Reviva Reports Q2 2025 Financial Results, Sustained Safety and Efficacy in Schizophrenia Trials.

• Reviva Pharmaceuticals reports Q2 2025 financial results • Sustained efficacy and safety in schizophrenia treatment • Completed Phase 2, Phase 3 trials, and 1-year OLE trial • Plans FDA meeting to discuss approval path for brilaroxazine • Potential NDA submission targeted for Q2 2026

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) reported its financial results for the second quarter ended June 30, 2025, and highlighted significant progress in its schizophrenia treatment program. The company reported a net loss of approximately $6.1 million, or $0.12 per share, compared to a net loss of $7.9 million, or $0.26 per share, in the same period last year [1].

Key highlights from the financial report include:

- Cash and Cash Equivalents: As of June 30, 2025, Reviva's cash and cash equivalents totaled approximately $10.4 million, compared to $13.5 million as of December 31, 2024.
- Operating Expenses: Total operating expenses for the quarter were $8.1 million, compared to $12.6 million in the same period last year, reflecting a decrease of $4.5 million.

The company also announced substantial progress in its clinical programs. Reviva's drug candidate, brilaroxazine (RP5063), demonstrated sustained efficacy and safety in a Phase 3 RECOVER open-label extension (OLE) 1-year study. The study showed robust broad-spectrum efficacy, including reductions in PANSS total score (–18.1), positive symptoms (–5.0), negative symptoms (–4.4), and negative Marder factor (–4.4). The drug was generally well-tolerated with a discontinuation rate of 35% after 1 year [1].

Reviva has completed two large randomized double-blind clinical trials, including one Phase 2 and one Phase 3 trial, and a 1-year OLE trial. The company is preparing for an End-of-Phase 3 meeting with the FDA in Q4 2025 to discuss the future New Drug Application (NDA) submission for brilaroxazine. The potential NDA submission is targeted for Q2 2026, pending favorable feedback from the FDA [1].

In addition, Reviva has plans to initiate a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia, pending FDA recommendation for a path to approval. The company also anticipates submitting an Investigational New Drug (IND) application for a liposomal-gel formulation of brilaroxazine in psoriasis by Q2 2026 [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/14/3133909/0/en/Reviva-Reports-Second-Quarter-2025-Financial-Results-and-Recent-Business-Highlights.html