Reviva Announces Q1 2024 Financial Results and Business Highlights

Reviva Pharmaceuticals Holdings, Inc., a Cupertino-based late-stage pharmaceutical firm, reported its financial results for the first quarter ending March 31, 2024, and shared recent business accomplishments focused on the central nervous system (CNS), inflammatory, and cardiometabolic diseases.

In the first quarter of 2024, Reviva made significant advancements in its brilaroxazine program for schizophrenia. The company reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the clinical trials required for a New Drug Application (NDA) submission, which it plans to submit by the fourth quarter of 2025. Additionally, the company expects to begin a pivotal RECOVER-2 trial in the second quarter of 2024 and anticipates topline data from a 1-year open-label extension (OLE) trial by the end of the same year.

Dr. Laxminarayan Bhat, Founder, President, and CEO of Reviva, expressed optimism about the progress and future milestones. He highlighted the anticipated catalysts for 2024, including the initiation of the RECOVER-2 trial and the collection of long-term safety and efficacy data from the OLE trial. This period is seen as transformative for Reviva, with a primary focus on bringing brilaroxazine to a broader patient base globally.

Key corporate activities included hosting a webinar featuring key opinion leaders (KOL) who discussed the topline results from the RECOVER-1 Phase 3 trial and the current treatment landscape for schizophrenia. Presenters included Larry Ereshefsky of Follow the Molecule and Mark Opler of WCG.

The company announced its alignment with the FDA regarding the Phase 3 program for brilaroxazine in schizophrenia. The FDA has accepted a 4-week RECOVER-2 study and indicated that two positive Phase 3 studies demonstrating efficacy at week 4, along with long-term safety data of at least 12 months, could support an NDA submission for the acute treatment of schizophrenia. Additionally, a long-term randomized withdrawal study post-approval is required to support the maintenance of effect.

Reviva presented successful Phase 3 trial data for brilaroxazine at the Schizophrenia International Research Society (SIRS) Annual Meeting and the American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting in 2024.

Anticipated future milestones include:
- Initiation of the Phase 3 RECOVER-2 trial in Q2 2024
- Topline data from the 1-year OLE trial in Q4 2024
- Topline data from the Phase 3 RECOVER-2 trial in Q3 2025
- Potential NDA submission for brilaroxazine by Q4 2025

Moreover, the company plans to initiate Phase 2a studies for other disorders such as bipolar disorder, major depressive disorder, and attention deficit hyperactivity disorder in 2024. An investigational new drug application (IND) for a liposomal-gel formulation of brilaroxazine targeting psoriasis is slated for 2025. Reviva is also seeking partnership opportunities and evaluating grant and non-dilutive financing options for its product candidates from various healthcare agencies and foundations.

Financially, Reviva reported a net loss of approximately $7.4 million, or $0.25 per share, for the quarter ending March 31, 2024, compared to a net loss of $6.9 million, or $0.31 per share, for the same period in 2023. The company's cash reserves totaled $12.0 million as of March 31, 2024, down from $23.4 million at the end of 2023.

Brilaroxazine, a new chemical entity discovered by Reviva, exhibits potent affinity and selectivity for key serotonin and dopamine receptors implicated in schizophrenia. Positive topline data from the global Phase 3 RECOVER-1 trial showed that the drug met all primary and secondary endpoints, with significant reductions in major symptom domains at week 4 compared to placebo. Brilaroxazine was generally well-tolerated, with fewer side effects and lower discontinuation rates than placebo. The drug also showed no significant interaction when combined with a CYP3A4 inhibitor in a drug-drug interaction study.

Reviva is developing brilaroxazine for additional neuropsychiatric indications, including bipolar disorder, major depressive disorder, and attention-deficit/hyperactivity disorder. The drug has also demonstrated promising nonclinical activity for inflammatory diseases such as psoriasis, pulmonary arterial hypertension (PAH), and idiopathic pulmonary fibrosis (IPF). Brilaroxazine has received Orphan Drug Designation from the FDA for the treatment of PAH and IPF.