Benzoyl Peroxide

NESS ZIONA, Israel, May 23, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced financial results for the first quarter ended March 31, 2025. Financial Results for the First Quarter Year Ended March 31st, 2025 Total revenue in the first quarter was $1 million compared to $0.5 million revenues for the same period in 2024. Research and development expenses were $8.8 million compared to $5.3 million in the same period in 2024. The increase of $3.5 million was primarily attributed to an increase of $3.6 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610, an increase of $0.5 million related to the commercialization of EPSOLAY and TWYNEO in territories outside of the U.S., offset by a decrease of $0.5 million in clinical trial expenses related to SGT-610. General and administrative expenses were $1.3 million compared to $1.8 million for the same period in 2024. The decrease of $0.5 million was mainly attributed to a decrease in payroll and stock-based compensation expenses due to cost measures being taken in 2024. Sol-Gel reported a net loss of $8.8 million for the first quarter of 2025 and of $3.2 basic and diluted loss per share, compared to a net loss of $6.3 million and a loss of $2.3 per basic and diluted share for the same period in 2024. 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. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About Sol-Gel Technologies 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. For additional information, please visit www.sol-gel.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to our expected cash runway. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management’s current expectations and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations, a delay in the timing of our clinical trials, the success of our clinical trials, and an increase in our anticipated costs and expenses, as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co-development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets, the potential delay in receiving such regulatory approvals and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our collaborators’ ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our collaborators’ ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our collaborators’ ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third-party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, China, Europe or Israel; and (xv) loss or retirement of key executives and research scientists; (xvi) general market, political and economic conditions in the countries in which the Company operates; and, (xvii) the current war between Israel and Hamas and any deterioration of the war in Israel into a broader regional conflict involving Israel with other parties. These factors and other important factors discussed in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on April 29, 2025, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Except as required by law, we undertake no obligation to update any forward-looking statements in this press release. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED BALANCE SHEETS(U.S. dollars in thousands)(Unaudited) December 31, March 31, 2024 2025Assets CURRENT ASSETS: Cash and cash equivalents$19,489 $16,890 Bank deposits 12 12 Marketable securities 4,425 - Accounts receivables 3,595 3,883 Prepaid expenses and other current assets 3,774 2,647 TOTAL CURRENT ASSETS 31,295 23,432 NON-CURRENT ASSETS: Restricted long-term deposits and cash equivalents 1,291 1,293 Long-term receivables 1,024 518 Property and equipment, net 202 183 Operating lease right-of-use assets 1,426 1,332 Other long-term assets 13 - Funds in respect of employee rights upon retirement 595 305 TOTAL NON-CURRENT ASSETS 4,551 3,631 TOTAL ASSETS$35,846 $27,063 Liabilities and shareholders' equity CURRENT LIABILITIES: Accounts payable$1,265 $438 Other accounts payable 3,590 3,702 Current maturities of operating leases 430 433 TOTAL CURRENT LIABILITIES 5,285 4,573 LONG-TERM LIABILITIES: Operating leases liabilities 878 746 Liability for employee rights upon retirement 833 363 Other long-term Liability 1,209 TOTAL LONG-TERM LIABILITIES 1,711 2,318 TOTAL LIABILITIES 6,996 6,891 SHAREHOLDERS' EQUITY: Ordinary shares, NIS 0.1 par value – authorized: 5,000,000 as of December 31, 2024 and March 31, 2025, respectively; issued and outstanding: 2,785,762 as of December 31, 2024 and March 31, 2025, respectively (*) 774 774 Additional paid-in capital 258,959 259,089 Accumulated deficit (230,883) (239,691) TOTAL SHAREHOLDERS' EQUITY 28,850 20,172 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$35,846 $27,063 (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. SOL-GEL TECHNOLOGIES LTD.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(U.S. dollars in thousands)(Unaudited) Three months endedMarch 31 2024 2025 LICENSE REVENUES$466 $1,031 RESEARCH AND DEVELOPMENT EXPENSES 5,345 8,843 GENERAL AND ADMINISTRATIVE EXPENSES 1,833 1,257 OPERATING LOSS 6,712 9,069 FINANCIAL INCOME,net (368) (261) LOSS FOR THE PERIOD 6,344 8,808 BASIC AND DILUTED LOSS PER ORDINARY SHARE 2.3 3.2 WEIGHTED AVERAGE NUMBER OF SHARES*OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE (*) 2,785,762 2,785,762 (*)All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. Sol-Gel Contact:Eyal Ben-OrChief Financial Officerir@sol-gel.com+972-8-9313429Source: Sol-Gel Technologies Ltd.

▎药明康德内容团队报道今日（5月9日），中国国家药监局（NMPA）官网刚刚发布的批件信息显示，高德美（Galderma）公司的阿达帕林过氧苯甲酰凝胶上市申请已获得批准。公开资料显示，这是一款每日一次的处方药（英文商品名：Epiduo），已经获美国FDA批准用于治疗寻常性痤疮。截图来源：NMPA官网寻常性痤疮是一种慢性炎症性皮肤病，特征为开放性或闭合性粉刺及炎性病变（如丘疹、脓疱或结节）。寻常性痤疮往往会导致严重的身心疾病，如永久性疤痕、自我形象不佳、抑郁及焦虑，尤其是在青少年及年轻人中。寻常痤疮有多种病因，包括炎症及感染。毛囊及伴随的皮脂腺阻塞、痤疮角化杆菌的毛囊定植以及多种促炎细胞因子的产生，均可能导致非炎症性及炎症性病变的形成。本次在中国获批产品为阿达帕林过氧苯甲酰凝胶（0.3%/2.5%），它结合了两种有效的药物来治疗顽固的痤疮，并通过畅通毛孔和杀死细菌来防止痤疮的形成。其中，阿达帕林为第3代维A酸药物。维A酸类药物具有改善毛囊皮脂腺导管口角化、溶解微粉刺和粉刺、抗炎、预防和改善痤疮炎症后色素沉着和痤疮瘢痕等作用，它还能增加皮肤渗透性，在联合治疗中可以增加外用抗菌及抗炎药物的疗效。过氧苯甲酰是一种抗氧化剂，可缓慢释放新生态氧和苯甲酸，具有杀灭痤疮丙酸杆菌、抗炎及轻度溶解粉刺作用。过氧苯甲酰可单独使用，也可联合外用维A酸类药物或外用抗生素使用。2018年5月，高德美宣布了ALAMO 4期研究结果，该研究评估了阿达帕林和过氧化苯甲酰凝胶加口服多西环素200mg在12周治疗期间，对严重炎性痤疮（非结瘤性/非结块性）患者的疗效和安全性。该研究达到了“12周治疗期结束时炎性病变数量减少”的主要疗效终点。结果显示，在研究参与者中，与基线相比，阿达帕林和过氧化苯甲酰凝胶加多西环素的病变计数大幅减少，炎症病变减少66.2%，非炎症病变减少58.7%，第12周总病变减少62.6%。此外，37.1%的研究参与者通过研究者总体评估反应（IGA）评分为0（清除）或1（几乎清除）。在12周时，80.1%的研究参与者不再被认为是口服异维甲酸（一种治疗严重痤疮的药物）的候选人。希望这款阿达帕林过氧苯甲酰凝胶早日来到中国患者身边，为患者带来更多的治疗选择。参考资料：[1]2025年05月09日药品批准证明文件送达信息.From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250509152738101.html[2]Galderma Announces Results of ALAMO: A Real-World, Phase 4 Study Demonstrating Efficacy and Safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Plus Oral Doxycycline 200 mg in Treating Severe Inflammatory Acne. Retrieved Mar 7, 2018, from https://www.galderma.com/news/galderma-announces-results-alamo-real-world-phase-4-study-demonstrating-efficacy-and-safety免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。