Accessibility StatementSkip Navigation PRINCETON, N.J., Nov. 19, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryteâ"¢ (sy ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File No. 001-14778 SOLIGENIX, INC. (Exact name of registrant as specified in its charter) DELAWARE 41-15050 ...

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].

Core Insights - Soligenix, Inc. is advancing the Phase 3 clinical development of HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin's lymphoma [1][20] - The company has updated its Medical Advisory Board (MAB) to include key opinion leaders in CTCL to provide strategic guidance as it progresses with clinical studies and regulatory interactions [2][3] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL [20] - The company is also developing other products, including SGX302 for psoriasis and dusquetide (SGX942) for inflammatory diseases [20][21] Clinical Development - The FLASH Phase 3 trial enrolled 169 patients with Stage IA, IB, or IIA CTCL, demonstrating a 16% response rate for HyBryte™ compared to 4% for placebo in the first treatment cycle [10] - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte™ treatment, significantly higher than the placebo group [11] - The third optional treatment cycle showed that 49% of patients who received HyBryte™ throughout all cycles demonstrated a positive treatment response [12] Safety and Efficacy - HyBryte™ is noted for its safety profile, as it is not associated with DNA damage, making it a safer alternative to current therapies that have significant side effects [13] - The treatment has received orphan drug and fast track designations from the FDA, indicating its potential for addressing unmet medical needs [9][16] Regulatory Pathway - Following the first Phase 3 study, both the FDA and EMA require a second successful Phase 3 trial for marketing approval, which is currently ongoing [14] - The FLASH2 study aims to replicate the successful design of the first trial while extending the treatment duration to 18 weeks [14] Market Potential - CTCL affects approximately 31,000 individuals in the U.S. and 38,000 in Europe, with around 3,200 and 3,800 new cases annually, respectively [19] - The company anticipates accelerated enrollment in the FLASH2 study due to its engagement with the CTCL community and previous trial experiences [14]

Core Insights - The article highlights significant advancements in clinical trials for biotech and medical tech companies, particularly focusing on Aethlon Medical, Envoy Medical, Soligenix, and MBX Biosciences, showcasing their recent progress and milestones in the sector [3][4]. Aethlon Medical, Inc. - Aethlon Medical is conducting an ongoing oncology clinical trial in Australia, evaluating the Hemopurifier in cancer patients unresponsive to anti-PD-1 therapy, with preliminary observations showing encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after treatment [5][7]. - In the initial cohort of three patients, decreases in seven out of ten examined microRNAs were noted, indicating potential effects on cancer growth and metastasis [6][8]. - The study's small sample size limits the ability to draw definitive conclusions about clinical efficacy or dose response, with further data needed from subsequent cohorts [11][12]. Envoy Medical, Inc. - Envoy Medical received FDA approval to expand its pivotal clinical trial for the Acclaim® cochlear implant, based on promising data from the first ten patients, allowing for a shortened timeline to commercialization by three to six months [13][14]. - The initial trial phase showed no serious adverse events, and the data indicated that the Acclaim® cochlear implant can achieve effectiveness for its intended use [16]. Soligenix, Inc. - Soligenix's confirmatory Phase 3 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL) has concluded its first Data Monitoring Committee meeting, confirming no safety concerns and an acceptable safety profile consistent with prior studies [17][18]. - The company anticipates providing updates on enrollment progress and response rates before year-end, with topline results expected in the second half of 2026 [19]. MBX Biosciences, Inc. - MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint with statistical significance in its Phase 2 Avail™ trial for chronic hypoparathyroidism, with 63% of treated patients meeting the primary composite endpoint [21][22]. - The company plans to initiate a Phase 3 clinical trial in 2026, building on the positive results from the Phase 2 trial, which demonstrated the potential for canvuparatide to become a best-in-class treatment for hypoparathyroidism [23][24].

Core Insights - Soligenix, Inc. is progressing with its confirmatory Phase 3 FLASH2 study for HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), with no safety concerns reported by the Data Monitoring Committee [1][2] - The study aims to enroll approximately 80 patients and is on track for an enrollment update in Q4 2025, with an interim efficacy analysis expected in the first 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 [15] - The company is also involved in developing other products, including treatments for psoriasis and inflammatory diseases [15][16] Product Details - HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin, activated by visible light, which has shown promising efficacy and safety in previous studies [3][4] - The FLASH2 study builds on the previous successful Phase 3 FLASH study, which demonstrated a 49% treatment response rate in patients completing 18 weeks of therapy [5][9] Clinical Study Design - FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that extends the treatment duration to 18 weeks without breaks, aiming to provide a more realistic assessment of HyBryte™'s efficacy [2][10] - The primary endpoint assessment will occur at the end of the 18-week treatment period, with the study replicating key design components from the first FLASH study [9][10] Regulatory Status - HyBryte™ has received orphan drug and fast track designations from the FDA, indicating its potential for expedited review due to the rarity of CTCL [4][12] - The FDA and EMA have indicated that a second successful Phase 3 trial is necessary for marketing approval, which the FLASH2 study aims to fulfill [9][10] 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 limited treatment options available [13][14] - The safety profile of HyBryte™ is a significant advantage, as it avoids the risks associated with traditional therapies that can lead to severe side effects, including secondary malignancies [8][12]

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].

Core Viewpoint - Soligenix, Inc. has successfully closed a public offering, raising approximately $7.5 million, which extends its cash runway through the end of 2026 to support key development milestones in its biopharmaceutical projects [1][3]. Funding and Financial Details - The company sold 5,555,560 shares of common stock and warrants at a combined price of $1.35 per share [1]. - The warrants have an exercise price of $1.35 per share, are immediately exercisable, and will expire five years from the issuance date [1]. - The net proceeds from the offering will be allocated to research and development, commercialization activities, working capital, and general corporate purposes [3]. Existing Warrants Amendment - Certain existing warrants from May 2023, April 2024, and July 2024 will be amended to have a reduced exercise price of $1.35 per share, aligning their expiration with the new warrants sold in the offering [2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs [6]. - The company is advancing its Specialized BioTherapeutics segment, particularly HyBryte™ (SGX301), aimed at treating cutaneous T-cell lymphoma, and is seeking regulatory approvals following successful Phase 3 study results [6]. - The Public Health Solutions segment includes vaccine development programs for ricin toxin, filoviruses, and COVID-19, supported by government funding [7].

Core Viewpoint - Soligenix, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $7.5 million to fund research, development, and general corporate purposes [3]. Group 1: Offering Details - The company is offering 5,555,560 shares of common stock and warrants to purchase an equal number of shares at a combined price of $1.35 per share and warrant [1]. - The existing warrants will be amended to have a reduced exercise price of $1.35 per share and will expire in line with the new warrants [2]. - The closing of the offering is expected around September 29, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for research and development, commercialization activities, working capital, and general corporate purposes [3]. Group 3: Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [7]. - The company is advancing HyBryte™ (SGX301) for the treatment of cutaneous T-cell lymphoma and has completed a second Phase 3 study [7]. - Other development programs include treatments for psoriasis, inflammatory diseases, and a ricin toxin vaccine candidate [8].

Core Insights - Soligenix, Inc. has appointed Dr. Tomas J. Philipson as a Strategic Advisor, bringing extensive experience in U.S. economic and healthcare policy to the company [1][2][3] - The company is advancing its lead product candidate, HyBryte, which is currently in a confirmatory Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma (CTCL) [3][9] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [15] - The company’s Specialized BioTherapeutics segment is working on HyBryte, a novel photodynamic therapy utilizing synthetic hypericin for CTCL treatment [15] Product Details - HyBryte (SGX301) is a first-in-class photodynamic therapy that uses safe, visible light for activation, targeting malignant T-cells in skin lesions [4] - The treatment has shown significant efficacy in clinical trials, with a 16% response rate in the first treatment cycle compared to 4% in the placebo group [5] - In the second treatment cycle, a 40% response rate was observed among patients receiving 12 weeks of HyBryte treatment [6] Clinical Trials - The first Phase 3 FLASH trial enrolled 169 patients, demonstrating statistically significant improvements in lesion reduction [5] - A second confirmatory Phase 3 trial, FLASH2, is expected to begin before the end of 2024, aiming to replicate the successful design of the first trial [9][10] - The FDA has awarded a $2.6 million Orphan Products Development grant to support an investigator-initiated study of HyBryte for early-stage CTCL [12] 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 [14][13] - The safety profile of HyBryte is a significant advantage, as it is not associated with DNA damage, unlike many existing therapies [8]