Jun 9, 2023

USFDA Approves LaNeo MDMA for Clinical Trial Use in the United States

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Approved Study to Examine Tolerability of MDMA in Schizophrenia at UCLA

VANCOUVER, British Columbia, June 09, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA)(OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA), is pleased to report that the US Food and Drug Administration (USFDA) has approved a clinical trial utilizing PharmAla’s LaNeo MDMA Investigational Medical Product (IMP) capsules (40mg). This is the first time that PharmAla’s IMP has been approved for trial use in the United States.

"While we’ve had great success with many regulators around the world, it’s still a major milestone to receive a stamp of approval from USFDA for our investigational drugs. As with any IMP supplier, there are always questions about Chemistry, Manufacturing and Control - even for well-known molecules. We believe that this announcement should confirm that our IMP conforms to the high levels of quality and documentation that one of the preeminent regulators in the world requires."
~ Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech

PharmAla supports numerous researchers around the world who are studying MDMA for a diverse series of indications. The company also provides Psilocybin to researchers through their partnership with Mindset Pharma. In Australia, which is allowing treatment of patients with both MDMA and Psilocybin through the Authorized Prescriber Program as of July 1st, PharmAla has formed a Joint Venture with Vitura Health (ASX:VIT) in order to distribute its products, called Cortexa.

“We found that the FDA scrutinized our materials and processes in a rigorous but fair fashion. As with all of our clients, we worked hard to support UCLA Researchers in their application to USFDA. We hope that they are pleased with the results, and look forward to providing them with their IMP as soon as DEA and Health Canada issue the relevant permits.”
~ Nick Kadysh, CEO, PharmAla Biotech

The PharmAla team, led by Sales Director David Purcell, will be hosting a booth for potential customers at Psychedelic Science 2023 Conference in Denver for the week of June 19-23. Researchers interested in information regarding PharmAla’s IMP can visit www.PharmAla.ca.

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 the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. 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.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: 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.


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