Sol-Gel Technologies Reveals Financial Results and Developments
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Sol-Gel Financial Results and Corporate Updates
- After executing recent transactions and implementing cost-control strategies, Sol-Gel anticipates its cash runway to extend through the first quarter of 2026.
- The ongoing Phase 3 clinical trial for SGT-610 focused on Gorlin Syndrome has over 30 clinical sites active, with top-line results expected by mid-2026.
- Sol-Gel is actively pursuing a proof-of-concept study for SGT-210, targeting a notable unmet need in dermatological treatment of Darier disease.
- Recently, Sol-Gel divested its rights to the Abbreviated New Drug Application (ANDA) for a generic version of Zoryve Cream (roflumilast cream 0.3%).
- Following a management restructuring, executive chairman Mori Arkin will take on the role of interim CEO starting January 1, 2025, pending shareholder approval.
- Sol-Gel has entered into licensing agreements concerning TWYNEO and EPSOLAY in Europe and South Africa, with ongoing negotiations for additional licenses in Latin America and other regions.
NESS ZIONA, Israel — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a biotechnology firm dedicated to developing innovative solutions for severe skin disorders, has released its financial results for the second quarter ending June 30, 2024, alongside key updates regarding corporate activities and clinical trials.
Recent Developments in Q2 2024
- The new agreement signed on August 15, 2024, with Padagis updates the previous collaborative contract for developing and marketing a generic version of Zoryve Cream. Under this agreement, Sol-Gel will receive unconditional quarterly payments over the next 24 months along with low single-digit royalties from future gross profits over five years. This change is projected to enhance Sol-Gel's financial standing by around $6 million.
- Recognizing the significant commercial potential of TWYNEO and EPSOLAY beyond the U.S. market, six initial license agreements have been established for several European countries, including South Africa. Sol-Gel anticipates additional agreements that could provide up to $3.7 million in upfront and regulatory milestone payments, earmarked for aligning these products with the respective regulations in new territories, with product launches expected in 2026 and 2027.
- In the Phase 3 clinical study for SGT-610, now conducted across 42 clinical sites, 140 subjects are set to participate, with initial results due in Q2 of 2026. If successful, SGT-610 could be the first approved treatment for preventing basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, targeting a market opportunity exceeding $300 million annually.
- The phase of proof-of-concept study for SGT-210 (topical erlotinib) for patients with Darier disease is currently underway. Darier disease presents significant unmet healthcare needs, and this market is projected at $200 to $300 million. Should the study prove successful, Sol-Gel plans to file for a Phase 2 Investigational New Drug application in Q2 2025.
- Pending approval from shareholders, Mr. Mori Arkin is set to replace Dr. Alon Seri-Levy as interim CEO from January 1, 2025. Mr. Arkin, with considerable experience in the pharmaceutical domain, aims to focus on his responsibilities in this role without seeking additional remuneration.
- As of July 12, 2024, Mr. Eyal Ben-Or, formerly the Director of Finance, has been appointed Chief Financial Officer. With previous experience from Mobileye and KPMG Israel, Mr. Ben-Or brings a wealth of expertise to the role. He will work closely with the outgoing CFO, Mr. Gilad Mamlok, until the transition completes at year's end.
Financial Performance for Q2 2024
In the second quarter, Sol-Gel reported total revenues of $5.4 million, primarily from licensing agreements with Beimei, Galderma, and Searchlight, which shows a significant increase from $0.6 million in Q2 2023. In terms of research and development expenses, the total reached $2.4 million, down from $5.3 million the year prior, indicating progress in operational efficiencies.
In summary, general and administrative expenses decreased to $1.4 million from $1.8 million in the same period last year, reflecting ongoing commitment to cost management. Net income stood at $1.9 million, translating to earnings of $0.07 per share, a notable turnaround compared to last year's loss of $6.0 million.
As of June 30, 2024, Sol-Gel maintained $15.6 million in cash, cash equivalents, and deposits, in addition to $14.9 million in marketable securities, culminating in a total resource balance of $30.5 million, forecasted to support operations into the first quarter of 2026.
About TWYNEO and EPSOLAY
TWYNEO represents a breakthrough in acne treatment, being the first topical formulation combining a fixed-dose of tretinoin and benzoyl peroxide. This innovation is crucial since these components often degrade when mixed, leading to reduced effectiveness. EPSOLAY offers a unique solution for treating inflammatory lesions of rosacea, employing patented technology for gradual release of benzoyl peroxide to ensure tolerability and effectiveness.
Understanding Gorlin Syndrome and SGT-610
SGT-610 stands to become the first preventive treatment for BCCs in individuals with Gorlin syndrome, a genetic disorder that increases risk for various tumors. With around 1 in 27,000 to 31,000 individuals affected in the U.S., the drug works by inhibiting the pathway that triggers tumor cell proliferation, thereby enhancing the patient's cellular regulation.
Insights on Darier Disease and SGT-210
Darier disease is a rare genetic condition that manifests through disruptive skin characteristics. SGT-210 targets this condition through a refined formulation of erlotinib that not only addresses Darier disease but could potentially find application in other hyperkeratosis-related disorders.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is dedicated to pioneering treatments for dermatological conditions through innovative drug development and strategic partnerships. The Company’s current portfolio boasts two FDA-approved products and features promising candidates aiming to address substantial market opportunities.
For more information, please inquire with:
Contact Information
Sol-Gel Contact:
Eyal Ben-Or
Chief Financial Officer
info@sol-gel.com
+972-8-9313429
Frequently Asked Questions
1. What are Sol-Gel Technologies’ primary financial achievements in Q2 2024?
In Q2 2024, Sol-Gel reported a significant jump in revenue to $5.4 million and achieved a net income of $1.9 million.
2. What is SGT-610, and what indication is it being studied for?
SGT-610 is a topical gel being developed for the prevention of basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome.
3. What recent organizational changes took place at Sol-Gel?
Mori Arkin is slated to become interim CEO, succeeding Dr. Alon Seri-Levy, with Mr. Eyal Ben-Or taking over as CFO.
4. What is the status of Sol-Gel’s licensing agreements?
Sol-Gel has initiated multiple licensing agreements for its products like TWYNEO and EPSOLAY across Europe and South Africa, with plans for further agreements in other territories.
5. How does TWYNEO advance acne treatment?
TWYNEO combines tretinoin and benzoyl peroxide in a method that prevents these ingredients from degrading, thus enhancing their individual effectiveness against acne.
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