Press Release

PharmAla Completes Pre-IND Meeting with FDA, to present at KCSA Virtual Investor Conference

Company invites individual and institutional investors, as well as advisors

VANCOUVER, BC, December 13, 2022 /Globe Newswire/ PharmAla Biotech (CSE:MDMA) is pleased to announce that it has completed its pre-IND meeting with the US Food and Drug Administration (USFDA). PharmAla thanks agency staff for guidance relating to its submission of an IND Data package, and looks forward to updating investors on its progress at the KCSA Virtual Investor Conference at 1:30 PM ET on December 15th.

DATE: December 15th, 2022

Available for 1x1 meetings: December 14th and 16th

“In less than 2 years, PharmAla has achieved significant milestones. We’re the first
publicly-traded company to synthesize GMP MDMA, and our novel drug development
program continues to bear significant fruit,” said Nick Kadysh, CEO of PharmAla
Biotech. “I look forward to updating both our current and new investors on our

Recent Company Milestones:

  • Presented pre-IND data to FDA regarding ALA-002, PharmAla’s first novel
    chemical entity
  • Became the only authorized global reseller for GMP Psilocybin manufactured by
    Mindset Pharma, now the only entity globally selling two GMP Psychedelic APIs
  • Completed manufacturing of our first batch of GMP MDMA in August 2022

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