RVPH: Psoriasis IND Expected
NASDAQ:RVPH
READ THE FULL RVPH RESEARCH REPORT
1Q:23 Financial and Operational Results
On May 15, 2023, Reviva Pharmaceutical Holdings, Inc. (NASDAQ:RVPH) reported 1Q:23 financial and operational results and filed its Form 10-Q with the SEC. Since our previous update just over a month ago, Reviva has presented and participated in scientific and investor conferences, held a key opinion leader (KOL) event with a CNS consulting expert and announced its intent to file an investigational new drug (IND) application for brilaroxazine in psoriasis. Looking ahead, management has guided towards a mid-2023 topline announcement for the RECOVER Phase III study in schizophrenia which is now over 60% enrolled. Reviva is also developing protocols for two Phase IIa trials in ADHD and PAH that are slated to launch following receipt of non-dilutive funding.
Highlights for 2023:
➢ Completion of multiple parallel studies in support of schizophrenia program – March 2023
➢ Poster presentation at Society of Biological Psychiatry convention – April 2023
➢ >60% enrollment reached – May 2023
Reviva generated no revenues in 1Q:23 and expended ($6.7) million in operational endeavors, producing a net loss of ($6.6) million or ($0.30) on a per share basis.
For the quarter ending March 31, 2023 and versus the same prior year period:
➢ Research & development expense totaled $5.2 million, down 10% from $5.8 million, primarily attributed to a decrease in Phase III clinical trial expenses and lower drug development costs. A decline in preclinical expenditures also contributed to the change. These contractions were partially offset by increases in spend related to safety and toxicology studies, salary raises, greater stock-based compensation and payroll taxes and higher consulting expenses;
➢ General & administrative expenses totaled $1.5 million, falling 7% from $1.6 million on account of lower health and commercial insurance, legal expenses and payroll related expenses. These were partially offset by higher consultant and professional expense and board compensation;
➢ Gain on remeasurement of warrant liabilities of $11,000 resulted from a decrease in the value of the share price during the measurement period;
➢ Net interest income was $139,000 which increased over prior year levels due to higher interest rates;
➢ Provision for taxes was $3,000 related to taxable subsidiary revenue operations;
➢ Net loss was ($6.6) million vs ($7.4) million, or ($0.30) and ($0.40) per share, respectively.
At the end of March 2023, Reviva held $11.3 million in cash on its balance sheet. Management expects this amount to sustain the firm until 3Q:23. 1Q:23 cash burn was ($8.0) million and cash contributions from financing were $0.7 million sourced from debt issued to fund director and officer liability insurance and warrant exercise. We expect to see continued warrant exercise as Reviva share price sustains prices above 52-week highs. Proceeds from warrant exercise will contribute additional cash to Reviva’s coffers.
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, 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.
Conference Attendance
Annual Scientific Convention of the Society of Biological Psychiatry
Reviva CEO Laxminarayan Bhat presented a poster entitled Brilaroxazine (RP5063), a novel serotonin-dopamine stabilizer, displays antipsychotic efficacy in rodents at the 78th Annual Scientific Convention of the Society of Biological Psychiatry. The conference was held in San Diego with the presentation given the evening of April 29, 2023.
The poster concluded that brilaroxazine demonstrated significant antipsychotic effects on pharmacologic-induced behaviors associated with psychosis and schizophrenia in three standard translational surrogate rodent models. The data supports the proposed mechanism of action which modulates the dopamine and 5-HT pathways and neuroinflammation in animal models.
Data from the poster was accepted for publication in Medical Research Archives as detailed in a May 1st press release. The preclinical findings were further supported in Reviva’s previously conducted Phase II REFRESH trial in schizophrenia. Brilaroxazine’s ability to favorably impact neuroinflammation, as shown in the preclinical models, is supportive of an additional element of effectiveness not present in approved antipsychotics.
Other Scientific Conferences
As outlined in a recent communication, Reviva will participate in several upcoming scientific conferences. Dr. Bhat will present materials at the International Societies for Investigative Dermatology (ISID) Meeting, American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Thoracic Society (ATS). Topics will range from preclinical study results to pharmacokinetics, with each addressing brilaroxazine. At ATS, Dr. Bhat will discuss efficacy of brilaroxazine in an animal model of idiopathic pulmonary fibrosis. Presentation dates range from May 12th to May 24th and span the globe from Tokyo, Japan to Washington, DC.
Investor Conference
On May 18th, Dr. Bhat will participate in an investor conference hosted by Lytham Partners that will be conducted virtually. Reviva’s CEO will join a panel entitled “Phase 3 Drugs to Watch” and be available for 1:1 meetings with investors. Details of the event are available in the associated press release.
IND Filing for Brilaroxazine in Psoriasis
Reviva intends to file an investigational new drug (IND) application with the FDA for brilaroxazine in psoriasis 2024. The basis for the filing relies on supportive preclinical data included in a recent poster that was presented in Tokyo, Japan at the ISID conference on May 12th. The poster demonstrates the therapeutic potential of brilaroxazine lipogel, a novel, proprietary lipogel formulation for the topical treatment of psoriasis. It also notes that mental illness is a common co-morbidity for psoriasis and inflammation.
The poster concluded that the brilaroxazine lipogel formulation provides an initial proof of concept for efficacy at the preclinical stage. This was based on results from the psoriasis area and severity index (PASI) score, Baker’s score based on hematoxylin and eosin (H&E) skin staining and proinflammatory cytokines. The work in the study supports D and 5-HT receptors as viable psoriasis targets and offers a first look at changes indicating anti-inflammatory, anti-fibrotic, and anti-proliferative effects. Details and images of the analysis are found in the poster link. A composition of matter patent has been filed for the associated brilaroxazine-lipogel formulation in the psoriasis indication.
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
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1. Reviva Corporate Presentation, KOL Webinar, May 2023
2. Screenshot from March 2023 Interview with Dr. Bhat.
