VYNE Therapeutics Announces Q3 2024 Financial Results and Business Update

BRIDGEWATER, N.J., Nov. 07, 2024 – VYNE Therapeutics Inc., a clinical-stage biopharmaceutical firm, has announced its financial results for the three and nine months ending on September 30, 2024. The company, which is dedicated to developing unique treatments for chronic inflammatory and immune-mediated conditions, also provided an update on its business operations.

David Domzalski, President and CEO of VYNE, expressed optimism about the company's progress, particularly highlighting the development of two clinical programs, VYN201 and VYN202. Domzalski emphasized the potential of these programs to offer new and effective therapies for immune-mediated diseases. The company has recently shared positive data from the Phase 1a single ascending dose (SAD) trial of VYN202, with more data expected by the end of 2024. Additionally, the ongoing Phase 2b trial for VYN201, aimed at treating nonsegmental vitiligo, has seen strong enrollment, reflecting the need for effective treatments in this area.

VYN201 is a locally-administered small molecule pan-BD BET inhibitor. The Phase 2b trial for this treatment, which began in June 2024, has surpassed its initial enrollment target. The trial is expected to be fully enrolled by December 2024, involving around 40 to 50 subjects per arm. This randomized, double-blind, vehicle-controlled trial assesses the efficacy, safety, and pharmacokinetics of a once-daily VYN201 gel in three different concentrations (1%, 2%, and 3%) compared to a vehicle over a 24-week period. Subjects are randomly assigned to one of these groups, and those in the active drug cohorts have the option to continue their treatment for an additional 28 weeks. Participants initially in the vehicle group will be re-randomized into one of the active dose cohorts for the extension period. Top-line results from this portion of the trial are expected in mid-2025.

VYN202, an oral small molecule BD2-selective inhibitor, has shown promising results in its Phase 1a trial. Data from the single ascending dose (SAD) portion, released in September 2024, indicated that VYN202 was generally well tolerated, with no adverse drug-related events. The trial demonstrated dose-dependent drug concentrations in the blood and a pharmacodynamic impact on key biomarkers associated with conditions like psoriasis and rheumatoid arthritis. VYNE aims to begin Phase 1b trials in adults with moderate-to-severe plaque psoriasis and moderately to severely active rheumatoid arthritis, with results anticipated in the second half of 2025.

Financially, VYNE reported a cash position of $70.2 million as of September 30, 2024, which is expected to support the company's operations through the end of 2025. As of that date, the company had 14,751,433 shares issued and outstanding, along with pre-funded warrants to purchase an additional 27,842,740 shares.

For the quarter ended September 30, 2024, VYNE generated revenues of $0.1 million, consistent with the same period in 2023. This revenue was derived from royalty agreements related to Finacea® foam. Research and development expenses saw a significant increase to $10.2 million, primarily due to costs associated with ongoing trials for VYN201 and VYN202. General and administrative expenses remained steady at approximately $3.0 million for the same periods in 2024 and 2023. Consequently, VYNE reported a net loss of $12.2 million for the quarter ended September 30, 2024, compared to a net loss of $6.6 million in the same period the previous year.

Overall, VYNE Therapeutics continues to advance its promising clinical programs, aiming to address significant unmet needs in the treatment of chronic inflammatory and immune-mediated conditions while maintaining a stable financial footing through its ongoing research and development efforts.