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Highlights:
Optimi Health (CSE:OPTI,OTC:OPTHF,FRA:8BN) is focused on becoming the leading global supplier of GMP-grade psilocybin and functional mushrooms for health and wellness markets. Capitalizing on the projected 6.41 percent market growth by 2026 for the psychedelic mushroom market, the company is anticipating the opening of its specially designed facility for GMP-grade psilocybin cultivation.
The facility is already licensed by Health Canada for psilocybin manufacturing and has the capacity to produce 2,000 kilograms per month. Optimi Health’s cultivation process has a six-week growth cycle while maintaining the standards and quality of GMP guidelines.
Company Highlights
- Optimi Health aims to become a global leader in GMP-certified psilocybin and functional mushroom products to cater to the emerging psychedelic segment of the wellness industry.
- Three revenue streams are in the works to fully capitalize on the diverse needs of the growing market: Optimi Labs, Optimi Farms and Optimi Products. Optimi Products is already generating revenue, while Optimi Farms is slated to become the primary revenue driver.
This Optimi Health profile is part of a paid investor education campaign.*
OPTI:CC
Optimi Health Announces Closing of Strategic Non-Brokered Private Placement
- $1.85 million in proceeds received through a strategic offering of units at $0.325 per unit with each unit comprised of one common share and one-half of one (1/2) Common Share purchase warrant exercisable at $0.50, for total potential proceeds of $3.27 million.
- Financing will fuel Optimi's ongoing commercialization efforts, support new product development and provide necessary working capital to be strategic in the marketplace, with opportunities being explored in Oregon and Alberta.
- Chip Wilson, founder of lululemon athletica inc., is an advisor to the Company and health and wellness advocate.
- The Private Placement increases Chip's ownership to 9.5% on a fully diluted basis.
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) (" Optimi " or the " Company "), a leading GMP producer and safe supply advocate licensed by Health Canada to produce and distribute natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce it has closed a non-brokered private placement of 5,692,308 units of the Company (each a " Unit ") at a price of $0.325 per Unit (the " Private Placement ") for gross proceeds of $1,850,000 with Wilson Capital, the Private Equity Division Chip Wilson's ( "Chip" ) family office. The Company intends to use the proceeds from the issuance of the Units to support its psychedelic product commercialization efforts, ongoing psilocybin and MDMA research and clinical trial initiatives, in-house drug development, and for general working capital.
Each Unit consists of one (1) common share of the Company (a " Common Share ") and one-half of one (1/2) Common Share purchase warrant (each whole warrant, a " Warrant "). Each Warrant is exercisable at $0.50 for a period of two (2) years from the date of issuance. The Common Shares and Warrants comprising the Units and any Common Shares issued upon exercise of the Warrants are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities laws.
Optimi welcomes this strategic investment led by the family office of Chip Wilson, founder of lululemon athletica inc., who also serves on the Advisory Board of Optimi. Mr. Wilson, stated, "Our participation in the placement speaks to our belief that the Company can achieve its plan to be a world leader in psychedelic product development and global distribution."
Optimi CEO, Bill Ciprick, commented, "It is important to demonstrate both to our existing shareholders and the market at large that Optimi's leadership is taking an active role in raising smart capital. When looking at a variety of potential funding options to lead this round of financing, apart from ensuring the terms of the financing were highly competitive, expanding its relationship with Chip through this investment was the preferred scenario given Chip's familiarity with the operational business, his ongoing support to Optimi in an advisory capacity, and understanding of management and the Board's track record and commitment to achieving its near and long-term corporate milestones."
The private placement increases the amount of the Company's Common Shares owned by Founders, members of the Advisory Board, Directors, and Officers.
Optimi co-founder, director and CFO, Jacob Safarik, says, "This pivotal financing puts the Company in the enviable position of being backed by one of the most trusted family offices in Canada. In a time of market instability, Optimi has maintained the necessary flexibility to execute on its path to profitability while strengthening its working capital position to continue pursuing important product development and research initiatives that support Optimi's position as a leading safe supply advocate," said Safarik. "It is crucial to our continued success that Optimi be ready for opportunities including the implementation of legal psychedelic therapy in new markets taking shape, such as Oregon and Alberta, and that we have a variety of safe, lab tested, EU-GMP psilocybin and MDMA products available to patients around the world as the global regulatory markets continue to evolve."
The strategic offering sets the foundation for the Company's upcoming expansion milestones, including Phase I and II psilocybin and MDMA clinical trials with ATMA Journey Centers, the rollout and expansion of Optimi's functional mushroom and psychedelic product catalogues, and establishing an operational footprint in Oregon's regulated psilocybin market.
Optimi co-founder, director and CMO, Dane Stevens, stated, "This sends the right message at the right time to investors paying close attention to the psychedelics market. When an investor like Chip Wilson offers to increase his position and back the future of Optimi, you find a way to get a deal done. Optimi would not exist without the vision and commitment of JJ and Chip Wilson, the Safarik family, and the shared belief that the work we are doing today will improve the health of so many in need for many years to come. With this strategic raise, we are building trust with shareholders and operations team alike, and demonstrating that the Company's Founders and leadership team are committed to the long-term success and growth of Optimi."
The Wilson family recently made news for their $100,000,000 donation, the largest in history, to the B.C. Parks Foundation — as well as the establishment of Solve FSHD (a foundation to research into a cure for facioscapulohumeral muscular dystrophy) with an additional $100 million, in September and March of 2022, respectively. These were facilitated by the Wilson 5 Foundation, the family's private foundation.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are produced at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA producer in North America.
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 Private Placement, including with respect to the use of proceeds, the future success of Optimi, activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. 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.
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
News Provided by GlobeNewswire via QuoteMedia
Alberta Puts Patients First By Regulating Psychedelic Therapy: Optimi Health
Highlights:
- The safe supply of psychedelic drug products manufactured at a GMP-level is critical in treating serious mental health issues. Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, has publicly stated that safe drug supply is paramount to reducing overdose deaths.
- Optimi Health is the largest cultivator of natural EU-GMP psilocybin and MDMA in North America.
- Optimi Health is licensed by Health Canada to supply clinical trials and patients approved under the Special Access Program.
Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a leading Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is applauding the government of Alberta's decision to regulate some psychedelics for therapeutic use in the province.
The proposed framework as stated by the Government of Alberta comes into effect on January 16, 2023. It would give a physician, psychiatrist, or doctor the ability to prescribe and administer psilocybin, MDMA, or other psychedelics produced by Optimi to patients under the Mental Health Services Protection Act.
Optimi CEO, Bill Ciprick, made the following statement on behalf of the Company:
"Yesterday, the Government of Alberta made a bold and politically courageous decision to regulate the use of psychedelic therapy for patients suffering from a variety of treatment-resistant conditions. They have accepted the substantial body of research, including the completion of a growing number of randomized clinical trials, which highlight psilocybin (the active ingredient in "magic" mushrooms) when paired with psychotherapy as an emerging and novel approach for the treatment of a host of mental health conditions, including treatment-resistant depression, substance-use disorder, and severe anxiety associated with a terminal diagnosis.
Thanks to Optimi's existing partnerships and supply agreements with clinics, therapists, and researchers within the Province of Alberta — including ATMA Journey Centers, Bloom Psychedelic Therapy and Research Centre, and SABI Mind — the Company is uniquely positioned to support the development of Alberta's regulated psychedelic therapy infrastructure.
The increasing evidence supporting the benefits of psilocybin-containing mushrooms when used as part of psychotherapy has resulted in growing international interest in moving quickly to increase patient access to this treatment given the impressive and growing track records of safety in both the therapeutic and naturalistic use contexts.
We have seen widespread, bi-partisan support for psilocybin and MDMA Bills introduced in State legislatures across the United States; the Biden Administration has appointed a special task force to understand and prepare for the regulation of psychedelics in the U.S; and recently, Canadian Minister of Mental Health and Addictions, the Honourable Carolyn Bennett, admitted that Canada needs a safe supply of drugs to fight the spiraling opioid crisis.
While we await further details on Alberta's regulatory framework, we encourage other provincial health ministries to start asking the right questions about psychedelic therapy, and to seek further guidance from the Psychedelic Association of Canada's Memorandum of Regulatory Analysis (MORA) which provides a step-by-step regulatory framework for end-of-life and palliative Canadians.
As a Health Canada licensed supplier of EU-GMP natural psilocybin and synthetic psychedelics, Optimi Health is committed to working with the Government of Alberta to supply the therapeutic psychedelics they need to treat those who are suffering."
Optimi's state-of-the-art EU-GMP cultivation and analytical facilities in Princeton, British Columbia are now fully operational. After completing the largest legal grow of natural psilocybin in Canada's history, the Company is aiming for first-mover advantage in Oregon as the demand for natural product intensifies in the legalized State and will be contacting the government of Alberta in the coming days to discuss supply.
"We believe a key differentiator in the psychedelics space is that Optimi is commercializing and ready to go now," said Dane Stevens, Optimi Co-Founder and Chief Marketing Officer. "While we eagerly wait for Health Canada to regulate access for something we believe to be a safe and efficacious medicine when delivered with therapy, this announcement by the Government of Alberta can help patients today. Optimi's timeline is now, and we are excited to be one of the first company's supplying tested, EU-GMP psychedelic products to regulated jurisdictions such as Oregon and Alberta," added Stevens.
More information on the regulatory administrative and service requirements proposed under Alberta's Mental Health Services Protection Act can be found here .
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
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 activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com . 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.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health, ATMA Journey Centers To Proceed With Phase I Natural Psilocybin and MDMA Clinical Trial Application to Health Canada
Optimi Health Corp . ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce that in conjunction with ATMA Journey Centers ("ATMA"), the companies have confirmed their intent to proceed with a Phase I clinical trial application (CTA) that will document the safety of the Optimi's natural psilocybin biomass and 3,4-methylenedioxy-methamphetamine (MDMA) in healthy patients.
Upon Health Canada approval, it would be the first trial to assess both safety and additional markers, such as the mystical experience questionnaire in healthy subjects that have consumed MDMA.
Optimi CEO, Bill Ciprick, says the goal of the clinical trial is to acquire data, including blood pressure, temperature, heart rate, and ECG readings, for Optimi's proprietary formulation using natural EU-GMP psilocybin and MDMA. These products are being produced and tested in-house at Optimi's 20,000 square foot facilities in Princeton, British Columbia.
"The clinical validation of our products on healthy subjects brings us one-step closer to commercialization," said Ciprick. "Coming off the success of ATMA's recently completed Phase I psilocybin trial and a No Objection Letter to conduct its N-500 Phase II psilocybin clinical trial on frontline healthcare professionals, we're excited to officially begin the process," he added. "For the thousands of trained professionals waiting to experience natural, EU-GMP psilocybin and MDMA, we share their enthusiasm and believe we have an ethical responsibility to supply them with a life-changing product that is receiving considerable attention from regulatory bodies across the world."
ATMA is currently the only Canadian organization that has received approval from Health Canada to conduct a Phase I safety trial with psilocybin in healthy therapists, which it completed last month. Health Canada recently provided ATMA with a No Objection Letter to conduct an N-500 psilocybin Phase II clinical trial aimed at studying the potential relief of COVID-19-associated mental health concerns in frontline healthcare providers, in addition to documenting the healthcare providers' firsthand evaluation of the potential effectiveness of psilocybin psychotherapy in the application.
ATMA CEO, David Harder, recognizes the historical context of the CTA and says his team is committed to building on the success of his company's leadership in therapist-centred and therapist-driven support and training.
"Securing a clinical trial using natural EU-GMP psilocybin and MDMA is key to the growth of training and providing for experiential learning with both of these molecules, and others, as they are developed by Optimi," said Harder. "This is critical in providing a solid training program for therapists to prepare for the need that is already at our doorstep," he added.
In August, psychedelic pioneer and industry stalwart, Rick Doblin, outlined his organization's (the Multidisciplinary Association for Psychedelic Studies – MAPS) goal to train 25,000 therapists in MDMA-assisted therapy for PTSD before 2030.
He added that a further 100,000 therapists could be "kept busy" through potential clinical indications for MDMA and psilocybin such as alcohol and substance abuse, social anxiety, and phobias.
In 2017, the Food and Drug Administration (FDA) granted Breakthrough Therapy designation to MDMA-assisted psychotherapy for the treatment of PTSD.
Optimi's plan for commercialization involves the Company being an active leader in meeting therapist demand for natural EU-GMP psilocybin and MDMA.
Both Ciprick and Harder have confirmed that Optimi will serve as the official clinical trial sponsor while ATMA delivers clinical research expertise through its medical advisory team led by Dr. Michael Blough. Details of the CTA protocol will be released upon receipt of a No Objection Letter from Health Canada.
The Optimi-ATMA partnership is intended as an expansion of the scope of the relationship which began with the signing of an initial psilocybin supply agreement in June 2022 and will serve as the basis for the further development of the Company's commercial pipeline.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
ABOUT ATMA JOURNEY CENTERS
ATMA is pioneering a therapist-centered and therapist-driven business model for the psychedelic industry, by building the largest online community platform for psychedelic practitioners. Education, training, and business support services will all be accessible on one user friendly technology platform. ATMA's philosophy of inclusivity will encourage more participation from healthcare professionals, which will in turn yield more data and experiences. Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, ATMA will be able to expand to other psychedelics as the regulatory environment also expands. ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.
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 activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. 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.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health Completes Largest Legal Natural Psilocybin Harvest in Canadian History
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), is pleased to announce that it has completed what it believes to be the largest legal natural psilocybin harvest in Canadian history. The Company is licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, as well as functional mushrooms that focus on the health and wellness markets.
Building off its first official harvest on May 27 th , which produced various strains of psilocybin for lab analysis and early-stage supply agreements, the Company is pleased to report that its investment in state-of-the art environmental controls and facility cultivation operations have resulted in a commercially harvested yield of more than 150 kg of Panaeolus cyanescens and Psilocybe cubensis.
All Optimi mushroom products are grown from the Company's world-leading psilocybin genetic bank and are grown in EU-GMP compliant clean rooms that ensure sterile cultivation and undergo almost 300 different analytical tests post-harvest.
"Our mushrooms are some of the most tested products on the planet as we cross the lines between Pharmaceutical, Agriculture, Botanical, and Food testing quality assays," said Optimi Chief Science Officer, Justin Kirkland. "This yield gives us the capacity and scale we need to advance our analytical schedule while also developing our product pipeline," he added.
Once analyzed and tested, both in-house and then by a licensed third-party lab according to Optimi's strict product specification and quality assurance standards, the Company will commence distribution of the harvested quantities to fulfill supply agreements signed in recent months with various industry partners and licensed research entities across the globe.
Optimi Chief Operations Officer, Bryan Safarik, says the yield exceeded expectations in terms of quality and quantity.
"By controlling and tracking all of the inputs digitally, we are able to consistently grow psilocybin-containing mushrooms at a much higher potency to maximize the amount of naturally occurring psilocybin within the mushroom," said Safarik. "These state-of-the-art controls are a key differentiator for what we offer the global market. The higher the potency, the less biomass you need to achieve the desired amount of pure psilocybin API, which means we can create considerably more natural psilocybin per square foot than a typical black market grow. More psilocybin in less space achieves more revenue per square foot," he added.
All surplus inventory from the harvest will be safely stored in Optimi's Level 8 Security Vault to ensure minimal degradation of the natural psilocybin.
Optimi will also be using the mushrooms to further develop its on-site extraction methods and will use the product to finalize its naturally derived psilocybin offerings this fall. The Company is working to supply various upcoming phase 1 & 2 clinical trials to build out the required human safety data in healthy Canadians, and eventually patients suffering from depression, anxiety, and PTSD.
Bringing a safe and federally licensed supply of psilocybin products to market beyond encapsulated biomass is integral to the Company's global innovation strategy.
On May 11 th , Optimi Labs announced the expansion of its on-site analytical laboratory, which allows the company to measure consistency in its product while it begins to build out proprietary formulations, extracts, and its product catalogue — beginning with the recently launched BLUE SERENITY . Biomass derived from this harvest is likewise intended for use in showcasing the stability and accuracy of dosing for patients who request access to natural psilocybin mushrooms via the Special Access Program and clinical trials.
The harvest includes the following psilocybin-containing mushroom strains:
Koh Samui
B Plus
Malabar
Penis Envy
Burma
Blue Pulaski
To access a complete photo gallery of this historic grow, please click here .
Authorized parties interested in purchasing or distributing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Investor Relations
Michael Kydd
investors@optimihealth.ca
+1 (902) 880 6121
www.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 activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. 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.
News Provided by GlobeNewswire via QuoteMedia
Optimi Health Signs First International Mushroom Supply Agreement with UK-based Avida Global
Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushroom products for transformational human experiences, is pleased to announce that it has entered into an agreement with Avida Global ("Avida"), a privately-held UK-based producer of high-quality wellness products, including nutraceuticals and medicinal cannabis oils, for the global well-being and medical markets.
In its first large-scale international distribution agreement, Optimi will supply Avida with an extensive catalog of Optimi Life functional mushroom supplement formulations. The supplements will be available for distribution to clients and partners worldwide via Avida Labs, Avida's white-labelling and manufacturing business.
Avida will function as the exclusive distributor for Optimi's line of functional mushroom products in the United Kingdom, the European Union, Switzerland, India, Japan, Indonesia, Thailand, and Israel.
The Europe functional mushroom market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.6 percent in the forecast period (2021 to 2028) and reach USD $107 million by 2028. The UK market is forecast to grow at a CAGR of 7.5 percent between 2021 - 2027.
Optimi CEO, Bill Ciprick, says the partnership unlocks a significant market opportunity to synergize Avida's impressive worldwide distribution network with Optimi's position as the top functional and psychedelic mushroom producer in North America.
"Optimi's objective has consistently been to become the world's number one supplier of functional and psychedelic mushroom products, bar none," said Ciprick. "We are now significantly closer to achieving that goal by globally elevating our Optimi Life functional mushroom brand with an industry-leading, EU-GMP partner such as Avida," he added. "This is directly in line with our goal to commercialize and generate revenue."
The terms of the agreement further stipulate the potential for the sale of psilocybin mushrooms via the same distribution networks in response to the still-evolving demands of international markets.
With operations in the UK and North-East Colombia, Avida Global Managing Director and Head of UK Operations, Paul Parkinson, says the international agreement with Optimi marks a significant expansion for Avida in the plant-based medicines category and will bring mutual benefits and exposure for both companies.
"Both Avida and Optimi share similar synergies putting quality and science at the heart of everything we do," said Parkinson. "Our partnership with Optimi complements the increasing global demand for natural, organic mushroom products and presents a unique opportunity for Avida Global in this nascent category. We are pleased to be building a strong and innovative product pipeline backed by exemplary service delivery and some of the most rigorous and stringent operational standards in the world," he added.
Ciprick and Parkinson jointly expressed their agreement that new generation, health-smart mushroom enthusiasts are reshaping the whole functional mind and body experience.
"Great products are supported by consumers who investigate the experience as much as the science behind these formulations," they added. "The unique thing about this partnership is that we are aligned and driven to meet those expectations as we further develop our product and service footprint in emerging health markets across the world."
Optimi recently announced the signing of a retail and e-commerce distribution agreement for Optimi Life nutraceutical products with Canadian outlets Well.ca, Vitasave, and Healthy Planet.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION, PLEASE CONTACT:
Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: www.optimihealth.ca
Avida Global
Poppy Butcher
PR & Communications Director
poppy.butcher@avidaglobal.com
+44 7956 169209
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
ABOUT AVIDA GLOBAL
Avida Global is a vertically integrated Global cannabis business headquartered in Surrey, UK, with a dedicated cultivation and production facility in North-East Colombia. The company was founded in 2018 with the vision of providing the highest quality medicinal cannabis products to patients and consumers around the world in order to bring quality to life. The Avida Global Group consists of Avida Global SAS, Avida Labs UK and Green Stem CBD.
Avida Labs is Avida Global's white-labelling and manufacturing business. Based in Surrey, UK, the company formulates and manufactures bespoke topical and ingestible white-label products, from plant to product, using the highest quality ingredients and latest manufacturing processes.
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 activities proposed to be conducted under the Company's approved Health Canada dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com . 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.
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Psychedelics Outlook Report
Table of Contents:
|  |
A Sneak Peek At What The Insiders Are Saying
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry."
— Naseem Husain, Horizons ETFs
"I see the US Food and Drug Administration approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025."
— Andrew DeAngelo, Forbes
Who We Are
The Investing News Network is a growing network of authoritative publications delivering independent, unbiased news and education for investors. We deliver knowledgeable, carefully curated coverage of a variety of markets including gold, cannabis, biotech and many others. This means you read nothing but the best from the entire world of investing advice, and never have to waste your valuable time doing hours, days or weeks of research yourself.
At the same time, not a single word of the content we choose for you is paid for by any company or investment advisor: We choose our content based solely on its informational and educational value to you, the investor.
So if you are looking for a way to diversify your portfolio amidst political and financial instability, this is the place to start. Right now.
Psychedelics Outlook 2024
Table of Contents
Psychedelics Market 2023 Year-End Review
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
Psychedelics Market 2023 Year-End Review
The psychedelics industry is maturing after the investment boom of 2020 and 2021, and patient long-term investors looking for opportunities to diversify their portfolios have options when it comes to exposure.
As clinical trials and research continue to demonstrate the potential benefits of psychedelic-assisted therapy (PAT), companies in the space are attracting more attention. The Investing News Network (INN) spoke with Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs, to get his thoughts on 2023.
"Compared to the market fervor in 2020/2021, like (2022), 2023 was a quieter and colder year in the psychedelics marketplace. This past year, no major catalysts emerged and there was continued consolidation in the industry — a trend that will likely continue," the expert said during the interview, emphasizing the period's slowness.
"That being said, clinical trials take time, and participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression, alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry," Husain added.
According to Research Nester, the psychedelic drug market was worth US$3 billion in 2022. If it grows at the firm's estimated compound annual growth rate of 14 percent, the market will be worth more than US$12 billion by 2035.
“There are 22 million American adults suffering from depression, 300 million people worldwide. So unfortunately, there's a very large unmet need and a massive market opportunity,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale explained in an end-of-year conversation with INN. “The (depression and anxiety) market is maybe around a US$40 billion potential. If you add in other potential indications … like postpartum depression, alcohol use disorder or eating disorders, you're looking at a total addressable market of maybe US$100 billion annually.”
Here INN looks back on the psychedelics space in 2023 and highlights key developments and trends.
Regulatory developments in the US and elsewhere
As more people struggle with mental health and the addiction crisis worsens, a growing body of evidence suggests that psychedelic substances may offer much-needed relief. Researchers have continued to demonstrate that these treatments can be used to treat a variety of mental health disorders, and may reduce healthcare costs as well.
This has sparked a shift in the US legislative landscape, with increasing bipartisan support for psychedelic drug reform. At the federal level, President Joe Biden has expressed his expectation that psychedelic therapies will be approved in specific circumstances, and in 2023, the Food and Drug Administration (FDA) took steps to facilitate the development of psychedelic therapies when it released a comprehensive guide for clinical investigations.
At the state level, Oregon and Colorado have emerged as pioneers in the regulated use of psychedelics, with Oregon granting its first license for a healing center in March after officially legalizing PAT in January. Likewise, Colorado passed its Regulated Natural Medicine and Legalization Act in July, and will progressively implement various PATs.
While some states have introduced legislation to legalize or decriminalize psychedelics, the legislative process can be slow and outcomes uncertain. For example, while Oklahoma has approved HB 3414 to increase research, other legislation is still working its way through the system, such as New York's Psychedelic Law Enforcement Reform Act.
In October, California Governor Gavin Newsom signed a bill to immediately allow doctors to prescribe psychedelic treatments if the substances are rescheduled. However, he vetoed SB 58, which sought to decriminalize the possession and personal use of a selected group of psychedelics, after it had already passed through the Senate and Assembly. Newsom said his reason for vetoing the bill was that it failed to meet guidelines that would criminalize possession outside of medical clearance. It also didn’t satisfy the criteria for treatment guidelines, such as dose information.
Outside the US, other countries have also been taking steps to regulate and explore the therapeutic potential of psychedelics. Canada, the US' northern neighbor, is one example — on a provincial level, Alberta enacted a new policy at the start of 2023 that regulates psychedelic drugs for mental health treatment.
Federally, most psychedelic therapies remain illegal. However, Canadians continue to lobby for increased access to these treatments, and in rare cases can be approved for PATs that are undergoing clinical trials through the country’s Special Access Program. Last year, the Senate’s Subcommittee on Veteran Affairs published a report calling on governments at all levels to perform a large-scale research program on PATs, as the treatments have the potential to greatly help military veterans, an underserved demographic for which mental health struggles are common.
One company making this a focus is the veteran-founded Apex Labs, whose psilocybin product APEX-90 was recently approved for a 160 macro-dose clinical trial starting in the first quarter of 2024. However, ahead of the trial, a Canadian military veteran with treatment-resistant depression was approved for the treatment through the Special Access Program; they received a dose on November 2 in Vancouver accompanied by psychotherapy.
For its part, Australia has taken a different approach. On July 1, legalization took effect for MDMA and psilocybin for the medical treatment of post-traumatic stress disorder (PTSD) and depression, respectively, in tandem with therapy.
“Time will tell, but the Australian announcement is likely the biggest ‘positive’ event for the space and could provide a model for other jurisdictions to emulate,” Husain said. “If a major country like Australia is able to successfully administer psychedelic medicines, that could prove a catalyst for Canada and other Commonwealth nations.”
Which psychedelics clinical trials moved forward in 2023?
The use of psychedelics for therapeutic purposes continued building momentum in 2023 as clinical trials investigating the efficacy of these substances for treating a range of mental health conditions reached new milestones.
One of the more notable trials of 2023 was Compass Pathways' (NASDAQ:CMPS) investigation of the effectiveness of its product, COMP360, in treating bipolar II depression. This was the first study of PAT on bipolar disorder. The results, which were published in JAMA Psychiatry on December 6, suggest that psilocybin combined with psychotherapy could be an effective and safe treatment for bipolar II depression. The company is also studying the use of COMP360 to treat mental health disorders such as anorexia, PTSD and treatment-resistant depression, among others.
Another significant development in the field of psychedelic therapies was the publication of positive results from MindMed’s (NASDAQ:MNMD,NEO:MMED) Phase 2b trial of its LSD-based product MM-120, which was being investigated as a potential treatment for generalized anxiety disorder. According to the company’s website, there is also evidence to suggest that MM-120 could be effective for treating chronic pain and substance use disorders. MindMed’s share price rose by 7 percent following the news. The company plans to move on to Phase 3 trials in 2024.
Cybin, another player in the psychedelics industry, reported positive topline data from Phase 2 clinical trials of CYB003 for major depressive disorder. “(It’s) really unprecedented to see 80 percent of patients in remission after two doses. I don't think we've ever seen anything like that in depression, ever,” Cybin’s Drysdale commented to INN about the results. The US Patent and Trademark Office granted the company a patent for its product on December 6.
Finally, MAPS Public Benefit, a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), submitted a new drug application to the FDA in December following positive results from Phase 3 trials that studied the efficacy of its MDMA-assisted therapy for treating PTSD. On January 5, MAPS Public Benefit announced it was changing its name to Lykos Therapeutics as it begins to focus on product commercialization pending FDA approval of its treatment.
Patenting and commercialization could be headwinds
The market for psychedelic therapies is evolving, and with the changing landscape there will be challenges that must be addressed. In a December 2022 research paper, experts explored the economic considerations surrounding PAT, including market dynamics and the potential for growth and consolidation in the space.
Bruce Campbell, president and portfolio manager at StoneCastle Investment Management, discussed MindMed in a market call with BNN Bloomberg: “One of the risks they obviously have with a company like (MindMed), they're going to need to continually raise money over time, much like the cannabis sector has done, to kind of build out their operations. So they're nowhere near the point where they're going to be cashflow positive. So you do have to be aware that if the stock runs up it could pull back on financing, and it's probably a position that you want to trade around.”
Campbell’s comments specifically address MindMed, but they also speak to the broader challenges and risks associated with investing in the psychedelics industry, including the need for ongoing funding and the potential volatility.
While some clinical trials have yielded promising results, companies must still overcome the complexities of patenting and commercializing their products. One issue that could hinder profitability is that psychedelic compounds are naturally occurring substances that may be difficult to protect under existing intellectual property laws.
To address this challenge, companies in the psychedelics industry are exploring a range of strategies, including developing novel formulations of compounds, combining them with other ingredients to create proprietary products and leveraging their expertise and data to establish a competitive advantage.
For example, Numinus Wellness (TSX:NUMI,OTCQX:NUMIF) made significant changes to its business in 2023 in order to increase its revenue, including launching a clinic licensing platform called Numinus Network, expanding its practitioner training programs and partnering with Healing Commercial Real Estate to find more clinics for its services. The company also closed operations at its non-revenue-producing Numinus Bioscience research lab.
After turning its focus to revenue-generating activities, Numinus reported significant growth in revenue in the fourth quarter of 2023, including US$5 million from the company’s wellness clinics.
As part of its focus on practitioner training, Numinus announced a partnership with MAPS in June, for which it submitted a clinical trial application to Health Canada. The purpose of the trial is to study how healthcare practitioners could establish protocols and procedures for MAPS’ MDMA-assisted therapy and identify any potential challenges. If successful, Numinus has plans to incorporate the therapy into its repertoire of PAT education and training programs.
While regulatory considerations are an important factor in the growth and development of the PAT industry, another trend affecting the sector is the increasing consolidation of the market through mergers and acquisitions.
“We've seen a huge amount of consolidation over the last couple of years, down from maybe 60 reported psychedelic companies to frankly only about a half a dozen now that are really focused on drug development,” Drysdale noted. Two such examples in 2023 were Cybin’s acquisition of Small Pharma and Otsuka’s (TSE:4578) acquisition of Mindset.
Psychedelics industry working to address ethical concerns
As the PAT sector develops, concerns are also arising, especially when it comes to the need for companies to balance affordable and equitable access to treatment as they pursue growth and expansion.
To this end, Beckley Waves, a venture studio that works exclusively with practitioners in the psychedelics space, established the New Ethics Council in June. The council is composed of experts who will be able to provide guidance on best practices. Among them is Beckley Waves founder Amanda Fielding, who has been an influential presence in the industry for generations, pouring over 55 years of research into the benefits of psychedelic experiences.
Investor takeaway
Looking back on recent developments in the psychedelics industry, it’s clear that in 2023 the field made significant strides in terms of clinical research, as well as some regulatory progress.
Of course, uncertainties still lie ahead in this young sector. “Despite positive broader market performance across other major indices, risk-off sentiment from 2022 persisted throughout 2023, which has led to a greater gulf between the psychedelic and biotech industries and other sectors,” said Husain.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
As research into psychedelic drugs continues to produce positive results, policymakers are taking note.
With promising clinical trials, increasing public acceptance and a growing desire for psychedelic-assisted therapies (PATs), the sector seems to be poised for significant growth in the coming years.
Heading into 2024, the Investing News Network (INN) turned to industry insiders to dig into what might be in store for the psychedelics market. Read on to learn what they had to say.
Institutions considering psychedelics investment
Psychedelics companies are seeing a growing influx of funding and support thanks to positive clinical trial results.
“I think we've seen a shift in the last maybe three or four months of the year where more institutions are starting to look back at the psychedelic space again,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale said in an interview with INN. “We had Steven Cohen's fund, Point72, make a significant investment in Cybin. They came in on our (at-the-market offering), and a number of other institutions are paying attention now as the sector is maturing.”
In addition, Lykos Therapeutics, which just changed its name from MAPS Public Benefit, secured US$100 million in Series A funding from a group of private investors in January 2024.
Lykos was previously focused on developing PATs for a range of mental health disorders, but after completing Phase III trials for its MDMA-assisted therapy for post-traumatic stress disorder in 2023, and then submitting a new drug application (NDA) to the US Food and Drugs Administration (FDA) in December, the company has changed its focus to bringing its MDMA treatment to market. The funding will be used to support these ongoing efforts.
Several of the same investors also recently contributed to a US$3.3 million funding round for Beckley Waves, a venture studio formed exclusively for the development of the psychedelics industry.
Regulatory change key for psychedelics progress
The regulatory landscape for these psychedelic substances will play a crucial role in shaping the market, with drug reform and decriminalization efforts having the potential to unlock significant growth opportunities.
While the current legislative landscape for psychedelics bears some similarities to that of the cannabis industry, there are also key differences, namely psychedelics companies' sole focus on therapeutic applications.
“In my opinion, the psychedelics industry is completely different than the cannabis market,” said Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs. “One is a medical and biotechnology opportunity, while another is primarily focused on retail, at least in the North American market. While both have legal barriers to overcome that could result in growth, the psychedelic pipeline is about pharmaceutical and regulatory development and less so about marketing and distribution like we’ve seen in the hyper-competitive cannabis sector.”
This crucial distinction could create greater accessibility for the patients who need these treatments. More and more practitioners are being allowed to administer psychedelic drugs via trials, and certain US states and Canadian provinces have legalized PATs or developed regulatory mechanisms to make them accessible, such as Health Canada’s Special Access Program. Even Australia, a country that has maintained a strict stance on cannabis, has approved the legal therapeutic use of MDMA and psilocybin, although some scientists have called the decision rushed.
In some cases, patients are circumventing federal roadblocks either by procuring illicit substances on their own, or by seeking treatment through private institutions. For example, psychedelic integration therapy, which helps individuals process and integrate insights gained during a psychedelic experience, is available in Vancouver, BC, but often at an exorbitant cost, and patients are left to source psychedelic compounds on their own.
What Drysdale and other market participants hope to achieve through their therapies is affordable and effective treatment, which needs Health Canada or FDA approval to be accessible.
“What we're doing is we are creating and producing synthetic, modified molecules, GMP manufactured, hoping to be FDA approved, prescribed by a doctor, reimbursed by your insurance company,” he said. “And I think that's what you need to attract the attention of patients who are already depressed and dealing with stuff. I think that some may go seek natural mushrooms, but if we can make these treatments really accessible through this regulated route first, then I think that's the most reliable and less risky way of providing really significant access.”
Potential rescheduling on the horizon
Could 2024 be the year for psychedelic drug reform? Some experts think the answer could be yes.
“I see the FDA approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025,” Andrew DeAngelo said in a Forbes article on cannabis and psychedelics market predictions for 2024. However, he also acknowledged that the industry is often unpredictable.
That said, there has been some progress on that front.
As mentioned, Lykos has now submitted an NDA to the FDA for its MDMA treatment, and the company requested a priority review because of the FDA’s designation of MDMA as a breakthrough therapy. If the FDA accepts the application, the process will take six months with a priority review or 10 months with a regular review.
If the FDA ultimately approves the treatment, MDMA would need to be moved from Schedule I to Schedule II, opening the door for other practitioners who have potential therapies in their pipelines.
While legalization is widely expected in the future, opinions vary on how quickly it will come. For instance, the American Medical Association predicts that most states will have legalized psychedelics by 2037 — that means current investors might still need to wait a while before they start seeing high returns on investment.
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry,” Husain said.
Investor takeaway
The evidence suggests that the psychedelics industry could be on the brink of significant growth in the coming years, but with some caveats. While clinical trial results have been promising and public acceptance is growing, the regulatory landscape will play a critical role in shaping the future of the market.
With the right regulations and approvals in place, psychedelics could revolutionize mental health treatments by offering affordable and effective therapies to those who need them.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Compass Pathways to participate in upcoming 23rd Annual Needham Virtual Healthcare Conference
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the 23 rd Annual Needham Virtual Healthcare Conference at 8:00am ET on April 9, 2024.
A live audio webcast of the presentation will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Availability of other information about Compass Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including, but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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Compass Pathways Board Chair and Co-Founder George Goldsmith and Co-Founder Ekaterina Malievskaia Step Down from Board of Directors
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that Board Chair and co-founder George Goldsmith and fellow co-founder Ekaterina Malievskaia have resigned their seats on the company's board of directors, effective March 29, 2024.
David Norton, lead independent director on the Compass board of directors, will become interim chair. Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
"When we started Compass eight years ago, we could not have imagined how the company would grow and mature," said George Goldsmith, outgoing board chair of Compass Pathways. "The company is on a strong, positive trajectory to develop psilocybin treatment under Kabir Nath's principled leadership. My commitment to transforming mental health care is unwavering. It is time to turn my attention to the next phase of making this vision a reality for patients, providers and health systems independent of any particular treatment modality."
"Everyone has a story, and too often this story includes the shortcomings of existing treatments and the pain and frustration of navigating the system," said Ekaterina Malievskaia. "I step down from the board convinced that the company is in good hands and on the right track financially, in its programs, and in preparation for a potential commercial launch to bring treatments to those in need. Innovation in mental health care remains as important to me as it was ten years ago, and I plan to continue to apply my experience and knowledge to the field."
"George and Katya leave an enduring legacy at Compass Pathways and across the field of mental health care," said David Norton. "Their leadership and compassion for people living with difficult-to-treat mental health conditions, their commitment to rigor and evidence, and their focus on ensuring broad and equitable access to innovation in mental health have moved us closer to achieving the vision they set when they launched the company: a world of mental wellbeing. Thanks to their leadership, Compass is in a strong position as it continues to execute its phase 3 program in treatment-resistant depression. We wish them all the best as they move into the next phase of their careers and continue their efforts to transform mental health care."
George and Ekaterina co-founded Compass Pathways in 2016. George served as Chief Executive Officer of the company from its founding until August 1, 2022, when Kabir Nath assumed the role. Ekaterina served as Chief Innovation Officer until she stepped down from her executive role in June 2023. This transition is a natural evolution as Compass has matured as a public company and progresses through late-stage clinical development and into commercial preparations.
Key accomplishments of their tenure at the company and on the board include:
- Building a mission driven, multi-disciplinary team of people committed to changing the patient experience of mental health care
- Achieving Breakthrough Therapy Designation from the US Food and Drug Administration and Innovative Licensing and Access Pathway designation in the UK for COMP360, Compass's proprietary formulation of synthetic psilocybin, in treatment-resistant depression (TRD)
- The design, launch and completion of the largest study of psilocybin ever conducted, the results of which were published in the New England Journal of Medicine and laid the groundwork for the company's phase 3 program in TRD
- Several rounds of successful financing, including a successful initial public offering on NASDAQ in September 2020
- The establishment of key partnerships, including the Centre for Mental Health Research and Innovation in collaboration with King's College London (KCL) and the South London and Maudsley NHS Foundation Trust
David Norton is a former Company Group Chairman of Global Pharmaceuticals for Johnson & Johnson. He began his career with J&J in 1979 and held several positions across the company, including Company Group Chairman, Worldwide Commercial and Operations for the CNS/internal medicine franchise, Company Group Chairman for the pharmaceutical businesses in Europe, the Middle East and Africa, and Company Group Chairman for the pharmaceutical businesses in North America. He has been a member of the Compass board of directors since 2018, serving as lead independent director. He also serves on the board of directors of Forepont Capital.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
Compass is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "will", "may", "might", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, Compass's expectations regarding its plans for a new board chair and Compass's expectations regarding its pivotal phase 3 program or other trials to support regulatory filings and approvals. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: market risks and other market conditions; the timing and outcome of the Company's search for a new board chair; clinical development is lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any future product candidates may be unsuccessful; establishing, maintaining, defending and enforcing our patents and other intellectual property rights covering our investigational COMP360 psilocybin treatment may be challenging and costly and our efforts to protect our patents and other intellectual property rights may be unsuccessful; our efforts to commercialize and to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage leadership changes; economic and geopolitical uncertainties and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov . Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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