Data Readout Positive from Trial of New Schizophrenia Drug
Research Report

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Disclosures for D. Boral Capital and Reviva Pharmaceuticals Holdings, June 3, 2025:

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Reviva Pharmaceuticals Holdings Inc. (RVPH:NASDAQ) completed and released data from the Phase 3 RECOVER open label extension (OLE) trial of its investigative drug for schizophrenia called brilaroxazine, reported D. Boral Capital Analyst Jason Kolbert in a June 3 research note. Also, the biopharma company initiated an at-the-market (ATM) equity facility for up to $50 million ($50M) in capital.

"The once-daily treatment demonstrated robust, broad-spectrum efficacy sustained over one year and was well tolerated, with no new safety signals," Kolbert wrote.

209% Upside Possible

On the news, D. Boral reiterated its $3 per share target price on Reviva, trading at the time of his report at $0.97 per share, Kolbert noted. The target implies 209% return potential.

The California-based pharmaceutical firm remains a Buy. As reported by Kolbert on June 3, Reviva's market cap was $45M. Its 52-week high and low were $4.28 and $0.49 per share.

Results at a Glance

Kolbert reviewed the key points from the trial data set. In this OLE study, 446 patients received pooled doses of Reviva's brilaroxazine, 15 milligrams (15 mg), 30 mg or 50 mg.

This investigative dopamine-serotonin system modulator led to significant improvement in all symptom categories, which was maintained throughout the year-long treatment period, Kolbert reported. Among the study participants who finished the entire treatment over 52 weeks, total scores on the PANSS, or Positive and Negative Syndrome Scale, improved by 18.6 points, and changes in positive and negative symptoms were favorable.

Existing antipsychotics can cause motor side effects like akathisia (a feeling of inner restlessness) and extrapyramidal symptoms (movement disorders such as tremors, stiffness and involuntary movements). However, none of the brilaroxazine trial patients experienced these.

One side effect that was experienced was mild weight gain, 1.52 kilograms overall. Patients on the 50 mg dose of brilaroxazine gained the least weight.

No serious adverse events were reported. The study discontinuation rate was 35%, but this was not due to tolerability or safety issues. Rather, it resulted from patients withdrawing consent or getting lost to follow-up.

As for treatment-emergent adverse events (TEAEs), 8.5% of patients reported such reactions, most commonly insomnia, sleep disturbance and headache, reported Kolbert. Of these patients, events were mild for 6.5% and moderate for 2%. All TEAEs were transient, and none became a material safety concern. No cardiac, gastrointestinal or liver-related toxicities were reported. Pertinent lab test results, including lipids, glucose and endocrine markers, remained stable or improved.

ATM Facility Pros, Cons

Kolbert pointed out that Reviva's new ATM facility for up to $50M in capital will provide funding flexibility and prevent a large dilutive financing. That said, it could create an overhang on the company's stock.

"With limited liquidity, any use of the ATM could drip shares into the market and cap upside moves, especially in the absence of near-term catalysts or broader small-cap biotech momentum," he added.

On the Horizon

Regarding upcoming catalysts, noted Kolbert, Reviva intends to start the registrational RECOVER-2 Phase 3 trial in schizophrenia in the coming months and by the end of Q2/25, will release the expected timelines for site activation and patient enrollment.

The biopharma still targets Q2/26 for submitting to the U.S. Food and Drug Administration a new drug application for the use of brilaroxazine for schizophrenia.