NESS ZIONA, Israel — November 20, 2025 — Leads & Copy — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) reported its third-quarter financial results ending September 30, 2025, and provided a corporate update, according to a recent press release.
The company’s ongoing Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome has sparked growing physician interest in its potential use for patients with severe, high-frequency basal cell carcinoma (BCC). Sol-Gel agreed to provide SGT-610 for compassionate use in a non-Gorlin patient in France with a severe form of high-frequency BCC who had a lesion harboring a PTCH-1 mutation.
Sol-Gel plans to supply the drug to additional high-frequency BCC patients with at least one PTCH-1 mutated lesion. The company is evaluating the initiation of a feasibility study in this new indication to further substantiate the rationale for a Phase 3 trial in 2027, pending successful completion of the Phase 3 Gorlin syndrome trial. A successful outcome could at least double the commercial potential of SGT-610, addressing the unmet need for effective and well-tolerated treatment options for patients where frequent Mohs surgeries are not sustainable.
The vehicle-controlled Phase 1b clinical trial (Stage 1) investigating SGT-210 (topical erlotinib) in patients with Darier disease has faced challenges due to the limited number of eligible patients in Israel, with only seven subjects completing the treatment so far. Sol-Gel has decided to conclude the current phase of the trial and proceed with an open-label extension where all enrolled patients will receive active treatment with SGT-210. The results of Stage 1 of the trial will be released in December 2025.
Sol-Gel also announced Health Canada marketing approval of EPSOLAY for treating inflammatory lesions of rosacea in adults on September 4, 2025.
Additionally, on August 19, 2025, Sol-Gel signed a license agreement with Viatris Pty Ltd, a subsidiary of Viatris Inc. (NASDAQ: VTRS), for commercializing TWYNEO and EPSOLAY in Australia and New Zealand. This agreement adds to the seven agreements signed during 2024 for various territories, including most European countries, South Africa, and South Korea. These agreements, combined with anticipated future agreements covering Latin American countries, Spain, and Portugal, are expected to provide upfront and regulatory milestone payments of up to $3.7 million.
Based on forecasts from current and potential partners, Sol-Gel expects TWYNEO and EPSOLAY to launch in most of these new territories in 2028 and 2027, respectively. Following launch, these transactions are expected to generate an annual royalty revenue stream, potentially growing to approximately $10 million by 2031 and beyond.
Mr. Mori Arkin, Executive Chairman of Sol-Gel, expressed excitement about doubling the potential of SGT-610 by addressing the unmet need for high-frequency BCC and highlighted the Health Canada approval of EPSOLAY and existing ex-U.S. partnerships.
Total revenue for the third quarter was $0.4 million, primarily from license revenue from ex-US licensing agreements, compared to $5.4 million for the same period in 2024. Research and development expenses were $5.7 million, compared to $4.8 million in 2024, primarily due to increased manufacturing and clinical trial expenses for SGT-610. General and administrative expenses decreased to $1 million from $1.4 million in 2024 due to cost-saving measures.
Sol-Gel reported a net loss of $5.9 million for the third quarter of 2025, or a loss of $2.13 per basic and diluted share, compared to a net loss of $0.4 million, or a loss of $0.13 per basic and diluted share, for the same period in 2024. As of September 30, 2025, Sol-Gel had $20.9 million in cash, cash equivalents, deposits and marketable securities. The company anticipates that its cash resources will fund cash requirements into the first quarter of 2027.
TWYNEO is a topical cream containing tretinoin, 0.1%, and benzoyl peroxide, 3%, for acne vulgaris treatment. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for treating inflammatory lesions of rosacea in adults.
SGT-610 is a hedgehog signaling pathway blocker with the potential to prevent BCCs in Gorlin syndrome patients. Gorlin syndrome is a genetic disorder caused by mutations in the PTCH1 gene, leading to uncontrolled division of BCC tumor cells.
Sol-Gel Technologies Ltd. is a dermatology company focused on identifying, developing, and commercializing drug products to treat skin diseases. Sol-Gel developed TWYNEO and EPSOLAY, which are approved by the FDA for treating acne vulgaris and rosacea, respectively.
Pipeline also includes ongoing Phase 3 clinical trial of Orphan drug and breakthrough drug candidate SGT-610, which is a new topical hedgehog inhibitor being developed to prevent the new basal cell carcinoma lesions in patients with Gorlin syndrome that is expected to have an improved safety profile compared to oral hedgehog inhibitors as well as topical drug candidate SGT-210 under investigation for the treatment of rare hyperkeratinization disorders.
Sol-Gel Contact:
Eyal Ben-Or
Chief Financial Officer
info@sol-gel.com
+972-8-9313429
Source: Sol-Gel Technologies Ltd.
