NESS ZIONA, Israel, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients with severe skin conditions, conducting a Phase-3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, a Phase-1b, double blinded clinical trial of SGT-210 (erlotinib ointment, 5%) on Darier disease patients and with two approved large-category dermatology products, TWYNEO and EPSOLAY, announced today that on August 27, 2025 Health Canada i ...

Core Insights - Sol-Gel Technologies, Ltd. is advancing its clinical pipeline with a focus on SGT-610 for Gorlin syndrome and SGT-210 for Darier disease, aiming to address significant unmet medical needs in dermatology [4][6][17] - The company reported a substantial increase in revenue for Q2 2025, totaling $17.2 million, compared to $5.4 million in Q2 2024, driven by product sales and licensing agreements [8] - Sol-Gel's financial position is strengthened by a recent agreement with Mayne Pharma, which is expected to extend its cash runway into Q1 2027 [5][7] Clinical Developments - Enrollment for the Phase 3 trial of SGT-610 has been completed, with top-line results anticipated in Q4 2026; this product has the potential to generate peak revenues exceeding $300 million annually if approved [4][6] - The ongoing Phase 1b trial for SGT-210 is facing recruitment challenges but is believed to have additional indications beyond Darier disease, with market potential estimated between $200 million to $300 million [6][9] - SGT-610 is designed to be the first therapy to prevent new basal cell carcinomas in Gorlin syndrome patients, addressing a critical need in this underserved population [4][14] Financial Performance - Research and development expenses increased to $4.6 million in Q2 2025 from $2.4 million in Q2 2024, primarily due to higher manufacturing and clinical trial costs for SGT-610 [9] - The company reported a net income of $11.6 million for Q2 2025, a significant turnaround from a net loss of $1.9 million in Q2 2024, reflecting improved operational performance [10] - As of June 30, 2025, Sol-Gel had $24.2 million in cash and marketable securities, which is expected to support operations into early 2027 [11] Product Portfolio - TWYNEO and EPSOLAY are two approved products in Sol-Gel's portfolio, with a recent agreement for their purchase in the U.S. for $16 million, enhancing the company's revenue stream [5][8] - TWYNEO is a topical cream for acne treatment, while EPSOLAY is designed for rosacea, both utilizing innovative delivery technologies to improve efficacy [12][13] - The company is focused on translating the global demand for these products into meaningful revenues, with expectations of royalties from international markets potentially reaching $10 million by 2031 [7]

Core Viewpoint - Sol-Gel Technologies, Ltd. reported financial results for the first quarter of 2025, showing an increase in total revenue but a higher net loss compared to the same period in 2024 [2][4]. Financial Performance - Total revenue for the first quarter of 2025 was $1 million, a 100% increase from $0.5 million in the same period in 2024 [2]. - Research and development expenses rose to $8.8 million from $5.3 million in the first quarter of 2024, primarily due to supplier-led manufacturing development for SGT-610 [3]. - General and administrative expenses decreased to $1.3 million from $1.8 million in the same period in 2024, attributed to cost measures taken in 2024 [4]. - The net loss for the first quarter of 2025 was $8.8 million, compared to a net loss of $6.3 million in the first quarter of 2024, with a basic and diluted loss per share of $3.2 compared to $2.3 in 2024 [4]. Cash Position - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities, expected to fund operations into the first quarter of 2027 [5]. Company Overview - Sol-Gel Technologies focuses on developing and commercializing drug products for skin diseases, with FDA-approved products TWYNEO and EPSOLAY for acne and rosacea, respectively [6]. - The company's pipeline includes SGT-610, an Orphan Drug candidate for basal cell carcinoma prevention, and SGT-210 for rare skin keratodermas [7].

Core Points - Sol-Gel Technologies Ltd. announced a 10-for-1 reverse share split to increase the per share market price and regain compliance with Nasdaq's minimum bid price requirement [4][5][6] Group 1: Reverse Share Split Details - The reverse share split will consolidate every ten ordinary shares into one ordinary share, effective at 11:59 p.m. Eastern Time on May 2, 2025 [3][5] - The first trading day on Nasdaq under the new share structure is expected to be May 5, 2025, with the symbol "SLGL" remaining unchanged [3][4] - The par value of the ordinary shares will increase from NIS 0.1 to NIS 1.0, and the total share capital will adjust from 50 million to 5 million ordinary shares [6] Group 2: Shareholder Approval and Process - Shareholders approved the reverse split ratio at a special meeting on April 1, 2025, with the board of directors confirming the 10-for-1 ratio on April 9, 2025 [2] - Equiniti Trust Company, LLC will act as the exchange and transfer agent for the reverse split, and shareholders holding shares electronically will not need to take action to receive post-split shares [7] Group 3: Company Overview - Sol-Gel Technologies is focused on developing and commercializing drug products for skin diseases, with FDA-approved products including TWYNEO for acne and EPSOLAY for rosacea [8] - The company's pipeline includes SGT-610, an orphan drug candidate for Gorlin syndrome, and SGT-210, a topical drug candidate for rare skin keratodermas [9]

Core Viewpoint - Sol-Gel Technologies has entered into a product purchase agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to EPSOLAY and TWYNEO, which will enhance the company's cash position and support the development of its product SGT-610 [1][6][7] Financial Summary - Sol-Gel will receive a total of $16 million from Mayne Pharma, with $10 million in Q2 2025 and $6 million in Q4 2025, extending the company's cash runway into Q1 2027 [1][9] - As of March 31, 2025, Sol-Gel had $16.9 million in cash and cash equivalents, with no marketable securities [5] Product Overview - EPSOLAY is a topical cream with 5% encapsulated benzoyl peroxide for treating inflammatory lesions of rosacea in adults [2][14] - TWYNEO is a fixed-dose combination cream containing 3% encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin for treating acne vulgaris [2][13] Development Focus - The company will concentrate on the clinical and commercial development of SGT-610, a hedgehog signaling pathway blocker aimed at preventing basal cell carcinomas in Gorlin syndrome patients [3][15] - The U.S. market potential for SGT-610 is estimated to be between $400 million and $500 million annually [4][9] Clinical Trial Progress - The Phase-III clinical trial for SGT-610 is progressing well, with 80% of the planned patient enrollment completed, and top-line results expected in Q4 2026 [8][9] - The ongoing Phase 1b trial for SGT-210 in Darier disease patients has seen 50% of participants complete the trial [9][12] Market Potential - The global business potential for EPSOLAY and TWYNEO is expected to exceed that of the U.S. market, with many partnership agreements already signed [6][7] - SGT-210 has an estimated market potential of $200 million to $300 million if clinical efficacy is demonstrated [12]