Sol-Gel Financial Results and Corporate Updates
- Following recent transactions and the implementation of cost-control measures, Sol-Gel expects its cash runway to last until the first quarter of 2026.
- The ongoing Phase 3 clinical trial for SGT-610, which targets Gorlin Syndrome, has activated over 30 clinical sites, with top-line results anticipated by mid-2026.
- Sol-Gel is actively working on a proof-of-concept study for SGT-210, aimed at addressing a significant unmet need in the dermatological treatment of Darier disease.
- Recently, Sol-Gel sold its rights to the Abbreviated New Drug Application (ANDA) for a generic version of Zoryve Cream (roflumilast cream 0.3%).
- After a management restructuring, executive chairman Mori Arkin will assume the role of interim CEO starting January 1, 2025, pending shareholder approval.
- Sol-Gel has entered into licensing agreements for TWYNEO and EPSOLAY in Europe and South Africa, while negotiations continue for additional licenses in Latin America and other regions.
NESS ZIONA, Israel — Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a biotechnology company focused on developing innovative treatments for severe skin disorders, has announced its financial results for the second quarter ending June 30, 2024, along with important updates regarding corporate activities and clinical trials.
Recent Developments in Q2 2024
- On August 15, 2024, Sol-Gel signed a new agreement with Padagis that updates the previous collaboration for developing and marketing a generic version of Zoryve Cream. This agreement will provide Sol-Gel with unconditional quarterly payments over the next 24 months and low single-digit royalties from future gross profits over five years. This is expected to improve Sol-Gel's financial position by approximately $6 million.
- Recognizing the significant commercial potential of TWYNEO and EPSOLAY beyond the U.S. market, Sol-Gel has established six initial license agreements in several European countries, including South Africa. The company anticipates further agreements that could yield up to $3.7 million in upfront and regulatory milestone payments, which are intended to align these products with regulations in new territories, with product launches expected in 2026 and 2027.
- In the Phase 3 clinical study for SGT-610, which is now being conducted across 42 clinical sites, 140 subjects are set to participate, with initial results expected in Q2 of 2026. If successful, SGT-610 could become 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 proof-of-concept study for SGT-210 (topical erlotinib) for patients with Darier disease is currently in progress. Darier disease presents significant unmet healthcare needs, and this market is estimated at $200 to $300 million. If the study is successful, Sol-Gel plans to file for a Phase 2 Investigational New Drug application in Q2 2025.
- Pending shareholder approval, Mr. Mori Arkin is set to take over as interim CEO from Dr. Alon Seri-Levy starting January 1, 2025. Mr. Arkin, who has extensive experience in the pharmaceutical industry, aims to fulfill his responsibilities in this role without seeking additional compensation.
- As of July 12, 2024, Mr. Eyal Ben-Or, who previously served as the Director of Finance, has been appointed Chief Financial Officer. With prior experience at Mobileye and KPMG Israel, Mr. Ben-Or brings valuable expertise to the position. He will collaborate closely with the outgoing CFO, Mr. Gilad Mamlok, until the transition is completed at the end of the year.
Financial Performance for Q2 2024
In the second quarter, Sol-Gel reported total revenues of $5.4 million, primarily driven by licensing agreements with Beimei, Galderma, and Searchlight. This marks a significant increase from $0.6 million in Q2 2023. Research and development expenses totaled $2.4 million, down from $5.3 million the previous year, indicating progress in operational efficiencies.
Overall, general and administrative expenses decreased to $1.4 million from $1.8 million during the same period last year, reflecting a continued commitment to cost management. The company achieved a net income of $1.9 million, resulting in earnings of $0.07 per share, a notable improvement compared to last year's loss of $6.0 million.
As of June 30, 2024, Sol-Gel held $15.6 million in cash, cash equivalents, and deposits, along with $14.9 million in marketable securities, bringing the total resource balance to $30.5 million, which is expected to support operations into the first quarter of 2026.
About TWYNEO and EPSOLAY
TWYNEO is a groundbreaking acne treatment, being the first topical formulation that combines a fixed dose of tretinoin and benzoyl peroxide. This innovation is significant because these ingredients often lose effectiveness when mixed. EPSOLAY provides a unique approach to treating inflammatory lesions of rosacea, utilizing patented technology for the gradual release of benzoyl peroxide to ensure both tolerability and effectiveness.
Understanding Gorlin Syndrome and SGT-610
SGT-610 is poised to become the first preventive treatment for BCCs in individuals with Gorlin syndrome, a genetic disorder that increases the risk of various tumors. Approximately 1 in 27,000 to 31,000 individuals in the U.S. are affected. The drug works by inhibiting the pathway that triggers tumor cell proliferation, thereby improving the patient's cellular regulation.
Insights on Darier Disease and SGT-210
Darier disease is a rare genetic condition characterized by disruptive skin features. SGT-210 targets this condition through an advanced formulation of erlotinib that not only addresses Darier disease but could also have applications in other hyperkeratosis-related disorders.
About Sol-Gel Technologies
Sol-Gel Technologies, Ltd. is committed to developing pioneering treatments for dermatological conditions through innovative drug development and strategic partnerships. The company’s current portfolio includes two FDA-approved products and features promising candidates aimed at addressing significant 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 increase 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 set to become interim CEO, succeeding Dr. Alon Seri-Levy, while Mr. Eyal Ben-Or will take 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 way that prevents these ingredients from degrading, thereby enhancing their individual effectiveness against acne.
