RVPH: RECOVER Parallel Studies Complete
NASDAQ:RVPH
READ THE FULL RVPH RESEARCH REPORT
2022 Financial and Operational Results
On March 30, 2023, Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) reported 2022 financial and operational results and filed its Form 10-K with the SEC. Over the last year Reviva was cleared to start and began its Phase III clinical trial, RECOVER, evaluating brilaroxazine for the treatment of schizophrenia. The company has continued to advance the trial, now enrolling over 50% of the targeted subjects. Looking ahead, management has guided towards a mid-2023 topline announcement for the study. Reviva has conducted a capital raise, benefitted from an increase in share price, participated in several investor conferences and received multiple patents around the globe since the beginning of 2022. Reviva is also developing protocols for two Phase IIa trials in ADHD and PAH that will launch following receipt of non-dilutive funding.
Highlights for 2022 and to date:
➢ Receipt of “May Proceed” letter from the FDA for Brilaroxazine - January 2022
➢ First patients dosed in Phase III RECOVER trial - February 2022
➢ KOL webinar on Brilaroxazine for schizophrenia hosted – May 2022
➢ Presentation at multiple investor conferences – May/June 2022
➢ Dr. Bhat participates in RedChip Interview – September 2022
➢ Annual shareholder meeting – November 2022
➢ Global composition of matter patents issued for RP1208 – November 2022
➢ Positive results from brilaroxazine drug-drug interaction studies – December 2022
➢ Completion of multiple parallel studies for schizophrenia program – March 2023
➢ 50% enrollment reached – March 2023
Reviva generated no revenues in 2022 and expended ($24.3) million in operational endeavors, producing a net loss of ($24.3) million or ($1.25) on a per share basis.
For the year ending December 31, 2022 and versus the same prior year period:
➢ Research & development expense totaled $18.9 million, up 290% from $4.9 million, primarily attributed to an increase in Phase III clinical trial activity and higher drug development costs for brilaroxazine, preclinical expenditures and other clinical expenses, manufacturing, testing, and delivery of chemicals, safety and toxicology studies and other clinical expenses. Other contributors to higher expenses included salaries, recruiting expenses and stock-based compensation which were slightly offset by a decrease in consulting expenses;
➢ General & administrative expenses totaled $5.4 million, rising 2% from $5.3 million, on account of higher consultant and professional fees, recruiting expenses, health and commercial insurance partially offset by lower legal expenses, salaries and wages and other expense;
➢ Loss on remeasurement of warrant liabilities of ($200,000) resulted from an increase in the estimated fair value of the warrants due to the equity price increase,
➢ Interest income was $183,000 which increased over prior year levels due to higher interest rates;
➢ Provision for taxes was $21,000 related to taxable subsidiary revenue operations;
➢ Net loss was ($24.3) million vs ($8.5) million, or ($1.25) and ($0.58) per share, respectively.
At the end of the reporting period, Reviva held $18.5 million in cash on its balance sheet. Management expects this amount to sustain the firm for the majority of 2023 but Reviva will need capital during 4Q:23. 2022 cash burn was ($19.0) million and cash contributions from financing were $7.8 million which was predominantly attributable to the September equity offering. Proceeds from this raise and other non-dilutive financing may enable Phase IIa studies this year in bipolar disorder, major depressive disorder (MDD), and attention-deficit/hyperactivity disorder (ADHD). We expect that some of the lower priced warrants may be exercised on the higher share price over the last few months, which may contribute additional cash to Reviva’s coffers.
Dr. Bhat Interview
Interviews with Reviva’s CEO, Dr. Laxminarayan Bhat:
➢ Reviva: Next Generation Blockbuster
➢ Reviva’s Clinical and Regulatory Timelines
➢ Reviva: More Than Schizophrenia
➢ Reviva's Brilaroxazine Addresses Antipsychotics' Biggest Hurdles
➢ Fireside Chat: Reviva's RP1208 & Thoughts on Peers
RP1208 Composition of Matter Patent
Reviva holds two compounds in its portfolio of assets: lead candidate brilaroxazine and secondary candidate RP1208. The latter of these is a triple reuptake inhibitor in preclinical development for depression and obesity. Both of these assets are fully owned by Reviva and the claim on their intellectual property was recently strengthened with the grant of a composition of matter patent in Canada. The patent (CA2858837C) protects the composition of novel phenylcycloalkylmethylamine derivatives (PDs) and methods of preparing them. The invention also provides methods of using PDs for the pharmacological treatment of obesity, depression and obesity related co-morbid indications.
Parallel Registrational Studies
Reviva has been completing several parallel registrational studies for its Phase III brilaroxazine study in schizophrenia. This includes the clinical absolute bioavailability, metabolism and excretion study, the non-clinical study of interactions with drug transporters as well as the pharmacokinetic, metabolism and excretion studies in mouse and dog models.
A drug-drug interaction (DDI) has also been completed, which is especially important in schizophrenia patients. Antipsychotic medications are the primary class of drugs used to treat schizophrenia, which work by blocking dopamine receptor activity in the brain. However, not all antipsychotic medications work equally well for all patients and some individuals may experience significant side effects. As a result, healthcare providers may need to prescribe a combination of different antipsychotics or other medications, such as mood stabilizers or antidepressants, to achieve the best results for their patients resulting in multiple drug regimens.
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1. Screenshot from March 2023 Interview with Dr. Bhat.
