Sol-Gel Announces Q1 2024 Financial Results and Corporate Updates

Sol-Gel Technologies, a leading dermatology company based in Israel, has released its financial results for the first quarter ending March 31, 2024, and provided significant corporate updates. The company is advancing in the field of dermatology with a strong focus on innovative treatments for severe skin conditions.

Sol-Gel is currently engaged in a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome. This trial marks an important milestone as it involves the first patient screened, and the study is ongoing. The company acquired patidegib, a topical hedgehog signaling pathway blocker, from PellePharm Inc. This drug is intended to prevent the development of new basal cell carcinoma (BCC) lesions in patients with Gorlin syndrome, a genetic disorder that leads to the formation of multiple BCCs. The trial will include approximately 140 subjects across 40 clinical centers in North America, the United Kingdom, and Europe.

Additionally, Sol-Gel has entered into an Asset Purchase Agreement with Beimei Pharma for the commercialization and manufacturing of TWYNEO® in China, Hong Kong, Macau, Taiwan, and Israel. This deal is valued at up to $15 million, with $10 million allocated for upfront and regulatory milestones and $5 million for royalties on net sales, pending government approvals.

In the realm of clinical research, Sol-Gel has initiated a proof-of-concept study for SGT-210 (topical erlotinib) targeting patients with Darier disease, a rare genetic disorder. SGT-210 is also being used in a compassionate use treatment for a pediatric patient with an ultra-rare disease, showing highly encouraging clinical responses. These promising results have spurred the company to explore additional commercially viable indications for keratoderma.

Furthermore, Sol-Gel's partner Padagis has submitted a First-to-File Abbreviated New Drug Application (ANDA) for a generic version of Zoryve® Cream (roflumilast cream 0.3%), used for the treatment of plaque psoriasis. If approved by the FDA, Padagis could secure 180 days of market exclusivity. However, Arcutis Biotherapeutics Inc. has initiated a patent infringement action in New Jersey regarding this ANDA.

Financially, Sol-Gel reported a net loss of $6.3 million for the first quarter of 2024, a significant improvement from the $10.7 million loss during the same period in 2023. The company's revenue for Q1 2024 was $0.5 million, mostly from licensing Galderma and Searchlight. Research and development expenses decreased to $5.3 million from $9.4 million in Q1 2023, and general and administrative expenses also saw a reduction. As of March 31, 2024, Sol-Gel held $16.2 million in cash and equivalents and $16.8 million in marketable securities, totaling $33.0 million in assets. The company anticipates that its cash resources will support operations into the second half of 2025.

Sol-Gel's CEO, Dr. Alon Seri-Levy, emphasized the company's focus on rare skin conditions without approved treatments. He highlighted the ongoing pivotal Phase 3 trial of SGT-610 and the proof-of-concept study for SGT-210 as critical to their mission. Dr. Seri-Levy also noted the potential market for SGT-610, estimated at over $300 million, and expressed optimism about future agreements for the commercialization of TWYNEO and EPSOLAY in additional territories.

In summary, Sol-Gel Technologies is making significant strides in dermatological treatments, particularly for rare conditions. With ongoing clinical trials, strategic partnerships, and solid financial management, the company is well-positioned to advance its innovative therapeutic solutions and broaden its market reach.