Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases, with a presentation scheduled at the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference [1][2]. Company Overview - Reviva is engaged in discovering, developing, and commercializing next-generation therapeutics targeting diseases that pose significant burdens to society and patients [2]. - The company's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Conference Details - The H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference will feature a pre-recorded presentation by Reviva's CEO, Laxminarayan Bhat, available on-demand starting June 16, 2025 [2]. - The conference is virtual and registration is required for access [2].

Reviva Pharmaceuticals Reviva | Corporate Presentation 3 Phase 3 RECOVER Open-Label Extension (OLE) Trial of Brilaroxazine in Schizophrenia June 2, 2025 at 8:00am EDT Forward-Looking Statements This presentation contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's expectations regarding the anticipate ...

Core Insights - Reviva Pharmaceuticals announced positive results from the Phase 3 RECOVER open-label extension study of brilaroxazine for schizophrenia, demonstrating sustained efficacy and a well-tolerated safety profile over one year [1][2][5] Efficacy and Safety - Brilaroxazine showed robust broad-spectrum efficacy across all major symptom domains of schizophrenia, with a statistically significant reduction in PANSS total score of -18.1 at 12 months [3][4] - The treatment was generally well-tolerated, with a discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up [1][9] - Improvements in multiple neuroinflammatory markers were observed, suggesting enhanced efficacy and reduced side effects [1][2][9] Clinical Data - The study included a pooled analysis of 446 patients receiving doses of 15 mg, 30 mg, and 50 mg, showing dose-dependent efficacy [2][4] - Key findings included a reduction in negative symptoms by -4.4 at 12 months and significant improvements in personal and social performance scores [3][4] - The treatment also demonstrated a low incidence of treatment-emergent adverse events, with most being mild or moderate in severity [9][10] Future Development - Reviva aims to advance brilaroxazine towards regulatory submission, with plans to explore its use in other neuropsychiatric conditions such as bipolar disorder and major depressive disorder [10][11] - The company has received Orphan Drug Designation from the FDA for brilaroxazine in treating pulmonary arterial hypertension and idiopathic pulmonary fibrosis [11][12]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Reviva's CEO, Laxminarayan Bhat, will participate in the Benchmark Healthcare House Call Virtual Investor Conference on May 29, 2025, at 11:15 a.m. ET [2]. - The company will also present at the Lytham Partners Spring 2025 Investor Conference on the same day at 2:00 p.m. ET [2].

Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program towards registration, with significant upcoming milestones including the full dataset from the long-term open-label extension trial expected in Q2 2025 and the initiation of the Phase 3 RECOVER-2 trial anticipated in mid-2025 [2][4]. Clinical Program Highlights - A total of 446 participants completed the long-term open-label extension trial for brilaroxazine, with 156 completing one year and 301 completing six months of treatment [1][5]. - The full data analysis from the RECOVER OLE trial will include clinical response, safety, efficacy, adherence, and biomarker data, expected to be reported in Q2 2025 [1][5]. - The company plans to submit a New Drug Application (NDA) for brilaroxazine in the fourth quarter of 2026, targeting unmet needs in schizophrenia treatment [2][5]. Financial Results - For the first quarter ended March 31, 2025, the company reported a net loss of approximately $6.4 million, or $0.13 per share, compared to a net loss of approximately $7.4 million, or $0.25 per share, for the same period in 2024 [10][12]. - As of March 31, 2025, cash and cash equivalents totaled approximately $5.3 million, down from approximately $13.5 million as of December 31, 2024 [10][11]. Anticipated Milestones and Events - The company will present a late-breaking poster on the RECOVER 12-month OLE trial at the 2025 American Society of Clinical Psychopharmacology annual meeting on May 28, 2025 [5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in mid-2025, contingent on additional financing [5].

Core Insights - Reviva Pharmaceuticals Holdings, Inc. is a late-stage pharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][2]. Company Overview - Reviva's current pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [2]. - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [2]. Upcoming Events - Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will present at the Citizens Life Sciences Conference on May 8, 2025, at 10:30 a.m. ET in New York, NY [1][2].