Building specialty psilocybin-based product pipeline

Evaluating potential for neuropsychiatric indications for clinical studies in 2022

TORONTO, Nov. 03, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.

PharmaTher is currently conducting IND-enabling research studies with MicroDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinicals studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021 by PharmaTher.

Revive is building a specialty psilocybin-based product pipeline with the aim to treat mental illness, substance abuse and neurological disorders. In addition to the proposed psilocybin MicroDose-MN™ patch, the Company has the following development and commercial programs:

  • Feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip;
  • Evaluating psilocybin as a potential treatment for methamphetamine use disorder, traumatic brain injury and stroke in a research collaboration with the University of Wisconsin-Madison;
  • Developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University; and
  • Research and commercialization agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda and commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

The collaboration agreement will give Revive the ability to evaluate the MicroDose-MN™ for psilocybin program to support upcoming clinical and commercial developments globally.

Michael Frank, CEO of the Company commented, “We are maintaining our focus in building a unique psilocybin-based product portfolio through research collaborations, licensing and commercialization agreements with academic research institutions and specialty pharmaceutical companies. The collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one fits all product profile solution with psilocybin and that for psilocybin to be a next generation therapeutic, it will require different use and delivery forms to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies.”

“Revive is a valued partner of PharmaTher and we are pleased to collaborate with them to achieve their objective in building a specialty psilocybin-based product pipeline that encompasses various delivery methods including our proprietary microneedle patch, which can deliver various psychedelics via the skin, enable flexible drug load capacity and combinations, and control-release delivery; overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems; maintain constant plasma levels for more than 24 hours; and aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office,” said Fabio Chianelli, CEO of PharmaTher.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at: PharmaTher.com and on Twitter and LinkedIn

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. 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: [email protected]
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 “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 annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.