Reviva Announces Q2 2024 Financial Results and Business Highlights

Reviva Pharmaceuticals Holdings, Inc., a pharmaceutical company focused on developing treatments for central nervous system, inflammatory, and cardiometabolic diseases, announced its second-quarter financial results for 2024 and highlighted significant business developments.

Reviva's CEO, Dr. Laxminarayan Bhat, expressed satisfaction with the progress of their late-stage brilaroxazine program. The company anticipates topline data from a one-year open-label extension (OLE) trial evaluating the long-term safety and tolerability of brilaroxazine in schizophrenia patients by the fourth quarter of 2024. Dr. Bhat also mentioned the expansion of their intellectual property to cover large markets for pulmonary hypertension (PH) and idiopathic pulmonary fibrosis (IPF), both conditions influenced by serotonin signaling disruptions. Brilaroxazine has demonstrated a favorable safety and efficacy profile in over 800 schizophrenia patients treated in trials, offering therapeutic potential across multiple indications.

Significant corporate highlights include the recent granting of U.S. Patent 12053477 by the USPTO, covering the use of brilaroxazine for IPF treatment, adding to existing patent protections in key global markets such as Japan. Additionally, brilaroxazine received Orphan Drug Designation from the U.S. FDA for IPF treatment in August 2024. The European Patent Office (EPO) granted European Patent EP3244896, which covers brilaroxazine use for treating PH and pulmonary arterial hypertension (PAH) in all patients, including those with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD). Furthermore, the U.S. FDA granted Orphan Drug Designation to brilaroxazine for PAH treatment in July 2024.

The ongoing one-year OLE study is progressing as expected across the USA, Europe (Bulgaria), and Asia (India). As of August 2024, 424 patients have enrolled, with 230 currently undergoing treatment. Sixty-five patients have completed 12 months of treatment, and 53 have completed nine months, while around 200 patients have reached six months. Long-term safety data from 100 patients who complete 12 months of treatment is necessary for the New Drug Application (NDA) submission to the FDA. Reviva expects to complete this long-term safety study by Q4 2024.

The company has also aligned with the FDA on the registrational Phase 3 program for brilaroxazine in treating schizophrenia. The FDA accepted a 4-week RECOVER-2 study, indicating that two positive Phase 3 studies showing efficacy at week four, combined with long-term safety data of at least 12 months, could support an NDA submission for the acute treatment of schizophrenia. Reviva also plans a long-term randomized withdrawal study post-approval to support the maintenance of effect.

Earlier in 2024, Reviva presented successful RECOVER Phase 3 clinical trial data at the Schizophrenia International Research Society (SIRS) Annual Meeting. The trial met all primary and secondary endpoints, showing statistically significant and clinically meaningful reductions in major symptom domains. 

Upcoming milestones for Reviva include the initiation of the registrational Phase 3 RECOVER-2 trial for schizophrenia in Q3 2024, with topline data expected by Q4 2025. The potential NDA submission for brilaroxazine in schizophrenia is targeted for Q1 2026. Reviva also plans to submit an investigational new drug application (IND) for a liposomal-gel formulation of brilaroxazine for psoriasis in 2025 and seeks partnership opportunities for pipeline development.

Financially, Reviva reported a net loss of approximately $7.9 million, or $0.26 per share, for the three months ended June 30, 2024, compared to a net loss of $11.7 million, or $0.52 per share, for the same period in 2023. For the first half of 2024, the net loss was approximately $15.3 million, or $0.51 per share, compared to $18.6 million, or $0.84 per share, for the same period in 2023. As of June 30, 2024, the company’s cash totaled approximately $6.2 million, down from $23.4 million as of December 31, 2023.

Brilaroxazine, a new chemical entity discovered in-house, has shown potent affinity and selectivity against serotonin and dopamine receptors implicated in conditions like schizophrenia, psoriasis, and interstitial lung diseases, including PH and IPF. The drug has demonstrated promising activity in nonclinical models for inflammatory diseases and has received Orphan Drug Designations from the U.S. FDA for PAH and IPF.

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