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Marker Therapeutics, Inc.

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FY2023 Annual Report · Marker Therapeutics, Inc.
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Marker Therapeutics, Inc.  
2024 Annual Report 

UNITED STATES 
SECURITIES AND EXCHANGE COMMISSION 
Washington, D.C. 20549 
FORM 10-K 

☒  ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended December 31, 2023

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: 001-37939 

MARKER THERAPEUTICS, INC. 
(Exact name of registrant as specified in its charter) 

Delaware 
(State or other jurisdiction of 
incorporation) 

9350 Kirby Drive, Suite 300  
Houston, Texas 
(Address of principal executive offices) 

45-4497941 
(IRS Employer Identification No.) 

77054 
(Zip code) 

(Telephone Number) 

(713) 400-6400 

4551 Kennedy Commerce Drive, Houston, Texas, 77032
(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act: 

Title of each class 
Common Stock, par value $0.001 per share 

   Trading Symbol(s)
  MRKR

Securities registered pursuant to Section 12(g) of the Act: None 

 Name of each exchange on which registered
The Nasdaq Stock Market LLC 

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 of Section 15(d) of the Act. Yes ☐  No ☒ 
Indicate by check mark whether the registrant (1) 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 checkmark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or 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 
Non-accelerated filer  

☐ 
☒ 

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. ☐ 
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 checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐  No ☒ 
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2023 (the last day of the registrant’s most recently completed 
second fiscal quarter) based on the closing sale price of $3.10 as reported on the Nasdaq Capital Market as of that date was approximately $23,100,000. 
The registrant had 8,902,897 shares of common stock outstanding as of March 18, 2024. 
Note Regarding Reverse Stock Splits 
On January 26, 2023, we filed an amendment to our Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect a reverse split of our 
authorized, issued and outstanding common stock at a ratio of one for ten. All historical share and per share amounts reflected in this report have been adjusted to reflect the reverse stock split. 
Documents Incorporated By Reference 
Portions of the registrant’s proxy statement relating to registrant’s 2024 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed with the Securities and Exchange Commission 
pursuant to Regulation 14A, not later than 120 days after the close of the registrant’s fiscal year, are incorporated by reference in Part III of this Annual Report on Form 10-K. Except with respect 
to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement is not deemed to be filed as part of this Annual Report on Form 10-K. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
TABLE OF CONTENTS 

Part I 
Item 1.  
Item 1A.  
Item 1B.  
Item 1C. 
Item 2.  
Item 3.  
Item 4.  
Part II 

Item 5.  
Item 6.  
Item 7.  
Item 7A.  
Item 8.  
Item 9.  
Item 9A.  
Item 9B.  
Item 9C. 
Part III 
Item 10.  
Item 11.  
Item 12.  
Item 13.  
Item 14.  
Part IV 
Item 15.  
Item 16.  

     FORWARD LOOKING STATEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  Business   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Risk Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Unresolved Staff Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Cybersecurity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Properties   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Legal Proceedings   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Mine Safety Disclosure  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity 
Securities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[Reserved]  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Management’s Discussion And Analysis Of Financial Condition And Results Of Operations  . . . . . . . . . . . . . .
  Quantitative And Qualitative Disclosures About Market Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Financial Statements   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Changes In And Disagreements With Accountants On Accounting And Financial Disclosure  . . . . . . . . . . . . . .
  Controls And Procedures  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Other Information  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  Directors, Executive Officers And Corporate Governance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Executive Compensation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Security Ownership Of Certain Beneficial Owners And Management And Related Stockholder Matters . . . . .
  Certain Relationships And Related Transactions, And Director Independence . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Principal Accounting Fees And Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  Exhibits, Financial Statement Schedules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Form 10-K Summary  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
  Signatures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS 

This annual report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that 
involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1: “Business,” Part I, 
Item 1A: “Risk Factors,” and Part 2, Item 7: “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” 
but are also contained elsewhere in this annual report. Any statements contained herein that are not statements of historical fact may be 
deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, 
“will”, “should”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential” or “continue”, the negative of 
such terms or other comparable terminology. These statements speak only as of the date of this Annual Report and involve known and 
unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially 
different from any future results, performance or achievements expressed or implied by the forward-looking statements. We have based 
these forward-looking statements largely on our current expectations and projections about future events and financial trends that we 
believe may affect our business, financial condition and results of operations.  Forward-looking statements in this annual report include 
statements as to: 

• 

• 

• 

• 

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• 

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our ability to continue as a going concern; 

the timing, progress and results of clinical trials of multi tumor associated antigen (“multiTAA”)-specific T cell therapies and 
our other product candidates, including statements regarding the timing of initiation and completion of preclinical studies or 
clinical trials or related preparatory work, the period during which the results of the trials will become available and our research 
and development programs; 

the timing of any submission of filings for regulatory approval of product candidates and our ability to obtain and maintain 
regulatory approvals for product candidates for any indication; 

our ability to successfully commercialize product candidates; 

our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates; 

our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of 
product candidates, if approved for commercial use; 

our  manufacturing  capabilities  and  strategy,  including  the  ease,  scalability  and  commercial  viability  of  our  manufacturing 
methods and processes, as well as our ability to maintain our relationship with Cell Ready LLC; 

our expectations regarding the scope of any approved indications for product candidates; 

the potential benefits of and our ability to maintain our relationships and collaborations with the Baylor College of Medicine 
(“BCM”), and other potential collaboration or strategic relationships; 

our ability to use the multiTAA-specific T cell platform to develop future product candidates; 

our  estimates  of  our  expenses,  ongoing  losses,  future  revenue,  capital  requirements  and  our  needs  for  or  ability  to  obtain 
additional funding; 

our ability to identify, recruit and retain key personnel; 

our ability to protect and enforce our intellectual property position for our product candidates, and the scope of such protection; 

our financial performance; 

ii 

• 

• 

our competitive position and the development of and projections relating to our competitors or our industry; and 

the impact of laws and regulations. 

You should refer to “Item 1A. Risk Factors” in this annual report for a discussion of important factors that may cause our actual results 
to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure 
you that the forward-looking statements in this annual report will prove to be accurate. Furthermore, if our forward-looking statements 
prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you 
should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and 
plans in any specified time frame, or at all. The forward-looking statements in this annual report represent our views as of the date of 
this annual report. We anticipate that subsequent events and developments may cause our views to change. However, while we may 
elect to update these forward-looking statements at some point in the future, we undertake no obligation to publicly update any forward-
looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, 
not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this annual report. 

You should read this annual report and the documents that we reference in this annual report and have filed as exhibits to this annual 
report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify 
all of our forward-looking statements by these cautionary statements. 

In this report all references to (i) “Marker” “we,” “us,” “our” or the “Company” mean Marker Therapeutics, Inc. and its wholly-owned 
subsidiaries, Marker Cell Therapy, Inc. and GeneMax Pharmaceuticals, Inc., which wholly owns GeneMax Pharmaceuticals Canada 
Inc., unless the context otherwise requires; (ii) “SEC” refers to the Securities and Exchange Commission; (iii) “Securities Act” refers to 
the United States Securities Act of 1933, as amended; (iv) “Exchange Act” refers to the United States Securities Exchange Act of 1934, 
as amended; and (v) all dollar amounts refer to United States dollars unless otherwise indicated. 

iii 

 
ITEM 1. BUSINESS 

Overview 

PART I 

We  are  a  clinical-stage  immuno-oncology  company  specializing  in  the  development  and  commercialization  of  novel  T  cell-based 
immunotherapies  for  the  treatment  of  hematological  malignancies  and  solid  tumor  indications.  We  developed  our  lead  product 
candidates from our multi tumor associated antigen (“multiTAA”)-specific T cell technology, which is based on the manufacture of 
non-engineered, tumor-specific T cells that recognize multiple tumor-associated antigens, or TAAs. This approach selectively expands 
tumor-specific  T  cells  from  a  patient’s/donor’s  blood  and  is  able  to  recognize  multiple  tumor  targets  to  produce  broad  spectrum 
anti- tumor  activity.  Targeting  multiple  antigens  simultaneously  exploits  the  natural  capacity  of  T  cells  to  recognize  and  kill  tumor 
targets  via  native  T  cell  receptors  (“TCR”),  while  limiting  tumor  adaptation/escape  by  antigen-negative  selection  or  antigen  down-
regulation. When infused into a patient with cancer, the multiTAA-specific T cells are designed to kill cancer cells expressing the TAA 
and potentially recruit the patient’s immune system to participate in the cancer killing process. 

We licensed the underlying technology for multiTAA-specific T cell therapy from Baylor College of Medicine, or BCM, in March 2018. 
BCM had utilized the therapy in seven exploratory clinical trials. In these studies, BCM treated over 150 patients suffering from a variety 
of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, or AML, acute lymphoblastic leukemia, or ALL, pancreatic 
cancer, breast cancer and various sarcomas. In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and 
decreased toxicity compared to other cellular therapies. 

We are advancing two product candidates for 3 clinical indications as part of our multiTAA-specific T cell program for: 

•  Autologous multiTAA product for the treatment of lymphoma and pancreatic cancer (MT-601) 

•  Off-the-Shelf (OTS) product in various indications (e.g., MT-401-OTS) 

We do not genetically engineer our multiTAA-specific T cell therapies and we believe that our product candidates are superior to T cells 
engineered with chimeric antigen receptors, or CAR-T, for several reasons including: 

•  Multiple targets → enhanced tumoricidal effect→ minimized tumor immune escape 

•  Clinical safety → no treatment-related side effects, including cytokine release syndrome (CRS) or other severe adverse effects 

(SAEs), were attributed to the use of multiTAA-specific T cell therapies to date 

•  Non-genetically engineered T cell products → selective expansion of tumor-specific T cells from a patient’s or donor’s blood 
capable of recognizing a broad range of tumor antigens → no risk of mutagenesis and reduced manufacturing complexity → 
lower cost 

For these reasons, we believe our endogenous T cell receptor-based therapies may provide meaningful clinical benefit and safety to 
patients with both hematological and solid tumors. 

1 

 
 
We  believe  that  the  simplicity  of  our  manufacturing  process  allows  additional  modifications  to  expand  multiTAA-specific  T  cell 
recognition of cancer targets. For example, we are assessing the potential of combining multiTAA-specific T cell products with other 
products. 

Company-Sponsored Clinical Development of MultiTAA Specific T Cell Therapies 

MT-601 for the Treatment of Lymphoma 

We developed MT-601, a multiTAA-specific autologous T cell product capable of recognizing multiple target antigens expressed by 
the tumor, thereby limiting tumor adaptation by negative antigen selection or downregulation. 

We are evaluating the safety and efficacy of MT-601 in a Phase 1, multicenter, open-label study (APOLLO) in participants with relapsed 
or refractory lymphoma who either failed or are ineligible for anti-CD19 CAR T cell therapy. MT - 601 is a multiTAA-specific T cell 
product  that  specifically  targets  six  different  tumor  antigens  upregulated  in  lymphoma  cells  (Survivin,  PRAME,  WT1,  NY-ESO-1, 
SSX-2,  MAGEA-4).  In  August 2022,  the  FDA  cleared  our  IND  application  for  MT-601  for  the  treatment  of  patients  with 
relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment. The Phase 1 
APOLLO trial was initiated in January 2023. In June 2023, we reported first enrollment in the dose escalation stage of the Phase 1 study. 
The study participant tolerated the treatment well without treatment-related adverse events and achieved a complete metabolic response 
eight weeks after the second infusion of MT - 601. Six months following the initial treatment with MT-601 the study participant has 
maintained a complete response to treatment and will continue to be monitored for long-term treatment effects and durability of response. 
To further validate these observations, additional patients are currently being enrolled in the Phase 1 study. 

MT-601 for the Treatment of Pancreatic Cancer 

We reported interim data for an ongoing Phase 1/2 clinical trial (TACTOPS) of the multiTAA-specific T cell therapy targeting five 
TAAs for the treatment of pancreatic adenocarcinoma being conducted by BCM. In this trial, we have observed a clinical benefit with 
4 of 13 patients (31%) showing objective responses in front-line unresectable or metastatic pancreatic cancer, which correlated with the 
post-infusion detection of tumor-reactive T cells in patient peripheral blood and within tumor biopsy samples in patients in the tumor-
resection arm of the trial. To date, we have not observed any cytokine release syndrome or neurotoxicity in this trial. 

In January 2022, the FDA granted orphan drug designation to MT-601 for the treatment of patients with pancreatic cancer. The FDA 
cleared our IND application for MT-601 in November 2022 to initiate the PANACEA study, a Phase 1 multicenter clinical trial in locally 
advanced,  unresectable  or  metastatic  pancreatic  cancer  to  assess  the  safety  and  efficacy  of  MT-601  in  combination  with  front-line 
chemotherapy. The PANACEA trial will include a dose escalation portion followed by a dose expansion portion. Clinical advancement 
will be pending additional financial support from non-dilutive grant activities.  

MT-401 for the Treatment of Patients with AML and MT-401-OTS Program 

MT-401 ARTEMIS Study: 

We previously announced discontinuation of the Phase 2 ARTEMIS study to prioritize the MT-401-OTS program in patients with Acute 
Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS). 

The previous ARTEMIS study was investigating MT-401 (zedenoleucel), in post-allogeneic hematopoietic stem cell transplant (HSCT) 
patients with AML. The study had three treatment arms, including patients with measurable residual disease (MRD), as well as patients 
with MRD negative complete remission or active disease. The dose administered in this multicenter trial was up to 200 million cells 
every two weeks for up to three doses. 

• 

In  April 2020,  the  Orphan  Product  Development  Office  of  the  United  States  Food  and  Drug  Administration,  or  the  FDA, 
granted orphan drug designation to MT-401 (zedenoleucel), a multiTAA-specific T cell therapy that targets four TAAs, for the 
treatment of AML. 

•  The  same  multiTAA-specific  T  cell  therapy  has  been  well  tolerated  in  an  ongoing  Phase  1  clinical  trial  in  AML  and 

myelodysplastic syndrome, or MDS, conducted by our strategic partner Baylor College of Medicine, or BCM. 

2 

•  As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the multiTAA-
specific  T  cell  therapy  after  receiving  an  allogeneic  HSCT  were  relapse  free  [median  leukemia-free  survival,  or  LFS,  not 
reached  at  a  median  follow-up  of  1.9  years],  with  11  of  15  patients  (two  patients  were  each  treated  during  two  different 
remissions) remaining alive (estimated two-year overall survival of 77%) at a median follow-up of 1.9 years post-infusion, 
which compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 
15  months and two-year survival probability of 42%]. 

•  Additionally, eight patients were treated for active disease that was resistant to salvage therapy post-HSCT with a median of 

five prior lines of therapy (range: four to 10). 

o  One of the eight patients crossed over from the adjuvant group, while two patients enrolled twice, but all three patients 

had active AML that failed another line of salvage therapy after their first multiTAA-specific T cell infusion. 

o  Two of the eight patients achieved objective responses, with one complete response and one partial response, with six 

patients continuing with stable disease. 

o  We have observed evidence of a patient’s natural immune system participating in cancer killing (epitope spreading) 

after infusion of our multiTAA-specific T cell therapy. 

In 2021, the ARTEMIS trial conducted by Marker has completed the safety lead-in portion, which tested the comparability of MT-401 
or zedenoleucel, the multiTAA-specific T cell product manufactured using peptides from two different vendors and enrolled six patients 
with active disease: one measurable residual disease (MRD) positive patient and five frank relapse patients. 

•  Consistent  with  the  results  of  the  BCM  Phase  1  trial,  there  were  no  dose-limiting  toxicities,  cytokine  release  syndrome  or 
neurotoxicity observed in this stage of the trial\. Correlative studies showed that the patient saw significant expansion of infused 
multiTAA-specific  T  cells.  There  were  no  objective  responses  from  the  frank  relapse  patients.  By  November 2022,  all  six 
patients had completed dose-limiting toxicity (DLT) periods with no DLTs reported. 

• 

In the fourth quarter of 2021, the manufacturing of MT-401 for the Phase 2 trial started at the Marker Cell Therapy cGMP 
manufacturing facility, named MCTF01. We transitioned to treating patients using MT-401 manufactured with Marker’s new 
T cell manufacturing process. The improved manufacturing process greatly reduced the manufacturing time and increased both 
the  antigen  specificity  and  diversity.  Specifically,  the  new  process  involves  an  improved  T  cell  manufacturing  process  for 
MT- 401 that reduces production time to 9 days (compared to the original process of >30 days). This allows a 90% decrease in 
the number of interventions during production and an improved final T cell product compared to the original product used in 
previous clinical trials on multiTAA-specific T cells. 

•  After completing the safety lead-in portion, we initiated the remainder of the Phase 2 trial in July 2021. Group 1 comprised 
adjuvant (disease-free) patients, with the primary endpoint of relapse-free survival of patients randomized to receive MT-401 
versus a control group. Group 2 comprised active disease patients in 2 single arm cohorts (MRD+ only and active disease), 
with primary endpoints of complete remission and duration of complete remission.  

We  were  previously  awarded  grants  from  the  FDA  Orphan  Products  Grant  program  ($2  million),  NIH  Small  Business  Innovation 
Research (SBIR) program ($2 million) and the Cancer Prevention and Research Institute of Texas (CPRIT, $13 million), to support the 
Phase  2  clinical  trial  of  MT-401.  All  funding  agencies  have  agreed  to  continue  their  financial  support  and  to  shift  funds  to  the 
MT-401-OTS program. 

Off-the-Shelf MT-401 (MT-401-OTS) for the Treatment of AML: 

Marker previously announced that it intends to focus on the advancement of the MT-401-OTS program in patients with AML. MT - 
401-OTS has the potential to provide treatment to patients in as little as 72 hours. Marker believes that this fast turnaround time would 
be beneficial for treating patients with rapid cancer progression, such as patients with measurable residual disease (MRD) in the AML 
setting. In the OTS program, we intend to dose patients using “banked” products based on partially human leukocyte antigen (HLA) 
matching. The U.S. FDA has cleared our clinical protocol to investigate MT-401-OTS as a treatment in patients with AML. We 

3 

 
 
already established a cellular inventory manufactured from healthy donors, with ongoing efforts to further expand the inventory. At full 
scale production, we estimate a single donor could provide treatment for approximately 40 patients, and the current stability program 
indicates that OTS multiTAA-specific T cell products are stable for more than a year in liquid nitrogen, which we expect will permit 
future on-demand availability for broad-scale implementation. We expect to dose the first patient in the second half of 2024, and, if our 
OTS program shows promising results in the clinic, we intend to expand the OTS platform to other hematological malignancies and 
solid tumors.  

Pipeline 

Our clinical-stage pipeline is set forth below: 

Our Strategy 

Our multiTAA-specific T cells are designed to enhance the capacity of non-engineered T cells to find and kill cancer by increasing the 
diversity and quantity of naturally occurring cancer killing T cells within the patient. 

Our  goal  is  to  be  the  leader  in  the  development  and  commercialization  of  transformative  immunotherapies  for  the  treatment  of 
hematological  malignancies  and  solid  tumors.  We  are  developing  a  portfolio  of  highly  differentiated  T  cell  therapies  utilizing  the 
multiTAA-specific T cell platform that we believe has the potential to significantly disrupt the current cell therapy landscape, while 
substantially improving survival and quality of life for patients with cancers. 

The key elements of our strategy include: 

•     Expedite clinical development, regulatory approval, and commercialization of our lead product candidates. 

Based on the results of the Phase 1 clinical trials of the multiTAA-specific T cell therapies conducted at BCM and the positive clinical 
data from the Phase 1 APOLLO study, we plan to prioritize the advancement of MT-601 in patients with lymphoma and to advance the 
MT-401-OTS program in patients with AML. 

4 

 
 
 
 
We intend to initiate future additional clinical trials in other tumor types based on emerging data. On June 26, 2023, we completed the 
previously announced transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell Ready Purchase 
Agreement, dated May 1, 2023, by and between us and Cell Ready. Following the Closing Date, on February 22, 2024, we and Cell 
Ready entered into a long-term contract, pursuant to which Cell Ready will perform a wide variety of services for us, including research 
and development, and manufacturing in support of our clinical trials. 

•     Continue  to  collaborate  with  our  partners  and  increase  our  clinical  activities  to  improve  and  develop  adoptive  cell  therapy 

technologies. 

We are contracting with Cell Ready to perform a wide variety of services to ensure the continuation of our research and development 
efforts and process development to optimize our manufacturing process, product quality and commercial scalability. We previously 
optimized the multiTAA-specific T cell manufacturing process by closing the system and reducing the total manufacturing time from 
the  original  36  days  (BCM)  to  nine  days.  The  improved  manufacturing  process  has  been  implemented  to  supply  all  of  the  clinical 
products used in our current company-sponsored clinical trials. We believe the improved manufacturing process enables products with 
increased antigen specificity and diversity, both of which have a strong linear correlation to anti-tumor activity and has resulted in a 
four-fold increase in potency in vitro. 

•     Invest in our platform to maximize the beneficial outcomes for cancer patients. 

We plan to explore new product opportunities by increasing and/or customizing the antigens we target to expand the indications in 
which  the  multiTAA-specific  T  cell  products  will  be  efficacious,  including  solid  tumors  or  other  hematologic  malignancies. 
Additionally, our research and development efforts may include the exploration of different doses and/or frequency of dosing and the 
relationship of these factors with potential therapeutic benefit. 

•     Leverage our relationships with our founding institutions, scientific founders and other scientific advisors. 

Our world-renowned scientific founders and scientific advisors have made seminal contributions to major discoveries in the field of 
immuno-oncology, and have significant experience in oncology, immunology and cell therapy. We intend to significantly leverage the 
knowledge, experience and advice of our scientific founders and advisors, as well as the institutional expertise of BCM and our other 
major institutional partners, to advance our therapies through the clinic and into commercialization. 

Background and History of Cancer Immunotherapies 

Despite advances in options for treatment, cancer continues to be one of the main causes of death in developed countries. Historically, 
cancer  therapy  has  been  constrained  to  surgery,  radiation,  and  chemotherapy.  More  recently,  advances  in  the  understanding  of  the 
immune  system’s  role  in  cancer  surveillance  have  led  to  immunotherapy  becoming  an  important  treatment  approach.  Cancer 
immunotherapy began with treatments that nonspecifically activated the immune system and had limited efficacy and/or significant 
toxicity. In contrast, newer immunotherapy treatments activate specific, potent immune cells, leading to improved safety and efficacy. 
Within  the  immunotherapy  category,  treatments  have  included  vaccines,  cytokine  therapies,  antibody  therapies,  and  adoptive  cell 
therapies. 

In  1996,  Dr. Dana  Leach,  Dr. Matthew  Krummel  and  Dr. James  Allison  reported  that  monoclonal  antibodies,  or  mAbs,  blocking 
CTLA-4  could  treat  tumors  in  animal  models.  Subsequently,  mAbs  that  targeted  CTLA-4  and  PD-1  became  known  as  immune 
checkpoint inhibitors, or ICIs. Immune checkpoints are a means by which cancer cells inhibit or turn down the body’s immune response 
to cancer. By interfering with these cloaking mechanisms, ICIs have shown an ability to activate T cells, shrink tumors, and improve 
patient survival. Recent clinical data from checkpoint inhibitors such as ipilimumab, nivolumab and pembrolizumab have confirmed 
both the validity of this approach and the importance of T cells as promising tools for the treatment of cancer. 

Despite these many advances, there persists a significant unmet need in cancer therapeutics. We believe that the use of human cells as 
a  therapeutic  modality  to  re-engage  the  immune  system  will  be  the  next  significant  advancement  in  the  treatment  of  cancer.  These 
cellular therapies may avoid the long-term side effects associated with current treatments and have the potential to be effective regardless 
of the type of previous treatments patients have experienced. 

5 

 
T Cell Therapy Overview 

The field of adoptive cell transfer is currently comprised primarily of CAR and TCR engineered T cells and has emerged from principles 
of basic immunology to become a paradigm-shifting clinical immunotherapy. T cell therapy, we believe has evolved as one of the most 
promising branches of immunotherapy. T cell immunotherapy involves the infusion of T cells into a patient. Immune cells used for 
immunotherapy treatments can either be collected from the patient (autologous) or harvested from a donor (allogeneic). The cells are 
retrieved and either genetically modified to express tumor-specific CARs or TCRs or stimulated with specific antigens. The cells are 
then  cultured  to  proliferate,  and  the  proliferated  cells  are  infused  into  the  patient.  Upon  infusion,  the  cells  can  target  and  eliminate 
cancerous  cells.  Unlike  chemotherapy,  which  is  unable  to  distinguish  between  healthy  and  malignant  cells,  T  cells  produced  for 
immunotherapy can selectively attack cancer cells that express the target antigen(s). This leads to a more effective treatment platform 
with fewer side effects. Some of these infused T cells may remain in the body for long periods, providing immunological memory, thus 
leading to longer and more durable responses. 

TCRs and CARs have distinct signaling properties and antigen sensitivities. TCRs recognize peptide fragments from proteins expressed 
either inside the cell or on the cell surface, which are presented to T cells via major histocompatibility complex molecules. CARs are 
programmed to recognize a specific cell surface protein. Because CARs are specific for a single antigen, or more precisely a single 
epitope within the single antigen, they are very narrowly focused and have limitations. When a CAR-T cell product is applied to a 
specific antigen of a heterogeneous disease, CAR-T cells may leave behind tumor cells that do not express the target antigen, which can 
lead to tumor relapse due to immune escape. 

Our approach is to avoid genetic engineering by relying upon the native T cell receptor, which has evolved over millions of years to 
provide T cells with an exquisite capacity to recognize and kill cancer cells. Use of the native T cell receptor is the bedrock of our 
versatile immunotherapy, which is intended to provide a cost-effective and non-toxic strategy to target multiple tumor antigens and lead 
to durable responses. The process entails expanding tumor-specific T cells from patients (autologous), or a patient’s hematopoietic stem 
cell donor (allogeneic). This is achieved by in vitro manipulation consisting of co-culturing a patient’s or donor’s antigen presenting 
cells with patient (or donor) peripheral blood mononuclear cells, or PBMCs, respectively. As a source of antigen, we use overlapping 
peptide libraries spanning each of several immunogenic target antigens that are typically associated with certain types of cancer. These 
peptides are at least 15 amino acids in length, overlapping by approximately 11 amino acids and span the entire length of each of the 
target  antigens.  This  typical  footprint  of  peptides  allows  us  to  induce  both  CD4+ (helper)  and  CD8+ (cytotoxic)  T  cells.  Following 
manufacture, these cells are frozen and stored for later infusion. Once infused, the natural characteristics of T cells take over and the 
T cells multiply in quantity, forming an army of T cells that kill the targeted cancer cells. 

The MultiTAA-Specific T Cell Therapies 

We are advancing two multiTAA-specific T cell therapies through clinical development: 

•  Autologous  multiTAA-specific  T  cell  therapies –  The  autologous  product  targets  the  NY-ESO-1,  PRAME,  MAGE -  A4, 
Survivin,  WT1  and  SSX2  antigens  (MT-601).  We  recently  reported  updated  clinical  data  from  our  Phase  1  clinical  trial 
investigating MT-601 for the treatment of patients with lymphoma who have relapsed after CAR T therapy. In addition, we 
received an Investigational New Drug (IND) cleared by the U.S. FDA to investigate MT-601 in a Phase 1 trial in patients with 
pancreatic cancer in combination with first-line chemotherapy. 

•  Off-the-Shelf (OTS) multiTAA-specific T cell therapies – The OTS product targets WT1, NY-ESO-1, PRAME, and Survivin 
antigens (MT-401-OTS). We plan to enroll patients that will be matched to the pre-manufactured inventory of MT - 401 - OTS 
products based on their human leukocyte antigen, or HLA. Because the MT-401-OTS product inventory is pre-manufactured, 
the T cell product is delivered to the patient in a significantly shorter amount of time than a patient-specific T cell product. 

While the blood source and the antigens for stimulation differ between the autologous and OTS therapies, the manufacturing process 
for each product is identical. 

6 

Cancers  are  heterogeneous  in  their  expression  of  antigens.  Tumors  generally  consist  of  individual  cancer  cells  expressing  different 
antigens, and each of those antigens can be present at a different level that can change over time. Therapies targeting only a single 
antigen are vulnerable to evolutionary escape mechanisms. 

While single-antigen specific therapies can eliminate all the tumor cells expressing the targeted antigen, the residual tumor cells that do 
not express that antigen may survive and expand. In addition, tumor cells may also downregulate or mutate the targeted antigen, thus 
becoming invisible to the T cell therapy. Both phenomena create a transformed tumor that is impervious to that therapy. This process is 
referred to as antigen-negative tumor escape. 

Our solution to the problem of tumor heterogeneity is the development of T cell products that are intended to simultaneously attack 
multiple  tumor-expressed  antigens  and  thereby  enable  more  complete  initial  tumor  targeting,  thus  minimizing  the  subsequent 
opportunity for the cancer to engage escape mechanisms. 

We believe our proprietary multiTAA-specific T cell platform may have meaningful advantages over current CAR and TCR-engineered 
cell  therapy  approaches.  Compared  to  current  gene-modified  T  cell  therapies,  the  multiTAA-specific  T  cell  product  candidates  are 
characterized by the following: 

•    Clinical benefits observed in early-stage clinical trials in multiple cancer indications. 

Based on our observations in clinical trials in AML, pancreatic cancer, lymphoma, ALL and MM, we believe that the multiTAA-specific 
T cell therapies have the potential to mediate a meaningful anti-tumor effect, as well as significant in vivo expansion of T cells. For 
example, in BCM’s Phase 1 clinical trial in lymphoma, there were complete responses, or CRs, in six of the fifteen evaluable patients 
with both Hodgkin lymphoma and non-Hodgkin lymphoma with active disease. Significantly, no patient with a CR has subsequently 

7 

 
 
 
 
 
 
relapsed with disease, whereas typically 30% or more of patients with CR in reported CAR-T studies relapse within one year. In patient 
results to date in this trial, observed therapeutic responses appear to be highly durable, with some patients being relapse-free beyond 
five years. In 2023, Marker treated the first patient in the Phase 1 APOLLO trial investigating the safety and efficacy of MT-601 in 
patients  with  lymphoma.  Marker  recently  reported  that  the  first  patient  treated  in  this  Phase  1  study  achieved  a  complete  response 
8 weeks after the second dose of MT-601 and that the patient maintained complete response to treatment 6 months after initial infusion 
with MT - 601. 

•    Non-genetically modified T cells. 

Unlike CAR and TCR-based approaches, the multiTAA-specific T cell therapy does not require genetic modification of T cells, a costly 
and complex process that significantly complicates the manufacturing of a patient product. We believe our multiTAA-specific T cell 
therapy represent a safe alternative to CAR-T cells and can be manufactured at a fraction of the cost of a gene-modified T cell product, 
with substantially reduced complexity of manufacturing. 

•    Low incidence rate of adverse events. 

As  of  January 2024,  the  multiTAA-specific  T  cell  therapy  was  generally  well  tolerated  by  the  patients  across  clinical  trials  in 
hematological and solid tumor indications, and no treatment-related adverse events, including CRS or neurotoxicity, were attributed to 
the use of multiTAA-specific T cell therapies to date. This appears to compare favorably with published CD19 CAR-T studies that have 
been associated with substantial tolerability concerns, including a Phase 1 trial in which 95% of patients had Grade 3 or higher adverse 
events during treatment and current investigations by the FDA regarding the risk of CAR-T cell therapies to potentially induce secondary 
cancers. 

•    Capable of addressing a broad repertoire of cancer cells. 

While CAR-T and TCR therapies generally target a single epitope, our manufacturing process selects for T cells that are specific for 
multiple peptides derived from several targeted antigens. Deep gene sequencing of our products shows that a typical patient dose usually 
consists of approximately 4,000 unique T cell clonotypes, some of which target up to six different tumor-associated antigens. The six 
antigen targets can be recognized by a very wide range of T cells, which we believe facilitates robust killing of targeted cancer cells. 

Clinical Development of Our multiTAA-Specific T Cell Therapies by BCM 

The  following  clinical  trials  were  conducted  by  BCM  pursuant  to  our  strategic  alliance.  In  each  trial,  correlative  studies  showed 
significant expansion of multiTAA-specific T cells, as well as evidence of epitope spreading against tumor-associated antigens that were 
not targeted by the multiTAA-specific T cell therapy. 

8 

Acute Myeloid Leukemia 

To  date,  available  treatments  for  post-transplant  AML  patients  are  limited  and  include  donor  lymphocyte  infusion,  which  has  an 
approximately  15%  overall  response  rate  but  a  30%  to  50%  risk  of  severe  and  debilitating  graft-versus-host  disease.  The  five-year 
mortality rate for patients who receive an allogeneic HSCT exceeds 50%, and patients who relapse after a transplant have a survival 
expectation of approximately 4.5 months.  

BCM recently completed a Phase 1 AML/MDS clinical trial of the multiTAA-specific T cell therapy for the treatment of patients with 
post-transplant AML. In this trial, patients in remission with high risk for relapse, as well as patients with active disease post-transplant 
were treated. As reported in a 2021 publication by Lulla et al., 11 of the 17 patients in the adjuvant disease setting dosed with the 
multiTAA-specific T cell therapy after receiving an allogeneic HSCT did not relapse during the follow-up period of the study [median 
LFS  not  reached  at  a  median  follow-up  of  1.9  years],  with  11  of  15  patients  (two  patients  were  each  treated  during  two  different 
remissions)  remaining  alive  (estimated  two-year  overall  survival  of  77%)  at  a  median  follow-up  of  1.9  years  post-infusion  which 
compares favorably with HSCT outcomes for risk-matched AML/MDS patients post-HSCT [median LFS of nine to 15 months and two-
year survival probability of 42%]. 

Additionally, eight patients were treated for active disease that was resistant to salvage therapy post-HSCT with a median of five prior 
lines of therapy (range: four to ten). One of the eight patients crossed over from the adjuvant group while two patients enrolled twice, 
but all three patients had active AML that failed another line of salvage therapy after their first multiTAA-specific T cell infusion. Two 
of the eight patients achieved objective responses with one complete response and one partial response, with six patients continuing 
with stable disease. 

In this trial, the multiTAA-specific T cell therapy was well tolerated, with no drug-related serious adverse events and no instances of 
greater than Grade 2 acute graft-versus-host disease or moderate-severe chronic GVHD. The maximum grade treatment-related adverse 
event was seen in one patient in the adjuvant disease group who had a possibly drug-related Grade 3 elevation of liver enzymes but was 
treated with prednisone with complete resolution. After discontinuing treatment and receiving decitabine, the patient relapsed and later 
re-enrolled in the trial in the active disease group and entered CR for 13 months and survived for 2.5 years. 

Pancreatic Cancer 

In May 2020, we reported interim data from an ongoing Phase 1/2 clinical trial of the multiTAA-specific T cell therapy for the treatment 
of pancreatic adenocarcinoma being conducted by BCM. In 2020, we reported that in this trial, BCM administered multiTAA-specific 
T cells to a total of 31 patients with advanced or borderline resectable pancreatic adenocarcinoma in three arms: 13 patients in Arm A, 
which included patients with unresectable/metastatic disease who were responding to standard first-line chemotherapy; 12 patients in 
Arm B, which included patients with progressive disease or therapy intolerance; and eight patients in Arm C, which includes patients 
with surgically resectable disease.  

Overall, we have observed a clinical benefit correlated with the detection of tumor-reactive T cells in patient peripheral blood (Arms A, 
B and C) and within tumor biopsy samples (Arm C) post-infusion. No cytokine release syndrome or neurotoxicity has been observed in 
any arm of the trial to date. 

9 

 
 
 
Arm A was designed to evaluate the safety and potential efficacy of using multiTAA-specific T cell therapy as part of first-line treatment 
for patients with pancreatic cancer. These patients in the chemo-responsive arm have completed at least three months of standard-of-
care chemotherapy (gemcitabine/nab-paclitaxel or FOLFIRINOX), which is the period during which a response to chemotherapy would 
typically occur, before receiving up to six administrations of multiTAA-specific T cell therapy in conjunction with chemotherapy.  

•  Out of the 13 evaluable patients (best overall response): 

o 

four patients experienced objective responses after administration of multiTAA-specific T cells; 

o  one patient experienced a radiographic complete response occurring at month nine after starting chemotherapy; 

o 

o 

three patients experienced partial responses per RECIST occurring at six-nine months after starting chemotherapy; 

six patients experienced stable disease; 

o  one patient experienced a mixed response. 

•  Patients had durable cancer control with nine of the 13 patients exceeding historical control of overall survival; 

•  Five patients enrolled in the study were not administered multiTAA-specific T cells, either because of disease progression (four 
patients) which made them ineligible for treatment, or because insufficient starting material from the patient was available for 
manufacturing (one patient); 

•  Evidence of epitope-spreading was observed in all responders, suggesting that the multiTAA-specific T cell therapy triggered 

the recruitment of a broader endogenous immune system response for improved anti-tumor activity; 

•  No infusion-related reactions, cytokine release syndrome or neurotoxicity was observed; 

In patients responding to therapy, significant expansion of the infused multiTAA-specific T cell therapy was observed. 

10 

Lymphoma 

BCM evaluated the multiTAA-specific T cell therapy (5 TAA product) in a Phase 1 clinical trial for the treatment of patients with 
lymphoma. A total of 32 patients received two protocol-specified infusions of multiTAA-specific T cells, 14 with Hodgkin lymphoma, 
or  HL,  and  18  with  aggressive  non-Hodgkin  lymphoma,  or  NHL,  [diffuse  large  B-cell  lymphoma,  or  DLBCL,  (n=12),  mantle  cell 
lymphoma, or MCL, (n=2), T-cell lymphoma (n=3) and composite lymphoma (HL and DLBCL, n=1)].    

As reported in a recent publication by Vasileiou et al., BCM had treated 15 patients with active disease (active lymphoma group), all of 
whom had completed a follow-up period beyond three months post-infusion. These patients were heavily pre-treated and had failed a 
median of five prior lines of therapy (range four to eight) for the HL patients and a median of three prior lines of therapy (range three to 
four) for the NHL patients. As illustrated below, in the active lymphoma group, six patients entered CR and nine patients had experienced 
stable disease. None of the patients in CR had relapsed, and the range for the duration of CR in these patients was between two and over 
five years after being infused with the multiTAA-specific T cell therapy with the exception of one patient who died of an unrelated 
pneumonia while in a CR. Responses in all six patients who entered CR were associated with an expansion of infused T cells, as well 
as induction of broad-based antigen spreading across many tumor-associated antigens. 

11 

 
 
 
BCM also treated 17 patients, including one patient who was treated a second time after a relapse, in remission (adjuvant lymphoma 
group). Like the active lymphoma group, these patients were heavily pre-treated with seven patients with HL treated with a median of 
4 prior lines of therapy (range three to five) and 10 patients with NHL with a median of three prior lines of therapy (range one to five). 
As illustrated below, in the adjuvant lymphoma group, all 17 patients had entered CR, with 14 patients in continued complete remission, 
or CCR, without relapsing. The duration of response ranged from approximately nine months to over five years. 

In both treatment groups, the multiTAA-specific T cell therapy was well tolerated, with no drug-related serious adverse events. 

Process Development and Manufacturing of the MultiTAA-Specific T Cell Therapies 

In the manufacturing process, blood is drawn from either the individual patient (in the case of the autologous T cells) or from a healthy 
donors/commercially  available  leukapheresis  material  (in  the  case  of  the OTS program).  Although  the  T  cells  that  are  selected  and 
expanded by our process exist in a patient’s circulating blood, these T cells are often present at very low frequencies. Researchers at 
BCM believe that these T cells are adversely affected by the suppressive tumor microenvironment. It is a well-accepted concept that 
cancers not only evade immune detection but often actively suppress the function of the human immune system. Our manufacturing and 
culturing process is intended to (1) identify the T cells specific for the antigens that we intend to target, (2) restore these T cells to 
functionality with respect to their anti-tumor capability and (3) expand the population of those T cells specific for our targets to achieve 
the required patient dose. 

After blood is drawn, PBMCs are isolated and used to manufacture a patient-specific product. These cells are placed inside a G-Rex 
manufacturing device and combined with an experimentally optimized mix of GMP-grade cytokines that is used to restore and enhance 
the functional capability of the cultured T cells. In addition, libraries of overlapping peptides, which we refer to as peptide pools, are 
added  to  the  cell  culture.  Each  peptide  within  a  peptide  pool  represents  a  small  segment  of  a  target  antigen,  which  a  T  cell  might 
recognize. Each library represents the entire protein sequence of a target antigen, with each peptide overlapping significantly with the 
peptides adjacent to it within the antigen’s protein sequence. This overlapping structure allows us to isolate, activate and expand any 
T cell that is specific for any segment of the antigens that we target in the unique genetic background of every patient. 

12 

 
 
 
The  G-Rex  is  a  cell  culture  device  manufactured  by  Wilson  Wolf  Manufacturing  Corporation,  or  Wilson  Wolf,  used  by  many  cell 
therapy developers, both in commercial and academic settings. The device allows a user to introduce cells, medium and other reagents 
into a cell culture chamber, which has a gas-permeable membrane at its bottom. The cells settle on this gas-permeable membrane through 
which oxygen and carbon dioxide are exchanged (i.e. the cells can breathe at the base of the device), while nutrients required for cell 
expansion are obtained from the medium above the cells. This system allows for the highly robust growth of cells in culture, by providing 
them with superior access to oxygen and nutrients. Cells manufactured in the device grow efficiently without need for agitation by a 
technician, scientist or automated system. 

Inside the G-Rex, PBMCs, including T cells and antigen-presenting cells, are exposed to the stimulating peptide pools. This results in 
the selective expansion of T cells that specifically recognize the target antigens. At the end of the manufacturing process, the resulting 
product is a mix of helper (CD4+) and cytotoxic (CD8+) T cells that recognize the targeted antigens. 

Once cell manufacturing is complete, the product is tested for identity, sterility, phenotype and functionality before it is released for 
infusion into a patient. Sampling of product indicates that, on average, approximately 4,000 different T cell clonotypes are present in a 
typical 5-antigen-specific patient product. 

Upon release of the final patient product, the cells are frozen and transported to the site where the cells will be administered. The standard 
dose for patients with lymphoma ranges from 100 to 400 million cells per adult patient. 

Manufacturing 

The manufacturing process was originally developed at Baylor College of Medicine, where we also conducted our clinical trials. In 
2021, we validated an additional manufacturing site (now Cell Ready) for our multiTAA-specific T cell products. 

On June 26, 2023, we completed the transaction with Cell Ready, LLC, or Cell Ready, pursuant to a Purchase Agreement, or the Cell 
Ready Purchase Agreement, dated May 1, 2023, by and between us and Cell Ready. Pursuant to the Cell Ready Purchase Agreement, 
effective as of the Closing Date, we (i) assigned to Cell Ready the leases for our two manufacturing facilities in Houston, Texas, or the 
Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at the Manufacturing Facilities and 
(iii)  assigned  to  Cell  Ready  our  rights,  title  and  interest  in  any  contracts  related  to  the  equipment  and  Manufacturing  Facilities 
(collectively referred to as the “Purchased Assets”). Cell Ready acquired the Purchased Assets for total consideration of $19.0 million.  

On February 22, 2024, we entered into a Master Services Agreement for Product Supply, or MSA, with Cell Ready. Cell Ready, which 
is owned by one of our directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO). 
Under the MSA, it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and 
manufacturing in support of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of 
various products and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of 
product, Cell Ready is required to supply such product in conformance with the product requirements set forth in the applicable work 
order(s).  Under  the  MSA,  Cell  Ready  is  to  use  only  personnel  with  sufficient  qualifications  and  experience  to  supply  the  services 
contemplated by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance 
with the MSA. Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to 
obtain and maintain all necessary regulatory approvals, at the Company’s expense. 

13 

Competition 

We face competition from numerous pharmaceutical and biotechnology companies, as well as from academic institutions, private and 
public research institutions, and government agencies. Treatment of relapsed patients with lymphoma remains a challenge with relatively 
low overall survival rates. To date, there are four CD19-directed CAR T cell therapies (Yescarta, Kymriah, Tecartus, and Bryanzi) 
approved for patients with relapsed lymphoma. However, up to 60% of CD19 CAR T cell treated patients will relapse, particularly in 
the third line setting (Chong EA et al, N Engl J Med, 2021). This highlights a significant unmet medical need for alternative and more 
effective treatments. Our multiTAA-specific T cell drug candidates may compete with product candidates from a number of companies, 
which are developing various types of immunotherapies to treat cancer, including non-CD19 targeting CAR T cells that target different 
antigens beyond CD19, multi-targeted CAR T cells as well as NK-CAR therapies. In addition, bispecific antibodies represent promising 
therapies for patients with lymphoma and provide competition in the oncology space. To date, MT-601 is the only natural T cell product 
that targets multiple tumor antigens being explored for CAR relapse patients with lymphoma. Therefore, MT-601 fills a void in the 
market by providing much needed treatment option to the lymphoma patient population.  

We  believe  that  our  non-engineered  T  cell  therapy  approaches  will  be  synergistic  and  may  improve  therapies  being  developed  by 
potential competitors. Many companies and institutions, either alone or together with their collaborative partners, have substantially 
greater financial, technical and human resources, and significantly greater experience than we do in the following: 

• 

• 

• 

• 

drug discovery; 

developing products; 

undertaking preclinical testing and clinical trials; 

obtaining FDA and other regulatory approvals of products; and 

•  manufacturing, marketing, distributing and selling products. 

Accordingly,  our  competitors  may  succeed  in  obtaining  patent  protection,  receiving  FDA  and  other  regulatory  approval  or 
commercializing products that compete with our drug candidates. 

In addition, any drug candidate that we successfully develop may compete with existing therapies that have long histories of safe and 
effective use. Competition may also arise from: 

• 

• 

• 

other drug development technologies and methods of preventing or reducing the incidence of disease; 

new small molecules; and/ or 

other classes of therapeutic agents. 

We  face,  and  will  continue  to  face,  competition  from  other  companies  for  collaborative  arrangements  with  pharmaceutical  and 
biotechnology companies, for establishing relationships with academic and research institutions and for licenses to drug candidates or 
proprietary technology. These competitors, either alone or with their collaborative partners, may succeed in developing products that 
are more effective than ours. 

Our ability to compete successfully will depend, in part, on our ability to: 

• 

• 

• 

develop proprietary products; 

develop and maintain products that reach the market first, are technologically superior to and/or are of lower cost than other 
products in the market; 

attract and retain scientific, product development and sales and marketing personnel; 

14 

• 

• 

obtain patent or other proprietary protection for our products and technologies; 

obtain required regulatory approvals; and 

•  manufacture, market, distribute and sell any products that we develop. 

In  a  number  of  countries,  including  in  particular,  developing  countries,  government  officials  and  other  groups  have  suggested  that 
pharmaceutical companies should make drugs available at a low cost. In some cases, governmental authorities have indicated that where 
pharmaceutical  companies  do  not  do  so,  their  patents  might  not  be  enforceable  to  prevent  generic  competition.  Some  major 
pharmaceutical companies have greatly reduced prices for their drugs in certain developing countries. If certain countries do not permit 
enforcement of any of our patents, sales of our products in those countries, and in other countries could be reduced by generic competition 
or by parallel importation of our product. Alternatively, governments in those countries could require that we grant compulsory licenses 
to allow competitors to manufacture and sell their own versions of our products in those countries, thereby reducing our product sales, 
or we could respond to governmental concerns by reducing prices for our products. In all these situations, our results of operations could 
be adversely affected. 

BCM Exclusive License Agreement 

On March 16, 2018, we entered into an exclusive license agreement, or the BCM License Agreement, with BCM, under which we 
received  a  worldwide,  exclusive  license  to  BCM’s  rights  in  and  to  certain  intellectual  property  rights,  including  European  patent 
EP 2470644 (estimated expiration date August 24, 2030), to develop and commercialize multiTAA-specific T cell product candidates. 

Exclusive License to BCM’s Subject Technology: 

1. “Generation of CTL Lines with Specificity Against Multiple Tumor Antigens or Multiple Viruses” 

2. “Pepmixes to Generate Multiviral CTLs with Broad Specificity” 

3. “Immunogenic Antigen Identification from a Pathogen and Correlation to Clinical Efficacy” 

4. “T cell performance assay as a prognostic factor for clinical outcome” 

In partial consideration for the exclusive rights granted under the BCM License Agreement, Marker Cell Therapy, Inc., an entity that is 
now our wholly owned  subsidiary,  issued  shares  of  its  common stock  to  BCM  valued  at  approximately  $5.0 million  at  the  time  of 
issuance. Such initial equity issuance was exchanged into merger consideration of 149,081 shares of our common stock and warrants to 
acquire 54,064 shares of our common stock in connection with the merger we completed in October 2018, each as adjusted to reflect 
the reverse stock split that we effected in January 2023. Additional consideration includes a royalty paid on net sales by us to BCM 
according to the royalty schedule in the BCM License Agreement. The royalty fee schedule is based on aggregate net sales in four 
different ranges: (1) less than $500 million, (2) $500 million to $1.0 billion, (3) $1.0 billion and over, and (4) $2.0 billion and over. The 
corresponding royalty percentages range from 0.65% to 5.0% - increasing in proportion to the aggregate net sales. The royalty fee may 
be reduced in the event that we must pay additional royalties with respect to third-party owned patent rights or technology necessary for 
the  use, manufacture or  sale of a  licensed product. We  also  agreed  to pay  BCM  up  to an  aggregate  of  $64.85  million  in milestone 
payments upon the occurrence of nine particular milestones relating to completion of the first dosing in clinical trials for a first and 
second distinct product, receipt of approval from the FDA and the achievement of certain net sales goals. We are also responsible for 
sublicensing fees. In addition, under the BCM License Agreement, we are responsible for reimbursing BCM for patent-related expenses. 
BCM is responsible for filing, prosecuting and maintaining all patent applications and patents included in the licensed patent rights, and 
we have agreed to reimburse BCM for all such related legal costs incurred after the date of the BCM License Agreement, except such 
legal  costs  shall  be  reduced  on  a  pro-rata  basis  on  a  patent  or  patent  application  basis  should  BCM  license  such  patent  or  patent 
application in additional fields of use to any third party. 

In addition, upon a liquidity event (as defined in the BCM License Agreement) of the Company, BCM will receive a liquidity incentive 
payment of 0.5% of the liquidity event proceeds (as defined in the BCM License Agreement). 

15 

We have agreed to indemnify BCM and certain persons affiliated with BCM against claims and liabilities directly or indirectly related 
to or arising out of the design, process, manufacture or use by any third party of the licensed products, even though such claims and 
liabilities result in whole or in part from the negligence of the BCM indemnified parties or are based upon doctrines of strict liability or 
product liability, but not claims or liabilities arising from the gross negligence or intentional misconduct of any such BCM indemnified 
parties. 

Unless  terminated  sooner,  the  license  will  expire  on  a  licensed  product-by-product  basis  and  country-by-country  basis,  on  the  later 
of (1) the date of expiration of the last valid claim of patent rights to expire that covers the sale of such licensed product in such country, 
or (2) the first date following the tenth anniversary of the first commercial sale of first licensed product by us in such country. After 
such expiration, but not termination, the licenses granted to us shall survive and become a perpetual, paid-in-full license in such country 
with respect to such licensed product. 

We have the right in our sole discretion to terminate the BCM License Agreement upon 60 days’ written notice to BCM. BCM has the 
right to terminate the agreement upon material default or failure of us of our overall obligation to perform any of the terms, covenants 
or provisions of the license agreement, including failure to make timely payment, taken as a whole, and which default or failure remains 
uncured thirty days after written notice from BCM of such material default or failure to correct such default or failure. Notwithstanding 
the foregoing, if a material default or failure is not susceptible to cure within the 30-day cure period, BCM’s right to terminate shall be 
suspended if, and for so long as, (1) we have provided BCM with a written plan that is reasonably calculated to effect a cure, (2) such 
plan is reasonably acceptable to BCM, in its sole but reasonable discretion, and (3) we commit to and do carry out such plan; provided, 
however, that, unless mutually agreed to by the parties in such plan, such suspension of BCM’s right to terminate shall not extend 
beyond 60 days after the original cure period. In addition, either party’s right to terminate the license agreement shall be tolled for so 
long as dispute resolution procedures are being pursued by the allegedly breaching party in good faith, and if it is finally and conclusively 
determined that the allegedly breaching party is in material breach, then the breaching party shall have the right to cure within 30 days 
after such determination. BCM also has the right to terminate the agreement if we shall (1) become involved in insolvency, dissolution, 
bankruptcy or receivership proceedings affecting the operation of our business, (2) make an assignment of all or substantially all of our 
assets for the benefit of creditors, or (3) if a receiver or trustee is appointed for us and we, after the expiration of 30 days following any 
of the enumerated events, are unable to secure a dismissal, stay or other suspension of such proceedings. 

In the event of termination of the BCM License Agreement, but not expiration, all rights to the subject technology and patent rights 
thereunder shall revert to BCM, except to the extent necessary to exercise any surviving right or license thereunder. We may sell any 
licensed products actually in our possession at the effective date of termination, provided that we continue to pay to BCM royalties on 
all such sales in accordance with the license agreement, otherwise comply with the terms of the license agreement and sell all such 
licensed products within six months after the effective date of the termination. 

In  furtherance  of  the  BCM  License  Agreement  and  as  contemplated  by  the  terms  thereof,  we  entered  into  a  Sponsored  Research 
Agreement, or the SRA, with BCM, which provides for the conduct of research for us by credentialed personnel at BCM’s Center for 
Cell and Gene Therapy. 

We have entered into additional agreements with BCM with respect to a strategic alliance to advance pre-clinical research, early-stage 
clinical trials, and Phase 2 clinical trials with respect to our product candidates, as well as continued access to our clinical data, and 
product manufacturing and support, including personnel and space at the institution for the foreseeable future. 

Intellectual Property 

Our  commercial  success  will  depend  in  part  on  our  ability  to  obtain  and  maintain  patent  and  other  proprietary  protection  for  our 
technology, inventions, improvements, and know-how related to the business; to defend and enforce proprietary rights, including any 
patents that we may own in the future; to preserve the confidentiality of our trade secrets and other intellectual property; to obtain and 
maintain licenses to use intellectual property owned by third parties; and to operate without infringing valid and enforceable patents and 
other proprietary rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell, or importing our 
products  may  depend  on  the  extent  to  which  we  have  rights  under  valid  and  enforceable  patents  or  trade  secrets  that  cover  these 
activities — for  example,  the  rights  obtained  under  exclusive  license  arrangements  such  as  those  pursuant  to  our  BCM  License 
Agreement. With respect to both licensed and company-owned intellectual property, we cannot be sure that patents will be granted with 
respect to any of our pending patent applications or with respect to any patent applications filed in the future, nor can we be sure that 

16 

any of our existing patents or any patents that may be granted in the future will be commercially useful in protecting our commercial 
products and methods of manufacturing the same. 

To achieve this objective, a strategic focus for us has been identifying and licensing key patents and patent applications that serve to 
enhance our intellectual property and technology position. Currently, all of our multiTAA-specific T cell intellectual property rights are 
licensed from BCM. Our intellectual property portfolio currently includes patent applications having: (1) claims directed to methods of 
generating  multi-antigen  specific  T  cell  products;  and  (2) claims  directed  to  therapeutic  uses  of  such  multi-antigen  specific  T  cell 
products. We believe our patent portfolio, together with our efforts to develop and patent next-generation technologies, provides us with 
a substantial intellectual property position. However, the area of patent and other intellectual property rights in biotechnology is an 
evolving one with many risks and uncertainties. 

Patents 

Patents and other proprietary rights are vital to our business operations. We protect our technology through various United States and 
foreign patent filings and maintain trade secrets that we own. Our policy is to seek appropriate patent protection both in the United States 
and abroad for our proprietary technologies and product candidates. An enforceable patent with appropriate claim coverage can provide 
an  advantage  over  competitors  who  may  seek  to  employ  similar  approaches  to  develop  therapeutics,  and  so  the  future  commercial 
success of products, and therefore our future success, will be in part dependent on our intellectual property strategy. We reassess the 
value of each patent at the time maintenance fees are due, and in cases where maintaining the patent is judged to be of no significant 
strategic value, we decline to pay the maintenance fee. 

There can be no assurance that our patents, and any patents that may be issued, assigned, or licensed to us in the future, will afford 
protection against competitors with similar technology. In addition, no assurances can be given that any patents issued, assigned, or 
licensed to us will not be infringed upon or designed around by others or that others will not obtain patents that we would need to license 
or design around. If existing or future patents held by third parties and containing broad claims over technology used by us were upheld 
by  a  court  or  other  authority  of  competent  jurisdiction,  the  holders  of  such  patents  could  require  us  to  obtain  licenses  to  use  such 
technology.  

Patent coverage may also vary from country to country based on the scope of available patent protection. Moreover, in the United States, 
patent term may be adjusted to account for delays by the United States Patent and Trademark Office, or USPTO, during prosecution. 
There are also opportunities to obtain an extension of term for patents covering a product in certain jurisdictions, which adds further 
complexity to the determination of patent life. 

The effect of the issued United States patents is that they provide us with patent protection for the claims covered by the patents. While 
the  expiration  of  a  product  patent  normally  results  in  a  loss  of  market  exclusivity  for  the  covered  product  or  product  candidate, 
commercial benefits may continue to be derived from , for example: (1) later- expiring patents on processes and intermediates related 
to improved methods of manufacture of the active ingredient of such product; (2) patents relating to the use of such product; (3) patents 
relating  to  novel  compositions  and  formulations;  and  (4) in  the  United  States  and  certain  other  countries,  other  types  of  market 
exclusivity that may be available under relevant law. The effect of patent expiration on our product candidates also depends upon many 
other  factors  such  as  the  nature of  the  market  and  the  position  of  the  product  in  it,  the  growth  of  the  market,  the complexities  and 
economics of the process for manufacture of the active ingredient of the product and the requirements of new drug provisions of the 
Federal Food, Drug and Cosmetic Act or similar laws and regulations in other countries. 

17 

Our pending patent applications cover a range of technologies, including specific embodiments and applications for treatment of various 
medical indications, improved application methods and adjunctive utilization with other therapeutic modalities. The coverage claimed 
in a patent application can be significantly reduced before the patent is issued. Accordingly, we do not know whether any of the patent 
applications we own, will acquire, license, or will license will issue as patents, or, if any patents are issued, whether they will provide 
significant  proprietary protection or will  be  challenged,  circumvented or  invalidated.  Because unissued  U.S.  patent applications  are 
maintained in secrecy for a period of eighteen months and U.S. patent applications filed prior to November 29, 2000 are not disclosed 
until such patents are issued, and since publication of discoveries/inventions in the scientific or patent literature often lags behind actual 
discovery/invention, we cannot be certain of the priority of inventions covered by pending patent applications and whether potentially 
relevant earlier patent filings exist. Moreover, we may have to participate in opposition proceedings in a foreign patent office, or for 
United States patent applications filed before March 16, 2013, in interference proceedings declared by the USPTO, to determine priority 
of invention, or in United States inter partes review or post-grant review procedures, any of which could result in substantial cost to us, 
even if the eventual outcome is favorable to us. There can be no assurance that the patents, if issued, would be held valid by a court or 
other authority of competent jurisdiction. An adverse outcome could subject us to significant liabilities to third parties, require disputed 
rights to be licensed from third parties, or require us to cease using such technology. 

We have patents and patent applications in other countries, as well as in the European Patent Office, that we believe provide equivalent 
or  comparable  protection for  our  product  candidates  in  jurisdictions  internationally  that  we  consider to  be key  markets.  Because of 
differences in patent laws and laws concerning proprietary rights, the extent of protection provided by U.S. patents or proprietary rights 
owned by us may differ from that of their foreign counterparts. 

Trade Secrets 

We also rely on trade secrets and know-how relating to our proprietary technology and product candidates, continuing innovation, and 
in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of immuno-oncology. However, trade 
secrets  can  be  difficult  to  protect.  We  also  plan  to  rely  on  regulatory  protection  afforded  through  orphan  drug  designations,  data 
exclusivity, market exclusivity and patent term extensions when available, as well as contractual agreements with our academic and 
commercial partners. 

We require each of our employees, consultants and advisors to execute a confidentiality agreement upon the commencement of any 
employment, consulting or advisory relationship with us. Each agreement provides that all confidential information developed or made 
known to the individual during the course of the relationship will be kept confidential and not be disclosed to third parties except in 
specified circumstances. In the case of employees, the agreements provide that all inventions conceived by an employee shall be our 
exclusive property. 

Trademarks 

We currently have pending with the USPTO applications for registration of the trademarks “Marker Therapeutics.” We also have rights 
to use other names essential to our business. Federally registered trademarks have a perpetual life if they are maintained and renewed 
on a timely basis and used properly as trademarks, subject to the rights of third parties to seek cancellation of the trademarks if they 
claim priority or confusion of usage. We regard our trademarks and other proprietary rights as valuable assets and believe they have 
significant value to us. 

We  believe  that  our  patents,  the  protection  of  discoveries  in  connection  with  our  development  activities,  our  proprietary  products, 
technologies, processes and know-how and all our intellectual property are important to our business. There can be no assurance that 
any of our patents, licenses or other intellectual property rights will afford us any protection from competition. 

Government Regulation 

The FDA and other regulatory authorities at federal, state, and local levels, as well as in foreign countries, extensively regulate, among 
other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, 
storage,  distribution,  record  keeping,  approval,  advertising,  promotion,  marketing,  post-approval  monitoring,  and  post-approval 
reporting of biologics such as those we are developing. We, along with third-party contractors, will be required to navigate the various 
preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to 
conduct studies or seek approval or licensure of our product candidates. 

18 

The  process  required  by  the  FDA  before  biologic  product  candidates  may  be  marketed  in  the  United  States  generally  involves  the 
following: 

• 

• 

• 

• 

• 

• 

• 

• 

completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s current Good Laboratory 
Practices, or GLP, regulation; 

submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually 
or when significant changes are made; 

approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is 
commenced; 

performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed 
biologic product candidate for its intended purpose; 

preparation of and submission to the FDA of a biologics license application, or BLA, after completion of all pivotal clinical 
trials; 

a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; 

satisfactory completion of an FDA Advisory Committee review, if applicable; 

satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed 
product is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to 
preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess 
compliance with Good Clinical Practices, or GCP; and 

•  FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the 

United States. 

19 

Preclinical and Clinical Development 

Prior  to  beginning  the  first  clinical  trial  with  a  product  candidate,  we  must  submit  an  IND  to  the  FDA.  An  IND  is  a  request  for 
authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on 
the general investigational plan and the protocol(s) for clinical studies. The IND also includes results of animal and in vitro studies 
assessing  the  toxicology,  pharmacokinetics,  pharmacology,  and  pharmacodynamic  characteristics  of  the  product;  chemistry, 
manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. 
An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt 
by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such 
a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions 
before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial. 
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators 
in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation 
in  any  clinical  study.  Clinical  trials  are  conducted  under  protocols  detailing,  among  other  things,  the  objectives  of  the  study,  the 
parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must 
be  made  for  each  successive  clinical  trial  conducted  during  product  development  and  for  any  subsequent  protocol  amendments. 
Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical 
trial and its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory 
authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are 
being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also include oversight 
by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board, which 
provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the 
study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no 
demonstration of efficacy. There are also requirements governing the reporting of ongoing clinical studies and clinical study results to 
public registries. 

For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap. 

•  Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or 
condition.  These  studies  are  designed  to  test  the  safety,  dosage  tolerance,  absorption,  metabolism  and  distribution  of  the 
investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on 
effectiveness. 

•  Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to 
evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety 
risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive 
Phase 3 clinical trials. 

•  Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, to provide 
statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed 
clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and 
to provide an adequate basis for product approval. 

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain 
more information about the product. These so- called Phase 4 studies may be made a condition to approval of the BLA. Concurrent with 
clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics 
of the product candidate and must 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 and purity of the final product, or for biologics, the safety, 
purity  and  potency.  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. 

20 

BLA Submission and Review 

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product 
development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product 
for one or more indications. The BLA must include all relevant data available from pertinent preclinical and clinical studies, 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.  The  submission  of  a  BLA  requires  payment  of  a  substantial 
application user fee to FDA, unless a waiver or exemption applies. 

Once a BLA has been submitted, the FDA’s goal is to review standard applications within ten months after it accepts the application for 
filing, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard 
and priority reviews, the review process is often significantly extended by FDA requests for additional information or clarification. The 
FDA  reviews  a  BLA  to  determine,  among  other  things,  whether  a  product  is  safe,  pure  and  potent  and  the  facility  in  which  it  is 
manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency. The 
FDA may convene an advisory committee to provide clinical insight on application review questions. Before approving a BLA, the 
FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application 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 a BLA, the FDA will typically inspect 
one  or  more  clinical  sites  to  assure  compliance  with  GCP.  If  the  FDA  determines  that  the  application,  manufacturing  process  or 
manufacturing facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or 
information.  Notwithstanding  the  submission  of  any  requested  additional  information,  the  FDA  ultimately  may  decide  that  the 
application does not satisfy the regulatory criteria for approval. 

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug 
substance  will  be  produced,  the  FDA  may  issue  an  approval  letter  or  a  Complete  Response  letter.  An  approval  letter  authorizes 
commercial marketing of the product with specific prescribing information for specific indications. A Complete Response letter will 
describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting 
the application are inadequate to support approval, the FDA may issue the Complete Response letter without first conducting required 
inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the Complete Response letter, the FDA may 
recommend  actions  that  the  applicant  might  take  to  place  the  BLA  in  condition  for  approval,  including  requests  for  additional 
information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require 
additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product. 

If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the 
indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and 
Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a known 
or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their 
safe  use,  and  could  include  medication  guides,  physician  communication  plans,  or  elements  to  assure  safe  use,  such  as  restricted 
distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, 
changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the 
product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product 
reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor 
the product’s safety and effectiveness after commercialization and may limit further marketing of the product based on the results of 
these post-marketing studies. 

21 

Expedited Development and Review Programs 

The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast-track program is 
intended to expedite or facilitate the process for reviewing new products that meet certain criteria. Specifically, new products are eligible 
for fast-track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to 
address  unmet  medical needs  for  the disease  or  condition. Fast  track designation  applies  to  the  combination of  the product  and  the 
specific indication for which it is being studied. The sponsor of a fast-track product has opportunities for frequent interactions with the 
review team during product development and, once a BLA is submitted, the product may be eligible for priority review. A fast-track 
product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before 
the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees 
to  accept  sections  of  the  BLA  and  determines  that  the  schedule  is  acceptable,  and  the  sponsor  pays  any  required  user  fees  upon 
submission of the first section of the BLA. 

A product intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough therapy designation 
to  expedite  its  development  and  review.  A  product  can  receive  breakthrough  therapy  designation  if  preliminary  clinical  evidence 
indicates  that  the  product  may  demonstrate  substantial  improvement  over  existing  therapies  on  one  or  more  clinically  significant 
endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast-track 
program  features,  as  well  as  more  intensive  FDA  interaction  and  guidance  beginning  as  early  as  Phase  1  and  an  organizational 
commitment to expedite the development and review of the product, including involvement of senior managers. 

Any marketing application for a biologic submitted to the FDA for approval, including a product with a fast-track designation and/or 
breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the FDA review and approval 
process, such as priority review and accelerated approval. A product is eligible for priority review if it has the potential to provide a 
significant improvement in the treatment, diagnosis or prevention of a serious disease or condition compared to marketed products. For 
products  containing  new  molecular  entities,  priority  review  designation  means  the  FDA’s  goal  is  to  take  action  on  the  marketing 
application within six months of the 60-day filing date (compared with ten months under standard review). 

Additionally, products studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive 
accelerated approval upon a determination that the 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 accelerated approval, the FDA will generally 
require the sponsor to perform adequate and well-controlled post-marketing clinical studies to verify and describe the anticipated effect 
on irreversible morbidity or mortality or other clinical benefit. In addition, the FDA currently requires as a condition for accelerated 
approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product. 

The regenerative medicine advanced therapy, or RMAT, designation is intended to facilitate an efficient development program for, and 
expedite review of, any drug that meets the following criteria: (1) it qualifies as a RMAT, which is defined as a cell therapy, therapeutic 
tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited 
exceptions; (2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and (3) preliminary 
clinical  evidence  indicates  that  the  drug  has  the  potential  to  address  unmet  medical  needs  for  such  a  disease  or  condition.  Like 
breakthrough therapy designation, RMAT designation provides potential benefits that include more frequent meetings with FDA to 
discuss the development plan for the product candidate and eligibility for rolling review and priority review. Products granted RMAT 
designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict 
long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites, including through expansion to additional 
sites.  Once  approved,  when  appropriate,  the  FDA  can  permit  fulfillment  of  post-approval  requirements  under  accelerated  approval 
through the submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence such as electronic 
health records; through the collection of larger confirmatory datasets; or through post-approval monitoring of all patients treated with 
the therapy prior to approval. 

Fast track designation, breakthrough therapy designation, priority review, accelerated approval, and RMAT designation do not change 
the standards for approval but may expedite the development or approval process. 

22 

Orphan Drug Designation 

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, 
which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the 
United States for which there is no reasonable expectation that the cost of developing and making available in the United States a drug 
or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan drug 
designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of the 
therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any 
advantage in, or shorten the duration of, the regulatory review or approval process. 

If  a  product  that  has  orphan  drug  designation  subsequently  receives  the  first  FDA  approval  for  the  disease  for  which  it  has  such 
designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not approve any 
other  applications,  including  a  full  BLA,  to  market  the  same  biologic  for  the  same  indication  for  seven  years,  except  in  limited 
circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not 
prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different 
disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the BLA 
application fee. 

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which 
it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the FDA later determines that 
the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet 
the needs of patients with the rare disease or condition. 

Post-Approval Requirements 

Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the 
FDA,  including,  among  other  things,  requirements  relating  to  record-keeping,  reporting  of  adverse  experiences,  periodic  reporting, 
product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, 
such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user 
fee  requirements,  under  which  FDA  assesses  an  annual  program  fee  for  each  product  identified  in  an  approved  BLA.  Biologic 
manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are 
subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain 
procedural  and  documentation  requirements  upon  us  and  our  third-party  manufacturers.  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 requirements upon us and any 
third-party manufacturers that we 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. 

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after 
the  product  reaches  the  market.  Later  discovery  of  previously  unknown  problems  with  a  product,  including  adverse  events  of 
unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in 
revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new 
safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, 
among other things: 

• 

• 

• 

• 

restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product 
recalls; 

fines, warning letters or holds on post-approval clinical studies; 

refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of 
existing product approvals; 

product seizure or detention, or refusal of the FDA to permit the import or export of products; or 

23 

• 

injunctions or the imposition of civil or criminal penalties. 

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims 
relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved 
label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to 
comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential 
civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling 
and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians 
may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the 
behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of 
off-label use of their products. 

Biosimilars and Reference Product Exclusivity 

The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the 
ACA, signed into law in 2010, includes a subtitle called the Biologics Price Competition and Innovation Act of 2009, or BPCIA, which 
created  an  abbreviated  approval  pathway  for  biological  products  that  are  biosimilar  to  or  interchangeable  with  an  FDA-approved 
reference biological product. 

Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product 
in  terms  of  safety,  purity,  and  potency,  can  be  shown  through  analytical  studies,  animal  studies,  and  a  clinical  study  or  studies. 
Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected 
to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times 
to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without 
increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. Complexities associated with 
the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, 
pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA. 

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the 
reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA 
until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company 
may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that 
applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency 
of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture, 
it  is  unclear  whether  products  deemed  “interchangeable”  by  the  FDA  will,  in  fact,  be  readily  substituted  by  pharmacies,  which  are 
governed by state pharmacy law. 

The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, recent government proposals have 
sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA 
exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of 
the BPCIA is subject to significant uncertainty. 

24 

Other Healthcare Laws and Compliance Requirements 

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities 
in the states and foreign jurisdictions in which they conduct their business. Such laws include, without limitation: the U.S. federal Anti-
Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering 
or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or 
service for which payment may be made under any federal healthcare program; federal civil and criminal false claims laws and civil 
monetary  penalty  laws,  which  prohibit,  among  other  things,  individuals  or  entities  from  knowingly  presenting,  or  causing  to  be 
presented, claims for payment to the federal government, including federal healthcare programs, that are false or fraudulent; the Health 
Insurance Portability and Accountability Act, or HIPAA, which created additional federal criminal statutes which prohibit, among other 
things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters, and 
which,  as  amended  by  Health  Information  Technology  for  Economic  and  Clinical  Health  Act,  or  HITECH,  also  imposes  certain 
requirements on HIPAA covered entities and their business associates and covered subcontractors relating to the privacy, security and 
transmission of individually identifiable health information; the U.S. federal Physician Payments Sunshine Act, which requires certain 
manufacturers  of  drugs,  devices,  biologics  and  medical  supplies  for  which  payment  is  available  under  Medicare,  Medicaid  or  the 
Children’s Health Insurance Program, with specific exceptions,  to annually report to the federal government, information related to 
payments or other transfers of value made to physicians (as defined by the Physician Payments Sunshine Act), other covered physicians 
and  teaching  hospitals,  as  well  as  ownership  and  investment  interests  held  by  health  care  professionals  and  their  immediate  family 
members; and U.S. state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in 
significant  ways,  and  may  not  have  the  same  effect,  thus  complicating  compliance  efforts.  In  addition,  certain  states  require 
pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance 
guidance promulgated by the federal government and certain states and local jurisdictions require the registration of pharmaceutical 
sales representatives. If their operations are found to be in violation of any of such laws or any other governmental regulations that 
apply, they may be subject to penalties, including, without limitation, significant civil, criminal and administrative penalties, damages, 
fines, disgorgement, imprisonment, exclusion from government-funded healthcare programs, such as Medicare and Medicaid or similar 
programs  in  other  countries  or  jurisdictions,  integrity  oversight  and  reporting  obligations  to  resolve  allegations  of  non-compliance, 
disgorgement, imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of our 
operations. 

Coverage and Reimbursement 

Significant uncertainty exists as to the coverage and reimbursement status of any pharmaceutical or biological product for which we 
obtain regulatory approval. Sales of any product depend, in part, on the extent to which such product will be covered by third-party 
payors,  such  as  federal,  state,  and  foreign  government  healthcare  programs,  commercial  insurance  and  managed  healthcare 
organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and 
amount of reimbursement to be provided are made on a plan-by-plan basis. In the United States, for example, principal decisions about 
reimbursement for new products are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the 
U.S. Department of Health and Human Services, or HHS. CMS decides whether and to what extent a new product will be covered and 
reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a 
substantial degree. However, one third-party payor’s determination to provide coverage for a product candidate does not assure that 
other payors will also provide coverage for the product candidate. Further, no uniform policy for coverage and reimbursement exists in 
the United States, and coverage and reimbursement can differ significantly from payor to payor. As a result, the coverage determination 
process is often time-consuming and costly. This process will require us to provide scientific and clinical support for the use of our 
products to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently 
or obtained in the first instance. Further, coverage policies and third-party reimbursement rates may change at any time. Even if favorable 
coverage  and  reimbursement  status  is  attained  for  one  or  more  products  for  which  the  company  receives  regulatory  approval,  less 
favorable coverage policies and reimbursement rates may be implemented in the future. 

For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly 
difficult because of the higher prices often associated with such drugs. Additionally, separate reimbursement for the product itself or the 
treatment or procedure in which the product is used may not be available, which may impact physician utilization. 

25 

In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, 
including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Third-party 
payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing 
the cost effectiveness of pharmaceutical or biological products, medical devices and medical services, in addition to questioning safety 
and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with 
existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a 
decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product. No regulatory 
authority  has  granted  approval  for  a  personalized  cancer  immunotherapy  based  on  a  vaccine  approach,  and  there  is  no  model  for 
reimbursement of this type of product. 

Healthcare Reform 

The United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare 
system. There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, 
improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and 
has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and 
reimbursement  of  pharmaceutical  and  biopharmaceutical  products,  especially  under  government-funded  health  care  programs,  and 
increased governmental control of drug pricing. 

In March 2010, the ACA was signed into law, which substantially changed the way healthcare is financed by both governmental and 
private insurers in the United States, and significantly affected the pharmaceutical industry. The ACA contained a number of provisions 
of particular importance to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment 
in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program 
are calculated for drugs that are inhaled, infused, instilled, implanted or injected, and annual fees based on pharmaceutical companies’ 
share of sales to federal health care programs. There have been executive, judicial and Congressional challenges to certain aspects of 
the ACA. For example, the Tax Cuts and Jobs Act was enacted, which, among other things, removed penalties for not complying with 
ACA’s individual mandate to carry health insurance. In addition, the 2020 federal spending package permanently eliminated, effective 
January 1,  2020,  the  ACA-mandated  “Cadillac”  tax  on  high-cost  employer-sponsored  health  coverage  and  medical  device  tax  and, 
effective January 1, 2021, also eliminated the health insurer tax. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on 
procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. 
Thus, the ACA will remain in effect in its current form. Prior to the U.S. Supreme Court ruling, on January 28, 2021, President Biden 
issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA 
marketplace. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules 
that limit access to healthcare, including, among others, reexamining Medicaid demonstration projects and waiver programs that include 
work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or 
the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is also unclear how such 
challenges, other such litigation, and the healthcare reform measures of the Biden administration will impact the ACA and our business. 

Other  legislative  changes  have  been  proposed  and  adopted  since  the  ACA  was  enacted,  including  aggregate  reductions  of  Medicare 
payments to providers of 2%, which due to subsequent legislative amendments, including the Infrastructure Investment and Jobs Act, will 
stay in effect per fiscal year through 2031, except for a temporary suspension from May 1, 2020 through March 32, 2021 due to COVID-19 
relief legislation, unless additional Congressional action is taken, and reduced payments to several types of Medicare providers. Under 
current  legislation  the  actual  reduction  in Medicare  payments  will  vary  from 1%  in  2022  to  up  to  3%  in  the  final  fiscal  year  of  this 
sequester. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates 
the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator 
multiple source drugs, beginning January 1, 2024. Congress is also considering additional health reform measures as part of other reform 
initiatives. Moreover, there has recently been heightened governmental scrutiny over the manner in which manufacturers set prices for 
their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation 
designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer 
patient  programs,  and  reform  government  program  reimbursement  methodologies  for  drug  products.  At  the  federal  level,  the 
Trump administration  used  several  means  to  propose  or  implement  drug  pricing  reform,  including  through  federal  budget  proposals, 
executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, the Trump Administration announced 
several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals. As a result, 
the FDA concurrently released a final rule and guidance in September 2020 providing pathways for states to build and submit importation

26 

plans for drugs from Canada. Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price 
reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, 
unless  the  price  reduction  is  required  by  law.  The  implementation  of  the  rule  has  been  delayed  by  the  Biden  administration  from 
January 1, 2022 to January 1, 2023 in response to ongoing litigation. The rule also creates a new safe harbor for price reductions reflected 
at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, 
the implementation of which have also been delayed until January 1, 2023. On November 20, 2020, CMS issued an interim final rule 
implementing  President  Trump’s  Most  Favored  Nation  executive  order,  which  would  tie  Medicare  Part  B  payments  for  certain 
physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021. As a result 
of litigation challenging the Most Favored Nation model, on December 27, 2021, CMS published a final rule that rescinded the Most 
Favored Nation model interim final rule. In July 2021, the Biden administration released an executive order, “Promoting Competition 
in  the  American  Economy,”  with  multiple  provisions  aimed  at  prescription  drugs.  In  response  to  Biden’s  executive  order,  on 
September 9,  2021,  HHS  released  a  Comprehensive  Plan  for  Addressing  High  Drug  Prices  that  outlines  principles  for  drug  pricing 
reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS 
can take to advance these principles. No legislation or administrative actions have been finalized to implement these principles. However, 
it is unclear whether these or similar policy initiatives will be implemented in the future. At the state level, legislatures have increasingly 
passed  legislation  and  implemented  regulations  designed  to  control  pharmaceutical  product  pricing,  including  price  or  patient 
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, 
and, in some cases, designed to encourage importation from other countries and bulk purchasing. Further, it is possible that additional 
governmental action is taken in response to the COVID-19 pandemic. 

Product Liability and Insurance 

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk 
if we commercialize any products. We have not experienced any product liability claims to date. We currently carry products and clinical 
trial liability insurance policies. There can be no assurance that liability claims will not exceed such insurance coverage limits, which 
could have a materially adverse effect on our business, financial condition or results of operations or that such insurance will continue 
to be available on commercially reasonable terms, if at all. 

Human Resources 

Employees 

As of December 31, 2023, we had 8 full-time employees. There were 6 in clinical and 2 were in administrative support. None of our 
employees is subject to a collective bargaining agreement. We consider our relationship with our employees to be good. 

Consultants 

We have consulting agreements with a number of leading academic scientists, clinicians and regulatory experts. They serve as important 
contacts for us throughout the broader scientific and clinical communities. They are distinguished individuals with expertise in numerous 
fields, including cellular biology, molecular biology, oncology, clinical, manufacturing and regulatory. 

We retain each consultant according to the terms of a consulting agreement. Under such agreements, we pay them a consulting fee and 
reimburse them for out-of-pocket expenses incurred in performing their services for us. In addition, some consultants hold options to 
purchase  our  common  stock,  subject  to  the  vesting  requirements  contained  in  separate  award  agreements.  Our  consultants  may  be 
employed by other entities and therefore may have commitments to their employer or may have other consulting or advisory agreements 
that may limit their availability to us. 

Human Capital Resources 

Our  human  capital  resources  objectives  include,  as  applicable,  identifying,  recruiting,  retaining,  incentivizing  and  integrating  our 
existing  and  additional  employees.  The  principal  purposes  of  our  equity  incentive  plans  are  to  attract,  retain  and  motivate  selected 
employees,  consultants  and  directors  through  the  granting  of  equity-based  compensation  awards.  We  strive  to  create  a  diverse 
environment,  and  our  commitment  to  diversity,  equity  and  inclusion  begins  with  our  leadership  team  of  diverse  backgrounds  and 
experiences. 100% of our executive officers are women or self-identify as a member of an underrepresented minority group. 

27 

Corporate Information 

We were incorporated under the laws of the State of Nevada in 1991 under the name “TapImmune, Inc.” and reincorporated in Delaware 
in October 2018 under the name “Marker Therapeutics, Inc.” Our principal executive offices are located at 9350 Kirby Drive, Suite 300, 
Houston, Texas 77054, and our telephone number is (713) 400-6400. Our common stock is listed for trading on the Nasdaq Capital 
Market under the symbol “MRKR”. 

Available Information 

Our  website  is  located  at  www.markertherapeutics.com.  We  make  available  free  of  charge  on  our  website  our  annual  reports  on 
Form 10- K,  quarterly  reports  on  Form 10-Q,  current  reports  on  Form 8-K  and  amendments  to  those  reports,  as  soon  as  reasonably 
practicable  after  we  electronically  file  or  furnish  such  materials  to  the  Securities  and  Exchange  Commission.  Our  website  and  the 
information contained therein or connected thereto are not intended to be incorporated into this Annual Report on Form 10-K. 

ITEM 1A. RISK FACTORS 

An  investment in  our  common  stock  involves  a  high  degree  of  risk.  You  should  carefully  consider  the  risks described below before 
making an investment decision in our securities. These risk factors are effective as of the date of this Form 10-K and shall be deemed to 
be modified or superseded to the extent that a statement contained in our future filings modifies or replaces such statement. All of these 
risks may impair our business operations. The forward-looking statements in this Form 10-K involve risks and uncertainties and actual 
results may differ materially from the results we discuss in the forward-looking statements. If any of the following risks actually occur, 
our business, financial condition or results of operations could be materially adversely affected. In that case, the trading price of our 
stock could decline, and you may lose all or part of your investment. 

Risks Associated with Our Business 

Our business is subject to numerous risks that you should be aware of before making an investment decision. These risks are described 
more fully in this “Risk Factors” section and include, among others: 

•  We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future. 

These factors raise substantial doubt regarding our ability to continue as a going concern. 

•  All of our product candidates are in clinical development. If we are unable to successfully develop, receive regulatory approval 
for and commercialize our product candidates, or successfully develop any other product candidates, or experience significant 
delays in doing so, our business will be harmed. 

•  The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical 

development and regulatory approval of our product candidates. 

•  The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results. 

•  Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious 
adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent 
or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the 
development of some of our product candidates. 

•  We are dependent on third-party vendors to maintain and support our manufacturing and cell processing. If any of our third-
party vendors experience disruptions, or otherwise cease or substantially reduce their operations, our business and operations 
could be adversely affected. 

•  Our  strategic  relationship  with  BCM  is  dependent,  in  part,  upon  our  ongoing  relationship  with  key  medical  and  scientific 

personnel and advisors. 

28 

•  Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among 

physicians, patients, healthcare payors and the medical community. 

•  The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of 

competition. We may be unable to compete with more substantial enterprises. 

• 

If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably. 

•  We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays. Even 
if we receive regulatory approval of our product candidates, we will be subject to ongoing quality and regulatory obligations 
and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we 
fail to comply with regulatory requirements or experience unanticipated problems with our product candidates. 

•  The price of our stock may be volatile. 

Risks Related to our Financial Position and Capital Needs 

We are a clinical stage company with a history of operating losses, and we expect losses to continue for the indefinite future. These 
factors raise substantial doubt regarding our ability to continue as a going concern. 

We are a clinical-stage immunotherapy company with a history of losses, and we may always operate at a loss. We expect that we will 
continue to operate at a loss throughout our development stage, and as a result, we may exhaust our financial resources and be unable 
to complete the development of our product candidates. We anticipate that our ongoing operational costs will increase significantly, and 
our deficit will continue to grow, as we continue conducting our clinical development program. 

We have no approved products or product candidates pending approval. As a result, we have not derived any revenue from the sales of 
products and have not yet demonstrated ability to obtain regulatory approval, formulate and manufacture commercial-scale products, or 
conduct sales and marketing activities necessary for successful product commercialization. We have no sources of significant revenue 
to provide incoming cash flows to sustain our future operations. Our ability to pursue our planned business activities depends upon our 
successful efforts to raise additional financing, which may be adversely impacted by potential worsening global economic conditions, 
including decades-high inflation and concerns of a recession in the United States or other major markets, and the recent disruptions to 
and volatility in the credit and financial markets in the United States and worldwide. Weakness and volatility in the capital markets and 
the economy in general could also increase our costs of borrowing. Such additional financing may not be available on favorable terms, 
or at all.  

We have sustained losses from operations in each fiscal year since our inception, and we expect losses to continue for the indefinite 
future  due  to  the  substantial  investment  in  research  and  development.  We  expect  that  our  cash  and  cash  equivalents  as  of 
December 31, 2023, together with the drawdowns from available grant funds, will enable us to fund our operating expenses and capital 
expenditure requirements into the fourth quarter of 2025. We expect to spend substantial additional sums on the continued administration 
and research and development of licensed and proprietary product candidates and technologies with no certainty that our approach and 
associated technologies will become commercially viable or profitable as a result of these expenditures. If we fail to raise a significant 
amount of capital, we may need to significantly curtail operations, allocate limited financial resources among our product candidates, 
or cease operations in the near future. If any of our product candidates fail in clinical trials or do not gain regulatory approval, we may 
never generate revenue. Even if we generate revenue in the future, we may not be able to become profitable or sustain profitability in 
subsequent periods. 

These and other factors raise substantial doubt regarding our ability to continue as a going concern, which may create negative reactions 
to the price of our common stock. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive 
less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of 
their investment. Further, the perception that we may be unable to continue as a going concern may impede our ability to pursue strategic 
opportunities or operate our business due to concerns regarding our ability to discharge our contractual obligations. In addition, if 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 to us on commercially reasonable terms, or at all. 

29 

Adverse developments affecting financial institutions, companies in the financial services industry or the financial services industry 
generally, such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations 
and liquidity. 

Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or 
other companies in the financial services industry or the financial services industry generally or concerns or rumors about any events of 
these kinds, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon 
Valley Bank, or SVB, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal 
Deposit Insurance Corporation, or the FDIC, as receiver.  

Although a statement by the U.S. Department of the Treasury, the Federal Reserve and the FDIC stated that all depositors of SVB would 
have access to all of their money after only one business day following the date of closure, uncertainty and liquidity concerns in the 
broader financial services industry remain. Inflation and rapid increases in interest rates have led to a decline in the trading value of 
previously issued government securities with interest rates below current market interest rates. The U.S. Department of Treasury, FDIC 
and Federal Reserve Board have announced a program to provide up to $25 billion of loans to financial institutions secured by such 
government securities held by financial institutions to mitigate the risk of potential losses on the sale of such instruments. However, 
widespread demands for customer withdrawals or other needs of financial institutions for immediate liquidity may exceed the capacity 
of such program. There is no guarantee that the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access to 
uninsured funds in the future in the event of the closure of other banks or financial institutions in a timely fashion or at all. 

Our  access  to  our  cash  and  cash  equivalents  in  amounts  adequate  to  finance  our  operations  could  be  significantly  impaired  by  the 
financial institutions with which we have arrangements directly facing liquidity constraints or failures. In addition, investor concerns 
regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest 
rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby 
making it more difficult for us to acquire financing on acceptable terms or at all. Any material decline in available funding or our ability 
to access our cash and cash equivalents could adversely impact our ability to meet our operating expenses, result in breaches of our 
contractual obligations or result in violations of federal or state wage and hour laws, any of which could have material adverse impacts 
on our operations and liquidity. 

Risks Related to the Development of our Product Candidates 

All of our product candidates are in clinical development. If we are unable to successfully develop, receive regulatory approval for 
and commercialize our product candidates, or successfully develop any other product candidates, or experience significant delays in 
doing so, our business will be harmed. 

We are early in our development efforts and all of our product candidates are still in clinical development. Each of our programs and 
product candidates will require additional preclinical and/or clinical development, regulatory approval, obtaining manufacturing supply, 
capacity and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment and 
significant marketing efforts before we generate any revenue from product sales. We do not have any products that are approved for 
commercial sale, and we may never be able to develop or commercialize marketable products. 

Our ability to generate revenue from our product candidates, which we do not expect will occur for several years, if ever, will depend 
heavily on the successful development, regulatory approval and eventual commercialization of our product candidates. The success of 
our multiTAA product candidates or any other product candidates that we develop or otherwise may acquire will depend on several 
factors, including: 

• 

• 

• 

timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally 
efficacious dose studies in animals, where applicable, and clinical trials; 

effective  investigational  new  drug  applications,  or  INDs,  from  the  FDA  or  comparable  foreign  applications  that  allow 
commencement of our planned clinical trials or future clinical trials for our product candidates; 

sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials; 

30 

• 

• 

• 

• 

• 

• 

• 

• 

• 

successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or GCPs, 
and current Good Laboratory Practices; 

successful  development  of,  or  making  arrangements  with  third-party  manufacturers  for,  our  commercial  manufacturing 
processes for any of our product candidates that receive regulatory approval; 

receipt of timely marketing approvals from applicable regulatory authorities; 

launching commercial sales of products, if approved, whether alone or in collaboration with others; 

acceptance of the benefits and use of our products, including method of administration, if approved, by patients, the medical 
community and third-party payors, for their approved indications; 

the prevalence and severity of adverse events experienced by our product candidates; 

the  availability,  perceived  advantages, cost,  safety and  efficacy  of  alternative  therapies  for  any  product  candidate,  and  any 
indications for such product candidate, that we develop; 

our ability to produce any product candidates we develop on a commercial scale; 

obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates 
and otherwise protecting our rights in our intellectual property portfolio; 

•  maintaining compliance with regulatory requirements, including the FDA’s current Good Manufacturing Practices, or cGMPs, 

and complying effectively with other procedures; 

• 

obtaining and maintaining third-party coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in 
the absence of such coverage and adequate reimbursement; and 

•  maintaining a continued acceptable safety, tolerability and efficacy profile of the products following approval. 

If we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays 
or an inability to successfully commercialize the product candidates we develop, which would materially harm our business. If we do 
not receive marketing approvals for any product candidate we develop, we may not be able to continue our operations. 

Because we have limited financial and management resources, we must focus on development programs and product candidates that we 
identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other 
indications for these product candidates that later prove to have greater commercial potential. Our resource allocation decisions may 
cause us  to fail  to  capitalize  on viable  commercial  products  or profitable  market  opportunities. Our  spending  on  current  and future 
development programs and product candidates for specific indications may not yield any commercially viable products. If we do not 
accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to 
that  product  candidate  through  collaboration,  licensing  or  other  royalty  arrangements  in  cases  in  which  it  would  have  been  more 
advantageous for us to retain sole development and commercialization rights to such product candidate. 

The  FDA  regulatory  approval  process  is  lengthy  and  time-consuming,  and  we  may  experience  significant  delays  in  the  clinical 
development and regulatory approval of our product candidates. 

Any immunotherapies that we may develop are not likely to be commercially available for at least three years. Any delay in obtaining 
FDA and/or other necessary regulatory approvals in the United States and in countries outside the United States for any investigational 
new drug and failure to receive such approvals would have an adverse effect on the investigational new drug’s potential commercial 
success and on our business, prospects, financial condition and results of operations. The time required to obtain approval by the FDA 
and non-U.S. regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and 
depends upon numerous factors, including the substantial discretion of the regulatory authorities. 

31 

We have not previously submitted a biologics license application, or BLA, to the FDA, or similar approval filings to comparable foreign 
authorities. A BLA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s 
safety  and  effectiveness  for  each  desired  indication.  The  BLA  must  also  include  significant  information  regarding  the  chemistry, 
manufacturing and controls for the product. We expect the novel nature of our product candidates to create further challenges in obtaining 
regulatory  approval.  For  example,  the  FDA  has  limited  experience  with  commercial  development  of  cell  therapies  for  cancer. 
Accordingly,  the  regulatory  approval  pathway  for  our  product  candidates  may  be  uncertain,  complex,  expensive  and  lengthy,  and 
approval may not be obtained, and the FDA or non-U.S. regulatory authorities may disagree with the design or implementation of our 
clinical trials or study endpoints. 

We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to: 

• 

• 

• 

• 

• 

• 

• 

the availability of financial resources to commence and complete the planned trials; 

reaching agreement on acceptable terms with prospective clinical research organizations, or CROs, and clinical trial sites, the 
terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; 

obtaining approval by an independent institutional review board, or IRB, at each clinical trial site; 

recruiting suitable patients to participate in a trial; 

having patients complete a trial or return for post-treatment follow-up; 

clinical trial sites deviating from trial protocol or dropping out of a trial; 

adding new clinical trial sites; or 

•  manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject by subject basis for use 

in clinical trials. 

Further,  the performance of our  CROs may  also be  interrupted by  health  epidemics or  other disruptions,  including  due  to  travel or 
quarantine policies or prioritization of resources toward such health epidemic or disruption. We could also encounter delays if physicians 
face unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing 
treatments that have established safety and efficacy profiles. Further, a clinical trial may be suspended or terminated by us, the IRB for 
the institutions in which such trials are being conducted, the Data and Safety Monitoring Board or Committee for such trial, or by the 
FDA  or  other  regulatory  authorities  due  to  a  number  of  factors.  Those  factors  could  include  failure  to  conduct  the  clinical  trial  in 
accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or 
other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to 
demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate 
funding to continue the clinical trial. If we experience termination of, or delays in the completion of, any clinical trial of our product 
candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be 
delayed.  In  addition,  any  delays  in  completing  our  clinical  trials  will  increase  our  costs,  slow  down  our  product  development  and 
approval process and jeopardize our ability to commence product sales and generate revenue. 

Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain 
outcome. Further, we may encounter substantial delays in completing the development of our product candidates. 

All of our product candidates are in clinical development and their risk of failure is high. The clinical trials and manufacturing of our 
product candidates are, and the manufacturing and marketing of our products, if approved, will be, subject to extensive and rigorous 
review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market 
our  product  candidates.  Before  obtaining  regulatory  approvals  for  the  commercial  sale  of  any  of  our  product  candidates,  we  must 
demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that our product candidates are both safe and 
effective for use in each target indication. In particular, because our product candidates are subject to regulation as biological products, 

32 

we  will  need  to  demonstrate  that  they  are  safe,  pure  and  potent  for  use  in  their  target  indications.  Each  product  candidate  must 
demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. 

Clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. 
Because our product candidates are based on new technologies and manufactured on a patient-by-patient basis for our multiTAA-specific 
T cell product candidates we expect that they will have substantial manufacturing costs. In addition, the initial estimates of the clinical 
cost of development may prove to be inadequate, particularly if clinical trial timing or outcome is different than predicted or regulatory 
agencies require further testing before approval. For example, we previously experienced temporary delays in enrollment due to the 
COVID-19 pandemic and in satisfying certain FDA requirements for our clinical study of MT-401 for the treatment of post-transplant 
AML, and any further delay to our planned timelines for our trial may impact our cost estimates for this trial. In addition, costs to treat 
patients with relapsed/refractory cancer and to treat potential side effects that may result from our product candidates can be significant. 
Some clinical trial sites may not bill, or obtain coverage from, Medicare, Medicaid, or other third-party payors for some or all of these 
costs for patients enrolled in our clinical trials, and we may be required by those trial sites to pay such costs. Accordingly, our clinical 
trial costs may be significantly higher per patient than those of more conventional therapeutic technologies or drug products. In addition, 
our proposed personalized product candidates involve several complex manufacturing and processing steps, the costs of which will be 
borne by us. Depending on the number of patients we ultimately enroll in our trials, and the number of trials we may need to conduct, 
our overall clinical trial costs may be higher than for more conventional treatments. Further, delays and interruptions to ongoing trials 
related to global pandemics, as experienced with COVID-19, can increase the duration and costs of such trials. We outsource some of 
the management of our clinical trials to third parties. Agreements with clinical investigators and medical institutions for clinical testing 
and with other third parties for data management services, place substantial responsibilities on these parties that, if unmet, could result 
in  delays  in,  or  termination  of,  our  clinical  trials.  If  any  of  our  clinical  trial  sites  fail  to  comply  with  FDA-approved  good  clinical 
practices, we may be unable to use the data gathered at those sites. If these clinical investigators, medical institutions or other third 
parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the 
clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials 
may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, agents. 
We cannot be certain that we will successfully recruit enough patients to complete our clinical trials nor that we will reach our primary 
endpoints. Delays in recruitment, lack of clinical benefit or unacceptable side effects would delay our clinical trials. 

We, or our regulators, may suspend or terminate our clinical trials for a variety of reasons. For example, in the fourth quarter of 2019 
the FDA placed a clinical hold on our IND of MT-401 for the treatment of patients with post-transplant AML and requested certain 
information  regarding  quality  and  technical  specifications  for  two  reagents  supplied  by  third-party  vendors  that  are  used  in  our 
manufacturing  process  but  not  present  in  the  final  product  infused  to  patients.  In  January 2021,  the  FDA  lifted  the  clinical  hold, 
permitting us to initiate a Phase 2 clinical trial for the treatment of post-transplant AML, with a safety lead-in portion. We completed 
the safety lead-in portion of the trial in June 2021, and we initiated the remainder of the Phase 2 trial in July 2021. We may voluntarily 
suspend or terminate our clinical trials at any time if we believe they present an unacceptable risk to the patients enrolled in our clinical 
trials or do not demonstrate clinical benefit. For example, in November 2019 we elected to suspend our Phase 2 clinical trial of TPIV200 
for  the  treatment  of  platinum-sensitive  advanced  ovarian  cancer  based  on  an  unblinded  review  of  interim  results  conducted  by  an 
independent Data and Safety Monitoring Board, or DSMB. Although the DSMB did not express any safety concerns with respect to 
TPIV200, we elected to suspend the trial because it did not meet the threshold for probability of clinical benefit based upon our pre-
specified criteria. In addition, regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any 
time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they 
present an unacceptable safety risk to the patients enrolled in our clinical trials. 

Our clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical 
trial  sites  are  not  in  compliance  with  applicable  regulatory  requirements  for  conducting  clinical  trials,  we  may  receive  reports  of 
observations or warning letters detailing deficiencies, and we will be required to implement corrective actions. If regulatory agencies 
deem our responses to be inadequate, or are dissatisfied with the corrective actions we or our clinical trial sites have implemented, our 
clinical trials may be temporarily or permanently discontinued, and we may be fined, we or our investigators may be precluded from 
conducting any ongoing or any future clinical trials, the government may refuse to approve our marketing applications or allow us to 
manufacture or market our products, and we may be criminally prosecuted. The lengthy approval process, as well as the unpredictability 
of future clinical trial results, may result in us failing to obtain regulatory approval for our product candidates, which would materially 
harm our business, results of operations and prospects. 

33 

The results of earlier preclinical and clinical trials may not be predictive of future clinical trial results. 

Failure can occur at any time during the clinical trial process. The results of preclinical testing and early clinical trials of our product 
candidates  may  not  be  predictive  of  the  results  of  larger,  later-stage  controlled  clinical  trials.  Product  candidates  that  have  shown 
promising results in early-stage clinical trials may still suffer significant setbacks in subsequent clinical trials. Our clinical trials to date 
have been conducted on a small number of patients in a single academic clinical site for a limited number of indications. We will have 
to conduct larger, well-controlled trials in our proposed indications at multiple sites to verify the results obtained to date and to support 
any  regulatory  submissions  for  further  clinical  development  of  our  product  candidates.  Our  assumptions  related  to  our  product 
candidates, such as with respect to lack of toxicity and manufacturing cost estimates, are based on early limited clinical trials and current 
manufacturing processes and may prove to be incorrect. Several companies in the biopharmaceutical industry have suffered significant 
setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles despite promising results in earlier, smaller clinical 
trials. Moreover, clinical data are often susceptible to varying interpretations and analyses. We do not know whether any Phase 2, Phase 
3,  or  other  clinical  trials  we  may  conduct  will  demonstrate  consistent  or  adequate  efficacy  and  safety  with  respect  to  the  proposed 
indication for use sufficient to receive regulatory approval or market our product candidates. 

If we do not achieve our projected development goals in the time frames we announce and expect, the commercialization of our 
products may be delayed. 

From time to time, we may estimate the timing of the accomplishment of various scientific, clinical, regulatory, manufacturing and other 
product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion 
of preclinical studies and clinical trials and the submission of regulatory filings, including IND submissions. From time to time, we may 
publicly  announce  the  expected  timing  of some  of  these milestones. All  of  these milestones  are,  and  will be,  based  on  a variety of 
assumptions. The actual timing of these milestones can vary significantly compared to our estimates, in some cases for reasons beyond 
our  control,  including  with  respect  to  challenges  related  to  enrollment,  manufacturing  and  our  reliance  on  third  parties  to  conduct, 
supervise or monitor some or all aspects of our clinical trials. We may experience numerous unforeseen events during, or as a result of, 
any future clinical trials that we conduct that could delay or prevent our ability to receive marketing approval or commercialize our 
product candidates. 

We  may  experience  difficulties  in patient  enrollment  in our future  clinical  trials  for  a  variety of reasons.  The  timely  completion of 
clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients 
who remain in the study until its conclusion. In addition, our clinical trials will compete with other clinical trials for product candidates 
that  are  in  the same  therapeutic  areas  as our  product  candidates,  and  this  competition will  reduce  the  number  and types  of patients 
available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted 
by one of our competitors. Accordingly, we cannot guarantee that our clinical trials will progress as planned or as scheduled. Delays in 
patient enrollment may result in increased costs or may affect the timing or outcome of our ongoing clinical trial and planned clinical 
trials,  which  could  prevent  completion  of  these  trials  and  adversely  affect  our  ability  to  advance  the  development  of  our  product 
candidates. 

Our preclinical studies and clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse 
or  unacceptable  side  effects  may  be  identified  during  the  development  of  our  product  candidates,  which  could  prevent  or  delay 
regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of 
some of our product candidates. 

Before obtaining regulatory approvals for the commercial sale of our product candidates, we must demonstrate through lengthy, complex 
and  expensive  preclinical  testing  and  clinical  trials  that  our  product  candidates  are  safe,  pure  and  effective  for  use  in  each  target 
indication, and failures can occur at any stage of testing. Preclinical studies and clinical trials often fail to demonstrate safety or efficacy 
of the product candidate studied for the target indication.  

34 

In addition to side effects caused by the product candidate, the administration process or related procedures also can cause adverse side 
effects. If any such adverse events occur, our clinical trials could be suspended or terminated. If we cannot demonstrate that any adverse 
events were not caused by the drug or administration process or related procedures, the FDA, EMA or foreign regulatory authorities 
could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Even if 
we are able to demonstrate that all future serious adverse events are not product-related, such occurrences could affect patient recruitment 
or the ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate 
any future clinical trial of any of our product candidates, the commercial prospects of such product candidates may be harmed and our 
ability to generate product revenues from any of these product candidates may be delayed or eliminated. In addition, these side effects 
may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from personalized cell therapy, as 
with our multiTAA-specific T cell therapy products, are not normally encountered in the general patient population and by medical 
personnel. Any of these occurrences may harm our ability to develop other product candidates, and may harm our business, financial 
condition and prospects significantly. 

If our product candidates are associated with side effects in clinical trials or have characteristics that are unexpected, we may need to 
abandon their development or limit development to more narrow uses in which the side effects or other characteristics are less prevalent, 
less severe or more acceptable from a risk-benefit perspective. The FDA or an IRB may also require that we suspend, discontinue, or 
limit our clinical trials based on safety information, or that we conduct additional animal or human studies regarding the safety and 
efficacy of our product candidates which we have not planned or anticipated. Such findings could further result in regulatory authorities 
failing to provide marketing authorization for our product candidates or limiting the scope of the approved indication, if approved. Many 
product candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented further 
development of the product candidate. 

Additionally, if one or more of our product candidates receives marketing approval, and we or others identify undesirable side effects 
caused by such products, a number of potentially significant negative consequences could result, including: 

• 

• 

regulatory authorities may withdraw approvals of such product; 

regulatory authorities may require additional warnings on the labels; 

•  we may be required to create a medication guide outlining the risks of such side effects for distribution to patients or other 

requirements subject to a REMS; 

•  we could be sued and held liable for harm caused to patients; 

•  we may not be able to achieve or maintain third-party payor coverage and adequate reimbursement; and 

• 

our reputation and physician or patient acceptance of our products may suffer. 

There can be no assurance that we will resolve any issues related to any product-related adverse events to the satisfaction of the FDA or 
foreign regulatory agency in a timely manner or at all. Moreover, any of these events could prevent us from achieving or maintaining 
market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and 
prospects. 

35 

We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity. 

Regulatory authorities in some jurisdictions, including the United States and the European Union, may designate drugs for relatively 
small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic 
intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United 
States, or more than 200,000 individuals in the United States for which there is no reasonable expectation that the cost of developing 
and making available in the United States a drug or biologic for this type of disease or condition will be recovered from sales in the 
United States for that drug or biologic. Generally, a product that has orphan drug designation and subsequently receives the first FDA 
approval for the disease for which it has such designation is entitled to orphan drug exclusive approval (or exclusivity), which means 
that the FDA may not approve any other applications to market the same drug or biologic for the same indication for seven years, except 
in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. A designated orphan 
drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan 
designation. 

The FDA has granted orphan drug designation for MT-401 for the treatment of AML after receiving an allogeneic stem cell transplant 
and for MT-601 for the treatment of patients with pancreatic cancer. In 2023, MT-401 was also granted orphan drug designation by the 
Committee for Orphan Medicinal Products of the European Medicines Agency (EMA) for the treatment of patients with AML. We may 
seek  orphan  drug  designation  for  other  indications  or  product  candidates.  Even  if  we  were  to  obtain  orphan  drug  designation  for  a 
product candidate, we may not obtain orphan exclusivity and that exclusivity may not effectively protect the drug from the competition 
of different drugs for the same condition, which could be approved during the exclusivity period. Additionally, after an orphan drug is 
approved, the FDA could subsequently approve another application for the same drug for the same indication if the FDA concludes that 
the later drug is shown to be safer, more effective or makes a major contribution to patient care. Orphan drug exclusive marketing rights 
in the United States also may be lost if the FDA or European Commission (on the basis of the opinion of the European Medicines 
Agency, or the EMA), later determines that the request for designation was materially defective or if the manufacturer is unable to assure 
sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. The failure to obtain an orphan drug 
designation for any product candidates we may develop, the inability to maintain that designation for the duration of the applicable 
period, or the inability to obtain or maintain orphan drug exclusivity could reduce our ability to make sufficient sales of the applicable 
product candidate to balance our expenses incurred to develop it, which would have a negative impact on our operational results and 
financial condition. 

Risks Related to Manufacturing 

We  rely  on  third-party  vendors  and  contract  manufacturing  organizations  to  maintain  and  support  our  manufacturing  and  cell 
processing operations. 

In July 2021, we opened an in-house cGMP manufacturing facility in Houston, Texas, where we manufactured the clinical supply of 
our product candidates. On June 26, 2023, we completed the previously announced transaction with Cell Ready, LLC (“Cell Ready”), 
pursuant to a Purchase Agreement (the “Cell Ready Purchase Agreement”), dated May 1, 2023, by and between us and Cell Ready. 
Pursuant to the Cell Ready Purchase Agreement, we (i) assigned to Cell Ready the leases for our two manufacturing facilities in Houston, 
Texas, or the Manufacturing Facilities, (ii) sold to Cell Ready all of the equipment and leasehold improvements at our manufacturing 
facilities  and  (iii)  assigned  to  Cell  Ready  our  rights,  title  and  interest  in  any  contracts  related  to  the  equipment  and  manufacturing 
facilities (collectively referred to as the “Purchased Assets”). On February 22, 2024, we entered into a Master Services Agreement for 
Product Supply (the “MSA”) with Cell Ready. Cell Ready, which is owned by one of our directors and shareholders, Mr. John Wilson, 
is a contract development and manufacturing organization (CDMO). Under the MSA, it is anticipated Cell Ready will perform a wide 
variety of services for us, including research and development, and manufacturing in support of our clinical trials. 

Although we expect Cell Ready’s cGMP manufacturing facility to be our primary source of multiTAA-specific T cell therapy-based 
product candidates and for commercial manufacturing of any products, if approved, we intend to evaluate additional potential third-
party manufacturing capabilities in order to provide potential multiple sources of clinical and commercial supply. Even if we can secure 
multiple sources of clinical and commercial supply, third-party manufacturers, such as Cell Ready, may not be able to meet our needs 
concerning timing, quantity, or quality and/or may cease or substantially reduce their business. If we are unable to contract for a sufficient 
supply of needed materials on acceptable terms, or if we should encounter delays or difficulties in our relationships with manufacturers, 
our  clinical  trials  may  be  delayed,  thereby  delaying  the  submission  of  product  candidates  for  regulatory  approval  or  the  market 
introduction and subsequent sales of any approved products. Any such delay may lower our revenues and potential profitability. If any 

36 

third-party breaches or terminates its agreement with us or fails to conduct its activities in a timely manner, the commercialization of 
our product candidates could be slowed down or blocked completely. It is possible that third-parties relied upon by us will change their 
strategic focus, pursue alternative technologies, or develop alternative product candidates, either on their own or in collaboration with 
others,  as  a  means  for  developing  treatments  for  the  diseases  targeted  by  our  collaborative  programs,  or  for  other  reasons.  The 
effectiveness of these third parties in marketing their own products may also affect our revenues and earnings. Also, if we enter into 
additional third-party agreements in the future, we may not be able to negotiate such agreements successfully and, even if established, 
these relationships may not be scientifically or commercially successful. In the event our relationship with a third-party manufacturer is 
terminated or substantially reduced for any reason, it is possible we will not be able to identify an alternative third-party manufacturer 
within a reasonable period of time, if ever, which would have an adverse effect our operations. 

Additionally, our manufacturing capabilities could be affected by cost-overruns, unexpected delays, equipment failures, labor shortages, 
natural disasters, power failures, competition with other clients, transportation difficulties and numerous other factors that could prevent 
us  from  fully  realizing  the  intended  benefits  of  our  manufacturing  strategy  and  have  a  material  adverse  effect  on  our  clinical 
development, commercialization plans and/or general operations. In addition, the manufacturing process for any product candidates that 
we  may  develop  is  subject  to  the  FDA  and  foreign  regulatory  authority  approval  process,  and  we  may  need  to  contract  with 
manufacturers who can meet all applicable FDA and foreign regulatory authority requirements on an ongoing basis. If our contract 
manufacturing organizations, or CMOs, ,including Cell Ready, are unable to reliably produce products to specifications acceptable to 
the FDA or other regulatory authorities, we may not obtain or maintain the approvals we need to commercialize any approved products. 
Even if we obtain regulatory approval for any of our product candidates, there is no assurance that either we or our CMOs will be able 
to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient 
quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Further, we may be 
required to establish multiple manufacturing facilities to expand our commercial footprint for any approved products, which may lead 
to regulatory delays or prove costly. Any of these challenges could delay completion of clinical trials, require bridging clinical trials or 
the  repetition  of  one  or  more  clinical  trials,  increase  clinical  trial  costs,  delay  approval  of  our  product  candidate,  impair 
commercialization efforts, increase our cost of goods, and have an adverse effect on our clinical development and/or commercialization 
plans. 

Our manufacturing process is reliant upon specialized equipment, and other specialty materials, which may not be available to us 
on acceptable terms or at all. We, our vendors, and contract manufacturing organizations rely or may rely on sole-source vendors 
or a limited number of vendors, which could impair the manufacture and supply of our product candidates. 

We depend on a limited number of vendors for supply of certain materials and equipment used in the manufacture of our multiTAA-
specific  T  cell  therapy-based  product  candidates.  For  example,  in  the  past,  we  purchased  equipment  and  reagents  critical  for  the 
manufacture  of  our  product  candidates  from  Wilson  Wolf  (a  company  controlled  by  our  director  John  Wilson),  Almac  and  other 
suppliers. Under the Cell Ready MSA, Cell ready is required to obtain all raw materials and components used in the production of our 
product candidates, other than as specified in applicable works orders delivered under the MSA. Some of our direct or indirect suppliers 
may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms or may otherwise be 
ill-equipped to support our needs. We also may not have supply contracts with many of these suppliers and may not be able to obtain 
supply contracts with them on acceptable terms or at all. Accordingly, we may not be able to obtain key materials and equipment to 
support clinical or commercial manufacturing. Further, the FDA may determine that our manufacturing process, or the materials required 
for the manufacture of our product candidates, are not acceptable, which would require us to find alternative suppliers or processes, 
which may not be available on favorable terms, if at all. 

For some of this equipment and materials, we may rely, and may now and/or in the future rely, on sole-source vendors or a limited 
number of vendors. An inability to continue to source product from any of these suppliers, which could be due to regulatory actions or 
requirements  affecting  the  supplier,  adverse  financial,  or  other  strategic  developments  experienced  by  a  supplier,  labor  disputes  or 
shortages, unexpected demands, or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which 
could adversely and materially affect our operating results or our ability to conduct clinical trials, either of which could significantly 
harm our business. 

37 

In the future, we may need to obtain rights to and supplies of specific materials and equipment to be used for the development of our 
product candidates. For example, our multiTAA-specific T cell manufacturing process is based, in part, upon the G-Rex® cell culture 
device  manufactured  by  Wilson  Wolf,  which  is  used  by  many  cell  therapy  developers,  both  in  commercial  and  academic  settings. 
Although we do hold the license to patents from BCM that could be used to prevent third parties from developing similar and competing 
processes, we do not own any exclusive rights to the G-Rex®. We may not be able to obtain rights to such materials and equipment on 
commercially reasonable terms, or at all, and if we are unable to alter our process in a commercially viable manner to avoid the use of 
such materials or find a suitable substitute, it would have a material adverse effect on our business. 

The manufacture of our product candidates is complex and we may encounter difficulties in production, particularly with respect to 
process development. If any of our third-party suppliers, including Cell Ready, encounter such difficulties, the supply of our product 
candidates for clinical trials, or our product candidates for patients, if approved, could be delayed or stopped, or we may be unable 
to maintain a commercially viable cost structure. 

Our product candidates are biologics, and the process of manufacturing our product candidates is complex, highly regulated and subject 
to multiple risks. For example, the manufacture of our multiTAA-specific T cell therapy-based product candidates involves complex 
processes, including drawing blood from patients/donors, manufacturing the clinical product, and ultimately infusing the product into a 
patient. As a result of the complexities, the cost to manufacture biologics is generally higher than traditional small molecule chemical 
compounds,  and  the manufacturing process  is  less  reliable  and  is  more  difficult  to reproduce.  Our manufacturing  processes  will  be 
susceptible to product loss or failure due to any of the following: logistical issues associated with the collection of blood cells, or starting 
material, from the patient or a donor, shipping such material to the manufacturing site, shipping the final product back to the patient, 
and  infusing  the patient  with  the  product;  manufacturing  issues  associated  with  the variability  in patients’  or donor’s starting  cells; 
interruptions in the manufacturing process; contamination; equipment failure; improper installation or operation of equipment, vendor 
or  operator  error;  inconsistency  in  cell  growth;  and  variability  in  product  characteristics.  Even  minor  deviations  from  normal 
manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. If for any reason we 
lose a patient’s or a donor’s cells, or later-developed product at any point in the process, the manufacturing process for that patient will 
need to be restarted and the resulting delay may adversely affect that patient’s outcome and/or the results of clinical trials. If microbial, 
viral, or other contaminations are discovered in our product candidates or in the manufacturing facilities in which our product candidates 
are  made,  such  manufacturing  facilities  may  need  to  be  closed  for  an  extended  period  of  time  to  investigate  and  remedy  the 
contamination. 

Because  our  autologous  multiTAA-specific  T  cell  therapy-based  product  candidates,  MT-601,  is  manufactured  for  each  particular 
patient, we will be required to maintain a chain of identity with respect to the patient’s blood cells as it moves from the patient to the 
manufacturing facility, through the manufacturing process, and back to the patient. Maintaining such a chain of identity is difficult and 
complex, and failure to do so could result in adverse patient outcomes, loss of product, or regulatory action including withdrawal of our 
product candidates from the market. Further, as product candidates are developed through preclinical to late-stage clinical trials towards 
approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are 
altered along the way in order to optimize processes and results. Such changes carry the risk that they will not achieve these intended 
objectives, and any of these changes could cause our product candidates to perform differently and affect the results of planned clinical 
trials or other future clinical trials. 

We currently have our clinical supply manufactured at Cell Ready’s manufacturing facility, and are working to develop commercially 
viable processes. Doing so is a difficult and uncertain task, and there are risks associated with scaling to the level required for advanced 
clinical  trials  or  commercialization,  including,  among  others,  cost  overruns,  potential  problems  with  process  scale  up,  process 
reproducibility,  stability  issues,  lot  consistency,  and  timely  availability  of  raw  materials.  As  a  result  of  these  challenges,  we  may 
experience delays in our clinical development and/or commercialization plans. We may ultimately be unable to reduce the cost of goods 
for our product  candidates  to  levels  that will  allow  for  an  attractive  return on  investment  if  and  when  those product  candidates  are 
commercialized. 

No assurance can be given that we will be able to develop a new, FDA-compliant, more efficient, lower cost manufacturing process 
upon which our business plan to commercialize multiTAA-based product candidates is dependent. 

In cooperation with our current contract manufacturers and suppliers, we developed and have implemented a new nine-day multiTAA-
specific T cell manufacturing process for our current as well as future clinical trials using a patient-specific manufacturing approach or 
using products manufactured from healthy donors (“Off-the-Shelf”). The new manufacturing process marks additional manufacturing 

38 

improvements compared to the processes used in the BCM Phase 1 and 2 trials (36-day manufacturing time) and our previous AML 
trial (20-day manufacturing time). The new nine-day manufacturing process enables increased antigen specificity and diversity, which 
has exhibited a strong linear correlation to anti-tumor activity in vitro. The new process produces a patient product that is four times 
more potent, with the potential to greatly improve tumor killing. This new, scaled-up, pharmaceutical manufacturing process is new and 
subject to uncertainties. We cannot guarantee that we will be able to more efficiently and cost effectively, and in a more automated 
manner produce, measure and control the physical and/or chemical attributes of our product candidates in a cGMP facility. We also 
have never manufactured our adoptive T cell therapy product candidate on a commercial scale. As a result, we cannot give any assurance 
that we will be able to establish a manufacturing process that can produce our product candidates at a cost or in quantities necessary to 
make them commercially viable. Moreover, we and our third-party manufacturers will have to continually adhere to current cGMP 
regulations enforced by the FDA through its facilities inspection program. If these facilities cannot pass a pre-approval plant inspection, 
the  FDA  premarket  approval  of  our  product  candidates  will  not  be  granted.  In  complying  with  cGMP  and  foreign  regulatory 
requirements, we and any of our third-party manufacturers will be obligated to expend time, money and effort in production, record-
keeping and quality control to assure that our product candidates meet applicable specifications and other requirements. If we or any of 
our third-party manufacturers fail to comply with these requirements, we may be subject to regulatory action. No assurance can be given 
that we or our partners will be able to establish and operate such a production facility. 

Cellular products are not considered to be well characterized products because there are hundreds of markers present on T cells, and 
even small changes in manufacturing processes could alter the cell subtypes. It is unclear at this time which of those markers are critical 
for  success of T  cells  to  combat  cancer, so our  ability  to predict  the outcomes with newer manufacturing  processes  is  limited.  The 
changes that we may make to the existing manufacturing process may require additional testing, which may increase costs and timelines 
associated with these developments. In addition to developing a multi-antigen T cell-based therapy on existing adoptive T cell therapy 
technology, we are currently evaluating the desirability of conducting clinical trials of our product candidates in combination with other 
existing drugs. These combination therapies will require additional testing, and clinical trials will require additional FDA regulatory 
approval and will increase our future cost of development. 

Risks Related to our Reliance on Third Parties 

We may not realize the expected benefits from the transaction with Cell Ready. 

We may not be able to achieve the full strategic and financial benefits expected to result from the closing of the transaction with Cell 
Ready,  or  such  benefits  may  be  delayed  or  not  occur  at  all.  In  particular,  we  have  made  the  strategic  decision  to  dispose  of  our 
manufacturing  facilities  and related  assets  in order  to focus on  clinical development  of  the  multiTAA-specific T  cell  therapy-based 
product candidates in our pipeline. Following the closing of the transaction, we no longer operate our own cGMP manufacturing facility 
and must rely on Cell Ready and other third parties for the clinical and, if approved, commercial manufacture of our product candidates. 
Although we entered into an MSA with Cell Ready for manufacturing, among other services, we may not realize the anticipated cost 
savings  associated with  contracting out our  manufacturing,  and  research  and  development  requirements.  The  assumptions  we made 
related to the Cell Ready transaction may prove to be inaccurate, including as to the expected benefits of the transaction and anticipated 
cost savings. An inability to realize the anticipated benefits of the Cell Ready transaction could have an adverse impact on our business, 
financial condition and results of operations. 

Following the closing of the transaction with Cell Ready, we no longer operate our own cGMP manufacturing facility and instead 
will rely on third parties, including Cell Ready, for the clinical and, if approved, commercial manufacture of our product candidates. 
The third-party manufacturing facilities on which we rely may have limited capacity or fail to meet the applicable stringent regulatory 
requirements. 

We do not have any cGMP manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the cGMP 
manufacture of our product candidates for clinical development and, if approved, commercial supply. We have entered into a long-term 
agreement  with  Cell  Ready,  pursuant  to  which  Cell  Ready  will  perform  a  wide  variety  of  services  for  us,  including  research  and 
development, and manufacturing in support of our clinical trials. There is no guarantee that we will or have properly estimated our 
required manufacturing capacities or that the third parties we rely on to provide required machinery and materials for the manufacturing 
process  will be  able  to  perform on our proposed  timelines  or  meet our manufacturing  demands,  if  at  all.  Also,  if we must  increase 
production capacity for any reason, we may need to make considerable investments that could lead to significant financing needs or 
require us to enter into subcontracting agreements in order to outsource part of the production. 

39 

 
 
If Cell Ready or any other third-party contract manufacturing organization on which we rely ceases or reduces its business or experiences 
capacity constraints, other disruptions, or delays in manufacturing our multiTAA-specific T cell therapy-based product candidates, our 
planned clinical trials and necessary manufacturing capabilities will be disrupted or delayed. Third-party manufacturers may not be able 
to meet our needs concerning timing, quantity, or quality. Additionally, Cell Ready may engage, be engaged by, or otherwise enter into 
arrangements with our competitors. If we are unable to contract for a sufficient supply of needed materials on acceptable terms, or if we 
should encounter delays or difficulties in our relationships with manufacturers, our clinical trials may be delayed, thereby delaying the 
submission of product candidates for regulatory approval or the market introduction and subsequent sales of any approved products. 
Any such delay may lower our revenues and potential profitability. If any third-party breaches or terminates its agreement with us or 
fails to conduct its activities in a timely manner, the commercialization of our product candidates could be slowed down or blocked 
completely. It is possible that third parties relied upon by us will change their strategic focus, pursue alternative technologies, or develop 
alternative product candidates, either on their own or in collaboration with others, as a means for developing treatments for the diseases 
targeted by our collaborative programs, or for other reasons. The effectiveness of these third parties in marketing their own products 
may also affect our revenues and earnings. We intend to continue to enter into additional third-party agreements in the future. However, 
we may not be able to negotiate any additional agreements successfully. Even if established, these relationships may not be scientifically 
or commercially successful. 

The facilities used by our contract manufacturers to manufacture our product candidates must be inspected by the FDA. We do not have 
control over a supplier’s or manufacturer’s compliance with laws, regulations and applicable cGMP standards or similar regulatory 
requirements  and  other  laws  and  regulations,  such  as  those  related  to  environmental  health  and  safety  matters.  If  our  contract 
manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the 
FDA or other regulatory authorities, we may be unable to obtain regulatory approval of our marketing applications. In addition, we have 
no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. 
If the FDA or a comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture 
of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, 
which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. 

Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed 
on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, 
seizures or recalls of product candidates or drugs, operating restrictions, and criminal prosecutions, any of which could significantly and 
adversely affect supply of our products. 

These factors could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of our product 
candidates, cause us to incur higher costs and prevent us from commercializing our products successfully, if approved. Furthermore, if 
our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of production 
at a substantially equivalent cost, our clinical trials may be delayed, or we could lose potential revenue. 

40 

 
 
 
 
Our strategic relationship with BCM is dependent, in part, upon our ongoing relationship with key medical and scientific personnel 
and advisors. 

Our multiTAA-specific T cell therapy has been developed through our collaboration with the Center for Cell and Gene Therapy at BCM, 
founded  by  Malcolm  K.  Brenner,  M.D.,  Ph.D.,  a  recognized  pioneer  in  immuno-oncology.  Our  strategic  relationship  with  BCM  is 
dependent, in part, on our relationship with certain key employees and advisors, some of whom serve on our Scientific Advisory board, 
and  in  particular  Dr. Vera,  our  founder,  President  and  Chief  Executive  Officer  and  Principal  Financial  and  Accounting  Officer.  If 
Dr. Vera discontinues his employment with us, our relationship with BCM may deteriorate, and our business could be harmed. We may 
also be dependent on BCM facilities and personnel to conduct research and development and manufacturing activities in the future. 

Although we have an exclusive license agreement with BCM under which we received a worldwide, exclusive license to BCM’s rights 
in and to three patent families to develop and commercialize the multiTAA-specific T cell product candidates, we will need to enter into 
additional agreements with BCM with respect to (i) a strategic alliance to advance preclinical research, early stage clinical trials, and 
clinical trials with respect to our product candidates, as well as continued access to our clinical data, and (ii) support, including personnel 
and space at the institution for the foreseeable future. Any delays in entering into new strategic agreements with BCM related to our 
product candidates could delay the development, manufacture, and clinical trials of our product candidates. 

An important element of our intellectual property portfolio is to license additional rights and technologies from BCM. Our inability to 
license the rights and technologies that we have identified, or newly developed multiTAA-specific T cell technology that we may in the 
future identify, could have a material adverse impact on our ability to complete the development of our product candidates or to develop 
additional product candidates. No assurance can be given that we will be successful in licensing any additional rights or technologies 
from BCM and others. Failure to obtain additional rights and licenses may detrimentally affect our planned development of additional 
product  candidates  and  could  increase  the  cost,  and  extend  the  timelines  associated  with  our  development  of  such  other  product 
candidates. 

We may not be able to establish or maintain the third-party relationships, including strategic collaborations, that are necessary to 
develop, commercialize and/or market some or all of our product candidates. 

We expect to depend on collaborators, partners, licensees, clinical research organizations and other third parties to support our discovery 
efforts, to formulate product candidates to manufacture our product candidates and to conduct clinical trials for some or all of our product 
candidates.  We  cannot  guarantee  that  we  will  be  able  to  successfully  negotiate  agreements  for  or  maintain  relationships  with 
collaborators,  partners,  licensees,  clinical  investigators,  vendors  and  other  third  parties  on  favorable  terms,  if  at  all.  Our  ability  to 
successfully  negotiate  such  agreements  will  depend  on,  among  other  things,  potential  partners’  evaluation  of  the  superiority  of  our 
technology over competing technologies and the quality of the preclinical and clinical data that it has generated, and the perceived risks 
specific to developing our product candidates. If we are unable to obtain or maintain these agreements, we may not be able to clinically 
develop, formulate, manufacture, obtain regulatory approvals for or commercialize our product candidates. Management of any third-
party relationships will require significant time and effort from our management team, coordination of our research and development 
programs with the research and development priorities of our collaborators and effective allocation of our resources to multiple projects. 

If we continue to enter into research and development collaborations at the early phases of drug development, our success will in part 
depend on the performance of our corporate collaborators. We will not directly control the amount or timing of resources devoted by 
our corporate collaborators to activities related to our immunotherapies. Our corporate collaborators may not commit sufficient resources 
to  their  research  and  development  programs  or  the  commercialization,  marketing  or  distribution  of  their  immunotherapies.  If  any 
corporate collaborator fails to commit sufficient resources, our preclinical or clinical development programs related to this collaboration 
could  be  delayed  or  terminated.  Also,  our  collaborators  may  pursue  existing  or  other  development-stage  products  or  alternative 
technologies in preference to those being developed in collaboration with us. Finally, if we fail to make required milestones or royalty 
payments to our collaborators or to observe other obligations in our agreements with them, our collaborators may have the right to 
terminate those agreements. 

Our strategy includes eventual substantial reliance upon strategic collaborations for marketing and commercialization of our product 
candidates, and we may rely even more on strategic collaborations for research, development, marketing and commercialization of our 
other  immunotherapies.  If  we  are  unsuccessful  in  securing  such  strategic  collaborations,  we  may  be  unable  to  commercialize  any 
approved products as we have not yet licensed, marketed or sold any of our immunotherapies or entered into successful collaborations 
for these services in order to ultimately commercialize our immunotherapies. Establishing strategic collaborations is difficult and time-

41 

consuming. Our discussions with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. 
Potential collaborators may reject collaborations based upon their assessment of our financial, clinical, regulatory or intellectual property 
position.  If  we  successfully  establish  new  collaborations,  these  relationships  may  never  result  in  the  successful  development  or 
commercialization of our immunotherapies or the generation of sales revenue. To the extent that we enter into co-promotion or other 
collaborative arrangements, our product revenues are likely to be lower than if we directly marketed and sold any products that we may 
develop. 

Our  employees,  independent  contractors,  consultants,  commercial  partners  and  vendors  may  engage  in  misconduct  or  other 
improper activities, including noncompliance with regulatory standards and requirements. 

We  are  exposed  to  the  risk  of  employee  fraud  or  other  illegal  activity  by  our  employees,  independent  contractors,  consultants, 
commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to: 
comply with the laws of the FDA and other similar foreign regulatory bodies, provide true, complete and accurate information to the 
FDA and other similar foreign regulatory bodies, comply with manufacturing standards we have established, comply with healthcare 
fraud  and  abuse  laws  in  the  United  States  and  similar  foreign  fraudulent  misconduct  laws,  or  report  financial  information  or  data 
accurately  or  to  disclose  unauthorized  activities  to  us.  If  we  obtain  FDA  approval  of  any  of  our  product  candidates  and  begin 
commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs 
associated with compliance with such laws are also likely to increase. These laws may impact, among other things, our current activities 
with principal investigators and research patients, as well as proposed and future sales, marketing and education programs. In particular, 
the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, 
are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations 
may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer 
incentive  programs  and  other  business  arrangements  generally.  Activities  subject  to  these  laws  also  involve  the  improper  use  of 
information obtained in the course of patient recruitment for clinical trials. 

Efforts to ensure that our business arrangements comply with applicable healthcare laws may involve substantial costs. It is possible 
that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, 
regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted 
against us, and we are not successful in defending ourselves or in asserting our rights, those actions could have a significant impact on 
our business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, 
imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, 
reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our 
ability to develop our business. In addition, the approval and commercialization of any of our product candidates outside the United 
States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. 

Risks Related to the Commercialization of our Product Candidates 

Our  commercial  success  depends  upon  attaining  significant  market  acceptance  of  our  product  candidates,  if  approved,  among 
physicians, patients, healthcare payors and the medical community. 

Even if we obtain regulatory approval for our product candidates, they may not gain market acceptance among physicians, healthcare 
payors, patients or the medical community. Market acceptance of our product candidates, if we receive approval, depends on a number 
of factors, including the: 

• 

• 

• 

• 

• 

efficacy and safety of our product candidates as demonstrated in clinical trials and post-marketing experience; 

clinical indications for which our product candidates may be approved; 

acceptance by physicians and patients of our product candidates as safe and effective; 

potential and perceived advantages of our product candidates over alternative treatments; 

safety of our product candidates seen in a broader patient group, including our use outside the approved indications should 
physicians choose to prescribe for such uses; 

42 

• 

• 

• 

• 

• 

• 

• 

prevalence and severity of any side effects; 

product labeling, or product insert requirements of the FDA or other regulatory authorities; 

timing of market introduction of our product candidates as well as competitive products; 

cost in relation to alternative treatments; 

pricing and the availability of coverage and adequate reimbursement by third-party payors and government authorities; 

relative convenience and ease of administration; and 

effectiveness of any sales and marketing efforts. 

If our product candidates are approved but fail to achieve market acceptance among physicians, patients, healthcare payors and the 
medical community, we may not be able to generate significant revenues, which would compromise our ability to become profitable. 

The market for any products that we successfully develop will also depend on the cost of the product. We do not yet have sufficient 
information to reliably estimate what it will cost to commercially manufacture our current product candidates, and the actual cost to 
manufacture these products could materially and adversely affect the commercial viability of these products. Our goal is to reduce the 
cost of manufacturing our therapies. However, unless we are able to reduce those costs to an acceptable amount, we may never be able 
to develop a commercially viable product. If we do not successfully develop and commercialize products based upon our approach or 
find suitable and economical sources for materials used in the production of our products, we will not become profitable. 

Even if we are successful in getting market approval, commercial success of any of our product candidates will also depend in large part 
on the availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare 
and Medicaid programs and managed care organizations, which may be affected by existing and future health care reform measures 
designed to reduce the cost of health care. Third-party payors could require us to conduct additional studies, including post-marketing 
studies related to the cost effectiveness of a product, to qualify for reimbursement, which could be costly and divert our resources. If 
government and other health care payors were not to provide adequate coverage and reimbursement levels for any of our products if 
approved, market acceptance and commercial success would be reduced. 

Our multiTAA-specific T cell therapy may be provided to patients in combination with other agents provided by third parties. The cost 
of such combination therapy may increase the overall cost of multiTAA-specific T cell therapy and may result in issues regarding the 
allocation  of  reimbursements  between  our  therapy  and  the  other  agents,  all  of  which  may  adversely  affect  our  ability  to  obtain 
reimbursement coverage for the combination therapy from third-party medical insurers. 

Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well 
as pricing regulations. 

Significant uncertainty exists as to the coverage and reimbursement status of any pharmaceutical or biological product for which we 
obtain regulatory approval. Sales of any product depend, in part, on the extent to which such product will be covered by third-party 
payors,  such  as  federal,  state,  and  foreign  government  healthcare  programs,  commercial  insurance  and  managed  healthcare 
organizations,  and  the  level  of  reimbursement  for  such  product  by  third-party  payors.  In  the  United  States,  for  example,  principal 
decisions about reimbursement for new products are typically made by the Centers for Medicare & Medicaid Services, or CMS. CMS 
decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private third-party payors often 
follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination 
to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. 
Further, no uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ 
significantly from payor to payor. As a result, the coverage determination process is often time-consuming and costly. This process will 
require us to provide scientific and clinical support for the use of our products to each third-party payor separately, with no assurance 
that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. For products administered under 
the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices 

43 

often associated with such drugs. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the 
product is used may not be available, which may impact physician utilization. We cannot be sure that coverage and reimbursement will 
be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be. 

In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, 
including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Third-party 
payors are increasingly challenging the prices charged for medical products and services, examining the medical necessity and reviewing 
the cost effectiveness of pharmaceutical or biological products, medical devices and medical services, in addition to questioning safety 
and efficacy. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with 
existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a 
decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product. 

If we are unable to establish or sustain coverage and adequate reimbursement for any product candidates from third-party payors, the 
adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or 
sell those product candidates, if approved. Coverage policies and third-party payor reimbursement rates may change at any time. Even 
if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less 
favorable coverage policies and reimbursement rates may be implemented in the future. 

Our future success is highly dependent upon our key personnel, and our ability to attract, retain, and motivate additional qualified 
personnel. We will also be required to establish sales and marketing capabilities or enter into agreements with third parties to market 
and sell any approved products. 

Our ability to compete in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and 
retain  highly  qualified  managerial,  scientific,  and  medical  personnel.  We  are  highly  dependent  on  our  management,  scientific,  and 
medical  personnel  and  consultants,  including  Juan  Vera,  M.D.,  our  President,  Chief  Executive  Officer,  and  Principal  Financial  and 
Accounting Officer, as well as others. The loss of the services of any of our executive officer, other key employees, and other scientific 
and medical advisors, and our inability to find suitable replacements could result in delays in product development and harm to our 
business.  We  have  a  priority  to  quickly  train  additional  qualified  scientific  and  medical  personnel  to  ensure  the  ability  to  maintain 
business continuity. Any delays in training such personnel could delay the development, manufacture, and clinical trials of our product 
candidates. 

Our ability to attract and retain highly skilled personnel is critical to our operations and expansion. We face competition for these types 
of  personnel  from  other  biotechnology  companies  and  more  established  organizations,  many  of  which  have  significantly  larger 
operations and greater financial, technical, human and other resources than us. We may not be successful in attracting and retaining 
qualified personnel on a timely basis, on competitive terms, or at all. If we are not successful in attracting and retaining these personnel, 
or integrating them into our operations, our business, prospects, financial condition and results of operations will be materially adversely 
affected. In such circumstances, we may be unable to conduct certain research and development programs, unable to adequately manage 
our clinical trials and development of our product candidates, and unable to adequately address our management needs. 

We do not currently have an organization for the sale, marketing and distribution of any approved products and the cost of establishing 
and maintaining such an organization may exceed the cost-effectiveness of doing so. In order to market any products approved by the 
FDA or comparable foreign regulatory authorities, we must build our sales, marketing, managerial and other non-technical capabilities 
or make arrangements with third parties to perform these services. If we are unable to establish adequate sales, marketing and distribution 
capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable. 
We will be competing with many companies that currently have extensive and well-funded sales and marketing operations. Without an 
internal commercial organization or the support of a third - party to perform sales and marketing functions, we may be unable to compete 
successfully against these more established companies. 

44 

The  biotechnology  and  immunotherapy  industries  are  characterized  by  rapid  technological  developments  and  a  high  degree  of 
competition. We may be unable to compete with more substantial enterprises. 

The  biotechnology  and  biopharmaceutical  industries  are  characterized  by  rapid  technological  developments  and  a  high  degree  of 
competition. As a result, our actual or proposed immunotherapies could become obsolete before we recoup any portion of our related 
research and development and commercialization expenses. Competition in the biopharmaceutical industry is based significantly on 
scientific and technological factors. These factors include the availability of patent and other protection for technology and products, 
the ability to commercialize technological developments and the ability to obtain governmental approval for testing, manufacturing and 
marketing. We compete with specialized biopharmaceutical firms in the United States, Europe and elsewhere, as well as a growing 
number of large pharmaceutical companies that are applying biotechnology to their operations. Many biopharmaceutical companies 
have focused their development efforts in the human therapeutics area, including cancer. Many major pharmaceutical companies have 
developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies. 
These companies, as well as academic institutions, governmental agencies and private research organizations, also compete with us in 
recruiting and retaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies 
in the pharmaceutical field will also depend to a considerable degree on the continuing availability of capital to us. 

Potential  competitors  in  the  market  for  treating  hematological  malignancies  include  numerous  pharmaceutical  and  biotechnology 
companies, as well as academic institutions, private and public research institutions, and government agencies. Treatment of relapsed 
patients with lymphoma remains a challenge with relatively low overall survival rates. To date, there are four CD19-directed CAR T 
cell therapies (Yescarta, Kymriah, Tecartus, and Bryanzi) approved for patients with relapsed lymphoma. However, up to 60% of CD19 
CAR T cell treated patients will relapse, particularly in the third line setting (Chong EA et al, N Engl J Med, 2021). This highlights a 
significant  unmet  medical  need  for  alternative  and  more  effective  treatments.  Our  multiTAA-specific  T  cell  drug  candidates  may 
compete with product candidates from a number of companies, which are developing various types of immunotherapies to treat cancer, 
including non-CD19 targeting CAR T cells that target different antigens beyond CD19, multi-targeted CAR T cells as well as NK-CAR 
therapies. In addition, bispecific antibodies represent promising therapies for patients with lymphoma and provide competition in the 
oncology space. To date, MT-601 is the only natural T cell product that targets multiple tumor antigens being explored for CAR relapse 
patients with lymphoma. Therefore, MT-601 fills a void in the market by providing much needed treatment to patient population. Current 
and  potential  competitors may have  substantially  greater research  and development  capabilities  and financial, scientific,  regulatory, 
manufacturing,  marketing,  sales,  human  resources,  and  experience  than  we  do.  Many  of  our  competitors  have  several  therapeutic 
products that have already been developed, approved and successfully commercialized, or are in the process of obtaining regulatory 
approval for their therapeutic products in the United States and internationally. While these universities and public and private research 
institutions primarily have educational objectives, they may develop proprietary technologies that lead to other FDA approved therapies 
or that secure patent protection that we may need for the development of our technologies and product candidates. 

Even if we obtain regulatory approval for our lead product candidate, the availability and price of competitors’ products could limit the 
demand and the price we will be able to charge for our therapy. We may not be able to implement our business plan if the acceptance 
of our product candidates is inhibited by price competition or the reluctance of physicians to switch from other methods of treatment to 
our product, or if physicians switch to other new therapies, drugs or biologic products or choose to reserve our product candidates for 
use in limited circumstances. We are aware of certain investigational new drugs under development or approved products by competitors 
that are used for the prevention, diagnosis, or treatment of certain diseases we have targeted for drug development. Various companies 
are developing  biopharmaceutical  products that  have  the potential  to directly  compete with our  immunotherapies  even  though  their 
approach may be different. The competition comes from both biotechnology firms and from major pharmaceutical companies. Many of 
these companies have substantially greater financial, marketing, and human resources than us. We also experience competition in the 
development  of  our  immunotherapies  from  universities,  other  research  institutions  and  others  in  acquiring  technology  from  such 
universities and institutions. 

In addition, certain of our immunotherapies may be subject to competition from investigational new drugs and/or products developed 
using other technologies, some of which have completed numerous clinical trials. 

45 

The market opportunities for our product candidates may be limited to those patients who are ineligible for or have failed prior 
treatments and may be small. 

The FDA often approves new oncology therapies initially only for use in patients with relapsed or refractory metastatic disease. We 
expect to initially seek approval of our product candidates in this setting. Subsequently, for those product candidates that prove to be 
sufficiently beneficial, if any, we would expect to seek approval in earlier lines of treatment and potentially as a first line therapy. There 
is no guarantee, however, that our product candidates, even if approved, would be approved for earlier lines of therapy, and, prior to any 
such approvals, we may have to conduct additional clinical trials. 

Our projections of both the number of people who have the cancers we are targeting, as well as the subset of people with these cancers 
in a position to receive second or third-line therapy, and who have the potential to benefit from treatment with our product candidates, 
are based on our research and estimates. These estimates have been derived from a variety of sources, including scientific literature, 
surveys of clinics, patient foundations, or market research by third parties, and may prove to be incorrect. We do not have verifiable 
internal  marketing  data  regarding  the  potential  size  of  the  commercial  market  for  our  product  candidates,  nor  have  we  obtained 
independent marketing surveys to verify the potential size of the commercial markets for our current product candidates or any future 
product candidates. Further, new studies may change the estimated incidence or prevalence of these cancers. The number of treatable 
patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for our product candidates 
may be limited or may not be amenable to treatment with our product candidates and may also be limited by the cost of our treatments 
and the reimbursement of those treatment costs by third-party payors. For instance, we expect our lead product candidate to initially 
target patients with lymphoma that relapsed after anti-CD19 CAR T cell therapy. Even if we obtain significant market share for our 
product  candidates,  because  the  potential  target  populations  might  be  small,  we  may  not  achieve  profitability  without  obtaining 
regulatory  approval  for  additional  indications,  and  we  may  spend  large  amounts  of  money  trying  to  obtain  approval  for  product 
candidates that have an uncertain commercial market. 

New regulatory pathways for biosimilar competition could reduce the duration of market exclusivity for our products. 

Under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, 
the ACA, there is an abbreviated path in the United States for regulatory approval of products that are demonstrated to be “biosimilar” 
or  “interchangeable”  with  an  FDA-approved  biological  product.  The  ACA  provides  a  regulatory  mechanism  that  allows  for  FDA 
approval of biologic drugs that are similar to (but not generic copies of) innovative drugs on the basis of less extensive data than is 
required by a full BLA. Under this regulation, an application for approval of a biosimilar may be filed four years after approval of the 
innovator product. However, qualified innovative biological products will receive 12 years of regulatory exclusivity, meaning that the 
FDA  may  not  approve  a  biosimilar  version  until  12  years  after  the  innovative  biological  product  was  first  approved  by  the  FDA. 
However, the term of regulatory exclusivity may not remain at 12 years in the United States and could be shortened. A number of 
jurisdictions outside of the United States have also established abbreviated pathways for regulatory approval of biological products that 
are biosimilar to earlier versions of biological products. For example, the European Union has had an established regulatory pathway 
for biosimilars since 2005. 

The increased likelihood of biosimilar competition has increased the risk of loss of innovators’ market exclusivity. Due to this risk, and 
uncertainties  regarding  patent  protection,  if  one  of  our  late-stage  product  candidates  or  other  clinical  candidates  are  approved  for 
marketing, it is not possible to predict the length of market exclusivity for any particular product with certainty based solely on the 
expiration of the relevant patent(s) or the current forms of regulatory exclusivity. It is also not possible to predict changes in United 
States regulatory law that might reduce biological product regulatory exclusivity. The loss of market exclusivity for a product would 
likely materially and negatively affect revenues from product sales of that product and thus our financial results and condition. 

46 

If  product  liability  lawsuits  are  brought  against  us,  we  may  incur  substantial  liabilities  and  may  be  required  to  limit 
commercialization of our product candidates. 

We face an inherent risk of product liability as a result of the clinical testing of our product candidates and will face an even greater risk 
if we commercialize any products. For example, we may be sued if our product candidates cause or are perceived to cause injury or are 
found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include 
allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent to the product, negligence, strict liability 
or a breach of warranties. Claims could also be asserted under state consumer protection laws. If we cannot successfully defend ourselves 
against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. 
Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, 
liability claims may result in: 

• 

• 

decreased demand for our product candidates; 

injury to our reputation; 

•  withdrawal of clinical trial participants; 

• 

• 

• 

• 

• 

• 

• 

• 

initiation of investigations by regulators; 

costs to defend the related litigation; 

a diversion of management’s time and our resources; 

substantial monetary awards to trial participants or patients; 

product recalls, withdrawals or labeling, marketing or promotional restrictions; 

loss of revenue; 

exhaustion of any available insurance and our capital resources; and 

the inability to commercialize any product candidate. 

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims 
could inhibit or prevent the commercialization of products we develop, alone or with collaborators. Our insurance policies may also 
have various exclusions, and we may be subject to a product liability claim for which we have no insurance coverage. While we obtained 
clinical trial insurance for our clinical trials, we may have to pay amounts awarded by a court or negotiated in a settlement that exceed 
our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay 
such amounts. Even if our agreements with any future collaborators entitle us to indemnification against losses, such indemnification 
may not be available or adequate should any claim arise. 

The multiple roles of Dr. Vera, our President, Chief Executive Officer, and Principal Financial and Accounting Officer, could limit 
his time and availability to us, and create, or appear to create, conflicts of interest. 

Dr. Vera  is  a  co-founder  and  director  of  Allovir  Inc.,  or  Allovir.  Allovir  has  technology  which  is  being  developed  under  a  license 
agreement with BCM by the same research group at BCM. Allovir is a clinical-stage biopharmaceutical company that is investigating 
and developing virus-specific T cell therapy technology for the prevention and/or treatment of viral infections. 

Further, Dr. Vera has certain fiduciary or other obligations to us and certain fiduciary or other obligations to Allovir and BCM. Such 
multiple obligations may in the future result in a conflict of interest with respect to presenting other potential business opportunities to 
us or to Allovir. A conflict of interest also may arise concerning the timing and scope of the parties’ planned and ongoing clinical trials, 
investigational new drug application filings and the parties’ opportunities for marketing their respective product candidates, as well as 

47 

our intellectual property rights with those of Allovir. In addition, he may be faced with decisions that could have different implications 
for us than for Allovir. 

Risks Related to Our Intellectual Property 

If we are unable to protect our proprietary rights, we may not be able to compete effectively or operate profitably. 

Our commercial success is dependent in part on our ability to obtain, maintain, and enforce the patents and other proprietary rights that 
we have licensed and may develop, and on our ability to avoid infringing the proprietary rights of others. We generally seek to protect 
our  proprietary  position  by  filing  patent  applications  in  the  United  States  and  abroad  related  to  our  product  candidates,  proprietary 
technologies and their uses that are important to our business. Our patent applications cannot be enforced against third parties practicing 
the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued 
claims  are directed  to  the  technology.  There  can be no  assurance  that  our patent  applications or  those  of  our  licensor will  result  in 
additional patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor 
can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties. Even issued 
patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before 
various patent offices or in courts. The degree of future protection for our proprietary rights is uncertain. Only limited protection may 
be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. This failure to properly 
protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition 
and results of operations. 

We  seek  to  protect  our  proprietary  technology  and  processes,  in  part,  by  entering  into  confidentiality  agreements  with  relevant 
employees, consultants, scientific advisors, and contractors. We also seek to preserve the integrity and confidentiality of our data and 
trade secrets by maintaining physical security of the premises and physical and electronic security of the information technology systems. 
While we have confidence in these individuals, organizations, and systems, agreements or security measures may be breached, and we 
may not have adequate remedies for any breach. In addition, trade secrets may otherwise become known or be independently discovered 
by competitors. To the extent that the consultants, contractors or collaborators use intellectual property owned by others in their work 
for us, disputes may arise as to the rights in related or resulting know-how and inventions. 

Although  we have patents  and  patent  applications  in other  countries, we  cannot  be  certain  that  the  claims  in other pending  U.S. or 
European patent applications, international patent applications, and patent applications in certain other foreign territories directed to 
methods of generating multi-antigen specific T cell product candidates, or our other product candidates, will be considered patentable 
by the USPTO, courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that the claims 
in our issued licensed European patent will not be found invalid or unenforceable if challenged. 

Most of our intellectual property rights are currently licensed from BCM, so that the preparation and prosecution of these patents and 
patent  applications  was  not  performed  by  us  or  under  our  control.  Furthermore,  patent  law  relating  to  the  scope  of  claims  in  the 
biotechnology field in which we operate is still evolving and, consequently, patent positions in our industry may not be as strong as in 
other more well-established fields. The patent positions of biotechnology companies can be highly uncertain and involve complex legal 
and  factual  questions  for  which  important  legal  principles  remain  unresolved.  No  consistent  policy  regarding  the  breadth  of  claims 
allowed in biotechnology patents has emerged to date. The patent application process is subject to numerous risks and uncertainties, and 
there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by 
obtaining and defending patents. These risks and uncertainties include the following: 

• 

• 

• 

the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, 
fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse 
of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; 

patent applications may not result in any patents being issued; 

patents  that  may  be  issued  or  in-licensed  may  be  challenged,  invalidated,  modified,  revoked,  circumvented,  found  to  be 
unenforceable or otherwise may not provide any competitive advantage; 

48 

• 

• 

• 

our  competitors,  many  of  whom  have  substantially  greater  resources  than  us,  and  many  of  whom  have  made  significant 
investments  in  competing  technologies,  may  seek  or  may  have  already  obtained  patents  that  will  limit,  interfere  with  or 
eliminate our ability to make, use and sell our potential product candidates; 

there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent 
protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy 
regarding worldwide health concerns; and 

countries  other  than  the  United  States  may  have  patent  laws  less  favorable  to  patentees  than  those  upheld  by  U.S.  courts, 
allowing foreign competitors a better opportunity to create, develop and market competing product candidates. 

The patent prosecution process is also expensive and time-consuming, and we may not be able to file and prosecute all necessary or 
desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially 
advantageous. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too 
late  to  obtain  patent  protection.  Moreover,  in  some  circumstances,  we  may  not  have  the  right  to  control  the  preparation,  filing  and 
prosecution of patent applications, or to maintain the patents, directed to technology that we license from third parties. We may also 
require  the  cooperation  of  our  licensor  in  order  to  enforce  the  licensed  patent  rights,  and  such  cooperation  may  not  be  provided. 
Therefore,  these  patents  and  applications  may  not  be  prosecuted  and  enforced  in  a  manner  consistent  with  the  best  interests  of  our 
business. We cannot be certain that patent prosecution and maintenance activities by our licensor have been or will be conducted in 
compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that 
may issue from such applications. If they fail to do so, this could cause us to lose rights in any applicable intellectual property that we 
in-license, and as a result our ability to develop and commercialize products or product candidates may be adversely affected and we 
may be unable to prevent competitors from making, using and selling competing products. 

In addition, identification of third-party patent rights that may be relevant to our technology is difficult because patent searching is 
imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent 
claims. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability and it is uncertain how much 
protection, if any, will be given to the patents we have licensed from a licensor if either the licensor or we attempt to enforce the patents 
and/or if they are challenged in court or in other proceedings, such as oppositions, invalidations, or like proceedings, which may be 
brought in foreign jurisdictions to challenge the validity of a patent. A third - party may challenge our patents, if issued, or the patent 
rights that we license from others in the courts or patent offices in the United States and abroad. It is possible that a competitor may 
successfully challenge our patents or that a challenge will result in loss of exclusivity or in patent claims being narrowed, invalidated or 
held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical products, or limit the 
duration of the patent protection of our products and product candidates. Moreover, the cost of litigation to defend the validity of patents 
and to prevent or remedy infringement can be substantial. If the outcome of litigation is adverse to us, third parties may be able to use 
our patented invention without payment to us. Moreover, it is possible that competitors may infringe our patents or successfully avoid 
them through design innovation. To stop violation of our patent rights, we may need to file a lawsuit. These lawsuits are expensive and 
would consume time and other resources, even if we were successful in stopping or remedying the violation of our patent rights. In 
addition, there is a risk that a court would decide that our patents are not valid and that we do not have the right to stop the other party 
from using the inventions. There is also the risk that, even if the validity of our patents was upheld, a court would refuse to stop the 
other party on the ground that its activities are not covered by, that is, do not infringe, our patents. 

Should third parties file patent applications, or be issued patents claiming technology also used or claimed by our licensor(s) or by us in 
any future  patent  application,  we may be required  to participate  in  interference proceedings  in  the USPTO  to determine priority of 
invention for those patents or patent applications that are subject to the first-to-invent law in the United States, or may be required to 
participate in derivation proceedings in the USPTO for those patents or patent applications that are subject to the “first-inventor-to-file” 
law in the United States. We may be required to participate in such interference or derivation proceedings involving our issued patents 
and pending applications. We may be required to cease using the technology or to license rights from prevailing third parties as a result 
of an unfavorable outcome in an interference proceeding or derivation proceeding. A prevailing party in that case may not offer us a 
license on commercially acceptable terms or on any terms. 

49 

If we, our licensing partners, or any potential future collaborator initiates legal proceedings against a third - party to enforce a patent 
directed to one of our product candidates, the defendant could counterclaim that the patent is invalid and/or unenforceable in whole or 
in part. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. 
Grounds for a validity challenge include an alleged failure to meet any of several statutory requirements, including lack of novelty, non-
obviousness  or  enablement.  Grounds  for  an  unenforceability  assertion  could  include  an  allegation  that  someone  connected  with 
prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution. Third 
parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. 
Such  mechanisms  include  re-examination,  post  grant  review,  and  equivalent  proceedings  in  foreign  jurisdictions  (e.g.,  opposition 
proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they are no longer directed to 
our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable, and prior art could 
render  our  patents  or  those  of  our  licensor  invalid  or  could  prevent  a  patent  from  issuing  from  one  or  more  of  our  pending  patent 
applications. There is no assurance that all potentially relevant prior art relating to our patents and patent applications has been found. 
There  is  also  no  assurance  that  there  is  not  prior  art  of  which  we  are  aware,  but  which  we  do  not  believe  affects  the  validity  or 
enforceability of a claim in our patents and patent applications, which may, nonetheless, ultimately be found to affect the validity or 
enforceability of a claim. Furthermore, even if our patents are unchallenged, they may not adequately protect our intellectual property, 
provide  exclusivity  for  our  product  candidates,  prevent  others  from  designing  around  our  claims  or  provide  us  with  a  competitive 
advantage. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and 
perhaps all, of the patent protection on our product candidates. In addition, if the breadth or strength of protection provided by our 
patents  and  patent  applications  is  threatened,  it  could  dissuade  companies  from  collaborating  with  us  to  license,  develop  or 
commercialize current or future product candidates. Such a loss of patent protection could have a material adverse impact on our business 
development. 

The use of our technologies could potentially conflict with the rights of others. 

Our potential competitors or other entities may have or acquire patent or proprietary rights that they could enforce against our licensor. 
There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property 
rights  in  the  biotechnology  and  pharmaceutical  industries,  including  patent  infringement  lawsuits,  interferences,  oppositions, 
reexaminations, inter partes review proceedings and post-grant review, or PGR, proceedings before the USPTO and/or corresponding 
foreign patent offices. Numerous third-party U.S. and foreign issued patents and pending patent applications exist in the fields in which 
we are developing product candidates. There may be third-party patents or patent applications with claims to materials, formulations, 
methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Such potential third-party 
patents or patent applications could limit our ability to make, use, sell, offer for sale or import our product candidates and products that 
may be approved in the future, or impair our competitive position by requiring us to alter our product candidates, pay licensing fees or 
cease activities. 

As the biotechnology industry expands and more patents are issued, the risk increases that our product candidates may be subject to 
claims of infringement of the patent rights of third parties. Because patent applications are maintained as confidential for a certain period 
of time, until the relevant application is published we may be unaware of third-party patents that may be infringed by commercialization 
of any of our product candidates, and we cannot be certain that we were the first to file a patent application related to a product candidate 
or technology. Moreover, because patent applications can take many years to issue, there may be currently-pending patent applications 
that later issue as patents that our product candidates may infringe. If our product candidates conflict with patent rights of others, third 
parties could bring legal actions against us or our collaborators, licensees, suppliers or customers, claiming damages and seeking to 
enjoin manufacturing and marketing of the affected product candidates. If these legal actions are successful, in addition to any potential 
liability  for  damages,  we  could  be  required  to  obtain  a  license  in  order  to  continue  to  manufacture  or  market  the  affected  product 
candidates. We may not prevail in any legal action and a required license under the patent may not be available on acceptable terms or 
at all. 

Changes  in U.S.  patent  law could diminish  the  value of  patents  in general,  thereby  impairing our  ability  to  protect  our product 
candidates. 

As is the case with other biopharmaceutical companies, our success is dependent on intellectual property, particularly patents. Obtaining 
and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity, and is therefore costly, time-
consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and 
other countries may diminish the value of our intellectual property. We cannot predict the breadth of claims that may be allowed or 

50 

enforced in our patents or in third-party patents. For example, on September 16, 2011, the Leahy-Smith America Invents Act, or Leahy-
Smith  Act,  was  signed  into  law.  The  Leahy-Smith  Act  includes  a  number  of  significant  changes  to  U.S.  patent  law.  These  include 
provisions that affect the way patent applications are prosecuted and may also affect patent litigation. In particular, under the Leahy-
Smith Act, the United States transitioned in March 2013 to a “first inventor to file” system in which the first inventor to file a patent 
application will be entitled to the patent. Third parties are allowed to submit prior art before the issuance of a patent by the USPTO and 
may  become  involved  in  post-grant  proceedings  including  post  grant  review,  derivation,  reexamination, inter-partes review  or 
interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, 
proceeding or litigation could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our 
competitive position. In addition, recent U.S. Supreme Court rulings on several patent cases have narrowed the scope of patent protection 
available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty 
with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of 
patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations 
governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing 
patents and patents that we might obtain in the future. While we do not believe that any of the patents owned or licensed by us will be 
found invalid based on these decisions, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may 
impact the value of our patents. 

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the 
world. 

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, 
and our intellectual property rights in some countries outside the United States may be less extensive than those in the United States. In 
addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the 
United States. Consequently, we may not be able to prevent third parties from practicing its inventions in all countries outside the United 
States, or from selling or importing products made using its inventions in and into the United States or other jurisdictions. Competitors 
may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may 
export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United 
States. These products may compete with our products and patents or other intellectual property rights may not be effective or sufficient 
to prevent them from competing. 

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. 
The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets 
and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us 
to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings 
to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects 
of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing 
and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other 
remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights 
around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or 
license. 

For example, the complexity and uncertainty of European patent laws have also increased in recent years. In Europe, a new unitary 
patent system was introduced by the end of 2023, which significantly impacts European patents, including those granted before  the 
introduction of such a system. Under the unitary patent system, European applications will have the option, upon grant of a patent, of 
becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court, or UPC. As the UPC is a new court 
system, there is no precedent for the court, increasing the uncertainty of any litigation. Patents granted before the implementation of the 
UPC will have the option of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries. Patents 
that  remain  under  the  jurisdiction  of  the  UPC  will  be  potentially  vulnerable  to  a  single  UPC-based  revocation  challenge  that,  if 
successful, could invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the long-term 
effects of any potential changes. 

51 

We  may  be  subject  to  claims  that  our  employees,  consultants  or  independent  contractors  have  wrongfully  used  or  disclosed 
confidential information of third parties. 

As is common in the biotechnology and pharmaceutical industries, in addition to our employees, we engage the services of consultants 
to assist us in the development of our product candidates. We have received confidential and proprietary information from third parties. 
We employ individuals or engage consultants who were previously employed at other biotechnology or pharmaceutical companies. We 
may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or 
disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessary to defend 
against these claims. Even if we are successful in defending against these claims, litigation could result in substantial cost and be a 
distraction to our management and employees. 

If we fail to comply with any obligations under our existing license agreements or any future license agreements, or disputes arise 
with respect to those agreements, it could have a negative impact on our business and our intellectual property rights. 

We are a party to license agreements with BCM that impose, and we may enter into additional licensing arrangements with third parties 
that may impose, diligence, development and commercialization timelines, milestone payment, royalty, insurance and other obligations 
on us. Our rights to use the licensed intellectual property are subject to the continuation of and our compliance with the terms of these 
agreements. Disputes may arise regarding our rights to intellectual property licensed to us from a third - party, including but not limited 
to: 

• 

• 

• 

• 

• 

• 

• 

• 

the scope of rights granted under the license agreement and other interpretation-related issues; 

the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the 
licensing agreement; 

the sublicensing of patent and other rights; 

our diligence obligations under the license agreement and what activities satisfy those diligence obligations; 

the ownership of inventions and know-how resulting from the creation or use of intellectual property by us, alone or with our 
licensors and collaborators; 

the scope and duration of our payment obligations; 

our rights upon termination of such agreement; and 

the scope and duration of exclusivity obligations of each party to the agreement. 

If disputes over intellectual property and other rights that we have licensed or acquired from third parties prevent or impair our ability 
to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the 
affected product candidates. If we fail to comply with our obligations under current or future licensing agreements, these agreements 
may be terminated or the scope of our rights under them may be reduced and we might be unable to develop, manufacture or market 
any product that is licensed under these agreements. 

Under our license agreement with BCM for our multiTAA-specific T cell therapy technologies, we are currently required to pay both 
substantial milestone payments and royalties to BCM based on our revenues from sales of any approved products utilizing the licensed 
technologies,  and  these  payments  could  adversely  affect  the  overall  profitability  for  us  of  any  products  that  we  may  seek  to 
commercialize.  In  order  to  maintain  our  license  rights  under  the  BCM  license  agreement,  we  will  need  to  meet  certain  specified 
milestones, subject to certain cure provisions, in the development of our product candidates. 

In  addition,  upon  a  liquidity  event  (as  defined  in  our  BCM  license  agreement  with  BCM)  of  the  licensee  under  the  BCM  license 
agreement (which, the licensee shall be the Company), BCM will receive a liquidity incentive payment of 0.5% of the liquidity event 

52 

proceeds (as defined in the BCM license agreement) received by such licensee or its stockholders in the liquidity event, thereby diluting 
the amount of proceeds available to the licensee or its stockholders in a liquidity event. 

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property. 

We may be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or 
other intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. 
If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Such 
an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation 
could result in substantial costs and distraction to management and other employees. 

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. 

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 
20 years from its earliest U.S. non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection 
it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be subject 
to competition from competitive products, including biosimilars. Given the amount of time required for the development, testing and 
regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are 
commercialized.  As  a  result,  our  owned  and  licensed  patent  portfolio  may  not  provide  sufficient  rights  to  exclude  others  from 
commercializing products similar or identical to our product candidates. 

Certain of our technologies are in-licensed from third parties, and the protection of those technologies is not entirely within our 
control. 

We have a world-wide exclusive license from BCM of the rights in and to three patent families to develop and commercialize multiTAA-
specific T cell product candidates in the field of oncology. As a result of these in-licenses, we could lose the right to develop each of the 
technologies if: 

• 

the owner (s) of the patent rights underlying the technologies that we license do not properly maintain or enforce the patents 
and intellectual property underlying those properties, 

•  BCM seeks to terminate our license in contravention of the license agreements; 

•  we fail to make all payments due and owing under any of the licenses; or 

•  we fail to obtain on commercially reasonable terms, if at all, in-licenses from BCM or others for other rights that are necessary 

to develop the technology that we have already in-licensed. 

If any of the above occurs, we could lose the right to use the in-licensed intellectual property, which would adversely affect our ability 
to commercialize our technologies, products or services. The loss of any current or future licenses from BCM, or the exclusivity rights 
provided by such license agreements, could materially harm our financial condition and operating results. 

53 

We rely upon patents and licensed technologies to protect our technology. We may be unable to protect our intellectual property 
rights, and we may be liable for infringing the intellectual property rights of others. 

Our ability to compete effectively depends on our ability to maintain the proprietary nature of our technologies and the proprietary 
technology of others with whom we have entered into collaboration and licensing agreements. We own or hold licenses to a number of 
issued patents and U.S. pending patent applications, as well as foreign patents and foreign counterparts. Our success depends in part on 
our ability to obtain patent protection both in the United States and abroad for our product candidates, as well as the methods for treating 
patients in the product indications using these product candidates. Such patent protection is costly to obtain and maintain, and sufficient 
funds might not be available. Our ability to protect our product candidates from unauthorized or infringing use by third parties depends 
in substantial part on our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the 
patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, 
our ability to obtain, maintain and enforce patents is uncertain and involves complex legal and factual questions. Even if our product 
candidates, as well as methods for treating patients for prescribed indications using these product candidates are covered by valid and 
enforceable patents and have claims with sufficient scope, disclosure and support in the specification, the patents will provide protection 
only for a limited amount of time. Accordingly, rights under any issued patents may not provide us with sufficient protection for our 
product candidates or provide sufficient protection to afford us a commercial advantage against competitive products or processes. 

In addition, we cannot guarantee that any patents will be issued from any pending or future patent applications owned by or licensed to 
us.  Even  if patents  have been  issued or  will  be  issued, we  cannot  guarantee  that  the  claims  of  these patents  are  or will  be  valid or 
enforceable or will provide us with any significant protection against competitive products or otherwise be commercially valuable to us. 
The laws of some foreign jurisdictions do not protect intellectual property rights to the same extent as in the United States and many 
companies  have  encountered  significant  difficulties  in  protecting  and  defending  such  rights  in  foreign  jurisdictions.  Furthermore, 
different countries have different procedures for obtaining patents, and patents issued in different countries offer different degrees of 
protection against use of the patented invention by others. If we encounter such difficulties in protecting or are otherwise precluded from 
effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed. 

The patent positions of biotechnology and pharmaceutical companies, including our patent positions, involve complex legal and factual 
questions,  and,  therefore,  validity  and  enforceability  cannot  be  predicted  with  certainty.  Patents  may  be  challenged,  deemed 
unenforceable, invalidated, or circumvented. Our patents can be challenged by our competitors who can argue that our patents are invalid 
and/or  unenforceable,  or  that  the  patent  claims  should  be  limited  or  narrowly  construed.  Patents  also  will  not  protect  our  product 
candidates if competitors devise ways of making or using these product candidates without infringing our patents. We will be able to 
protect our proprietary rights from unauthorized use by third parties only to the extent that our technologies, methods of treatment, 
product candidates, and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets 
and we have the funds to enforce our rights, if necessary. 

The expiration of our owned or licensed patents before completing the research and development of our product candidates and receiving 
all required approvals in order to sell and distribute the products on a commercial scale can adversely affect our business and results of 
operations. 

54 

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensor, which could be expensive, time-
consuming and unsuccessful. 

We may face legal claims involving stockholders, consumers, competitors, entities from whom we license technology, entities with 
whom  we  collaborate,  persons  claiming  that  we  are  infringing  on  their  intellectual  property  and  others.  The  biotechnology  and 
pharmaceutical industries have been characterized by extensive litigation regarding patents and other intellectual property rights, and 
companies have employed intellectual property litigation to gain a competitive advantage. Competitors may infringe our intellectual 
property rights or those of our licensor. To counter infringement or unauthorized use, we may be required to file infringement claims, 
which can be expensive and time-consuming. In addition, in a patent infringement proceeding, a court may decide that one or more of 
the patents which we own or in-license is not valid or is unenforceable, and/or is not infringed. An adverse result in any litigation or 
defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and 
could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial 
litigation expense and would be a substantial diversion of employee resources from our business. In addition, litigation may be necessary 
to enforce our issued patents, to protect our trade secrets and know-how, or to determine the enforceability, scope, and validity of the 
proprietary rights of others. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may 
not be commercially meaningful. In the event of a successful claim of infringement against us, we may have to pay substantial damages, 
including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or 
redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on any issued patent and/or pending patent 
applications will be due to the USPTO and foreign patent agencies in several stages over the lifetime of our patents and/or applications. 
The  USPTO  and  various  foreign  governmental  patent  agencies  require  compliance  with  a  number  of  procedural,  documentary,  fee 
payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to 
help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with 
rules applicable to the particular jurisdiction. However, there are situations in which noncompliance can result in abandonment or lapse 
of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events 
that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official 
actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. In such an 
event, our competitors might be able to enter the market, which would have a material adverse effect on our business development. 

Interference  or  derivation  proceedings  provoked  by  third  parties  or  brought  by  us  or  declared  by  the  USPTO  may  be  necessary  to 
determine the priority of inventions with respect to our patents or patent applications or those of our licensor. Should third parties file 
patent applications or be issued patents claiming technology also used or claimed by us, we may be required to participate in interference 
or  derivation  proceedings  in  the  USPTO  to  determine  priority  of  invention.  We  may  be  required  to  participate  in  interference  or 
derivation proceedings involving our issued patents and pending applications. An unfavorable outcome could require us to cease using 
the related technology or to attempt to license rights from the prevailing party. Our business could be harmed if the prevailing party 
does not offer us a license on commercially acceptable terms. 

The costs of litigation or any proceeding relating to our intellectual property or contractual rights could be substantial even if resolved 
in our favor. Some of our competitors or financial funding sources have far greater resources than we do and may be better able to afford 
the costs of complex legal procedures. Also, in a lawsuit for infringement or contractual breaches, even if frivolous, we will require 
considerable time commitments on the part of management, our attorneys and consultants. Defending these types of proceedings or 
legal actions involve considerable expense and could negatively affect our financial results. 

We may be unable to adequately prevent disclosure of trade secrets and other proprietary information. 

We also rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate 
or  obtainable.  However,  trade  secrets  are  difficult  to  protect.  We  rely  in  part  on  confidentiality  agreements  with  our  employees, 
consultants, outside scientific collaborators, sponsored researchers, and other advisors to protect our trade secrets and other proprietary 
information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate 
remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade 
secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our 
proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position. 

55 

If we are unable to obtain licenses needed for the development of our product candidates, or if we breach any of the agreements 
under  which  we  license  rights  to  patents  or  other  intellectual  property  from  third  parties,  we  could  lose  license  rights  that  are 
important to our business. 

If we are unable to maintain and/or obtain licenses needed for the development of our product candidates in the future, we may have to 
develop alternatives to avoid infringing on the patents of others, potentially causing increased costs and delays in product development 
and introduction or precluding the development, manufacture, or sale of planned product candidates. Some of our licenses provide for 
limited periods of exclusivity that require minimum license fees and payments and/or may be extended only with the consent of the 
licensor. We might not meet these minimum license fees in the future, or these third parties might not grant extensions on any or all 
such licenses. This same restriction may be contained in licenses obtained in the future. 

Additionally, the patents underlying the licenses might not be valid and enforceable. To the extent any product candidates developed by 
us are based on licensed technology, royalty payments on the licenses will reduce our gross profit from such product sales and may 
render the sales of such product candidates uneconomical. In addition, the loss of any current or future licenses or the exclusivity rights 
provided therein could materially harm our business financial condition and our operations. 

Risks Related to Government Regulation 

We are subject to extensive regulation, which can be costly, time consuming and can subject us to unanticipated delays. Even if we 
receive regulatory approval of our product candidates, we will be subject to ongoing quality and regulatory obligations and continued 
regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with 
regulatory requirements or experience unanticipated problems with our product candidates. 

All of our current and future product candidates, cell processing and manufacturing activities, are subject to comprehensive regulation 
by the FDA in the United States and by comparable authorities in other countries. The process of obtaining FDA and other required 
regulatory approvals, including foreign approvals, is expensive and often takes many years and can vary substantially based upon the 
type, complexity and novelty of the products involved. In addition, regulatory agencies may lack experience with our technologies and 
product  candidates,  which  may  lengthen  the  regulatory  review  process,  increase  our  development  costs  and  delay  or  prevent  their 
commercialization.  

No adoptive T cell therapy using multiTAA-specific T cells has been approved for marketing in the U.S. by the FDA. Consequently, 
there is no precedent for the successful commercialization of products based on our technologies. In addition, we have had only limited 
experience in filing and pursuing applications necessary to gain regulatory approvals, which may impede our ability to obtain timely 
FDA  approvals,  if  at  all.  We  have  not  yet  sought  FDA  approval  for  any  adoptive  T  cell  therapy  product.  We  will  not  be  able  to 
commercialize any of our potential product candidates until we obtain FDA approval, and so any delay in obtaining, or inability to 
obtain, FDA approval would harm our proposed business. 

If we violate regulatory requirements at any stage, whether before or after marketing approval is obtained, we may be fined, forced to 
remove a product from the market and experience other adverse consequences including delay, which could materially harm our business 
development. Additionally, we may not be able to obtain the labeling claims necessary or desirable for the promotion of our products. 
We may also be required to undertake post-marketing trials. Prescription drugs may be promoted only for the approved indications in 
accordance with the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion 
of off-label uses, and a company that is found to have improperly promoted off-label may be subject to significant liability. However, 
physicians  may,  in  their  independent  medical  judgment,  prescribe  legally  available  products  for  off-label  uses.  The  FDA  does  not 
regulate the behavior of physicians in their choice of treatment but the FDA does restrict manufacturer’s communications on the subject 
of off-label use of their products. In addition, if we or others identify side effects after any of our adoptive T cell therapy products are 
on the market, or if manufacturing problems occur, regulatory approval may be withdrawn, and reformulation of our products may be 
required. 

56 

Any regulatory approvals that we receive for our product candidates will require surveillance to monitor the safety and efficacy of the 
product candidate. The FDA may also require a risk evaluation and mitigation strategy in order to approve our product candidates, which 
could entail requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as 
restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or a comparable foreign 
regulatory  authority  approves  our  product  candidates,  the  manufacturing  processes,  labeling,  packaging,  distribution,  adverse  event 
reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and 
ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, 
registration,  as  well  as  continued  compliance  with  cGMPs  and  cGCPs  for  any  clinical  trials  that  we  conduct  post-approval.  Later 
discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, 
or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in, 
among other things: 

• 

• 

• 

• 

• 

restrictions  on  the  marketing  or  manufacturing  of  our  product  candidates,  withdrawal  of  the  product  from  the  market,  or 
voluntary or mandatory product recalls; 

fines, warning letters or holds on clinical trials; 

refusal  by  the  FDA  to  approve  pending  applications  or  supplements  to  approved  applications  filed  by  us  or  suspension  or 
revocation of license approvals; 

product seizure or detention, or refusal to permit the import or export of our product candidates; and 

injunctions or the imposition of civil or criminal penalties. 

The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could 
prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government 
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable 
to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory 
compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability. 

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful 
in obtaining regulatory approval of our product candidates in other jurisdictions. 

Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to 
obtain  or  maintain  regulatory  approval  in  any  other  jurisdiction,  while  a  failure  or  delay  in  obtaining  regulatory  approval  in  one 
jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing 
approval  of  a  product  candidate,  comparable  regulatory  authorities  in  foreign  jurisdictions  must  also  approve  the  manufacturing, 
marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve 
requirements  and  administrative  review  periods  different  from,  and  greater  than,  those  in  the  United  States,  including  additional 
preclinical studies or clinical trials as clinical studies conducted in one jurisdiction may not be accepted by regulatory authorities in 
other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it 
can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval. 

We may also submit marketing applications in other countries. Regulatory authorities in jurisdictions outside of the United States have 
requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign 
regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us 
and could delay or prevent the introduction of our products in certain countries. If we fail to comply with the regulatory requirements in 
international markets and/or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize 
the full market potential of any approved product candidates will be harmed. 

57 

Any relationships with healthcare professionals, principal investigators, consultants, customers (actual and potential) and third-
party payors in connection with our current and future business activities are and will continue to be subject, directly or indirectly, 
to federal and state healthcare laws. If we are unable to comply, or have not fully complied, with such laws, we could face penalties, 
contractual damages, reputational harm, diminished profits and future earnings and curtailment or restructuring of our operations. 

Our  business operations  and  activities  may  be  directly, or  indirectly,  subject  to  various  federal  and  state  healthcare  laws,  including 
without  limitation,  fraud  and  abuse  laws,  false  claims  laws,  data  privacy  and  security  laws,  as  well  as  transparency  laws  regarding 
payments or other items of value provided to healthcare providers. These laws may restrict or prohibit a wide range of business activities, 
including, but not limited to, research, manufacturing, distribution, pricing, discounting, marketing and promotion, sales commission, 
customer incentive programs and other business arrangements. These laws may impact, among other things, our current activities with 
principal investigators and research subjects, as well as current and future sales, marketing, patient co-payment assistance and education 
programs. 

Such laws include: 

• 

• 

• 

the  federal  Anti-Kickback  Statute  which  prohibits,  among  other  things,  persons  and  entities  from  knowingly  and  willfully 
soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in 
return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which 
payment may be made under a federal healthcare program such as Medicare and Medicaid; 

the federal civil and criminal false claims laws, including the federal civil False Claims Act, and civil monetary penalties laws, 
which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or 
causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement 
to avoid, decrease or conceal an obligation to pay money to the federal government; 

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability 
for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to 
healthcare matters; 

•  HIPAA,  as  amended  by  the  Health  Information  Technology  for  Economic  and  Clinical  Health  Act,  or  HITECH,  and  its 
implementing  regulations,  which  also  imposes  obligations,  including  mandatory  contractual  terms,  on  covered  entities, 
including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that 
create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as 
their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable 
health information; 

• 

• 

the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical 
supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific 
exceptions, to report annually to CMS, information related to payments or other transfers of value made to physicians (defined 
to  include  doctors,  dentists,  optometrists,  podiatrists  and  chiropractors),  other  health  care  professionals)(such  as  physician 
assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests 
held by physicians and their immediate family members; and  

analogous state, local, and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to 
sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third - 
party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical 
industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state 
laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and 
other  healthcare  providers  or  marketing  expenditures  or  drug  pricing;  state  and  local  laws  that  require  the  registration  of 
pharmaceutical sales representatives; state and local “drug takeback” laws and regulations; and state and foreign laws governing 
the privacy and security of health information in some circumstances, many of which differ from each other in significant ways 
and often are not preempted by HIPAA, thus complicating compliance efforts. 

58 

Efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. While our 
interactions  with  healthcare  professionals  have  been  structured  to  comply  with  these  laws  and  related  guidance,  it  is  possible  that 
governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, 
regulations or case law interpreting applicable fraud and abuse or other healthcare laws. If our operations or activities are found to be in 
violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to, without 
limitation,  significant  civil,  criminal  and  administrative  penalties,  damages,  monetary  fines,  disgorgement,  imprisonment,  possible 
exclusion  from  participation  in  Medicare,  Medicaid  and  other  federal  healthcare  programs,  additional  reporting  requirements  and 
oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with 
these  laws,  contractual  damages,  reputational  harm,  diminished  profits  and  future  earnings  and  curtailment  or  restructuring  of  our 
operations, any of which could adversely affect our ability to operate. 

In  addition,  any  sales  of our product once  commercialized  outside  the U.S. will  also  likely  subject  us  to  foreign  equivalents of  the 
healthcare laws mentioned above, among other foreign laws. 

Recently enacted and future legislation in the United States and other countries may affect the prices we may obtain for our product 
candidates and increase the difficulty and cost to commercialize our product candidates. 

In the United States and many other countries, rising healthcare costs have been a concern for governments, patients and the health 
insurance sector, which has resulted in a number of changes to laws and regulations, and may result in further legislative and regulatory 
action regarding the healthcare and health insurance systems that could affect our ability to profitably sell any product candidates for 
which we have obtained marketing approval. 

For example, the ACA was enacted in the United States in March 2010, with the stated goals of containing healthcare costs, improving 
quality and expanding access to healthcare, and includes measures to change health care delivery, increase the number of individuals 
with  insurance,  ensure  access  to  certain  basic  health  care  services,  and  contain  the  rising  cost  of  care.  There  have  been  judicial, 
Congressional and executive branch challenges to certain aspects of the ACA. For example, Congress considered legislation that would 
repeal  or  repeal  and  replace  all  or  part  of  the  ACA.  While  Congress  has  not  passed  repeal  legislation,  several  bills  affecting  the 
implementation of certain taxes under the ACA have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision that 
repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to 
maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. Additionally, the 
2020  federal  spending  package  permanently  eliminated,  effective  January 1,  2020,  the  ACA-mandated  “Cadillac”  tax  on  high-cost 
employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health insurer tax. On 
June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its 
entirety because the “individual mandate” was repealed by Congress. Further, on August 16, 2022, President Biden signed the Inflation 
Reduction  Act  of  2022,  or  IRA,  into  law,  which  among  other  things,  extends  enhanced  subsidies  for  individuals  purchasing  health 
insurance coverage in ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D 
program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer 
discount program. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is also unclear how 
such challenges and the healthcare reform measures of the Biden administration will impact the ACA and our business. 

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In addition, other federal health reform measures have been proposed and adopted in the United States. For example, as a result of the 
Budget  Control  Act  of  2011  and  subsequent  legislative  amendments  thereto,  including  the  Infrastructure  Investment  and  Jobs  Act, 
providers are subject to Medicare payment reductions of 2% per fiscal year until 2031, unless additional Congressional action is taken. 
Under current legislation the actual reduction in Medicare Payments will vary from 1% in 2022 to up to 3% in the fiscal year of this 
sequester. Further, the American Taxpayer Relief Act of 2012 reduced Medicare payments to several providers and increased the statute 
of limitations period for the government to recover overpayments to providers from three to five years. The Medicare Access and CHIP 
Reauthorization Act of 2015 ended the use of the statutory formula, also referred to as the Sustainable Growth Rate, for clinician payment 
and also introduced a quality payment program, or the Quality Payment Program, under which certain individual Medicare providers 
will  be  subject  to  certain  incentives  or  penalties  based  on  new  program  quality  standards.  This  Quality  Payment  Program  provides 
clinicians with two ways to participate, including through the Advanced Alternative Payment Models, or APMs, and the Merit-based 
Incentive Payment System, or MIPS. In November 2019, CMS issued a final rule finalizing the changes to the Quality Payment Program. 
It is still unclear how the introduction of the Quality Payment Program will impact overall physician reimbursement under the Medicare 
program. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments 
from private payors. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which 
eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and 
innovator multiple source drugs, beginning January 1, 2024. 

Also,  there  has  been  heightened  governmental  scrutiny  recently  over  pharmaceutical  pricing  practices  in  light  of  the  rising  cost  of 
prescription drugs and biologics. Such scrutiny has resulted in several recent Congressional inquiries and proposed and enacted federal 
and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing 
and manufacturer patient programs, and reform government program reimbursement methodologies for products. At the federal level, 
for example, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” 
with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, the Department of 
Health and Human Services, or HHS, released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug 
pricing  reform  and  sets out  a  variety of potential  legislative  policies  that  Congress  could pursue  as well  as  potential  administrative 
actions HHS can take to advance these principles. In addition, the IRA, among other things (i) directs HHS to negotiate the price of 
certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposes rebates under Medicare Part B and 
Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 
2023, although they may be subject to legal challenges. It is currently unclear how the IRA will be implemented but it is likely to have 
a significant impact on the pharmaceutical industry. In addition, the Biden administration released an additional executive order on 
October 14, 2022, directing HHS to report on how the Center for Medicare and Medicaid Innovation can be further leveraged to test 
new models for lowering drug costs for Medicare and Medicaid beneficiaries.  

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and 
biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and 
marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and 
bulk purchasing. 

The combination of healthcare cost containment measures, increased health insurance costs, reduction of the number of people with 
health insurance coverage, as well as future legislation and regulations focused on reducing healthcare costs by reducing the cost of, or 
reimbursement and access to, pharmaceutical products, may limit or delay our ability to commercialize our products, generate revenue 
or attain profitability. 

As  described  above,  the  ACA  and  potential  regulations  thereunder  easing  the  entry  of  competing  follow-on  biologics  into  the 
marketplace, other new legislation or implementation of existing statutory provisions on importation of lower-cost competing drugs 
from other jurisdictions, and legislation on comparative effectiveness research are examples of previously enacted and possible future 
changes in laws that could adversely affect our business. 

We expect that additional state and federal healthcare reform measures will continue to be adopted in the future. While it is not possible 
to predict whether and when any such changes will occur, changes in the laws, regulations, and policies governing the development and 
approval  of  our  product  candidates  and  the  commercialization,  importation,  and  reimbursement  of  our  product  candidates  could 
adversely affect our business. 

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We are subject to stringent and changing laws, regulations, rules, contractual obligations, policies and other obligations related to 
data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or 
regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss 
of revenue or profits; loss of customers or sales; and other adverse business consequences. 

In the ordinary course of our business, we may collect, receive, store, process, generate, use, transmit, disclose, make accessible, protect, 
secure, dispose of, share (collectively, processing) personal data and other sensitive data, including proprietary and confidential business 
data, intellectual property, trade secrets, data regarding clinical trial subjects, and sensitive third-party data. We may rely on third parties 
(such as service providers) for our data processing-related activities. Our data processing activities subject us to numerous data privacy 
and  security  obligations,  such  as  various  laws,  regulations,  guidance,  industry  standards,  external  and  internal  privacy  and  security 
policies, contracts, and other obligations that govern the processing of personal data by us and on our behalf. 

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach 
notification laws, personal data privacy laws, and consumer protection laws. For example, HIPAA, as amended by HITECH, imposes 
specific requirements relating to the privacy, security, and transmission of individually identifiable health information. Additionally, the 
California Consumer Privacy Act of 2018, or CCPA, applies to personal data of consumers, business representatives, and employees, 
and requires businesses to provide specific disclosures in privacy notices and honor requests of California residents to exercise certain 
privacy rights. The CCPA provides for civil penalties of up to $7,500 per violation and allows private litigants affected by certain data 
breaches to recover significant statutory damages. Although the CCPA exempts some data processed in the context of clinical trials, the 
CCPA increases compliance costs and potential liability with respect to other personal data we maintain about California residents. In 
addition, California Privacy Rights Act of 2020, or CPRA, expands the CCPA’s requirements, including by adding a new right for 
individuals to correct their personal data and establishing a new regulatory agency to implement and enforce the law. Other states, such 
as Virginia and Colorado, have also passed comprehensive privacy laws, and similar laws are being considered in several other states, 
as well as at the federal and local levels. While these states, like the CCPA, also exempt some data processed in the context of clinical 
trials, these developments further complicate compliance efforts and increase legal risk and compliance costs for us and the third parties 
upon whom we rely. Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy 
and security. For example, the European Union’s General Data Protection Regulation (“EU GDPR”), the United Kingdom’s GDPR 
(“UK GDPR”), Brazil’s General Data Protection Law (Lei Geral de Proteção de Dados Pessoais, or “LGPD”) (Law No. 13,709/2018), 
and China’s Personal Information Protection Law (“PIPL”) impose strict requirements for processing personal data. For example, under 
the EU GDPR, companies may face temporary or definitive bans on data processing and other corrective actions, fines of up to 20 million 
euros or 4% of annual global revenue, whichever is greater, or private litigation related to processing of personal data brought by classes 
of data subjects or consumer protection organizations authorized at law to represent their interests. 

We are also bound by contractual obligations related to data privacy and security, and our efforts to comply with such obligations may 
not be successful. For example, certain privacy laws, such as the CCPA, require our customers to impose specific contractual restrictions 
on their service providers. We publish privacy policies, marketing materials and other statements, regarding data privacy and security. 
If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of our 
practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences. Obligations related to 
data privacy and security are quickly changing, becoming increasingly stringent, and creating regulatory uncertainty. Additionally, these 
obligations  may  be  subject  to  differing  applications  and  interpretations,  which  may  be  inconsistent  or  conflict  among  jurisdictions. 
Preparing for and complying with these obligations requires us to devote significant resources, which may necessitate changes to our 
services, information technologies, systems, and practices and to those of any third parties that process personal data on our behalf. 

We may at times fail (or be perceived to have failed) in our efforts to comply with our data privacy and security obligations. Moreover, 
despite our efforts, our personnel or third parties on whom we rely may fail to comply with such obligations, which could negatively 
impact our business operations. If we or the third parties on which we rely fail, or are perceived to have failed, to address or comply 
with applicable data privacy and security obligations, we could face significant consequences, including but not limited to: government 
enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar); litigation (including class-action claims); 
additional reporting requirements and/or oversight; bans on processing personal data; and orders to destroy or not use personal data. 
Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to: 
interruptions or stoppages in our business operations (including clinical trials); inability to process personal data or to operate in certain 
jurisdictions; limited ability to develop or commercialize our products; expenditure of time and resources to defend any claim or inquiry; 
adverse publicity; or substantial changes to our business model or operations. 

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Risks Related to our Securities 

The price of our stock may be volatile. 

The listing of our common stock on Nasdaq does not assure that a meaningful, consistent and liquid trading market currently exists or 
will exist in the future. The trading price of our common stock may fluctuate substantially. The price of our common stock that will 
prevail in the market may be higher or lower than the price at which our shares of common stock, depending on many factors, some of 
which are beyond our control and may not be related to our company or our operating performance. These fluctuations could cause you 
to lose part or all of your investment in our common stock. Those factors that could cause fluctuations include, but are not limited to, 
the following: 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

price and volume of fluctuations in the overall stock market from time to time; 

fluctuations in stock market prices and trading volumes of similar companies; 

the thinly traded nature of our common stock; 

actual or anticipated changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts; 

results of our preclinical studies and clinical trials or delays in anticipated timing; 

the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock , or sales of large 
blocks of our stock and sales by insiders and our institutional investors; 

announcements of new collaboration agreements with strategic partners or developments by our existing collaboration partners; 

announcements of acquisitions, mergers or business combinations; 

competitive  developments,  including  announcements  by  competitors  of  new  products  or  services  or  significant  contracts, 
acquisitions, strategic partnerships, joint ventures or capital commitments; 

general economic conditions and trends, including changes in interest rates, and other national and global conditions, including 
pandemics and related global economic uncertainty; 

•  major catastrophic events; 

• 

• 

• 

• 

• 

• 

• 

departures of key personnel; 

events affecting BCM, Cell Ready or any future collaborators; 

announcements of new product candidates or technologies, commercial relationships or other events , including the results of 
clinical trials, or variations in our quarterly operating results; 

regulatory developments in the United States and other countries , including changes in the structure of healthcare payment 
systems, or other positive and negative events relating to healthcare and the overall pharmaceutical and biotechnology sectors; 

failure of our common stock to maintain listing requirements on Nasdaq; 

the outcome of any litigation to which we are a party; 

changes in accounting principles; and 

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• 

discussion of our company or our stock price by the financial and scientific press and in online investor communities. 

The stock market in general, and the Nasdaq Capital Market, or Nasdaq, 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, including potentially worsening economic conditions, may negatively affect the market 
price of our common stock, regardless of our actual operating performance. In the past, following periods of volatility in the market 
price  of  a  company’s  securities,  securities  class  action  litigation has often  been brought  against  that  company. Due  to  the potential 
volatility of our stock price, we may therefore be the target of securities litigation in the future. Securities litigation could result in 
substantial costs and divert management’s attention and resources from our business. 

We completed a reverse stock split of our shares of common stock, which may reduce and may limit the market trading liquidity of 
the shares due to the reduced number of shares outstanding and may potentially have an anti-takeover effect. 

We completed a reverse stock split, or the Reverse Stock Split, of our common stock by a ratio of one-for-ten (1:10) effective January 26, 
2023. The liquidity of our common stock may be adversely affected by the Reverse Stock Split as a result of the reduced number of 
shares outstanding following the Reverse Stock Split. In addition, the Reverse Stock Split may increase the number of stockholders who 
own odd lots of our common stock, creating the potential for such stockholders to experience an increase in the cost of selling their 
shares and greater difficulty affecting such sales. Reducing the number of outstanding shares of our common stock through the Reverse 
Stock Split is intended, absent other factors, to increase the per share market price of our common stock. However, other factors, such 
as  our  financial  results,  market  conditions  and  the  market  perception  of  our  business  may  adversely  affect  the  market  price  of  our 
common stock. As a result, there can be no assurance that the Reverse Stock Split will result in the intended benefits, that the market 
price of our common stock will remain higher following the Reverse Stock Split or that the market price of our common stock will not 
decrease in the future. 

Sales of additional equity securities may adversely affect the market price of our common stock and your rights may be reduced. 
Our stockholders may experience dilution in the future and it may adversely affect the market price of our securities. 

We expect to continue to incur drug development and sale, general and administrative costs. Until such time, if ever, as we can generate 
substantial product revenue, we expect to fund our cash requirements through a combination of equity offerings, debt financings and 
potential collaboration, license and development agreements. We do not currently have a committed external source of funds, but have 
entered  into  the  ATM  agreement  under  which  we  may  sell  shares.  To  the  extent  that  we  sell  equity  securities  or  convertible  debt 
securities, including under the ATM agreement, your ownership interest will be diluted, and the terms of these securities may include 
liquidation or other preferences that adversely affect your rights as a common stockholder. The sale or the proposed sale of substantial 
amounts of our common stock or other equity securities in the public markets may adversely affect the market price of our common 
stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting 
our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. 

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third 
parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product 
candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt 
financings when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization 
efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. 

As of December 31, 2023, we had 8.9 million shares of our common stock issued and outstanding (as adjusted for the Reverse Stock 
Split).  Those  outstanding  shares  represent  a  minority  of  our  authorized  shares,  meaning  that  the  ownership  position  of  the  current 
stockholders could be diluted significantly were we to issue a large number of additional shares. In addition, as of December 31, 2023, 
there were outstanding options for an aggregate of approximately 0.7 million shares of common stock at a weighted average exercise 
price of $25.42 per share (each as adjusted for the Reverse Stock Split). We have registered the resale of the shares issuable upon exercise 
of  our  outstanding  warrants,  and  as  a  result  the  shares  issued  upon  exercise  will  be  tradable  by  the  exercising  party.  Upon  such 
registration, the holders may sell these shares in the public markets from time to time, without limitations on the timing, amount, or 
method of sale. If our stock price rises, the holders may exercise their warrants and options and sell a large number of shares. This could 
cause the market price of our common stock to decline and cause existing stockholders to experience significant further dilution. 

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We do not intend to pay cash dividends. 

We have not declared or paid any cash dividends on our common stock, and we do not anticipate declaring or paying cash dividends for 
the foreseeable future. Any future determination as to the payment of cash dividends on our common stock will be at our board of 
directors’ discretion and depends on our financial condition, operating results, capital requirements and other factors that our board of 
directors considers to be relevant. 

General Risk Factors 

If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, or are perceived 
to  have been compromised, we  could  experience  adverse  consequences,  including  but  not  limited  to  regulatory  investigations or 
actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of 
customers or sales; and other adverse consequences. 

In the ordinary course of our business, we and the third parties upon which we rely, may collect, receive, store, use, transmit, disclose, 
transfer,  disclose,  make  accessible,  protect,  secure,  dispose  of,  transmit,  share,  or  otherwise  process  proprietary,  confidential,  and 
sensitive  data,  including  personal  data  (such  as  health-related  data  regarding  clinical  trial  subjects),  intellectual  property,  and  trade 
secrets. 

Cyberattacks, malicious internet-based activity, and online and offline fraud and other similar activities threaten the confidentiality, 
integrity, and availability of our sensitive information and information technology systems, and those of the third parties upon which 
we rely. Such threats are prevalent and continue to rise, are increasingly difficult to detect, and come from a variety of sources, including 
traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), 
sophisticated nation-states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-
attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense 
activities. During times of war and other major conflicts, we, the third parties upon which we rely, may be vulnerable to a heightened 
risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systems and operations, supply chain, and 
ability to produce, sell and distribute our goods and services. We and the third parties upon which we rely may be subject to a variety 
of  threats,  including,  but  not  limited  to,  malicious  code  (such  as  viruses  and  worms),  social  engineering  attacks  (including  through 
phishing attacks), malware (including as a result of advanced persistent threat intrusions), denial of service attacks (such as credential 
stuffing), credential harvesting, software bugs, server malfunctions, software or hardware failures, unauthorized access, natural disasters, 
fire, terrorism, successful breaches, personnel misconduct or error, or human or technological error, war and telecommunication and 
electrical failures.  

In particular, severe ransomware attacks are becoming increasingly prevalent and severe, and can lead to significant interruptions in our 
operations, loss of sensitive data, reputational harm, and diversion of funds. Extortion payments may alleviate some of the negative 
impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or 
regulations prohibiting such payments. Additionally, future pandemics could pose increased risks to our information technology systems 
and data if our employees are required to work from home, utilizing network connections outside our premises. Future or past business 
transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems 
could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, we 
may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to 
integrate companies into our information technology environment and security program. 

We rely on third parties (such as service providers and technologies) to process sensitive information in a variety of contexts, including 
without limitation third-party providers of cloud-based infrastructure, encryption and authentication technology, employee email, and 
other functions. Our ability to monitor these third parties’ cybersecurity practices is limited, and these third parties may not have adequate 
information security measures in place. If our third-party service providers experience a security incident or other interruption, we could 
experience adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their privacy 
or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. 
In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in 
our supply chain or our third-party partners’ supply chains have not been compromised. Any of the previously identified or similar 
threats could cause a security incident or other incident during which our information technology systems or data could be compromised, 
which could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure 

64 

of, or access to our data; it could also disrupt our ability (and that of third parties upon which we rely) to operate our business, including 
conducting our clinical trials. For example, if a compromise were to occur and cause interruptions in our operations, it could result in a 
material disruption of our drug development programs. Similarly, 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 and the further development of our product candidates 
could be delayed. 

We may expend significant resources or modify our business activities (including our clinical trial activities) in an effort to protect 
against the compromise of our information technology systems and data. Further, certain data privacy and security obligations may 
require  us  to  implement  and  maintain  specific  security  measures,  industry-standard  or  reasonable  security  measures  to  protect  our 
information  technology  systems  and  data.  While  we  have  implemented  security  measures  designed  to  prevent  our  information 
technology systems and data from being compromised, there can be no assurance that these measures will be effective. We may be 
unable to detect vulnerabilities in our information technology systems because the threats against these systems change frequently, are 
often  sophisticated,  and  may  not  be  detected  until  after  a  compromise  has  occurred.  Despite  our  efforts  to  identify  and  remediate 
vulnerabilities, if any, in our information technology systems, our efforts may not be successful. Further, we may experience delays in 
developing and deploying remedial measures designed to address any identified vulnerabilities. 

If we (or a third - party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we 
may experience adverse consequences, including: government enforcement actions (for example, investigations, fines, penalties, audits, 
and inspections); additional reporting requirements and/or oversight; restrictions on processing data (including personal data); litigation 
(including class actions); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in 
our operations (including availability of data); financial loss; and other similar harms. Additionally, applicable data privacy and security 
obligations may require us to notify relevant stakeholders; such disclosures are costly, and the disclosures or the failure to comply with 
such requirements could lead to adverse consequences. Our contracts may not contain limitations of liability, and even where they do, 
there can be no assurance that limitations of liability in our contracts are sufficient to protect us from claims related to our data privacy 
and security obligations. We  have  cybersecurity  insurance  for  a breach  event  covering expenses for notification,  credit  monitoring, 
investigation, crisis management, public relations and legal advice. We also maintain property and casualty insurance that may cover 
restoration of data, certain physical damage or third-party injuries caused by potential cybersecurity incidents. However, damage and 
claims arising from such incidents may not be covered or may exceed the amount of any insurance available. Additionally, we cannot 
be sure that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future 
claims. 

As a result of being a public company, we are obligated to develop and maintain proper and effective internal controls over financial 
reporting,  and  any  failure  to  maintain  the  adequacy  of  these  internal  controls  may  adversely  affect  investor  confidence  in  our 
company and, as a result, the value of our common stock. 

We are required, pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, to furnish a report by management on, among other 
things, the effectiveness of our internal control over financial reporting. We are also required to disclose significant changes made in 
our internal control procedures on a quarterly basis. 

To  comply  with  Section  404,  we  have  engaged  in  the  costly  and  challenging  process  of  compiling  the  system  and  processing 
documentation necessary to perform the evaluation needed to comply with Section 404. Our compliance with Section 404 requires that 
we incur substantial professional fees and expend significant management efforts, and we may need to hire additional accounting and 
financial staff with appropriate public company experience and technical accounting knowledge and compile the system and process 
documentation necessary to perform the evaluation needed to comply with Section 404. 

During the evaluation and testing process of our internal controls, if we identify one or more material weaknesses in our internal control 
over financial reporting, we will be unable to assert that our internal control over financial reporting is effective. We cannot assure you 
that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any 
failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition 
or results of operations. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent 
registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial 
reporting, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common 

65 

stock could decline, and we could be subject to sanctions or investigations by the Nasdaq, the SEC or other regulatory authorities. Failure 
to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control 
systems required of public companies, could also restrict our future access to the capital markets. 

Our ability to use net operating losses and certain other tax attributes to offset future taxable income may be subject to limitation. 

Our net operating loss, or NOL, carryforwards could expire unused and be unavailable to offset future income tax liabilities because of 
their limited duration or because of restrictions under U.S. tax law. Our federal NOLs generated in tax years beginning before January 1, 
2018, are permitted to be carried forward for only 20 years under applicable U.S. tax law. Our federal NOLs generated in tax years 
beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% 
of taxable income. It is uncertain if and to what extent various states will conform to federal tax law.  

In  addition,  under  Section  382  and  Section  383  of  the  Internal  Revenue  Code  of  1986,  as  amended,  or,  the  Code,  if  a  corporation 
undergoes an “ownership change,” its ability to use its pre-change NOL carryforwards and other pre-change tax attributes (such as 
research tax credits) to offset its post-change income may be limited. A Section 382 “ownership change” generally occurs if one or more 
stockholders or groups of stockholders who own at least 5% of our stock increase their ownership by more than 50 percentage points 
(by value) over their lowest ownership percentage over a rolling three-year period. We may have experienced ownership changes in the 
past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which are outside our 
control). As a result, if we earn net taxable income, our ability to use our pre-change NOLs to offset such taxable income may be subject 
to limitations. Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes. In addition, at the 
state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently 
increase state taxes owed. 

Consequently, even if we achieve profitability, we may not be able to utilize a material portion of our net operating loss carryforwards 
and certain other tax attributes, which could have a material adverse effect on cash flow and results of operations. 

Catastrophic events may disrupt our business. 

In the event of a major hurricane or other serious weather event or catastrophic event such as fire, power loss, cyberattack, war, terrorist 
attack or epidemic or pandemic that impacts the facilities of any third parties on which we may rely, we may be unable to continue our 
operations and may experience delays in our manufacturing process and shipment of clinical supply to trial sites or interruptions in our 
clinical  trials  and  research  activities,  all  of  which  could  delay  our  development  plans  and  materially  harm  our  business,  results  of 
operations and prospects. 

Our business and operations could be adversely affected by the effects of health epidemics, including pandemics.  

Our business and operations could be adversely affected by the effects of health epidemics, as was recently experienced in connection 
with the COVID-19 virus, which was declared by the World Health Organization as a global pandemic.  

Remote work policies, quarantines, shelter-in-place and similar government orders, shutdowns or other restrictions on the conduct of 
business operations related to the pandemics or other health epidemics may negatively impact productivity. For instance, the COVID- 19 
pandemic disrupted our ongoing research and development activities and delayed certain of our clinical programs and timelines. In 
addition, although our employees are accustomed to working remotely, changes in internal controls due to remote work arrangements 
may result in control deficiencies in the preparation of our financial reports, which could be material. Such orders may also impact 
personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which 
would disrupt our supply chain and could affect our ability to conduct ongoing and planned clinical trials and preparatory activities.  

Health epidemics may also affect the conduct of our clinical trials. Although we are enrolling patients and initiating clinical sites in our 
Phase 2 trial of MT-401 (zedenoleucel) for post-transplant AML, we previously experienced temporary delays in enrollment due to the 
COVID-19 pandemic and in satisfying certain FDA requirements to move forward with the trial, which together resulted in a delay in 
our overall timelines for this trial. Our ongoing and future clinical trials may be also affected by future pandemics. Patient enrollment 
and clinical site initiation, while ongoing, may be delayed due to prioritization of hospital resources toward pandemics or other health 
emergencies, if they arise. Some patients may not be able to comply with clinical trial protocols if quarantines impede patient movement 

66 

or interrupt healthcare services. Similarly, we may be unable to recruit and retain patients and principal investigators and site staff who, 
as healthcare providers, may have heightened exposure to health epidemics, which would adversely impact clinical trial operations.  

The extent to which future pandemics impact our business and operations, including our clinical development and regulatory efforts, 
will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the continued geographic 
spread of the disease, the duration and effect of any future business disruptions in the United States and other countries to contain and 
treat patients with the disease. Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our clinical 
and regulatory  activities,  healthcare  systems  or  the  global  economy  as  a  whole. However,  these  impacts  could  adversely  affect our 
business, financial condition, results of operations and growth prospects and may also have the effect of heightening many of the other 
risks and uncertainties described in this “Risk Factors” section. 

Unfavorable global political or economic conditions could adversely affect our business, financial condition or results of operations.  

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. 
For example, in recent years the COVID-19 pandemic, decades-high inflation and concerns about an economic recession in the United 
States or other major markets resulted in widespread unemployment, economic slowdown and extreme volatility in the capital markets. 
The Federal Reserve recently raised interest rates multiple times in response to concerns about inflation and is expected to continue to 
raise rates. Higher interest rates, coupled with reduced government spending and volatility in financial markets, including with respect 
to foreign exchange, may increase economic uncertainty. A severe or prolonged economic downturn, such as the global financial crisis, 
could result in a variety of risks to our business, including our ability to raise additional capital when needed on acceptable terms, if at 
all. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not 
occur. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption, or cause our customers to 
delay making payments for our services. In addition, military conflicts such as between Russia and Ukraine could disrupt or otherwise 
adversely impact our operations and those of third parties upon which we rely, although we have not experienced any such disruption 
to date. Related sanctions, export controls or other actions have been or may in the future be initiated by nations including the United 
States, the European Union or Russia (e.g., potential cyberattacks, disruption of energy flows, etc.), which could adversely affect our 
business and/or our supply chain, our CROs, CMOs and other third parties with whom we conduct business. Any of the foregoing could 
harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could 
adversely impact our business.  

If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity 
financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive. Increased inflation rates can 
adversely affect us by increasing our costs, including labor and employee benefit costs. Any significant increases in inflation and related 
increase in interest rates could have a material adverse effect on our business, results of operations and financial condition. 

Changes in tax laws or regulations could materially adversely affect our company. 

New tax laws or regulations could be enacted at any time, and existing tax laws or regulations could be interpreted, modified or applied 
in a manner that is adverse to us, which could adversely affect our business and financial condition. For instance, the United States 
recently passed the Inflation Reduction Act, which provides for a minimum tax equal to 15% of the adjusted financial statement income 
of certain large corporations, as well as a 1% excise tax on certain share buybacks by public corporations that would be imposed on such 
corporations. In addition, it is uncertain if and to what extent various states will conform to federal tax legislation. The impact of such 
changes or future legislation could increase our U.S. tax expense and could have a material adverse impact on our business and financial 
condition. 

ITEM 1B. UNRESOLVED STAFF COMMENTS 

None. 

67 

 
 
 
ITEM 1C. CYBERSECURITY 

We operate in the biotechnology sector, which is subject to various cybersecurity risks that could adversely affect our business, financial 
condition, and results of operations, including intellectual property theft; fraud; extortion; harm to employees or customers; violation of 
privacy laws and other litigation and legal risk; and reputational risk. We have implemented a risk-based approach to identify and assess 
the cybersecurity threats that could affect our business and information systems. Our cybersecurity program is aligned with industry 
standards and best practices, such as the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework. We expect 
the third-party vendors that provide our IT services to use various tools and methodologies to manage cybersecurity risk and to monitor 
and evaluate our cybersecurity posture and performance on an ongoing basis through regular vulnerability scans, penetration tests and 
threat  intelligence  feeds.  We  expect  to  require  third-party  service  providers  with  access  to  personal,  confidential  or  proprietary 
information to implement and maintain cybersecurity practices consistent with applicable legal standards and industry best practices. 

Our business depends on the availability, reliability, and security of our information systems, networks, data, and intellectual property. 
Any  disruption,  compromise,  or  breach  of  our  systems  or  data  due  to  a  cybersecurity  threat  or  incident  could  adversely  affect  our 
operations,  customer  service,  product  development,  and  competitive  position.  They  may  also  result  in  a  breach  of  our  contractual 
obligations or legal duties to protect the privacy and confidentiality of our stakeholders. Such a breach could expose us to business 
interruption, lost revenue, ransom payments, remediation costs, liabilities to affected parties, cybersecurity protection costs, lost assets, 
litigation, regulatory scrutiny and actions, reputational harm, customer dissatisfaction, harm to our vendor relationships, or loss of market 
share. 

Cybersecurity Governance and Oversight 

Our board of directors addresses our cybersecurity risk management as part of its general oversight function. Our cybersecurity risk 
assessment  and  management  processes  are  implemented  and  maintained  by  various  members  of  our  management  team,  third  party 
service providers and other employees, who we believe have a combination of relevant expertise, experience, education and training. 

Certain members of our management team are responsible for hiring appropriate personnel and third-party IT service providers, helping 
to  integrate  cybersecurity  risk  considerations  into  our  overall  risk  management  strategy,  communicating  key  priorities  to  relevant 
personnel, approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security 
assessments and other security-related reports. 

Our  cybersecurity  incident  response  processes  are  designed  to  escalate  certain  cybersecurity  incidents  to  members  of  management 
depending on the circumstances, including in some cases to our executive team. Our cybersecurity incident management team, and other 
individuals as needed, work to help us mitigate and remediate cybersecurity incidents of which we are notified. In addition, our incident 
response processes include a procedure for reporting certain cybersecurity incidents to the board of directors. 

The board of directors receives regular reports from management concerning our cybersecurity risk management program. The board 
also receives various summaries and/or presentations related to cybersecurity threats, risks and mitigation. 

68 

 
 
 
 
 
 
 
 
ITEM 2. PROPERTIES 

We do not own any real estate or other properties. We do not directly lease any property but utilize office space through our service 
agreements with Cell Ready at 9350 Kirby Drive, Suite 300, Houston, Texas 77054, which is also our principal business office. 

ITEM 3. LEGAL PROCEEDINGS 

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Other than as described 
below, we are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding 
against us that we believe could have an adverse effect on our business, operating results or financial condition. 

ITEM 4. MINE SAFETY DISCLOSURE 

Not Applicable 

69 

 
 
 
 
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 for trading on the Nasdaq Capital Market under the symbol “MRKR”. As of March 18, 2024, we had 36 
stockholders of record, whom are holding shares. The price of our common stock on March 18, 2024 was $4.43 per share. 

Dividend Policy 

No dividends have been declared or paid on our common stock. We have incurred recurring losses and do not currently intend to pay 
any cash dividends in the foreseeable future. 

Recent Sales of Unregistered Securities 

We did not record any issuances of unregistered securities during the fourth quarter of 2023. 

Issuer Repurchase Of Equity Securities 

We did not repurchase any equity securities. 

ITEM 6. [RESERVED]  

70 

 
 
ITEM  7.  MANAGEMENT’S  DISCUSSION  AND  ANALYSIS  OF  FINANCIAL  CONDITION  AND  RESULTS  OF 
OPERATIONS 

The following discussion of our financial condition, changes in financial condition, plan of operations and results of operations should 
be  read  in  conjunction  with  (i) our  audited  consolidated  financial  statements  as  of  December 31,  2023  and  December 31,  2022  and 
(ii) the section entitled “Business”, included in this annual report. The discussion contains forward-looking statements that involve risks, 
uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a 
result of many factors. 

Company Overview 

We  are  a  clinical-stage  immuno-oncology  company  specializing  in  the  development  and  commercialization  of  novel  T  cell-based 
immunotherapies  for  the  treatment  of  hematological  malignancies  and  solid  tumor  indications.  We  developed  our  lead  product 
candidates from our multiTAA-specific T cell technology, which is based on the manufacture of non-engineered, tumor-specific T cells 
that recognize multiple tumor-associated antigens, or TAAs. MultiTAA-specific T cells are able to recognize multiple tumor targets to 
produce broad spectrum anti-tumor activity. When infused into a patient with cancer, the multiTAA-specific T cells are designed to kill 
cancer cells expressing the TAA and potentially recruit the patient’s immune system to participate in the cancer killing process.  

We licensed the underlying technology for multiTAA-specific T cell therapy from Baylor College of Medicine, or BCM, in March 2018. 
BCM had utilized the therapy in seven exploratory clinical trials. In these studies, BCM treated over 150 patients suffering from a variety 
of cancers including lymphoma, multiple myeloma, acute myeloid leukemia, or AML, acute lymphoblastic leukemia, or ALL, pancreatic 
cancer, breast cancer and various sarcomas. In those studies, BCM saw evidence of clinical benefit, expansion of infused cells, and 
decreased toxicity compared to other cellular therapies.  

We are advancing two product candidates for 3 clinical indications as part of our multiTAA-specific T cell program for: 

•  Autologous multiTAA product for the treatment of lymphoma and pancreatic cancer (MT-601) 

•  Off-the-Shelf (OTS) product in various indications (e.g., MT-401-OTS) 

We do not genetically engineer our multiTAA-specific T cell therapies and we believe that our product candidates are superior to T cells 
engineered with chimeric antigen receptors, or CAR-T, for several reasons including: 

•  Multiple targets → enhanced tumoricidal effect→ minimized tumor immune escape  

•  Clinical safety → no treatment-related side effects, including cytokine release syndrome (CRS) or other severe adverse effects 

(SAEs), were attributed to the use of multiTAA-specific T cell therapies to date 

•  Non-genetically engineered T cell products → no risk of mutagenesis and reduced manufacturing complexity → lower cost 

For these reasons, we believe our endogenous T cell receptor-based therapies may provide meaningful clinical benefit and safety to 
patients with both hematological and solid tumors.  

We  believe  that  the  simplicity  of  our  manufacturing  process  allows  additional  modifications  to  expand  multiTAA-specific  T  cell 
recognition of cancer targets. For example, we are assessing the potential of combining multiTAA-specific T cell products with other 
products. 

Reverse Stock Split 

On January 24, 2023, our board of directors approved the filing of a certificate of amendment to our amended and restated certificate of 
incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect the one-for-ten (1:10) Reverse Stock 
Split of our outstanding common stock and a reduction in the total number of authorized shares of our common stock from 300,000,000 
to 30,000,000 (the “Shares Reduction”). The Amendment became effective at 5:00 p.m. Eastern Time on January 26, 2023.  

71 

 
 
Pursuant to the Amendment, at the effective time of the Amendment, every ten (10) shares of our issued and outstanding common stock 
was automatically combined into one (1) issued and outstanding share of common stock and the authorized shares of our common stock 
was reduced from 300,000,000 to 30,000,000, without any change in par value per share. The Reverse Stock Split affected all shares of 
our common stock outstanding immediately prior to the effective time of the Amendment. No fractional shares were issued as a result 
of the Reverse Stock Split. Stockholders of record who would otherwise be entitled to receive a fractional share received a cash payment 
in lieu thereof. As a result of the Reverse Stock Split, proportionate adjustments were made to the per share exercise price and/or the 
number of shares issuable upon the exercise or vesting of all stock options and warrants issued by us and outstanding immediately prior 
to the effective time of the Amendment, which resulted in a proportionate decrease in the number of shares of our common stock reserved 
for issuance upon exercise or vesting of such stock options and warrants and a proportionate increase in the exercise price of all such 
stock options and warrants. In addition, the number of shares reserved for issuance under our equity compensation plans immediately 
prior to the effective time of the Amendment were reduced proportionately. All share and per share amounts of common stock presented 
in this Annual Report on Form 10-K have been retroactively adjusted to reflect the one-for-10 (1:10) Reverse Stock Split. 

Financial Overview 

Research and Development Expenses 

Our  research  and development  expenses  are  primarily  costs  associated with our  clinical  trials,  including compensation,  share-based 
compensation expense and benefits for employees and selected consultants, manufacturing expenses and fees paid to third parties. 

Clinical costs are expensed as incurred. Costs and timing of clinical trials and development of our product candidates will depend on a 
variety of factors that include, but are not limited to, the following: 

• 

• 

• 

• 

• 

• 

• 

• 

• 

• 

per patient clinical trial costs; 

the number of patients that participate in the clinical trials; 

the number of sites included in the clinical trials; 

the length of time required to enroll eligible patients; 

the number of doses that patients receive; 

the drop-out or discontinuation rates of patients; 

potential additional safety monitoring or other studies requested by regulatory agencies; 

the duration of patient follow-up; 

the efficacy and safety profile of the product candidates; and 

the ability to successfully manufacture patient doses. 

In  addition,  the  potential  for  success  of  each  product  candidate  will  depend  on  numerous  factors,  including  clinical  trial  outcomes, 
acceptance by regulatory authorities, competition, manufacturing capability and commercial viability. We determine which programs 
to pursue and how much to fund each program in response to ongoing scientific assessments, competitive developments, clinical trial 
results, as well as an assessment of each product candidate’s commercial potential. We anticipate our clinical trial costs will continue to 
increase over the next several years due to increased spending on the clinical development and manufacturing of our product candidates. 

72 

 
 
General and Administrative Expenses 

General and administrative expenses consist primarily of personnel costs, including share-based compensation, legal fees relating to 
patent and corporate matters, insurance costs, consulting and professional fees, audit and investor relations. 

Income Taxes 

We recognized $4,000 in state tax expense for the year ended December 31, 2023 and none for the year ended December 31, 2022. 

Other Income (Expense) 

Other income (expense), net consists of interest income and arbitration settlement expenses. 

Results of Operations For the Years Ended December 31, 2023 and 2022 

The following table summarizes the results of our continuing operations (rounded to the thousand except for per share amounts) for the 
years ended December 31, 2023 and 2022, together with the changes to those items: 

For the Years Ended 
December 31,  

2023 

2022 

Change 

Revenues: 

Grant income  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses: 

Research and development  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from operations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expenses): 

Arbitration settlement  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from continuing operations before income taxes. . . . . . . . . .

$

3,311,000
3,311,000

$

3,514,000   $ 
3,514,000  

 (203,000)
 (203,000)

10,417,000
7,476,000
17,893,000
(14,582,000)

11,968,000  
11,336,000  
23,304,000  
(19,790,000) 

    (1,551,000)
    (3,860,000)
    (5,411,000)
 5,208,000

—
539,000
 (14,042,000)

(233,000) 
248,000  
 (19,775,000) 

 233,000
 291,000
 5,733,000

(6)%
(6)%

(13)%
(34)%
(23)%
(26)%

(100)%
117 %
 (29)%

Revenue 

We did not generate any revenue during the years ended December 31, 2023 and 2022, respectively, from the sales or licensing of our 
product candidates. 

In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from the Cancer 
Prevention  and  Research  Institute  of  Texas,  or  CPRIT,  to  support  our  Phase  2  clinical  trial  of  MT-401.  During  the  years  ended 
December 31, 2023 and 2022, respectively, we recognized $2.7 million and $3.4 million of revenue associated with the CPRIT grant. 

On September 13, 2022, we received notice from the FDA that we had been awarded a $2.0 million grant from the FDA’s Orphan 
Products Grant program to support our Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. During the years 
ended December 31, 2023 and 2022, we recognized $0.4 million and $0.1 million of revenue associated with the FDA grant, 
respectively. 

73 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
    
    
     
 
      
 
 
  
 
  
 
  
 
  
 
  
 
 
In May 2023, we received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation Research 
(“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-
care therapy with hypomethylating agents. During the year ended December 31, 2023, we recognized $0.2 million of revenue associated 
with the SBIR grant. 

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program. 

Operating Expenses 

Operating expenses incurred during the fiscal year ended December 31, 2023 were $17.9 million compared to $23.3 million in the prior 
year. Significant changes and expenditures in operating expenses are outlined as follows: 

Research and Development Expense 

Research and development expenses or clinical trial costs decreased by 13% to $10.4 million for the year ended December 31, 2023, 
compared to $12.0 million for the year ended December 31, 2022, mainly as a result of the Cell Ready transaction. 

The decrease of $1.6 million in 2023 was primarily attributable to the following: 

• 

• 

• 

decrease of $2.1 million in process development expenses, 

decrease of $0.8 million in AML Phase 2 clinical trial expenses, offset by 

increase of $1.3 million in Cell Ready (outsourced) clinical manufacturing costs and process development expenses. 

General and Administrative Expenses 

General and administrative expenses decreased by 34% to $7.5 million for the year ended December 31, 2023 from $11.3 million during 
the prior period. 

The decrease in general and administrative expenses of $3.8 million mainly comprised the following: 

• 

• 

• 

• 

• 

decrease  of  $3.2  million  in  headcount-related  expenses,  including  stock-based  compensation  expense  and  net  of  severance 
expense, 

decrease of $0.6 million in rent and utilities expense, primarily as a result of the Cell Ready transaction, including its assumption 
of facility leases, 

decrease of $0.6 million in legal and professional fees,  

decrease of $0.2 million in insurance expense, offset by 

increase of $0.8 million in consulting expenses. 

In  2023,  the  Company  implemented  changes  to  its  organizational  structure  due  to  the  transaction  with  Cell  Ready  and  to  reduce 
operational  costs.  In  connection  with  these  changes,  the  Company  reduced  headcount,  including  the  separation  of  its  former  Chief 
Executive Officer, Peter Hoang, in May 2023 and its former Chief Accounting Officer, Michael Loiacono, in June 2023. During the 
second quarter of 2023, the Company recorded $0.9 million of severance and termination-related costs. The payments of these costs 
were completed in July of 2023. Effective May 1, 2023, the Company’s board of directors appointed Dr. Juan Vera as the Company’s 
President and Chief Executive Officer.  

74 

Effective June 30, 2023, the board of directors appointed Eliot M. Lurier as the Company’s Interim Chief Financial Officer, whereby 
Mr. Lurier provided consulting services to the Company pursuant to a consulting between the Company and Danforth Advisors, LLC 
(“Danforth”) and received no compensation directly from the Company. On November 17, 2023, the Company terminated the consulting 
agreement between the Company and Danforth, effective January 16, 2024. 

On November 17, 2023, Mr. Lurier ceased serving as the Company’s Interim Chief Financial Officer and Dr. Vera was appointed as the 
Company’s Principal Financial and Accounting Officer. 

Other Income /(Expense) 

Arbitration settlement 

An arbitration proceeding was brought against us before the Financial Industry Regulatory Authority, Inc., or FINRA by a broker seeking 
to  be  paid  compensation  for  two  financing  transactions  that  occurred  in  2018,  a  warrant  conversion  and  a  private  placement,  each 
brokered by another broker. The broker’s claims were based on a placement agent agreement for a private placement it brokered in 
2017, under which it alleged it was entitled to compensation for the 2018 transactions. The FINRA panel found in favor of the broker 
and awarded the broker $2.4 million for compensation, interest and attorney fees. As of December 31, 2021, we recorded an accrual of 
$2.4 million in accrued liabilities on our consolidated balance sheet and a $2.4 million charge to other expenses. On September 17, 2021, 
the broker filed a petition to confirm the FINRA arbitration award in the Supreme Court of New York for the County of New York. We 
removed the case to the United States District Court for the Southern District of New York on September 27, 2021. On October 22, 2021, 
we filed a motion in federal court to vacate the award. On March 9, 2022, we were notified that our motion to vacate the award was 
denied and the broker was awarded an additional $0.1 million in interest. Post judgment interest accrued at 1.02% until the judgment 
was paid. We paid the $2.5 million judgment on March 24, 2022. On January 4, 2023, we were notified that the broker was awarded an 
additional $0.1 million in attorneys’ fees, which we recorded to other expenses during fiscal year ending December 31, 2022. We paid 
the $0.1 million on January 9, 2023. 

Interest Income 

Interest income was $0.5 million and $0.2 million for the years ended December 31, 2023 and 2022, respectively, and was attributable 
to interest income relating to funds that are held in U.S. Treasury notes and U.S. government agency-backed securities.  

Net Loss from continuing operations  

The  decrease  in  our  net  loss  from  continuing  operations  during  the  year  ended  December 31,  2023  compared  to  the  year  ended 
December 31, 2022 was due to higher grant income and related party service revenue, cost reductions in our research and development 
activities and moderate stabilization of our clinical trial activities. We anticipate that we will continue to incur net losses in the future as 
we continue to invest in research and development activities, including clinical development of our multiTAA T cell product candidates. 

Liquidity and Capital Resources 

We have not generated any revenues from the sales or licensing of our product candidates since inception and only have limited revenue 
associated with grants to fund research. We have financed our operations primarily through public and private offerings of our stock 
and debt including warrants and the exercise thereof, grants, and more recently through the cash proceeds received from the Cell Ready 
transaction and additional grants to fund research. 

75 

The following table sets forth our cash and cash equivalents and working capital as of December 31, 2023 and 2022: 

Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Working capital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cash Flows 

     December 31, 2023       December 31, 2022
11,782,000
8,837,000

 15,111,000 
 14,053,000 

$
$

$
$

The following table summarizes our cash flows for the years ended December 31, 2023 and 2022: 

Continuing operations: 

Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$   (10,341,000)
 1,105,000

$ (21,513,000)
202,000

Discontinued operations 

Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by (used in) investing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) in cash and cash equivalents  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 (6,099,000)
 18,664,000
 3,329,000

$ 
$ 

(5,459,000)
(4,945,000)
$
$ (31,715,000)

For the Years Ended 
December 31,  

2023 

2022 

Continuing Operations 

Operating Activities 

Net cash used in operating activities from continuing operations during the year ended December 31, 2023 was $10.3 million. The use 
of cash primarily related to our net loss from continuing operations of $14.0 million, partially offset by a $2.8 million increase from 
changes in assets and liabilities and $0.9 million of stock-based compensation. 

Net cash used in operating activities from continuing operations during the year ended December 31, 2022 was $21.5 million. The use 
of cash primarily related to our net loss from continuing operations of $19.8 million and a $4.7 million decrease from changes in assets 
and liabilities. This decrease was partially offset by $3.3 million of stock-based compensation. 

Financing Activities 

Net  cash  provided  by  financing  activities  was  $1.1  million  and  $0.2  million  during  the  years  ended  December 31,  2023  and  2022, 
respectively, primarily due to the net proceeds received from sale of common stock through the ATM Agreement as well as the exercise 
of stock options. 

Discontinued Operations 

Operating Activities 

Net cash used in operating activities from discontinued operations during the year ended December 31, 2023 was $6.1 million, which 
primarily related to our net loss from discontinued operations of $3.0 million, which is net of $2.5 million in revenue for which cash 
had been received in the prior period. 

Net cash used in operating activities from discontinued operations during the year ended December 31, 2022 was $5.5 million, which 
primarily related to our net loss from discontinued operations of $10.2 million, partially offset by cash received in advance of related 
party revenue recorded. 

76 

 
 
 
 
 
 
 
 
 
 
 
 
     
     
 
 
 
 
 
 
 
  
 
Investing Activities 

Net  cash  provided  by  investing  activities  from  discontinued  operations  for  the  year  ended  December 31,  2023  was  $18.7  million 
primarily due to the proceeds from the Cell Ready transaction, net of transaction costs.  

Net cash used in investing activities from discontinued operations was $4.9 million for the year ended December 31, 2022. $1.3 million 
in purchases of property and equipment for the year ended December 31, 2022 were comprised of laboratory equipment along with 
$0.1 million of computers, software and equipment and $0.1 million of furniture and fixtures. $3.5 million of purchases in construction 
in progress related to a second modular cleanroom and the continued buildout of our former manufacturing facility. 

Future Capital Requirements 

To date, we have not generated any revenues from the commercial sale of approved drug products, and we do not expect to generate 
substantial revenue for at least the next several years. If we fail to complete the development of our product candidates in a timely 
manner or fail to obtain their regulatory approval, our ability to generate future revenue will be compromised. We do not know when, 
or if, we will generate any revenue from our product candidates, and we do not expect to generate significant revenue unless and until 
we obtain regulatory approval of, and commercialize, our product candidates. We expect our expenses to increase in connection with 
our  ongoing  activities,  particularly  as  we  continue  the  research  and  development  of,  continue  or  initiate  clinical  trials  of  and  seek 
marketing approval for our product candidates. In addition, if we obtain approval for any of our product candidates, we expect to incur 
significant commercialization expenses related to sales, marketing, manufacturing and distribution. We anticipate that we will need 
substantial additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive 
terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. 

In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from the 
CPRIT to support the Company’s Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the 
Company’s  Phase  2  clinical  trial  evaluating  MT-401  when  given  as  an  adjuvant  therapy  to  patients  with  acute  myeloid  leukemia 
following  a  hematopoietic  stem  cell  transplant.  The  primary  objectives  of  the  adjuvant  arm  of  the  trial  are  to  evaluate  relapse-free 
survival after MT-401 treatment when compared with a randomized control group. Through the date of this filing, the Company has 
received $6.8 million of funds from the CPRIT grant. The Company recorded $2.7 million of grant income related to the CPRIT grant 
as  revenue  for  the  year  ended  December 31,  2023  and  at  December 31,  2023,  the  Company  recorded  $0.5  million  of  grant  income 
receivable. 

On September 13, 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the 
FDA’s Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant 
AML. The Company recorded $0.4 million of grant income related to the FDA grant as revenue for the year ended December 31, 2023 
and at December 31, 2023, the Company recorded $0.3 million of grant income receivable. In February 2024, the Company received 
$0.3 million of funds from the FDA grant.  

In May 2023, the Company announced that it had received a $2.0 million grant from the National Institutes of Health Small Business 
Innovation Research (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients 
following standard-of-care therapy with hypomethylating agents. The Company recorded $0.2 million of grant income related to the 
SBIR grant as revenue for the year ended December 31, 2023 and at December 31, 2023, the Company recorded $0.2 million of grant 
income receivable. In February 2024, the Company received $0.2 million of funds from the SBIR grant.  

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program. 

As  of  December 31,  2023,  we  had  working  capital  of  $14.1  million,  compared  to  working  capital  of  $8.8  million  as  of 
December 31, 2022.  Operating  expenses  incurred  during  the  fiscal  year  ended  December 31,  2023  were  $17.9  million  compared  to 
$23.3 million in the prior year. Based on our clinical plans and our timing expectations related to the progress of our programs, we 
expect that, together with drawdowns of available grant funds, our cash and cash equivalents as of December 31, 2023 will enable us to 
fund  our  operating  expenses  and  capital  expenditure  requirements  into  the  fourth  quarter  of  2025.  We  have  based  this  estimate  on 
assumptions  that  may  prove  to  be  wrong,  and  we  could  utilize  our  available  capital  resources  sooner  than  we  currently  expect. 
Furthermore, our operating plan may change, and we may need additional funds sooner than planned in order to meet operational needs 
and capital requirements for 

77 

 
 
product development and commercialization. Because of the numerous risks and uncertainties associated with the development and 
commercialization of our product candidates and the extent to which we may enter into additional collaborations with third parties to 
participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating 
expenditures associated with our current and anticipated clinical trials. Our future funding requirements will depend on many factors, 
as we: 

• 

• 

• 

• 

• 

• 

initiate or continue clinical trials of our product candidates; 

continue  the research  and development  of our product  candidates  and seek  to  discover  additional  product  candidates;  seek 
regulatory approvals for our product candidates if they successfully complete clinical trials; 

continue development of our manufacturing capabilities and our manufacturing facility; 

establish sales, marketing and distribution infrastructure and scale-up manufacturing capabilities to commercialize any product 
candidates that may receive regulatory approval; 

evaluate strategic transactions we may undertake; and 

enhance  operational,  financial  and  information  management  systems  and  hire  additional  personnel,  including  personnel  to 
support development of our product candidates and, if a product candidate is approved, our commercialization efforts. 

Because all of our product candidates are in the early stages of clinical and preclinical development and the outcome of these efforts is 
uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of product 
candidates or whether, or when, we may achieve profitability. Until such time, if ever, that we can generate substantial product revenue, 
we expect to finance our cash needs through a combination of equity or debt financings and collaboration arrangements. 

We plan to continue to fund our operations and capital funding needs through equity and/or debt financing. We may also consider new 
collaborations or selectively partner our technology. To the extent that we raise additional capital through the sale of equity or convertible 
debt securities, the ownership interests of our stockholders will be diluted, and the terms may include liquidation or other preferences 
that adversely affect the rights of our existing stockholders’ common stock. The incurrence of indebtedness would result in increased 
fixed payment obligations and could involve certain restrictive covenants, such as limitations on our ability to incur additional debt, 
limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely impact 
our ability to conduct our business. If we raise additional funds through strategic partnerships and alliances and licensing arrangements 
with  third  parties,  we  may  have  to  relinquish  valuable  rights  to  our  technologies  or  product  candidates  or  grant  licenses  on  terms 
unfavorable  to  us.  We may  also be  required  to  pay  damages  or  have  liabilities  associated with  litigation  or  other  legal proceedings 
involving our company. 

In addition to the foregoing, based on our current assessment, we do not expect any material impact on our long-term liquidity due to 
the COVID-19 pandemic. However, we will continue to assess the effect of the pandemic on our operations. Further, the COVID-19 
pandemic, decades-high inflation and concerns about an economic recession in the United States or other major markets has resulted in, 
among other things, volatility in the capital markets that may have the effect of reducing our ability to access capital, which could in the 
future  negatively  affect  our  liquidity.  In  addition,  a  recession  or  market  correction  due  to  these  factors  could  materially  affect  our 
business and the value of our common stock. 

ATM Agreement 

In August 2021, we entered into a Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & 
Co. and RBC Capital Markets, LLC, or the Sales Agents, pursuant to which we can offer and sell, from time to time at our sole discretion 
through the Sales Agents, shares of our common stock having an aggregate offering price of up to $75.0 million. Any shares of our 
common  stock  sold  will  be  issued  pursuant  to  our  shelf  registration  statement  on  Form S-3  (File  No. 333-258687),  which  the  SEC 
declared effective on August 19, 2021. However, our use of the shelf registration statement on Form S-3 will be limited for so long as 
we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may sell under the registration statement and 
in accordance with the ATM agreement. The Sales Agents will be entitled to compensation under the Sales Agreement at a commission 

78 

 
 
rate equal to 3.0% of the gross sales price per share sold under the ATM Agreement, and we have provided each of the Sales Agents 
with indemnification and contribution rights. During the year ended December 31, 2023, we sold 265,334 shares of our common stock 
under  the  ATM  Agreement  for  proceeds  of  $1.0  million.  During  the  year  ended  December 31,  2022,  we  sold  60,651  shares  of  our 
common stock under the ATM agreement for proceeds of $202,100. 

Stock Purchase Agreement 

On December 12, 2022, we entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, or 
Lincoln Park, which provides that, upon the terms and subject to the conditions of the agreement, we have the right, but not the obligation, 
to sell to Lincoln Park up to $25,000,000 of shares of our common stock, or the Purchase Shares, from time to time over a 24-month 
term, at a variable price with certain market-based terms as defined in the agreement. The purchase agreement does not exhibit any of 
the  characteristics  for  liability  classification  under  ASC  Topic  480,  Distinguishing  Liabilities  from  Equity.  During  the  year  ended 
December 31,  2023,  we  sold  12,500  shares  of  our  stock  under  the  Purchase  Agreement.  In  January 2023,  Lincoln  Park  was  issued 
180,410 shares of stock as a commitment fee at a value of $0.5 million. On February 29, 2024, we terminated the Purchase Agreement 
with Lincoln Park effective March 1, 2024. 

Going Concern 

We have no sources of revenue to provide incoming cash flows to sustain our future operations. Prior to the Cell Ready transaction, 
there was substantial doubt regarding the Company’s ability to continue as a going concern, which was alleviated by the proceeds from 
the transaction. As outlined above, we expect that our cash and cash equivalents including drawdowns from available grant funds will 
enable  us  to  fund  our  operations  into  the  fourth  quarter  of  2025.  However,  our  ability  to  pursue  our  longer  term  planned  business 
activities is dependent upon our successful efforts to raise additional capital and obtain grant funding. 

Our consolidated financial statements have been prepared on a going concern basis, which implies that we will continue to realize our 
assets and discharge our liabilities in the normal course of business. Our financial statements do not include any adjustments to the 
recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable 
to continue as a going concern. 

Critical Accounting Policies and Estimates  

The consolidated financial statements are prepared in conformity with U.S. GAAP, which require the use of estimates, judgments and 
assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial 
statements, and the reported amounts of expenses in the periods presented.  

On  an  ongoing  basis,  we  evaluate  our  estimates  and  judgments,  including  those  related  to  accrued  expenses  and  stock-based 
compensation. We base our estimates on historical experience and on various other assumptions 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 and the 
reported amounts of expenses that are not readily apparent from other sources. Actual results could differ from those estimates. 

Discontinued Operations 

The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as 
such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its 
operations  and  financial  results.  Therefore,  the  Purchased  Assets,  related  party  revenue,  service  revenue  and  related  expenses  are 
classified as discontinued operations for all periods presented herein. See Note 6 to the accompanying financial statements for further 
information. 

Property and Equipment 

Leasehold improvements, furniture, equipment and software are recorded at cost and are depreciated using the straight-line method over 
the estimated useful lives of the related assets, which range from three to five years. Leasehold improvements are amortized over the 
shorter of the estimated useful life or the remaining lease term. 

79 

Stock-Based Compensation 

The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company 
estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model 
was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In 
addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and 
expected option life: 

Expected Term — The expected life of stock options was estimated using the “simplified method,” as the Company has limited 
historical  information  to  develop  reasonable  expectations  about  future  exercise  patterns  and  post-vesting  employment 
termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the 
contractual life of each grant.  

Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock 
trading prices.  

Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U. S. Treasury zero-
coupon issues with an equivalent remaining term.  

Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to 
pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models. 

The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the 
awards. The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the 
period in which the related services are received as if the Company had paid cash for those services. Forfeitures are accounted for as 
incurred.  

Grant Income 
Grant  Income  represents  funding  under  cost  reimbursement  programs  from  government  agencies  and  non-profit  foundations  for 
qualified research and development activities performed by the Company. In applying the provisions of ASC Topic 606, Revenue from 
Contracts with Customers (“ASC 606”), we determined that grants and awards are out of the scope of ASC 606 because the funding 
entities do not meet the definition of a “customer”, as defined by ASC 606, as there is not considered to be a transfer of control of goods 
or services. With respect to each grant or award, the Company determines if it has a collaboration in accordance with ASC Topic 808, 
Collaborative Arrangements (“ASC 808”). To the extent the grant or award is within the scope of ASC 808, the Company recognizes 
the award upon achievement of certain milestones as credits to research and development expenses. For grant and awards outside the 
scope of ASC 808, the Company applies ASC 606 by analogy, and revenue is recognized when the Company incurs expenses related to 
the grants for the amount the Company is entitled to under the provisions of the contract. 

80 

 
  
  
  
 
 
In August 2021, we received notice of a Product Development Research award totaling approximately $13.1 million from CPRIT to 
support our Phase 2 clinical trial of MT-401.  

The Company determined that the CPRIT Contract is not in the scope of ASC 808 or ASC 606. In accordance with ASC 730-20-25-8, 
the financial risk associated with the research and development has been transferred to CPRIT, because repayment of the grant depends 
solely on the results of research and development having future economic benefit. The Company accounts for this arrangement as a 
contract to perform research and development for others and applies ASC 606 by analogy. 

The  Company  recognizes  grant  income  when  amounts  eligible  for  reimbursement  are  determinable  and  have  been  incurred,  the 
applicable conditions under the grant arrangements have been met, and collectability of amounts due is reasonably assured or already 
received. The classification of costs incurred related to grants is based on the nature of the activities performed by the Company. Grant 
Income is recognized when the related costs are incurred. Restricted cash received from grants in advance of incurring qualifying costs 
is  recorded  as  deferred  revenue  and  recognized  as  revenue  when  qualifying  costs  are  incurred.  Qualifying  grant  income  earned  in 
advance of cash received from grants is recognized as revenue and recorded as other receivable. 

In September 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the FDA’s 
Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML.  

In May 2023, the Company announced that it had received a $2.0 million grant from the National Institutes of Health Small Business 
Innovation Research (“SBIR”) program to support the development and investigation of MT-401 for the treatment of AML patients 
following standard-of-care therapy with hypomethylating agents. 

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program. 

New Accounting Standards 

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts 
as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards 
that are not yet effective will have a material impact on its financial position or results of operations upon adoption.  

Recently Issued Accounting Standards Not Yet Adopted 

Improvements to Reportable Segment Disclosures 

In  November 2023,  the  Financial  Accounting  Standards  Board  (the  “FASB”)  issued  Accounting  Standards  Update  (“ASU”) 
No. 2023-07,  Segment  Reporting  (Topic  280):  Improvements  to  Reportable  Segment  Disclosures.  The  ASU  requires  disclosures  to 
include significant segment expenses that are regularly provided to the chief operating decision maker, among other provisions. The 
ASU is effective for fiscal year periods beginning after December 15, 2023, and interim periods within fiscal years beginning after 
December 15, 2024. Early adoption is permitted and the ASU requires retrospective application to all prior periods presented in the 
financial statements. The Company is currently evaluating the standard to determine the impact of adoption to its consolidated financial 
statements and disclosures. 

Improvements to Income Tax Disclosures 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 
2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of 
information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other 
amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning 
the  year  ended  December 31,  2025.  Early  adoption  is  permitted.  Upon  adoption,  the  guidance  can  be  applied  prospectively  or 
retrospectively. We do not expect the adoption of this guidance to have a material impact on its consolidated financial statements. 

81 

Off-Balance Sheet Arrangements 

We have not entered into any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our 
financial condition, changes in financial condition, revenues, expenses, results of operations, liquidity, capital expenditures or capital 
resources that is material to investors. 

Tax Loss and Credit Carryforwards 

As of December 31, 2023, we have approximately $131.8 million of federal and $38.4 million of state net operating loss carryforwards 
that may be available to offset future taxable income, if any. The federal net operating loss carryforwards of $38.0 million, if not utilized, 
will expire between 2030 and 2037. The federal net operating loss carryforwards of $93.8 million generated in 2018 and thereafter are 
subject  to  an  80%  limitation  on  taxable  income,  do  not  expire  and  will  carry  forward  indefinitely.  The  state  net  operating  loss 
carryforwards of $21.7 million, if not utilized, will begin to expire in 2035. The state net operating loss carryforwards of $16.6 million 
generated in 2018 and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. 
Any change in ownership greater than 50% under Section 382 of the Internal Revenue Code places significant annual limitations on the 
use of such net operating loss carryforwards.  

At December 31, 2023 and 2022, we recorded a 100% valuation allowance against our deferred tax assets of approximately $39.7 million 
and  $41.3  million,  respectively,  as  our  management  believes  it  is  uncertain  that  they  will  be  fully  realized.  For  the  year  ended 
December 31, 2023, we realized $3.6 million of federal net operating losses and $0.1 million of state net operating losses as a result of 
the gain on sale of assets and capitalization for Section 174 R&E expenditures. If we determine in the future that we will be able to 
realize all or a portion of our net operating loss carryforwards, an adjustment to valuation allowance against our deferred tax assets 
would increase net income in the period in which we make such a determination. 

Inflation 

Inflation  affects  the  cost  of  raw  materials,  goods  and  services  that  we  use.  In  recent  years,  inflation  has  been  modest.  However, 
fluctuations in energy costs and commodity prices can affect the cost of all raw materials and components. The competitive environment 
somewhat limits our ability to recover higher costs resulting from inflation by raising prices. Although we cannot precisely determine 
the effects of inflation on our business, it is management’s belief that the effects on future revenues and operating results will not be 
significant. We do not believe that inflation has had a material impact on our results of operations for the periods presented, except with 
respect to payroll-related costs and other costs arising from or related to government-imposed regulations. 

Recent Developments 

On February 22, 2024, we entered into a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready LLC (“Cell 
Ready”) to provide services previously performed by the company until the disposition of its contract development and manufacturing 
operations.  Cell  Ready,  which  is  owned  by  one  of  our  directors  and  shareholders,  Mr. John  Wilson,  is  a  contract  development  and 
manufacturing organization (CDMO). 

Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services from time to time 
by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to supply such product 
in conformance with the product requirements set forth in the applicable work order(s). The MSA contains customary representations, 
warranties and indemnification provision. The initial term of the MSA is three years and may be extended upon the mutual written 
agreement of the parties. Either party may terminate the MSA (a) for material breach by the other party if such breach has not been 
cured within 30 days following notice of termination or (b) if the other party is the subject of an insolvency event. 

Under the MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated 
by the MSA, provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA. 
Further, Cell Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain 
all necessary regulatory approvals, at the Company’s expense.  

With regard to intellectual property, the MSA provides that each party will solely and exclusively own all right, title and interest in and 
to  their  Background  IP  and  all  inventions  derived  from  such  background  IP  (such  invention  being  referred  to  as  Foreground  IP). 

82 

Background  IP  means  all  intellectual  property  either  (a) owned  or  controlled  by  a  party  prior  to  the  effective  date  of  the  MSA  or 
(b) developed or acquired by a party independently from performance under the MSA without the use of, reliance on, or access to the 
other parties confidential information. Furthermore, pursuant to the MSA, Cell Ready grants to the Company a non-exclusive, perpetual, 
irrevocable, transferable, assignable, fully-paid up, royalty-free, worldwide license to and under any of Cell Ready’s Background IP and 
Foreground  IP  to  the  extent  they  are  incorporated  or  embedded  in  any  deliverables  provided  to  the  Company  or  in  the  process  of 
generating or manufacturing such deliverables and reasonably necessary or useful for the Company to make, have made, manufacture, 
have manufactured, use, have used, offer for sale, sell, import, and otherwise exploit such deliverables. The Company grants to Cell 
Ready until the termination or expiry of any applicable Work Order and for a period not exceeding the term of the MSA, a non-exclusive, 
fully paid-up, non-transferable, non-sublicensable limited license under and to the Company’s Background IP made available to Cell 
Ready pursuant to a Work Order solely to the extent required for Cell Ready to provide the services under such Work Order. 

Also on February 22, 2024, the Company entered into Work Order #1 under the MSA, pursuant to which Cell Ready will provide the 
Company with GMP drug product for Marker MT-401 and/or MT-601. The services include the delivery of final drug product and 
quality control testing. The Company also requested Cell Ready to provide general support services in connection therewith. The total 
projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated to exceed $750,000. The services will cover 
the anticipated manufacturing costs for the first quarter of 2024. Additional Work Orders are expected to be generated for the remainder 
of 2024. 

The above description of the MSA and Work Order #1 do not purport to be complete and are qualified in their entirety by reference to 
the full text of the MSA and Work Oder #1, copies of which are attached hereto as Exhibits 10.8 and 10.9 and are incorporated herein 
by reference. The MSA has been filed as an exhibit to this Annual Report on Form 10-K to provide investors with information regarding 
the terms of the MSA and is not intended to modify or supplement any factual disclosures about the Company in its public reports filed 
with  the  SEC.  In  particular,  the  MSA  is  not  intended  to  be,  and  should  not  be  relied  upon  as,  disclosure  regarding  any  facts  and 
circumstances relating to the Company. The representations, warranties, and covenants contained in the MSA have been made solely 
for the purposes of the MSA and as of specific dates; were solely for the benefit of the parties to the MSA; are not intended as statements 
of fact to be relied upon by the parties’ shareholders; may no longer be true as of a given date; and may apply standards of materiality 
in a way that is different from what may be viewed as material by shareholders. Security holders are not third-party beneficiaries under 
the MSA and should not rely on the representations, warranties, and covenants or any descriptions thereof as characterizations of any 
actual state of facts or of the condition of the Company. 

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information 
required under this item. 

ITEM 8. FINANCIAL STATEMENTS 

The  Financial  Statements  are  incorporated  herein  by  reference  to  pages  beginning  on  page  F-1  at  the  end  of  this  report  and  the 
supplementary data is not applicable. 

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL 
DISCLOSURE 

We have had no changes in, or disagreements with our principal independent accountants. 

83 

 
ITEM 9A. CONTROLS AND PROCEDURES 

Evaluation of Disclosure Controls and Procedures 

We have established disclosure controls and procedures, as such term is defined in Rule 13a-15(e) under the Securities Exchange Act 
of 1934. Under the supervision and with the participation of our management, we conducted an evaluation of the effectiveness of our 
disclosure controls and procedures as of December 31, 2023 to ensure that the information required to be disclosed by us in the reports 
that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time 
periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures 
designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange 
Act of 1934 is accumulated and communicated to our management, including our principal executive officer and principal financial 
officer as appropriate, to allow timely decisions regarding required disclosure. Our management, with participation of our principal 
executive  officer  and  principal  financial  officer,  has  evaluated  the  effectiveness  of  our  disclosure  controls  and  procedures  as  of 
December 31, 2023. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure 
controls and procedures were effective as of December 31, 2023 to provide reasonable assurance that the information required to be 
disclosed  by  us  in  this  Annual  Report  was  (a) reported  within  the  time  periods  specified  by  SEC  rules  and  regulations  and 
(b) communicated to our management, including our Chief Executive Officer and Principal Financial Officer, to allow timely decisions 
regarding any required disclosure. 

Management’s Report on Internal Control Over Financial Reporting  

Our  management  is  responsible  for  establishing  and  maintaining  adequate  internal  control  over  financial  reporting,  as  such  term  is 
defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including 
our principal executive officer and principal financial and accounting officer, we conducted an evaluation of the effectiveness of our 
internal control over financial reporting as of December 31, 2023 based on the framework in Internal Control—Integrated Framework 
2013  issued  by  the  Committee  of  Sponsoring  Organizations  of  the  Treadway  Commission  (COSO).  Based  on  that  evaluation,  our 
management concluded that our internal control over financial reporting was effective as of December 31, 2023. 

Cybersecurity 

We  utilize  information  technology  for  internal  and  external  communications  with  vendors,  clinical  sites,  banks,  investors  and 
shareholders. Loss, disruption or compromise of these systems could significantly impact operations and results. 

We are not aware of any material cybersecurity violation or occurrence. We believe our efforts toward prevention of such violation or 
occurrence, including system design and controls, processes and procedures, training and monitoring of system access, limit, but may 
not prevent unauthorized access to our systems. 

Other than temporary disruption to operations that may be caused by a cybersecurity breach, we consider cash transactions to be the 
primary  risk  for  potential  loss.  We  and  our  financial  institution  take  steps  to  minimize  the  risk  by  requiring  multiple  levels  of 
authorization and other controls. 

84 

 
 
Changes in Internal Control Over Financial Reporting 

There were no  changes  in our  internal  control over  financial  reporting (as  defined  in Exchange Act Rules  13a-15(f) and  15d-15(f)) 
during the fiscal quarter ended December 31, 2023 that materially affected, or are reasonably likely to materially affect, our internal 
control over financial reporting. 

Inherent Limitations on Effectiveness of Internal Controls 

In designing and evaluating the disclosure controls and procedures, management does not expect that our internal control over financial 
reporting will prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only 
reasonable, not absolute, assurance that the objectives of the control systems are met. Further, 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. The design of any 
disclosure controls and procedures also is based in part upon 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. Our management, including 
our Chief Executive Officer and Principal Financial and Accounting Officer, believes that our disclosure controls and procedures and 
internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at 
the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal 
control over financial reporting will prevent all errors and all fraud. 

ITEM 9B. OTHER INFORMATION 

Rule 10b5–1 trading arrangement. During the fourth quarter of 2023, no director or Section 16 officer adopted or terminated any Rule 
10b5-1 plan or non-Rule 10b5-1 trading arrangements. 

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS  

Not applicable. 

85 

 
 
 
 
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 

PART III 

The information required by this item and not set forth below will be set forth in the sections headed “Election of Directors,” “Executive 
Officers” and “Delinquent Section 16(a) Reports” in our definitive proxy statement for our 2023 Annual Meeting of Stockholders, or 
our  Proxy  Statement,  to  be  filed  with  the  SEC  within  120  days  after  the  end  of  the  fiscal  year  ended  December 31,  2023  and  is 
incorporated herein by reference. 

We have adopted a written code of business conduct and ethics that applies to our directors, officers and employees, including our 
principal executive officer, principal financial and accounting officer or controller, or persons performing similar functions, known as 
the  Code  of  Ethics  and  Business  Conduct.  The  Code  of  Ethics  and  Business  Conduct  is  available  on  our  website  at 
www.markertherapeutics.com under the Corporate Governance section of our Investors page. If we make any substantive amendments 
to, or grant any waivers from, the code of business conduct and ethics for any officer or director, we will disclose the nature of such 
amendment or waiver on our website or in a current report on Form 8-K. 

ITEM 11. EXECUTIVE COMPENSATION 

The information required by this item will be set forth in the section headed “Executive Compensation” in our Proxy Statement and is 
incorporated herein by reference. 

ITEM  12.  SECURITY  OWNERSHIP  OF  CERTAIN  BENEFICIAL  OWNERS  AND  MANAGEMENT  AND  RELATED 
STOCKHOLDER MATTERS 

The  information  required  by  this  item  will  be  set  forth  in  the  section  headed  “Securities  Authorized  for  Issuance  Under  Equity 
Compensation  Plans”  and  “Security  Ownership  of  Certain  Beneficial  Owners  and  Management”  in  our  Proxy  Statement  and  is 
incorporated herein by reference. 

The  information  required  by  Item  201(d) of  Regulation  S-K  will  be  set  forth  in  the  section  headed  “Executive  Compensation”  and 
“Information  Regarding  the  Board  of  Directors  and  Corporate  Governance”  in  our  Proxy  Statement  and  is  incorporated  herein  by 
reference. 

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE 

The information required by this item will be set forth in the section headed “Transactions with Related Persons and Indemnification” 
and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement and is incorporated herein by 
reference. 

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 

The information required by this item will be set forth in the section headed “Principal Accountant Fees and Services” in our Proxy 
Statement and is incorporated herein by reference. 

86 

 
 
 
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 

(a)       The documents filed as part of this report are as follows: 

PART IV 

1.         The financial statements and accompanying report of independent registered public accounting firm are set forth immediately 

following the signature page of this report beginning on page F-1. 

2.         All financial statement schedules are omitted because they are inapplicable, not required or the information is included elsewhere 

in the financial statements or the notes thereto. 

3.        The following is a list of exhibits filed as part of this Annual Report on Form 10-K. 

EXHIBIT INDEX 

Exhibit  
number 

Exhibit description 

   Form   

File no. 

    Exhibit 

Filing  
date 

Filed 
herewith

Incorporated by Reference 

3.1 

  Certificate of Incorporation 

8-K

001-37939  

3.4 

10/17/18

3.2 

3.3 

Certificate of Amendment to Certificate of Incorporation of 
Marker Therapeutics, Inc. 

8-K

001-37939  

3.1 

5/27/22

Certificate of Amendment to Certificate of Incorporation of 
Marker Therapeutics, Inc. 

3.4 

  Bylaws of Marker Therapeutics, Inc. 

4.0 

  Form of Common Stock Certificate of Marker Therapeutics, Inc. 

4.1 

  Description of Securities of Marker Therapeutics, Inc. 

8-K

001-37939  

8-K

001-37939  

3.1 

3.6 

1/26/23

10/17/18

X

X

10.1 

10.2 

10.3 

Exclusive License Agreement between Baylor College of 
Medicine and Marker Therapeutics, Inc. dated March 16, 2018*** 

10-K 001-37939  

10.21 

3/15/19

Sponsored Research Contract between Baylor College of Medicine 
and Marker Therapeutics, Inc. dated November 16, 2018*** 

10-K 001-37939  

10.22 

3/15/19

Consulting Agreement between Dr. Juan Vera and Marker 
Therapeutics, Inc. dated October 19, 2018* 

8-K

001-37939  

10.1 

10/23/18

10.4 

  Form of Director and Officer Indemnification Agreement* 

10-K 001-37939  

10.39 

3/15/19

10.5 

Marker Therapeutics, Inc. 2020 Equity Incentive Plan 

333-23913
6

S-8

99.1 

6/12/20

10.6 

10.7 

Form of Stock Option Grant Notice and Stock Option Agreement 
under the Marker Therapeutics, Inc. 2020 Equity Incentive Plan. 

10-Q 001-37939  

10.1 

11/9/20

Form of Restricted Stock Unit Grant Notice and Restricted Stock 
Unit Award Agreement under the Marker Therapeutics, Inc. 2020 
Equity Incentive Plan. 

10-Q 001-37939  

10.2 

11/9/20

87 

 
 
 
 
 
  
  
 
   
 
 
 
 
   
 
 
 
 
   
 
 
 
 
   
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
   
 
 
 
 
   
 
 
 
   
 
 
 
 
 
   
 
 
 
 
   
 
 
 
 
   
 
 
Exhibit  
number 

10.8 

10.9 

10.10 

Exhibit description 

   Form   

File no. 

    Exhibit 

Filing  
date 

Filed 
herewith

Incorporated by Reference 

Master Services Agreement for Product Supply between Marker 
Therapeutics, Inc. and Cell Ready LLC dated February 22, 2024**

Work Order #1 between Marker Therapeutics, Inc. and Cell Ready 
LLC dated February 22, 2024** 

Controlled Equity Offering Sales Agreement, dated as of 
August 10, 2021, by and among Marker Therapeutics, Inc. and 
Cantor Fitzgerald & Co. and RBC Capital Markets, LLC

S-3 

333-25868
7 

1.2 

8/10/21 

21.1 

  List of Subsidiaries 

23.1 

  Consent of Marcum LLP, an independent public accounting firm. 

24.1 

  Powers of Attorney (included on signature page) 

31.1 

31.2 

32.1 

32.2 

Certification of Chief Executive Officer pursuant to Securities 
Exchange Act of 1934 Rule 13a-14(a) or 15d-14a 

Certification of Chief Financial Officer pursuant to Securities 
Exchange Act of 1934 Rule 13a-14(a) or 15d-14a 

Certification of Chief Executive Officer pursuant to 18 U. S. C. 
Section 1350 as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002# 

Certification of Chief Financial Officer pursuant to 18 U. S. C. 
Section 1350 as adopted pursuant to Section 906 of the Sarbanes-
Oxley Act of 2002# 

97 

  Incentive Compensation Recoupment Policy

101.INS    XBRL Instance Document 

101.SCH   XBRL Taxonomy Extension Schema Document

101.CAL   XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF   XBRL Taxonomy Extension Definition Linkbase Document

101.LAB   XBRL Taxonomy Extension Label Linkbase Document

101.PRE    XBRL Taxonomy Extension Presentation Linkbase Document

104 

Cover Page Interactive Data File (formatted as Inline XBRL and 
contained in Exhibit 101 filed herewith) 

*     Executive management contract or compensatory plan or arrangement. 

88 

X 

X 

X

X

X

X

X

X

X

X

X

X

X

X

X

X

 
 
 
 
  
  
 
   
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
   
 
 
 
 
 
 
 
 
**   Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as 

amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

*** Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for conditional treatment and this exhibit 

has been submitted separately with the SEC. 

#     These certifications are being furnished solely to accompany this annual report pursuant to 18 U.S.C. Section 1350 and are not 
being filed for  purposes  of Section 18 of  the  Securities  Exchange Act of 1934,  as  amended,  and  are not  to  be  incorporated  by 
reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation 
language in such filing. 

ITEM 16. FORM 10-K SUMMARY 

None. 

89 

 
 
SIGNATURES 

Pursuant to the requirements of Section 13 and 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. 

Dated: March 25, 2024 

Marker Therapeutics, Inc.

By: /s/ Juan Vera
Juan Vera
Chief Executive Officer and Treasurer (Principal Executive 
Officer and Principal Financial and Accounting Officer)

90 

 
  
   
  
  
  
  
 
 
 
POWER OF ATTORNEY 

Each of the undersigned officers and directors of Marker Therapeutics, Inc., hereby constitutes and appoints Juan Vera their true and 
lawful attorney-in-fact and agent, for them and in their name, place and stead, in any and all capacities, to sign their name to any and all 
amendments  to  this  Report  on  Form 10-K,  and  other  related  documents,  and  to  cause  the  same  to  be  filed  with  the  Securities  and 
Exchange Commission, granting unto said attorneys, full power and authority to do and perform any act and thing necessary and proper 
to be done in the premises, as fully to all intents and purposes as the undersigned could do if personally present, and the undersigned for 
himself hereby ratifies and confirms all that said attorney shall lawfully do or cause to be done by virtue hereof. 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on 
March 25, 2024 on behalf of the registrant and in the capacities indicated. 

Signature 

      Title 

      Date

/s/ Juan Vera 
Juan Vera 

/s/ N. David Eansor 
N. David Eansor 

/s/ John Wilson 
John Wilson 

/s/ Katharine Knobil 
Katharine Knobil 

/s/ Steve Elms 
Steve Elms 

President, Chief Executive Officer and 
Treasurer, Director (Principal Executive 
Officer and Principal Financial and 
Accounting Officer)

Chairman 

Director 

Director 

Director 

March 25, 2024 

March 25, 2024 

March 25, 2024 

March 25, 2024 

March 25, 2024 

91 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MARKER THERAPEUTICS, INC. 
CONSOLIDATED FINANCIAL STATEMENTS 

DECEMBER 31, 2023 AND DECEMBER 31, 2022 

Report of Independent Registered Public Accounting Firm (PCAOB ID Number 688)  . . . . . . . . . . . . . . . . . . . . . . . . . .      
Consolidated Balance Sheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   
Consolidated Statements of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   
Consolidated Statements of Stockholders’ Equity  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   
Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   
Notes to the Consolidated Financial Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   

F-2
F-4
F-5
F-6
F-7
F-8

F-1 

 
 
 
 
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 

To the Shareholders and Board of Directors of 
Marker Therapeutics, Inc. 

Opinion on the Financial Statements 

We have audited the accompanying consolidated balance sheets of Marker Therapeutics, Inc. (the “Company”) as of December 31, 2023 
and 2022, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years in the period 
ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial 
statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the 
results  of  its  operations  and  its  cash  flows  for  each  of  the  two  years  in  the  period  ended  December 31,  2023,  in  conformity  with 
accounting principles generally accepted in the United States of America. 

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 audits. 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 audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits 
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 audits 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 audits 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  audits  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 audits provide a reasonable basis for our opinion. 

Critical Audit Matter Description 

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were 
communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to 
the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical 
audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the 
critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they 
relate. 

Discontinued Operations – Recognition and deconsolidation of assets sold to a related party. 

Critical Audit Matter Description 

The Company evaluates the classification of assets and liabilities in connection with any disposition of significant assets to determine 
the appropriate financial statement recognition. We identified the sale of a significant portion of the Company’s operations comprising 
a majority of its net assets in a sale to a related party as a critical audit matter due to the related party nature of the transaction and the 
significance of the disposition resulting in a strategic shift in the Company’s business activities. The accounting for the disposition of 
net  assets  included  in  consolidated  net  assets  requires  auditor  judgment  when  performing  audit  procedures  to  evaluate  whether 
management appropriately recognized the classification of net assets sold and revenues and costs associated with discontinued operations 
and the calculation of gain or loss on sale to a related party. 

F-2 

How the Critical Audit Matter Was Addressed in the Audit 

Our audit procedures related to the evaluation of the sale of certain operations to a related party, Cell Ready, LLC, included the following, 
among others: 

•  We evaluated management’s assessment of the transaction: 

•  As the sale of an asset or business; 

•  To determine gain or loss recognition; 

•  To determine classification of items between continuing and discontinued operations; 

•  To determine accounting for transaction costs; and 

•  Testing of completeness and accuracy of deconsolidation of net assets. 

•  We inspected Board of Director’s minutes for authorization of the transaction. 

•  We evaluated management’s assessment of the business purpose of the transaction in connection with our review of related 

party transactions. 

•  We examined the transaction documents to ensure the Company recognized and disclosed all significant transaction terms. 

•  We examined key employee agreements, including modifications to employee stock options, in connection with the sale for 

recognition and disclosure. 

/s/ Marcum LLP 

Marcum LLP 

We have served as the Company’s auditor since 2014. 

Houston, TX 
March 25, 2024 

F-3 

 
 
MARKER THERAPEUTICS, INC. 
CONSOLIDATED BALANCE SHEETS 

December 31,  
2023 

December 31,  
2022 

ASSETS 
Current assets: 

Cash and cash equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prepaid expenses and deposits  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current assets of discontinued operations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current assets  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-current assets of discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

$ 

15,111,450
 988,126
 1,027,815
 —
 17,127,391
 —

  $ 

 17,127,391   $

11,782,172
1,849,239
2,402,004
585,840
16,619,255
17,802,929
 34,422,184

LIABILITIES AND STOCKHOLDERS’ EQUITY 
Current liabilities: 

Accounts payable and accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Related party payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Current liabilities of discontinued operations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Non-current liabilities of discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 

$

 1,745,193
 1,329,655
 —
 3,074,848
 —
 3,074,848

2,521,193
—
5,260,616
7,781,809
7,039,338
14,821,147

Stockholders’ equity: 

Preferred stock, $0.001 par value, 5 million shares authorized, 0 shares issued and 

outstanding at December 31, 2023 and 2022, respectively . . . . . . . . . . . . . . . . . . . . . . . . . . .

Common stock, $0.001 par value, 30 million shares authorized, 8.9 million and  
8.4 million shares issued and outstanding as of December 31, 2023 and 2022,  
respectively (see Note 10)  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Additional paid-in capital  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accumulated deficit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total liabilities and stockholders’ equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 —

—

 8,891
 450,329,515
   (436,285,863)
 14,052,543
 17,127,391   $

  $ 

8,406
447,641,680
(428,049,049)
19,601,037
 34,422,184

On  January 26,  2023,  the  Company  effected  a  one-for-ten  (1-for-10)  reverse  stock  split  of  its  common  stock  and  a  corresponding 
reduction in the total number of authorized shares of its common stock from 300,000,000 to 30,000,000. All historical share and per 
share amounts reflected in this report have been adjusted to reflect the reverse stock split.  

The accompanying notes are an integral part of these consolidated financial statements. 

F-4 

 
 
 
 
 
     
     
 
  
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
MARKER THERAPEUTICS, INC. 
CONSOLIDATED STATEMENTS OF OPERATIONS 

Revenues: 

Grant income  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total revenues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses: 

Research and development  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from operations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other income (expenses): 

Arbitration settlement  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interest income . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from continuing operations before income taxes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax expense . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss from continuing operations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For the Years Ended 
December 31,  

2023 

2022 

$ 

 3,311,133
 3,311,133

$

3,513,544
3,513,544

 10,416,789
 7,475,722
 17,892,511
 (14,581,378)

 —
 539,158
 (14,042,220)
 3,675
 (14,045,895)

11,968,428
11,336,120
23,304,548
(19,791,004)

(232,974)
248,063
(19,775,915)
—
 (19,775,915)

Discontinued operations: 

Loss from discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gain on disposal of discontinued operations, net of $63,000 in tax . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

  $ 

(10,154,779)
 (2,922,406)
—
 8,731,487
 5,809,081
(10,154,779)
 (8,236,814)  $  (29,930,694)

Net earnings (loss) per share: 

Loss from continuing operations, basic and diluted  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from discontinued operations, basic and diluted . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss per share, basic and diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 
$ 
$ 

 (1.59)
 0.66
 (0.94)

$
$
$

(2.37)
(1.22)
(3.58)

Weighted average number of common shares outstanding:

Basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diluted. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8,809,382
8,809,382

8,351,003
8,351,003

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock. All historical share and 
per share amounts reflected in this report have been adjusted to reflect the reverse stock split.  

The accompanying notes are an integral part of these consolidated financial statements. 

F-5 

 
 
 
 
 
     
 
 
 
     
     
 
 
  
 
 
  
  
  
  
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
  
  
  
 
 
 
 
 
 
 
 
MARKER THERAPEUTICS, INC. 
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 

Common Stock 
Shares 

  Par value  

Additional 
 Paid- 
in Capital 

  Accumulated 

Deficit 

Total 
Stockholders’ 
Equity 

Balance at January 1, 2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  
Issuance of common shares for cash, net  . . . . . . . . . . . . . . . . . . . . . .
 Stock-based compensation   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 Net loss  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance at December 31, 2022  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  
Shares issued pursuant to ATM and Lincoln Park agreements  . . . . .
Issuance of common stock as commitment fee   . . . . . . . . . . . . . . . . .
Issuance of common stock from exercise of stock options  . . . . . . . .
Stock-based compensation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 Net loss  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Fractional shares adjustment due to reverse split  . . . . . . . . . . . . . . . .
Balance at December 31, 2023  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  

60,651
37,252
—
 8,405,771
277,834
180,410
27,518
—
—
(113)

 8,307,868 $  8,308 $  442,095,642   $   (398,118,355) $  43,985,595
202,130
5,344,006
(29,930,694)
 19,601,037
1,014,640
—
90,478
1,583,202
(8,236,814)
—
 14,052,543

202,069     
5,343,969     
 —     
 447,641,680    
1,014,363    
(180)   
90,450    
1,583,202    
 —    
 —    
 450,329,515    

—
—
 (29,930,694)
 (428,049,049)
 —
—
—
—
 (8,236,814)
—

61
37
—
 8,406
277
180
28
—
—
—
 8,891  

 (436,285,863)  

 8,891,420  

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock. All historical share and 
per share amounts reflected in this report have been adjusted to reflect the reverse stock split.  

The accompanying notes are an integral part of these consolidated financial statements. 

F-6 

 
 
 
 
 
 
  
 
 
 
  
   
 
 
 
 
 
  
  
  
 
 
 
 
MARKER THERAPEUTICS, INC. 
CONSOLIDATED STATEMENTS OF CASH FLOWS 

Cash Flows from Operating Activities: 

Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Less: gain (loss) from discontinued operations, net of $63,000 in tax . . . . . . . . . . . . . . . . . . . . .
Net loss from continuing operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reconciliation of net loss to net cash used in operating activities: 

Stock-based compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Gain on lease termination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Changes in operating assets and liabilities: 

Prepaid expenses and deposits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other receivables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Accounts payable and accrued expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash used in operating activities - continuing operations . . . . . . . . . . . . . . . . . . . . . . . .
Net cash used in operating activities - discontinued operations . . . . . . . . . . . . . . . . . . . . . .
Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cash Flows from Investing Activities: 

Net cash provided by (used in) investing activities - discontinued operations . . . . . . . . . . . . .
Net cash provided by (used in) investing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cash Flows from Financing Activities: 

Proceeds from issuance of common stock, net  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Proceeds from stock options exercise  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net increase (decrease) in cash and cash equivalents  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents at beginning of the year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cash and cash equivalents at end of the year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Supplemental schedule of non-cash financing and investing activities: 

Capital expenditures in accounts payable  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Issuance of common stock as commitment fee for future financing . . . . . . . . . . . . . . . . . . . . . .
Changes to right of use assets and lease liability due to close out of operating lease . . . . . . . . .

For the Years Ended 
December 31,  

2023 

2022 

$ 

(8,236,814)
5,809,081 
(14,045,895)

$ (29,930,694)
(10,154,779)
(19,775,915)

 858,269
 —

3,304,634
(278,681)

 861,113
 1,374,189
 611,262
 —
 (10,341,062)
 (6,098,899)
 (16,439,961)

 18,664,122
 18,664,122

 1,014,640
 90,477
 1,105,117
 3,329,278
 11,782,172
 15,111,450

104,147
(2,401,767)
(1,319,710)
(1,146,186)
(21,513,478)
(5,458,675)
(26,972,153)

(4,945,136)
(4,945,136)

202,130
—
202,130
(31,715,159)
43,497,331
11,782,172

$

For the Years Ended  
December 31,  

2023 

2022 

 180

 — $
$
 — $

57,607
—
3,459,332

$ 

$ 
$ 
$ 

The accompanying notes are an integral part of these consolidated financial statements. 

F-7 

 
 
 
 
 
 
 
 
 
     
     
 
 
 
 
  
 
  
 
  
 
 
  
  
  
 
 
 
  
  
 
 
  
  
 
 
  
  
  
  
  
 
 
 
 
 
    
 
 
    
   
 
 
 
 
 
MARKER THERAPEUTICS, INC. 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 
FOR THE FISCAL YEARS DECEMBER 31, 2023 AND 2022 

NOTE 1:    NATURE OF OPERATIONS 

Marker Therapeutics, Inc., a Delaware corporation (the “Company” or “we”), is a clinical-stage immuno-oncology company specializing 
in the development and commercialization of novel T cell-based immunotherapies for the treatment of hematological malignancies and 
solid tumor indications. The Company’s multiTAA-specific T cell technology is based on the selective expansion of non-engineered, 
tumor-specific T cells that recognize tumor associated antigens, which are tumor targets, and kill tumor cells expressing those targets. 
These  T  cells  are  designed  to  recognize  multiple  tumor  targets  to  produce  broad  spectrum  anti-tumor  activity.  The  Company  was 
incorporated in Nevada in 1992 and reincorporated in Delaware in October 2018.  

Purchase Agreement with Cell Ready 

On June 26, 2023, the Company completed the previously announced transaction with Cell Ready, LLC (“Cell Ready”) pursuant to a 
Purchase Agreement (the “Cell Ready Purchase Agreement), dated May 1, 2023, by and between the Company and Cell Ready. Mr. John 
Wilson is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, therefore Cell Ready is a related 
party. Pursuant to the Cell Ready Purchase Agreement, effective as of the Closing Date, the Company (i) assigned to Cell Ready the 
leases for the Company’s two manufacturing facilities in Houston, Texas (the “Manufacturing Facilities”), (ii) sold to Cell Ready all of 
the equipment and leasehold improvements at the Manufacturing Facilities and (iii) assigned to Cell Ready its rights, title and interest 
in the Company’s Master Services Agreement for Product Supply (the “MSA”), dated April 7, 2023, by and between the Company, Cell 
Ready and Indapta Therapeutics, Inc., as well as its rights, title and interest in any contracts related to the equipment and Manufacturing 
Facilities (collectively, the “Purchased Assets”). Cell Ready acquired the Purchased Assets for total consideration of $19.0 million. In 
connection with the purchase of the Manufacturing Facilities, Cell Ready also extended offers of employment to approximately 50 of 
the Company’s former employees in its manufacturing, development, quality, and regulatory affairs functions.  

The Purchased Assets constituted a significant disposition. Based upon the magnitude of the disposition and because the Company is 
exiting certain manufacturing operations, the disposition represents a significant strategic shift that will have a material effect on the 
Company’s operations and financial results. Accordingly, the assets sold meet the definition of a discontinued operation, as defined by 
Accounting Standards Codification (“ASC”) 205-20 - Discontinued Operations, and prior comparative periods have been retroactively 
adjusted to reflect the current presentation. See additional discussion at Note 6. 

On  February 22,  2024,  we  entered  into  a  Master  Services  Agreement  for  Product  Supply  (the  “MSA”)  with  Cell  Ready  to  provide 
outsourced services previously performed by the Company prior to its asset sale to Cell Ready. Cell Ready, which is owned by one of 
our directors and shareholders, Mr. John Wilson, is a contract development and manufacturing organization (CDMO). Under the MSA, 
it is anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in 
support of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products 
and services from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready 
is required to supply such product in conformance with the product requirements set forth in the applicable work order(s). Under the 
MSA, Cell Ready is to use only personnel with sufficient qualifications and experience to supply the services contemplated by the MSA, 
provide its personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA. Further, Cell 
Ready is required to provide the Company with assistance and cooperation in order for the Company to obtain and maintain all necessary 
regulatory approvals, at the Company’s expense. 

F-8 

Organizational Changes 

In  2023,  the  Company  implemented  changes  to  its  organizational  structure  due  to  the  transaction  with  Cell  Ready  and  to  reduce 
operational  costs.  In  connection  with  these  changes,  the  Company  reduced  headcount,  including  the  separation  of  its  former  Chief 
Executive Officer, Peter Hoang, in May 2023 and its former Chief Accounting Officer, Michael Loiacono, in June 2023. During the 
second quarter of 2023, the Company recorded $0.9 million of severance and termination-related costs. The payments of these costs 
were completed in July of 2023. Effective May 1, 2023, the Company’s board of directors appointed Dr. Juan Vera as the Company’s 
President and Chief Executive Officer.  

Effective June 30, 2023, the board of directors appointed Eliot M. Lurier as the Company’s Interim Chief Financial Officer, whereby 
Mr. Lurier provided consulting services to the Company pursuant to a consulting between the Company and Danforth Advisors, LLC 
(“Danforth”) and received no compensation directly from the Company. On November 17, 2023, the Company terminated the consulting 
agreement between the Company and Danforth, effective January 16, 2024. 

On November 17, 2023, Mr. Lurier ceased serving as the Company’s Interim Chief Financial Officer and Dr. Vera was appointed as the 
Company’s Principal Financial and Accounting Officer. 

Reverse Stock Split  

On January 26, 2023, the Company effected a one-for-ten (1-for-10) reverse stock split of its common stock (the “Reverse Stock Split”) 
and  a  corresponding  reduction  in  the  total  number  of  authorized  shares  of  its  common  stock  from  300,000,000  to  30,000,000.  The 
Reverse  Stock  Split,  which  was  approved  by  stockholders  at  an  annual  stockholder  meeting  on  May 24,  2022,  was  consummated 
pursuant to a Certificate of Amendment filed with the Secretary of State of Delaware on January 26, 2023. The Reverse Stock Split was 
effective on January 26, 2023. All references to common stock, warrants to purchase common stock, options to purchase common stock, 
share data, per share data and related information contained in the consolidated financial statements have been retrospectively adjusted 
to reflect the effect of the Reverse Stock Split for all periods presented. 

NOTE 2:    FINANCIAL CONDITION, GOING CONCERN AND MANAGEMENT PLANS 

As of December 31, 2023, the Company had cash and cash equivalents of approximately $15.1 million. The Company’s activities since 
inception  have  consisted  principally  of  acquiring  product  and  technology  rights,  raising  capital,  and  performing  research  and 
development. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations 
are dependent on future events, including, among other things, its ability to access potential markets; secure financing; successfully 
progress its product candidates through preclinical and clinical development; obtain regulatory approval of one or more of its product 
candidates; maintain and enforce intellectual property rights; develop a customer base; attract, retain and motivate qualified personnel; 
and develop strategic alliances and collaborations. From inception, the Company has been funded by a combination of equity, debt 
financings and grants. 

In  August 2021,  the  Company  entered  into  a  Controlled  Equity  OfferingSM  Sales  Agreement  (the  “ATM  Agreement”)  with  Cantor 
Fitzgerald & Co. and RBC Capital Markets, LLC (the “Sales Agents”), pursuant to which the Company can offer and sell, from time to 
time at its sole discretion through the Sales Agents, shares of its common stock having an aggregate offering price of up to $75.0 million. 
Any  shares  of  its  common  stock  sold  will  be  issued  pursuant  to  the  Company’s  shelf  registration  statement  on  Form S-3  (File 
No. 333-258687),  which  the  SEC  declared  effective  on  August 19,  2021,  however,  our  use  of  the  shelf  registration  statement  on 
Form S-3 will be limited for so long as we are subject to General Instruction I.B.6 of Form S-3, which limits the amounts that we may 
sell under the registration statement and in accordance with the ATM agreement. The Sales Agents will be entitled to compensation 
under the Sales Agreement at a commission rate equal to 3.0% of the gross sales price per share sold under the ATM Agreement, and 
we have provided each of the Sales Agents with indemnification and contribution rights. During the year ended December 31, 2023, the 
Company sold 265,334 shares of its common stock under the ATM Agreement for proceeds of $1.0 million. 

In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from the 
Cancer Prevention and Research Institute of Texas (“CPRIT”) to support the Company’s Phase 2 clinical trial of MT-401. The CPRIT 
award is intended to support the adjuvant arm of the Company’s Phase 2 clinical trial evaluating MT-401 when given as an adjuvant 
therapy to patients with acute myeloid leukemia following a hematopoietic stem cell transplant. The primary objectives of the adjuvant 
arm of the trial are to evaluate relapse-free survival after MT-401 treatment when compared with a randomized control group. Through 

F-9 

 
the date of this filing, the Company has received $6.8 million of funds from the CPRIT grant. The Company recorded $2.7 million of 
grant income related to the CPRIT grant as revenue for the year ended December 31, 2023. 

In September 2022, the Company received notice from the U.S. Food and Drug Administration (the “FDA”) that it had awarded the 
Company  a  $2.0  million grant  from  the  FDA’s Orphan Products  Grant  program  to  support  the  Company’s  Phase 2 clinical  trial  of 
MT-401 for the treatment of post-transplant AML The Company recorded $0.4 million and $0.1 million of grant income related to the 
FDA  grant  as  revenue  for  the  year  ended  December 31,  2023  and  December 31,  2022,  respectively.  As  of  December 31,  2023,  the 
Company recorded $0.3 million of grant income receivable. In February 2024, the Company received $0.3 million of funds from the 
FDA grant.  

In May 2023, the Company received notice of a $2.0 million grant from the National Institutes of Health Small Business Innovation 
Research program to support the development and investigation of MT-401 for the treatment of AML patients following standard-of-
care therapy with hypomethylating agents. The Company recorded $0.2 million of grant income related to the SBIR grant as revenue 
for  the  year  ended  December 31,  2023.  As  of  December 31,  2023,  the  Company  recorded  $0.2  million  as  other  receivable,  which 
represented grant  income  earned  in  advance  of  funds  to be received from  the  SBIR. In  February 2024,  the  Company  received  $0.2 
million of funds from the SBIR grant. 

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program. 

In December 2022, the Company entered into a purchase agreement, or the Purchase Agreement, with Lincoln Park Capital Fund, LLC, 
or Lincoln Park, which provides that, upon the terms and subject to the conditions of the agreement, the Company has the right, but not 
the obligation, to sell to Lincoln Park up to $25,000,000 of shares of its common stock, or the Purchase Shares, from time to time over 
a 24-month term. For the year ended December 31, 2023, the Company sold 12,500 shares of its common stock under the Purchase 
Agreement for proceeds of approximately $33,000. In January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment 
fee at a value of $0.5 million. On February 29, 2024, the Company terminated the Purchase Agreement with Lincoln Park effective 
March 1, 2024. 

As described in Note 1, on June 26, 2023, the Company completed the transaction with Cell Ready pursuant to the Cell Ready Purchase 
Agreement for total consideration of $19.0 million. On February 22, 2024, the Company entered into a Master Services Agreement for 
Product Supply (the “MSA”) with Cell Ready, a contract development and manufacturing organization (CDMO). Under the MSA, it is 
anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support 
of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services 
from time to time by entering into work orders with Cell Ready.  

The Company expects to continue to incur substantial losses over the next several years during its development phase. 

Based on the Company’s clinical and research and development plans and its timing expectations related to the progress of its programs, 
the Company expects that its cash and cash equivalents as of December 31, 2023, including drawdowns of available grant funds, will 
enable the Company to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025. Prior to the 
Cell Ready transaction, there was substantial doubt regarding the Company’s ability to continue as a going concern, which was alleviated 
by the proceeds from the transaction. 

The Company has based this estimate on assumptions that may prove to be wrong, and the Company could utilize its available capital 
resources sooner than it currently expects. Furthermore, the Company’s operating plan may change, and it may need additional funds 
sooner  than  planned  in  order  to  meet  operational  needs  and  capital  requirements  for  product  development  and  commercialization. 
Because of the numerous risks and uncertainties associated with the development and commercialization of the Company’s product 
candidates  and  the  extent  to  which  the  Company  may  enter  into  additional  collaborations  with  third  parties  to  participate  in  their 
development  and  commercialization,  the  Company  is  unable  to  estimate  the  amounts  of  increased  capital  outlays  and  operating 
expenditures associated with its current and anticipated clinical trials. The Company’s future funding requirements will depend on many 
factors, as it: 

• 

• 

initiates or continues clinical trials of its product candidates; 

continues the research and development of its product candidates and seeks to discover additional product candidates; 

F-10 

• 

seeks regulatory approvals for any product candidates that successfully complete clinical trials; 

•  maintains and enforces intellectual property rights; 

• 

• 

• 

• 

enters into contract manufacturing arrangements with Cell Ready or other contract manufacturing organizations for clinical 
manufacturing supply; 

establishes  sales,  marketing  and  distribution  infrastructure  and  scale-up  manufacturing  capabilities  to  commercialize  any 
product candidates that may receive regulatory approval; 

evaluates strategic transactions the Company may undertake; and 

enhances operational, financial and information management systems and hires additional personnel, including personnel to 
support development of product candidates and, if a product candidate is approved, commercialization efforts. 

The Company does not have sufficient sources of revenue to provide incoming cash flows to sustain its future operations beyond the 
fourth quarter of 2025. As outlined above, its ability to pursue its long-term planned business activities is dependent upon its successful 
efforts to raise additional capital and grant income. 

The current macro-economic environment of decades-high inflation and concerns about an economic recession in the United States or 
other  major  markets  has  resulted  in,  among  other  things,  volatility  in  the  capital  markets  that  may  have  the  effect  of  reducing  the 
Company’s ability to access capital, which could in the future negatively affect the Company’s liquidity. In addition, a recession or 
market correction due to these factors could materially affect the Company’s business and the value of its common stock. 

NOTE 3:    SIGNIFICANT ACCOUNTING POLICIES 

Basis of Presentation 

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted 
in the United States of America and pursuant to the rules and regulations of the Securities Exchange Commission (“SEC”). Any reference 
in these footnotes to applicable guidance is meant to refer to the authoritative U.S. generally accepted accounting principles (“GAAP”) 
as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting 
Standards Board (“FASB”). 

Principles of Consolidation 

These  consolidated  financial  statements  include  the  accounts  of  the  Company  and  its  wholly-owned  subsidiaries,  Marker  Cell 
Therapy, Inc. and GeneMax Pharmaceuticals Inc. – a dormant subsidiary that wholly owns GeneMax Pharmaceuticals Canada, Inc. All 
significant intercompany balances and transactions are eliminated upon consolidation. 

Use of Estimates 

Preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and 
assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the 
financial statements and the reported amounts of expenses during the reporting period. Accordingly, actual results may differ materially 
from  those  estimates.  Management  considers  many  factors  in  selecting  appropriate  financial  accounting  policies,  controls,  and  in 
developing  the  estimates  and  assumptions  that  are  used  in  the  preparation  of  these  financial  statements.  Management  must  apply 
significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, 
sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be 
representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future 
outcomes, and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following 
areas, among others: stock-based compensation expense and income taxes. 

F-11 

Cash, Cash Equivalents and Credit Risk 

The Company considers highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash 
and cash equivalents at December 31, 2023 consisted of cash and certificates of deposit in institutions in the United States. Balances at 
certain institutions have exceeded Federal Deposit Insurance Corporation insured limits and U.S. government agency securities. 

The Company maintains cash in accounts which are in excess of the Federal Deposit Insurance Corporation (“FDIC”) insured limits of 
$250,000.  As  of  December 31,  2023  and  December 31,  2022,  the  Company  had  approximately  $1.4.  million  and  $2.3  million, 
respectively  in  cash  at  financial  institutions.  As  of  December 31,  2023,  the  Company  had  approximately  $13.7  million  in  U.S. 
government agency securities. 

In the event cash is received from grants in advance of incurring qualifying costs, it is recorded as restricted cash until it is earned and 
recorded to grant income. 

Discontinued Operations 

The Purchased Assets sold to Cell Ready pursuant to the Cell Ready Purchase Agreement constituted a significant disposition and as 
such, the Company concluded that the disposition of its Purchased Assets represented a strategic shift that had a major effect on its 
operations  and  financial  results.  Therefore,  the  Purchased  Assets,  related  party  revenue,  service  revenue  and  related  expenses  are 
classified as discontinued operations for all periods presented herein. See Note 6 for further information. 

Patents and Patent Application Costs 

Although the Company believes that its patents and underlying technology have continuing value, the amount of future benefits to be 
derived from the patents is uncertain. Patent costs are, therefore, expensed as incurred.  

Stock-Based Compensation 

The Company incurs stock-based compensation expense related to the issuance of common stock and stock options. The Company 
estimates the fair value of stock options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model 
was developed for use in estimating the fair value of traded options, which have no vesting restrictions and are fully transferable. In 
addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and 
expected option life: 

Expected Term — The expected life of stock options was estimated using the “simplified method,” as the Company has limited 
historical  information  to  develop  reasonable  expectations  about  future  exercise  patterns  and  post-vesting  employment 
termination behavior for its stock options grants. The simplified method is based on the average of the vesting tranches and the 
contractual life of each grant.  

Expected Volatility — The Company computes stock price volatility over expected terms based on its historical common stock 
trading prices.  

Risk-Free Interest Rate — The Company bases the risk-free interest rate on the implied yield available on U.S. Treasury zero-
coupon issues with an equivalent remaining term.  

Expected Dividend — The Company has never declared or paid any cash dividends on its common shares and does not plan to 
pay cash dividends in the foreseeable future, and, therefore, uses an expected dividend yield of zero in its valuation models. 

The Company amortizes the fair value of the awards expected to vest on a straight-line basis over the requisite service period of the 
awards. The Company recognizes fair value of stock options granted to nonemployees as stock-based compensation expense over the 
period in which the related services are received as if the Company had paid cash for those services. Forfeitures are accounted for as 
incurred. 

F-12 

 
Research and Development Costs 

Research and development expenses consist of costs associated with clinical trial programs. Costs incurred by third parties are expensed 
as the contracted work is performed. The Company accrues for costs incurred as the services are being provided by monitoring the status 
of  the  clinical  trial  or  project  and  the  invoices  received  from  its  external  service  providers.  The  Company  estimates  depend  on  the 
timeliness and accuracy of the data provided by the vendors regarding the status of each project and total project spending. The Company 
adjusts its accrual as actual costs become known. Where contingent milestone payments are due to third parties under research and 
development arrangements, the milestone payment obligations are expensed when the milestone events are achieved. 

Income Taxes 

The Company follows the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities 
are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of assets 
and liabilities and their respective tax balances. Potential deferred tax assets and liabilities are measured using enacted tax rates expected 
to apply to the taxable income in the years in which those differences are expected to be recovered or settled. The effect on potential 
deferred tax assets and liabilities of a change in tax rates is recognized in the statement of operations in the period that includes the date 
of allowances against deferred tax assets.  

Tax benefits are recognized only for tax positions that are more likely than not to be sustained upon examination by tax authorities. The 
amount recognized is measured as the largest amount of benefit that is greater than 50 percent likely to be realized upon settlement. A 
liability for “unrecognized tax benefits” is recorded for any tax benefits claimed in the Company’s tax returns that do not meet these 
recognition and measurement standards. As of December 31, 2023 and 2022, no liability for unrecognized tax benefits was required to 
be reported. The guidance also discusses the classification of related interest and penalties on income taxes. The Company’s policy is 
to record interest and penalties on uncertain tax positions as a component of income tax expense. No interest or penalties were recorded 
during the years ended December 31, 2023 and 2022. 

Grant Income 

Grant  Income  represents  funding  under  cost  reimbursement  programs  from  government  agencies  and  non-profit  foundations  for 
qualified research and development activities performed by the Company. In applying the provisions of ASC Topic 606, Revenue from 
Contracts with Customers (“ASC 606”), the Company determined that grants and awards are out of the scope of ASC 606 because the 
funding entities do not meet the definition of a “customer”, as defined by ASC 606, as there is not considered to be a transfer of control 
of goods or services. With respect to each grant or award, the Company determines if it has a collaboration in accordance with ASC 
Topic 808, Collaborative Arrangements (“ASC 808”). To the extent the grant or award is within the scope of ASC 808, the Company 
recognizes the award upon achievement of certain milestones as credits to research and development expenses. For grant and awards 
outside the scope of ASC 808, the Company applies ASC 606 by analogy, and revenue is recognized when the Company incurs expenses 
related to the grants for the amount the Company is entitled to under the provisions of the contract. 

Loss per Common Share 

Basic  loss  per  share  includes  only  the  weighted  average  common  shares  outstanding,  without  consideration  of  potentially  dilutive 
securities. Diluted loss per share includes the weighted average common shares outstanding and any potentially dilutive common stock 
equivalent shares in the calculation. 

New Accounting Standards 

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts 
as of the specified effective date. Unless otherwise discussed, the Company does not believe that the impact of recently issued standards 
that are not yet effective will have a material impact on its financial position or results of operations upon adoption.  

F-13 

Recently Issued Accounting Standards Not Yet Adopted 

Improvements to Reportable Segment Disclosures 

In  November 2023,  the  Financial  Accounting  Standards  Board  (the  “FASB”)  issued  Accounting  Standards  Update  (“ASU”) 
No. 2023-07,  Segment  Reporting  (Topic  280):  Improvements  to  Reportable  Segment  Disclosures.  The  ASU  requires  disclosures  to 
include significant segment expenses that are regularly provided to the chief operating decision maker, among other provisions. The 
ASU is effective for fiscal year periods beginning after December 15, 2023, and interim periods within fiscal years beginning after 
December 15, 2024. Early adoption is permitted and the ASU requires retrospective application to all prior periods presented in the 
financial statements. The Company is currently evaluating the standard to determine the impact of adoption to its consolidated financial 
statements and disclosures. 

Improvements to Income Tax Disclosures 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (ASU 
2023-09), which improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of 
information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other 
amendments to improve the effectiveness of income tax disclosures. This guidance will be effective for the annual periods beginning 
the  year  ended  December 31,  2025.  Early  adoption  is  permitted.  Upon  adoption,  the  guidance  can  be  applied  prospectively  or 
retrospectively. We do not expect the adoption of this guidance to have a material impact on its consolidated financial statements.  

NOTE 4:    NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS 

Basic loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during 
the reporting period. Diluted loss per common share is computed similarly to basic loss per common share except that it reflects the 
potential dilution that could occur if dilutive securities or other obligations to issue common stock were exercised or converted into 
common stock. 

The following table sets forth the computation of net loss per share for the years ended December 31, 2023 and 2022, respectively: 

For the Years Ended 
December 31,  

2023 

2022 

Numerator: 
Loss from continuing operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$   (14,045,895)
5,809,081
 (8,236,814)

$ 

$ (19,775,915)
(10,154,779)
$ (29,930,694)

Denominator: 
Weighted average common shares outstanding, basic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Weighted average common shares outstanding, diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8,809,382
8,809,382

8,351,003
8,351,003

Net earnings (loss) per share: 
Loss from continuing operations, basic and diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income (loss) from discontinued operations, basic and diluted. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net loss per share, basic and diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 
$ 
$ 

 (1.59)
 0.66
 (0.94)

$
$
$

(2.37)
(1.22)
(3.58)

F-14 

 
 
 
 
 
 
 
     
 
 
 
     
     
 
  
 
 
 
  
  
  
 
 
 
  
  
 
The following securities, rounded to the thousand, were not included in the diluted net loss per share calculation because their effect 
was anti-dilutive for the periods presented: 

Common stock options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    
Common stock purchase warrants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    
Potentially dilutive securities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .    

NOTE 5:     OTHER RECEIVABLE 

For the Years Ended 
December 31,  

2023 
 738,000
 —
 738,000

2022 
886,000
1,848,000
2,734,000

Qualifying grant income earned in advance of cash received from grants is recognized as revenue and recorded as other receivable. The 
Company  recorded  $2.7  million  of  grant  income  related  to  the  CPRIT  grant  for  the  year  ended  December 31,  2023.  At 
December 31, 2023, the Company recorded $0.5 million of grant income receivable related to the CPRIT grant. 

Additionally, the Company recorded $0.4 million and $0.2 million of grant income related to the FDA and SBIR grants, respectively, 
for the year ended December 31, 2023. At December 31, 2023, the Company recorded $0.3 million and $0.2 million of grant income 
receivable related to the FDA and SBIR grants, respectively. 

The Company received $0.3 million and $0.2 million of funds from FDA and SBIR in February 2024, respectively. 

NOTE 6:    DISCONTINUED OPERATIONS 

As discussed in Note 1, on June 26, 2023, the Company completed the previously announced transaction with Cell Ready for cash 
consideration of $19.0 million, resulting in derecognition of the Purchased Assets and a gain on sale of approximately $8.7 million, net 
of $63,000 in tax. 

The assets and liabilities classified in discontinued operations as of December 31, 2023 and 2022 are as follows: 

Prepaid expenses and other current assets . . . . . . . . . . . . . . . . . . . .
Total current assets of discontinued operations . . . . . . . . . . . . .
Fixed Assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Right of use assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total non-current assets of discontinued operations. . . . . . . . . .
Total assets of discontinued operations . . . . . . . . . . . . . . . . . . . .

Accounts payable   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Related party deferred revenue   . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Short-term lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total current liabilities of discontinued operations. . . . . . . . . . .
Long-term lease liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total non-current liabilities of discontinued operations. . . . . . .
Total liabilities of discontinued operations . . . . . . . . . . . . . . . . .

$

$

$

$

December 31,  
2023 

December 31,  
2022 

—  
—  
—  
—  
—  
—  

—  
—  
—  
—  
—  
—  
—  

$ 

$ 

$ 

$ 

585,840
 585,840
 12,323,143
 5,479,786
 17,802,929
 18,388,769

 2,183,418
 2,500,000
 577,198
 5,260,616
 7,039,338
 7,039,338
 12,299,954

F-15 

 
 
 
 
 
 
 
 
 
     
     
 
 
 
 
 
 
 
 
 
     
     
 
 
  
 
 
 
 
 
 
 
  
 
 
Net loss from discontinued operations consists of the following for the years ended December 31, 2023 and 2022, respectively, excluding 
the gain on disposal: 

For the Years Ended 
December 31, 

2023 

2022 

Revenues: 

Service revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Related party service revenue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total revenues  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Operating expenses: 

Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
Total operating expenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Loss from discontinued operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

816,641    $
3,500,000     
4,316,641     

—
5,500,000
5,500,000

677,090     

6,561,957      14,170,894
1,483,885
7,239,047      15,654,779
$ (2,922,406)   $(10,154,779)

The following table summarizes our cash flows for the years ended December 31, 2023 and 2022: 

For the Years  Ended 
December 31, 

2023 

2022 

Continuing operations: 

Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by financing activities . . . . . . . . . . . . . . . . . . . . . . .

$ (10,341,000)   $  (21,513,000)
 202,000

1,105,000  

Discontinued operations 

Net cash used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . . .
Net cash provided by (used in) investing activities . . . . . . . . . . . . . . .
Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . . . . .

(6,099,000)  

 (5,459,000)
$ 18,664,000   $   (4,945,000)
3,329,000   $  (31,715,000)
$

Related Party Service Revenue 

In April 2022, the Company entered into a binding services agreement (“Wilson Wolf Agreement”) with Wilson Wolf Manufacturing 
Corporation (“Wilson Wolf”). Mr. John Wilson is a member of the Company’s board of directors and is serving as the CEO of Wilson 
Wolf. Wilson Wolf is in the business of creating products and services intended to simplify and expedite the transition of cell therapies 
and gene-modified cell therapies to mainstream society (the “Wilson Wolf Mission”). Pursuant to the Wilson Wolf Agreement, Wilson 
Wolf made a cash payment to the Company in the amount of $8.0 million, as consideration for certain training and research services. 

In March 2023, the Company recognized the final $2.5 million of revenue pursuant to this $8.0 million agreement and an additional 
$1.0 million because the Work Direction was completed within one year from the onset of the Wilson Wolf Agreement, achieving the 
agreed milestone. The Wilson Wolf Agreement and related service obligations were completed upon achievement of this final milestone, 
and no obligations remain. 

Service Revenue 

In  April 2023,  the  Company  signed  the  Indapta  Master  Services  Agreement,  pursuant  to  which  the  Company  provided  services  to 
Indapta. Under an executed work order of that agreement, now complete, the Company recognized $0.8 million for the services during 
the period ended June 30, 2023. Effective as of the closing date of the Purchase Agreement with Cell Ready, the rights and obligations 
to the Indapta Agreement were transferred to Cell Ready, and as such the revenues and expenses are reflected in discontinued operations. 

F-16 

 
 
 
 
 
 
 
 
 
 
    
     
 
 
   
      
 
 
 
 
 
 
 
 
 
 
 
   
        
 
  
    
  
 
  
 
 
NOTE 7: PROPERTY AND EQUIPMENT 

Substantially all of the previously reported property and equipment was disposed of as a result of the Cell Ready transaction. See Note 6: 
Discontinued Operations for details. 

NOTE 8:     LEASES 

Substantially all of the previously reported leases were disposed of as a result of the Cell Ready transaction. See Note 6: Discontinued 
Operations for details. 

NOTE 9:    ACCOUNTS PAYABLE, ACCRUED LIABILITIES, AND RELATED PARTY PAYABLE 

Accounts payable, accrued liabilities, and related party payable consist of the following as of December 31, 2023 and 2022, respectively: 

Accounts payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Compensation and benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Professional fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Related party payable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Arbitration settlement fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tax fees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total accounts payable and accrued liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . .

     December 31,       December 31, 

$

2022 

2023 
961,000   $  1,101,000
 750,000
 57,000  
 518,000
303,000  
—
1,330,000  
 114,000
 —  
—
219,000  
 38,000
205,000  
   2,521,000
3,075,000  

The $1.3 million related-party payable reflects amounts payable to Cell Ready for outsourced product development and manufacturing 
services. This amount was paid during February 2024. See Note 14: Related Party Transactions. 

NOTE 10:    STOCKHOLDERS’ EQUITY 

Increase in Authorized Shares 

During June 2022, the Company’s board of directors and stockholders approved a Certificate of Amendment (the “Amendment”) to the 
Company’s Certificate of Incorporation to increase the authorized shares of common stock of the Company from 15,000,000 shares to 
30,000,000 shares. The Company filed the Amendment with the Secretary of State of Delaware on May 25, 2022. 

Reverse Stock Split 

On January 26, 2023, the Company effected the Reverse Stock Split and a corresponding reduction in the total number of authorized 
shares of its common stock from 300,000,000 to 30,000,000. The Reverse Stock Split, which was approved by stockholders at an annual 
stockholder meeting on May 24, 2022, was consummated pursuant to a Certificate of Amendment filed with the Secretary of State of 
Delaware on January 26, 2023. The Reverse Stock Split was effective on January 26, 2023. All historical share and per share amounts 
reflected in this report have been adjusted to reflect the Reverse Stock Split. 

Preferred Stock 

The Company has authorized up to 5,000,000 shares of preferred stock, $0.001 par value per share, for issuance. The preferred stock 
will  have  such  rights,  privileges  and  restrictions,  including  voting  rights,  dividend  conversion  rights,  redemption  privileges  and 
liquidation preferences, as shall be determined by the Company’s board of directors upon its issuance. To date, the Company has not 
issued any preferred shares. 

F-17 

 
 
 
 
 
 
 
 
 
 
  
 
  
  
  
  
 
Common Stock 

The Company has authorized up to 30,000,000 shares of common stock, $0.001 par value per share, for issuance. Significant 2023 and 
2022 common stock transactions were as follows: 

2023 Common Stock Transactions 

Issuance of Stock Pursuant to ATM Agreement 

During the year ended December 31, 2023, the Company sold 265,334 shares of its common stock under the ATM Agreement for net 
proceeds of $1.0 million. 

Stock Purchase Agreement with Lincoln Park 

In December 2022, the Company entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park which provides that, 
upon the terms and subject to the conditions of the agreement, the Company has the right, but not the obligation, to sell to Lincoln Park 
up to $25,000,000 of shares of its common stock (the “Purchase Shares”) from time to time over a 24-month term, at a variable price 
with  certain  market-based  terms  as  defined  in  the  Purchase  Agreement.  The  Purchase  Agreement  does  not  exhibit  any  of  the 
characteristics for liability classification under ASC Topic 480, Distinguishing Liabilities from Equity. Instead, the purchase agreement 
is indexed to the Company’s own stock under ASC Subtopic 815-40, Contracts in Entity’s Own Equity, and classified as equity. In 
January 2023, Lincoln Park was issued 180,410 shares of stock as a commitment fee at a value of $0.5 million. During the year ended 
December 31, 2023, the Company sold 12,500 shares of its common stock under the Purchase Agreement for proceeds of approximately 
$33,000. The Company terminated the Purchase Agreement with Lincoln Park on February 29, 2024 effective March 1, 2024. 

Exercise of Stock Options 

During the year ended December 31, 2023, certain outstanding options were exercised for 27,518 shares of common stock providing 
aggregate proceeds to the Company of approximately $0.1 million. 

2022 Common Stock Transactions 

Issuance of Restricted Stock Units to Executives 

During  the  year  ended  December 31,  2022,  upon  the  recommendation  of  the  compensation  committee  of  the  Company’s  board  of 
directors, and pursuant to the Company’s 2020 Equity Incentive Plan, the Company’s board of directors approved the issuance of a total 
of 37,252 shares of common stock, valued at a total of approximately $180,200, subject to restricted stock units, which were immediately 
vested upon grant, to certain executives as performance bonuses for performance during the year ended December 31, 2021. 

Issuance of Stock Pursuant to ATM Agreement 

During the year ended December 31, 2022, the Company issued and sold 60,651 shares of its common stock under the ATM Agreement 
for net proceeds of $202,100. 

Stock Purchase Agreement with Lincoln Park 

During the year ended December 31, 2022, the Company did not sell any shares of its common stock under the Purchase Agreement. 

F-18 

 
 
Share Purchase Warrants 

A summary of the Company’s share purchase warrants as of December 31, 2023 and 2022, respectively, and changes during the period 
is presented below: 

Balance - January 1, 2022  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expired or cancelled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance - December 31, 2022 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expired or cancelled . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Balance - December 31, 2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Number of 
    Warrants 
   1,983,000
(135,000)
   1,848,000
(1,848,000)

$

— $

  Weighted Average 
  Weighted Average     Remaining Contractual  Total Intrinsic
    Exercise Price 

Life (in years) 

Value 

44.20   
39.70   
44.51   
44.51   
—   

$

1.70
—
0.79
—
— $

$

 —
—
 —
—
 —

All warrants outstanding at December 31, 2022 expired according to their terms on October 16, 2023. As of December 31, 2023, the 
Company had no outstanding warrants. 

NOTE 11:    STOCK BASED COMPENSATION 

Stock Options  

On May 19, 2020, the Board adopted the 2020 Equity Incentive Plan (“2020 Equity Incentive Plan”) which replaced the 2014 Omnibus 
Stock Option Plan. The 2020 Plan was further amended effective May 2022 to increase the number of shares of common stock authorized 
for issuance under the plan by 850,000 shares. The 2020 Plan allows for grants of stock options, restricted shares, stock bonuses and 
other equity-based awards to employees and non-employee directors of the Company. Awards under the 2020 Plan may be at prices and 
for terms as determined by the Company’s board of directors and may have vesting requirements as determined by the Board, provided 
that the exercise price for any stock option must be at least equal to the fair market value (as defined in the 2020 Plan) of a share of the 
stock  on  the  grant  date.  Once  granted,  the  exercise  price  of  an  option  may  not  be  reduced  without  the  approval  of  the  Company’s 
stockholders, other than under certain limited circumstances such as a stock split or take any other action with respect to a stock option 
that would be treated as a repricing under the rules and regulations of the Nasdaq Stock Exchange. 

Options granted under the 2020 Plan have a maximum term of ten years from the date of grant and generally vest over four years. 

2023 Equity Incentive Awards 

On February 27, 2023, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of 
directors  approved  a  total  of  316,855  options  to  purchase  the  Company’s  common  stock  as  equity-based  incentive  awards  to  the 
Company’s executive officers and management team. Each option award was granted with an exercise price of $2.14 per share, the 
closing price of the Company’s common stock on the Nasdaq Global Market on February 27, 2023, with the option award vesting in 48 
equal monthly installments over a four-year period, subject to such executive officer’s continued service on the applicable vesting date. 
Additionally, on February 27, 2023, the compensation committee of the Company’s board of directors approved a total of 87,677 options 
to purchase the Company’s common stock to non-executive employees and management team of the Company as equity-based incentive 
awards. Each option award was granted with an exercise price of $2.14 per share, the closing price of the Company’s common stock on 
the Nasdaq Global Market on February 27, 2023, with the option award vesting in 48 equal monthly installments over a four-year period, 
subject to such employee’s continued service on the applicable vesting date.  

The above awards were in addition to 7,000 stock option awards issued during the three months ended March 31, 2023 to new employees 
upon their commencement of employment with the Company. Each option award was granted with an exercise price of $2.769 per share, 
the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2023, with 25% of the option award 
vesting in one year and the remaining 75% vesting in 36 equal monthly installments thereafter over a three-year period, subject to such 
employee’s continued service on the applicable vesting date. 

On May 10, 2023, the Company’s board of directors approved a one-time share option grant of 100,000 shares of common stock to 
Dr. Vera for his appointment as the Company’s Chief Executive Officer. The option has a term of ten years and will vest in equal annual 

F-19 

 
 
 
 
 
 
 
 
    
   
  
 
installments on May 10, 2024, May 10, 2025, May 10, 2026, and May 10, 2027, subject to Mr. Vera’s continued service to the Company 
as of the applicable vesting date. Each option award was granted with an exercise price of $1.42 per share, the closing price of the 
Company’s common stock on the Nasdaq Global Market on May 10, 2023. 

On June 6, 2023, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by 
the Company’s board of directors, a total of 32,000 stock option awards were issued to independent members of the board of directors 
of the Company. Each option award was granted with an exercise price of $1.72 per share, the closing price of the Company’s common 
stock on the Nasdaq Global Market on June 6, 2023. Each Option award will vest in one year subject to the director’s continuance of 
service through June 6, 2024. 

For  the  year  ended  December 31,  2023,  the  Company  recorded  incremental  stock-based  compensation  expense  of  approximately 
$0.3 million pertaining to the modification of stock options in connection with the termination of certain employees that were hired by 
Cell Ready or transitioned as independent consultants. The modification provided for an acceleration of unvested options, resulting in a 
change in compensation expense that was immediately recognized. $0.2 million is reflected in loss from discontinued operations. 

2022 Equity Incentive Awards 

On February 17, 2022, pursuant to the Company’s 2020 Equity Incentive Plan, the compensation committee of the Company’s board of 
directors  approved  a  total  of  125,000  options  to  purchase  the  Company’s  common  stock  as  equity-based  incentive  awards  to  the 
Company’s  executive  officers.  Each  option  award  was  granted  with  an  exercise  price  of  $4.60  per  share,  the  closing  price  of  the 
Company’s common stock on the Nasdaq Global Market on February 17, 2022, with the option award vesting in 48 equal monthly 
installments over a four-year period, subject to such executive officer’s continued service on the applicable vesting date. Additionally, 
on February 17, 2022, the compensation committee of the Company’s board of directors approved a total of 39,500 options to purchase 
the Company’s common stock to non-executive employees of the Company as equity-based incentive awards. Each option award was 
granted with an exercise price of $4.60 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on 
February 17, 2022, with the option award vesting in 48 equal monthly installments over a four-year period, subject to such employee’s 
continued service on the applicable vesting date. 

The  above  awards  were  in  addition  to  17,500  stock  option  awards  issued  during  the  three  months  ended  March 31,  2022  to  new 
employees upon their commencement of employment with the Company. Each option award was granted with an exercise price of 
$10.00 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on January 3, 2022, with 25% of the 
option award vesting in one year and the remaining 75% vesting in 36 equal monthly installments thereafter over a three-year period, 
subject to such employee’s continued service on the applicable vesting date.  

21,000 stock option awards were issued during the three months ended June 30, 2022 to new employees upon their commencement of 
employment with  the  Company.  Each  option  award  was granted  with  an  exercise price  of $4.30 per share,  the  closing price of  the 
Company’s common stock on the Nasdaq Global Market on April 1, 2022, with 25% of the option award vesting in one year and the 
remaining  75%  vesting  in  36  equal  monthly  installments  thereafter  over  a  three-year  period,  subject  to  such  employee’s  continued 
service on the applicable vesting date.  

10,000 stock option awards were issued during the three months ended September 30, 2022 to new employees upon their commencement 
of employment with the Company. Each option award was granted with an exercise price of $3.50 per share, the closing price of the 
Company’s common stock on the Nasdaq Global Market on July 1, 2022, with 25% of the option award vesting in one year and the 
remaining  75%  vesting  in  36  equal  monthly  installments  thereafter  over  a  three-year  period,  subject  to  such  employee’s  continued 
service on the applicable vesting date. 

Additionally, 7,000 stock option awards were issued during the three months ended December 31, 2022 to new employees upon their 
commencement of employment with the Company. Each option award was granted with an exercise price of $3.73 per share, the closing 
price of the Company’s common stock on the Nasdaq Global Market on October 3, 2022, with 25% of the option award vesting in one 
year and the remaining 75% vesting in 36 equal monthly installments thereafter over a three-year period, subject to such employee’s 
continued service on the applicable vesting date. 

Also, pursuant to the Company’s Non-Employee Director Compensation Policy, which had previously been approved by the Company’s 
board of directors, 40,000 stock option awards were issued during the year ended December 31, 2022 to independent members of the 

F-20 

board of directors of the Company. Each option award was granted on May 24, 2022 with an exercise price of $3.377 per share, the 
closing price of the Company’s common stock on the Nasdaq Global Market on May 24, 2022. Each option award vested over one year 
subject to the director’s continuance of service through May 24, 2023.  

As of December 31, 2023, approximately 1.1 million shares of common stock are available to be issued under the 2020 Plan. 

Stock Options  

A summary of the Company’s stock option activity for the years ended December 31, 2023 and December 31, 2022, is as follows: 

   Weighted Average

Outstanding as of January 1, 2022  . .    
Granted . . . . . . . . . . . . . . . . . . . . . . .    
Canceled/Expired . . . . . . . . . . . . . . .   

768,623 $
260,000
(142,450)

Outstanding as of 

  Number of Shares   Exercise Price 

  Weighted Average  

Remaining 
Contractual 
  Total Intrinsic Value     Life (in years) 
7.7
 —  
7.8
 —  
—
 —  

54.69 $
4.68
36.78

December 31, 2022 . . . . . . . . . . . . .    
Granted . . . . . . . . . . . . . . . . . . . . . . .    
Exercised  . . . . . . . . . . . . . . . . . . . . .    
Canceled/Expired . . . . . . . . . . . . . . .    

886,173
544,532
(27,518)
(665,292)

42.90
1.99
3.29
30.41

 —  
 —  
 —  
 —  

Outstanding as of 

December 31, 2023 . . . . . . . . . . . . .    
Options vested and exercisable . . . . .    

737,895 $
404,343 $

25.42 $
43.53 $

1,317,000  
244,000  

7.3
5.6
—
—

7.6
6.6

The Black-Scholes option pricing model is used to estimate the fair value of stock options granted under the Company’s share-based 
compensation plans. The weighted average assumptions used in calculating the fair values of stock options that were granted during the 
years ended December 31, 2023 and 2022, respectively, were as follows: 

Exercise price . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected term (years)  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
Expected stock price volatility  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Risk-free rate of interest  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Expected dividend rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .

$

$ 

1.99  
 6.0  
 91 %     
 4 %     
 0 %     

 4.70
5.9
85 %
2 %
0 %

The following table sets forth stock-based compensation expenses recorded during the respective periods: 

For the Years Ended 
December 31,  

2023 

2022 

For the Years Ended 
December 31,  

2023 

2022 

Stock Compensation expenses: 

Research and development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
General and administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
Stock compensation in continuing operations . . . . . . . . . . . . . . . . . . . . . . .
Stock compensation in discontinued operations . . . . . . . . . . . . . . . . . . . . . .
Total stock compensation expenses  . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .

$

338,000   $ 
520,000  
858,000  
725,000  

 783,000
 2,522,000
 3,305,000
    2,039,000
$ 1,583,000   $   5,344,000

At December 31, 2023, the total stock-based compensation cost related to unvested awards not yet recognized was $0.4 million. The 
expected weighted average period compensation costs to be recognized was 1.8 years. Future option grants will impact the compensation 
expense recognized. 

F-21 

 
 
 
 
 
 
 
 
  
 
   
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
    
     
 
  
 
 
 
 
 
 
 
    
 
 
 
    
     
    
 
 
 
 
 
 
 
 
NOTE 12: GRANT INCOME 

CPRIT 
In August 2021, the Company received notice of a Product Development Research award totaling approximately $13.1 million from 
CPRIT to support the Company’s Phase 2 clinical trial of MT-401. The CPRIT award is intended to support the adjuvant arm of the 
Company’s  Phase  2  clinical  trial  evaluating  MT-401  when  given  as  an  adjuvant  therapy  to  patients  with  acute  myeloid  leukemia 
following  a  hematopoietic  stem  cell  transplant.  The  primary  objectives  of  the  adjuvant  arm  of  the  trial  are  to  evaluate  relapse-free 
survival after MT-401 treatment when compared with a randomized control group. 

If restricted cash received from grants in advance of incurring qualifying costs, it is recorded as deferred revenue and recognized as 
revenue when qualifying costs are incurred. There was no restricted cash recorded as of December 31, 2023 and December 31, 2022. If 
qualifying grant income is earned in advance of cash received from grants, it is recognized as revenue and recorded as other receivable. 

The  Company  recorded  $2.7  million  and  $3.4  million  of  grant  income  related  to  the  CPRIT  grant  as  revenue  for  the  years  ended 
December 31, 2023 and 2022, respectively. At December 31, 2023, the Company had recorded $0.5 million as other receivable, which 
represented grant income earned in advance of the next tranche of funds to be received from CPRIT. 

FDA 

In September 2022, the Company received notice from the FDA that it had awarded the Company a $2.0 million grant from the FDA’s 
Orphan Products Grant program to support the Company’s Phase 2 clinical trial of MT-401 for the treatment of post-transplant AML. 
The  Company  recorded  $0.4  million  and  $0.1  million  of  grant  income  related  to  the  FDA  grant  as  revenue  for  the  years  ended 
December 31,  2023  and  December 31,  2022,  respectively.  As  of  December 31,  2023,  the  Company  recorded  $0.3  million  as  other 
receivable, which represented grant income earned in advance of funds to be received from the FDA. In February 2024, the Company 
received $0.3 million of funds from the FDA grant. 

SBIR 

In  May 2023,  the  Company  announced  it  had  received  a  $2.0  million  grant  from  the  National  Institutes  of  Health  Small  Business 
Innovation Research program to support the development and investigation of MT-401 for the treatment of AML patients following 
standard-of-care therapy with hypomethylating agents. The Company recorded $0.2 million of grant income related to the SBIR grant 
as revenue for the year ended December 31, 2023. As of December 31, 2023, the Company recorded $0.2 million as other receivable, 
which represented grant income earned in advance of funds to be received from the SBIR. In February 2024, the Company received 
$0.2 million of funds from the SBIR grant. 

All funding agencies have agreed to continue their financial support and to shift funds to the MT-401-OTS program. 

NOTE 13:    LEGAL PROCEEDINGS 

From time to time, the Company may be party to ordinary, routine litigation incidental to their business. The Company knows of no 
material, active or pending legal proceedings against the Company, nor is the Company involved as a plaintiff in any material proceeding 
or pending litigation. There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or 
beneficial shareholder, is an adverse party or has a material interest adverse to the Company’s interest. 

F-22 

 
NOTE 14:    RELATED PARTY TRANSACTIONS 

The following table sets forth related party transaction expenses recorded for the years ended December 31, 2023 and 2022, respectively. 

For the Years Ended 
December 31,  

Baylor College of Medicine  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Bio-Techne Corporation  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Cell Ready  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Wilson Wolf Manufacturing Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Total Research and development  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

2022 

2023 
13,000      $  1,142,000
 101,000
—
 265,000
$ 1,620,000    $  1,508,000

 —  
1,330,000   
277,000  

$1.3 million of related party transactions are included in accounts payable and accrued liabilities as of December 31, 2023. See Note 9 
for additional information. 

Agreements with The Baylor College of Medicine (“BCM”). 

In November  2018,  January 2020  and  February 2020,  the  Company  entered  in  Sponsored  Research  Agreements with  BCM, which 
provided for the conduct of research for the Company by credentialed personnel at BCM’s Center for Cell and Gene Therapy. 

In September 2019, May 2020 and July 2021, the Company entered into Clinical Supply Agreements with BCM, which provided for 
BCM to provide to the Company multi tumor antigen specific products. 

In October 2019, the Company entered in a Workforce Grant Agreement with BCM, which provided for BCM to provide to the Company 
manpower costs of projects for manufacturing, quality control testing and validation run activities. 

In August 2020, the Company entered in a Clinical Trial Agreement with BCM, which provided for BCM to provide to the Company 
investigator-initiated research studies. 

BCM is also a shareholder of the Company’s common stock. 

The Company has also entered into a Clinical Site Agreement with BCM, which provided for BCM to conduct clinical trials for the 
Company and is a part of continuing operations. 

Purchases from Bio-Techne Corporation. 

The Company is currently utilizing Bio-Techne Corporation and two of its brands for the purchases of reagents, primarily cytokines. 
Mr. David Eansor is a member of the Company’s board of directors and was serving as the President of the Protein Sciences Segment 
of  Bio-Techne  Corporation.  Mr. Eansor  resigned  from  Bio-Techne  Corporation  on  March 1,  2022,  and  as  such,  two  months  of 
transactions in 2022 are included in the table above. 

Purchases from Wilson Wolf. 

The Company is currently utilizing Wilson Wolf for the purchases of cell culture devices called G-Rexes. Mr. John Wilson is a member 
of the Company’s board of directors and is serving as the CEO of Wilson Wolf Manufacturing Corporation. 

Purchases from Cell Ready, LLC. 

The Company is currently utilizing Cell Ready, LLC for its clinical manufacturing supply and product development. Mr. John Wilson 
is a member of the Company’s board of directors and is serving as the CEO of Cell Ready, LLC. On February 22, 2024, we entered into 
a Master Services Agreement for Product Supply (the “MSA”) with Cell Ready. Cell Ready, which is owned by one of our directors 
and  shareholders,  Mr. John  Wilson,  is  a  contract  development  and  manufacturing  organization  (CDMO).  Under  the  MSA,  it  is 
anticipated Cell Ready will perform a wide variety of services for us, including research and development, and manufacturing in support 

F-23 

 
 
 
 
 
 
 
 
   
     
 
 
 
of our clinical trials. Pursuant to the MSA, the Company may contract with Cell Ready for the provision of various products and services 
from time to time by entering into work orders with Cell Ready. If the services involve the supply of product, Cell Ready is required to 
supply such product in conformance with the product requirements set forth in the applicable work order(s). Under the MSA, Cell Ready 
is  to  use  only  personnel  with  sufficient  qualifications  and  experience  to  supply  the  services  contemplated  by  the  MSA,  provide  its 
personnel with adequate training and assume full responsibility for its personnel’s compliance with the MSA. Further, Cell Ready is 
required  to  provide  the  Company  with  assistance  and  cooperation  in  order  for  the  Company  to  obtain  and  maintain  all  necessary 
regulatory approvals, at the Company’s expense. Also on February 22, 2024, the Company entered into Work Order #1 under the MSA, 
pursuant to which Cell Ready will provide the Company with GMP drug product for Marker MT-401 and/or MT-601. The services 
include the delivery of final drug product and quality control testing. The Company also requested Cell Ready to provide general support 
services in connection therewith. The total projected sum (inclusive of taxes) for the services under Work Order #1 are not anticipated 
to exceed $750,000. The services will cover the anticipated manufacturing costs for the first quarter of 2024. Additional Work Orders 
are expected to be generated for the remainder of 2024. 

NOTE 15:    INCOME TAXES 

The Company has no federal income tax expense due to operating losses incurred for the years ended December 31, 2023 and 2022. 
The Company recognized $4,000 in state tax expense for the year ended December 31, 2023. 

The effects of temporary differences that give rise to significant portions of the deferred tax assets as of December 31, 2023 and 2022 
are as follows: 

For the Years Ended  
 December 31,  

2023 

2022 

Deferred Tax Assets 

Net Operating Loss Carryforward  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stock Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Capitalized R&E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Research and Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Less: Valuation Allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
Total Deferred Tax Assets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$ 29,352,000   $   30,072,000
 5,642,000
 4,818,000
 733,000
 41,265,000
   (41,265,000)
—

2,598,000  
7,026,000  
733,000  
39,709,000  
(39,709,000) 
$

 —   $ 

Total Deferred Tax Liabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$

 —   $ 

Net Deferred Tax Assets/(Liabilities) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .   $

 —   $ 

—

 —

The Company assesses the likelihood that deferred tax assets will be realized. To the extent that realization is not likely, a valuation 
allowance is established. Based upon the history of losses, management believes that it is more likely than not, that future benefits of 
deferred tax assets will not be realized and has established a full valuation allowance for the years ended December 31, 2023 and 2022. 
The Company has research and development tax credit carryforwards of $733,000 available to offset future federal income taxes. The 
research and development tax credit carryforwards begin to expire in 2030. 

The Company has approximately $131.8 million of federal and $38.4 million of state Net Operating Losses (“NOL”s) that may be 
available to offset future taxable income, if any. The federal net operating loss carryforwards of $38.0 million, if not utilized, will expire 
between 2030 and 2037. The federal net operating loss carryforwards of $93.8 million generated in 2018 and thereafter are subject to 
an 80% limitation on taxable income, do not expire and will carry forward indefinitely. The state net operating loss carryforwards of 
$21.7 million, if not utilized, will begin to expire in 2035. The state net operating loss carryforwards of $16.6 million generated in 2018 
and thereafter are subject to an 80% limitation on taxable income, do not expire and will carry forward indefinitely. 

In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s net operating loss carryforwards may be 
limited in the event of a change in ownership. A full Section 382 analysis has not been prepared and NOLs could be subject to limitation 
under Section 382. 

F-24 

 
 
 
 
 
 
 
 
 
 
    
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Effective for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered 
incidental  to  research  and  experimentation  (R&E)  activities  under  IRC  Section  174.  While  taxpayers  historically  had  the  option  of 
deducting these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization 
of R&E expenses for tax years beginning after December 31, 2021. Expenses incurred in connection with R&E activities in the US must 
be amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period. 
R&E activities are broader in scope than qualified research activities considered under IRC Section 41 (relating to the research tax 
credit).  For  the  year  ended  December 31,  2023  and  2022,  the  Company  performed  an  analysis  based  on  available  guidance  and 
determined that it will continue to be in a loss position even after the required capitalization and amortization of its R&E expenses. The 
Company will continue to monitor this issue for future developments, but it does not expect R&E capitalization and amortization to 
require it to pay cash taxes now or in the near future. 

The Company’s income tax returns for 2019 to 2023 are still open and subject to audit. In addition, net operating losses arising from 
prior years are also subject to examination at the time they are utilized in future years. 

For the years ended December 31, 2023 and 2022, the expected tax expense (benefit) from continuing operations based on the U. S. 
federal statutory rate is reconciled with the actual tax provision (benefit) as follows: 

For the Years Ended December 31,  

2023 

2022 

U.S. federal statutory rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .
State taxes, net of federal benefit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Tax rate change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Permanent Differences 

Amount 
$ (2,948,000)
(20,000)
(9,000)

  Percent of    
     Pretax Loss       

Amount 

21.00 %   $  (4,153,000)
 (28,000)
 10,000

0.14 %    
0.06 %    

Percent of  
     Pretax Loss      
21.00 %
0.14 %
(0.05)%

- Other permanent differences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Change in valuation allowance  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Deferred true-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Income tax provision/(benefit) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .

25,000
(1,556,000)
4,512,000
4,000

$

(0.18)%    
11.08 %    
(32.14)%    
(0.04)%   $ 

 288,000
 2,864,000
 1,019,000
—

(1.46)%
(14.48)%
(5.15)%
0.00 %

The Company recognized approximately $4,000 in state tax expense for the year ended December 31, 2023. 

ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax 
positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not 
to be sustained upon examination by taxing authorities. As of December 31, 2023, and 2022, there were no unrecognized tax benefits. 
The Company recognizes accrued interest and penalties as income tax expense. No amounts were accrued for the payment of interest 
and penalties at December 31, 2023 and 2022. The Company is currently not aware of any issues under review that could result in 
significant payments, accruals or material deviation from its position in the next year. 

NOTE 16: 

SUBSEQUENT EVENTS 

On February 22, 2024, the Company entered into a Master Services Agreement for Product Supply (the “Agreement”) with Cell Ready, 
a  contract  development  and  manufacturing  organization  (CDMO).  Cell  Ready  is  owned  by  one  of  the  Company’s  directors  and 
shareholders, Mr. John Wilson. See Note 1 and Note 14.  

On February 29, 2024, Marker Therapeutics, Inc. (the “Company”) delivered notice to Lincoln Park Capital Fund, LLC, an Illinois 
limited liability company (“LPC”), terminating the Purchase Agreement, dated December 12, 2022 (the “Purchase Agreement”), with 
LPC effective March 1, 2024 (the “Termination Date”). The Company projects a financial runway through the fourth quarter of 2025 
and does not anticipate an immediate need for capital acquisition. 

F-25 

 
 
 
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
    
 
   
 
 
 
BOARD OF DIRECTORS 

David Eansor, Chairman of the Board of Directors 
Former President of Protein Sciences Segment, Bio-
Techne Corporation 

Steven Elms, Director 
Managing Partner, Aisling Capital 

CORPORATE HEADQUARTERS 

Marker Therapeutics, Inc. 
9350 Kirby Drive, Suite 300 
Houston, Texas 77054 

T: (713) 400-6400 
www.markertherapeutics.com  

COMMON STOCK LISTING 

Katharine Knobil, Director 
Former Chief Medical Officer, Agilent Technologies 
Inc. 

Nasdaq Capital Market  
Ticker Symbol: MRKR 

Juan Vera, Director 
President and Chief Executive Officer, Marker 
Therapeutics, Inc. 

John Wilson, Director 
Chief Executive Officer, Wilson Wolf 
Manufacturing Corporation 

EXECUTIVE OFFICERS 

Juan Vera 
President and Chief Executive Officer, Marker 
Therapeutics, Inc. 

ANNUAL MEETING OF STOCKHOLDERS 

Thursday, June 6, 2024, at 9:00 a.m. Central Time at:  
http://viewproxy.com/markertherapeutics/2024/htype.
asp. 

REGISTRAR AND TRANSFER AGENT 

Equiniti Trust Company, LLC 
6201 15th Avenue 
Brooklyn, New York 11219 
T: (800) 937-5449 

LEGAL COUNSEL 

Shumaker, Loop & Kendrick, LLP 
Tampa, Florida 

INDEPENDENT AUDITORS 

Marcum LLP 
New York, New York 

INVESTOR RELATIONS 

Marker Therapeutics, Inc. 
Investor Relations 
9350 Kirby Drive, Suite 300 
Houston, Texas 77054 
E: investor.relations@markertherapeutics.com  
T: (713) 400-6400