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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 announced the acquisition of patidegib, a hedgehog signaling pathway blocker, from PellePharm. This drug is targeted for treating Gorlin syndrome, a rare disease with no FDA-approved therapies. The acquisition is set to close around January 30, 2023, with a total upfront payment of $4.7 million and potential milestone payments totaling up to $70.7 million. The Phase 3 study for SGT-610 is expected to start in the latter half of 2023, aiming for FDA approval by the end of 2025, with projected peak sales exceeding $300 million annually.
Sol-Gel Technologies (NASDAQ: SLGL) reported Q3 2022 financial results with revenue of $0.3 million, a significant decline from $8.8 million in Q3 2021. The decreased revenue is attributed to lower sales from EPSOLAY and TWYNEO, despite improvements in prescriber adoption. Research and development expenses dropped to $2.0 million from $6.0 million year-over-year, aiding in cash management. The company reported a loss of $3.4 million, down from a profit of $1.3 million in the previous year. However, Sol-Gel's cash runway is projected to last through Q1 2024, supported by ongoing partnerships.
Sol-Gel Technologies (NASDAQ: SLGL) has appointed Michael Glezin as Vice President of Business Development. Glezin, who has over a decade of experience in in-licensing and out-licensing within multiple territories, will focus on securing new business opportunities and commercial partnerships outside the U.S. His prior experience includes a senior role at Dexcel Pharma. CEO Alon Seri-Levy emphasized that Glezin's expertise will enhance Sol-Gel's growth potential and revenue streams from its microencapsulation technology and approved drugs, TWYNEO and EPSOLAY, which are exclusively licensed to Galderma.
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL) reported strong prescription volumes for its products EPSOLAY and TWYNEO, indicating a favorable launch trajectory. The company received a $3.5 million milestone payment from Galderma for FDA approval of EPSOLAY, boosting revenues to $3.5 million for Q2 2022, compared to $0.9 million in the previous year. R&D expenses decreased to $2.4 million, contributing to a reduced net loss of $0.1 million compared to $8.0 million in Q2 2021. With $36.6 million in cash and securities, Sol-Gel can fund its operations through the end of 2023.
Sol-Gel Technologies (NASDAQ: SLGL) has announced that CEO Alon Seri-Levy will present a corporate update at the 2022 Jefferies Global Healthcare Conference from June 8-10, 2022, in New York, NY. The presentation will occur on June 8 at 8:30 am ET in Track 9, with additional 1:1 meetings available. Sol-Gel is focused on developing topical drug products for skin diseases, including TWYNEO® and EPSOLAY, both licensed to Galderma for U.S. commercialization. The company is also advancing early-stage candidates SGT-210, SGT-310, and SGT-510 for other dermatologic indications.
Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology-focused company, announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The event will feature an on-demand presentation starting May 24 at 7:00 AM EDT, along with one-on-one meetings. Sol-Gel specializes in developing topical drugs, including TWYNEO® for acne treatment and EPSOLAY for rosacea, both licensed to Galderma. The company is also advancing early-stage drug candidates for various dermatological diseases.
Sol-Gel Technologies (SLGL) announced FDA approval for EPSOLAY®, a benzoyl peroxide cream for treating inflammatory lesions of rosacea, marking their second product launch within a year. Partner Galderma is set to launch EPSOLAY this quarter, following the successful U.S. launch of TWYNEO in April, targeting acne vulgaris. Despite nominal revenue of $0 for Q1 2022, and a reported loss of $5.6 million, the company expects its cash runway to extend through the end of 2023, thanks to partnerships that are poised to enhance product availability in dermatological treatments.
Sol-Gel Technologies (NASDAQ: SLGL) announced FDA approval for EPSOLAY, a benzoyl peroxide cream (5%) for treating rosacea in adults. The exclusive commercialization rights have been granted to Galderma. Clinical trials demonstrated a nearly 70% reduction in inflammatory lesions after 12 weeks, with 50% of patients achieving clear or almost clear skin. EPSOLAY's microencapsulation technology allows for sustained drug release, enhancing efficacy and safety. The product is patent-protected until 2040, indicating strong market potential for the 16 million Americans affected by rosacea.
Sol-Gel Technologies (NASDAQ: SLGL) announced the U.S. launch of TWYNEO, the first FDA-approved topical cream combining tretinoin and benzoyl peroxide for acne treatment. Launched by partner Galderma at the American Academy of Dermatology conference on March 25-29, 2022, TWYNEO is available by prescription across major U.S. pharmacy chains. The product's microencapsulation technology allows for controlled release of its active ingredients, addressing acne in adults and pediatric patients aged nine and older.
Sol-Gel Technologies (SLGL) reported 2021 revenue of $31.3 million, a combination of $7.5 million in licensing and $23.8 million in collaboration revenue. The company achieved net income of $3.2 million or $0.14 earnings per share, compared to a loss in 2020. Following an agreement with Padagis, Sol-Gel will receive $21.5 million over 24 months, allowing it to focus on high-value drug development. The launch of TWYNEO® is set for Spring 2022, enhancing its product portfolio alongside the anticipated EPSOLAY approval.
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