PRINCETON, N.J., Dec. 18, 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 the results from its Phase 2a proof of concept study evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide fo ...

Soligenix, Inc. (NASDAQ:SNGX) on Wednesday announced extended results of its ongoing Phase 2a trial of SGX302 (synthetic hypericin) for mild-to-moderate psoriasis.In this extension (Cohort 3) of the exploratory phase of the study, an additional four patients were enrolled and treated with an improved topical gel formulation of synthetic hypericin.The gel formulation was specifically designed to improve ease of application to larger areas of the skin.SGX302 gel therapy was well tolerated by all patients with ...

"We are pleased with the preliminary findings from our ongoing Phase 2a trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "The optimized gel formulation was designed to improve the patient experience, with both easier dispensation and skin application. The expansion of this psoriasis study continues our evaluation of synthetic hypericin into other disease indications, including non- orphan indications, where there remains an unmet medical need. Current estimates ...

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing therapies for rare diseases with significant unmet medical needs [3][4] - The U.S. healthcare system faces increasing challenges from chronic illnesses and rare disorders, particularly among older populations, with over 30 million Americans affected by rare diseases [2][3] - Soligenix is advancing several therapies, including HyBryte(TM) for cutaneous T-cell lymphoma, and is positioned to align with national healthcare goals under the current administration [3][4] Company Overview - Soligenix Inc. specializes in developing and commercializing products for rare diseases, with a focus on HyBryte(TM) as a novel photodynamic therapy for cutaneous T-cell lymphoma [4] - The company is also expanding its pipeline to include treatments for psoriasis and inflammatory diseases, as well as vaccine candidates for bioterrorism threats and COVID-19 [5] Industry Context - The increasing burden of rare diseases among aging populations highlights the urgent need for innovative treatments, as many conditions lack FDA-approved therapies [2][3] - The company's initiatives are supported by government grants and contracts from agencies such as NIAID, DTRA, and BARDA, indicating a strong alignment with public health objectives [5]

Core Insights - Soligenix, Inc. has completed the enrollment of 50 patients for the interim analysis in its Phase 3 study of HyBryte™ for treating cutaneous T-cell lymphoma (CTCL) [1][2] - The interim analysis is expected to occur in the second quarter of 2026, with a planned overall blinded study response rate of 25% [2][10] - The study builds on previous successful trials, demonstrating a response rate of 48% among patients who have completed the treatment phase to date [2][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs [16] - The company is advancing HyBryte™ (SGX301), a novel photodynamic therapy utilizing synthetic hypericin, for the treatment of CTCL [16][3] - The company also has other development programs targeting conditions such as psoriasis and inflammatory diseases [16] Study Details - The FLASH2 study is a randomized, double-blind, placebo-controlled trial enrolling approximately 80 subjects with early-stage CTCL [2][10] - The study design replicates the first successful Phase 3 FLASH study, extending the treatment to 18 weeks without breaks [10][11] - Previous studies indicated a treatment response of 49% in patients completing 18 weeks of therapy in the first Phase 3 study [11][6] Treatment Efficacy - HyBryte™ has shown a response rate of 75% in an ongoing investigator-initiated study, with a benign safety profile observed [2][5] - The treatment has demonstrated significant anti-proliferative effects on malignant T-cells and has received orphan drug and fast track designations from the FDA [5][10] - The first Phase 3 study showed a statistically significant improvement in lesion reduction compared to placebo [6][7] 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 [15][14] - There is currently no approved front-line therapy for CTCL, making HyBryte™ a potentially safer and effective treatment option [9][14] - The FDA and EMA require a second successful Phase 3 trial for marketing approval, which Soligenix is currently pursuing with the FLASH2 study [10][19]

Financial Performance - For the three months ended September 30, 2025, the net loss was $2.53 million, compared to a net loss of $1.72 million for the same period in 2024, indicating an increase in loss of approximately 47.1%[10] - For the nine months ended September 30, 2025, the net loss was $8.18 million, up from $5.28 million in 2024, reflecting an increase of about 55.5%[10] - Basic and diluted net loss per share for the nine months ended September 30, 2025, was $2.30, compared to $3.84 in 2024, showing an improvement of approximately 40.0%[8] - The net loss applicable to common stockholders for the nine months ended September 30, 2025, was $8,184,191, compared to $5,279,210 in 2024, representing a 55% increase[10] - The adjusted loss from operations for the Company was $(2,580,483) for the three months ended September 30, 2025, reflecting significant expenses in both segments[71] - For the nine months ended September 30, 2025, the total research and development expenses were $4,844,593, with general and administrative expenses amounting to $3,168,297[73] - The total loss from operations for the nine months ended September 30, 2025, was $4,926,589, compared to $2,144,124 in 2024, reflecting a 129.5% increase[74] Assets and Liabilities - Total assets increased to $11.29 million as of September 30, 2025, compared to $8.97 million as of December 31, 2024, reflecting a growth of approximately 26.5%[7] - Total current assets rose to $10.88 million, up from $8.83 million, marking an increase of about 23.3%[7] - Total liabilities decreased to $3.70 million from $4.85 million, a reduction of approximately 23.7%[7] - Total current liabilities decreased from $4,848,412 as of September 30, 2024, to $3,422,021 as of September 30, 2025, reflecting a reduction of approximately 29.4%[7] - The accumulated deficit as of September 30, 2025, was $242,154,943, compared to $230,983,386 as of September 30, 2024, reflecting an increase in the deficit of approximately 4.9%[12] Shareholder Equity - Shareholders' equity improved to $7.60 million, compared to $4.12 million, representing a growth of about 84.5%[7] - As of September 30, 2025, total shareholders' equity increased to $7,597,976 from $5,935,188 as of September 30, 2024, representing a growth of approximately 28.1%[12] - Total common stock shares outstanding increased from 2,295,304 as of September 30, 2024, to 9,861,130 as of September 30, 2025, reflecting a significant increase of 330%[12] Expenses - Research and development expenses for the three months ended September 30, 2025, were $1.58 million, compared to $0.97 million in 2024, an increase of approximately 63.1%[8] - General and administrative expenses for the nine months ended September 30, 2025, totaled $3.17 million, slightly up from $3.16 million in 2024, indicating a marginal increase of about 0.3%[8] - The total operating expenses for the nine months ended September 30, 2025, reached $8,370,870, compared to $5,727,002 in 2024, which is an increase of 46%[8] Funding and Grants - The company reported no grant revenue for the three and nine months ended September 30, 2025, compared to $119,371 in the same periods of 2024[8] - The company has received approximately $1.1 million from a U.S. FDA Orphan Products Development grant for an expanded study of HyBryte™[19] - The company plans to submit additional contract and grant applications for further support of its programs, although there is no assurance of obtaining additional funding[22] Public Offering and Financing - The company issued 4,064,080 shares of common stock in connection with the September 2025 public offering, raising $7,498,522 after issuance costs[13] - Issuance costs associated with the September 2025 public offering totaled $742,549, impacting the net proceeds from the offering[13] - The Company completed a public offering on September 29, 2025, raising approximately $7.5 million by issuing 4,064,080 shares of common stock and pre-funded warrants[53] Clinical Development - The company is developing HyBryte™ for the treatment of cutaneous T-cell lymphoma, with patient enrollment for the second Phase 3 study, FLASH2, beginning in December 2024, and top-line results expected in the second half of 2026[16] - The company plans to expand the development of synthetic hypericin into psoriasis (SGX302) and dusquetide (SGX945) into Behçet's Disease, with ongoing clinical trials[27] Strategic Initiatives - The company is exploring merger and acquisition strategies and evaluating additional financing opportunities[22] - The company’s focus remains on advancing its product development pipeline in the Specialized BioTherapeutics segment, which is its primary strategic priority[68] Risks and Compliance - The company is subject to risks common in the biotechnology industry, including regulatory compliance and dependence on key personnel[20] - The Company’s ability to secure government grants and contracts is crucial for the sustainability of the Public Health Solutions segment, which covers employee salaries and overhead costs[69]

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]