PharmAla Completes Historic First Shipment of MDMA and Psilocybin to Cortexa

Shipment marks the first batch of Psychedelic molecules explicitly for the Authorized Prescriber Scheme

VANCOUVER, British Columbia, Nov. 07, 2023 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is pleased to announce that it has completed its first shipment of MDMA and psilocybin to Cortexa, its 50:50 Australian Joint Venture with Vitura Health Limited (ASX: VIT). This shipment marks the first time that any molecules recently re-scheduled under the Authorized Prescriber Scheme were brought into Australia explicitly for use under that scheme, rather than for clinical trial purposes. The shipment, completed in several parts, includes both psilocybin and MDMA, and contains a both API and finished drug product capsules.

“As the Australian market continues to develop we are seeing significant interest among both clinical trial practitioners and clinic operators who are racing to establish themselves as the most capable actors in the provision of treatments to patients,” said Nick Kadysh, CEO, PharmAla Biotech. “However, when it comes to the provision of pharmaceutical grade medicines which underpin those treatments, I don’t believe there is competition: Cortexa stands as the industry leader in the import, sale and distribution of psilocybin and MDMA for medical purposes.”

The provision of these materials for Cortexa’s commercial use, as well as the transfer of relevant intellectual property to Cortexa, allows for Cortexa to subsequently rely on domestic manufacturing within Australia, rather than imports. This should allow for lower cost-of-goods and a shorter time to market , for these products.

“As PharmAla’s JV partner in Cortexa, we at Vitura Health are proud to continue to lead the industry in the provision of both of GMP grade Psilocybin and MDMA, which will be used in treating patients as soon as possible. However, as almost anyone involved in this industry can attest, the import of these materials presents significant logistical and regulatory challenges.” said Rodney Cocks, CEO of Vitura Health. “That’s why I’m pleased that Cortexa, as demand grows, can embark upon its next logical step, scaling domestic manufacture of GMP grade psilocybin and MDMA to fulfill local demand without the difficulty, cost, and lag of foreign-made materials”

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 the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its 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

About Cortexa

Cortexa Pty Ltd, is an incorporated joint venture with Canadian-based PharmAla Biotech (CSE:MDMA) and Australia-based Vitura Health Limited (ASX:VIT). Cortexa aims to be the leading supplier of psychedelics, GMP MDMA and GMP psilocybin, for research and therapeutic use in Australia.

www.cortex.com.au

About Vitura Health

Vitura Health Limited is diversified digital health business operating in healthcare across medicinal cannabis, psychedelics and telehealth listed on the ASX (ASX:VIT) and, via its subsidiaries, operates the following businesses:

• Burleigh Heads Cannabis – www.burleighheadscannabis.com
• CanView – www.canview.com.au
• Cortexa – www.cortex.com.au
• Doctors on Demand – www.doctorsondemand.com.au
• CDA Clinics – www.cdaclinics.com.au
• Cannadoc – www.cannadoc.com.au

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