Revive Therapeutics Advances with Next-Generation Bucillamine Development

Rhea-AI Summary

Revive Therapeutics (RVVTF) announces advancement in developing a next-generation lyophilized formulation of Bucillamine in collaboration with the University of Waterloo. The company is positioning New Bucillamine to target public health emergencies, including pandemic influenza and emerging infectious diseases. Bucillamine, which already holds FDA Orphan Drug Designation for ischemia-reperfusion injury in organ transplantation since 2022, shows promise in enhancing solid tumor treatments. The company is working with Defence R&D Canada to evaluate Bucillamine for nerve agent exposure, with results expected by June 2025. Clinical trials could begin in H2 2025, pending positive results. Revive is pursuing various FDA incentives and exploring partnerships to accelerate development and commercialization.

Positive

• FDA Orphan Drug Designation already secured for ischemia-reperfusion injury application
• Potential expansion into multiple high-value markets including cancer treatment and nerve agent exposure
• Ongoing collaboration with Defence R&D Canada with results expected June 2025
• Strategic pursuit of multiple FDA incentives including Emergency Use Authorization and Fast Track designation

Negative

• Pending arbitration settlement with LTS Lohmann Therapie-System AG
• Clinical trials for nerve agent exposure application not yet started
• No immediate revenue generation from current developments

TORONTO, June 04, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company dedicated to developing innovative therapeutics for critical medical needs, is pleased to announce the advancement of its next-generation lyophilized formulation of Bucillamine (“New Bucillamine”). Developed in collaboration with the esteemed University of Waterloo, this breakthrough aims to address significant unmet medical needs and unlock substantial value for shareholders.

Strategic Development Targeting High-Value Opportunities

Revive is strategically positioning New Bucillamine to target public health emergencies such as pandemic influenza and emerging infectious diseases. Additionally, the company will pursue FDA incentives, including Emergency Use Authorization, Orphan Drug Designation, Fast Track, and Breakthrough Therapy designations, maximizing the potential for rapid market entry and revenue generation.

Highlighting its potential, Bucillamine, a potent antioxidant and anti-inflammatory, already boasts FDA Orphan Drug Designation for ischemia-reperfusion injury following solid organ transplantation. This designation, awarded in 2022, underscores the compound's promise and provides a pathway to accelerated development and commercialization. Furthermore, research suggests Bucillamine may enhance solid tumor treatments in cancer and the Company has been contacted by a prominent clinical researcher from a U.S. University Cancer Institute to investigate Bucillamine for boosting anti-tumor effects in patients with advanced solid tumors, potentially opening up another significant market segment.

Strong Partnerships and Ongoing Research Driving Growth

Revive is committed to fostering strong pharmaceutical and government collaborations to accelerate New Bucillamine's clinical and commercial development. Currently, the company is working with Defence R&D Canada – Suffield Research Centre (DRDC), part of the Canadian Department of National Defence, on a study evaluating Bucillamine for nerve agent exposure. Positive results, expected by June 2025, could pave the way for human clinical trials in the second half of 2025 and subsequent FDA and Health Canada approvals. The potential applications of Bucillamine extend to traumatic brain injury and viral infections, further expanding its market potential and long-term value for investors.

Revive also reports that it is continuing to work with LTS Lohmann Therapie-System AG to settle the previously announced arbitration award.

About Revive Therapeutics Ltd.

Revive Therapeutics is a specialty life sciences company dedicated to developing innovative therapeutics for critical medical needs. Revive strategically prioritizes its drug development pipeline to leverage FDA regulatory incentives like Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations, positioning for rapid advancement and market entry. Currently, our efforts are concentrated on unlocking the vast potential of Bucillamine for infectious diseases and medical countermeasures, including the pioneering treatment of nerve agent exposure. Furthermore, Revive is vigorously advancing our Psilocybin and molecular hydrogen therapeutic programs, exploring new frontiers in medical science. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three and nine months ended March 31, 2025 ("MD&A"), dated May 29, 2025, which is available on the Company's profile at www.sedarplus.ca.

FAQ

What is the new development announced by Revive Therapeutics (RVVTF)?

Revive Therapeutics announced the advancement of a next-generation lyophilized formulation of Bucillamine, developed in collaboration with the University of Waterloo.

What FDA designations does Bucillamine currently have?

Bucillamine currently holds FDA Orphan Drug Designation for ischemia-reperfusion injury following solid organ transplantation, awarded in 2022.

What are the potential applications for Revive's new Bucillamine formulation?

The potential applications include pandemic influenza, emerging infectious diseases, solid tumor treatments in cancer, nerve agent exposure, traumatic brain injury, and viral infections.

When are the results expected from the Defence R&D Canada study on Bucillamine?

Results from the Defence R&D Canada study on Bucillamine for nerve agent exposure are expected by June 2025.

What is Revive Therapeutics' timeline for human clinical trials?

Pending positive results from the Defence R&D Canada study, human clinical trials are planned to begin in the second half of 2025.