Reviva Pharmaceuticals (RVPH 1.35%), a clinical-stage biotechnology company specializing in treatments for central nervous system and respiratory diseases, issued its second quarter results on August 14, 2025. The highlight of the release was the completion of key clinical studies for its lead drug candidate, brilaroxazine, marking a significant milestone on the path toward regulatory submission. The company reported a net loss of $6.1 million, or $(0.12) per share (GAAP), Revenue remained at zero, consistent with its precommercial status. Operating costs declined compared to the prior-year period. The period demonstrates progress in Reviva's clinical strategy, but its limited cash balance and continued need for external funding remain prominent.
| Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
|---|---|---|---|---|
| EPS (GAAP) | ($0.12) | ($0.12) | ($0.26) | N/A |
| Revenue (GAAP) | $0.0 | $0.0 | $0.0 | — |
| Net Loss | $6.1 million | $7.9 million | 22.8% | |
| Research & Development Expense | $3.7 million | $5.6 million | 33.9% | |
| Cash & Cash Equivalents (end of period) | $10.4 million | $13.5 million(as of Dec 31, 2024) | (23.1%)(vs. Dec 31, 2024) |
Source: Analyst estimates for the quarter provided by FactSet.
Company Overview and Business Focus
Reviva Pharmaceuticals is focused on developing novel therapies for central nervous system disorders, with a particular emphasis on schizophrenia and related conditions. Its lead candidate, brilaroxazine, is an oral drug under development for several psychiatric and respiratory diseases, such as schizophrenia, bipolar disorder, and pulmonary arterial hypertension.
Recently, its main effort has centered on moving brilaroxazine through advanced-stage clinical trials and preparing for regulatory submission. The company’s success relies on demonstrating the clinical benefits of brilaroxazine, securing patents to protect its innovations, and funding ongoing research. Other key factors are advancing a second drug candidate, RP1208, and forming commercialization partnerships.
Quarter Highlights: Financials and Clinical Developments
Reviva reported a GAAP net loss of $6.1 million, compared to $7.9 million in the prior-year period. Operating expenses (GAAP) dropped to $6.1 million, Research and development expenses (GAAP) decreased by 33.3% compared to the prior-year period. This reduction came as Reviva completed the major clinical work needed for its upcoming regulatory filing.
The company did not generate any revenue, which is typical for a biotechnology business before product launches. Meanwhile, the end-of-period cash balance (GAAP) was $10.4 million, down from $13.5 million as of December 31, 2024. This cash burn continues to indicate finite funding—less than two quarters of operational runway is likely at the current spend rate, based on cash and cash equivalents of approximately $10.4 million and a net loss of approximately $6.1 million—making future financing necessary for ongoing development work.
The most notable operational progress was the completion of all key clinical studies supporting a potential New Drug Application (NDA) for brilaroxazine in schizophrenia, pending FDA feedback on whether additional trials will be required. The company wrapped up its open-label extension (OLE) trial, which tracked patient outcomes over one year. In this study, the Positive and Negative Syndrome Scale (PANSS), a tool used to measure schizophrenia symptoms, showed improvements over one year in the open-label extension (OLE) trial: total score fell by 18.1 points, positive symptoms by 5.0, and negative symptoms by 4.4. The trial enrolled 446 patients and reported a 35% discontinuation rate after one year in the OLE trial of brilaroxazine for schizophrenia.
Reviva raised $10.0 million in gross proceeds through a public equity offering during Q2 2025. However, this resulted in increased dilution for shareholders, as shares outstanding rose to 68.0 million as of June 30, 2025, up from 46.6 million as of December 31, 2024. Total stockholders’ equity (GAAP) turned negative, at $(0.46) million as of Q2 2025, highlighting a balance sheet risk and the potential for future Nasdaq compliance issues.
Although the company continues to mention intellectual property initiatives and sees the potential for patent coverage extending to 2045 and beyond, it provided few specifics on new filings or exclusivity length in this period, though management restated its intent to seek commercial partners as the regulatory process advances. The pipeline expanded as well, with an investigational new drug (IND) application planned for a new formulation of brilaroxazine in psoriasis by mid-2026.
Looking Ahead: Financial Outlook and Key Events
Management did not offer any formal financial guidance for the year or forthcoming quarters. The expected end-of-Phase 3 meeting with the U.S. Food and Drug Administration is scheduled for the last quarter of 2025. If the outcome is positive, Reviva will target an NDA submission for brilaroxazine in Q2 2026. There remains a risk that the FDA may request additional late-stage clinical trials, which could delay regulatory submission further. The company affirmed its intent to use the current data package, excluding the planned Phase 3 RECOVER-2 trial, for its NDA submission, with a potential NDA targeted for Q2 2026, but acknowledged that the regulatory path could shift if the agency seeks more clinical data.
No other significant events or changes in dividend policy were declared in this release. RVPH does not currently pay a dividend. Investors should continue to monitor Reviva's cash reserves, progress on regulatory milestones, feedback from the FDA, and any developments related to business partnerships or commercial plans for brilaroxazine.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
