Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, announced today it has entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (ASX: MYX) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. The deal, valued at $16 million, will be paid in two installments: $10 million in Q2 2025 and $6 million in Q4 2025.
This strategic transaction follows the mutual termination of Sol-Gel's exclusive five-year license agreement with Galderma for both products in the U.S. market. The infusion of capital is expected to extend Sol-Gel's cash runway into the first quarter of 2027, providing sufficient resources to complete its ongoing Phase III clinical trial for SGT-610.
Strategic Refocus on Innovative Pipeline
With the proceeds from this agreement, Sol-Gel will concentrate on the clinical and commercial development of SGT-610, its most advanced innovative product. SGT-610 is a hedgehog signaling pathway blocker designed to potentially become the first-ever preventative treatment for basal cell carcinomas (BCCs) in patients with Gorlin syndrome, a rare genetic disorder.
"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," said Mori Arkin, Chairman of the Board and CEO of Sol-Gel. "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."
SGT-610 Market Potential and Clinical Progress
Based on recent independent market research commissioned by Sol-Gel and the prevalence of Gorlin syndrome in the U.S., the company now estimates the U.S. market potential for SGT-610 to be between $400 and $500 million annually.
The Phase III clinical trial for SGT-610 is progressing well, with all 41 sites open for enrollment and approximately 80% of the planned number of patients already enrolled. The company expects to complete recruitment by Q3 2025 and announce top-line results in Q4 2026.
Mr. Arkin expressed optimism about the trial's potential success, citing post-hoc analysis of results from a Phase III clinical study of patidegib conducted by PellePharm Inc., Sol-Gel's predecessor. While that study did not achieve statistical significance of the primary endpoint, subsequent analysis with the assistance of independent statisticians and clinical experts revealed that Gorlin syndrome patients with confirmed hedgehog mutations showed significant response to patidegib (P<0.01).
About EPSOLAY and TWYNEO
EPSOLAY is a topical cream containing encapsulated benzoyl peroxide (5%) for the treatment of inflammatory lesions of rosacea in adults. It utilizes a proprietary technology to encapsulate BPO within silica-based microcapsules, creating a barrier between the medication and the skin for controlled release.
TWYNEO is a fixed-dose combination of encapsulated benzoyl peroxide (3%) and encapsulated tretinoin (0.1%) cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. It is the first acne treatment containing this specific combination, using silica core shell structures to separately micro-encapsulate the active ingredients, preventing the degradation of tretinoin by benzoyl peroxide.
Additional Pipeline Development
Sol-Gel also provided an update on SGT-210, a topical erlotinib drug candidate formulated for the treatment of Darier disease and other hyperkeratosis-related indications. The Phase 1b trial in Darier patients is ongoing, with 50% of patients having already completed the trial. The company estimates the market potential for SGT-210 to be between $200 and $300 million.
"If the trial demonstrates the clinical efficacy that we expect, we anticipate filing for a Phase 2 IND in Q2 2025," said Mr. Arkin. He noted that SGT-210 is currently being used in a compassionate use treatment for a pediatric patient with a rare disease, with repeated requests for supply suggesting positive outcomes.
Financial Position
As of March 31, 2025, Sol-Gel had $16.9 million in cash, cash equivalents, and deposits. This represents a decrease from December 31, 2024, when the company reported $19.5 million in cash, cash equivalents, and deposits, plus $4.4 million in marketable securities for a total balance of $23.9 million.
Global Expansion Plans
Beyond the U.S. transaction, Sol-Gel is in advanced stages of establishing a commercial network for EPSOLAY and TWYNEO outside the United States. Multiple partnership agreements have already been signed, with others 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," Mr. Arkin stated.
About Gorlin Syndrome and SGT-610
Gorlin syndrome is an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S. It 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 not needed.
Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, potentially allowing cells to function normally and reducing the production of new tumors.
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel pharmaceuticals. The company is a leader in dermatology and women's health in the United States and provides contract development and manufacturing services to clients worldwide. With a 40-year track record in developing new oral drug delivery systems, Mayne Pharma has successfully commercialized numerous products globally.
