VYNE Therapeutics has a cash runway of around 16 months, with $50m in cash and no debt as of March 2025. The company's cash burn rate has increased 35% in the last year, which may shorten its cash runway. While VYNE Therapeutics has already begun generating revenue from operations, its revenue is not significant, and investors should be mindful of the company's increasing investment in the business.
Title: VYNE Therapeutics Faces Cash Runway Concerns After Phase 2b Vitiligo Trial Failure
VYNE Therapeutics (NASDAQ:VYNE), a clinical-stage biopharmaceutical company, has experienced a significant setback with the failure of its Phase 2b trial for repibresib gel in nonsegmental vitiligo. The trial, which evaluated the effectiveness of repibresib gel in treating vitiligo, failed to meet its primary and key secondary endpoints [1]. This failure has raised concerns about the company's cash runway and financial health, given its increased cash burn rate and limited revenue generation.
The Phase 2b trial, which enrolled 177 subjects across 45 sites in North America, tested three different concentrations of repibresib gel (1%, 2%, and 3%) against a vehicle control. The trial did not achieve the primary endpoint of F-VASI50, which measures the proportion of patients achieving at least a 50% improvement in facial vitiligo using the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to vehicle. Additionally, the trial missed the key secondary endpoint of F-VASI75 [1].
Despite the overall failure, the company highlighted that nominally statistically significant effects were seen in certain secondary and exploratory outcomes at the highest tested dose (3%). This included a 43.6% improvement in F-VASI scores from baseline compared to 25.6% for the vehicle, and a 28.3% improvement in T-VASI versus 16.2% in the vehicle group [1]. VYNE attributed the underwhelming results to “an unusually high vehicle effect” and elevated dropout rates in the treatment arms [1].
The company announced it will terminate the extension phase of the trial and seek an external partner for continued development of repibresib. As of June 30, 2025, VYNE reported having approximately $39.6 million in cash, cash equivalents, and investments on hand [1]. However, the company's cash burn rate has increased by 35% in the last year, which may shorten its cash runway [2].
While VYNE Therapeutics has already begun generating revenue from operations, its revenue is not significant. The company's financial performance reflects its development-stage status, with revenue of just $0.6 million in the last twelve months and an EBITDA of -$45.44 million [2]. This increased investment in the business and the failure of the repibresib trial have raised questions about the company's financial sustainability.
Investors should be mindful of VYNE Therapeutics' increasing cash burn rate and the potential impact on its cash runway. The company's current ratio of 4.47 indicates a healthy liquidity position, but the failure to meet trial endpoints and the need to seek external partners for further development may pose additional financial challenges [2].
References
[1] https://in.investing.com/news/stock-market-news/vyne-therapeutics-stock-falls-after-vitiligo-trial-fails-to-meet-endpoints-93CH-4934414
[2] https://stockanalysis.com/stocks/vyne/revenue/
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