Study Supported by $2.6 Million FDA Orphan Products Development Grant "We are pleased with the initial study results and with the FDA's support of the IIS that provides CTCL patients an opportunity to access HyBryte™ in an open-label setting," stated Christopher J. Schaber, President and CEO of Soligenix, Inc. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. Following the initial Phase 3 FLA ...

Core Insights - Soligenix's HyBryte™ shows promising results in treating cutaneous T-cell lymphoma (CTCL) compared to Valchlor®, with a higher percentage of patients achieving significant improvement in their condition [24][23][12] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [20][24] - The company is advancing its pipeline, which includes other therapeutic candidates for various conditions [20] Clinical Study Results - In a recent comparability study, 60% of patients treated with HyBryte™ achieved a ≥50% improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score after 12 weeks, compared to 20% for Valchlor® [24][23] - The study involved 10 patients, with a favorable safety profile for HyBryte™, as no adverse events related to the therapy were reported, while 60% of Valchlor® patients experienced adverse events [2][24] Treatment Efficacy - HyBryte™ demonstrated a cumulative improvement in mCAILS of 52.5% compared to 34.7% for Valchlor® after 12 weeks [23] - The treatment was well tolerated across all patients, contrasting with Valchlor®, where one patient had to withdraw due to allergic contact dermatitis [23][2] Future Developments - Following the positive results, a second Phase 3 trial (FLASH2) is expected to begin before the end of 2024 to further evaluate HyBryte™ [6][12] - The FDA has granted an Orphan Products Development grant of $2.6 million to support the evaluation of HyBryte™ for expanded treatment options [7] Industry 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][8] - The treatment landscape for CTCL is limited, with existing therapies often associated with significant side effects, highlighting the potential of HyBryte™ as a safer alternative [16][8]

Group 1 - Soligenix is developing thermostabilized subunit vaccines, including SuVax™ and MarVax™, which have shown complete protection in non-human primate studies against filoviruses [2][10][27] - The company has received Orphan Drug Designation from the FDA for both Sudan ebolavirus and Marburg marburgvirus, providing market exclusivity and various financial benefits [5][13] - The thermostabilization technology allows vaccines to remain stable at ambient temperatures, facilitating easier distribution and use [2][20][27] Group 2 - The company is focused on rare diseases with unmet medical needs, with additional products in development for conditions like cutaneous T-cell lymphoma and inflammatory diseases [8][24] - Soligenix's vaccine programs are supported by government grants and contracts from agencies like NIAID and BARDA, enhancing its financial position [4][24] - The upcoming presentation at the ASM Microbe Conference will highlight the advantages of the company's vaccine technology compared to other platforms [10][11][26]

In addition to the positive clinical results to date, Soligenix has received regulatory validation with the granting of Orphan Drug Designation and Fast Track Status by the U.S. Food and Drug Administration (FDA), and Orphan Designation by the European Medicines Agency (EMA) for HyBryte™ in the treatment of early-stage CTCL. The full article can be found at: https://prismmarketview.com/prism-marketview-highlights-soligenixs- promising-hybryte-replication-trial-setting-the-stage-for-success/ NEW YORK, June 0 ...

Common Stock Will Begin Trading on Split-Adjusted Basis on June 6, 2024 PRINCETON, N.J., May 31, 2024 /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 intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 16 pre-split shares. The reverse stock split will become ...

Core Viewpoint - Soligenix, Inc. is urging eligible stockholders to vote their shares at the upcoming reconvened meeting on May 30, 2024, emphasizing the importance of shareholder participation in corporate governance [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [5]. - The company is advancing its Specialized BioTherapeutics segment, which includes HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and is seeking regulatory approvals for potential worldwide commercialization [5]. - Other development programs include SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [5]. 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 [6][7]. - The vaccine programs utilize the proprietary ThermoVax® technology and have received government funding from agencies such as NIAID, DTRA, and BARDA [7]. Voting Information - Eligible stockholders can vote by contacting the company's proxy solicitor, Alliance Advisors, and must have held shares as of the record date, April 10, 2024 [2]. - Stockholders who sold their shares after the record date are still encouraged to vote [2]. Proxy Materials - The company filed a definitive proxy statement and proxy card with the SEC on April 29, 2024, and stockholders are urged to read these documents for important information regarding the Annual Meeting [3][4].

Core Points - Soligenix, Inc. announced the adjournment of its 2024 Annual Meeting of Stockholders to solicit additional votes on proposals outlined in its definitive proxy statement [1][5] - The reconvened Annual Meeting is scheduled for May 30, 2024, at 9:00 a.m. Eastern Time, and will be held virtually [2] - As of the adjournment, approximately 48% of the shares of common stock had been voted, which was below the required quorum [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), a novel photodynamic therapy for cutaneous T-cell lymphoma, and is seeking regulatory approvals following the successful completion of its second Phase 3 study [7] - Other development programs include SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [8] 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 [9] - These programs are supported by government funding from agencies such as NIAID, DTRA, and BARDA [9]

Most shareholders can vote by calling 1-833-782-7145 PRINCETON, N.J., May 23, 2024 /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, encourages its eligible stockholders to vote "FOR" a Reverse Stock Split. The Company and its Board of Directors believe it is important to maintain the listing of the Common Stock on The Nasdaq Capital ...

NEW YORK, May 21, 2024 (GLOBE NEWSWIRE) -- PRISM MarketView presents an in-depth interview with Dr. Christopher Schaber, President and Chief Executive Officer of Soligenix, Inc. (NASDAQ:SNGX). The late-stage biopharmaceutical company is advancing a broad pipeline of therapeutic and vaccine candidates across its two business segments, emphasizing its strategic focus on diversified drug development. Soligenix has recently achieved success in its first Phase 3 clinical trial of HyBryte™ (synthetic hypericin) f ...

Under the Company's Public Health Solutions business segment, Soligenix is developing thermostabilized subunit vaccines. Thermostabilization is achieved by using a combination of Generally Recognized as Safe (GRAS) excipients and lyophilization (freeze-drying) to yield a single-vial presentation of vaccine that is stable at ambient and higher temperatures and that can be reconstituted with water for injection immediately prior to use. Mono-, bi- and tri-valent vaccine candidates for filoviruses (including S ...