RVPH: RECOVER Enrollment Complete
NASDAQ:RVPH
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2Q:23 Financial and Operational Results
On August 15, 2023, Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) reported 2Q:23 financial and operational results and filed its Form 10-Q with the SEC. Since our previous update in May, Reviva has presented at scientific and investor conferences and was added to the Russell Microcap Index. In an August 17th press release, Reviva announced that it had completed enrollment for its Phase III RECOVER study for brilaroxazine in schizophrenia and that it expects to report topline data in October.
Looking ahead, management expects to complete a capital raise to support the confirmatory Phase III study evaluating brilaroxazine in schizophrenic patients and to several Phase II candidates. These programs seek to address Major Depressive Disorder (MDD), Attention-deficit/hyperactivity disorder (ADHD) and psoriasis.
Highlights for 2023:
➢ Completion of multiple parallel studies in support of schizophrenia program – March
➢ Added to Russell Microcap index - June
➢ RECOVER full enrollment reached – August
Reviva generated no revenues in 2Q:23 and expended ($12.1) million in operational endeavors, producing a net loss of ($12.4) million or ($0.55) on a per share basis. For the quarter ending June 30, 2023 and versus the same prior year period:
➢ Research & development expense totaled $9.0 million, doubling from $4.5 million, primarily attributed to higher Phase III clinical trial expenses and drug development costs, and increases in stock-based compensation, safety and toxicology expense and salary costs. These increases were partially offset by lower manufacturing and testing expense, preclinical expenditures, and recruiting expenses;
➢ General & administrative expenses totaled $3.1 million, rising 200% from $1.0 million on account of greater stock-based compensation, legal expenses, recruiting expenses, consultant and professional expenses, and salary and board of director compensation. These were partially offset by a decrease in health and commercial insurance;
➢ Loss on remeasurement of warrant liabilities of ($456,000) resulted from an increase in the value of the share price during the measurement period;
➢ Net interest income was $90,000 which decreased over prior year levels due to lower cash balances;
➢ Provision for taxes was $6,000 related to taxable subsidiary revenue operations;
➢ Net loss was ($12.4) million vs ($5.3) million, or ($0.55) and ($0.29) per share, respectively.
At the end of June 2023, Reviva held $11.2 million in cash on its balance sheet. Management expects this amount to sustain the firm until the fourth quarter of this year. 2Q:23 cash burn was ($5.3) million and cash contributions from financing were $5.2 million representing proceeds from exercise of warrants.
Summary of Scientific and Investor Conferences
➢ Poster presentation at Society of Biological Psychiatry convention – April 29, 2023
➢ AGP’s Virtual Healthcare Conference – May 23, 2023
➢ Benchmark Virtual Healthcare House Call Conference – May 23, 2023
➢ American Society for Pharmacology and Experimental Therapeutics poster presentation – May 2023
➢ International Societies for Investigative Dermatology (psoriasis) – May 2023
➢ Annual Scientific Convention of the Society of Biological Psychiatry – May 2023
➢ American Thoracic Society International Conference (IPF) – May 2023
➢ Maxim Group Virtual Healthcare Conference – June 2023
➢ H.C. Wainwright Neuropsychiatry Virtual Conference – June 2023
RECOVER Phase III Trial
As of mid-August 2023, Reviva has fully enrolled its Phase III, RECOVER (NCT05184335), trial, ultimately enrolling 402 patients. Subjects have been enrolled in the United States (~60%), Europe (~10%) and Asia (~30%). As illustrated in the following exhibit, the trial was designed as a four-week efficacy study followed by a one-year safety extension.
Brilaroxazine was administered at fixed doses of 15 mg or 50 mg once daily. The study assessed both dose levels over 28 days in the double-blind phase in acute schizophrenia for a total of three arms, randomized 1:1:1, including placebo. In the 52-week open-label extension in stable schizophrenia, subjects will be dosed at 15 mg, 30 mg or 50 mg. Primary outcome measures are the change in total Positive and Negative Syndrome Scale (PANSS) scores from baseline over the 28-day evaluation period. Secondary outcome measures include antipsychotic efficacy using a variety of scales and subscales. In the Phase II REFRESH study, 15 mg was the best performing, with the 50 mg arm a close second in terms of efficacy.
Inclusion of the 50 mg dose arm will allow therapeutic insight, both in terms of efficacy and safety, of higher doses in the population and will give Reviva an additional opportunity to meet primary endpoints. The open-label cohort will comprise both subjects who participated in the double-blind phase and new (de novo) subjects. With a 52-week open-label extension following the 28-day double-blind phase, the trial is expected in total to last 56 weeks. As demonstrated in earlier studies, brilaroxazine represents class-leading tolerability in terms of side-effects, a significant deterrent to treatment adherence in the target patient population.
Top-line data is expected to be reported in October 2023 for the RECOVER trial. A one year open-label extension of the study is active and 50% enrolled. The extension is expected to be completed in the third quarter of 2024.
Schizophrenia Key Opinion Leader Event
On May 2nd, 2023, Reviva hosted a key opinion leader (KOL) event featuring Larry Ereshefsky PharmD, BCPP, FCCP. He is a retired professor of Psychiatry, Pharmacology and Psychiatry at The University of Texas and Chief Scientific Officer and owner of Follow the Molecule LLC. The event included an introduction by Reviva CEO Laxminarayan Bhat, PhD, a review of antipsychotics, the unmet need and translational aspects by Dr. Ereshefsky then a review of brilaroxazine by Dr. Bhat followed by a question-and-answer session.
Dr. Ereshefsky began with a review of the clinical features of schizophrenia, identifying both the positive and negative symptoms that appear in those suffering from the affliction. Due to the debilitating symptoms, patients are not able to fully function at work or in society. Costs related to the physical, psychological, emotional, social and financial aspects run at over an estimated $340 billion broken down into direct health care costs, direct non-health care costs and indirect costs. The largest financial impact is caregiving which makes up a third of the total.
Schizophrenia is a progressive illness that consists of positive symptoms, negative symptoms and cognitive deficits that worsen over time. Multiple neural circuits, receptors and transmitters are implicated in the progression of the disease. A new theme that has come into focus is that there is an immune and inflammatory process that contributes to psychiatric and neurologic disorders. While there are medications available, they do not work very well, have poor tolerability and negative side effects which leads to poor or non-compliance with drug regimens.
While antipsychotics have improved with new generations, there are still shortcomings, such as metabolic, endocrine, neuroleptic and autonomic side effects that have not been fully resolved. Dr. Ereshefsky’s presentation continued with a technical discussion of brilaroxazine’s performance in animal models and its functional activity in a number of dopamine, serotonin and nicotinic receptors in comparison with other approved antipsychotics. Brilaroxazine’s mechanism of action suggests that it can temper the inflammatory response and provide another path to addressing the disease.
The presentation continued with a summary of some of the dimensions where brilaroxazine has a favorable profile compared to approved products.
➢ Reduction in inflammatory cytokines and chemokines in animal models;
➢ May have lower metabolic side effect profile (weight gain);
➢ Lower expected levels of drug-drug interaction;
➢ Less prevalence of extrapyramidal movement disorder;
➢ Lower sedation levels;
➢ Additional details provided in related presentation.
A replay of the event is available here.
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1. Source: Reviva Pharmaceuticals July 2023 Corporate Presentation
2. Reviva Corporate Presentation, KOL Webinar, May 2023
