Soligenix Forges Ahead: Celebrating Groundbreaking Milestones and Robust Financial Growth in Q2 2024

Soligenix, Inc. (Nasdaq: SNGX), a leading biopharmaceutical company committed to addressing significant unmet medical needs in rare diseases and public health threats, is thrilled to announce a quarter of substantial progress and encouraging financial results for the second quarter of 2024. The company's innovative pipeline, spanning critical areas from infectious diseases to oncology, continues to advance, bolstered by strategic funding and regulatory achievements.A cornerstone of Soligenix's public health preparedness efforts, RiVax®, its groundbreaking ricin toxin vaccine, received a significant boost with an additional $11.1 million in funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).This critical support underscores the U.S.

government's commitment to Project BioShield, aiming to develop essential medical countermeasures against potential bioterror threats. The Phase 3 clinical trial for RiVax is actively enrolling, marking a pivotal step towards delivering a thermostable, subunit vaccine designed to protect against ricin toxin exposure, a grave public health concern.Complementing its biodefense portfolio, Soligenix is also making strides with Marbox (oral beclomethasone dipropionate) for the treatment of acute radiation syndrome (ARS).With continued support from NIAID, the program recently completed a Phase 1 clinical trial, demonstrating a favorable safety and tolerability profile.

Preclinical studies are now underway to further establish Marbox's efficacy, positioning it as a potential critical therapeutic for a condition with limited treatment options.In the realm of rare diseases and dermatology, Soligenix has achieved a monumental regulatory breakthrough with SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL).The company successfully submitted a New Drug Application (NDA) for SGX301 to the U.S.

Food and Drug Administration (FDA). This submission was not only accepted for review but also assigned a crucial PDUFA goal date of February 24, 2025. Importantly, the FDA has indicated it does not plan to hold an Advisory Committee meeting, streamlining the review process for this novel photodynamic therapy that promises a new paradigm in CTCL management.This marks a significant step towards bringing a much-needed non-steroidal, non-chemotherapeutic option to patients suffering from this debilitating skin cancer.Furthermore, Soligenix continues to explore partnerships for its previously successful Phase 3 candidate, SGX942 (dusquetide), which has shown promise in treating oral mucositis.The company remains committed to finding a suitable commercialization partner to make this important therapy available to patients.Financially, Soligenix delivered a strong performance in the second quarter of 2024, reflecting the ongoing momentum of its pipeline.

Grant revenue saw a notable increase, reaching $2.0 million for Q2 2024, up from $1.7 million in Q2 2023, primarily driven by the enhanced NIH funding for the RiVax program.Research and development expenses were $2.2 million, a slight increase from $2.0 million in the prior year, attributed to the accelerated development of RiVax and the advanced stages of SGX301.

General and administrative expenses remained stable at $1.3 million for both periods. Impressively, the company's net loss improved to $1.4 million for Q2 2024, compared to $1.6 million in Q2 2023, showcasing enhanced operational efficiency.Soligenix concluded the quarter with a solid cash position of $6.9 million as of June 30, 2024, providing a strong foundation for continued innovation.These accomplishments underscore Soligenix's unwavering dedication to addressing critical medical needs and its ability to consistently achieve significant clinical and regulatory milestones.With a robust pipeline and prudent financial management, Soligenix is well-positioned for continued growth and impact in the biopharmaceutical landscape...