Soligenix, Inc.

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the Fiscal Year Ended December 31, 2024
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
For the transition period from ____________ to ____________
Commission File No. 001-14778
SOLIGENIX, INC.
(Exact name of registrant as specified in its charter)
Delaware
41-1505029
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification Number)
29 EMMONS DRIVE, SUITE B-10
PRINCETON, NJ
08540
(Address of principal executive offices)
(Zip Code)
(609) 538-8200
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12 (b) of the Act:
Title of each class
   Trading Symbol (s)   
Name of each exchange on which registered
Common Stock, par value $0.01 per share
SNGX
The Nasdaq Capital Market
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☑
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☑
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or
an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
⌧
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal
control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared
or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in
the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
The aggregate market value of the common stock held by non-affiliates of the registrant was $3,977,875 (assuming, for this purpose, that executive
officers, directors and holders of 10% or more of the common stock are affiliates), based on the closing price of the registrant’s common stock as reported
on The Nasdaq Capital Market on June 30, 2024.
On March 14, 2025, there were 3,155,603 shares of the registrant’s common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE: None.

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i
SOLIGENIX, INC.
ANNUAL REPORT ON FORM 10-K
For the Year Ended December 31, 2024
Table of Contents
Item
   
Description
    Page
Cautionary Note Regarding Forward-Looking Statements
ii
Part I
1.
Business
1
1A.
Risk Factors
30
1B.
Unresolved Staff Comments
51
1C
Cybersecurity
51
2.
Properties
52
3.
Legal Proceedings
52
Part II
5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
53
6.
Selected Financial Data
54
7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
54
8.
Financial Statements and Supplementary Data
64
9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
64
9A.
Controls and Procedures
64
9B.
Other Information
65
9C.
Disclosure Regarding Foreign Jurisdictions
65
Part III
10.
Directors, Executive Officers and Corporate Governance
65
11.
Executive Compensation
70
12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
75
13.
Certain Relationships and Related Transactions and Director Independence
77
14.
Principal Accountant Fees and Services
78
Part IV
15.
Exhibits and Financial Statement Schedules
78
Signatures
83
Consolidated Financial Statements
F-1

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ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form  10-K contains forward-looking statements, within the meaning of the Private Securities
Litigation Reform Act of 1995, that reflect our current expectations about our future results, performance, prospects and
opportunities. These forward-looking statements are not guarantees of future performance and are subject to significant
risks, uncertainties, assumptions and other factors, which are difficult to predict and may cause actual results to differ
materially from those expressed in, or implied by, any forward-looking statements. The forward-looking statements within this
report may be identified by words such as “believes,” “anticipates,” “expects,” “intends,” “may,” “would,” “will” and other
similar expressions. However, these words are not the exclusive means of identifying these statements. Statements that are
not historical facts are based on our current expectations, beliefs, assumptions, estimates, forecasts and projections for our
business and the industry and markets related to our business and are forward-looking statements.
Actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important
factors which may affect these actual outcomes and results include, without limitation:
●
uncertainty as to whether our product candidates will be sufficiently safe and effective to support regulatory
approvals;
●
uncertainty inherent in developing therapeutics and vaccines, and manufacturing and conducting preclinical and
clinical trials;
●
our ability to obtain future financing or funds when needed, either through the raising of capital, the incurrence of
convertible or other indebtedness or through strategic financing or commercialization partnerships;
●
our ability to secure government grants or contracts to support our vaccine development;
●
our ability to maintain our listing on Nasdaq and meet Nasdaq’s listing requirements;
●
that product development and commercialization efforts will be reduced or discontinued due to difficulties or delays
in clinical trials or a lack of progress or positive results from research and development efforts;
●
maintenance and progression of our business strategy;
●
the possibility that our products under development may not gain market acceptance;
●
our expectations about the potential market sizes and market participation potential for our product candidates may
not be realized;
●
our expected revenues (including sales, milestone payments and royalty revenues) from our product candidates and
any related commercial agreements of ours may not be realized;
●
the ability of our manufacturing partners to supply us or our commercial partners with clinical or commercial supplies
of our products in a safe, timely and regulatory compliant manner and the ability of such partners to timely address
any regulatory issues that have arisen or may arise in the future;
●
competition existing today or that may arise in the future, including the possibility that others may develop
technologies or products superior to our products;
●
the effect that global pathogens could have on financial markets, materials sourcing, service providers, patients,
clinical study sites, governments and population (e.g. Coronavirus Disease 2019 (“COVID-19”)); and
●
other factors, including those “Risk Factors” set forth under Part I, Item 1A. “Risk Factors” in this Annual Report.
Except as expressly required by the federal securities laws, we undertake no obligation to publicly update or revise any
forward-looking statements to reflect events or circumstances occurring subsequent to the filing of this Form 10-K with the

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iii
United States (“U.S.”) Securities and Exchange Commission (“the SEC”) or for any other reason. You should carefully review
and consider the various disclosures we make in this report and our other reports filed with the SEC that attempt to advise
interested parties of the risks, uncertainties and other factors that may affect our business.
Note Regarding Reverse Stock Split
On June 5, 2024, we completed a reverse stock split of our issued and outstanding shares of common stock at a ratio of
one-for-sixteen, whereby every sixteen shares of our issued and outstanding common stock were automatically combined
into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares
were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse
stock split were rounded up to the next whole number. Our common stock began trading on The Nasdaq Capital Market on a
reverse split basis at the market opening on June 6, 2024. All share and per share data have been restated to reflect this
reverse stock split.

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1
PART I
Item 1. Business
This Annual Report on Form 10-K contains statements of a forward-looking nature relating to future events or our future
financial performance. These statements are only predictions and actual events or results may differ materially. In evaluating
such statements, you should carefully consider the various factors identified in this report that could cause actual results to
differ materially from those indicated in any forward-looking statements, including those set forth in “Risk Factors” in this
Annual Report on Form 10-K. See “Cautionary Note Regarding Forward Looking Statements.”
Our Business Overview
We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases
where there is an unmet medical need. We maintain two active business segments: Specialized BioTherapeutics and Public
Health Solutions.
Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of
HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy (“PDT”),
utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”).
With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and
agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3
placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early stage
disease, we began patient enrollment during December 2024 for the second Phase 3 study called “FLASH2” (Fluorescent
Light Activated Synthetic Hypericin 2). We anticipate top-line results in the second half of 2026. Upon successful completion
of the Phase 3 FLASH2 study, regulatory approval will be sought to support potential commercialization worldwide.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and
our first-in-class Innate Defense Regulator (“IDR”) technology, dusquetide (SGX942 and SGX945), for the treatment of
inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate
and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs
targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19
(caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with
government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the
Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
An outline of our business strategy follows:
●
Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-
controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3
FLASH study, continue enrollment and execution of the FLASH2 study, while at the same time, continue discussions
with the U.S. Food and Drug Administration (“FDA”) on potential modifications to the development path to
adequately address their feedback.
●
Expand development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a
Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a
small Phase 1/2 pilot study in mild-to-moderate psoriasis patients.
●
Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency
(“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment of oral mucositis would be
required to support a marketing authorization, design a second study and attempt to identify a potential partner(s) to
continue this development program.

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●
Expand development of dusquetide under the research name SGX945 into Behçet’s Disease by conducting a
Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in
aphthous ulcers induced by chemotherapy and radiation.
●
Continue development of our heat stabilization platform technology, ThermoVax®, in combination with programs for
RiVax® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent
combinations), with U.S. government and non-governmental organization funding support.
●
Continue to apply for and secure additional government funding for each of our Specialized BioTherapeutics and
Public Health Solutions programs through grants, contracts and/or procurements.
●
Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives,
including but not limited to merger/acquisition strategies.
●
Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with
existing pipeline compounds for development.
Corporate Information
We were incorporated in Delaware in 1987 under the name Biological Therapeutics, Inc. In 1987, we merged with Biological
Therapeutics, Inc., a North Dakota corporation, pursuant to which we changed our name to “Immunotherapeutics, Inc.” We
changed our name to “Endorex Corp.” in 1996, to “Endorex Corporation” in 1998, to “DOR BioPharma, Inc.” in 2001, and
finally to “Soligenix, Inc.” in 2009. Our principal executive offices are located at 29 Emmons Drive, Suite B-10, Princeton,
New Jersey 08540 and our telephone number is (609) 538-8200.
Our Product Candidates in Development
The following tables summarize our product candidates under development:
Specialized BioTherapeutics Product Candidates
Soligenix Product Candidate     
Therapeutic Indication
    
Stage of Development
HyBryte™
Cutaneous T-Cell Lymphoma
Phase 
2 
trial 
completed; 
demonstrated
significantly higher response rate compared to
placebo; 
Phase 
3 
trial 
completed;
demonstrated statistical significance in primary
endpoint in March 2020 (Cycle 1) and
demonstrated 
continued 
improvement 
in
treatment response with extended treatment in
April 2020 (Cycle 2) and October 2020 (Cycle
3); new drug application (“NDA”) submitted to
FDA December 2022; FDA refusal to file
(“RTF”) letter received February 2023; second
Phase 3 trial based upon EMA-accepted
protocol 
began 
patient 
enrollment 
in
December 
2024 
with 
top-line 
results
anticipated in the second half of 2026;
discussions continue with FDA on modifying
the development path to adequately address
FDA’s preference for a longer duration
comparative study over a placebo-controlled
trial
SGX302
Mild-to-Moderate Psoriasis
Positive proof-of-concept demonstrated in a
small Phase 1/2 pilot study; Phase 2a protocol

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Soligenix Product Candidate     
Therapeutic Indication
    
Stage of Development
and Investigation New Drug (“IND”) clearance
received from the FDA; Phase 2a study
remains 
ongoing 
having 
demonstrated
biological effect in Cohort 1 and clinically
meaningful benefit in Cohort 2
SGX942†
Oral Mucositis in Head and Neck
Cancer
Phase 
2 
trial 
completed; 
demonstrated
significant response compared to placebo with
positive long-term (12 month) safety also
reported; 
Phase 
3 
clinical 
trial 
results
announced December 2020: the primary
endpoint of median duration of severe oral
mucositis (“SOM”) did not achieve the pre-
specified criterion for statistical significance
(p≤0.05); although biological activity was
observed with a 56% reduction in the median
duration of SOM from 18 days in the placebo
group to 8 days in the SGX942 treatment
group; analyzed full dataset from Phase 3
study and designing a second Phase 3 clinical
trial; continued development contingent upon
identification of partnership
SGX945
Aphthous Ulcers in Behçet’s Disease
Phase 2a protocol and IND clearance received
from the FDA; Phase 2a study   initiated in 4Q
2024
Public Health Solutions†
Soligenix Product Candidate
Indication
Stage of Development
ThermoVax®
    Thermostability of vaccines for Ricin toxin,
Ebola, and Marburg viruses
    Pre-clinical
RiVax®
Vaccine against Ricin Toxin Poisoning
Phase 1a, 1b, and 1c trials completed, safety and
neutralizing 
antibodies 
for 
protection
demonstrated
SGX943
Therapeutic against Emerging
Infectious Diseases
Pre-clinical
†
Contingent upon continued government contract/grant funding or other funding source.
Specialized BioTherapeutics Overview
Synthetic Hypericin
Synthetic Hypericin is a potent photosensitizer that is topically applied to skin lesions, taken up by cutaneous T-cells and
then activated by safe visible light. Hypericin is also found in several species of Hypericum plants, although the active moiety
used in HyBryte™ and SGX302 is chemically synthesized by a proprietary manufacturing process and not extracted from
plants. Importantly, hypericin is optimally activated with visible light thereby avoiding the negative consequences of
ultraviolet (“UV”) light. Other light therapies using UVA or UVB light can result in serious adverse effects including secondary
skin cancers.
Combined with photoactivation, in clinical trials synthetic hypericin has demonstrated significant anti-proliferative effects on
activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In both

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settings, it appears that the mode of action is an induction of cell death in a concentration as well as a light dose-dependent
fashion. These effects appear to result, in part, from the generation of singlet oxygen during photoactivation of hypericin.
Synthetic hypericin is one of the most efficient known generators of singlet oxygen, the key component for phototherapy. The
generation of singlet oxygen induces necrosis and apoptosis in cells. The use of topical synthetic hypericin coupled with
directed visible light results in generation of singlet oxygen only at the treated site. We believe that the use of visible light (as
opposed to cancer-causing UV light) is a major advance in photodynamic therapy. In a small published Phase 1/2 proof of
concept pilot clinical study using synthetic hypericin twice weekly for six weeks, statistically significant efficacy was
demonstrated in patients with CTCL (58.3% response, p=0.04) and psoriasis (80% response, p<0.02). Subsequently, a
published Phase 3 study in CTCL has further confirmed the biological efficacy of synthetic hypericin (termed HyBryte™ in
the context of CTCL).
HyBryte™ – for Treating Cutaneous T-Cell Lymphoma
HyBryte™ is a novel, first-in-class, PDT, that utilizes safe visible light for activation. The active ingredient in HyBryte™ is
synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated by visible fluorescent light
16 to 24 hours later.
Based on the positive and previously published Phase 1/2 results, we initiated our Phase 3 clinical study of HyBryte™ for the
treatment of CTCL during December  2015 and completed the trial in 2020. This trial, referred to as the “FLASH”
(Fluorescent Light Activated Synthetic Hypericin) study, aimed to evaluate the response to HyBryte™ as a skin directed
therapy to treat early stage CTCL. We completed the study with approximately 35 CTCL centers across the U.S.
participating in this trial. The Phase 3 protocol was a highly powered, double-blind, randomized, placebo-controlled,
multicenter trial that enrolled 169 subjects (166 evaluable). The trial consisted of three treatment cycles, each of eight weeks
duration. Treatments were administered twice weekly for the first six weeks and treatment response was determined at the
end of the eighth week. In the first treatment cycle, approximately 66% of subjects received HyBryte™ and 33% received
placebo treatment of their index lesions. In the second cycle, all subjects received HyBryte™ treatment of their index lesions,
and in the third cycle, all subjects received HyBryte™ treatment of all of their lesions. The majority of subjects enrolled
elected to continue into the third optional, open-label cycle of the study. Subjects were followed for an additional six months
after their last evaluation visit. The primary efficacy endpoint was assessed on the percentage of patients in each of the two
treatment groups (i.e., HyBryte™ and placebo) achieving a partial or complete response of the treated lesions, defined as a
≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (“CAILS”) score for three index lesions
at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline. Secondary endpoints for the trial
included the duration of responses, the extent of the regression of the tumors, and the safety of the treatment. We continue
to work closely with the Cutaneous Lymphoma Foundation, as well as the National Organization for Rare Disorders.
Positive primary endpoint analysis for the Phase 3 study for HyBryte™ was completed in March 2020. The study enrolled
169 patients (166 evaluable) randomized 2:1 to receive either HyBryte™ (116 patients) or placebo (50 patients) and
demonstrated a statistically significant treatment response (p=0.04) in the CAILS primary endpoint assessment at 8 weeks
for Cycle 1. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their index lesions
compared to only 4% of patients in the placebo group at 8 weeks. HyBryte™ treatment in the first cycle was safe and well
tolerated.
Analysis of the second open-label treatment cycle (Cycle 2) was completed in April 2020, showing that continued treatment
with HyBryte™ twice weekly for an additional 6 weeks (12 weeks total) increased the positive response rate to 40%
(p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). After the subsequent additional 6-week
treatment, the response rate in patients receiving a total of 12 weeks treatment increased two and a half-fold. Treatment
responses were assessed at Week 8 (after 6 weeks of treatment) and at Week 16 (after 12 weeks of treatment). A positive
response was defined as an improvement of at least 50% in the CAILS score for the three index lesions evaluated in both
Cycles 1 and 2. The data continued to indicate that HyBryte™ was safe and well tolerated.
Analysis of the optional third open-label treatment cycle (Cycle 3) was completed in October 2020. Cycle 3 was focused on
safety and all patients could elect to receive HyBryte™ treatment of all their lesions for an additional 6 weeks or up to 18
weeks in total. Of note, 66% of patients elected to continue with this optional safety cycle of the study. Of the subset of
patients that received HyBryte™ throughout all three cycles of treatment (18 weeks), 49% of them demonstrated a treatment
response (p=0.046 vs. patients completing 12 weeks of HyBryte™ treatment in Cycle 2; p<0.0001 vs. patients receiving
placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not

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systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3,
HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.
In addition, continued analysis of results from the protocol mandated efficacy cycles (Cycles 1 and 2) of the study revealed
that 12 weeks of treatment (Cycle 2) with HyBryte™ is equally effective on both patch (response 37%, p=0.0009) and plaque
(response 42%, p<0.0001) lesions when compared to Cycle 1 placebo lesion responses, further demonstrating the unique
benefits of the more deeply penetrating visible light activation of hypericin.
Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would
require a second successful Phase 3 trial to support marketing approval.  With agreement from the EMA on the key design
components, the confirmatory Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter study treating
approximately 80 subjects with early-stage CTCL. It will evaluate the efficacy and safety of HyBryte™ topically applied to
CTCL lesions twice weekly for 18 weeks, with each application followed 21 (±3) hours later by the administration of safe,
visible light at a wavelength of 500 to 650 nm. The light will be administered starting at 6 J/cm2 twice weekly. This will be
increased upwards by 2 J/cm2 until: 1) the patient experiences a Grade 1 erythema, 2) the patient reaches the maximum
dose of 30 J/cm2, or 3) the patient cannot tolerate the treatment time, whichever comes first. All of the patient’s lesions that
are readily available for exposure to the visible light source will be treated and three to five index lesions of each patient will
be prospectively identified and indexed for the modified composite assessment of index lesions severity (“mCAILS”)
evaluation prior to randomization (baseline). The primary efficacy endpoint will be assessed on the percent of patients in
each of the two treatment groups (i.e., HyBryte™ and placebo) achieving a Partial or Complete Response (yes/no) of the
treated lesions defined as a ≥ 50% reduction in the total mCAILS score for the three to five index lesions following 18 weeks
of treatment compared to the total mCAILS score at baseline.  Other secondary measures will assess treatment response
(including duration), degree of improvement, time to relapse and safety.  Following treatment, all patients will be followed
every four weeks for a total of 12 weeks (through Week 30). The Data Monitoring Committee will conduct one (1) interim
analysis when approximately 60% of the total subjects have completed the primary endpoint evaluation. The primary efficacy
endpoint and the key safety endpoints will be analyzed. A sample size recalculation may be performed after examining the
assumptions or the trial halted for either futility, safety concerns, or overwhelming efficacy. We, the participating clinical
investigators, and any other personnel involved in trial conduct will remain blinded to study treatment until completion of the
trial.
HyBryte™ has received Orphan Drug designation as well as Fast Track designation from the FDA. The Orphan Drug Act is
intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and
disorders. In addition to providing a seven-year term of market exclusivity for HyBryte™ upon final FDA approval, Orphan
Drug designation also positions us to be able to leverage a wide range of financial and regulatory benefits, including
government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a NDA for
HyBryte™, and certain tax credits. In addition, Fast Track is a designation that the FDA reserves for a drug intended to treat
a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the
condition. Fast Track designation is designed to facilitate the development and expedite the review of new drugs. For
instance, we were eligible to submit a NDA for HyBryte™ on a rolling basis, permitting the FDA to review sections of the
NDA prior to receiving the complete submission. Additionally, NDAs for Fast Track development programs ordinarily will be
eligible for priority review. HyBryte™ for the treatment of CTCL also was granted Orphan Drug designation from the EMA
Committee for Orphan Medical Products and Promising Innovative Medicine (“PIM”) designation from the MHRA, as well as
Innovation Passport under the Innovative Licensing and Access Pathway (“ILAP”) in the UK.
During January 2021, we signed an exclusive Supply, Distribution and Services Agreement with The Daavlin Distributing Co.
(“Daavlin”), securing long-term supply and distribution of a commercially ready light device, which is an integral component
of the regulatory and commercial strategy for HyBryte™ for the treatment of CTCL. Pursuant to the agreement, Daavlin will
exclusively manufacture the proprietary light device for use with HyBryte™ for the treatment of CTCL. Upon approval of
HyBryte™ by the FDA, we will promote HyBryte™ and the companion light device, and facilitate the direct purchase of the
device from Daavlin. Daavlin will exclusively distribute and sell the HyBryte™ light device to us, physicians and patients.
In April 2021, the FDA conditionally accepted HyBryte™ as the proposed brand name for SGX301 or synthetic hypericin, in
the treatment of early stage CTCL. The name HyBryte™ was developed in compliance with the FDA’s Guidance for Industry,
Contents of a Complete Submission for the Evaluation of Proprietary Names. The FDA’s conditional approval validates
HyBryte™ as a proprietary name that is consistent with the FDA’s goal of preventing medication errors and potential harm

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to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the HyBryte™
proprietary name is conditioned on FDA approval of the product candidate, SGX301.
In May 2021, HyBryte™ was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the
UK’s ILAP. The decision to award the Innovation Passport to the HyBryte™ program was made by the Innovative Licensing
and Access Pathway Steering Group, which is comprised of representatives from MHRA, the National Institute for Health
and Care Excellence (“NICE”), and the Scottish Medicines Consortium (“SMC”). ILAP was launched at the start of 2021 to
accelerate the development and access to promising medicines, thereby facilitating patient access to new medicines. The
pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and
interactions with the MHRA, NICE, and SMC. The innovation passport designation is the first step in the ILAP process and
triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and
development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day
accelerated assessment, rolling review and a continuous benefit risk assessment.
In June 2021, we received a Paediatric Investigation Plan (“PIP”) waiver from the EMA for HyBryte™. As part of the
regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to provide a
PIP outlining their strategies for investigation of the new medicinal products in the pediatric population. In some instances, a
waiver negating the need for a PIP for certain conditions may be granted by the EMA when development of a medicine for
use in children is not feasible or appropriate, as is the case for HyBryte™ in CTCL which is extremely rare in children.
In September 2021, we were granted orphan drug designation for the active ingredient hypericin for the treatment of T-cell
lymphoma, extending the target population beyond CTCL as previously granted by the FDA.
In July 2022, the results of our successful Phase 3 FLASH study evaluating HyBryte™ for the treatment of CTCL were
published in the Journal of the American Medical Association (JAMA) Dermatology.
In July 2022, we received agreement from the FDA on an initial pediatric study plan (“iPSP”) for HyBryte™ for the treatment
of CTCL. The agreed iPSP stipulates that we intend to request a full waiver of pediatric studies upon submission of the NDA.
Agreement with FDA on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.
In September 2022, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte™ for
expanded treatment in patients with early-stage CTCL. The grant, totaling $2.6 million over four years, was awarded to a
prestigious academic institution that was a leading enroller in the published positive Phase 3 FLASH study in the treatment
of early stage CTCL.
In December 2022, we submitted the HyBryte™ NDA for the treatment of CTCL with the FDA.
In February 2023, we received a RTF letter from the FDA for the HyBryte™ NDA. Upon preliminary review, the FDA
determined that the NDA was not sufficiently complete to permit substantive review.
In April  2023, the United States Adopted Names (“USAN”) Council approved the use of the nonproprietary name of
“hypericin sodium” for the novel active ingredient in both HyBryte™ (research name SGX301) for the treatment of CTCL and
SGX302 for the treatment of mild-to-moderate psoriasis.
In April 2023, we had a Type A meeting with the FDA to clarify and respond to the issues identified in the RTF letter received
from the FDA and to seek additional guidance concerning information that the FDA would require for a resubmitted NDA to
be deemed acceptable to file, in order to advance HyBryte™ towards marketing approval and U.S. commercialization. In
order to accept an NDA filing for HyBryte™, the FDA is requiring positive results from a second, Phase 3 pivotal study in
addition to the Phase 3, randomized, double-blind, placebo-controlled FLASH study previously conducted in this orphan
indication. Based on this feedback, we have decided to collaboratively engage in discussions with the FDA in order to define
the protocol and evaluate the feasibility of conducting the additional clinical trial.
In May 2023, we were granted a follow-on Type A meeting with the FDA to initiate formal discussions regarding the protocol
design of a second, Phase 3 pivotal study evaluating HyBryte™ in the treatment of CTCL in support of potential FDA
marketing approval. While discussions have been collaborative, the FDA has expressed a preference for a longer duration
comparative study over a placebo-controlled trial.  Given the shorter time to potential commercial revenue and the similar
trial design to the first FLASH study afforded by the EMA accepted protocol, we determined to initiate the FLASH2 study in

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support of worldwide potential approval. At the same time, we will continue discussions with the FDA on modifying the
development path to adequately address their feedback.
In August 2023, patient enrollment was opened for the investigator-initiated study (“IIS”). IIS is supported by an Orphan
Products Development grant of $2.6 million over four years awarded by the FDA to a prestigious academic institution that
was a leading enroller in the published positive Phase 3 FLASH study in the treatment of early stage CTCL. The IIS will
evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ in patients with early-stage CTCL.
In March 2024, we received agreement from the EMA on the key design components of a confirmatory Phase 3 placebo-
controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease.
This confirmatory 18-week study is expected to enroll approximately 80 patients in the US and Europe and began patient
enrollment in December 2024 with top-line results anticipated in the second half of 2026.
In June  2024, we announced positive clinical results from a comparability study evaluating HyBryte™ versus Valchlor®
(mechlorethamine gel) in the treatment of early stage CTCL. The open-label study enrolled 10 patients (5 patients per group)
with treatment success defined as a ≥50% improvement in a patient’s cumulative mCAILS score after 12 weeks of topical
treatment compared to baseline. The study demonstrated that HyBryte™ treatment resulted in 60% of patients achieving a
50% or better improvement in their mCAILS score versus 20% of Valchlor® patients. When comparing the tolerance of the
topical therapies in this trial, it is notable that all patients tolerated HyBryte™ well and had no adverse events “Related” to
the therapy. In contrast, 60% of the Valchlor® treated patients had at least one adverse event “Related” to the therapy. These
adverse events in the Valchlor® group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis,
with one patient requiring steroid treatment, one requiring temporary interruption of Valchlor® treatment, and one requiring
permanent discontinuation of Valchlor®. No such instances were reported in the HyBryte™ group.
In July 2024, we announced an interim update on the open-label, IIS evaluating extended HyBryte™ treatment for up to
12 months in patients with early stage CTCL. To date, the trial sponsored by Dr. Ellen Kim, has enrolled and treated six
patients with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy
with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving “Treatment Success”, as
predefined in the study’s protocol as ≥50% improvement in their cumulative mCAILS score compared to baseline. Of the
three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the
remaining three patients, two had only recently started HyBryte™ therapy and had not yet reached their first efficacy
evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but had not
yet achieved the success threshold. In addition, HyBryte™ appears to be safe and well tolerated in all patients, with no
treatment-related adverse events reported to date.
In September 2024, the European Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic
Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured
through a unique proprietary process.  Synthetic hypericin is the active pharmaceutical ingredient in  HyBryte™, our
photodynamic therapy for the treatment of CTCL, for which a confirmatory Phase 3 clinical trial has been initiated. This new
European granted patent (EP3423428) is a related patent to US Pat. No. 10,053,413, previously issued in the U.S. Both
patents are expected to expire in 2036, and form part of a larger patent family, including previously granted U.S. patents
covering methods of use (US Pat. No. 7,122,518) and methods of synthesis (US Pat. No. 8,629,302), as well as other
granted patents throughout the world.
In October 2024, we established a partnership agreement with Sterling Pharma Solutions Limited   to optimize and
implement a commercially viable, scalable production technology for synthetic hypericin. We are currently working to transfer
and optimize the manufacturing processes and analytics to enable GMP manufacturing for clinical trials with the intent of
establishing a long-term commercial manufacturing collaboration.
In October 2024, the Hong Kong Patent Office granted the patent entitled "Systems and Methods for Producing Synthetic
Hypericin". The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured
through a unique proprietary process.  Synthetic hypericin is the active pharmaceutical ingredient in  HyBryte™, our
photodynamic therapy for the treatment of CTCL, for which a confirmatory Phase 3 clinical trial has been initiated. This new
granted patent (HK1260757) is a related patent to US Pat. Nos. 10,053,413 and 10,526,268, previously issued in the U.S.,
and is in the same family as another patent granted in Europe. These patents are expected to expire in 2036, and form part
of a larger collection of different patent families, including previously granted foreign patents covering liquid formulations

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and methods of use (EP Pat. No. 2,571,507) and issued U.S. patents for methods of synthesis (US Pat. No. 8,629,302), as
well as other granted patents throughout the world.
In November 2024, we announced the formation of a European Medical Advisory Board to provide additional medical/clinical
strategic guidance to advance the confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the
safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease.
In December 2024, we announced positive clinical results from analysis of the post-treatment data from a comparability
study evaluating HyBryte™ versus Valchlor® (mechlorethamine gel) in the treatment of early stage CTCL. The open-label
study has demonstrated continued improvement in HyBryte™ treated patients and their individual lesions even after
stopping treatment. The study, which enrolled 10 patients randomized 1:1 with 12 weeks of treatment and 4 weeks of follow-
up post-treatment, was previously reported to demonstrate a positive difference in the overall per patient treatment response
rate (60% in the HyBryte™ group vs. 20% in the Valchlor® group) at the end of treatment. After the 4-week follow-up period
(Week 16), the majority (3 of 5) of HyBryte™ patients continued to demonstrate improvement with at least a further 10%
improvement (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of the
HyBryte™ patients achieving a "complete response". In contrast, of the four patients that completed the Valchlor® arm of the
study, none achieved this level of improvement by Week 16. For patients, a treatment response was defined as a ≥50%
improvement in their cumulative mCAILS score over 3 to 5 lesions. Treatment response was also assessed on individual
lesions. There was a similar continued improvement in the lesion responses over time, with the plaque lesions of particular
interest given their increasing association with risk of overall disease progression and long-term mortality. At the 12-week
(end of treatment) timepoint, the HyBryte™ treated plaque lesions were statistically significantly improved compared to the
Valchlor® treated plaques (63%, [10/16] treatment success with HyBryte™ vs. 17%, [2/12] with Valchlor®, p=0.02). By Week
16, the response rates in lesions treated with HyBryte™ were statistically significant responses for all lesions (72%
HyBryte™ vs 28% Valchlor®, p=0.02) and specifically for plaque lesions (75% responding plaque lesions with HyBryte™
treatment vs. 17% with Valchlor®, p=0.006) relative to the Valchlor® group. No safety concerns with HyBryte™ were raised
during the follow-up period.
In December 2024, we opened patient enrollment for our confirmatory Phase 3 study evaluating HyBryte™ (synthetic
hypericin) in the treatment of CTCL.
In January 2025, we announced an interim update on the open-label, IIS evaluating extended  HyBryte™  (synthetic
hypericin) treatment for up to 12 months in patients with early-stage CTCL. The trial is sponsored by Ellen Kim, MD, Director,
Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of
Dermatology at the Hospital of the  University of Pennsylvania  who was a leading enroller in the  Phase 3 FLASH
(Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date, nine patients have
been enrolled and treated with HyBryte™ over a time period of up to 54 weeks. Patients have responded positively to
HyBryte™ therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving
"Treatment Success". Treatment Success is predefined in the study's protocol as a greater than or equal to 50%
improvement in the cumulative mCAILS score compared to Baseline. Of the five Treatment Successes, three were achieved
within the first 12 weeks of treatment, with two patients achieving a "complete response" by 18 weeks. Of the remaining
patients, two have recently started the study and two had to drop from the study for logistical reasons (e.g., need to care for
an elderly parent), with one showing a substantial improvement (>30%) by their Week 18 visit. In addition, HyBryte™
appears to be safe and well tolerated in all patients.
We estimate the potential worldwide market for HyBryte™ is in excess of $250 million for the treatment of CTCL. This
potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this
statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there
are a number of factors that could cause our expectations to change or not be realized.
Cutaneous T-Cell Lymphoma
CTCL is a class of non-Hodgkin’s lymphoma (“NHL”), a type of cancer of the white blood cells that are an integral part of the
immune system. Unlike most NHLs, which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is
caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to
migrate to the skin. These skin-trafficking malignant T-cells migrate to the skin, causing various lesions to appear that may
change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mycosis
fungoides (“MF”) is the most common form of CTCL. It generally presents with skin involvement only,

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manifested as scaly, erythematous patches. Advanced disease with diffuse lymph node and visceral organ involvement is
usually associated with a poorer response rate to standard therapies. A relatively uncommon sub-group of CTCL patients
present with extensive skin involvement and circulating malignant cerebriform T-cells, referred to as Sézary syndrome.
These patients have substantially graver prognoses (expected five-year survival rate of 24%), than those with MF (expected
five-year survival rate of 88%).
CTCL mortality is related to stage of disease, with median survival generally ranging from about 12 years in the early stages
to only 2.5 years when the disease has advanced. There is currently no FDA-approved drug for front-line treatment of early
stage CTCL. Treatment of early-stage disease generally involves skin-directed therapies. One of the most common
unapproved therapies used for early-stage disease is oral 5 or 8-methoxypsoralen (“Psoralen”) given with ultraviolet A
(“UVA”) light, referred to as PUVA, which is approved for dermatological conditions such as disabling psoriasis not
adequately responsive to other forms of therapy, idiopathic vitiligo and skin manifestations of CTCL in persons who have not
been responsive to other forms of treatment. Psoralen is a mutagenic chemical that interferes with DNA causing mutations
and other malignancies. Moreover, UVA is a carcinogenic light source that when combined with the Psoralen, results in
serious adverse effects including secondary skin cancers; therefore, the FDA requires a Black Box warning for PUVA.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease
in the United States and Europe (European Union and United Kingdom). It is estimated, based upon review of historic
published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000
individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000
individuals in Europe (based on ECIS prevalence estimates, with approximately 3,800 new cases annually). We estimate,
based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it
affects over 20,000 individuals in the U.S., with approximately 2,800 new cases seen annually.
SGX302 – for Treating Mild-to-Moderate Psoriasis
SGX302 (synthetic hypericin) is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous
T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the dysregulated T-cells
found in psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using UV
light associated with more severe potential long-term toxicities. The use of visible light in the red-yellow spectrum has the
advantage of deeper penetration into the skin (much more than UV light) potentially treating deeper skin disease and thicker
plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Further, this treatment
approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-
damaging drugs and other phototherapies that are dependent on UVA or UVB exposure. The use of SGX302 coupled with
safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive
treatments used in psoriasis.
In September 2021, following the validation of synthetic hypericin’s biologic activity in the positive Phase 3 FLASH study in
CTCL, as well as positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis
patients, we decided to expand this novel therapy into a Phase 2a clinical trial in mild-to-moderate psoriasis.
In June 2022, we received FDA IND clearance for our Phase 2a clinical trial (protocol number HPN-PSR-01) titled, "Phase 2
Study Evaluating SGX302 in the Treatment of Mild-to-Moderate Psoriasis." In December 2022, we initiated patient
enrollment for the Phase 2a study (protocol number HPN-PSR-01) evaluating SGX302 in the treatment of mild-to-moderate
psoriasis. The Phase 2a clinical trial (protocol number HPN-PSR-01) will target enrollment of up to 42 patients ages 18 years
or older with mild to moderate, stable psoriasis covering 2 to 30% of the body. In both Parts A and B, all patients will apply
the study drug twice per week and activate the drug with visible light 24 ± 6 hours later using the supplied visible light
devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on
completion, will be followed for a four-week follow-up period in which patients will not receive other psoriasis treatments. In
Part A, five to ten patients will be assigned open-label SGX302 (0.25% hypericin) at the time of enrollment. Once the
tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be
randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic
assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients
will be assessed for overall disease status through four weeks of follow-up. Efficacy endpoints will include the extent of
lesion clearance and patient reported quality of life indices. Routine safety data also will be collected.

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In October 2022, we announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to
advance the Phase 2a clinical development of SGX302 for the treatment of mild-to-moderate psoriasis.
In July 2023, we expanded the Phase 2a trial of SGX302 after demonstration of biological effect in the initial five subjects
(Cohort 1). The study is expected to enroll at least an additional ten subjects, exploring the use of SGX302 in the standard of
care psoriasis setting, prior to undertaking the larger phase of the study.
In January 2024, positive preliminary results of clinical success were demonstrated in the Cohort 2 subjects enrolled in the
ongoing Phase 2a study. In the four evaluable patients from Cohort 2 (one patient withdrew early in the treatment course for
personal reasons unrelated to the study), two reached a disease status of “Almost Clear” represented by an Investigator
Global Assessment score of 1, which is considered the standard clinical measure for treatment success in psoriasis. In
addition, the Psoriasis Activity and Severity Index score, another well-characterized measure of treatment success, for
patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment. SGX302 therapy was well tolerated
by all patients with no drug related adverse events identified.
We estimate the potential worldwide market for SGX302 is in excess of $1 billion for the treatment of mild-to-moderate
psoriasis. This potential market information is a forward-looking statement, and investors are urged not to place undue
reliance on this statement. While we have determined this potential market size based on assumptions that we believe are
reasonable, there are a number of factors that could cause our expectations to change or not be realized.
Psoriasis
Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no
cure.  Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular,
arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors
contribute to development of psoriasis including both genetic and environmental factors (e.g., skin trauma, infections, and
medications).  The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated
inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised
plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back.
Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement
of less than 3% of the body surface area (“BSA”), while moderate psoriasis will typically involve 3-10% BSA and severe
psoriasis greater than 10% BSA.  Between 20% and 30% of individuals with psoriasis will go on to develop chronic,
inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability.  Studies have also associated
psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL.  Although
psoriasis can occur at any age, most patients present with the condition before age 35.
Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies
from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque
formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical
photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer.
Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization
(“WHO”) Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed
countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published
studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million
people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis
treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027.
Dusquetide
Dusquetide (research name: SGX94) is an IDR that regulates the innate immune system to simultaneously reduce
inflammation, eliminate infection and enhance tissue healing. Dusquetide is based on a new class of short, synthetic
peptides known as IDRs. It has a novel mechanism of action in that it modulates the body’s reaction to both injury and
infection and is both simultaneously anti-inflammatory and anti-infective. IDRs have no direct antibiotic activity but modulate
host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive
pathogens including both antibiotic sensitive and resistant strains, as well as accelerating resolution of tissue damage
following exposure to a variety of agents including bacterial pathogens, trauma and chemo- or radiation-therapy. IDRs

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represent a novel approach to the control of infection and tissue damage via highly selective binding to an intracellular
adaptor protein, sequestosome-1, also known as p62, which has a pivotal function in signal transduction during activation
and control of the innate defense system. Preclinical data indicate that IDRs may be active in models of a wide range of
therapeutic indications including life-threatening bacterial infections as well as the severe side-effects of chemo- and
radiation-therapy. Additionally, due to selective binding to p62, dusquetide may have potential anti-tumor action.
Dusquetide has demonstrated efficacy in numerous animal disease models including mucositis, oncology, colitis, skin
infection and other bacterial infections and has been evaluated in a double-blind, placebo-controlled Phase 1 clinical trial in
84 healthy volunteers with both single ascending dose and multiple ascending dose components. Dusquetide was shown to
have a good safety profile and be well-tolerated in all dose groups when administered by IV over 7 days and was consistent
with safety results seen in pre-clinical studies. We believe that market opportunities for dusquetide include, but are not
limited to, oral and gastrointestinal mucositis, oncology (e.g., breast cancer), acute Gram-positive bacterial infections (e.g.,
methicillin resistant Staphylococcus aureus (“MRSA”)), acute Gram-negative infections (e.g., acinetobacter, melioidosis),
and acute radiation syndrome.
SGX942 – for Treating Oral Mucositis in Head and Neck Cancer
SGX942 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of oral mucositis in
head and neck cancer patients. Oral mucositis in this patient population is an area of unmet medical need where there are
currently no approved drug therapies. Accordingly, we received Fast Track designation for the treatment of oral mucositis as
a result of radiation and/or chemotherapy treatment in head and neck cancer patients from the FDA. In addition, dusquetide
has been granted PIM designation in the UK by the MHRA for the treatment of SOM in head and neck cancer patients
receiving chemoradiation therapy.
We initiated a Phase 2 clinical study of SGX942 for the treatment of oral mucositis in head and neck cancer patients in
December of 2013. We completed enrollment in this trial and released positive results in December 2015. In this Phase 2
proof-of-concept clinical study that enrolled 111 patients, SGX942, at a dose of 1.5 mg/kg, successfully reduced the median
duration of SOM by 50%, from 18 days to 9 days (p=0.099) in all patients and by 67%, from 30 days to 10 days (p=0.040) in
patients receiving the most aggressive chemoradiation therapy for treatment of their head and neck cancer. The p-values
met the prospectively defined statistical threshold of p<0.1 in the study protocol. A less severe occurrence of oral mucositis,
ulcerative oral mucositis (defined as oral mucositis with a WHO score ≥2 corresponding to the occurrence of overt ulceration
in the mouth), was also monitored during the study. In the patients receiving the most aggressive chemoradiation therapy,
the median duration of oral mucositis was found to decrease from 65 days in the placebo treated patients to 51 days in the
patients treated with SGX942 1.5 mg/kg (p=0.099).
In addition to identifying the best dose of 1.5 mg/kg, this study achieved all objectives, including increased incidence of
“complete response” of tumor at the one month follow-up visit (47% in placebo vs. 63% in SGX942 at 1.5 mg/kg). Decreases
in mortality and decreases in infection rate were also observed with SGX942 treatment, consistent with the preclinical results
observed in animal models. Data from this Phase 2 trial are published in the Journal of Biotechnology.
SGX942 was found to be generally safe and well tolerated, consistent with the safety profile observed in the prior Phase 1
study conducted in 84 healthy volunteers. The long-term (12  month) follow-up data was consistent with the preliminary
positive safety and efficacy findings. While the placebo population experienced the expected 12-month survival rate of
approximately 80%, as defined in the Surveillance, Epidemiology, and End Results statistics 1975-2012 from the National
Cancer Institute, the SGX942 1.5 mg/kg treatment group reported a 12-month survival rate of 93% (7% mortality in the
SGX942 1.5 mg/kg group compared to 19% in the placebo group). Similarly, tumor resolution (complete response) at
12 months was better in the SGX942 1.5 mg/kg treatment group relative to the placebo population (80% in the 1.5 mg/kg
group compared to 74% in the placebo group). The long-term follow-up results from the Phase 2 study are published in
Biotechnology Reports.
In September  2016, we and SciClone Pharmaceuticals,  Inc. (“SciClone”) entered into an exclusive license agreement,
pursuant to which we granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in defined
territories. Under the terms of the license agreement, SciClone will be responsible for all aspects of development, product
registration and commercialization in the territories, having access to data generated by us. In exchange for exclusive rights,
SciClone will pay us royalties on net sales, and we will supply commercial drug product to SciClone on a cost-plus basis,
while maintaining worldwide manufacturing rights.

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Based on the positive and previously published Phase 2 results (Study IDR-OM-01), in July 2017, we initiated a Phase 3
clinical trial referred to as the “DOM–INNATE” (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity)
study. Approximately 50 U.S. and European oncology centers participated in this trial. The Phase 3 protocol (Study IDR-OM-
02) was a highly powered, double-blind, randomized, placebo-controlled, multinational trial that sought to enroll
approximately 260 subjects with squamous cell carcinoma of the oral cavity and oropharynx who were scheduled to receive
a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin
chemotherapy given as a dose of 80-100 mg/m2 every third week. Subjects were randomized to receive either 1.5 mg/kg
SGX942 or placebo given twice a week during and for two weeks following completion of chemoradiation therapy (“CRT”).
The primary endpoint for the study was the median duration of SOM, which was assessed by oral examination at each
treatment visit and then through six weeks following completion of CRT. Oral mucositis is evaluated using the WHO Grading
system. SOM is defined as a WHO Grade of ≥3. Subjects are followed for an additional 12 months after the completion of
treatment.
In April  2019, the Paediatric Committee of the EMA approved our PIP for SGX942, a prerequisite for filing a Marketing
Authorization Application (“MAA”) for any new medicinal product in Europe. The EMA also agreed that we may defer
conducting the PIP until successful completion of our pivotal Phase 3 clinical trial of SGX942, which allowed us to file the
adult indication MAA prior to completion of the PIP.
In June  2020, the pivotal Phase 3 DOM–INNATE study (Study IDR-OM-02) completed enrollment of 268 subjects. In
December 2020, the results of our Phase 3 clinical trial for SGX942 showed that the primary endpoint of median duration of
SOM did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed
with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment
group. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was
not statistically significant. Other secondary endpoints supported the biological activity of dusquetide, including a statistically
significant 50% reduction in the median duration of SOM in the per-protocol population, which decreased from 18 days in the
placebo group to 9 days in the SGX942 treatment group (p=0.049), consistent with the findings in the Phase 2 trial (Study
IDR-OM-01). Similarly, incidence of SOM also followed this biological trend as seen in the Phase 2 study, decreasing by
16% in the SGX942 treatment group relative to the placebo group in the per-protocol population. The per-protocol population
was defined as the population receiving a minimum of 55 Gy radiation and at least 10 doses of study drug (placebo or
SGX942) throughout the intended treatment period, with no major protocol deviations (e.g. breaks in study drug
administration longer than 8 days between successive doses).
Following analysis of the full dataset, including the 12-month long-term follow-up safety data in late 2021, we held a meeting
with the MHRA to review the study results and to obtain further clarity on the future of the oral mucositis development
program. The meeting was informative with the outcome being that based on the SGX942 biologic activity observed and the
consistency in response between the Phase 2 and Phase 3 trials, the Phase 3 DOM-INNATE study could serve as the first
of two Phase 3 studies required to support potential marketing authorization, assuming the second Phase 3 clinical trial
achieves the required level of statistical significance in its primary endpoint. With the benefit of a robust preclinical and
clinical data package for SGX942, we now will analyze the data to design a second Phase 3 study and will look to identify a
potential partner(s) to continue this development program.
In January 2022, dusquetide proved effective at reducing tumor size in nonclinical xenograft models. Recent studies,
recapitulating results from previously published studies, have confirmed the efficacy of dusquetide as a stand-alone and
combination anti-tumor therapy, with radiation, chemotherapy and targeted therapy, in the context of the MCF-7 breast
cancer cell line. Of note, these results are consistent with a potential direct anti-tumor effect identified with SGX942 and is
another important consideration in the oral mucositis treatment space.
In June 2022, an article was published describing the binding of our IDR, dusquetide, to the p62 protein. Dusquetide binds to
p62 or SQSTM-1, a scaffold protein implicated in a number of intracellular signaling networks implicated in tumor cell
survival, including autophagy. This publication elaborates on the direct interaction of dusquetide with p62, as well as some of
the direct downstream consequences of that interaction, consistent with its observed anti-infective, anti-tumor and anti-
inflammatory activities. This information advances the understanding of dusquetide's novel mechanism of action and
supports the development of analogs related to dusquetide.
We estimate the potential worldwide market for SGX942 is in excess of $500 million for the treatment of oral mucositis. This
potential market information is a forward-looking statement, and investors are urged not to place undue reliance on this

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statement. While we have determined this potential market size based on assumptions that we believe are reasonable, there
are a number of factors that could cause our expectations to change or not be realized.
Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but
is most commonly associated with the mouth, followed by the small intestine. We estimate, based upon our review of historic
studies and reports, and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000
people in the U.S. per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating
and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastro-intestinal damage
causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal
treatment outcomes.
The mechanisms of mucositis have been extensively studied and have been linked to the interaction of chemotherapy
and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is regarded as a
secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the
primary cause of the lesions.
We estimate, based upon our review of historic studies and reports, and an interpolation of data on the incidence of oral
mucositis, that oral mucositis is a subpopulation of approximately 90,000 patients in the U.S., with a comparable number in
Europe. Oral mucositis almost always occurs in patients with head and neck cancer treated with radiation therapy (greater
than 80% incidence of severe mucositis) and is common in patients undergoing high dose chemotherapy and hematopoietic
cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning
regimen used for myeloablation.
SGX945 – for Treating Aphthous Ulcers in Behçet’s Disease
SGX945 is our product candidate containing our IDR technology, dusquetide, targeting the treatment of aphthous Ulcers in
Behçet’s Disease. Behçet’s Disease is an orphan disease and an area of unmet medical need.
In November  2023, the FDA cleared the IND application for a Phase 2a clinical trial entitled, “Pilot Study of SGX945
(Dusquetide) in the Treatment of Aphthous Ulcers in Behçet’s Disease.” The study is designed to evaluate the safety and
potential efficacy of SGX945 (dusquetide) in the resolution of aphthous flares in Behçet’s Disease and began patient
enrollment in the second half of 2024.
In January 2024, SGX945 received Fast Track designation for the treatment of oral lesions of Behçet’s Disease from the
FDA.
In February 2024, we announced the formation of a Medical Advisory Board to provide medical/clinical strategic guidance to
advance the clinical development of SGX945 for the treatment of Behçet's Disease.
In November 2024, we opened patient enrollment for the Phase 2 study (protocol number DUS-AUBD-01) evaluating
SGX945 (dusquetide) in the treatment of Behçet's Disease.
We estimate the potential worldwide market for SGX945 is in excess of $200 million for the treatment of aphthous ulcers in
Behçet’s Disease. This potential market information is a forward-looking statement, and investors are urged not to place
undue reliance on this statement. While we have determined this potential market size based on assumptions that we
believe are reasonable, there are a number of factors that could cause our expectations to change or not be realized.
Behçet’s Disease
Behçet’s Disease (“BD”) is commonly known as an inflammatory disorder of the blood vessels (vasculitis). Often first
diagnosed in young adults, its effects and severity will wax and wane over time. Major signs and symptoms usually include
mouth sores (approximately 95% of patients), skin rashes and lesions (approximately 50% of patients), genital sores
(approximately 50% of patients), leg ulcers (approximately 40% of patients) and eye inflammation (approximately 15% of

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patients). It is a painful disease, directly impacting the patient’s quality of life and ability to productively engage in life
activities, including work.
BD is thought to be an auto-immune disease with both genetic and environmental factors. It is most common along the “silk
road” in the Middle East and East Asia, including Turkey, Iran, Japan and China. There are approximately 18,000 known
cases of BD in the U.S. and 80,000 in Europe. There are as many as 1,000,000 people worldwide living with BD.
There is no cure for BD, rather treatments are prescribed to manage symptoms. Treatments may include both maintenance
therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and leg ulcers).
Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to reduce
inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side effects that
become more concerning with more chronic use. Genital ulcers are often associated with significant genital scarring while
leg ulcers can result in a post-thrombotic syndrome. Other treatments for BD flares involve suppressing the immune system
with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and kidney
problems, low blood counts and high blood pressure. Finally, anti-inflammatory drugs are also used, including anti-TNF
medications. The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of
oral ulcers. Unfortunately, apremilast is associated with both high cost and side effects including diarrhea, nausea, upper
respiratory tract infection and headache.
Public Health Solutions Overview
ThermoVax® – Thermostability Platform Technology
ThermoVax® is a novel method for thermostabilizing vaccines with a variety of adjuvants, resulting in a single vial which can
be reconstituted with water for injection immediately prior to use. One of the adjuvants utilized in ThermoVax® is aluminum
salts (known colloquially as “Alum”). Alum is the most widely employed adjuvant technology in the vaccine industry.
The value of ThermoVax® lies in its potential ability to eliminate the need for cold chain production, transportation, and
storage for Alum-adjuvanted vaccines. This would relieve the high costs of producing and maintaining vaccines under
refrigerated conditions. Based on historical reports from WHO and other scientific reports, we believe that a meaningful
proportion of vaccine doses globally are wasted due to excursions from required cold chain temperature ranges. This is due
to the fact that many vaccines need to be maintained either between 2 and 8 degrees Celsius (“C”), frozen below  -20
degrees C, or frozen below -60 degrees C, and even brief excursions from these temperature ranges usually necessitate the
destruction of the product or the initiation of costly stability programs specific for the vaccine lots in question. ThermoVax®
has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines for ricin exposure in
emergency settings.
ThermoVax® development, specifically in the context of an Alum adjuvant, was supported pursuant to our $9.4 million NIAID
grant enabling development of thermo-stable ricin (RiVax®) and anthrax vaccines. Proof-of-concept preclinical studies with
ThermoVax® indicate that it is able to produce stable vaccine formulations using adjuvants, protein immunogens, and other
components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage
conditions. These studies were conducted with our Alum-adjuvanted ricin toxin vaccine, RiVax® and our Alum-adjuvanted
anthrax vaccine. Each vaccine was manufactured under precise lyophilization conditions using excipients that aid in
maintaining native protein structure of the key antigen. When RiVax® was kept at 40 degrees C (104 degrees Fahrenheit
(“F”)) for up to one year, all of the animals vaccinated with the lyophilized RiVax® vaccine developed potent and high titer
neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax® vaccine kept at 40 degrees C did not
develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to
temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8
degrees C. When the anthrax vaccine was kept for up to 16 weeks at 70 degrees C, it was able to develop a potent antibody
response, unlike the liquid formulation kept at the same temperature. Moreover, we also have demonstrated the compatibility
of our thermostabilization technology with other secondary adjuvants such as TLR-4 agonists.
We also entered into a collaboration agreement with Axel Lehrer,  PhD of the Department of Tropical Medicine, Medical
Microbiology and Pharmacology, John A. Burns School of Medicine (“JABSOM”), University of Hawai’i at Manoa (“UH
Manoa”) and Hawaii Biotech, Inc. (“HBI”) to develop a heat stable subunit Ebola vaccine. Dr. Lehrer, a co-inventor of the
Ebola vaccine with HBI, has shown proof of concept efficacy with subunit Ebola vaccines in non-human primates (“NHP”).
The most advanced Ebola vaccines involve the use of vesicular stomatitis virus and adenovirus vectors – live, viral vectors

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which complicate the manufacturing, stability and storage requirements. Dr. Lehrer’s vaccine candidate is based on highly
purified recombinant protein antigens, circumventing many of these manufacturing difficulties. Dr.  Lehrer and HBI have
developed a robust manufacturing process for the required proteins. Application of ThermoVax® may allow for a product that
can avoid the need for cold chain distribution and storage, yielding a vaccine ideal for use in both the developed and
developing world. This agreement has expired in accordance with its terms.
In December 2010, we executed a worldwide exclusive license agreement with the University of Colorado (“UC”) for certain
patents relating to ThermoVax® in all fields of use. In April 2018, the UC delivered a notice of termination of our license
agreement based upon our failure to achieve one of the development milestones: initiation of the Phase 1 clinical trial of the
heat stabilization technology by March  31, 2018. After negotiating with the UC, we and the UC agreed to extend the
termination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to
keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat
stabilization technology in our field of use.
During September  2017, we were awarded funding of approximately $700,000 over five years under a NIAID Research
Project (R01) grant awarded to UH Manoa for the development of a trivalent thermostabilized filovirus vaccine (including
protection against Zaire ebolavirus, Sudan ebolavirus and Marburg Marburgvirus). Previous collaborations demonstrated the
feasibility of developing a heat stable subunit Ebola vaccine. Under the terms of the subaward, we will continue to support
vaccine formulation development with our proprietary vaccine thermostabilization technology, ThermoVax®. Ultimately, the
objective is to produce a thermostable trivalent filovirus vaccine for protection against Ebola and related diseases, allowing
worldwide distribution without the need for cold storage. Based on current U.S. government needs, efforts have been
expanded to focus on a monovalent or bivalent vaccine to specifically address Marburg marburgvirus.
In October 2018, in a series of related transactions, (a) we and the UC agreed to terminate the original license agreement,
(b)  the UC and VitriVax,  Inc. (“VitriVax”) executed a worldwide exclusive license agreement for the heat stabilization
technology for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was
amended and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines.
We paid a $100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense
agreement to maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale
of a sublicensed product, upon which point, we shall pay an earned royalty of 2% of net sales subject to a minimum royalty
of $50,000 each year. We are also required to pay royalty on any sub-sublicense income based on a declining percentage of
all sub-sublicense income calculated within the contractual period until reaching a minimum of 15% after two  years. In
addition, we are required to pay VitriVax milestone fees of: (a)  $25,000 upon initiation of a Phase 2 clinical trial of the
sublicensed product, (b) $100,000 upon initiation of a Phase 3 clinical trial of the sublicensed product, (c) $100,000 upon
regulatory approval of a sublicensed product, and (d)  $1 million upon achieving $10 million in aggregate net sales of a
sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.
In March 2020, we entered into a research collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine,
Medical Microbiology and Pharmacology, JABSOM, UH Manoa to further expand the filovirus collaboration to investigation of
potential coronavirus vaccines, including for SARS-CoV-2 (causing COVID-19). This research collaboration will utilize the
technology platform developed in the search for filovirus vaccines and will use well-defined surface glycoprotein(s) from one
or more coronaviruses, which are expected to be protective for COVID-19.
During April 2020, we obtained an exclusive worldwide license for CoVaccine HT™, a novel vaccine adjuvant, from SERB
Pharmaceuticals (formerly BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation) (“SERB”), for the
fields of coronavirus infection (including SARS-CoV-2, the cause of COVID-19), and pandemic flu. CoVaccine HT™ is a
novel adjuvant, which has been shown to enhance both cell-mediated and antibody-mediated immunity. We and our
collaborators, including UH Manoa and Dr. Axel Lehrer, have successfully demonstrated the utility of CoVaccine HT™ in the
development of our heat stable filovirus vaccine program, with vaccine candidates against Ebola and Marburg virus disease.
Given this previous success, CoVaccine HT™ will potentially be an important component of our vaccine technology platform
currently being assessed for use against coronaviruses including SARS-CoV-2, the cause of COVID-19. The license
agreement was executed between us and SERB, which owns the CoVaccine HT™ intellectual property.
In September 2020, the Journal of Pharmaceutical Sciences published a scientific article detailing the thermostabilization of
the filovirus GP proteins and key assays describing their stability.

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During October  2020, Frontiers in Immunology published a scientific article describing CiVax™, a prototype COVID-19
vaccine, using the novel CoVaccine HT™ adjuvant and demonstrating significant immunogenicity, including strong total and
neutralizing antibody responses, with a balanced Th1 response, as well as enhancement of cell mediated immunity. These
are all considered to be critical attributes of a potential COVID-19 vaccine.
In December  2020, NIAID awarded us a Direct to Phase II Small Business Innovation Research (“SBIR”) grant of
approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of
COVID-19 and Ebola Virus Disease (“EVD”) vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. This
award also is supporting immune characterization of this novel, emulsified adjuvant that has unique potency and
compatibility with lyophilization strategies to enable thermostabilization of subunit vaccines.
During August 2021, positive data demonstrated the efficacy of multiple filovirus vaccine candidates in NHP, including
thermostabilized multivalent vaccines in a single vial platform presentation. Collaborators at UH Manoa describe the potent
efficacy of vaccine candidates protecting against three life-threatening filoviruses, Zaire ebolavirus, Sudan ebolavirus and
Marburg Marburgvirus in an article titled "Recombinant Protein Filovirus Vaccines Protect Cynomolgus Macaques from
Ebola, Sudan, and Marburg Viruses", published in Frontiers in Immunology. These vaccine candidates contain highly purified
protein antigens combined with the novel CoVaccine HT™ adjuvant, in both monovalent (single antigen) and bivalent (two
antigen) formulations. Most recently, efforts to formulate all three antigens and adjuvant into a thermostable single-vial
vaccine platform has also been shown to protect 75% of vaccinated NHPs against subsequent Sudan ebolavirus challenge,
with further development to test efficacy against other filovirus infections ongoing.
During August 2021, Vaccine published a scientific article describing the formulation of single-vial platform presentations of
monovalent (single antigen), bivalent (two antigens) and trivalent (three antigens) combinations of filovirus vaccine
candidates.
During September 2021, an accelerated preprint was posted on bioRxiv of pre-clinical immunogenicity studies for CiVax™
(heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses, including
against the Beta, Gamma and Delta variants of concern. The scientific article was subsequently published on March 9, 2022
in ACS Infectious Diseases. The work is part of an ongoing collaboration with Axel Lehrer, PhD, Associate Professor at the
Department of Tropical Medicine, Medical Microbiology and Pharmacology, JABSOM, UH Manoa. Development continues
under a non-dilutive $1.5 million grant from the NIAID awarded to us in December 2020.
In December 2021, 100% protection of NHPs against lethal  Sudan  ebolavirus challenge was achieved using a bivalent,
thermostabilized vaccine formulated in a single vial, reconstituted only with water immediately prior to use. This milestone is
part of an ongoing collaboration with UH Manoa and further demonstrates the broad applicability of the vaccine platform,
and its potential role in the U.S. government's initiative for pandemic preparedness.
In May  2022, the U.S. Patent and Trademark Office issued a Notice of Allowance for the patent application titled
“Composition and Methods of Manufacturing Trivalent Filovirus Vaccines.” The allowed claims are directed to unique,
proprietary composition and methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants
comprising sucrose fatty acid esters prior to lyophilization. The described vaccine platform has previously been successfully
applied to filovirus vaccines (as mono-, bi- and tri-valent candidates for Zaire ebolavirus, Sudan ebolavirus and Marburg
marburgvirus) as well as SARS-CoV-2 vaccine. No currently licensed lyophilized vaccine that contains an adjuvant is
presented in a single vial format and there are few reports of successfully using nano-emulsions in lyophilized formulations.
Previous work has demonstrated the use of a single vial platform to co-lyophilize antigen(s) and a nano-emulsion adjuvant,
CoVaccine HT™, maintaining key adjuvant stability characteristics including particle size and colloidal stability, as well as
maintaining immunogenicity. This most recent milestone confirms that, in the context of lethal challenge with Sudan
ebolavirus, complete protection is maintained with the thermostabilized formulation.
In June 2022, 100% protection of NHPs against lethal  Marburg marburgvirus  challenge was achieved using a bivalent,
thermostabilized vaccine formulated in a single vial, reconstituted only with sterile water immediately prior to use. This
important milestone is part of an ongoing collaboration with UH Manoa, demonstrating the successful presentation of one or
more antigen(s) within the same formulation while maintaining full potency and thermostability. It further demonstrates the
broad applicability of the heat stable vaccine platform, and its potential role in the U.S. government's initiative for pandemic
preparedness.

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In September 2023, positive data demonstrated two-year stability of thermostabilized bivalent and trivalent filovirus vaccine
candidates at temperatures of 40 degrees C (104 degrees F) when formulated in a single vial, needing reconstitution only
with sterile water immediately prior to use. This important milestone is part of an ongoing collaboration with UH Manoa,
demonstrating the successful presentation of one or more antigen(s)  within the same formulation while maintaining full
potency and thermostability. It further demonstrates the broad applicability of the heat stable vaccine platform, and its
potential role in the U.S. government’s initiative for pandemic preparedness.
In January 2024, Vaccine published the preclinical efficacy results of our novel, single-vial, thermostabilized bivalent filovirus
vaccine providing 100% protection against both Sudan ebolavirus (SUDV) and Marburg marburgvirus (MARV) infections.
The manuscript was entitled “Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus
and marburgvirus infection”.
In April 2024, we received orphan drug designation for the active ingredient in SuVax™, the subunit protein vaccine of
recombinantly expressed SUDV glycoprotein, for the prevention and post-exposure prophylaxis against SUDV infection.
In April 2024, we received orphan drug designation for the active ingredient in MarVax™, the subunit protein vaccine of
recombinantly expressed MARV glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection. 
In April 2024, we received notice of intent to grant additional patents based on our patent application titled “Compositions
and Methods of Manufacturing Trivalent Filovirus Vaccines” in the United Kingdom and South Africa, with other international
jurisdictions pending.
RiVax® – for Protection Against Ricin Toxin Exposure
RiVax® is our proprietary vaccine candidate being developed to protect against exposure to ricin toxin and if approved,
would be the first ricin vaccine. The immunogen in RiVax® induces a protective immune response in animal models of ricin
exposure and functionally active antibodies in humans. The immunogen consists of a genetically inactivated ricin A chain
subunit that is enzymatically inactive and lacks residual toxicity of the holotoxin. RiVax® has demonstrated statistically
significant (p < 0.0001) preclinical survival results, providing 100% protection against acute lethality in an aerosol exposure
non-human primate model (Roy et al, 2015, Thermostable ricin vaccine protects rhesus macaques against aerosolized ricin:
Epitope-specific neutralizing antibodies correlate with protection, PNAS USA 112:3782-3787), and has also been shown to
be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. Results of the first Phase 1 human
trial of RiVax® established that the immunogen was safe and induced antibodies that we believe may protect humans from
ricin exposure. The antibodies generated from vaccination, concentrated and purified, were capable of conferring immunity
passively to recipient animals, indicating that the vaccine was capable of inducing functionally active antibodies in humans.
The outcome of this study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, A
Pilot Clinical Trial of a Recombinant Ricin Vaccine in Normal Humans, PNAS, 103:2268-2273). The second trial that was
completed in September 2012 and was sponsored by University of Texas Southwestern Medical Center (“UTSW”) evaluated
a more potent formulation of RiVax® that contained an Alum adjuvant. The results of the Phase 1b study indicated that Alum-
adjuvanted RiVax® was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than
adjuvant-free RiVax®. The outcomes of this second study were published in the Clinical and Vaccine Immunology.
We have adapted the original manufacturing process for the immunogen contained in RiVax® for thermostability and large
scale manufacturing and recent studies have confirmed that the thermostabilized RiVax® formulation enhances the stability
of the RiVax® antigen, enabling storage for at least 1  year at temperatures up to 40 degrees C (104 degrees F). The
program will pursue approval via the FDA “Animal Rule” since it is not possible to test the efficacy of the vaccine in a clinical
study which would expose humans to ricin. Uniform, easily measured and species-neutral immune correlates of protection
that can be measured in humans and animals, and are indicative of animal survival to subsequent ricin challenge, are
central to the application of the “Animal Rule.” Recent work has identified such potential correlates of immune protection in
animals and work to qualify and validate these approaches is continuing, with the goal of utilizing these assays in a planned
Phase 1/2 clinical trial with the thermostable RiVax® formulation. During September 2018, we published an extended stability
study of RiVax®, showing up to 100% protection in mice after 12 months storage at 40 degrees C (104 degrees F) as well as
identification of a potential in vitro stability indicating assay, critical to adequately confirming the long-term shelf life of the
vaccine. We have entered into a collaboration with IDT Biologika GmbH (“IDT”) to scale-up the formulation/filling process
and continue development and validation of analytical methods established at IDT to advance the program. We also initiated
a development agreement with Emergent BioSolutions, Inc. (“EBS”) to implement a commercially viable, scalable production
technology for the RiVax® drug substance protein antigen.

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The development of RiVax® has been sponsored through a series of overlapping challenge grants, UC1, and cooperative
grants, U01, from the NIH, granted to us and to UTSW where the vaccine originated. The second clinical trial was supported
by a grant from the FDA’s Office of Orphan Products to UTSW. To date, we and UTSW have collectively received
approximately $25 million in grant funding from the NIH for the development of RiVax®. In September 2014, we entered into
a contract with the NIH for the development of RiVax® pursuant to which we were awarded an additional $21.2 million of
funding in the aggregate. The development agreements with EBS and IDT were specifically funded under this NIH contract.
In 2017, NIAID exercised options to fund additional animal efficacy studies and good manufacturing practices compliant
RiVax® bulk drug substance and finished drug product manufacturing, which is required for the conduct of future preclinical
and clinical safety and efficacy studies. The exercised options provide us with approximately $4.5 million in additional non-
dilutive funding, bringing the total amount awarded to date under this contract to $21.2 million, which expired in
February 2021. The total award of up to $21.2 million supported the preclinical, manufacturing and clinical development
activities necessary to advance heat stable RiVax® with the FDA. In addition to this funding for the development of RiVax®,
biomarkers for RiVax® testing have been successfully identified, facilitating potential approval under the FDA Animal Rule.
During December 2019, we initiated a third Phase 1 double-blind, placebo-controlled, randomized study in eight healthy
adult volunteer subjects designed to evaluate the safety and immunogenicity of RiVax® utilizing ThermoVax®. During
January  2020, we suspended the study after Emergent Manufacturing Operations Baltimore LLC (“EMOB”), the
manufacturer of the drug substance, notified us that, after releasing the final drug product to us, EMOB identified that the
active drug substance tested outside the established specification parameters. Two subjects had received doses as part of
the study before the manufacturer provided this notice. Those two subjects were monitored with no safety issues noted and
data was captured in accordance with the study protocol. They did not receive further doses of study drug.
During April 2020, we received notification from NIAID that they would not be exercising the final contract option to support
the conduct of a Phase 1/2 clinical study in healthy volunteers. As a result, the total contract award will not exceed $21.2
million. This contract expired in February 2021.
In November 2021, an article was published on pre-clinical immunogenicity studies for RiVax® demonstrating enduring
protection for at least 12 months post-vaccination. These results, coupled with the previous demonstration of efficacy in mice
and NHPs as well as long-term thermostability (at least 1 year at 40 degrees C or 104 degrees F), reinforce the practicality
of stockpiling and potentially utilizing the RiVax® vaccine in warfighters and civilian first responders without the complexities
that arise for vaccines that require stringent cold chain handling.
RiVax® has been granted Orphan Drug designation as well as Fast Track designation by the FDA for the prevention of ricin
intoxication. In addition, RiVax® has also been granted Orphan Drug designation in the European Union (“EU”) from the
EMA Committee for Orphan Medical Products.
Assuming development efforts are successful for RiVax®, we believe potential government procurement contract(s) could
reach as much as $200 million. This potential procurement contract information is a forward-looking statement, and investors
are urged not to place undue reliance on this statement. While we have determined this potential procurement contract value
based on assumptions that we believe are reasonable, there are a number of factors that could cause our expectations to
change or not be realized.
As a new chemical entity, an FDA approved RiVax® vaccine has the potential to qualify for a biodefense Priority Review
Voucher (“PRV”). Approved under the 21st Century Cures Act in late 2016, the biodefense PRV is awarded upon approval
as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context. PRVs
are transferable and can be sold, with sales in recent years of approximately $100 million. When redeemed, PRVs entitle the
user to an accelerated review period of nine months, saving a median of seven months review time as calculated in 2009.
However, FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an
additional user fee (approximately $2.5 million for fiscal year 2025).
In December 2022, we published a paper demonstrating statistically significant correlates of protection predicting survival
after lethal aerosolized ricin challenge in non-human primates. The article titled “Serum antibody profiling identifies vaccine-
induced correlates of protection against aerosolized ricin toxin in rhesus macaques” was published in the journal npj
Vaccines.

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Ricin Toxin
Ricin toxin can be cheaply and easily produced, is stable over long periods of time, is toxic by several routes of exposure
and thus has the potential to be used as a biological weapon against military and/or civilian targets. As a bioterrorism agent,
ricin could be disseminated as an aerosol, by injection, or as a food supply contaminant. The potential use of ricin toxin as a
biological weapon of mass destruction has been highlighted in a Federal Bureau of Investigation Bioterror report released in
November 2007 titled Terrorism 2002-2005, which states that “Ricin and the bacterial agent anthrax are emerging as the
most prevalent agents involved in WMD investigations.” Al Qaeda in the Arabian Peninsula had threatened the use of ricin
toxin to poison food and water supplies and in connection with explosive devices. Domestically, the threat from ricin remains
a concern for security agencies. In April 2013, letters addressed to the U.S. President, a Senator and a judge tested positive
for ricin. As recently as September 2020, ricin-laced letters addressed to the White House and others addressed to Texas
law enforcement agencies were intercepted before delivery raising fresh concerns about the deadly toxin.
The Centers for Disease Control and Prevention has classified ricin toxin as a Category B biological agent. Ricin works by
first binding to glycoproteins found on the exterior of a cell, and then entering the cell and inhibiting protein synthesis leading
to cell death. Once exposed to ricin toxin, there is no effective therapy available to reverse the course of the toxin. The
recent ricin threat to government officials has heightened the awareness of this toxic threat. Currently, there is no FDA
approved vaccine to protect against the possibility of ricin toxin being used in a terrorist attack, or its use as a weapon on the
battlefield nor is there a known antidote for ricin toxin exposure.
SGX943 – for Treating Emerging and/or Antibiotic-Resistant Infectious Diseases
SGX943 is an IDR, containing the same active ingredient as SGX942. Dusquetide is a fully synthetic, 5-amino acid peptide
with high aqueous solubility and stability. Extensive in vivo preclinical studies have demonstrated enhanced clearance of
bacterial infection with SGX943 administration. SGX943 has shown efficacy against both Gram-negative and Gram-positive
bacterial infections in preclinical models, independent of whether the bacteria is antibiotic-resistant or antibiotic-sensitive.
The innate immune system is responsible for rapid and non-specific responses to combat bacterial infection. Augmenting
these responses represents an alternative approach to treating bacterial infections. In animal models, IDRs are efficacious
against both antibiotic-sensitive and antibiotic-resistant infections, both Gram-positive and Gram-negative bacteria, and are
active irrespective of whether the bacteria occupy a primarily extracellular or intracellular niche. IDRs are also effective as
stand-alone agents or in conjunction with antibiotics. An IDR for the treatment of serious bacterial infections encompasses a
number of clinical advantages including:
●
Treatment when antibiotics are contraindicated, such as:
o
before the infectious organism and/or its antibiotic susceptibility is known; or
o
in at-risk populations prior to infection.
●
An ability to be used as an additive, complementary treatment with antibiotics, thereby:
o
enhancing efficacy of sub-optimal antibiotic regimens (e.g., partially antibiotic-resistant infections);
o
enhancing clearance of infection, thereby minimizing the generation of antibiotic resistance (e.g., in treating
melioidosis); and
o
reducing the required antibiotic dose, again potentially minimizing the generation of antibiotic resistance.
●
An ability to modulate the deleterious consequences of inflammation in response to the infection, including the
inflammation caused by antibiotic-driven bacterial lysis.
●
Being unlikely to generate bacterial resistance since the IDR acts on the host, and not the pathogen.
Importantly, systemic inflammation and multi-organ failure is the ultimate common outcome of not only emerging and/or
antibiotic-resistant infectious diseases, but also of most biothreat agents (e.g., Burkholderia pseudomallei), indicating that

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dusquetide would be applicable not only to antibiotic-resistant infection, but also to biothreat agents, especially where the
pathogen is not known and/or has been engineered for enhanced antibiotic resistance.
The Drug Approval Process
The FDA and comparable regulatory agencies in state, local and foreign jurisdictions impose substantial requirements on the
clinical development, manufacture and marketing of new drug and biologic products. The FDA, through regulations that
implement the Federal Food, Drug, and Cosmetic Act, as amended (“FDCA”), and other laws and comparable regulations
for other agencies, regulate research and development activities and the testing, manufacture, labeling, storage, shipping,
approval, recordkeeping, advertising, promotion, sale, export, import and distribution of such products. The regulatory
approval process is generally lengthy, expensive and uncertain. Failure to comply with applicable FDA and other regulatory
requirements can result in sanctions being imposed on us or the manufacturers of our products, including holds on clinical
research, civil or criminal fines or other penalties, product recalls, or seizures, or total or partial suspension of production or
injunctions, refusals to permit products to be imported into or exported out of the U.S., refusals of the FDA to grant approval
of drugs or to allow us to enter into government supply contracts, withdrawals of previously approved marketing applications
and criminal prosecutions.
Before human clinical testing in the U.S. of a new drug compound or biological product can commence, an Investigational
New Drug (“IND”), application is required to be submitted to the FDA. The IND application includes results of pre-clinical
animal studies evaluating the safety and efficacy of the drug and a detailed description of the clinical investigations to be
undertaken.
Clinical trials are normally done in three phases, although the phases may overlap. Phase 1 trials are smaller trials
concerned primarily with metabolism and pharmacologic actions of the drug and with the safety of the product. Phase 2 trials
are designed primarily to demonstrate effectiveness and safety in treating the disease or condition for which the product is
indicated. These trials typically explore various doses and regimens. Phase 3 trials are expanded clinical trials intended to
gather additional information on safety and effectiveness needed to clarify the product’s benefit-risk relationship and
generate information for proper labeling of the drug, among other things. The FDA receives reports on the progress of each
phase of clinical testing and may require the modification, suspension or termination of clinical trials if an unwarranted risk is
presented to patients. When data is required from long-term use of a drug following its approval and initial marketing, the
FDA can require Phase 4, or post-marketing, studies to be conducted.
With certain exceptions, once successful clinical testing is completed, the sponsor can submit a NDA, for approval of a drug,
or a Biologic License Application (“BLA”), for biologics such as vaccines, which will be reviewed, and if successful, approved
by the FDA, allowing the product to be marketed. The process of completing clinical trials for a new drug is likely to take a
number of years and require the expenditure of substantial resources. Furthermore, the FDA or any foreign health authority
may not grant an approval on a timely basis, if at all. The FDA may deny the approval of a NDA or BLA, in its sole discretion,
if it determines that its regulatory criteria have not been satisfied or may require additional testing or information. Among the
conditions for marketing approval is the requirement that the prospective manufacturer’s quality control and manufacturing
procedures conform to good manufacturing practice regulations. In complying with standards contained in these regulations,
manufacturers must continue to expend time, money and effort in the area of production, quality control and quality
assurance to ensure full technical compliance. Manufacturing facilities, both foreign and domestic, also are subject to
inspections by, or under the authority of, the FDA and by other federal, state, local or foreign agencies.
Even after initial FDA or foreign health authority approval has been obtained, further studies, including Phase 4 post-
marketing studies, may be required to provide additional data on safety and will be required to gain approval for the
marketing of a product as a treatment for clinical indications other than those for which the product was initially tested. For
certain drugs intended to treat serious, life-threatening conditions that show great promise in earlier testing, the FDA can
also grant conditional approval. However, drug developers are required to study the drug further and verify clinical benefit as
part of the conditional approval provision, and the FDA can revoke approval if later testing does not reproduce previous
findings. The FDA may also condition approval of a product on the sponsor agreeing to certain mitigation strategies that can
limit the unfettered marketing of a drug. Also, the FDA or foreign regulatory authority will require post-marketing reporting to
monitor the side effects of the drug. Results of post-marketing programs may limit or expand the further marketing of the
product. Further, if there are any modifications to the drug, including any change in indication, manufacturing process,

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labeling or manufacturing facility, an application seeking approval of such changes will likely be required to be submitted to
the FDA or foreign regulatory authority.
In the U.S., the FDCA, the Public Health Service Act, the Federal Trade Commission Act, and other federal and state
statutes and regulations govern, or influence the research, testing, manufacture, safety, labeling, storage, record keeping,
approval, advertising and promotion of drug, biological, medical device and food products. Noncompliance with applicable
requirements can result in, among other things, fines, recall or seizure of products, refusal to permit products to be imported
into the U.S., refusal of the government to approve product approval applications or to allow us to enter into government
supply contracts, withdrawal of previously approved applications and criminal prosecution. The FDA may also assess civil
penalties for violations of the FDCA involving medical devices.
For biodefense development, such as with RiVax®, the FDA has instituted policies that are expected to result in shorter
pathways to market. This potentially includes approval for commercial use utilizing the results of animal efficacy trials, rather
than efficacy trials in humans. However, we will still have to establish that the vaccine and countermeasures it is developing
are safe in humans at doses that are correlated with the beneficial effect in animals. Such clinical trials will also have to be
completed in distinct populations that are subject to the countermeasures; for instance, the very young and the very old, and
in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an influence over the
benefit-risk scenarios for deploying the countermeasures and in establishing the number of doses utilized in the Strategic
National Stockpile. We may not be able to sufficiently demonstrate the animal correlation to the satisfaction of the FDA, as
these correlates are difficult to establish and are often unclear. Invocation of the animal rule may raise issues of confidence
in the model systems even if the models have been validated. For many of the biological threats, the animal models are not
available and we may have to develop the animal models, a time-consuming research effort. There are few historical
precedents, or recent precedents, for the development of new countermeasure for bioterrorism agents. Despite the animal
rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure and it may require
safety and immunogenicity trials in additional populations. Approval of biodefense products may be subject to post-
marketing studies, and could be restricted in use in only certain populations.
Vaccines are approved under the BLA process that exists under the Public Health Service Act. In addition to the greater
technical challenges associated with developing biologics, the potential for generic competition is lower for a BLA product
than a small molecule product subject to a NDA under the Federal Food, Drug and Cosmetic Act. Under the Patient
Protection and Affordable Care Act enacted in 2010, a “generic” version of a biologic is known as a biosimilar and the
barriers to entry – whether legal, scientific, or logistical – for a biosimilar version of a biologic approved under a BLA are
higher.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare
disease or condition – generally a disease or condition that affects fewer than 200,000 individuals in the U.S. Orphan drug
designation must be requested before submitting a NDA or BLA. After the FDA grants orphan drug designation, the generic
identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does
not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA or BLA
applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug
designation is entitled to a seven-year exclusive marketing period in the U.S. for that product, for that indication. During the
seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or biologic for the
same disease, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug
exclusivity. Orphan drug exclusivity does not prevent the 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 NDA or BLA application user fee.
Fast Track Designation and Accelerated Approval
The FDA is required to facilitate the development, and expedite the review, of drugs or biologics that are intended for the
treatment of a serious or life-threatening disease or condition for which there is no effective treatment and which
demonstrate the potential to address unmet medical needs for the condition. Under the fast track program, the sponsor of a
new drug or biologic candidate may request that the FDA designate the candidate for a specific indication as a fast track
drug or biologic concurrent with, or after, the filing of the IND for the candidate. The FDA must determine if the drug or
biologic candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request. Unique to a fast

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track product, the FDA may initiate review of sections of a fast track product’s NDA or BLA before the application is
complete. This rolling review is available if the applicant provides, and the FDA approves, a schedule for the submission of
the remaining information and the applicant pays applicable user fees. However, the FDA’s time period goal for reviewing an
application does not begin until the last section of the NDA or BLA is submitted. Additionally, the fast track designation may
be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data emerging in the clinical trial
process.
Any product submitted to the FDA for marketing, including under a fast track program, may be eligible for other types of FDA
programs intended to expedite development and review, such as accelerated approval. Drug or biological products studied
for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic
benefit over existing treatments may receive accelerated approval, which means the FDA may approve the product based
upon 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.
In clinical trials, a surrogate endpoint is a measurement of laboratory or clinical signs of a disease or condition that
substitutes for a direct measurement of how a patient feels, functions, or survives. Surrogate endpoints can often be
measured more easily or more rapidly than clinical endpoints. A drug or biologic candidate approved on this basis is subject
to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to
confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm a clinical benefit
during post-marketing studies, will allow the FDA to withdraw the drug or biologic from the market on an expedited basis. All
promotional materials for drug candidates approved under accelerated regulations are subject to prior review by the FDA.
Pediatric Information
Under the Pediatric Research Equity Act (“PREA”), NDAs or BLAs or supplements to NDAs or BLAs must contain data to
assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to
support dosing and administration for each pediatric subpopulation for which the drug is safe and effective. The FDA may
grant full or partial waivers, or deferrals, for submission of data. Unless otherwise required by regulation, PREA does not
apply to any drug for an indication for which orphan designation has been granted.
Paediatric Investigation Plan
As part of the regulatory process for the registration of new medicines with the EMA and the MHRA, pharmaceutical
companies are required to provide a PIP outlining our strategy for investigation of the new medicinal products in the
paediatric population. In some instances, a waiver negating the need for a PIP for certain conditions may be granted by the
EMA or MHRA when development of a medicine for use in children is not feasible or appropriate.
Innovative Licensing and Access Pathway
The ILAP was launched in the UK at the start of 2021 to accelerate the development and access to promising medicines,
thereby facilitating patient access to new medicines. The pathway, part of the UK’s plan to attract life sciences development
in the post-Brexit era, features enhanced input and interactions with the MHRA and other stakeholders including the NICE,
and the SMC. The decision to award the Innovation Passport is made by an ILAP Steering Group, which is comprised of
representatives from MHRA, NICE, and SMC. The Innovation Passport designation is the first step in the ILAP process and
triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and
development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day
accelerated assessment, rolling review and a continuous benefit risk assessment.
Early Access to Medicines Scheme
Launched in April  2014 in the United Kingdom by the MHRA, the Early Access to Medicines Scheme (“EAMS”) offers
severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new
medicines earlier than they would normally be accessible. PIM designation is the first phase of EAMS and is awarded

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following an assessment of early nonclinical and clinical data by the MHRA. The criteria product candidates must meet to
obtain PIM designation are:
●
Criterion 1 – The condition should be life-threatening or seriously debilitating with a high unmet medical need (i.e.,
there is no method of treatment, diagnosis or prevention available or existing methods have serious limitations).
●
Criterion 2 – The medicinal product is likely to offer major advantage over methods currently used in the UK.
●
Criterion 3  – The potential adverse effects of the medicinal product are likely to be outweighed by the benefits,
allowing for the reasonable expectation of a positive benefit risk balance. A positive benefit risk balance should be
based on preliminary scientific evidence that the safety profile of the medicinal product is likely to be manageable
and acceptable in relation to the estimated benefits.
False Claims Laws
The federal False Claims Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be
presented, a false claim for payment to, or approval by, the federal government or knowingly making, using, or causing to be
made or used a false record or statement material to a false or fraudulent claim to the federal government. As a result of a
modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for
money or property presented to the U.S. government.
Anti-Kickback Laws
The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering,
paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in
return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable
under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to
include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.
United States Healthcare Reform
Federal Physician Payments Sunshine Act and its implementing regulations require that certain manufacturers of drugs,
devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health
Insurance Program (with certain exceptions) to report information related to certain payments or other transfers of value
made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on
behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by
physicians and their immediate family members.
In addition, we may be subject to data privacy and security regulation by both the federal government and the states in
which we conduct our business. The Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the
Health Information Technology for Economic and Clinical Health Act (“HITECH”), and its implementing regulations, imposes
certain requirements relating to the privacy, security and transmission of individually identifiable health information. Among
other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”  –
independent contractors or agents of covered entities that receive or obtain protected health information in connection with
providing a service on behalf of a covered entity. HITECH also created four new tiers of civil monetary penalties, amended
HIPAA to make civil and criminal penalties directly applicable to business associates and possibly other persons, and gave
state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal
HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws govern
the privacy and security of health information in certain circumstances, many of which differ from each other in significant
ways and may not have the same effect, thus complicating compliance efforts.
Third-Party Suppliers and Manufacturers
Drug substance and drug product manufacturing is outsourced to qualified suppliers. We do not have manufacturing
capabilities/infrastructure and do not intend to develop the capacity to manufacture drug products substances. We have

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agreements with third-party manufacturers to supply bulk drug substances for our product candidates and with third parties
to formulate, package and distribute our product candidates. Our employees include professionals with expertise in
pharmaceutical manufacturing development, quality assurance and third-party supplier management who oversee work
conducted by third-party companies. We believe that we have on hand or can easily obtain sufficient amounts of product
candidates to complete our currently contemplated clinical trials. All of the drug substances used in our product candidates
currently are manufactured by single suppliers. While we have not experienced any supply disruptions, the number of
manufacturers of the drug substances is limited. In the event it is necessary or advisable to acquire supplies from alternative
suppliers, assuming commercially reasonable terms could be reached, the challenge would be the efficient transfer of
technology and know-how from current manufactures to the new supplier. Formulation and distribution of our finished
product candidates also currently are conducted by single suppliers but we believe that alternative sources for these
services are readily available on commercially reasonable terms, subject to the efficient transfer of technology and know-
how from current suppliers to the new supplier.
All of the current agreements for the supply of bulk drug substances for our product candidates and for the formulation or
distribution of our product candidates relate solely to the development (including preclinical and clinical) of our product
candidates. Under these contracts, our product candidates are manufactured upon our order of a specific quantity. In the
event that we obtain marketing approval for a product candidate, we will qualify secondary suppliers for all key
manufacturing activities supporting the marketing application.
Marketing and Collaboration
We do not currently have any sales and marketing capability, other than to potentially market our biodefense vaccine
products directly to government agencies. With respect to other commercialization efforts, we currently intend to seek
distribution and other collaboration arrangements for the sales and marketing of any product candidate that is approved,
while also evaluating the potential to commercialize on our own in orphan disease indications. From time to time, we have
had and are having strategic discussions with potential collaboration partners for our biodefense vaccine product
candidates, although no assurance can be given that we will be able to enter into one or more collaboration agreements for
our product candidate on acceptable terms, if at all. We believe that both military and civilian health authorities of the U.S.
and other countries will increase their stockpiling of therapeutics and vaccines to treat and prevent diseases and conditions
that could ensue following a bioterrorism attack.
On August 25, 2013, we entered into an agreement with SciClone, pursuant to which SciClone provided us with access to its
oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 in the
People’s Republic of China, including Hong Kong and Macau, subject to the negotiation of economic terms. SciClone’s data
library was generated from two sequential Phase 2 clinical studies conducted in 2010 and 2012 evaluating SciClone’s
compound, SCV-07, for the treatment of oral mucositis caused by chemoradiation therapy in head and neck cancer patients,
before SciClone terminated its program. By analyzing data available from the placebo subjects in the SciClone trials, we
acquired valuable insight into disease progression, along with quantitative understanding of its incidence and severity in the
head and neck cancer patient population. This information assisted us with the design of the SGX942 Phase 2 clinical trial,
in which positive preliminary results were announced in December 2015.
On September 9, 2016, we and SciClone entered into an exclusive license agreement, pursuant to which we granted rights
to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong
and Macau, as well as Taiwan, South Korea and Vietnam. Under the terms of the license agreement, SciClone will be
responsible for all aspects of development, product registration and commercialization in the territories, having access to
data generated by us. In exchange for exclusive rights, SciClone will pay us royalties on net sales, and we will supply
commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights. We also
entered into a common stock purchase agreement with SciClone pursuant to which we sold 1,471 shares of our common
stock to SciClone for approximately $2,040.00 per share, for an aggregate price of $3 million.
Competition
Our competitors are pharmaceutical and biotechnology companies, most of whom have considerably greater financial,
technical, and marketing resources than we do. Universities and other research institutions, including the U.S. Army Medical
Research Institute of Infectious Diseases, also compete in the development of treatment technologies, and we face
competition from other companies to acquire rights to those technologies.

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HyBryte™ Competition
There is currently no approved cure for CTCL and treatments are prescribed to manage symptoms. The FDA has approved
several treatments for later stages (IIB-IV) of CTCL and/or in conditions that are unresponsive to prior treatment. Three are
targeted therapies (Targretin®-caps, Ontak® and Adcetris®), two are histone deacetylases inhibitors (Zolina® and Istodax®)
and the remaining two are topical therapies (Valchor® and Targretin®-gel). There are currently no FDA approved therapies
for the treatment of front-line, early stage (I-IIA) CTCL; however certain topical chemotherapies and topical, radiation,
photodynamic and other therapies which are approved for indications other than CTCL are prescribed off-label for the
treatment of early stage CTCL. These include narrow-band ultraviolet B (NB-UVB) light therapy and psoralen combined with
ultraviolet A UVA light therapy (“PUVA”); however, PUVA treatments are usually limited to three times per week and 200
times in total due to the potentially carcinogenic side effect, while NB UVB is known to be effective against patches but less
so against plaque lesions, common in early stage CTCL. There are other drugs currently in development that may have the
potential to be used in early stage (I-IIA) CTCL, primarily in early Phase 1 and 2 clinical studies. Other treatments for later
stage disease are not considered direct competitors.
SGX302 Competition
There is currently no approved cure for psoriasis and treatments are prescribed to manage symptoms. The FDA has
approved several topical and systemic treatments for psoriasis. Systemic therapies dominate the treatment of severe and
increasingly the more severe moderate patients, and include biologics aimed at reducing systemic inflammation. Skin
directed therapy remains the primary treatment for mild-to-moderate disease. Current therapies for mild-to-moderate disease
include psoralen activated by ultraviolet A (“PUVA”, a photodynamic therapy), emollients, topical steroids, vitamin D
preparations including retinoids (e.g., Sorilux®, Dovonex®, Cacitrene®), coal tar, salicylic acid, calcineurin inhibitors (e.g.,
Prograf®, Elidel®, Zorac®, Tazorac®) and dithranols (e.g., Drithocreme®). Other phototherapy approaches include the use of
both broad-band and narrow-band ultraviolet B light. There are also a number of ongoing Phase 2 and 3 clinical trials in mild
to moderate psoriasis.
Compared to PUVA, photoactivated hypericin uses non-carcinogenic and more penetrative visible light (unlike ultraviolet
light used with PUVA) and a non-mutagenic compound hypericin (unlike psoralen used with PUVA), and is more highly
targeted and more commensurate with long-term treatment. Compared to other skin-directed therapies, photoactivated
hypericin has demonstrated a comparatively low local irritancy/adverse event rate with minimal long-term skin effects.
Compared to systemic therapies, commonly used in more severe patients only, photoactivated hypericin does not cause
immunosuppression.
SGX94/942/945 Competition
Because SGX94 (dusquetide) uses a novel mechanism of action in combating bacterial infections, there are no direct
competitors at this time. Bacterial infections are routinely treated with antibiotics and SGX94 treatment is anticipated to be
utilized primarily where antibiotics are insufficient (e.g., due to antibiotic resistance) or contra-indicated (e.g., in situations
where the development of antibiotic resistance is a significant concern). Many groups are working on the antibiotic
resistance problem and research into the innate immune system is intensifying, making emerging competition likely (from
companies such as Celtaxsys Inc., Innaxon Therapeutics and Innate Pharma SA).
There is currently one drug approved for the treatment of oral mucositis in hematological cancer (palifermin). There are
currently no approved drugs for treatment of oral mucositis in cancers with solid tumors (e.g., head and neck cancer). There
are several drugs in clinical development for oral mucositis – three in Phase 3 (brilacidin by Innovation Pharmaceuticals,
Inc., a mucobuccal tablet by Monopar Therapeutics LLC and GC4419 by Galera Therapeutics, Inc.). There are various
natural products in small and/or open label studies (including sage, turmeric, honey and olive oil). In addition, there are
medical devices approved for the treatment of oral mucositis including MuGard®, GelClair®, Episil®, and Caphosol®. These
devices attempt to create a protective barrier around the oral ulceration with no biologic activity in treating the underlying
disease.
There is currently no approved cure for BD and treatments are prescribed to manage symptoms. Treatments may include
both maintenance therapies and those specifically addressing mucocutaneous flares (e.g., mouth ulcers, genital ulcers and
leg ulcers). Corticosteroids are generally applied topically to sores and as eyedrops and may also be given systemically to
reduce inflammation. Although used frequently, they have limited efficacy over the long-term and have significant side

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effects that become more concerning with more chronic use. Other treatments for BD flares involve suppressing the immune
system with drugs (e.g., cyclosporine or cyclophosphamide). These drugs come with a higher risk of infection, liver and
kidney problems, low blood counts and high blood pressure. For skin and mucosal manifestations of BD, anti-inflammatory
drugs are also used, including colchicine, azathioprine, anti-TNF, anti-interferon alpha, anti-IL-17 and anti-IL-23 medications.
The only approved drug in BD is apremilast, which is used as a maintenance therapy to prevent formation of oral ulcers.
Apremilast is associated with both high cost and side effects including diarrhea, nausea, upper respiratory tract infection and
headache.
ThermoVax® Competition
Multiple groups and companies are working to address the unmet need of vaccine thermostability using a variety of
technologies. In addition, other organizations, such as the Bill and Melinda Gates Foundation and PATH, have programs
designed to advance technologies to address this need.
Several stabilization technologies currently being developed involve mixing vaccine antigen +/- adjuvant with various
proprietary excipients or co-factors that either serve to stabilize the vaccine or biological product in a liquid or dried
(lyophilized) form. Examples of these approaches include the use of various plant-derived sugars and macromolecules being
developed by companies such as iosBio. Variation Biotechnologies, Inc. (“VBI”) is developing a lipid system (resembling
liposomes) to stabilize viral antigens, including virus-like particles (“VLPs”), and for potential application to a conventional
influenza vaccine among others.
Additionally, companies like Panacea Biotec Ltd. are developing proprietary vaccines with the application of some form of
stabilization technology.
Public Health Solutions Competition
We face competition in the area of biodefense product development from various public and private companies, universities
and governmental agencies, such as the U.S. Army, some of whom may have their own proprietary technologies which may
directly compete with our technologies.
The U.S. Army Medical Research Institute of Infectious Diseases, the DoD’s lead laboratory for medical research to counter
biological threats is also developing a ricin vaccine candidate, RVEc™. RVEc™ has been shown to be fully protective in
mice exposed to lethal doses of ricin toxin by the aerosol route. Further studies, in both rabbits and nonhuman primates,
were conducted to evaluate RVEc™’s safety as well as its immunogenicity, with positive results observed. No further data
has been released in recent years. A monoclonal antibody is also being developed by Mapp Biopharmaceutical Inc. as a
ricin therapeutic, with administration 4 hours after exposure demonstrating efficacy while administration 12 hours after ricin
exposure was not protective in animal models.
There are no approved vaccines to prevent infection and/or mitigate exposure to Sudan ebolavirus or Marburg marburgvirus.
There are other vaccine candidates in development, primarily using viral-vectored vaccine platforms. These platforms may
be contra-indicated in the immune-compromised, pregnant individuals or children. They may also have limited efficacy on
repeat administration.
Patents and Other Proprietary Rights
Our goal is to obtain, maintain and enforce patent protection for our products, formulations, processes, methods and other
proprietary technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties,
both in the U.S. and in other countries. Our policy is to actively seek to obtain, where appropriate, the broadest intellectual
property protection possible for our product candidates, proprietary information and proprietary technology through a
combination of contractual arrangements and patents, both in the U.S. and elsewhere in the world.
We also depend upon the skills, knowledge and experience of our scientific and technical personnel, as well as that of our
advisors, consultants and other contractors, none of which is patentable. To help protect our proprietary knowledge and
experience that is not patentable, and for inventions for which patents may be difficult to enforce, we rely on trade secret
protection and confidentiality agreements to protect our interests. To this end, we require all employees, consultants,
advisors and other contractors to enter into confidentiality agreements, which prohibit the disclosure of confidential

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information and, where applicable, require disclosure and assignment to us of the ideas, developments, discoveries and
inventions important to our business.
In 2014, we acquired a novel PDT that utilizes safe visible light for activation, which we refer to as HyBryte™. The active
ingredient in HyBryte™ is synthetic hypericin, a photosensitizer which is topically applied to skin lesions and then activated
by fluorescent light 16 to 24 hours later. As part of the acquisition, we acquired a license agreement relating to the use of
photo-activated hypericin, composition of matter patent for HyBryte™ (U.S. patent 8,629,302) and additional issued and
pending applications, both in the U.S. and abroad. U.S. patent 8,629,302 is expected to expire in September  2030. In
August  2018, we were granted a U.S. patent (No.  10,053,513) titled “Systems and Methods for Producing Synthetic
Hypericin.” This newly issued patent, expected to expire in 2036, broadens the production around synthetic hypericin. Our
proprietary formulation of synthetic hypericin also has been granted a European patent for the treatment of psoriasis, EP
2571507, and complements the method of treatment claims covered by the previously issued U.S. patent 6001882,
Photoactivated hypericin and the use thereof. Further, on January  7, 2020, we also were granted a U.S. patent
(No. 10,526,268) titled “Systems and Methods for Producing Synthetic Hypericin”, which further expanded protection for the
composition of purified synthetic hypericin. This patent is also expected to expire in 2036. Patent protection is also pursued
worldwide with similar patents and expiry dates.
In addition to issued and pending patents, we also have “Orphan Drug” designations for HyBryte™ in the U.S. and the EU
for CTCL, as well as for RiVax® in the U.S. and EU. Our Orphan Drug designations provide for seven years of post-approval
marketing exclusivity in the U.S. and ten years exclusivity in Europe. We have pending patent applications for this indication
that, if granted, may extend our anticipated marketing exclusivity beyond the U.S. seven year or EU ten year post-approval
exclusivity provided by Orphan Drug legislation.
In 2013, we expanded our patent portfolio to include innate defense regulation through the acquisition of the novel drug
technology, known as SGX94. By binding to the pivotal regulatory protein p62, also known as sequestosome-1, SGX94
regulates the innate immune system to reduce inflammation, eliminate infection and enhance healing. As part of the
acquisition, we acquired all rights, including composition of matter patents for SGX94 as well as other analogs and crystal
structures of SGX94 with its protein target p62, including U.S. patent 8,124,721 (expiring 2028), 9,416,157 (expiring 2028)
and 8,791,061 (expiring 2029), both in the U.S. and abroad. SGX94 was developed pursuant to discoveries made by
Professors B. Brett Finlay and Robert Hancock of University of British Columbia (“UBC”). We also have rights to the
background technology patents (U.S. patent numbers 7,507,787 [expiring 2024], 7,687,454 [expiring 2026] and 11,311,598
[expiring 2034]). The U.S. Patent Office has also granted patents titled “Novel Peptides and Analogs for Use in the
Treatment of Oral Mucositis.” The issued patents (U.S. patent numbers 9,850.279 and 10,253,068, both expiring in 2034)
claim therapeutic use of dusquetide and related IDR analogs, and adds to composition of matter claims for dusquetide and
related analogs that have been granted in the U.S. and worldwide.
ThermoVax® is the subject of U.S. patents 8,444,991 (expiring February 2030) and 8,808,710 (expiring March 2028) both
issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active Adjuvant-Bound Dried Vaccine Composition”
and licensed to us by VitriVax, Inc. ThermoVax® is also U.S. patent application number 15/694.023 filed September 17,
2017 titled “Thermostable Vaccine Compositions and Methods of Preparing Same” and jointly invented by the UC and us.
The patent application and the corresponding foreign filings are pending or granted and they address the use of adjuvants in
conjunction with vaccines that are formulated to resist thermal inactivation. The license agreement covers thermostable
alum-adjuvanted vaccines for ricin toxin and Ebola virus. An additional patent, covering vaccine combinations such as ricin
toxin and anthrax, was filed in 2015 and granted on May 21, 2019 in the U.S. (No. 10,293,041, titled “Multivalent Stable
Vaccine Composition and Methods of Making Same”) and is expected to expire in 2035. A patent for unique, proprietary
compositions and methods directed to combinations of glycoprotein antigens with nano-emulsion adjuvants comprising
sucrose fatty acid esters prior to lyophilization was filed in 2020, granted in 2022 and expiring in 2040 (No. 11,433,129 titled
“Compositions and Methods of Manufacturing Trivalent Filovirus Vaccines.”) Patent protection is also pursued worldwide with
similar patents and expiry dates.
Additional vaccine thermostabilization patents specific for anti-viral vaccines, including filovirus and coronavirus have been
filed but are not yet granted. If granted, expiry dates would range from 2040 to 2041. Patent protection is also pursued
worldwide with similar patents and expiry dates.

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HyBryte™ License Agreement
In September 2014, we acquired a worldwide exclusive license agreement with New York University and Yeda Research and
Development Company Ltd. for the rights to a novel PDT that utilizes safe visible light for activation, which we refer to as
HyBryte™. To maintain this license, we are obligated to pay $25,000 in annual license fees. In addition, we will pay the
licensors: (a) a royalty amount equal to 3% of all net sales of HyBryte™ made directly by us and/or any affiliates; (b) a
royalty amount equal to 2.5% of all net sales of HyBryte™ made by our sublicensees, subject to stated maximums and
(c) 20% of all payments, not based on net sales, received by us from our sublicensees. This license may be terminated by
either party upon notice of a material breach by the other party that is not cured within the applicable cure period. The
exclusive license includes rights to several issued U.S. patents, including U.S. patent numbers 6,867,235 and 7,122,518,
among other domestic and foreign patent applications. U.S. Patent numbers 6,867,235 and 7,122,518 expired in
January 2020 and November 2023, respectively.
We acquired the license agreement for HyBryte™ and related intangible assets, including U.S. patent 8,629,302, properties
and rights pursuant to an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”). As consideration for the
assets acquired, we initially paid $275,000 in cash and issued 771 shares of common stock with a market value of
$3,750,000, and in March 2020 we issued 8,151 shares of common stock at a value of $5,000,000 (based upon an effective
per share price of $614.40) as a result of HyBryte™ demonstrating statistical significant treatment response in the Phase 3
clinical trial. Provided the final success-orientated milestone is attained, we will be required to make a payment of up to $5
million, if and when achieved, payable in our common stock.
SGX94 License Agreements
On December 18, 2012, we acquired a first in class drug technology, known as SGX94 (dusquetide), representing a novel
approach to modulation of the innate immune system. SGX94 is an IDR that regulates the innate immune system to reduce
inflammation, eliminate infection and enhance tissue healing by binding to the pivotal regulatory protein p62, also known as
sequestosome-1. As part of the acquisition, we acquired all rights, including composition of matter patents, preclinical and
Phase 1 clinical study datasets for SGX94. We also assumed a license agreement with UBC to advance the research and
development of the SGX94 technology. The license agreement with UBC provides us with exclusive worldwide rights to
manufacture, distribute, market sell and/or license or sublicense products derived or developed from this technology. Under
the license agreement we are obligated to pay UBC (i) an annual license maintenance fee of CAD $1,000, and (ii) milestone
payments which could reach up to CAD $1.2 million. This license agreement (a) will automatically terminate if we file, or
become subject to an involuntary filing, for bankruptcy, and (b) may be terminated by UBC in the event of, among other
things, our insolvency, dissolution, grant of a security interest in the technology licensed to us pursuant to the license
agreement, or material breach of or failure to perform material obligations under the license agreement or other research
agreements between us and UBC.
ThermoVax® License Agreement
On December 21, 2010, we executed a worldwide exclusive license agreement with the UC for ThermoVax®, which is the
subject of U.S. patent number 8,444,991 issued on May 21, 2013 titled “Method of Preparing an Immunologically-Active
Adjuvant-Bound Dried Vaccine Composition.” This patent and its corresponding foreign filings are licensed to us by the UC
and they address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation. U.S.
Patent 8,444,991 is expected to expire in December 2031. The license agreement also covers thermostable vaccines for
biodefense as well as other potential vaccine indications. In addition, we, in conjunction with UC, filed domestic and foreign
patent applications claiming priority back to a provisional application filed on May 17, 2011 titled: “Thermostable Vaccine
Compositions and Methods of Preparing Same.” In April  2018, the UC delivered a notice of termination of our license
agreement based upon our failure to achieve one of the development milestones: initiation of the Phase 1 clinical trial of the
heat stabilization technology by March  31, 2018. After negotiating with the UC, we and the UC agreed to extend the
termination date to October 31, 2018 in order to allow us time to agree upon a potential agreement that would allow us to
keep the rights to, and to continue to develop, the heat stabilization technology or a product candidate containing the heat
stabilization technology in our field of use.
On October  31, 2018, in a series of related transactions, (a)  we and the UC agreed to terminate the original license
agreement, (b) the UC and VitriVax executed a worldwide exclusive license agreement for the heat stabilization technology
for all fields of use, and (c) we and VitriVax executed a worldwide exclusive sublicense agreement, which was amended

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and restated in October 2020, for the heat stabilization technology for use in the fields of ricin and Ebola vaccines. We paid a
$100,000 sublicense fee on the effective date of the sublicense agreement. Under the amended sublicense agreement to
maintain the sublicense we are obliged to pay a minimum annual royalty of $20,000 until first commercial sale of a
sublicensed product, upon which point, we will be required to pay an earned royalty of 2% of net sales subject to a minimum
royalty of $50,000 each  year. We are also required to pay royalties on any sub-sublicense income based on a
declining percentage of all sub-sublicense income calculated within the contractual period until reaching a minimum of 15%
after two years. In addition, we are required to pay VitriVax milestone fees of: (a) $25,000 upon initiation of a Phase 2 clinical
trial of the sublicensed product, (b)  $100,000 upon initiation of a Phase 3 clinical trial of the sublicensed product,
(c) $100,000 upon regulatory approval of a sublicensed product, and (d) $1 million upon achieving $10 million in aggregate
net sales of a sublicensed product in the U.S. or equivalent. To date none of these milestones have been met.
RiVax® License Agreement
In June 2003, we executed a worldwide exclusive option to license patent applications with UTSW for the nasal, pulmonary
and oral uses of a non-toxic ricin vaccine. In June 2004, we entered into a license agreement with UTSW for the injectable
rights to the ricin vaccine and, in October 2004, we negotiated the remaining oral rights to the ricin vaccine. To maintain this
license, we are obligated to pay $50,000 in annual license fees. Through this license, we have rights to the issued patent
number 7,175,848 titled “Ricin A chain mutants lacking enzymatic activity as vaccines to protect against aerosolized ricin.”
This patent includes methods of use and composition claims for RiVax®.
CoVaccine HT™ License Agreement
In April 2020, we executed an agreement for the exclusive worldwide license of CoVaccine HT™, a novel vaccine adjuvant,
from BTG, a division of Boston Scientific Corporation (NYSE: BSX), for the fields of SARS-CoV-2, the cause of COVID-19
and pandemic flu. The agreement was executed with Protherics Medicines Development, one of the companies that make
up the BTG specialty pharmaceuticals business, which owns the CoVaccine HT™ intellectual property.
Research and Development Expenditures
We spent approximately $5.2 million and $3.3 million in the years ended December 31, 2024 and 2023, respectively, on
research and development. The amounts we spent on research and development per product during the years ended
December 31, 2024 and 2023 are set forth in “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in this Annual Report on Form 10-K.
Human Capital
We are committed to a work environment that is welcoming, inclusive and encouraging. To achieve our plans and goals, it is
imperative that we attract and retain top talent. In order to do so, we aim to have a safe and encouraging workplace, with
opportunities for our employees to grow and develop professionally, supported by strong compensation, benefits, and other
incentives. In addition to competitive base salaries, we offer every full-time employee a cash target bonus, a comprehensive
benefits package and equity compensation.
As of December 31, 2024, we employed a total of 16 persons, including 2 part-time employees and 14 full-time employees,
five of whom are MDs/PhDs. In addition to our employees, we contract with third-parties for the conduct of certain clinical
development, manufacturing, accounting and administrative activities. We anticipate increasing the number of our
employees. We have no collective bargaining agreements with our employees, and none are represented by labor unions.
We consider our relationships with our employees to be good.
Available Investor Information
We file electronically with the Securities and Exchange Commission (“SEC”) our annual reports on Form 10-K, quarterly
reports on Form  10-Q, current reports on Form  8-K, and amendments to those reports filed or furnished pursuant to
Section  13(a)  of 15(d)  of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We make available
through our website, free of charge, copies of these reports as soon as reasonably practicable after we electronically file or
furnish them to the SEC. Our website is located at www.soligenix.com. You can also request copies of such documents by
contacting the company at (609) 538-8200 or sending an email to info@soligenix.com.

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Item 1A. Risk factors
An investment in our securities involves a high degree of risk. You should carefully consider the following information about
these risks, together with the other information about these risks contained in this Annual Report, as well as the other
information contained in this Annual Report generally, before deciding to buy our securities. Any of the risks we describe
below could adversely affect our business, financial condition, operating results or prospects. The market prices for our
securities could decline if one or more of these risks and uncertainties develop into actual events and you could lose all or
part of your investment. Additional risks and uncertainties that we do not yet know of, or that we currently think are
immaterial, may also impair our business operations. You should also refer to the other information contained in this Annual
Report, including our financial statements and the related notes.
Summary of Risk Factors
Our business is subject to a number of risks and uncertainties that you should understand before making an investment
decision. These risks include, but are not limited to, the following:
Risks Related to our Business
●
We have had significant losses and anticipate future losses; if additional funding cannot be obtained, we may reduce
or discontinue our product development and commercialization efforts.
●
Our losses from operations, negative cash flows, and shareholders’ deficit as of December  31,  2024 raise
substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity
financings.
●
The report of our independent registered accounting firm on our audited financial statements for the fiscal year
ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern.
●
If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will
be significantly impaired.
●
We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which
may make it difficult to predict our future performance.
●
We have no approved products on the market and therefore do not expect to generate any revenues from product
sales in the foreseeable future, if at all.
●
Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us
to unanticipated delays.
●
There may be unforeseen challenges in developing our biodefense products.
●
We are dependent on government funding, which is inherently uncertain, for the success of our public health
business segment operations.
●
If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related
services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture
and market our products.
●
We rely on third parties for pre-clinical and clinical trials of our product candidates and, in some cases, to maintain
regulatory files for our product candidates. If we are not able to maintain or secure agreements with third parties for
pre-clinical and clinical trials of our product candidates on acceptable terms, if these third parties do not perform
their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us,
we may not be able to obtain regulatory approval for, or commercialize, our product candidates.

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●
The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers
encounter problems manufacturing our products, our business could suffer.
●
We may use our financial and human resources to pursue a particular research program or product candidate and
fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater
likelihood of success.
●
Even if approved, our products will be subject to extensive post-approval regulation.
●
Even if we obtain regulatory approval to market our product candidates, our product candidates may not be
accepted by the market.
●
We do not have extensive sales and marketing experience and our lack of experience may restrict our success in
commercializing some of our product candidates.
●
Our products, if approved, may not be commercially viable due to change in health care practice and third party
reimbursement limitations.
●
Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent
marketing approval, or, if approval is received, require them to be taken off the market, require them to include
safety warnings or otherwise limit their sales.
●
If we fail to obtain or maintain orphan drug exclusivity for our product candidates, our competitors may sell products
to treat the same conditions and our revenue will be reduced.
●
Federal and/or state health care reform initiatives could negatively affect our business.
●
We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the
third party relationships we need to develop, manufacture and market our products.
●
We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not
be sufficient.
●
We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or
disposal of these chemicals could affect us and be time consuming and costly.
●
We may not be able to compete with our larger and better-financed competitors in the biotechnology industry.
●
Competition and technological change may make our product candidates and technologies less attractive or
obsolete.
●
Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our
business.
●
Instability and volatility in the financial markets could have a negative impact on our business, financial condition,
results of operations, and cash flows.
●
Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults
or non-performance, could adversely affect our operations and liquidity.
●
Changes in U.S. and international trade policies may adversely impact our business and operating results.
●
We may not be able to utilize all of our net operating loss carryforwards.

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●
Global pathogens could have an impact on financial markets, materials sourcing, patients, governments and
population (e.g. COVID-19).
Risks Related to our Intellectual Property
●
We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be
liable for significant costs and damages if we face a claim of intellectual property infringement by a third party.
●
We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
●
If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and
defend against litigation.
Risks Related to Technology and Intellectual Property
●
Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails,
our business could be adversely affected.
●
A cybersecurity incident could negatively impact our business and our relationships with our employees, service
providers, patients, clinical study sites and government agencies.
Risks Related to our Securities
●
The price of our common stock may be highly volatile.
●
If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would
limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the
secondary market and negatively impact our ability to raise capital.
●
Shareholders may suffer substantial dilution related to issued stock warrants and options.
●
Our shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if
they need to sell shares to raise money or otherwise desire to liquidate their shares.
●
We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our
stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common
stock.
●
Upon our dissolution, our stockholders may not recoup all or any portion of their investment.
●
The issuance of our common stock pursuant to the terms of the asset purchase agreement with Hy Biopharma may
cause dilution and the issuance of such shares of common stock, or the perception that such issuances may occur,
could cause the price of our common stock to fall.
●
Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that
adversely affect holders of our common stock.
Risks Related to our Business
We have had significant losses and anticipate future losses; if additional funding cannot be obtained, we may
reduce or discontinue our product development and commercialization efforts.
We have experienced significant losses since inception and, at December  31,  2024, had an accumulated deficit of
approximately $234.0 million. We expect to incur additional operating losses in the future and expect our cumulative losses
to increase. As of December 31, 2024, we had approximately $7.8 million in cash and cash equivalents available, and as

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of March 14, 2025 we had approximately $7.7 million in cash and cash equivalents available. Without additional funding,
based on our projected budgetary needs and funding from existing contracts and grants over the next year, we expect to be
able to maintain the current level of our operations to the end of 2025.
In September 2014, we entered into a contract with the NIH for the development of RiVax® to protect against exposure to
ricin toxin that would provide up to $24.7 million of funding in the aggregate over six years if options to extend the contract
are exercised by the NIH. In 2017, we were awarded two separate grants from the NIH of approximately $1.5 million each to
support our pivotal Phase 3 trials of HyBryte™ for the treatment of CTCL and SGX942 for the treatment of oral mucositis in
head and neck cancer. In December 2020, we were awarded Direct to Phase II SBIR grant from NIAID of approximately
$1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and EVD
vaccine candidates in conjunction with the CoVaccine HT™ adjuvant. Our biodefense grants have an overhead component
that allows us an agency-approved  percentage over our incurred costs. We estimate that the overhead component
associated with our existing contracts and grants will fund some fixed costs for direct employees working on these contracts
and grants as well as other administrative costs. As of December 31, 2024, we had approximately $554,000 in awarded
grant funding available.
Our product candidates are positioned for or are currently in clinical trials, and we have not yet generated any significant
revenues from sales or licensing of these product candidates. From inception through December  31,  2024, we have
expended approximately $124 million developing our current product candidates for pre-clinical research and development
and clinical trials. We currently expect to spend approximately $6 million for the  year ending December  31, 2025 in
connection with the development of our therapeutic and vaccine products, licenses, employment agreements, and
consulting agreements, of which approximately $0.1 million is expected to be reimbursed through our existing government
grants.
We have no control over the resources and funding U.S. government agencies may devote to our programs, which may be
subject to periodic renewal and which generally may be terminated by the government at any time for convenience. Any
significant reductions in the funding of U.S. government agencies or in the funding areas targeted by our business could
materially and adversely affect our biodefense program and our results of operations and financial condition. If we fail to
satisfy our obligations under the government contracts, the applicable Federal Acquisition Regulations allow the government
to terminate the agreement in whole or in part, and we may be required to perform corrective actions, including but not
limited to delivering to the government any incomplete work. If U.S. government agencies do not exercise future funding
options under the contracts or grants, terminate the funding or fail to perform their responsibilities under the agreements or
grants, it could materially impact our biodefense program and our financial results.
Unless and until we are able to generate sales or licensing revenue from one of our product candidates, we will require
additional funding to meet these commitments, sustain our research and development efforts, provide for future clinical trials,
and continue our operations. There can be no assurance we can raise such funds. If additional funds are raised through the
issuance of equity securities, stockholders may experience dilution of their ownership interests, and the newly issued
securities may have rights superior to those of the common stock. If additional funds are raised by the issuance of debt, we
may be subject to limitations on our operations. If we cannot raise such additional funds, we may have to delay or stop some
or all of our drug development programs.
Our losses from operations, negative cash flows, and shareholders' deficit as of December  31,  2024 raise
substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity
financings.
We have concluded that substantial doubt exists about our ability to continue as a going concern for the 12 months following
the issuance of the financial statements included in this Annual Report on Form 10-K. As of  December 31, 2024, we had
cash and cash equivalents of approximately  $7.8  million and current liabilities of approximately  $4.8  million.  As of  the
issuance date of these financial statements, we believe that we have sufficient resources available to support our
development activities and business operations and timely satisfy our obligations as they come due into the fourth quarter of
2025. We do not have sufficient cash and cash equivalents as of the date of filing this Annual Report on Form 10-K to
support our operations for at least the 12 months following the issuance of the financial statements.

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To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include
securing:
●
additional capital, potentially through a combination of public or private equity offerings and strategic transactions,
including potential alliances and drug product collaborations;
●
additional proceeds from government contract and grant programs; and
●
additional proceeds from the sale of shares of our common stock via the At Market Issuance Sales Agreement
(“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”).
Other than the AGP Sales Agreement which was entered into on August 16, 2024, none of these alternatives are committed
at this time. There can be no assurance that we will be successful in obtaining sufficient funding on acceptable terms to fund
continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that we will
require, or achieve the other strategies to alleviate the conditions that raise substantial doubt about our ability to continue as
a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, we will not
have sufficient cash resources and liquidity to fund our business operations for at least the 12 months following the date the
financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require us to
delay, limit, or eliminate the development of business opportunities and our ability to achieve our business objectives and our
competitiveness, and our business, financial condition, and results of operations will be materially adversely affected. In
addition, market instability, including as a result of geopolitical instability, may reduce our ability to access capital, which
could negatively affect our liquidity and ability to continue as a going concern. In addition, the perception that we may not be
able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to
meet our contractual obligations.
 
The report of our independent registered accounting firm on our audited financial statements for the fiscal year
ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern.
 
The auditor’s opinion on our audited financial statements for the year ended December 31, 2024 includes an explanatory
paragraph stating that we have incurred recurring losses from operations that raise substantial doubt about our ability to
continue as a going concern. While we believe that we will be able to obtain the capital we need to continue our operations,
there can be no assurances that we will be successful in these efforts or will be able to resolve our liquidity issues or
eliminate our operating losses. If we are unable to obtain sufficient funding, we would need to significantly reduce our
operating plans and curtail some or all of our development efforts. Accordingly, our business, prospects, financial condition,
and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If
we seek additional financing to fund our business activities in the future and there remains substantial doubt about our ability
to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on
commercially reasonable terms or at all.
If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will
be significantly impaired.
In order to generate revenues and profits, our organization must, along with corporate partners and collaborators, positively
research, develop and commercialize our technologies or product candidates. Our current product candidates are in various
stages of clinical and pre-clinical development and will require significant further funding, research, development, pre-clinical
and/or clinical testing, regulatory approval and commercialization, and are subject to the risks of failure inherent in the
development of products based on innovative or novel technologies. Specifically, each of the following is possible with
respect to any of our product candidates:
●
we may not be able to maintain our current research and development schedules;
●
we may be unable to secure procurement contracts on beneficial economic terms or at all from the U.S. government
or others for our biodefense products;
●
we may encounter problems in clinical trials; or

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●
the technology or product may be found to be ineffective or unsafe, or may fail to obtain marketing approval.
If any of the risks set forth above occur, or if we are unable to obtain the necessary regulatory approvals as discussed below,
we may be unable to develop our technologies and product candidates and our business will be seriously harmed.
Furthermore, for reasons including those set forth below, we may be unable to commercialize or receive royalties from the
sale of any other technology we develop, even if it is shown to be effective, if:
●
it is not economical or the market for the product does not develop or diminishes;
●
we are not able to enter into arrangements or collaborations to manufacture and/or market the product;
●
the product is not eligible for third-party reimbursement from government or private insurers;
●
others hold proprietary rights that preclude us from commercializing the product;
●
we are not able to manufacture the product reliably;
●
others have brought to market similar or superior products; or
●
the product has undesirable or unintended side effects that prevent or limit its commercial use.
We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which
may make it difficult to predict our future performance.
We are a late-stage biopharmaceutical company. Our operations to date have been primarily limited to developing our
technology and undertaking pre-clinical studies and clinical trials of our product candidates in our two active business
segments, Specialized BioTherapeutics and Public Health Solutions. We have not yet obtained regulatory approvals for any
of our product candidates. Consequently, any predictions made about our future success or viability may not be as accurate
as they could be if we had commercialized products. Our financial condition has varied significantly in the past and will
continue to fluctuate from quarter-to-quarter or  year-to-year due to a variety of factors, many of which are beyond our
control. Factors relating to our business that may contribute to these fluctuations include other factors described elsewhere
in this Annual Report and also include:
●
our ability to obtain additional funding to develop our product candidates;
●
delays in the commencement, enrollment and timing of clinical trials;
●
the success of our product candidates through all phases of clinical development;
●
any delays in regulatory review and approval of product candidates in clinical development;
●
our ability to obtain and maintain regulatory approval for our product candidates in the U.S. and foreign jurisdictions;
●
potential side effects of our product candidates that could delay or prevent commercialization, limit the indications for
any approved drug, require the establishment of risk evaluation and mitigation strategies, or cause an approved
drug to be taken off the market;
●
our dependence on third-party contract manufacturing organizations to supply or manufacture our products;
●
our dependence on contract research organizations to conduct our clinical trials;
●
our ability to establish or maintain collaborations, licensing or other arrangements;
●
market acceptance of our product candidates;

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●
our ability to establish and maintain an effective sales and marketing infrastructure, either through the creation of a
commercial infrastructure or through strategic collaborations;
●
competition from existing products or new products that may emerge;
●
the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our products;
●
our ability to discover and develop additional product candidates;
●
our ability and our licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights
important to our business;
●
our ability to attract and retain key personnel to manage our business effectively;
●
our ability to build our finance infrastructure and improve our accounting systems and controls;
●
potential product liability claims;
●
potential liabilities associated with hazardous materials; and
●
our ability to obtain and maintain adequate insurance policies.
Accordingly, the results of any quarterly or annual periods should not be relied upon as indications of future operating
performance.
We have no approved products on the market and therefore do not expect to generate any revenues from product
sales in the foreseeable future, if at all.
To date, we have no approved product on the market and have not generated any significant product revenues. We have
funded our operations primarily from sales of our securities and from government contracts and grants. We have not
received, and do not expect to receive for at least the next several years, if at all, any revenues from the commercialization
of our product candidates. To obtain revenues from sales of our product candidates, we must succeed, either alone or with
third parties, in developing, obtaining regulatory approval for, manufacturing and marketing drugs with commercial potential
or successfully obtain government procurement or stockpiling agreements. We may never succeed in these activities, and
we may not generate sufficient revenues to continue our business operations or achieve profitability.
Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects
us to unanticipated delays.
Our business is subject to very stringent federal, foreign, state and local government laws and regulations, including the
Federal Food, Drug and Cosmetic Act, the Environmental Protection Act, the Occupational Safety and Health Act, and state
and local counterparts to these acts. These laws and regulations may be amended, additional laws and regulations may be
enacted, and the policies of the FDA and other regulatory agencies may change.
The regulatory process applicable to our products requires pre-clinical and clinical testing of any product to establish its
safety and efficacy. This testing can take many years, is uncertain as to outcome, and requires the expenditure of substantial
capital and other resources. We estimate that the clinical trials of our product candidates that we have planned will take at
least several years to complete. Furthermore, failure can occur at any stage of the trials, and we could encounter problems
that cause us to abandon or repeat clinical trials. Favorable results in early studies or trials, if any, may not be repeated in
later studies or trials. Even if our clinical trials are initiated and completed as planned, we cannot be certain that the results
will support our product candidate claims. Success in preclinical testing, Phase 1 and Phase 2 clinical trials does not ensure
that later Phase 2 or Phase 3 clinical trials will be successful. In addition, we, the FDA or other regulatory authorities may
suspend clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or the FDA or
other regulatory authorities find deficiencies in our submissions or conduct of our trials.

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We may not be able to obtain, or we may experience difficulties and delays in obtaining, necessary domestic and foreign
governmental clearances and approvals to market a product (for example, the FDA may not recognize fast track designation
upon an NDA submission, resulting in no priority review and subjecting us to longer potential review times than originally
anticipated). Also, even if regulatory approval of a product is granted, that approval may entail limitations on the indicated
uses for which the product may be marketed.
Following any regulatory approval, a marketed product and its manufacturer are subject to continual regulatory review. Later
discovery of problems with a product or manufacturer may result in restrictions on such product or manufacturer. These
restrictions may include product recalls and suspension or withdrawal of the marketing approval for the product.
Furthermore, the advertising, promotion and export, among other things, of a product are subject to extensive regulation by
governmental authorities in the U.S. and other countries. If we fail to comply with applicable regulatory requirements, we
may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating
restrictions and/or criminal prosecution.
There may be unforeseen challenges in developing our biodefense products.
For development of biodefense vaccines and therapeutics, the FDA has instituted policies that are expected to result in
accelerated approval. This includes approval for commercial use using the results of animal efficacy trials, rather than
efficacy trials in humans, referred to as the Animal Rule. However, we will still have to establish that the vaccines we are
developing are safe in humans at doses that are correlated with the beneficial effect in animals. Such clinical trials will also
have to be completed in distinct populations that are subject to the countermeasures; for instance, the very young and the
very old, and in pregnant women, if the countermeasure is to be licensed for civilian use. Other agencies will have an
influence over the risk benefit scenarios for deploying the countermeasures and in establishing the number of doses utilized
in the Strategic National Stockpile. We may not be able to sufficiently demonstrate the animal correlation to the satisfaction
of the FDA, as these correlates are difficult to establish and are often unclear. Invocation of the Animal Rule may raise
issues of confidence in the model systems even if the models have been validated. For many of the biological threats, the
animal models are not available and we may have to develop the animal models, a time-consuming research effort. There
are few historical precedents, or recent precedents, for the development of new countermeasures for bioterrorism agents.
Despite the Animal Rule, the FDA may require large clinical trials to establish safety and immunogenicity before licensure
and it may require safety and immunogenicity trials in additional populations. Approval of biodefense products may be
subject to post-marketing studies, and could be restricted in use in only certain populations. The government’s biodefense
priorities can change, which could adversely affect the commercial opportunity for the products we are developing. Further,
other countries have not, at this time, established criteria for review and approval of these types of products outside their
normal review process, i.e., there is no Animal Rule equivalent, and consequently there can be no assurance that we will be
able to make a submission for marketing approval in foreign countries based on such animal data.
Additionally, few facilities in the U.S. and internationally have the capability to test animals with ricin, or otherwise assist us in
qualifying the requisite animal models. We have to compete with other biodefense companies for access to this limited pool
of highly specialized resources. We therefore may not be able to secure contracts to conduct the testing in a predictable
timeframe or at all.
We are dependent on government funding, which is inherently uncertain, for the success of our biodefense
operations.
We are subject to risks specifically associated with operating in the biodefense industry, which is a new and unproven
business area. We do not anticipate that a significant commercial market will develop for our biodefense products. Because
we anticipate that the principal potential purchasers of these products, as well as potential sources of research and
development funds, will be the U.S. government and governmental agencies, the success of our biodefense division will be
dependent in large part upon government spending decisions. The funding of government programs is dependent on
budgetary limitations, congressional appropriations and administrative allotment of funds, all of which are inherently
uncertain and may be affected by changes in U.S. government policies resulting from various political and military
developments. Our receipt of government funding is also dependent on our ability to adhere to the terms and provisions of
the original grant and contract documents and other regulations. We can provide no assurance that we will receive or
continue to receive funding for grants and contracts we have been awarded. The loss of government funds could have a
material adverse effect on our ability to progress our biodefense business.

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If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related
services do not timely supply these products and services, it may delay or impair our ability to develop,
manufacture and market our products. We do not have or anticipate having internal manufacturing capabilities.
We rely on suppliers for our drug substance raw materials and third parties for certain manufacturing-related services to
produce material that meets appropriate content, quality and stability standards, which material will be used in clinical trials
of our products and, after approval, for commercial distribution. To succeed, clinical trials require adequate supplies of drug
substance and drug product, which may be difficult or uneconomical to procure or manufacture. We and our suppliers and
vendors may not be able to (i)  produce our drug substance or drug product to appropriate standards for use in clinical
studies, (ii) perform under any definitive manufacturing, supply or service agreements with us or (iii) remain in business for a
sufficient time to be able to develop, produce, secure regulatory approval of and market our product candidates. If we do not
maintain important manufacturing and service relationships, we may fail to find a replacement supplier or required vendor or
develop our own manufacturing capabilities which could delay or impair our ability to obtain regulatory approval for our
products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers and
vendors, we may not be able to enter into agreements with them on terms and conditions favorable to us and, there could be
a substantial delay before a new facility could be qualified and registered with the FDA and foreign regulatory authorities.
We rely on third parties for pre-clinical and clinical trials of our product candidates and, in some cases, to maintain
regulatory files for our product candidates. If we are not able to maintain or secure agreements with such third
parties on acceptable terms, if these third parties do not perform their services as required, or if these third parties
fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory
approval for, or commercialize, our product candidates.
We rely on academic institutions, hospitals, clinics and other third-party collaborators for preclinical and clinical trials of our
product candidates. Although we monitor, support, and/or oversee our pre-clinical and clinical trials, because we do not
conduct these trials ourselves, we have less control over the timing and cost of these studies and the ability to recruit trial
subjects than if we conducted these trials wholly by ourselves. If we are unable to maintain or enter into agreements with
these third parties on acceptable terms, or if any such engagement is terminated, we may be unable to enroll patients on a
timely basis or otherwise conduct our trials in the manner we anticipate. In addition, there is no guarantee that these third
parties will devote adequate time and resources to our studies or perform as required by a contract or in accordance with
regulatory requirements, including maintenance of clinical trial information regarding our product candidates. If these third
parties fail to meet expected deadlines, fail to timely transfer to us any regulatory information, fail to adhere to protocols or
fail to act in accordance with regulatory requirements or our agreements with them, or if they otherwise perform in a
substandard manner or in a way that compromises the quality or accuracy of their activities or the data they obtain, then
preclinical and/or clinical trials of our product candidates may be extended, delayed or terminated, or our data may be
rejected by the FDA or regulatory agencies.
The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers
encounter problems manufacturing our products, our business could suffer.
The FDA and foreign regulators require manufacturers to register manufacturing facilities. The FDA and foreign regulators
also inspect these facilities to confirm compliance with current Good Manufacturing Practice (“cGMP”) or similar
requirements that the FDA or foreign regulators establish. We, or our materials suppliers, may face manufacturing or quality
control problems causing product production and shipment delays or a situation where we or the supplier may not be able to
maintain compliance with the FDA’s cGMP requirements, or those of foreign regulators, necessary to continue
manufacturing our drug substance. Any failure to comply with cGMP requirements or other FDA or foreign regulatory
requirements could adversely affect our clinical research activities and our ability to market and develop our products.
We may use our financial and human resources to pursue a particular research program or product candidate and
fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater
likelihood of success.
Because we have limited financial and human resources, we are currently focusing on the regulatory approval of certain
product candidates. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other
indications 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 existing and future product

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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 strategic alliance, 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, or we may allocate
internal resources to a product candidate in an area in which it would have been more advantageous to enter into a
partnering arrangement.
Even if approved, our products will be subject to extensive post-approval regulation.
Once a product is approved, numerous post-approval requirements apply. Among other things, the holder of an approved
NDA is subject to periodic and other FDA monitoring and reporting obligations, including obligations to monitor and report
adverse events and instances of the failure of a product to meet the specifications in the NDA. Application holders must
submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product
labeling, or manufacturing process. Application holders must also submit advertising and other promotional material to the
FDA and report on ongoing clinical trials.
Depending on the circumstances, failure to meet these post-approval requirements can result in criminal prosecution, fines,
injunctions, recall or seizure of products, total or partial suspension of production, denial or withdrawal of pre-marketing
product approvals, or refusal to allow us to enter into supply contracts, including government contracts. In addition, even if
we comply with FDA and other requirements, new information regarding the safety or effectiveness of a product could lead
the FDA to modify or withdraw product approval.
Even if we obtain regulatory approval to market our product candidates, our product candidates may not be
accepted by the market.
Even if the FDA approves one or more of our product candidates, physicians and patients may not accept it or use it. Even if
physicians and patients would like to use our products, our products may not gain market acceptance among healthcare
payors such as managed care formularies, insurance companies or government programs such as Medicare or Medicaid.
Acceptance and use of our products will depend upon a number of factors including: perceptions by members of the health
care community, including physicians, about the safety and effectiveness of our drug product; cost-effectiveness of our
product relative to competing products; availability of reimbursement for our product from government or other healthcare
payers; and effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any.
The degree of market acceptance of any product that we develop will depend on a number of factors, including:
●
cost-effectiveness;
●
the safety and effectiveness of our products, including any significant potential side effects, as compared to
alternative products or treatment methods;
●
the timing of market entry as compared to competitive products;
●
the rate of adoption of our products by doctors and nurses;
●
product labeling or product insert required by the FDA for each of our products;
●
reimbursement policies of government and third-party payors;
●
effectiveness of our sales, marketing and distribution capabilities and the effectiveness of such capabilities of our
collaborative partners, if any; and
●
unfavorable publicity concerning our products or any similar products.
Our product candidates, if successfully developed, will compete with a number of products manufactured and marketed by
major pharmaceutical companies, biotechnology companies and manufacturers of generic drugs. Our products may also
compete with new products currently under development by others. Physicians, patients, third-party payors and the medical

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community may not accept and utilize any of our product candidates. If our products do not achieve market acceptance, we
will not be able to generate significant revenues or become profitable.
Because we expect sales of our current product candidates, if approved, to generate substantially all of our product
revenues for the foreseeable future, the failure of these products to find market acceptance would harm our business and
could require us to seek additional financing.
We do not have extensive sales and marketing experience and our lack of experience may restrict our success in
commercializing some of our product candidates.
We do not have extensive experience in marketing or selling pharmaceutical products whether in the U.S. or internationally.
To obtain the expertise necessary to successfully market and sell any of our products, the development of our own
commercial infrastructure and/or collaborative commercial arrangements and partnerships will be required. Our ability to
make that investment and also execute our current operating plan is dependent on numerous factors, including, the
performance of third party collaborators with whom we may contract.
Our products, if approved, may not be commercially viable due to change in health care practice and third party
reimbursement limitations.
Initiatives to reduce the federal deficit and to change health care delivery are increasing cost-containment efforts. We
anticipate that Congress, state legislatures and the private sector will continue to review and assess alternative benefits,
controls on health care spending through limitations on the growth of private health insurance premiums and Medicare and
Medicaid spending, price controls on pharmaceuticals, and other fundamental changes to the health care delivery system.
Any changes of this type could negatively impact the commercial viability of our products, if approved. Our ability to
successfully commercialize our product candidates, if they are approved, will depend in part on the extent to which
appropriate reimbursement codes and authorized cost reimbursement levels of these products and related treatment are
obtained from governmental authorities, private health insurers and other organizations, such as health maintenance
organizations. In the absence of national Medicare coverage determination, local contractors that administer the Medicare
program may make their own coverage decisions. Any of our product candidates, if approved and when commercially
available, may not be included within the then current Medicare coverage determination or the coverage determination of
state Medicaid programs, private insurance companies or other health care providers. In addition, third-party payers are
increasingly challenging the necessity and prices charged for medical products, treatments and services.
Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent
marketing approval, or, if approval is received, require them to be taken off the market, require them to include
safety warnings or otherwise limit their sales.
Serious adverse events or undesirable side effects from any of our product candidates could arise either during clinical
development or, if approved, after the approved product has been marketed. The results of future clinical trials may show
that our product candidates cause serious adverse events or undesirable side effects, which could interrupt, delay or halt
clinical trials, resulting in delay of, or failure to obtain, marketing approval from the FDA and other regulatory authorities.
If any of our product candidates cause serious adverse events or undesirable side effects:
●
regulatory authorities may impose a clinical hold which could result in substantial delays and adversely impact our
ability to continue development of the product;
●
regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field
alerts to physicians and pharmacies;
●
we may be required to change the way the product is administered, conduct additional clinical trials or change the
labeling of the product;
●
we may be required to implement a risk minimization action plan, which could result in substantial cost increases
and have a negative impact on our ability to commercialize the product;

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●
we may be required to limit the patients who can receive the product;
●
we may be subject to limitations on how we promote the product;
●
sales of the product may decrease significantly;
●
regulatory authorities may require us to take our approved product off the market;
●
we may be subject to litigation or product liability claims; and
●
our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the affected product or could
substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating
significant revenues from the sale of our products.
If we fail to obtain or maintain orphan drug exclusivity for our product candidates, our competitors may sell
products to treat the same conditions and our revenue will be reduced.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is intended to treat a rare disease or
condition, defined as a patient population of fewer than 200,000 in the U.S., or a patient population greater than 200,000 in
the U.S. where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the
U.S. In the EU, the EMA’s Committee for Orphan Medicinal Products grants orphan drug designation to promote the
development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically
debilitating condition affecting not more than five in 10,000 persons in the EU. Additionally, designation is granted for
products intended for the diagnosis, prevention, or treatment of a life-threatening, seriously debilitating or serious and
chronic condition when, without incentives, it is unlikely that sales of the drug in the EU would be sufficient to justify the
necessary investment in developing the drug or biological product or where there is no satisfactory method of diagnosis,
prevention, or treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the
condition.
In the U.S., orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards
clinical trial costs, tax advantages, and user-fee waivers. In addition, if a product receives the first FDA approval for the
indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may
not approve any other application to market the same drug for the same indication for a period of seven years, except in
limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the
manufacturer is unable to assure sufficient product quantity. In the EU, orphan drug designation entitles a party to financial
incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product
approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where
it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.
Even though we have orphan drug designation for HyBryte™ in the U.S. and Europe, and RiVax® in the U.S., we may not be
the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing
drugs or biologic products. Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not
effectively protect the product from competition because different drugs with different active moieties can be approved for the
same condition. Absent patent or other intellectual property protection, even after an orphan drug is approved, the FDA or
EMA may subsequently approve the same drug with the same active moiety for the same condition if the FDA or EMA
concludes that the later drug is safer, more effective, or makes a major contribution to patient care.
Federal and/or state health care reform initiatives could negatively affect our business.
The availability of reimbursement by governmental and other third-party payers affects the market for any pharmaceutical
product. These third-party payers continually attempt to contain or reduce the costs of healthcare. There have been a
number of legislative and regulatory proposals to change the healthcare system and further proposals are likely. Medicare’s
policies may decrease the market for our products. Significant uncertainty exists with respect to the reimbursement status of
newly approved healthcare products.

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Third-party payers are increasingly challenging the price and cost-effectiveness of medical products and services. Once
approved, we might not be able to sell our products profitably or recoup the value of our investment in product development
if reimbursement is unavailable or limited in scope, particularly for product candidates addressing small patient populations.
On July  15, 2008, the Medicare Improvements for Patients and Providers Act of 2008 became law with a number of
Medicare and Medicaid reforms to establish a bundled Medicare payment rate that includes services and drug/labs that were
separately billed at that time. Bundling initiatives that have been implemented in other healthcare settings have occasionally
resulted in lower utilization of services that had not previously been a part of the bundled payment.
In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.
The requirements governing drug pricing vary widely from country to country. We expect that there will continue to be a
number of U.S. federal and state proposals to implement governmental pricing controls. While we cannot predict whether
such legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect
on our business, financial condition and profitability.
We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the
third party relationships we need to develop, manufacture and market our products.
We currently rely on license agreements from New York University, Yeda Research and Development Company Ltd., the
University of Texas Southwestern Medical Center, the University of British Columbia, and George B. McDonald, MD as well
as sublicense agreement from VitriVax for the rights to commercialize key product candidates. We may not be able to retain
the rights granted under these agreements or negotiate additional agreements on reasonable terms, if at all. Our existing
license agreements impose, and we expect that future license agreements will impose, various diligence, milestone
payment, royalty, and other obligations on us. If we fail to comply with our obligations under these agreements, or we are
subject to a bankruptcy, we may be required to make certain payments to the licensor, we may lose the exclusivity of our
license, or the licensor may have the right to terminate the license, in which event we would not be able to develop or market
products covered by the license.
Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop
our drug candidates. See “Business – Patents and Other Proprietary Rights” for a description of our license agreements.
Licensing of intellectual property is of critical importance to our business and involves complex legal, business, and scientific
issues. Disputes may arise regarding intellectual property subject to a licensing agreement, 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 joint creation or use of intellectual property by our
licensors and us and our collaborators; and
●
the priority of invention of patented technology.
If disputes over intellectual property and other rights that we have licensed 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.
Additionally, the research resulting in certain of our licensed patent rights and technology was funded by the U.S.
government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology.
When new technologies are developed with government funding, the government generally obtains certain rights in any
resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial
purposes. The government can exercise its march-in rights if it determines that action is necessary because we fail to

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achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety
needs, to meet requirements of federal regulations or to give preference to U.S. industry. In addition, our rights in such
inventions may be subject to certain requirements to manufacture products embodying such inventions in the U.S. Any
exercise by the government of such rights could harm our competitive position, business, financial condition, results of
operations and prospects.
Furthermore, we currently have very limited product development capabilities and no manufacturing, marketing or sales
capabilities. For us to research, develop and test our product candidates, we need to contract or partner with outside
researchers, in most cases with or through those parties that did the original research and from whom we have licensed the
technologies. If products are successfully developed and approved for commercialization, then we will need to enter into
additional collaboration and other agreements with third parties to manufacture and market our products. We may not be
able to induce the third parties to enter into these agreements, and, even if we are able to do so, the terms of these
agreements may not be favorable to us. Our inability to enter into these agreements could delay or preclude the
development, manufacture and/or marketing of some of our product candidates or could significantly increase the costs of
doing so. In the future, we may grant to our development partners rights to license and commercialize pharmaceutical and
related products developed under the agreements with them, and these rights may limit our flexibility in considering
alternatives for the commercialization of these products. Furthermore, third-party manufacturers or suppliers may not be able
to meet our needs with respect to timing, quantity and quality for the products.
Additionally, if we do not enter into relationships with additional third parties for the marketing of our products, if and when
they are approved and ready for commercialization, we would have to build our own sales force or enter into
commercialization agreements with other companies. Development of an effective sales force in any part of the world would
require significant financial resources, time and expertise. We may not be able to obtain the financing necessary to establish
a sales force in a timely or cost effective manner, if at all, and any sales force we are able to establish may not be capable of
generating demand for our product candidates, if they are approved.
We may suffer product and other liability claims; we maintain only limited product liability insurance, which may
not be sufficient.
The clinical testing, manufacture and sale of our products involves an inherent risk that human subjects in clinical testing or
consumers of our products may suffer serious bodily injury or death due to side effects, allergic reactions or other
unintended negative reactions to our products. As a result, product and other liability claims may be brought against us. We
currently have clinical trial and product liability insurance with aggregate limits of liability of $10 million, which may not be
sufficient to cover our potential liabilities. Because liability insurance is expensive and difficult to obtain, we may not be able
to maintain existing insurance or obtain additional liability insurance on acceptable terms or with adequate coverage against
potential liabilities. Furthermore, if any claims are brought against us, even if we are fully covered by insurance, we may
suffer harm such as adverse publicity.
We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or
disposal of these chemicals could affect us and be time consuming and costly.
Our research and development processes and/or those of our third party contractors involve the controlled use of hazardous
materials and chemicals. These hazardous chemicals are reagents and solvents typically found in a chemistry laboratory.
Our operations also may produce hazardous waste products. Federal, state and local laws and regulations govern the use,
manufacture, storage, handling and disposal of hazardous materials. While we attempt to comply with all environmental laws
and regulations, including those relating to the outsourcing of the disposal of all hazardous chemicals and waste products,
we cannot eliminate the risk of contamination from or discharge of hazardous materials and any resultant injury. In the event
of such an accident, we could be held liable for any resulting damages and any liability could materially adversely affect our
business, financial condition and results of operations.
Compliance with environmental laws and regulations may be expensive. Current or future environmental regulations may
impair our research, development or production efforts. We might have to pay civil damages in the event of an improper or
unauthorized release of, or exposure of individuals to, hazardous materials. We are not insured against these environmental
risks. We may agree to indemnify our collaborators in some circumstances against damages and other liabilities arising out
of development activities or products produced in connection with these collaborations.

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In addition, the federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal
of hazardous or radioactive materials and waste products may require us to incur substantial compliance costs that could
materially adversely affect our business, financial condition and results of operations.
We may not be able to compete with our larger and better financed competitors in the biotechnology industry.
The biotechnology industry is intensely competitive, subject to rapid change and sensitive to new product introductions or
enhancements. Most of our existing competitors have greater financial resources, larger technical staffs, and larger research
budgets than we have, as well as greater experience in developing products and conducting clinical trials. Our competition is
particularly intense in the gastroenterology and transplant areas and is also intense in the therapeutic area of inflammatory
bowel diseases. We face intense competition in the biodefense area from various public and private companies and
universities as well as governmental agencies, such as the U.S. Army, which may have their own proprietary technologies
that may directly compete with our technologies. In addition, there may be other companies that are currently developing
competitive technologies and products or that may in the future develop technologies and products that are comparable or
superior to our technologies and products. We may not be able to compete with our existing and future competitors, which
could lead to the failure of our business.
Additionally, if a competitor receives FDA approval before we do for a drug that is similar to one of our product candidates,
FDA approval for our product candidate may be precluded or delayed due to periods of non-patent exclusivity and/or the
listing with the FDA by the competitor of patents covering its newly-approved drug product. Periods of non-patent exclusivity
for new versions of existing drugs such as our current product candidates can extend up to three and one-half years. See
“Business – The Drug Approval Process.”
These competitive factors could require us to conduct substantial new research and development activities to establish new
product targets, which would be costly and time consuming. These activities would adversely affect our ability to
commercialize products and achieve revenue and profits.
Competition and technological change may make our product candidates and technologies less attractive or
obsolete.
We compete with established pharmaceutical and biotechnology companies that are pursuing other forms of treatment for
the same indications we are pursuing and that have greater financial and other resources. Other companies may succeed in
developing products earlier than us, obtaining FDA approval for products more rapidly, or developing products that are more
effective than our product candidates. Research and development by others may render our technology or product
candidates obsolete or noncompetitive, or result in treatments or cures superior to any therapy we develop. We face
competition from companies that internally develop competing technology or acquire competing technology from universities
and other research institutions. As these companies develop their technologies, they may develop competitive positions that
may prevent, make futile, or limit our product commercialization efforts, which would result in a decrease in the revenue we
would be able to derive from the sale of any products.
There can be no assurance that any of our product candidates will be accepted by the marketplace as readily as these or
other competing treatments. Furthermore, if our competitors’ products are approved before ours, it could be more difficult for
us to obtain approval from the FDA. Even if our products are successfully developed and approved for use by all governing
regulatory bodies, there can be no assurance that physicians and patients will accept our product(s)  as a treatment of
choice.
Furthermore, the pharmaceutical research industry is diverse, complex, and rapidly changing. By its nature, the business
risks associated therewith are numerous and significant. The effects of competition, intellectual property disputes, market
acceptance, and FDA regulations preclude us from forecasting revenues or income with certainty or even confidence.
Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our
business.
We currently have 16 employees and we depend upon these employees, in particular Dr.  Christopher Schaber, our
President and Chief Executive Officer, to manage the day-to-day activities of our business. Because we have such limited
personnel, the loss of any of them or our inability to attract and retain other qualified employees in a timely manner would

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likely have a negative impact on our operations. We may be unable to effectively manage and operate our business, and our
business may suffer, if we lose the services of our employees.
Instability and volatility in the financial markets could have a negative impact on our business, financial condition,
results of operations, and cash flows.
During recent years, there has been substantial volatility in financial markets due at least in part to the uncertainty regarding
the global economic environment. In addition, there has been substantial uncertainty in the capital markets and access to
additional financing is uncertain. Moreover, customer spending habits may be adversely affected by current and future
economic conditions. These conditions could have an adverse effect on our industry and business, including our financial
condition, results of operations, and cash flows.
To the extent that we do not generate sufficient cash from operations, we may need to issue stock or incur indebtedness to
finance our plans for growth. Recent turmoil in the credit markets and the potential impact on the liquidity of major financial
institutions may have an adverse effect on our ability to fund our business strategy through borrowings, under either existing
or newly created instruments in the public or private markets on terms we believe to be reasonable, if at all.
Changes in U.S. and international trade policies may adversely impact our business and operating results.
The U.S. government has recently made statements and taken certain actions that may lead to potential changes to U.S.
and international trade policies, including imposing several rounds of tariffs and export control restrictions affecting certain
products manufactured in other countries. It is unknown whether and to what extent new tariffs, export controls, or other new
laws or regulations will be adopted, or the effect that any such actions would have on us or our business or industry.
Any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, may increase
the cost of manufacturing our product candidates, affect the demand for our drug products (if and once approved), the
competitive position of our product candidates, and import or export of raw materials and finished product candidate used in
our and our collaborators’ preclinical studies and clinical trials. If any new tariffs, export controls, legislation and/or
regulations are implemented, or if existing trade agreements are renegotiated, such changes could have an adverse effect
on our business, financial condition and results of operations.
Adverse developments affecting financial institutions 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 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 (“SVB”) was closed by the California
Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (the “FDIC”)
as receiver. Despite subsequent actions taken by the U.S. Department of the Treasury, the U.S. Federal Reserve and the
FDIC to ensure that all depositors of SVB had access to all of their cash deposits following the closure of SVB, uncertainty
and liquidity concerns in the broader financial services industry remain.
We maintain cash balances at a third-party financial institution in excess of the FDIC insurance limit. Our access to our cash
and cash equivalents in amounts adequate to finance our operations could be significantly impaired to the extent the
financial institution with which we maintain cash balances faces liquidity constraints or failures. Any material decline in 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 significant disruptions to our business, any of which could have material
adverse impacts on our operations and liquidity. There is no guarantee that the U.S. Department of Treasury, the U.S.
Federal Reserve and the FDIC 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.
We may not be able to utilize all of our net operating loss carryforwards.
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology
companies to sell unused net operating loss (“NOL”) carryforwards to other New Jersey-based corporate taxpayers. We sold
2023, 2022 and 2021 New Jersey NOL carryforwards, resulting in the recognition of $409,114 and $1,767,803 of income tax
benefit, net of transaction costs during the years ended December 31, 2024 and 2023, respectively. We have

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not yet sold our 2024 New Jersey NOL carryforwards but may do so in the future. If there is an unfavorable change in the
State of New Jersey’s Technology Business Tax Certificate Program (whether as a result of a change in law, policy or
otherwise) that terminates the program or eliminates or reduces our ability to use or sell our NOL carryforwards or if we are
unable to find a suitable buyer to utilize our New Jersey NOL carryforwards to the extent the NOLs expire before we are able
to utilize them against our taxable income, our cash taxes may increase which may have an adverse effect on our financial
condition.
Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and
population (e.g. COVID-19).
Global pathogens (e.g., SARS-CoV-2, the pathogen responsible for COVID-19) could cause an impact on financial markets
and therefore repercussions to our operating business, including but not limited to, the sourcing of materials for our product
candidates, manufacture of supplies for our preclinical and/or clinical studies, delays in clinical operations, which may
include the availability or the continued availability of patients for our trials due to such things as quarantines, our conduct of
patient monitoring and clinical trial data retrieval at investigational study sites.
The impacts of outbreaks are highly uncertain and cannot be predicted, and we cannot provide any assurance that any
outbreak will not have a material adverse impact on our operations or future results or filings with regulatory health
authorities. The extent of the impact to us, if any, will depend on future developments, including actions taken to contain the
pathogen.
Risks Related to our Intellectual Property
We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be
liable for significant costs and damages if we face a claim of intellectual property infringement by a third party.
Our near and long-term prospects depend in part on our ability to obtain and maintain patents, protect trade secrets and
operate without infringing upon the proprietary rights of others. In the absence of patent and trade secret protection,
competitors may adversely affect our business by independently developing and marketing substantially equivalent or
superior products and technology, possibly at lower prices. We could also incur substantial costs in litigation and suffer
diversion of attention of technical and management personnel if we are required to defend ourselves in intellectual property
infringement suits brought by third parties, with or without merit, or if we are required to initiate litigation against others to
protect or assert our intellectual property rights. Moreover, any such litigation may not be resolved in our favor.
Although we and our licensors have filed various patent applications covering the uses of our product candidates, patents
may not be issued from the patent applications already filed or from applications that we might file in the future. Moreover,
the patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions, and
has been the subject of much litigation. Any patents we own or license, now or in the future, may be challenged, invalidated
or circumvented. To date, no consistent policy has been developed in the U.S. Patent and Trademark Office (the “PTO”)
regarding the breadth of claims allowed in biotechnology patents.
In addition, because patent applications in the U.S. are maintained in secrecy until patent applications publish or patents
issue, and because publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we
cannot be certain that we and our licensors are the first creators of inventions covered by any licensed patent applications or
patents or that we or they are the first to file. The PTO may commence interference proceedings involving patents or patent
applications, in which the question of first inventorship is contested. Accordingly, the patents owned or licensed to us may
not be valid or may not afford us protection against competitors with similar technology, and the patent applications licensed
to us may not result in the issuance of patents.
It is also possible that our owned and licensed technologies may infringe on patents or other rights owned by others, and
licenses to which may not be available to us. We may be unable to obtain a license under such patent on terms favorable to
us, if at all. We may have to alter our products or processes, pay licensing fees or cease activities altogether because of
patent rights of third parties.
In addition to the products for which we have patents or have filed patent applications, we rely upon unpatented proprietary
technology and may not be able to meaningfully protect our rights with regard to that unpatented proprietary technology.
Furthermore, to the extent that consultants, key employees or other third parties apply technological information developed

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by them or by others to any of our proposed projects, disputes may arise as to the proprietary rights to this information,
which may not be resolved in our favor.
We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
The pharmaceutical industry has been characterized by extensive litigation regarding patents and other intellectual property
rights, and companies have employed intellectual property litigation to gain a competitive advantage. We may become
subject to infringement claims or litigation arising out of patents and pending applications of our competitors, or additional
interference proceedings declared by the PTO to determine the priority of inventions. The defense and prosecution of
intellectual property suits, PTO proceedings, and related legal and administrative proceedings are costly and time-
consuming to pursue, and their outcome is uncertain. 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. An
adverse determination in litigation or interference proceedings to which we may become a party could subject us to
significant liabilities, require us to obtain licenses from third parties, or restrict or prevent us from selling our products in
certain markets. Although patent and intellectual property disputes might be settled through licensing or similar
arrangements, the costs associated with such arrangements may be substantial and could include our paying large fixed
payments and ongoing royalties. Furthermore, the necessary licenses may not be available on satisfactory terms or at all.
Competitors may infringe our patents, and we may file infringement claims to counter infringement or unauthorized use. This
can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a
court may decide that a patent of ours is not valid or is unenforceable or may refuse to stop the other party from using the
technology at issue on the grounds that our patents do not cover its technology. An adverse determination of any litigation or
defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly.
Also, a third party may assert that our patents are invalid and/or unenforceable. There are no unresolved communications,
allegations, complaints or threats of litigation related to the possibility that our patents are invalid or unenforceable. Any
litigation or claims against us, whether or not merited, may result in substantial costs, place a significant strain on our
financial resources, divert the attention of management and harm our reputation. An adverse decision in litigation could
result in inadequate protection for our product candidates and/or reduce the value of any license agreements we have with
third parties.
Interference proceedings brought before the PTO may be necessary to determine priority of invention with respect to our
patents or patent applications. During an interference proceeding, it may be determined that we do not have priority of
invention for one or more aspects in our patents or patent applications and could result in the invalidation in part or whole of
a patent or could put a patent application at risk of not issuing. Even if successful, an interference proceeding may result in
substantial costs and distraction to our management.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or
interference proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In
addition, there could be public announcements of the results of hearings, motions or other interim proceedings or
developments. If investors perceive these results to be negative, the price of our common stock could be adversely affected.
If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and
defend against litigation.
If our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur
substantial costs and we may have to: obtain licenses, which may not be available on commercially reasonable terms, if at
all; abandon an infringing product candidate; redesign our products or processes to avoid infringement; stop using the
subject matter claimed in the patents held by others; pay damages; and/or defend litigation or administrative proceedings
which may be costly whether we win or lose, and which could result in a substantial diversion of our financial and
management resources.
Risks Related to Technology and Intellectual Property
Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails,
our business could be adversely affected.

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Our operations are increasingly dependent on technology. Our information technology systems are critical to our ability to
develop our products and otherwise operating our business. Problems with the operation of the information or
communication technology systems we use could adversely affect, or temporarily disable, all or a portion of our operations.
Further, any systems failures could impede our ability to timely collect and report financial results in accordance with
applicable laws.
A cybersecurity incident could negatively impact our business and our relationships with our employees, service
providers, patients, clinical study sites and government agencies.
We use information technology and operational technology assets, including computer and information networks, in
substantially all aspects of our business operations. We also use mobile devices, social networking and other online
activities to connect with our employees, service providers, patients, clinical study sites and government agencies. Such
uses give rise to cybersecurity risks, including security breach, espionage, system disruption, theft and inadvertent release
of information. Our business involves the storage and transmission of numerous classes of sensitive and/or confidential
information and intellectual property, including clinical trial participants’ personal information, private information about
employees and financial and strategic information about us and our business partners. If we fail to assess and identify
cybersecurity threats, we may become increasingly vulnerable to such threats. Additionally, while we have implemented
measures to prevent security breaches and cyber incidents, our preventive measures and incident response efforts may not
be entirely effective. Also, the regulatory environment surrounding information security and privacy is increasingly
demanding, with the frequent imposition of new and constantly changing requirements. This changing regulatory landscape
may cause increasingly complex compliance challenges, which may increase our compliance costs. Any failure to comply
with these changing security and privacy laws and regulations could result in significant penalties, fines, legal challenges
and reputational harm. The theft, destruction, loss, misappropriation, or release of sensitive and/or confidential information or
intellectual property, or interference with our information technology systems or the technology systems of third parties on
which we rely, could result in business disruption, negative publicity, brand damage, violation of privacy laws, loss of
confidence, potential liability and competitive disadvantage.
Risks Related to our Securities
The price of our common stock may be highly volatile.
The market price of our securities, like that of many other research and development public pharmaceutical and
biotechnology companies, has been highly volatile and the price of our common stock may be volatile in the future due to a
wide variety of factors, including:
●
announcements by us or others of results of pre-clinical testing and clinical trials;
●
announcements of technological innovations, more important bio-threats or new commercial therapeutic products by
us, our collaborative partners or our present or potential competitors;
●
failure of our common stock to continue to be listed or quoted on a national exchange or market system, such as
Nasdaq or the New York Stock Exchange;
●
our quarterly operating results and performance;
●
developments or disputes concerning patents or other proprietary rights;
●
mergers or acquisitions;
●
litigation and government proceedings;
●
adverse legislation;
●
changes in government regulations;

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●
our available working capital;
●
economic and other external factors; and
●
general market conditions.
Since January 1, 2024, the closing stock price of our common stock has fluctuated between a high of $15.03 per share to a
low of $2.00 per share. On March 14, 2025, the last reported sale price of our common stock on The Nasdaq Capital Market
was $2.30 per share. The fluctuation in the price of our common stock has sometimes been unrelated or disproportionate to
our operating performance. In addition, potential dilutive effects of future sales of shares of common stock and warrants by
us, as well as potential sale of common stock by the holders of warrants and options, could have an adverse effect on the
market price of our shares.
If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which
would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities
in the secondary market and negatively impact our ability to raise capital.
Companies trading on Nasdaq, such as our company, must be reporting issuers under Section 12 of the Exchange Act, and
must meet the listing requirements in order to maintain the listing of common stock on The Nasdaq Capital Market. If we do
not meet these requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability
of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.
If our common stock is delisted from Nasdaq, it will have material negative impact on the actual and potential liquidity of our
securities, as well as material negative impact on our ability to raise future capital. If, for any reason, Nasdaq should delist
our common stock from trading on its exchange and we are unable to obtain listing on another national securities exchange
or take action to restore our compliance with the Nasdaq continued listing requirements, a reduction in some or all of the
following may occur, each of which could have a material adverse effect on our shareholders:
●
the liquidity of our common stock;
●
the market price of our common stock;
●
our ability to obtain financing for the continuation of our operations;
●
the number of institutional and general investors that will consider investing in our securities;
●
the number of market makers in our common stock;
●
the availability of information concerning the trading prices and volume of our common stock; and
●
the number of broker-dealers willing to execute trades in shares of our common stock.
Shareholders may suffer substantial dilution related to issued common stock warrants, and options.
As of March 14, 2025, we had a number of agreements or obligations that may result in dilution to investors. These include:
●
common stock warrants to purchase a total of approximately 1,467,581 shares of our common stock at a current
weighted average exercise price of $11.01;
●
options to purchase approximately 72,985 shares of our common stock at a current weighted average exercise price
of $59.19; and
●
5,770,122 shares of common stock available for future issuance under our 2015 Equity Incentive Plan.

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We also have an incentive compensation plan for our management, employees and consultants. We have granted, and
expect to grant in the future, options to purchase shares of our common stock to our directors, employees and consultants.
To the extent that pre-funded warrants, common stock warrants, or options are exercised, our stockholders will experience
dilution and our stock price may decrease.
Additionally, the sale, or even the possibility of the sale, of the shares of common stock underlying these pre-funded
warrants, common stock warrants, and options could have an adverse effect on the market price for our securities or on our
ability to obtain future financing.
Our shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all
if they need to sell shares to raise money or otherwise desire to liquidate their shares.
Our common stock has from time to time been “thinly-traded,” meaning that the number of persons interested in purchasing
our common stock at or near ask prices at any given time may be relatively small or non-existent. This situation is
attributable to a number of factors, including the fact that we are a small company that is relatively unknown to stock
analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales
volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to
follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we
become more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity
in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading
activity that will generally support continuous sales without an adverse effect on share price. We cannot give stockholders
any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or
that current trading levels will be sustained.
We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our
stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common
stock.
We have never declared or paid cash dividends on our common stock and do not anticipate paying any cash dividends to
holders of our common stock in the foreseeable future. Consequently, our stockholders must rely on sales of their common
stock after price appreciation, which may never occur, as the only way to realize any future gains on their investments. There
is no guarantee that shares of our common stock will appreciate in value or even maintain the price at which our
stockholders have purchased their shares.
Upon our dissolution, our stockholders may not recoup all or any portion of their investment.
In the event of our liquidation, dissolution or winding-up, whether voluntary or involuntary, the proceeds and/or our assets
remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be distributed to the
holders of common stock on a pro rata basis. There can be no assurance that we will have available assets to pay to the
holders of common stock, or any amounts, upon such a liquidation, dissolution or winding-up. In this event, our stockholders
could lose some or all of their investment.
The issuance of our common stock pursuant to the terms of the asset purchase agreement with Hy Biopharma Inc.
may cause dilution and the issuance of such shares of common stock, or the perception that such issuances may
occur, could cause the price of our common stock to fall.
On April 1, 2014, we entered into an option agreement pursuant to which Hy Biopharma granted us an option to purchase
certain assets, properties and rights (the “Hypericin Assets”) related to the development of Hy Biopharma’s synthetic
hypericin product candidate for the treatment of CTCL, which we refer to as HyBryte™, from Hy Biopharma. In exchange for
the option, we paid $50,000 in cash and issued 18 shares of common stock in the aggregate to Hy Biopharma and its
assignees. We subsequently exercised the option, and on September  3, 2014, we entered into an asset purchase
agreement (the “Asset Purchase Agreement”) with Hy Biopharma, pursuant to which we purchased the Hypericin Assets.
Pursuant to the Asset Purchase Agreement, we initially paid $275,000 in cash and issued 771 shares of common stock in
the aggregate to Hy Biopharma and its assignees, and the licensors of the license agreement acquired from Hy Biopharma.
Also, on September 3, 2014, we entered into a Registration Rights Agreement with Hy Biopharma, pursuant to which we
may be required to file a registration statement with the SEC. In March 2020, we issued 8,151 shares of common stock at a
value of $5,000,000 (based upon an effective per share price of $614.40 as a result of HyBryte™ demonstrating

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statistically significant treatment response in the Phase 3 clinical trial. We will be required to issue up to $5.0 million worth of
our common stock (subject to a cap equal to 19.9% of our issued and outstanding common stock) in the aggregate, if
HyBryte™ is approved for the treatment of CTCL by either the FDA or the EMA.
The number of shares that we may issue under the Asset Purchase Agreement will fluctuate based on the market price of
our common stock. Depending on market liquidity at the time, the issuance of such shares may cause the trading price of
our common stock to fall.
We may ultimately issue all, some or none of the additional shares of our common stock that may be issued pursuant to the
Asset Purchase Agreement. We are required to register any shares issued pursuant to the purchase agreement for resale
under the Securities Act of 1933, as amended (the “Securities Act”). After any such shares are registered, the holders will be
able to sell all, some or none of those shares. Therefore, issuances by us under the purchase agreement could result in
substantial dilution to the interests of other holders of our common stock. Additionally, the issuance of a substantial number
of shares of our common stock pursuant to the Asset Purchase Agreement, or the anticipation of such issuances, could
make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might
otherwise wish to effect sales.
Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that
adversely affect holders of our common stock.
Under our Certificate of Incorporation, our Board of Directors is authorized to issue up to 350,000 shares of preferred stock,
of which none are issued and outstanding as of the date of this prospectus. Also, our Board of Directors, without stockholder
approval, may determine the price, rights, preferences, privileges and restrictions, including voting rights, of those shares. If
our Board of Directors causes shares of preferred stock to be issued, the rights of the holders of our common stock would
likely be subordinate to those of preferred holders and therefore could be adversely affected. Our Board of Directors’ ability
to determine the terms of preferred stock and to cause its issuance, while providing desirable flexibility in connection with
possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to
acquire a majority of our outstanding common stock. Preferred shares issued by our Board of Directors could include voting
rights or super voting rights, which could shift the ability to control our company to the holders of the preferred stock.
Preferred stock could also have conversion rights into shares of our common stock at a discount to the market price of our
common stock, which could negatively affect the market for our common stock. In addition, preferred stock would have
preference in the event of liquidation of our company, which means that the holders of preferred stock would be entitled to
receive the net assets of our company distributed in liquidation before the holders of our common stock receive any
distribution of the liquidated assets.
Item 1B. Unresolved Staff Comments
None.
Item 1C. Cybersecurity
Cybersecurity Risk Management and Strategy
Our technology and cybersecurity programs are crucial to maintaining secure operations, which enable us to deliver on our
promise to maintain stakeholder trust. Our Chief Financial Officer (“CFO”) is responsible for establishing, implementing and
executing our cybersecurity program and strategy. Our CFO has over nine years of information technology, information
technology audit, and cybersecurity experience, and is involved in following the latest developments in cybersecurity,
including potential threats and innovative risk management techniques.
Our cybersecurity program is a critical component of our enterprise risk management process overseen by our Board of
Directors, and we have integrated cybersecurity-related risks into our overall enterprise risk management framework.
Additionally, cybersecurity-related risks are included in the risk universe that the risk management function evaluates to
assess top risks to the enterprise on an annual basis.
Our personnel responsible for cybersecurity proactively identifies, manages, and mitigates cyber risk in a variety of ways,
including but not limited to:

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a.
cyber incident response, IT disaster recovery, and business continuity plans;
b.
cybersecurity assessments and remediation planning as part of our due diligence process; and
c.
identity and access management controls.
A primary element of our cybersecurity program is the implementation of controls that are aligned with industry guidelines
and applicable regulations to identify threats, deter attacks, and protect our information security assets. We do not engage
third parties in connection with our cybersecurity program.
Cybersecurity Governance
Our Board of Directors oversees the management of our cybersecurity risk exposures and the steps management has taken
to monitor and control such exposures. Annually, the Board of Directors receives an update from our CFO and other
members of management on relevant topics, including cybersecurity program maturity progress, new capabilities
implemented, and notable incidents or events should they occur. In accordance with our cybersecurity incident response
plan, our Board of Directors is promptly informed of potentially material cybersecurity incidents, including with respect to our
third-party service providers.
Although we have experienced cybersecurity incidents from time to time that have not had a material adverse effect on our
business, financial condition, or results of operations, there can be no assurance that a cyber-attack, security breach, or
other cybersecurity incident will not have a material adverse effect on us in the future. For a discussion regarding risks from
cybersecurity threats that have or are reasonably likely to affect us, see our risk factors, including the risk factors titled “Our
strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business
could be adversely affected.” and “A cybersecurity incident could negatively impact our business and our relationships with
employees, service providers, patients, clinical study sites and government agencies.” in Item 1A of this Annual Report on
Form 10-K.
Item 2. Properties
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite  B-10 in Princeton, New
Jersey pursuant to a lease which expires in October 2025. This office space currently serves as our corporate headquarters,
and both of our business segments (Specialized BioTherapeutics and Public Health Solutions), operate from this space. The
current rent is approximately $11,625 per month. Our office space is sufficient for our current needs. We may add new space
or expand existing space as we add employees, and we believe that suitable additional or substitute space will be available
as needed to accommodate any such expansion of our operations.
Item 3. Legal Proceedings
None.

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53
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Our common stock is traded on The Nasdaq Capital Market under the symbol “SNGX.” The following table sets forth the
high and low sales prices per share of our common stock for the periods indicated, as reported by The Nasdaq Capital
Market.
    
Price Range
Period
    
High
    
Low
Year Ended December 31, 2023:
 
   
  
First Quarter
$
 129.57
$
 28.00
Second Quarter
$
 67.20
$
 10.26
Third Quarter
$
 11.86
$
 6.73
Fourth Quarter
$
 32.00
$
 6.08
Year Ended December 31, 2024:
 
  
 
  
First Quarter
$
 19.20
$
 8.89
Second Quarter
$
 14.92
$
 2.50
Third Quarter
$
 14.83
$
 1.83
Fourth Quarter
$
 4.87
$
 2.65
Our stock is listed on The Nasdaq Capital Market under the symbol “SNGX.” The Nasdaq Capital Market prices set forth
above represent inter-dealer quotations, without adjustment for retail mark-up, mark-down or commission, and may not
represent the prices of actual transactions. On March 14, 2025, the last reported price of our common stock quoted on The
Nasdaq Capital Market was $2.30 per share.
Unregistered Sales of Equity Securities
Other than as previously reported, we did not issue any unregistered shares during the year ended December 31, 2024. We
issued a total of 9,139 shares of common stock to two lenders upon conversion of approximately $100,000 of principal under
promissory notes at a conversion price of $10.88 on January 3, 2024. We issued a total of 27,651 shares of common stock
to two lenders upon conversion of approximately $155,000 of principal under promissory notes at a conversion price of
$5.60 on April 15, 2024.
The issuance of common stock as described above was exempt under Section 4(a)(2) of the Securities Act of 1933, as
amended. The recipients are knowledgeable, sophisticated and experienced in making investment decisions of this kind and
received adequate information about us or had adequate access to information about us.
Transfer Agent
Shares of our common stock are issued in registered form. Equiniti Trust Company, LLC, 6201 15th Avenue, Brooklyn, NY
11219 (Telephone: (718) 921-8200; Facsimile: (718) 765-8719) is the registrar and transfer agent for shares of our common
stock.
Holders of Common Stock
As of March 14, 2025, there were 186 holders of record of our common stock. As of such date, 3,155,603 shares of our
common stock were issued and outstanding.
Dividends
We have never declared nor paid any cash dividends, and currently intend to retain all our cash and any earnings for use in
our business and, therefore, do not anticipate paying any cash dividends in the foreseeable future. Any future determination
to pay cash dividends will be at the discretion of the Board of Directors and will be dependent upon our consolidated
financial condition, results of operations, capital requirements and such other factors as the Board of Directors deems
relevant.

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54
Item 6. Selected Financial Data
Not applicable.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Our Business Overview
We are a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases
where there is an unmet medical need. We maintain two active business segments: Specialized BioTherapeutics and Public
Health Solutions.
Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of
HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy, utilizing
topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With
successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study and agreement
from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled
study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early stage disease, we began
patient 
enrollment 
during 
December 
2024 
for 
the 
second 
Phase 
3 
study 
called 
“FLASH2”
(Fluorescent  Light  Activated  Synthetic  Hypericin 2). We anticipate top-line results in the second half of 2026. Upon
successful completion of the Phase 3 FLASH2 study, regulatory approval will be sought to support potential
commercialization worldwide.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and
our first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945), for the treatment of
inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate
and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease and our vaccine programs
targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19
(caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with
government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Biomedical
Advanced Research and Development Authority and the Defense Threat Reduction Agency.
An outline of our business strategy follows:
●
Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-
controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3
FLASH study, continue enrollment and execution of the FLASH2 study, while at the same time, continuing
discussions with the U.S. Food and Drug Administration (“FDA”) on potential modifications to the development path
to adequately address their feedback.
●
Expand development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a
Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a
small Phase 1/2 pilot study in mild-to-moderate psoriasis patients.
●
Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency
(“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment of oral mucositis would be
required to support a marketing authorization, design a second study and attempt to identify a potential partner(s) to
continue this development program.
●
Expand development of dusquetide under the research name SGX945 into Behçet’s Disease by conducting a
Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in
aphthous ulcers induced by chemotherapy and radiation.

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55
●
Continue development of our heat stabilization platform technology, ThermoVax®, in combination with programs for
RiVax® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent
combinations), with United States (“U.S.”) government and non-governmental organization funding support.
●
Continue to apply for and secure additional government funding for each of our Specialized BioTherapeutics and
Public Health Solutions programs through grants, contracts and/or procurements.
●
Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives,
including but not limited to merger/acquisition strategies.
●
Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with
existing pipeline compounds for development.
Corporate Information
We were incorporated in Delaware in 1987 under the name Biological Therapeutics, Inc. In 1987, we merged with Biological
Therapeutics, Inc., a North Dakota corporation, pursuant to which we changed our name to “Immunotherapeutics, Inc.” We
changed our name to “Endorex Corp.” in 1996, to “Endorex Corporation” in 1998, to “DOR BioPharma, Inc.” in 2001, and
finally to “Soligenix, Inc.” in 2009. Our principal executive offices are located at 29 Emmons Drive, Suite B-10, Princeton,
New Jersey 08540 and our telephone number is (609) 538-8200.
Our Product Candidates in Development
The following tables summarize our product candidates under development:
Specialized BioTherapeutics Product Candidates
Soligenix Product Candidate
    
Therapeutic Indication
    
Stage of Development
HyBryte™
Cutaneous T-Cell Lymphoma
Phase 2 trial completed; demonstrated
significantly higher response rate compared
to placebo; Phase 3 trial completed;
demonstrated 
statistical 
significance 
in
primary endpoint in March 2020 (Cycle 1)
and demonstrated continued improvement
in 
treatment 
response 
with 
extended
treatment in April 2020 (Cycle 2) and
October 
2020 
(Cycle 
3); 
new 
drug
application 
(“NDA’) 
submitted 
to 
FDA
December 2022; FDA refusal to file (“RTF”)
letter received February 2023; second
Phase 3 trial based upon EMA-accepted
protocol 
began 
patient 
enrollment 
in
December 
2024 
with 
top-line 
results
anticipated in the second half of 2026;
discussions continue with FDA on modifying
the 
development 
path 
to 
adequately
address FDA’s preference for a longer
duration comparative study over a placebo-
controlled trial
SGX302
Mild-to-Moderate Psoriasis
Positive proof-of-concept demonstrated in a
small Phase 1/2 pilot study; Phase 2a
protocol and Investigation New Drug (“IND”)
clearance received from the FDA; Phase 2a
study 
remains 
ongoing 
having
demonstrated biological effect in Cohort 1
and clinically meaningful benefit in Cohort 2

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56
Soligenix Product Candidate
    
Therapeutic Indication
    
Stage of Development
SGX942†
Oral Mucositis in Head and Neck Cancer
Phase 2 trial completed; demonstrated
significant response compared to placebo
with positive long-term (12 month) safety
also reported; Phase 3 clinical trial results
announced December 2020: The primary
endpoint of median duration of severe oral
mucositis (“SOM”) did not achieve the pre-
specified 
 
criterion 
 
for 
 
statistical
 significance  (p≤0.05);  although biological
activity was observed with a 56% reduction
in the median duration of SOM from 18
days in the placebo group to 8 days in the
SGX942 treatment group; analyzed full
dataset from Phase 3 study and designing a
second Phase 3 clinical trial; continued
development contingent upon identification
of partnership
SGX945
Aphthous Ulcers in Behçet’s Disease
Phase 2a protocol and IND clearance
received from the FDA; Phase 2a study
initiated in 4Q 2024
Public Health Solutions†
Soligenix Product Candidate
 
Indication
 
Stage of Development
ThermoVax®
Thermostability of vaccines for Ricin toxin,
Ebola, and Marburg viruses
   Pre-clinical
RiVax®
Vaccine against Ricin Toxin Poisoning
Phase 1a, 1b and 1c trials completed,
safety and neutralizing antibodies for
protection demonstrated
SGX943
Therapeutic against Emerging Infectious
Diseases
Pre-clinical
†
Contingent upon continued government contract/grant funding or other funding source.
Critical Accounting Policies
Our management’s discussion and analysis of our financial condition and results of operations are based upon our
consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in
the U.S. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities, costs and expenses and the disclosure of contingent assets and
liabilities. We base our estimates on historical experience, known trends and events and various other factors that we
believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions
on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in the notes to our financial statements appearing at
the end of this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the
assumptions and estimates used in the preparation of our financial statements.
Research and Development Costs
As part of the process of preparing our financial statements, we are required to estimate our accrued research and
development expenses. This process involves reviewing open contract and purchase orders, communicating with our

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57
personnel to identify services that have been performed on our behalf and estimating the level of service performed and the
associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The
majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when
contractual milestones are met; however, some require advance payments. We make estimates of our accrued expenses as
of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples
of estimated accrued research and development expenses include fees paid to:
●
contract research organizations (“CROs”) in connection with performing research activities on our behalf and
conducting preclinical studies and clinical trials on our behalf;
●
investigative sites or other service providers in connection with clinical trials;
●
vendors in connection with preclinical and clinical development activities; and
●
vendors related to product manufacturing and distribution of preclinical and clinical supplies.
We base our expenses related to preclinical studies and clinical trials on our estimates of the services received and efforts
expended pursuant to quotes and contracts with multiple CROs that conduct and manage preclinical studies and clinical
trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and
may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level
of services provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors
such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing fees, we estimate
the time period over which services will be performed, enrollment of patients, number of sites active and the level of effort to
be expended in each period. If the actual timing of the performance of services or the level of effort varies from our estimate,
we adjust the accrual or amount of prepaid expense accordingly. Although we do not expect our estimates to be materially
different from amounts actually incurred, our understanding of the status and timing of services performed relative to the
actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low
in any particular period. During the year ended December 31, 2024, we made adjustments to estimated accrued clinical trial
expenses for completed trials of approximately $1.4 million. These adjustments resulted in decreases to research and
development expenses in the accompanying consolidated statements of operations during the year ended
December 31, 2024.
Use of Estimates and Assumptions
The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires
management to make estimates and assumptions such as the fair value of stock options and to accrue for clinical trials in
process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ
from those estimates.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07,
Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update enhances the segment
reporting requirements by increasing transparency and providing investors with additional insights into how an entity’s Chief
Operating Decision Maker (“CODM”) evaluates segment performance and allocates resources.
The standard requires public entities to disclose significant segment expenses that are regularly reviewed by the CODM and
included in the reported measure of segment profit or loss. Additionally, entities must provide a reconciliation of total
segment amounts to consolidated financial statements, as well as enhanced qualitative disclosures regarding the
methodology used to identify reportable segments and assess performance. The update applies to all public entities,
including those with a single reportable segment, and expands segment disclosures in interim financial statements.
ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years
beginning after December 15, 2024. We have adopted ASU 2023-07 for the year ended December 31, 2024, and have
updated our segment disclosures accordingly. The adoption of this standard did not impact the recognition or measurement
of our financial statements but resulted in enhanced segment-related disclosures in the notes to the consolidated financial
statements.

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58
Material Changes in Results of Operations
Year Ended December 31, 2024 Compared to 2023
For the year ended December 31, 2024, we had a net loss of $8,266,576 as compared to a net loss of $6,140,730 for the
prior year, representing increased net loss of $2,125,846 or 35%. The increase in net loss is primarily attributed to decreases
in gross profit and income tax benefits as well as an increase in operating expenses, offset by increases in interest income,
tax credits and the change in the fair value of debt. For the year ended December 31, 2024, we had revenues of $119,371
as compared to $839,359 for the prior year, representing a decrease of $719,988 or 86%. The decrease in revenues was
primarily a result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a
decrease in revenue associated with the zero margin grant for the HyBryte™ investigator initiated study.
We incurred costs related to contract and grant revenues in the year ended December 31, 2024 and 2023 of $119,371 and
$742,048, respectively, representing a decrease of $622,677 or 84%. The decrease in costs was primarily the result of the
conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in the zero
margin grant for the HyBryte™ investigator initiated study.
Our gross profit for the year ended December 31, 2024 was $0 or 0% of total revenues as compared to $97,311 or 12% of
total revenues for the prior year, representing a decrease of $97,311 or 100%. The decrease in gross profit was primarily the
result of the conclusion of higher margin grants associated with the development of SGX943 and CiVax™ and a decrease in
the zero margin grant for the HyBryte™ investigator initiated study.
Research and development expenses increased by $1,910,890 or 58% to $5,223,589 for year ended December 31, 2024 as
compared to $3,312,699 for the prior  year. The increase in research and development spending for the  year ended
December 31, 2024 was primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s
Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed
clinical trials.
General and administrative expenses decreased by $266,644 or 6%, to $4,215,908 for the year ended December 31, 2024,
as compared to $4,482,552 for the prior  year. This decrease is primarily related to a reduction in legal and consulting
expenses.
In April 2023, we entered into an amendment (the “2023 Amendment”) to the convertible debt financing agreement with
Pontifax Medison Finance (“Pontifax”) (see Note 5 – Debt). The 2023 Amendment resulted in the extinguishment of the
original convertible debt for accounting purposes. We elected to account for the amended convertible debt using the fair
value option, which requires us to record changes in fair value as a component of other income or expense.  The fair value
of the convertible debt on the date of the amendment was approximately $3,304,000, which resulted in the recognition of a
loss on extinguishment of approximately $394,000 on our accompanying consolidated statements of operations during the
year ended December  31,  2023. The fair value of the convertible debt as of December  31,  2023 was approximately
$3,260,934, which resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible
debt on our accompanying consolidated statements of operations for the year ended December 31, 2023. For 2023 and
through the 2024 Amendment (described below), the fair value of the convertible debt was estimated using the Monte Carlo
valuation method.
In October 2024, we entered into an amendment (the “2024 Amendment”) to the convertible debt financing agreement with
Pontifax, as amended. The 2024 Amendment resulted in a substantial modification of the debt for accounting purposes, as
defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying amount, of the
debt before the 2024 Amendment and upon reacquisition was diminimus. Accordingly, no gain or loss was recognized
related to the extinguishment related to the 2024 Amendment. Furthermore, as the 2024 Amendment resulted in a
substantial modification, as defined, we elected not to account for the convertible debt using the fair value option in
accordance with the applicable guidance. We determined the embedded conversion feature, after the 2024 Amendment,
does not require bifurcation and therefore the convertible debt, as amended, has been recorded as a single liability classified
instrument in accordance with ASU 2020-06. As a result of this election, we recognized a gain of $260,933 of other income
from the change in the fair value of the convertible debt on our accompanying 2024 consolidated statement of operations.
Total other income for the year ended December 31, 2024 was $763,807 as compared to $210,593 of total other expense
for the prior year, reflecting a decrease of $974,400 or 463%. The decrease in total other expense was primarily associated

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with the reduction in interest resulting from the repayment of a portion of the convertible debt principal balance, higher
interest income earned on cash balances, an increase in tax credits, an increase in other income resulting from the change
in the fair value of the convertible debt and approximately $394,000 of a loss on extinguishment of debt resulting from an
amendment to the original convertible debt loan agreement was recognized in 2023.
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology
companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers. We sold 2023, 2022 and
2021 New Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $409,114
and $1,767,803 during the years ended December 31, 2024 and 2023, respectively. We sold our 2023 New Jersey NOLs
and have recorded a receivable of $409,114 which is included in prepaid expenses and other current assets on the
accompanying consolidated balance sheet for the year ended December 31, 2024. We have not yet sold our 2024 New
Jersey NOL carryforwards but may do so in the future. We will continue to explore opportunities to sell unused NOL
carryforwards for the year ended December  31,  2024. However, there can be no assurance as to the continuation or
magnitude of this program in future years.
Business Segments
We maintain two active business segments for the years ended December 31, 2024 and 2023: Specialized BioTherapeutics
and Public Health Solutions.
The Specialized BioTherapeutics business segment had revenue of $119,371 for the year ended December 31, 2024 as
compared to $395,124 for the year ended December 31, 2023, representing a decrease of $275,753 or 70%. The decrease
was due to decreased reimbursable development activity under the grant to support the investigator-initiated study of
HyBryte™ for expanded treatment in patients with early-stage CTCL.
Revenues for the Public Health Solutions business segment for the year ended December 31, 2024 were $0 as compared to
$444,235 for the year ended December 31, 2023, representing a decrease of $444,235 or 100%. The decrease in revenues
was primarily the result of the conclusion of the grant associated with the development of SGX943.
Loss from operations for the Public Health Solutions business segment for the year ended December  31,  2024 was
$254,576 as compared to loss from operations of $36,531 for the year ended December 31, 2023, representing an increase
in loss of $218,045 or 597%. The loss for the year ended December 31, 2024 is attributable to additional expenses incurred
due to the expiration of grants and contracts. Loss from operations for the Specialized BioTherapeutics business segment
for the year ended December 31, 2024 was $4,365,034 as compared to $2,812,303 for the year ended December 31, 2023,
representing an increase in loss of $1,552,731 or 55%. This increase in loss is primarily related to preliminary costs
associated with the initiation of our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial
offset by an adjustment of estimated accruals for completed clinical trials.
Financial Condition and Liquidity
Cash and Working Capital
As of December  31,  2024, we had cash and cash equivalents of $7,819,514 as compared to $8,446,158 as of
December 31, 2023, representing a decrease of $626,644 or 7%. As of December 31, 2024, we had working capital of
$3,980,218, representing an increase of $625,006 as compared to working capital of $3,355,212 for the prior  year. The
decrease in cash and cash equivalents was primarily related to cash used in operating activities and debt principal
repayments offset by cash provided by financing activities. The increase in working capital is primarily the result of a
reduction in outstanding convertible debt resulting from principal repayments and debt conversions partially offset by cash
used in operating activities during the year ended December 31, 2024.
We believe that we have sufficient resources available to support our development activities and business operations and to
satisfy our obligations as they become due through the end of 2025. However, as of the date of filing this Annual Report on
Form 10-K, we do not have sufficient cash and cash equivalents to support our operations for at least 12 months following
the issuance of our financial statements on March 21, 2025. As a result, these conditions raise substantial doubt about our
ability to continue as a going concern through 12 months after the issuance date of the financial statements

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To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, our plans include
securing:
●
additional capital, potentially through a combination of public or private equity offerings and strategic transactions,
including potential alliances and drug product collaborations;
●
additional proceeds from government contract and grant programs; and
●
additional proceeds from the sale of shares of our common stock via the At Market Issuance Sales Agreement
(“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”).
Other than the AGP Sales Agreement, which was entered into on August 16, 2024, none of these alternatives are currently
committed. There is no assurance that we will obtain sufficient funding on acceptable terms, if at all, to continue operations,
enter into strategic transactions that provide the necessary capital, or implement other strategies to mitigate the substantial
doubt about our ability to continue as a going concern. If these alternatives are unavailable or not secured on satisfactory
terms, we will not have sufficient cash resources or liquidity to fund our operations for at least 12 months after the financial
statements are issued. Failure to obtain adequate capital when needed may force us to delay, reduce, or eliminate business
development efforts, negatively impacting our ability to achieve our objectives, remain competitive, and maintain our
financial condition and operating results. Additionally, market instability, including geopolitical factors, may limit our access to
capital, further straining our liquidity and ability to continue as a going concern. The perception of financial instability may
also deter potential business partners due to concerns about our ability to fulfill contractual obligations.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to
recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be
necessary should we be unable to continue as a going concern.
Our plans with respect to our liquidity management include, but are not limited to, the following:
●
We have up to $554,000 in active government grant funding still available as of December 31, 2024 to support our
associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants
for convenience. We plan to submit additional contract and grant applications for further support of our programs
with various funding agencies. However, there can be no assurance that we will obtain additional governmental
grant funding;
●
We will continue to use equity instruments to provide a portion of the compensation due to vendors and
collaboration partners and expect to continue to do so for the foreseeable future;
●
We will continue to pursue NOL sales in the state of New Jersey pursuant to its Technology Business Tax Certificate
Transfer Program if the program is available;
●
We plan to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition
strategies. However, there can be no assurances that we can consummate such transactions;
●
We plan to use the proceeds from a completed public offering on April 22, 2024 of 204,694 shares of our common
stock, pre-funded warrants to purchase 537,500 shares of our common stock and common warrants to purchase up
to 742,194 shares of our common stock at a combined public offering price of $6.40 for further support of our
programs, as well as for working capital. The pre-funded warrants have an exercise price of $0.02. The common
warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the
issuance date. The total gross proceeds to us from this offering were approximately $4.75 million before deducting
commissions and other estimated offering expenses of approximately $0.45 million;
●
We plan to use the proceeds from a warrant inducement agreement (the “Inducement Agreement”) on July 9, 2024
with certain holders (the “Holders”) of our existing Warrant to Purchase Shares of Common Stock (“Existing
Warrants”) to purchase shares of our common stock for further support of our programs, as well as for working
capital. In consideration of the Holders’ agreement to exercise their Existing Warrants, we (i) decreased the exercise

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price of the Existing Warrants from $6.40 per share to $6.00 per share and (ii) issued new warrants (“New
Warrants”) to the Holders to purchase a number of shares of common stock equal to 150% of the number of shares
of common stock issued upon exercise of the Holders’ Existing Warrants. Pursuant to the Inducement Agreement,
the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of our common
stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until
1:30 p.m., Eastern Time. The total gross proceeds to us was approximately $4.2 million from the exercise of the
Existing Warrants before deducting financial advisory fees and other expenses;
●
We have up to approximately $2.1 million remaining from the AGP Sales Agreement as of March 14, 2025 under the
prospectus supplement dated August 16, 2024. From January 1, 2025 through March 14, 2025, we sold 628,758
shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $4.23 per share for
total gross proceeds of approximately $2.7 million; and
●
We are currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute
them when appropriate. However, there can be no assurances that we can consummate such a transaction, or
consummate a transaction at favorable pricing.
Reverse Stock Split
On June 5, 2024, we completed a reverse stock split of our issued and outstanding shares of common stock at a ratio of
one-for-sixteen, whereby every sixteen shares of our issued and outstanding common stock were automatically combined
into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares
were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse
stock split were rounded up to the next whole number. Our common stock began trading on The Nasdaq Capital Market on a
reverse split basis at the market opening on June 6, 2024. All share and per share data have been restated to reflect this
reverse stock split.
Expenditures
Under our budget and based upon our existing product development agreements and license agreements pursuant to letters
of intent and option agreements, we expect our total research and development expenditures for the  year ending
December 31, 2025 to be approximately $6 million before any contract or grant reimbursements, of which approximately all
relates to the Specialized BioTherapeutics business segment. We anticipate grant reimbursements for the same period of
approximately $0.1 million to offset research and development expenses in the Specialized BioTherapeutics business
segment.
The table below details our costs for research and development by program and amounts reimbursed for the years ended
December 31, 2024 and 2023:
    
2024
    
2023
Research & Development Expenses
 
   
  
RiVax® and ThermoVax® Vaccines
$
 253,994
$
 133,186
SGX942 (Dusquetide)
 
 (330,257)
 
 (28,570)
HyBryte™ (SGX301 or synthetic hypericin)
 
 4,691,803
 
 2,698,609
Other
 
 608,049
 
 509,474
Total
$
 5,223,589
$
 3,312,699
Reimbursed under Government Contracts and Grants
 
  
 
  
CiVax™
 —
 311,495
SGX943
 
 —
 
 35,429
HyBryte™ (investigator-initiated study)
 119,371
 395,124
Total
 119,371
 742,048
Grand Total
$
 5,342,960
$
 4,054,747

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Contractual Obligations
We have licensing fee commitments of approximately $230,000 as of December  31,  2024 over the next five years for
several licensing agreements with partners and universities. Additionally, we have collaboration and license agreements,
which upon clinical or commercialization success may require the payment of milestones of up to approximately $13.2
million, royalties on net sales of covered products ranging from 2% to 3%, sub-license IND milestones on covered products
of up to approximately $200,000, sub-license income royalties on covered products up to 15% and sub-license global net
sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved. However, there can be no assurance
that clinical or commercialization success will occur.
We currently lease approximately 6,200 square feet of office space at 29 Emmons Drive, Suite  B-10 in Princeton, New
Jersey. This office space currently serves as our corporate headquarters, and both of our business segments (Specialized
BioTherapeutics and Public Health Solutions), operate from this space. Pursuant to the lease which expires October 2025,
the current rent is $11,625 per month. Our office space is sufficient for our current needs.
In September 2014, we entered into an asset purchase agreement with Hy Biopharma pursuant to which we acquired
certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic
hypericin product. As consideration for the assets acquired, we initially paid $275,000 in cash and issued 771 shares of
common stock with a fair value based upon our stock price on the date of grant of $3.75 million. These amounts were
charged to research and development expense during the third quarter of 2014 as the assets will be used in our research
and development activities and do not have alternative future use pursuant to generally accepted accounting principles in
the U.S.
In January 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to increase the
number of shares of common stock from 21 to 2,084, issuable to Dr.  Schaber immediately prior to the completion of a
transaction, or series or a combination of related transactions, negotiated by our Board of Directors whereby, directly or
indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third
party.
In March 2020, we filed a prospectus supplement covering the offer and sale of up to 8,151 shares of our common stock,
which were issued to Hy Biopharma. We were required to issue the shares to Hy Biopharma as payment following the
achievement of a milestone under the asset purchase agreement, specifically, the Phase 3 clinical trial of HyBryte™ being
successful in the treatment of CTCL. The number of shares of our common stock issued to Hy Biopharma was calculated
using an effective price of $614.40 per share, based upon a formula set forth in the asset purchase agreement.
Provided the final success-oriented milestone is attained, we will be required to make a payment of up to $5 million, if and
when achieved. The potential future payment will be payable in our common stock, not to exceed 19.9% of our outstanding
stock.
In December 2020, we entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”),
the healthcare-dedicated venture and debt fund of the Pontifax life science funds. Under the terms of the Loan Agreement,
we had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and
had an interest only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest
rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the
outstanding principal was to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The
agreement is secured by a lien covering substantially all of our assets, other than intellectual property.
Upon the closing of this transaction, we borrowed the first tranche of $10 million. We did not utilize our option to draw the
second or third tranche of $5 million each, which expired on December 15, 2021 and March 15, 2022, respectively.
In April 2023, we entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 Amendment called
for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any
prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3
million. The 2023 Amendment also provided for interest only through June 30, 2024, reduced quarterly principal repayments
to $750,000 and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced the conversion price with
respect to the remaining principal amount to (i) 90% of the closing price of our common stock on the day before the delivery
of a conversion notice with respect to the first 36,790 shares of our common stock issuable upon conversion and to (ii)

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$27.20 with respect to all shares of our common stock issuable upon conversion thereafter. The remaining terms of the
agreement remained unmodified.
On January 3, 2024, Pontifax delivered a conversion notice to us electing to convert a portion of the remaining principal
balance into shares of our common stock. Upon conversion, we issued 9,139 shares of our common stock at $10.88 per
share, reducing the remaining principal balance by $99,416.
On April 15, 2024, Pontifax delivered a conversion notice to us electing to convert a portion of the remaining principal
balance into shares of our common stock. Upon conversion, we issued 27,651 shares of our common stock at $5.60 per
share, reducing the remaining principal balance by $154,840.
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. We elected to
account for the amended convertible debt using the fair value option. The fair value of the convertible debt on the date of the
amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of approximately
$394,000 on our accompanying consolidated statements of operations for the year ended December 31, 2023.  The fair
value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which resulted in the recognition of
$43,066 of other income from the change in the fair value of the convertible debt on our accompanying consolidated
statements of operations for the year ended December 31, 2023. For 2023 and through the 2024 Amendment (described
below), the fair value of the convertible debt was estimated using the Monte Carlo valuation method.
In October 2024, we entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024
Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first
501,648 shares of our common stock issuable upon conversion and (ii) $4.23 with respect to all shares of our common stock
issuable upon conversion thereafter. The remaining terms of the agreement remained in effect with minimal, non-material
modifications to those terms. The 2024 Amendment resulted in a substantial modification of the debt for accounting
purposes, as defined, which is accounted for as an extinguishment. The difference between the fair value, or net carrying
amount, of the debt before the 2024 Amendment and upon reacquisition was diminimus.  Accordingly, no gain or loss was
recognized related to the extinguishment related to the 2024 Amendment. Furthermore, as the 2024 Amendment resulted in
a substantial modification, as defined, we elected not to account for the convertible debt using the fair value option in
accordance with the applicable guidance. We determined the embedded conversion feature, after the 2024 Amendment,
does not require bifurcation and therefore the convertible debt, as amended, has been recorded as a single liability classified
instrument in accordance with ASU 2020-06. As a result of this election, we recognized a gain of $260,933 of other income
from the change in the fair value of the convertible debt on our accompanying 2024 consolidated statement of operations.
In February 2025, we fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all related
liens and security interests securing the Company’s obligations were released. We did not incur any prepayment penalties
for the early repayment.
Contingencies
We follow subtopic 450-20 of the FASB Accounting Standards Codification to report accounting for contingencies. Certain
conditions may exist as of the date the financial statements are issued, which may result in a loss to us but which will only be
resolved when one or more future events occur or fail to occur. We assess such contingent liabilities, and such assessment
inherently involves an exercise of judgment. A liability is only recorded if management determines that it is both probable
and reasonably estimable.
CARES Act Employee Retention Credit
The Coronavirus Aid, Relief, and Economic Security Act provides for an employee retention credit (“CARES ERC”), which is
a refundable tax credit equal to 70% of qualified wages paid to employees during a quarter, capped at $10,000 of qualified
wages per employee.
We qualified for the CARES ERC for qualified wages through September 30, 2021. We have submitted filings for refunds of
the CARES ERC but cannot reasonably estimate when or if we will receive any or all of the requested refunds. We have
elected to follow subtopic 450-30 of the FASB Accounting Standards Codification and to account for the CARES ERC only
when all uncertainties regarding realization have been resolved. For the years ended December 31, 2024 and 2023, we

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received refunds of approximately $313,000 and $121,000, respectively. The refunds were recorded as other income on our
accompanying consolidated statements of operations for the years ended December 31, 2024 and 2023, respectively.
Item 8. Financial Statements and Supplementary Data
The information required by this Item 8 can be found beginning on page F-1 of this Annual Report on Form 10-K and is
incorporated herein by reference.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are our controls and other procedures that are 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, as amended
(the “Exchange Act”) 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 under the Exchange Act 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 recognizes that any controls and procedures, no
matter how well designed and operated, can only provide reasonable assurance of achieving their objectives and
management necessarily applies its judgment in evaluating the possible controls and procedures.
Our management has evaluated, with the participation of our principal executive officer and principal financial officer, the
effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the
Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, our management, including
our principal executive officer and principal financial officer, has concluded that, as of the end of the period covered by this
report, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal
control over financial reporting is a process designed by, or under the supervision of, our principal executive and principal
financial officers and effected by our Board of Directors, management and other personnel to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles and includes those policies and procedures that:
●
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and
dispositions of our assets;
●
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are
being made only in accordance with authorizations of management and directors; and
●
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the financial statements.
Because of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections
of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

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Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2024. In making
this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway
Commission (“COSO”) in Internal Control-Integrated Framework, 2013.
Based on our assessment, management has concluded that, as of December 31, 2024, our internal control over financial
reporting is effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation of such
internal control that occurred during our last fiscal quarter that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Item 9B. Other Information
Item 9C Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not applicable.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
The table below contains information regarding the current members of the Board of Directors and executive officers. The
ages of individuals are provided as of March 14, 2025.
Name
   
Age
   
Position
Christopher J. Schaber, PhD
58
Chairman of the Board, Chief Executive Officer and President
Gregg A. Lapointe, CPA, MBA
66
Director
Diane L Parks, MBA
72
Director
Robert J. Rubin, MD
79
Director
Jerome B. Zeldis, MD, PhD
74
Director
Jonathan Guarino, CPA, CGMA
52
Chief Financial Officer, Senior Vice President and Corporate Secretary
Oreola Donini, PhD
53
Chief Scientific Officer and Senior Vice President
Richard Straube, MD
73
Chief Medical Officer and Senior Vice President
Christopher J. Schaber,  PhD has over 30  years of experience in the pharmaceutical and biotechnology industry.
Dr.  Schaber has been our President and Chief Executive Officer and a director since August  2006. He was appointed
Chairman of the Board in October 2009. He also has served on the board of directors of the Biotechnology Council of New
Jersey (“BioNJ”) since January 2009 and the Alliance for Biosecurity since October 2014, and has been a member of the
corporate council of the National Organization for Rare Disorders (“NORD”) since October 2009. He also serves on the
scientific advisory board for private start-up medical device company, Simphotek, Inc. Prior to joining Soligenix, Dr. Schaber
served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he
was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs,
quality control and assurance, manufacturing and distribution, pre-clinical and clinical research, and medical affairs, as well
as coordination of commercial launch preparation activities. From 1996 to 1998, Dr. Schaber was a co-founder of Acute
Therapeutics, Inc., and served as its Vice President of Regulatory Compliance and Drug Development. From 1994 to 1996,
Dr. Schaber was employed by Ohmeda PPD, Inc., as Worldwide Director of Regulatory Affairs and Operations. From 1989
to 1994, Dr. Schaber held a variety of regulatory, development and operations positions with The Liposome Company, Inc.,
and Elkins-Sinn Inc., a division of Wyeth-Ayerst Laboratories. Dr. Schaber received his BA degree from Western Maryland
College, his MS degree in Pharmaceutics from Temple University School of Pharmacy and his PhD degree in
Pharmaceutical Sciences from the Union Graduate School. During his career, Dr. Schaber has played a significant role in
raising in excess of $350 million through both public offerings and private placements, as well as approximately $100 million
in non-dilutive funding awards from state and federal governmental agencies. Dr.  Schaber was selected to serve as a
member of our Board of Directors because of his extensive experience in drug development and pharmaceutical operations,
including his experience as a senior executive officer with our company and Discovery Laboratories, Inc., and as a member

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of the board of directors of BioNJ and Simphotek; because of his proven ability to raise funds and provide access to capital;
and because of his advanced degrees in science and business.
Gregg A. Lapointe, CPA, MBA has been a director since March  2009. Mr.  Lapointe is currently CEO of Cerium
Pharmaceuticals, Inc. and serves on the board of directors of Rigel Pharmaceuticals, Inc., and Astria Therapeutics, Inc.
Mr.  Lapointe has previously served on the board of directors of ImmunoCellular Therapeutics  Ltd., Raptor
Pharmaceuticals,  Inc., SciClone Pharmaceuticals,  Inc., the Pharmaceuticals Research and Manufacturers of America
(PhRMA), Questcor Pharmaceuticals, Inc. and the board of trustees of the Keck Graduate Institute of Applied Life Sciences.
He previously served in varying roles for Sigma-Tau Pharmaceuticals, Inc. (now known as Leadiant Biosciences, Inc.), a
private biopharmaceutical company, from September 2001 through February 2012, including Chief Operating Officer from
November  2003 to April  2008 and Chief Executive Officer from April  2008 to February  2012. From May, 1996 to
August  2001, he served as Vice President of Operations and Vice President, Controller of AstenJohnson,  Inc. (formerly
JWI Inc.). Prior to that, Mr. Lapointe spent several years in the Canadian medical products industry in both distribution and
manufacturing. Mr. Lapointe began his career at Price Waterhouse. Mr. Lapointe received his B.A. degree in Commerce
from Concordia University in Montreal, Canada, a graduate diploma in Accountancy from McGill University and his M.B.A.
degree from Duke University. He is a C.P.A. in the state of Illinois. Mr. Lapointe was selected to serve as a member of our
Board of Directors because of his significant experience in the areas of global strategic planning and implementation,
business development, corporate finance, and acquisitions, and his experience as an executive officer and board member in
the pharmaceutical and medical products industries.
Diane L. Parks, MBA has been a director since July 2019. From February 2016 until July 2018, she served as Head of U.S.
Commercial and Senior Vice President of Marketing, Sales  & Market Research at Kite Pharma,  Inc., a privately-held
biopharma company developing cancer immunotherapy products with a primary focus on genetically engineered autologous
T cell therapy with chimeric antigen receptors. From October 2014 to October 2015, Ms. Parks served as Vice President of
Global Marketing at Pharmacyclics LLC, a privately-held biopharmaceutical company primarily focused on the development
of cancer therapies. Prior to Pharmacyclics LLC, Ms.  Parks held senior leadership roles as Vice President of Sales for
Amgen,  Inc., a publicly-traded biopharmaceutical company, representing oncology and nephrology products, and Senior
Vice President of Specialty Biotherapeutics and Managed Care at Genentech, Inc., a biotechnology company that discovers,
develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions
that was acquired by Roche Holding AG in 2009. At Genentech, she led the launches of multiple products as well as
commercial development of Lucentis® and Rituxan®. Since May 2019, she has been a member of the board of directors of
Calliditas Therapeutics AB, a biopharmaceutical company, the shares of which are traded on the Nasdaq Stockholm
Exchange, that is developing and commercializing pharmaceutical products for patients with significant unmet medical
needs in niche indications. She is also a member of the board of directors of Kura Oncology, a biopharmaceutical company,
the shares of which are traded on US Nasdaq, that is developing a pipeline of precision medicines for the treatment of solid
tumors and blood cancers. Since October 2019 Ms. Parks has been a member of the board of directors for TriSalus Life
Sciences, an early stage company focused on improving patient outcomes in pancreatic and other highly intractable solid
tumors. Ms. Parks holds a BS from Kansas State University and a master’s of business administration in marketing from
Georgia State University. She has been a commercial leader in the biotech and pharma industry for over 30  years.
Ms. Parks was selected to serve as a member of our Board of Directors because of her over 30 years’ experience as a
businesswoman and commercial executive with an extensive record of driving profitable growth for large pharmaceutical and
biotech companies.
Robert J. Rubin, MD has been a director since October 2009. Dr. Rubin was a clinical professor of medicine at Georgetown
University from 1995 until 2012 when he was appointed a Distinguished Professor of Medicine. From 1987 to 2001, he was
President of the Lewin Group (purchased by Quintiles Transnational Corp. in 1996), an international health policy and
management consulting firm. From 1994 to 1996, Dr.  Rubin served as Medical Director of ValueRx, a pharmaceutical
benefits company. From 1992 to 1996, Dr. Rubin served as President of Lewin-VHI, a health care consulting company. From
1987 to 1992, he served as President of Lewin-ICF, a health care consulting company. From 1984 to 1987, Dr. Rubin served
as a principal of ICF,  Inc., a health care consulting company. From 1981 to 1984, Dr.  Rubin served as the Assistant
Secretary for Planning and Evaluation at the Department of Health and Human Services and as an Assistant Surgeon
General in the U.S. Public Health Service. Dr. Rubin has served on the Board of BioTelemetry, Inc. (formerly known as
CardioNet, Inc.) from 2007 to February 2021. He is currently on the Board of Cerium Pharmaceuticals where he is also the
acting Chief Medical Officer since July 2022. He is a board certified nephrologist and internist. Dr.  Rubin received an
undergraduate degree in Political Science from Williams College and his medical degree from Cornell University Medical
College. Dr. Rubin was selected to serve as a member of our Board of Directors because of his vast experience in the

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health care industry, including his experience as a nephrologist, internist, clinical professor of medicine and Assistant
Surgeon General, and his business experience in the pharmaceutical industry.
Jerome B. Zeldis, MD,  PhD has been a director since June  2011. In March 2023 Dr. Zeldis retired as Executive Vice
President, Research and Development of Neximmune. He was the Chief Medical Officer and President of Clinical Research,
Drug Safety and Regulatory of Sorrento Therapeutics, Inc. and Celularity, Inc. Previously, Dr. Zeldis was Chief Executive
Officer of Celgene Global Health and Chief Medical Officer of Celgene Corporation, a publicly traded, fully integrated
biopharmaceutical company. He was employed by Celgene from 1997 to 2016. From September 1994 to February 1997, Dr.
Zeldis worked at Sandoz Research Institute and the Janssen Research Institute in both clinical research and medical
development. He has been a board member of several biotechnology companies and is currently on the boards of Metastat,
Inc., PTC Therapeutics Inc., BioSig Technologies, Inc., the Castleman's Disease Organization and Alliqua, Inc. He has
previously served on the boards of the NJ Chapter of the Arthritis Foundation and PTC Therapeutics, Inc. Additionally, he
has served as Assistant Professor of Medicine at the Harvard Medical School from July 1987 to September 1988, Associate
Professor of Medicine at University of California, Davis from September 1988 to September 1994, Clinical Associate
Professor of Medicine at Cornell Medical School from January 1995 to December 2003 and Professor of Clinical Medicine at
the Robert Wood Johnson Medical School from July 1998 to June 2010. Dr. Zeldis received a BA and an MS from Brown
University, and an MD, and a PhD in Molecular Biophysics and Biochemistry from Yale University. Dr. Zeldis trained in
Internal Medicine at the UCLA Center for the Health Sciences and in Gastroenterology at the Massachusetts General
Hospital and Harvard Medical School. Dr. Zeldis was selected to serve as a member of our Board of Directors because of
his experience as an executive officer of a publicly traded biopharmaceutical company and in clinical research and medical
development, and his experience in the health care industry, including his experience as an internist, gastroenterologist and
professor of medicine.
Jonathan Guarino, CPA, CGMA has been with our company since September  2019 and is currently our Senior Vice
President and Chief Financial Officer. Mr.  Guarino has had significant experience with both development-stage and
commercial companies. From September  2016 to July  2019, he served as Corporate Controller for Hepion
Pharmaceuticals, Inc. (formerly ContraVir Pharmaceuticals, Inc.), a New Jersey-based public biotechnology company, where
he contributed to the establishment of the financial infrastructure, as well as assisted with capital fund-raising and debt
financings. He worked as Controller for Suite K Value Added Services LLC from August 2015 to September 2016 and as a
senior manager of technical accounting for Covance, Inc., from June 2014 to May 2015. Prior to these positions, he held
accounting and finance positions of increasing importance with several companies, including PricewaterhouseCoopers LLP,
BlackRock, Inc. and Barnes & Noble, Inc. Mr. Guarino is a CPA (certified public accountant) and CGMA (chartered global
management accountant), who received his BS in Business from Montclair State University.
Oreola Donini, PhD, has been with our company since August 2013 and is currently our Chief Scientific Officer and Senior
Vice President, a position she has held since December  2014. Dr.  Donini served as our Vice President of Preclinical
Research and Development from August  2013 until December  2014. She has more than 20  years’ experience in drug
discovery and preclinical development with start-up biotechnology companies. From 2012 to 2013, Dr. Donini worked with
ESSA Pharma  Inc. as Vice President Research and Development. From 2004 to 2013, Dr.  Donini worked with Inimex
Pharmaceuticals Inc. (“Inimex”), lastly as Senior Director of Preclinical R&D from 2007 to 2013. Prior to joining Inimex, she
worked with Kinetek Pharmaceuticals Inc., developing therapies for infectious disease, cancer and cancer supportive care.
Dr.  Donini is a co-inventor and leader of our SGX94 innate defense regulator technology, developed by Inimex and
subsequently acquired by us. She was responsible for overseeing the manufacturing and preclinical testing of SGX94, which
demonstrated efficacy in combating bacterial infections and mitigating the effects of tissue damage due to trauma, infection,
radiation and/or chemotherapy treatment. These preclinical studies resulted in a successful Phase 1 clinical study and
clearance of Phase 2 protocols for oral mucositis in head and neck cancer and acute bacterial skin and skin structure
infections. While with ESSA Pharma Inc. as the Vice President of Research and Development, Dr. Donini led the preclinical
testing of a novel N-terminal domain inhibitor of the androgen receptor for the treatment of prostate cancer. While with
Kinetek Pharmaceuticals Inc., her work related to the discovery of novel kinase and phosphatase inhibitors for the treatment
of cancer. Dr.  Donini received her PhD from Queen’s University in Kinston, Ontario, Canada and completed her post-
doctoral work at the University of California, San Francisco. Her research has spanned drug discovery, preclinical
development, manufacturing and clinical development in infectious disease, cancer and cancer supportive care.
Richard Straube, MD has been with our company since January 2014 and is currently our Senior Vice President and Chief
Medical Officer. Dr. Straube is a board-certified pediatrician with over 35 years’ experience in both academia and industry,
including clinical research experience in host-response modulation. From 2009 until joining our company, he was Chief
Medical Officer of Stealth Peptides Incorporated, a privately-held, clinical stage, biopharmaceutical company. Prior to joining

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us, Dr.  Straube served from 1988 to 1993 in various capacities, including most recently as Senior Director, Infectious
Diseases and Immunology, Clinical Research, for Centocor, Inc., a privately-held biopharmaceutical company focused on
developing monoclonal antibody-based diagnostics. While at Centocor, Inc., Dr. Straube was responsible for the initial anti-
cytokine and anti-endotoxin programs targeted at ameliorating inappropriate host responses to infectious and immunologic
challenges. Programs that he managed at Centocor,  Inc. include assessments of immunomodulation using monoclonal
removal of inciting molecular triggers, removal of internal immune-messengers, augmentation of normal host defenses, and
maintenance of normal sub-cellular function in the face of injury. From 1993 to 1995, Dr. Straube was Director of Medical
Affairs at T-cell Sciences,  Inc., a privately-held biotechnology company. From 1995 to 1997, he was Director of Clinical
Investigations of the Pharmaceutical Products Division of Ohmeda Corp., a privately-held biopharmaceutical company. He
served from 1998 to 2007 as Executive Vice President of Research and Development and Chief Scientific Officer at INO
Therapeutics LLC, a privately-held biotherapeutics company, where he was responsible for the clinical trials and subsequent
approval of inhaled nitric oxide for the treatment of persistent pulmonary hypertension of the newborn. From 2007 to 2009,
Dr.  Straube was the Chief Medical Officer at Critical Biologics Corporation, a privately-held biotechnology company.
Dr. Straube received his medical degree and residency training at the University of Chicago, completed a joint adult and
pediatrician infectious diseases fellowship at the University of California, San Diego (“UCSD”), and as a Milbank Scholar
completed training in clinical trial design at the London School of Hygiene and Tropical Medicine. While on the faculty at the
UCSD Medical Center, his research focused on interventional studies for serious viral infections.
Board Leadership Structure
Our Board of Directors believes that Dr. Schaber’s service as both the Chairman of our Board of Directors and our Chief
Executive Officer is in the best interest of our company and our stockholders. Dr. Schaber possesses detailed and in-depth
knowledge of the issues, opportunities and challenges facing our company and our business and, therefore, is best
positioned to develop agendas that ensure that the Board of Directors’ time and attention are focused on the most important
matters. His combined role enables decisive leadership, ensures clear accountability, and enhances our ability to
communicate our message and strategy clearly and consistently to our stockholders, employees, and collaborative partners.
Mr. Lapointe, Ms. Parks, Dr. Rubin, and Dr. Zeldis are independent and the Board of Directors believes that the independent
directors provide effective oversight of management. Moreover, in addition to feedback provided during the course of
meetings of the Board of Directors, the independent directors hold executive sessions. Following an executive session of
independent directors, the independent directors’ report back to the full Board of Directors regarding any specific feedback
or issues, provide the Chairman with input regarding agenda items for Board of Directors and Committee meetings, and
coordinate with the Chairman regarding information to be provided to the independent directors in performing their duties.
The Board of Directors believes that this approach appropriately and effectively complements the combined Chairman/Chief
Executive Officer structure.
Although we believe that the combination of the Chairman and Chief Executive Officer roles is appropriate under the current
circumstances, our corporate governance guidelines do not establish this approach as a policy, and the Board of Directors
may determine that it is more appropriate to separate the roles in the future.
Role of the Board of Directors in Risk Oversight
One of the key functions of our Board of Directors is informed oversight of our risk management process. Our Board of
Directors does not have a standing risk management committee, but rather administers this oversight function directly
through the Board of Directors as a whole, as well as through various standing committees of our Board of Directors that
address risks inherent in their respective areas of oversight. The Board of Directors is engaged in the oversight of risk
through regular updates from Dr. Schaber, in his role as our Chief Executive Officer, and other members of our management
team, regarding those risks confronting us (including risks relating to regulatory compliance, information technology and
cybersecurity, environmental and sustainability, climate change and public health), the actions and strategies necessary to
mitigate those risks and the status and effectiveness of those actions and strategies. The updates are provided at regularly
scheduled Board of Directors and committee meetings as well as through more frequent informal meetings that include our
Board of Directors, our Chief Executive Officer, our Chief Financial Officer, our Chief Medical Officer and our Chief Scientific
Officer and other members of our management team. The Board of Directors provides insight into the issues, based on the
experience of its members, and provides constructive challenges to management’s assumptions and assertions.
In particular, our Board of Directors is responsible for monitoring and assessing strategic risk exposure and our Audit
Committee has the responsibility to consider and discuss our major financial risk exposures and the steps our management

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has taken to monitor and control these exposures, including guidelines and policies to govern the process by which risk
assessment and management is undertaken. The Audit Committee also monitors compliance with legal and regulatory
requirements. Our Nominating and Corporate Governance Committee monitors the effectiveness of our corporate
governance practices, including whether they are successful in preventing illegal or improper liability-creating conduct. Our
compensation committee assesses and monitors whether any of our compensation policies and programs has the potential
to encourage excessive risk-taking.
Committees of the Board of Directors
Our Board of Directors has the following three committees: (1) Compensation, (2) Audit and (3) Nominating and Corporate
Governance. Our Board of Directors has adopted a written charter for each of these committees, which are available on our
website at www.soligenix.com under the “Investors” section.
Nominating and
Audit
Compensation
Corporate Governance
Director
    
Committee
    
Committee
    
Committee
Gregg A. Lapointe, CPA
Diane L. Parks, MBA
Robert J. Rubin, MD
Jerome B. Zeldis, MD, PhD
– Committee Chair
– Member
Audit Committee
Our Board of Directors has an Audit Committee, which is comprised of Mr. Lapointe (Chair), Ms. Parks and Dr. Rubin. The
Audit Committee assists our Board of Directors in monitoring the financial reporting process, the internal control structure
and the independent registered public accountants. Its primary duties are to serve as an independent and objective party to
monitor the financial reporting process and internal control system, to review and appraise the audit effort of the independent
registered public accountants and to provide an open avenue of communication among the independent registered public
accountants, financial and senior management, and our Board of Directors. Our Board of Directors has determined that
Mr. Lapointe, Ms. Parks and Dr. Rubin are “independent” directors, within the meaning of applicable listing standards of The
Nasdaq Stock Market LLC (“Nasdaq”) and the Exchange Act and the rules  and regulations thereunder. Our Board of
Directors has also determined that the members of the Audit Committee are qualified to serve on the committee and have
the experience and knowledge to perform the duties required of the committee and that Mr. Lapointe qualifies as an “audit
committee financial expert” as that term is defined in the applicable regulations of the Exchange Act.
Compensation Committee
Our Board of Directors has a Compensation Committee, which is comprised of Dr. Rubin (Chair), Ms. Parks and Dr. Zeldis.
The Compensation Committee is responsible for reviewing and approving the executive compensation program, assessing
executive performance, setting salary, making grants of annual incentive compensation and approving certain employment
agreements. Our Board of Directors has determined that Dr. Rubin, Mr. Lapointe and Dr. Zeldis are “independent” directors
within the meaning of applicable listing standards of Nasdaq and the Exchange Act and the rules  and regulations
thereunder.
Nominating and Corporate Governance Committee
Our Board of Directors has a Nominating and Corporate Governance Committee (“Nominating Committee”), which is
comprised of Dr. Zeldis (Chair), Mr. Lapointe and Dr. Rubin. The Nominating Committee makes recommendations to the
Board of Directors regarding the size and composition of our Board of Directors, establishes procedures for the nomination
process, identifies and recommends candidates for election to our Board of Directors. Our Board of Directors has
determined that Dr. Zeldis, Mr. Lapointe and Ms. Parks are “independent” directors, as such term is defined by the applicable
Nasdaq listing standards.

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Code of Ethics
We have adopted a code of ethics that applies to all our executive officers and senior financial officers (including our chief
executive officer, chief financial officer, chief accounting officer and any person performing similar functions). A copy of our
code of ethics is publicly available on our website at www.soligenix.com under the “Investors” section. If we make any
substantive amendments to our code of ethics or grant any waiver, including any implicit waiver, from a provision of the code
to our chief executive officer, chief financial officer or chief accounting officer, we will disclose the nature of such amendment
or waiver in a Current Report on Form 8-K.
Diversity Considerations in Identifying Director Nominees
We do not have a formal diversity policy or set of guidelines in selecting and appointing directors that comprise our Board of
Directors. However, when making recommendations to our Board of Directors regarding the size and composition of our
Board of Directors, our Nominating Committee does consider each individual director’s qualifications, skills, business
experience and capacity to serve as a director and the diversity of these attributes for the Board of Directors as a whole.
Compensation Committee Interlocks and Insider Participation
No member of our Compensation Committee is or has at any time during the past  year been one of our officers or
employees. None of our executive officers currently serves or in the past year has served as a member of the Board of
Directors or Compensation Committee of any entity that has one or more executive officers serving on our Board of
Directors or Compensation Committee.
Insider Trading Policy
Our Board of Directors has adopted an Insider Trading Policy, which applies to all of our directors, officers, employees,
agents and representatives and is reasonably designed to promote compliance with insider trading laws, rules and
regulations, and any applicable Nasdaq listing standards. The Insider Trading Policy expressly prohibits our directors,
officers, employees, agents and representatives from purchasing or selling our securities while in possession of material,
non-public information, or otherwise using such information for their personal benefit. It further prohibits our directors,
officers, employees, agents and representatives from engaging in hedging transactions, such as purchasing or writing
derivative securities including puts and calls and entering into short sales or short positions with respect to our stock.
Our directors, officer, employees, agents and representatives are permitted to enter into trading plans that are intended to
comply with the requirements of Rule 10b5-1 of the Exchange Act, so that they can prudently diversify their asset portfolios
and exercise their stock options before expiration.
Our Insider Trading Policy is posted on the “Investors — Corporate Governance” section of our website:
http://www.soligenix.com and has been filed as an exhibit to this Annual Report.
Clawback Policy
In 2023, we adopted a Clawback Policy in compliance with Nasdaq rules. Under our Clawback Policy, if we are required to
prepare an accounting restatement due to material noncompliance with the financial reporting requirements under United
States securities laws, we will be entitled to recover (and will seek to recover), from our executive officers, any excess
incentive-based compensation received by our executive officers during the three-year period prior to the date on which we
are required to prepare the restatement. This policy applies to both equity-based and cash compensation awards. The
“excess compensation” is the difference between the actual amount that was paid and the amount that would have been
paid if the financial statements were prepared properly in the first instance. To ensure that we can enforce the Clawback
Policy, we require each executive officer subject to the policy to execute an acknowledgement stating that the executive has
received and reviewed the policy and agrees that he or she is fully bound by the policy.
Item 11. Executive Compensation
In 2024, in furtherance of our compensation philosophy and objectives, the Compensation Committee engaged Setren &
Associates, Inc. (“S&A”), an outside executive compensation consulting firm determined to be independent by the

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Compensation Committee, to conduct a review of, and recommend changes to, our compensation program for our most
highly compensated executive officers. A representative of S&A attended Compensation Committee meetings at the
invitation of the Compensation Committee Chairman and was also in direct contact with the Compensation Committee and
company management from time to time. S&A provided the Compensation Committee with assistance and advice in the
review of our salary structure, annual and equity incentive awards and other related executive pay issues. In addition, S&A
provided advice regarding marketplace trends and best practices relating to competitive pay levels.
S&A did not provide any services to us other than its services as the Compensation Committee’s independent compensation
consultant, and S&A did not receive any fees or compensation from us other than the fee it received as the independent
compensation consultant. S&A provided similar services to us and received similar compensation in 2023. The
Compensation Committee confirmed that S&A’s work for the Compensation Committee did not create any conflicts of
interest.
Summary Compensation
The following table contains information concerning the compensation paid during each of the two years ended
December  31,  2024 and 2023, respectively to our Chief Executive Officer and each of the three other most highly
compensated executive officers (collectively, the “Named Executive Officers”).
Summary Compensation
Option
All Other
Name
    
Position
     Year     
Salary
    
Bonus
    
Awards
    Compensation    
Total
Christopher J. Schaber (1)
 
CEO &   2024
$ 540,255
$ 108,051
$ 148,950
$
 35,370
$  832,627
  President   2023
$ 519,476
$  72,727
$  75,482
$
 32,800
$  700,484
Jonathan Guarino (2)
 
CFO &   2024
$ 254,800
$  42,806
$  66,200
$
 35,370
$  399,177
  Senior VP  2023
$ 245,000
$  31,605
$  45,289
$
 32,800
$  354,693
Oreola Donini (3)
 
CSO &   2024
$ 312,000
$  49,453
$  66,200
$
 4,452
$  432,105
  Senior VP  2023
$ 300,000
$  37,800
$  45,289
$
 4,505
$  387,594
Richard C. Straube (4)
 
CMO &   2024
$ 197,039
$  31,921
$  39,720
$
 —
$  268,680
  Senior VP  2023
$ 189,461
$  22,736
$  37,741
$
 —
$  249,938
(1) Dr. Schaber deferred the payment of his 2024 bonus of $108,051 until January 15, 2025. Option awards figure includes
the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation
represents health insurance costs paid by us.
(2) Mr. Guarino deferred the payment of his 2024 bonus of $42,806 until January 15, 2025. Option awards figure includes
the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation
represents health insurance costs paid by us.
(3) Dr. Donini deferred the payment of her 2024 bonus of $49,453 until January 15, 2025. Option awards figure includes the
value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation
represents health insurance costs paid by us.
(4) Dr. Straube deferred the payment of his 2024 bonus of $31,921 until January 15, 2025. Option awards figure includes
the value of common stock option awards at grant date as calculated under FASB ASC 718. Other compensation
represents health insurance costs paid by us.
Employment and Severance Agreements
In August 2006, we entered into a three-year employment agreement with Christopher J. Schaber, PhD. Pursuant to this
employment agreement we agreed to pay Dr. Schaber a base salary of $300,000 per year and a minimum annual bonus of
$100,000. Dr. Schaber’s employment agreement automatically renews every three years, unless otherwise terminated, and
last was automatically renewed in December 2019 for an additional term of three years. We agreed to issue him options to

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purchase 833 shares of our common stock, with one third immediately vesting and the remainder vesting over three years.
Upon termination without “Just Cause” as defined by this agreement, we would pay Dr. Schaber nine months of severance,
as well as any accrued bonuses, accrued vacation, and we would provide health insurance and life insurance benefits for
Dr.  Schaber and his dependents. No unvested options shall vest beyond the termination date. Dr.  Schaber’s monetary
compensation (base salary of $300,000 and bonus of $100,000) remained unchanged from 2006 with the 2007 renewal.
Upon a change in control of the company due to merger or acquisition, all of Dr.  Schaber’s options shall become fully
vested, and be exercisable for a period of five years after such change in control (unless they would have expired sooner
pursuant to their terms). In the event of his death during the term of the agreement, all of his unvested options shall
immediately vest and remain exercisable for the remainder of their term and become the property of Dr.  Schaber’s
immediate family.
In January 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to increase the
number of shares of common stock from 21 to 2,084, issuable to Dr.  Schaber immediately prior to the completion of a
transaction or series or a combination of related transactions negotiated by our Board of Directors whereby, directly or
indirectly, a majority of our capital stock or a majority of our assets are transferred from us and/or our stockholders to a third
party.
In December 2020, our Board of Directors authorized an amendment to Dr. Schaber’s employment agreement to modify the
severance terms. Upon termination without “Just Cause” as defined by this agreement, we would pay Dr.  Schaber
twelve months of severance, as well as a pro rata bonus calculated by the average of his prior two year’s annual bonuses, if
any, and based on the number of months that he was employed during the year in which his employment was terminated;
however, in the case of termination without “Just Cause” within one year following a change in control or the sale or other
disposition of all or substantially all of our assets Dr. Schaber will be entitled 18 months of severance and health insurance
and life insurance benefits for him and his dependents.
On June 22, 2011, the Compensation Committee eliminated his fixed minimum annual bonus payable and revised it to an
annual targeted bonus of 40% of his annual base salary. On December 8, 2022, the Compensation Committee approved an
increase in salary for Dr. Schaber to $519,476. On December 8, 2023, the Compensation Committee approved an increase
in salary for Dr. Schaber to $540,255. On December 12, 2024, the Compensation Committee approved an increase in salary
for Dr. Schaber to $559,164.
In July 2013, we entered into a one-year employment agreement with Oreola Donini, PhD, our Vice President Preclinical
Research & Development. Pursuant to the agreement, we agreed to pay Dr. Donini $170,000 (CAD) per year and a targeted
annual bonus of 20% of base salary. We also issued her options to purchase 2,666 shares of our common stock with one-
quarter immediately vesting and the remainder vesting over three years. Dr. Donini’s employment agreement automatically
renews each  year, unless otherwise terminated, and has automatically renewed each  year since execution. Upon
termination without “Just Cause”, as defined in Dr. Donini’s employment agreement, we would pay Dr. Donini three months
of severance, accrued bonuses and vacation, and health insurance benefits. No unvested options vest beyond the
termination date. In December  2014, Dr.  Donini was named Chief Scientific Officer and Senior Vice President. Upon
Dr. Donini’s promotion to Chief Scientific Officer, the Compensation Committee increased her targeted bonus to 30% of her
annual base salary. On December 8, 2022, the Compensation Committee approved an increase in salary for Dr. Donini to
$300,000. On December 8, 2023, the Compensation Committee approved an increase in salary for Dr. Donini to $312,000.
On December 12, 2024, the Compensation Committee approved an increase in salary for Dr. Donini to $322,920.
In December 2014, we entered into a one-year employment agreement with Richard C. Straube, MD, our Chief Medical
Officer and Senior Vice President. Pursuant to the agreement, we agreed to pay Dr.  Straube $300,000 per  year and a
targeted annual bonus of 30% of base salary. We also issued him options to purchase 666 shares of our common stock with
one-third immediately vesting and the remainder vesting over three  years. On March  26, 2019, we entered into an
amendment to our employment agreement with Dr.  Straube. Pursuant to the amended agreement, which amendment
became effective as of April 1, 2019, Dr. Straube will be required to devote at least 20 hours per week to the performance of
his duties and we will pay him $170,000 per year. The amended employment agreement automatically renews each year,
unless otherwise terminated. Upon termination without “Just Cause”, as defined in the amended employment agreement, we
would pay Dr. Straube one month of severance. No unvested options vest beyond the termination date. On December 8,
2022, the Compensation Committee approved an increase in salary for Dr. Straube to $189,461. On December 8, 2023, the
Compensation Committee approved an increase in salary for Dr.  Straube to $197,039. On December  12, 2024, the
Compensation Committee approved an increase in salary for Dr. Straube to $203,935.

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73
On September 9, 2019, we entered into a one-year employment agreement with Jonathan Guarino, CPA, CGMA, our Senior
Vice President and Chief Financial Officer. Pursuant to the agreement, we agreed to pay Mr. Guarino $220,000 per year and
a targeted annual bonus of 30% of base salary. We also issued him options to purchase 2,666 shares of our common stock
with one-quarter immediately vesting and the remainder vesting over three  years. Mr.  Guarino’s employment agreement
automatically renews each  year, unless otherwise terminated. Upon termination without “Just Cause”, as defined in
Mr. Guarino’s employment agreement, we would pay Mr. Guarino three months of severance, accrued salary, bonuses and
vacation, and health insurance benefits. No unvested options vest beyond the termination date. On December 8, 2022, the
Compensation Committee approved an increase in salary for Mr.  Guarino to $245,000. On December  8, 2023, the
Compensation Committee approved an increase in salary for Mr.  Guarino to $254,800. On December  12, 2024, the
Compensation Committee approved an increase in salary for Mr. Guarino to $263,718.
Equity Award Grant Practices and Timing Disclosure
As part of our commitment to transparency and sound corporate governance, we disclose below our policies and practices
related to the grant of equity awards in proximity to the release of material nonpublic information.
Policies and Practices on the Timing of Equity Awards
Our Board of Directors and Compensation Committee oversee the granting of equity awards, including stock options, to our
executives. The timing of such awards is determined in accordance with the following policies and practices:
●
Pre-Determined Grant Schedule: We generally grant equity awards on a predetermined schedule, typically in
connection with our annual compensation cycle or as part of an executive's new hire or promotion package.
●
Consideration of Material Nonpublic Information: The Board and Compensation Committee consider whether
material nonpublic information may be available when granting equity awards. We do not grant options with the
intent to take advantage of anticipated movements in stock price due to the release of such information.
●
Disclosure Timing: The Company does not intentionally time the disclosure of material nonpublic information for the
purpose of affecting the value of executive compensation.
Equity Awards Granted in Close Proximity to Material Nonpublic Information Disclosure
During the last fiscal year, the Company did not grant any stock options to named executive officers during the period
beginning four business days before and ending one business day after the filing of a periodic report on Form 10-Q or Form
10-K, or the filing or furnishing of a Form 8-K disclosing material nonpublic information (excluding Form 8-K disclosures of
material new option award grants under Item 5.02(e)).
As no such grants occurred during the relevant period, no further disclosure or tabular presentation is necessary.

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74
Outstanding Equity Awards at Fiscal Year-End
The following table contains information concerning unexercised options, stock that has not vested, and equity incentive
plan awards for the Named Executive Officers outstanding at December 31, 2024. We have never issued Stock Appreciation
Rights.
    
    
    
    
Equity
        
    
    
Incentive Plan
Awards:
Number of
Securities
Number of Securities
Underlying
Option
Underlying Unexercised
Unexercised
Exercise
Option
Options (#)
Unearned
Price
Expiration
Name
Exercisable
Unexercisable
Options (#)
($)
Date
Christopher J. Schaber
 
 58  
 —  
 —
$  2,712.00   12/30/2025
 
 250  
 —  
 —
$
 482.40   12/06/2027
 
 250  
 —  
 —
$
 232.80   12/12/2028
 
 250  
 —  
 —
$
 230.40   01/01/2029
 
 250  
 —  
 —
$
 297.60   12/11/2029
 
 250  
 —  
 —
$
 348.00   01/01/2030
 250
 —
 —
$
 561.60
12/09/2030
 250
 —
 —
$
 307.20
01/03/2031
 
 250  
 —  
 —
$
 187.20   12/08/2031
 
 52  
 —  
 —
$
 165.60   01/02/2032
 186
 11
 11
$
 165.60
01/02/2032
 442
 141
 141
$
 129.60
12/07/2032
 4,688
 4,687
 4,687
$
 10.72
12/07/2033
 11,250
 33,750
 33,750
$
 3.31
12/10/2034
Jonathan Guarino
 
 166  
 —  
 —
$
 232.80   09/08/2029
 
 41  
 —  
 —
$
 297.60   12/11/2029
 
 166  
 —  
 —
$
 561.60   12/09/2030
 195
 13
 13
$
 187.20
12/08/2031
 252
 81
 81
$
 129.60
12/07/2032
 2,815
 2,810
 2,810
$
 10.72
12/07/2033
 5,000
 15,000
 15,000
$
 3.31
12/10/2034
Oreola Donini
 
 29  
 —  
 —
$  2,712.00   12/30/2025
 
 83  
 —  
 —
$
 640.80   03/30/2027
 
 145  
 —  
 —
$
 482.40   12/06/2027
 
 166  
 —  
 —
$
 232.80   12/12/2028
 
 250  
 —  
 —
$
 297.60   12/11/2029
 
 291  
 —  
 —
$
 561.60   12/09/2030
 
 291  
 —  
 —
$
 187.20   12/08/2031
 252
 81
 81
$
 129.60
12/07/2032
 2,815
 2,810
 2,810
$
 10.72
12/07/2033
 5,000
 15,000
 15,000
$
 3.31
12/10/2034
Richard C. Straube
 
 29  
 —  
 —
$  2,712.00   12/30/2025
 
 83  
 —  
 —
$
 640.80   03/30/2027
 
 145  
 —  
 —
$
 482.40   12/06/2027
 
 166  
 —  
 —
$
 232.80   12/12/2028
 
 125  
 —  
 —
$
 297.60   12/11/2029
 
 166  
 —  
 —
$
 561.60   12/09/2030
 
 166  
 —  
 —
$
 187.20   12/08/2031
 252
 81
 81
$
 129.60
12/07/2032
 2,344  
 2,343  
 2,343
$
 10.72   12/07/2033
 3,000
 9,000
 9,000
$
 3.31
12/10/2034
 

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75
Compensation of Directors
The following table contains information concerning the compensation of the non-employee directors during the year ended
December 31, 2024.
    
Fees Earned
    
    
    
Paid in Cash
Option
Name
 (1)
Awards (2)
Total
Gregg A. Lapointe
$
 55,000
$
 30,002
$
 85,002
Diane L. Parks
$
 47,500
$
 30,002
$
 77,502
Robert J. Rubin
$
 57,500
$
 30,002
$
 87,502
Jerome B. Zeldis
$
 50,000
$
 30,002
$
 80,002
(1)
Directors who are compensated as full-time employees receive no additional compensation for service on our Board of
Directors. Each independent director who is not a full-time employee is paid $35,000 annually, on a prorated basis, for
their service on our Board of Directors, the chairman of our Audit Committee is paid $15,000 annually, on a prorated
basis, and the chairmen of our Compensation and Nominating Committees is paid $10,000 annually, on a prorated
basis. Additionally, Audit Committee members are paid $7,500 annually and Compensation and Nominating Committee
members are paid $5,000 annually. This compensation is paid quarterly.
(2)
We maintain a stock option grant program pursuant to the nonqualified stock option plan, whereby members of our
Board of Directors or its committees who are not full-time employees receive an initial grant of fully vested options to
purchase 15,000 shares of common stock. Upon re-election to the Board, each Board member will receive stock options
with a value of $30,000, calculated using the closing price of the common stock on the trading day prior to the date of
the annual meeting of our stockholders, which vest at the rate of 25% per quarter, commencing with the first quarter
after each annual meeting of stockholders.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The table below provides information regarding the beneficial ownership of the common stock as of March 14, 2025, of
(1) each of our directors, (2) each of the Named Executive Officers, and (3) our directors and officers as a group. As of
March 14, 2025, we are not aware of any person beneficially owning more than 5% of our outstanding common stock.
Except as otherwise indicated, and subject to applicable community property laws, we believe the persons named in the
table have sole voting and investment power with respect to all shares of common stock held by them.
    
Shares of
    
    
 
Common
 
Stock
 
Beneficially
Percent
 
Name of Beneficial Owner
Owned **
of Class
 
Christopher J. Schaber (1)
 
 22,502  
*
Gregg A. Lapointe (2)
 
 5,232  
*
Diane L. Parks (3)
 
 5,174  
*
Robert J. Rubin (4)
 
 5,220  
*
Jerome B. Zeldis (5)
 
 5,297  
*
Jonathan Guarino (6)
 
 16,314  
*
Oreola Donini (7)
 16,268
*
Richard Straube (8)
 10,394
*
All directors and executive officers as a group (8 persons) (9)
 
 86,401  
2.67 %
(1) Includes 379 shares of common stock and options to purchase 22,123 shares of common stock exercisable within
60 days of March 14, 2025. The address of Dr. Schaber is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New
Jersey 08540.
(2) Includes 31 shares of common stock and options to purchase 5,201 shares of common stock exercisable within 60 days
of March 14, 2025. The address of Mr. Lapointe is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey
08540.

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76
(3) Includes 63 shares of common stock and options to purchase 5,111 shares of common stock exercisable within 60 days
of March 14, 2025. The address of Ms. Parks is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey
08540.
(4) Includes 19 shares of common stock and options to purchase 5,201 shares of common stock exercisable within 60 days
of March 14, 2025. The address of Dr. Rubin is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey
08540.
(5) Includes 96 shares of common stock and options to purchase 5,201 shares of common stock exercisable within 60 days
of March 14, 2025. The address of Dr. Zeldis is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey
08540.
(6) Includes 46 shares of common stock and options to purchase 16,268 shares of common stock exercisable within
60 days of March 14, 2025. The address of Mr. Guarino is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New
Jersey 08540.
(7) Includes options to purchase 16,268 shares of common stock exercisable within 60 days of March 14, 2025. The
address of Dr. Donini is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New Jersey 08540.
(8) Includes 34 shares of common stock and options to purchase 10,360 shares of common stock exercisable within 60
days of March 14, 2025. The address of Dr. Straube is c/o Soligenix, 29 Emmons Drive, Suite B-10, Princeton, New
Jersey 08540.
(9) Includes 668 shares of common stock and options to purchase 85,733 shares of common stock exercisable within
60 days of March 14, 2025.
*
Indicates less than 1%.
**
Beneficial ownership is determined in accordance with the rules of the SEC. Shares of common stock subject to options
or warrants currently exercisable or exercisable within 60  days of March 14, 2025 are deemed outstanding for
computing the percentage ownership of the stockholder holding the options or warrants, but are not deemed outstanding
for computing the  percentage ownership of any other stockholder.  Percentage of ownership is based on 3,155,603
shares of common stock outstanding as of March 14, 2025.
Equity Compensation Plan Information
In December 2005, our Board of Directors approved the 2005 Equity Incentive Plan, which was approved by stockholders on
December 29, 2005. The maximum number of shares of our common stock available for issuance under the 2005 Equity
Incentive Plan is 300,000 shares. In April 2015, our Board of Directors approved the 2015 Equity Incentive Plan, which was
approved by stockholders on June 18, 2015. On September 22, 2022, the stockholders approved an amendment to the
2015 Plan to increase the maximum numbers of shares of common stock available for issuance under the plan from
2,000,000 to 6,000,000 shares. As of December 31, 2024, there are 5,770,122 shares currently available for future grants
under the 2015 Plan.

Table of Contents
77
The following table sets forth certain information, as of December 31, 2024, with respect to the following compensation plans
(including individual compensation arrangements) under which our equity securities are authorized for issuance:
●
all compensation plans previously approved by our security holders; and
●
all compensation plans not previously approved by our security holders.
    
         
    
Number of
Securities
Remaining
Available for
Future
Number of
Issuance
Securities to
Weighted-
Under Equity
be Issued
Average
Compensation
upon Exercise
Exercise
Plans
of
Price of
(excluding
Outstanding
Outstanding
securities
Options,
Options,
reflected in
Warrants and
Warrants and
the first
Plan Category
Rights
Rights
column)
Equity compensation plans approved by security holders (1)
 
 229,919
$
 21.94  
 5,770,122
Equity compensation plans not approved by security holders
 
 —
 
 —  
 —
Total
 
 229,919
$
 21.94  
 5,770,122
(1) Includes our 2005 Equity Incentive Plan and our 2015 Equity Incentive Plan. Our 2005 Equity Incentive Plan expired in
2015 and thus no securities remain available for future issuance under that plan.
Item 13. Certain Relationships and Related Transactions and Director Independence
Related Party Transactions
Our audit committee is responsible for the review, approval and ratification of related party transactions. The audit committee
reviews these transactions under our Code of Ethics, which governs conflicts of interests, among other matters, and is
applicable to our employees, officers and directors.
We are party to a registration rights agreement with certain stockholders. The agreement provides that the stockholders
have the right to require that we register its shares under the Securities Act for sale to the public, subject to certain
conditions. The stockholders also have piggyback registration rights, which means that, if not already registered, they have
the right to include their shares in any registration that we effect under the Securities Act, subject to specified exceptions.
We must pay all expenses incurred in connection with the exercise of these demand registration rights.
We are unable to estimate the dollar value of the registration rights to the holders of these rights. The amount of
reimbursable expenses under the agreements depends on a number of variables, including whether registration rights are
exercised incident to a primary offering by us, the form on which we are eligible to register such a transaction, and whether
we have a shelf registration in place at the time of a future offering.
Other than the employment agreements and compensation paid to our directors, we did not engage in any other
transactions with related parties since January 1, 2023. For a discussion of our employment agreements and compensation
paid to our directors, see “Item 11. Executive Compensation.”
Director Independence
The Board of Directors has determined that Mr. Lapointe, Ms. Parks, Dr. Rubin, and Dr. Zeldis are “independent” as such
term is defined by the applicable listing standards of Nasdaq. Our Board of Directors based this determination primarily on a
review of the responses of the Directors to questionnaires regarding their employment, affiliations and family and other
relationships.

Table of Contents
78
Item 14. Principal Accountant Fees and Services
The following table highlights the aggregate fees billed during each of the two years ended December 31, 2024 and 2023 by
Cherry Bekaert LLP.
    
2024
    
2023
Audit fees
$
 214,463
$
 59,870
Total
$
 214,463
$
 59,870
Audit Fees
This category includes the fees for the examination of our consolidated financial statements, review of our Annual Report on
Form 10-K, quarterly reviews of the interim financial statements included in our Quarterly Reports on Form 10-Q and
periodic review of documents to be filed with the SEC, including registration statements.
Tax Fees
Our principal accountants did not bill us for any services for tax compliance, tax advice and tax planning.
Other Fees
Our principal accountants did not bill us for any services or products other than as reported above in this Item 14 during
each of the two years.
Pre-Approval Policies and Procedures
The audit committee has adopted a policy that requires advance approval of all audit services and permitted non-audit
services to be provided by the independent auditor as required by the Exchange Act. The audit committee must approve the
permitted service before the independent auditor is engaged to perform it. The audit committee approved all of the services
described above in accordance with its pre-approval policies and procedures.
Part IV
Item 15. Exhibits and Financial Statements Schedules
(1) Consolidated Financial Statements:
The financial statements required to be filed by Item 8 of this Annual Report on Form 10-K and filed in this Item 15, are as
follows:
Table of Contents
F-1
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-2
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-3
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Changes in Equity and Shareholders’ Equity (Deficit) for the Years Ended
December 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Consolidated Financial Statements
F-7 – F-26
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 00677)
F-27
(2) Financial Statement Schedules

Table of Contents
79
Schedules are omitted because they are not applicable, or are not required, or because the information is included in the
consolidated financial statements and notes thereto.
(3) Exhibits:
2.1
Agreement and Plan of Merger, dated May 10, 2006 by and among the Company, Corporate Technology
Development, Inc., Enteron Pharmaceuticals, Inc. and CTD Acquisition, Inc. (incorporated by reference to
Exhibit 2.1 included in our Registration Statement on Form SB-2 (File No. 333-133975) filed on May 10, 2006).
3.1
Second Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 included in
our current report on Form 8-K filed on June 22, 2012).
3.2
Amended and Restated By-laws (incorporated by reference to Exhibit 3.1 included in our Quarterly Report on
Form 10-QSB, as amended, for the fiscal quarter ended June 30, 2003).
3.3
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 included in our current report on Form 8-K filed on June 22, 2016).
3.4
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 included in our current report on Form 8-K filed on October 7, 2016).
3.5
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 included in our current report on Form 8-K filed on June 14, 2017).
3.6
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 of our current report on Form 8-K filed on September 28, 2018).
3.7
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation (incorporated by
reference to Exhibit 3.1 of amendment number 1 to current report on Form 8-K filed on December 3, 2020).
3.8
Amendment to Amended and Restated By-laws (incorporated by reference to Exhibit 3.1 included in our
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020).
3.9
Certificate of Designation of the Series D preferred stock of the Company dated December 27, 2022
(incorporated by reference to Exhibit 3.1 to our Registration Statement on Form 8-A filed on December 27,
2022).
3.10
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation of Soligenix, Inc.
(incorporated by reference to Exhibit 3.1 included in our current report on Form 8-K filed on February 9, 2023).
3.11
Certificate of Amendment to Second Amended and Restated Certificate of Incorporation of Soligenix, Inc.
(incorporated by reference to Exhibit 3.1 included in our current report on Form 8-K filed on May 31, 2024).
4.1
Description of Securities. *
4.2
Registration Rights Agreement, dated December 15, 2020 by and among Soligenix, Inc. and the other parties
named therein (incorporated by reference to Exhibit 4.1 included in our current report on Form 8-K filed on
December 16, 2020).
10.1
License Agreement between the Company and the University of Texas Southwestern Medical Center
(incorporated by reference to Exhibit 10.9 included in our Annual Report on Form 10-KSB filed March 30, 2004,
as amended, for the fiscal year ended December 31, 2004).
10.2
2005 Equity Incentive Plan, as amended on September 25, 2013 (incorporated by reference to Exhibit 10.1
included in our current report on Form 8-K filed on September 30, 2013). **

Table of Contents
80
10.3
Form S-8 Registration of Stock Options Plan dated December 30, 2005 (incorporated by reference to our
registration statement on Form S-8 filed on December 30, 2005). **
10.4
Form S-8 Registration of Stock Options Plan dated June 20, 2014 (incorporated by reference to our registration
statement on Form S-8 filed on June 20, 2014). **
10.5
Form S-8 Registration of Stock Options Plan dated December 11, 2015 (incorporated by reference to our
registration statement on Form S-8 filed on December 14, 2015). **
10.6
Employment Agreement dated December 27, 2007, between Christopher J. Schaber, PhD and the Company
(incorporated by reference to Exhibit 10.30 included in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2008). **
10.7
Exclusive License Agreement dated November 24, 1998, between Enteron Pharmaceuticals, Inc. and George
B. McDonald, MD and amendments (incorporated by reference to Exhibit 10.42 included in our Registration
Statement on Form S-1 (File No. 333-157322) filed on February 13, 2009).
10.8
First Amendment to Employment Agreement dated as of July 12, 2011, between the Company and Christopher
J. Schaber, PhD (incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on July 14,
2011).**
10.9
Amendment to the Exclusive License Agreement dated as of July 26, 2011, between George McDonald, MD
and the Company (incorporated by reference to Exhibit 10.2 of our current report on Form 8-K filed on July 28,
2011).
10.10
Amendment No. 2 to the Collaboration and Supply Agreement between the Company, Enteron and Sigma-Tau
dated as of December 20, 2012 (incorporated by reference to Exhibit 10.1 of our current report on Form 8-K
filed on December 27, 2012). †
10.11
Amendment to Exclusive License Agreement dated as of December 20, 2012 between Enteron and McDonald
(incorporated by reference to Exhibit 10.4 of our current report on Form 8-K filed on December 27, 2012).
10.12
Amendment to Consulting Agreement dated as of December 20, 2012 between Enteron and McDonald
(incorporated by reference to Exhibit 10.5 of our current report on Form 8-K filed on December 27, 2012).
10.13
Contract HHSO100201300023C dated September 18, 2013 between the Company and the U.S. Department of
Health and Human Services Biomedical Advanced Research and Development Authority (incorporated by
reference to Exhibit 10.1 of our current report on Form 8-K filed on September 24, 2013). †
10.14
Contract HHSN272201300030C dated September 24, 2013 by and between the Company and the National
Institutes of Health (incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on
September 30, 2013). †
10.15
Employment Agreement dated as of January 6, 2014 between the Company and Richard Straube, M.D.
(incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on January 8, 2014). **
10.16
Asset Purchase Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.
(incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on September 5, 2014). †
10.17
Registration Rights Agreement dated September 3, 2014 between the Company and Hy Biopharma, Inc.
(incorporated by reference to Exhibit 10.2 of our current report on Form 8-K filed on September 5, 2014).
10.18
Contract HHSN272201400039C dated September 17, 2014 by and between the Company and the National
Institutes of Health (incorporated by reference to Exhibit 10.1 of our current report on Form 8-K filed on
September 23, 2014). †

Table of Contents
81
10.19
Lease Agreement dated November 21, 2014, between the Company and CPP II, LLC (incorporated by
reference to Exhibit 10.42 included in our Annual Report on Form 10-K for the fiscal year ended December 31,
2014).
10.20
At Market Issuance Sales Agreement dated August 11, 2017 between Soligenix, Inc. and FBR Capital Markets
& Co. (incorporated by reference to Exhibit 1.1 included in our Quarter Report on Form 10-Q for the fiscal
quarter ended June 30, 2017).
10.21
Form of Registration Rights Agreement dated October 31, 2017 (incorporated by reference to Exhibit 10.3
included in our current report on Form 8-K filed on October 31, 2017).
10.22
First Amendment to Employment Agreement dated as of April 1, 2019 between the Company and Richard
Straube, M.D. (incorporated by reference to Exhibit 10.30 included in our Annual Report on Form 10-K for the
fiscal year ended December 31, 2018.**
10.23
Soligenix, Inc. 2015 Equity Incentive Plan, as amended on June 18, 2017, September 27, 2018, September 6,
2019 and September 22, 2022. (incorporated by reference to Exhibit 10.1 included in our current report on Form
8-K filed on September 23, 2022).
10.24
Employment Agreement dated as of September 6, 2019 between the Company and Jonathan L. Guarino
(incorporated by reference to Exhibit 10.2 included in our current report on Form 8-K filed on September 11,
2019).**
10.25
Second Amendment to Employment Agreement dated as of January 2, 2020, between Soligenix, Inc. and
Christopher J. Schaber, PhD (incorporated by reference to Exhibit 10.1 included in our current report on Form
8-K filed on January 3, 2020).**
10.26
Amendment No. 1 to At Market Issuance Sales Agreement dated August 28, 2020 between Soligenix, Inc. and
B. Riley FBR, Inc. (incorporated by reference to Exhibit 10.2 included in our current report on Form 8-K filed on
August 28, 2020).
10.27
Third Extension and Amendment to Lease dated July 7, 2020 between CPP II LLC and Soligenix, Inc.
(incorporated by reference to Exhibit 10.1 included in our Quarterly Report on Form 10-Q for the fiscal quarter
ended September 30, 2020).
10.28
Loan and Security Agreement, dated December 15, 2020. (incorporated by reference to Exhibit 10.1 included in
our current report on Form 8-K filed on December 16, 2020).
10.29
Third Amendment to Employment Agreement dated as of December 10, 2020, between Soligenix, Inc. and
Christopher J. Schaber, PhD. (incorporated by reference to Exhibit 10.2 included in our current report on Form
8-K filed on December 16, 2020). **
10.30
Form S-8 Registration Statement dated December 11, 2015 relating to Soligenix, Inc. 2015 Equity Incentive
Plan (incorporated by reference to our registration statement on Form S-8 filed on October 28, 2022). **
10.31
First Amendment to Loan and Security Agreement, dated April 19, 2023 (incorporated by reference to Exhibit
10.1 included in our current report on Form 8-K filed on April 19, 2023).
10.32
Form of Pre-Funded Warrant issued in April 2024 public offering (incorporated by reference to Exhibit 4.1
included in our current report on Form 8-K filed on April 22, 2024).
10.33
Form of Common Warrant issued in April 2024 public offering (incorporated by reference to Exhibit 4.2 included
in our current report on Form 8-K filed on April 22, 2024).
10.34
Securities Purchase Agreement dated April 17, 2024 (incorporated by reference to Exhibit 10.2 included in our
current report on Form 8-K filed on April 22, 2024).

Table of Contents
82
10.35
Form of Warrant to Purchase Shares of Common Stock issued in connection with July 2024 warrant
inducement agreement (incorporated by reference to Exhibit 4.1 included in our current report on Form 8-K filed
on July 9, 2024).
10.36
Form of Warrant Inducement Agreement, by and between the Company and each Holder (incorporated by
reference to Exhibit 10.1 included in our current report on Form 8-K filed on July 9, 2024).
10.37
At Market Issuance Sales Agreement dated August 16, 2024 between Soligenix, Inc. and A.G.P./Alliance Global
Partners (incorporated by reference to Exhibit 10.1 included in our current report on Form 8-K filed on August
16, 2024).
10.38
Amendment to Loan and Security Agreement dated as of October 8, 2024 (incorporated by reference to Exhibit
10.1 included in our current report on Form 8-K filed on October 11, 2024).
19.1
Insider Trading Policy. (incorporated by reference to Exhibit 19.1 included in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2023).
21.1
Subsidiaries of the Company. *
23.1
Consent of Cherry Bekaert LLP. *
31.1
Certification of the Chief Executive Officer pursuant to Exchange Act rule 13(a)-14(a) (under Section 302 of the
Sarbanes-Oxley Act of 2002). *
31.2
Certification of the Chief Financial Officer pursuant to Exchange Act rule 13(a)-14(a) (under Section 302 of the
Sarbanes-Oxley Act of 2002). *
32.1
Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
32.2
Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. *
97
Incentive Compensation Recoupment Policy. (incorporated by reference to Exhibit 97 included in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2023).
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File – The cover page interactive data file does not appear in the Interactive Data
File because its XBRL tags are embedded within the Inline XBRL document
*
Filed herewith.
**
Indicates management contract or compensatory plan.
†
Portions of this exhibit have been omitted pursuant to a request for confidential treatment.

Table of Contents
83
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
SOLIGENIX, INC.
By: /s/ Christopher J. Schaber
Christopher J. Schaber, PhD
Chief Executive Officer and President
Date: March 21, 2025
In accordance with the Exchange Act, this report has been signed below by the following persons on behalf of the registrant
and in the capacities indicated and on the dates indicated.
Name
    
Capacity
    
Date
Chairman of the Board, Chief Executive
Officer
/s/ Christopher J. Schaber
and
March 21, 2025
Christopher J. Schaber, PhD
President (principal executive officer)
/s/ Gregg A. Lapointe
Director
March 21, 2025
Gregg A. Lapointe, CPA
/s/ Diane L. Parks
Director
March 21, 2025
Diane L. Parks, MBA
/s/ Robert J. Rubin
Director
March 21, 2025
Robert J. Rubin, MD
/s/ Jerome B. Zeldis
Director
March 21, 2025
Jerome B. Zeldis, MD, PhD
/s/ Jonathan Guarino   
Chief Financial Officer, Senior Vice
President, and
March 21, 2025
Jonathan Guarino, CPA, CGMA
Corporate Secretary (principal accounting
officer)

Table of Contents
F-1
SOLIGENIX, INC. AND SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
Table of Contents
Page
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-2
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-3
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Changes in Equity and Shareholders’ Equity (Deficit) for the Years Ended
December 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Consolidated Financial Statements
F-7 – F-26
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 00677)
F-27

Table of Contents
F-2
Soligenix, Inc. and Subsidiaries
Consolidated Balance Sheets
As of December 31, 2024 and 2023
December 31, 
December 31, 
    
2024
    
2023
Assets
 
 
  
Current assets:
 
   
  
Cash and cash equivalents
$
7,819,514
$
8,446,158
Unbilled revenue
—
171,254
Research and development incentives receivable, current
 
—
 
23,894
Deferred issuance cost
103,847
—
Prepaid expenses and other current assets
 
905,269
 
866,014
Total current assets
 
8,828,630
 
9,507,320
Security deposit
 
22,777
 
22,777
Office furniture and equipment, net
 
6,113
 
11,927
Right-of-use lease assets
 
108,963
 
229,834
Research and development incentives receivable, net of current portion
 
—
 
25,468
Total assets
$
8,966,483
$
9,797,326
Liabilities and shareholders' equity
 
  
 
  
Current liabilities:
 
  
 
  
Accounts payable
$
667,896
$
1,111,226
Accrued expenses
 
2,359,339
 
2,418,002
Accrued compensation
 
336,442
 
251,115
Lease liabilities, current
 
111,862
 
121,765
Convertible debt
1,372,873
2,250,000
Total current liabilities
 
4,848,412
 
6,152,108
Non-current liabilities:
 
  
 
  
Convertible debt
 
—
 
1,010,934
Lease liabilities, net of current portion
 
—
 
111,862
Total liabilities
 
4,848,412
 
7,274,904
Commitments and contingencies (Note 10)
 
  
 
  
Shareholders’ equity:
 
  
 
  
Preferred stock, 350,000 shares authorized; none issued or outstanding at
December 31, 2024 and December 31, 2023, respectively
—
—
Common stock, $.001 par value; 75,000,000 shares authorized; 2,514,499 and 648,761
shares issued and outstanding at December 31, 2024 and December 31, 2023,
respectively⁽¹⁾
 
2,514
 
649
Additional paid-in capital (1)
 
238,040,520
 
228,203,706
Accumulated other comprehensive income
 
45,789
 
22,243
Accumulated deficit
 
(233,970,752)
 
(225,704,176)
Total shareholders’ equity
 
4,118,071
 
2,522,422
Total liabilities and shareholders’ equity
$
8,966,483
$
9,797,326
(1) Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.
The accompanying notes are an integral part of these consolidated financial statements.

Table of Contents
F-3
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Operations
For the Years Ended December 31, 2024 and 2023
Year Ended
December 31, 
    
2024
    
2023
Revenues:
 
   
  
Grant revenue
$
119,371
$
839,359
Total revenues
 
119,371
 
839,359
Cost of revenues
 
(119,371)
 
(742,048)
Gross profit
 
—
 
97,311
Operating expenses:
 
  
 
  
Research and development
 
5,223,589
 
3,312,699
General and administrative
 
4,215,908
 
4,482,552
Total operating expenses
 
9,439,497
 
7,795,251
Loss from operations
 
(9,439,497)
 
(7,697,940)
Other income (expense):
 
  
 
  
Foreign currency transaction gain
 
1,591
 
1,483
Interest income (expense), net
 
213,975
 
(49,129)
Research and development incentives
(25,488)
23,784
CARES Act employee retention credit
312,753
120,771
Other income
43
43,223
Loss on extinguishment of debt
 
—
 
(393,791)
Change in fair value of convertible debt
260,933
43,066
Total other income (expense)
763,807
(210,593)
Net loss before income taxes
 
(8,675,690)
 
(7,908,533)
Income tax benefit
 
409,114
 
1,767,803
Net loss applicable to common stockholders
$
(8,266,576)
$
(6,140,730)
Basic and diluted net loss per share (1)
$
(4.98)
$
(12.66)
Basic and diluted weighted average common shares outstanding (1)
 
1,660,413
 
484,995
(1) Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.
The accompanying notes are an integral part of these consolidated financial statements.

Table of Contents
F-4
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Comprehensive Loss
For the Years Ended December 31, 2024 and 2023
Year Ended
December 31, 
    
2024
    
2023
Net loss
$
(8,266,576)
$
(6,140,730)
Other comprehensive income (loss):
 
 
Foreign currency translation adjustments
23,546
(2,504)
Comprehensive loss
$
(8,243,030)
$
(6,143,234)
The accompanying notes are an integral part of these consolidated financial statements.

Table of Contents
F-5
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Changes in Equity and Shareholders’ Equity (Deficit)
For the Years Ended December 31, 2024 and 2023
    
        
        
     Accumulated         
        
Mezzanine Equity-
Additional
Other
Series D Preferred Stock
Common Stock
Paid–In
Comprehensive
Accumulated
Shares
Par Value      Shares
Par Value
Capital
Income (Loss)
Deficit
Total
Balance, December 31, 2022
 
—
$
43
181,898
$
182
$ 217,067,691
$
24,747
$ (219,563,446)
$ (2,470,826)
Issuance of common stock pursuant to
At Market Issuance Sales Agreement
 
—
—
53,202
 
53
 
3,091,409
 
—
 
—
 
3,091,462
Issuance costs associated with At
Market Issuance Sales Agreement
 
—
—
—
—
(113,217)
 
—
 
—
 
(113,217)
Redemption of Series D preferred stock
—
(43)
—
—
—
—
 
—
—
Issuance of common stock in May 2023
public offering
—
—
143,844
144
8,495,673
—
 
—
8,495,817
Issuance costs associated with May
2023 public offering
—
—
—
—
(834,061)
—
—
(834,061)
Issuance of common stock to vendors
 
—
—
3,125
 
3
 
72,997
 
—
 
—
 
73,000
Issuance of common stock for purchase
option
—
—
1,978
2
49,998
—
—
50,000
Exercise of pre-funded warrants
—
—
264,714
265
3,034
—
—
3,299
Share-based compensation expense
 
—
—
—
 
—
 
370,182
 
—
 
—
 
370,182
Foreign currency translation adjustment  
—
—
—
 
—
 
—
 
(2,504)
 
—
 
(2,504)
Net loss
 
—
—
—
 
—
 
—
 
—
 
(6,140,730)
 
(6,140,730)
Balance, December 31, 2023
 
—
$
—
648,761
$
649
$ 228,203,706
$
22,243
$ (225,704,176)
$
2,522,422
Issuance of common stock pursuant to
At Market Issuance Sales Agreement
 
—
—
229,078
 
229
 
1,071,330
 
—
 
—
 
1,071,559
Issuance costs associated with At
Market Issuance Sales Agreement
 
—
—
—
—
(24,484)
 
—
 
—
 
(24,484)
Issuance of common stock and pre-
funded warrants in April 2024 public
offering
—
—
204,694
205
4,741,195
—
—
4,741,400
Issuance costs associated with April
2024 public offering
—
—
—
—
(625,065)
—
—
(625,065)
Issuance of common stock to vendors
 
—
—
5,000
 
5
 
15,795
 
—
 
—
 
15,800
Fractional shares issued in June 2024
reverse stock split
—
—
114,735
115
(115)
—
Issuance of common stock upon
exercise of warrants
—
—
34,816
35
222,787
—
—
222,822
Issuance of common stock upon
exercise of pre-funded warrants
—
—
537,500
537
8,063
—
—
8,600
Issuance of common stock from warrant
inducement
 
—
—
703,125
 
703
 
4,218,047
 
—
 
—
 
4,218,750
Issuance costs associated with warrant
inducement
—
—
—
—
(7,552,457)
—
—
(7,552,457)
Warrant modification - incremental fair
value
 
—
—
—
 
—
 
7,177,683
 
—
 
—
 
7,177,683
Issuance of common stock from
conversion of debt
—
—
36,790
36
254,220
—
—
254,256
Share-based compensation expense
 
—
—
—
 
—
 
329,815
 
—
 
—
 
329,815
Foreign currency translation adjustment  
—
—
—
 
—
 
—
 
23,546
 
—
 
23,546
Net loss
 
—
—
—
 
—
 
—
 
—
 
(8,266,576)
 
(8,266,576)
Balance, December 31, 2024
 
—
$
—
2,514,499
$
2,514
$ 238,040,520
$
45,789
$ (233,970,752)
$
4,118,071
Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.
The accompanying notes are an integral part of these consolidated financial statements.

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F-6
Soligenix, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
For the Years Ended December 31, 2024 and 2023
    
2024
    
2023
Operating activities:
 
   
  
Net loss
$
(8,266,576)
$
(6,140,730)
Adjustments to reconcile net loss to net cash used in operating activities:
 
  
 
  
Amortization and depreciation
 
5,814
 
6,554
Non-cash lease expense
 
120,871
 
111,153
Share-based compensation
 
329,815
 
370,182
Issuance of common stock to vendors for services
 
15,800
 
73,000
Issuance of common stock for purchase option
—
50,000
Loss on extinguishment of debt
 
—
 
393,791
Change in fair value of convertible debt
(260,933)
(43,066)
Amortization of deferred issuance costs associated with convertible debt
 
—
 
12,518
Change in operating assets and liabilities:
 
 
Contracts and grants receivable
 
171,254
 
(56,124)
Prepaid expenses and other current assets
 
(39,255)
 
(591,805)
Research and development incentives receivable
 
48,643
 
90,016
Operating lease liability
 
(121,765)
 
(108,948)
Accounts payable and accrued expenses
 
(492,613)
 
(2,685,073)
Accrued compensation
 
85,327
 
(85,577)
Net cash flows from operating activities
 
(8,403,618)
 
(8,604,109)
Financing activities:
 
  
 
  
Proceeds from issuance of common stock pursuant to At Market Issuance Sales Agreement
 
1,071,559
 
3,091,462
Costs associated with an At Market Issuance Sales Agreement
 
(128,331)
 
(93,011)
Proceeds from issuance of common stock and pre-funded warrants
4,741,400
8,495,817
Stock issuance costs associated with public offerings
(625,065)
(834,061)
Proceeds from the exercise of warrants
4,450,172
3,299
Issuance costs associated with warrant inducement
(374,774)
—
Convertible debt repayments
 
(1,372,872)
 
(7,000,000)
Net cash flows from financing activities
 
7,762,089
 
3,663,506
Effect of exchange rate on cash and cash equivalents
 
14,885
 
27,146
Net decrease in cash and cash equivalents
 
(626,644)
 
(4,913,457)
Cash and cash equivalents at beginning of year
 
8,446,158
 
13,359,615
Cash and cash equivalents at end of year
$
7,819,514
$
8,446,158
Supplemental information:
 
  
 
  
Cash paid for state income taxes
$
42,162
$
20,730
Cash paid for interest
$
227,735
$
552,058
Cash paid for lease liabilities:
 
 
  
Operating lease
$
136,917
$
133,817
Non-cash investing and financing activities:
 
  
 
  
Pontifax conversion of portion of debt principal into common stock
$
254,256
$
—
Deferred issuance cost reclassified to additional paid-in capital
$
250,698
$
20,208
Redemption liability for Series D preferred stock
$
—
$
43
Warrant modification - incremental value
$
7,177,683
$
—
The accompanying notes are an integral part of these consolidated financial statements.

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F-7
Soligenix, Inc. and Subsidiaries
Notes to Consolidated Financial Statements
Note 1. Nature of Business
Basis of Presentation
Soligenix,  Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical need. The Company maintains two active business
segments: Specialized BioTherapeutics and Public Health Solutions.
The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential
commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel
photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell
lymphoma (“CTCL”). With successful completion of the first Phase 3 FLASH (Fluorescent Light Activated Synthetic
Hypericin) study and agreement from the European Medicines Agency (“EMA”) on the key design components of a
confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL
patients with early stage disease, the Company began patient enrollment during December 2024 for the second Phase 3
study, called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2). The Company anticipates top-line results in the
second half of 2026. Upon successful completion of the Phase 3 FLASH2 study, regulatory approval will be sought to
support potential commercialization worldwide.
Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, and
the Company’s first-in-class Innate Defense Regulator (“IDR”) technology, and dusquetide (SGX942 and SGX945) for the
treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s
Disease.
The Company’s Public Health Solutions business segment includes development programs for RiVax®, its ricin toxin vaccine
candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine
programs, including a program targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the
prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs incorporates the use of the
Company’s proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has
been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases
(“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.
The Company primarily generates revenues under government grants and contracts. The Company was awarded a
subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan
Products Development grant over four years for an expanded study of HyBryte™ in the treatment of CTCL. The Company
will continue to apply for additional government funding.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to,
development of new technological innovations, dependence on key personnel, protections of proprietary technology,
compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability.
Liquidity
The Company has evaluated whether conditions and events, considered in the aggregate, raise substantial doubt about its
ability to continue as a going concern within one year after the date the consolidated financial statements are issued. As of
December 31, 2024, the Company had an accumulated deficit of $233,970,752 and working capital of $3,980,218. For the
year ended December 31, 2024, the Company incurred a net loss of $8,266,576 and used $8,403,618 of cash in operating
activities. The Company expects to continue generating losses for the foreseeable future, and its liquidity needs will depend
largely on budgeted operational expenditures related to the advancement of its product candidates.
Management believes that the Company has sufficient resources to support development activities, business operations,
and meet its obligations through the fourth quarter of 2025. However, as of the date of this filing, the Company does not

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F-8
have sufficient cash and cash equivalents to fund operations for at least 12 months following the issuance of these financial
statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern.
To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the
Company’s plans include securing:
●
additional capital, potentially through a combination of public or private equity offerings and strategic transactions,
including potential alliances and drug product collaborations;
●
additional proceeds from government contract and grant programs; and
●
additional proceeds from the sale of shares of the Company’s common stock via the At Market Issuance Sales
Agreement (“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”).
While the AGP Sales Agreement is in place, none of the other funding alternatives are currently committed. There is no
assurance that the Company will be successful in securing sufficient financing on acceptable terms, if at all. Failure to obtain
adequate funding may require the Company to delay, reduce, or eliminate certain business activities and development
programs, materially impacting its financial condition and results of operations.
Additionally, macroeconomic and geopolitical uncertainties may further restrict access to capital, exacerbating liquidity
challenges. Furthermore, concerns regarding the Company’s ability to continue as a going concern could negatively impact
relationships with business partners, vendors, and other stakeholders.
The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to
recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be
necessary should the Company be unable to continue as a going concern.
Management’s business strategy can be outlined as follows:
●
Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-
controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3
FLASH study, continue enrollment and execution of the FLASH2 study, while at the same time, continuing
discussions with the FDA on potential modifications to the development path to adequately address their feedback.
●
Expand development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a
Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a
small Phase 1/2 pilot study in mild-to-moderate psoriasis patients.
●
Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency
(“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be
required to support a marketing authorization, design a second study and attempt to identify a potential partner(s) to
continue this development program.
●
Expand development of dusquetide under the research name SGX945 into Behçet’s Disease by conducting a
Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in
aphthous ulcers induced by chemotherapy and radiation.
●
Continue development of the Company’s heat stabilization platform technology, ThermoVax®, in combination with its
programs for RiVax® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and
multivalent combinations), with United States (“U.S.”) government or non-governmental organization funding
support.
●
Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public
Health Solutions programs through grants, contracts and/or procurements.

Table of Contents
F-9
●
Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives,
including but not limited to merger/acquisition strategies.
●
Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with
existing pipeline compounds for development.
The Company’s plans with respect to its liquidity management include, but are not limited to, the following:
●
The Company has up to approximately $554,000 in active government grant funding still available as of
December 31, 2024 to support its associated research programs through May 2026, provided the federal agencies
do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant
applications for further support of its programs with various funding agencies. However, there can be no assurance
that the Company will obtain additional governmental grant funding.
●
The Company will continue to use equity instruments to provide a portion of the compensation due to vendors and
collaboration partners and expects to continue to do so for the foreseeable future.
●
The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its
Technology Business Tax Certificate Transfer Program if the program is available.
●
The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger
and acquisition strategies. However, there can be no assurances that the Company can consummate such
transactions.
●
The Company plans to use the proceeds from a completed public offering on April 22, 2024 of 204,694 shares of its
common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to
purchase up to 742,194 shares of its common stock at a combined public offering price of $6.40 for further support
of its programs, as well as for working capital. The pre-funded warrants have an exercise price of $0.02. The
common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years
from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75
million before deducting commissions and other estimated offering expenses of approximately $0.45 million.
●
The Company plans to use the proceeds from a warrant inducement agreement (the “Inducement Agreement”) on
July 9, 2024 with certain holders (the “Holders”) of the Company’s existing Warrant to Purchase Shares of Common
Stock (“Existing Warrants”) to purchase shares of common stock of the Company for further support of its programs,
as well as for working capital. In consideration of the Holders’ agreement to exercise their Existing Warrants, the
Company (i) decreased the exercise price of the Existing Warrants from $6.40 per share to $6.00 per share and (ii)
issued new warrants (“New Warrants”) to the Holders to purchase a number of shares of common stock equal to
150% of the number of shares of common stock issued upon exercise of the Holders’ Existing Warrants. Pursuant
to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to
703,125 shares of the Company’s common stock at a reduced exercise price of $6.00 per share on July 9, 2024,
the date of the Inducement Agreement, until 1:30 p.m., Eastern Time. The total gross proceeds to the Company
was approximately $4.2 million from the exercise of the Existing Warrants before deducting financial advisory fees
and other expenses.
●
The Company has up to approximately $2.1 million remaining from the AGP Sales Agreement as of March 14, 2025
under the prospectus supplement dated August 16, 2024. From January 1, 2025 through March 14, 2025, the
Company sold 628,758 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price
of $4.23 per share for total gross proceeds of approximately $2.7 million.
●
The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may
execute them when appropriate. However, there can be no assurances that it can consummate such a transaction,
or consummate a transaction at favorable pricing.

Table of Contents
F-10
Reverse Stock Split
On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a
ratio of one-for-sixteen, whereby every sixteen shares of the Company’s issued and outstanding common stock were
automatically combined into one issued and outstanding share of common stock without any change in the par value per
share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise
have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began
trading on The Nasdaq Capital Market on a reverse split basis at the market opening on June 6, 2024. All share and per
share data have been restated to reflect this reverse stock split.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant
intercompany accounts and transactions have been eliminated as a result of consolidation.
Operating Segments
Operating segments are defined as components of an enterprise about which separate financial information is available that
is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate
resources to an individual segment and in assessing the performance of the segment. The Company divides its operations
into two operating segments: Specialized BioTherapeutics and Public Health Solutions.
Cash and Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash
equivalents.
Contracts and Grants Receivable
Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an
institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the
respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no
allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations.
Impairment of Long-Lived Assets
Office furniture and equipment, right of use assets and website development costs with finite lives are evaluated and
reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be
recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets
exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted
cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference
between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve
significant judgment.
The Company did not record any impairment of long-lived assets for the years ended December 31, 2024 and 2023.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. Disclosures regarding the fair value of all financial instruments are
required for financial statement purposes, regardless of whether they are recognized in the financial statements. Fair value
disclosures are based on information available to the Company as of December  31,  2024 and 2023. Accordingly, the
estimates presented in these financial statements may not necessarily reflect the amounts that could be realized upon the
disposition of these financial instruments.

Table of Contents
F-11
Fair Value valuation techniques include a three-level hierarchy based on whether the inputs to those valuation techniques
are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while
unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in
active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3
measurement).
The three levels of the fair value hierarchy are as follows:
●
Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to
access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted
market prices such as exchange-traded instruments and listed equities.
●
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either
directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation
methodologies. These models consider various assumptions, including volatility factors, current market prices and
contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in
the marketplace, can be derived from observable data or are supported by observable levels at which transactions
are executed in the marketplace.
●
Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair
values are determined using pricing models, discounted cash flows or similar techniques and at least one significant
model assumption or input is unobservable.
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value
hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest
level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a
particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or
liability.
The carrying amounts reported in the consolidated balance sheets for cash and cash equivalents, contracts and grants
receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued
compensation approximate their fair value based on the short-term maturity of these instruments.
Deferred Issuance Costs
The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-
process equity financings as deferred issuance costs until such financings are consummated. After consummation of the
equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a
result of the issuance.
Change in Accounting Estimates
The Company accrues clinical trial expenses per contracts with clinical sites over the course of the clinical trial period.
Accrued trial expenses are assessed for accuracy on an ongoing basis during the trial period and beyond. For the year
ended December 31, 2024, the Company made adjustments to estimated accrued clinical trial expenses for completed trials
of approximately $1.4 million. These adjustments resulted in decreases to research and development expenses in the
accompanying consolidated statements of operations during the year ended December 31, 2024.
Revenue Recognition
The Company’s revenues include revenues generated from government contracts and grants. The revenue from
government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered
by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and
management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the
Company incurs reimbursable internal expenses that are related to the government contracts and grants.

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F-12
The Company also records revenue from contracts with customers in accordance with applicable accounting guidance which
requires an entity to recognize revenue when its customer obtains control of promised goods or services, in an amount that
reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue
recognition for arrangements that an entity determines are within the scope of this guidance, the entity performs the
following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii)
determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v)
recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model
to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or
services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of this
guidance, the Company assesses the goods or services promised within each contract and determines those that are
performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as
revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the
performance obligation is satisfied.
Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as
future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based
royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be
recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to
which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not
recognized any royalty revenue.
Research and Development Costs
Research and development costs are charged to expense when incurred in accordance with applicable accounting
guidance. Research and development includes costs such as clinical trial expenses, contracted research and license
agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee
benefits, equipment depreciation and allocation of various corporate costs.
Share-Based Compensation
Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to
directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance).
Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of
three years. These options have a ten year life for as long as the individuals remain employees or directors. In general,
when an employee or director terminates their position, the options will expire within three  months, unless otherwise
extended by the Board.
The fair value of options issued during the years ended December  31,  2024 and 2023 was estimated using the Black-
Scholes option-pricing model and the following assumptions:
●
a dividend yield of 0%;
●
an expected life of four years;
●
volatility of 108% - 130% for 2024 and 94% - 110% for 2023; and
●
risk-free interest rates ranging from 4.16% to 4.76% in 2024 and ranging from 3.48% to 4.35% in 2023.
The fair value of each option grant made during 2024 and 2023 was estimated on the date of each grant and recognized as
share-based compensation expense ratably over the option vesting periods, which approximates the service period. The
expected term of options granted is derived using company history of options exercised. The risk-free rate is based on the
U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The Company accounts for
forfeitures as they are incurred.
From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for
services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the

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F-13
grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-
employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-
208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such
shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified
awards to non-employees is measured on the date of grant and is recognized when the services are performed.
Foreign Currency Transactions and Translation
In 2018, the Company changed the status of a wholly-owned subsidiary in the UK from inactive to active and incurred
expenditures in multiple currencies including the U.S. dollar, the British Pound and the Euro to fund its clinical trial operations
in the UK and select countries in Europe. In accordance with FASB ASC 830 Foreign Currency Matters, the UK subsidiary
expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related
transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are
translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as
a cumulative translation adjustment (“CTA”), which is a component of accumulated other comprehensive loss. In 2024 and
2023, the Company recognized foreign currency transaction gains of $1,591 and $1,483, respectively, in the accompanying
consolidated statements of operations.
Income Taxes
Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax basis. A valuation allowance is
established when it is more likely than not that all or a portion of a deferred tax asset will not be realized. A review of all
available positive and negative evidence is considered, including the Company’s current and past performance, the market
environment in which the Company operates, the utilization of past tax credits, and the length of carryback and carryforward
periods. Deferred tax assets and liabilities are measured utilizing tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The Company sold 2023, 2022 and 2021 New
Jersey NOL carryforwards resulting in the recognition of income tax benefits, net of transaction costs of $409,114 and
$1,767,803 during the years ended December 31, 2024 and 2023, respectively. The Company sold its 2023 New Jersey
NOLs and has recorded a receivable of $409,114 which is included in prepaid expenses and other current assets on the
accompanying consolidated balance sheet for the year ended December  31,  2024. The Company recognizes accrued
interest and penalties associated with uncertain tax positions, if any, as part of income tax expense. There were no tax
related interest and penalties recorded for 2024 and 2023. Additionally, the Company has not recorded an asset for
unrecognized tax benefits or a liability for uncertain tax positions at December 31, 2024 or 2023.
Research and Development Incentive Income and Receivable
The Company recognizes other income from UK research and development incentives when there is reasonable assurance
that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably
measured. The small or medium sized enterprise (“SME”) research and development tax relief program supports companies
that seek to research and develop an advance in their field and is governed through legislative law by HM Revenue  &
Customs as long as specific eligibility criteria are met.
Management has assessed the Company’s research and development activities and expenditures to determine which
activities and expenditures are likely to be eligible under the SME research and development tax relief program described
above. At each period end, management estimates the refundable tax offset available to the Company based on available
information at the time. As the tax incentives may be received without regard to an entity’s actual tax liability, they are not
subject to accounting for income taxes. As a result, amounts realized under the SME research and development tax relief
program are recorded as a component of other income.
The research and development incentive receivable represents an amount due in connection with the above-described tax
relief program. The Company has recorded a research and development incentive receivable of approximately $0 and
$49,000 as of December 31, 2024 and 2023, respectively in the consolidated balance sheets. As a result of certain rule
changes to the SME research and development tax relief program, the Company is no longer participating in the program as
of December 31, 2024. Accordingly, during 2024, the Company adjusted previously recorded research and development

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F-14
incentive receivables to zero resulting in a loss of $25,468 recognized in the accompanying 2024 consolidated statement of
operations.
The following table shows the change in the UK research and development incentives receivable from December 31, 2023
to December 31, 2024:
    
Current
    
Long-Term
 
Total
Balance at December 31, 2023
 
$
23,894
$
25,468
$
49,362
UK research and development incentives, transfer
 
25,468
(25,468)  
—
UK research and development incentives, adjustments
(25,468)
(20)
(25,488)
UK research and development incentives cash receipt
 
(23,848)
 
—
 
(23,848)
Foreign currency translation
 
(46)
 
20
 
(26)
Balance at December 31, 2024
$
—
$
—
$
—
Loss Per Share
Basic earnings per share (“EPS”) is computed by dividing loss applicable to common stockholders by the weighted-average
number of common shares outstanding for the period. Included within the Company’s weighted average common shares
outstanding (basic and diluted) for the year ended December 31, 2024, are common shares issuable upon the exercise of
the pre-funded warrants as these pre-funded warrants are exercisable at any time for nominal consideration.
The following table summarizes outstanding instruments which were not included in the computation of diluted EPS as to do
so would have been antidilutive:
December 31, 
December 31, 
    
2024
    
2023
Common stock purchase warrants
1,467,581
408,640
Stock options
 
229,919  
56,609
Convertible debt
 
360,335  
273,973
Total
 
2,057,835  
739,222
Use of Estimates and Assumptions
The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires
management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for
clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results
could differ from those estimates.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07,
Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update enhances the segment
reporting requirements by increasing transparency and providing investors with additional insights into how an entity’s Chief
Operating Decision Maker (“CODM”) evaluates segment performance and allocates resources.
The standard requires public entities to disclose significant segment expenses that are regularly reviewed by the CODM and
included in the reported measure of segment profit or loss. Additionally, entities must provide a reconciliation of total
segment amounts to consolidated financial statements, as well as enhanced qualitative disclosures regarding the
methodology used to identify reportable segments and assess performance. The update applies to all public entities,
including those with a single reportable segment, and expands segment disclosures in interim financial statements.
ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years
beginning after December 15, 2024. The Company has adopted ASU 2023-07 for the year ended December 31, 2024, and
has updated its segment disclosures accordingly. The adoption of this standard did not impact the recognition or
measurement of the Company’s financial statements but resulted in enhanced segment-related disclosures in the notes to
the consolidated financial statements.

Table of Contents
F-15
Note 3. Leases
The Company classifies a lease for its office space as an operating lease, and records a related right-of-use lease asset and
lease liability accordingly. Pursuant to the lease which expires October 2025, the current rent is $11,625 per month.
The following represents a reconciliation of contractual lease cash flows to the right-of-use lease asset and liability
recognized in the financial statements:
Operating
    
Lease
    
Contractual cash payments for the remaining lease term as of December 31, 2024
2025
 
$
116,250
Less implied interest
4,388
Total
$
111,862
Discount rate applied
 
8.47 %  
Remaining lease term (months) as of December 31, 2024
 
10
Lease expense for the year ended December 31, 2023:
 
  
Lease expense
$
136,022
Total
$
136,022
Lease expense for the year ended December 31, 2024:
Lease expense
$
136,022
Total
$
136,022
Note 4. Accrued Expenses
The following is a summary of the Company’s accrued expenses:
December 31, 
    
2024
    
2023
Clinical trial expenses
$
1,135,542
$
1,993,784
Other
 
1,223,797
 
424,218
Total
$
2,359,339
$
2,418,002
Note 5. Debt
In December 2020, the Company entered into a $20 million convertible debt financing agreement (the “Loan Agreement”)
with Pontifax Medison Debt Financing (“Pontifax”), the healthcare-dedicated venture and debt fund of the Pontifax life
science funds. Under the terms of the Loan Agreement, the Company had access to up to $20 million in convertible debt
financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years with a
fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an
unused line of credit fee. After the interest-only period, the outstanding principal was to be repaid in quarterly payments of
$1 million each commencing in the first quarter of 2023. The agreement was secured by a lien covering substantially all of
the Company’s assets, other than intellectual property.
Upon the closing of this transaction, the Company accessed the first tranche of $10 million, had the option to draw the
second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing
of the HyBryte™ NDA, subject to certain conditions. The Company elected to let the options to borrow both the second and
third tranches expire as of December 15, 2021 and March 15, 2022, respectively.
In April 2023, the Company entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023
Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest,
waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal
balance of $3 million. The 2023 Amendment also provided for interest only through June 30, 2024, reduced quarterly
principal repayments to $750,000 and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced the

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F-16
conversion price with respect to the remaining principal amount to (i) 90% of the closing price of the Company’s common
stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of the Company’s common
stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon
conversion thereafter. The remaining terms of the agreement remained unmodified.
On January 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining
principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 9,139 shares of the
Company’s common stock at $10.88 per share, reducing the remaining principal balance by $99,416.
On April 15, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining
principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 27,651 shares of the
Company’s common stock at $5.60 per share, reducing the remaining principal balance by $154,840.
The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. The Company
elected to account for the amended convertible debt using the fair value option. The fair value of the convertible debt on the
date of the amendment was approximately $3,304,000, which resulted in the recognition of a loss on extinguishment of
approximately $394,000 on the Company’s accompanying consolidated statements of operations for the year ended
December 31, 2023. The fair value of the convertible debt as of December 31, 2023 was approximately $3,260,934, which
resulted in the recognition of $43,066 of other income from the change in the fair value of the convertible debt on the
Company’s accompanying consolidated statements of operations for the year ended December 31, 2023. For 2023 and
through the 2024 Amendment (described below), the fair value of the convertible debt was estimated using the Monte Carlo
valuation method.
In October 2024, the Company entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended.
The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81
for the first 501,648 shares of the Company’s common stock issuable upon conversion and (ii) $4.23 with respect to all
shares of the Company’s common stock issuable upon conversion thereafter. The remaining terms of the agreement
remained in effect with minimal, non-material modifications to those terms. The 2024 Amendment resulted in a substantial
modification of the debt for accounting purposes, as defined, which is accounted for as an extinguishment. The difference
between the fair value, or net carrying amount, of the debt before the 2024 Amendment and upon reacquisition was
diminimus. Accordingly, no gain or loss was recognized related to the extinguishment related to the 2024 Amendment.
Furthermore, as the 2024 Amendment resulted in a substantial modification, as defined, the Company elected not to account
for the convertible debt using the fair value option in accordance with the applicable guidance. The Company determined the
embedded conversion feature, after the 2024 Amendment, does not require bifurcation and is therefore the convertible debt,
as amended, has been recorded as a single liability classified instrument in accordance with ASU 2020-06.  As a result of
this election, the Company recognized a gain of $260,933 of other income from the change in the fair value of the
convertible debt on the Company’s accompanying 2024 consolidated statement of operations.
In February 2025, the Company fully repaid all outstanding obligations and terminated the Loan Agreement. As a result, all
related liens and security interests securing the Company’s obligations were released. The Company did not incur any
prepayment penalties for the early repayment.
Interest expense incurred during the years ended December 31, 2024 and 2023 was $192,998 and $402,615, respectively.
Interest expense paid during the years ended December 31, 2024 and 2023 was $227,735 and $552,058, respectively.
Annual principal and interest payments due, according to the agreement’s contractual terms, assuming no conversion is as
follows as of December 31, 2024:
Year
    
Principal
    
Interest
    
Total
2025
 
1,372,873
 
43,646
 
1,416,519
Total
$
1,372,873
$
43,646
$
1,416,519

Table of Contents
F-17
Note 6. Income Taxes
The income tax benefit consisted of the following for the years ended December 31, 2024 and 2023:
    
2024
    
2023
State & Local
 
(409,114)
 
(1,767,803)
Income tax benefit
$
(409,114)
$
(1,767,803)
The significant components of the Company’s deferred tax assets and liabilities at December 31, 2024 and 2023 are as
follows:
    
2024
    
2023
Net operating loss carry forwards
$
28,438,000
$
27,522,000
Orphan drug and research and development credit carry forwards
 
9,617,000
 
8,921,000
Equity based compensation
 
227,000
 
246,000
Intangibles
 
1,401,000
 
1,409,000
Capitalized research and development
 
2,482,000
 
2,311,000
Lease liability
 
69,000
 
66,000
Other
(85,000)
(12,000)
Total
 
42,149,000
 
40,463,000
Valuation allowance
(42,087,000)
(40,398,000)
Net deferred tax assets
62,000
65,000
Right of use asset
(62,000)
(65,000)
Total gross deferred tax liabilities
 
(62,000)
 
(65,000)
Net deferred tax assets
$
—
$
—
The Company had gross NOLs at December  31,  2024 of approximately $124.6 million for federal tax purposes,
approximately $21.9 million for state tax purposes and approximately $3.7 million for foreign tax purposes. Federal losses
generated in 2018 or later will carry forward indefinitely. In addition, the Company has approximately $9.6 million of various
tax credits which credit the Company may be able to utilize its NOLs to reduce future federal and state income tax liabilities.
However, these NOLs are subject to various limitations under Internal Revenue Code (“IRC”) Section 382. IRC Section 382
limits the use of NOLs to the extent there has been an ownership change of more than 50 percentage points. In addition, the
NOL carryforwards are subject to examination by the taxing authority and could be adjusted or disallowed due to such
exams. Although the Company has not undergone an IRC Section 382 analysis, it is likely that the utilization of the NOLs
may be substantially limited.
The Company and one or more of its subsidiaries files income tax returns in the U.S. federal jurisdiction, and various state
and local jurisdictions. During the years ended December 31, 2024 and 2023 in accordance with the State of New Jersey’s
Technology Business Tax Certificate Program, which allowed certain high technology and biotechnology companies to sell
unused NOL carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carry
forwards, resulting in the recognition of $409,114 and $1,767,803, respectively, of income tax benefit, net of transaction
costs. The Company sold its 2023 New Jersey NOLs and has recorded a receivable of $409,114 which is included in
prepaid expenses and other current assets on the accompanying consolidated balance sheet for the year ended
December 31, 2024. There can be no assurance as to the continuation or magnitude of this program in the future.

Table of Contents
F-18
Reconciliations of the difference between income tax benefit computed at the federal and state statutory tax rates and the
provision for income tax benefit for the years ended December 31, 2024 and 2023 were as follows:
    
2024
    
2023
 
Federal tax at statutory rate
 
(21.0)%
(21.0)%
State tax benefits, plus sale of NJ NOL, net of federal benefit
 
(12.2) 
(21.6)
Foreign tax rate difference
 
—  
0.1
Orphan drug and research and development credits
 
(8.1) 
(2.0)
Permanent differences
 
1.3  
0.9
Foreign NOL adjustments
 
0.6  
0.7
Expiration of tax attributes
 
15.2  
14.2
Change in valuation allowance
 
19.5  
6.3
Income tax benefit
 
(4.7)%  
(22.4)%
Entities are also required to evaluate, measure, recognize and disclose any uncertain income tax provisions taken on their
income tax returns. The Company has analyzed its tax positions and has concluded that as of December 31, 2024, there
were no uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception
and as such, tax years subject to potential tax examination could apply from 2005, the earliest year with a net operating loss
carryover, because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or
state taxing authorities. Interest and penalties, if any, as they relate to income taxes assessed, are included in the income
tax provision. The Company did not have any unrecognized tax benefits and has not accrued any interest or penalties for
the years ended December 31, 2024 and 2023.
Note 7. Shareholders’ Equity
Preferred Stock
The Company has 350,000 shares of preferred stock authorized as of December 31, 2024.
Series D Preferred Stock
On December 21, 2022, the Board of Directors of the Company declared a dividend for the stockholders of record on
January 3, 2023. The dividend consisted of one one-thousandth of a share of Series D preferred stock, par value $0.001 per
share, for each outstanding share of the Company's common stock. The Series D preferred stock had the following rights
and restrictions:
General; Transferability - Series D preferred stock shares will be in book-entry form without certificates. Transfers can only
happen alongside common stock transfers, with 1/1,000th of a Series D preferred stock share transferred for each common
stock share transferred.
Voting Rights - Each Series D preferred stock share gives the holder 1,000,000 votes. If a shareholder owns a fraction of a
share, they will have a proportional number of votes.
Series D preferred stock and common stock shares only vote together on two specific matters:
1.
Any plan to change the Company's Certificate of Incorporation for a reverse stock split.
2.
Any plan to delay a stockholders' meeting to vote on a reverse stock split (the "Adjournment Proposal").
When voting on the reverse stock split or the Adjournment Proposal, each Series D preferred stock share (or fraction of a
share) will vote the same way as the common stock share it was issued from.
Dividend Rights - The holders of Series D preferred stock will not be entitled to receive dividends of any kind.
Liquidation Preference - If the Company undergoes liquidation, dissolution, or winding up, Series D preferred stock has
priority over common stock for asset distribution. In such a situation, Series D preferred stockholders will receive a cash
payment of $0.001 per share before any distribution is made to common stockholders.

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F-19
Redemption - If Series D preferred stockholders do not attend or vote by proxy at a meeting for the reverse stock split and
Adjournment Proposal, their shares will be automatically redeemed by the Company. If any Series D preferred stock remains
after this redemption, it can be redeemed in one of two ways:
1.
The Board decides to redeem the shares at a time and date of their choosing.
2.
The shares will be automatically redeemed when the Company's stockholders approve the reverse stock split
during a meeting for this purpose.
When Series D preferred stock is redeemed, stockholders receive a cash payment based on the number of shares they
own. For every 100 whole shares redeemed, the stockholder will get $0.10 in cash.
The Series D preferred stock shares were classified as mezzanine equity as of December 31, 2022 since they were not
mandatorily redeemable but were redeemable based on an event not entirely controlled by the Company. All Series D
preferred stock were redeemed in conjunction with the special meeting of the shareholders’ on February 8, 2023.
Common Stock
The following items represent transactions in the Company’s common stock for the year ended December 31, 2024:
●
The Company issued Pontifax 9,139 shares of fully vested common stock pursuant to conversion of a portion of the
convertible debt principal balance at a conversion price of $10.88 per share on January 3, 2024. The conversion
price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the
conversion notice.
●
The Company issued Pontifax 27,651 shares of fully vested common stock pursuant to conversion of a portion of
the convertible debt principal balance at a conversion price of $5.60 per share on April 15, 2024. The conversion
price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the
conversion notice.
●
The Company sold 204,694 shares of common stock and 537,500 pre-funded warrants pursuant to the April 2024
public offering for $6.40 per share on April 22, 2024.
●
 The Company issued 97,375 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the April 2024 public offering with an exercise price of $0.02 on April 22, 2024.
●
The Company issued 69,125 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the April 2024 public offering with an exercise price of $0.02 on June 11, 2024.
●
The Company issued 117,000 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the April 2024 public offering with an exercise price of $0.02 on June 14, 2024.
●
The Company issued 130,000 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the April 2024 public offering with an exercise price of $0.02 on June 20, 2024.
●
The Company issued 124,000 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the April 2024 public offering with an exercise price of $0.02 on June 25, 2024.
●
The Company issued 703,125 shares of common stock pursuant to the exercise of warrants associated with the
April 2024 public offering with an exercise price of $6.00 on July 10, 2024.
●
The Company issued 31,250 shares of common stock pursuant to the exercise of warrants associated with the April
2024 public offering with an exercise price of $6.40 on July 10, 2024.
●
The Company issued 2,190 shares of common stock pursuant to the exercise of warrants associated with the April
2024 public offering with an exercise price of $6.40 on July 11, 2024.

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F-20
●
The Company issued 1,376 shares of common stock pursuant to the exercise of warrants associated with the April
2024 public offering with an exercise price of $6.40 on July 23, 2024.
●
The Company sold 229,078 shares of common stock pursuant to the AGP Sales Agreement at a weighted average
price of $4.72 per share.
The issuance of the Company’s common stock in connection with the convertible debt financing agreement as described
above was exempt under Section 3(a)(9) of the Securities Act of 1933, as amended.
The issuances of the Company’s common stock in connection with the April 2024 public offering and upon the exercise of
warrants described above were registered on a Registration Statement on Form S-1.
The issuance of the Company’s common stock pursuant to the AGP Sales Agreement described above was registered on a
Registration Statement on Form S-3.
The following items represent transactions in the Company’s common stock for the year ended December 31, 2023:
●
The Company issued a vendor 3,125 shares of fully vested common stock with a fair value based on a closing price
of $23.36 per share on April 27, 2023, the date of issuance.
●
The Company sold 53,202 shares of common stock pursuant to an At Market Issuance Sales Agreement with B.
Riley Securities, Inc. (“B. Riley”) at a weighted average price of $58.11 per share.
●
The Company issued 1,978 shares of fully vested common stock pursuant to an exclusive option agreement at
$25.28 per share on May 2, 2023. The share price was calculated using the average closing price of the common
stock for the ten days immediately preceding April 27, 2023, the effective date of the option agreement.
●
The Company sold 143,844 shares of common stock and 264,815 pre-funded warrants pursuant to the May 2023
public offering for $20.80 per share on May 9, 2023.
●
The Company issued 126,438 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the May 2023 public offering with an exercise price of $0.02 on May 9, 2023.
●
The Company issued 58,625 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the May 2023 public offering with an exercise price of $0.02 on May 10, 2023.
●
 The Company issued 21,125 shares of common stock pursuant to the exercise of pre-funded warrants associated
with the May 2023 public offering with an exercise price of $0.02 on May 22, 2023.
●
The Company issued 25,001 shares of common stock pursuant to the cashless exercise of pre-funded warrants
associated with the May 2023 public offering with an exercise price of $0.02 on June 8, 2023.
●
The Company issued 33,525 shares of common stock pursuant to the cashless exercise of pre-funded warrants
associated with the May 2023 public offering with an exercise price of $0.02 on September 6, 2023.
All issuances of the Company’s common stock for the years ended December 31, 2024 and 2023 described above, other
than shares issued to vendors or issued pursuant to the exclusive option agreement, were registered on a Registration
Statement on Form S-8 (SEC File No. 333-208515), a Registration Statement on Form S-1 (333-271049) and a Registration
Statement on Form S-3 (SEC File No. 333-239928). The certificates evidencing unregistered shares reflect a Securities Act
of 1933, as amended, restrictive legend.
The issuances of the Company’s common stock to vendors and pursuant to the exclusive option agreement as described
above were exempt under Section 4(a)(2) of the Securities Act of 1933, as amended. The recipients are knowledgeable,
sophisticated and experienced in making investment decisions of this kind and received adequate information about the
Company or had adequate access to information about the Company. The vendors represented to the Company that the
vendors are not “consultants” for purposes of Nasdaq Listing Rule 5635(c).

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F-21
At Market Issuance Sales Agreement with B. Riley
On August  11, 2017, the Company entered into an At Market Issuance Sales Agreement with B. Riley (“B. Riley Sales
Agreement”) to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering
program under which B. Riley acts as sales agent. Under the B. Riley Sales Agreement, the Company set the parameters
for the sale of shares, including the number of shares to be issued, the time period during which sales may be requested to
be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which
sales may not be made. The B. Riley Sales Agreement provided that B. Riley was entitled to compensation for its services in
an amount equal to 3% of the gross proceeds from the sale of shares sold under the B. Riley Sale Agreement. The B. Riley
Sales Agreement has expired.
AGP At Market Issuance Sales Agreement
In August 2024, the Company entered into the AGP Sales Agreement to sell shares of the Company’s common stock from
time to time, through an “at-the-market” equity offering program (the “AGP ATM”). In connection with the sale of shares via
the AGP ATM, the Company determines, among other things, the number of shares to be issued, the time period during
which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day, and
any minimum price below which sales may not be made. Pursuant to the terms, AGP is entitled to compensation for its
services in an amount up to 3% of the gross proceeds from the sale of shares under the AGP ATM. The Company has no
obligation to sell any shares under the AGP ATM, and may suspend solicitation and offers at any time. The AGP ATM may
be terminated by the Company or AGP upon notice, or at any time under certain circumstances, including but not limited to
the occurrence of a material adverse change in the Company. The AGP ATM will terminate upon the earliest of (a)
December 15, 2026, (b) the sale of all of the shares of common stock subject to the AGP ATM, (c) the termination of the
AGP Sales Agreement as permitted therein, or (d) the mutual agreement of the parties.
The AGP Sales Agreement provides for the offer and sale of shares of common stock having an aggregate offering price of
up to $5.8 million. As of March 14, 2025, there was approximately $2.1 million available for future sale of common stock
pursuant to the AGP ATM.
July 2024 Warrant Inducement
On July 9, 2024, the Company entered into the Inducement Agreement with the Holders of the Company’s Existing Warrants
to purchase shares of common stock of the Company. Pursuant to the Inducement Agreement, the Holders agreed to
exercise for cash their Existing Warrants to purchase up to 703,125 shares of common stock at a reduced exercise price of
$6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m. Eastern Time. The aggregate gross
proceeds received by the Company was approximately $4.2 million from the exercise of the Existing Warrants offset by total
issuance costs of approximately $7.5 million. Issuance costs include financial advisory, banker, and legal fees of
approximately $0.4 million and the fair value of the warrant modification and the fair value of the New Warrants issued
totaling approximately $7.2 million. Because the modification represented a short-term inducement, the Company applied
modification accounting guidance related to the fair value of the modification associated with the warrants that were
exercised under the Inducement Agreement. Accordingly, the Company recognized the incremental fair value of the
modification of the Existing Warrants exercised along with the fair value of the New Warrants issued as compared to the
original warrants, together totaling approximately $7.2 million, as an issuance cost of the warrant exercise. Per the terms of
the Inducement Agreement, the Company issued an aggregate of 1,054,688 New Warrants.
The fair value of the New Warrants issued under the Inducement Agreement was estimated using the Black-Scholes
warrant-pricing model and the following assumptions:
●
a dividend yield of 0%;
●
an expected life of 5 years;
●
volatility of 127.25%; and
●
risk free interest rate of 4.24%.

Table of Contents
F-22
Note 8. Stock Option Plans and Warrants to Purchase Common Stock
Stock Option Plans
The Amended and Restated 2005 Equity Incentive Plan (“2005 Plan”) was replaced by the 2015 Plan, which was approved
in June 2015. No securities are available for future issuance under the 2005 Plan. As of December 31, 2024, there are
5,770,122 shares currently available for grants under the 2015 Plan. The plan is divided into four separate equity programs:
1)
the Discretionary Option Grant Program, under which eligible persons may, at the discretion of the Plan
Administrator, be granted options to purchase shares of common stock,
2)
the Salary Investment Option Grant Program, under which eligible employees may elect to have a portion of their
base salary invested each year in options to purchase shares of common stock,
3)
the Automatic Option Grant Program, under which eligible nonemployee Board members will automatically receive
options at periodic intervals to purchase shares of common stock, and
4)
the Director Fee Option Grant Program, under which non-employee Board members may elect to have all, or any
portion, of their annual retainer fee otherwise payable in cash applied to a special option grant.
Shares available for grant under the 2015 Plan were as follows:
Shares available for grant at January 1, 2024
    
5,943,590
Options granted
 
(173,740)
Options forfeited
 
272
Options exercised
—
Shares available for grant at December 31, 2024
 
5,770,122
Activity under the 2005 Plan and the 2015 Plan for the years ended December 31, 2024 and 2023:
    
    
    
Weighted
Average
Exercise
    
Options
    
Price
Balance outstanding at December 31, 2022
 
11,946
$
435.32
Granted
 
45,715
 
10.45
Forfeited
 
(1,052)
 
533.80
Cancelled
—
—
Exercised
—
—
Balance outstanding at December 31, 2023
 
56,609
$
90.58
Granted
 
173,740
 
3.35
Forfeited
 
(430)
 
1,549.28
Cancelled
—
—
Exercised
 
—
 
—
Balance outstanding at December 31, 2024
 
229,919
$
21.94
As of December 31, 2024, there were 72,985 options exercisable with a weighted average exercise price of $59.19 and a
weighted average remaining contractual term of 8.92 years. As of December  31,  2024, there were 229,919 options
outstanding with a weighted average remaining term of 9.54 years. Options outstanding as of December 31, 2024 had no
intrinsic value.

Table of Contents
F-23
The Company awarded 173,740 and 45,715 stock options during the years ended December  31,  2024 and 2023,
respectively, which had a weighted average grant date fair value per share of $2.90 and $8.05, respectively. The weighted-
average exercise price, by price range, for outstanding options to purchase common stock at December 31, 2024 was:
    
Weighted
    
    
    
    
Average
Remaining
Contractual
Outstanding
Exercisable
Price Range
    
Life in Years     
Options
    
Options
$3.31 - $10.78
 
9.74  
218,268  
61,868
$129.60 - $640.80
 
5.83  
11,382  
10,848
$1,776.00- $3,624.00
1.05
269
269
Total
 
9.54  
229,919  
72,985
The Company’s share-based compensation expense for the years ended December 31, 2024 and 2023 was recognized as
follows:
Share-based compensation
    
2024
    
2023
Research and development
$
131,917
$
150,466
General and administrative
 
197,898
 
219,716
Total
$
329,815
$
370,182
At December 31, 2024, the total compensation cost for stock options not yet recognized was approximately $596,000 and
will be expensed over the next three years.
Warrants to Purchase Common Stock
Warrant activity for the years ended December 31, 2024 and 2023 was as follows:
         
    
Weighted
Average
Exercise
    
Warrants
    
Price
Balance at December 31, 2022
 
42
$
468.00
Granted
 
673,455
 
14.56
Exercised
 
(264,815)
 
0.002
Expired
 
(42)
 
468.00
Balance at December 31, 2023
 
408,640
$
24.00
Granted (1)
 
2,334,382
 
2.73
Exercised
 
(1,275,441)
 
3.71
Expired
 
—
 
—
Balance at December 31, 2024
1,467,581
$
11.01
(1) Excludes pre-funded warrants issued in connection with public offerings.
The remaining life, by grant date, for outstanding warrants at December 31, 2024 was:
         
    
Remaining
    
    
    
    
Exercise
Contractual
Outstanding
Exercisable
Grant Date
    
Price
    
Life in Years
    
Warrants
    
Warrants
May 09, 2023
$
24.00  
3.36  
408,640  
408,640
April 22, 2024
6.40
4.31
4,253
4,253
July 10, 2024
6.00
4.53
1,054,688
1,054,688
Total
 
1,467,581  
1,467,581

Table of Contents
F-24
Note 9. Concentrations
At December 31, 2024 and 2023, the Company had deposits in major financial institutions that exceeded the amount under
protection by the Securities Investor Protection Corporation (“SIPC”) and the Federal Deposit Insurance Corporation
(“FDIC”). Currently, the Company is covered up to $250,000 by the SIPC and FDIC and at times maintains cash balances in
excess of the SIPC and FDIC coverages.
Note 10. Commitments and Contingencies
The Company has commitments of approximately $230,000 as of December 31, 2024 over the next five years for several
licensing agreements with partners and universities. Additionally, the Company has collaboration and license agreements,
which upon clinical or commercialization success, may require the payment of milestones of up to approximately $13.2
million, royalties on net sales of covered products ranging from 2% to 3%, sub-license income royalties on covered products
up to 15% and sub-license global net sales royalties on covered products ranging from 1.5% to 2.5%, if and when achieved.
However, there can be no assurance that clinical or commercialization success will occur.
The Company currently leases approximately 6,200 square feet of office space. This office space currently serves as the
Company’s corporate headquarters, and both of the Company’s business segments (Specialized BioTherapeutics and
Public Health Solutions), operate from this space. Pursuant to the lease which expires October 2025, the current rent is
$11,625 per month.
As a result of the above agreements, the Company has future contractual obligations over the next five years as follows:
    
Research and
    
         
Year
    
Development
    
Leases
    
Total
2025
$
46,000
$
116,250
$
162,250
2026
 
46,000
 
—
 
46,000
2027
 
46,000
 
—
 
46,000
2028
46,000
—
46,000
2029
46,000
—
46,000
Total
$
230,000
$
116,250
$
346,250
Note 11. Operating Segments
Soligenix, Inc. operates in two reportable segments:
●
Specialized BioTherapeutics – Focuses on developing and commercializing products for orphan diseases and areas
of unmet medical need in oncology and inflammation.
●
Public Health Solutions – Concentrates on vaccines and therapeutics for biodefense and infectious diseases.
The Company’s Chief Operating Decision Maker, identified as the Chief Executive Officer, evaluates segment performance
and allocates resources primarily based on the ability of the Specialized BioTherapeutics segment to advance its product
development pipeline through a combination of government grants and contracts as well as shareholder investment. This
segment represents the Company’s primary focus and strategic priority.
In contrast, the Public Health Solutions segment is fully funded by government sources, with no investor capital used. The
ability of this segment to secure government grants and contracts is a key determinant of its sustainability and its
contribution to the Company’s overall financial position. Funding from Public Health Solutions enables the Company to cover
employee salaries, allocate funds to certain overhead costs such as rent and utilities, and supplement working capital.
Secondary to this, the CODM considers Adjusted Loss from Operations, which excludes non-cash share-based
compensation and depreciation/amortization from operating expenses (R&D and G&A), and Net Loss Before Income Taxes,
which incorporates these costs along with other income and expenses.

Table of Contents
F-25
Segment Revenues and Profit (Loss)
The following table presents the revenues, significant expenses, and operating results of the Company's reportable
segments for the year ended December 31, 2024:
   
Specialized
BioTherapeutics
Public
Health
Solutions
Total
Segments
Adjustments
Corporate
Adjustments
Consolidated
Revenues
$
119,371
$
-
$
119,371
$
-
$
-
$
-
$
119,371
Cost of revenues
(119,371)
-
(119,371)
-
-
-
(119,371)
    Gross profit
-
-
-
-
-
-
-
Significant expenses:
    Research and development
4,233,771
249,852
4,483,623
135,987
603,979
-
5,223,589
    General and administrative
-
-
-
4,016,266
199,642
4,215,908
Adjusted loss from operations
(4,233,771)
(249,852)
(4,483,623)
(135,987)
(4,620,245)
(199,642)
(9,439,497)
    Share-based compensation
127,774
4,143
131,917
(131,917)
197,898
(197,898)
-
    Depreciation and amortization
3,489
581
4,070
(4,070)
1,744
(1,744)
-
Loss from operations
(4,365,034)
(254,576)
(4,619,610)
-
(4,819,887)
-
(9,439,497)
Other (expenses) income, net
(22,342)
-
(22,342)
-
786,149
-
763,807
Net loss before income taxes
$
(4,387,376)
$
(254,576)
$
(4,641,952)
$
-
$
(4,033,738)
$
-
$
(8,675,690)
The following table presents the revenues, significant expenses, and operating results of the Company's reportable
segments for the year ended December 31, 2023:
Specialized

BioTherapeutics
Public
Health

Solutions
Total

Segments
Adjustments
Corporate
Adjustments
Consolidated
Revenues
$
395,124
$
444,235
$
839,359
$
-
$
-
$
-
$
839,359
Cost of revenues
(395,124)
(346,924)
(742,048)
-
-
-
(742,048)
    Gross profit
-
97,311
97,311
-
-
-
97,311
Significant expenses:
    Research and development
2,524,356
128,405
2,652,761
155,052
504,886
-
3,312,699
    General and administrative
138,332
-
138,332
4,122,536
221,684
4,482,552
Adjusted loss from operations
(2,662,688)
(31,094)
(2,693,782)
(155,052)
(4,627,422)
(221,684)
(7,697,940)
    Share-based compensation
145,683
4,782
150,465
(150,465)
219,717
(219,717)
-
    Depreciation and amortization
3,932
655
4,587
(4,587)
1,967
(1,967)
-
Loss from operations
(2,812,303)
(36,531)
(2,848,834)
-
(4,849,106)
-
(7,697,940)
Other (expenses) income, net
25,267
-
25,267
-
(235,860)
-
(210,593)
Net loss before income taxes
$
(2,787,036)
$
(36,531)
$
(2,823,567)
$
-
$
(5,084,966)
$
-
$
(7,908,533)
Reconciliation to Consolidated Loss Before Income Taxes
The following table provides a reconciliation of total segment loss to consolidated loss before income taxes:
Year ended December 31,
2024
2023
Loss from operations - reportable segments
$
(4,619,610)
$
(2,848,834)
Loss from operations - corporate
(4,819,887)
(4,849,106)
Interest income (expense), net
213,975
(49,129)
Other income (expense), net
549,832
(161,464)
Net loss before income taxes
$
(8,675,690)
$
(7,908,533)
Segment Assets
The Company’s total assets by segment as of December 31, 2024, are presented below:
Specialized
BioTherapeutics
Public Health
Solutions
Total
Segments
Corporate
Consolidated
Total assets
$
48,604
$
2,038
$
50,642
$ 8,915,841
$
8,966,483

Table of Contents
F-26
The Company’s total assets by segment as of December 31, 2023, are presented below:
Specialized
BioTherapeutics
Public Health
Solutions
Total
Segments
Corporate
Consolidated
Total assets
$
272,099
$
3,976
$
276,075
$ 9,521,251
$
9,797,326
Significant Expense Categories Considered by CODM
The CODM regularly reviews the following significant expense categories when assessing segment performance and
resource allocation:
●
Government Grant and Contract Funding – Both the Specialized BioTherapeutics and Public Health Solutions
segments apply for and receive government grants and contracts. However, Public Health Solutions is exclusively
funded by government sources, whereas Specialized BioTherapeutics utilizes a mix of government funding and
shareholder investment.
●
Research & Development – Includes expenses for clinical trials, regulatory compliance, and R&D-related payroll.
●
General & Administrative – Comprises salaries, professional fees, and facility costs.
●
Share-Based Compensation – Represents non-cash stock option and restricted stock unit expenses.
●
Depreciation & Amortization – Costs related to the use of tangible and intangible assets.
●
Other Income/Expenses – Includes interest income and one-time gains/losses.
Chief Operating Decision Maker and Use of Multiple Measures of Segment Profit/Loss
The Company's CODM primarily evaluates segment performance based on two key financial measures:
●
Advancement of Specialized BioTherapeutics Through a Combination of Funding Sources – Assesses the
effectiveness of shareholder investment and government grants in progressing product development.
●
Ability to Secure Government Grants and Contracts (Public Health Solutions Only) – Determines segment
sustainability and funding for shared resources.
●
Adjusted Loss from Operations – Excludes non-cash share-based compensation and depreciation/amortization
expenses for a clearer picture of operating performance.
●
Net Loss Before Income Taxes – Incorporates all expenses, including non-cash charges and other
income/expenses, for a comprehensive profitability analysis.

Table of Contents
F-27
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of Soligenix, Inc.
Princeton, New Jersey
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Soligenix, Inc. (the “Company”) as of December 31,
2024 and 2023, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity (deficit),
and cash flows the years ended December 31, 2024 and 2023, and the related notes (collectively referred to as the
“consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material
respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its
cash flows for each of the years then ended in conformity with accounting principles generally accepted in the United States
of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. As
discussed in Note 1 to the financial statements, the Company has recurring losses and negative cash flows from operations
that raise substantial doubt about its ability to continue as a going concern. Management’s evaluations of the events and
conditions and management’s plans regarding those matters are also described in Note 1. The financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s financial statements based on our 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 audit to obtain reasonable assurance about whether the financial statements are free of material misstatement,
whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. As part of our 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 Matters
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.

Table of Contents
F-28
Critical Audit Matter Description
As discussed in Note 5 to the consolidated financial statements, in October 2024, the Company amended its existing
convertible debt agreement with Pontifax (the “Pontifax Note”), resulting in the accounting for the amendment as a debt
extinguishment. This process involved significant management judgment in determining the appropriate accounting
treatment and required a complex analysis of the terms of the amended agreement compared to the original agreement. The
Company recorded no gain or loss on extinguishment of debt.  As a result of the amendment, the Company has elected to
no longer account for the Pontifax note using the fair value option.
We identified the accounting for the amended convertible debt as a critical audit matter due to the significant judgments
required by management in assessing whether the terms of the amended agreement were substantially different from the
original agreement, which impacted the accounting treatment. As a result, a high degree of auditor judgment and effort was
required in performing audit procedures to evaluate the accounting treatment.
How the Critical Audit Matter was Addressed in the Audit
Our principal audit procedures performed to address this critical audit matter included the following:
●
We obtained an understanding of the process and controls related to the accounting for complex transactions.
●
We obtained the Amendment 2 to the Pontifax note and obtained an understanding and evaluated the Company’s
process and methodology including the judgments and estimates regarding the determination of no gain or loss on
extinguishment and the election taken.
●
We obtained an understanding and evaluated the Company’s analysis of the applicable accounting literature related
to the treatment of the amendment to the Pontifax note, including the election to not account for the Pontifax note,
as amended, under the fair value option.
●
We evaluated the disclosures surrounding the accounting treatment for the amendment to the Pontifax note and
ensured that these were disclosed in accordance with the relevant accounting guidance.
/s/ Cherry Bekaert LLP
We have served as the Company’s auditor since 2023.
Tampa, Florida
March 21, 2025

1
EXHIBIT 4.1
SOLIGENIX, INC.
DESCRIPTION OF SECURITIES
The following description of the terms of our securities is not complete and is qualified in its entirety by reference to
our Certificate of Incorporation, as amended (the “Certificate of Incorporation”) and our Bylaws, as amended (the “Bylaws”),
both of which are filed as exhibits to our Annual Reports on Form 10-K.
Under our Certificate of Incorporation and Bylaws, we are authorized to issue 75,350,000 shares of capital stock,
consisting of 75,000,000 shares of common stock, par value $0.001 per share, 230,000 shares of undesignated preferred
stock (none of which are currently outstanding), 10,000 shares of Series B Convertible Preferred Stock, par value $0.05 per
share (none of which are currently outstanding), 10,000 shares of Series C Convertible Preferred Stock, par value $0.05 per
share (none of which are currently outstanding), and 100,000 shares of Series A Junior Participating Preferred Stock, par
value $0.001 per share (none of which are currently outstanding).
All outstanding shares of common stock are validly issued, fully paid, and nonassessable.
Common Stock
Voting Rights
Holders of our common stock are entitled to one vote for each share held in the election of directors and in all other
matters to be voted on by stockholders. There is no cumulative voting in the election of directors. The affirmative vote of the
holders of a plurality of the shares of common stock represented at an annual meeting is required to elect each director.
Dividends and Liquidation Rights
Holders of common stock are entitled to receive dividends as may be declared from time to time by our Board of
Directors out of funds legally available therefor. In the event of liquidation, dissolution or winding up of the Company, holders
of common stock are to share in all assets remaining after the payment of liabilities.
Conversion, Redemption and Other Rights
Holders of common stock have no pre-emptive or conversion rights and are not subject to further calls or
assessments. There are no redemption or sinking fund provisions applicable to the common stock. The rights of the holders
of the common stock are subject to any rights that may be fixed for holders of preferred stock.
Preferred Stock
Our Certificate of Incorporation authorizes the issuance of 230,000 shares of undesignated preferred stock, 10,000
shares of Series B Convertible Preferred Stock, par value $0.05 per share (the “Series B Preferred Stock”), 10,000 shares of
Series C Convertible Preferred Stock, par value $0.05 per share (the “Series C Preferred Stock”), and 100,000 shares of
Series A Junior Participating Preferred Stock, par value $0.001 per share (the “Junior Preferred Stock”). Our Board of
Directors is empowered, without stockholder approval, to designate and issue additional series of preferred stock with
dividend, liquidation, conversion, voting or other rights, including the right to issue convertible securities with no limitations
on conversion, which could adversely affect the voting power or other rights of the holders of our common stock,
substantially dilute a common stockholder’s interest and depress the price of our common stock.
No shares of the Series B Preferred Stock, the Series C Preferred Stock or the Junior Preferred Stock are
outstanding. Due to the terms of the Series C Preferred Stock, no additional shares of Series C Preferred Stock can be
issued.
Series B Preferred Stock
Our Certificate of Incorporation authorizes the issuance of 10,000 shares of Series B Preferred Stock, none of which
are outstanding and 6,411 of which have been converted to common stock and therefore are not reissuable.

2
Voting Rights
Each holder of Series B Preferred Stock is entitled to the number of votes equal to the number of whole shares of
common stock into which the shares of Series Preferred Stock held by such holder is then convertible (as adjusted from time
to time pursuant to our Certificate of Incorporation) with respect to any and all matters presented to the stockholders for their
action or consideration. Except as provided by law, holders of Series B Preferred Stock vote together with the holders of
common stock as a single class.
Dividends and Liquidation Rights
The holders of the Series B Preferred Stock are entitled to a dividend of 8% per annum, payable annually in shares
of Series B Preferred Stock. In addition, when and if our Board of Directors shall declare a dividend payable with respect to
the then outstanding shares of common stock, the holders of the Series B Preferred Stock are entitled to the amount of
dividends per share as would be payable on the largest number of whole shares of common stock into which each share of
Series B Preferred Stock could then be converted.
In the event of liquidation, dissolution or winding up of the Company, the holders of Series B Preferred Stock then
outstanding will be entitled to be paid an amount equal to $1,000 per share (subject to adjustment in the event of any stock
dividend, stock split, combination or other similar recapitalization affecting such shares pursuant to our Certificate of
Incorporation), plus any dividends declared but unpaid thereon before any payment is made to the holders of common stock,
Junior Preferred Stock or any other class or series of stock ranking on liquidation junior to the Series B Preferred Stock.
After the holders of the Series B Preferred Stock have been paid in full, the remaining assets of the Company will be
distributed to the holders of Junior Preferred Stock and common stock, subject to the preferences of the Junior Preferred
Stock.
Conversion, Redemption and Other Rights
Each share of Series B Preferred Stock is convertible into 1.333 shares of common stock. The conversion ratio is
subject to an adjustment upon the issuance of additional shares of common stock for a price below the closing price of the
common stock and equitable adjustment for stock splits, dividends, combinations, reorganizations and similar events.
Subject to certain conditions, after the second anniversary of the issuance of the Series B Preferred Stock, the
Company will have the right, but not the obligation, to redeem the then-outstanding shares of Series B Preferred Stock for
cash in an amount calculated pursuant to the terms of our Certificate of Incorporation.
Junior Preferred Stock
Voting Rights
The holders of the Junior Preferred Stock will have 10,000 votes per share of Junior Preferred Stock on all matters
submitted to a vote of our stockholders, including the election of directors.
Dividends and Liquidation Rights
If our Board of Directors declares or pays dividends on common stock, the holders of the Junior Preferred Stock
would be entitled to receive a per share dividend payment of 10,000 times the dividend declared per share of common stock.
In the event we make a distribution on the common stock, the holders of the Junior Preferred Stock will be entitled to a per
share distribution, in like kind, of 10,000 times such distribution made per share of common stock. In the event of any
merger, consolidation or other transaction in which shares of common stock are exchanged, each share of Junior Preferred
Stock will be entitled to receive 10,000 times the amount received per share of common stock. These rights are protected by
customary anti-dilution provisions.
Upon any liquidation, dissolution or winding up, no distribution may be made to the holders of shares of stock
ranking junior to the Junior Preferred Stock unless the holders of the Junior Preferred Stock have received the greater of (i)
$37.00 per one one-thousandth share plus an amount equal to accrued and unpaid dividends and distributions thereon, and
(ii) an amount equal to 10,000 times the aggregate amount to be distributed per share to holders of common stock. Further,
no distribution may be made to the holders of stock ranking on a parity upon liquidation, dissolution or winding up

3
with the Junior Preferred Stock, unless distributions are made ratably on the Junior Preferred Stock and all other shares of
such parity stock in proportion to the total amounts to which the holders of the Junior Preferred Stock are entitled above and
to which the holders of such parity shares are entitled.
Anti-Takeover Provisions
Provisions in our Certificate of Incorporation and Bylaws may discourage certain types of transactions involving an
actual or potential change of control of our company which might be beneficial to us or our security holders.
As noted above, our Certificate of Incorporation permits our Board of Directors to issue shares of any class or series
of preferred stock in the future without stockholder approval and upon such terms as our Board of Directors may determine.
The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of
any class or series of preferred stock that may be issued in the future.
Our Bylaws generally provide that any board vacancy, including a vacancy resulting from an increase in the
authorized number of directors, may be filled by a majority of the directors, even if less than a quorum.
Additionally, our Bylaws provide that stockholders must provide timely notice in writing to bring business before an
annual meeting of shareholders or to nominate candidates for election as directors at an annual meeting of shareholders.
Notice for an annual meeting is timely if our secretary receives the written notice not less than 45 days and no more than 75
days prior to the anniversary of the date that we mailed proxy materials for the preceding year’s annual meeting. However, if
the date of the annual meeting is advanced more than thirty (30) days prior to, or delayed by more than thirty (30) days after,
the anniversary of the preceding year’s annual meeting, notice by the stockholder to be timely must be delivered not later
than the close of business on the later of (i) the 90th day prior to such annual meeting or (ii) the 10th day following the day on
which public announcement of the date of such annual meeting is first made. Our Bylaws also specify the form and content
of a shareholder’s notice. These provisions may prevent shareholders from bringing matters before an annual meeting of
shareholders or from making nominations for directors at an annual meeting of shareholders.
Delaware Anti-Takeover Statute
We are subject to the provisions of Section 203 of the Delaware General Corporation Law (the “DGCL”) regulating
corporate takeovers. In general, Section 203 prohibits a publicly held Delaware corporation from engaging, under certain
circumstances, in a business combination with an interested stockholder for a period of three years following the date the
person became an interested stockholder unless:
●
prior to the date of the transaction, our Board of Directors approved either the business combination or the
transaction which resulted in the stockholder becoming an interested stockholder;
●
upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the
interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the
transaction commenced, calculated as provided under Section 203; or
●
at or subsequent to the date of the transaction, the business combination is approved by our Board of
Directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the
affirmative vote of at least two-thirds of the outstanding voting stock which is not owned by the interested
stockholder.
Generally, a business combination includes a merger, asset or stock sale, or other transaction resulting in a financial
benefit to the interested stockholder. An interested stockholder is a person who, together with affiliates and associates, owns
or, within three years prior to the determination of interested stockholder status, did own 15% or more of a corporation’s
outstanding voting stock. We expect the existence of this provision to have an anti-takeover effect with respect to
transactions our Board of Directors does not approve in advance. We also anticipate that Section 203 may also discourage
attempts that might result in a premium over the market price for the shares of common stock held by stockholders.
Forum Selection Provisions
As permitted by the DGCL, our Bylaws require, to the fullest extent permitted by law, unless we consent in writing to
the selection of an alternative forum, that the Court of Chancery of the State of Delaware, shall be the sole and exclusive

4
forum for (i) any derivative action or proceeding brought on behalf of the company, (ii) any action asserting a claim for
breach of a fiduciary duty owed by any director, officer, other employee or stockholder of the company to the company or the
our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the DGCL, our Certificate of
Incorporation or our Bylaws or (iv) any action asserting a claim governed by the internal affairs doctrine.
Further, our Bylaws provided that, unless we consent in writing to the selection of an alternative forum, the federal
district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and exclusive forum for
the resolution of any complaint asserting a cause of action arising under the Securities Act.
Exclusions or Limitations to Forum Selection Provisions
Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or
liability created by the Exchange Act or the rules and regulations thereunder. Accordingly, the exclusive forum provisions in
our Bylaws do not apply to claims arising under the Exchange Act. The forum selection provisions, however, are intended to
apply to the fullest extent permitted by law, including to actions or claims arising under the Securities Act. However, it is
possible that a court could find our forum selection provisions to be inapplicable or unenforceable with respect to actions or
claims arising under the Securities Act. Even if a court accepts that our forum selection provisions apply to actions or claims
arising under the Securities Act, our stockholders shall not be deemed to have waived compliance with the federal securities
laws and the rules and regulations thereunder.
Transfer Agent
The transfer agent and registrar for our common stock is Equiniti Trust Company, LLC. Its address is 6201 15th
Avenue, Brooklyn, NY 11219 and its telephone number is (718) 921-8200.
Listing
Our common stock is listed on The Nasdaq Capital Market under the symbol “SNGX.”

EXHIBIT 21.1
SUBSIDIARIES OF SOLIGENIX, INC.
The following represents a list of Soligenix, Inc.’s subsidiaries:
Name
    
Ownership
    
State of Incorporation
 
Enteron Pharmaceuticals, Inc.
100.00%
Delaware
Orasomal Technologies Inc.
75.30%
Delaware
Soligenix BioPharma Canada Incorporated
100.00%
Canada
Soligenix UK Limited
100.00%
United Kingdom
Soligenix NE B.V.
100.00%
Netherlands
Soligenix Biopharma HI, Inc.
100.00%
Hawaii

Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to the incorporation by reference in the Registration Statements of Soligenix, Inc. on Form S-3 (Nos. 333-
252153 and 333-274265) and Form S-8 (Nos. 333-130801, 333-196941, 333-208515 and 333-268051) of our report dated
March 21, 2025, on our audit of the financial statements as of December 31, 2024 and for the year then ended, which report
is included in this Annual Report on Form 10-K to be filed on or about March 21, 2025. Our report includes an explanatory
paragraph about the existence of substantial doubt concerning the Company's ability to continue as a going concern.
/s/ Cherry Bekaert LLP
CHERRY BEKAERT LLP
Tampa, Florida
March 21, 2025

EXHIBIT 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934
I, Christopher J. Schaber, Ph.D., certify that:
1.   I have reviewed this Form 10-K of Soligenix, Inc. for the fiscal year ended December 31, 2024;
2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in
all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4.   The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.      Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b.   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles;
c.   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d.   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.   The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a.     All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b.   Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
March 21, 2025
/s/ Christopher J. Schaber
Christopher J. Schaber, Ph.D.
President and Chief Executive Officer

EXHIBIT 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934
I, Jonathan Guarino, certify that:
1.
I have reviewed this Form 10-K of Soligenix, Inc. for the fiscal year ended December 31, 2024;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in
all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the
periods presented in this report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and
procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be
designed under our supervision, to ensure that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which
this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting
principles;
c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our
conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;
and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons
performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and
report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the
registrant’s internal control over financial reporting.
March 21, 2025
/s/ Jonathan Guarino
Jonathan Guarino
Senior Vice President and Chief Financial Officer

EXHIBIT 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with this Form 10-K of Soligenix, Inc. (the “Company”) for the fiscal year ended December 31, 2024, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies, pursuant
to 18 U.S.C. Section 1350, that:
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
March 21, 2025
/s/ Christopher J. Schaber
Christopher J. Schaber, Ph.D.
President and Chief Executive Officer

EXHIBIT 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with this Form 10-K of Soligenix, Inc. (the “Company”) for the fiscal year ended December 31, 2024, as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certifies, pursuant
to 18 U.S.C. Section 1350, that:
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
March 21, 2025
/s/ Jonathan Guarino
Jonathan Guarino
Senior Vice President and Chief Financial Officer