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Dec 30, 2024
Reviva Q4 2024 Earnings Report
Reviva reported its full year 2024 financial results and provided business highlights.
Key Takeaways
Reviva Pharmaceuticals Holdings, Inc. reported a net loss of approximately $29.9 million for the fiscal year ended December 31, 2024, an improvement from the $39.3 million net loss in the prior year. The company highlighted positive preliminary topline data from its Phase 3 RECOVER study's open-label extension, showing sustained broad-spectrum efficacy and a well-tolerated safety profile for brilaroxazine.
Favorable long-term safety and robust broad-spectrum efficacy were sustained over 1-year for once-daily brilaroxazine in the open-label extension (OLE) trial.
The company reported a net loss of approximately $29.9 million, or $0.90 per share, for the fiscal year ended December 31, 2024.
Cash and cash equivalents totaled approximately $13.5 million as of December 31, 2024.
Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine is expected mid-2025.
Reviva
Reviva
Forward Guidance
Reviva anticipates initiating the registrational Phase 3 RECOVER-2 trial for brilaroxazine in mid-2025, with a potential NDA submission targeted for the fourth quarter of 2026. The company also expects to report the full data set from the RECOVER OLE study in Q2 2025.
Positive Outlook
- Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025.
- Potential New Drug Application (NDA) submission for brilaroxazine targeted for the fourth quarter of 2026.
- Full data analysis of the OLE trial, including vocal and blood biomarker data, expected in Q2 2025.
- Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected later in 2025.
- Pursue partnership opportunities for the development of our pipeline.
Challenges Ahead
- Initiation of registrational Phase 3 RECOVER-2 trial is subject to receipt of additional financing.
- No specific negative forward guidance was provided beyond the need for additional financing for the RECOVER-2 trial.