Reviva Pharmaceuticals Holdings, Inc. - RVPH STOCK NEWS

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) reported Q2 2024 financial results and recent business highlights. Key points include:

1. Topline data from 1-year open-label extension (OLE) trial in schizophrenia expected Q4 2024.

2. Registrational RECOVER-2 trial in schizophrenia to initiate Q3 2024; topline data expected Q4 2025.

3. European patent granted for brilaroxazine use in treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH).

4. U.S. patent granted for brilaroxazine in treating idiopathic pulmonary fibrosis (IPF).

5. Q2 2024 net loss of $7.9 million ($0.26 per share), compared to $11.7 million ($0.52 per share) in Q2 2023.

6. Cash position of $6.2 million as of June 30, 2024.

Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) has announced the grant of U.S. Patent 12053477 by the USPTO for the use of brilaroxazine in treating idiopathic pulmonary fibrosis (IPF) and pulmonary fibrosis in patients with COPD, sickle cell anemia, scleroderma, or lung cancer. This patent complements existing protection in Japan. Notably, brilaroxazine has received Orphan Drug Designation from the FDA for IPF treatment.

Dr. Laxminarayan Bhat, CEO of Reviva, emphasized the expansion of their intellectual property portfolio, highlighting brilaroxazine's potential in treating inflammatory conditions related to serotonin signaling disruption. This patent strengthens Reviva's position in developing treatments for interstitial lung diseases.

Reviva Pharmaceuticals announced that the European Patent Office has granted European Patent EP3244896 for the use of brilaroxazine in treating pulmonary hypertension (PH) and pulmonary arterial hypertension (PAH), including patients with chronic obstructive pulmonary disease (COPD) or sickle cell disease (SCD).

This extends the company's existing patent protections in key markets such as the U.S., China, and Japan.

Brilaroxazine, which has an Orphan Drug Designation from the FDA for PAH, targets the underlying disruption in serotonin signaling responsible for PH/PAH. It has shown favorable safety and tolerability in over 800 subjects in multiple clinical trials.

Recent studies have demonstrated a significant reduction in proinflammatory biomarkers and pulmonary arterial pressure, underscoring its therapeutic potential.

Reviva aims to explore further clinical development opportunities for brilaroxazine in treating PH and PAH.

Reviva Pharmaceuticals Holdings announced the closing of a $3 million registered direct offering, involving the sale of 1,898,734 shares of common stock and warrants to purchase an equal number of shares, priced at $1.58 per share. The warrants, priced at $1.455 per share, are immediately exercisable and expire in five years. H.C. Wainwright & Co. acted as the exclusive placement agent. The proceeds will fund the Phase 3 RECOVER-2 trial, working capital, and other corporate purposes. Additionally, certain existing warrants were amended, reducing their exercise price from $5.00 to $1.455 per share. The offering was conducted under an effective registration statement filed with the SEC.

Reviva Pharmaceuticals Holdings announced a $3 million direct offering for 1,898,734 shares of common stock and warrants, each priced at $1.58 per share. The warrants, priced at $1.455 per share, will expire in five years. The offering is set to close on May 29, 2024, pending customary conditions. H.C. Wainwright & Co. is the exclusive placement agent. Gross proceeds will fund the Phase 3 RECOVER-2 trial, working capital, and other corporate needs. Previously issued warrants will be amended to a reduced exercise price of $1.455 per share, effective upon closing.

Reviva Pharmaceuticals (NASDAQ: RVPH) announced that its CEO, Dr. Laxminarayan Bhat, will participate in a panel discussion at the BIO International Convention from June 3-6, 2024, in San Diego. The panel, titled 'Challenging Biotech’s One-Track Mind When it Comes to Neuropsychiatric Drug Innovation,' will occur on June 4 at 4:15 p.m. PT. Reviva focuses on developing therapies for CNS, inflammatory, and cardiometabolic diseases, aiming to meet unmet medical needs. This participation underscores the company's active involvement in the biotech community and its commitment to innovation.

Reviva Pharmaceuticals has provided an update on the enrollment status of its open-label extension (OLE) study for brilaroxazine in treating schizophrenia. As of May 15, 2024, 358 patients have been enrolled, with 223 currently undergoing treatment across sites in the USA, Europe, and Asia. Notably, over 90 patients have completed 6-9 months of treatment, and 23 have completed a full year. This study aims to gather long-term safety data to support a New Drug Application (NDA) submission to the FDA by Q4 2025. Brilaroxazine has been generally well-tolerated among participants, and topline data from the study are expected in Q4 2024.

Reviva Pharmaceuticals (NASDAQ: RVPH) reported its first-quarter 2024 financial results and provided significant business updates. Key highlights include gaining FDA alignment on brilaroxazine's clinical trials for its NDA submission in schizophrenia, with the registrational RECOVER-2 trial set to begin in Q2 2024 and topline data expected Q3 2025. An open-label extension trial's topline data is anticipated in Q4 2024.

Financially, Reviva faced a net loss of $7.4 million for Q1 2024, compared to a $6.9 million loss in Q1 2023. The company's cash reserves dropped from $23.4 million at the end of 2023 to $12.0 million as of March 31, 2024. Upcoming catalysts include potential Phase 2a studies for bipolar disorder, major depressive disorder, and ADHD, and an IND submission for a liposomal-gel formulation of brilaroxazine in psoriasis in 2025.

Reviva Pharmaceuticals Holdings, Inc. will present new preclinical efficacy data on brilaroxazine in idiopathic pulmonary fibrosis at the 2024 ATS International Conference. The data will be presented by the CEO, Laxminarayan Bhat, in a late-breaking poster presentation. The presentation will focus on the effectiveness of brilaroxazine on functional and underlying pathological inflammation and fibrosis parameters in an animal model. This event will take place on May 21, 2024, in San Diego, CA.