VYNE Announces Q1 2024 Financial Results and Business Update

VYNE Therapeutics Inc., a clinical-stage biopharmaceutical company, recently shared its financial results for the quarter ending March 31, 2024, along with key updates on its current projects. The company focuses on creating innovative treatments for immuno-inflammatory conditions. 

David Domzalski, President and CEO of VYNE, highlighted significant milestones achieved in the first quarter, including the progress of the VYN201 program towards a Phase 2b trial. Domzalski noted that clinical trial sites are being rapidly activated, with the first subject expected to be dosed in the current quarter. Additionally, the company received IND clearance for the VYN202 program, with plans to dose the first healthy volunteers in a Phase 1a trial within this quarter.

The upcoming Phase 2b trial for VYN201 is designed to include approximately 160 subjects with either active or stable nonsegmental vitiligo. The trial will evaluate the efficacy, safety, and pharmacokinetics of VYN201 gel in three concentrations (1%, 2%, and 3%) compared to a vehicle over a 24-week period. Participants will be randomized into four groups, with around 40 subjects in each group. After the initial 24 weeks, those in the vehicle group will be re-randomized to receive one of the VYN201 gel concentrations for an additional 28 weeks. Top-line results from this trial are anticipated by mid-2025.

For VYN202, an oral small molecule BD2-selective BET inhibitor, the U.S. Food and Drug Administration has cleared the Investigational New Drug application. The company plans to start dosing healthy volunteers in a Phase 1a trial, which includes both single ascending dose and multiple ascending dose evaluations, this quarter. Results from this trial are expected in the latter half of the year. Depending on the success of Phase 1a, VYNE intends to initiate Phase 1b trials in patients with moderate-to-severe plaque psoriasis and moderate-to-severe adult-onset rheumatoid arthritis, with results expected in the second half of 2025.

In addition to clinical updates, VYNE also provided details on its financial standing as of March 31, 2024. The company reported cash, cash equivalents, restricted cash, and marketable securities totaling $86.0 million. This financial reserve is expected to sustain operations through the end of 2025. Revenue for the quarter was $0.1 million, similar to the same period in the previous year, derived from royalty agreements with LEO Pharma for Finacea foam.

Research and development expenses saw a notable increase, rising to $3.7 million from $2.7 million in the first quarter of 2023. This increase was primarily due to preparatory activities for the upcoming trials of VYN202 and VYN201. General and administrative expenses also climbed to $3.8 million from $3.2 million, driven by higher consulting and professional fees, as well as employee-related expenses.

The company reported a net loss of $6.2 million for the first quarter of 2024, compared to a net loss of $5.6 million for the same period in the previous year. The net loss per share was $0.15, down significantly from $1.74 in the first quarter of 2023. 

VYNE’s proprietary BET domain inhibitors, central to its InhiBET™ platform, include VYN201 and VYN202. VYN201 is a locally administered pan-BD BET inhibitor, while VYN202 is an orally available BD2-selective BET inhibitor.

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