Mr. Nicholas Kadysh reports

USFDA APPROVES LANEO MDMA FOR CLINICAL TRIAL USE IN THE UNITED STATES

The United States Food and Drug Administration (USFDA) has approved a clinical trial utilizing Pharmala Biotech Holdings Inc.'s LaNeo MDMA investigational medical product (IMP) capsules (40 milligrams (mg)). This is the first time that Pharmala's IMP has been approved for trial use in the United States.

"While we've had great success with many regulators around the world, it's still a major milestone to receive a stamp of approval from USFDA for our investigational drugs," said Dr. Harpreet Kaur, vice-president of research at Pharmala Biotech. "As with any IMP supplier, there are always questions about chemistry, manufacturing and control -- even for well-known molecules. We believe that this announcement should confirm that our IMP conforms to the high levels of quality and documentation that one of the pre-eminent regulators in the world requires.

Pharmala supports numerous researchers around the world who are studying MDMA for a diverse series of indications. The company also provides psilocybin to researchers through their partnership with Mindset Pharma. In Australia, which is allowing treatment of patients with both MDMA and psilocybin through the authorized prescriber program as of July 1, Pharmala has formed a joint venture with Vitura Health in order to distribute its products, called Cortexa.

"We found that the FDA scrutinized our materials and processes in a rigorous but fair fashion," said Nick Kadysh, chief executive officer, Pharmala Biotech. "As with all of our clients, we worked hard to support UCLA researchers in their application to USFDA. We hope that they are pleased with the results and look forward to providing them with their IMP as soon as DEA and Health Canada issue the relevant permits."

The Pharmala team, led by sales director David Purcell, will be hosting a booth for potential customers at Psychedelic Science 2023 Conference in Denver for the week of June 19 to 23.

About Pharmala Biotech Holdings Inc.

Pharmala Biotech 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.

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