Core Insights - Reviva Pharmaceuticals is advancing its late-stage brilaroxazine program, demonstrating sustained long-term safety and robust efficacy in treating schizophrenia, with a registrational Phase 3 trial expected to begin in mid-2025 [1][2][4] Clinical Program Highlights - Brilaroxazine has shown broad-spectrum efficacy across major symptom domains of schizophrenia, with long-term data indicating sustained efficacy over one year [2][5] - The open-label extension (OLE) study reported a decrease in PANSS total scores by 18.6 points, with significant reductions in both positive and negative symptoms [5] - The treatment was generally well tolerated, with a discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up, and no serious adverse events reported [5] Financial Results - For the fiscal year ended December 31, 2024, the company reported a net loss of approximately $29.9 million, a decrease from a net loss of $39.3 million in 2023 [7][16] - Cash and cash equivalents as of December 31, 2024, totaled approximately $13.5 million, down from $23.4 million in 2023 [7][14] Anticipated Milestones - Full data from the RECOVER OLE study, including biomarker data, is expected in Q2 2025 [2][11] - The initiation of the registrational Phase 3 RECOVER-2 trial is anticipated in mid-2025, with a potential New Drug Application (NDA) submission targeted for Q4 2026 [2][11]

Presenter: Dr. Laxminarayan Bhat, Founder & CEO, Reviva Pharmaceuticals CUPERTINO, Calif., March 30, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, announced today topline data from the long-term open label extension portion of the Phase 3 RECOVER study evaluating brilaroxazine in schizophreni ...

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] - The company will present at the Oppenheimer 35 Annual Healthcare Life Sciences Conference on February 12, 2025, at 2:40 p.m. ET [1][2] Company Overview - Reviva's 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]

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][3] - The company will participate in the 2025 BIO CEO & Investor Conference, highlighting its commitment to addressing mental health through innovative targets and endpoints [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 [3] - The company has secured composition of matter patents for both drug candidates in the United States, Europe, and several other countries, indicating a strong intellectual property position [3]

Company Overview - Reviva Pharmaceuticals Holdings, Inc. is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (CNS), inflammatory, and cardiometabolic diseases [1][3] - The company has two drug candidates in its pipeline: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] Upcoming Event - Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva, will participate in a webcasted presentation at the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025, at 12:30 p.m. ET [1][2] - The webcast can be accessed through the conference home page or directly via provided links, with a replay available afterward [2] Intellectual Property - Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. has announced a public offering of 12 million shares of common stock, along with series A and B warrants, aiming to raise approximately $18 million for research and development and general corporate purposes [1][2]. Group 1: Offering Details - The public offering includes 12,000,000 shares of common stock priced at $1.50 each, accompanied by series A warrants for 6,000,000 shares and series B warrants for 12,000,000 shares [1]. - Series A warrants are exercisable immediately at an exercise price of $1.50 per share and expire in six months, while series B warrants are also exercisable immediately at the same price but expire in five years [1]. - The offering is expected to close around December 18, 2024, subject to customary closing conditions [1]. Group 2: Financial Proceeds - Reviva anticipates gross proceeds of approximately $18 million from the offering, excluding underwriting discounts and commissions [2]. - The net proceeds will be allocated to fund research and development activities, working capital, and other general corporate purposes [2]. Group 3: Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [5]. - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [5]. - Reviva holds composition of matter patents for both drug candidates in the United States, Europe, and several other countries [5].

Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. is proposing an underwritten public offering of common stock and warrants to fund research and development activities, working capital, and other corporate purposes [1][2]. Group 1: Offering Details - The offering will include shares of common stock and warrants, all offered by the company [1]. - The final terms of the offering will depend on market conditions, and there is no assurance regarding the completion or size of the offering [2]. - Citizens JMP Securities, LLC is acting as the sole bookrunner for the proposed offering [3]. Group 2: Regulatory Information - The securities will be offered under a shelf registration statement on Form S-3, which was filed with the SEC on January 26, 2022, and became effective on February 2, 2022 [4]. - A preliminary prospectus supplement and base prospectus will be filed with the SEC and will be available on the SEC's website [4]. Group 3: Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in CNS, inflammatory, and cardiometabolic diseases [6]. - The company's pipeline includes two drug candidates, brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [6]. - Reviva has been granted composition of matter patents for both drug candidates in the United States, Europe, and several other countries [6].

Core Insights - Reviva Pharmaceuticals announced positive preliminary topline data for brilaroxazine, demonstrating favorable long-term safety and robust broad-spectrum efficacy sustained over one year in patients with schizophrenia [1][2][3] Group 1: Efficacy and Safety Findings - Brilaroxazine showed dose-dependent efficacy with significant decreases in PANSS total scores: -15.2, -18.6, and -20.8 points for doses of 15 mg, 30 mg, and 50 mg respectively [3][4] - The pooled data indicated a clinically meaningful and sustained long-term efficacy with an 18.6-point decrease in PANSS total scores, a 5.2-point decrease in PANSS positive symptoms, and a 4.5-point decrease in PANSS negative symptoms, all with p ≤ 0.0001 [3][4] - The treatment was generally well tolerated, with only 15.2% of participants reporting at least one treatment-related adverse event, mostly mild or moderate in severity [4][5] Group 2: Study Design and Participant Details - The open-label extension (OLE) of the RECOVER study included 435 patients across three dose groups: 139 in 15 mg, 155 in 30 mg, and 141 in 50 mg [2][3] - The study comprised 156 rollover participants from the double-blind portion and 279 de novo participants, with preliminary efficacy results presented for 113 patients who completed one year of treatment [2][3] Group 3: Future Outlook - Full data from the OLE portion of the RECOVER study, including long-term safety, tolerability, and efficacy data, is expected to be reported in Q1 2025 [1][2] - Reviva aims to submit a New Drug Application (NDA) to the FDA based on the long-term safety data from at least 100 patients who completed one year of treatment [5][9]

Reviva Pharmaceuticals (NASDAQ: RVPH ) looks to improve the standard of care treatment for schizophrenia, and is well underway to do so. The FDA requires two well-controlled trials and long-term data for that purpose. Reviva has already presented goodI am a long-term investor focused on growth markets, AI and biotech opportunities in my more volatile portfolio. I try to look for undervalued and under-the-radar stocks with serious potential and good scientific or other background. My ambition here is to cove ...

Financial Performance - The company reported a net loss of approximately $8.4 million, or $0.25 per share, for Q3 2024, compared to a net loss of approximately $11.3 million, or $0.48 per share, for the same period in 2023[7]. - For the nine months ended September 30, 2024, the company reported a net loss of approximately $23.7 million, or $0.75 per share, compared to a net loss of approximately $29.9 million, or $1.32 per share, for the same period in 2023[8]. - The net loss for the three months ended September 30, 2024, was $8,365,798, compared to a net loss of $11,345,936 for the same period in 2023, representing a 26.1% improvement[17]. - Basic and diluted net loss per share for the three months ended September 30, 2024, was $(0.25), an improvement from $(0.48) in the same period of 2023[17]. - Total other income, net for the nine months ended September 30, 2024, was $869,739, compared to $248 for the same period in 2023[17]. - The company reported a gain on remeasurement of warrant liabilities of $728,771 for the nine months ended September 30, 2024, compared to a loss of $(305,972) in the prior year[17]. - Interest income for the nine months ended September 30, 2024, was $313,956, a decrease from $341,854 in the same period of 2023[17]. - The company incurred interest expense of $(13,786) for the nine months ended September 30, 2024, compared to $(20,414) in the same period of 2023[17]. - Provision for income taxes for the nine months ended September 30, 2024, was $14,781, down from $21,531 in the same period of 2023[17]. Cash and Liabilities - As of September 30, 2024, the company's cash totaled approximately $5.6 million, down from approximately $23.4 million as of December 31, 2023[8]. - Total liabilities as of September 30, 2024, were approximately $17.6 million, compared to $18.0 million as of December 31, 2023[16]. Operating Expenses - For the three months ended September 30, 2024, total operating expenses were $8,462,534, a decrease of 26.5% compared to $11,563,954 for the same period in 2023[17]. - Research and development expenses for the nine months ended September 30, 2024, were $18,226,497, down 21.7% from $23,312,661 in the prior year[17]. - Total operating expenses for the nine months ended September 30, 2024, were $24,514,283, down 18.1% from $29,884,290 in the prior year[17]. Clinical Trials and Drug Development - The ongoing 1-year open-label extension (OLE) trial for brilaroxazine has 108 patients who have completed 1 year of treatment, which is a requirement for New Drug Application (NDA) submission[4]. - Topline data from the OLE trial is expected in December 2024, with full data analysis including long-term safety and efficacy expected in Q1 2025[6]. - The company is targeting a potential NDA submission for brilaroxazine in schizophrenia in Q2 2026[6]. - The company presented positive speech latency data for brilaroxazine from the Phase 3 RECOVER trial, supporting its efficacy for negative symptoms of schizophrenia[5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in Q1 2025, subject to additional financing[6]. - The company has received Orphan Drug Designation from the U.S. FDA for brilaroxazine for the treatment of pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF)[11].