Highlights include Revenue Growth, Expansion of IP Licensing, and formation of Cortexa Joint Venture
VANCOUVER, BC December 29th, 2023 - PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC: PMBHF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is pleased to file its audited financial statements for the year ended on August 31, 2023.
Following is a short list of the company’s achievements in the relevant period:
- PharmAla became the first publicly traded company to produce GMP MDMA, and the first company to release its LaNeo™ GMP MDMA Drug Product
- PharmAla became the first company to treat patients for PTSD with MDMA in Canada through the Special Access Program
- PharmAla completed a deal with Australia's Vitura Health to form a 50:50 Joint Venture called Cortexa; Cortexa is already the premier supplier of MDMA and Psilocybin to both Clinical Trials and Patients in Australia through the Authorized Prescriber Scheme.
- PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.
- Disclosed 7 Novel Chemical Entities (NCE), with more in the pipeline
- Submitted and received guidance from regulators on Phase 2 trials for PharmAla’s lead NCE, ALA-002.
“This has been an exciting year for PharmAla, and for MDMA more broadly” said Nick Kadysh, CEO, PharmAla Biotech. “I’m incredibly proud of the team’s performance this year. We are excited to continue to build off of the milestones we achieved at PharmAla in 2023. The recent filing of the MAPS New Drug Application for MDMA-Assisted Therapy for PTSD provides a favourable industry tailwind. I strongly believe that 2024 will be the Year of MDMA; with our established track record and success in 2023, as well as our newly acquired global reach, it will be our year as well.”
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.
Nicholas Kadysh, CEO