- First Numinus Network™ partner enters into
agreement
- Recent cost containment initiatives have resulted in
approximately $4.2 million of
annualized savings, extending cash runway
- Well positioned to provide psychedelic-assisted therapy
insurance reimbursement, as a result of recent US insurance payor
code approval
- MDMA-assisted therapy expected to be approved for treatment
in US in 2024 – Numinus well positioned to be a key provider of
this therapy
VANCOUVER, BC, May 25, 2023
/PRNewswire/ - 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," said Payton Nyquvest,
Founder and CEO, Numinus.
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/.
About Numinus
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.
Forward-looking
statements
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.