Numinus CEO Outlines MDMA Assisted-Therapy Strategy; Believes MAPS Phase 3 Data Coming Soon

On this new Psychedelic Series Podcast, TDR Founder Shadd Dales spoke with Payton Nyquvest, CEO of Numinus Wellness Inc. (OTC:NUMIF. The podcast focused on the latest news that Numinus is aligning its business initiatives to prepare for future approval of MDMA-assisted therapy, and what the entire ecosystem will look like if the FDA approves such therapy at a future date.

On the subject of its business strategy, Payton described the steps the company is taking to prepare for a comprehensive therapy rollout plan, should one be needed. There are many moving parts to this equation, including the need to train thousands of practitioners, setup insurance reimbursement packages and more. Payton breaks down how Numinus is going about this plan, with a goal on achieving cost savings and a sustainable trajectory of growth with minimal capital expenditures.

Of note: the assumption of MDMA assisted-therapy is not part of the company’s cash flow forecasts, so approval by the FDA should have a material effect on projections that are currently disclosed.

Furthermore, the Numinus CEO revealed that he expects “over the next, kind of, thirty to sixty days, is probably going to be generating a lot of the attention. You know, in particular, we know, that the readout from the second Phase III should happen within the next thirty to sixty days. That’s what we continue to be told.”

Of course, Payton is referring to additional Multidisciplinary Association for Psychedelic Studies (MAPS) Phase 3 MDMA assisted therapy results which are expected out this summer. Should the results mirror the robust MAPP results released in January, it is hoped that the FDA will take action on granting approval for the therapy.

MAPS second Phase 3 trial MAPP2 study involved a rigorous research protocol, including a randomized, double-blind, placebo-controlled design. Participants were individuals diagnosed with chronic, treatment-resistant PTSD, and they underwent a series of preparatory sessions to establish rapport with therapists and prepare for the MDMA sessions.