 4,188 service-based RSUs were issued at a grant date fair
value of $129.75. The 2021 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date
of grant, and vest 34% on the third anniversary of the date of grant. The 2021 RSUs were granted under the 2021 Plan.
On February 7, 2022, the compensation committee of the Board approved restricted stock unit grants to certain of
the Company’s employees (“2022 RSUs”). An aggregate of 5,934 service-based RSUs were issued at a grant date fair
value of $45.50. The 2022 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date
of grant, and vest 34% on the third anniversary of the date of grant. The 2022 RSUs were granted under the 2021 Plan.
On June 10, 2022, the compensation committee of the Board approved restricted stock unit grants to certain of the
Company’s employees (“2022 RSU Awards”). An aggregate of 968 service-based RSUs were issued at a grant date fair
value of $33.25. The 2022 RSU Awards will be settled in stock, vest 33% on each of the first and second anniversary of the
date of grant, and vest 34% on the third anniversary of the date of grant. The 2022 RSU Awards were granted under the
2021 Plan.
On March 13, 2023, the compensation committee of the Board approved restricted stock unit grants to certain of
the Company’s employees (“2023 RSUs”). An aggregate of 6,769 service-based RSUs were issued at a grant date fair
value of $18.25. The 2023 RSUs will be settled in stock, vest 33% on each of the first and second anniversary of the date
of grant, and vest 34% on the third anniversary of the date of grant. The 2023 RSUs were granted under the First A&R
2021 Plan.
On April 1, 2024, the compensation committee of the Board approved restricted stock unit grants as inducement
awards to certain of the Company’s employees who joined the Company on April 1, 2024 in connection with the Merger
(“Inducement RSUs”). An aggregate of 21,200 service-based RSUs were issued at a grant date fair value of $25.00. The
Inducement RSUs will be settled in stock, vest 25% on each of the first four anniversaries of the date of grant. The
Inducement RSUs were granted outside of the Company’s incentive plans in accordance with Nasdaq Listing Rule 5635(c)
(4).
A summary of RSU activity for the twelve months ended December 31, 2024 is as follows:
2021 RSUs
2022 RSUs
2022 RSU Awards
2023 RSUs
Inducement
RSUs
Outstanding and unvested January 1, 2024
1,032
2,980
440
5,436
-
Granted
-
-
-
-
21,200
Vested
(200)
(1,490)
(220)
(1,812)
-
Forfeited/Cancelled
(832)
(1,207)
-
(2,906)
-
Outstanding and unvested December 31, 2024
-
283
220
718
21,200
At December 31, 2024, the unrecognized compensation cost related to unvested service-based RSUs was $443,000,
which will be recognized over the remaining service period of 3.2 years.
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F-27
Grants of PSUs and SARs
During 2020 and 2021, the compensation committee of the Board and the Board approved a cash bonus program of
cash-settled stock appreciation right (“SAR”) awards to the Company’s employees and non-employee directors, and cash-
settled performance stock unit (“PSU”) awards to the Company’s employees. These awards were granted outside of the
Amended 2018 Plan and the 2021 Plan. As the Company’s stock price has decreased since these awards were issued, their
impact on the results of operations and balance sheet of the Company was not material during 2024 or 2023.
9. Restructuring
On April 8, 2024, Traws Pharma terminated 11 of its 17 employees, some of whom have been retained as
consultants. The associated severance costs of $884,000 were expensed in the second quarter of 2024. The Company
recorded these restructuring charges based on each employee’s role to the respective research and development and general
and administrative operating expense categories on its consolidated statements of operations and comprehensive loss. The
Company paid all severance costs as of December 31, 2024.
10. Segment Information
The Company has one operating segment. The Company’s chief operating decision maker (“CODM”) is the chief
executive officer. The Company’s CODM manages the Company’s operations on a consolidated basis for the purpose of
allocating resources. All the Company’s long-lived assets are held in the United States.
The accounting policies of its segment are the same as those described in the summary of significant accounting
policies. The CODM assesses performance for its segment based on net loss, which is reported on the consolidated
statements of operations and comprehensive loss. The measure of segment assets is reported on the balance sheet as total
assets. The CODM uses cash forecast models in deciding how to invest into the segment. The CODM analyzes the
Company’s net loss and monitors budget versus actual results to assess the performance of the Company.
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F-28
The table below summarizes the significant expense categories regularly reviewed by the CODM for the years
ended December 31, 2024 and 2023:
Years ended December 31,
2024
2023
Revenue
$
226,000
$
226,000
Less:
Acquired in-process research and development
117,464,000
—
Research and development expenses:
Preclinical & clinical development
7,441,000
4,060,000
Personnel related
2,787,000
2,400,000
Other research and development (a)
2,619,000
4,970,000
Total research and development expenses
12,847,000
11,430,000
General and administrative expenses:
Professional & consulting fees
5,954,000
2,162,000
Personnel related
3,035,000
3,264,000
Other general and administrative (b)
3,300,000
3,668,000
Total general and administrative
12,289,000
9,094,000
Series A warrant and pre-funded warrant expense
24,438,000
—
Other income, net
(289,000)
(1,350,000)
Net loss
$ (166,523,000)
$ (18,948,000)
(a)
Other research and development expenses include stock based compensation, manufacturing,
formulation, development, and consulting fees.
(b)
Other general and administrative expenses include stock based compensation, public company costs, and
insurance.
11. Income Taxes
The Company accounts for income taxes under FASB ASC 740 (“ASC 740”). Deferred income tax assets and
liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which
are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
Income taxes have been based on the following income (loss) before income tax expense:
December 31,
2024
2023
Domestic
$(161,830,000)
$(18,949,000)
Foreign
(4,696,000)
1,000
$(166,526,000)
$(18,948,000)
As of December 31, 2024, the Company had federal net operating loss (“NOL”) carry forwards of $128,054,000, state
NOL carry forwards of $34,934,000, foreign NOL of $219,000 and federal research and development tax credit carry
forwards of $0, which may be available to reduce future taxable income. The federal NOL, that was generated before the
2024 tax year, and the tax credit carry forwards will begin to expire at various dates starting in 2025. The state NOL carry
forwards will begin to expire at various dates starting in 2025. In accordance with Section 382 of the Internal Revenue
Code of 1986, as amended, a change in equity ownership of greater than 50% within a three-year period results in an
annual limitation on the Company’s ability to utilize its NOL carryforwards created during the tax periods prior to the
change in ownership. The Company has determined that they have gone through an ownership change during 2024 and is
currently in process of completing an ownership change analysis pursuant to Section 382. Because the Company has
incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state
income tax authorities.
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F-29
The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken
by the Company in its tax filings or positions is more likely than not to be realized. The Company recognized no material
adjustment for unrecognized income tax benefits. Through December 31, 2024, the Company had no unrecognized tax
benefits or related interest and penalties accrued.
The principal components of the Company’s deferred tax assets are as follows:
December 31,
2024
2023
Deferred tax assets:
Net operating loss carryovers
$ 28,324,000
$
74,029,000
R&D tax credits
—
93,031,000
Non-qualified stock options
2,509,000
641,000
Deferred revenue
696,000
752,000
Fixed assets
2,000
1,000
Accrued expenses
459,000
486,000
Capitalized research and development costs
4,839,000
5,339,000
Healthcare withholding - SARs
11,000
12,000
Deferred tax assets
36,840,000
174,291,000
Less valuation allowance
(36,840,000)
(174,291,000)
Net deferred tax assets
$
—
$
—
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available
evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After
consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against
its deferred tax assets at December 31, 2024. The Company experienced a net change in valuation allowance of
$(137,452,000) and $4,157,000 for the years ended December 31, 2024 and 2023, respectively.
A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected
in the financial statements is as follows:
December 31,
2024
2023
Federal income tax expense at statutory rate
21.0 %
21.0 %
Permanent items
(17.9)
(0.1)
Foreign permanent items
(0.7)
—
Foreign rate differential
0.1
—
State income tax, net of federal benefit
0.5
5.4
State expirations
—
(8.6)
Tax credits
—
17.7
Change in valuation allowance
83.6
(21.9)
Deferred tax adjustment
(1.0)
(9.4)
State tax rate change
—
—
Sec 382 expirations
(84.0)
—
Other
(1.6)
(4.1)
Effective income tax rate
— %
— %
12. Research and Development Arrangements and Related Party Transactions
Research and development arrangements with unrelated parties
The Company has entered into various licensing and right-to-sublicense agreements with educational institutions
for the exclusive use of patents and patent applications, as well as any patents that may develop from research being
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F-30
conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research
have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University
(“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a
percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty
payments. As no sales had been generated through December 31, 2024 under the licensed patents, the Company has not
incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple a percentage
of any sublicensing fees received by the Company.
Research and development arrangements with related parties
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement
with ChemDiv, Inc. (“ChemDiv”). Pursuant to the Master Research and Development Agreement, ChemDiv provided
services related to preclinical drug discovery to Trawsfynydd prior to the Merger and continues to provide services to the
Company post-Merger. Dr. Nikolay Savchuk, COO of the Company and a director on the Board, is a stockholder of
ChemDiv and a member of its board of directors. Subsequent to the Merger and through December 31, 2024, the Company
made payments to ChemDiv of $5,024,000 which primarily relate to services completed prior to the Merger. During the
year ended December 31, 2024, $460,000 was expensed as R&D in the Company’s consolidated statements of operations
related to ChemDiv’s services, of which $10,000 was included in accounts payable as of December 31, 2024 in the
Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement
with Viriom, Inc. (“Viriom”). Pursuant to the Master Research and Development Agreement, Viriom provided services
related to virology to Trawsfynydd prior to the Merger and continues to provide services to the Company post-Merger.
Nikolay Savchuk, COO of the Company, serves as President of Viriom and as a member of its board of directors. Dr.
Savchuk has investment control of Viriom and indirectly holds a significant number of its shares of common stock through
a limited liability company of which Dr. Savchuk is the managing member and equity holder. Dr. Robert R. Redfield,
M.D., our Chief Medical Officer, serves as a strategic advisor and member of Viriom’s board of directors. Additionally, Dr.
C. David Pauza Ph.D., our Chief Science Officer, served as the Chief Science Officer of Viriom until April 1, 2024, after
which time he resigned from any position with Viriom; and Iain Dukes, Executive Chairman of the Company, served as
CEO of Viriom and as a member of its board of directors. During the year ended December 31, 2024, $128,000 was
expensed as R&D in the Company’s consolidated statements of operations related to Viriom’s services, of which $113,000
and $15,000 was included in accounts payable and accrued expenses, respectively, as of December 31, 2024, in the
Company’s consolidated balance sheets.
Prior to consummation of the Merger, Trawsfynydd entered into a Master Research and Development Agreement
with Expert Systems, Inc. (“Expert”). Pursuant to the Master Research and Development Agreement, Expert provided drug
development and consulting services to Trawsfynydd prior to the Merger and continues to provide services to the Company
post-Merger. An immediate family member of Dr. Savchuk has significant ownership in Expert. During the year ended
December 31, 2024, $149,000 was expensed in the Company’s consolidated statements of operations related to Expert’s
services. As of December 31, 2024, $77,000 and $72,000 was included in accounts payable and accrued expenses,
respectively, in the Company’s consolidated balance sheets.
License Agreement with related party
In addition, prior to consummation of the Merger, Trawsfynydd entered into a License Agreement (the “Viriom
License Agreement”) with Viriom, pursuant to which Trawsfynydd obtained an exclusive, royalty-free, sublicensable,
world-wide license to certain Viriom patents, applications, and technical information (collectively, the “Viriom Licensed
IP”) to make, have made, use, sell, offer for sale and import several classes of novel compounds related to the treatment
and prevention of viral diseases, specifically for use of the Viriom Licensed IP in the development of treatment and
methods to prevent viral disease in Canada, China, the European Union, Hong Kong, Japan, the United States and all areas
covered by PCT applications for the Viriom Licensed IP. No annual license fees, royalties, or milestone payments are
required. Additionally, pursuant to the Viriom License Agreement, Trawsfynydd obtained the right to control prosecution,
defense of infringement and enforcement. As a result of the Merger, the rights and obligations of Trawsfynydd under the
Viriom License Agreement were transferred to the Company (through its subsidiaries).
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F-31
Unless terminated earlier pursuant to the agreement, the Viriom License Agreement shall remain in force and
effect for the life of the last-to-expire patent included in the Viriom Licensed IP or last-to-be abandoned patent application
licensed under the agreement, whichever is later. The Viriom License Agreement can be terminated by either party due to
the material breach of either party (subject to a cure period).
Related party purchase of securities
In connection with the Merger, on April 1, 2024, TPAV purchased 13,489 shares of Company common stock and
1,070.93 shares of Series C Preferred Stock for an aggregate purchase price of $9,499,995 pursuant to the April 2024
Purchase Agreement. Nikolay Savchuk, the Company’s Chief Operating Officer and a director on the Board, serves as the
sole manager on the board of managers of TPAV.
Additionally, TPAV purchased 96,348 Class B Units, consisting of pre-funded warrants to purchase 96,348 shares
of Company common stock and Series A Warrants to purchase 96,348 shares of Company common stock for an aggregate
purchase price of $491,664 in the December 2024 financing.
Werner Cautreels, our Chief Executive Officer and a member of our Board, also purchased 96,348 Class B Units,
consisting of pre-funded warrants to purchase 96,348 shares of Company common stock and Series A Warrants to purchase
96,348 shares of Company common stock for an aggregate purchase price of $491,664 in the December 2024 financing.
13. License and Collaboration Agreements
SymBio Agreement
In July 2011, the Company entered into a license agreement with SymBio Pharmaceuticals Limited (“SymBio”),
which has been subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and
commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use
commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territory and the
Company has similar obligations outside of the licensed territory. The Company has also entered into an agreement with
SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the
Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial
supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product
and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-
stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license
or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the
licensed territory.
Under the terms of the SymBio license agreement, the Company received an upfront payment of $7,500,000 in 2011.
In addition, the Company could receive regulatory, development and sales-based milestone payments as well as royalty
payments at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio.
Royalties will be payable under the SymBio agreement on a country-by-country basis in the licensed territory, until the
later of the expiration of marketing exclusivity in those countries, a specified period of time after first commercial sale of
rigosertib in such country, or the expiration of all valid claims of the licensed patents covering rigosertib or the
manufacture or use of rigosertib in such country. If no valid claim exists covering the composition of matter of rigosertib or
the use of or treatment with rigosertib in a particular country before the expiration of the royalty term, and specified
competing products achieve a specified market share percentage in such country, SymBio’s obligation to pay the Company
royalties will continue at a reduced royalty rate until the end of the royalty term. In addition, the applicable royalties
payable to the Company may be reduced if SymBio is required to pay royalties to third-parties for licenses to intellectual
property rights necessary to develop, use, manufacture or commercialize rigosertib in the licensed territory. The license
agreement with SymBio will remain in effect until the expiration of the royalty term. However, the SymBio license
agreement may be terminated earlier due to the uncured material breach or bankruptcy of a party, or force majeure. If
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F-32
SymBio terminates the license agreement in these circumstances, its licenses to rigosertib will survive, subject to SymBio’s
milestone and royalty obligations, which SymBio may elect to defer and offset against any damages that may be
determined to be due from the Company. In addition, the Company may terminate the license agreement in the event that
SymBio brings a challenge against it in relation to the licensed patents, and SymBio may terminate the license agreement
without cause by providing the Company with written notice within a specified period of time in advance of termination.
The Company assessed the SymBio arrangement in accordance with ASC 606 and determined that its performance
obligations under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the
research and development services to be provided by the Company and its obligation to serve on a joint committee. The
Company concluded that the license was not distinct since it was of no benefit to SymBio without the ongoing research and
development services and that, as such, the license and the research and development services should be bundled as a
single performance obligation. Since the provision of the license and research and development services are considered a
single performance obligation, the $7,500,000 upfront payment is being recognized as revenue ratably through December
2037, the expected period over which the Company expects the research and development services to be performed.
SymBio’s purchases of rigosertib as development-stage product or for commercial requirements represent options
under the agreement and revenues are therefore recognized when control of the product is transferred, which is typically
when shipped. If SymBio orders the supplies from the Company, the Company expects the pricing for this supply to equal
its third-party manufacturing cost plus a pre-negotiated percentage, which will not result in a significant incremental
discount to market rates. In January 2018, the agreement was amended to provide SymBio a discount of 35% on future
purchases, limited to a cumulative total amount of $300,000.
HanX Narazaciclib (ON 123300) Agreement
In December 2017, the Company entered into a license and collaboration agreement with HanX Biopharmaceuticals,
Inc. (“HanX”), a company focused on development of novel oncology products, for the further development, registration
and commercialization of narazaciclib in Greater China. Narazaciclib is a preclinical compound which the Company
believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the
collaboration was that HanX provided all funding required for the Chinese IND enabling studies necessary in order to seek
IND approval by the National Medical Products Administration (“Chinese FDA”). The Chinese IND was approved in
January 2020. The Company and HanX also intended for these studies underlying the Chinese IND approval, to meet the
US FDA standards for IND approval. Accordingly, such studies were used by the Company for an IND filing with the US
FDA in November 2020. In September 2020, a Phase 1 Study with narazaciclib in cancer patients was initiated in China.
The Company maintains global rights to the study and study data outside of China. The US FDA Study May Proceed letter
was issued in December 2020. Enrollment into the US phase 1 study (“Study 19-01”) commenced in May 2021.
If the compound receives regulatory approval and is commercialized, the Company would receive regulatory and
commercial milestone payments, as well as royalties on sales in the Greater China territory.
Pint Agreement
On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “Pint
License Agreement”) and a Securities Purchase Agreement (the “Pint Securities Purchase Agreement”) with Pint
International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”).
Under the terms of the Pint License Agreement, the Company granted Pint an exclusive, royalty-bearing license, with
the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any
pharmaceutical product (the “Pint Licensed Product”) containing rigosertib in all uses of rigosertib in humans in Latin
American countries (the “Pint Territory”, including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba,
Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras,
Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela).
Pint agreed to make an upfront equity investment in the Company’s common stock. In addition, the Company could
receive additional regulatory, development and sales-based milestone payments, an additional equity investment, as well
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F-33
as tiered, double digit royalties based on net aggregate net sales in the Pint Territory. Pint and the Company have also
agreed to enter into a supply agreement providing for Pint purchasing rigosertib and the Pint Licensed Product from the
Company within 90 days of FDA approval of an NDA for the Pint Licensed Product.
Pint may terminate the Pint License Agreement in whole (but not in part) at any time upon 45 days’ prior written
notice. The Pint License Agreement also contains certain provisions for termination by either party in the event of breach
of the Pint License Agreement by the other party, subject to a cure period, or bankruptcy of the other party.
In addition, under the Pint Securities Purchase Agreement, if the FDA approves the NDA for the Pint Licensed
Product, Pint will reimburse the Company for certain research and development expenses. Half of the reimbursement
amount will be paid in cash, the other half of the amount will be by an equity investment at a premium to the average of the
volume weighted average price of common stock for the ten consecutive trading days ended on the day the FDA approves
the NDA.
Knight Agreement
In November 2019, the Company entered into a Distribution, License and Supply Agreement (the “Knight License
Agreement”) with Knight Therapeutics Inc. (“Knight”). Under the terms of the Knight License Agreement, the Company
granted Knight (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent
rights and know-how to develop and manufacture any product (the “Knight Licensed Product”) containing rigosertib for
Canada (and Israel should Knight exercise its option) (the “Knight Territory”) and in human uses (the “Knight Licensed
Field”), and (ii) an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and
know-how to commercialize the Knight Licensed Product in the Knight Territory and in the Knight Licensed Field.
Knight has also agreed to obtain from the Company all of Knight’s requirements of the Knight Licensed Products for
the Knight Territory, and the Company has agreed to supply Knight with all of its requirements of the Knight Licensed
Products. The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the
Knight Licensed Products.
In addition, the Company has granted Knight an exclusive right of first refusal with respect to all or any part of the
Knight Territory, to store, market, promote, sell, offer for sale and/or distribute any ROFR Products. As used in the Knight
License Agreement, “ROFR Products” means all products other than the Knight Licensed Product that are owned, licensed,
or controlled by the Company as of the effective date and all improvements thereto.
The Company is eligible to receive clinical, regulatory and sales-based milestone payments. The Company is also
eligible to receive tiered double-digit royalties based on net sales in the Knight Territory.
The Knight License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Knight
Territory and contains customary provisions for termination by either party in the event of breach of the Knight License
Agreement by the other party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any
sublicensee or assignee.
Specialised Therapeutics Asia Pte. Ltd. Agreement
On December 18, 2019, the Company entered into a Distribution, License and Supply Agreement (the “STA License
Agreement”) with Specialised Therapeutics Asia Pte. Ltd. (“STA”). Under the terms of the STA License Agreement, the
Company granted STA (i) a non-exclusive, royalty-bearing license, with the right to sublicense, under certain Company
patent rights and know-how to develop and manufacture any product (the “STA Licensed Product”) containing rigosertib
for Australia and New Zealand (the “STA Territory”) and in human uses (the “Field”), and (ii) an exclusive, royalty-
bearing license, with the right to sublicense, under certain Company patent rights and know-how to commercialize the STA
Licensed Product in the STA Territory and in the Field.
STA has also agreed to obtain from the Company all of STA’s requirements of the STA Licensed Products for the STA
Territory, and the Company has agreed to supply STA with all of its requirements of the STA Licensed Products.
Table of Contents
F-34
The Company may, at its discretion, use the services of a contract manufacturer to manufacture and package the STA
Licensed Products.
The Company may be entitled to receive clinical, regulatory and sale-based milestone payments. The Company may
also be entitled to receive tiered double-digit royalties based on net sales in the Territory.
The License Agreement is for a term of 15 years from the launch on a country-by-country basis in the Territory and
contains customary provisions for termination by either party in the event of breach of the License Agreement by the other
party (subject to a cure period), bankruptcy of the other party, or challenges to the patents by any sublicensee or assignee.
14. Subsequent Events
At the Market Offering Agreement
On March 10, 2025, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”)
with Citizens JMP Securities, LLC (“Citizens”), pursuant to which the Company may offer and sell shares of its common
stock, having aggregate sales price of up to $50,000,000 (subject to certain limitations set forth in the ATM Agreement),
from time to time, to or through Citizens, acting as sales agent and/or principal.
Amendment of Series A Warrants and pre-funded warrants
On February 18, 2025, the Company and certain of the purchasers of Units in the December 2024 offering entered
into amendments to the Series A Warrants (the “Series A Warrant Amendment”), pursuant to which the Series A Warrants
issued to such purchasers were amended to (i) increase the threshold for a change of control, for purposes of determining
whether a Fundamental Transaction (as defined in the Series A Warrants) has occurred, from 50% of the outstanding
common stock of the Company to greater than 50% of the outstanding common stock of the Company, (ii) revise the
expected volatility rate to be applied for purposes of determining the Black Scholes Value of the Series A Warrants to be
utilized for calculating consideration payable to the holders of the Series A Warrants in connection with a Fundamental
Transaction that is not within the Company’s control, and (iii) remove Section 3(h) of the Series A Warrants, which, under
certain circumstances, provided for adjustments to the exercise price of the Series A Warrants in the event of a reverse
stock split, stock consolidation, or a recapitalization or similar event involving the Company’s common stock based on the
volume weighted average price of the Company’s common stock over the eleven trading day period commencing five
trading days immediately preceding such event and the five trading days immediately following such event.
Subsequent to the year ended December 31, 2024, certain purchasers exercised their pre-funded warrants for an
aggregate of 1,382,559 shares of our common stock. On March 27, 2025, the Company and those purchasers holding all
pre-funded warrants outstanding as of such date entered into amendments to the pre-funded warrants (the “PFW
Amendment”), pursuant to which the pre-funded warrants issued to such purchasers were amended to increase the
threshold for a change of control, for purposes of determining whether a Fundamental Transaction (as defined in the pre-
funded warrants) has occurred, from 50% of the outstanding common stock of the Company to greater than 50% of the
outstanding common stock of the Company.
Exhibit 4.7
AMENDMENT TO PRE-FUNDED COMMON STOCK PURCHASE WARRANT
TRAWS PHARMA, INC.
THIS AMENDMENT TO PRE-FUNDED COMMON STOCK PURCHASE WARRANT (this
“Amendment”), dated as of March 26, 2025, is being entered into by and between Traws Pharma, Inc., a
Delaware corporation (the “Company”), and __________ (the “Holder”), and amends that certain Pre-
Funded Common Stock Purchase Warrant to purchase up to ___________ shares of the Company’s
common stock, par value $0.01 per share (“Common Stock”), at an exercise price that was pre-funded to
the Company, except for a nominal exercise price of $0.01 per share, issued by the Company to the Holder
on December 31, 2024 (the “Existing Warrant”).
WHEREAS, the Holder is, and as of the effective date of this Amendment will be, the holder of the
Warrants; and
WHEREAS, the Holder and the Company have agreed to amend and restate Section 3(d) of the
Warrants pursuant to the provisions of Section 5(l) of the Warrants.
NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
Definitions. Capitalized terms used and not defined in this Amendment have the respective meanings
ascribed to them in the respective Warrants.
Amendment To Existing Warrant.
Section 3(d) of the Existing Warrant is amended and restated in its entirety with the following:
Fundamental Transaction. If, at any time while this Warrant is outstanding, (i) the Company,
directly or indirectly, in one or more related transactions effects any merger or consolidation of the
Company with or into another Person, (ii) the Company, directly or indirectly, effects any sale,
lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its
assets in one or a series of related transactions, (iii) any, direct or indirect, purchase offer, tender
offer or exchange offer (whether by the Company or another Person) is completed pursuant to
which holders of Common Stock are permitted to sell, tender or exchange their shares for other
securities, cash or property and has been accepted by the holders of more than 50% of the
outstanding Common Stock, (iv) the Company, directly or indirectly, in one or more related
transactions effects any reclassification, reorganization or recapitalization of the Common Stock or
any compulsory share exchange pursuant to which the Common Stock is effectively converted into
or exchanged for other securities, cash or property, or (v) the Company, directly or indirectly, in one
or more related transactions consummates a stock or share purchase agreement or other business
combination (including, without limitation, a reorganization, recapitalization, spin-off, merger or
scheme of arrangement) with another Person or group of Persons whereby such other Person or
group acquires more than 50% of the outstanding shares of Common Stock (not including any
shares of Common Stock held by the other Person or other Persons making or party to, or
associated or affiliated with the other Persons making or party to, such stock or share purchase
agreement or other business combination) (each a “Fundamental Transaction”), then, upon any
subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant
Share that would have been issuable upon such exercise immediately prior to the occurrence of such
Fundamental Transaction, at the option of the Holder (without regard to any limitation in
Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the
successor or acquiring corporation or of the Company, if it is the surviving corporation, and any
additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental
Transaction by a holder of the number of shares of Common Stock for which this Warrant is
exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in
Section 2(e) on the exercise of this Warrant). For purposes of any such exercise, the determination
of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based
on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such
Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate
Consideration in a reasonable manner reflecting the relative value of any different components of
the Alternate Consideration. If holders of Common Stock are given any choice as to the securities,
cash or property to be received in a Fundamental Transaction, then the Holder shall be given the
same choice as to the Alternate Consideration it receives upon any exercise of this Warrant
following such Fundamental Transaction. The Company shall cause any successor entity in a
Fundamental Transaction in which the Company is not the survivor (the “Successor Entity”) to
assume in writing all of the obligations of the Company under this Warrant in accordance with the
provisions of this Section 3(e) pursuant to written agreements in form and substance reasonably
satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such
Fundamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange
for this Warrant a security of the Successor Entity evidenced by a written instrument substantially
similar in form and substance to this Warrant which is exercisable for a corresponding number of
shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of
Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any
limitations on the exercise of this Warrant) prior to such Fundamental Transaction, and with an
exercise price which applies the exercise price hereunder to such shares of capital stock (but taking
into account the relative value of the shares of Common Stock pursuant to such Fundamental
Transaction and the value of such shares of capital stock, such number of shares of capital stock and
such exercise price being for the purpose of protecting the economic value of this Warrant
immediately prior to the consummation of such Fundamental Transaction), and which is reasonably
satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental
Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the
date of such Fundamental Transaction, the provisions of this Warrant referring to the “Company”
shall refer instead to the Successor Entity), and may exercise every right and power of the Company
and shall assume all of the obligations of the Company under this Warrant with the same effect as if
such Successor Entity had been named as the Company herein.
Miscellaneous.
No Other Amendment. Except as expressly amended and modified herein, all terms and conditions
set forth in the Existing Warrant shall remain unchanged and in full force and effect.
Governing Law. All questions concerning the construction, validity, enforcement and interpretation
of this Amendment shall be governed by and construed and enforced in accordance with the
internal laws of the State of New York, without regard to the principles of conflicts of law
thereof.
Counterparts; Execution. This Agreement may be executed in two (2) or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument. Counterparts may be delivered via facsimile, electronic mail (including pdf or any
electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g.,
www.docusign.com) or other transmission method and any counterpart so delivered shall be
deemed to have been duly and validly delivered and be valid and effective for all purposes. At
the request of any party hereto, all parties hereto agree to execute and deliver an original of this
Amendment as well as any facsimile, telecopy or other reproduction hereof.
Independent Counsel. This Amendment has been drafted by counsel for the Company. The Holder
hereby declares and represents that the Holder has been advised and provided opportunity to
obtain independent legal and tax advice and to review all documents and agreements with said
independent counsel and tax advisor.
Headings. The headings used in this Amendment are for the convenience of reference only and
shall not, for any purpose, be deemed a part of this Amendment.
********************
(Signature Page Follows)
IN WITNESS WHEREOF, the parties have caused this Amendment to Pre-Funded Common Stock
Purchase Warrant to be executed as of the date first above indicated.
TRAWS PHARMA, INC.
By:
_________________________
Name:
Werner Cautreels
Title:
Chief Executive Officer
THE HOLDER:
______________________________
Name:
Exhibit 4.8
DESCRIPTION OF THE REGISTRANT’S SECURITIES
REGISTERED PURSUANT TO SECTION 12 OF THE
SECURITIES ACT OF 1934
The following is a summary of the material terms and provisions of the securities of Traws Pharma, Inc.
(“us,” “our,” “we” or the “Company”) that are registered under Section 12 of the Securities Exchange Act of
1934, as amended, and certain provisions of our certificate of incorporation, as amended and restated
(“Charter”), and bylaws, as amended and restated (“Bylaws”), that are currently in effect. This summary
does not purport to be complete and is qualified in its entirety by the provisions of our Charter and Bylaws,
each previously filed with the Securities and Exchange Commission (“SEC”) and incorporated by reference
as an exhibit to the Annual Report on Form 10-K of which this Exhibit 4.8 is a part, as well as to the
applicable provisions of the Delaware General Corporation Law (the “DGCL”). We encourage you to read
our Charter, Bylaws and the applicable portions of the DGCL carefully.
General
Our authorized capital stock consists of 255,000,000 shares, all with a $0.01 par value of per share, of
which:
●
250,000,000 shares are designated as common stock; and
●
5,000,000 shares are designated as preferred stock
(A) Description of Common Stock
Our common stock is listed on The Nasdaq Capital Market under the symbol “TRAW.”
Voting Rights
Holders of our common stock are entitled to one vote for each share of common stock held of record for the
election of our directors and all other matters requiring stockholder action, except with respect to
amendments to our Charter to alter or change the powers, preferences, rights or other terms of any
outstanding preferred stock if the holders of such affected series of preferred stock are entitled to vote on
such an amendment. Holders of our common stock do not have cumulative voting rights. In the case of
election of directors, all matters to be voted on by our stockholders must be approved by a plurality of the
votes entitled to be cast by all shares of common stock. Accordingly, the holders of a majority of the
outstanding shares of common stock entitled to vote in any election of directors can elect all of the directors
standing for election, if they so choose, other than any directors that holders of any preferred stock we may
issue may be entitled to elect. Except as otherwise provided by our Charter, Bylaws, the rules or regulations
of any stock exchange applicable to the Company, or applicable law or pursuant to any regulation applicable
to the Company or its securities, all other matters presented to our stockholders at a duly called or convened
meeting, at which a quorum is present, shall be determined by a majority of the votes cast on the matter
affirmatively or negatively.
Dividends
Dividends may be declared and paid on shares of our common stock as and when determined by our board
of directors, subject to any preferential dividend or other rights of any then outstanding preferred stock and
to the requirements of applicable law. Subject to preferences that may apply to any shares of preferred stock
outstanding at the time, the holders of our common stock will be entitled to share equally, identically and
ratably in any dividends that our board of directors may determine to issue from time to time.
Liquidation Rights
In the event of any voluntary or involuntary liquidation, dissolution or winding up of our affairs, holders of
our common stock would be entitled to share ratably in our assets that are legally available for distribution
to stockholders after payment of our debts and other liabilities. If we have any preferred stock outstanding
at such time, holders of the preferred stock may be entitled to distribution and/or liquidation preferences.
Other Rights
Holders of our common stock also do not have any conversion, redemption, sinking fund or preemptive
rights. The rights, preferences and privileges of the holders of our common stock will be subject to, and may
be adversely affected by, the rights of the holders of shares of any series of our preferred stock that we have
designated or may designate and issue in the future.
All outstanding shares of our common stock are, and any shares of common stock that we may issue in the
future will be, fully paid and non-assessable.
(B) Description of Preferred Stock
On April 1, 2024, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of
the Series C Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) providing for the
designation of 5,000,000 shares of the Company’s preferred stock as Series C Non-Voting Convertible
Preferred Stock (the “Series C Preferred Stock”). Shares of our Series C Preferred Stock do not trade on an
exchange.
Voting Rights
Except as otherwise required by applicable law, the Series C Preferred Stock does not have voting rights.
However, as long as any shares of Series C Preferred Stock are outstanding, the Company shall not, without
the affirmative vote of the holders of a majority of the then-outstanding shares of the Series C Preferred
Stock, (i) alter or change adversely the powers, preferences or rights given to the Series C Preferred Stock
or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to,
the Charter or Bylaws of the Company, or file any articles of amendment, certificate of designations,
preferences, limitations and relative rights of any series of preferred stock, in each case if any such action
would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for
the benefit of the Series C Preferred Stock, regardless of whether any of the foregoing actions shall be by
means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification,
conversion or otherwise, (ii) issue further shares of Series C Preferred Stock, (iii) prior to the earlier of
stockholder approval of the conversion of the Series C Preferred Stock or the six-month anniversary of the
Closing (as defined in the Certificate of Designation), consummate either: (A) any Fundamental Transaction
(as defined in the Certificate of Designation) or (B) any stock sale to, or any merger, consolidation or other
business combination of the Company with or into, another entity in which the stockholders of the
Company immediately before such transaction do not hold at least a majority of the capital stock of the
Company immediately after such transaction, or (iv) enter into any agreement with respect to any of the
foregoing.
Dividends
Holders of Series C Preferred Stock are entitled to receive dividends on shares of Series C Preferred Stock
equal to, on an as-if-converted-to-common stock basis, and in the same form as dividends actually paid on
shares of our common stock.
Liquidation Rights
In the event of the liquidation, dissolution, or winding up of the affairs of the Company, whether voluntary
or involuntary, the holders of Series C Preferred Stock shall rank on parity with common stockholders as to
the distributions of assets.
Conversion Rights
Following stockholder approval of the conversion of the shares of Series C Preferred Stock in accordance
with Nasdaq rules, each share of Series C Preferred Stock automatically converted into 400 shares of
common stock, subject to certain limitations, including the Beneficial Ownership Limitation (defined
below). Subsequent to the foregoing automatic conversion, and subject to the beneficial ownership
limitation, holders of Series C Preferred Stock have the right to convert the shares of the Series C Preferred
Stock into 400 shares of common stock at any time.
Beneficial Ownership Limitation
A holder of Series C Preferred Stock is prohibited from converting shares of Series C Preferred Stock into
shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would
beneficially own more than between 4.9% and 19.9% (to be established by the holder thereof) of the total
number of shares of common stock issued and outstanding immediately after giving effect to such
conversion (the “Beneficial Ownership Limitation”).
Redemption Rights
In the event the Company was unable to obtain an affirmative stockholder vote to permit conversion within
nine months after the initial issuance of the Series C Preferred Stock, each holder of Series C Preferred
Stock could elect, at the holder’s option, to have the shares of Series C Preferred Stock be redeemed by the
Company at an amount equal to the last reported closing trading price of the common stock at such time on
an as-converted to common stock basis, as further described in the Certificate of Designation. The
redemption right expired in connection with the Company obtaining the affirmative stockholder vote in
September 2024.
(C) Anti-Takeover Effects of Delaware Law and the Company’s Charter and Bylaws
Provisions of our Charter and Bylaws may delay or discourage transactions involving an actual or potential
change of control or change in our management, including transactions in which stockholders might
otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to
be in their best interests. Therefore, these provisions could adversely affect the price of our common stock.
Among other things, our Charter and Bylaws will:
●
permit our board of directors to issue up to 5,000,000 shares of preferred stock, with any rights,
preferences and privileges as they may designate (as of December 31, 2024, 5,000,000 shares have
been designated as Series C Preferred Stock);
●
provide that all vacancies on our board of directors, including as a result of newly created
directorships, may, except as otherwise required by law, be filled by the affirmative vote of a
majority of directors then in office, even if less than a quorum;
●
require that any action to be taken by our stockholders must be effected at a duly called annual or
special meeting of stockholders and not be taken by written consent;
●
provide that stockholders seeking to present proposals before a meeting of stockholders or to
nominate candidates for election as directors at a meeting of stockholders must provide advance
notice in writing, and also specify requirements as to the form and content of a stockholder’s notice;
●
not provide for cumulative voting rights, thereby allowing the holders of a majority of the shares of
common stock entitled to vote in any election of directors to elect all of the directors standing for
election; and
●
provide that special meetings of our stockholders may be called only by the board of directors or by
such person or persons requested by a majority of the board of directors to call such meeting.
In addition to the provisions of our Charter and Bylaws, we are subject to the provisions of Section 203 of
the DGCL (“Section 203”) regulating corporate takeovers. In general, Section 203 prohibits a publicly-held
Delaware corporation from engaging, under certain circumstances, in a business combination with an
interested stockholder for a period of three years following the date the person became an interested
stockholder unless:
●
prior to the date of the transaction, the board of directors of the corporation approved either the
business combination or the transaction which resulted in the stockholder becoming an interested
stockholder;
●
upon completion of the transaction that resulted in the stockholder becoming an interested
stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding for purposes of determining the
voting stock outstanding, the outstanding voting stock owned by the interested stockholder, (i)
shares owned by persons who are directors and also officers and (ii) shares owned by employee
stock plans in which employee participants do not have the right to determine confidentially
whether shares held subject to the plan will be tendered in a tender or exchange offer; or
●
at or subsequent to the date of the transaction, the business combination is approved by the board of
directors of the corporation and authorized at an annual or special meeting of stockholders, and not
by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is
not owned by the interested stockholder.
Generally, a business combination includes a merger, asset, stock sale or other transaction resulting in a
financial benefit to the interested stockholder. An interested stockholder is a person who, together with
affiliates and associates, owns or, within three years prior to the determination of interested stockholder
status, did own 15% or more of a corporation’s outstanding voting stock. We expect the existence of Section
203 to have an anti-takeover effect with respect to transactions our Board does not approve in advance. We
also anticipate that Section 203 may discourage business combinations or other attempts that might result in
a premium over the market price for the shares of common stock held by our stockholders.
Exhibit 10.31
MASTER RESEARCH AND DEVELOPMENT AGREEMENT
THIS AGREEMENT is made effective as of January 5, 2022 ("Agreement Date”)
BETWEEN:
1.
Full Name:
Viriom, Inc.
Address:
12760 High Bluff Drive, Suite #370
San Diego, CA 92130
Tele phone:
858-794-4860
(hereinafter referred to as "Viriom"); and
2.
Full Name:
Trawsfynydd Therapeutics Inc.
Address:
1209 Orange Street,
Wilmington, DE 19801
Telephone:
858-794-1930
(hereinafter referred to as "Customer").
WHEREAS, VIRIOM is a biotech company engaged in the research, development and providing related
services in the area of virology; and
WHEREAS, Customer is a biotechnology company involved in the research. development,
manufacture and sale of new and useful pharmaceutical products, and Customer desires to engage
the VIRIOM on a confidential basis to provide Customer with certain products and/or services;
VIRIOM and Customer hereby agree as follows:
1.
DEFINITIONS
In this Agreement the following expressions shall have the following meanings:
1.1
"Affiliates" shall mean the companies under the control of, controlled by or under common
control with either of the Parties. For the purposes of this definition, the term "control" shall
mean ownership of the majority of the stock of such Party.
1.2
“Agreement" means this Research and Development Agreement together with the Exhibits
attached hereto and the Appendices executed by both Parties and attached hereto from time to
time. Such appendices shall set forth the program(s) to be performed by VIRIOM hereunder
('"Program", "Work Order") and the payment schedule(s) with respect thereto ("Payment
Schedule"), and such other terms and conditions as may be agreed upon by the Parties. Work
Orders as discussed in Section 2.3 will be deemed Appendices when properly executed by both
Parties.
1.3
"Confidential Information" means the information (whether oral, written or in any other form)
concerning transactions, dealings, projects, plans, proposals and other business affairs of Customer
and of VIRIOM and any and all Technical Information used in and/or developed by
VIRIOM's Personnel and Customer's Personnel in the course of or in connection with the
Services and Program.
1.4
"Exclusive Product" means a Product to which VIRIOM has granted Customer exclusive rights
as provided in Section 4.3.
1.5
“Intellectual Property Rights" means patents, patent applications, copy right, know-how and
other intellectual prope1ty rights.
1.6
"Limited Exclusivity Product" means a Product to which VIRIOM has granted Customer
limited exclusivity rights as set forth in section 4.4.
1.7
"VIRIOM's Personnel" means VIRIOM's directors, consultants, employees and any other
persons engaged in the Progran1 under the direction of VIRIOM.
1.8
"Non-Exclusive Product" means a Product for which no exclusive rights have been
granted by VIRIOM to Customer as set forth in section 4.2.
1.9
"Parties" means VIRIOM and Customer and "Party" means VIRIOM or Customer.
1.10
"Product" means both the chemical entity designated in the applicable Program and all
testing data and results obtained in the applicable Program.
1.11
"Program" shall mean the work to be pe1formed pursuant to a Work Order.
1.12
"Related Compound" shall mean any compound which is a Homologue, Isomer, Analogue or
First-order derivative of a chemical entity Product that has Exclusive or Limited Exclusivity
status. "Homologue" shall mean a compound differing from such a Product by a methylene
group or an ethylene group or a similar or equivalent group that does not affect the central
relationship of the functional groups in the Product. "Isomer" shall mean a compound differing
from such a Product by positional isomery, geometric isomery, or stereochemical isomery.
"Analogue" shall mean a compound which differs from another compound by the replacement
of a single group within the compound. "First-order derivative" shall mean a compound
derived from such a Product by a single chemical reaction excluding, however, any compound
which differs from any Product to such an extent that it would not reasonably be considered to
be an obvious extension of a
Product.
1.13
"Services" means the services to be carried out by VIRIOM to perform under the
Program(s).
l.14
"Specifications" means the specifications, if any, identified in the Program.
1.15
"Technical Information" means, but is not limited to, improvements, inventions, developments,
techniques, processes, methods, specifications, procedures, data, compound structures,
formulae; testing methods and materials, test results, trade secrets and know-how,
all as the same may be used in and/or arise from the performance of the Services.
1.16
“Customer's Personnel" means Customer' s directors, consultants, employees and any other
persons under the direction of Customer having access to the substance and results of the
Program.
1.17
"T&M" means cost of the Program related to VIRIOM expenditure for the Program billed by
VIRIOM to the Customer including but not limited by time, materials, VIRIOM personnel
wages, overhead, lease of space and equipment spent on the Program.
1.18
"FTE" means cost of the Program billed by VIRIOM to the Customer related to the cost of
VIRIOM Full Time Employee with reasonable skills, technical competence and suitable
qualification engaged in the Program for a specified period.
1.19
"Fixed Price" means the cost of the Program as agreed between the Parties at the time of
issuance and acceptance of a Work Order.
2.
Work Orders
2.1 Work Proposal
From time to time, Customer shall provide to VIRIOM a work proposal detailing a Program that
includes Customer's description of Product(s), Specifications (e.g., purity, quantity,
methodologies, et cetera). and the date required for Customer' s receipt of Product(s) ("Work
Proposal").
Customer shall further designate in the Work Proposal the proprietary position it requires with
respect to each of the Products. The proprietary positions requested by Customer shall be
designated as "Exclusive", "Non- Exclusive", or "Limited Exclusivity". In the absence of any
such explicit designation, it shall be understood that Customer requests an “Exclusive" position
with respect to each of the Products.
2.2 Offer
If VIRIOM is interested in carrying out the Program set forth in the Work Proposal, it shall
notify Customer by providing it with a written offer that includes VIRIOM's proposed Payment
Schedule and other terms not contained in this Agreement for each and all of the contemplated
work in the Work Proposal ("Offer"). If the proprietary position requested by Customer is not
available, VIRIOM shall notify Customer what proprietary position is available. An Offer, if
made by VIRIOM, shall be provided to Customer within two (2) weeks of VIRIOM's receipt of
the Work Proposal. It is understood that the Payment Schedule shall be based, in part, on the
proprietary position that Customer requests and the availability of such position with respect to
the applicable Product(s).
2.3
Work Order
If Customer accepts VIRIOM's Offer, Customer shall submit a written Work Order to
VIRIOM authorizing it to carry out the Program w1der the terms set forth in the Offer
("Work Request"). Customer shall be under no obligation to accept the Offer. If the Work
Order contains terms and conditions conflicting with, or different from, (i) the Offer or the
(ii) the terms of this Agreement, then such conflicting or different terms
contained in the Work Order will not be deemed accepted by VIRIOM (even if VIRIOM
conducts work under the Work Proposal) unless the Work Proposal is executed by VIRIOM in
accordance with Section 12.6. All Work Requests will contain at least the information
presented in Exhibit 1.
2.4
Multiple Work Proposals, Offers, and Work Orders may be executed under the scope of this
Master Research Agreement.
3.
The Services
3.1
VIRIOM shall use its reasonable endeavors to commence the Services on or before the
commencement date set forth in the applicable Program and to complete the Services on or
before the completion date set forth in the applicable Program, subject to extension by mutual
written agreement of the Parties.
3.2
VIRIOM shall ensure that VIRIOM's Personnel exercise reasonable skill, care and
diligence in the performance of the Services.
3.3
VIRIOM shall ensure that VIRIOM's Personnel involved with the Services are technically
competent and suitably qualified to carry out the parts of the Services assigned to them.
3.4
VIRIOM and Customer shall appoint Program Managers and a to-be-named Designated
Supervisor for each specific Program as set forth in each Work Order. The YIR1OM Program
Manager and the Customer Designated Supervisor shall be the principal points of contact
between the Parties for all matters relating to this Agreement. VIRIOM may change its
Program Manager and Customer may change its Program Manager or Designated Supervisor
by giving 10 (ten) days notice in writing to the other Party.
3.5
No variation to the Services shall be made without the prior written agreement of the duly
authorized representative of each Party to such variation.
4.
Proprietary Nature of Products; Restrictions
4.1
Upon payment to VIRIOM as provided in the Work Order for any Exclusive Product, and made
in accordance with Section 6 of the Agreement, Customer shall have title to the physical samples
and test results for Products it receives for such payment, and Customer shall have no further
obligation to VIRIOM with respect to such Products unless otherwise provided in this
Agreement.
4.2
VIRIOM shall not use, sell or supply any Exclusive Product, nor grant any rights with respect
thereto, nor disclose any infom1ation related thereto, to any third party (other than an Affiliate
of Customer) for any purpose whatsoever.
4.3
Any Product designated as "Non-Exclusive Product" may be offered for sale to others by
VIRIOM.
4.4
a. If Customer elects “Limited Exclusivity'' for a Program, and requests a period of
exclusivity, then for the period of time to specified in the Work Order ("Period of
Exclusivity"), VIRIOM shall not use, sell or supply any Limit ed Exclusivity Product, nor
grant any rights with respect thereto, nor disclose any information related thereto, to any third
party (other than an Affiliate of Customer).
b. If Customer elects "Limited Exclusivity" for a Program, and requests a limited number of
sales of Product to third parties, then VIRIOM shall not sell or supply such Products to more
than the number of third parties specified in the Work Order, (other than an Affiliate of
Customer).
4.5
At any time during the Period of Limited Exclusivity, Customer may request to extend the
Period of Exclusivity by paying VIRIOM for each month of extended exclusivity, as agreed
upon in writing by the Parties. After the Period of Exclusivity, and any agreed-to extensions
thereof, the Product shall become Non-Exclusive.
4.6
No Product nor Related Compound(s) shall have Exclusive or Limited Exclusivity status if the
Product or Related Compound is listed in VIRIOM's catalog or database at the time that
VIRIOM receives a Work Proposal for the Product.
5.
INFORMATION AND REPORTS
5.1 VIRIOM shall keep Customer fully informed of the progress of the Services by providing
summary reports to the Designated Supervisor at the end of each month until the Services are
complete d or the Agreement is terminated.
5.2
VIRIOM shall ensure that its key personnel involved with a Program and the Program Manager
are reasonably available for telephone and face-to-face discussions with Customer's Personnel as
may be agreed upon by the Parties. If Customer requests VIRIOM Personnel to attend any
further meetings other than those on VIRIOM premises, VIRIOM shall be reimbursed for
reasonable travel expenses incurred by VIRJOM Personnel attending any such meetings.
5.3
VIRIOM shall provide such written reports to Customer as may be specified in the applicable
Program. VIRIOM shall promptly provide Customer with copies of all Technical Information,
data, records and supporting documentation reasonably requested by Customer relating to the
Services, subject to the provisions of Section 7, including without limitation Product
information such as analytical and structure determination information.
6
INVOICE AND PAYMENT
6.1
VIRIOM shall submit an invoice to Customer for each payment due in accordance with the
applicable Payment Schedule related to the Fixed Price, T&M, or FTE business arrangement for
the corresponding Work Order.
6.2
Customer shall pay VIRIOM's invoice in accordance with the schedule established in the
applicable Work Order. In the absence of Work Order payment schedule, Customer shall pay
VIRIOM's invoice within 30 (thirty) days after Customer' s receipt of corresponding Product or
a part of the Product in compliance with Specifications and Program schedule.
6.3
Unless otherwise agreed upon by Customer, it reserves the right to reject any Product delivered
after a period of time that is twice as long as the provided for in the Work Order for delivery of
Product.
7
INTELLECTUAL PROPERTY RIGHTS
7.1
With respect to all Products designated as Exclusive by Customer, VIRIOM will promptly
disclose to Customer any inventions, know-how or discoveries relating to Products, developed
or discovered as a result of the work contemplated under this Agreement, whether or not
patentable. VIRIOM agrees to assign or cause assignments of any such inventions to Customer,
at Customer's cost, and provide reasonable assistance to Customer at Customer's cost in
preparing and prosecuting such patent applications thereon, as Customer deems necessary to
adequately protect its rights in such inventions, know-how and discoveries.
7.2
Except for purposes of the work contemplated by this Agreement, no right or license to use the
Confidential Information or any technology or intellectual prope1iy rights of Customer is
granted by implication or otherwise.
7.3
VIRIOM shall disclose in writing to Customer, in advance, any Intellectual Property Rights
patents of VIRIOM or any Intellectual Property Rights known to VIRIOM belonging to a third
party which may be infringed by the use of a Product, or process for making a Product,
developed for Customer by VIRIOM hereunder.
8
CONFIDENTIAL INFORMATION
8.1
The Parties shall procure that VIRIOM's Personnel and Customer's Personnel shall:
(i)
not disclose any of the other Party's Confidential Information to any person other than
VIRIOM's Personnel and/or Customer's Personnel who have entered into legally binding
confidentiality obligations at least as restrictive in scope to those set out in this Clause 8;
(ii)
not use any Confidential Information for any purpose other than in accordance with
this Agreement; and
(iii) take all reasonable steps necessary to prevent the unauthorized disclosure and/or use of
any Confidential Information which steps shall at least equal those taken to protect Recipient's
own Confidential Information.
8.2
The obligations of Clause 8.1 shall not apply to any Confidential Information which:
(i)
is in the public domain at the ti.me of disclosure or subsequent to the time of
disclosure to enters the public domain through no fault of receiving Party;
(ii)
either Patt y can prove by docun1entary evidence was already in the possession of that
Patty prior to the date of this Agreement;
(iii)
is the subject of at1 order to disclose by a Court having the right and power to make
such an order;
(iv)
is received from a third party not under an obligation of confidentiality to either Party;
or
(v)
is required to be disclosed by legal or regulatory process; provided, in each case the
Party required to disclose timely informs the other Party and uses reasonable efforts to limit the
disclosure and maintain confidentiality to the extent possible and permits the other party to
intervene and contest or attempt to limit the disclosure.
8.3
Any Confidential Information, including without limitation research results, data and other
Technical Information, developed by VIRIOM's Personnel in the course of or in connection
with the performance of the Services hereunder relating to an Exclusive Product shall belong
solely to Customer and shall be considered Customer's Confidential Information subject to the
provisions of Sections 8.1 and 8.2 above.
8.4
Customer may disclose VIRIOM's Confidential Information to its corporate licensees and
collaborators, for development of the Product, on a need to know basis ar1d provided that any
such licensees, and collaborators are made aware of the confidential nature of the Information
and execute agreements at least as restrictive as the provisions contained in this Agreement to
maintain the confidentiality thereof.
9
WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY
9.1
Warranties
9.1.1 The Parties understand that the Product(s) may possess chemical, physical and
toxicological
properties that are unknown at this time. Each Patty agrees to observe all the
safety precautions that a technically qualified, prudent researcher would observe when handling
chemical compounds of unknown toxicity, in order to limit exposure to laboratory personnel and
the environment. Access to the Product(s) will be restricted to technically qualified individuals
who have been adequately notified as to the known and potential hazards of these Product(s) and
adequately instructed as to their proper handling
9.1.2 Each Party shall promptly inform the other of any toxicity, instability, or other hazards known to
it that would impede the safe handling of Product(s).
9.1.3 EXCEPT AS MAY BE OTHERWISE STATED HEREIN, VIRIOM MAKES NO
REPRESENTATIONS, AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS OR RELATED
COMPOUNDS FURNISHED HEREUNDER. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FORA PARTICULAR PURPOSE,
OR THAT THE USE OF PRODUCTS OR COMPOUNDS WILL NOT INFRINGE ANY
PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY.
9.2
Indemnities
9.2.1
VIRIOM assumes the entire risk of injury or damage resulting from its preparation,
handling, use, or testing of Product under VIRIOM's control and agrees to indemnify and hold
Customer harmless from any loss, damage, claim, or cost of defending against any claim
arising from VIRIOM's preparation, handling, use, or testing of Product under VIRIOM's control
except to the extent that such loss or damage was caused by Customer's negligence.
9.2.2
Customer assumes the entire risk of injury or damage resulting from its preparation,
handling, use, or testing of Product under Customer's control and agrees to indemnify and hold
VIRJOM harmless from any loss, damage, claim, or cost of defending against any claim arising
from Customer's preparation, handling, use, or testing of Product except to the extent that such
loss or damage was caused by VIRIOM's negligence.
9.2.3
Customer also agrees to indemnify, hold harmless and defend VIRIOM, and its
directors, officers, employees, Affiliates, and agents, against any and all legal claims,
proceedings, demands, liability and expenses of any kind, including legal expense and
reasonable attorney fees, for death, illness, personal injury, property damage, infringement,
improper business practices and noncompliance with applicable laws, arising out of or relating
to the design, manufacture, distribution, advertisement, consumption, sale, or use of any
Products or Related Compounds.
10.
TERMINATION
10. l
Termination Events
10.1.1 Termination Right. Each Party shall have the right to terminate this Agreement
without cause at any time upon not less than thirty (30) days prior written notice.
10.1.2 If either Party shall be in material breach of this Agreement, and should such breach
continue for sixty (60) days after written notification to the Party in breach, then the non-
breaching Party may at its option terminate this Agreement or suspend the performance of its
obligations under this Agreement by giving the Party in breach immediate notice of
termination or suspension. Suspension by one Party of performance shall not preclude such
Party later terminating this Agreement pursuant to this Clause 10.1.3.
10.l.3 In the event of termination by either Party, Customer shall pay VIRIOM for all
amounts due hereunder prior to the effective date of termination. In addition, Customer shall
reimburse VIRIOM for all raw materials and components purchased or ordered pursuant to
non-cancelable orders prior to receipt of the notice of termination, to the extent that such
costs are not included in the payments otherwise due to VIRIOM. At Customer's request,
VIRIOM shall deliver such materials and any finished Product(s) then in its possession to
Customer, at Customer' s cost and per Customer' s instructions.
10.1.4 In the event that:
(i)
either Party becomes insolvent, or an order is made or a resolution passed for the
winding up of either party other than for the purposes of a solvent scheme of reconstruction or
amalgamation or internal reorganization; or
(ii)
an administrator, administrative receiver or receiver is appointed in respect of either
Party' s assets and/or business; or
(iii)
as a result of financial difficulties either Party makes any voluntary arrangement
with its creditors: or
(iv)
as a consequence of debt and/or maladministration, either Party takes or suffers any
similar or analogous action to those listed in i), ii) or iii) above;
then the other Party shall be entitled to terminate this Agreement by giving immediate written
notice of termination.
10.2
Consequences of Termination
10.2.1 Termination shall be without prejudice to any other right or remedy the Parties may
have arising on or before the date of termination.
10.2.2. Termination pursuant to this provision shall not relieve either Party of any obligation
accrued hereunder prior to the date of termination. Following termination of this Agreement
Sections 1, 4, 7, 8, 9, 10 and 12 shall remain in full force and effect.
10.2.3. Provided that VIRIOM does not terminated the Agreement persuant to Clause
10.1.2, VIRIOM shall deliver to Customer all results up to the effective date of termination and
fulfill its obligations under Section 5.3 hereof. Upon request, each Party shall promptly return to
the other all written copies or other embodiments of the other's Confidential Information;
provided that the receiving party may retain one complete copy of the Confidential Information
solely to be able to monitor its obligations under this Agreement for archival purposes.
Customer may retain such of VIRIOM's Confidential Information as it may require in order to
practice any license granted to it under this Agreement.
11.
FORCE MAJEURE
11.1
If either Party is affected by any circumstances beyond its reasonable control (including, without
limitation, any strike, lock out or other form of industrial action) it shall forthwith notify the
other Party of the nature and extent thereof.
11.2
Neither Party shall be deemed to be in breach of this Agreement, or otherwise be liable to the
other, by reason of any delay in performance, or non-performance, of any of its obligations
hereunder to the extent such delay or non-performance is due to any such circumstance as is
described in Section 11.1 of this clause of which it has notified the other Party; and the time for
performance of that obligation shall be extended accordingly.
11.3
If any of the circumstances described in Section 11.1 of this clause notified as aforesaid prevails
for a continuous period in excess of six months, the Parties hereto shall enter into bona fide
discussions with a view to alleviating its effects, or to agreeing upon such alternative
arrangements as may be fair and reasonable in all the circumstances.
12.
MISCELLANEOUS
12.1
Assignment
This Agreement may not be assigned by either Party without the prior written consent of the
other Party, except that either of the Parties may, upon written notice to the other (which
notice shall identify the assignee with specificity), assign this Agreement and the rights
hereunder to a successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business pertaining to the subject matter of this
Agreement provided such successor also assumes any surviving duties and obligations hereunder
of the assigning Party.
12.2
Relationship of the Parties
Nothing in this Agreement shall create, evidence or imply any agency, partnership or joint
venture between the Parties. Neither Party shall act or describe itself as the agent of the other
Party nor shall it represent that it has authority to make commitments on behalf of the other
Party.
12.3
Waiver
Failure or delay by either Party to exercise any right or remedy under this Agreement shall
not be deemed to be a waiver of that right or remedy, or prevent it from exercising that or any
other right or remedy on that occasion or on any other occasion.
12.4
Severance
In the event that any provision of this Agreement shall, for any reason, be held to be invalid or
unenforceable in any respect such invalidity or unenforceability shall not affect any other
provision hereof, and this Agreement shall be construed as if such invalid or unenforceable
provision had not been included herein; however, the parties shall attempt to negotiate in good
faith a valid, legal, and enforceable substitute provision that most nearly reflects the original
intent of the parties.
12.5
Clause Headings
The headings used in this Agreement are for convenience only and shall not affect its
interpretation.
12.6
Entire Agreement and Amendments
This Agreement constitutes the entire agreement and understanding of the Parties relating to the
subject matter of this Agreement and supersedes all prior oral and written agreements,
w1derstandi.ngs or arrangements between them relating to such subject matter. The Parties
acknowledge that they are not relying on any agreement, understanding, arrangement, warranty
representative or term which is not set out in this Agreement. No variation, amendment,
modification or supplement to this Agreement shall be valid unless made in writing and signed by
the duly authorized representative of each Party.
12.7
Notices
Unless otherwise expressly agreed by the Party receiving notice, any notice or other
communication required or permitted to be given by either Party under any provision of this
Agreement must be in writing, in the English language, and mailed (certified or registered mail,
postage prepaid, return receipt requested) or sent by hand or overnight courier, or by
facsimile (with acknowledgment received), charges prepaid and addressed to the intended
recipient at such Party's address set forth below, or to such other address or number as such Party
may from time to time specify by notice to the other Party as provided in this Section. All notices
and other communications given in accordance with the provisions of this Agreement will be
deemed to have been given and received (i) when actually delivered by band, by mail, or by
courier, or (ii) when transmitted by facsimile (with acknowledgment received and a copy of such
notice is sent no later than the next business day by a reliable overnight or two-day courier
service, with acknowledgment of receipt).
12.8
Governing Law and Disputes
This Agreement is entered into in San Diego, California, U.S.A. and the construction validity
and performance of this Agreement shall be governed in all respects by the laws of the State of
California, as such laws are applied to agreements entered into and to be performed entirely
within California The Parties consent to the exclusive jurisdiction of courts located in
California and agree that any disputes relating to this Agreement shall be resolved in the
appropriate state court located in the County of San Diego or the appropriate federal com1 for
San Diego, California.
12.9 Counterparts
This Agreement may be executed in any number of counterparts and by the different Parties
hereto by separate counterparts, each of which when so executed shall be an original, and all
of which shall constitute one and the same instrument.
12.10 Attorney's Fees
In the event a dispute arises over this Agreement. the prevailing party in any litigation,
arbitration or other action shall be awarded reasonable attorney's fees and costs.
SIGNED for and on behalf of VIRIOM:
By: /s/ Ronald Demete Date: ___1/5/22_______
Name: Ronald Demete
Title:
CFO
SIGNED for and on behalf of Customer:
By: _/s/ Nikolay Savchuk__ Date: ___1/5/22_______
Name: Nikolay Savchuk
Title: CEO
Exhibit 10.33
MASTER RESEARCH AND DEVELOPMENT AGREEMENT
THIS AGREEMENT is made effective as of 09/23/2022 (“Agreement Date”)
BETWEEN:
1.
Full Name:
Address:
ChemDiv, Inc.
12760 High Bluff drive, Suite 370
Telephone:
San Diego, CA, 92130
858-794-4860
(hereinafter referred to as “CDI”); and
2.
Full Name:
Address:
Telephone:
Trawsfynydd Therapeutics, Inc.
1209 Orange Street,
Wilmington, DE 19801
858-794-1930
(hereinafter referred to as “Customer”).
WHEREAS, CDI is a CRO company engaged in the sale of drug discovery services to life
science companies; offering expertise in preclinical drug discovery services including screening
libraries, medicinal chemistry, in-vitro and in-vivo biological testing and related services useful
for pharmaceutical research and development; and
WHEREAS, Customer is a biotechnology company involved in the research, development,
manufacture and sale of new and useful pharmaceutical products, and Customer desires to engage
the CDI on a confidential basis to provide Customer with certain products and/or intermediates
thereof;
CDI and Customer hereby agree as follows:
1.
DEFINITIONS
In this Agreement the following expressions shall have the following meanings:
1.1
“Affiliates” shall mean the companies under the control of, controlled by or under
common control with either of the Parties. For the purposes of this definition, the term
“control” shall mean ownership of the majority of the stock of such Party.
1.2
“Agreement” means this Research and Development Agreement together with the Exhibits
attached hereto and the Appendices executed by both Parties and attached hereto from time
to time. Such appendices shall set forth the program(s) to be performed by CDI hereunder
(“Program”, “Work Order”) and the payment schedule(s) with respect
thereto (“Payment Schedule”), and such other terms and conditions as may be agreed upon
by the Parties. Work Orders as discussed in Section 2.3 will be deemed Appendices when
properly executed by both Parties.
1.3
“Confidential Information” means the information (whether oral, written or in any other
form) concerning transactions, dealings, projects, plans, proposals and other business
affairs of Customer and of CDI and any and all Technical Information used in and/or
developed by CDI’s Personnel and Customer’s Personnel in the course of or in
connection with the Services and Program.
1.4
“Exclusive Product” means a Product to which CDI has granted Customer exclusive
rights as provided in Section 4.3.
1.5
“Intellectual Property Rights” means patents, patent applications, copyright, know-how
and other intellectual property rights.
1.6
“Limited Exclusivity Product” means a Product to which CDI has granted Customer
limited exclusivity rights as set forth in section 4.4.
1.7
“CDI’s Personnel” means CDI’s directors, consultants, employees and any other
persons engaged in the Program under the direction of CDI.
1.8
“Non-Exclusive Product” means a Product for which no exclusive rights have been
granted by CDI to Customer as set forth in section 4.2.
1.9
“Parties” means CDI and Customer and “Party” means CDI or Customer.
1.10
“Product” means both the chemical entity designated in the applicable Program and all
testing data and results obtained in the applicable Program.
1.11
“Program” shall mean the work to be performed pursuant to a Work Order.
1.12
“Related Compound” shall mean any compound which is a Homologue, Isomer,
Analogue or First-order derivative of a chemical entity Product that has Exclusive or
Limited Exclusivity status. “Homologue” shall mean a compound differing from such a
Product by a methylene group or an ethylene group or a similar or equivalent group that does
not affect the central relationship of the functional groups in the Product. “Isomer” shall
mean a compound differing from such a Product by positional isomery, geometric isomery,
or stereochemical isomery. “Analogue” shall mean a compound which differs from another
compound by the replacement of a single group within the compound.
“First-order derivative” shall mean a compound derived from such a Product by a single
chemical reaction excluding, however, any compound which differs from any Product to
such an extent that it would not reasonably be considered to be an obvious extension of a
Product.
1.13
“Services” means the services to be carried out by CDI to perform under the Program(s).
1.14
“Specifications” means the specifications, if any, identified in the Program.
1.15
“Technical Information” means, but is not limited to, improvements, inventions,
developments, techniques, processes, methods, specifications, procedures, data,
compound structures, formulae; testing methods and materials, test results, trade secrets
and know-how, all as the same may be used in and/or arise from the performance of the
Services.
1.16
“Customer’s Personnel” means Customer’s directors, consultants, employees and any
other persons under the direction of Customer having access to the substance and results
of the Program.
1.17
“T&M” means cost of the Program related to CDI expenditure for the Program billed by
CDI to the Customer including but not limited by time, materials, CDI personnel wages,
overhead, lease of space and equipment spent on the Program.
1.18
“FTE” means cost of the Program billed by CDI to the Customer related to the cost of
CDI Full Time Employee with reasonable skills, technical competence and suitable
qualification engaged in the Program for a specified period.
1.19
“Fixed Price” means the cost of the Program as agreed between the Parties at the time of
issuance and acceptance of a Work Order.
2.
Work Orders
2.1 Work Proposal
From time to time, Customer shall provide to CDI a work proposal detailing a Program
that includes Customer’s description of Product(s), Specifications (e.g., purity, quantity,
methodologies, et cetera), and the date required for Customer’s receipt of Product(s)
(“Work Proposal”).
Customer shall further designate in the Work Proposal the proprietary position it requires
with respect to each of the Products. The proprietary positions requested by Customer shall
be designated as “Exclusive”, “Non-Exclusive”, or “Limited Exclusivity”. In the absence of
any such explicit designation, it shall be understood that Customer requests an “Exclusive”
position with respect to each of the Products.
2.2 Offer
If CDI is interested in carrying out the Program set forth in the Work Proposal, it shall
notify Customer by providing it with a written offer that includes CDI’s proposed Payment
Schedule and other terms not contained in this Agreement for each and all of the
contemplated work in the Work Proposal (“Offer”). If the proprietary position requested by
Customer is not available, CDI shall notify Customer what proprietary position is available.
An Offer, if made by CDI, shall be provided to Customer within two (2) weeks of CDI’s
receipt of the Work Proposal. It is understood that the Payment Schedule shall be based, in
part, on the proprietary position that Customer requests and the availability of such position
with respect to the applicable Product(s).
2.3
Work Order
If Customer accepts CDI’s Offer, Customer shall submit a written Work Order to CDI
authorizing it to carry out the Program under the terms set forth in the Offer (“Work
Request”). Customer shall be under no obligation to accept the Offer. If the Work Order
contains terms and conditions conflicting with, or different from, (i) the Offer or the (ii) the
terms of this Agreement, then such conflicting or different terms contained in the Work
Order will not be deemed accepted by CDI (even if CDI conducts work under the Work
Proposal) unless the Work Proposal is executed by CDI in accordance with Section
12.6. All Work Requests will contain at least the information presented in Exhibit 1.
2.4
Multiple Work Proposals, Offers, and Work Orders may be executed under the scope of
this Master Research Agreement.
3.
The Services
3.1
CDI shall use its reasonable endeavors to commence the Services on or before the
commencement date set forth in the applicable Program and to complete the Services on or
before the completion date set forth in the applicable Program, subject to extension by
mutual written agreement of the Parties.
3.2
CDI shall ensure that CDI’s Personnel exercise reasonable skill, care and diligence in the
performance of the Services.
3.3
CDI shall ensure that CDI’s Personnel involved with the Services are technically
competent and suitably qualified to carry out the parts of the Services assigned to them.
3.4
CDI and Customer shall appoint Program Managers and a to-be-named Designated
Supervisor for each specific Program as set forth in each Work Order. The CDI Program
Manager and the Customer Designated Supervisor shall be the principal points of contact
between the Parties for all matters relating to this Agreement. CDI may change its Program
Manager and Customer may change its Program Manager or Designated Supervisor by
giving 10 (ten) days notice in writing to the other Party.
3.5
No variation to the Services shall be made without the prior written agreement of the duly
authorized representative of each Party to such variation.
4.
Proprietary Nature of Products; Restrictions
4.1
Upon payment to CDI as provided in the Work Order for any Exclusive Product, and made
in accordance with Section 6 of the Agreement, Customer shall have title to the physical
samples and test results for Products it receives for such payment, and Customer shall have
no further obligation to CDI with respect to such Products unless otherwise provided in
this Agreement.
4.2
CDI shall not use, sell or supply any Exclusive Product, nor grant any rights with respect
thereto, nor disclose any information related thereto, to any third party (other than an
Affiliate of Customer) for any purpose whatsoever.
4.3
Any Product designated as “Non-Exclusive Product” may be offered for sale to others by
CDI.
4.4
a. If Customer elects “Limited Exclusivity” for a Program, and requests a period of
exclusivity, then for the period of time to specified in the Work Order (“Period of
Exclusivity”), CDI shall not use, sell or supply any Limited Exclusivity Product, nor grant
any rights with respect thereto, nor disclose any information related thereto, to any third
party (other than an Affiliate of Customer).
b. If Customer elects “Limited Exclusivity” for a Program, and requests a limited number
of sales of Product to third parties, then CDI shall not sell or supply such Products to more
than the number of third parties specified in the Work Order, (other than an Affiliate of
Customer).
4.5
At any time during the Period of Limited Exclusivity, Customer may request to extend the
Period of Exclusivity by paying CDI for each month of extended exclusivity, as agreed
upon in writing by the Parties. After the Period of Exclusivity, and any agreed-to
extensions thereof, the Product shall become Non-Exclusive.
4.6
No Product nor Related Compound(s) shall have Exclusive or Limited Exclusivity status if
the Product or Related Compound is listed in CDI’s catalog or database at the time that
CDI receives a Work Proposal for the Product.
5.
INFORMATION AND REPORTS
5.1
CDI shall keep Customer fully informed of the progress of the Services by providing
summary reports to the Designated Supervisor at the end of each month until the Services
are completed or the Agreement is terminated.
5.2
CDI shall ensure that its key personnel involved with a Program and the Program Manager
are reasonably available for telephone and face-to-face discussions with Customer’s
Personnel as may be agreed upon by the Parties. If Customer requests CDI Personnel to
attend any further meetings other than those on CDI premises, CDI shall be reimbursed for
reasonable travel expenses incurred by CDI Personnel attending any such meetings.
5.3
CDI shall provide such written reports to Customer as may be specified in the applicable
Program. CDI shall promptly provide Customer with copies of all Technical Information,
data, records and supporting documentation reasonably requested by Customer relating to
the Services, subject to the provisions of Section 7, including without limitation Product
information such as analytical and structure determination information.
6.
INVOICE AND PAYMENT
6.1
CDI shall submit an invoice to Customer for each payment due in accordance with the
applicable Payment Schedule related to the Fixed Price, T&M, or FTE business
arrangement for the corresponding Work Order.
6.2
Customer shall pay CDI’s invoice in accordance with the schedule established in the
applicable Work Order. In the absence of Work Order payment schedule, Customer shall
pay CDI’s invoice within 30 (thirty) days after Customer’s receipt of corresponding
Product or a part of the Product in compliance with Specifications and Program schedule.
6.3
Unless otherwise agreed upon by Customer, it reserves the right to reject any Product
delivered after a period of time that is twice as long as the provided for in the Work Order
for delivery of Product.
7.
INTELLECTUAL PROPERTY RIGHTS
7.1
With respect to all Products designated as Exclusive by Customer, CDI will promptly
disclose to Customer any inventions, know-how or discoveries relating to Products,
developed or discovered as a result of the work contemplated under this Agreement,
whether or not patentable. CDI agrees to assign or cause assignments of any such
inventions to Customer, at Customer’s cost, and provide reasonable assistance to
Customer at Customer’s cost in preparing and prosecuting such patent applications
thereon, as Customer deems necessary to adequately protect its rights in such inventions,
know-how and discoveries.
7.2
Except for purposes of the work contemplated by this Agreement, no right or license to
use the Confidential Information or any technology or intellectual property rights of
Customer is granted by implication or otherwise.
7.3
CDI shall disclose in writing to Customer, in advance, any Intellectual Property Rights
patents of CDI or any Intellectual Property Rights known to CDI belonging to a third
party which may be infringed by the use of a Product, or process for making a Product,
developed for Customer by CDI hereunder.
8.
CONFIDENTIAL INFORMATION
8.1
The Parties shall procure that CDI’s Personnel and Customer’s Personnel shall:
(i)
not disclose any of the other Party’s Confidential Information to any person other than
CDI’s Personnel and/or Customer’s Personnel who have entered into legally binding
confidentiality obligations at least as restrictive in scope to those set out in this Clause 8;
(ii)
not use any Confidential Information for any purpose other than in accordance with this
Agreement; and
(iii)
take all reasonable steps necessary to prevent the unauthorized disclosure and/or use of
any Confidential Information which steps shall at least equal those taken to protect
Recipient’s own Confidential Information.
8.2
The obligations of Clause 8.1 shall not apply to any Confidential Information which:
(i)
is in the public domain at the time of disclosure or subsequent to the time of
disclosure to enters the public domain through no fault of receiving Party;
(ii)
either Party can prove by documentary evidence was already in the possession of that
Party prior to the date of this Agreement;
(iii)
is the subject of an order to disclose by a Court having the right and power to make such
an order;
(iv)
is received from a third party not under an obligation of confidentiality to either Party; or
(v)
is required to be disclosed by legal or regulatory process; provided, in each case the Party
required to disclose timely informs the other Party and uses reasonable efforts to limit the
disclosure and maintain confidentiality to the extent possible and permits the other party
to intervene and contest or attempt to limit the disclosure.
8.3
Any Confidential Information, including without limitation research results, data and other
Technical Information, developed by CDI’s Personnel in the course of or in connection
with the performance of the Services hereunder relating to an Exclusive Product shall
belong solely to Customer and shall be considered Customer’s Confidential Information
subject to the provisions of Sections 8.1 and 8.2 above.
8.4
Customer may disclose CDI’s Confidential Information to its corporate licensees and
collaborators, for development of the Product, on a need to know basis and provided that
any such licensees, and collaborators are made aware of the confidential nature of the
Information and execute agreements at least as restrictive as the provisions contained in
this Agreement to maintain the confidentiality thereof.
9.
WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY
9.1
Warranties
9.1.1 The Parties understand that the Product(s) may possess chemical, physical and
toxicological properties that are unknown at this time. Each Party agrees to observe all the
safety precautions that a technically qualified, prudent researcher would observe when
handling chemical compounds of unknown toxicity, in order to limit exposure to
laboratory personnel and the environment. Access to the Product(s) will be restricted to
technically qualified individuals who have been adequately notified as to the known and
potential hazards of these Product(s) and adequately instructed as to their proper handling.
9.1.2 Each Party shall promptly inform the other of any toxicity, instability, or other hazards
known to it that would impede the safe handling of Product(s).
9.1.3 EXCEPT AS MAY BE OTHERWISE STATED HEREIN, CDI MAKES NO
REPRESENTATIONS, AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS OR RELATED
COMPOUNDS FURNISHED HEREUNDER. THERE ARE NO EXPRESS OR
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, OR THAT THE USE OF PRODUCTS OR COMPOUNDS
WILL NOT INFRINGE ANY PATENT OR OTHER INTELLECTUAL PROPERTY
RIGHTS OF A THIRD PARTY.
9.2
Indemnities
9.2.1
CDI assumes the entire risk of injury or damage resulting from its preparation, handling,
use, or testing of Product under CDI’s control and agrees to indemnify and hold Customer
harmless from any loss, damage, claim, or cost of defending against any claim arising from
CDI’s preparation, handling, use, or testing of Product under CDI’s control except to the
extent that such loss or damage was caused by Customer’s negligence.
9.2.2
Customer assumes the entire risk of injury or damage resulting from its preparation,
handling, use, or testing of Product under Customer’s control and agrees to indemnify
and hold CDI harmless from any loss, damage, claim, or cost of defending against any
claim arising from Customer’s preparation, handling, use, or testing of Product except to
the extent that such loss or damage was caused by CDI’s negligence.
9.2.3
Customer also agrees to indemnify, hold harmless and defend CDI, and its directors,
officers, employees, Affiliates, and agents, against any and all legal claims,
proceedings, demands, liability and expenses of any kind, including legal expense and
reasonable attorney fees, for death, illness, personal injury, property damage,
infringement, improper business practices and noncompliance with applicable laws,
arising out of or relating to the design, manufacture, distribution, advertisement,
consumption, sale, or use of any Products or Related Compounds.
10.
TERMINATION
10.1
Termination Events
10.1.1 Termination Right. Each Party shall have the right to terminate this Agreement without
cause at any time upon not less than thirty (30) days prior written notice.
10.1.2 If either Party shall be in material breach of this Agreement, and should such breach
continue for sixty (60) days after written notification to the Party in breach, then the non-
breaching Party may at its option terminate this Agreement or suspend the performance of
its obligations under this Agreement by giving the Party in breach immediate notice of
termination or suspension. Suspension by one Party of performance
shall not preclude such Party later terminating this Agreement pursuant to this Clause
10.1.3.
10.1.3 In the event of termination by either Party, Customer shall pay CDI for all amounts due
hereunder prior to the effective date of termination. In addition, Customer shall reimburse
CDI for all raw materials and components purchased or ordered pursuant to non-
cancelable orders prior to receipt of the notice of termination, to the extent that such costs
are not included in the payments otherwise due to CDI. At Customer’s request, CDI shall
deliver such materials and any finished Product(s) then in its possession to Customer, at
Customer’s cost and per Customer’s instructions.
10.1.4 In the event that:
(i)
either Party becomes insolvent, or an order is made or a resolution passed for the
winding up of either party other than for the purposes of a solvent scheme of
reconstruction or amalgamation or internal reorganization; or
(ii)
an administrator, administrative receiver or receiver is appointed in respect of either
Party’s assets and/or business; or
(iii)
as a result of financial difficulties either Party makes any voluntary arrangement with its
creditors; or
(iv)
as a consequence of debt and/or maladministration, either Party takes or suffers any
similar or analogous action to those listed in i), ii) or iii) above;
then the other Party shall be entitled to terminate this Agreement by giving immediate
written notice of termination.
10.2
Consequences of Termination
10.2.1 Termination shall be without prejudice to any other right or remedy the Parties may
have arising on or before the date of termination.
10.2.2. Termination pursuant to this provision shall not relieve either Party of any obligation
accrued hereunder prior to the date of termination. Following termination of this
Agreement Sections 1, 4, 7, 8, 9, 10 and 12 shall remain in full force and effect.
10.2.3. Provided that CDI does not terminated the Agreement pursuant to Clause 10.1.2, CDI shall
deliver to Customer all results up to the effective date of termination and fulfill its
obligations under Section 5.3 hereof. Upon request, each Party shall promptly return to the
other all written copies or other embodiments of the other's Confidential Information;
provided that the receiving party may retain one complete copy of the Confidential
Information solely to be able to monitor its obligations under this Agreement for archival
purposes. Customer may retain such of CDI’s Confidential Information as it may require in
order to practice any license granted to it under this Agreement.
11.
FORCE MAJEURE
11.1
If either Party is affected by any circumstances beyond its reasonable control (including,
without limitation, any strike, lock out or other form of industrial action) it shall forthwith
notify the other Party of the nature and extent thereof.
11.2
Neither Party shall be deemed to be in breach of this Agreement, or otherwise be liable to
the other, by reason of any delay in performance, or non-performance, of any of its
obligations hereunder to the extent such delay or non-performance is due to any such
circumstance as is described in Section 11.1 of this clause of which it has notified the other
Party; and the time for performance of that obligation shall be extended accordingly.
11.3
If any of the circumstances described in Section 11.1 of this clause notified as aforesaid
prevails for a continuous period in excess of six months, the Parties hereto shall enter into
bona fide discussions with a view to alleviating its effects, or to agreeing upon such
alternative arrangements as may be fair and reasonable in all the circumstances.
12.
MISCELLANEOUS
12.1
Assignment
This Agreement may not be assigned by either Party without the prior written consent of the
other Party, except that either of the Parties may, upon written notice to the other (which
notice shall identify the assignee with specificity), assign this Agreement and the rights
hereunder to a successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business pertaining to the subject matter of
this Agreement provided such successor also assumes any surviving duties and obligations
hereunder of the assigning Party.
12.2
Relationship of the Parties
Nothing in this Agreement shall create, evidence or imply any agency, partnership or joint
venture between the Parties. Neither Party shall act or describe itself as the agent of the
other Party nor shall it represent that it has authority to make commitments on behalf of the
other Party.
12.3
Waiver
Failure or delay by either Party to exercise any right or remedy under this Agreement
shall not be deemed to be a waiver of that right or remedy, or prevent it from exercising
that or any other right or remedy on that occasion or on any other occasion.
12.4
Severance
In the event that any provision of this Agreement shall, for any reason, be held to be invalid
or unenforceable in any respect, such invalidity or unenforceability shall not affect any
other provision hereof, and this Agreement shall be construed as if such invalid or
unenforceable provision had not been included herein; however, the parties shall attempt to
negotiate in good faith a valid, legal, and enforceable substitute provision that most nearly
reflects the original intent of the parties.
12.5
Clause Headings
The headings used in this Agreement are for convenience only and shall not affect its
interpretation.
12.6
Entire Agreement and Amendments
This Agreement constitutes the entire agreement and understanding of the Parties relating
to the subject matter of this Agreement and supersedes all prior oral and written
agreements, understandings or arrangements between them relating to such subject matter.
The Parties acknowledge that they are not relying on any agreement, understanding,
arrangement, warranty representative or term which is not set out in this Agreement. No
variation, amendment, modification or supplement to this Agreement shall be valid unless
made in writing and signed by the duly authorized representative of each Party.
12.7
Notices
Unless otherwise expressly agreed by the Party receiving notice, any notice or other
communication required or permitted to be given by either Party under any provision of
this Agreement must be in writing, in the English language, and mailed (certified or
registered mail, postage prepaid, return receipt requested) or sent by hand or overnight
courier, or by facsimile (with acknowledgment received), charges prepaid and addressed to
the intended recipient at such Party’s address set forth below, or to such other address or
number as such Party may from time to time specify by notice to the other Party as
provided in this Section. All notices and other communications given in accordance with
the provisions of this Agreement will be deemed to have been given and received (i) when
actually delivered by hand, by mail, or by courier, or (ii) when transmitted by facsimile
(with acknowledgment received and a copy of such notice is sent no later than the next
business day by a reliable overnight or two-day courier service, with acknowledgment of
receipt).
12.8
Governing Law and Disputes
This Agreement is entered into in San Diego, California, U.S.A. and the construction
validity and performance of this Agreement shall be governed in all respects by the laws of
the State of California, as such laws are applied to agreements entered into and to be
performed entirely within California The Parties consent to the exclusive jurisdiction of
courts located in California and agree that any disputes relating to this Agreement shall
be resolved in the appropriate state court located in the County of San Diego or the
appropriate federal court for San Diego, California.
12.9
Counterparts
This Agreement may be executed in any number of counterparts and by the different
Parties hereto by separate counterparts, each of which when so executed shall be an
original, and all of which shall constitute one and the same instrument.
12.10 Attorney’s Fees
In the event a dispute arises over this Agreement, the prevailing party in any litigation,
arbitration or other action shall be awarded reasonable attorney’s fees and costs.
Said Program Managers may be changed by each party giving the other ten (10) days written
notice of said change.
Accepted and Authorized.
For Customer
For ChemDiv, Inc
/s/ Nikolay Savchuk____________
/s/ Rouslan Michtchenko _______
Printed Name: Nikolay Savchuk
Printed Name: Rouslan Michtchenko
Date: 9/23/2022
Date: 9/23/2022
Exhibit 10.34
MASTER RESEARCH AND DEVELOPMENT AGREEMENT
THIS AGREEMENT is made with an effective date of 09/01/2022 ("Agreement Date"); BETWEEN:
1.
Full Name:
Expert Systems, Inc.
Address:
12760 High Bluff Dr. Ste 370 San Diego, CA 92130
(hereinafter referred to as "Contractor").
2.
Full Name:
Trawsfynydd Therapeutics, Inc.
Address:
1209 Orange St. Wilmington DE, 19801
(hereinafter referred to as "Customer").
WHEREAS, Expert Systems, Inc. is a pharmaceutical company involved in the research, development,
manufacture and sale of new and useful pharmaceutical products; and
WHEREAS, Customer in the sale of drug discovery services to life science companies; offering expertise in
preclinical drug discovery services including screening libraries, medicinal chemistry, in-vitro and in-vivo
biological testing and related services useful for pharmaceutical research and development; and
WHEREAS, Customer desires to engage Expert Systems, Inc. on a confidential basis to provide Customer with
certain drug development services and consulting;
Now therefore, Expert Systems, Inc. and Customer hereby agree as follows:
1.
DEFINITIONS
ln this Agreement the following expressions shall have the following meanings:
1.1
"Affiliates" shall mean the companies under the control of, controlled by or under common control with
either of the Parties. For the purposes of this definition, the term "control" shall mean ownership of the
majority of the stock of such Party.
1.2
"Agreement" means this Research and Development Agreement together with the Exhibits attached
hereto and the Appendices executed by both Parties and attached hereto from time to time. Such
appendices shall set forth the program(s) to be performed by Expert Systems, Inc. hereunder
("Program", "Work Order") and the payment schedule(s) with respect thereto ("Payment Schedule"),
and such other terms and conditions as may be agreed upon by the Parties. Work Orders as discussed in
Section 2.3 will be deemed Appendices when properly executed by both Parties.
1.3
"Confidential Information" means the information (whether oral, written or in any other form)
concerning transactions, dealings, projects, plans, proposals and other business affairs of Customer and
of Expert Systems, Inc. and any and all Technical Information used
in and/or developed by Expert Systems, Inc.'s Personnel and Customer's Personnel in the course of or in
connection with the Services and Program.
1.4
(reserved)
1.5
"Intellectual Property Rights" means patents, patent applications, copyright, know-how and other
intellectual property rights.
1.6
(reserved)
1.7
"Expert Systems, Inc.'s Personnel" means Expert Systems, Inc.'s directors, consultants, employees and
any other persons engaged in the Program under the direction of Expert Systems, Inc.
1.8
(reserved)
1.9
"Parties" means Expert Systems, Inc. and Customer and "Party" means Expert Systems, Inc. or
Customer.
1.10
"Product" means both the tangible material designated, if applicable, in the applicable Program and all
testing data and results obtained in the applicable Program.
1.11
"Program" shall mean the work to be performed pursuant to a Work Order.
1.13
"Services" means the services to be carried out by Expert Systems, Inc. to perform under the Program(s).
1.14
"Specifications" means the specifications, if any, identified in the Program.
1.15
"Technical Information" means, but is not limited to, improvements, inventions, developments,
techniques, processes, methods, specifications, procedures, data, compound structures, formulae; testing
methods and materials, test results, trade secrets and know how, all as the same may be used in and/or
arise from the performance of the Services.
1.16
"Customer's Personnel" means Customer's directors, consultants, employees and any other persons
under the direction of Customer having access to the substance and results of the Program.
1.17
"T&M" means cost of the Program related to Expert Systems, Inc. expenditure for the Program billed by
Expert Systems, Inc. to the Customer including but not limited by time, materials, Expert Systems, Inc.
personnel wages, overhead, lease of space and equipment spent on the Program.
1.18
"FTE" means cost of the Program billed by Expert Systems, Inc. to the Customer related to the cost of
Expert Systems, Inc. Full Time Employee with reasonable skills, technical competence and suitable
qualification engaged in the Program for a specified period.
1.19
"Fixed Price" means the cost of the Program as agreed between the Parties at the time of issuance and
acceptance of a Work Order.
2.
Work Orders
2.1
Work Proposal
From time to time, Customer shall provide to Expert Systems, Inc. a work proposal detailing a Program
that includes Customer's description of Product(s), Specifications (e.g., purity, quantity, methodologies,
et cetera), and the date required for Customer's receipt of Product(s) ("Work Proposal").
2.3
Work Order
If Customer accepts Expert Systems, Inc.'s Offer, Customer shall submit a written Work Order to Expert
Systems, Inc. authorizing it to carry out the Program under the terms set forth in the Offer ("Work
Request"). Customer shall be under no obligation to accept the Offer. If the Work Order contains terms
and conditions conflicting with, or different from, (i) the Offer or the (ii) the terms of this Agreement,
then such conflicting or different terms contained in the Work Order will not be deemed accepted by
Expert Systems, Inc. (even if Expert Systems, Inc. conducts work under the Work Proposal) unless the
Work Proposal is executed by Expert Systems, Inc. in accordance with Section 12.6. All Work Requests
will contain at least the information presented in Exhibit 1.
2.4
Multiple Work Proposals, Offers, and Work Orders may be executed under the scope of this Master
Research Agreement.
3.
The Services
3.1
Expert Systems, Inc. shall use its reasonable endeavors to commence the Services on or before the
commencement date set forth in the applicable Program and to complete the Services on or before the
completion date set forth in the applicable Program, subject to extension by mutual written agreement of
the Parties.
3.2
Expert Systems, Inc. shall ensure that Expert Systems, Inc.'s Personnel exercise reasonable skill, care
and diligence in the performance of the Services.
3.3
Expert Systems, Inc. shall ensure that Expert Systems, Inc.'s Personnel involved with the Services are
technically competent and suitably qualified to carry out the parts of the Services assigned to them.
3.4
Expert Systems, Inc. and Customer shall appoint Program Managers and a to-be-named Designated
Supervisor for each specific Program as set forth in each Work Order. The Expert Systems, Inc. Program
Manager and the Customer Designated Supervisor shall be the principal points of contact between the
Parties for all matters relating to this Agreement. Expert Systems, Inc. may change its Program Manager
and Customer may change its Program Manager or Designated Supervisor by giving 10 (ten) days
notice in writing to the other Party.
3.5
No variation to the Services shall be made without the prior written agreement of the duly authorized
representative of each Party to such variation.
4.
Proprietary Nature of Products; Restrictions
4.1
Upon payment to Expert Systems, Inc. as provided in the Work Order and made in accordance with
Section 6 of the Agreement, Customer shall have title to the tangible materials and test results for
Products it receives for such payment, and Customer shall have no further obligation to Expert Systems,
Inc. with respect to such Products unless otherwise provided in this Agreement.
5.
INFORMATION AND REPORTS
5.1
Expert Systems, Inc. shall keep Customer fully informed of the progress of the Services by providing
summary reports to the Designated Supervisor at the end of each month until the Services are completed
or the Agreement is terminated.
5.2
Expert Systems, Inc. shall ensure that its key personnel involved with a Program and the Program
Manager are reasonably available for telephone and face-to-face discussions with Customer's Personnel
as may be agreed upon by the Parties. If Customer requests Expert Systems, Inc. Personnel to attend any
further meetings other than those on Expert Systems, Inc. premises, Expert Systems, Inc. shall be
reimbursed for reasonable travel expenses incurred by Expert Systems, Inc. Personnel attending any
such meetings.
5.3
Expert Systems, Inc. shall provide such written reports to Customer as may be specified in the applicable
Program. Expert Systems, Inc. shall promptly provide Customer with copies of all Technical
Information, data, records and supporting documentation reasonably requested by Customer relating to
the Services, subject to the provisions of Section 7, including without limitation Product information
such as analytical and structure determination information.
6.
INVOICE AND PAYMENT
6.1
Expert Systems, Inc. shall submit an invoice to Customer for each payment due in accordance with the
applicable Payment Schedule related to the Fixed Price, T&M, or FTE business arrangement for the
corresponding Work Order.
6.2
Customer shall pay Expert Systems, Inc.'s invoice in accordance with the schedule established in the
applicable Work Order. In the absence of Work Order payment schedule, Customer shall pay Expert
Systems, Inc.'s invoice within 10 (ten) days after Customer's receipt of corresponding Product or a part
of the Product in compliance with Specifications and Program schedule.
6.3
Unless otherwise agreed upon by Customer, it reserves the right to reject any Product delivered after a
period of time that is twice as long as the provided for in the Work Order for delivery of Product.
7.
INTELLECTUAL PROPERTY RIGHTS
7.1
With respect to all Products, Expert Systems, Inc. will promptly disclose to Customer any inventions,
know-how or discoveries relating to Products, developed or discovered as a result of the work
contemplated under this Agreement, whether or not patentable. Expert Systems, Inc. agrees to assign or
cause assignments of any such inventions to Customer, at Customer's cost, and provide reasonable
assistance to Customer at Customer's cost in preparing and prosecuting such patent applications thereon,
as Customer deems necessary to adequately protect its rights in such inventions, know-how and
discoveries.
7.2
Except for purposes of the work contemplated by this Agreement, no right or license to use the
Confidential Information or any technology or intellectual property rights of Customer is granted by
implication or otherwise.
7.3
Expert Systems, Inc. shall disclose in writing to Customer, in advance, any Intellectual Property Rights
patents of Expert Systems, Inc. or any Intellectual Property Rights known to Expert Systems, Inc.
belonging to a third party which may be infringed by the use of a Product, or process for making a
Product, developed for Customer by Expert Systems, Inc. hereunder.
8.
CONFIDENTIAL INFORMATION
8.1
The Parties shall procure that Expert Systems, Inc.' s Personnel and Customer's Personnel shall:
(i)
not disclose any of the other Party's Confidential Information to any person other than Expert
Systems, Inc.'s Personnel and/or Customer's Personnel who have entered into legally binding
confidentiality obligations at least as restrictive in scope to those set out in this Clause 8;
(ii)
not use any Confidential Information for any purpose other than in accordance with this Agreement; and
(iii) take all reasonable steps necessary to prevent the unauthorized disclosure and/or use of any
Confidential Information which steps shall at least equal those taken to protect Recipient's own
Confidential Information.
8.2
The obligations of Clause 8.1 shall not apply to any Confidential Information which:
(i)
is in the public domain at the time of disclosure or subsequent to the time of disclosure to enters
the public domain through no fault of receiving Party;
(ii)
either Party can prove by documentary evidence was already in the possession of that Party
prior to the date of this Agreement;
(iii)is the subject of an order to disclose by a Court having the right and power to make such an order;
(iv)
is received from a third party not under an obligation of confidentiality to either Party; or
(v)
is required to be disclosed by legal or regulatory process; provided, in each case the Party required to
disclose timely informs the other Party and uses reasonable efforts to limit the disclosure and maintain
confidentiality to the extent possible and permits the other party to intervene and contest or attempt to
limit the disclosure.
8.3
Any Confidential Information, including without limitation research results, data and other Technical
Information, developed by Expert Systems, Inc.'s Personnel in the course of or in connection with the
performance of the Services hereunder relating to an Exclusive Product shall belong solely to Customer
and shall be considered Customer's Confidential Information subject to the provisions of Sections 8.1
and 8.2 above.
8.4
Customer may disclose Expert Systems, Inc.' s Confidential Information to its corporate licensees and
collaborators, for development of the Product, on a need to know basis and provided that any such
licensees, and collaborators are made aware of the confidential nature of the Information and execute
agreements at least as restrictive as the provisions contained in this Agreement to maintain the
confidentiality thereof.
9.
WARRANTIES, INDEMNITIES AND LIMITATION OF LIABILITY
9.1
Warranties
9.1.1
The Parties understand that the Product(s) may possess chemical, physical and toxicological
properties that are unknown at this time. Each Party agrees to observe all the safety precautions that a
technically qualified, prudent researcher would observe when handling chemical compounds of
unknown toxicity, in order to limit exposure to laboratory personnel and the environment. Access to the
Product(s) will be restricted to technically qualified individuals who have been adequately notified as to
the known and potential hazards of these Product(s) and adequately instructed as to their proper
handling.
9.1.2
Each Party shall promptly inform the other of any toxicity, instability, or other hazards known to
it that would impede the safe handling of Product(s).
9.1.3
EXCEPT AS MAY BE OTHERWISE STATED HEREIN, Expert Systems, Inc.
MAKES NO REPRESENTATIONS, AND EXTENDS NOW ARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS OR RELATED
COMPOUNDS FURNISHED HEREUNDER. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR
THAT THE USE OF PRODUCTS OR COMPOUNDS WILL NOT INFRINGE ANY PATENT OR
OTHER INTELLECTUAL PROPERTY RIGHTS OF A THIRD PARTY.
9.2
Indemnities
9.2.1
Expert Systems, Inc. assumes the entire risk of injury or damage resulting from its preparation,
handling, use, or testing of Product under Expert Systems, Inc.'s control and
agrees to indemnify and hold Customer harmless from any loss, damage, claim, or cost of defending
against any claim arising from Expert Systems, Inc.'s preparation, handling, use, or testing of Product
under Expert Systems, Inc.'s control except to the extent that such loss or damage was caused by
Customer's negligence.
9.2.2
Customer assumes the entire risk of injury or damage resulting from its preparation, handling,
use, or testing of Product under Customer' s control and agrees to indemnify and hold Expert Systems,
Inc. harmless from any loss, damage, claim, or cost of defending against any claim arising from
Customer' s preparation, handling, use, or testing of Product except to the extent that such loss or
damage was caused by Expert Systems, Inc.' s negligence .
9.2.3
Customer also agrees to indemnify, hold harmless and defend Expert Systems, Inc., and its
directors, officers, employees, Affiliates, and agents, against any and all legal claims, proceedings,
demands, liability and expenses of any kind, including legal expense and reasonable attorney fees, for
death, illness, personal injury, property damage, infringement, improper business practices and
noncompliance with applicable laws, arising out of or relating to the design, manufacture, distribution,
advertisement, consumption, sale, or use of any Products or Related Compounds.
10.
TERMINATION
10.1
Termination Events
10.1.1 Termination Right. Each Party shall have the right to terminate this Agreement without cause
at any time upon not less than thirty (30) days prior written notice.
10.1.2 If either Party shall be in material breach of this Agreement, and should such breach continue
for sixty (60) days after written notification to the Party in breach, then the non breaching Party may at
its option terminate this Agreement or suspend the performance of its obligations under this Agreement
by giving the Party in breach immediate notice of termination or suspension. Suspension by one Party
of performance shall not preclude such Party later terminating this Agreement pursuant to this Clause
10.1.3.
10.1.3 In the event of termination by either Party, Customer shall pay Expert Systems, Inc. for all
amounts due hereunder prior to the effective date of termination. In addition, Customer shall reimburse
Expert Systems, Inc. for all raw materials and components purchased or ordered pursuant to non-
cancelable orders prior to receipt of the notice of termination, to the extent that such costs are not
included in the payments otherwise due to Expert Systems, Inc. At Customer's request, Expert Systems,
Inc. shall deliver such materials and any finished Product(s) then in its possession to Customer, at
Customer' s cost and per Customer' s instructions.
10.1.4 In the event that:
(i)
either Party becomes insolvent, or an order is made or a resolution passed for the winding up of
either party other than for the purposes of a solvent scheme of reconstruction or amalgamation or
internal reorganization; or
(ii)
an administrator, administrative receiver or receiver is appointed in respect of either Party' s
assets and/or business; or
(iii)
as a result of financial difficulties either Party makes any voluntary arrangement with its
creditors; or
(iv)
as a consequence of debt and/or maladministration, either Party takes or suffers any similar or
analogous action to those listed in i), ii) or iii) above;
then the other Party shall be entitled to terminate this Agreement by giving immediate written notice of
termination.
10.2
Consequences of Termination
10.2.1 Termination shall be without prejudice to any other right or remedy the Parties may have arising
on or before the date of termination.
10.2.2. Termination pursuant to this provision shall not relieve either Party of any obligation accrued
hereunder prior to the date of termination. Following termination of this Agreement Sections 1, 4, 7, 8,
9, a0 and 12 shall remain in full force and effect.
10.2.3. Provided that Expert Systems, Inc. does not terminated the Agreement pursuant to Clause
10.1.2, Expert Systems, Inc. shall deliver to Customer all results up to the effective date of termination
and fulfill its obligations under Section 5.3 hereof. Upon request, each Party shall promptly return to the
other all written copies or other embodiments of the other's Confidential Information; provided that the
receiving party may retain one complete copy of the Confidential Information solely to be able to
monitor its obligations under this Agreement for archival purposes. Customer may retain such of
Expert Systems, Inc.' s Confidential Information as it may require in order to practice any license
granted to it under this Agreement.
11.
FORCE MAJEURE
11.1
If either Party is affected by any circumstances beyond its reasonable control (including, without
limitation, any strike, lock out or other form of industrial action) it shall forthwith notify the other Party
of the nature and extent thereof.
11.2
Neither Party shall be deemed to be in breach of this Agreement, or otherwise be liable to the other, by
reason of any delay in performance, or non-performance, of any of its obligations hereunder to the
extent such delay or non-performance is due to any such circumstance as is described in Section 11.1 of
this clause of which it has notified the other Party; and the time for performance of that obligation shall
be extended accordingly.
11.3
If any of the circumstances described in Section 11.1 of this clause notified as aforesaid prevails for a
continuous period in excess of six months, the Parties hereto shall enter into bona fide discussions with
a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and
reasonable in all the circumstances.
12.
MISCELLANEOUS
12.1
Assignment
This Agreement may not be assigned by either Party without the prior written consent of the other
Party, except that either of the Parties may, upon written notice to the other (which notice shall identify
the assignee with specificity), assign this Agreement and the rights hereunder to a successor in
connection with the merger, consolidation, or sale of all or substantially all of its assets or that portion of
its business pertaining to the subject matter of this Agreement provided such successor also assumes
any surviving duties and obligations hereunder of the assigning Party.
12.2
Relationship of the Parties
Nothing in this Agreement shall create, evidence or imply any agency, partnership or joint venture
between the Parties. Neither Party shall act or describe itself as the agent of the other Party nor shall it
represent that it has authority to make commitments on behalf of the other Party.
12.3
Waiver
Failure or delay by either Party to exercise any right or remedy under this Agreement shall not be
deemed to be a waiver of that right or remedy, or prevent it from exercising that or any other right or
remedy on that occasion or on any other occasion.
12.4
Severance
In the event that any provision of this Agreement shall, for any reason, be held to be invalid or
unenforceable in any respect, such invalidity or unenforceability shall not affect any other provision
hereof, and this Agreement shall be construed as if such invalid or unenforceable provision had not
been included herein; however, the parties shall attempt to negotiate in good faith a valid, legal, and
enforceable substitute provision that most nearly reflects the original intent of the parties.
12.5
Clause Headings
The headings used in this Agreement are for convenience only and shall not affect its interpretation.
12.6
Entire Agreement and Amendments
This Agreement constitutes the entire agreement and understanding of the Parties relating to the subject
matter of this Agreement and supersedes all prior oral and written agreements, understandings or
arrangements between them relating to such subject matter. The Parties acknowledge that they are not
relying on any agreement, understanding, arrangement, warranty representative or term which is not set
out in this Agreement. No
variation, amendment, modification or supplement to this Agreement shall be valid unless made in
writing and signed by the duly authorized representative of each Party.
12.7
Notices
Unless otherwise expressly agreed by the Party receiving notice, any notice or other communication
required or permitted to be given by either Party under any provision of this Agreement must be in
writing, in the English language, and mailed (certified or registered mail, postage prepaid, return receipt
requested) or sent by hand or overnight courier, or by facsimile (with acknowledgment received),
charges prepaid and addressed to the intended recipient at such Party' s address set forth below, or to
such other address or number as such Party may from time to time specify by notice to the other Party
as provided in this Section. All notices and other communications given in accordance with the
provisions of this Agreement will be deemed to have been given and received (i) when actually
delivered by hand, by mail, or by courier, or (ii) when transmitted by facsimile (with acknowledgment
received and a copy of such notice is sent no later than the next business day by a reliable overnight or
two-day courier service, with acknowledgment of receipt).
12.8
Governing Law and Disputes
This Agreement is entered into in San Diego, California, U.S.A. and the construction validity and
performance of this Agreement shall be governed in all respects by the laws of the State of California, as
such laws are applied to agreements entered into and to be performed entirely within California The
Parties consent to the exclusive jurisdiction of courts located in California and agree that any disputes
relating to this Agreement shall be resolved in the appropriate state court located in the County of San
Diego or the appropriate federal court for San Diego, California.
12.9 Counterparts
This Agreement may be executed in any number of counterparts and by the different Parties hereto by
separate counterparts, each of which when so executed shall be an original, and all of which shall
constitute one and the same instrument.
12.10 Attorney's Fees
In the event a dispute arises over this Agreement, the prevailing party in any litigation, arbitration or
other action shall be awarded reasonable attorney's fees and costs.
The remainder of this page intentionally blank. Signature on next page
Accepted and Authorized For Customer
/s/ Nikolay Savchuk____________
Printed Name: Nikolay Savchuk
Date: 9/25/2022
For Expert Systems, Inc.
/s/ Igor Kogan__________________
Printed Name: Igor Kogan
Date: 9/25/2022
EXHIBIT 10.36
LICENSE AGREEMENT
This License Agreement (this “Agreement”), effective as of January 20, 2023 (“Effective Date”), is entered into
by and between Viriom, Inc., a Delaware corporation having its corporate office at 12760 High Bluff Drive, Suite 370,
San Diego, CA 92130 (“Licensor”), and Trawsfynydd Therapeutics, Inc., a Delaware corporation having its corporate
office at 12760 High Bluff Drive, Suite 370, San Diego, CA 92130 (“Licensee”). Licensor or Licensee are sometimes
referred to herein individually as a “Party” and, collectively, as the “Parties.”
BACKGROUND
A.
Licensor is engaged in the development of global drug development platforms targeting infectious and
malignant diseases and various related proprietary rights.
B.
Licensee, is engaged in the developments of small molecule chemistries, drug prototype molecules and
related data for pharmaceutical research and development (“Licensee Business”). Licensee wishes to license from
Licensor the right to use certain patents from Licensor for the Licensed Use (as defined below).
C.
Licensor is willing to license to Licensee the right for the Licensee to use certain patents to support the
Licensed Use, and Licensee wishes to license on an exclusive basis such patents, all pursuant to the terms below.
NOW THEREFORE, in consideration of the premises and of the mutual covenants and agreements contained
herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties intending to be legally bound agree as follows:
DEFINITIONS
“Affiliate” means any entity Controlling, Controlled by, or under common Control with the referenced entity,
where “Control” means the possession, direct or indirect, of the power to direct or cause the direction of the
management and policies of an entity, whether through the ownership of more than fifty (50%) of the outstanding voting
securities, by contract, or otherwise.
“Confidential Information” means, with respect to a Party hereto, non-public information that such Party
provides to the other Party under this Agreement, and is clearly and conspicuously marked confidential, including but
not limited to, financial statements and projections, customer and supplier information, research, designs, plans,
methods, processes, procedures, and know-how, whether in tangible or intangible form. A record of any disclosure of
confidential information provided in oral or visual form shall be reduced to writing and provided to the receiving party
by the disclosing party within thirty (30) days of said disclosure. Notwithstanding the foregoing, Confidential
Information of a Party shall not include information which the other Party can establish by its records: (a) is within the
public domain prior to the time of the disclosure by the disclosing Party or thereafter becomes within the public domain
other than as a result of disclosure by the receiving Party or any of its representatives in violation of this Agreement; (b)
was, on or before the date of disclosure in the rightful possession of the receiving Party; (c) is acquired by the receiving
Party from a Third Party having the right to disclose without burden of confidentiality to either Party; or (d) is hereafter
independently developed by the receiving Party without use of the disclosing Party’s Confidential Information, as
verified by the receiving Party’s written or electronic records.
“Force Majeure” means any occurrence beyond the reasonable control of a Party and without fault of such Party
affected, which (a) prevents or substantially interferes with the performance by such Party of any of its obligations
hereunder and (b) occurs by reason of any act of God, flood, fire, explosion, earthquake, casualty or accident, worldwide
pandemic, or war, revolution, civil commotion, act of terrorism, blockage or embargo, or any
injunction, law, order, proclamation, regulation, ordinance, demand or requirement of any Governmental Authority or
representative of any such Governmental Authority.
“Licensed Patents” means the patents and patent applications listed on Exhibit A attached hereto, together with
all continuing applications thereof including divisions, substitutions, and continuations-in-part; any patents issuing on
any of the foregoing applications including reissues, reexaminations and extensions; and all foreign applications and
patents corresponding to any of the foregoing.
“Territory” means Canada, China, European Union, Hong Kong, Japan, United States and all areas covered by
PCT application(s) for the Licensed Patents.
“Third Party” means any person or entity that is not a Party to this Agreement or an Affiliate of a Party to this
Agreement.
LICENSE
Licensor hereby grants to Licensee an exclusive, royalty-free, fully paid-up (upon payment of the License Fee),
sublicensable, worldwide license under the Licensed Patents, specifically for the use of developing treatments of and
methods to prevent viral diseases (the “Licensed Use”) in the Territory, subject to the terms of this Agreement (the
“License Grant”).
CONSIDERATION
In exchange for the License Grant pursuant to Section 2.1 hereof for the Term (as defined below), Licensee shall
pay to Licensor a one-time non-refundable license fee set forth on Exhibit B attached hereto (the “License Fee”).
PATENT MATTERS
Patent Prosecution. From and after the date of this Agreement, the provisions of this Section 4 shall control the
prosecution and maintenance of the Licensed Patents. Licensee shall direct and control in all respects the preparation,
filing and prosecution of the United States and foreign patent applications for the Patents (including any interferences
and foreign oppositions. In the event Licensee elects not to prosecute the Licensed Patents for any reason, Licensor will
have the right, but not the obligation, to prosecute and maintain the Licensed Patents. Licensee shall be obligated to
reimburse Licensor for all costs incurred by Licensor for such prosecution and maintenance (the “Reimbursements”)
and pay such Reimbursements within thirty (30) days after receipt of invoice from Licensor. Licensee shall provide
Licensor no less than ninety days’ notice of Licensee’s intent to not prosecute or maintain any of the Licensed Patents.
Any failure by Licensee to pay the Reimbursement or provide timely notice of its intent to not prosecute and/or maintain
the License Patents will be deemed a material breach of this Agreement.
Ownership. The Licensed Patents and any and all patent applications resulting from the Licensed Patents shall
be owned solely by Licensor and nothing in this Agreement shall give Licensee any right of ownership to the Patents.
Prosecution and Defense of Infringements. Licensee shall prosecute any and all infringements of any Licensed
Patents and shall defend all charges of third party infringement of the Licensed Patents. Licensee may enter into
settlements, stipulated judgments or other arrangements respecting such infringement, at its own expense and without
the consent of the Licensor, provided that such settlement, stipulated judgment or other arrangement shall not impose
any financial obligations on the Licensor or otherwise adversely affect the Licensor in any manner, including but not
limited to Licensor’s rights under this Agreement, , in which case Licensee shall seek the consent of the Licensor prior
to entering into such settlement, stipulated judgment or other arrangement, and Licensor shall not unreasonably
withhold such consent. Licensor agrees to provide reasonable assistance of a technical nature which
Licensee may require in any litigation arising in accordance with the provisions of this Section 4.3, for which Licensee
shall pay to Licensor a reasonable hourly rate of compensation.
Patent Enforcement. Licensee shall have the first right (but not the obligation), at its own expense and with
legal counsel of its own choice, to bring suit (or take other appropriate legal action) against any actual, alleged or
threatened infringement of the Licensed Patents. Licensor agrees to take all actions necessary to assist Licensee in any
suit, including joining in such suit as a party if legally required, at Licensee’s expense. Licensor shall have the right, at
its own expense, to be represented in any such action by counsel of Licensor’s own choice; provided, however, that
under no circumstances shall the foregoing affect the right of Licensee to control the suit as described in this Section
4.4.
REPRESENTATIONS AND WARRANTIES
Licensor’s Representations. Licensor represents and warrants to the Licensee that (i) Licensor owns all right,
title and interest in and to the Licensed Patents, has the right to grant the rights and license hereby granted to Licensee,
and has not granted to any third party any rights or licenses conflicting with the rights granted to Licensee pursuant to
this Agreement; (ii) The conception, development and reduction to practice of the inventions claimed in the Licensed
Patents has not constituted or involved the misappropriation of trade secrets or other proprietary rights or property of
any third party and there are no claims, judgments or settlements against, or amounts with respect thereto owed by,
Licensor or any of its Affiliates relating to the Licensed Patents; (iii) The use of the Licensed Patents within the
Licensed Use, including the research, development, sale, import, export or other exploitation by Licensee of resulting
embodiments of the Licensed Patents will not infringe any issued patent rights controlled by a third party or the claims
included in any published patent application in the Territory; and (iv) No third party is infringing, threatening to infringe
or misappropriating or threatening to misappropriate any Licensed Patents and neither Licensor nor any of its Affiliates
have received any written notice of any unauthorized use, infringement, misappropriation, or dilution by any third party,
including any current or former employee or consultant of Licensor or its Affiliates, of any Licensed Patents.
Mutual Representations. Each Party represents and warrants to the other that (i) such Party is a company or
corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is
organized; (ii) such Party has the legal power and authority to execute, deliver and perform this Agreement; (iii) the
execution, delivery and performance by such Party of this Agreement has been duly authorized by all necessary
corporate action; (iv) this Agreement constitutes the legal, valid and binding obligation of such Party, enforceable
against such Party in accordance with its terms; and (v) the execution, delivery and performance of this Agreement will
not cause or result in a violation of any law, of such Party’s charter documents, or of any contract by which such Party is
bound.
Limitation of Liability. EXCEPT WITH RESPECT TO CLAIMS ARISING UNDER SECTION 6
(Confidential Information), IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES BE LIABLE
HEREUNDER TO THE OTHER PARTY, ITS AFFILIATES OR ANY OTHER PERSON OR ENTITY FOR
SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR OTHER INDIRECT DAMAGES (INCLUDING,
BUT NOT LIMITED TO, LOSS OF PROFITS OR LOSS OF USE DAMAGES) ARISING FROM OR RELATED TO
THIS AGREEMENT OR THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS, EVEN IF SUCH
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES.
CONFIDENTIAL INFORMATION
Each Party shall (i) maintain the other Party’s Confidential Information in confidence during the term of this
Agreement and for five (5) years thereafter; (ii) limit dissemination of the other Party’s Confidential Information to
those of such Party’s and its Affiliates’ directors, officers, employees, agents, subcontractors, and sublicensees who
require such Confidential Information in order to perform this Agreement, (iii) not disclose the other Party’s
Confidential Information to any other person or entity, and (iv) use the other Party’s Confidential Information only to
the extent necessary to perform this Agreement. If the receiving Party is compelled to disclose Confidential Information
of the disclosing Party by order of a court of competent jurisdiction, law, regulation or stock market rule, any such
disclosure shall not be a breach hereunder, provided that reasonable advance notice is given to the disclosing Party to
permit the disclosing Party to ensure that such disclosure is subject to all applicable governmental or judicial protection
available for like material.
TERM AND TERMINATION
Term. This Agreement will commence on the Effective Date and will remain in effect for the life of the last-to-
expire Licensed Patent or last-to-be abandoned patent application licensed under this Agreement, which is later (the
“Term”).
Termination for Breach. Each Party may terminate this Agreement upon the breach of any material provision of
this Agreement by the other Party if the defaulting Party has not cured such breach within thirty (30) days after receipt
of written notice thereof. In the event a Party disputes the occurrence of a breach giving rise to termination under this
Agreement, then no termination shall take effect during the pendency of such proceedings, and the 30-day cure period
shall begin upon the date the relevant authority provides an order that such a breach has occurred.
Effect of Termination. Termination of this Agreement shall automatically terminate all rights granted by
Licensor to Licensee hereunder. Termination of this Agreement shall not relieve either Party of any obligations accrued
prior to the date of termination. All rights and obligations of the Parties set forth herein that expressly or by their nature
survive the expiration or termination of this Agreement, including, without limitation, the provisions of Sections 5
(Representations and Warranties), 6 (Confidential Information), 7.3 (Effect of Termination), 8 (Indemnification) and 9
(Miscellaneous) shall continue in full force and effect subsequent to and notwithstanding the expiration or termination
of this Agreement until they are satisfied or by their nature expire and shall bind the Parties and their legal
representatives, successors, and permitted assigns
INDEMNIFICATION
Indemnification by Licensee. Licensee shall defend, indemnify, and hold harmless Licensor, its Affiliates, and
its and their directors, officers, shareholders, employees and agents, and their respective heirs, successors and assigns
(“Licensor Indemnitees”) from and against any and all liabilities, claims, damages, losses, costs and expenses
(including reasonable attorney’s fees) (collectively, “Liabilities”) owing to Third Parties suffered or sustained by a
Licensor Indemnitee, or to which a Licensor Indemnitee becomes subject, arising out of or attributable to (i) Licensee’s
breach of any provisions in this Agreement, (ii) Licensee’s use of the Licensed Patents (other than as a result of a breach
by the Licensor of any of the representations in Section 5.1) or (iii) the Licensee Business.
Indemnification by Licensor. Licensor shall defend, indemnify, and hold harmless Licensee, its Affiliates, and
its and their directors, officers, shareholders, employees and agents, and their respective heirs, successors and assigns
(“Licensor Indemnitees”) from and against any and all Liabilities owing to Third Parties suffered or sustained by a
Licensee Indemnitee, or to which a Licensee Indemnitee becomes subject, arising out of or attributable to Licensor’s
breach of any provisions of this Agreement.
Process. The Party seeking indemnification under this Section 8 shall provide the indemnifying Party with
prompt written notice of any Liabilities for which indemnification is sought. The indemnified Party shall cooperate
fully with the indemnifying Party in defense of such Liabilities, and will permit the indemnifying Party to conduct and
control such defense and the disposition of such Liabilities (including all decisions relative to litigation, appeal, and
settlement). The indemnified Party shall not enter into any settlement or compromise of any Liabilities without the
indemnifying Party’s prior written consent. The indemnified Party may, at its own expense, participate in its defense of
Liabilities.
MISCELLANEOUS
Limited Disclosure. Licensee may, under a written agreement obligating the recipient to confidentiality and
limited use no less restrictive than those set forth in Section 6 (Confidential Information) disclose the existence and
terms of this Agreement in its dealings with funding sources such as venture investors and banks or potential acquirors
of Licensee.
Publicity. Licensee shall not issue a press release or other publication disclosing the general nature of this
transaction without the prior written consent of Licensor, which consent will not be unreasonably withheld.
Relationship of Parties. The relationship of the Parties is that of independent contractors, and nothing herein
shall be construed as establishing one Party or any of its employees as the agent, legal representative, joint venturer,
partner, employee, or servant of the other. Except as set forth herein, neither Party shall have any right, power or
authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of the other.
Neither Party shall hold itself out as being the agent, legal representative, joint venturer, partner, employee, or servant of
the other Party or as having authority to represent or act for the other Party in any capacity whatsoever, except as
authorized herein.
Assignment. Neither party may assign this Agreement without the prior written consent of the other party,
except to an entity that acquires all or substantially all of its assets or business related to the subject matter of this
Agreement.
Amendment. This Agreement shall not be amended except by an instrument in writing executed by both
Parties.
Entire Agreement. This Agreement, including any exhibits or schedules hereto, constitutes the entire, full, and
complete agreement between the Parties concerning the subject matter hereof, and supersedes all prior agreements,
negotiations, representations, and discussions, written or oral, express or implied, between the Parties in relation thereto.
Severability. Any term or provision of this Agreement that is invalid or unenforceable in any situation in any
jurisdiction shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or
enforceability of the offending term or provision in any other situation or in any other jurisdiction.
Governing Law. This Agreement shall be interpreted and enforced in accordance with laws of the State of
California in the United States of America, without regard to its conflicts of laws rules, provided, that those matters
pertaining to the validity or enforceability of patent rights shall be interpreted and enforced in accordance with the laws
of the territory in which such patent rights exist.
Notices. All communication concerning this Agreement, including payments, notices, demands or requests
required or permitted hereunder shall be given in writing and shall be considered to have been duly delivered: (a) at the
time personally delivered; or (b) on the date sent by email of a PDF document (with confirmation of transmission) if
sent during normal business hours of the recipient; or (c) ten (10) days after being deposited prepaid in registered or
certified mail; or (d) two (2) days after being deposited with a reputable private overnight mail courier service prepaid,
requesting delivery in the fastest manner available. The addresses to be used for all payments, notices, demands or
requests shall be the addresses set forth in the first paragraph of this Agreement, unless and until changed by either Party
by providing proper notice to the other Party.
Waiver. No waiver by either Party of any breach of the terms of this Agreement shall be deemed a waiver of
any subsequent breach thereof.
Force Majeure. Except for the payment obligations hereunder, neither Licensee nor Licensor shall be liable for
failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of
its obligations, if such failure or delay is due to a Force Majeure. In the event of such Force Majeure, the Party affected
shall use commercially reasonable efforts to cure or overcome the same and resume performance of its obligations
hereunder. Notice of a Party’s failure or delay in performance due to Force Majeure must be given to the other Party
within the (10) days after its occurrence.
Headings. Headings used herein are for descriptive purposes only and shall not control or alter the meaning of
this Agreement as set forth in the text.
Counterparts and Facsimile Signature. This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original but all of which together shall constitute one and the same instrument. This
Agreement may be executed by facsimile signature.
[Remainder of Page Left Blank – Signature Page to Follow]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed, effective as of the Effective
Date.
TRAWSFYNYYD THERAPEUTICS, INC.
VIRIOM, INC.
By: /s/ Nikolay Savchuk
By: /s/ Iain Dukes
Name: Nikolay Savchuk
Name: Iain Dukes
Title:
Chief Executive Officer
Title:
Chief Executive Officer
Date:__March 21, 2024______________
Date: __ March 21, 2024_____________
[Signature Page to Trawsfynydd-Viriom License Agreement]
EXHIBIT A
LICENSED PATENTS
PCT/RU2020/000163, WO2020/226532 “Substituted 3,4,12,12a-tetrahydro-1h-
[1,4]oxazino[3,4-c]pyrido[2,1- f][1,2,4]triazine-6,8-dione, pharmaceutical composition, and methods
for preparing and using same”
Priority: RU 2019113751 dd. 05/07/2019
Name of
Country
Applicants
Application Number
Date of
Application
Case Status
Publication
Date
Patent
N
Canada
Ivachtchenko
CA 3,106,620
March 27,
Examination
November 12,
Alexandre
2020
2020
Vasilievich
Ivashchenko
Andrey
Alexandrovich
Ivachtchenko
Alena
Alexandrovna
Savchuk
Nikolay
Filippovich
ASAVI, LLC
Hong
Ivachtchenko
HK62021033188.5
June 16,
Pending
Kong
Alexandre
2021
Vasilievich
Ivashchenko
Andrey
Alexandrovich
Ivachtchenko
Alena
Alexandrovna
Savchuk
Nikolay
Filippovich
ASAVI, LLC
PCT
Ivachtchenko
Alexandre
PCT/RU2020/000163
March 27,
2020
Pending
November 12,
2020
Vasilievich
Ivashchenko
WO
Andrey
Alexandrovich
2020/226532 A1
Ivachtchenko
Alena
Alexandrovna
Savchuk
Nikolay
Filippovich
ASAVI, LLC
PCT/RU2020/000163, WO2020/226532
“Substituted 3,4,12,12a-tetrahydro-1h-[1,4]oxazino [3,4-c]pyrido[2,1-f][1,2,4] triazine-6, 8-
dione, pharmaceutical composition, and methods for preparing and using same”
Priority: RU 2019113751 dd. 05/07/2019
Application Number Title
Territory
20781429.4
(EN) SUBSTITUTED
3,4,12,12A-
TETRAHYDRO-1H-
[1,4]OXAZINO[3,4- C]PYRIDO[2,1-
F][1,2,4]TRIAZINE-6,8- DIONE,
PHARMACEUTICAL
COMPOSITION, AND
METHODS
FOR
PREPARING AND USING SAME
European
Union
202080001974.5
China
the JP patent
application
number will be
indicated upon
receipt from the JP
Office
Japan
16/768,892
(EN) SUBSTITUTED
3,4,12,12A- TETRAHYDRO-
1H-[1,4]OXAZINO[3,4-
C]PYRIDO[2,1-F]
[1,2,4]TRIAZINE-6,8- DIONE,
PHARMACEUTICAL
COMPOSITION, AND
METHODS FOR PREPARING
AND USING SAME
USA
EXHIBIT B
LICENSE FEE
Licensee shall issue a SAFE (“SAFE”) to the Licensor for the purchase amount of
$13,059,996.170 (the “Purchase Amount”), which SAFE shall provide that the SAFE shall
convert into 2,466,888 shares of the Licensee’s Series Seed Preferred Stock (the “Conversion
Shares”) at the election of the Licensor, or if a Liquidity Event (as defined in the SAFE) occurs
prior to such election by Licensor, Licensor shall be entitled to either the payment of the Purchase
Amount in cash or the issuance of Common Stock.
**********
Exhibit 10.46
SEPARATION AGREEMENT AND RELEASE OF ALL CLAIMS
This Separation Agreement (“Agreement”) is made by and between Traws Pharma, Inc.
(“Traws” or “Company”) and Werner Cautreels (“Cautreels” or “you”). In consideration for the
execution of this Agreement, and the performance of the terms and conditions herein, Traws and
Cautreels (collectively the “Parties”) agree as follows:
Termination of Employment. The Parties agree that Cautreels served the Company as
its Chief Executive Officer. The Parties’ employment relationship terminated for all purposes on
March 31, 2025 (the “Termination Date”). Notwithstanding the foregoing, the Parties agree that
after the Termination Date, Cautreels will continue to serve as a non-employee director of the
Company until the next annual meeting of stockholders of the Company or until his successor is
elected and qualified, subject to his earlier death, resignation or removal. Beginning on April 1,
2025, Cautreels will provide consulting services to the Company as outlined herein.
Payment of Moneys Owed. Cautreels acknowledges that as of Termination Date,
Cautreels has been paid all monies, wages, or salary due or earned during the Parties’
relationship, including any accrued, unused vacation. Cautreels is entitled to the payment of all
undisputed wages due regardless of whether Cautreels signs this Agreement. Cautreels’s accrual
of, and eligibility for, vacation, sick leave, holiday pay, and any other employee benefits and
privileges, if any, ceased on the Termination Date. Cautreels further acknowledges that Cautreels
is not aware of the amount or existence of any unreimbursed business expenses incurred as a
result of duties of his employment relationship with Company.
Consideration. The purpose of this Agreement is to allow payment to Cautreels of
consideration and to cause the release of any and all potential claims against the Company and
all persons and entities being released herein from every claim and/or cause of action that
Cautreels has or may have against the Company and all persons and entities being released
herein. To avoid any legal claims, and in consideration for Cautreels’s promises in this
Agreement, including the general release of claims, if Cautreels signs and does not revoke this
Agreement, Traws agrees to pay the amounts below:
$10,000.00, less standard payroll deductions and withholdings, paid in one lump sum in
accordance with the Company’s normal payroll practices.
Cautreels agrees that Traws is not required to make any of the payments identified in this section
if Cautreels fails to sign, or if Cautreels revokes, this Agreement.
Acknowledgment of Consideration. The Parties understands and agree that the Parties
will not receive the consideration specified herein, unless the Parties execute, and do not revoke,
this Agreement, and fulfill the other promises contained herein. The Parties agree that Parties
have no independent legal duty to provide each other with the consideration set forth in this
Agreement absent the terms of the Agreement itself. As such, Cautreels acknowledges that the
payment described in Paragraph 3, above, represents an amount above and beyond that to which
Cautreels would be entitled if Cautreels did not enter into this Agreement.
Complete and General Release. In consideration for the payment provided for in
Paragraph 3, above, Cautreels unconditionally hereby covenants not to sue and fully and
unconditionally forever releases and discharges Traws, Onconova Therapeutics, Inc., their past,
present, and future representatives, directors, officers, employees, and agents, their attorneys,
affiliates, members, and shareholders, as well as all parent companies, affiliated companies,
subsidiary companies, clients, client facilities, consultants, predecessors, assignors, and/or
assigns (collectively, “Released Parties”), from and against any and all claims, causes of action,
judgments, liens, demands, damages, obligations, suits, contracts, liabilities, losses, costs, and
expenses, including, but not limited to, attorneys’ fees and disbursements, or offsets of any nature
whatsoever (collectively, “Claims”) that Cautreels now has, has had, or may hereafter have
against Released Parties arising out of the Parties’ relationship, the cessation of this relationship,
including but not limited to those claims arising out of or relating to (i) Cautreels’s performance
and reputation, (ii) harassment, (iii) discrimination, (iv) retaliation, and (v) any Claims arising under
the Title VII of the Civil Rights Act of 1964, the Civil Rights Act of 1991, the Americans with
Disabilities Act, the Age Discrimination in Employment Act, the Federal Rehabilitation Act, the
Employee Retirement Income Security Act, the Family and Medical Leave Act, the Fair Labor
Standards Act, the Pennsylvania Human Relations Act (PHRA), Pennsylvania Whistleblower Law,
the Pennsylvania Public Employee Relations Act, the Philadelphia Fair Practices Ordinance, and
any other applicable state or federal laws relating to employment. Except for any rights created
by this Agreement, this General Release is intended to be interpreted as broadly as possible and
to apply to any and all claims available to Cautreels in any forum, including, but not limited to, any
claims for unpaid wages, unpaid penalties or premiums, liquidated damages, class or
representative actions governing employment (to the fullest extent allowed by applicable law),
constructive termination, negligent or intentional infliction of emotional distress, harassment,
discrimination, wrongful termination, negligence, breach of contract, breach of the covenant of
good faith and fair dealing, promissory estoppel, fraud, negligent or intentional misrepresentation,
negligent or intentional interference with contract or prospective economic advantage, unfair
business practices, defamation, libel, slander, personal injury; assault, battery, invasion of privacy,
false imprisonment, conversion, disability benefits, violation of any provision of federal or state law
governing employment, and any claim for attorneys’ fees or costs. All such claims are forever
barred and by this Agreement. The Company hereby covenants not to sue and fully and
unconditionally forever releases and discharges Cautreels and his spouse, heirs, attorneys,
advisors, and agents from and against any and all claims, causes of action, judgments, liens,
demands, damages, suits, contracts, liabilities, losses, costs, and expenses.
However, this release shall not apply to claims for workers’ compensation benefits or
unemployment insurance benefits or any other claims that Cautreels cannot, by statute, lawfully
waive by this Agreement. This Agreement does not limit Cautreels’s right to receive an award for
information provided to the U.S. Securities and Exchange Commission pursuant to Section 21 F-
17 of the Dodd Frank Wall Street Reform and Consumer Protection Act. This Agreement does not
prevent Cautreels from complying with a discovery request, from testifying at a hearing or trial
involving a claim of sexual harassment or participating in any related investigation or exercising
their right under state or federal law to engage in concerted activity for mutual aid or protection.
Covenant Not to Sue. A “covenant not to sue” is a legal term that means Cautreels
promises not to file a lawsuit in court. It is different from the Complete and General Release of
claims contained in Paragraph 5, above. Besides waiving and releasing the claims covered by
Paragraph 5, above, Cautreels represents and warrants that Cautreels has not filed, and agrees
that Cautreels will not file, or cause to be filed, any judicial complaint or lawsuit involving any
claims Cautreels has released in Paragraph 5, and Cautreels agrees to withdraw any judicial
complaints or lawsuits Cautreels has filed, or that were filed on Cautreels’s behalf, prior to the
Effective Date. Cautreels agrees and acknowledges that, if Cautreels sues the Company or any
other Released Party in violation of this Agreement, then Cautreels shall pay all legal expenses,
including reasonable attorneys’ fees, incurred by any Released Party in defending against
Cautreels’s suit. Notwithstanding this Covenant Not to Sue, Cautreels may bring a claim against
the Company to enforce this Agreement.
Release of Unknown Claims. As part of this Agreement, Cautreels acknowledges and
agrees that Cautreels has reviewed and hereby expressly waives the provisions of Section 1542
of the California Civil Code, or any similar state or federal statute. Section 1542 provides as
follows:
“A general release does not extend to claims that the creditor
or releasing party does not know or suspect to exist in his or
her favor at the time of executing the release and that, if known
by him or her, would have materially affected his or her
settlement with the debtor or released party.”
Cautreels acknowledges and agrees that this Agreement extends to all claims or causes of action,
of every nature and kind whatsoever, known or unknown, suspected or unsuspected, enumerated
in this Agreement or otherwise. Cautreels understands and agrees that Cautreels may hereafter
discover presently unknown or unsuspected facts or claims different from or in addition to those
that Cautreels now knows or believes to be true as to the matters released herein. Nevertheless,
it is Cautreels’s intention, through this Agreement, to fully, finally and forever release all such
matters, and all claims related thereto, which do now exist, may exist or heretofore have existed.
Exclusions. Excluded from this Agreement are any claims or rights that cannot be waived
by law, including the right to file a charge of discrimination with, or participate in an investigation
conducted by, an administrative agency. Cautreels is waiving, however, the right to any monetary
recovery or other relief in connection with such a charge. Nothing in this agreement prevents you
from discussing or disclosing information about unlawful acts in the workplace, such as
harassment or discrimination or any other conduct that you have reason to believe is unlawful.
Also excluded from the Release are any rights or claims arising under this Agreement.
Inapplicability of California Labor Code Section 206.5 Or Similar Statutes. Cautreels
and Traws acknowledge and agree that California Labor Code section 206.5 is inapplicable. That
section provides:
An employer shall not require the execution of a release of a claim or right on
account of wages due, or to become due, or made as an advance on wages to be
earned, unless payment of those wages has been made. A release required or
executed in violation of the provisions of this section shall be null and void as
between the employer and the employee. Violation of this section by the employer is
a misdemeanor.
Older Worker’s Benefit Protection Act. This Agreement constitutes a knowing and
voluntary waiver of any and all rights or claims that Cautreels has or may have under the federal
Age Discrimination in Employment Act (“ADEA”), as amended by the Older Workers’ Benefit
Protection Act of 1990, 29 U.S.C. §§ 621 et seq. This Paragraph and this Agreement are written
in a manner calculated to be understood by Cautreels. Cautreels is hereby advised in writing to
consult with an attorney before signing this Agreement. Cautreels has up to 21 days in which to
consider signing this Agreement, although Cautreels may sign this Agreement at any time within
the 21-day period. If Cautreels decides not to use all 21 days, Cautreels knowingly and voluntarily
waives any claims that Cautreels was not given the 21-day period or did not use the entire 21
days to consider this Agreement. If Cautreels does sign it, Cautreels may revoke this Agreement
at any time within the 7-day period following the date Cautreels signs this Agreement by providing
written notice of revocation to Iain Dukes via email to dukesi@orbimed.com, so that such written
notice is received before the 7-day period revocation period expires. If Cautreels signs and does
not revoke this Agreement within the 7-day revocation period, this Agreement will become
effective on the 8th day after it is fully executed (the “Effective Date”). In addition, Cautreels
agrees that if Cautreels revokes this Agreement as provided above, the Agreement shall not be
effective or enforceable and Cautreels will not receive the consideration provided for in Paragraph
3, above. Cautreels acknowledges that Cautreels is signing this Agreement knowingly and
voluntarily and intends to be bound legally by its terms.
Cooperation with Investigation or Litigation. In the event any of the Released Parties
are engaged in an investigation, prosecution or litigation of any kind on claims or a subject matter
in which you are involved, have information, or are a witness or defendant, you agree to fully
respond to any inquiries, provide written materials or documents in a timely manner, and
otherwise provide us or our attorneys with any and all information necessary for the defense of the
case. You further agree not to disclose any attorney-client privileged communications, attorney
work product or any other confidential communications regarding such investigation, prosecution
or litigation matters. The provisions of this paragraph apply to any investigation, prosecution or
litigation initiated involving the Released Parties in which you may be asked to assist after your
execution of this Agreement.
Participation in Claims. Cautreels agrees that Cautreels will not counsel or assist any
attorneys or their clients in the presentation or prosecution of any disputes, differences,
grievances, claims, charges, or complaints by any third party against the Company or the
Released Parties, unless under a subpoena or other court order to do so. Cautreels further
agrees and promises not to encourage or facilitate any future litigation or claims against Company
or the Released Parties. This does not prevent Cautreels from providing information to an agency
of the federal, state or local government, or filing a charge or complaint with such an agency.
Non-Disparagement. Cautreels agrees that they shall not disparage the reputation of any
Released Parties to any person or entity whatsoever. This includes written statements, oral
statements, or other conduct that could reasonably disparage any Releasee’s reputation
(including, but not limited to, any third-party media outlet, Glassdoor, Yelp, Facebook, Twitter,
LinkedIn, Instagram, TikTok, Snapchat or other social media service or personal website).
Cautreels further agrees that Cautreels shall take all reasonable steps to prevent others from
making such statements on Cautreels’s behalf. If the Company has a good faith belief that
Cautreels has violated this Agreement by posting on a website/forum (social media, third party, or
otherwise), the Parties agree that the website/forum administrator shall be required to remove the
applicable posting. If the Company has a good faith belief that Cautreels has violated this
Agreement by posting on a website/forum (social media, third party, or otherwise) but the posting
is anonymous, the Parties agree that the website/forum administrator is authorized to disclose the
identity of the poster, if the individual is Cautreels, at the request of the Company. The Parties
agree that the Company is permitted to provide a copy of this Agreement to the website/forum in
support of the request. Nothing in this paragraph shall preclude Cautreels from responding
truthfully to inquiries made in connection with any legal or governmental proceeding pursuant to
subpoena or other legal process. If at any time in the future Cautreels believes that they may be
required by subpoena or other legal process that implicates this paragraph, they shall provide
written notification to the Company no less than ten court days before any such compelled
disclosure is due to be made. Cautreels agrees and understands that this paragraph is a material
term and condition for the Company. Nothing in this Agreement shall restrict your rights pursuant
to Section 7 of the National Labor Relations Act. The Company, limited to its current board
members and executive officers for purposes of this section, agrees that they shall not disparage
the reputation of Cautreels to any person or entity whatsoever.
Non-Disclosure of Trade Secrets, Confidential or Proprietary Information. Cautreels
understands and agrees that Cautreels will not, for any reason, disclose to others or use for the
benefit of anyone other than Traws any trade secret, “confidential information” or proprietary
information of Traws, including, but not limited to, information relating to Traws’ customers, clients,
employees, consultants, affiliates, partners, vendors, services, know-how, techniques, computer
systems, programs, policies and procedures, research, projects, future developments, costs,
losses or profits. Cautreels further understands and agrees that the use of any trade secret,
confidential or proprietary information belonging to Traws shall be a material breach of this
Agreement. By signing this Agreement, Cautreels warrants and represents that, as of the date of
the signing of this Agreement, Cautreels has not used or disclosed the Company’s trade secret,
confidential or proprietary information in any manner that contravenes this provision.
Definition of Confidential Information. For purposes of this Agreement, Cautreels
acknowledges
that
“confidential”
information
includes,
without
limitation,
information regarding Company’s operations, finances, financial losses, financial
improprieties, vendors, clients or partners including all materials, documents
(including, vendor companies and their respective contacts, without limitation)
financial reports, and all other tangible media of expression, information related to
current, future and proposed programs, operations, financial arrangements,
information related to current, future or proposed operations of Company, including,
without limitation, information concerning financial information, procurement
requirements, vendor information, compensation of employees or independent
contractors of Company (other than Cautreels’s compensation information), reports
and information, financial studies, loss studies, strategic plans of Company, and
drawings, specifications and plans. The confidential information also includes,
without limitation, all proprietary and confidential information of any third party
disclosed to Company, its employees, vendors or independent contractors, in the
course of Company’s business, Company’s terms and conditions, the terms,
conditions and status of any existing agreements and relationships between
Company and any vendors, partners, suppliers, subcontractors or other entities,
Company processes and techniques, data, formulae, and compositions, service
techniques and protocols, ideas, and strategic plans possessed, developed,
accumulated or acquired, financial information, and any other matter or thing,
whether or not recorded on any medium (a) by which Company derives actual or
potential economic value from such matter or thing being not generally known to
other persons or entities who might obtain economic value from its disclosure or
use, or (b) which gives Company an opportunity to obtain an advantage over its
competitors who do not know or use the same. Confidential information does not
include information which has been released by Company to the general public or
is otherwise readily ascertainable from public or published information or sources.
Cautreels Representations Regarding Confidential Information. Cautreels affirms and
represents that Cautreels has not copied, photographed, photocopied, altered,
modified, disassembled, decompiled, or in any manner reproduced any materials
containing or constituting confidential information and has returned all such
materials, together with any copies thereof, to Company. Cautreels further
represents that Cautreels will not publish any confidential information belonging to
Company prior to Company’s intentional public disclosure of that confidential
information, at which time it will no longer be confidential information to the limited
extent that it is actually publicly disclosed. Disclosure of confidential information is
not precluded if such disclosure is in response to a valid order of a court or other
governmental body of the United States or any political subdivision thereof;
provided that Cautreels will first give notice to Company and, before responding to
the court order, permit Company to make a reasonable effort to obtain a protective
order regarding that confidential information.
Return of All Company Materials. Cautreels acknowledges that all tangible information
and property, including all cameras, laptops, computers, phones, customer property, files, digital
files, digital coding, records, summaries, bills, invoices, copies, excerpts, data, memoranda,
letters, notes, written policies and procedures, manuals and other information or material
pertaining to Cautreels’s work for the Company or containing confidential information that came
into Cautreels’s custody, possession or knowledge or were compiled, prepared, developed or
used by Cautreels at any time in the course of or in connection with Cautreels’s work for the
Company, and all tangible property put in Cautreels’s custody or possession by the Company in
connection with Cautreels’s work for the Company is solely the property of the Company.
Cautreels hereby certifies that Cautreels will return to Traws by March 31, 2025, all such tangible
information and, to the extent that any such tangible information is later discovered in the
possession, custody, or control of Cautreels, Cautreels agrees that Cautreels will immediately
return to the Company all such tangible information in Cautreels’s possession, custody, or control.
Cautreels further certifies that Cautreels has returned to Traws all property and equipment of
Traws, whether in hard copy or electronic format, including any files or documents that Cautreels
may have copied or transferred from any Company computer desktop or laptop, iPad/electronic
tablet and cell phone prior to returning them to Company, including but not limited to keys and fob,
and, again, to the extent that any Traws property or equipment is later discovered in Cautreels’s
possession, custody, or control, Cautreels agrees to immediately return to the Company all such
Company property and equipment. Cautreels also agrees not to delete any Company related
information from any electronic device provided to Cautreels by the Company.
Transition Services. Starting April 1, 2025, Cautreels will carry out such consulting duties
and responsibilities, which shall be consistent with his expertise, as requested by the Interim Chief
Executive Officer or Chief Executive Officer of the Company, as applicable, including transitioning
Cautreels’s duties and responsibilities and completing tasks as required by the Company. During
the Transition Period, Cautreels will continue to serve the Company faithfully, conscientiously and
to the best of his ability as outlined in Exhibit 1.
On-The-Job Injury. Cautreels certifies that Cautreels has not experienced a job-related
illness or injury for which Cautreels has not already filed a claim.
CIRCULAR 230 DISCLAIMER. EACH PARTY TO THIS AGREEMENT (FOR
PURPOSES OF THIS SECTION, THE “ACKNOWLEDGING PARTY”; AND EACH PARTY TO
THIS AGREEMENT OTHER THAN THE ACKNOWLEDGING PARTY, AN “OTHER PARTY”)
ACKNOWLEDGES AND AGREES THAT (1) NO PROVISION OF THIS AGREEMENT, AND NO
WRITTEN COMMUNICATION OR DISCLOSURE BETWEEN OR AMONG THE PARTIES OR
THEIR ATTORNEYS AND OTHER ADVISERS, IS OR WAS INTENDED TO BE, NOR SHALL
ANY SUCH COMMUNICATION OR DISCLOSURE CONSTITUTE OR BE CONSTRUED OR BE
RELIED UPON AS, TAX ADVICE WITHIN THE MEANING OF UNITED STATES TREASURY
DEPARTMENT CIRCULAR 230 (31 CFR PART 10, AS AMENDED); (2) THE ACKNOWLEDGING
PARTY (A) HAS RELIED EXCLUSIVELY UPON HIS, HER OR ITS OWN
INDEPENDENT LEGAL AND TAX ADVISERS FOR ADVICE (INCLUDING TAX ADVICE) IN
CONNECTION WITH THIS AGREEMENT, (B) HAS NOT ENTERED INTO THIS AGREEMENT
BASED UPON THE RECOMMENDATION OF ANY OTHER PARTY OR ANY ATTORNEY OR
ADVISOR TO ANY OTHER PARTY, AND (C) IS NOT ENTITLED TO RELY UPON ANY
COMMUNICATION OR DISCLOSURE BY ANY ATTORNEY OR ADVISER TO ANY OTHER
PARTY TO AVOID ANY TAX PENALTY THAT MAY BE IMPOSED ON THE ACKNOWLEDGING
PARTY; AND (3) NO ATTORNEY OR ADVISER TO ANY OTHER PARTY HAS IMPOSED ANY
LIMITATION THAT PROTECTS THE CONFIDENTIALITY OF ANY SUCH ATTORNEY’S OR
ADVISER’S TAX STRATEGIES (REGARDLESS OF WHETHER SUCH LIMITATION IS LEGALLY
BINDING) UPON DISCLOSURE BY THE ACKNOWLEDGING PARTY OF THE TAX
TREATMENT
OR
TAX
STRUCTURE
OF
ANY
TRANSACTION,
INCLUDING
ANY
TRANSACTION CONTEMPLATED BY THIS AGREEMENT.
Governing Law and Interpretation. Any and all disputes between the Parties, arising
under or relating to this Agreement or any other dispute arising between the Parties, further
including any disagreement as to whether such dispute or claim is arbitrable, shall be adjudicated
and resolved exclusively through binding arbitration before the American Arbitration Association
pursuant to the American Arbitration Association’s then-in-effect National Rules for the Resolution
of Employment Disputes (hereafter “Rules”), except as modified by this Agreement. The initiation
and conduct of any arbitration hereunder shall be in accordance with the Rules and each side
shall bear its own costs and counsel fees in such arbitration. Any arbitration hereunder shall be
conducted in Philadelphia, Pennsylvania, and any arbitration award shall be final and binding on
the Parties. The arbitrator shall have no authority to depart from, modify, or add to the written
terms of this Agreement. The arbitration shall be conducted on a strictly confidential basis, and
neither the Company nor the Employee shall disclose the existence of a claim, the nature of a
claim, any documents, exhibits, or information exchanged or presented in connection with such a
claim, or the result of any claim (collectively, “Arbitration Materials”) to any third party, with the sole
exception of the Parties’ attorneys, accountants, and any other person reasonably necessary to
litigate the arbitration (provided that they each agree to keep the Arbitration Materials
confidential). Notwithstanding the foregoing, the arbitrator may grant interim injunctive relief or,
notwithstanding anything to the contrary in this Agreement, the Company or Employee may
commence litigation in court to obtain injunctive relief or an order requiring specific performance to
enforce or prevent any violations of the Restrictive Covenants. The arbitration provisions of this
Section 19 shall be interpreted according to, and governed by, the Federal Arbitration Act, 9
U.S.C. § 1 et seq., and any action pursuant to such Act to enforce any rights hereunder shall be
brought exclusively in the United States District Court for the Eastern District of Pennsylvania,
including the confirmation of any award arising out of the arbitration. The Parties consent to the
jurisdiction of (and the laying of venue in) such court. Employee also irrevocably and
unconditionally consents to the service of any process, pleadings, notices or other papers. The
Parties hereby agree to take all steps necessary to protect the confidentiality of the Arbitration
Materials in connection with any court proceeding, agree to take all appropriate steps to file all
confidential information (and documents containing confidential information) under seal in any
such proceeding where possible, and agree to the entry of an appropriate protective order
encompassing the confidentiality terms of this Agreement. If a party seeks to enforce the terms of
this Agreement and is deemed the prevailing party by a Court or Arbitrator, the prevailing party
shall be entitled to reasonable attorney’s fees and costs.
Severability. If any provision of this Agreement is held to be void, null or unenforceable,
the remaining parts, terms, or portions shall remain in full force and effect and shall not be
affected, and said illegal or invalid part, term, or provision shall be deemed not to be part of this
Agreement.
Taxes. Cautreels agrees that he is solely liable for any and all income tax, other taxes, or
assessments owed by Cautreels in connection with any payment made pursuant to this
Agreement. Cautreels shall cooperate in the defense of any tax claims brought against Company
associated with any payment made pursuant to this Agreement and shall indemnify and hold
Company harmless against any action taken against it in the event any taxing authority
challenges the allocation or characterization of the payment and/or seeks payment of taxes,
interest, penalties, or other assessments from it in connection with any payments paid pursuant to
this Agreement.
No Admission of Wrongdoing. The Parties agree that neither this Agreement nor the
furnishing of the consideration for this Agreement shall be deemed or construed as an admission
of liability or wrongdoing on the part of the Released Parties, nor shall they be admissible as
evidence in any proceeding other than for the enforcement of this Agreement.
Modification. This Agreement may not be amended, modified or superseded in any
respect except in a written instrument signed by both Parties. No oral statement by any employee
of the Company shall modify or otherwise affect the terms and provisions of this Agreement.
Entire Agreement. This Agreement sets forth the entire agreement between the Parties
hereto, and fully supersedes any prior written or oral agreements or understandings between the
Parties except for the terms of any confidentiality, non-disclosure, or arbitration agreements, which
shall remain in full force and effect. Cautreels acknowledges that Cautreels has not been offered
or relied on any representations, promises, inducements, or agreements of any kind made to
Cautreels in connection with Cautreels’s decision to accept this Agreement, except for those
expressly set forth in this Agreement.
Counterparts. This Agreement may be executed by the Parties in counterparts, which are
defined as duplicate originals, all of which taken together shall be construed as one document. A
signature by facsimile, PDF or email on this Agreement shall be as legally binding as an original
signature.
Acknowledgment. By signing the Agreement, Cautreels acknowledges that Cautreels has
read this Agreement, fully understands the contents of this Agreement, freely, voluntarily and
without coercion enters into this Agreement, and is signing it with full knowledge that it is intended,
to the maximum extent permitted by law, as a complete release and waiver of any and all claims.
By signing the Agreement, Cautreels affirms that Cautreels has full authority to enter into this
Agreement and to be bound by it, and that Cautreels is knowingly and voluntarily entering into this
Agreement free of any duress or coercion. Traws hereby advises Cautreels in writing to consult
with an attorney of Cautreels’s choice prior to execution of this Agreement and Traws will provide
Cautreels at least 5 days to consult with an attorney. If Cautreels chooses to sign the Agreement
in less than five days, Cautreels acknowledges this choice was voluntary and without coercion,
fraud, or misrepresentation.
Binding Agreement. Cautreels’s obligations and agreements under this Agreement shall
be binding on Cautreels’s heirs, executors, legal representatives and assigns and shall inure to
the benefit of any successors and assigns of the Company. The Company’s obligations and
agreements under this Agreement shall be binding upon the Company’s affiliates, divisions,
assigns and successors, including, without limitation, any person(s) or entity(ies) acquiring,
directly or indirectly, all or substantially all of the business and/or assets of the Company whether
by purchase, merger, consolidation, reorganization, or otherwise (and such successor shall
thereafter be deemed included in the definition of “the Company” for purposes of this Agreement),
and shall inure to the benefit of Cautreels’s heirs, executors, and assigns. This Agreement is
personal in nature and none of the Parties hereto shall, without the consent of the other Party,
assign, transfer or delegate this Agreement or any rights or obligations hereunder except as
expressly provided in the preceding sentences of this section.
PLEASE READ CAREFULLY. THIS AGREEMENT INCLUDES A RELEASE OF ALL KNOWN
AND UNKNOWN CLAIMS.
THE PARTIES ACKNOWLEDGE THAT THEY HAVE EXECUTED THIS AGREEMENT FREELY
AFTER INDEPENDENT INVESTIGATION AND WITHOUT FRAUD OR UNDUE INFLUENCE.
THE PARTIES ACKNOWLEDGE THAT THEY HAVE READ THIS AGREEMENT AND FULLY
UNDERSTAND EACH AND EVERY PROVISION CONTAINED HEREIN AND INTEND TO BE
BOUND BY ALL OF ITS TERMS. NEITHER PARTY HAS MADE, NOR RELIED UPON, ANY
ORAL OR WRITTEN REPRESENTATIONS NOT CONTAINED IN THIS AGREEMENT AND ITS
INCORPORATED DOCUMENTS.
I acknowledge that I have been provided the opportunity to consider this Agreement for at least 21
days (although I may choose to execute them earlier). I understand that I cannot sign this
agreement until after the Termination Date in order to be eligible to receive the separation and
other benefits outlined in this Agreement.
EXECUTED ON March 31, 2025, by:
___/s/ Werner Cautreels____________
Werner Cautreels
EXECUTED ON March 31, 2025, by:
__/s/ Ian Dukes___________________
Iain Dukes
Executive Chairman
Traws Pharma, Inc.
Exhibit 10.47
Consulting Services Agreement
This Consulting Services Agreement (“Agreement”) is made and entered into as of April 1, 2025
(“Effective Date”) between Traws Pharma, Inc. (“Company”) and Werner Cautreels (“Contractor”). In
consideration of the mutual promises contained in this Agreement, the parties agree as follows:
PAST ACTIVITIES FOR COMPANY
All services performed by Contractor and all
information and other materials disclosed between
the parties prior to the Effective Date will be
governed by the terms of this Agreement, except
where the services are covered by a separate
agreement between Contractor and Company.
Accordingly, to the extent that Company and
Contractor
had
an
employment
or
other
relationship prior to this Agreement and (i)
Contractor received access to any information from
or on behalf of Company that would have been
“Confidential Information” (as defined below) if
Contractor received access to such information
during the period of engagement with Company
under this Agreement; or (ii) Contractor conceived,
created, authored, invented, developed or reduced
to practice any item, including any intellectual
property
rights,
that
would
have
been
an
“Invention” (as defined below) if conceived,
created, authored, invented, developed or reduced
to practice during the period of Contractor’s
provision of services to Company under this
Agreement, then that information will be deemed
“Confidential Information” and any item will be
deemed an “Invention,” and this Agreement will
apply to the information and items as if disclosed,
conceived, created, authored, invented, developed
or reduced to practice under this Agreement.
SERVICES AND COMPENSATION
Services. Subject to the terms and conditions
of this Agreement and at Company’s request and
direction, Contractor will perform for Company the
services (“Services”) described in Exhibit A during
the term of this Agreement.
Scope. Company and Contractor acknowledge
and agree that Contractor’s services under this
Agreement fall outside the usual course of
Company’s business operations.
Performance. Contractor retains full control
over the means, methods, and manner of
performing Services. Company shall not dictate
the specific manner in which Services are provided
but may collaborate with Contractor to set
commercially
reasonable
deadlines
and
expectations for deliverables.
Time of Performance. Contractor shall
determine its own hours of work and the location
where services will be performed, consistent with
the nature of the work required under this
Agreement, provided such services are timely as
per Company’s expectations.
Compensation.
As
consideration
for
Contractor’s proper performance of the Services,
and pursuant to the negotiation between Company
and Contractor, Company will pay Contractor the
compensation for Services as set forth in
Exhibit A.
TERM AND TERMINATION
Term. This Agreement commences on the
Effective Date and will continue for nine (9) months
from the Effective Date, subject to earlier
termination, as provided below, or extension by
mutual agreement of the parties.
Termination. Either party may terminate this
Agreement at any time and for any reason by
giving thirty (30) days prior written notice to the
other party. Company may terminate this
Agreement immediately and without prior notice if
Contractor refuses to or is unable to perform the
Services, is in breach of any material provision of
this Agreement, or Company is dissatisfied with the
quality of Contractor’s work under this Agreement.
For avoidance of doubt, in the event that
Contractor continues to serve as a director of the
Company as of the date of termination of this
Agreement, such termination of this Agreement
shall in no way affect or change Contractor’s role
as a non-employee director of the Company.
Survival. Upon termination, all rights and
duties of the parties toward each other cease,
except that:
Within 30 days of termination, Company
will pay all amounts owing to Contractor for
Services or Contractor will return to Company any
amount paid to Contractor as a retainer that is not
owed against Services; and
Sections 3, 4, 5, 6, 7, 8, and 10 survive
termination of this Agreement.
Return of Materials. Upon the termination of
this Agreement, or upon Company’s earlier
request, Contractor will deliver to Company all of
Company’s property and Confidential Information
(as defined in Section 4.1) that is in Contractor’s
possession or control.
CONFIDENTIALITY
Definition. “Confidential Information” means
any non-public information that relates to the actual
or anticipated business, research, or development
of Company and any proprietary information, trade
secrets, and know-how of Company that is
disclosed to Contractor by Company, directly or
indirectly, in writing, orally, or by inspection or
observation of tangible items. Confidential
Information includes, but is not limited to, research,
product plans, products, services, customer lists,
development
plans,
inventions,
processes,
formulas,
technology,
designs,
drawings,
marketing,
finances,
and
other
business
information. Confidential Information is the sole
property of Company.
Exceptions. Confidential Information does not
include any information that: i) was publicly known
and made generally available in the public domain
prior
to
the
time
Company
disclosed
the
information to Contractor, ii) became publicly
known and made generally available, after
disclosure to Contractor by Company, through no
wrongful action or inaction of Contractor or others
who were under confidentiality obligations.
Nondisclosure and Nonuse. Contractor will
not, during and after the term of this Agreement,
disclose the Confidential Information to any third
party or use the Confidential Information for any
purpose other than the performance of the
Services on behalf of Company. Contractor will
take all reasonable precautions to prevent any
unauthorized
disclosure
of
the
Confidential
Information including, but not limited to, having
each employee of Contractor, if any, with access to
any
Confidential
Information,
execute
a
nondisclosure agreement containing terms that are
substantially similar to the terms contained in this
Agreement.
Former
Client
Confidential
Information.
Contractor will not improperly use or disclose any
proprietary information or trade secrets of any
former or concurrent client of Contractor or other
person or entity in violation of this Agreement.
Furthermore, Contractor will not bring onto the
“Premises” of the Company any unpublished
document or proprietary information belonging to
any client, person, or entity unless consented to in
writing by the client, person, or entity. Contractor
will indemnify and hold Company harmless from
and against all claims, liabilities, damages, and
expenses, including reasonable attorneys’ fees
and costs of suit, arising out of or in connection
with
any
violation
or
claimed
violation
of
Contractor’s duty to maintain the confidence of the
third party’s information.
Third-Party Confidential Information. Company
has received, and in the future will receive, from
third parties confidential or proprietary information
subject to a duty on Company’s part to maintain
the confidentiality of the information and to use it
only for certain limited purposes. Contractor owes
Company and these third parties, during and after
the term of this Agreement, a duty to hold this
confidential and proprietary information in the
strictest confidence and not to disclose it to any
person or entity, or to use it except as necessary in
carrying out the Services for Company consistent
with Company’s agreements with these third
parties.
OWNERSHIP
Assignment. All works of authorship, designs,
inventions,
improvements,
technology,
developments, discoveries, and trade secrets
conceived, made, or discovered by Contractor
during the period of this Agreement, solely or in
collaboration with others, that relate in any manner
to
the
business
of
Company
(collectively,
“Inventions”) will be the sole property of Company.
In
addition,
Inventions
that
constitute
copyrightable subject matter will be considered
“works made for hire” as that term is defined in the
United States Copyright Act. To the extent that
ownership of the Inventions does not by operation
of law vest in Company, Contractor will assign (or
cause to be assigned) and does hereby assign
fully to Company all right, title, and interest in and
to the Inventions, including all related intellectual
property rights and the right to sue for past,
present and future infringement.
Further Assurances. Contractor will assist
Company and its designees in every proper way to
secure Company’s rights in the Inventions and
related intellectual property rights in all countries.
Contractor will disclose to Company all pertinent
information and data with respect to Inventions and
related intellectual property rights. Contractor will
execute all applications, specifications, oaths,
assignments, and other instruments that Company
deems necessary in order to apply for and obtain
these rights and in order to assign and convey to
Company, its successors, assigns, and nominees
the sole and exclusive right, title, and interest in
and
to
these
Inventions,
and
any
related
intellectual property rights. Contractor’s obligation
to provide assistance will continue after the
termination or expiration of this Agreement.
Pre-Existing Materials. If in the course of
performing the Services, Contractor incorporates
into any Invention any other work of authorship,
invention, improvement, or proprietary information,
or other materials owned by Contractor or in which
Contractor has an interest, Contractor will grant
and does now grant to Company a nonexclusive,
royalty-free,
perpetual,
irrevocable,
worldwide
license
to
reproduce,
manufacture,
modify,
distribute, use, import, and otherwise exploit the
material as part of or in connection with the
Invention.
Attorney-in-Fact. If Contractor’s unavailability
or any other factor prevents Company from
pursuing or applying for any application for any
United
States
or
foreign
registrations
or
applications covering the Inventions and related
intellectual property rights assigned to Company,
then
Contractor
irrevocably
designates
and
appoints Company as Contractor’s agent and
attorney in fact. Accordingly, Company may act for
and in Contractor’s behalf and stead to execute
and file any applications and to do all other lawfully
permitted acts to further the prosecution and
issuance of the registrations and applications with
the same legal force and effect as if executed by
Contractor.
CONTRACTOR’S WARRANTIES
As an inducement to Company entering into
and consummating this Agreement, Contractor
represents, warrants, and covenants as follows:
Organization Representations; Enforceability.
Contractor
represents
and
warrants
that:
iii)Contractor is duly organized, validly existing, and
in good standing in the jurisdiction stated in the
preamble to this Agreement, iv)the execution and
delivery of this Agreement by Contractor and the
transactions contemplated hereby have been duly
and validly authorized by all necessary action on
the part of Contractor, and v)this Agreement
constitutes a valid and binding obligation of
Contractor that is enforceable in accordance with
its terms.
Compliance
with
Company
Policies.
Contractor will perform the Services in accordance
with all policies and procedures provided by
Company, including any third-party policies and
procedures that Company is required to comply
with.
No Conflict. The entering into and performance
of this Agreement by Contractor does not and will
not: vi)violate, conflict with, or result in a material
default under any other contract, agreement,
indenture,
decree,
judgment,
undertaking,
conveyance, lien, or encumbrance to which
Contractor is a party or by which it or any of
Contractor’s property is or may become subject or
bound, or vii)violate any applicable law or
government regulation. Contractor will not grant
any rights under any future agreement, nor will it
permit
or
suffer
any
lien,
obligation,
or
encumbrances that will conflict with the full
enjoyment by Company of its rights under this
Agreement.
Right to Make Full Grant. Contractor has and
will have all requisite ownership, rights, and
licenses to fully perform its obligations under this
Agreement and to grant to Company all rights with
respect to the Inventions and related intellectual
property rights to be granted under this Agreement,
free and clear of any and all agreements, liens,
adverse claims, encumbrances, and interests of
any person or entity, including, without limitation,
Contractor’s employees, agents, artists, and
contractors and their contractors’ employees,
agents, and artists, who have provided, are
providing, or will provide services with respect to
the development of the Inventions.
Pre-existing Works and Third-Party Materials.
Contractor will not, without Company’s prior
written consent, incorporate any pre-existing works
or
third-party
materials
into
the
Inventions.
Additionally, Contractor has the right to assign and
transfer rights to pre-existing works and third-party
materials as specified in this Agreement.
Noninfringement. Nothing contained in the
Inventions or required in order for Contractor to
create and deliver the Inventions under this
Agreement does or will infringe, violate, or
misappropriate any intellectual property rights of
any third party. Further, no characteristic of any
Invention does or will cause manufacturing, using,
maintaining, or selling the Invention to infringe,
violate, or misappropriate the intellectual property
rights of any third party.
No Pending or Current Litigation. Contractor is
not involved in litigation, arbitration, or any other
claim and knows of no pending litigation,
arbitration, other claim, or fact that may be the
basis of any claim regarding any of the materials
Contractor has used or will use to develop or has
incorporated or will incorporate into the Inventions
to be delivered under this Agreement.
No Harmful Content. The Inventions as
delivered by Contractor to Company will not
contain matter that is injurious to end-users or their
property,
or
which
is
scandalous,
libelous,
obscene, an invasion of privacy, or otherwise
unlawful or tortious.
Inspection and Testing of Inventions. Prior to
delivery to Company, Contractor will inspect and
test each Invention and the media upon which it is
to be delivered, if applicable, to ensure that the
Invention and media contain no computer viruses,
booby traps, time bombs, or other programming
designed to interfere with the normal functioning of
the Invention or Company’s or an end-user’s
equipment, programs, or data.
Services. The Services will be performed in a
timely, competent, professional, and workmanlike
manner by qualified personnel.
INDEMNIFICATION
Indemnification. Contractor will indemnify,
defend, and hold harmless Company and its
directors, officers, and employees from and against
all taxes, losses, damages, liabilities, costs, and
expenses, including attorneys’ fees and other legal
expenses, arising directly or indirectly from or in
connection with claims or demands, including but
not limited to the following: viii)any negligent,
reckless, or intentionally wrongful act of Contractor
or Contractor’s assistants, employees, or agents,
ix) any breach by Contractor or Contractor’s
assistants, employees, or agents of any of the
covenants,
warranties,
or
representations
contained in this Agreement, x) any failure of
Contractor to perform the Services in accordance
with all applicable laws, rules, and regulations, or
xi) any violation or claimed violation of a third
party’s rights resulting in whole or in part from
Company’s use of the work product of
Contractor under this Agreement; xii)any failure by
Contractor to comply with its obligations under
applicable federal, state, or local laws, including
but not limited to tax, labor, employment, or
workers’ compensation laws, with respect to
Contractor’s personnel or independent contractors;
or xiii)claim, demand, lawsuit, or administrative
proceeding filed or asserted by Contractor’s
employees,
contractors,
or
any
individuals
otherwise associated with Contractor, related to the
performance of services for or on behalf of
Contractor, including but not limited to any
allegation or claim that Contractor Personnel are
employees of Company or any claim of entitlement
to employment benefits, wages, or other rights
from
Company
by
Contractor’s
personnel,
including but not limited to claims for: (i) unpaid
wages; (ii) overtime; (iii) meal or rest breaks
violations;
(iv)
workers’
compensation;
(v)
unemployment insurance; or (vi) any other benefit
or right available under applicable law.
Procedure. In the event of any claim subject to
this
indemnification
provision,
the
following
procedure and guidelines shall apply: (1) Company
shall promptly notify Contractor in writing of the
claim; (2) Contractor shall, at its sole expense,
assume the defense of such claim with counsel
reasonably acceptable to and agreed to by
Company; (3) Company shall have the right to
participate in such defense, at its own expense,
with counsel of its choice; and (4) Contractor shall
not settle any claim without the prior written
consent of Company if such settlement: (a) admits
fault or liability on the part of Company in any
capacity; or (b) imposes any obligation or
restriction on Company beyond the scope of this
Agreement.
Intellectual Property Infringement. In the event
of any claim concerning the intellectual property
rights of a third party that would prevent or limit
Company’s use of the Inventions, Contractor will,
in addition to its obligations under Section 7.1(a),
take one of the following actions at its sole
expense:
procure for Company the right to continue
use of the Invention or infringing part thereof; or
modify
or
amend
the
Invention
or
infringing part thereof or replace the Invention or
infringing part thereof with another Invention
having substantially the same or better capabilities.
ARBITRATION AND EQUITABLE RELIEF
Arbitration. Except as provided in Section 8.3
below, any dispute or controversy arising out of,
relating to, or concerning any interpretation,
construction, performance, or breach of this
Agreement, will be settled by arbitration to be held
in Philadelphia, Pennsylvania, in accordance with
the rules then in effect of the American Arbitration
Association. The arbitrator may grant injunctions
or other relief in the dispute or controversy. The
decision of the arbitrator will be final, conclusive,
and binding on the parties to the arbitration.
Judgment may be entered on the arbitrator’s
decision in any court having jurisdiction. Company
and Contractor will each pay one-half of the costs
and expenses of the arbitration, and each will
separately pay their own counsel fees and
expenses,
unless
prohibited
by
statute
or
arbitration rule. All decisions regarding the
enforceability of this arbitration provision are
delegated to the Arbitrator.
Waiver or Right to Jury Trial and Class,
Representative Actions. This arbitration clause
constitutes a waiver of Contractor’s right to a
jury trial, as well as a waiver of the right of
Contractor or any of its member constituents to
participate
in
all
class,
collective,
or
representative actions for any and all disputes
relating to all aspects of the independent contractor
relationship, including, but not limited to, the
interpretation and enforcement of this agreement,
all claims for both express and implied, for breach
of contract, breach of the covenant of good faith
and fair dealing, negligent or intentional infliction of
emotional
distress,
negligent
or
intentional
misrepresentation,
negligent
or
intentional
interference with contract or prospective economic
advantage, defamation, any and all claims for
violation of any federal, state, or municipal
statutes, including any claims under the Labor
Code or similar federal, state, or municipal statutes
governing employment claims.
Equitable Remedies. The parties may apply to
any court of competent jurisdiction for a temporary
restraining order, preliminary injunction, or other
interim or conservatory relief, as necessary,
without breach of this Agreement and without
abridgement of the powers of the arbitrator.
Consideration. Each party’s promise to resolve
claims by arbitration in accordance with the
provisions of this Agreement, rather than through
the courts, is consideration for the other party’s like
promise.
Arbitration
Forum,
Rules,
and
Venue.
Arbitration shall be conducted before a single
neutral
arbitrator
in
accordance
with
the
Commercial Arbitration Rules of the American
Arbitration Association (AAA) then in effect, except
as modified herein or agreed to between the
parties. The arbitration shall take place in the
closest AAA office to Company’s address, unless
otherwise agreed in writing by the parties.
Independent
Status
of
Contractor.
In
recognition
of
Contractor’s
status
as
an
independent business entity, the parties agree that
any
arbitration
involving
the
employment,
classification,
or
compensation
of
personnel
employed or associated with Contractor shall be
the sole responsibility of Contractor, and Company
shall not be named as a party to such disputes,
and in the event of being named, Contractor shall
indemnify, defend and hold harmless Company in
accordance with this Agreement.
Confidentiality. All arbitration proceedings,
including
the
existence
of
the
arbitration,
submissions, evidence, and any award, shall be
maintained in strict confidence by the parties,
except as may be necessary to enforce or
challenge the arbitration award or as required by
law.
Pre-Arbitration Negotiation. Prior to initiating
arbitration, the parties agree to engage in good-
faith discussions to resolve any disputes informally.
If such discussions fail, either party may submit
the dispute to arbitration by providing written notice
to the other party, formally filing a demand for
arbitration (the “Demand”), and thereafter serving
the Demand on the other party.
INDEPENDENT CONTRACTOR; BENEFITS
Independent Contractor. Contractor and
Company expressly acknowledge and agree that
Contractor is an independent contractor and shall
perform the Services under this Agreement as an
independent contractor. Nothing in this Agreement
shall be construed to create an employment
relationship between Contractor and Company.
Nothing in this Agreement will in any way be
construed to constitute Contractor as an agent,
partner, employee, joint venturer or representative
of Company.
No Agency Relationship. Without limiting the
generality of the foregoing, Contractor is not
authorized to bind Company to any liability or
obligation or to represent that Contractor has any
authority.
Materials
and
Equipment.
Except
for
proprietary materials necessary to perform the
contracted services, Contractor shall provide all
necessary tools, equipment, and other materials to
complete the Services under this Agreement.
Company will provide Contractor with secure
laptops to perform services, and Contractor agrees
to return all Company equipment and information
at the conclusion of the term of this Agreement.
No Exclusivity. Contractor represents and
warrants that it customarily engages in an
independently established trade, occupation, or
business of the same nature as the services
provided under this Agreement, as set out in
Exhibit A, and regularly contracts with other
businesses for similar services. Contractor is free
to contract with other businesses to provide the
same or similar services without restriction by
Company. Contractor represents and warrants
that it actively markets and holds itself out to the
public as available to provide similar services to
other clients or businesses. Notwithstanding the
foregoing, Contractor shall honor its confidentiality
obligations to the Company and shall not use or
disclose any Confidential Information with any
other businesses in violation of this Agreement.
Licenses,
Registrations
and
Permits.
Contractor represents that the Services under this
Agreement do not require a license from the
Contractors’ State License Board pursuant to
Chapter 9 of Division 3 of the Business and
Professions Code. Contractor shall obtain and
maintain
all
necessary
business
licenses,
registrations, or permits required to lawfully
operate as an independent business in the
jurisdiction where services are performed.
Legal Obligations. Contractor is responsible for
complying with all federal, state, and local laws
applicable to independent contractors, including
but not limited to tax obligations, workers’
compensation obligations, business registrations,
and professional licensing requirements.
No Benefits. As an independent contractor,
Contractor shall not be entitled to any benefits
provided by Company to its employees, including
but not limited to health insurance, retirement
benefits, paid time off, or workers’ compensation
coverage.
Contractor will indemnify and hold Company
harmless to the extent of any obligation imposed
on Company xiv) to pay in withholding taxes or
similar items or xv) resulting from a determination
that Contractor is not an independent contractor.
Benefits. Contractor acknowledges that it is
solely responsible for any employment-related
benefits
to
its
employees
or
independent
contractors, including, but not limited to workers’
compensation benefits, paid vacation, sick leave,
medical
insurance,
and
401(k)
participation.
Contractor acknowledges and agrees that
Contractor’s employees will not receive any such
benefits from Company either as a contractor or
employee.
If
a
Contractor
employee
or
independent contractor is deemed by a state or
federal agency or court of law as an employee of
Company,
Contractor
agrees
to
indemnify
Company for any and all taxes, losses, damages,
liabilities, costs, and expenses, including attorneys’
fees and other legal expenses, arising directly or
indirectly from that reclassification of Contractor’s
employee pursuant to Section 7 of this Agreement.
MISCELLANEOUS
Non assignment and No Subcontractors.
Neither this Agreement nor any rights under this
Agreement
may
be
assigned
or
otherwise
transferred by Contractor, in whole or in part,
whether voluntarily or by operation of law, without
the prior written consent of Company. Contractor
may not utilize a subcontractor or other third party
to perform its duties under this Agreement without
the prior written consent of Company. Subject to
the foregoing, this Agreement will be binding upon
and will inure to the benefit of the parties and their
respective
successors
and
assigns.
Any
assignment in violation of the foregoing will be null
and void.
Notices. Any notice required or permitted
under the terms of this Agreement or required by
law must be in writing and must be: xvi) delivered
in person, xvii) sent by first class registered mail, or
air mail, as appropriate, or xviii) sent by overnight
air courier, in each case properly posted and fully
prepaid to the appropriate address as set forth
below. Either party may change its address for
notices by notice to the other party given in
accordance with this Section. Notices will be
deemed given at the time of actual delivery in
person, three business days after deposit in the
mail as set forth above, or one day after delivery to
an overnight air courier service.
Waiver. Any waiver of the provisions of this
Agreement or of a party’s rights or remedies under
this Agreement must be in writing to be effective.
Failure, neglect, or delay by a party to enforce the
provisions of this Agreement or its rights or
remedies at any time, will not be construed as a
waiver of the party’s rights under this Agreement
and will not in any way affect the validity of the
whole or any part of this Agreement or prejudice
the party’s right to take subsequent action.
Exercise or enforcement by either party of any
right or remedy under this Agreement will not
preclude the enforcement by the party of any other
right or remedy under this Agreement or that the
party is entitled by law to enforce.
Severability. If any term, condition, or provision
in this Agreement is found to be invalid, unlawful,
or unenforceable to any extent, the parties will
endeavor in good faith to agree to amendments
that will preserve, as far as possible, the intentions
expressed in this Agreement. If the parties fail to
agree on an amendment, the invalid term,
condition, or provision will be severed from the
remaining terms, conditions, and provisions of this
Agreement, which will continue to be valid and
enforceable to the fullest extent permitted by law.
Confidentiality of Agreement. Contractor will
not disclose any terms of this Agreement to any
third party without the consent of Company, except
as required by applicable laws.
Counterparts. This Agreement may be
executed in counterparts, each of which will be
deemed to be an original and together will
constitute one and the same agreement.
Governing Law. The internal laws of the state
of Pennsylvania, but not the choice of law rules,
govern this Agreement.
Headings. Headings are used in this
Agreement for reference only and will not be
considered when interpreting this Agreement.
Integration. This Agreement and all exhibits
contain the entire agreement of the parties with
respect to the subject matter of this Agreement and
supersede
all
previous
communications,
representations, understandings, and agreements,
either oral or written, between the parties with
respect to said subject matter. No terms,
provisions, or conditions of any purchase order,
acknowledgement, or other business form that
either party may use in connection with the
transactions contemplated by this Agreement will
have any effect on the rights, duties, or obligations
of the parties under, or otherwise modify, this
Agreement, regardless of any failure of a receiving
party to object to these terms, provisions, or
conditions. This Agreement may not be amended,
except by a writing signed by both parties.
[Signature Page to Follow]
“Company”
Traws Pharma, Inc.
“Contractor”
Werner Cautreels
Signature: /s/ Iain Dukes
Signature: /s/ Werner Cautreels
Name: Iain Dukes
Title: Executive Chairman
EXHIBIT A
Services and Compensation
Services. Services include, but are not limited to, the following: director and board management,
as determined by the Interim Chief Executive Officer or Chief Executive Officer, as applicable.
Compensation: Compensation under this Agreement shall be according to the terms set forth
below: Monthly Amount of $10,000 as long as services are rendered to the satisfaction of the
Interim Chief Executive Officer or Chief Executive Officer, as applicable.
Company will reimburse Contractor for all reasonable expenses incurred by Contractor in
performing Services pursuant to this Agreement, if Contractor receives written consent from an
authorized agent of Company prior to incurring the expenses and submits receipts for the
expenses to Company in accordance with Company policy.
Exhibit 21.1
Subsidiary
Jurisdiction of
Incorporation
Onconova Europe GmbH
Germany
Trawsfynydd Therapeutics, LLC
Delaware, U.S.
Throxavir Therapeutics AU Pty Ltd
Australia
Trawsfynydd Therapeutics AU Pty Ltd
Australia
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the registration statements (Nos. 333-191161, 333-194228, 333-204210, 333-210694,
333-215575, 333-222400, 333-226199, 333-233410, 333-258336, 333-268393 and 333-283262) on Form S-8, (Nos. 333-273081, 333-
280642 and 333-284285) on Form S-3, and (Nos. 333-222374 and 333-224315) on Form S-1 of our report dated March 31, 2025, with
respect to the consolidated financial statements of Traws Pharma, Inc. and subsidiaries.
/s/ KPMG LLP
Philadelphia, Pennsylvania
March 31, 2025
Exhibit 23.2
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the following Registration Statements:
(1) Registration Statement (Form S-8 No. 333-191161) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(2) Registration Statement (Form S-8 No. 333-194228) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(3) Registration Statement (Form S-8 No. 333-204210) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(4) Registration Statement (Form S-8 No. 333-210694) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(5) Registration Statement (Form S-8 No. 333-215575) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(6) Registration Statement (Form S-8 No. 333-222400) pertaining to the Onconova Therapeutics, Inc. 2013
Equity Compensation Plan
(7) Registration Statement (Form S-8 No. 333-226199) pertaining to the Onconova Therapeutics, Inc. 2018
Omnibus Incentive Compensation Plan
(8) Registration Statement (Form S-8 No. 333-233410) pertaining to the Onconova Therapeutics, Inc. 2018
Omnibus Incentive Compensation Plan
(9) Registration Statement (Form S-8 No. 333-258336) pertaining to the Onconova Therapeutics, Inc. 2021
Incentive Compensation Plan
(10)
Registration Statement (Form S-8 No. 333-268393) pertaining to the Onconova Therapeutics, Inc.
2021 Omnibus Incentive Compensation Plan, as Amended and Restated
(11)
Registration Statement (Form S-8 No. 333-283262) pertaining to the Traws Pharma, Inc. 2021
Incentive Compensation Plan, Trawsfynydd Therapeutics, Inc. 2021 Stock Plan and Traws Pharma,
Inc. Inducement Restricted Stock Equity Awards
(12)
Registration Statement (Form S-3 No. 333-273081) of Onconova Therapeutics, Inc.
(13)
Registration Statement (Form S-3 No. 333-280642) of Traws Pharma, Inc.
(14)
Registration Statement (Form S-3 No. 333-284285) of Traws Pharma, Inc.
(15)
Registration Statement (Form S-1 No. 333-222374) of Onconova Therapeutics, Inc., and
(16)
Registration Statement (Form S-1 No. 333-224315) of Onconova Therapeutics, Inc.;
of our report dated April 1, 2024 (except for the second paragraph of Note 1, and Note 10, as to which the date is
March 31, 2025), with respect to the consolidated financial statements of Traws Pharma, Inc. (formerly Onconova
Therapeutics, Inc.) included in this Annual Report (Form 10-K) of Traws Pharma, Inc. for the year ended December
31, 2024.
/s/ Ernst & Young LLP
Philadelphia, Pennsylvania
March 31, 2025
Exhibit 31.1
CERTIFICATIONS
I, Werner Cautreels, Ph.D., certify that:
1.
I have reviewed this Annual Report on Form 10-K of Traws Pharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or other persons
performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
/s/ Werner Cautreels, Ph.D.
Werner Cautreels, Ph.D.
Chief Executive Officer
(Principal Executive Officer)
Dated: March 31, 2025
Exhibit 31.2
CERTIFICATIONS
I, Nora Brennan, certify that:
1.
I have reviewed this Annual Report on Form 10-K of Traws Pharma, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading
with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all
material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods
presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is
being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or other persons
performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
/s/ Nora Brennan
Nora Brennan
Interim Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
Dated: March 31, 2025
Exhibit 32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on Form 10-K of Traws Pharma, Inc. (the “Company”) for the year ended December 31,
2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Werner Cautreels, Ph.D.,
Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that, based on my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
/s/ Werner Cautreels, Ph.D.
Werner Cautreels, Ph.D.
Chief Executive Officer
(Principal Executive Officer)
Dated: March 31, 2025
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date
hereof, regardless of any general incorporation language in such filing.
Exhibit 32.2
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report on Form 10-K of Traws Pharma, Inc. (the “Company”) for the year ended December 31,
2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Nora Brennan, Interim
Chief Financial Officer, hereby certifies, pursuant to 18 U.S.C. Section 1350, that, based on my knowledge:
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as
amended; and
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
/s/ Nora Brennan
Nora Brennan
Interim Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
Dated: March 31, 2025
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date
hereof, regardless of any general incorporation language in such filing.