SOLIGENIX INC

DEF 14A 1 tm2410995-2_def14a.htm DEF 14A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A INFORMATION

Proxy Statement Pursuant to Section 14(a) of

the Securities Exchange Act of 1934

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Preliminary Proxy Statement.

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Definitive Proxy Statement.

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Definitive Additional Materials.

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Soliciting Material Pursuant to §240.14a-12

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SOLIGENIX, INC.

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(Name of Registrant as Specified in Its Charter)

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Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a6(i)(1) and 0-11.

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April 30, 2024​

Dear Stockholder:

We appreciate your investment and support of our company. This continues to be a very important year for us. We remain energized by the promise of our rare disease pipeline as we focus on advancing HyBryte™ (synthetic hypericin) as a potential new first-in-class treatment for cutaneous T-cell lymphoma (“CTCL”). With positive results already demonstrated in our Phase 3 FLASH (Fluorescent Light And Synthetic Hypericin) study, we have collaboratively engaged in discussions with both the U.S. Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) to define a feasible and highly executable trial design for the second confirmatory Phase 3 clinical trial to support potential worldwide marketing approval. Recently, we received agreement from the EMA on the key design components of a confirmatory Phase 3 study evaluating the safety and efficacy of HyBryte™ in CTCL patients with early-stage disease. This confirmatory study, called FLASH2, replicates the double-blind, placebo-controlled design used in the successful first Phase 3 FLASH study. While discussions with FDA remain ongoing, we anticipate being able to accelerate enrollment in support of this study where we are confident we can statistically demonstrate HyBryte’s™ increased effect over a more prolonged, “real world” treatment course. See the table on the next page for diagrams showing the similarities between the first Phase 3 trial and second Phase 3 trial.

Our Phase 2a clinical trial evaluating SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis remains ongoing, after observing a clear biological signal and clinical success in the second cohort of four patients, with two patients reaching treatment success. We also have expanded our rare disease pipeline and will be initiating a Phase 2a clinical trial with SGX945 (dusquetide) for the treatment of aphthous ulcers of Behçet’s disease later this year with top-line results in early 2025. Under our Public Health Solutions business segment, we continue with our proprietary heat stable vaccine platform technology ThermoVax®, including development of novel filovirus vaccine candidates (protecting against viruses such as Sudan Ebola and Marburg), and a ricin toxin vaccine, RiVax®. We remain committed to the long-term interests of our stockholders as we advance our late-stage rare disease pipeline, most notably the confirmatory Phase 3 CTCL trial, while also continuing to evaluate all potential strategic options to increase value, including, but not limited to, merger and acquisition (“M&A”) opportunities.

In support of these efforts, our director nominees represent a wide range of backgrounds and expertise. We believe our diversity of experiences, perspectives, and skills contributes to the Board of Directors’ effectiveness in managing risk and providing guidance that positions the Company for long-term success. Of our five directors, four are independent, which includes all committee members.

This Proxy Statement contains details of the business to be conducted during the Annual Meeting and describes our corporate governance policies and practices. In addition to communicating information and our perspectives, we believe in the value of listening to our stockholders. Feedback from our stockholders helps us prioritize our efforts and enhance our transparency.

Whether or not you participate in the Annual Meeting, it is important that your shares be represented and voted during the meeting. We urge you to vote promptly and submit your proxy (1) via the Internet (2) by telephone or (3) if you received your proxy materials by mail, by signing, dating, and returning the enclosed proxy card or voting instruction form in the envelope provided for your convenience.

As we look to the year ahead, we remain excited about the opportunities we have in terms of our business, stockholder value creation, and positive impacts on a global scale. Thank you for the opportunity to serve you and our company as directors. On behalf of all directors, I extend our gratitude for your support and request that you vote in the affirmative for the proposals to be considered at the Annual Meeting to assure we are properly positioned for potential growth and success in the future.

Sincerely,

Christopher J. Schaber, PhD

Chairman of the Board of Directors, President and Chief Executive Officer

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The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6 week double-blind, placebo-controlled treatment cycle (Cycle 1). In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In the second study, all important clinical study design components remain the same as in the first study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte’s™ increased effect over a more prolonged, “real world” treatment course.

The confirmatory Phase 3, randomized, double-blind, placebo-controlled, multicenter study includes 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 3 to 5 index lesions in 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 3-5 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 4 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. Soligenix, participating clinical investigators, and any personnel involved in trial conduct will remain blinded to study treatment until completion of the trial.

The Annual Meeting will be held entirely online. Stockholders may participate in the Annual Meeting by visiting the following website: www.virtualshareholdermeeting.com/sngx2024. To participate in the Annual Meeting, you will need the 16-digit control number included on your proxy card or on the instructions that accompanied your proxy materials.​

Who May Vote:

Admittance to the virtual meeting will be limited to stockholders. The Board of Directors has fixed the close of business on April 10, 2024 as the record date for the determination of stockholders entitled to notice of and to vote at the Annual Meeting and any postponement or adjournment thereof. Accordingly, only stockholders of record at the close of business on that date will be entitled to vote at the meeting. A list of stockholders eligible to vote at the meeting will be available for inspection for a period of 10 days prior to the meeting, during regular business hours, at our corporate headquarters. If you want to inspect the stockholder list prior to the meeting, please call our Corporate Secretary at (609) 538-8200 to schedule an appointment. In addition, the list of stockholders also will be available during the Annual Meeting through the meeting website for stockholders who choose to attend.​

How to attend:

You will need to have your 16-Digit Control Number included on your proxy card or on the instructions that accompanied your proxy materials to join the Annual Meeting.​

Please Vote As Soon As Possible in one of the following ways:

By Order of the Board of Directors,

Christopher J. Schaber, PhD

President and Chief Executive Officer

Princeton, New Jersey

April 30, 2024

This Proxy Statement includes estimates, projections, statements relating to our business plans, objectives, and expected operating results that are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would” and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties that may cause actual results to differ materially. We describe risks and uncertainties that could cause actual results and events to differ materially in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of our Forms 10-K and 10-Q. We undertake no obligation to update or revise publicly any forward-looking statements, whether because of new information, future events, or otherwise.