Soligenix Inc Stock Price, News & Analysis

Soligenix, Inc. (SNGX) provided a corporate update highlighting a positive Phase 3 study of SGX301 for cutaneous T-cell lymphoma, with plans for a new drug application (NDA) submission. The company also reported promising preclinical results for its heat-stable COVID-19 vaccine candidate, CiVax™, while maintaining a strong cash position of over $30 million to support growth. Notably, SGX301's U.S. peak annual sales could exceed $90 million. However, disappointing results from SGX942's Phase 3 trial for oral mucositis raised concerns, as it did not meet statistical significance despite showing biological activity.

Soligenix, Inc. (Nasdaq: SNGX) announced that its CEO, Christopher J. Schaber, PhD, will present at the BIO CEO & Investor Digital Conference from February 16-18, 2021. The presentation will be available for on-demand viewing starting February 15 at 9:00 AM EST. Soligenix is advancing its drug application for SGX301, a treatment for cutaneous T-cell lymphoma, following a successful Phase 3 study. The conference offers an opportunity for one-on-one meetings with management, focusing on the company's rare disease pipeline and potential partnerships.

Soligenix, Inc. (Nasdaq: SNGX) announced the Hong Kong Registrar of Patents granted a patent for the therapeutic use of synthetic hypericin in treating cutaneous T-cell lymphoma (CTCL). The patent, published on January 29, 2021, enhances Soligenix's patent estate, protecting synthetic hypericin and its therapeutic methods. SGX301, a first-in-class photodynamic therapy, demonstrated a statistically significant treatment response in a pivotal Phase 3 study. CEO Christopher J. Schaber emphasized the potential for marketing approval and commercialization while pursuing global partnership opportunities.

Soligenix (Nasdaq: SNGX) announced an Investor Webcast Event on January 26, 2021, to discuss U.S. commercialization planning for SGX301, a novel photodynamic therapy for early-stage Cutaneous T-Cell Lymphoma (CTCL). SGX301 demonstrated a statistically significant treatment response in the Phase 3 FLASH trial after just 6 weeks (p=0.04) compared to placebo. Continued treatment improved outcomes, with 40% response in the second cycle. SGX301 was well tolerated, showing no mutagenic risks. The event will include insights from leading experts and management.

Soligenix, Inc. (SNGX) has entered an exclusive Supply, Distribution and Services Agreement with Daavlin for the SGX301 light device, aimed at treating cutaneous T-cell lymphoma (CTCL). This partnership is pivotal for the commercialization strategy of SGX301 upon FDA approval. Daavlin, with a 40-year history in phototherapy, will manufacture the device, while Soligenix will promote and facilitate purchases of the product. Both companies emphasize the integration of drug and device in achieving operational excellence for patient care.

Soligenix, Inc. (SNGX) received a $1.5 million Direct to Phase II SBIR grant from NIAID to support the development of COVID-19 and Ebola vaccine candidates. The funding will enhance the evaluation and manufacturing of the CiVax™ vaccine, known for its heat-stability and ability to induce a robust immune response. The grant aims to facilitate immunogenicity studies in animal models, leveraging the unique properties of the CoVaccine HT™ adjuvant. This initiative aligns with the growing global demand for diverse vaccination solutions amidst the ongoing pandemic.

Soligenix announced preliminary top-line results from its Phase 3 DOM-INNATE trial evaluating SGX942 (dusquetide) for treating severe oral mucositis in head and neck cancer patients undergoing chemoradiation. While the primary endpoint of median duration of SOM did not meet statistical significance (p≤0.05), a 56% reduction was observed, decreasing from 18 days in the placebo group to 8 days in the treatment group. Secondary endpoints indicated a statistically significant 50% reduction in the per-protocol population. The company plans further analysis and has approximately $20 million cash to support its pipeline.

Soligenix, Inc. (SNGX) secured a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing. The deal enhances Soligenix's financial flexibility as it progresses its rare disease pipeline, including SGX301 for cutaneous T-cell lymphoma and SGX942 for oral mucositis in head and neck cancer patients. The financing includes three tranches: $10 million drawn initially, and up to $10 million in two additional tranches, contingent upon milestones. The first two tranches can be converted to equity at $4.10 and $4.92 per share respectively.

Soligenix, Inc. (Nasdaq: SNGX) announced significant advancements with its heat-stable ricin toxin vaccine, RiVax®. Recent studies demonstrated that vaccinated mice maintained protection for over 365 days against ricin exposure. This thermostabilization allows for easy stockpiling without cold chain logistics, making it ideal for military and civilian use. The vaccine, supported by over $40 million in non-dilutive funding, could qualify for FDA's Animal Rule approval. RiVax® has received Orphan Drug and Fast Track designations, enhancing its development pipeline for biodefense applications.