Reviva Pharmaceuticals (RVPH) - 2025 Q2 - Quarterly Results

Report Overview Reviva Pharmaceuticals provides an executive summary of its Q2 2025 financial results and strategic advancements, particularly for brilaroxazine in schizophrenia Second Quarter 2025 Financial Results and Business Highlights Reviva Pharmaceuticals reported its Q2 2025 financial results and key business highlights, primarily focusing on the advancement of its lead drug candidate, brilaroxazine, for schizophrenia. A significant milestone was the successful completion of the OLE 1-year trial, reinforcing its safety and efficacy profile, with a planned FDA meeting in Q4 2025 and a target NDA submission in Q2 2026 - Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) is a late-stage pharmaceutical company developing therapies for central nervous system (CNS), inflammatory, and cardiometabolic diseases[1] - Planned meeting with the Food and Drug Administration (FDA) to discuss brilaroxazine's path to approval for schizophrenia in Q4 2025; potential NDA submission targeted for Q2 2026[1] Clinical Program and Business Highlights This section details the clinical progress of brilaroxazine, including successful trial completion, and outlines the company's patent strategy and pipeline expansion efforts Brilaroxazine Clinical Development Reviva achieved major clinical milestones for brilaroxazine, including the successful completion of its global OLE 1-year trial, demonstrating sustained broad-spectrum efficacy and a well-tolerated safety profile. The company is preparing for an End-of-Phase 3 meeting with the FDA in Q4 2025 to discuss NDA submission - Successful completion of the global OLE 1-year trial for brilaroxazine, reinforcing long-term safety, broad-spectrum sustained efficacy, and strong adherence profile[2] - Once daily brilaroxazine (pooled 15, 30, and 50 mg, N=446) demonstrated robust broad-spectrum efficacy sustained over 1-year, with PANSS total score reduction of –18.1, positive symptoms –5.0, negative symptoms –4.4, and negative Marder factor –4.4[5] - Brilaroxazine was generally well tolerated with a discontinuation rate of 35% after 1-year for pooled doses[5] Patent Portfolio and Pipeline Expansion Reviva is actively expanding its diversified patent portfolio for brilaroxazine, aiming for market exclusivity up to 2045 and beyond, covering composition of matter and lifecycle management strategies for various indications - Continuing efforts aimed at expansion of strong diversified patent portfolio comprising composition of matter and lifecycle management strategies for innovative formulations and method of treatment for different major indications with clear regulatory path including potential patent and/or market exclusivity up to 2045 and beyond[5] Anticipated Milestones and Events Reviva Pharmaceuticals outlines key upcoming corporate and clinical milestones, including regulatory meetings, NDA submissions, and financial activities Key Milestones and Corporate Activities Reviva has outlined several key upcoming milestones, including an FDA meeting in Q4 2025, a target NDA submission for brilaroxazine in schizophrenia in Q2 2026, and an IND submission for a new brilaroxazine formulation in psoriasis by Q2 2026. The company also completed a $10.0 million public equity offering and is assessing plans for a potential Phase 3 RECOVER-2 trial - Planned meeting with FDA to discuss brilaroxazine's path to approval in Q4 2025[9] - Potential NDA submission for brilaroxazine in schizophrenia targeted in Q2 2026[9] - Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected by Q2 2026[9] - Completed public equity offering raising gross proceeds of $10.0 million, before deducting placement agent fees and other offering expenses[9] - Plans are being assessed to initiate a potential registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia pending FDA recommendation for a path to approval[9] - Pursuing partnership opportunities for the development of our pipeline[9] Financial Performance This section presents Reviva's Q2 2025 financial results, including condensed balance sheets and statements of operations, highlighting key financial metrics and changes Q2 2025 Financial Summary For the three months ended June 30, 2025, Reviva reported a reduced net loss of $6.1 million, an improvement from $7.9 million in the prior year period. Cash and cash equivalents stood at $10.4 million as of June 30, 2025, down from $13.5 million at December 31, 2024 Net Loss and Net Loss per Share | Metric | Q2 2025 | Q2 2024 | Change (YoY) | | :----- | :------ | :------ | :----------- | | Net Loss | $(6.1) million | $(7.9) million | $(1.8) million (Improved) | | Net Loss per Share (Basic & Diluted) | $(0.12) | $(0.26) | $(0.14) (Improved) | Cash and Cash Equivalents | Metric | June 30, 2025 | December 31, 2024 | Change | | :----- | :------------ | :---------------- | :----- | | Cash and Cash Equivalents | $10.4 million | $13.5 million | $(3.1) million | Condensed Consolidated Balance Sheets (Unaudited) As of June 30, 2025, Reviva's total assets were $11.6 million, a decrease from $15.5 million at December 31, 2024. This was primarily due to a reduction in cash and cash equivalents, prepaid clinical trial costs, and other current assets. Total liabilities also decreased, while stockholders' equity moved into a deficit position Condensed Consolidated Balance Sheets (Unaudited) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | | :----------------- | :------------ | :---------------- | | Cash and cash equivalents | $10,363,714 | $13,476,331 | | Total current assets | $10,815,125 | $14,683,367 | | Total Assets | $11,634,846 | $15,503,088 | | Total current liabilities | $12,077,303 | $14,601,506 | | Total Liabilities | $12,093,993 | $14,690,516 | | Total stockholders' equity (deficit) | $(459,147) | $812,572 | Condensed Consolidated Statements of Operations (Unaudited) For the three months ended June 30, 2025, total operating expenses decreased to $6.1 million from $8.1 million in the prior year, primarily due to a significant reduction in research and development expenses. This led to a lower net loss of $6.1 million compared to $7.9 million in Q2 2024 Condensed Consolidated Statements of Operations (Unaudited) | Operating Expense | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :---------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $3,724,755 | $5,584,347 | $7,838,292 | $11,368,212 | | General and administrative | $2,348,227 | $2,545,296 | $4,772,857 | $4,683,537 | | Total operating expenses | $6,072,982 | $8,129,643 | $12,611,149 | $16,051,749 | | Net loss | $(6,053,610) | $(7,859,919) | $(12,486,450) | $(15,293,527) | | Net loss per share (Basic and diluted) | $(0.12) | $(0.26) | $(0.25) | $(0.51) | About Reviva Pharmaceuticals Holdings, Inc. Reviva Pharmaceuticals is a late-stage biopharmaceutical company focused on CNS, inflammatory, and cardiometabolic diseases, with a pipeline featuring brilaroxazine and RP1208 Company Overview and Pipeline Reviva is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing next-generation therapeutics for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases. Its pipeline includes brilaroxazine (RP5063) and RP1208, both proprietary new chemical entities with granted composition of matter patents - Reviva is a late-stage biopharmaceutical company developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases[7] - Current pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both new chemical entities discovered in-house with composition of matter patents granted in the US, Europe, and other countries[7] Forward-Looking Statements This section provides a disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties, and clarifies the company's non-obligation to update future projections Disclaimer and Risk Factors This section contains standard forward-looking statements regarding the company's plans for its brilaroxazine program, potential approvals, FDA meetings, NDA submissions, clinical trial plans, market opportunities, and financial performance. These statements are based on current expectations and involve known and unknown risks and uncertainties, cautioning investors against undue reliance. The company explicitly states it undertakes no obligation to publicly update these statements - Forward-looking statements relate to future events or financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results to differ materially[10] - The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise[10] Contacts This section provides essential contact information for corporate and investor relations inquiries for Reviva Pharmaceuticals Holdings, Inc Corporate and Investor Relations Information Contact information for corporate inquiries and investor relations is provided for Reviva Pharmaceuticals Holdings, Inc - Corporate Contact: Laxminarayan Bhat, PhD, Reviva Pharmaceuticals Holdings, Inc. (www.revivapharma.com)[11](index=11&type=chunk) - Investor Relations Contact: PJ Kelleher, LifeSci Advisors, LLC (pkelleher@lifesciadvisors.com)[11]