Sol-Gel and Mayne Pharma Announce the Purchase of EPSOLAY® and TWYNEO® in the U.S.
Sol-Gel Technologies (NASDAQ: SLGL) has entered into a product purchase agreement with Mayne Pharma for the U.S. rights to EPSOLAY and TWYNEO. The deal will provide Sol-Gel with $16 million in two installments during 2025, extending their cash runway into Q1 2027.
The company will focus on developing SGT-610, a potential first-ever preventative treatment for basal cell carcinomas in Gorlin syndrome patients, with an estimated U.S. market potential of $400-500 million annually. The Phase III trial has achieved 80% patient enrollment, with top-line results expected in Q4 2026.
As of March 31, 2025, Sol-Gel reported $16.9 million in cash and equivalents. The company is also advancing SGT-210, a treatment for Darier disease with a market potential of $200-300 million, with 50% of patients having completed the Phase 1b trial.
Sol-Gel Technologies (NASDAQ: SLGL) ha stipulato un accordo di acquisto prodotto con Mayne Pharma per i diritti negli Stati Uniti di EPSOLAY e TWYNEO. L'accordo garantirà a Sol-Gel 16 milioni di dollari in due tranche nel corso del 2025, estendendo la liquidità dell'azienda fino al primo trimestre 2027.
L'azienda si concentrerà sullo sviluppo di SGT-610, un potenziale primo trattamento preventivo per i carcinomi basocellulari nei pazienti con sindrome di Gorlin, con un potenziale di mercato negli Stati Uniti stimato tra 400 e 500 milioni di dollari all'anno. Lo studio di Fase III ha raggiunto l'80% di arruolamento dei pazienti, con i risultati principali attesi nel quarto trimestre 2026.
Al 31 marzo 2025, Sol-Gel ha riportato 16,9 milioni di dollari in contanti e equivalenti. L'azienda sta inoltre portando avanti lo sviluppo di SGT-210, un trattamento per la malattia di Darier con un potenziale di mercato di 200-300 milioni di dollari, con il 50% dei pazienti che ha completato la Fase 1b dello studio.
Sol-Gel Technologies (NASDAQ: SLGL) ha firmado un acuerdo de compra de productos con Mayne Pharma para los derechos en EE. UU. de EPSOLAY y TWYNEO. El acuerdo proporcionará a Sol-Gel 16 millones de dólares en dos pagos durante 2025, extendiendo su liquidez hasta el primer trimestre de 2027.
La compañía se enfocará en desarrollar SGT-610, un posible primer tratamiento preventivo para carcinomas basocelulares en pacientes con síndrome de Gorlin, con un potencial de mercado en EE. UU. estimado entre 400 y 500 millones de dólares anuales. El ensayo de fase III ha alcanzado el 80% de inscripción de pacientes, con resultados principales esperados para el cuarto trimestre de 2026.
Al 31 de marzo de 2025, Sol-Gel reportó 16,9 millones de dólares en efectivo y equivalentes. La compañía también avanza con SGT-210, un tratamiento para la enfermedad de Darier con un potencial de mercado de 200-300 millones de dólares, con el 50% de los pacientes habiendo completado el ensayo de fase 1b.
Sol-Gel Technologies (NASDAQ: SLGL)가 Mayne Pharma와 미국 내 EPSOLAY 및 TWYNEO 권리에 관한 제품 구매 계약을 체결했습니다. 이 계약을 통해 Sol-Gel은 2025년 동안 두 차례에 걸쳐 1,600만 달러를 받게 되어 2027년 1분기까지 자금 운용 기간을 연장할 수 있게 되었습니다.
회사는 고를린 증후군 환자의 기저 세포 암종을 예방할 수 있는 최초의 잠재적 치료제인 SGT-610 개발에 주력할 예정이며, 미국 시장 잠재력은 연간 4억~5억 달러로 추정됩니다. 3상 임상시험은 환자 등록의 80%를 달성했으며, 주요 결과는 2026년 4분기에 발표될 예정입니다.
2025년 3월 31일 기준으로 Sol-Gel은 1,690만 달러의 현금 및 현금성 자산을 보유하고 있습니다. 또한 Darier 병 치료제인 SGT-210도 개발 중이며, 시장 잠재력은 2억~3억 달러로 예상되며, 환자의 50%가 1b상 임상시험을 완료했습니다.
Sol-Gel Technologies (NASDAQ : SLGL) a conclu un accord d'achat de produits avec Mayne Pharma pour les droits américains sur EPSOLAY et TWYNEO. Cet accord fournira à Sol-Gel 16 millions de dollars en deux versements durant 2025, prolongeant ainsi leur trésorerie jusqu'au premier trimestre 2027.
L'entreprise se concentrera sur le développement de SGT-610, un potentiel premier traitement préventif des carcinomes basocellulaires chez les patients atteints du syndrome de Gorlin, avec un potentiel de marché américain estimé entre 400 et 500 millions de dollars par an. L'essai de phase III a atteint 80 % de recrutement des patients, avec des résultats principaux attendus au quatrième trimestre 2026.
Au 31 mars 2025, Sol-Gel a déclaré disposer de 16,9 millions de dollars en liquidités et équivalents. L'entreprise fait également progresser SGT-210, un traitement pour la maladie de Darier avec un potentiel de marché de 200 à 300 millions de dollars, avec 50 % des patients ayant terminé l'essai de phase 1b.
Sol-Gel Technologies (NASDAQ: SLGL) hat eine Produktkaufvereinbarung mit Mayne Pharma für die US-Rechte an EPSOLAY und TWYNEO abgeschlossen. Der Deal sichert Sol-Gel 16 Millionen US-Dollar in zwei Raten im Jahr 2025 und verlängert damit die Liquiditätsreichweite bis ins erste Quartal 2027.
Das Unternehmen wird sich auf die Entwicklung von SGT-610 konzentrieren, einer potenziell ersten präventiven Behandlung für Basalzellkarzinome bei Gorlin-Syndrom-Patienten, mit einem geschätzten US-Marktpotenzial von 400 bis 500 Millionen US-Dollar jährlich. Die Phase-III-Studie hat eine Patientenrekrutierung von 80 % erreicht, die wichtigsten Ergebnisse werden für das vierte Quartal 2026 erwartet.
Zum 31. März 2025 meldete Sol-Gel 16,9 Millionen US-Dollar an liquiden Mitteln und Äquivalenten. Das Unternehmen treibt außerdem SGT-210 voran, eine Behandlung für die Darier-Krankheit mit einem Marktpotenzial von 200 bis 300 Millionen US-Dollar, wobei 50 % der Patienten die Phase-1b-Studie abgeschlossen haben.
- Secured $16 million from Mayne Pharma deal, extending cash runway to Q1 2027
- SGT-610 shows significant market potential of $400-500 million annually in the U.S.
- Phase III trial for SGT-610 reached 80% enrollment milestone
- Multiple partnership agreements signed for EPSOLAY and TWYNEO outside U.S.
- Cash position decreased from $23.9 million in December 2024 to $16.9 million in March 2025
- Previous Phase III study by PellePharm for similar treatment failed to achieve statistical significance
Insights
Sol-Gel secures $16M from Mayne Pharma sale, extends runway to Q1 2027 while advancing promising rare disease pipeline with significant market potential.
The announced $16 million product purchase agreement with Mayne Pharma represents a strategic pivot for Sol-Gel as the clinical-stage dermatology company monetizes its FDA-approved assets to focus on its high-potential rare disease pipeline. This transaction significantly strengthens Sol-Gel's financial position, extending cash runway into Q1 2027, which is critically important as it provides sufficient capital to complete the pivotal Phase III trial for SGT-610.
The structure of the deal is particularly favorable, with $10 million coming in Q2 2025 and $6 million in Q4 2025, providing immediate capital infusion when considering the company's $16.9 million cash position as of March 31, 2025. This effectively triples Sol-Gel's operational runway, removing near-term financing risk that typically plagues small biotech companies.
What makes this deal particularly compelling is Sol-Gel's strategic focus on SGT-610, which targets an attractive rare disease indication with competition. The newly estimated U.S. market potential of $400-500 million annually for SGT-610 in Gorlin syndrome represents a substantial opportunity relative to Sol-Gel's $13.9 million market capitalization. The 80% enrollment milestone in the Phase III trial indicates solid execution, with top-line data expected Q4 2026.
While the company's optimism regarding SGT-610 is based on post-hoc analysis of previous Phase III data (which requires cautious interpretation), the strategic refocusing and extended cash runway position Sol-Gel to potentially deliver significant value if clinical results are positive. The additional development of SGT-210 for Darier disease, with 50% patient completion in the Phase 1b study and estimated market potential of $200-300 million, provides a secondary value driver in the company's refocused pipeline.
Sol-Gel's strategic divestiture extends runway through critical Phase III trial completion while focusing on rare diseases with blockbuster potential.
The product purchase agreement with Mayne Pharma represents a scientifically sound strategic decision for Sol-Gel. By divesting rights to EPSOLAY and TWYNEO in the U.S. market, the company secures crucial funding while maintaining ex-U.S. partnership opportunities that management indicates could exceed domestic value. This allows Sol-Gel to concentrate resources on its rare disease programs where the scientific rationale appears compelling.
The SGT-610 program targeting the hedgehog signaling pathway in Gorlin syndrome addresses fundamental disease biology. Gorlin syndrome results from mutations in the PTCH1 gene, a negative regulator of hedgehog signaling, making this pathway a mechanistically rational therapeutic target. The company's refinement of patient selection based on confirmed hedgehog mutations shows disciplined scientific decision-making that potentially increases probability of success.
The post-hoc analysis revealing a p-value <0.01 when focusing on patients with confirmed hedgehog mutations suggests strong biological activity, though such retrospective analyses require cautious interpretation. Sol-Gel's decision to specifically design their trial with these insights increases the likelihood of demonstrating statistical significance in the ongoing Phase III study.
For SGT-210, the use of topical erlotinib (an EGFR inhibitor) for Darier disease represents innovative drug repurposing. EGFR signaling modulates keratinocyte differentiation and proliferation, processes dysregulated in Darier disease. The compassionate use case suggesting clinical benefit, while anecdotal, provides encouraging biological validation.
Both development programs target rare dermatological conditions with substantial unmet needs and minimal competition, positioning Sol-Gel to potentially dominate these therapeutic niches if clinical development succeeds. The extended cash runway provides the necessary financial stability to reach crucial data readouts without dilutive financing.
- Sol-Gel to receive
$16 million during 2025 - Cash runway is expected to extend into the first quarter of 2027; Company expects to have sufficient cash to complete its Phase III clinical trial
- SGT-610 Phase III clinical trial top-line results are expected in the fourth quarter of 2026; a significant milestone in the clinical trial of recruiting more than
80% of the patients has been achieved - Sol-Gel now estimates the U.S. market potential for SGT-610 to be between
$400 t o$500 million annually - SGT-210 Phase 1b trial in Darier patients is ongoing;
50% of the patients have already completed the trial
NESS ZIONA, Israel, April 17, 2025 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company, today announced it has entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (ASX: MYX) (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
EPSOLAY is a topical cream containing encapsulated benzoyl peroxide,
Facilitating the amounts received from this agreement with Mayne Pharma, Sol-Gel will concentrate on the clinical and commercial development of its most advanced innovative product, SGT-610, a hedgehog signaling pathway blocker designed to potentially become the first ever preventative treatment of basal cell carcinomas (BCCs) in Gorlin syndrome patients, if approved.
Based on recent independent market research commissioned by Sol-Gel, in which the optimal price recommendation has been established, and based on prevalence of Gorlin syndrome in the U.S., Sol-Gel now estimates the U.S. market potential for SGT-610 to be between
As of December 31, 2024, Sol-Gel had
As of March 31, 2025, Sol-Gel had
“We are pleased to enter into this agreement with Mayne Pharma,” said Mori Arkin, Chairman of the Board and CEO of Sol-Gel. “Having concluded this U.S. transaction, we are in advanced stages of establishing the commercial network of Epsolay and Twyneo outside the U.S. Many partnership agreements have already been signed and others are under negotiation. If the forecasts of our partners, who all made upfront payments for the rights in their territories, are accurate, we believe that the value of the global business could far exceed that of the U.S. business alone.
“This agreement with Mayne Pharma is expected to significantly enhance our cash position and enable us to bolster our SGT-610 program and bring the Phase-III trial to completion. In addition to the potential of SGT-610 in the U.S., we believe that the worldwide potential of SGT-610 is very significant as Gorlin syndrome is prevalent globally.
“Our Phase-III clinical trial is progressing well, with all of our 41 sites open for enrollment and approximately
“With the funding of the clinical trial accomplished and the timeline established, we would like to share with our investors the reasons as to why we are optimistic about the trial’s potential success.”
Mr. Arkin further commented, “It is important to note that all the data supporting our optimistic outlook are based on our post-hoc analysis of the results of the Phase-III clinical study of patidegib that was conducted by our predecessor, PellePharm Inc.
“This type of analysis is called a ‘post-hoc analysis’, which we cannot assure you that its conclusions will be replicated in our study. With that said, I would like to explain the reasons for our optimism.
“The study conducted by PellePharm did not achieve the statistical significance of the primary endpoint. However, with the assistance of three independent statisticians and several clinical experts, all commissioned by Sol-Gel, significant findings were made after studying the data.
“Gorlin syndrome patients who lacked the PTCH-1 mutation responded poorly to patidegib.
“When we included in our analysis only patients with a confirmed hedgehog mutation and excluded an additional subset of patients, the superiority of patidegib became very significant – P <0.01. Our experts believe that this selection is not only warranted statistically but is based on sound scientific considerations.”
Mr. Arkin further commented, “I am also pleased to share an update on Sol-Gel’s of our vehicle controlled phase 1b clinical trial on SGT-210 (topical erlotinib) in patients with Darier disease, a significant unmet medical need with an estimated market potential of
About TWYNEO and EPSOLAY
TWYNEO is a topical cream containing a fixed-dose combination of tretinoin,
EPSOLAY is a topical cream containing benzoyl peroxide (BPO),
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 Darier Disease and SGT-210
SGT-210 is a topical erlotinib drug candidate that is formulated for the treatment of Darier Disease and other hyperkeratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor that acts on the epidermal growth factor receptor, a protein present on cell surfaces that plays a key role in promoting cell growth and division. Darier Disease is a rare, genetic keratinization disorder which is classically characterized scaly crusted papules in a seborrheic distribution and in skin folds.
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.
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercializing novel pharmaceuticals, to offer patients better, safe and more accessible medicines. Mayne Pharma is a leader in dermatology and women’s health in the United States and also provides contract development and manufacturing services to clients worldwide. Mayne Pharma has a 40- year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialized in numerous products that continue to be marketed around the world. To learn more about Mayne Pharma, please visit Maynepharma.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 to be received under our current and future licensing agreements, our expected cash runway, the potential of Sol-Gel’s assets including Twyneo, Epsolay, SGT-610, and SGT-210, the timeline for advancing SGT-610, and SGT-210, and the size of SGT-610’s market. 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, delays in regulatory milestones, such as a delay in top-line results for our SGT-610 clinical trial, our ability to enter into further collaborations, lower than anticipated annual revenue income from new collaborations and 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 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
+972-8-9313429
FAQ
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