Numinus Announces Key Milestones in MAPS-Sponsored MDMA-Assisted Therapy for PTSD Clinical Trial

 

Numinus has received approvals from Health Canada and the Institutional Ethics Review Board

VANCOUVER, BC, Jan. 19, 2022 – Numinus Wellness Inc. (TSXV:NUMI)  (“Numinus” or the “Company”), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has completed key steps to prepare to enroll participants at its clinics participating in “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX)”, sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).

The Canadian study sites, which will continue to study the safety of MDMA-assisted therapy in treating severe PTSD, under the leadership of MAPS Public Benefit Corporation (MAPS PBC) as study sponsor, have recently received regulatory authorization from Health Canada, ethical approval from an Institutional Review Board (IRB) and a Section 56 exemption from the Controlled Drug and Substance Act (Canada), which will allow the use of MDMA throughout the duration of the clinical trial.

“We are thrilled that our talented team of doctors and researchers at Numinus Wellness Inc. (TSXV:NUMI)  are helping pave the path forward to greater access to safe psychedelic-assisted psychotherapy with this study further evaluating the safety of MDMA-assisted therapy in treating severe PTSD,” says Payton Nyquvest, Founder and CEO, Numinus Wellness Inc. (TSXV:NUMI) . “This is an exciting next step in the MAPPUSX study, happening at our clinics in both British Columbia and Quebec, and we look forward to how this work supports expanded collaboration with MAPS in the future.”

Numinus Wellness Inc. (TSXV:NUMI)  will host the Canadian sites for MAPPUSX, managed through Numinus’ two recently acquired, purpose-designed clinics, allowing for quick completion of the Canadian segment of the MAPS-sponsored trial.

“The recent approvals from Health Canada and the IRB, coupled with our clinics in Montreal and Vancouver already being regulatorily compliant, allow us to quickly conduct this phase of the research at these sites,” said Dr. Joe Flanders, VP, Psychology, Numinus Wellness Inc. (TSXV:NUMI)  and therapist for the Montreal site of the trial. “I’m proud to be a part of this study alongside our clinical and research teams as we work towards examining the important findings around MDMA-assisted therapy for PTSD and, ultimately, translating research findings into mainstream clinical practice.”

The trial will be open to eligible participants who were previously enrolled in the placebo arm of the parent study (MAPP1) or who were not able to receive treatment due to COVID-19 restrictions.

NOTE

The safety of MDMA-assisted therapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. Food and Drug Administration (FDA), does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of MDMA-assisted therapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.

About Numinus

Numinus Wellness Inc. (TSXV: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 Wellness Inc. (TSXV:NUMI)  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 Wellness Inc. (TSXV:NUMI) , 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.

About MAPS

Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. MAPS is sponsoring the most advanced psychedelic therapy research in the world: Phase 3 clinical trials of MDMA-assisted therapy for PTSD. Since its founding, MAPS has raised over $130 million for psychedelic and marijuana research and education and has earned both the Guidestar Platinum Seal of Transparency and a 4-Star Rating from Charity Navigator. Learn more at maps.org

ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)

MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization. Learn more at www.mapspublicbenefit.org

Forward-looking statements

This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, , “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws.

SOURCE Numinus Wellness Inc. (TSXV:NUMI)(OTCPK:LKYSF)

[BONUS-POPUP id=”1″]

Please See Disclaimer

 


Disclosure:

1) The author of the Article, or members of the author’s immediate household or family, do not own any securities of the companies set forth in this Article. The author determined which companies would be included in this article based on research and understanding of the sector.

2)The Article was issued on behalf of and sponsored by, Numinus Wellness Inc. Market Jar Media Inc. has or expects to receive from Numinus Wellness Inc.’s Digital Marketing Agency of Record (Native Ads Inc.) ninety-two thousand, nine hundred and fifty-six American dollars for 65 days (45 business days).

3) Statements and opinions expressed are the opinions of the author and not Market Jar Media Inc., its directors or officers. The author is wholly responsible for the validity of the statements. The author was not paid by Market Jar Media Inc. for this Article. Market Jar Media Inc. was not paid by the author to publish or syndicate this Article. Market Jar has not independently verified or otherwise investigated all such information. None of Market Jar or any of their respective affiliates, guarantee the accuracy or completeness of any such information. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Market Jar Media Inc. requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Market Jar Media Inc. relies upon the authors to accurately provide this information and Market Jar Media Inc. has no means of verifying its accuracy.

4) The Article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Market Jar Media Inc.'s terms of use and full legal disclaimer as set forth here. This Article is not a solicitation for investment. Market Jar Media Inc. does not render general or specific investment advice and the information on Microsmallcap.com should not be considered a recommendation to buy or sell any security. Market Jar Media Inc. does not endorse or recommend the business, products, services or securities of any company mentioned on Microsmallcap.com.

5) Market Jar Media Inc. and its respective directors, officers and employees hold no shares for any company mentioned in the Article.

6) This document contains forward-looking information and forward-looking statements, within the meaning of applicable Canadian securities legislation, (collectively, “forward-looking statements”), which reflect management's expectations regarding Numinus Wellness Inc.’s future growth, future business plans and opportunities, expected activities, and other statements about future events, results or performance. Wherever possible, words such as “predicts”, “projects”, “targets”, “plans”, “expects”, “does not expect”, “budget”, “scheduled”, “estimates”, “forecasts”, “anticipate” or “does not anticipate”, “believe”, “intend” and similar expressions or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative or grammatical variation thereof or other variations thereof, or comparable terminology have been used to identify forward-looking statements. These forward-looking statements include, among other things, statements relating to: (a) revenue generating potential with respect to Numinus Wellness Inc.’s industry; (b) market opportunity; (c) Numinus Wellness Inc.’s business plans and strategies; (d) services that Numinus Wellness Inc. intends to offer; (e) Numinus Wellness Inc.’s milestone projections and targets; (f) Numinus Wellness Inc.’s expectations regarding receipt of approval for regulatory applications; (g) Numinus Wellness Inc.’s intentions to expand into other jurisdictions including the timeline expectations relating to those expansion plans; and (h) Numinus Wellness Inc.’s expectations with regarding its ability to deliver shareholder value. Forward-looking statements are not a guarantee of future performance and are based upon a number of estimates and assumptions of management in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances, as of the date of this document including, without limitation, assumptions about: (a) the ability to raise any necessary additional capital on reasonable terms to execute Numinus Wellness Inc.’s business plan; (b) that general business and economic conditions will not change in a material adverse manner; (c) Numinus Wellness Inc.’s ability to procure equipment and operating supplies in sufficient quantities and on a timely basis; (d) Numinus Wellness Inc.’s ability to enter into contractual arrangements with additional Pharmacies; (e) the accuracy of budgeted costs and expenditures; (f) Numinus Wellness Inc.’s ability to attract and retain skilled personnel; (g) political and regulatory stability; (h) the receipt of governmental, regulatory and third-party approvals, licenses and permits on favorable terms; (i) changes in applicable legislation; (j) stability in financial and capital markets; and (k) expectations regarding the level of disruption to as a result of COVID-19. Such forward-looking information involves a variety of known and unknown risks, uncertainties and other factors which may cause the actual plans, intentions, activities, results, performance or achievements of Numinus Wellness Inc. to be materially different from any future plans, intentions, activities, results, performance or achievements expressed or implied by such forward-looking statements. Such risks include, without limitation: (a) Numinus Wellness Inc.’s operations could be adversely affected by possible future government legislation, policies and controls or by changes in applicable laws and regulations; (b) public health crises may adversely impact Numinus Wellness Inc.’s business; (c) the volatility of global capital markets; (d) political instability and changes to the regulations governing Numinus Wellness Inc.’s business operations (e) Numinus Wellness Inc. may be unable to implement its growth strategy; and (f) increased competition.

Except as required by law, Numinus Wellness Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future event or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Neither does Numinus Wellness Inc. nor any of its representatives make any representation or warranty, express or implied, as to the accuracy, sufficiency or completeness of the information in this document. Neither Numinus Wellness Inc. nor any of its representatives shall have any liability whatsoever, under contract, tort, trust or otherwise, to you or any person resulting from the use of the information in this document by you or any of your representatives or for omissions from the information in this document.

7) Any graphs, tables or other information demonstrating the historical performance or current or historical attributes of Numinus Wellness Inc. or any other entity contained in this document are intended only to illustrate historical performance or current or historical attributes of Numinus Wellness Inc. or such entities and are not necessarily indicative of future performance of Numinus Wellness Inc. or such entities.