Cortexa Commences Manufacturing GMP LaNeo™ MDMA in Australia

Novel Composition of MDMA Enantiomers leading to next-generation MDMA possibilities

TORONTO, April 05, 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 pleased to announce that, in another Australian first, its joint venture, Cortexa Pty. Ltd. (“Cortexa”), is proud to have commenced batch manufacturing of GMP LaNeo® MDMA 40mg capsules to support both clinical trials and clinical use under the TGA’s Authorised Prescriber pathway.

In doing so, Cortexa achieves another significant milestone, domestic Australian manufacturing, further strengthening its position as a leader in the Australian psychedelic landscape by executing on its plan to develop a reliable local supply. This advantage will free local clinicians and researchers from the costly and time-consuming burden of importation and provides seamless access to medication.

Optima Ovest Appointed as Contract Manufacturer

After a comprehensive due diligence process, Cortexa is pleased to announce it has entered an exclusive arrangement with Perth-based contract manufacturer Optima Ovest (Optima). Optima was established in 1995 and has extensive experience in the manufacture of GMP, clinical-grade pharmaceutical products, with the capacity to scale operations in line with demand.

Combined with Cortexa’s access to intellectual property and manufacturing experience from PharmAla, the agreement with Optima allows not only the establishment of onshore manufacture, but ensures a secure, domestic source of medication independent of the international supply chain.

“Domestic manufacture is a critical step in the growth of Cortexa, and part of the original plan for the business as envisioned by PharmAla and our partners at Vitura Health,” said Nick Kadysh, CEO, PharmAla Biotech. “I believe it is important not only because it brings us closer to our ultimate end customer – the patient – but because it signals our commitment to a growing Australian domestic market for LaNeo™ MDMA.”

Cortexa Growing the Australian Market

Since its inception in May 2023, Cortexa has quickly established itself as the leader in the emerging therapeutic area of psychedelic-assisted therapy in Australia through navigating the regulatory framework, being the first to complete importation, achieving supply of products to clinical trials and the authorised prescriber scheme and now the commencement of onshore manufacturing.

In addition, Cortexa will shortly commence a medical education program designed to increase awareness of Psychedelic Assisted Therapy amongst the broader adult psychiatry community and continue its engagement with peak bodies and key customers to further expand the market in Australia.

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