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Numinus Submits Clinical Trial Application to Health Canada for Experiential Psilocybin-Assisted Therapy Training Research

  • New clinical trial will provide experiential training to therapists learning to conduct psilocybin-assisted therapy.

  • Clinical trial dosing will use Numinus Bioscience’s Psilocybin Tea, EnfiniTea – one of the first Phase 1 clinical trials that will report on whole Psilocybe mushroom safety.

VANCOUVER, BCDec. 8, 2022  – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX:NUMI/" target="_blank" rel="noopener">TSX:NUMI) (OTCQX:NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that its research division has submitted a clinical trial application to Health Canada to begin a new experiential training study that will enable practitioners training to provide Psilocybin-Assisted Therapy (PAT) the ability to experience and observe psilocybin sessions to further their understanding and PAT education.  Additionally, the clinical trial will use Numinus Bioscience’s EnfiniTea, a whole mushroom Psilocybe tea product, for trial dosing. This is one of the first clinical trials globally that will be conducted with whole Psilocybe mushrooms, to assess their safety.

“We’re proud to offer one of the first training programs with the option to participate in an experiential clinical trial for practitioners looking to expand their psychedelic-assisted therapy education,” said Paul Thielking, Chief Science Officer, Numinus. “As these important therapies continue to develop and gain support, we foresee the psychedelic sector may experience a shortage in sufficiently trained PAT therapists.  We’re honored to offer this unique experiential clinical trial opportunity alongside our well-regarded psychedelic training programs to expand the number of highly qualified practitioners and drive further access to those in need of these mental health treatments.”

The clinical trial, formally titled A Phase 1, Open-Label, Single-Arm Study to Evaluate Psilocybin Experiential Training in Healthy Volunteers and Expand Knowledge and Qualifications of Therapists Planning to Conduct Psilocybin-Assisted Therapy (NUMT2), will initially be conducted at Numinus’ clinic in Vancouver. Numinus expects the clinical trial may be expanded to include additional Numinus clinic locations in the future.

“We expect the EnfiniTea Psilocybe tea we’ve developed will support expanded access to important psychedelic-assisted therapies, as it’s uniquely shelf stable, consistently dosed and economical to produce,” said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus Bioscience. “We’re pleased to be able to utilize this product in the NUMT2 clinical trial, as research on whole Psilocybe  mushroom in a clinical setting  is limited in Canada and the results of this trial may support regulators in expanding access to whole-mushroom psychedelic-assisted therapies through Canada’s Special Access Programme and other expanded access frameworks.”

The NUMT2 clinical trial protocol will enable each practitioner volunteering for the trial to participate in both experiential and observational roles, receiving psilocybin-assisted therapy, as well as observing another participant receiving the therapy under the supervision and guidance of an experienced and trained therapy provider. Numinus intends to initially draw on volunteers for the clinical trial through those who have expressed interest through the Company’s practitioner training program.  The clinical trial will also be open to other practitioners interested in volunteering to expand their knowledge of PAT therapy practices.

Companies interested in learning more about EnfiniTea for clinical trial use are invited to email biosciences@numinus.com for more information.

About Numinus

Numinus Wellness (TSX:NUMI/" target="_blank" rel="noopener">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 LinkedInFacebookTwitter, 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. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. There is no assurance that Health Canada will approve the application. The Company 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.

For further information: Investor Contact: Jamie Kokoska, Vice President, Investor Relations & Financial Communications, jamie.kokoska@numinus.com; Media Contact: Hilary Strath, Director, Communications, hilary.strath@numinus.com

Featured Image Depositphotos @realcg

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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.) one hundred nine thousand four hundred and forty USD for 23 days (16 business days).

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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 CV-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 such as CV-19 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.

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