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Sol-Gel Technologies Ltd. (NASDAQ: SLGL) is a clinical-stage specialty pharmaceutical company dedicated to developing and commercializing innovative topical dermatological drug products. The company's core focus is on utilizing its proprietary microencapsulation delivery system, which leverages silica-based microcapsules to enhance the efficacy and tolerability of dermatological treatments. This technology creates a protective barrier around drug substances, controlling the release rate and reducing side effects. Sol-Gel's lead product candidates, Vered for papulopustular rosacea and Twin and Sirs-T for acne vulgaris, are prime examples of this advanced delivery system in action.
Sol-Gel has achieved significant milestones in its product pipeline. The company has received FDA approval for two major dermatology products: TWYNEO® and EPSOLAY®. TWYNEO, which combines tretinoin and benzoyl peroxide, is designed for the topical treatment of acne vulgaris. EPSOLAY, which contains encapsulated benzoyl peroxide, addresses inflammatory lesions of rosacea. Both products are commercialized in the U.S. by Galderma.
A key highlight of Sol-Gel's innovative approach is SGT-610, a hedgehog signaling pathway blocker in development for the prevention of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome. This candidate, which has received Orphan Drug and Breakthrough Therapy designations from the FDA, is currently undergoing pivotal Phase 3 testing. If approved, SGT-610 could become the first treatment specifically for Gorlin syndrome, a genetic disorder that predisposes individuals to developing BCC.
Financially, Sol-Gel reported a revenue of $0.2 million for the third quarter of 2023, primarily from licensing agreements. The company incurred research and development expenses of $4.7 million and general and administrative expenses of $1.9 million in the same quarter. Despite a net loss of $5.7 million, Sol-Gel maintains a robust financial position with $26.1 million in cash, cash equivalents, and deposits, and $17.2 million in marketable securities as of September 30, 2023. This financial stability is expected to support the company's operations and capital expenditure requirements into the second half of 2025.
Sol-Gel's commitment to addressing unmet needs in dermatology extends beyond its own products. The company is actively engaged in discussions with potential partners to secure new international licenses for its marketed products. This strategy aims to generate non-dilutive capital and expand the global reach of its innovative dermatological treatments.
For more detailed information, please visit www.sol-gel.com.
Sol-Gel Technologies (NASDAQ: SLGL) has received a 180-day extension until May 19, 2025, to regain compliance with Nasdaq's minimum bid price requirement. The company has transferred from Nasdaq Global Market to Nasdaq Capital Market effective November 15, 2024. To maintain listing, Sol-Gel must achieve a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. The company is considering various options, including a potential reverse share split, to meet this requirement.
Sol-Gel Technologies (NASDAQ: SLGL) reported Q3 2024 financial results with total revenue of $5.4 million, primarily from licensing agreements, compared to $0.2 million in Q3 2023. The company reported a net loss of $0.4 million ($0.01 per share), improved from a $5.7 million loss in Q3 2023. Cash position stands at $29.2 million, expected to fund operations into Q1 2026.
Key developments include Mori Arkin's approval as interim CEO starting January 2025, transfer to Nasdaq Capital Market, and ongoing Phase 3 trial of SGT-610 for Gorlin Syndrome with 40+ active clinical sites. New licensing agreements for TWYNEO and EPSOLAY are expected to generate up to $3.7 million in milestone payments.
Sol-Gel Technologies (NASDAQ: SLGL) reported Q2 2024 financial results and provided corporate updates. Key highlights include:
- Cash runway extended into Q1 2026
- Ongoing Phase 3 trial of SGT-610 for Gorlin Syndrome with top-line results expected by Q2 2026
- Proof-of-concept study for SGT-210 in Darier disease ongoing
- New agreement with Padagis for generic Zoryve® Cream, enhancing cash position by ~$6 million
- License agreements signed for TWYNEO and EPSOLAY in Europe and South Africa
- Q2 2024 revenue: $5.4 million; Net income: $1.9 million ($0.07 per share)
- Cash balance: $30.5 million as of June 30, 2024
Sol-Gel Technologies (NASDAQ: SLGL) has signed six exclusive license agreements for the commercialization of TWYNEO® and EPSOLAY® in Europe and South Africa. The company will receive upfront and regulatory milestone payments totaling up to low 7-digit USD, along with either fixed transfer sale prices or low double-digit royalties from net sales. These payments are backed by commitments to minimum annual sales.
The agreements cover major European countries, including Germany, UK, France, and others, as well as South Africa. Sol-Gel's partners will be responsible for regulatory submissions, with Sol-Gel providing assistance. These new collaborations add to existing agreements in the US, Canada, and China, highlighting the commercial potential of both drugs.
Sol-Gel is also conducting a Phase 3 trial of SGT-610 for Gorlin syndrome and a clinical study of SGT-210 for Darier disease, aiming to strengthen its business position further.
Sol-Gel Technologies (NASDAQ: SLGL) announced significant management changes. CEO Dr. Alon Seri-Levy will step down from his position and board membership by December 31, 2024, subject to shareholder approval. He will continue as a consultant for one year. Eyal Ben-Or, previously Director of Finance, has been appointed as the new Chief Financial Officer (CFO) effective July 12, 2024, replacing Gilad Mamlok.
Under Dr. Seri-Levy's leadership, Sol-Gel developed FDA-approved products EPSOLAY® and TWYNEO®, completed a successful U.S. IPO, and acquired SGT-610 related assets. The company is currently conducting a Phase 3 clinical trial of SGT-610 for Gorlin syndrome. Chairman Mori Arkin expressed gratitude for Dr. Seri-Levy's contributions and confidence in Ben-Or's appointment.
Sol-Gel Technologies announced on May 28, 2024, receiving a notification from Nasdaq regarding non-compliance with the minimum bid price rule of $1 per share. The company’s shares have traded below $1 for 33 consecutive business days, triggering this notice. This notice does not affect the current listing, and shares will continue trading under the symbol SLGL. Sol-Gel has 180 days, until November 18, 2024, to regain compliance. If the share price reaches $1 for 10 consecutive days before the deadline, compliance will be restored. Sol-Gel is evaluating options to address this issue.
Sol-Gel Technologies (NASDAQ: SLGL) announced its Q1 2024 financial results and corporate updates. Key highlights include an ongoing Phase 3 trial of SGT-610 for Gorlin Syndrome and a proof-of-concept study for SGT-210 in Darier disease. The company entered an Asset Purchase Agreement with Beimei Pharma to commercialize TWYNEO® in several regions, potentially earning up to $15M. Financially, Q1 revenue was $0.5M, up from $0.3M in Q1 2023. However, total prescriptions for TWYNEO and EPSOLAY declined by 23% and 14% respectively. R&D expenses decreased to $5.3M, contributing to a reduced net loss of $6.3M compared to $10.7M in Q1 2023.
Sol-Gel Technologies (NASDAQ: SLGL) has entered into a significant asset purchase agreement with Shenzhen Beimei Pharmaceutical Co. to commercialize TWYNEO® for acne vulgaris in mainland China, Hong Kong, Macau, Taiwan, and Israel.
Sol-Gel will receive up to $15 million, including $10 million in upfront and regulatory milestone payments, with the remaining $5 million as royalties on net sales. This agreement enhances the potential reach of TWYNEO beyond the U.S. market.
Beimei will handle the registration and commercialization of TWYNEO in these regions. This strategic move aims to address the unmet clinical need in the acne market, particularly among adolescents in China.
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