Press Release

Patent Allowance Granted for P-1 Molecule by US Patent and Trademark Office

Novel MDMA-Like Drug Could Be Used for Numerous Neurological and Psychiatric Indications

Toronto, ON – March 20, 2024 - 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 thrilled to announce that allowance has been granted for the Composition of Matter of its PharmAla-1 (P-1) molecule by the US Patent and Trademark Office (USPTO). P-1 is an enantiomerically pure composition of (R)-2-[(2H-1,3-BENZODIOXOL-5-YL)METHYL]PYRROLIDINE.

“In proof-of-concept rodent models at the laboratory of Prof. William Fantegrossi, P1 showed a number of features which we believe to be extremely valuable in a therapeutic context,” said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “The molecule has an excellent therapeutic window; it shows a strong pro-social signal at dosage levels far below racemic MDMA. We also believe it can induce neuroplasticity, like many drugs in the tryptamine class, by crossing the cell membrane and binding to serotonin receptors within the cell. And of course, like all the molecules we choose to develop, P-1 has an excellent safety profile with low abuse liability.”

The composition was identified through PharmAla’s computational chemistry program at the University of Windsor, made possible by a grant from the Ontario Centres of Innovation. P-1 was submitted to the USPTO through the Patent Prosecution Highway program, allowing for accelerated patent examination. As the molecule is ready for pre-clinical and clinical development, the Company has elected to change its designation to APA-001.

“We foresee that APA-001 could potentially be used in a number of indications. The company is currently assessing those indications which show the most promise,” said Nick Kadysh, Founding CEO, PharmAla Biotech. “The potential for a drug that could not only assist with psychological trauma, but also neurological damage, could find broad applicability in the treatment of conditions such as Traumatic Brain Injury (TBI) and stroke. In addition there is potential applicability for the fear disorders often discussed in the context of MDMA.”

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 a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.

Media Inquiries

Nicholas Kadysh, CEO