Numinus Welcomes Psychedelic Pioneer,
Rick Doblin, Ph.D., as Strategic
Adviser
Updates Market on Closing of Previously Announced
Bought Deal
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VANCOUVER, BC, Feb. 14,
2024 /CNW/ - Numinus Wellness Inc.
("Numinus" or the "Company") (TSX: NUMI), a mental
health care company advancing traditional and innovative behavioral
health treatments with a focus on safe, evidence-based
psychedelic-assisted therapies, congratulates the Multidisciplinary
Association for Psychedelic Studies ("MAPS") for incubating the
research that led to the first new drug application to the USFDA,
submitted by Lykos Therapeutics (formerly MAPS Public Benefit
Corporation) on the acceptance of its new drug application to the
U.S. Food and Drug Administration ("FDA") for MDMA (midomafetamine
capsules) used in combination with psychological intervention for
individuals with PTSD. The FDA has granted the application a
priority review, which mandates the authority to take action within
six months. A Prescription Drug User Fee Act ("PDUFA") target
action date of August 11, 2024, has
been set.
"This is an exciting development and, if approved, would be the
first MDMA-assisted therapy available in the U.S. for the millions
of Americans struggling with PTSD," said Payton Nyquvest, Numinus Founder and CEO.
"Getting here was the result of over 20 years of clinical research
that was begun by MAPS, the nonprofit organization that founded
Lykos, and we are proud to have collaborated with them through
participation in the clinical research at our Cedar Clinical
Research facilities. There needs to be a dedicated focus on
building the infrastructure to be able to administer MDMA-AT if the
FDA approves. Numinus has been at the forefront of this effort
through training and offering services that are sustainable and
scalable while ensuring the highest quality outcomes for clients.
We look forward to actively supporting these efforts in the
immediate future to continue to help meet the needs of over the 14
million people diagnosed with PTSD in the
United States."
"Psychotherapy is a component of the proposed treatment, and
with our clinic network, practitioner training program and
protocols we have developed in conjunction with our clinical
research programs, we would like to be able to offer MDMA-assisted
therapy as soon as regulators allow," added Michael Tan, President and COO of Numinus. "It's
important to note that in our Canadian clinics, we are currently
treating patients with MDMA-assisted therapy on a limited scope
under the current regulatory exceptions. The combination of our
experience and infrastructure positions us to be a leading provider
of psychedelic-assisted therapy."
Strategic Advisor
Numinus further proudly announced that Rick Doblin, Ph.D., the Founder and President of
MAPS, is independently joining as an unpaid, non-exclusive
strategic adviser of Numinus to help guide enhancements to and
foster empirical validation of Numinus treatment modalities and
training assets related to MDMA-assisted therapy. Numinus and
Dr. Doblin share a common goal of ensuring broad access to
treatment, focusing on inclusivity and making quality care
accessible to all those seeking transformative therapeutic
treatments. This appointment fortifies the company's commitment to
training programs which support the efficacy and safety of
MDMA-assisted therapy for PTSD.
"We are honored to welcome Dr. Rick
Doblin to Numinus as an unpaid strategic adviser. His wealth
of experience and commitment to the advancement of
psychedelic-assisted therapies align seamlessly with Numinus'
mission to provide transformative and accessible care to
individuals worldwide," said Payton
Nyquvest.
"My hope in becoming an unpaid, non-exclusive Numinus Strategic
Advisor is to accelerate our collective mission to expand access to
psychedelic-assisted therapies. I look forward to contributing to
the evolution of MDMA-related training and care programs,
ultimately advancing the standard of care in this transformative
field." expressed Dr. Rick
Doblin.
Bought Deal Market
Update
Numinus also today provided an update regarding the previously
announced bought deal for aggregate gross proceeds to the Company
of $6,000,000 (the "Offering"). While
MAPS remains a significant collaborator with Numinus in
experiential training and other mission-critical areas of our
business, including the addition of Rick
Doblin as a strategic advisor to Numinus, MAPS is not able
to participate in the Offering. Integrated V.C. is also not
participating in the Offering. The Offering is expected to
close on or about February 16,
2024.
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 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 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; the effectiveness of
any advice provided by a strategic advisor or future collaborations
related thereto, if any; dependence on obtaining regulatory
approvals and the possibility that the Offering does not close when
expected, or at all, because conditions to closing are not
satisfied on a timely basis, or because the underwriters exercise
their termination rights; ability of Numinus to maintain or
increase earnings; ability of Numinus to achieve or maintain
profitability; the Company's need for additional financing and the
effects of financial market conditions and other factors on the
availability of capital; and other risks that are set forth in our
annual information form dated November 29,
2023 and available on SEDAR at
www.sedarplus.ca. 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.
SOURCE Numinus Wellness Inc.