treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Additionally, despite the biologic activity observed in aphthous ulcers induced by chemotherapy and radiation, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales o ...

Core Insights - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, highlighting significant progress in its clinical pipeline and upcoming milestones for 2026 [1][2] Clinical Developments - Top-line results from the Phase 2a trial of SGX302 for mild-to-moderate psoriasis showed that the gel therapy was well tolerated, with one patient achieving "Almost Clear" status and over 50% improvement in PASI score [1] - The Phase 2a trial of SGX945 for Behçet's Disease demonstrated biological efficacy, with results comparable to apremilast, indicating potential for home-based treatment in future studies [1] - Ongoing studies for HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) show promising results, with 75% of patients achieving "Treatment Success" after 18 weeks of treatment [1] Market Opportunities - Peak annual net sales for HyBryte™ in the U.S. are expected to exceed $90 million, with a total addressable worldwide CTCL market estimated at over $250 million annually [2] - The psoriasis market opportunity with SGX302 is projected to exceed $1 billion annually, while SGX945 for Behçet's Disease is estimated at approximately $200 million annually [2] - Overall, the potential for significant commercial returns across the rare disease pipeline is estimated at around $2 billion in global annual sales [2] Financial Position - As of September 30, 2025, the company reported approximately $10.5 million in cash, with additional non-dilutive funding of about $500 thousand from New Jersey's NOL sales program [2] - The company is focused on advancing its development programs and has sufficient capital to meet its goals through 2026 [2]

Core Viewpoint - Soligenix, Inc. is focused on advancing its late-stage biopharmaceutical pipeline, particularly in the treatment of rare diseases, with significant upcoming milestones and a strategic approach to resource allocation and potential partnerships [2][8]. Recent Accomplishments - The company announced the conclusion of the first Data Monitoring Committee (DMC) meeting for its Phase 3 study of HyBryte™, confirming no safety concerns and an acceptable safety profile consistent with prior studies [2][5]. - Soligenix expanded its Medical Advisory Board in Europe to enhance strategic guidance for the Phase 3 study of HyBryte™ [5]. - The company appointed Tomas J. Philipson, PhD, as a Strategic Advisor to leverage his extensive government relationships [5]. - The FDA granted orphan drug designation to dusquetide for the treatment of Behçet's Disease based on positive Phase 2a results [5]. Financial Results - For the quarter ended September 30, 2025, Soligenix reported no revenue, with a net loss of $2.5 million, or ($0.58) per share, compared to a net loss of $1.7 million, or ($0.78) per share for the same period in 2024 [4][5]. - Research and development expenses increased to $1.6 million from $1.0 million year-over-year, primarily due to costs associated with the Phase 3 CTCL trial [6]. - General and administrative expenses were $1.0 million, slightly up from $0.9 million in the previous year [7]. - The company's cash position was approximately $10.5 million as of September 30, 2025, providing sufficient operating runway through 2026 [2][7].

Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [3] - The company has a Specialized BioTherapeutics segment that is advancing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), towards potential commercialization following the successful completion of a second Phase 3 study [3] - Other development programs include SGX302 for psoriasis, SGX942 for inflammatory diseases, and SGX945 for Behçet's Disease [3] Public Health Solutions - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine candidate, and vaccines targeting filoviruses and COVID-19 [4] - The vaccine programs utilize the proprietary ThermoVax® technology and have received support from government grants and contracts from agencies such as NIAID, DTRA, and BARDA [4] Upcoming Events - Christopher J. Schaber, Ph.D., President and CEO of Soligenix, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with an on-demand presentation available on September 5, 2025 [1] - Key management members will hold one-on-one meetings throughout the conference, and registered attendees can schedule meetings via the conference platform [2]

Company Overview - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [5] - The company is advancing its HyBryte(TM) platform, a novel therapy for cutaneous T-cell lymphoma (CTCL), primarily affecting older adults [4][5] - Soligenix has established U.S.-based manufacturing for HyBryte's active ingredient, showcasing domestic innovation [4] Industry Context - The aging American population is leading to an increase in chronic and rare diseases, with over 30 million Americans affected by rare diseases [3] - There is a growing need for accurate diagnoses and effective treatments, particularly as many rare conditions lack FDA-approved therapies [3] - The Trump administration's initiatives aim to improve access to treatments and accelerate medical innovation in this sector [4] Product Development - The Specialized BioTherapeutics segment is moving towards potential commercialization of HyBryte(TM) after successful completion of the second Phase 3 study [5] - Other development programs include synthetic hypericin for psoriasis and dusquetide for inflammatory diseases [5] - The Public Health Solutions segment includes vaccine candidates for ricin toxin, filoviruses, and COVID-19, supported by government grants [6]

Core Insights - Soligenix, Inc. is focused on developing and commercializing products for rare diseases with unmet medical needs, with a promising late-stage pipeline and potential strategic options including partnerships and M&A opportunities [1][3] Financial Overview - The company has sufficient capital and cash runway to meet its goals into Q1 2026, with expected peak annual net sales of HyBryte™ in the U.S. exceeding $90 million and a total addressable worldwide CTCL market estimated at over $250 million annually [2][13] - The total addressable worldwide psoriasis market opportunity with SGX302 is estimated to exceed $1 billion annually, while SGX945 in Behçet's Disease (BD) has a market opportunity of approximately $200 million annually, leading to potential global annual sales of around $2 billion [2][11] Clinical Development - The confirmatory Phase 3 FLASH2 study for HyBryte™ is ongoing, with top-line results expected in the second half of 2026, and enrollment is on track [4][5] - The ongoing Phase 2a study of SGX302 in mild-to-moderate psoriasis has shown promising results, with previous cohorts demonstrating biologic activity and early clinical success [7][10] - A pilot Phase 2a proof of concept clinical trial for SGX945 in Behçet's Disease is expected to yield top-line results in Q3 2025 [11] Market Potential - Psoriasis affects approximately 60-125 million people globally, with the global treatment market valued at around $30 billion in 2023 and projected to reach $58-67 billion by 2030 [8][9] - Behçet's Disease is an orphan disease with around 18,000 known cases in the U.S. and 50,000 in Europe, impacting the quality of life for patients [12] Manufacturing and Partnerships - The company has successfully transferred the manufacturing of synthetic hypericin to a U.S. facility, optimizing the process for larger batch production [10] - Soligenix is actively pursuing partnerships in ex-U.S. markets to enhance its marketing authorizations for HyBryte™ and explore other potential cutaneous indications [6][14]

Core Viewpoint - Soligenix, Inc. has successfully completed the transfer of synthetic hypericin active ingredient manufacturing to the U.S., optimizing a scalable production process for its topical drug products HyBryte™ and SGX302, aimed at treating cutaneous T-cell lymphoma (CTCL) and psoriasis respectively [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, particularly HyBryte™ for CTCL and SGX302 for psoriasis [15]. - The company is advancing its clinical programs and aims for potential commercialization worldwide following successful clinical trials [2][15]. Product Details - HyBryte™ is a first-in-class photodynamic therapy using synthetic hypericin, which is activated by safe visible light, targeting malignant T-cells in skin lesions [3]. - The treatment has shown significant anti-proliferative effects and has received orphan drug and fast track designations from the FDA and EMA [3][8]. Clinical Trial Results - The Phase 3 FLASH trial enrolled 169 patients, demonstrating a 16% response rate for HyBryte™ compared to 4% for placebo in the first treatment cycle [4]. - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte™ treatment [5]. - The third optional treatment cycle showed that 49% of patients who received HyBryte™ throughout all cycles had a positive treatment response [7]. Future Development - A second Phase 3 trial, FLASH2, is expected to begin before the end of 2024, replicating the successful design of the first trial with an extended treatment duration [9]. - The FDA has indicated that a longer duration comparative study may be preferred, and discussions are ongoing to address their feedback [9]. Financial Support - The FDA awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study evaluating HyBryte™ for expanded treatment in early-stage CTCL patients [11].

Core Viewpoint - The combination of the COVID adenovirus vaccine and CiVax™ shows broader protection against COVID-19 variants compared to a two-shot mRNA vaccination series, indicating potential advantages in vaccine efficacy and distribution logistics [1][2]. Group 1: CiVax™ Vaccine Development - CiVax™ is a heat-stable subunit vaccine candidate for COVID-19, demonstrating broad immune responses in preclinical studies with mice and non-human primates [2][4]. - The vaccine can be stored at ambient temperatures and requires only reconstitution with sterile water before use, simplifying global vaccination efforts [2][3]. - Development of CiVax™ was partially funded by a $1.5 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) [5]. Group 2: Technological Advancements - The ThermoVax® platform has successfully stabilized vaccines for various pathogens, enhancing the standard protein subunit vaccination technology [2][9]. - CiVax™ has shown efficacy as a booster after other primary vaccinations against COVID-19, providing broad immune coverage [4][2]. Group 3: Collaboration and Research - The development of CiVax™ is a result of collaboration with Axel Lehrer, PhD, from the University of Hawaiʻi at Mānoa, focusing on heat-stable vaccines for both COVID-19 and filoviruses [2][3]. - The research emphasizes the need for robust technology platforms to rapidly develop vaccines for emerging infectious diseases, as demonstrated by the COVID-19 pandemic [6].

Core Insights - Soligenix, Inc. is presenting findings on the efficacy of HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL) and psoriasis at two major dermatology conferences in March 2025 [1][4][6] Group 1: Clinical Findings - Recent supportive studies indicate that longer treatment times with HyBryte™ improve efficacy, with a study showing a 40% response rate in patients treated for 12 weeks compared to a 4% response in the placebo group [5][11] - The Phase 3 FLASH trial demonstrated that 16% of patients receiving HyBryte™ achieved at least a 50% reduction in lesions, significantly higher than the 4% in the placebo group [10] - HyBryte™ has shown a statistically significant improvement in treating both plaque and patch lesions of CTCL, with response rates of 42% and 37% respectively [11] Group 2: Safety and Regulatory Status - HyBryte™ has received orphan drug and fast track designations from the FDA, indicating its potential as a safe and effective treatment for CTCL [9] - The treatment mechanism of HyBryte™ is not associated with DNA damage, making it a safer alternative compared to current therapies that carry significant side effects [13] - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in early-stage CTCL patients [17] Group 3: Market Potential - 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, indicating significant commercial potential for HyBryte™ in treating psoriasis [23] - CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, highlighting a substantial patient population for potential treatment [19] Group 4: Company Overview - Soligenix, Inc. focuses on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and SGX302 for psoriasis [24]

Table of Contents As filed with the Securities and Exchange Commission on April 2, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SOLIGENIX, INC. (Exact Name of Registrant as Specified in Its Charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 41-1505029 (I.R.S. Employer Identification Number) Soligenix, Inc. 29 Emmons Drive, Suite B-10 Princeton, New Jersey 08540 (6 ...