PRINCETON, N.J., July 8, 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, today issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. The content of this letter is provided below.Dear Friends and Shareholders,I would like to start by thanking you for your continued support, and hope ...

Active Ingredient Manufacturing Transfer to the U.S. Complete PRINCETON, N.J., July 1, 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 successfully completed the transfer of the manufacturing process for its synthetic hypericin active ingredient under its partnership agreement with Sterling Pharma So ...

PRINCETON, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- via IBN – 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, today spotlights the efforts of Ellen Kim, M.D., Lead Principal Investigator for the Company’s Phase 3 FLASH (1 and 2) studies in early stage cutaneous T-cell lymphoma (CTCL), in advancing HyBryte™ (synthetic hypericin) as a potential new th ...

PRINCETON, N.J., May 9, 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 its recent accomplishments and financial results for the quarter ended March 31, 2025."Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones. These include top-line resul ...

Interim Results from FDA-Funded Study Reinforces HyBryte's™ Rapid Response and Strong Safety ProfilePRINCETON, N.J., April 14, 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 interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ (synthetic hypericin) treatme ...

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [1][5] - The company has selected IBN to lead its corporate communications efforts, leveraging IBN's extensive distribution network to enhance visibility [1][4] Company Overview - Soligenix operates through two main segments: Specialized BioTherapeutics, which targets oncology and inflammation therapies, and Public Health Solutions, which focuses on vaccines and therapeutics for biothreats and infectious diseases [2] - The company is advancing multiple late-stage clinical programs, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, and other candidates for psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945) [2][5] Public Health Initiatives - The Public Health Solutions segment includes development programs for vaccines against ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™), supported by approximately $60 million in non-dilutive government grants and contracts [3][6] - The vaccine development utilizes proprietary heat stabilization technology known as ThermoVax® [6] Strategic Partnerships - IBN will utilize its investor-focused distribution network, which includes over 5,000 syndication outlets and a large social media following, to increase awareness for Soligenix [4][5] - IBN has over 19 years of experience and has assisted more than 500 client partners, positioning it to effectively reach a broad audience [5]

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 Viewpoint - Soligenix, Inc. is focused on advancing its clinical programs and achieving significant development milestones, particularly in the treatment of rare diseases with unmet medical needs, while managing its financial resources effectively [2][9]. Recent Accomplishments - The company has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) and has reported positive interim results from an open-label study of HyBryte™ [7][9]. - Formation of a European Medical Advisory Board to provide strategic guidance for the ongoing clinical studies [7]. Financial Results - For the year ended December 31, 2024, Soligenix reported revenues of $0.1 million, a decrease from $0.8 million in the previous year, primarily due to timing issues with government grant funding [4]. - The net loss for the year was $8.3 million, or ($4.98) per share, compared to a net loss of $6.1 million, or ($12.66) per share, in the prior year, influenced by a reverse stock split and increased research and development expenses [5][6]. - Research and development expenses rose to $5.2 million from $3.3 million, driven by costs related to new clinical trials [6]. Cash Position - As of December 31, 2024, the company had approximately $7.8 million in cash, which is expected to support operations through 2025 while exploring various strategic options for funding [2][8].

Two Presentations Highlight Data Demonstrating Hypericin Photodynamic Therapy Potential with a Preliminary Comparison to Current TherapyPRINCETON, N.J., March 6, 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 its lead investigators for the cutaneous T-cell lymphoma (CTCL) and psoriasis programs are present ...