Reviva Pharmaceuticals Holdings, Inc. - RVPH STOCK NEWS

Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced new vocal biomarker data from its Phase 3 RECOVER trial of brilaroxazine in schizophrenia. The data, presented during a virtual key opinion leader event, showed statistically significant speech latency results, reinforcing the drug's strong efficacy for negative symptoms and other key symptom domains of schizophrenia.

Highlights include:

• Brilaroxazine demonstrated a safety profile comparable to placebo
• Strong efficacy across major symptom domains, including negative symptoms
• Vocal biomarker data provides an objective tool supporting primary and secondary endpoints
• Additional data from an ongoing open-label extension study expected in Q4 2024

Experts emphasized brilaroxazine's potential to address unmet needs in schizophrenia treatment, particularly its efficacy for negative symptoms and cognition, coupled with a strong efficacy-to-side-effect ratio.

Reviva Pharmaceuticals Holdings (NASDAQ: RVPH), a late-stage pharmaceutical company focusing on CNS, inflammatory, and cardiometabolic diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024.

Key details include:

• CEO Dr. Laxminarayan Bhat will deliver a corporate update
• A pre-recorded presentation will be available on-demand from September 9, 7:00 a.m. ET
• Management will participate in virtual one-on-one meetings

Investors can access the presentation via a provided webcast link and arrange meetings with management through H.C. Wainwright sales representatives.

Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced a virtual key opinion leader (KOL) event scheduled for September 4, 2024, at 2:00 PM ET. The event will focus on discussing vocal biomarker data from the Phase 3 RECOVER trial of brilaroxazine in schizophrenia. Two experts, Dr. Brian Kirkpatrick and Dr. Mark Opler, will lead the discussion on:

1. The unmet medical need and current treatment landscape for schizophrenia patients
2. Application of speech latency as an objective vocal biomarker in schizophrenia trials
3. Results of the vocal biomarker data and their relationship to primary and secondary endpoints

The event aims to provide insights into the efficacy of brilaroxazine in treating schizophrenia symptoms, particularly focusing on negative symptoms, social functioning, and cognition.

Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) has announced the pricing of an underwritten offering of 4,761,905 shares of common stock (or pre-funded warrants) and investor warrants to purchase up to 4,761,905 shares. The combined offering price is $1.05 per share, priced at-the-market under Nasdaq rules. The company expects to receive gross proceeds of approximately $5.0 million.

The offering includes warrants with an exercise price of $0.7964 per share, exercisable immediately and expiring in five years. Reviva intends to use the proceeds to fund research and development activities, including its Phase 3 RECOVER-2 trial, and for working capital. The offering is expected to close on or about August 22, 2024.

Additionally, Reviva has agreed to amend certain existing warrants held by the investor, reducing their exercise price to $0.7964 per share.

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.