Earnings release
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SOL - GEL Sol - Gel Reports Second Quarter 2026 Financial Results and Provides Corporate Updates August 20 , 2026 • Pivotal Phase 3 clinical trial of SGT - 610 ( patidegib gel , 2 % ) for Gorlin syndrome remains ongoing , with top - line results on track for anticipated readout in late November 2026 • Sol - Gel has initiated a proof - of - concept study in High - frequency BCC ( HF - BCC ) • Sol - Gel initiated a study evaluating topical patidegib as a neo - adjuvant in BCC surgery , prompted by physician interest in oral HHi use ahead of Mohs surgery • Sol - Gel has expanded its Gorlin syndrome pipeline with a provisional patent filing for an intra - cystic injectable targeting odontogenic keratocysts ( OKC ) NESS ZIONA , Israel , Aug. 20 , 2026 ( GLOBE NEWSWIRE ) -- Sol - Gel Technologies , Ltd. ( NASDAQ : SLGL ) , a dermatology company , pioneering treatments for patients with rare and severe skin conditions , today announced financial results for the second quarter ended June 30 , 2026 , and provided a corporate update . Q2 2026 and Recent Corporate Developments • Sol - Gel's pivotal Phase 3 clinical trial of SGT - 610 ( patidegib gel , 2 % ) for Gorlin syndrome continues to advance . The dropout rate to date has been considerably lower than originally anticipated , with 10 of 113 patients discontinuing , representing 9 % . Last patient last visit is expected in September 2026 , and top - line results are scheduled for late November 2026 . • Sol - Gel continues to advance its U.S. commercial readiness activities for SGT - 610 . If approved , the Company intends to retain full U.S. commercial rights and commercialize SGT - 610 through a cost - effective model utilizing an experienced third - party commercialization services organization . Given the concentrated nature of the Gorlin syndrome treatment landscape , which includes specialized dermatologists , Mohs surgeons and genetics centers , the Company expects to reach the treating population through a small , focused field organization supported by outsourced commercial infrastructure and capabilities . This approach is designed to support an effective U.S. launch while preserving capital , avoiding the need to build a full - scale commercial organization internally and enabling Sol - Gel to retain full U.S. product economics . Market access , distribution , patient support and medical affairs planning are progressing in parallel with the Phase 3 trial . • Sol - Gel initiated a proof - of - concept study evaluating the safety and efficacy of patidegib gel in non - Gorlin subjects with high - frequency basal cell carcinoma ( HF - BCC ) . Enrollment is expected to begin in early October 2026. The single - center , open - label study is designed to provide insight into the role of the hedgehog ( HH ) pathway in non - Gorlin subjects , who tend to develop multiple BCCs over their lifetime . Approximately 20 subjects aged 18 and above with facial , head and neck HF - BCC are expected to be enrolled . Safety and efficacy will be assessed following twice - daily application for up to 12 months . This study will enable us to gather information on HF - BCC response to patidegib , which are necessary to the planning of the pivotal registration study currently anticipated for late 2027 or in first half of 2028 . • Based on inquiries of physicians , who are using off - label oral hedgehog inhibitors ( HHi ) as a neo - adjuvant in Mohs surgery , we have initiated a small study examining the potential role of topical neo - adjuvant use of patidegib in BCC surgery , enrollment is expected to begin in October 2026 . • Sol - Gel has filed a provisional patent application for an intra - cystic , injectable HHi treatment of odontogenic keratocysts ( OKC ) , a devastating manifestation of Gorlin syndrome affecting the jaws with a prevalence comparable to that of BCC in Gorlin patients . As OKC tends to recur following surgical removal , many patients must undergo frequent surgeries over the course of their lifetime , which in many cases result in irreparable damage to the jaws . The unmet medical need is extremely high , and the Company is now in the process of evaluating the economic feasibility of such a project . The decision to consider OKC as a target for the Company's R & D was communicated and enthusiastically received by the leadership of the Gorlin Syndrome Alliance ( GSA ) . Mr. Mori Arkin , Executive Chairman of Sol - Gel , stated : " The second quarter of 2026 was marked by disciplined execution across our clinical programs , most importantly the continued advancement of our pivotal Phase 3 trial of SGT - 610 in Gorlin syndrome toward what we believe could be the most important milestone in Sol - Gel's history . With last patient last visit expected in September 2026 and top - line results anticipated in late November 2026 , we are approaching the culmination of several years of work aimed at establishing topical patidegib as the first treatment designed to prevent the development of new basal cell carcinomas in patients with Gorlin syndrome . We are particularly encouraged by patient retention in the study , with only 10 of 113 patients discontinuing to date . We believe this approximately 9 % dropout rate , which remains considerably below our original assumptions for a trial of this duration , reflects both the commitment of the Gorlin community and the tolerability profile of topical patidegib . " Mr. Arkin further commented " At the same time , we are systematically expanding the potential opportunity for topical patidegib beyond its initial indication . During the quarter , we initiated a proof - of - concept study in non - Gorlin patients with high - frequency basal cell carcinoma , or HF - BCC , an indication that we believe could meaningfully expand the commercial potential of patidegib . The data generated from this study are expected to inform the design of a pivotal registration study that we currently anticipate initiating in late 2027 or the first half of 2028. In parallel , following interest from