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Shroom Shmooz

In the second of our series of spotlights on psychedelic therapies, we look at 3,4-methylenedioxymethamphetamine (MDMA), a Schedule I substance that is leading the psychedelic charge to therapeutic legitimacy. MDMA, better known as ecstasy or molly, is a pure human-made synthesized compound that uniquely combines the characteristics of a stimulant with hallucinogenic properties. No other psychedelic shares those characteristics. The parallel release of dopamine and serotonin brings together a positive mood and prosocial effects. Impressive clinical studies have shown that because of these characteristics, MDMA’s therapeutic value lies in its deployment as a tool to make psychotherapy (the talk part of the treatment) much more effective. MDMA’s 30-year plus journey from abused rave party drug to therapeutic legitimacy is nearing completion. Under the stewardship of Multidisciplinary Association for Psychedelic Studies (MAPS), a not-for-profit-medical organization founded by psychedelic activist Rick Doblin, MDMA, a substance the US made illegal in 1985, is on the cusp of legalization. MAPS recently announced that the NDA for its MDMA-Assisted Therapy (MDMA-AT) candidate for treating post-traumatic stress disorder (PTSD), which it submitted in December 2023, had been accepted for review by the FDA. The FDA also granted the application Priority Review, meaning that the therapy stands to be approved in August 2024. On this timeline, the therapy could become legally available for prescription by the end of 2024 or very early 2025. In the public traded space, there is only one investible option to play the MDMA story. In drug development, MDMA is dominated by MAPS PBC, rebranded to Lykos Therapeutics, which is a private company. While MAPS has indicated that the door is open to a Lykos IPO in the future, for now, wellness clinic operator Numinus (TSX: NUMI) is potentially the only meaningful way to gain exposure to the MDMA therapy breakthrough and rollout. Ultimately, the MDMA breakthrough story becomes a bigger story than MDMA itself. Once MDMA-AT for PTSD is legalized as is expected this year, MAPS will still have heavy lifting to do in terms of its rollout implementation. MAPS expects this process to take multiple years. The main beneficiaries will be the psychedelic-assisted therapies that follow MDMA-AT into the market as they will likely be able leverage the infrastructure put into place.