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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) will report its second quarter 2021 financial results on August 4, 2021, at 7:05 AM ET. The company focuses on developing topical drug products for skin diseases, utilizing its microencapsulation technology platform. TWYNEO and EPSOLAY are under investigation for acne and rosacea, respectively, with NDAs filed with the FDA. However, the approval for EPSOLAY is delayed due to COVID-19 travel restrictions affecting the FDA's inspection of the production site.
Sol-Gel Technologies (NASDAQ: SLGL) announced positive pre-clinical data for its investigational drug, SGT-510, showing superiority over roflumilast cream in a psoriasis model. The human xenograft study, conducted at the Technion Institute, revealed a 60% recovery rate with SGT-510 compared to 30% with roflumilast. Sol-Gel also plans to develop tapinarof cream, aiming for affordability and innovation. Their study for SGT-210 indicated modest improvements in palmoplantar keratoderma. The company will discuss these results in a conference call today at 8 AM EDT.
Sol-Gel Technologies (NASDAQ: SLGL) has announced two exclusive 5-year license agreements with Galderma for the commercialization of its investigational products, EPSOLAY and TWYNEO, in the U.S. EPSOLAY targets inflammatory lesions of rosacea, while TWYNEO is aimed at treating acne vulgaris. The agreements could yield Sol-Gel up to $15 million in upfront and milestone payments, plus royalties ranging from mid-teen to high-teen percentages of net sales. These collaborations are expected to enhance Sol-Gel's financial position without dilution, while the products await FDA approval.
Sol-Gel Technologies, a clinical-stage dermatology firm, will present a company overview at two upcoming virtual investor conferences. The first is the Jefferies Healthcare Conference, scheduled for June 1, 2021, where CEO Dr. Alon Seri-Levy will speak at 8:30 am EDT. The second is the Raymond James Human Health Innovation Conference on June 22, 2021, at 10:00 am EDT. The company focuses on developing topical treatments for skin diseases, with NDA submissions for two products pending FDA review. Recordings of the presentations will be available on their website.
Sol-Gel Technologies (NASDAQ: SLGL) announced its Q1 2021 financial results, reporting revenue of $0.7 million and a loss of $4.1 million, down from a $7.1 million loss in Q1 2020. The company is in advanced negotiations for the commercialization of EPSOLAY® and TWYNEO® with PDUFA goal dates of April 26, 2021, and August 1, 2021, respectively. R&D expenses decreased to $2.5 million, primarily due to reduced clinical trial costs. Sol-Gel has $34.2 million in cash and equivalents expected to sustain operations into Q3 2022.
Sol-Gel Technologies (NASDAQ: SLGL) has provided an update on its EPSOLAY® (benzoyl peroxide) 5% topical cream, aimed at treating inflammatory lesions of rosacea. Initially scheduled for FDA action by April 26, 2021, the process has been delayed due to the COVID-19 pandemic impacting pre-approval inspections. The FDA confirmed that it could not proceed with the NDA until an inspection is conducted. Sol-Gel is actively following up with the FDA to schedule this inspection, as it remains crucial for the product's approval.
Sol-Gel Technologies (NASDAQ: SLGL) reported FY 2020 revenue of $8.8 million, driven largely by collaborations with Perrigo. The company achieved significant milestones, with FDA accepting NDAs for Epsolay and Twyneo, scheduled for PDUFA dates of April 26 and August 1, 2021, respectively. However, Sol-Gel incurred a net loss of $29.3 million, worsening from $24.6 million in 2019. Cash and securities totaled $50.2 million, expected to fund operations through Q3 2022. Operational plans include partnering for commercialization to enhance market capture.
Sol-Gel Technologies (NASDAQ: SLGL), a dermatology-focused clinical-stage company, announced its participation in upcoming virtual investor conferences. CEO Dr. Alon Seri-Levy will speak at the Raymond James Institutional Investors Conference on March 1, 2021, at 8:20 AM ET, while CFO Gilad Mamlok will present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. A replay of the H.C. Wainwright presentation will be available on the company’s website for 30 days. The company continues to advance its pipeline of topical treatments for skin diseases.
Sol-Gel Technologies (NASDAQ: SLGL), a clinical-stage dermatology firm, announced its participation in two upcoming virtual investor conferences. Dr. Alon Seri-Levy, CEO, will present at the Solebury Trout 2021 Virtual Investor Conference from January 11-15, 2020, with on-demand access available. Additionally, CFO Gilad Mamlok will speak at the H.C. Wainwright BioConnect 2021 Virtual Conference from January 11-14, 2020, accessible to participants. Sol-Gel is focused on developing topical drugs for skin diseases, including treatments for acne and rosacea.
Sol-Gel Technologies (NASDAQ: SLGL) reported third-quarter 2020 revenues of $2.1 million, driven by generic product sales, with expectations of a revenue decrease due to increased competition. The FDA has accepted the New Drug Application (NDA) for Epsolay, targeting rosacea, with a PDUFA goal date of April 26, 2021. Additionally, an NDA for Twyneo has been submitted for acne treatment. The company reported a net loss of $8.6 million and has $57.3 million in cash and marketable securities, sufficient to fund operations through the third quarter of 2021.
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