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Dec 31, 2023
Reviva Q4 2023 Earnings Report
Reviva reported its financial results for the full year 2023, highlighting the successful completion of the RECOVER-1 Phase 3 trial and progress towards NDA submission.
Key Takeaways
Reviva Pharmaceuticals reported a net loss of $39.3 million for the year ended December 31, 2023, compared to a net loss of $28.3 million for the previous year. The company's cash and cash equivalents totaled $23.4 million as of December 31, 2023, compared to $18.5 million as of December 31, 2022. The company is targeting a potential NDA submission in Q3 2025.
RECOVER-1 Phase 3 trial met all primary and secondary endpoints with statistically significant reductions across all major symptom domains in schizophrenia.
Initiation of registrational RECOVER-2 trial expected in the second quarter of 2024; topline data expected Q2 2025.
Topline data from 1-year open-label extension (OLE) trial expected Q4 2024.
Preparation is underway to support a New Drug Application (NDA) submission for brilaroxazine in schizophrenia targeted for Q3 2025.
Reviva
Reviva
Forward Guidance
Reviva anticipates several milestones including the initiation of the RECOVER-2 trial, topline data from the OLE trial and RECOVER-2 trial, and a potential NDA submission for brilaroxazine.
Positive Outlook
- Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in Q2 2024
- Topline data from 1-year open-label extension (OLE) trial expected Q4 2024
- Topline data from registrational Phase 3 RECOVER-2 trial expected Q2 2025
- Potential NDA submission for brilaroxazine in schizophrenia targeted for Q3 2025
- May initiate Phase 2a studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024
Challenges Ahead
- The company reported a net loss for the year ended December 31, 2023.
- Clinical trial expenses were understated in previously issued financial statements.
- Company must evaluate grant and other non-dilutive financing opportunities for our product candidates from Federal and State Healthcare Agencies and Foundations
- Company must pursue partnership opportunities for the development of our pipeline
- Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2025