How hallucinogenic beer shaped history: issue 33

Hello and welcome back.

Thank you to everyone who registered for our Mental Health Town Hall. We can’t wait to connect with you! If you haven’t signed up yet, don’t worry, it’s not too late. Keep reading for details.

Here’s what’s in store for you in today’s issue:

🍄 How psychedelics helped an ancient empire maintain power

🍄 Add some ecstasy to your sex life

🍄 Microdosing DMT

🍄 Australian gov’t funds 2 psychedelic studies

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Healing at home with Nue Life’s innovative ketamine wellness program

In this episode of the Daily Mushroom Podcast, we have Juan Pablo Cappello, co-founder and CEO of Nue Life Health. Nue Life’s at-home ketamine wellness program is proving to be highly beneficial for patients with treatment-resistant depression. The key is in the company’s unique approach to integration, which utilizes intuitive AI, music therapy, and group support

Nue Life is a public benefits corporation, and its entire founding team is made up of people of colour and women. Learn how Juan Pablo Cappello used spiritual wisdom to create a conscious business in his talk, 4 Pillars of Conscious Startups.

This will be an inspiring event for anyone who dreams of running a tech startup or wants to bring conscious leadership to their workplace.

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Add some ecstasy to your sex life

Over 90% of people experienced increased sexual desire and satisfaction after taking MDMA. But that’s not the only way it can improve your sex life.

Mindcure (MCUR) is studying MDMA-assisted-therapy as a treatment for Hypoactive Sexual Desire Disorder (HSDD), which is characterized by low sex drive and emotional distress. 

The goal is to use MDMA to get to the root cause of the issue, which may be a history of negative sexual experiences and relationships or struggles with self worth or body image.

Microdosing DMT

Algernon Pharmaceuticals (AGN) found that microdoses of DMT can increase the growth of neurons in the brain by up to 40%. An upcoming study will see if this can benefit stroke patients.

Phase I of the study, which is awaiting approval in the UK, will determine the maximum amount of DMT that can be taken without producing a psychedelic effect. Phase II will test repeated doses on acute and recovering stroke patients.

Treating alcoholism in Europe

Last year, Awakn Life Sciences (AWKN) found that MDMA-assisted therapy helped alcoholics reduce alcohol consumption by 85% – from an average of 130.6 units per week to just 18.7.

Now, the company is exploring a partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to treat alcohol use disorder across Europe, where alcohol is one of the top five causes of disease and disability in most countries. Awakn may license MAPS’ pre-clinical data to get the treatment to market faster.

Microdosing eases depression

In a preclinical animal model, Wesana Health (WESA) found that a single high dose of psilocybin rapidly improved depressive behaviours for 14 days. A regimen of psilocybin microdoses and CBD was able to sustain the results and reduced depressive behaviours by an additional 64%.

Let’s keep the microdosing evidence coming!

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Be an industry insider

How can DMT be improved to better treat addiction? How do our genetics influence our psychedelic experiences? How does ketamine change our brain wave patterns? Does music make psychedelic therapy more effective?

These are all questions that Entheon Biomedical (ENBI) is answering with ongoing clinical research. Learn what they’ve discovered so far and their next steps at our Mental Health Town Hall this February 3rd!

We’ll be joined by Entheon’s Founder and CEO, Scientific Advisor, and Communications Manager to discuss the company’s findings and the future of psychedelic therapy. Register now for free to get the inside scoop 👇

Save the toads

Did you know that potent psychedelics like 5-MeO-DMT and bufotenin come from the venom of the Colorado River Toad? 

With growing demand to study these compounds and increased recreational use, wild populations of the toad are threatened in some areas.

Alvarius Research Inc. recently developed a toad conservation program to address this issue. The company is also collaborating with Egret Bioscience to develop synthetic “toad-free” versions of the compounds.

Psychedelics → power?

An ancient South American empire called the Wari Empire may have used a hallucinogenic beer to maintain its power.

The Wari people brewed a beer-like drink with seeds from the vilca tree, which contain a psychedelic compound called bufotenin (one of the substances found in toad venom!). 

Archeologists believe that Wari leaders served the drink at feasts to strengthen social connections with guests from surrounding regions. Guests likely had a euphoric or spiritual experience, compelling them to “acknowledge the power of their hosts or feel the need to owe them a favor in the future,” explains one archeology expert. 

Could this be why the empire maintained political control for hundreds of years? 🤔

Connect with your microdosing community

If you’re looking to try microdosing, what better way to get started than with a community of like-minded individuals. 

Dose Day is a microdosing peer support network that connects you with a small group with similar intentions and interests. Meet with your group weekly to see how the power of community can support you on your journey.

Whether you’re an artist, an executive, a consciousness junkie or someone looking to improve their mental health, there is a group for you.

Plus, half the fee supports palliative care patients with end-of-life anxiety.

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Psygen Industries Ltd. is building Canada’s first manufacturing facility dedicated to synthetic psychedelics. The company received authorization to produce and sell psilocybin, psilocin, LSD, DMT, mescaline, and 2C-B through a Health Canada Dealer’s License. It has already established over 20 supply agreements with domestic and international companies 👏

Numinus Wellness (NUMI) is enrolling patients for a multi-site study on MDMA for PTSD, which will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). The study received approval from both Health Canada and the Institutional Ethics Review Board.

Eleusis, a UK-based company focused on psilocybin therapy for depression, is planning to go public through a $446M merger with Silver Spike Acquisition Corp. II (SPKB). Eleusis will apply to have its shares listed on the NASDAQ under the symbol ‘ELEU’.

Red Light Holland (TRIP) is collaborating with an advocacy group called the Psychedelic Medicine Alliance Washington to promote a bill that would legalize guided psilocybin sessions in Washington State. The company has hired a lobbyist with experience in cannabis regulation and is launching a social media campaign and educational events to raise awareness about the benefits of psilocybin.

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Here’s what you missed in the legal world:

  • University of Sydney researchers received $3M in funding from the Australian government to support MDMA and psilocybin studies! The MDMA study will investigate combined PTSD and alcohol use disorder, and the psilocybin study will be focused on anorexia nervosa. Read more…
  • A Kansas legislator filed a bill to legalize the possession of up to 50 grams of psilocybin or psilocin, as well as the cultivation of psilocybin mushrooms. Read more…
  • A Utah Rep. filed a bill that would establish a task force to research the therapeutic potential of psychedelics. Read more…
  • Representatives from seven US states (Oregon, Nebraska, Michigan, Arizona, Texas, Minnesota, and Pennsylvania) have submitted a letter urging the Drug Enforcement Administration (DEA) to allow terminally-ill patients access to psilocybin treatments. The lawmakers believe that psilocybin qualifies as an investigational drug and should therefore be accessible through Right to Try laws. Read more…

Video of the Week

Playlist of the Week

Lexston Announces the Launch of a Psychedelic Mushrooms Genetic Identification Test

Lexston Announces the Launch of a Psychedelic Mushrooms Genetic Identification Test

Vancouver, British Columbia, January 24, 2022. Lexston Life Sciences Corp. (the “Company” or “Lexston”) (CSE: LEXT) (OTCQB: LEXTF) is pleased to announce that the Company’s wholly owned subsidiary, Egret Bioscience Ltd. (“Egret”) has developed and validated a targeted genetic barcode consisting of eight Single Nucleotide Polymorphism (“SNP”) for psychedelic mushroom genetic identification (“Egret Psilocybe Assay”). Egret has previously developed and published similar genetic identification tests for the Cannabis Industry (https://t.co/rh1VJ5cf0a) and have been offering this service to licensed producers through its affiliated licensed lab, Zenalytic Laboratories Ltd. In early January, the Controlled Substances Directorate of Health Canada amended their regulations to allow practitioners to prescribe restricted drugs, such as psilocybin and psilocin through the Special Access Program (“SAP”) for patient with treatment resistant depression and other debilitating illnesses that have failed to respond to conventional treatments. As with other restricted drugs, Health Canada has mandated a stringent quality control and compliance routine testing for every batch destined for the SAP. One of the key requirements put in place by the regulator is the requirement for a genetic identity test. “Our team has been steadfast at work to develop and implement validated state-of-the-art methods for genetic identification of psychedelic mushrooms. Our assay provides the first of its kind Psilocybe genetic barcode, a rapid and efficient diagnostic test able to provide individual genetic strain identification and differentiate strains from the main groups of Psilocybe mushrooms, in particular P. cubensis, P. tampanensis and P. mexicana (P. galindoi). This traceability and authentication tool will be paramount in establishing best practice for the psychedelic industry.” Stated Jag Bal, CEO and Director of Lexston.

Lexston Phylogenetic tree

Phylogenetic tree showing the relationship between 84 psychedelic mushroom samples from which the Egret genetic barcode was developed. Reproduced from data made available by McKernan and colleagues (2021; https://doi.org/10.12688/f1000research.55301.2). Of particular note, the more potent P. cubensis accessions such as P. Envy cluster closely to the P. azurescens, P. tampanensis and P. mexicana accessions.

For more information and to subscribe to the Company’s mailing list, please visit https://lexston.ca/contact/ 

About Lexston Life Sciences Corp.

Lexston Life Sciences Corp. (“Lexston”) is a Canadian biotechnology company providing cannabis testing and research services. Lexston is also in the process of securing licensing under the exemptions prescribed by section 56 of the Controlled Drugs and Substances Act (Canada) to enable the expansion of prescribed by section 56 of the Controlled Drugs and Substances Act (Canada) to enable the expansion of psychedelic molecules in the lab and point of care. Lexston intends to develop and validate methods for standardized manufacturing of plant derived psychedelics in support of burgeoning trials in the field of mental health and wellness.

On Behalf of the Board of Directors

LEXSTON LIFE SCIENCES CORP.

Jagdip Bal
Chief Executive Officer
Telephone: (604) 928-8913

Neither the Canadian Securities Exchange nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

929 Mainland Street Vancouver, BC V6B 1S3

Phone: (604) 928-8913

Fax: (604) 628-0129

Email: admin@lexston.net

Website: www.lexston.ca

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of LEXT to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.

Risks, uncertainties, and other factors involved with forward-looking information could cause actual events, results, performance, prospects, and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Numinus Wellness Inc. Reports Q1 2022 Results

Numinus Wellness Inc. Reports Q1 2022 Results

  • Ended quarter with strong cash position of $53.9 million
  • Revenues grew 245% year-over-year to $0.8 million for the quarter
  • Generated gross profit of $50,965 during the quarter, representing a 6.5% gross margin
  • Well-positioned to offer psychedelic-assisted psychotherapy services through Canada’s newly expanded Special Access Program
  • Clinical trial application made to Health Canada to begin Phase 1 study for proprietary psilocybe extract
  • MAPS-sponsored MDMA-Assisted Therapy for PTSD study to begin shortly; approvals received from Health Canada and the Institutional Review Board

All financial results are reported in Canadian dollars unless otherwise stated.

VANCOUVER, BC, Jan. 20, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSX: NUMI) (OTC: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced its fiscal first quarter results for the three months ended November 30, 2021.

“We have made significant advancements in all areas of our business over the last several months, with many exciting opportunities on the horizon,” said Payton Nyquvest, Founder and CEO. “Of note, the partnership across our lab and clinical teams has been instrumental in passing key milestones on two major clinical trials: one for a proprietary Psilocybe formulation and the other a MAPS-sponsored MDMA study. In addition, we’re continuing to make discoveries in our Bioscience lab and recently begun genetic testing on several newly-acquired psychedelic mushroom species.” 

Mr. Nyquvest continued, “The recent amendments by Health Canada to the Special Access Programme further underscore the importance and growth potential of Numinus’ wellness clinic network. With facilities purpose-designed for a wide range of psychedelic-assisted psychotherapies, therapists already trained on providing Psilocybin-assisted and MDMA-assisted therapies, and a Health Canada distribution license that allows us to import, possess, produce, and distribute psychedelic compounds – Numinus is well positioned as a national leader to provide these important treatments to those who qualify. I’m encouraged by the recent changes by Health Canada and proud of everyone at Numinus for the ongoing leadership, drive and commitment to our mission over the past quarter.”

First Quarter Financial Highlights:

  • Cash balance of $53.9 million as of November 30, 2021
  • Revenues grew 244.5% year-over-year to $0.8 million in Q1 2021, due primarily to the acquisition of Mindspace. Sequentially, revenues grew 60.9% compared to Q4 2021.
  • Gross profit of $50,965 in Q1 2022, compared to gross loss of $38,135 in Q1 2021
  • Gross margin was 6.5%, compared to -16.6% in Q1 2021
  • Loss was $5.4 million for Q1 2022, compared to a loss of $1.9 million in Q1 2021

Operational Highlights During and Subsequent to Fiscal First Quarter 2022:

Numinus Bioscience – Laboratory Operations

  • Q1 2022 revenue of $141,702, a 56.4% sequential increase from Q4 2021, but a 27.7% decrease from $196,090 in Q1 2021. This year-over-year decline is primarily due to the Company ceasing cannabis related activities during 2021 to dedicate resources towards advancing psychedelic-centered service offerings – including psychedelic analytical testing and contract laboratory services, to align with the Company’s strategy and overall objectives.
  • On November 29, 2021, the Company announced that Numinus Bioscience developed proprietary psychedelic drug tests with new toxicity and potency scans. These new analytical tests will accelerate Numinus’ research and development capabilities and generate new revenue streams through third-party client product testing.

Phase 1 clinical trial on NBIO-01:

  • On October 24, 2021, Numinus announced it finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived psilocybin extract (“NBIO-01”), advancing Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology.
  • On January 14, 2022, the Company submitted its clinical trial application to Health Canada for its Phase 1 trial of NBIO-01. The clinical trial, named HOPE, is a two-phase study that will take place at a Vancouver based clinic. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

MAPS-sponsored MDMA-assisted therapy for PTSD clinical trial study (“MAPPUSX”):

  • On November 10, 2021, the Company announced it will host the Montreal and Vancouver sites of the MAPPUSX study, which will continue to evaluate the safety of MDMA in treating severe PTSD, titled “A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD.”
  • On January 19, 2022, Numinus announced that it had received approvals from Health Canada and the Institutional Review Board to proceed with its clinical trial study for MAPPUSX. Enrollment for the trial is expected to begin shortly and 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.

Subsequent to the quarter:

  • Numinus Bioscience secured several additional strains of psychedelic mushroom species and has already begun genomic analysis of these spore prints for research purposes.

Numinus Health – Numinus Wellness Clinic Network

  • Q1 2022 revenue of $647,915, a 61.9% sequential increase from Q4 2021, and a 1,857.6% increase compared to $33,098 during the same period last year when Numinus had only one clinic, which was impacted by COVID-19 during the quarter.
  • On September 23, 2021, Numinus completed the acquisition of the Neurology Centre of Toronto (“NCT”) for less than $1.0 million, allowing for the planned expansion of NCT into a comprehensive neurologic care center specialized in psychedelic neurology.
  • During Q1 2022, clients received a total of 6,217 appointments through Numinus clinics (including one-on-one and group therapy sessions, neurology-related appointments and Ketamine-assisted psychotherapy), representing a 91.9% increase in clinic appointments compared to the prior quarter (Q4 2021), due in part to the acquisition of NCT. On a same-store basis, excluding NCT, client appointments increased 42.0% compared to the prior quarter.
  • On November 10, 2021, the Company announced that it had secured two additional clinic locations in Vancouver and Montreal that will primarily be used for clinical research studies in the near-term.

Subsequent to the quarter:

  • Numinus has finalized a formal Ketamine-Assisted Psychotherapy (“KAP”) training program for therapists, with virtual training sessions occurring over the next two months. This training program will expand the number of Numinus therapists qualified to provide KAP sessions to clients.
  • As of January 20, 2022, Numinus has five wellness clinics offering services to clients (one in Vancouver, one in Toronto, and three in Montreal) that have a total of 21 treatment rooms. In addition, the Company has two dedicated research clinics where psychedelic studies are being conducted (one in Vancouver and one in Montreal).

Corporate Updates

  • On November 22, 2021, the Company changed its OTC ticker symbol to “NUMIF” (from “LKYSF”) to better align with its Canadian ticker symbol.
  • Subsequent to the quarter:
  • On December 16, 2021, Numinus graduated to the TSX (from the TSX-Venture), trading under the symbol “NUMI”.

Industry Updates

  • On January 5, 2022, Health Canada implemented amendments to the Special Access Programme (“SAP”). These amendments now enable:
    • Doctors and practitioners to apply for psychedelic medicines that have shown promise through Phase 2 or Phase 3 trials, on behalf of their patients, when other traditional medicines and therapies have not proven effective.
    • Doctors and patients to hear, within 48 hours of the application being submitted, if access to psychedelic medicines are approved for their case. If approved, doctors can refer patients to clinics – such as Numinus’ wellness clinics, to receive psychedelic-assisted psychotherapy.
    • Companies holding a Health Canada dealers license, including Numinus Bioscience, to act as a licensed distributor of certain psychedelic medicines for SAP approved cases.

Q1 2022 Key Performance Metrics:

For the quarter ended November 30:
20222021% change
     Numinus Bioscience¹ revenue141,702196,090-27.7%
     Numinus Healthrevenue647,91533,0981,857.6%
Total Revenue$789,617$229,188244.5%
Cost of revenue(738,652)(267,323)176.3%
Gross Profit (Loss)$50,965$(38,135)n.m.
   Gross profit margin6.5%-16.6%n.m.
General and administrative expenses(3,736,890)(1,285,448)190.7%
Share-based compensation(400,568)(174,250)129.9%
Sales and marketing expenses(760,519)(269,243)182.5%
Depreciation(51,829)(91,261)-43.2%
Research and development expenses(330,626)(89,727)268.5%
Transaction costs(45,092)100.0%
Loss before other items$(5,274,559)$(1,948,064)170.8%
Other items(79,530)19,327n.m.
Loss and comprehensive loss$(5,354,089)$(1,928,737)177.6%
Loss per share, basic and diluted$(0.03)$(0.02)50.0%
Average number of shares outstanding, basic and diluted203,409,202112,364,99881.0%
1 Numinus Bioscience consists of revenues generated through Numinus’ Laboratory Operations.
Numinus Health consists of revenues generated through Numinus’ clinic network.

Numinus’ condensed consolidated financial statements for the three months ended November 30, 2021 and related management’s discussion and analysis are available on Numinus’ Investor Relations website at www.investors.numinus.com and under the Company’s profile on SEDAR at www.sedar.com.  These documents were prepared in accordance with IFRS and with TSX-Venture disclosure timeline requirements, as the company was listed on the TSX-Venture at quarter end.

Conference Call and Webcast Details

Interested parties are invited to participate in the Company’s Q1 2022 results conference call and webcast. On the call Numinus executives will review the Company’s performance and recent initiatives, and answer questions from analysts.

Date:Thursday, January 20, 2022
Time:5:30 p.m. (EST)
Dial-In:1 (833) 989-2968 (Toll-free North America), 1 (236) 714-4028 (International)
Code:2670376
Webcast:https://event.on24.com/wcc/r/3574506/6105A28282486D6F95F7834E9C5632E2

The webcast will also be archived on the Events and Presentations page of Numinus’ Investor Relations website: https://www.investors.numinus.com/events-and-presentations

About Numinus
Numinus Wellness (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
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”, “believes”, “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.

For further information: Investor Contact, Jamie Kokoska, Vice President, Investor Relations, jamie.kokoska@numinus.com, +1 833-686-4687; Media Contact, May Lee, Communications Manager, may.lee@numinus.com

Global Wellness’ Shanti Therapeutics Announce Psychedelic Drug Development Agreement

Global Wellness’ Shanti Therapeutics Announce Psychedelic Drug Development Agreement

Vancouver, British Columbia, January 20, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB: GWSFF) (Frankfurt:O3X4) (“Global” or the “Company”) announces that it has signed an agreement with Next Frontier Pharmaceuticals, Inc.’s subsidiary Benuvia Manufacturing, Inc.; a merger partner of Jupiter Wellness (NASDAQ: JUPW) to work with Shanti Therapeutics as the manager of their novel psychedelic development program using MDMA.

Benuvia, based in Round Rock, Texas, is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia has a growing portfolio of drug products and intellectual property, and an 83,000 square foot synthetic compound manufacturing facility that is permitted by the U.S. DEA for Schedule I to III controlled substances, and is FDA registered. Benuvia also has a platform of drug master files and drug development libraries, manufacturing process technologies, and intellectual property, including patents, for the development and manufacture of organic and synthetic cannabinoids, and has a pending application for quota with the U.S. DEA to manufacture psychedelic APIs. Benuvia has begun focusing on three primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine, or DMT, and 3,4-Methylenedioxymethamphetamine, or MDMA.

“Shanti chose Benuvia as its development partner due to its proven track record and best in class status as a developer and manufacturer of synthetic APIs.  We are creating a pipeline of novel agonists as a new class of therapeutics designed to treat the root causes of mental illness disorders and chronic pain.” said Meris Kott, CEO, Global Wellness Strategies Inc. “By partnering with Benuvia, Shanti will continue with its strategy of collaborating with the emerging leaders in the field to realize our mission to provide innovative new medicines to patients.”

“We are excited to announce our entry into the global psychedelic market and our partnership program with emerging providers of psychedelic-based drugs focused on mental illness and chronic pain indications,” said Shannon Soqui, Executive Chairman of Next Frontier Pharmaceuticals. “As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to increase Next Frontier Pharmaceuticals’ and Benuvia’s position as a leading drug developer and provider of APIs focused on cannabinoids and psychedelics.”

As part of its launch into the market, Benuvia has signed an agreement to provide life cycle management services to Shanti Therapeutics for their psychedelic development program which uses MDMA. Benuvia will develop and file intellectual property on formulations of MDMA, and will provide full toxicology, and chemistry, manufacturing and controls, or CMC, and full data analysis. In addition, Benuvia, through its partners, will manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomization, and assistance with clinical trials. This will enable Benuvia to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.

“We are excited to partner with Shanti Therapeutics as we have a shared vision to develop and commercialize innovative medicines that provide an alternative treatment option for health care providers and their patients,” said Brandon Kidd, Chief Business Development Officer of Next Frontier Pharmaceuticals. “As pharmaceutical companies look to optimize the life cycle management of their cannabinoid and psychedelic drug products, Benuvia is an ideal partner to facilitate all facets of the process from drug development and formulation to manufacturing.”

About Global Wellness Strategies

Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.

About Shanti Therapeutics Pty Ltd
Shanti Therapeutics Pty Ltd, is a subsidiary of Global Wellness Strategies Inc. and  is a clinical stage drug development company focused on identifying novel uses for MDMA in the treatment of acute and chronic pain management.  Its core strategy involves identifying innovative uses for entheogen drugs and pushing them into in-human clinical trials.  Its lead asset is scheduled to commence Phase 2 clinical trials in late 2022.

About Next Frontier Pharmaceuticals, Inc.
Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., is a leading drug developer and provider of cannabinoid and psychedelic APIs.  Benuvia owns the FDA approved cannabinoid drug SYNDROS® (dronabinol oral solution CII), and the largest captive synthetic cannabinoid manufacturing facility in the U.S.  SYNDROS® is FDA approved as a prescription drug for the treatment of chemotherapy-induced nausea and vomiting in cancer patients and loss of appetite in AIDS patients who have lost weight. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for six Investigational New Drugs (INDs). The Company’s 83,000 square foot manufacturing facility in Texas is permitted by the U.S. DEA to manufacture and export Schedule I to III controlled substances and is FDA registered. The facility has received millions in manufacturing infrastructure investments and currently operates for Benuvia’s internal capacity needs and as a contract manufacturer of APIs.  Next Frontier Pharmaceuticals also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids and provides life cycle management services for drug development companies focused on cannabinoids and psychedelics.

For further information visit websites:

www.globalwellnessstrategies.com and  www.shantitherapeutics.com

Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com

Further information about the Company is available on www.SEDAR.com under the Company’s profile.

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute “forward–looking statements” or “forward-looking information” (collectively “forward-looking information”) as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “anticipates” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein

Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD

Survey Finds Majority of Affected Americans Approve of Psychedelics as an Alternative Treatment to Address Anxiety, Depression and PTSD

VANCOUVER, BRITISH COLUMBIA, Jan. 11, 2021 – A new survey conducted by The Harris Poll on behalf of Delic Holdings Corp (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, reports that nearly two thirds of Americans who suffer from anxiety/depression/PTSD (65%) believe that psychedelic medicine (i.e. ketamine, psilocybin and MDMA) should be made available to patients with treatment-resistant anxiety, depression or PTSD. 

According to the survey, conducted online in December, 2021 among 953 U.S. adults who suffer from anxiety/depression/PTSD, nearly two-thirds (63%) of Americans who have used prescription medications to treat anxiety/depression/PTSD say that while the medication helped, they still experienced residual feelings of anxiety, depression or PTSD. Furthermore, 18% say that the medication did not improve their condition/made it worse.

“We are witnessing a silent crisis impacting people across the globe exacerbated by an ongoing pandemic, and the results of this survey should compel more medical professionals and lawmakers to support in-depth studies on the therapeutic benefits of psychedelic medicine,” said Matt Stang, co-founder and CEO of Delic. “This promising family of new medicines has the potential to be more effective than traditional medicines with minimal side effects, giving people their best selves back. Our country’s mental health crisis not only impacts public health, but also the economy–each year, untreated mental illness costs the U.S. up to $300 billion in lost productivity.”

According to the study, 83% of Americans experiencing anxiety, depression or PTSD would be open to pursuing alternative treatments proven to be more effective than prescription medication with fewer side effects. Among those who suffer from anxiety/depression/PTSD, many would be open to using the following substances which have been identified as potential alternative treatments for those seeking to address their mental health conditions:

  • Ketamine: 66% would be open to pursuing treatment using ketamine to treat anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.
  • Psilocybin: 62% said they would be open to pursuing treatment using psilocybin prescribed by a physician to address their anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.
  • MDMA: 56% would be open to pursuing treatment using MDMA prescribed by a physician to treat their anxiety, depression or PTSD if it was proven more effective than prescription medication with fewer side effects.

Survey Method

This survey was conducted online within the United States by The Harris Poll on behalf of Delic from December 6 – 8, 2021 among 2,037 adults ages 18 and older, among whom 953 suffer from anxiety/depression/PTSD. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact delic@mattio.com.

About The Harris Poll

The Harris Poll is one of the longest running surveys in the U.S., tracking public opinion, motivations and social sentiment since 1963. It is now part of Harris Insights & Analytics, a global consulting and market research firm that strives to reveal the authentic values of modern society to inspire leaders to create a better tomorrow. We work with clients in three primary areas: building twenty first century corporate reputation, crafting brand strategy and performance tracking, and earning organic media through public relations research. Our mission is to provide insights and advisory to help leaders make the best decisions possible.

About Delic Corp

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

Forward Looking Statements

This media advisory contains forward–looking statements and forward–looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward–looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, ” expects” or, “proposed”, “is expected”, “intends”, “anticipates”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. More particularly and without limitation, this news release contains forward–looking statements and information concerning a national consumer survey conducted by The Harris Poll. Such forward-looking statements and information reflect management’s current beliefs and are based on assumptions made by and information currently available to the company with respect to the matter described in this new release. Forward-looking statements involve risks and uncertainties, which are based on current expectations as of the date of this release and subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those exp “We are witnessing a silent crisis impacting people across the globe exacerbated by an ongoing pandemic, and the results of this survey should compel more medical professionals and lawmakers to support in-depth studies on the therapeutic benefits of psychedelic medicine,” said Matt Stang, co-founder and CEO of Delic ressed or implied by such statements. Additional information about these assumptions and risks and uncertainties is contained under “Risk Factors and Uncertainties” in the Company’s latest annual information form filed September 23, 2019, which is available under the Company’s SEDAR profile at www.sedar.com, and in other filings that the Company has made and may make with applicable securities authorities in the future. Forward-looking statements contained herein are made only as to the date of this press release and we undertake no obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. The Canadian Securities Exchange has not reviewed, approved or disapproved the content of this news release.

Mydecine Signs LOI with The Newly Institute to Provide Psychedelic-Assisted Psychotherapy to Patients under Health Canada’s Special Access Program

Mydecine Signs LOI with The Newly Institute to Provide Psychedelic-Assisted Psychotherapy to Patients under Health Canada’s Special Access Program

Under Mydecine’s recently announced Special Access Support and Supply Program, the Company will supply cGMP Psilocybin and MDMA to The Newly. The companies will partner to co-develop protocols, therapy manuals, and training needed to treat patients who need specific care.

VANCOUVER, British Columbia, Jan. 18, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced it has signed a Letter of Intent (LOI) with The Newly Institute Inc. (“The Newly”), a Calgary, Alberta based company opening private inter-disciplinary mental health clinics across Canada, to collaborate on expanding psychedelic-assisted psychotherapy to patients.

The Newly offers rapid access outpatient programs providing innovative mental health, addiction and trauma therapies. The Newly opened its first location last year in Calgary and intends to open additional clinics in cities across Canada beginning in 2022. Mydecine and The Newly have world-class teams of medical and scientific experts positioning their companies to provide the highest quality and most responsible care to patients. Together, the companies will create the package of resources needed for patients and practitioners to successfully gain acceptance into Health Canada’s Special Access Program (SAP).

The Newly is the first partner under Mydecine’s recently announced Special Access Support and Supply Program (SASSP). The companies will develop protocols and therapy manuals for a variety of indications. Mydecine will provide cGMP psilocybin and MDMA alongside the safety and efficacy data needed to gain acceptance into Health Canada’s SAP. The Newly will provide the clinic locations and experienced therapists needed to perform the treatments. The companies intend to enter into a revenue sharing agreement.

The Newly’s Chief Scientific Officer Dr. Marshall Ross said, “We believe this partnership with Mydecine brings many positives to The Newly, and more importantly, to Canadians in need. Research supports that psychedelic-assisted psychotherapy can break down deeply rooted psychological defenses, facilitate therapeutic breakthroughs and effect substantial improvements in long-term mental health. We will promote and exemplify safe and effective treatment techniques by implementing and studying our evidence-based protocols for the use of psychedelics in our practice.”

Mydecine Chief Medical Officer Dr. Rakesh Jetly said, “The recent changes to Canada’s SAP program are encouraging, but in order to make a significant positive impact on patients, we need to ensure these therapies are carried out safely and effectively. We are excited to work hand-in-hand with The Newly team to develop the evidence-based protocols, therapy manuals, training and other resources physicians need in order to promote the successful integration of these treatments into their existing infrastructure.”

The Newly’s President & CEO Arthur H. Kwan said, “Our goal at The Newly is to build a network of clinics across Canada that deliver innovative and leading-edge mental health treatments to individuals in need. The platform we’re developing can be very effective in enabling us to deploy new and innovative best-practice treatments and therapies. We are pleased to partner with a company like Mydecine to enhance the mental health care being provided to Canadians.”

Mydecine CEO Josh Bartch said, “We couldn’t think of a better partner than The Newly to act as the model site for our SASSP. Both companies come with incredibly talented and experienced medical and scientific teams who value treatments based on evidence and data. Collaboration is the foundation of all work processes and essential to our overall success. I believe this partnership will set the gold standard for these psychedelic-assisted therapies while making them more accessible to patients.”

Working collaboratively will allow the companies’ experts to share common ideas and goals surrounding proper therapy protocols. The different perspectives and expertise across the teams will enable the most effective, innovative, and scalable treatment solutions. Mydecine will also support The Newly’s patients with post-therapy needs through their digital health platform called Mindleap. Additionally, both companies plan to create an exclusive research database to aid in future developments.

Sign up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: www.mydecine.com and follow the Company on TwitterInstagram, and LinkedIn.

For more information, please contact:

Investor & Media Contact:
Morgan Kervitsky, Director of Marketing
(720) 689-4638
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

About The Newly Institute

The Newly Institute Inc., a Calgary, Alberta based private company, believes mental health treatment is in drastic need of a paradigm shift. Our vision is to provide long-lasting change within the industry, our community and with our patients. We have pioneered an intensive bio-psycho-social-spiritual treatment model that can be supplemented by medically managed psychedelic-assisted therapies when appropriate. Our medical professionals help patients overcome deeply embedded traumas, addiction and pain that are preventing them from living fully in their everyday lives. While our programs are based on evidence and data, our approach is personal as we know it is vital that people feel safe as together we do the difficult work necessary to achieve wellness.

The Newly is on track to becoming Canada’s largest and premier operator of inter-disciplinary mental health clinics. We currently operate an 11,000 square foot clinic in Calgary with additional locations planned for Fredericton, New Brunswick, Edmonton, Alberta and St. John’s, Newfoundland and Labrador, as well as in several more Canadian cities. Learn more at www.thenewly.ca.

For further information, please contact:

Media Contact:
Stephen Lewis, VP, Public Relations
(403) 472-6574
info@thenewly.ca

On behalf of the Board of Directors:
Arthur H. Kwan, President & CEO
info@thenewly.ca

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Source: Mydecine Innovations Group Inc.

Released January 18, 2022

Optimi Health Submits Natural Psilocybin Combined Drug Delivery and Extraction Formulations for Provisional Patent

Optimi Health Submits Natural Psilocybin Combined Drug Delivery and Extraction Formulations for Provisional Patent

Company identifies unique two-part extraction and transdermal delivery process

VANCOUVER, BC (GLOBE NEWSWIRE – January 18, 2022) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, is pleased to announce a second provisional patent for a proprietary two-part processing method that involves the extraction and transdermal delivery of psilocybin active components.

The extraction process uses a highly viscous material to isolate key components of psychedelic mushrooms and dissolves the psilocybin into a molecular solution. Using the same energy, the active ingredients are then repelled into the skin when applied topically. Due to the skin’s highly permeable membrane, Optimi’s solution has a natural time-release effect, which allows for a more sustained release into the body and provides a patient with the ability to experience the desired outcome for longer periods of time.

As Chief Science Office Justin Kirkland explains, “The most novel part of this process is that we are performing two very different functions with a single unique component. This component works much like the attraction and repulsion properties of a magnet with a North and South end. We leverage this energy to perform two functions. First, the attraction energy will extract psilocybin out of the mushroom. Second, when this same material is applied to the skin, it will advance the drug through the skin and into the bloodstream.”

Containing all GRAS certified ingredients, this solution can then be loaded into our proprietary drug delivery system for direct passage through the skin into the bloodstream. Transdermal application avoids the first pass metabolism and degradation of psilocybin by the liver that occurs with traditional oral drug delivery, which increases bioavailability of the active ingredient.

In the continued effort to champion all things natural, Optimi’s delivery system has been designed to require no additional shuttling agents. Instead, the repulsion technology steadily pushes the active ingredient through the various layers of the skin, and treatment begins almost immediately upon application. This new process will help to reduce costs and resources while providing patients with a superior product.

Optimi is focused on providing patients with a safe, consistent, and pure psychedelic product. Developing multiple extraction and delivery system methods is part of the Company’s commitment to ensuring patients have options when deciding their treatment.

“This unique chemistry provides improved bioavailability of Optimi’s psilocybin,” said Optimi CEO Bill Ciprick. “Our IP is evidence of Optimi Health’s continued commitment to sustainability by using green chemistry to achieve both the extraction and topical formulations.” Mr. Ciprick adds, “As patient access remains the focal point among regulators, lobbyists and Companies such as our own, we look forward to being able to provide our variety of therapies to those in need.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://optimihealth.ca/

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

The CSE does not accept responsibility for the adequacy or accuracy of this release.Search

CATEGORIES

OPTIMI HEALTH SUBMITS NATURAL PSILOCYBIN COMBINED DRUG DELIVERY AND EXTRACTION FORMULATIONS FOR PROVISIONAL PATENT

18 JANUARY 2022

OPTIMI HEALTH PROVIDES DEALER LICENSE UPDATE AND COMMENTS ON HEALTH CANADA’S AMENDMENTS TO THE SPECIAL ACCESS PROGRAM (SAP)

5 JANUARY 2022

OPTIMI HEALTH RECEIVES DEALERS LICENSE INSPECTION AND INTRODUCES QUALITY ASSURANCE DEPARTMENT

21 DECEMBER 2021

OPTIMI HEALTH REQUESTS FINAL INSPECTION FOR DEALER’S LICENSE

7 DECEMBER 2021

OPTIMI HEALTH ENGAGES EXPERT MANAGEMENT CONSULTANCY TO DRIVE CORPORATE VISIBILITY

3 NOVEMBER 2021

OPTIMI HEALTH APPOINTS PRINCIPAL INVESTIGATOR FOR CLINICAL DOSING STUDY

19 OCTOBER 2021Email

Numinus Submits Clinical Trial Application for Phase 1 Trial on Proprietary Psilocybin Product

Numinus Submits Clinical Trial Application for Phase 1 Trial on Proprietary Psilocybin Product

The trial evaluates Numinus’ first trademarked product and patent-pending production process

VANCOUVER, BC, Jan. 14, 2022 /CNW/ – Numinus Wellness Inc. (“Numinus”) (TSX: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to announce that it has formally submitted the clinical trial application (“CTA”) to Health Canada for its Phase 1 study, HOPE, on a naturally derived Psilocybe extract formulation, NBIO-01. This milestone further progresses and solidifies Numinus’ long-standing work on developing safe and effective psychedelic products out of its Health Canada-licensed research facility, Numinus Bioscience.

“This application significantly advances our product development pipeline, which is aimed at broadening access to safe and effective products for psychedelic-assisted therapies,” says Sharan Sidhu, Science Officer and General Manager, Numinus Bioscience. “The trial will assess safety and bioavailability and be a stepping stone to the next stage for our IP development. This natural product has been developed to be shelf stable, minimally variable and consistently meet label claims. The trial will not only assess safety but also give us data on comparative bioavailability.”

NBIO-01 is Numinus Bioscience’s first proprietary formulation developed from extracts generated using patent-pending technology, for which a patent was earlier submitted to the US Patent and Trade Office and announced on June 24, 2021. The formulation has been developed to stably deliver psilocybin and other synergistic compounds and will be studied for safety and bioavailability.

As Numinus’ first fully autonomous clinical trial, HOPE is a two-phase study that will take place at a Numinus clinic in Vancouver. Upon approval, Numinus will begin testing the extract for bioavailability and tolerability on 20 healthy volunteers, followed by testing against a psilocybin comparator on a further 28 healthy volunteers.

“At Numinus, we are focused on developing products and services in-house to ensure that high-quality standards are maintained,” says Payton Nyquvest, Founder & CEO, Numinus. “I am very proud of the Numinus team – from our Bioscience experts who developed the product, to our clinical research team who will administer the study. We look forward to achieving more milestones in our mission to make psychedelic-assisted therapies accessible to all who wish to safely use them.”

About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal and be well through the development and delivery of innovative mental healthcare 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
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.

For further information: May Lee, Communications Manager, Numinus, may.lee@numinus.com; For investor inquiries: Jamie Kokoska, VP, Investor Relations, Numinus, jamie.kokoska@numinus.com

NeonMind Appoints Canadian Medical Leader In Anesthesiology, Dr. Daniel Bainbridge, MD, FRCPC To Its Specialty Clinics Advisory Board

NeonMind Appoints Canadian Medical Leader In Anesthesiology, Dr. Daniel Bainbridge, MD, FRCPC To Its Specialty Clinics Advisory Board

Dr. Bainbridge’s Expertise and Network Provides Safety Best-Practices for Administration of Intravenous Ketamine (IV-Ketamine) at NeonMind Clinics

Vancouver, B.C. – January 13, 2022: NeonMind Biosciences Inc. (CSE: NEON) (OTCQB: NMDBF) (FRA: 6UF) (“NeonMind” or the “Company”), an integrated drug development and wellness company, announced today the appointment of Dr. Daniel Bainbridge, MD, FRCPC, past President of the Canadian Anesthesiologists Society, Professor from the Department of Anesthesia and Perioperative Medicine at the University of Western Ontario, and Anesthesia Consultant at London Health Sciences Centre, to its Specialty Clinics Advisory Board.

NeonMind’s medical services division is establishing specialty clinics to enhance access to interventional psychiatry treatments including intravenous ketamine treatment (“IV-ketamine”) which has shown promise as a rapid treatment for mood and anxiety disorders and has been included as a recommended treatment into Canadian guidelines by the Canadian Network for Mood and Anxiety Treatments1. Dr. Bainbridge will utilize his substantial experience to ensure NeonMind’s protocols, procedures, training, and practices of administering intravenous ketamine are best-in-class and practical from a safety perspective.  With over 20 years as a practicing anesthesiologist and his leadership role with the Canadian Anesthesiologists Society, Dr. Bainbridge has vast experience with ketamine and a large network of contacts for NeonMind to train and employ to assure patient safety.

“We are excited to welcome the Canadian leader in anesthesiology, Dr. Bainbridge, to our Specialty Clinics Advisory Board. At NeonMind, we are focused on enhancing access to interventional psychiatry to help address the mental health crisis, including IV-ketamine for mood and anxiety disorders. Safety is of utmost importance for NeonMind’s specialty clinics and, with Dr. Bainbridge’s involvement in building our programs, we can assure patients and healthcare providers they are receiving best-in-class care for their IV-ketamine administration. He will prove invaluable to enhancing access and wider adoption of NeonMind’s IV-ketamine treatment programs,” said Robert Tessarolo, President & CEO of NeonMind.

Dr. Bainbridge commented, “The evidence supports that IV-ketamine is safe and well tolerated at the therapeutic doses used to treat patients suffering from mood and anxiety disorders. The ketamine doses used are magnitudes lower than for procedural sedation, let alone general anesthesia. Ketamine administration requires specific procedures and expertise and can be safely provided in specialty clinics with the appropriately trained health care provider. My colleagues at NeonMind understand this with the aim of enhancing access to this transformational treatment for mood and anxiety disorders utilizing safe and effective care programs. I am excited to work with NeonMind in developing IV-ketamine administration practices and establishing a clinic network to enhance access to these treatment programs for patients in need.”

  1. Swainson, J., McGirr, A., Blier, P., Brietzke, E., Richard-Devantoy, S., Ravindron, N., Blier, J., McIntyre, R., Milev, R., Parikh, S., Schaffer, A., Taylor, V., Tourjman, V., van Ameringen, M., Yatham, L., Ravindran, A. and Lam, R., 2021. The Canadian Network for Mood and Anxiety Treatments (CANMAT) Task Force Recommendations for the Use of Racemic Ketamine in Adults with Major Depressive Disorder. The Canadian Journal of Psychiatry, 66(12), pp.1102-1102.

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.


Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.

rob@neonmind.com

Tel: 416-750-3101

Investor Relations:

KCSA Strategic Communications

Scott Eckstein/Tim Regan

neonmind@kcsa.com

Tel: 212-896-1210

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

Wesana Health Provides Strategic and Operational Updates

Wesana Health Provides Strategic and Operational Updates

  • Wesana granted pre-IND meeting with FDA, currently set for March 11, 2022
  • Wesana Clinics exhibited a record quarter of billings, new patient visits, telemedicine utilization, overall patient appointments, and ketamine administrations
  • New flagship clinic set to open in late Q1 2022 showcasing the service evolution of Wesana Clinics
  • Strategic restructuring program to realize $1.1M in general corporate overhead reduction and improve operational efficiencies

CHICAGO and TORONTO, Jan. 12, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.  (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pleased to announce the following strategic and operational updates to the Company’s Care Development and Care Delivery businesses in addition to leadership changes as the Company streamlines its strategy going into FY 2022.

Care Development

Program overview

Wesana’s drug development program looks to utilize combination therapy to treat the symptoms associated with Traumatic Brain Injury (“TBI”), such as depression and anxiety, and migraines. By utilizing psilocybin and cannabidiol (“CBD”), a combination therapy of compounds with demonstrated effectiveness, Wesana’s lead drug candidate, SANA-013, is targeted to improve neuroplasticity and neurogenesis while acting as an anti-neuroinflammatory. In contrast to therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects over a short time-period, SANA-013 utilizes a loading dose of psilocybin in combination with self-administered at-home maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.

Pre-IND meeting milestone

The U.S Food and Drug Administration (“FDA”) granted the Company’s request for a pre-Investigational New Drug (“IND”) meeting to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of TBI-related major depressive disorder (“MDD”).

In the pre-IND meeting, scheduled for March 11, the Company expects to receive feedback from the FDA on its toxicology program and research to-date. The outcome of the meeting will provide key development guidance in advance of IND clearance and initiation of the Phase I clinical trial, currently anticipated to occur in late 2022.

Mark Wingertzahn, Chief Scientific Officer of Wesana commented: “We are impressed with the latest Wesana data and look forward to discussing our drug development approach with regulators in the US and abroad.”

Care Delivery

Record Q4 numbers at Wesana Clinics

The Company is pleased to report that following its previously announced milestone of 4,000 ketamine infusions since the clinic’s inception, Wesana Clinics (the “Clinics”) have shown tremendous growthThe Clinics realized a record quarter in Q4 of billings, new patient visits, telemedicine utilization, overall patient appointments, and ketamine administrations. The record quarter can be attributed to an increase in marketing efforts inclusive of relationship building with the provider and therapist community and strategic and targeted marketing communications.

Wesana Clinics saw a 40% increase in new patient volume and a 29% increase in new appointments relative to the previous quarter. In December 2021, compared to the prior month, Ketamine infusions have also exceeded previous records by 52% while Spravato appointments have increased by 35%. Additionally, the Clinics are expanding access to mental health care through higher utilization of telemedicine appointments. Telemedicine appointments accounted for 57% of all appointments in the last quarter.

Dr. Abid Nazeer, Wesana’s Chief Medical Officer, commented: “I am incredibly pleased with the growth and optimization of the clinics since Wesana’s acquisition in September. Even taking into consideration the backdrop of increasing COVID-19 cases in Chicago, our ability to achieve record numbers is evidence that there is a growing need for accessible, effective, and patient-focused quality mental health care models that integrate established treatment approaches with novel care paradigms. Wesana’s expertise in marketing combined with our existing success in operations has created a winning combination for our patients and improved operating leverage for shareholders.”

Clinic Expansion within Chicago

The Company is also pleased to announce the expansion of clinical operations through the build-out of a third clinic in Naperville, Illinois. Strategically located approximately 25 minutes from the company’s clinic in Oak Brook, IL and 45 minutes from the clinic in downtown Chicago, the Naperville clinic will serve as a key expansion center that will benefit from existing referral sources and marketing initiatives as current locations reach capacity.

At approximately 3,100 square feet, the clinic will offer ketamine treatments in addition to existing Wesana Clinics insurance reimbursable services such as general psychiatric care, Spravato, individual psychotherapy, neurocognitive testing and addiction medicine. The Naperville clinic will also look to showcase the evolution of the clinics through new value-added, insurance reimbursable services such as deep Transcranial Magnetic Stimulation (“dTMS”), group psychotherapy, cognitive training and other mental health and wellness care. The launch of the clinic is currently targeted for late Q1 2022.

“The Naperville expansion is a natural evolution for our clinics business and allows us to realize our vision of Wesana Clinics 2.0,” commented Daniel Carcillo, Chief Executive Officer of Wesana Health. “Serving as our flagship, we are positioned to help the Naperville community with much needed mental health access through new integrated and more effective personalized approaches to healing. Based on our research and understanding of our patient population, we are confident that the new clinic will be a validation of our view on the evolution of our clinics business into a more comprehensive care model.”

Leadership Changes

Israel Mirsky, Chief Marketing and Strategy Officer of Wesana, has transitioned out of the organization to pursue other opportunities. As an early executive of Wesana, Mr. Mirsky was instrumental in building out the Company’s marketing function and in refining the Company’s strategy. The Company would like to thank Mr. Mirsky for his contributions in the early stages of the company and for his role in building out one of Wesana’s key functions.

Hayim Raclaw, Chief Operating Officer of Wesana, has transitioned out of the organization to pursue other opportunities. As co-founder and CEO of PsyTech, Hayim led the development of the clinics and clinical software divisions that now comprise the Care Delivery segment of Wesana. The Company would like to thank Mr. Raclaw for a successful integration of PsyTech’s assets into Wesana and for his contributions to the combined organization.

“On behalf of the management team, I would like to thank Israel and Hayim for their commitment and contributions to building Wesana to its current stage and wish them all the best in their future endeavors,” commented Daniel Carcillo. “As our strategy continues to evolve on both sides of our business, these transitions serve as needed steps to realize our vision of helping patients transcend the barriers in mental health and performance.”

Additional Restructuring

The Company also announces a strategic restructuring program as part of the next phase of the business. The restructuring includes a reorganization and simplification of the Company’s operating structure and a reduction in the workforce. The restructuring program specifically looked to reduce layers of management, remove duplicative roles, and outsource certain non-core functions in order to streamline operations and drive efficiency. The overall restructuring program has reduced general corporate overhead annualized commitments by $1.1M excluding charges associated with severance and related costs.

“We are announcing extensive changes today to make Wesana a stronger, more durable and focused company,” said Zed Wang, Chief Financial Officer of Wesana. “This includes making the difficult decision to part ways with some of our workforce. Saying goodbye to teammates is not a decision that was taken lightly, and we remain very grateful to everyone for their hard work and dedication to Wesana. These changes better positioned our organization by allowing our organization to be laser focused on executional excellence, R&D, quality and accessibility of care.”

On behalf of the Board of Directors:

“Daniel Carcillo” Chief Executive Officer

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and proprietary protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

Investor Relations:

Keenan Gentry

Email: IR@wesanahealth.com 

Phone: 702.329.8038

Media Contacts:

Isadora Forman

Email: media@wesanahealth.com

Phone: 917.653.4613

Cautionary Note Regarding Forward-Looking Information

This press release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase I clinical trials in late 2022, the launch of the Naperville clinic in late Q1 2022 and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Certain factors that influence successfully initiating Phase I clinical trials in late 2022 include: (i) the Company has retained industry leading experts/consultant to assist with strategy, drafting and submission of pre-IND/CTA meeting Packages; (ii) preparation of materials and internal discussions with consultants have been ongoing, productive and in line with timeline expectations; (iii) the Company has submitted an authorization letter to the FDA authorizing one of its Contact Research Organizations to communicate directly with the FDA on the Company’s behalf and personnel capable of attending the pre-IND/CTA meetings on behalf of the Company have been engaged; (iv) timelines for completion of pre-clinical studies and the receipt of a final report on the Anxiety and Depression Effects Study have been met; (v) the Company has identified the next key IND-enabling studies, including the pharmacology and toxicology assessments necessary to support submissions; (vi) the Company has substantially completed drafting the protocols for the above-referenced IND enabling studies, including the pharmacology and toxicology assessments; (vii) the pre-IND meeting is contemplated to provide the Company with the requisite guidance as to whether the protocols for the IND enabling studies are sufficient.

Certain assumptions that influence successfully initiating Phase I clinical trials in late 2022 include: (i) third parties assisting the Company with the pre-IND/CTA submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND/CTA meetings are positive and support that a drug development plan and future clinical trials are going to be acceptable to the FDA and Health Canada; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests from FDA/Health Canada as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.

Certain factors that influence successfully launching the Naperville clinic in late Q1 2022 include: (i) the Company has identified a third clinic location and property and is finalizing the lease, (ii) should the Company procure additional capital and proceed with a lease in connection with the identified third property, renovations and permitting of the property for the purpose of clinic operations are expected to be minimal, and (iii) the Company has an internal team dedicated to identifying potential target clinics and locations and evaluating and addressing issues that may arise during due diligence of any potential targets.

Certain assumptions that influence successfully launching the Naperville clinic in late Q1 2022 include: (i) there are no significant delays in the buildout for the Naperville clinic early in Q1 2022, and (ii) there are no significant delays in renovation/permitting.

Furthermore, such forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual performance, achievements, actions, events, results, or conditions of the Company to be materially different from any future performance, achievements, actions, events, results or conditions expressed or implied by such forward-looking information. Such factors include, among others: reliance on third parties to plan, conduct and monitor product research and development; failure to comply with health and data protection laws and regulations; violations of laws and regulations resulting in repercussions; regulatory or political change; maintaining and enhancing reputation and brand recognition; ability to protect intellectual property; requirements to share intellectual property with service providers; negative operating cash flow and going concern; the detrimental impact of future losses and negative cash flow from operations; unfavorable publicity or consumer perception; not achieving publicly announced milestones; psychedelic inspired drugs possibly never being approved as medicines; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; exposure to the fluctuation of foreign exchange rates; enforcement of judgments and effecting service of process on directors and officers; general economic, market and business conditions, and other risks factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such forward-looking information will prove to be accurate as actual results and future events could differ materially from those anticipated in such information. Accordingly, readers should not place undue reliance on forward-looking information. Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.