Numinus Aligns Business Initiatives to Prepare for Future Approval of MDMA-Assisted Therapy

Numinus Wellness Inc. (TSX: NUMI / OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce several recent initiatives aimed at best positioning the company for the expected FDA approval of MDMA-assisted therapy (“MDMA-AT”) in the United States in the first half of 2024. In anticipation of this regulatory approval, Numinus has undertaken several initiatives to prepare the company for a rapid rollout of MDMA-AT services (using the MAPS protocol), including the recently launched Numinus Network™ clinic expansion program, reallocation of resources towards revenue producing activities, cost containment initiatives, and preparation for insurance reimbursement systems.

In 2017, the FDA granted ‘breakthrough’ status to MDMA and phase 3 trials for MDMA-AT are underway or have been completed. Further, in 2022, a letter from an official at the US Department of Health and Human Services indicated that it anticipated that the FDA would approve MDMA by 2024. As of the date of this news release, MDMA has not been approved by any regulatory agency for any indication.

New Numinus Network™ Partner

Numinus is excited to announce that it has welcomed its first Practitioner Partner, in Toronto, Ontario, through its recently launched Numinus Network™ program. Through this new clinic partnership, the practitioner will have the opportunity to provide Numinus’ psychedelic-assisted therapies to her established client base in partnership with the Numinus medical team and leveraging Numinus clinic locations. 

Numinus is in discussions with other prospective Numinus Network™ practitioner partners and licensing partners, and believes this clinic and service expansion strategy could play an integral role in offering future MDMA-assisted therapies. It is expected at least 15,000 practitioners trained on MAPS MDMA-AT protocols will be needed to meet the demand for these services in the next three years, assuming MDMA-AT is approved by the FDA in early 2024.

Focusing on Revenue Producing Activities

Numinus has recently completed several cost containment initiatives to refocus operations on revenue producing activities and to extend the Company’s cash runway. These initiatives have included an 8% staffing reduction (in non-revenue producing roles), a reallocation of resources towards revenue generating activities and the renegotiation of certain vendor contracts. Collectively, these activities have reduced Numinus’ annualized cash expenses by approximately $4.2 million, extending the Company’s cash runway past anticipated MDMA approval. It is anticipated MDMA-AT will receive FDA approval by early 2024 – presenting a large growth opportunity that should greatly accelerate Numinus’ pathway to profitability and positive cash flow, through higher-margin services.

Insurance Code for Long-Term Psychedelic Therapy approved by AMA

Numinus congratulates the American Medical Association (AMA) on approving its first insurance billing code for long-form psychedelic-assisted therapy, through a joint application by MAPS PBC and COMPASS Pathways.  The Current Procedural Terminology (CPT®) III code for psychedelic therapies is expected to go into effect when it is published on January 1, 2024. Once effective, the CPT code will provide physicians and other qualified healthcare professionals a process to code and seek insurance reimbursement for delivering psychedelic therapies as they are approved by the FDA.

Numinus has a well-established US insurance payor program in place, and has reimbursed more than $15 million for Spravato® (esketamine) prescriptions and treatments in the past five years. Numinus expects its insurance payor relationships and infrastructure will provide a seamless opportunity to reimburse its clients for future psychedelic-assisted therapies, and is already in the process of educating its insurance payor relationships about the pending psychedelic-assisted therapy CPT code.

Practitioner Training Initiatives

Numinus is committed to being a leader in psychedelic-assisted therapy training for practitioners, which will become increasingly more important to the sector should MDMA-AT be approved. Today, seven classes are available for practitioner and medical professional registration as part of Numinus’ Psychedelic-Therapy Certification Pathway – which provides specialization options for Ketamine, MDMA, or Psilocybin-assisted therapies. Additional classes will be available to register for soon.  More information about Numinus’ training program can be found at: https://numinus.com/our-training-selection/.

Numinus Wellness Inc. (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.