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Fourth Quarter and Fiscal Year 2021 Financial and Operational Results
On March 15, 2022, Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) announced fourth quarter and fiscal year 2021 financial and operational results and filed its Form 10-K with the SEC. On February 1, 2022, Reviva announced that the first patients had been dosed in the Phase III RECOVER trial assessing RP5063 (brilaroxazine) in acute exacerbation of schizophrenia.
Highlights for the fourth quarter and to-date include:
➢ Presentation at H.C. Wainwright 23rd Annual Global Investment Conference - September 2021
➢ Presentation at Benzinga Healthcare Small Cap Conference - September 2021
➢ Presentation at H.C. Wainwright BioConnect Virtual Conference - January 2022
➢ Receipt of "May Proceed" letter from the FDA - January 2022
➢ First patients dosed in Phase III RECOVER trial - February 2022
Reviva generated no revenues in 2021 and expended ($10.1) million in operational costs, producing a net loss of ($8.5) million or ($0.58) on a per share basis.
For the year ending December 31, 2021 and versus the same ending December 31, 2020:
➢ Research & development expense totaled $4.9 million, up significantly from $0.3 million, primarily attributed to acceleration of research and development activities ahead of clinical trials, higher drug development costs, salary expenditures and increased consulting costs;
➢ General & administrative expenses totaled $5.3 million, increasing 146% from $2.1 million, primarily attributable to a $1.8 million increase in legal and accounting consulting expenses, an increase of insurance costs by $1.2 million now that Reviva is public, and a $0.9 million increase in salary and related expenses for new personnel, offset by a decrease of approximately $1.1 million in warrant expense;
➢ Gain on remeasurement of warrant liabilities was $1.6 million versus nil;
➢ Interest expense was nil versus $1.4 million;
➢ Net loss was ($8.5) million vs ($3.8) million, or ($0.58) and ($1.24) per share, respectively.
At the end of the reporting period, Reviva held $29.7 million in cash on its balance sheet, buoyed by the $34.5 million capital raise completed in mid-2021. Cash burn was ($10.7) million. Management expects this amount to sustain the firm through 2022. With RECOVER results expected in 2023, Reviva will be required to raise additional funds in the near term. Proceeds from this raise may enable Phase IIa studies this year in bipolar disorder, MDD, and ADHD.
"May Proceed Letter," First Patients Dosed in RECOVER
Reviva announced on January 10, 2022 the receipt of a May Proceed letter from the FDA regarding pivotal Phase III clinical trials for brilaroxazine in schizophrenia, including one long-term safety trial. Through the letter, the FDA allowed Reviva to proceed with brilaroxazine's clinical investigation. Reviva's Phase III trial designated RECOVER is now underway, a four-week efficacy study followed by a one-year safety extension. The trial will target enrollment of 400 subjects. Based on the construction of the study, which could be extended due to exogenous events, we see the trial lasting 16 – 18 months with results available mid-2023.
Shortly after receiving its "May Proceed" letter from the FDA, Reviva announced on February 1, 2022 that the first patients had been dosed in its long-term, randomized, double-blind, multicenter Phase III RECOVER trial (NCT05184335) evaluating effect and safety of brilaroxazine in acute schizophrenia versus placebo. Reviva initiated the first clinical site in Bentonville, Arkansas with two patients dosed at the Pillar Clinical trial site led by its principal investigator, Fayz A. Hudefi, M.D. Brilaroxazine will be given at fixed doses of 15 mg or 50 mg once daily and the study will assess both 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 will be 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. We remind investors that in the Phase II REFRESH study (NCT01490086), the 15mg arm was the best performing, with the 50mg 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, in higher doses in a population almost double the size, 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 patient population suffering from schizophrenia.
Interview
We invited Reviva CEO, Dr. Laxminarayan Bhat, into the studio for an interview and discussion on Reviva and its lead candidate, brilaroxazine.
Topics discussed include:
➢ Reviva Pharmaceuticals: New Treatment for Schizophrenia
➢ Reviva Pharmaceuticals (RVPH) Active Clinical Trials
➢ Reviva Pharmaceuticals: Brilaroxazine - More than Schizophrenia
The interview is divided into several parts and provides a unique conversational, and expert exploration of Reviva and its value proposition for the investor. Importantly, Reviva CEO Dr. Bhat, who founded the company over 16 years ago, delves into Reviva's lead candidate, which is discussed in terms of the unmet need and its position in the schizophrenia treatment landscape. The effect of its enhanced tolerability on treatment discontinuation is covered, which stands out as a major hurdle in the treatment of schizophrenia. Market size of the antipsychotic drug class is reviewed and clinical trial design, namely clinical measures of symptoms, are detailed. The pleiotropic effect of brilaroxazine is explained in terms of its dichotomous pursuit of both neurological and pulmonary indications. The interview concludes with an overview of the financial condition of the firm and upcoming milestones.
Milestones
Reviva has a number of upcoming milestones that relate to the launch of its Phase III trial in schizophrenia. Preparation for Phase II trials for Brilaroxazine in additional indications is underway with regulatory work expected in the next quarters followed by launch, pending funding. We provide additional detail on recent and anticipated achievements below:
➢ Phase III trial design finalization with FDA – January 2022
➢ Launch of Phase III RP5063 trial (RECOVER) in acute and maintenance schizophrenia – 1Q:22
➢ First patient enrolled in RECOVER – February 2022
➢ Regulatory submissions for PAH & IPF – 1Q:22
➢ KOL event – March 2022
➢ Phase IIa studies in bipolar disorder, MDD, and ADHD (pending funding) – 2H:22
➢ Phase III schizophrenia RECOVER topline data – mid-2023
Company Pipeline
Summary
Reviva announced fourth quarter and fiscal year 2021 financial and operational results and filed its Form 10-K with the SEC. Highlights for the fourth quarter and to date include the initiation of Reviva's Phase III RECOVER trial for RP5063 in acute exacerbation of schizophrenia that includes a 52-week open label extension with focus on treatment safety, which may permit a potential ‘superior safety' label with the FDA. The first patients were enrolled in February and topline data is expected in mid-2023.
In the financial sphere, Reviva expended ($10.1) million in operational costs during 2021, producing a net loss of ($8.5) million or ($0.58) on a per share basis. At the end of the reporting period, Reviva held $29.7 million in cash on its balance sheet, buoyed by the $34.5 million capital raise completed in mid-2021. Cash burn for the year was ($10.7) million. Management expects this amount to sustain the firm through 2022.
Reviva's lead candidate, brilaroxazine, represents class-leading tolerability in an indication where side effects deter treatment adherence.
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1. Reviva 2021 10-K
2. Reviva Pharmaceuticals: New Treatment for Schizophrenia – CEO Interview
3. Source: Reviva Pharmaceuticals 2021 Form 10-K.
