Reviva Reports Full Year 2025 Financial Results and Recent Business Highlights

Core Insights - Reviva Pharmaceuticals is advancing its brilaroxazine program for schizophrenia, with plans for a second Phase 3 trial (RECOVER-2) to gather additional efficacy and safety data before submitting a New Drug Application (NDA) [1][2] Clinical Development and Regulatory - The FDA has provided clear guidance, recommending a second Phase 3 trial to enhance the data package for brilaroxazine [2][3] - Brilaroxazine has shown broad-spectrum efficacy in major symptom domains of schizophrenia, including negative symptoms and anxiety/depression, with a well-tolerated safety profile observed in over 900 subjects [3] - The Phase 3 RECOVER open-label extension study demonstrated robust efficacy sustained over one year, with significant improvements in PANSS total score and other clinical measures [3] - Only less than 1% of patients reported symptom relapse during the one-year treatment period, and no clinically meaningful changes in movement disorder scales were observed [3][7] Financial Results - For the fiscal year ended December 31, 2025, the company reported a net loss of approximately $19.9 million, or $5.48 per share, an improvement from a net loss of approximately $29.9 million, or $17.73 per share, in 2024 [6][16] - The company’s cash and cash equivalents increased to approximately $14.4 million as of December 31, 2025, compared to $13.5 million in 2024 [8][14] Financing - Reviva completed several public equity offerings, raising gross proceeds of $10.0 million in March 2026, $9.0 million in September 2025, and $10.0 million in June 2025 [7] - The company plans to use the net proceeds from the March 2026 offering to fund the RECOVER-2 Phase 3 trial and for general corporate purposes [7] Anticipated Milestones and Events - The RECOVER-2 trial is expected to initiate in mid-2026, with trial-related activities starting in Q2-2026 and patient enrollment planned for Q3-2026 [7] - Additional publications on brilaroxazine for schizophrenia treatment are anticipated in 2026 [7]