Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as “expects”, “will”, “anticipates”, and “estimates”; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief “snapshot” of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled “Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

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VANCOUVER, British Columbia, Jan. 24, 2023 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE: MDMA), a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules (including MDMA) and its manufacturing partners have received an export permit for 300 grams of its LaNeo MDMA. PharmAla believes this is the largest single Health Canada export permit ever granted by weight to date.

“We’re incredibly proud of this milestone. It is additional proof that the clinical development of MDMA is moving forward. PharmAla exists to assist our client researchers around the world by not only saying we’ll provide them with research materials, but actually delivering.” said Nick Kadysh, CEO of PharmAla. “The global psychedelics industry is still in its infancy, but strong demand for these molecules helps ensure a foundational role for manufacturers like PharmAla.”

The MDMA is destined for a client in the United Kingdom; the materials will be used in research and development, for a proposed commercial purpose.

PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers two clinical-grade Psychedelic APIs. On January 24^th, at 12:00 noon EST, PharmAla will be hosting a webinar for researchers considering the use of its products in upcoming clinical trials.

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

About PharmAla
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: [email protected]
Phone: 1-855-444-6362
Website: www.PharmAla.ca

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “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 PharmAla’s current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla 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. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in PharmAla’s management’s discussion and analysis which is available on PharmAla’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

LOS ANGELES, Nov. 30, 2022 (GLOBE NEWSWIRE) — Irwin Naturals Inc. (CSE: IWIN) (OTC: IWINF) (FRA: 97X) (“Irwin” or the “Company”) announced today it reached a binding, arms-length, agreement to acquire Serenity Health, LLC in Louisville, Kentucky, on November 25, 2022. The move continues Irwin’s national ketamine clinic rollup strategy that has seen the Company move quickly toward its goal of building Irwin Naturals Emergence into the world’s largest chain of psychedelic mental health clinics. Irwin Naturals was founded in 1994, building itself into a nationally renowned company with its first-in-class line of nutraceuticals that are available in more than 100,000 stores across North America. The Irwin Naturals brand is recognized in 80 percent of American households.¹

Klee Irwin, CEO of Irwin Naturals, said, “With each clinic we bring under the umbrella of Irwin Naturals Emergence, we take another step toward the forefront of this new approach to mental healthcare. We are the world’s first household name to enter the space and are moving fast with the goal of being the first mover in this market.”

Irwin Naturals Emergence already includes clinics in Florida, Vermont, New Hampshire, Iowa, and Georgia. Currently, ketamine is the only psychedelic available for use in the United States outside of clinical trials when used as prescribed. However, MDMA and psilocybin may be authorized for therapeutic use in the future. This creates the possibility of radically changing the way we treat mental-health concerns.

Beth Ann Nevius, cofounder and CEO of Serenity Health, said, “What impressed us about Irwin’s approach to America’s mental health crisis is its philosophy of using national scale to drive down patient costs. Furthermore, the Irwin team has proven itself capable of building a national brand with an exceptionally faithful customer base. We are looking forward to becoming part of the Irwin team and taking this great brand nationwide, making mental healthcare accessible to all.”

Irwin Naturals Emergence is a wholly owned subsidiary of Irwin Naturals, and it was formed when the Company decided to enter the fast-growing sector of psychedelic mental healthcare. Over the past year, Irwin Naturals Emergence has identified ketamine clinics that practice a high standard of care to explore the possibility of adding these clinics to the national chain. This offers the possibility of increased economic efficiency because of the national scale of the operation that could help drive down operating costs, making it possible to pass savings along to the consumer in the form of sliding-scale discounts and even pro-bono treatments for those in need. Irwin Naturals’ name and reputation makes it an impactful voice in this new area of mental healthcare due to the Company’s history in safely caring for the health of its patients vouching for the safety and the efficacy of psychedelic treatment.

Irwin added, “We see ourselves as the Coca Cola first mover, and will be leveraging our brand equity and status as a cult brand to expand rapidly as society embraces the psychedelic mental health revolution. This is important because, as a psychedelic, ketamine is an effective treatment for many mental health disorders. However, some Americans are not clear on its potential. The trusted Irwin brand will be the welcome face of a familiar friend in a crowd of strangers – making this life-saving solution a bit less intimidating to those in need.”

The Agreement is subject to certain customary closing conditions and regulatory approvals. The total consideration will be paid in upfront and deferred consideration. Also included are contingent payments based on milestones related to expansion and profitability goals.

About Irwin Naturals
Irwin Naturals has been a household name and best-in-class herbal supplement formulator since 1994. It is now leveraging its brand to enter into both the cannabis and psychedelic industries. On a mission to heal the world with plant medicine, Irwin has operated profitably for over 27 years². Irwin’s growing portfolio of products is available in more than 100,000 retail doors across North America, where nearly 100 million people know the Irwin Naturals brand.³ In 2018, the Company first leveraged its brand to expand into the cannabis industry by launching hemp-based CBD products into the mass market. The Company is now leveraging its famous halo of brand trust with an objective to become one of the first household name brands to offer THC-based products and psychedelic mental health treatment. Irwin Naturals became a publicly traded company on the Canadian Securities Exchange (CSE) in August 2021. The Company’s shares began to be traded on the OTCQB Venture Market in November 2021. More information on the Company’s stock can be found via Bloomberg as well as the Wall Street Journal.

For investor-related information about the Company, please visit ir.irwinnaturals.com/

To contact the Company’s Investor Relations department, please call toll-free at (800) 883-4851 or send an email to [email protected].

“Klee Irwin”
________________________________
Klee Irwin
Chief Executive Officer
T: 310-306-3636
[email protected]
IR Information

Press Contact
Irwin Naturals Investor Relations
Cassandra Bassanetti-Drumm
T: 310-306-3636
[email protected]

Regulatory Overview

The following is a brief summary of regulatory matters concerning ketamine in the United States (“US”). Under the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”), ketamine is currently a Schedule III drug as well as being listed under the associated Narcotic Control Regulations and psilocybin is currently a Schedule I drug.

Most US States have enacted Controlled Substances Acts (“State CSAs”) which regulate the possession, use, sale, distribution, and manufacture of specified drugs or categories of drugs and establish penalties for State CSA violations and form the basis for many state and local drug laws enforcement activity. State CSAs have either adopted drug schedules identical or similar to the federal CSA schedules or, in some instances, have incorporated the federal scheduling mechanism. Among other requirements, some US States have established a prescription drug monitoring or review programs to collect information about prescription and dispensing of controlled substances for the purposes of monitoring, analysis and education.

In the United States, facilities holding or administering controlled substances must be registered with the US Drug Enforcement Agency (“DEA”) to perform this activity. As such, medical professionals and/or the clinics in which they operate, as applicable, are also required to have a DEA license to obtain and administer ketamine (a “DEA License”). While ketamine is a controlled substance in the United States, it is approved for general anesthetic induction under the US Food, Drug, and Cosmetic Act. Once a drug is approved for use, physicians may prescribe that drug for uses that are not described in the product’s labeling or that differ from those tested by the manufacturer and approved by the Food and Drug Administration (the “FDA”). Licensed medical practitioners may prescribe ketamine legally in Canada or the United States where they believe it will be an effective treatment in their professional judgment.

Please see Irwin’s filing statement on its SEDAR profile for more information on the regulatory environment and regulations surrounding the US THC industry.

Forward-Looking Information
This news release contains certain forward-looking statements that reflect the current views and/or expectations of management of the Company with respect to performance, business and future events. Forward-looking statements can often be identified by words such as “may”, “will”, “would”, “could”, “should”, “believes”, “estimates”, “projects”, “potential”, “expects”, “plans”, “intends”, “anticipates”, “targeted”, “continues”, “forecasts”, “designed”, “goal”, “objective,” or the negative of those words or other similar or comparable words. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which the Company operates. Forward-looking statements in this news release include statements related to information concerning the ability of the Company to perform the terms of the transaction referenced herein; the receipt of all necessary approvals, including regulatory approvals; expectations for other economic, market, business and competitive factors; and the Company expanding their activities in the business in the U.S. cannabis and psychedelics markets. The potential entrance by the Company into these new business segments are in their preliminary stages and may be subject to approval from the board of directors of the Company as well as any regulatory approval, including that of the Canadian Securities Exchange. These statements are based on numerous assumptions that are believed by management to be reasonable in the circumstances, and are subject to a number of risks and uncertainties, including without limitation: board and regulatory approval, including the approval of the Canadian Securities Exchange; Irwin being able to acquire and/or enter into business relationships to enter into these new markets; the Company obtaining the required licenses; and changes to regulations and laws regarding cannabis or psychedelics. Further information on the regulatory environment and risks will be contained in future disclosures. Forward-looking statements are subject to a number of known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from that which are expressed or implied by such forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties, and assumptions which are difficult to predict. Accordingly, readers should not place undue reliance on forward-looking statements and information, which are qualified in their entirety by this cautionary statement. The Company does not undertake any obligation to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.

Neither the CSE nor its Market Regulator (as that term is defined in policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

SOURCE: Irwin Naturals Inc.

¹ Consumer brand recognition information is based on a Company survey with a sample size of 500 randomly selected adults.
² Under several corporate structures, Klee Irwin has operated the Irwin brand profitably since 1994, as measured by EBITDA adjusted for extraordinary costs.
³ Consumer brand recognition information is based on a Company survey with a sample size of 500
randomly selected adults.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

VANCOUVER, British Columbia, Nov. 02, 2022 (GLOBE NEWSWIRE) — PharmAla Biotech (CSE:MDMA) is pleased to announce that it has submitted its pre-IND data meeting package to the US Food and Drug Administration (USFDA) in advance of its pre-IND meeting scheduled for later this month. PharmAla will be requesting FDA feedback on the nonclinical and CMC development plan to support the initial clinical trial for ALA-002.

“As a ‘regulatory-first’ organization, we know that regulators like FDA are rightly concerned with safety of novel medicines. One of the key goals for PharmAla was the development of MDXX compounds that show an improved safety profile compared to generic MDMA,” said Nick Kadysh, CEO of PharmAla Biotech. “We hope that USFDA will see the same potential in our pre-clinical results which we do.”

PharmAla’s goal is to bring ALA-002 into the clinic as a treatment for disorders in adults diagnosed with Autism Spectrum Disorder (ASD). As such, ALA-002 was tested not only in general population research, but also in generally accepted autism mouse models.

“ALA-002 is the first molecule of which we are bringing to USFDA, and we believe it will be an incredibly valuable tool to treat conditions commonly occurring alongside ASD,“ said Dr. Harpreet Kaur, Vice President of Research for PharmAla Biotech. “However, we are hard at work identifying new molecules in the MDXX class that also have clinical promise. Using our proprietary MDXX drug discovery algorithm, we believe we will have even more molecules to bring to regulators in the near future – including the ABA series of non-controlled molecules.”

Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as “expects”, “will”, “anticipates”, and “estimates”; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief “snapshot” of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled “Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

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Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as “expects”, “will”, “anticipates”, and “estimates”; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief “snapshot” of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled “Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

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VANCOUVER, BC — 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 mushrooms for transformational human experiences, has received permission from Health Canada to manufacture and distribute additional psychedelic substances, most notably MDMA, under the amended terms outlined in its June 20, 2022 application to Health Canada.

Under the leadership of Chief Science Officer Justin Kirkland, Optimi will now act as wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.

The Company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.

Optimi CEO, Bill Ciprick, says the Company’s in-house capacity to produce a wide range of scalable formulations puts Optimi at the forefront of the commercial manufacturing and supply of psychedelics.

“From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we’ve done that through operational transparency and investing in smart infrastructure.”

He further added, “On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house Standard Operating Procedures (SOP),” said Ciprick.

The terms of the amendment took effect as of Friday, August 5, 2022, and will allow the Company to increase the overall output potential of its Princeton, British Columbia facility to better address the needs of the evolving psychedelic market as part of Optimi’s planned year of commercialization.

Since applying for the amendment in June, the Company has met with industry stakeholders, drug developers, and clinical trial researchers interested in exploring Optimi’s production capabilities, reaffirming the Company’s decision to proceed with this phase of its commercialization strategy.
Regulatory Opportunity

In May 2022 it was reported by online publication, The Intercept, that the Joe Biden administration was anticipating FDA regulation of MDMA and psilocybin within the next two years and was “exploring the prospect of establishing a federal task force” to review the psychedelic ecosystem.

With 130 MDMA clinical trials currently listed between Canada and United States, and the prospect of the Biden Administration looking to regulate MDMA and psilocybin, Optimi is already preparing for future international and domestic regulatory movement that could positively impact the Company.

“The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government’s recent decision to decriminalize MDMA up to 2.5 grams in British Columbia,” said Optimi regulatory affairs advisor, Michael Kydd. “Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a licence to produce EU-GMP MDMA at an unmatched scale will benefit the Company when we eventually see these wholesale policy changes,” added Kydd.

On August 10, Optimi unveiled Blue Serenity Natural Psilocybin in collaboration with renowned psilocybin advocate, Thomas Hartle. The product is now available to patients who face a serious or life-threatening condition and have been approved under Canada’s Special Access Program.

In addition to MDMA, the Company now has Health Canada approval to manufacture and distribute additional substances including:

N,N-Dimethyltryptamine (“DMT”);

3,4,5-trimethoxyphenethylamine (“Mescaline”);

2-(2-chlorophenyl)-2- (methylamino)cyclohexanone (“Ketamine”);

Lysergic Acid Diethylamide (“LSD”);

1-(1-phenylcyclohexyl)piperidine (“Phencyclidine”);

4-Hydroxybutanoic Acid (“GHB”);

4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole (“Harmaline”);

4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol (“Harmalol”);

Salvia Divinorum, Salvinorin A; and,

4-Bromo-2,5-Dimethoxybenzeneethanamine (“2C-B”).

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other additional psychedelics are invited to contact [email protected] 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.

Company aims to increase health equity by developing more accessible treatment modalities better suited for existing healthcare infrastructure

DENVER, July 19, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, announced it has successfully synthesized multiple short-acting MDMA analogs. This family of analogs have been specifically designed by experts at Mydecine to have a shorter half life than traditional MDMA. The Company has named this family of novel molecules MYCO-006 and have applied for patent coverage with the World Intellectual Property Organization.

3,4-methylenedioxymethamphetamine (MDMA), commonly known as ecstasy, is a synthetic drug that acts as a stimulant and hallucinogen. In July 2021, Mydecine announced a provisional patent application for a family of MDMA-like compounds intended to reduce harm and improve safety compared to the traditional drug. Mydecine is targeting a 1-2 hour duration novel MDMA analog that will produce the same effects as traditional MDMA.

“There is a growing body of research that shows MDMA has the potential to make therapy more effective. From Rick Ingrasc’s early work in the early 70’s and 80’s with couples counseling, to MAPS more recent work with PTSD, MDMA has shown strong positive results removing interpersonal distrust and communication blocks without interfering with cognition. This effect allows therapy to be more effective. This is particularly important for patients suffering from conditions like post-traumatic stress disorder (PTSD), where patients focus on their traumas in order to identify, understand and change their thinking and behavior patterns,” said Chief Scientific Officer Rob Roscow.

Current recommended treatments for PTSD include trauma-focused psychotherapies, such as prolonged exposure, cognitive processing therapy, and eye movement desensitization and reprocessing. MDMA has been shown to increase feelings of well-being and interpersonal trust while decreasing feelings of fear and defensiveness. For these reasons, research has shown MDMA can increase the effectiveness of therapy.

Roscow goes on to say, “Although MDMA has shown great promise, the effects of the drug last 8 or more hours which is not ideal for a traditional medical setting. At Mydecine, we believe that in order to make treatments accessible to the majority of the population, we must make drug products that can be implemented into our existing healthcare infrastructure.”

Chief Medical Officer Dr. Rakesh Jetly said, “We applaud MAPS for their work with MDMA assisted therapy and the impressive efficacy data they have published. MAPS has shown their model works, but there may be times and conditions where a shorter acting medicine could be just as safe and effective while more efficient.”

“Psychedelic-assisted psychotherapy utilizing classic MDMA can take upwards of 12 hours to complete one session and a large amount of resources. By the time you’ve completed the pre-session preparation, the mystical experience, patient post-experience monitoring and post-therapy paperwork, both the patient and doctor are exhausted. Under this model, therapists would only be able to treat 2-4 patients per month. Our hope is by decreasing the half-life of MDMA, we can create treatments that can be easily repeated at your typical healthcare facility in order to make accessible and affordable treatments for patients,” added Dr. Jetly.

“For these treatment modalities to be adopted and accepted by the general medical community, there must be a drug product that can be administered at existing clinics and hospitals in less time, and that will be reimbursed by insurance providers. We believe shortening the half life of MDMA is an important necessary step to making this possible,” said CEO Josh Bartch. “Considering the incredible efficacy data being published on MDMA, and the frequent effect of boosting trust and well-being, we are incredibly excited about the potential to increase health equity for the large population in need with our MYCO-006 family of novel molecules.”

Mydecine’s mission is to become a trusted source of safe and effective medication-based treatments to address the unmet needs for mental health and addiction disorders.

Learn more about Mydecine’s drug development process by visiting their YouTube channel here.

About Mydecine Innovations Group
Mydecine Innovations GroupTM (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Administration
[email protected]

Investor Relations
Morgan Kervitsky, Director of Administration
[email protected]

On behalf of the Board of Directors:
Joshua Bartch, Chairperson and CEO
[email protected]

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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About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

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