- Composition of matter provisional patent application filed for a new form of brilaroxazine designed to extend patent life and commercial exclusivity through 2046 -
- FDA feedback on use of new form of brilaroxazine in the RECOVER-2 trial and future NDA expected in mid-2026 -
- Initiation of patient enrollment in RECOVER-2 registrational Phase 3 trial expected Q3 2026 -
“During the first quarter, we further refined our development strategy to strengthen the long-term value of brilaroxazine,” said
Clinical Program and Business Highlights
U.S. composition of matter provisional patent application filed seeking an accelerated review process for a new form of brilaroxazine designed to extend patent life and commercial exclusivity potentially through 2046.- Planned use of a new form of brilaroxazine in the RECOVER-2 Phase 3 trial in schizophrenia and in the future New Drug Application (NDA) submission. The Company is optimistic about receiving FDA alignment on this strategy, with FDA feedback on using the new brilaroxazine form in the RECOVER-2 Phase 3 trial expected in mid-2026.
- Published clinical vocal biomarker data from the RECOVER Phase 3 clinical trial highlighting the therapeutic potential of brilaroxazine for the treatment of schizophrenia in the peer-reviewed journal Biological Psychiatry, in an article entitled A Single, Interpretable Vocal Biomarker for Enriching Antipsychotic Clinical Trials.
- Completed public equity offering in
March 2026 , raising gross proceeds of$10.0 million , before deducting placement agent fees and other offering expenses. - Common stock to transition from Nasdaq listing to OTCQB Venture Market quotation, upon market open on
May 14, 2026 . Ticker symbol remains “RVPH”.
Anticipated Milestones and Events
- Initiation of patient enrollment in the RECOVER-2 Phase 3 trial expected in Q3 2026.
- FDA feedback on use of a new form of brilaroxazine in RECOVER-2 trial expected mid-2026.
- Additional publications on brilaroxazine for the treatment of schizophrenia expected in 2026.
- Pursuing partnership opportunities for the development of our pipeline.
Financial Results for 2026
- The Company reported a net loss of approximately
$3.2 million , or$0.46 per share, for the three months endingMarch 31, 2026 , compared to a net loss of approximately$6.4 million , or$2.61 per share, for the three months endingMarch 31, 2025 . All share and per share amounts in this press release including the accompanying tables have been retrospectively adjusted as appropriate to reflect the Company’s one-for-twenty (1:20) reverse stock split of the Company’s issued and outstanding common stock effected onMarch 9, 2026 . - As of
March 31, 2026 , the Company’s cash and cash equivalents totaled approximately$22.2 million compared to approximately$14.4 million as ofDecember 31, 2025 .
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 (
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 plans for its brilaroxazine program including intended steps of advancing further clinical development and additional steps towards potential approval, the Company’s statements regarding its planned registrational RECOVER-2 Phase 3 trial evaluating brilaroxazine for the treatment of schizophrenia, including the expected timing of initiation of patient enrollment, statements about the Company’s planned use of a new form of brilaroxazine in its RECOVER-2 Phase 3 trial and in its future NDA submission, statements about anticipated FDA feedback, optimism about FDA alignment, and the timing thereof, statements about the Company’s strategy to strengthen the long-term value of brilaroxazine and the potential to extend patent protection and commercial exclusivity, statements about potential NDA and other regulatory submissions, 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, statements about the transition of the Company’s common stock to quotation on the OTCQB Venture Market (which is subject to additional risks compared to being listed on a national securities exchange including the Company’s ability to maintain compliance with the standards for continued quotation on the OTC Markets, together with limited liquidity, increased volatility, sporadic trading in the public market for the Company’s common stock, and that our ability to raise additional capital while trading on the OTC Markets may be adversely impacted), market opportunity, ability to raise sufficient funding, the Company’s cash position and its projected cash runway, statements about 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
Corporate Contact:
www.revivapharma.com
Investor Relations Contact:
PJ Kelleher
pkelleher@lifesciadvisors.com
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) | ||||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 22,190,231 | $ | 14,438,792 | ||||
| Prepaid clinical trial costs | 819,721 | — | ||||||
| Prepaid expenses and other current assets | 549,684 | 664,685 | ||||||
| Total current assets | 23,559,636 | 15,103,477 | ||||||
| Non-current prepaid clinical trial costs | — | 819,721 | ||||||
| Total Assets | $ | 23,559,636 | $ | 15,923,198 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Liabilities | ||||||||
| Short-term debt | $ | 231,274 | $ | 406,875 | ||||
| Accounts payable | 2,085,268 | 3,009,074 | ||||||
| Accrued clinical expenses | 2,675,687 | 2,582,094 | ||||||
| Accrued compensation | 408,519 | 485,899 | ||||||
| Other accrued liabilities | 718,407 | 791,611 | ||||||
| Total current liabilities | 6,119,155 | 7,275,553 | ||||||
| Total Liabilities | 6,119,155 | 7,275,553 | ||||||
| Stockholders’ Equity | ||||||||
| Common stock, par value of | 12,348 | 11,655 | ||||||
| Preferred Stock, par value of | — | — | ||||||
| Additional paid-in capital | 204,762,072 | 192,773,942 | ||||||
| Accumulated deficit | (187,333,939 | ) | (184,137,952 | ) | ||||
| Total stockholders' equity | 17,440,481 | 8,647,645 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 23,559,636 | $ | 15,923,198 | ||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) | ||||||||
| Three Months Ended | ||||||||
| 2026 | 2025 | |||||||
| Operating expenses | ||||||||
| Research and development | $ | 1,435,135 | $ | 4,113,537 | ||||
| General and administrative | 1,836,817 | 2,424,630 | ||||||
| Total operating expenses | 3,271,952 | 6,538,167 | ||||||
| Loss from operations | (3,271,952 | ) | (6,538,167 | ) | ||||
| Other income (expense) | ||||||||
| Gain on remeasurement of warrant liabilities | — | 61,194 | ||||||
| Interest expense | (6,653 | ) | (11,620 | ) | ||||
| Interest income | 89,354 | 86,111 | ||||||
| Other expense, net | (3,390 | ) | (25,145 | ) | ||||
| Total other income, net | 79,311 | 110,540 | ||||||
| Loss before provision for income taxes | (3,192,641 | ) | (6,427,627 | ) | ||||
| Provision for income taxes | 3,346 | 5,213 | ||||||
| Net loss | $ | (3,195,987 | ) | $ | (6,432,840 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (0.46 | ) | $ | (2.61 | ) | ||
| Weighted average shares outstanding | ||||||||
| Basic and diluted | 7,022,945 | 2,462,573 | ||||||
