Mr. Nicholas Kadysh reports

PHARMALA SIGNS AGREEMENT AND INITIATES R&D WITH COREALIS PHARMA FOR GMP MANUFACTURING OF ITS PATENTED ALA-002 DRUG PRODUCT

Pharmala Biotech Holdings Inc. has signed an agreement with Corealis Pharma Inc., a good manufacturing practice-compliant contract development and manufacturing organization (CDMO) based in Laval, Que., for the GMP manufacturing of ALA-002 drug product for clinical supply.

The agreement adds a high-quality drug product manufacturer to Pharmala's ALA-002 supply chain. Corealis was selected following a technical, quality, and regulatory evaluation of contract development and manufacturing organizations (CDMOs).

"We're confident that Corealis is the right partner to execute this work," said Farnoud Kazemzadeh, chief operating officer, Pharmala Biotech. "We are also excited to bring this drug development work back to Canada."

Corealis has already begun R&D (research and development) on the drug product formulation, with GMP manufacturing of the first ALA-002 drug product batch scheduled upon completion of development activities. ALA-002 will initially be developed and launched as a 50-milligram capsule.

"We are pleased to support Pharmala with the clinical manufacture of ALA-002. This expansion builds on our expertise in oral solid dosage development and manufacturing, enabling us to support the development of potential therapies for conditions such as PTSD," said David Leroux-Petersen, chief executive officer of Corealis Pharma.

"As MDMA winds its way towards regulatory approval in more jurisdictions -- with media reports indicating that a new drug application (NDA) has been accepted for review by the U.S. Food and Drug Administration (USFDA) -- it is critically important that Pharmala's next-generation patented MDMA-derived products be ready for testing and clinical development," said Nicholas Kadysh, founding chief executive officer of Pharmala. "Since the signing of our U.S. out-licensing agreement for ALA-002 earlier this year, interest in the asset has only increased. Having a GMP drug product formulation completed is a necessary step for clinical research (both in-house and via partners) but also opens the door to numerous new commercial opportunities."

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 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.

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