PharmAla Completes Shipment of LaNeo™ MDMA to Johns Hopkins

Rhea-AI Summary

PharmAla Biotech (OTCQB:MDXXF) has successfully delivered its LaNeo™ MDMA to Johns Hopkins University from its new U.S. distribution site. This marks a significant milestone for MDMA research in the United States, particularly benefiting investigator-sponsored clinical trials.

The company's LaNeo™ MDMA, which is already being used in clinical trials globally and in commercial medical applications in several countries, is now imported and approved for use in the continental US by state and federal regulators. Additionally, PharmAla has settled a $150,000 debt through the issuance of 1,666,667 common shares at $0.09 per share.

Positive

• Successfully established U.S. distribution capabilities for LaNeo™ MDMA
• Secured partnership with prestigious Johns Hopkins University for clinical trials
• Product already in commercial medical use in multiple countries
• Reduced debt obligations through share issuance

Negative

• Share issuance for debt settlement creates dilution for existing shareholders

TORONTO, Oct. 02, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTCQB:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is pleased to announce that it has completed its shipment of LaNeo™ MDMA to Johns Hopkins University from its newly onboarded distribution site in the United States.

“Our delivery to Johns Hopkins represents a new day for MDMA research in the United States, especially for those investigator-sponsored clinical trials who have struggled with investigational medical product sourcing in the past,” said Nick Kadysh, CEO, PharmAla Biotech. “We believe that ensuring a supply for PharmAla’s large and growing pool of Clinical Trial customers will ensure that data on MDMA’s efficacy in the treatment of a number of disorders becomes widely available – and will speed the day that MDMA is accepted worldwide as a powerful treatment not just for PTSD, but for a range of disorders.”

PharmAla’s LaNeo™ MDMA – already in use in Clinical Trials worldwide, and in commercial medical use in a growing number of countries – is now imported, released, and ready for use in the continental US, as approved by state and federal regulators.

Issuance of Shares for Debt Settlement

In addition, as previously announced, the Company has settled $150,000 of amounts owing to an arm’s length creditor through the issuance of 1,666,667 common shares in the capital of the Corporation at the deemed price of $0.09 per share.

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)(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.

FAQ

What is the significance of PharmAla's MDMA shipment to Johns Hopkins University?

The shipment represents a breakthrough for MDMA research in the US, particularly for investigator-sponsored clinical trials, and demonstrates PharmAla's ability to distribute through its new US facility with regulatory approval.

Where is PharmAla's LaNeo™ MDMA currently being used?

LaNeo™ MDMA is being used in clinical trials worldwide and has achieved commercial medical use authorization in multiple countries, now including continental US approval.

How did PharmAla (MDXXF) settle its recent debt?

PharmAla settled $150,000 of debt through the issuance of 1,666,667 common shares at a deemed price of $0.09 per share to an arm's length creditor.

What medical conditions is PharmAla's MDMA targeting?

PharmAla's MDMA is being investigated for PTSD treatment and has potential applications for a range of other disorders, according to the company.

What regulatory approvals has PharmAla received for LaNeo™ MDMA in the US?

PharmAla has received both state and federal regulatory approval for importing and using LaNeo™ MDMA in the continental United States.