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Sep 30, 2023
Reviva Q3 2023 Earnings Report
Reviva reported results for the third quarter of 2023, highlighting the successful Phase 3 RECOVER trial for brilaroxazine in schizophrenia.
Key Takeaways
Reviva Pharmaceuticals announced positive topline results for its Phase 3 RECOVER trial, with brilaroxazine demonstrating statistically significant and clinically meaningful reductions in schizophrenia symptoms. The company reported a net loss of $10.5 million for the third quarter of 2023 and has $5.0 million in cash reserves.
Phase 3 RECOVER trial met all primary and secondary endpoints with statistically significant and clinically meaningful reductions in schizophrenia symptoms at week 4 using 50 mg of brilaroxazine compared to placebo.
Consistent efficacy and safety findings observed across Phase 2 REFRESH and Phase 3 RECOVER trials, reinforcing brilaroxazine's competitive profile.
Topline data from the 1-year open-label extension (OLE) trial is expected in Q4 2024.
A registrational Phase 3 RECOVER-2 trial is expected to start in Q1 2024, supporting a planned NDA submission to the FDA in 2025.
Reviva
Reviva
Forward Guidance
Reviva anticipates several milestones, including topline data from the 1-year OLE trial in Q4 2024 and initiation of a Phase 3 RECOVER-2 trial in Q1 2024. They also plan to explore studies in bipolar disorder, MDD, and ADHD, and pursue partnerships and non-dilutive financing.
Positive Outlook
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024
- Initiation of a registrational Phase 3 RECOVER-2 trial expected Q1 2024
- May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024
- Submit investigational new drug application (IND) for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2024
- Pursue partnership opportunities for the development of our pipeline
Challenges Ahead
- Evaluate grant and other non-dilutive financing opportunities for our product candidates from Federal and State Healthcare Agencies and Foundations
- Reliance on successful clinical trials for product development.
- Dependence on regulatory approvals for commercialization.
- Potential challenges in securing partnerships for pipeline development.
- Risks associated with raising sufficient funding for operations.