Tretinoin

Sol-Gel to receive $16 million during 2025 Cash runway is expected to extend into the first quarter of 2027; Company expects to have sufficient cash to complete its Phase III clinical trial SGT-610 Phase III clinical trial top-line results are expected in the fourth quarter of 2026; a significant milestone in the clinical trial of recruiting more than 80% of the patients has been achieved Sol-Gel now estimates the U.S. market potential for SGT-610 to be between $400 to $500 million annually SGT-210 Phase 1b trial in Darier patients is ongoing; 50% of the patients have already completed the trial April 17, 2025 -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced it has entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. Under the terms of the agreement, Sol-Gel will receive a total of $16 million in two installments: $10 million in the second quarter of 2025 and $6 million in the fourth quarter of 2025, which is expected to extend the Company’s cash runway into the first quarter of 2027. This agreement was executed following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products. EPSOLAY is a topical cream containing encapsulated benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea (papulopustular rosacea) in adults. TWYNEO is a fixed-dose combination of encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream for the treatment of acne vulgaris. Facilitating the amounts received from this agreement with Mayne Pharma, Sol-Gel will concentrate on the clinical and commercial development of its most advanced innovative product, SGT-610, a hedgehog signaling pathway blocker designed to potentially become the first ever preventative treatment of basal cell carcinomas (BCCs) in Gorlin syndrome patients, if approved. Based on recent independent market research commissioned by Sol-Gel, in which the optimal price recommendation has been established, and based on prevalence of Gorlin syndrome in the U.S., Sol-Gel now estimates the U.S. market potential for SGT-610 to be between $400 and $500 million annually. As of December 31, 2024, Sol-Gel had $19.5 million in cash, cash equivalents, and deposits and $4.4 million in marketable securities for a total balance of $23.9 million. As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits and no marketable securities for a total balance of $16.9 million. “We are pleased to enter into this agreement with Mayne Pharma,” said Mori Arkin, Chairman of the Board and CEO of Sol-Gel. “Having concluded this U.S. transaction, we are in advanced stages of establishing the commercial network of Epsolay and Twyneo outside the U.S. Many partnership agreements have already been signed and others are under negotiation. If the forecasts of our partners, who all made upfront payments for the rights in their territories, are accurate, we believe that the value of the global business could far exceed that of the U.S. business alone. “This agreement with Mayne Pharma is expected to significantly enhance our cash position and enable us to bolster our SGT-610 program and bring the Phase-III trial to completion. In addition to the potential of SGT-610 in the U.S., we believe that the worldwide potential of SGT-610 is very significant as Gorlin syndrome is prevalent globally. “Our Phase-III clinical trial is progressing well, with all of our 41 sites open for enrollment and approximately 80% of the planned number of patients enrolled. We confidentially expect to complete recruitment no later than the third quarter of this year and announce top-line results in the fourth quarter of 2026. “With the funding of the clinical trial accomplished and the timeline established, we would like to share with our investors the reasons as to why we are optimistic about the trial’s potential success.” Mr. Arkin further commented, “It is important to note that all the data supporting our optimistic outlook are based on our post-hoc analysis of the results of the Phase-III clinical study of patidegib that was conducted by our predecessor, PellePharm Inc. “This type of analysis is called a ‘post-hoc analysis’, which we cannot assure you that its conclusions will be replicated in our study. With that said, I would like to explain the reasons for our optimism. “The study conducted by PellePharm did not achieve the statistical significance of the primary endpoint. However, with the assistance of three independent statisticians and several clinical experts, all commissioned by Sol-Gel, significant findings were made after studying the data. “Gorlin syndrome patients who lacked the PTCH-1 mutation responded poorly to patidegib. “When we included in our analysis only patients with a confirmed hedgehog mutation and excluded an additional subset of patients, the superiority of patidegib became very significant – P Mr. Arkin further commented, “I am also pleased to share an update on Sol-Gel’s of our vehicle controlled phase 1b clinical trial on SGT-210 (topical erlotinib) in patients with Darier disease, a significant unmet medical need with an estimated market potential of $200 to $300 million. If the trial will demonstrate the clinical efficacy that we expect, we anticipate filing for a Phase 2 IND in Q2 2025. SGT-210 is currently being used in a compassionate use treatment for a pediatric patient suffering from a rare disease, and the repeated requests for supply from the patient’s family indicates to us that the drug was probably helpful for this patient.” TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment. SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. SGT-210 is a topical erlotinib drug candidate that is formulated for the treatment of Darier Disease and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor, a protein present on cell surfaces that plays a key role in promoting cell growth and division. Darier Disease is a rare, genetic keratinization disorder which is classically characterized scaly crusted papules in a seborrheic distribution and in skin folds. Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products for the treatment of skin diseases. Sol-Gel developed TWYNEO which is approved by the FDA for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved by the FDA for the treatment of inflammatory lesions of rosacea in adults. The Company’s pipeline includes Orphan Drug candidate, SGT-610 under investigation for the prevention of new basal cell carcinomas in Gorlin syndrome patients, and also includes topical drug candidate SGT-210 under investigation for the treatment of rare skin keratodermas. Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel pharmaceuticals, to offer patients better, safe and more accessible medicines. Mayne Pharma is a leader in dermatology and women’s health in the United States and also provides contract development and manufacturing services to clients worldwide. Mayne Pharma has a 40- year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialized in numerous products that continue to be marketed around the world. The content above comes from the network. if any infringement, please contact us to modify.