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 Viewpoint - Soligenix, Inc. has demonstrated the extended stability of its ebolavirus vaccines using the ThermoVax® platform, maintaining potency after two years at high temperatures, which is crucial for deployment in virus-endemic regions and for pandemic preparedness [1][2]. Group 1: Vaccine Stability and Efficacy - The bivalent and trivalent vaccines, targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed no change in potency after two years of storage at 40°C (104°F) [1]. - The vaccines have exhibited broad immune responses in mice and up to 100% protection in non-human primates [2][3]. - The ThermoVax® platform enhances the stability of vaccines, making them competitive with other technologies that require stringent cold-storage [2][3]. Group 2: Vaccine Development and Manufacturing - The filovirus vaccines are subunit protein vaccines developed in collaboration with Dr. Axel Lehrer, utilizing a robust protein manufacturing process [3][4]. - The vaccines are designed to be heat-stable and can be lyophilized, allowing for easy reconstitution with water prior to use [3]. - The adjuvant used in the vaccines has been tested in Phase 1 and Phase 2 clinical studies, supporting its safety and efficacy [4]. Group 3: Regulatory and Market Position - Soligenix has received Orphan Drug Designation from the FDA for its filovirus vaccines, providing market exclusivity and various financial benefits [5]. - The company is positioned to leverage government grants and regulatory advantages to support clinical trials and potential market entry [5]. Group 4: Public Health Context - Filoviruses, including Ebola and Marburg, have high mortality rates and limited treatment options, highlighting the need for effective vaccines [6][7]. - Recent outbreaks of Sudan and Marburg viruses underscore the importance of developing vaccines that can be stored and distributed easily in affected regions [6][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]

Core Insights - Soligenix, Inc. is advancing HyBryte™ (synthetic hypericin) as a potential new therapy for early-stage cutaneous T-cell lymphoma (CTCL), specifically targeting mycosis fungoides (MF), the most common form of CTCL [1][7] - The company emphasizes the urgent need for safer and more effective therapies for CTCL, as there has not been a new FDA-approved skin-directed therapy in over 10 years [3][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and other therapeutic programs [7] - The company is also involved in vaccine development for biodefense and infectious diseases, supported by government funding [8] Clinical Development - Dr. Ellen Kim, the Lead Principal Investigator, highlighted the promising clinical results from ongoing Phase 3 FLASH studies, noting that participants have experienced positive outcomes with no serious adverse events leading to dropouts [3][4] - HyBryte™ operates through a unique mechanism that does not damage DNA, theoretically reducing the risk of skin cancer compared to traditional phototherapy [4] Research and Future Directions - Dr. Kim expressed excitement about the open enrollment in HyBryte™ clinical trials, emphasizing the critical role of patient participation in advancing new therapies [6] - The company aims to seek regulatory approvals for HyBryte™ following the successful completion of its second Phase 3 study [7]

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].