PharmAla to supply Johns Hopkins Medicine for Clinical Trial

TORONTO, Sept. 11, 2024 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is proud to announce that it has been contracted as a supplier of MDMA to a clinical trial at Johns Hopkins Medicine.

“We’re looking forward to continuing to provide exceptional service – as well as robust investigational drug product – to researchers in the US and around the world,” said Nicholas Kadysh, CEO, PharmAla Biotech. “Over the past month we have been in communication with a great number of researchers, and we believe that only PharmAla is in a position to fulfill the need for GMP MDMA that has met the quality standards set by regulators like FDA.”

Researchers can access a new tool, offered at https://pharmala.ca/clinical-trials, which provides access to drug product quality information, which researchers can examine directly. PharmAla is confident that it can offer research customers rapid support to convert their clinical trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing and Control package.

Conclusion of Contract with Red Light Holland

PharmAla is disclosing that the Company initiated procedures to terminate its agreement with Red Light Holland, and that said contract was concluded on September 3, 2024.

Presentation at European Behavioural Pharmacology Society (“EBPS”) Workshop

PharmAla is furthermore pleased to have been selected to present the data on its novel proprietary molecule, APA-01, as “Hot Topics” at the EBPS Workshop on September 26th. The presentation “APA-01 : Development of a potent entactogen with improved safety pharmacology compared to MDMA” discusses results of PharmAla’s pre-clinical animal research.

“We are delighted with our acceptance for Hot Topics, a testament to the work we continue to do in identifying and validating novel MDMA-like molecules with improved safety pharmacology,” said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “We are pleased that our work with the Fantegrossi lab has continued to be noted and considered highly by academic researchers and are looking forward to presenting some of our results.”

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTCQB: MDXXF) 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 as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. 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

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.