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SLGL

Sol-GelC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-20
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Investor releaseQuarter not tagged2026-08-20

Sol-Gel Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

GlobeNewswire
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…Read full document

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 physicians who are already using off-label oral hedgehog inhibitors ahead of Mohs surgery, we initiated a study evaluating topical patidegib as a neo-adjuvant treatment in BCC surgery. Both programs represent capital-efficient opportunities to extend the reach and potential value of an asset we know well." Lastly, Mr. Arkin commented "We also took an important step toward addressing another significant manifestation of Gorlin syndrome through our provisional patent filing covering an intra-cystic injectable hedgehog inhibitor for odontogenic keratocysts, or OKCs. These cysts can be serious and recurrent, and repeated surgical interventions can result in substantial and irreversible damage. We believe that a locally administered treatment could address an important unmet medical need, and the positive response to this initiative from the leadership of the Gorlin Syndrome Alliance reinforces our conviction that this is an area of meaningful importance to patients. Taken together, these initiatives reflect our strategy of remaining highly focused on the upcoming SGT-610 Phase 3 readout while selectively pursuing capital-efficient opportunities that have the potential to create substantial additional value from our expertise in hedgehog pathway inhibition." Financial Results for the Second Quarter 2026 Revenue for the second quarter was $0.6 million, compared to revenue of $17.3 million for the same period in 2025. The decrease is mainly attributed to $16.7 million from sale of IP under the agreement with Mayne in the second quarter of 2025. Research and development expenses were $3.7 million compared to $4.6 million for the same period in 2025. The decrease of $0.9 million was primarily attributed to a decrease in clinical trial expenses related to SGT-610. General and administrative expenses were $1.0 million compared to $1.4 million for the same period in 2025. Sol-Gel reported a net loss of $3.7 million for the second quarter of 2026 and loss of $1.13 per basic and diluted share, compared to a net income of $11.6 million for the second quarter of 2025 and earnings of $4.17 per basic and diluted share for the same period in 2025. As of June 30, 2026, Sol-Gel had $18.0 million in cash, cash equivalents, and deposits and $31.3 million in marketable securities for a total balance of $49.3 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2028. About Sol-Gel Technologies Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety profile relative to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®. 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 statements regarding the timing of clinical milestones for the Phase 3 program of SGT-610 in Gorlin syndrome, the timing of milestones for other studies of patidegib gel, the Company’s cash runway and the future commercial activities for SGT-610. 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, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 trial or the success of our clinical trials, higher burn rate than expected, a delay in enrollment for a proof-of-concept study evaluating patidegib gel in non-Gorlin subjects with HF-BCC and in the timing of a pivotal registration study, that the commercialization of SGT-610, if approved, will not be as expected or successful as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (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 security situation in Israel. 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 March 19, 2026, 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 Investor Relations:Eyal Ben-Or Chief Financial [email protected]

Investor releaseQuarter not tagged2026-08-13

MeiraGTx Holdings PLC (MGTX) Q2 Earnings and Revenues Surpass Estimates

Zacks
MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $1.71 per share, beating the Zacks Consensus Estimate of a loss of $0.39 per share. This compares to a loss of $0.48 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +538.46%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.57, delivering a surprise of -32.56%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. MeiraGTx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $321.43 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 20,637.68%. This compares to year-ago revenues of $3.69 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MeiraGTx shares have added about 63% since the beginning of the year versus the S&P 500's gain of 13.2%. While MeiraGTx has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MeiraGTx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Ra…Read full document

MeiraGTx Holdings PLC (MGTX) came out with quarterly earnings of $1.71 per share, beating the Zacks Consensus Estimate of a loss of $0.39 per share. This compares to a loss of $0.48 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +538.46%. A quarter ago, it was expected that this company would post a loss of $0.43 per share when it actually produced a loss of $0.57, delivering a surprise of -32.56%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. MeiraGTx, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $321.43 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 20,637.68%. This compares to year-ago revenues of $3.69 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. MeiraGTx shares have added about 63% since the beginning of the year versus the S&P 500's gain of 13.2%. While MeiraGTx has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for MeiraGTx was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.50 on $1.55 million in revenues for the coming quarter and -$1.69 on $3.39 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 39% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Sol-Gel Technologies Ltd. (SLGL), another stock in the broader Zacks Medical sector, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $2.31 per share in its upcoming report, which represents a year-over-year change of -155.4%. The consensus EPS estimate for the quarter has been revised 1.3% higher over the last 30 days to the current level. Sol-Gel Technologies Ltd.'s revenues are expected to be $0.15 million, down 99.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report MeiraGTx Holdings PLC (MGTX) : Free Stock Analysis Report Sol-Gel Technologies Ltd. (SLGL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-03

Supernus Pharmaceuticals (SUPN) Matches Q2 Earnings Estimates

Zacks
Supernus Pharmaceuticals (SUPN) came out with quarterly earnings of $0.54 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.91 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this drugmaker would post earnings of $0.28 per share when it actually produced earnings of $0.59, delivering a surprise of +110.71%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Supernus, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $219.06 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.84%. This compares to year-ago revenues of $165.45 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Supernus shares have lost about 10.2% since the beginning of the year versus the S&P 500's gain of 9.4%. While Supernus has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Supernus was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the comin…Read full document

Supernus Pharmaceuticals (SUPN) came out with quarterly earnings of $0.54 per share, in line with the Zacks Consensus Estimate . This compares to earnings of $0.91 per share a year ago. These figures are adjusted for non-recurring items. A quarter ago, it was expected that this drugmaker would post earnings of $0.28 per share when it actually produced earnings of $0.59, delivering a surprise of +110.71%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Supernus, which belongs to the Zacks Medical - Generic Drugs industry, posted revenues of $219.06 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.84%. This compares to year-ago revenues of $165.45 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Supernus shares have lost about 10.2% since the beginning of the year versus the S&P 500's gain of 9.4%. While Supernus has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Supernus was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.63 on $221.97 million in revenues for the coming quarter and $2.49 on $868.92 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Generic Drugs is currently in the bottom 7% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Sol-Gel Technologies Ltd. (SLGL), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $2.31 per share in its upcoming report, which represents a year-over-year change of -155.4%. The consensus EPS estimate for the quarter has been revised 1.3% higher over the last 30 days to the current level. Sol-Gel Technologies Ltd.'s revenues are expected to be $0.15 million, down 99.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Supernus Pharmaceuticals, Inc. (SUPN) : Free Stock Analysis Report Sol-Gel Technologies Ltd. (SLGL) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-28

Sol-Gel Reports First Quarter 2026 Financial Results and Provides Corporate Updates

GlobeNewswire
Sol-Gel received a Notice of Allowance for a method-of-use patent extending intellectual property protection for topical patidegib (SGT-610) until 2044 Sol-Gel completed an oversubscribed underwritten offering, raising gross proceeds of approximately $33.1 million from leading healthcare specialist investors 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 the fourth quarter of 2026 Sol-Gel signed an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India NESS ZIONA, Israel, May 28, 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 first quarter ended March 31, 2026, and provided a corporate update. Q1 2026 and Recent Corporate Developments In May 2026, the company received a Notice of Allowance (U.S. Patent Application No. 19/266,342) from the U.S. Patent and Trademark Office for our patent application covering a method-of-use that is critical to successful topical patidegib therapy. This patent will provide protection for SGT-610 until 2044. In March 2026, Sol-Gel closed an underwritten offering resulting in aggregate gross proceeds of approximately $33.1 million. The offering included participation from new and existing investors, including Great Point Partners, LLC, Trails Edge Capital Partners, Surveyor Capital (a Citadel company), Affinity Asset Advisors, Squadron Capital Management, Stonepine Capital Management and AuGC BioFund. TD Cowen and LifeSci Capital acted as joint book-running managers for the offering. Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome continues to advance, and the Company remains on track to report top-line results in the fourth quarter of 2026; preparations for a proof-of-concept study of SGT-610 in HF-BCC are ongoing. In April 2026, Sol-Gel entered into an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India. This agreement is in addition to the eight agreements for the commercialization of TWYNEO® and EPSOLAY Sol-Gel signed during 2024 and 2025 in various territories covering most European countries, South…Read full document

Sol-Gel received a Notice of Allowance for a method-of-use patent extending intellectual property protection for topical patidegib (SGT-610) until 2044 Sol-Gel completed an oversubscribed underwritten offering, raising gross proceeds of approximately $33.1 million from leading healthcare specialist investors 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 the fourth quarter of 2026 Sol-Gel signed an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India NESS ZIONA, Israel, May 28, 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 first quarter ended March 31, 2026, and provided a corporate update. Q1 2026 and Recent Corporate Developments In May 2026, the company received a Notice of Allowance (U.S. Patent Application No. 19/266,342) from the U.S. Patent and Trademark Office for our patent application covering a method-of-use that is critical to successful topical patidegib therapy. This patent will provide protection for SGT-610 until 2044. In March 2026, Sol-Gel closed an underwritten offering resulting in aggregate gross proceeds of approximately $33.1 million. The offering included participation from new and existing investors, including Great Point Partners, LLC, Trails Edge Capital Partners, Surveyor Capital (a Citadel company), Affinity Asset Advisors, Squadron Capital Management, Stonepine Capital Management and AuGC BioFund. TD Cowen and LifeSci Capital acted as joint book-running managers for the offering. Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome continues to advance, and the Company remains on track to report top-line results in the fourth quarter of 2026; preparations for a proof-of-concept study of SGT-610 in HF-BCC are ongoing. In April 2026, Sol-Gel entered into an exclusive license agreement with Sun Pharmaceutical Industries Ltd. for the commercialization of TWYNEO® in India. This agreement is in addition to the eight agreements for the commercialization of TWYNEO® and EPSOLAY Sol-Gel signed during 2024 and 2025 in various territories covering most European countries, South Africa, South Korea, Australia and New Zealand. These already signed agreements, together with agreements we anticipate signing in the future covering Latin American countries, Spain and Portugal, have the potential to provide upfront and regulatory milestone payments of up to $4.5 million. The above excludes Sol-Gel's previously signed agreements with Beimei Pharma (China, Hong Kong, Macau, Taiwan and Israel) and Searchlight Pharma (Canada).Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel now expects that TWYNEO and EPSOLAY will launch in the majority of these new territories during 2028 and 2027 respectively, and following launch, these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream with the potential to reach approximately $10 million by 2031 and potentially grow in subsequent years. Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: “The first quarter of 2026 was a period of substantial progress on every front that matters to Sol-Gel. The Notice of Allowance extending the exclusivity of patidegib until 2044 marks a major milestone in the value creation of SGT-610 and Sol-Gel as a company. In parallel, the successful completion of our oversubscribed offering, with broad participation from leading healthcare specialist investors, is expected to provide Sol-Gel with the financial resources to support operations into 2028, allowing us to execute our Phase 3 program of SGT-610 through top-line readout and to support its pre-commercialization activities." Mr. Arkin further commented: "We believe that the combination of our March 2026 financing and the Notice of Allowance for a method-of-use patent protecting topical patidegib until 2044 fundamentally reshapes the long-term opportunity for SGT-610. We now have both the capital and intellectual property runway to pursue the prevention of new BCCs in Gorlin syndrome, for which top-line results are expected in the fourth quarter of 2026. We continue to be excited about the potential of the high-frequency BCC indication, which could double the commercial potential of patidegib, and we look forward to initiating a proof-of-concept study." Lastly, Mr. Arkin commented: "The license agreement with Sun Pharma for India, one of the largest dermatology markets in the world, is another important step in unlocking the global value of TWYNEO through partnerships with leading companies in their respective territories. While the commercialization of our legacy products is a non-core business of Sol-Gel, we believe that this activity has the potential to become an asset of substantial value, in the not-too-distant future. At the appropriate time, we plan to monetize this business and use the non-dilutive funds to support our long-term strategy of developing innovative treatments for unmet medical needs in dermatology." Financial Results for the First Quarter 2026 Revenue for the first quarter was $0.1 million, compared to revenue of $1.0 million for the same period in 2025. The decrease is mainly attributed to a milestone payment from Searchlight in the first quarter of 2025. Research and development expenses were $2.8 million compared to $8.8 million for the same period in 2025. The decrease of $6.0 million was primarily attributed to a decrease of $3.9 million due to expenses associated with supplier-led manufacturing development to support future commercialization of SGT-610 in the first quarter of 2025, a decrease of $1.1 million in clinical trial expenses related to SGT-610 and a decrease of $0.8 million in expenses related to the manufacturing development of EPSOLAY and TWYNEO. General and administrative expenses were $1.2 million compared to $1.3 million for the same period in 2025. Sol-Gel reported a net loss of $3.7 million for the first quarter of 2026 and loss of $1.31 per basic and diluted share, compared to a net loss of $8.8 million and loss of $3.2 per basic and diluted share for the same period in 2025. As of March 31, 2026, Sol-Gel had $10.1 million in cash, cash equivalents, and deposits and $42.7 million in marketable securities, for a total balance of $52.8 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2028. About Sol-Gel Technologies Sol-Gel is a specialized dermatology company advancing innovative therapies for rare and serious skin diseases. Its lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3, orphan- and breakthrough-designated topical hedgehog inhibitor being developed for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, with the potential to offer an improved safety profile relative to oral hedgehog inhibitors. Subject to regulatory approval in Gorlin syndrome, SGT-610 may also represent a future opportunity in high-frequency BCC. Sol-Gel is also advancing SGT-210, an investigational topical EGFR inhibitor for indications with significant unmet need, and has developed two FDA-approved dermatology products, TWYNEO® and EPSOLAY®. 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 statements regarding the timing of clinical milestones for the Phase 3 program of SGT-610 in Gorlin syndrome, the Company’s cash runway, the timing of the launch of the commercialization of TWYNEO® and EPSOLAY in various territories and the anticipated financial benefits of the Company’s agreements for the commercialization of TWYNEO® and EPSOLAY. 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, the risk of a delay in reporting the top-line results of Sol-Gel’s pivotal Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, that we will not successfully complete the Gorlin Phase 3 trial or the success of our clinical trials, a delay in the launch of the commercialization of TWYNEO® and EPSOLAY in various territories, that the financial benefits of the Company’s agreements for the commercialization of TWYNEO® and EPSOLAY will not be as anticipated as well as the following factors: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses; (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 security situation in Israel. 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 March 19, 2026, 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. * The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. Sol-Gel Investor Relations:Eyal Ben-Or Chief Financial [email protected]

Investor releaseQuarter not tagged2025-11-20

Sol-Gel Reports Third Quarter 2025 Financial Results and Provides Corporate Updates

GlobeNewswire
Sol-Gel intends to pursue high-frequency BCC as an additional indication for its lead drug candidate SGT-610, which, if approved, could at least double the drug’s commercial potential In September 2025, Sol-Gel announced Health Canada approval of EPSOLAY Sol-Gel signed an additional agreement with Viatris covering Australia and New Zealand for both EPSOLAY and TWYNEO NESS ZIONA, Israel, Nov. 20, 2025 (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 third quarter ending September 30, 2025, and provided a corporate update. Q3 2025 and Recent Corporate Developments Sol-Gel’s ongoing Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, for which top-line results are expected in the fourth quarter of 2026, has led to growing physician interest in its potential use in patients with severe, high-frequency basal cell carcinoma (BCC). One such case, a non-Gorlin patient in France with a devastating form of high-frequency BCC, was found to have a lesion harboring a PTCH-1 mutation, and Sol-Gel agreed to provide SGT-610 for compassionate use. Sol-Gel plans to supply the drug to additional high-frequency BCC patients with at least one PTCH-1 mutated lesion and is evaluating the initiation of a feasibility study in this new indication to further substantiate the rationale for a Phase 3 trial in 2027, subject to the successful completion of the Phase 3 Gorlin syndrome trial. High-frequency BCC is also a rare disease; however, its prevalence is estimated to be at least ten times higher than that of Gorlin syndrome. Even if clinical development focuses only on patients with the most severe forms of high-frequency BCC, a successful outcome is expected to at least double the commercial potential of SGT-610. For many of these patients, there is a significant unmet need for an effective and well-tolerated treatment, as frequent and potentially disfiguring Mohs surgeries are often no longer sustainable. Sol-Gel’s vehicle-controlled Phase 1b clinical trial (Stage 1) investigating SGT-210 (topical erlotinib) in patients with Darier disease has been challenged by the limited number of eligible patients in Israel. As a result, only seven subjects who completed the treatment were enrolled so far. Consequently, So…Read full document

Sol-Gel intends to pursue high-frequency BCC as an additional indication for its lead drug candidate SGT-610, which, if approved, could at least double the drug’s commercial potential In September 2025, Sol-Gel announced Health Canada approval of EPSOLAY Sol-Gel signed an additional agreement with Viatris covering Australia and New Zealand for both EPSOLAY and TWYNEO NESS ZIONA, Israel, Nov. 20, 2025 (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 third quarter ending September 30, 2025, and provided a corporate update. Q3 2025 and Recent Corporate Developments Sol-Gel’s ongoing Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, for which top-line results are expected in the fourth quarter of 2026, has led to growing physician interest in its potential use in patients with severe, high-frequency basal cell carcinoma (BCC). One such case, a non-Gorlin patient in France with a devastating form of high-frequency BCC, was found to have a lesion harboring a PTCH-1 mutation, and Sol-Gel agreed to provide SGT-610 for compassionate use. Sol-Gel plans to supply the drug to additional high-frequency BCC patients with at least one PTCH-1 mutated lesion and is evaluating the initiation of a feasibility study in this new indication to further substantiate the rationale for a Phase 3 trial in 2027, subject to the successful completion of the Phase 3 Gorlin syndrome trial. High-frequency BCC is also a rare disease; however, its prevalence is estimated to be at least ten times higher than that of Gorlin syndrome. Even if clinical development focuses only on patients with the most severe forms of high-frequency BCC, a successful outcome is expected to at least double the commercial potential of SGT-610. For many of these patients, there is a significant unmet need for an effective and well-tolerated treatment, as frequent and potentially disfiguring Mohs surgeries are often no longer sustainable. Sol-Gel’s vehicle-controlled Phase 1b clinical trial (Stage 1) investigating SGT-210 (topical erlotinib) in patients with Darier disease has been challenged by the limited number of eligible patients in Israel. As a result, only seven subjects who completed the treatment were enrolled so far. Consequently, Sol-Gel has decided to conclude the current phase of the trial and to proceed with an open-label extension in which all enrolled patients will receive active treatment with SGT-210. Sol-Gel will release the results of Stage 1 of the trial in December 2025. On September 4, 2025, Sol-Gel announced Health Canada marketing approval of EPSOLAY for the treatment of inflammatory lesions of rosacea in adults. On August 19, 2025, Sol-Gel signed an additional license agreement for the commercialization of TWYNEO and EPSOLAY in Australia and New Zealand with Viatris Pty Ltd, a subsidiary of Viatris Inc. (NASDAQ: VTRS). This agreement is in addition to the seven agreements Sol-Gel signed during 2024 in various territories covering most European countries, South Africa and South Korea. These already signed agreements, together with agreements we anticipate signing in the future covering Latin American countries, Spain and Portugal, are expected to provide upfront and regulatory milestone payments of up to $3.7 million. Based on the forecasts received from Sol-Gel’s current and potential partners, Sol-Gel now expects that TWYNEO and EPSOLAY will launch in the majority of these new territories in 2028 and 2027 respectively, and following launch, these transactions are anticipated to provide Sol-Gel with an annual royalty revenue stream with the potential to grow gradually to approximately $10 million for the year 2031 and further. Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "Sol-Gel continued to make steady progress in the third quarter as we advance our late-stage pipeline in dermatologic rare diseases. Our pivotal Phase 3 trial of SGT-610 for Gorlin syndrome is ongoing, and we remain focused on executing this study to deliver top-line results in the fourth quarter of 2026. We are particularly excited about the opportunity of at least doubling the potential of this important drug by adding the unmet need of high-frequency BCC." Mr. Arkin further commented "The recently announced Health Canada approval of EPSOLAY, alongside our existing ex-U.S. partnerships for TWYNEO and EPSOLAY, underscores our ability to unlock the value of our approved products through collaborations that provide non-dilutive revenue streams. We are delighted that additional companies with strong market presence in their territories have joined our growing partnership network. The number of territories and the identity of our partners make us confident about reaching our target of $10 million EBITDA from this business alone, by 2031. As we look ahead, we remain committed to advancing SGT-610 and SGT-210 to support our strategy of becoming a leader in rare dermatological diseases and to create long-term value for patients and shareholders." Financial Results for the Third Quarter 2025 Total revenue for the third quarter was $0.4 million, which primarily consisted of license revenue from ex-US licensing agreements, compared to total revenue of $5.4 million for the same period in 2024, which primarily consisted of $0.4 million royalty revenue from Galderma, $0.6 royalty revenue from Searchlight, $3.8 million under the agreement with Padagis and $0.5 million under the ex-US licensing agreements. Research and development expenses were $5.7 million compared to $4.8 million for the same period in 2024. The increase of $0.9 million was primarily attributed to an increase of $0.8 million in manufacturing development expenses related to SGT-610 and an increase of $0.7 million in clinical trial expenses for SGT-610, offset by a decrease of $0.4 million in professional expenses related to ex-US activities in EPSOLAY and TWYNEO and a decrease of $0.3 million in professional expenses related to a generic product candidate. General and administrative expenses were $1 million compared to $1.4 million for the same period in 2024. The decrease is mainly attributed to a decrease in payroll and expenses due to the adoption of cost saving measures during 2024. Sol-Gel reported a net loss of $5.9 million for the third quarter of 2025 and loss of $2.13 per basic and diluted share, compared to a net loss of $0.4 million and loss of $0.13 per basic and diluted share for the same period in 2024. As of September 30, 2025, Sol-Gel had $6.8 million in cash, cash equivalents, and deposits and $14.1 million in marketable securities for a total balance of $20.9 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About TWYNEO and EPSOLAY TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide tolerable and effective treatment. About Gorlin Syndrome and SGT-610 SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. About Sol-Gel Technologies Sol-Gel Technologies Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat 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 also includes Phase 3 clinical trial of Orphan 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 hyper keratinization disorders. For additional information, please visit our new website: 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 the amounts expected to be received under our current and future licensing agreements our expected cash runway, the size of the markets for SGT-610 and SGT-210, the timeline for advancing SGT-610 and SGT-210, including the timing for top-line results and the timing for payments from Mayne Pharma. 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, lower than anticipated annual revenue from our current and future licensing agreements or a delay in generating revenue, the risk that the market for SGT-610 and SGT-210 will not be as anticipated, including with respect to High-Frequency BCC for SGT-610, our ability to enter into further collaborations, a delay in the timing of our clinical trials, top-line results and regulatory filings, a delay in receipt of payments from Mayne Pharma and others, 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 March 13, 2024, 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 Contact: Eyal Ben-Or Chief Financial Officer [email protected] +972-8-9313429 Source: Sol-Gel Technologies Ltd. *All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split.

Investor releaseQuarter not tagged2025-08-15

Sol-Gel Reports Second Quarter 2025 Financial Results and Provides Corporate Updates

GlobeNewswire
Patient enrollment for our ongoing Phase-3 clinical trial of SGT-610 for Gorlin Syndrome has been completed; top-line results are expected in the fourth quarter of 2026 Phase-1b proof-of-concept clinical trial of SGT-210 for Darier disease is ongoing Sol-Gel and Mayne Pharma Announce the Purchase of EPSOLAY and TWYNEO in the U.S. for a total consideration of $16 million to be received during 2025 Following recent transactions, Sol-Gel’s cash runway is expected to extend into the first quarter of 2027 NESS ZIONA, Israel, Aug. 15, 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, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Q2 2025 and Recent Corporate Developments Subject enrollment for the Phase 3 study in Sol-Gel’s key asset SGT-610 has been completed; Top-line results are expected in the fourth quarter of 2026. SGT-610 is a topically applied patidegib, a hedgehog signaling pathway blocker 2% gel. If approved, SGT-610 is expected to be the first product for the prevention of new BCC lesions in Gorlin syndrome patients and is targeting potential peak revenue exceeding $300 million annually. Sol-Gel’s vehicle-controlled proof-of-concept phase-1b clinical trial for SGT-210 (topical erlotinib) in patients with Darier disease is ongoing. Darier disease is a significant unmet medical need, with a market potential estimated between $200 to $300 million. Due to the circumstances which prevailed in Israel in the last months, recruitment of patients has been slowed down. Therefore, the study completion and top-line results are expected in the fourth quarter of 2025. Pending positive results, we anticipate filing for a Phase 2 IND, promptly following the completion of the present study. SGT-210 is currently being used in compassionate treatment in a pediatric patient suffering from Olmsted disease, a debilitating rare skin disorder for which there is no approved treatment. In addition, Sol-Gel supports a request from a leading hospital, for another debilitating skin condition. On April 17, 2025, Sol-Gel announced it had entered into a…Read full document

Patient enrollment for our ongoing Phase-3 clinical trial of SGT-610 for Gorlin Syndrome has been completed; top-line results are expected in the fourth quarter of 2026 Phase-1b proof-of-concept clinical trial of SGT-210 for Darier disease is ongoing Sol-Gel and Mayne Pharma Announce the Purchase of EPSOLAY and TWYNEO in the U.S. for a total consideration of $16 million to be received during 2025 Following recent transactions, Sol-Gel’s cash runway is expected to extend into the first quarter of 2027 NESS ZIONA, Israel, Aug. 15, 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, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced financial results for the second quarter ended June 30, 2025 and provided a corporate update. Q2 2025 and Recent Corporate Developments Subject enrollment for the Phase 3 study in Sol-Gel’s key asset SGT-610 has been completed; Top-line results are expected in the fourth quarter of 2026. SGT-610 is a topically applied patidegib, a hedgehog signaling pathway blocker 2% gel. If approved, SGT-610 is expected to be the first product for the prevention of new BCC lesions in Gorlin syndrome patients and is targeting potential peak revenue exceeding $300 million annually. Sol-Gel’s vehicle-controlled proof-of-concept phase-1b clinical trial for SGT-210 (topical erlotinib) in patients with Darier disease is ongoing. Darier disease is a significant unmet medical need, with a market potential estimated between $200 to $300 million. Due to the circumstances which prevailed in Israel in the last months, recruitment of patients has been slowed down. Therefore, the study completion and top-line results are expected in the fourth quarter of 2025. Pending positive results, we anticipate filing for a Phase 2 IND, promptly following the completion of the present study. SGT-210 is currently being used in compassionate treatment in a pediatric patient suffering from Olmsted disease, a debilitating rare skin disorder for which there is no approved treatment. In addition, Sol-Gel supports a request from a leading hospital, for another debilitating skin condition. On April 17, 2025, Sol-Gel announced it had entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (Mayne Pharma) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. Under the terms of the agreement, Sol-Gel will receive a total of $16 million in two installments: $10 million already received during the second quarter of 2025 and $6 million expected in the fourth quarter of 2025, which is expected to extend the Company’s cash runway into the first quarter of 2027. This agreement was executed following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. On May 5, 2025, Sol‑Gel implemented a 10‑for‑1 reverse share split of its ordinary shares, reducing shares outstanding from approximately 27.9 million to 2.8 million and adjusting authorized share capital to 5 million shares (par value NIS 1.0); the split, approved by shareholders on April 1, 2025, was intended to raise the per‑share price and maintain Sol‑Gel’s Nasdaq Capital Market listing, with trading continuing under the ticker "SLGL" on a split‑adjusted basis. Mr. Mori Arkin, Executive Chairman of Sol-Gel, stated: "Sol‑Gel entered the second half of 2025 in a markedly stronger position. We have now completed enrollment in our pivotal Phase 3 trial of SGT‑610 for Gorlin syndrome, keeping us firmly on track to report top‑line data in the fourth quarter of 2026. If approved, SGT‑610 is expected to be the first therapy designed to prevent new basal cell carcinomas in this underserved population, with peak revenue which we estimate at more than $300 million annually. Our continuous interaction with physicians and patients of Gorlin disease makes us more conscious than before of the debilitating effects of this disease and the urgent need for a therapy that will improve the quality of life for these patients." Mr. Arkin further commented "Our second key asset, SGT‑210, continues to advance despite certain recruitment impediments. The compassionate‑use requests of SGT-210 that we receive support our belief that this drug may have additional important indications beyond Darier disease." Mr. Arkin added "Commercially, we’ve taken decisive steps to unlock the full value of our approved products. The agreement with Mayne Pharma extends our cash runway into the first quarter of 2027 and allows us to accelerate investment in our R&D pipeline and, outside the United States, agreements executed last year position TWYNEO and EPSOLAY for launch in most new territories beginning in 2027‑2028. According to partner forecasts, royalties from these ex‑U.S. markets are expected to grow to potentially approximately $10 million by 2031." Lastly, Mr. Arkin noted "As we look ahead, we remain firmly focused on delivering pivotal data for SGT‑610, advancing SGT‑210, and translating the global demand for TWYNEO and EPSOLAY into meaningful, non‑dilutive revenues, all in service of creating long‑term value for patients and shareholders alike." Financial Results for the Second Quarter 2025 Total revenue for the second quarter was $17.2 million, which primarily consisted of $0.5 million in royalty revenue from Galderma and $16 million from sale of IP under the agreement with Mayne, compared to total revenue of $5.4 million for the same period in 2024, which primarily consisted of $0.6 million royalty revenue from Galderma and $4.8 million under the agreement with Beimei. Research and development expenses were $4.6 million compared to $2.4 million for the same period in 2024. The increase of $2.2 million was primarily attributed to an increase of $1.7 million in manufacturing development expenses related to SGT-610 and an increase of $1.0 million in clinical trial expenses for SGT-610, offset by a decrease of $0.3 million in payroll and stock-based compensation expenses mainly due to the adoption of cost saving measures during 2024. General and administrative expenses were $1.4 million compared to $1.4 million for the same period in 2024. Sol-Gel reported a net income of $11.6 million for the second quarter of 2025 and earnings of $4.17 per basic and diluted share, compared to a net loss of $1.9 million and earnings of $0.71 per basic and diluted share for the same period in 2024. As of June 30, 2025, Sol-Gel had $10.2 million in cash, cash equivalents, and deposits and $14 million in marketable securities for a total balance of $24.2 million. The Company expects its cash resources to fund cash requirements into the first quarter of 2027. About TWYNEO and EPSOLAY TWYNEO is a topical cream containing a fixed-dose combination of tretinoin, 0.1%, and benzoyl peroxide, 3%, cream for the treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is the first acne treatment that contains a fixed-dose combination of benzoyl peroxide and tretinoin. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. TWYNEO uses silica (silicon dioxide) core shell structures to separately micro-encapsulate tretinoin crystals and benzoyl peroxide crystals enabling inclusion of the two active ingredients in the cream. EPSOLAY is a topical cream containing benzoyl peroxide (BPO), 5%, for the treatment of bumps and blemishes (inflammatory lesions) of rosacea in adults. EPSOLAY utilizes a proprietary, patented technology to encapsulate BPO within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release BPO over time to provide a tolerable and effective treatment. About Gorlin Syndrome and SGT-610 SGT-610, a hedgehog signaling pathway blocker, has the potential to be the first ever treatment for prevention of BCCs in Gorlin syndrome patients, if approved. Gorlin syndrome, an autosomal dominant genetic disorder affecting approximately 1 in 27,000-31,000 people in the U.S., is mostly caused by inheritance of one defective copy of the tumor suppressor patched homolog 1 (PTCH1) gene. Normally, the PTCH1 gene blocks the smoothened, frizzle class receptor (SMO) gene, turning off the hedgehog signaling pathway when it is not needed. Mutations in the PTCH1 gene may cause a loss of PTCH1 function, release of SMO, and may allow BCC tumor cells to divide uncontrollably. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus, allowing cells to function normally and reducing the production of new tumors. About Sol-Gel Technologies Sol-Gel Technologies, Ltd. is a dermatology company focused on identifying, developing and commercializing or partnering drug products to treat 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 also includes Phase 3 clinical trial of Orphan 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. For additional information, please visit our new website: 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 the amounts expected to be received under our current and future licensing agreements our expected cash runway, the size of the markets for SGT-610 and SGT-210, t the timeline for advancing SGT-610 and SGT-210, including the timing for top-line results and the timing for payments from Mayne Pharma. 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, the risk that the amounts received from our current and future licensing agreements will not be as anticipated, the risk that the market for SGT-610 and SGT-210 will not be as anticipated, 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, top-line results and regulatory filings, a delay in receipt of payments from Mayne Pharma and others, 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 March 13, 2024, 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 Contact: Eyal Ben-Or Chief Financial Officer [email protected] +972-8-9313429 Source: Sol-Gel Technologies Ltd. *All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split. *All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split.

Investor releaseQuarter not tagged2025-05-23

Sol-Gel Reports First Quarter 2025 Results

GlobeNewswire
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…Read full document

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 Contact: Eyal Ben-Or Chief Financial Officer [email protected] +972-8-9313429 Source: Sol-Gel Technologies Ltd.

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook