Financial Data and Key Metrics Changes - The combined net revenue for Q3 2025 was approximately $3.1 million, representing a 4% increase compared to Q2 2025 revenue of approximately $3 million, and equaled Q3 2024 revenue of approximately $3.1 million [4][19] - Loss from operations decreased by $24,000 from $7.2 million in Q3 2024 to $7.3 million in Q3 2025 [19] - Non-GAAP recurring EBITDA for Q3 2025 was a net loss of $8.9 million, compared to a loss of $9.2 million in Q3 2024 [20] - Net loss attributable to common shareholders decreased by $352,000 from $9.9 million in Q3 2024 to $9.5 million in Q3 2025 [20] Business Line Data and Key Metrics Changes - Mytesi prescription volume increased by approximately 0.9% in Q3 2025 over Q2 2025, but decreased by 3.6% compared to Q3 2024 [19] Company Strategy and Development Direction - The company aims to negotiate business development partnerships for licensed rights to develop and commercialize late-stage health products, focusing on generating non-dilutive funding [5][21] - Key late-stage initiatives include crofelemer for orphan indications related to intestinal failure and cancer therapy-related diarrhea, with plans for expedited regulatory pathways [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the convergence of key clinical and regulatory catalysts expected to enhance value for stakeholders, including patients and shareholders [5][21] - The company anticipates significant collaborations and licensing deals that will support late-stage product development and regulatory approval [21] Other Important Information - Crofelemer has shown a groundbreaking reduction of parenteral support by up to 37% for patients with intestinal failure, which is significant given the lack of approved treatments for MVID [9][10] - The company is in discussions with multiple potential partners for the commercialization of Canalivia, an animal health product for chemotherapy-induced diarrhea in dogs [16] Q&A Session Summary - No specific questions or answers were provided in the content regarding the Q&A session.

Core Viewpoint - Soligenix, Inc. is expanding its European Medical Advisory Board to enhance strategic guidance for the Phase 3 study of HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with top-line results expected in the second half of 2026 [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment [20]. - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, aimed at treating CTCL [20]. Clinical Study Details - The confirmatory Phase 3 study, named FLASH2, will enroll approximately 80 patients and is designed to replicate the successful elements of the previous Phase 3 FLASH trial, which showed a 49% treatment response rate [15]. - The FLASH2 study will extend the double-blind, placebo-controlled assessment to 18 weeks, with the primary endpoint assessed at the end of this period [15]. Advisory Board Expansion - The European Medical Advisory Board now includes five esteemed dermatologists, enhancing the company's expertise in clinical strategies and regulatory interactions [2][3][4][7][8]. - The board members are recognized leaders in the field of dermatology and CTCL, contributing valuable insights for the upcoming clinical study [2][3][4][7][8]. Treatment Mechanism and Efficacy - HyBryte™ employs synthetic hypericin activated by visible light, which penetrates deeper into the skin compared to ultraviolet light, potentially treating more severe skin conditions [9]. - In previous studies, HyBryte™ demonstrated a statistically significant improvement in lesion reduction compared to placebo, with a 16% response rate in the first treatment cycle [10]. Safety Profile - HyBryte™ is noted for its safety, with no systemic absorption and a mechanism of action that does not involve DNA damage, making it a safer alternative to existing therapies [14]. - The treatment has been well tolerated across multiple cycles, with a significant portion of patients opting to continue treatment in the optional safety cycle [13]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [19][18]. - The company aims to address the significant safety risks associated with existing treatments, positioning HyBryte™ as a potentially safer and effective option for patients [14].

Financial Data and Key Metrics Changes - The total net revenue for the company's prescription products was approximately $2.2 million in Q1 2025, a decrease of about 6% compared to $2.4 million in Q1 2024 and a 37% decrease from $3.5 million in Q4 2024 [25] - Loss from operations increased by $1.2 million from $8.2 million in Q1 2024 to $9.4 million in Q1 2025 [26] - Net loss attributable to common shareholders increased by approximately $1.2 million from $9.2 million in Q1 2024 to $10.4 million in Q1 2025 [26] Business Line Data and Key Metrics Changes - Mytesi prescription volume increased by approximately 1.8% in Q1 2025 compared to Q1 2024 but decreased by approximately 13.5% compared to Q4 2024 [26] - Dispensed prescriptions for Mytesi and Profelymer increased by approximately 2% in Q1 2025 compared to Q1 2024, indicating increased demand for treatments [5] Market Data and Key Metrics Changes - Short bowel syndrome affects approximately 10,000 to 20,000 people in Europe and a similar number in the United States, qualifying for orphan designation [19] - MVID is an ultra-rare condition with an estimated prevalence of just a couple hundred patients globally [19] Company Strategy and Development Direction - The company is focusing on the convergence of key catalysts that are expected to be transformational for stakeholders, including paradigm-shifting medicines and mechanisms of action [5] - There are ongoing proof of concept trials for crofelemer in both pediatric and adult patients with rare diseases, with results expected throughout 2025 and into 2026 [21] - The company is exploring expedited regulatory approval pathways for its products, including the FDA's breakthrough therapy program [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the multiple expected near-term catalysts throughout 2025 and early 2026, viewing them as important and potentially transformative [27] - The management highlighted the significance of the initial proof of concept results for crofelemer, which could modify disease progression for patients with intestinal failure [12] Other Important Information - The company is also pursuing business development opportunities related to its product CANALIVIA CA1, which is conditionally approved for chemotherapy-induced diarrhea in dogs [28] - The management emphasized the importance of addressing supportive care needs in cancer treatment, as diarrhea can impact treatment outcomes [24] Q&A Session Summary Question: What are the expected catalysts for the company in the near term? - Management highlighted multiple expected catalysts throughout 2025 and early 2026 that are viewed as important for stakeholders [27] Question: How does the company plan to address the regulatory pathways for its products? - The company is exploring expedited regulatory approval pathways, including the FDA's breakthrough therapy program and EMA's PRIME program [19]

Core Viewpoint - Sanofi's investigational BTK inhibitor, rilzabrutinib, has received orphan drug designation from the FDA for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), addressing significant unmet medical needs in these rare diseases [1][2]. Company Developments - Rilzabrutinib is currently undergoing mid-stage studies for both wAIHA and IgG4-RD, with no approved therapies available for these conditions [1]. - Data from a phase IIb study for wAIHA indicated clinically meaningful outcomes in response rates and disease markers [5]. - A phase IIa study for IgG4-RD patients showed a reduction in disease flare and other disease markers after 52 weeks of treatment, with further details to be announced at an upcoming medical conference [6]. Regulatory Status - A regulatory application for rilzabrutinib to treat immune thrombocytopenia (ITP) is under review in the United States, with a decision expected on August 29, 2025. The drug has received both fast-track and orphan drug designations for ITP [8]. - Rilzabrutinib is also under review in the European Union and China for ITP treatment [9]. Market Performance - Year-to-date, Sanofi's shares have increased by 11.9%, outperforming the industry average rise of 0.8% [3].

Table of Contents THE SECURITIES ACT OF 1933 SOLIGENIX, INC. (Exact Name of Registrant as Specified in Its Charter) As filed with the Securities and Exchange Commission on March 15, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER (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 ( ...