Sol-Gel Technologies Ltd.

Our Company is an innovative dermatology company that develops treatments for severe skin conditions. The company has achieved two New Drug Application (NDA) approvals and is developing product candidates for orphan indications. It successfully developed Twyneo and Epsolay, pioneer topical drugs approved for the treatment of acne vulgaris and inflammatory lesions of rosacea, respectively. The current product candidate pipeline includes SGT-610 (Patidegib Gel 2%), a new chemical entity hedgehog signaling pathway blocker, which is in a Phase 3 clinical trial for the chronic use and prevention of new Basal Cell Carcinoma (BCC) in Gorlin syndrome patients. The company also plans to examine SGT-610 for a potential new indication: high-frequency BCC, and is developing the SGT-210 topical drug candidate platform for new indications. Twyneo, an FDA-approved product, is a once-daily, non-antibiotic topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide (BPO) and encapsulated tretinoin, for the treatment of acne vulgaris. Epsolay, also FDA-approved, is a once-daily topical cream containing encapsulated BPO for the treatment of inflammatory lesions of rosacea. From 2022 until April 2025, Twyneo and Epsolay were marketed in the U.S. by Galderma. In April 2025, the company sold its U.S. rights for Twyneo and Epsolay to Mayne, following the mutual termination of the exclusive five-year license agreement with Galderma, which was entered into in June 2021. In June 2023, the company entered into two exclusive license agreements with Searchlight for the exclusive right to Twyneo and Epsolay in Canada, for a fifteen-year term renewable for subsequent five-year periods. In May 2024, Beimei purchased and licensed the rights to commercialize and manufacture Twyneo in China, Hong Kong, Macau, Taiwan, and Israel.