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Mar 31
VYNE Q1 2025 Earnings Report
VYNE Therapeutics reported its first quarter 2025 financial results, showing a net loss of $8.6 million and a decrease in total assets.
Key Takeaways
VYNE Therapeutics reported a net loss of $8.6 million for the first quarter of 2025, with total revenues of $0.2 million. The company continued to progress its Phase 2b trial for repibresib gel in vitiligo, with top-line results expected mid-2025, and anticipates a cash runway into the second half of 2026. However, its Phase 1b psoriasis trial for VYN202 was placed on clinical hold due to testicular toxicity observed in a non-clinical toxicology study.
Net loss for Q1 2025 was $8.6 million, compared to $6.2 million in Q1 2024.
Total revenues for Q1 2025 were $0.2 million, primarily from royalty revenue.
Cash, cash equivalents, and marketable securities totaled $50.3 million as of March 31, 2025, with an expected cash runway into 2H 2026.
The Phase 1b psoriasis trial for VYN202 was placed on clinical hold due to testicular toxicity observed in a non-clinical toxicology study.
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VYNE Revenue by Segment
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CapyFin.com Forward Guidance
VYNE Therapeutics expects top-line results from its Phase 2b trial for repibresib gel in vitiligo in mid-2025 and anticipates its cash runway to extend into the second half of 2026. The company is actively working with the FDA to resolve the clinical hold on its Phase 1b psoriasis trial for VYN202.
Positive Outlook
- Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025.
- Expected cash runway into 2H 2026.
- Repibresib is a distinct compound from VYN202 with no testicular toxicity observed in non-clinical studies.
- Vitiligo remains an area of significant unmet need, positioning repibresib as a potential differentiated therapy.
- Company is diligently working with the FDA to resolve the clinical hold on VYN202.
Challenges Ahead
- Phase 1b psoriasis trial for VYN202 placed on clinical hold by the FDA.
- Clinical hold on VYN202 due to observation of testicular toxicity in a non-clinical toxicology study.
- Suspension of all screening, enrollment, and patient dosing in the VYN202 Phase 1b trial.
- Uncertainty regarding the timeline for resolving the clinical hold on VYN202.
- No serious adverse events observed in subjects enrolled in the VYN202 Phase 1b trial to date, but the hold still impacts progress.