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]

Core Insights - Reviva Pharmaceuticals Holdings, Inc. announced topline data from the long-term open label extension of the Phase 3 RECOVER study evaluating brilaroxazine for schizophrenia, to be presented at the 2025 Congress of the Schizophrenia International Research Society [1][2] Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing next-generation therapeutics for unmet medical needs, particularly in central nervous system (CNS), inflammatory, and cardiometabolic diseases [3] - The company's pipeline includes two drug candidates: brilaroxazine (RP5063) and RP1208, both of which are new chemical entities discovered in-house [3] - Reviva has secured composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

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].