Water Tower Hour Recap
Founding CEO and President of PharmAla Biotech (CSE: MDMA/OTCQB: MDXXF) Nick Kadysh joined us on the Water Tower Hour podcast. Those interested can listen to this podcast on Apple Podcasts, Google Podcasts, Spotify, or on our website. Links accessible in our full report. Canada-based PharmAla, established in December 2020, runs a dual-tracked psychedelics business. It is a pre-eminent GMP manufacturer and supplier of clinical-grade MDMA (LaNeo™) for both research and commercial use in selected jurisdictions from which it is generating ~C$3 million of annualized revenue. The company also develops novel MDMA-derived Novel Chemical Entities (NCEs) with its Phase II stage lead molecule ALA-002 targeting the treatment of social anxiety in patients with autism. The importance of understanding the regulatory environment. With Kadysh and his team’s regulatory background, he underlies his belief that understanding the regulatory aspect of the psychedelics sector is foundational to being successful in the space, a premise upon which PharmAla has been built. Why the MDMA focus? PharmAla’s MDMA focus was born out of the belief the company could build a first mover advantage in a substance that has attracted far less interest when compared with other psychedelics (psilocybin, DMT, and LSD), but which from a regulatory perspective is the furthest along than the others (thanks to MAPS work on MDMA-assisted therapy for PTSD). PharmAla is currently supplying MDMA for 15 clinical trials. NCE development pipeline and expanding IP. For its development program, PharmAla focuses on developing drugs like MDMA (MDXX class of drugs that have a prosocial effect) with a strong safety profile and special effects for target populations. Kadysh also announced that ALA-002 (a novel mixture of MDMA enantiomers) had just been granted allowance by the USPTO for a composition of materials patent. This follows a similar grant last week for its less advanced APA-001 molecule that could target several mental health disorders. Kadysh goes on to describe its robust patent process. Pending legalization of MAPS’ MDMA-assisted therapy. Kadysh shares his thoughts on what type of rescheduling he expects once MAPS’ therapy is approved, which is expected to happen in August, and the implications for PharmAla’s business. Differentiated approach. Kadysh discusses the company’s operational goals for 2024. Unlike its peers in the psychedelics sector, PharmAla can boast a roster of achievements without overstretching its balance sheet. It has not needed to raise external capital since 2021 and has recently turned profitable. It is no surprise that its shares have outperformed its publicly traded peers over the last challenging couple of years.
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