Reviva Pharmaceuticals (RVPH)

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Reviva Pharmaceuticals (RVPH) - 2025 Q2 - Quarterly Results
2025-08-14 20:35
Exhibit 99.1 Reviva Reports Second Quarter 2025 Financial Results and Recent Business Highlights – Planned meeting with Food and Drug Administration (FDA) to discuss brilaroxazine's path to approval for schizophrenia in Q4 2025; potential NDA submission targeted for Q2 2026 – Cupertino, Calif., August 14, 2025 – Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) ("Reviva" or the "Company"), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of ce ...
Reviva Pharmaceuticals (RVPH) - 2025 Q2 - Quarterly Report
2025-08-14 20:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☒ 1934 For the quarterly period ended June 30, 2025 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF ☐ 1934 For the transition period from ____ to ____ Commission file number: 001-38634 Reviva Pharmaceuticals Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware 85-4306526 ...
Reviva Reports Second Quarter 2025 Financial Results and Recent Business Highlights
Globenewswire· 2025-08-14 20:25
Core Insights - Reviva Pharmaceuticals is advancing its brilaroxazine program towards potential registration, with a planned meeting with the FDA in Q4 2025 to discuss the New Drug Application (NDA) submission targeted for Q2 2026 [2][5] Clinical Program and Business Highlights - The company successfully completed a 1-year open-label extension (OLE) trial for brilaroxazine, demonstrating a well-tolerated safety profile and robust broad-spectrum efficacy across all symptom domains in schizophrenia [1][5] - Brilaroxazine showed a significant reduction in PANSS total score by 18.1, positive symptoms by 5.0, and negative symptoms by 4.4, with a discontinuation rate of 35% after 1 year [5] - Reviva is expanding its patent portfolio, aiming for potential patent and market exclusivity up to 2045 and beyond [5] - A late-breaking poster presentation on the RECOVER 12-month OLE trial was presented at the 2025 ASCP annual meeting [5] Financial Results - For the second quarter ended June 30, 2025, the company reported a net loss of approximately $6.1 million, or $0.12 per share, compared to a net loss of approximately $7.9 million, or $0.26 per share, for the same period in 2024 [10][13] - As of June 30, 2025, cash and cash equivalents totaled approximately $10.4 million, down from approximately $13.5 million as of December 31, 2024 [10][11] Anticipated Milestones and Events - The company plans to initiate a potential registrational Phase 3 RECOVER-2 trial for brilaroxazine pending FDA recommendations [5] - An IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis is expected by Q2 2026 [10]
Reviva Pharmaceuticals Holdings, Inc. Announces Pricing of $10 Million Public Offering
Globenewswire· 2025-06-26 12:40
Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. has announced a public offering of 20 million shares of common stock and associated warrants, aiming to raise approximately $10 million to fund research and development activities and for general corporate purposes [1][3]. Group 1: Offering Details - The public offering includes 20,000,000 shares of common stock and Series C and D warrants, priced at $0.50 per share, with total gross proceeds expected to be around $10 million before expenses [1]. - Series C Warrants and Series D Warrants will have an exercise price of $0.50 per share, with Series C Warrants expiring in five years and Series D Warrants expiring in 12 months [2]. - The closing of the offering is anticipated on or about June 27, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended to support research and development activities, working capital, and other general corporate purposes [3]. 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 and protected by composition of matter patents in multiple regions [6].
Reviva Pharmaceuticals Holdings, Inc. Announces Proposed Public Offering
Globenewswire· 2025-06-25 20:17
Core Viewpoint - Reviva Pharmaceuticals Holdings, Inc. plans to offer shares of its common stock and warrants in a public offering to fund research and development activities and for general corporate purposes [1][2]. Company Overview - Reviva is a late-stage biopharmaceutical company focused on developing therapies for unmet medical needs in central nervous system (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 and have been granted composition of matter patents in multiple regions [5]. Offering Details - The offering will be conducted under an effective shelf registration statement on Form S-3, filed with the U.S. Securities and Exchange Commission (SEC) [3]. - A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering [2].
Reviva to Participate in the H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference
GlobeNewswire News Room· 2025-06-05 12:00
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 Holdings (RVPH) Update / Briefing Transcript
2025-06-02 13:00
Reviva Pharmaceuticals Holdings (RVPH) Update Summary Company Overview - Reviva Pharmaceuticals is a late-stage pharmaceutical company focused on developing next-generation therapies for central nervous system, respiratory, and metabolic diseases using chemical genomics-driven technologies [3][2]. Key Points from the Call Clinical Trials and Drug Development - Reviva is presenting results from the Phase 3 RECOVER trial, which focuses on the long-term safety, tolerability, and efficacy of viloroxazine in treating schizophrenia [11][12]. - The RECOVER trial included nearly 1,000 patients across multiple studies, demonstrating a differentiated clinical profile for viloroxazine [11]. - The drug showed strong efficacy in both acute and stable schizophrenia, with over 50% better adherence outcomes compared to historical data [12][11]. Efficacy Results - The efficacy of viloroxazine was highlighted, showing significant improvements in both positive and negative symptoms of schizophrenia, with effect sizes for PANSS total and positive symptoms being notably large [20][22]. - The drug demonstrated sustained decreases in psychopathology over a one-year period, with substantial improvements in negative symptoms and social cognition [27][30][33]. - The open-label extension trial indicated that patients experienced a 46.1% decrease in symptoms for the 15 mg dose and a 49.6% decrease for the 50 mg dose over the trial period [28]. Safety and Tolerability - The discontinuation rate due to adverse effects was low at 16% for viloroxazine compared to 22% for placebo, indicating good tolerability [20][44]. - Common side effects included somnolence and headache, with no significant extrapyramidal symptoms reported [45][69]. - The drug showed a weight gain of only 1.2 kg over 13 months, indicating a weight-neutral effect, which is a significant improvement over other atypical antipsychotics [52][70]. Metabolic Profile - Viloroxazine demonstrated reductions in cholesterol and LDL levels, suggesting a favorable metabolic profile compared to existing treatments [53][70]. - The drug also showed a significant reduction in prolactin levels, which is often elevated in patients taking other antipsychotics, potentially improving sexual function [57][71]. Neuroinflammation and Biomarkers - The drug's effects on neuroinflammatory markers were noted, with significant reductions in interleukins and TNF-alpha, suggesting a broad anti-inflammatory effect that may contribute to its efficacy in treating schizophrenia [63][65]. - Improvements in brain-derived neurotrophic factor (BDNF) levels were also reported, which is associated with better neuronal signaling and recovery from damage [64]. Additional Insights - The call emphasized the importance of addressing both positive and negative symptoms in schizophrenia treatment, with viloroxazine showing robust efficacy in both areas [74][76]. - The potential for viloroxazine to improve quality of life and functioning in patients with schizophrenia was highlighted, with suggestions that it could be effective in both acute and chronic settings [35][36]. Conclusion - Reviva Pharmaceuticals is advancing its clinical development of viloroxazine, which shows promise as a treatment for schizophrenia with a favorable safety and efficacy profile compared to existing therapies. The drug's ability to address both positive and negative symptoms, along with its favorable metabolic effects, positions it as a potential next-generation antipsychotic [35][71].
Reviva Pharmaceuticals Holdings (RVPH) Earnings Call Presentation
2025-06-02 12:12
Efficacy of Brilaroxazine - Brilaroxazine demonstrated a significant decrease of 18 points in PANSS total score at Week 52 compared to baseline (p ≤ 0.0001) [41] - There was a 5-point decrease in PANSS positive symptoms score at 12 months with brilaroxazine pooled (15, 30 & 50 mg) vs baseline (p ≤ 0.001) [47] - Brilaroxazine showed a 4.4-point decrease in PANSS negative symptoms score at 12 months compared to baseline (p ≤ 0.001) [50] - 58.5% of patients showed >1-point improvement on the CGI-S scale at 12 months with brilaroxazine pooled (15, 30, & 50 mg) vs baseline (p ≤ 0.001) [69] Safety and Tolerability of Brilaroxazine - In the 52-week open-label trial, 37.2% of patients experienced any treatment emergent adverse event (TEAE) [84] - The pooled brilaroxazine dose group reported a mild weight gain of 1.52 kg [104] - There was a decrease in cholesterol of -8.3 mg/dL overall (p=0.030) and LDL cholesterol of -8.0 mg/dL overall (p=0.0093) in the 12-month OLE trial [90] - A clinically significant decrease in serum prolactin levels of -12.50 ug/L overall was observed from baseline to week-52/EOT [94] - There was an improvement in thyroid (T3) hormone levels of 0.044 ug/L overall (P ≤ 0.05) [97] Trial Design and Demographics - The RECOVER open-label extension (OLE) trial enrolled 446 patients with stable schizophrenia [37]
Reviva Announces Positive Full Dataset for 1-Year Phase 3 RECOVER Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia
Globenewswire· 2025-06-02 11:00
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]
Reviva Pharmaceuticals Holdings (RVPH) 2025 Conference Transcript
2025-05-29 19:02
Summary of Reviva Pharmaceuticals Holdings (RVPH) Conference Call Company Overview - **Company**: Reviva Pharmaceuticals Holdings (RVPH) - **Industry**: Pharmaceuticals, specifically focused on neuropsychiatric disorders - **Key Product**: Duloxazine, currently in phase three development for schizophrenia Core Points and Arguments 1. **Pipeline Development**: Reviva is developing next-generation therapies for neuro dysfunction, with Duloxazine being the most advanced molecule aimed at treating schizophrenia and potentially other psychiatric conditions such as bipolar disorder, major depressive disorder, and ADHD [4][5] 2. **Market Potential**: The indications targeted by Reviva represent a multibillion-dollar market, with over 24 million people suffering from schizophrenia globally, and around 4 million in the US alone [7][8] 3. **Unmet Needs**: Approximately 30% of schizophrenia patients do not respond to current treatments, highlighting the need for better options that address negative symptoms and treatment adherence [8][10] 4. **Efficacy and Safety**: Duloxazine has shown a 12-16% discontinuation rate in trials, significantly lower than the 30-70% seen with existing antipsychotics, indicating better treatment adherence [12][26] 5. **Neuroinflammation**: The drug also targets neuroinflammation, which is a significant factor in disease progression and comorbidities in psychiatric patients [9][21] 6. **Phase Three Data**: The pivotal phase three study involved 411 patients and demonstrated a statistically significant outcome with a 10-point separation from placebo, indicating robust efficacy [14][15] 7. **Negative Symptoms**: Duloxazine showed a 2-point separation in negative symptoms, a chronic condition that is difficult to treat, with only a few existing drugs demonstrating significant outcomes [17][20] 8. **Biomarkers**: The use of digital biomarkers, such as speech patterns, has confirmed the drug's efficacy in patients with severe negative symptoms [19][24] 9. **Safety Profile**: The safety profile of Duloxazine is comparable to placebo, with minimal motor side effects and manageable weight gain, which is often a concern with antipsychotics [26][27] 10. **Future Development**: Reviva plans to initiate a second phase three study (RECOVER 2) to further support the NDA submission, expected by the end of next year [34][43] Additional Important Content - **Mechanism of Action**: Duloxazine directly modulates dopamine and serotonin receptors, addressing both behavioral symptoms and inflammatory cascades, which differentiates it from existing treatments [39][40] - **Long-term Efficacy**: Data from long-term studies indicate sustained efficacy and safety, with dropout rates significantly lower than those of other antipsychotics [31][32] - **Regulatory Pathway**: The company is on track to meet the requirements for NDA submission, having completed necessary trials and safety studies [42][43] This summary encapsulates the key points discussed during the conference call, highlighting Reviva Pharmaceuticals' strategic focus on addressing significant unmet needs in the treatment of schizophrenia and related disorders.