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Core One Labs Completes Sale of Non-Core Assets

Vancouver, British Columbia, Canada – January 15, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) is pleased to announce that further to its October 30, 2020 press release, the Company has completed the sale of certain of its non-core assets and subsidiaries in California for CAD$3,000,000 plus the assumption of approximately USD$4,000,000 in related liabilities.

The completion of this sale allows the Company to focus its core business on the continued development of psychedelic alternative medicines and experiential therapies, and its CannaStripTM delivery technology.

The Company’s goal is to use its proprietary technologies to advance natural-based medicines for the treatment of mental health illnesses and addiction.  Core One’s team of leading scientists, specializing in protein expression and biosynthetic fermentation, have developed a patentable method of producing psilocybin that will afford the Company the ability to manufacture consistent high-quality GMP API psilocybin at scale, and provide pharmaceutical companies, API manufacturers and medical research organizations conducting clinical trials, access to product at a significantly lower cost than other psilocybin-producing companies.

In consideration for the acquisition of the Assets (as defined below), the purchaser will complete a series of cash payments to the Company totaling CAD$3,000,000 and will assume responsibility for all outstanding liabilities and obligations of Reveur Holdings Inc., Core, CSPA, LDS Agrotech Inc., LDS Scientific Inc., Agrotech LLC and LDS Development Corp., including all continuing employment obligations and certain additional liabilities of the Company associated with these assets. The total value of the assumed liabilities is approximately USD$4,000,000.

The assets being sold are composed of the following:

  • all of the issued and outstanding share capital of Rêveur Holdings Inc. (“Rêveur”), a California corporation, including its principal assets which are all of the issued and outstanding share capital of Core Isogenics Inc. (“Core”), a California corporation, and CSPA Group, Inc. (“CSPA”), a California corporation;
  • all of the issued and outstanding share capital of LDS Agrotech Inc. (“AgroCo”), a Nevada corporation, held by Core One which represents 75% of the outstanding share capital of AgroCo;
  • all of the issued and outstanding share capital of LDS Scientific Inc. (“SciCo”), a Nevada corporation, held by Core One which represents 75% of the outstanding share capital of SciCo;
  • the membership interest in Agrotech LLC (“AgroLLC”), a California limited liability company, held by Core One which represents a fifty percent 50% membership interest in AgroLLC;
  • all of the issued and outstanding share capital of LDS Development Corporation (“DevCo”), a California corporation, except for all tangible and intangible assets of DevCo related to the manufacturing and distribution of “CannaStrips” including all associated intellectual property and manufacturing equipment (the “Excluded Assets”); and
  • all tangible and intangible assets currently being held by and utilized by Rêveur, Core, CSPA and DevCo, including, without limitation, all existing contracts, leases, client files, client billing records, vendor records, furniture, fixtures, equipment, employee files, employee time records, and other information customary for the cultivation, manufacturing and distribution of cannabis and cannabis related products, but excluding the Excluded Assets.

 

(collectively, the “Assets”)

“The completion of this sale eliminates monthly expenses related to the operation in Adelanto, California and provides the Company with increased working capital. This increased working capital will allow us to focus resources on the development of psychedelics as alternative medicines, which we believe will have a significant and positive impact on the future of those suffering from mental illness and addictions.” stated Joel Shacker CEO of the Company.

 

In connection with the completion of the Asset sale, the Company has issued 350,000 common shares to two arms-length third-parties who assisted with facilitating such sale. These shares will be subject to a hold period of four months and one day.

 

Also in connection with the divestment of the Adelanto assets, the Company announces the resignation of Mr. Casey Fenwick as President of Core One.  The Company wishes to thank Mr. Fenwick for his service, and much success in his future endeavours.

 

The Company further announces that it intends to settle $74,000.00 in outstanding indebtedness to an arms-length party through the issuance of 88,095 common shares at a price of $0.84 per share. The shares issued under the debt settlement will be subject to a hold period of four months and one day from the date of issuance.

 

Finally, the Company announces that it intends to grant up to 6,720,000 incentive stock options (the “Options”) to certain directors, officers, employees and consultants of the Company.  The Options are exercisable at a price of $1.05 for a period of three years from the date of grant. The Company’s Stock Option Plan governs these incentive options, as well as the terms and conditions of their exercise, which is in accordance with policies of the Canadian Securities Exchange.

 

About Core One Labs Inc.

Core One Labs Inc. is a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.  The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its IP technology to focus on delivering psychedelic molecules with an initial focus on psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.

 

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

 

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

 

Cautionary Disclaimer Statement:

 

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

 

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970.  Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Mydecine Innovations Group Upsizes Previously Announced Bought Deal

Published at newswire.ca

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DENVER, Jan. 14, 2021 /CNW/ – Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, is pleased to announce that it has agreed to increase the size of its previously announced bought deal financing led by Canaccord Genuity Corp. (“Canaccord Genuity” or the “Underwriter”). Canaccord Genuity has agreed to purchase, on a bought deal basis pursuant to the filing of a short form prospectus, an aggregate of 30,000,000 units of the Company (the “Units”) at a price of C$0.50 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$15,000,000 (the “Offering”).

Each Unit will be comprised of one common share in the capital of the Company (a “Common Share”) and one Common Share purchase warrant (a “Warrant”). Each Warrant will be exercisable to acquire one Common Share (a “Warrant Share”) for a period of 36 months following the Closing Date at an exercise price of $0.70 per Warrant Share.

The Company has granted the Underwriter an option (the “Over-Allotment Option”) to purchase up to an additional 4,500,000 Units at the Issue Price for a period of 30 days following the Closing. If the Over-Allotment Option is exercised in its entirety, the aggregate gross proceeds of the Offering will be C$17,250,000.

The Company plans to use the net proceeds of the Offering to invest in additional clinical trials, for expansion of its intellectual property portfolio, continued development of its drug pipeline, expanded research and development partnerships and initiatives and for general working capital purposes.

The Units will be offered by way of a short form prospectus to be filed in all provinces of Canada except Quebec. The Offering is expected to close on February 3, 2021 (the “Closing Date”), and is subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and stock exchange approvals, including the approval of the Canadian Securities Exchange and the applicable securities regulatory authorities. The Company will use best efforts to obtain the necessary approvals to list the Common Shares and the Warrants on the Canadian Securities Exchange.

The Underwriter shall be paid a cash commission equal to 7.0% of the aggregate gross proceeds of the Offering payable in cash or Units, or any combination of cash or Units at the option of the Underwriter, and warrants (the “Underwriter’s Warrants”) exercisable at any time prior to the date that is 36 months from the Closing Date to acquire that number of Units which is equal to 7.0% of the aggregate number of Units issued pursuant to the Offering, at an exercise price equal to the Issue Price. Additionally, the Company shall pay the Underwriter a corporate finance fee equal to that number of Units which is equal to 2.5% of the aggregate number of Units issued pursuant to the Offering.

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

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. 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, and which may include, but are not limited to, statements with respect to the expected Closing date of the Offering, the listing of the Common Shares and Warrant Shares on the Canadian Securities Exchange, the use of proceeds of the Offering, and the timing of such events. 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 COVD-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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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Mydecine Innovations Group Announces C$10 Million Bought Deal Offering of Units

Published at newswire.ca

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DENVER, Jan. 14, 2021 /CNW/ – Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, is pleased to announce that it has entered into an agreement with Canaccord Genuity Corp. (“Canaccord Genuity” or the “Underwriter”), pursuant to which Canaccord Genuity has agreed to purchase, on a bought deal basis pursuant to the filing of a short form prospectus, an aggregate of 20,000,000 units of the Company (the “Units”) at a price of C$0.50 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$10,000,000 (the “Offering”).

Each Unit will be comprised of one common share in the capital of the Company (a “Common Share”) and one Common Share purchase warrant (a “Warrant”). Each Warrant will be exercisable to acquire one Common Share (a “Warrant Share”) for a period of 36 months following the Closing Date at an exercise price of $0.70 per Warrant Share.

The Company has granted the Underwriter an option (the “Over-Allotment Option”) to purchase up to an additional 3,000,000 Units at the Issue Price for a period of 30 days following the Closing. If the Over-Allotment Option is exercised in its entirety, the aggregate gross proceeds of the Offering will be C$11,500,000.

The Company plans to use the net proceeds of the Offering to invest in additional clinical trials, for expansion of its intellectual property portfolio, continued development of its drug pipeline, expanded research and development partnerships and initiatives and for general working capital purposes.

The Units will be offered by way of a short form prospectus to be filed in all provinces of Canada except Quebec. The Offering is expected to close on February 3, 2021 (the “Closing Date”), and is subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and stock exchange approvals, including the approval of the Canadian Securities Exchange and the applicable securities regulatory authorities. The Company will use best efforts to obtain the necessary approvals to list the Common Shares and the Warrants on the Canadian Securities Exchange.

The Underwriter shall be paid a cash commission equal to 7.0% of the aggregate gross proceeds of the Offering payable in cash or Units, or any combination of cash or Units at the option of the Underwriter, and warrants (the “Underwriter’s Warrants”) exercisable at any time prior to the date that is 36 months from the Closing Date to acquire that number of Units which is equal to 7.0% of the aggregate number of Units issued pursuant to the Offering, at an exercise price equal to the Issue Price. Additionally, the Company shall pay the Underwriter a corporate finance fee equal to that number of Units which is equal to 2.5% of the aggregate number of Units issued pursuant to the Offering.

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

About Mydecine Innovations Group
Mydecine Innovations Group™ (CSE: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

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.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. 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, and which may include, but are not limited to, statements with respect to the expected Closing date of the Offering, the listing of the Common Shares and Warrant Shares on the Canadian Securities Exchange, the use of proceeds of the Offering, and the timing of such events. 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 COVD-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. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

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Mydecine Innovations Group Uniquely Positioned To Take Over 2021

Published at Microdose.com

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Obstacles That Mydecine Overcame This Previous Year

2020 was both a phenomenal and challenging year for the psychedelic renaissance. In terms of sheer popularity, there is no question that psychedelic medicine has perked the ears of the public. This shift in attitude towards these powerful psychoactive compounds is reflected in our popular media, and likewise, the activity of investors at large. Headlines pertaining to the use of psychedelics to treat PTSD, for example, indisputably put the spotlight on innovative psychedelic biopharma company Mydecine Innovations Group (CSE: MYCO).

Mydecine not only had a successful year, but an important year, considering the company’s ability to accomplish things that have never been done before in this nascent industry. Indeed, Mydecine was first to get CGMP status to produce/sell/export medical psilocybin. Similarly, the life science company was first to execute a legal import and export of psilocybin mushrooms. But this is not to say that the company did not face difficulties.

According to Josh Bartch, CEO and Director at Mydecine, the psychedelic industry faced struggles in the same manner than all industries did in 2020 amid a public health crisis. “As you would expect, our number one hurdle was dealing with the unprecedented global pandemic which has temporarily hindered some of the progress with in-person clinical studies,” said Bartch. “With that said, we have introduced tools such as our digital telehealth platform, Mindleap Health, for patients and specialists to connect remotely to find innovative solutions which allow patients and specialists to connect remotely.”

Given that Mydecine was able to navigate this previous year, teaming with the University of Alberta to push the overton window of what is possible in psychedelic R&D, then surely they will be an even greater force to reckon with this year.

Want to learn more about Mindleap? Stream our PsyFi episode with Nikolai Vassev, Founder of Mindlep Health. The PsyFi podcast is available on YouTube, Spotify, and Apple Podcasts.

mydecine innovations group psychedelic medicine new research

Mydecine is at a Significant Advantage Market-Wise

Clinical prowess is at the core of the excitement surrounding Mydecine, but from an investor’s standpoint, we ought to discuss Mydecine’s position marketwise. The company has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze psychoactive mushroom compounds. More importantly, Mydecine does so with full government approval through Health Canada – making them inherently a key player in the emerging psychedelic market.

Clearly, the company is not tied down to any one specific goal. For example, the company’s acquisition of Mindleap – a digital platform and mobile app that connects patients to psychedelic therapy/specialists – makes them valuable in both medicinal and technological markets. Furthermore, the accessibility of the app will likely draw in the average interested consumer, making psychedelics less of a niche interest and more of a groundbreaking treatment for the masses. The app brings the entire industry forward in this regard. Mydecine is also pursuing the R&D of non-psychedelic medicinal mushrooms, and this additional facet of diversified revenue adds to their investor appeal.

mydecine innovations group psychedelic medicine new research

The Clinical Efforts that Separate Mydecine from Other Companies

Psychedelic enthusiasts will recall that during the tail end of 2020, Mydecine announced that it has engaged Ethica CRO as a partner for their Phase 2A PTSD clinical trials. This brings society closer to helping the long neglected psychological needs of war veterans and EMS/frontline workers. Moreover, these trials are international (taking place at Leiden University Medical Centre in the Netherlands, the University of Western Ontario, and the University of Alberta), which means the aforementioned neglected demographics will be helped all across the globe. Mydecine has other clinical sites on the horizon in the USA, Europe, and Australia, too.

Furthermore, Mydecine’s SAB member Dr. David Erritzoe helped execute a large-scale microdosing study co-sponsored by the National Institute for Health Research at Imperial College of London (a name that should ring a bell for readers in the psychedelic medicine community). Similarly, Mydecine was involved with a first-of-its-kind Microdose study at Mcquery University in Australia. Though Mydecine is perhaps best known for their noble efforts to treat PTSD, we can expect Mydecine to tackle many indications with this level of clinical ambition (e.g., psychedelic-assisted therapy in treatment of substance use disorder).

With that being said, Mydecine is able to take on these projects with a clear advantage specific to only them: the ability to isolate compounds no one else has their hands on yet thanks to their collaboration with the University of Alberta. Mydecine filed seven patent applications to further explore the medicinal properties of mushrooms.

Curious how psychedelics can be utilized in the treatment of PTSD? Check out our PsyFi episode with Colonel Rakesh Jetly, MD, the senior advisor in Psychiatry for the Canadian Armed Forces and Head of the Centre of Excellence on Mental Health. Our PsyFi podcast can be found on YouTube, Spotify, and Apple Podcasts.

mydecine innovations group psychedelic medicine new research

Mydecine Will Continue to Thrive in 2021

A capital markets analyst at Canaccord Genuity Group, one of the most prominent investment banks in psychedelic medicine, recently estimated that the psychedelic market will be worth nearly $100 billion. With recent decriminalization/legalization efforts surrounding psilocybin, the market is in a great position. It should be no surprise that Mydecine was listed as one of the “top psychedelic firms to watch” in the publication of this analyst’s estimate. Mydecine is uniquely positioned to thrive in 2021.

Moreover, Mydecine’s successes to come are good for society at large. We mustn’t forget that the company’s over encompassing goal is to alleviate mental health crisis, which is particularly important after the rough year we all shared. There is no doubt that Mydecine will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply.

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Core One Labs Announces Breakthrough in Solving Psilocybin Dosing Problems by Introducing Biosynthetic Psilocybin to its Patented Thinstrip Delivery Method

Vancouver, British Columbia, Canada – January 12, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce its plans to initiate another intellectual property strategy that will utilize its patented transmucosal thinstrip delivery method (“thinstrip delivery method”) in combination with its proprietary biosynthetic psilocybin, developed by its wholly-owned subsidiary, Vocan Biotechnologies Inc. (“Vocan”).

The Company’s existing thinstrip delivery method has been patented for use with THC and CBD (CannaStripsTM) and has the potential for use with all naturally occurring compounds, including psilocybin

Through cutting-edge research by the Company’s team at Vocan, a cost effective method for producing biosynthesized psilocybin has been developed. This low cost method of psilocybin production, in combination with the incorporation of psilocybin into the Company’s thinstrip technology, will result in an innovative and first-to-market delivery method of psilocybin for medical purposes.

Core One’s objective in developing the psilocybin thinstrips is to assist with the delivery of revolutionary psychedelic treatment methods to address mental health conditions such as depression, anxiety and addictions.

Methods of accurate dosing and effective delivery of psilocybin have gone relatively under-researched, and current methods utilized by companies using traditional oral delivery methods can cause hallucinations, digestive issues, and inaccurate dosages resulting in undesired side effects. The Company’s patented sublingual transmucosal (orally dissolvable) thinstrip technology, for the delivery of psilocybin, will aim to address these issues, and anticipates the provision of many potential advantages and benefits such as the rapid dissolving and onset of action to the bloodstream, as well as concentration control and time released dosing. Thinstrip delivery technology is a natural, non-toxic, biodegradable, biocompatible composite, which is user friendly. The sublingual polymer thinstrip, with nano particulated active ingredients, skips the digestive system and is absorbed directly into the bloodstream through the membranes in the mouth, resulting in optimum bioavailability (absorption percentage) of the active ingredients. Direct delivery to the bloodstream means that dosages can be less potent with the same affect.

According to the World Health Organization, almost 350 million people worldwide were affected by depression in 2016.  Common antidepressant drugs help maintain the balance of various hormones and chemicals in the brain which assists in the treatment of depression.

The Center for Disease Control and Prevention (CDC), reported that the percentage of people above the age of 12 years using antidepressants in the U.S. rose 12.7% in 2011-2014.  According to MedGadget, the antidepressant drug market was valued at $13.69 billion in 2018 and is expected to reach $15.88 billion by 2025.  The CDC said that in the U.S., antidepressants were the most commonly prescribed drugs in 2013 and from over 16 million long term users, around 70% are female.

“One of the critical issues surrounding the use of psilocybin is accurate dosing in oral delivery methods. Our breakthrough technology is a game changer in the psychedelic space and has the potential to revolutionize the way patients receive psychedelics as medicine and reduce over concentrations and resulting adverse effects.” stated Dr. Robert E.W. Hancock, Executive Chairman of the Company.

 

About Core One Labs Inc.

Core One Labs Inc. is a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.  The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its technology to focus on delivering psychedelic molecules with an initial focus on psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.

 

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970.  Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Vireo Health Launches Amplifi™, the First Terpene-Enhanced Brand of Dry Cannabis Flower

The new brand of cannabis flower is first to be packaged in Vireo’s TerpSafe™ packaging technology

MINNEAPOLIS, Jan. 8, 2021 /PRNewswire/ — Vireo Health International Inc., (“Vireo” or the “Company”) (CNSX: VREO, OTCQX: VREOF), the leading physician-founded, science-focused multi-state cannabis company, today announced that the Company has launched a new line of naturally-augmented cannabis flower called Amplifi™. The product line will feature dry cannabis flower strains sold in 3.5-gram TerpSafeTM jars. Amplifi is the first brand that utilizes Vireo’s new TerpSafe packaging technology, a proprietary patent-pending system that not only preserves the existing terpene profile but can naturally augment the terpene content of cannabis flower over time.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

Amplifi products launched in Vireo’s popular Ultimate Purple strain and are currently available at licensed dispensaries in Maryland. The brand’s second strain, Gorilla Girl, will be available later this month. In addition to the launch in Maryland, the Company expects Amplifi products to be available in Arizona at the Vireo dispensary located in Phoenix and at third-party dispensaries statewide starting in February.

“We are excited to announce the launch of Amplifi, a new brand that will feature several of our most popular strains of dry cannabis flower,” said Chief Executive Officer of Vireo Health, Kyle Kingsley, M.D. “Not only will Amplifi feature Vireo’s next generation strains, but the flower’s terpenes will be preserved and enhanced by our TerpSafe packaging. We believe that this proprietary technology will become the standard for flower packaging throughout the industry.”

Recently featured in a peer-reviewed research paper published in the Journal of Cannabis Research, Vireo’s new TerpSafe technology is a novel approach shown to preserve cannabis flower by inhibiting the gradual loss of terpenes. The technology works effectively towards terpene preservation for a variety of different cannabis flowers, grown and stored under various conditions. Multiple lab tests and real-world analyses have shown that cannabis flower stored in traditional packaging lost nearly half of its native terpenes over a four-week period. When the same flower was stored in Vireo’s TerpSafe packaging system, the terpene content increasedover the same four-week period.

Researchers were also able to successfully adjust the terpene profile of cannabis stored using the TerpSafe technology. This will provide patients and manufacturers the ability to customize the terpene profile of their cannabis as a result.

“In addition to keeping cannabis flower fresher for longer, what sets TerpSafe apart from conventional terpene-preserving packaging is that it is proven to reinfuse the product even after multiple openings,” said Vireo Chief Scientific Officer, Eric Greenbaum. “Our research design included conditions which mimicked patient use, where the bottles were opened periodically over a period of weeks and conclusively showed that the terpene-preservation capabilities of our system are not adversely affected by the jar being opened at a normal-use rate.”

The new packaging will enable cultivators and manufacturers to protect and enhance the naturally occurring terpenes in cannabis flower. This helps ensure the terpene levels in cannabis products are preserved throughout the distribution chain – from greenhouse to the customer home – so that consumers can enjoy a robust and consistent flavor profile.

Last year, Vireo signed a limited exclusive licensing agreement with eBottles420, the largest supplier of cannabis packaging in North America, to manufacture and distribute TerpSafe packaging.

About Vireo Health International, Inc.

Vireo Health International, Inc. is a physician-led cannabis company focused on bringing the best of technology, science, and engineering to the cannabis industry. Vireo manufactures proprietary, branded cannabis products in environmentally-friendly, state-of-the-art greenhouses and other facilities and distributes its products through its growing network of Green Goods™ retail locations and third-party dispensaries. Vireo’s team of more than 400 employees, led by scientists, engineers, and cultivation experts, is focused on efficiency and the creation of best-in-class products, while driving scientific innovation within the cannabis industry and developing meaningful intellectual property. Today, Vireo is licensed to grow and/or process cannabis in seven markets. The Company is operational in five of those markets – including the core markets of Arizona, Maryland, Minnesota, New Mexico, and New York. The Company holds 29 total retail dispensary licenses, of which 16 are currently open for business. For more information about Vireo Health, please visit www.vireohealth.com.

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, such information is being provided as preliminary financial results and the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “plans,” “expects” or “does not expect,” “is expected,” “look forward to,” “budget” “scheduled,” “estimates,” “forecasts,” “will continue,” “intends,” “anticipates,” “does not anticipate,” “believes,” “should,” “should not,” or variations of such words and phrases or indicates that certain actions, events or results “may,” “could,” “would,” “might,” “should,” or “will” “be taken,” “occur,” or “be achieved.”  Forward-looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, the value of assets, the amount of liabilities, the designation of certain businesses or assets as “core” or “non-core,” decisions about allocation of capital and other resources, future developments, the future operations, potential market opportunities including the potential effects of the approval of adult-use cannabis in one or more markets, potential opportunities to monetize assets, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. Forward-looking information includes statements with respect to the opportunities for the Company to leverage increasing scale to improve sales growth and operating performance; the anticipation that the medical-only state markets in which the Company’s subsidiaries operate could enact recreational-use legislation over the near-to mid-term future; the anticipated benefits of strategic initiatives; the effects of reduction of corporate overhead and SG&A expenses; improvement to unit economics; expansion of retail dispensaries in key markets; the expectation that such expansion will drive stronger revenue growth, operating margins and free cash flow; the anticipated closing of certain divestitures and the timing thereof; the anticipated benefits of the land purchase option acquired by the Company in New York; the Company’s anticipation that it will enter into definitive loan documents with Green Ivy Capital and receive proceeds from a resultant loan; the expectation that a preliminary base shelf prospectus will become final or that any securities will be sold under a base shelf prospectus; the anticipated share issuance and proceeds related to the Company’s redemption of all subordinate voting share purchase warrants issued to participants in the March 10, 2020, private placement; the transition of the Company’s financial reporting from IFRS to U.S. GAAP; and updates on actual and proposed development initiatives, including estimates of the timing of completion of such initiatives. Forward-looking information includes both known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this press release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue and cash on hand may differ materially from the revenue and cash values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment; and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct, including preliminary financial expectations regarding the annualized reduction of corporate overhead and SG&A expenses. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to, risks related to preliminary financial results being subject to the completion of the Company’s financial closing procedures and not being audited or reviewed by the Company’s independent registered public accounting firm; the timing of recreational-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to the COVID-19 pandemic; federal, state, local and foreign government laws, rules and regulations, including federal and state laws in the United States relating to cannabis operations in the United States; limited operating history; changes in laws, regulations and guidelines; operational, regulatory and other risks; execution of business strategy; management of growth; difficulty to forecast; conflicts of interest; risks inherent in an agricultural business; liquidity and additional financing; foreign private issuer status and the risk factors set out in the Company’s listing statement dated March 19, 2019, filed with the Canadian securities regulators and available under the Company’s profile on SEDAR at www.sedar.com and in the Company’s registration statement on Form 10, filed November 5, 2020 on EDGAR with the U.S. Securities and Exchange Commission.

The statements in this press release are made as of the date of this release. The Company disclaims any intent or obligation to update any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.

Vireo's new terpene enhanced dry flower cannabis line, Amplifi TM, packaged in the Company's TerpSafe TM packaging.

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SOURCE Vireo Health International, Inc.

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Vireo Health Announces Closing of Previously Announced Purchase of Cannabis Licenses in Nevada

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Leading Microbiologist, Dr. Robert E.W. Hancock Appointed As Executive Chairman of Core One Labs Inc.

Vancouver, British Columbia, Canada – January 7, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) is pleased to announce the appointment of Dr. Robert E.W. Hancock as Executive Chairman of the Company, effective January 6, 2021.

Dr. Hancock is an internationally renowned academic in Microbiology and Immunology – having bestowed upon him the title of UBC Killam Professor of Microbiology and Immunology – is the Director of the University of British Columbia’s R.E.W Hancock Laboratory at the Centre for Microbial Diseases and Immunity Research, as well as a former Associate Faculty Member of the Wellcome Trust Sanger Institute in Cambridge, UK – one of the top 3 Genome campuses worldwide.

Receiving his PhD from the University of Adelaide, in 1975, Dr. Hancock has become one of the World’s most highly cited International Scientific Indexing (ISI) research authors, with more than 108,000 citations, and has published more than 780 papers and reviews in his fields of expertise.  Dr. Hancock is the holder of the important position of the Canadian Research Chair in Health and Genomics, as appointed by the Government of Canada, and is also a recipient of the Order of Canada, in addition to numerous other major health research awards.

Dr. Hancock is a co-founder of several companies, both private and public, including Micrologix, Inimex, ABT Innovations, and Sepset Biotherapeutics, and is the CEO of Vocan Biotechnologies Inc. (“Vocan”), a biotechnology company that Core One acquired on December 31, 2020.

Vocan is focused on advancing the knowledge of natural-based medicines for the treatment of mental health illnesses, including addictions, and has identified a patentable method of producing psilocybin, the active ingredient in psychotropic mushrooms.  With the acquisition of Vocan, the Company is in the process of preparing to produce pharmaceutical grade psilocybin for use by researchers engaging in clinical trials, as well as for the recreational and micro-dosing markets.

Dr. Hancock’s role as CEO for Vocan Biotechnologies, positions him as the best fit to lead the Company as Executive Chairman, and provide direction to the Company on its path to becoming a leader in the area of psychedelics as alternative medicines.

“I am honored to be joining Core One labs as the Chair of their Board. The Company’s innovative business strategy and strong leadership team will position it to grow into one of the largest and most influential companies addressing the health and social benefits of safe psychedelic compounds.”, stated Dr. Hancock.

“We are excited to welcome Dr. Hancock to the Company as Executive Chairman.  I look forward to working with him closely as his nearly 40 years of leadership in microbiology research will be vital to guiding our strategic initiatives in the alternative medicine market. His cutting edge research, and focus on producing low cost biosynthesized psilocybin at a large scale is a driving force behind Core One’s position as a leader in the space” stated Joel Shacker CEO of the Company.

Dr. Hancock’s appointment to the Company’s Board of Directors fills the vacancy created by Casey Fenwick, who has resigned as a director of the Company effective immediately to focus on other ventures.  The board of directors of the Company thanks Mr. Fenwick for his service to the Company.

 

About Core One Labs Inc.

Core One Labs Inc. is a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.  The Company has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. With this technology, the Company intends to further develop its IP technology to focus on delivering psychedelic molecules with an initial focus on psilocybin. Core One also holds an interest in walk-in medical clinics which maintain a database of over 200,000 patients combined. Through research and development in these clinics, including the integration of its intellectual property related to psychedelic treatments and novel drug therapies, the Company intends to work towards regulatory approval for research that advances psychedelic-derived treatments for mental health disorders.

 

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

 

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

 

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions and expectations. They are not guarantees of future performance. The Company cautions that all forward looking statements are inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with environmental and governmental regulations. In addition, marijuana remains a Schedule I drug under the United States Controlled Substances Act of 1970.  Although Congress has prohibited the US Justice Department from spending federal funds to interfere with the implementation of state medical marijuana laws, this prohibition must be renewed each year to remain in effect.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information. In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription. Health Canada has not approved psilocybin as a drug for any indication. Core One Labs Inc. does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs Inc. believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs Inc. does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Technology Networks

Substance use disorders have a debilitating impact on the wellbeing of individuals and their families. Like many other mental health disorders, these conditions have proved stubbornly resistant to treatment. The potential of psychedelic compounds to treat substance use disorders has led Canadian R&D company Entheon Biomedical to investigate the therapeutic use of the psychedelic dimethyltryptamine (DMT). The company has commissioned a clinical trial investigating the safety and efficacy of intravenous DMT. Technology Networks spoke to Entheon’s CEO, Timothy Ko, to find out more.

Ruairi Mackenzie (RM): What will be involved in the first stage of your DMT clinical trial?

Timothy Ko (TK): We have a clinical study agreement in place with a contract research organization, the Centre for Human Drug Research (CHDR) located in Leiden, Netherlands, to conduct an early phase clinical trial with DMT on humans. The objective of the study is to evaluate the safety of DMT in humans and, specifically, we’re looking to better understand the pharmacodynamics and pharmacokinetics of DMT when administered intravenously.

This will be a data-centric clinical trial, gathering vital information on the biochemical and physiological changes that occur when DMT is administered. This trial will give us further insight into the drug’s effects on the central nervous system and its impact on subjective experience, providing not only pharmacokinetic/pharmacodynamic but also a host of other valuable biometric data. All of this is critical to properly understand DMT’s potential as part of a therapeutic protocol to treat substance use disorders.

RM: What do you see as the unique challenges in treating substance abuse disorders in comparison to other mental health disorders?

TK: The success rates of current treatments and interventions are dismal, and as a society, we have become conditioned to accept these low rates of success as a foregone conclusion. We want to turn those assumptions upside down – to invert the addiction-recovery ratio and we believe we can do it through the development of a DMT-based therapeutic protocol.

Substance-use disorder is obviously a very complicated situation for both the individual grappling with it and for a society and public health system that is tasked with addressing and remedying the devastating effects and widespread damage that stems from unchecked substance-use disorder. With no straightforward solution present, our belief is that a medicalized, psychedelic-assisted therapy model provide a powerful tool for substance-use sufferers to gain the clarity and support required to reclaim their lives.

RM: How is DMT well placed to meet those challenges?

TK: Through extensive talks with our scientific advisors, a review of the literature and historical studies, DMT emerged as our ideal candidate for addiction treatment. DMT belongs to a class of psychedelic compounds, including psilocybin and LSD, which have shown high therapeutic value, and it is the psychoactive ingredient in ayahuasca. Being endogenous to the human body, DMT can be found in many plant species, and throughout its research history DMT has demonstrated a strong safety and toxicology profile. In addition, DMT is rapidly metabolized, so it is well-suited for a shorter, more tailored therapy experience, which has the added benefit of decreased costs and increased scalability. The ability to maintain a flexible and short therapy duration provides an element of control that cannot presently be achieved with other longer-lasting psychedelics. DMT is short-acting, powerful and has demonstrated safety in humans. These are the core reasons why we chose to focus our efforts on DMT.

RM: Do you believe that DMT will prove efficacious for all substance use disorders, or will it treat certain disorders more effectively?

TK: Our initial target indications will be nicotine addiction, alcohol-dependency and opioid use disorder. That being said, our DMT-assisted therapeutic protocol is being designed to address the core mechanisms underlying drug-seeking and using behaviour. Understanding that these drug-seeking behaviours are generated from a complex psychological and emotional place, DMT holds promise to directly address this base state, from which all manner of substance-use disorders are thought to originate from. From this standpoint, our aim is to prove efficacy for the initial target indication and then expand to focus on additional indications and substance-use disorders.

RM: What is the timeline for your DMT trial? How soon do you believe psychedelic-based therapeutics could be widely available?

TK: Recognizing the potential constraints of the ongoing coronavirus pandemic, we currently anticipate that our clinical trial at CHDR will commence in Q3 of 2021. We are doing everything we need logistically to ensure our trial remains on track.

Recently we announced our DMT drug-supply agreement with Psygen Labs, and that they have successfully completed production of our DMT research batch. This represents a major step in our clinical pathway, as the commencement of clinical trials and preparation hinges on having a consistent and high-quality drug supply. Once all necessary permits and licenses are in place, our drug-supply will be shipped to CHDR for requisite testing and formulation.

We are proving the safety and efficacy of our treatment protocol through standard regulatory channels that traditional drug developers go through – the FDA, EMA, and Health Canada. We expect that given our current trajectory, we would like to be in the final stages of clinical development and ready to seek final approvals and pursue commercialization in 4-5 years. But really, given the pressing need for effective treatments, paired with the growing loss of life from overdose, and the significant social and economic impact of substance-use disorders, an effective and scientifically validated solution cannot come quickly enough.

Timothy Ko was speaking to Ruairi J Mackenzie, Science Writer for Technology Networks

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Tonic Magazine

Using Psychedelics To Treat Addictions

5 Questions About The DMT Molecule

Jamie Bussin and Timothy Ko

In Episode #162 of THE TONIC Talk Show,  the CEO of Entheon Biomedical spoke about the efficacies of treating addictions with stabilized DMT molecules. This is an excerpt from that interview. The full interview can be found at www.thetonic.ca

I think what’s driving this is the faults within the current medical system’s treatment of substance use and abuse. Our work addresses the limitations of the current medicalized treatment model for treating substance disorder. Societally we’re all bearing witness to those failures. In Vancouver alone, we have overdose deaths at a rate of 120 to 180 persons per month. Drug addictions and substance disorders tear at the fabric of society at every imaginable level. Hospital costs and policing is a drain. On a personal level it’s destructive to individuals and their families. All of the conventional models of treatments are extremely low on the efficacy rates,  as low as 5 to 10%. Stand-alone treatments for individuals can cost from $5,000 to $30,000;  some drug users will have 6 drug treatment stents in their life – often resulting in death.

Your company, Entheon, is taking a different approach. What is that? Trying to stabilize the patient with a variety of things. Whether it’s medication such as antidepressants, antipsychotics and psychedelics, so that they can do some introspective work such as psychotherapy, a 12 step-like therapy, with a view to assessing their internal make up, what their barriers are, what their catchments are so that they can rework that and get to a place of meaningful reformation of their internal characteristics and from there their behaviors will change. But the reality is that for a lot of drug abusers there is this intractable trauma that makes conventional methods difficult. As you delve deeper into their core truths, the trauma patients tend to retreat even further even into dissociation. We understand with psychedelics, that really key component of creating profound introspection, that epiphanic unearthing of core truths can’t just be delivered without context of a psychotherapy environment. We’re creating that network of support that precedes and follows the psychedelic experience to help optimize integration of that experience so the individual can have some consolidation, recontextualizing who they are, their belief systems, what motivates them and breaking through their traumatic barriers so they can have different behaviours, that aren’t driven by pain or fear.

Why are you using the DMT molecule for this purpose? DMT is the active ingredient in Ayahuasca – a psychoactive “jungle brew” employed generally in South American cultures to treat “diseases of despair” – the existential feeling of being lost. The Ayahuasca experience creates this massively profound introspective journey where the individual will have these deeply personal experiences. One of the limitations of Ayahuasca is that it is very difficult to create repeatable, precise doses for medical purposes. We’re taking a purely synthetic version of DMT and administering it in a safe, gradual and precise way that is controllable by a physician. The Ayahuasca experience can take 6-12 hours during which the individual may have an overwhelmingly difficult situation they may not be prepared for – there is no “off switch”. Whereas our approach is via a regulated intravenous pump. If the experience gets too intense, we can modulate the dosing or even stop it altogether, with a return to baseline functions within 15-20 minutes. The patients arrive at that therapeutic place gradually. We’re using the right molecules delivered in the right way so that we can create a very customized, safe experience.

Explain a little bit about the regulatory process you’ve gone through.  Even though psychedelics are in a unique space, novel in some regards, the reality is that the population that we’re trying to help are medicalized. They have medical disorders. The traditional drug discovery pathway that exists for other pharmaceutical companies exists for us too.  So we’re engaged in all the necessary clinical trial steps and we’re engaging all the necessary regulators like Health Canada, the FDA and the European agency when appropriate. We have signed our clinical trials agreement with our research partner in the Netherlands. We also have our GMP production agreement signed. We anticipate having all the pieces in place for human clinical trials in Q3 or Q4.

I understand that the work Entheon is doing is very personal for you. Everyone has probably been affected by knowing someone with addictions. My story is no different. My brother was a longtime drug user, since the age of 17. He suffered a traumatic event in his teens, and his way of coping was to take up drugs. Initially it started pretty innocently. But over the course of two decades that drug use did escalate to being highly problematic and apparent and involved over 8 treatment attempts. He was medicated. He spent hundreds if not thousands of hours with therapists. For two years I was responsible for overseeing my brother’s care. I saw well intentioned professionals earnestly trying to help my brother, but he slipped further into a state of dissociation and we lost him eventually. I’ve used DMT and have undergone psychotherapy to help me work through my own traumatic issues relating to my family of origin and my relationship with my brother and my father – issues woven into the fabric of who I was. DMT really did help me reformat my understanding of my attachments and resentments, my outlook on life. I was teetering on the edge of something very dark and I’m so lucky that I found out what was on the other side of that.

For more information about Timothy Ko and his work at Entheon Biomedical please visit entheonbiomedical.com