VANCOUVER, BC, May 25, 2023 /CNW/ - Numinus Wellness Inc. ("Numinus" or the "Company") (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.
"With MAPS anticipated to receive approval for MDMA-assisted therapy in the first half of 2024, we're excited to be positioned as a leading psychedelic-assisted therapy clinical operator and we're already taking steps to ensure Numinus is ready to provide broader access to this important treatment as soon as regulators allow."
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.
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.
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.
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.
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.
Learn more at www.numinus.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.
Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements, including approval of MDMA-assisted therapy for any indication or at all; restrictions that may be placed on use of MDMA by regulatory authorities; safety and efficacy of MDMA-assisted therapy; acceptance, uptake and commercialization of MDMA-assisted therapy; availability of insurance or other payor coverage for MDMA-AT, if any; continued demand for Spravato®; effect of cost containment measures on Numinus business and financial position; changes to cash burn rate, expenses, corporate programs or priorities, or unanticipated costs affecting cash runway, commercialization, uptake and viability of the Numinus Network™ (including Practitioner Partnership program); commercial viability of any or all of the Numinus Network™ members; availability or continued availability of the services to be delivered to Numinus Network members; client uptake of services from members of the Numinus Network™; practitioner uptake of Numinus training; continued offering of Numinus training; continued legal availability of experiential component of training or availability of licensed practitioners or professional corporations to deliver the same; the effect, if any, of having obtained certification on any particular trainee or such trainee's business or profile; and other risks that are set forth in our annual information form dated December 12, 2022 and available on SEDAR at www.sedar.com. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. Numinus does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.
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SOURCE Numinus Wellness Inc.
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