Reviva Pharmaceuticals reports 446 participants in brilaroxazine trial; Phase 3 RECOVER-2 trial expected mid-2025.
Quiver AI Summary
Reviva Pharmaceuticals Holdings, Inc. announced that 446 participants have completed their long-term open-label extension (OLE) trial for brilaroxazine, with 156 participants receiving one year of treatment and 301 six months. The complete dataset from the RECOVER OLE trial, which will detail clinical responses, safety, efficacy, adherence, and biomarker data, is expected to be released in Q2 2025. Additionally, the company plans to initiate the registrational Phase 3 RECOVER-2 trial for brilaroxazine in mid-2025. Reviva aims for a New Drug Application (NDA) submission for brilaroxazine by Q4 2026. Financially, Reviva reported a net loss of approximately $6.4 million for Q1 2025 and had $5.3 million in cash as of March 31, 2025.
Potential Positives
- 446 participants completed the long-term open-label extension trial, showcasing strong recruitment and engagement in the brilaroxazine study.
- Full dataset from the RECOVER OLE trial, expected in Q2 2025, will provide important data on clinical response, safety, and efficacy, potentially strengthening the case for brilaroxazine.
- Initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is scheduled for mid-2025, marking significant progress towards FDA approval.
Potential Negatives
- The company's significant decrease in cash and cash equivalents from approximately $13.5 million to $5.3 million may raise concerns regarding its financial stability and ability to fund ongoing and future projects.
- The net loss for the first quarter of 2025 remains substantial at approximately $6.4 million, although it is a slight improvement compared to the previous year; ongoing losses could indicate challenges in achieving profitability.
- The Phase 3 RECOVER-2 trial initiation is pending additional financing, which suggests potential issues in securing funds to support critical clinical developments.
FAQ
What were the key findings from the brilaroxazine long-term OLE trial?
The trial included 446 participants, with 156 completing one year and 301 six months of treatment, demonstrating promising efficacy and safety.
When is the full data set from the RECOVER OLE trial expected?
Full data analysis highlighting clinical response, safety, and biomarker data is expected in Q2 2025.
What is the timeline for the registrational Phase 3 RECOVER-2 trial?
The initiation of the RECOVER-2 trial for brilaroxazine is expected in mid-2025, pending financing.
When does Reviva plan to submit a New Drug Application for brilaroxazine?
The potential NDA submission for brilaroxazine is targeted for the fourth quarter of 2026.
What financial results did Reviva report for Q1 2025?
Reviva reported a net loss of approximately $6.4 million for the first quarter ended March 31, 2025.
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Full Release
– 446 participants completed the brilaroxazine long-term open-label extension (OLE) trial with 156 completing one-year and 301 completing six months of treatment –
– Full data set from RECOVER OLE highlighting clinical response, safety, efficacy, adherence, and biomarker data expected in Q2 2025 –
– Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025 –
CUPERTINO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- 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 central nervous system (CNS), inflammatory and cardiometabolic diseases, today reported financial results for the first quarter ended March 31, 2025 and summarized recent business highlights.
“Our late stage brilaroxazine program is advancing towards registration and we are excited for our important near-term catalysts ahead. Notably, the full dataset from our global OLE trial will include data from 446 participants of which 156 have completed at least one-year of treatment. We look forward to reporting clinical response, safety, adherence, and biomarker data in the second quarter of the year,” said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. “Brilaroxazine continues to demonstrate what we believe is a differentiated and promising therapeutic profile across our robust data package that is expected to include a successful placebo-controlled Phase 3 trial with a long-term open label extension for up to 1-year, a successful Phase 2 study, and a compelling drug-drug interaction study. We believe the findings from these studies reinforce the potential of once daily brilaroxazine to address major unmet needs for patients with schizophrenia, and we are targeting a potential New Drug Application (NDA) submission for brilaroxazine in the fourth quarter of 2026.”
First Quarter 2025 and Recent Business Highlights
Clinical Program Highlights
Long-term OLE portion of the RECOVER Phase 3 trial is complete
446 patients have completed the trial
156 patients have completed 1-year (12 months) of treatment
301 patients have completed 6 months of treatment
Biomarkers designed to independently support safety and efficacy
Long-term safety data from 100 patients who have completed 12 months of treatment is a requirement for brilaroxazine’s NDA submission to the FDA
Presenting a late-breaking poster presentation on the RECOVER 12-month OLE trial for brilaroxazine in schizophrenia at the 2025 American Society of Clinical Psychopharmacology (ASCP) annual meeting on Wednesday May 28, 2025, in Scottsdale, AZ.
Positive topline data from the long-term OLE portion of the Phase 3 RECOVER study evaluating brilaroxazine in schizophrenia presented as an oral presentation on March 30th at the 2025 Congress of the Schizophrenia International Research Society (SIRS) in Chicago, Illinois.
Anticipated Milestones and Events
Full data analysis of the OLE trial including long-term safety, tolerability and efficacy, as well as vocal and blood biomarker data expected in Q2 2025
Initiation of registrational Phase 3 RECOVER-2 trial evaluating brilaroxazine for the treatment of schizophrenia expected in mid-2025, subject to receipt of additional financing
Potential NDA submission for brilaroxazine in schizophrenia targeted for the fourth quarter of 2026
Investigational new drug application (IND) submission for liposomal-gel formulation of brilaroxazine in psoriasis expected later in 2025
Pursue partnership opportunities for the development of our pipeline
Financial Results for March 31, 2025
The Company reported a net loss of approximately $6.4 million, or $0.13 per share, for the three months ended March 31, 2025, compared to a net loss of approximately $7.4 million, or $0.25 per share, for the three months ended March 31, 2024.
As of March 31, 2025, the Company’s cash and cash equivalents totaled approximately $5.3 million compared to approximately $13.5 million as of December 31, 2024.
About Reviva
Reviva is a late-stage biopharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing unmet medical needs and burdens to society, patients, and their families. Reviva's current pipeline focuses on the central nervous system (CNS), inflammatory and cardiometabolic diseases. Reviva's pipeline currently includes two drug candidates, brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. Reviva has been granted composition of matter patents for both brilaroxazine and RP1208 in the United States, Europe, and several other countries.
Forward-Looking Statements
This press release 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 the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s 1-year open label extension (OLE) trial evaluating the long-term safety and tolerability for brilaroxazine in schizophrenia, the registrational Phase 3 RECOVER-2 trial, the Company’s expectations regarding the anticipated clinical profile of its product candidates, including statements regarding anticipated efficacy or safety profile, and those relating to the Company’s expectations, intentions or beliefs regarding matters including product development and clinical trial plans and the timing thereof, including the anticipated timing of the availability of trial data, clinical and regulatory timelines and expenses, planned or intended additional trials or studies and the timing thereof, planned or intended regulatory submissions and the timing thereof, trial results, market opportunity, ability to raise sufficient funding, competitive position, possible or assumed future results of operations, business strategies, potential opportunities for development including partnerships, growth or expansion opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and the Company’s other filings from time to time with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Corporate Contact:
Reviva Pharmaceuticals Holdings, Inc.
Laxminarayan Bhat, PhD
www.revivapharma.com
Investor Relations Contact:
LifeSci Advisors, LLC
Bruce Mackle
bmackle@lifesciadvisors.com
REVIVA PHARMACEUTICALS HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | |||||||
March 31, | December 31, | ||||||
2025 | 2024 | ||||||
Assets | |||||||
Cash and cash equivalents | $ | 5,289,404 | $ | 13,476,331 | |||
Prepaid clinical trial costs | 211,855 | 540,601 | |||||
Prepaid expenses and other current assets | 756,066 | 666,435 | |||||
Total current assets | 6,257,325 | 14,683,367 | |||||
Non-current prepaid clinical trial costs | 819,721 | 819,721 | |||||
Total Assets | $ | 7,077,046 | $ | 15,503,088 | |||
Liabilities and Stockholders’ Equity (Deficit) | |||||||
Liabilities | |||||||
Short-term debt | $ | 224,300 | $ | 458,154 | |||
Accounts payable | 4,721,043 | 6,283,430 | |||||
Accrued clinical expenses | 5,524,163 | 6,723,719 | |||||
Accrued compensation | 556,884 | 635,587 | |||||
Other accrued liabilities | 482,864 | 500,616 | |||||
Total current liabilities | 11,509,254 | 14,601,506 | |||||
Warrant liabilities | 27,816 | 89,010 | |||||
Total Liabilities | 11,537,070 | 14,690,516 | |||||
Commitments and contingencies | |||||||
Stockholders’ Equity (Deficit) | |||||||
Common stock, par value of $0.0001; 315,000,000 shares authorized; 46,739,949 and 46,579,199 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | 4,674 | 4,658 | |||||
Preferred Stock, par value of $0.0001; 10,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024 | — | — | |||||
Additional paid-in capital | 166,241,192 | 165,080,964 | |||||
Accumulated deficit | (170,705,890 | ) | (164,273,050 | ) | |||
Total stockholders' equity (deficit) | (4,460,024 | ) | 812,572 | ||||
Total Liabilities and Stockholders’ Equity (Deficit) | $ | 7,077,046 | $ | 15,503,088 | |||
REVIVA PHARMACEUTICALS HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | |||||||
Three Months Ended March 31, | |||||||
2025 | 2024 | ||||||
Operating expenses | |||||||
Research and development | $ | 4,113,537 | $ | 5,783,865 | |||
General and administrative | 2,424,630 | 2,138,241 | |||||
Total operating expenses | 6,538,167 | 7,922,106 | |||||
Loss from operations | (6,538,167 | ) | (7,922,106 | ) | |||
Other income (expense) | |||||||
Gain on remeasurement of warrant liabilities | 61,194 | 456,177 | |||||
Interest expense | (11,620 | ) | (3,487 | ) | |||
Interest income | 86,111 | 173,098 | |||||
Other (expense) income, net | (25,145 | ) | (129,894 | ) | |||
Total other (expense) income, net | 110,540 | 495,894 | |||||
Loss before provision for income taxes | (6,427,627 | ) | (7,426,212 | ) | |||
Provision for income taxes | 5,213 | 7,396 | |||||
Net loss | $ | (6,432,840 | ) | $ | (7,433,608 | ) | |
Net loss per share: | |||||||
Basic and diluted | $ | (0.13 | ) | $ | (0.25 | ) | |
Weighted average shares outstanding | |||||||
Basic and diluted | 48,644,339 | 29,887,325 | |||||
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