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 present a late-breaking poster on the RECOVER 12-month open label extension trial for brilaroxazine in schizophrenia at the 2025 ASCP annual meeting [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 [3] - The company has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries [3]

Clinical Development and Trials - The company announced positive topline results from the Phase 3 RECOVER-1 trial, achieving a statistically significant 10.1-point reduction in PANSS total score for brilaroxazine 50 mg compared to placebo at week 4 (p<0.001) [438]. - Brilaroxazine demonstrated a well-tolerated safety profile with no drug-related serious adverse events reported after 4 weeks of treatment, and a low discontinuation rate of 16% for the 50 mg dose compared to 22% for placebo [442]. - The ongoing Open Label Extension (OLE) trial has enrolled 435 patients, with preliminary results showing a dose-dependent efficacy with PANSS total score reductions of -15.2, -18.6, and -20.8 points for 15 mg, 30 mg, and 50 mg doses respectively after 1 year [449]. - The company plans to initiate the registrational global Phase 3 RECOVER-2 trial in mid-2025, with completion anticipated in Q3 2026, subject to additional financing [441]. - Brilaroxazine's clinical development includes a completed positive Phase 2 REFRESH trial and ongoing long-term safety assessments, with NDA submission planned for Q4 2026 [441]. - Key secondary endpoints in the RECOVER-1 trial also showed statistically significant improvements, including a 2.8-point reduction in positive symptoms and a 2.0-point reduction in negative symptoms at week 4 [439]. - The OLE trial reported a treatment discontinuation rate of 35%, primarily due to withdrawal of consent and loss to follow-up, with no significant adverse events related to brilaroxazine treatment [455]. - The company has completed Phase 1 studies for multiple indications of brilaroxazine, including schizophrenia and bipolar disorder [464]. Financial Performance and Funding - The company raised approximately $2.8 million from the May 2024 Offering and $3.6 million from the August 2024 Offering, after deducting expenses [452][454]. - As of December 31, 2024, the company reported a working capital surplus of approximately $0.1 million and an accumulated deficit of $164.3 million [460]. - The net loss for the years ended December 31, 2024 and 2023 was approximately $29.9 million and $39.3 million, respectively [460]. - The company expects to incur approximately $67 million in clinical costs over the next three years for the development of brilaroxazine for schizophrenia [466]. - The December 2024 Underwritten Offering included the sale of 12,000,000 shares of common stock at a combined public offering price of $1.50 per share, generating net proceeds of approximately $16.5 million [459]. - The company has not generated any revenues from product sales and has incurred losses since inception [460]. - The company plans to raise significant additional capital to fund ongoing operations and development efforts, indicating potential liquidity concerns [489]. - The company completed a registered direct offering in May 2024, raising net proceeds of approximately $2.8 million [493]. - In August 2024, the company completed an underwritten offering, raising approximately $3.6 million in net proceeds [494]. - The company completed an underwritten offering on December 18, 2024, raising net proceeds of $16.5 million from the sale of 12,000,000 shares of common stock and associated warrants [495]. - For the year ended December 31, 2024, net cash used in operating activities was approximately $33.5 million, primarily due to a net loss of approximately $29.9 million [497]. - The company reported a decrease in net operating assets and liabilities of approximately $4.5 million for the year ended December 31, 2024, mainly due to a decrease in accrued clinical expenses [497]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately $23.7 million, primarily from the issuance of common stock and warrants [499]. - The company had a net loss of approximately $39.3 million for the year ended December 31, 2023, with net cash used in operating activities of approximately $28.3 million [498]. - For the year ended December 31, 2023, net cash provided by financing activities was approximately $33.2 million, including proceeds from the issuance of common stock and warrants [500]. - The company does not currently have any committed external sources of capital and may face dilution of stockholder ownership if additional capital is raised [496]. Expenses and Financial Outlook - Research and development expenses are expected to increase significantly as the company advances its development programs and seeks regulatory approval [462]. - The company aims to expand its infrastructure and clinical programs, leading to increased general and administrative expenses [468]. - Research and development expenses decreased from approximately $31.4 million in 2023 to $22.9 million in 2024, a reduction of $8.5 million or 27.1% [480][481]. - General and administrative expenses slightly decreased from approximately $8.1 million in 2023 to $7.9 million in 2024, a reduction of $0.2 million or 2.4% [483]. - The company reported a net loss of approximately $29.9 million for the year ended December 31, 2024, compared to a net loss of approximately $39.3 million in 2023, reflecting an improvement of $9.3 million [477]. - Cash and cash equivalents decreased from approximately $23.4 million in 2023 to $13.5 million in 2024, a decline of $9.9 million or 42.3% [488]. - Total assets decreased from approximately $23.7 million in 2023 to $15.5 million in 2024, a reduction of $8.2 million or 34.6% [488]. - The company expects to incur significant expenses and operating losses as it continues research and clinical development of product candidates, including brilaroxazine [490]. - The company recognized a gain on remeasurement of warrant liabilities of approximately $0.7 million in 2024, compared to a loss of $0.2 million in 2023 [484]. Regulatory and Designation - The company has received Orphan Drug Designation from the FDA for brilaroxazine for the treatment of pulmonary arterial hypertension and idiopathic pulmonary fibrosis [434]. - The company continues to face uncertainties regarding the successful development and marketing approval of its product candidates [466]. - The Series A Common Stock Warrants are exercisable immediately and expire on June 18, 2025, with an exercise price of $1.50 per share [495]. - The Series B Common Stock Warrants are also exercisable immediately, expiring on December 18, 2029, with an exercise price of $1.50 per share [495]. - The company does not have any off-balance sheet arrangements as defined under SEC rules [501].

Financial Performance - Reviva reported a net loss of approximately $29.9 million, or $0.90 per share, for the fiscal year ended December 31, 2024, a decrease from a net loss of approximately $39.3 million, or $1.65 per share, for the fiscal year ended December 31, 2023[6] - Cash and cash equivalents totaled approximately $13.5 million as of December 31, 2024, down from approximately $23.4 million as of December 31, 2023[6] - The company reported a total operating expense of $30.8 million for the fiscal year 2024, down from $39.5 million in 2023[15] - The company completed a public follow-on offering with aggregate gross proceeds of approximately $18.0 million in December 2024[7] Clinical Trials and Efficacy - The ongoing Phase 3 RECOVER study showed a dose-dependent efficacy with decreases in PANSS total scores of -15.2, -18.6, and -20.8 points at the 15, 30, and 50 mg doses respectively, from baseline to end-of-treatment at 52 weeks[3] - The pooled data from the RECOVER study demonstrated a clinically meaningful and sustained long-term efficacy for schizophrenia, with a PANSS total score decrease of 18.6 points (from 71.6 to 53), p ≤ 0.0001[3] - The anticipated registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected to initiate in mid-2025, subject to additional financing[7] - A potential New Drug Application (NDA) submission for brilaroxazine is targeted for the fourth quarter of 2026[7] - The company expects to report the full data set from the RECOVER OLE study, including vocal and blood biomarker data, in the second quarter of 2025[2] Adverse Events - The most common treatment-related adverse events (TRAEs) reported were weight increase (3.2%), insomnia (1.8%), and somnolence (1.6%)[7]

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. 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]