News Details

By John Vandermosten, CFA

OTCQB: RVPH

READ THE FULL RVPH RESEARCH REPORT

Reviva Pharmaceuticals Holdings, Inc. (OTCQB: RVPH) reported second quarter 2026 results on August 12^th, 2026. Earlier this year, Reviva engaged with the FDA seeking feedback regarding a formulation change for brilaroxazine to be used in its second RECOVER trial. The company expects a response from the agency in 4Q:26. If the agency consents, management has indicated that Reviva will conduct a 30-patient bioequivalence study using the new formulation to ensure comparability of the new formulation. It will then begin the Phase III RECOVER II study. If these steps are successful, patient enrollment is anticipated in 2Q:27 and trial completion approximately one year later. Additional capital will be required to begin. In support of the new formulation, Reviva has filed for a composition of matter patent for brilaroxazine that, if granted, will extend patent life and commercial exclusivity until 2046.

Operating and Financial Results

On August 12^th, 2026, Reviva reported 2Q:26 financial and operating results and filed its Form 10-Q with the SEC. Reviva generated no revenues in 2Q:26 and posted an operating loss of $2.6 million, with expenses falling by 57% due to the completion of the RECOVER open label extension (OLE) study last year. For the quarter ending June 30^th, 2026 and versus the same prior quarterly period:

• Research & development expense totaled $1.4 million, down 63% from $3.7 million, with the change attributable to lower salaries and wages, stock-based compensation, external research and development costs partially offset by a slight rise in non-clinical consulting costs;
• General & administrative expenses totaled $1.2 million, declining 48% from $2.3 million on account of reduced stock-based compensation, consultant and professional expenses, and legal expenses;
• Other income of $172,000 compared to $27,000 with the difference almost entirely attributable to higher interest income;
• Provision for taxes was $3,000 compared to $8,000 related to payment of state and foreign taxes;
• Net loss was $2.4 million vs $6.1 million, or $0.19 and $2.43 per share, respectively.^[1]

As of June 30^th, 2026, Reviva held $19.9 million in cash on its balance sheet. Cash burn for the first six months of 2026 was $5.9 million while cash flows from financing were $11.4 million. Financing transactions from a public offering and an ATM facility were slightly offset by repayment of short-term debt. Reviva notes in its 2Q:26 10-Q filing that it does not have sufficient cash to support operations for the next 12 months. We estimate that there are sufficient funds to conduct operations until 1Q:27. Reviva does hold a substantial number of warrants at $0.50 and $0.34 that could generate additional capital if exercised.

Regulatory Path

Reviva is exploring other alternatives to extend its patent life including finding a closely related indication centered on the negative symptoms of schizophrenia using a new and improved formulation. It is also planning another trial that will focus on negative symptoms, an area where brilaroxazine differentiates itself from its peers. If successful and approved, this could establish Reviva’s drug as the go-to product for treatment of negative symptoms.

RECOVER Trial Background

RECOVER was a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in 411 patients with acute schizophrenia compared to placebo. Brilaroxazine was administered at fixed doses of 15 mg or 50 mg once daily for 28 days. The primary endpoint was a decrease in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo from baseline to Day 28. Key secondary endpoints include clinical global impression (CGI) severity, positive and negative symptoms, social functioning and cognition. Topline for the trial was first announced in October 2023. The primary endpoint was met with the trial producing a 10.1-point reduction in PANSS score relative to placebo at four weeks for the 50 mg dose. Brilaroxazine also achieved statistically significant and clinically meaningful reductions in all major symptom domains and secondary endpoints at week 4 with the 50 mg dose vs. placebo. The 15 mg dose of brilaroxazine was numerically superior to placebo on the primary endpoint and most secondary endpoints, and reached statistical significance on two key secondary endpoints.

OLE Background

Following the conclusion of the RECOVER study, patients were given the opportunity to continue on brilaroxazine to gather long-term safety and tolerability in an OLE study. A total of 435 patients were actively on treatment in the study across the three doses of 15 mg (n=139), 30 mg (n=155) and 50 mg (n=141). 156 subjects rolled over from the double-blind portion of the Phase III trial and 279 were new participants in the OLE.

The OLE was designed to take place in parallel with RECOVER and evaluate the long-term safety of brilaroxazine. To be valid, it was designed to evaluate at least 100 subjects that were part of the RECOVER trial. The study is listed under the identifier NCT05184335 on clinicaltrials.gov in a shared entry with RECOVER. It evaluated flexible doses of brilaroxazine of 15, 30 or 50 mg. Data from the trial will be part of Reviva’s NDA package.

Company Pipeline

Milestones

• Publication of clinical vocal biomarker data in Biological Psychiatry – January 2026
• $10 million public offering closed – March 2026
• NASDAQ delisting and OTCQB Venture Market listing – May 14^th, 2026
• FDA feedback on use of new brilaroxazine formulation in RECOVER II – 4Q:26
• USPTO may grant patent for new brilaroxazine formulation – 4Q:26
• Launch bioequivalence study to confirm comparability with new formulation – 4Q:26/1Q:27
• Enroll first patient in RECOVER 2 Phase III trial – 2Q:27
• Complete RECOVER II Phase III trial enrollment – 2H:27
• Topline readout of RECOVER II Phase III trial – 2028
• Potential brilaroxazine NDA submission to FDA for schizophrenia – 2028

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^{[1] We adjust prior year earnings per share using a 1:20 reverse stock split effective March 9th, 2026.}