Soligenix, Inc. - SNGX STOCK NEWS

Soligenix, Inc. (SNGX) has submitted a Type A Meeting Request to the U.S. FDA to discuss a refusal to file letter related to its NDA for HyBryte™ (synthetic hypericin) for treating cutaneous T-cell lymphoma (CTCL). This meeting is anticipated within 30 days of the FDA's receipt of the request. The Phase 3 FLASH trial showed statistically significant results, with 16% of HyBryte™ patients achieving a 50% lesion reduction compared to 4% in the placebo group. HyBryte™ utilizes safe, visible light for treatment, avoiding risks associated with traditional therapies. Soligenix is advancing regulatory approval and commercialization efforts for HyBryte™.

Soligenix announced it received a Refusal to File (RTF) letter from the FDA regarding its HyBryte™ new drug application for treating cutaneous T-cell lymphoma (CTCL). The FDA stated that the submission was incomplete for substantive review. Soligenix plans to request a Type A meeting with the FDA to address concerns and discuss the resubmission process. HyBryte™, utilizing synthetic hypericin, has previously shown promising results in clinical trials, with 16% of patients achieving significant lesion reduction. The company remains focused on advancing this treatment option despite the setback.

Soligenix, Inc. (NASDAQ: SNGX) announced a reverse stock split, effective February 9, 2023, at a ratio of 1-for-15. This move reduces the outstanding shares from approximately 43.3 million to about 2.9 million, maintaining stockholder percentage interests except for fractional shares. Trading on a split-adjusted basis begins on February 10, 2023. Shareholders approved the split at a special meeting on February 8, granting the Board discretion to set the ratio between 1-for-2 to 1-for-20. The new CUSIP number for the common stock is 834223505. The company is focused on rare disease therapeutics and vaccine development.

Soligenix, a late-stage biopharmaceutical company, will present at the Virtual Investor Summit on January 26, 2023, at 9:00 AM ET. This event highlights 25 micro-cap companies with significant catalysts and performance. Soligenix is recognized for its lead product candidate, HyBryte™, aimed at treating cutaneous T-cell lymphoma, with a new drug application submitted for regulatory approval. The Investor Summit is complimentary for qualified investors, and one-on-one meetings with Soligenix management can be scheduled. For attendance or additional information, visit the summit website.

Soligenix, Inc. (SNGX) announced a dividend of one one-thousandth of a share of newly designated Series D Preferred Stock, effective January 4, 2023. Each share of Series D Preferred Stock will vote on a potential reverse stock split and will grant 1,000,000 votes per share. CEO Christopher Schaber highlighted challenges faced due to market conditions and a Nasdaq deficiency letter regarding the minimum bid price. The reverse stock split is considered essential for maintaining Nasdaq listing, potentially enhancing attractiveness for institutional investors.

Soligenix, Inc. (Nasdaq: SNGX) announced the publication of preclinical studies on RiVax^®, a heat-stable ricin toxin vaccine. The studies demonstrated statistically significant correlates of protection in non-human primates, essential for advancing FDA approval under the "Animal Rule." RiVax^® provided up to 100% protection against lethal ricin exposure, showing stability for over a year at high temperatures. This progress, supported by over $40 million in non-dilutive funding, positions the vaccine favorably for further studies and potential inclusion in the Strategic National Stockpile.

Soligenix, Inc. (Nasdaq: SNGX) announced the opening of patient enrollment for its Phase 2a study (HPN-PSR-01) evaluating SGX302 (synthetic hypericin) for treating mild-to-moderate psoriasis, a condition affecting 7.5 million people in the U.S. and 60-125 million worldwide. The study aims to enroll up to 42 patients, applying the drug twice weekly for 18 weeks. The innovative therapy uses visible light to activate the drug, potentially minimizing risks associated with traditional treatments. Successful preliminary results from previous trials bolster the company's confidence in this approach.

Soligenix, Inc. (SNGX) announced the submission of a New Drug Application (NDA) for HyBryte™ to the FDA for treating early-stage cutaneous T-cell lymphoma (CTCL), a rare cancer affecting over 25,000 patients in the U.S. The estimated worldwide market for HyBryte™ exceeds $250 million. The NDA has received both orphan drug and fast track designations, with potential FDA approval anticipated in the second half of 2023. Results from the Phase 3 FLASH trial showed significant improvement in lesion reduction, emphasizing HyBryte™ as a promising treatment option with a favorable safety profile.

Soligenix, Inc. (SNGX) has received preliminary approval for a tax credit from the New Jersey Economic Development Authority, enabling the company to transfer this credit and gain approximately $1.2 million in net proceeds. This marks the thirteenth consecutive year of receiving Net Operating Loss funding, totaling nearly $9 million to support its rare disease pipeline. Additionally, Soligenix plans to file a new drug application for HyBryte™ for treating cutaneous T-cell lymphoma and initiate a Phase 2a study of SGX302 for psoriasis. The company has over $16 million in cash and aims for peak annual sales exceeding $90 million.