PharmAla Receives First Office Action for PharmAla-1 PCT Filing

PCT Examiner Finds Molecule to be both Novel and Inventive

VANCOUVER, British Columbia, Sept. 25, 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 proud to announce that it has received the first office action from the Patent Cooperation Treaty (PCT) filing for the company’s novel PharmAla-1 (P-1) molecule. The filing for P-1 showed the molecule to be novel, with no previous Prior Art shown; It was also found to be inventive, due to the beneficial toxicology of P-1 compared to similar molecules, as shown by preclinical rodent model data generated by the laboratory of Prof. William Fantegrossi at the University of Arkansas for Medical Sciences.

“The generation of novel intellectual property is incredibly important for drug discovery companies like PharmAla. This First Office Action for P-1 shows that our drug discovery pipeline yields novel, inventive molecules with significant value as neuropsychiatric therapeutics,” said Nick Kadysh, CEO, PharmAla Biotech. “Our development pipeline, which can yield new molecules appropriate for pre-clinical development, is an incredible asset for PharmAla. We look forward to demonstrating this value to Pharmaceutical companies engaged in the development of Central Nervous System (CNS) Small Molecules.”

PharmAla-1 was first discovered through computational in-silico modelling exercises via PharmAla Biotech’s partnership with the University of Windsor, for which PharmAla has also received a grant from the Ontario Centres for Innovation. Proof-of-concept testing for P-1 showed significant efficacy and pro-social effect at dosage levels far lower than MDMA, PharmAla’s primary comparator molecule, as well as excellent safety pharmacology. P-1 is not considered a controlled substance anywhere in the world.

PharmAla will attend the BIO Investor Day in San Francisco on October 16^th-19^th, 2023, where it intends to share the results of this and other research with pharmaceutical industry representatives.

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’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