PharmAla Biotech Holdings Inc. announced that they have completed a Letter of Intent ("LOI"), and received initial Ethics Board Approval, to initiate an Observational Trial (the "Trial") on patients treated with 3,4 Methylenedioxymethamphetamine ("MDMA") through Health Canada's Special Access Program (SAP). The Parties will each play an important role in the execution of this trial:harmAla a Biotech is currently the only manufacturer of GMP MDMAor clinical use in Canada. PharmAla willll provide drug product to physicians under SAP through its licensed distribution partners, and connect clinicians and patients with UC researchers for voluntary data collection.

The University of Calgary, under the direction of Dr. Leah Mayo, Parker Research Chair in Psychedelics, will assess data pertaining to efficacy of MDMA in the treatment of PTSD under real-world circumstances. The University of Calgary will have full rights to publication of data generated by the trial, with no limitation by the Parties. Heroic Hearts Project Canada, a charity supporting veteran mental health by facilitating access to psychedelic-assisted therapy, will offer its future program participants who receive MDMA-assisted therapy via the SAP the option to participate in the Trial and thereby contribute RWE.

The announcement of the Trial comes following the release of the Senate of Cana's Subcommittee on Veterarans report, The Time is Now: Granting equitable access to psychedelic-assisted therapies, which urged Veterans Affairs Canada to increase research into the treatment of veterans' "moral injuries" such as Post-Traumatic Stress Disorder with psychedelic molecules, including MDMA. This trial will generate Real World Evidence ("RWE") on the efficacy of MDMA in the treatment the treatment of Post-Traumatic Stress Disorder which may be submitted to Health regulators, including Health Canada and Veterans Affairs Canada. The Parties hope that data collected in the Trial will add to the knowledge base of both regulators and the scientific community on the real-world evidence of efficacy and safety of these treatments.

The Parties' initial submission to the Review Ethics Board has been approved, and the parties intend to proceed to data gathering immediately. Subsequent Ethics Review Board submissions are contemplated in the LOI. As the trial is Observational in nature, no patients will be dosed as part of the trial's protocol.

The goal of the trial is to gather data on the efficacy of treatment for patients who are already qualified for treatment under the Special Access Program.