NESS ZIONA, Israel, March 23, 2026 (GLOBE NEWSWIRE) -- Sol-Gel Technologies Ltd. (the “Company”) (NASDAQ: SLGL) today announced the pricing of an underwritten offering of 459,112 ordinary shares (the “Shares”) at a price of $72.00 per Share, resulting in gross proceeds to the Company, before deducting underwriting discounts and commissions and other estimated offering expenses, of approximately $33.1 million. All of the Shares are to be sold by the Company. The offering is expected to close on or about Marc ...

分组1 - Sol-Gel Technologies Ltd. reported a quarterly loss of $1.07 per share, significantly worse than the Zacks Consensus Estimate of $0.39, representing an earnings surprise of -374.36% [1] - The company posted revenues of $0.7 million for the quarter ended December 2025, missing the Zacks Consensus Estimate by 89.29%, compared to revenues of $0.28 million a year ago [2] - The stock has increased by approximately 78.8% since the beginning of the year, while the S&P 500 has declined by 3.2% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$1.84 on revenues of $0.9 million, and for the current fiscal year, it is -$6.81 on revenues of $5.28 million [7] - The Medical - Generic Drugs industry, to which Sol-Gel Technologies belongs, is currently ranked in the bottom 23% of over 250 Zacks industries, indicating potential challenges for stock performance [8]

Core Viewpoint - Sol-Gel Technologies, Ltd. has filed its annual report on Form 20-F for the fiscal year ended December 31, 2025, which includes audited financial statements and is accessible via the SEC and the company's investor relations website [1] Group 1: Company Overview - Sol-Gel is a specialized dermatology company focused on innovative therapies for rare and serious skin diseases [2] - The lead investigational candidate, SGT-610 (patidegib gel, 2%), is a Phase 3 topical hedgehog inhibitor aimed at preventing new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome [2] - SGT-610 has the potential to offer an improved safety profile compared to oral hedgehog inhibitors and may also have future applications in high-frequency BCC [2] - The company is also developing SGT-210, an investigational topical EGFR inhibitor, targeting indications with significant unmet medical needs [2] - Sol-Gel has two FDA-approved dermatology products: TWYNEO® and EPSOLAY® [2] Group 2: Financial Reporting - The annual report on Form 20-F includes complete audited financial statements for 2025 and is available for shareholders upon request [1]

Financial Performance - The company incurred a net loss of $27.2 million in 2023, $10.6 million in 2024, and $6.1 million in 2025, with an accumulated deficit of $237 million as of December 31, 2025[38]. - The company anticipates ongoing losses as it invests in research and development and seeks regulatory approvals for its product candidates[38]. - The company expects continued significant expenses and operating losses over the next several years as it conducts advanced-stage clinical studies for SGT-610 and develops SGT-210[43]. - The company may need to raise substantial additional funding to pursue its business objectives, which could lead to dilution of shareholder value[43]. Product Development and Regulatory Approval - The company has not yet obtained regulatory approval for its product candidates in the United States or any other country, which poses a risk to its business[31]. - The company may face increased costs and delays in the marketing approval process if the FDA requires additional studies or data for its product candidates[49]. - The company expects to utilize the FDA's Section 505(b)(2) pathway for some product candidates, but if unavailable, development could take significantly longer and cost more[79]. - The company has filed two NDAs under Section 505(b)(2) of the FDCA, with Twyneo receiving FDA marketing approval in July 2021 and Epsolay in April 2022[189]. - The company may be required to perform additional clinical trials to support changes from branded reference drugs, potentially delaying regulatory approvals[192]. Market Competition and Commercialization - The company faces intense competition in the dermatology market, which may hinder its ability to achieve commercial success[31]. - The company’s future success is highly dependent on the market perception of its products and their safety and quality[31]. - The company faces significant competition for its product candidates, including SGT-610, Twyneo, and Epsolay, from established companies with greater resources and market experience[126][129]. - Sales of SGT-610, Twyneo, and Epsolay will depend heavily on third-party payor coverage and reimbursement levels, which are critical for profitability[135]. Clinical Trials and Patient Enrollment - The company may face challenges in enrolling patients for clinical trials, which could delay the development of its product candidates[31]. - The company faces intense competition for patient enrollment in clinical trials, which could delay or prevent the trials from proceeding[68]. - The company is dependent on ongoing clinical trials, and any delays could significantly harm its ability to generate product revenues[66]. - The company may experience delays in clinical trials due to various factors, including patient recruitment challenges and regulatory compliance issues[63]. Intellectual Property and Legal Risks - The company’s success is contingent on its ability to protect its intellectual property, which involves complex legal challenges[173]. - The company may face patent infringement lawsuits that could delay or prevent the review or approval of its product candidates[189]. - The company has granted licenses to third parties for its intellectual property, which may lead to increased competition and reduced market share[179]. - The company may incur substantial costs and management resource diversion due to legal proceedings related to intellectual property rights[183]. Regulatory Environment and Compliance - The company must comply with extensive regulatory requirements, including manufacturing and labeling, which could affect the commercial viability of its products[93]. - The enforcement of healthcare laws is uncertain and may change rapidly, complicating compliance efforts and diverting resources[141]. - The company faces risks related to compliance with healthcare regulatory laws, which could lead to significant penalties and operational impacts[139]. - Regulatory approval processes are lengthy and unpredictable, with the potential for changes in approval policies that could affect the company's product candidates[69]. Operational Challenges - The company relies on third-party partners for the commercialization of its products, which may affect its ability to achieve significant market penetration[31]. - The company is dependent on contract manufacturers for compliance with cGMP requirements, and any failure could jeopardize regulatory approvals[162]. - Manufacturing difficulties could significantly impact the ability to provide product candidates to patients and delay commercialization efforts[171]. - The company relies on third-party manufacturers for the production of product candidates and approved products, increasing risks related to supply and compliance[161]. External Factors and Risks - The company faces significant risks due to political, economic, and military conditions in Israel, which could adversely affect its operations and financial condition[196]. - Recent hostilities, including attacks from Hamas and Hezbollah, have escalated tensions in the region, potentially impacting the company's ability to conduct business[197]. - Exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel may negatively impact future revenues, as a substantial portion of revenues is expected to be generated in foreign currencies[201]. - The company may face claims for remuneration or royalties for assigned service invention rights by employees, which could lead to litigation and adversely affect its business[211].

Company Overview - Sol-Gel Technologies (SLGL) is a clinical-stage dermatology company with a market capitalization of $262 million, focusing on developing and commercializing topical drug products for skin diseases [1][5] - The company is based in Israel and its product candidates include VERED for papulopustular rosacea and TWIN and SIRS-T for acne vulgaris, which are currently in clinical stages [1][6] Stock Performance - SLGL has demonstrated exceptional technical momentum, with a remarkable increase of 1,310% over the past 52 weeks [6][7] - The stock reached a three-year high of $97.97 on March 3 and recently traded at $84.92, with a 50-day moving average of $69.77 [4][7] - Over the past month, SLGL has made 10 new highs and is up 11.89% [7] Technical Indicators - The stock has a Weighted Alpha of +613.54 and a 100% "Buy" opinion from Barchart, indicating strong bullish sentiment [7] - SLGL maintains its Trend Seeker "Buy" signal, and the Relative Strength Index (RSI) is at 54.02, suggesting a balanced momentum [7]

Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]

Core Insights - Sol-Gel Technologies, Ltd. has announced the results of its Phase 1b study of SGT-210 for Darier disease, which did not show efficacy compared to the vehicle control [2][3] - The company will not proceed with further development of SGT-210 in this indication and will focus on low-cost feasibility studies in other areas of unmet medical need [3] Company Overview - Sol-Gel Technologies is a dermatology company that develops treatments for skin diseases, including FDA-approved products like TWYNEO for acne and EPSOLAY for rosacea [5][6] - The company is currently advancing its Phase 3 clinical trial for SGT-610, a hedgehog signaling pathway blocker aimed at preventing basal cell carcinomas (BCCs) in patients with Gorlin syndrome [4][6] Product Pipeline - SGT-610 is positioned to be the first treatment for preventing BCCs in Gorlin syndrome patients, targeting the underlying genetic cause linked to the PTCH1 gene [4] - The company is also investigating SGT-210 for rare hyperkeratinization disorders, although the recent study results have halted its advancement in Darier disease [6]

Core Insights - Sol-Gel Technologies, Ltd. reported financial results for Q3 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, primarily due to lower licensing revenue [6][8] - The company is advancing its late-stage pipeline, particularly focusing on SGT-610 for Gorlin syndrome and exploring its potential for high-frequency basal cell carcinoma (BCC) [4][5] - Sol-Gel has secured additional partnerships and regulatory approvals, which are expected to enhance its revenue streams and market presence [3][5] Financial Performance - Total revenue for Q3 2025 was $0.4 million, a decrease from $5.4 million in Q3 2024, with the previous revenue primarily derived from various licensing agreements [6] - Research and development expenses increased to $5.7 million in Q3 2025 from $4.8 million in Q3 2024, attributed to higher manufacturing and clinical trial costs [7] - The company reported a net loss of $5.9 million for Q3 2025, compared to a net loss of $0.4 million in Q3 2024, resulting in a loss of $2.13 per share [8] Corporate Developments - Sol-Gel is pursuing high-frequency BCC as an additional indication for SGT-610, which could potentially double the drug's commercial value if approved [5] - The company received Health Canada approval for EPSOLAY in September 2025 and signed a licensing agreement with Viatris for commercialization in Australia and New Zealand [5][6] - Sol-Gel's ongoing Phase 3 trial for SGT-610 is expected to yield top-line results in Q4 2026, with growing interest from physicians regarding its use in severe BCC cases [4][5] Market Outlook - Sol-Gel anticipates that TWYNEO and EPSOLAY will launch in new territories by 2028 and 2027, respectively, with projected annual royalty revenue reaching approximately $10 million by 2031 [3] - The company aims to leverage its partnerships to unlock the value of its approved products and create non-dilutive revenue streams [4][5] - The market for SGT-610 and SGT-210 is expected to grow, particularly in the context of rare dermatological diseases, with a focus on addressing significant unmet medical needs [6][12]

Core Insights - Sol-Gel Technologies, Ltd. has received a Notice of Compliance from Health Canada for EPSOLAY, a treatment for inflammatory lesions of rosacea in adults, marking a significant regulatory milestone for the company [1][2][3] Group 1: Product Approvals and Partnerships - The approval of EPSOLAY is a result of Sol-Gel's partnership with Searchlight Pharma, which holds the exclusive license for commercializing EPSOLAY in Canada [2] - Sol-Gel is eligible to receive up to $11 million in potential payments related to TWYNEO and EPSOLAY in Canada, along with tiered royalties on net sales, enhancing the company's financial position [2][3] - The company aims to commercialize EPSOLAY and TWYNEO globally, with launches expected in various territories starting in 2027 and 2028 [3] Group 2: Financial Outlook - Ex-U.S. contributions to the company's EBITDA are projected to gradually increase, potentially reaching approximately $10 million annually by 2031, excluding milestone payments [3] - The non-dilutive revenue from partnerships is expected to support Sol-Gel's growth strategy and strengthen its balance sheet [2][3] Group 3: Product Details - EPSOLAY is a topical cream containing 5% benzoyl peroxide, designed to treat inflammatory lesions of rosacea using a patented technology for sustained release [5] - TWYNEO is a fixed-dose combination cream for acne vulgaris, containing 0.1% tretinoin and 3% benzoyl peroxide, utilizing micro-encapsulation technology to enhance efficacy [4] Group 4: Clinical Trials and Pipeline - Sol-Gel is conducting a Phase-3 clinical trial for SGT-610, a potential treatment for Gorlin syndrome, which could be the first to prevent basal cell carcinomas in affected patients [1][9] - The company is also investigating SGT-210 for the treatment of rare hyperkeratinization disorders, indicating a diverse pipeline in dermatological therapies [9]

Financial Performance - Total revenue for the six months ended June 30, 2025, was $18,292,000, representing a 210% increase compared to $5,899,000 for the same period in 2024[8] - Net income for the six months ended June 30, 2025, was $2,802,000, compared to a net loss of $4,368,000 for the same period in 2024[8] - Operating income for the three months ended June 30, 2025, was $11,230,000, a significant improvement from an operating loss of $1,624,000 for the same period in 2024[8] - The total revenue for the six months ended June 30, 2025, was $18.292 million, a substantial increase from $5.899 million in the same period of 2024[49] Assets and Liabilities - Cash and cash equivalents decreased to $10,221,000 as of June 30, 2025, from $19,489,000 as of December 31, 2024[5] - Total current assets increased to $36,262,000 as of June 30, 2025, up from $31,295,000 as of December 31, 2024[5] - Total liabilities increased to $7,425,000 as of June 30, 2025, compared to $6,996,000 as of December 31, 2024[5] - Shareholders' equity rose to $31,882,000 as of June 30, 2025, from $28,850,000 as of January 1, 2025[5] - The Company’s marketable securities increased from $4.425 million on December 31, 2024, to $14.054 million by June 30, 2025, indicating a significant growth in investments[45] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $13,489,000, compared to $7,783,000 for the same period in 2024[8] - As of June 30, 2025, the Company recognized R&D expenses of $13.489 million for the six months ended, compared to $7.783 million for the same period in 2024, reflecting an increase of approximately 73%[49] - The Company plans to fund approximately $2.9 million for a hydrogenator to support the commercial manufacturing of Patidegib API[28] Agreements and Contracts - The company has two approved drugs: Twyneo® and Epsolay®, with Twyneo® available for purchase since April 14, 2022, and Epsolay® since June 2, 2022[24] - The company entered into a Termination Agreement with Padagis, which includes a payment of $4,250,000 and future royalties[24] - The Company entered into an asset purchase agreement with PellePharm for the acquisition of assets related to patidegib, with an upfront payment of $4 million and potential future payments totaling up to $70 million based on development and commercial milestones[25] - The Company expects to receive a total of $16 million from Mayne Pharma in two installments, with $10 million received in May 2025 and $6 million expected in Q4 2025[30] - The Company entered into a Termination Agreement with Padagis for the sale of rights related to Roflumilast cream and foam, receiving $4,250 in total, paid in eight quarterly installments, plus 2% royalties on gross profits[54] - The Company entered into a product purchase agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to EPSOLAY and TWYNEO, entitled to receive $16 million in total, with $10 million in Q2 2025 and $6 million in Q4 2025[57] Operational Updates - The Company’s subsidiary in the U.S. ceased operations in 2024, impacting its marketing and regulatory affairs[31] - The Company continues to monitor its operations in Israel amid ongoing geopolitical tensions, with no material impact reported as of June 30, 2025[33] Revenue Recognition - The Company recognized revenue of $24 and $42 from continuing services for the six months ended June 30, 2025, and 2024, respectively, and $750 as license revenue in 2025 compared to $0 in 2024[54] - For the six months ended June 30, 2025, the Company did not recognize any revenue from the sale of intellectual property, compared to $4.8 million for the same period in 2024[56] - The Company allocated $200 to support services to be recognized over time, with only $8 thousand recognized for continuing support as of June 30, 2025[57] - The Company has identified multiple performance obligations in agreements, recognizing revenue from the sale of IP at a point in time upon transfer of control[54] Stock Options - The Company granted 14,054 options to executive officers in February 2025 at an exercise price of $8.96 per share, vesting over four years[59] - The weighted average fair value of options granted in February 2025 was $53, with an expected volatility of 69.85% and a risk-free interest rate of 4.48%[61] Management and Segmentation - The Chief Executive Officer manages the Company's business activities as a single operating segment, using consolidated net income to assess performance[63]