PharmAla Biotech to supply Mind Medicine Australia with GMP MDMA for Clinical Trial

PharmAla's GMP MDMA will accelerate trial work funded by Australia's premier Psychedelics charity

VANCOUVER, BC, April 8, 2022 /CNW/ - PharmAla Biotech is proud to have been selected as the MDMA manufacturing partner for Mind Medicine Australia. Mind Medicine Australia's order will be available for delivery later this year, for use in an ethics approved healthy persons trial and will be subject to all necessary government approvals being obtained.

"We'd like to congratulate Nick and his team for the ground-breaking work that they have done in developing GMP, medical grade MDMA for use in clinical trials and regulatory approved expanded access schemes," said Peter Hunt, Board Chair of Mind Medicine Australia. "There is a desperate need for innovation in the mental health sector for hard-to-treat illnesses such as post-traumatic stress disorder which cause enormous suffering.  Clinical trials have shown that MDMA assisted therapy is safe to use in clinically controlled environments and can achieve high remission rates for people suffering from post-traumatic stress disorder".

Mind Medicine Australia is a registered charity founded by Tania de Jong AM and Peter Hunt AM in 2019. Mind Medicine Australia supports clinical research and is working towards regulatory-approved and evidence-based psychedelic-assisted therapies being available through the medical system in Australia for patients suffering from relevant treatment resistant mental illnesses including depression and post-traumatic stress disorder. Mind Medicine Australia connects medical practitioners, consumers, academia, government, industry, regulatory bodies, philanthropists, investors and other stakeholders and provides therapist training and clinical support for psychedelic assisted therapies through its Mind Medicine Institute. Mind Medicine Australia is focused specifically on the clinical application of regulatory approved medicinal psilocybin and medicinal MDMA assisted therapies for certain mental illnesses; its focus is entirely clinical in nature.

"PharmAla is currently the only company in North America which has completed a full GMP value chain for MDMA. We're so excited to be able to advance the work of Mind Medicine Australia, an organization which I have long admired for both their scientific rigour and advocacy efforts," said Nick Kadysh, PharmAla's CEO. "I know that these research materials will be put to good use, healing people and generating the data which Mind Medicine will use in their continuing efforts to legalize and destigmatize MDMA and other psychedelic-based treatments."

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a "regulatory first" organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America's first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla's research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas School for Medical Sciences in the United States and at InterVivo Solutions in Canada. For more information, visit www.PharmAla.ca.

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept 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 PharmAla's current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla 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. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla 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. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in PharmAla's management's discussion and analysis which is available on PharmAla's profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction

SOURCE PharmAla Biotech Inc.

Nicholas Kadysh, Chief Executive Officer, PharmAla Biotech Holdings Inc., Email: [email protected], Phone: [phone], Website: www.PharmAla.ca