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INN: Psychedelic Trends 2020: The Heat is On

2020 marked the beginning of the psychedelics investment story as the capital markets fully embraced the alternative drug sector.

The idea of investing in a psychedelic drug company may have sounded unlikely before 2020.

But now investors are enjoying the dawn of a new alternative drug market that is trying to capitalize on the medical benefits of psychedelic substances.

In 2020, investors saw the arrival of a number of new public companies that are exploring various pathways in the psychedelics space, primarily operating under the promise of new medicine.

It’s no exaggeration to say that 2020 served as the launching pad for psychedelics in the eyes of the capital markets. And that included us, as here at the Investing News Network (INN) we launched our own psychedelics-focused vertical.

Read on to get a sense of the psychedelics trends that are setting the stage for this promising new industry, with commentary from insiders and experts.

Psychedelics trends 2020: Markets get their bets ready as listings erupt

As mentioned, this year catapulted a fresh stock universe into existence as a variety of new companies went public across different exchanges.

While it wasn’t the first of the year, the listing of Compass Pathways (NASDAQ:CMPS) was one of the biggest landmark events for the industry in 2020. The company was the first psychedelics operation to list directly on the NASDAQ, opening the door for others to follow.

“It’s shown to the world what insiders have known for a long time — that this vision of bringing psychedelic medicine to the world isn’t a pipe dream, it’s very real and it’s happening now,” Michael Hoyos, co-founding partner, Americas, with the Conscious Fund, previously told INN.

Fellow companies also celebrated Compass Pathways’ debut as the arrival of a new era.

“Compass’ successful IPO is further evidence that psychedelics are gaining traction as a viable solution for treating mental health and addiction,” JR Rahn, co-founder and co-CEO of Mind Medicine (MindMed) (NEO:MMED,OTCQB:MMEDF), said.

During an online talk in the leadup to the Compass Pathways listing, Bill Stern, managing partner at Venture Group Capital, said the listing looked set to “change the industry dramatically.”

Dugan Selkirk, media relations manager for Vancouver-based private firm Universal Ibogaine, was not elusive about the significance of the NASDAQ listing. “The top blew off with Compass Pathways’ mega IPO in the US markets, which has put the wind back into the sails of the industry, and we see this pattern continuing with momentum into 2021.”

Jos Schmitt, president and CEO of the NEO Exchange, told INN he believes investors have to get over any stigma surrounding these substances, because he believes the opportunity is too great to pass up.

Back in March, when MindMed went public, the NEO saw Canada’s first official listing of a company operating in the psychedelics space.

A fellow securities executive previously told INN he was unsure when he first heard about the psychedelics investment shot. “I will admit, I was a bit skeptical at first,” said Richard Carleton, CEO of the Canadian Securities Exchange (CSE).

Carleton changed his mind after seeing the research that has been conducted and meeting with companies directly to discuss the sector.

The CSE is now the capital markets home of nearly 30 listings related to the psychedelics industry.

Psychedelics trends 2020: Pandemic highlights need for mental health alternatives

Florian Brand, co-founder and CEO of privately held ATAI Life Sciences, told INN he came into 2020 expecting a natural progression of the interest in therapies using psychedelics. But instead the executive found a significant jump in attention, thanks in large part to the focus on mental health created by the effects of a global pandemic.

Brand said the uncertainty surrounding COVID-19 has “precipitated an increased focus on mental health and the failures of our current standards of care.”

Doug Drysdale, CEO of Cybin (NEO:CYBN), echoed Brand’s sentiment, saying he believes the pandemic accelerated the acceptance of using alternative methods to treat mental health issues.

“We are seeing a paradigm shift in the public view and complacency for the norm of Big Pharma traditional, (and) in many cases dangerous and non-effective, treatments,” Josh Bartch, CEO of Mydecine Innovations Group (CSE:MYCO), told INN.

Psychedelics trends 2020: Executives ask for patience in face of growing buzz

As the psychedelics industry first started to develop, it became clear that one of the most direct points of comparison would be with the cannabis industry.

“Had cannabis not come along, it probably would have been a longer road to be having some of these conversations,” Ronan Levy, co-founder and executive chairman of Field Trip Health (CSE:FTRP), previously told INN.

To a degree it’s understandable, as both are alternative drug markets exploring new uses in the face of strict regulations. But some members of the psychedelics industry have been quick to deter investors from believing psychedelics will see similar hype runs to those experienced in the cannabis industry.

This leaves the question of if investors should play the market or get ready for long-term bets only.

Payton Nyquvest, chairman and CEO of Numinus Wellness (TSXV:NUMI), previously told INN that anyone entering this space has to understand the long-term roadmap ahead. “There’s no quick pathway to be able to do this,” he said.

Brand said it’s the responsibility of psychedelics companies to fully research these compounds and learn their entire medical benefits, as well as the potential risks attached.

“Viewing psychedelics as a panacea is alluring, but in reality there’s risks we still need to quantify,” said Brand of ATAI Life Sciences. “It’s incumbent on us and others in the space to build out the data and support for safe and accessible treatment, and not let excitement get ahead of the hard work to build a sustainable, impactful industry.”

Drysdale told INN that in his view the most challenging aspect for the psychedelics market in 2020 was the pressure to gain credibility and attention due to the rush of companies going public.

“Psychedelics are leading with science, creating massive intellectual property (IP) opportunities, and both of these things rely on regulation holding the industry to standards and pace,” Kelsey Ramsden, president and CEO Mind Cure Health (CSE:MCUR,OTCQB:MCURF), told INN. “As a company who is in high-growth mode with fast-moving IP projects, being patient can be challenging.”

That sentiment of longevity for investments was echoed by Carleton, who said he sees the psychedelics market as a “pharma play.”

Hoyos told INN the industry needs to be careful to not repeat the mistakes made in the cannabis space, which led to a large part of the sector wanting to make a quick buck compared to growing steadily.

“For investing in the space, I think the full value will be realized in the longer term, but there will be opportunities for exit liquidity events a lot sooner,” Hoyos added.

Psychedelics trends 2020: Studies set path for changing perspectives

One of the biggest factors helping psychedelics is the launch and continuation of medical studies evaluating particular drug treatments based on psychedelics and boosting the legitimacy of the industry.

Timothy Ko, CEO at Entheon Biomedical (CSE:ENBI), told INN that 2020 will be remembered as a year in which the psychedelics industry established itself and came into the spotlight thanks to the work of those “who have historically utilized, researched and spoken for the value of psychedelic compounds.”

Investors will need to keep an eye on the development of several studies moving forward, as these will offer the most concrete answers on whose drugs are worth betting on. These studies, particularly those to obtain approval from the US Food and Drug Administration, are extremely lengthy and costly events for the companies in play.

“I think the challenge and gift of regulation resting in the balance of scientific proof is what will both make this a stable and rapidly growing investment sector,” Ramsden said.

Thanks to recognition from medical authorities, more investors are starting to look into what’s at stake with psychedelics.

Psychedelics trends 2020: Investor takeaway

The psychedelics industry found its groove in 2020 and discovered investors ready to listen and get involved. This growth in attention may be partially due to the effects of lockdowns and the uncertainty caused by COVID-19, but it is also backed by the medical research being conducted.

In 2020, investors discovered the enthusiasm for psychedelics goes well beyond college dorm rooms.

Don’t forget to follow us @INN_LifeScience for real-time news updates!

Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: Cybin, Mind Cure Health, Numinus Wellness and Universal Ibogaine are clients of the Investing News Network. This article is not paid-for content.

The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.

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Push for Alternative Therapies Prods Researchers Towards Psilocybin

‍FinancialBuzz.com News Commentary

NEW YORK, Dec. 15, 2020 /PRNewswire/ — The psychedelics market is currently navigating a similar legal situation to the one the cannabis market found itself in for many years. Psychedelics are not legal for recreational use in Canada or the United States, yet medical research on the efficiency of such products may help reduce some of the stigma around them. In fact, some major developments have already begun to change the landscape for the better in this market. For example, earlier in 2019, the state of Colorado became the first state to decriminalize Magic Mushrooms (mushrooms containing psilocybin), taking the substance on a similar path to legalization as that of cannabis. Then, in November 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is studying the effects of psilocybin as an anti-depressant. Currently, despite the obstacles imposed by the legal status for such products, the psychedelic drugs market is expected to expand with a CAGR of 16.3%, reaching USD 6,859.95 Million by 2027, according to Data Bridge Market Research. Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO), Havn Life Sciences Inc. (OTC: HAVLF), Revive Therapeutics Ltd. (OTC: RVVTF), Mind Medicine (MindMed) Inc. (OTC: MMEDF), Hollister Biosciences Inc. (OTC: HSTRF)

In recent years, there has been a significant flow of new information describing the effects of psychedelic compounds on the brain. For instance, Proceedings of the National Academy of Sciences published data that helped explain that, under the influence of psilocybin, one of such active compounds often found in various types of mushrooms, the brain creates a feedback loop of neuron activity and neurotransmitter release (the chemical messengers that neurons use to communicate). According to the study, this provides an understanding of why psilocybin is showing considerable promise as a therapeutic intervention for neuropsychiatric disorders including depression, anxiety, and addiction. “Using this model will be crucial for truly understanding how psilocybin can rebalance neuropsychiatric disorders such as treatment-resistant depression and addiction,” Morten Kringlebach, the study’s first author and a senior research fellow at the University of Oxford, explained according to Inverse.

Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO) announced last week, “that it has completed its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The Company is now preparing to export the harvest to its Canadian cGMP Facility which has a Health Canada schedule 1 Dealer’s License attached to it, allowing for legal import.

‘We are pleased to announce the completion of our first commercial harvest of natural psilocybin mushrooms,’ said Joshua Bartch, CEO and Chairman of Mydecine. ‘There is more research needed on these compounds in order to better understand the entourage effect experienced by patients which has shown dramatically effective results compared to single-molecule synthetic psilocybin in preliminary studies. As the industry grows, the need for naturally occurring psilocybin and access to large quantities of these molecules will be paramount and we are excited to be the first to advance this movement at scale.’

Once received by the Company’s facility in Canada, the psilocybin mushrooms will be extracted, purified, and turned into a cGMP final product for controlled therapeutic purposes. Mydecine’s final product be made available for purchase by other licensed institutions and companies conducting clinical research into the efficacy of these compounds to treat various health conditions including anxiety, addiction, depression and PTSD. Portions of the harvest will also be used for Mydecine’s proprietary genetic, pharmacology, and clinical research. The clinical use will be for the studies and developing protocols of psilocybin-assisted psychotherapy to treat PTSD in veterans and other frontline workers.”

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MindMed Upsizes Previously Announced Bought Deal Public Offering

/THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES./

NEW YORK, Dec. 15, 2020 /CNW/ – Mind Medicine (MindMed) Inc. (NEO: MMED) (OTCQB: MMEDF) (DE: MMQ) (“MindMed” or the “Company”), a leading psychedelic medicine biotech company, is pleased to announce that it has agreed to increase the size of its previously announced bought deal financing led by Canaccord Genuity Corp. (the “Lead Underwriter”). The Lead Underwriter has agreed, on behalf of a syndicate of underwriters (collectively, the “Underwriters”), to purchase, on a bought deal basis pursuant to the filing of a short form prospectus, an aggregate of 18,200,000 units of the Company (the “Units”) at a price of C$4.40 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$80,080,000 (the “Offering”).

Each Unit shall consist of one subordinate voting share (each a “Subordinate Voting Share”) and one-half of one Subordinate Voting Share purchase warrant of the Company (each whole warrant, a “Warrant”). Each Warrant shall be exercisable to acquire one Subordinate Voting Share at an exercise price of C$5.75 per Subordinate Voting Share for a period of 3 years from the closing of the Offering, subject to a Warrant acceleration right exercisable by the Company if the daily volume weighted average trading price of the Company’s Subordinate Voting Shares on the NEO Exchange is greater than C$9.00 per Subordinate Voting Share for the preceding 5 consecutive trading days.

The Company has granted the Underwriters an option (the “Over-Allotment Option”) to purchase up to an additional 2,730,000 Units at the Issue Price, exercisable at any time, for a period of 30 days after and including the Closing Date, which would result in additional proceeds of C$12,012,000.

The Underwriters are to be paid a cash commission equal to 6% of the gross proceeds of the Offering and to receive Unit purchase warrants of the Company (the “Underwriters’ Warrants”) equal to 6% of the number of Units sold under the Offering, with each Underwriters’ Warrant being exercisable to acquire one Unit at the Issue Price for a period of 36 months from the closing of the Offering.

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 January 5, 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 NEO Exchange and the applicable securities regulatory authorities. The Company will use best efforts to obtain the necessary approvals to list the Subordinate Voting Shares and the Warrant Shares on the NEO Exchange.

The net proceeds of the Offering will be used for investment in Project Lucy, Albert (the Company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.

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 MindMed

MindMed is a leading psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and experiential therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the Company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the closing of the Offering, regulatory approvals and the intended use of proceeds of the Offering. There are numerous risks and uncertainties that could cause actual results and MindMed’s plans and objectives to differ materially from those expressed in the forward-looking information. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities of the Company will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons except in certain transactions exempt from the registration requirements of the U.S. Securities Act).

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MindMed Announces Successful Completion of Pre-IND Meeting with the FDA for Project Lucy

Provides Clinical Development Update on 18-MC

  • Based on positive pre-IND meeting with U.S. Food and Drug Administration (FDA), MindMed is now prepared to open an Investigational New Drug (IND) in August 2021 with a Phase 2b clinical trial for LSD assisted therapy in anxiety
  • MindMed continues dose escalation of 18-MC in Phase I SAD/MAD; Meeting confirmed with FDA

NEW YORK, Dec. 14, 2020 /PRNewswire/ — MindMed (NEO: MMED,OTCQB: MMEDF, DE: MMQ), a leading psychedelic medicine biotech company today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of lysergic acid diethylamide (LSD) assisted therapy for an anxiety disorder.

The successful completion of this engagement with the FDA is an important milestone for the company and provides regulatory clarity and confidence as MindMed advances its lead clinical development program in the U.S. MindMed intends to open the IND with the FDA in August 2021, with a Phase 2b clinical trial evaluating experiential doses of LSD in an anxiety disorder.

MindMed Co-Founder & Co-CEO J.R. Rahn said “The FDA is one of the most impactful organizations for regulated drug development globally.  We look forward to working through the FDA pathway on psychedelic assisted therapies in strict compliance with their proven drug development guidelines and commencing our Phase 2b trial for Project Lucy in 2021.”

18-MC (Project Layla) Phase 1 Clinical Development Update

Preliminary data has been analyzed for MindMed’s addiction treatment program evaluating the ibogaine derivative 18-MC, which the company has named Project Layla. The preliminary data from the Phase 1 Multiple Ascending Dose (MAD) and Single Ascending Dose (SAD) study has shown that the drug is safe and well tolerated at the doses tested to date, and no Serious Adverse Events (SAEs) have been reported.

Based on the excellent safety profile observed to date, MindMed’s clinical team and 18-MC’s Medical Director, Dr. Judy Ashworth, have decided to continue dose escalation in the study to gather higher dosing data. Once that additional data has been reviewed, MindMed will directly thereafter initiate the Phase 2a proof of concept study.  A meeting with the FDA has been confirmed to continue discussions regarding the 18-MC clinical development plan.

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and performance of Mind Medicine (MindMed) Inc. (“MindMed”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, MindMed’s and its collaborators’ ability to continue to conduct research and clinical programs, MindMed’s ability to manage its supply chain, product sales of products marketed by MindMed and/or its collaborators (collectively, “Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Products and Product candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Product candidates and new indications for Products; unforeseen safety issues resulting from the administration of Products and Product candidates in patients, including serious complications or side effects in connection with the use of MindMed’s Products and product candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict MindMed’s ability to continue to develop or commercialize Products; ongoing regulatory obligations and oversight impacting Products, research and clinical programs, and business, including those relating to patient privacy; uncertainty of market acceptance and commercial success of Products and Product candidates and the impact of studies on the commercial success of Products and Product candidates; the availability and extent of reimbursement of Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; competing drugs and product candidates that may be superior to Products and Product candidates; the extent to which the results from the research and development programs conducted by MindMed or its collaborators may be replicated in other studies and lead to therapeutic applications; the ability of MindMed to manufacture and manage supply chains for multiple products and product candidates; the ability of MindMed’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labelling, distribution, and other steps related to MindMed’s Products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of MindMed to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, other litigation and other proceedings and government investigations relating to MindMed and its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on MindMed’s business, prospects, operating results, and financial condition. Any forward-looking statements are made based on management’s current beliefs and judgment. MindMed does not undertake any obligation to update publicly any forward-looking statement.

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MindMed Announces $50 Million Bought Deal Public Offering

/THIS NEWS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT INTENDED FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES./

NEW YORK, Dec. 14, 2020 /CNW/ – Mind Medicine (MindMed) Inc. (NEO: MMED) (OTCQB: MMEDF) (“MindMed” or the “Company”), the leading neuro-pharmaceutical company for psychedelic inspired medicines, is pleased to announce that it has entered into an agreement with Canaccord Genuity Corp. (the “Lead Underwriter”) pursuant to which the Lead Underwriter has agreed, on behalf of a syndicate of underwriters (collectively, the “Underwriters”), to purchase, on a bought deal basis pursuant to the filing of a short form prospectus, an aggregate of 11,364,000 units of the Company (the “Units”) at a price of C$4.40 per Unit (the “Issue Price”) for aggregate gross proceeds to the Company of C$50,001,600 (the “Offering”).

Each Unit shall consist of one subordinate voting share (each a “Subordinate Voting Share”) and one-half of one Subordinate Voting Share purchase warrant of the Company (each whole warrant, a “Warrant”). Each Warrant shall be exercisable to acquire one Subordinate Voting Share at an exercise price of C$5.75 per Subordinate Voting Share for a period of 3 years from the closing of the Offering, subject to a Warrant acceleration right exercisable by the Company if the daily volume weighted average trading price of the Company’s Subordinate Voting Shares on the NEO Exchange is greater than C$9.00 per Subordinate Voting Share for the preceding 5 consecutive trading days.

The Company has granted the Underwriters an option (the “Over-Allotment Option”) to purchase up to an additional 1,704,600 Units at the Issue Price, exercisable at any time, for a period of 30 days after and including the Closing Date, which would result in additional proceeds of C$7,500,240.

The Underwriters are to be paid a cash commission equal to 6% of the gross proceeds of the Offering and to receive Unit purchase warrants of the Company (the “Underwriters’ Warrants”) equal to 6% of the number of Units sold under the Offering, with each Underwriters’ Warrant being exercisable to acquire one Unit at the Issue Price for a period of 36 months from the closing of the Offering.

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 January 5, 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 NEO Exchange and the applicable securities regulatory authorities. The Company will use best efforts to obtain the necessary approvals to list the Subordinate Voting Shares and the Warrant Shares on the NEO Exchange.

The net proceeds of the Offering will be used for investment in Project Lucy, Albert (the Company’s digital medicine division), additional microdosing research and development, Project Layla (18-MC) as well as general working capital.

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 MindMed

MindMed is a leading psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and experiential therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to the Company’s groundbreaking approach to developing the next-generation of psychedelic inspired medicines and therapies.

MindMed trades on the Canadian exchange NEO Exchange under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: www.mindmed.co

MindMed Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the closing of the Offering, regulatory approvals and the intended use of proceeds of the Offering. There are numerous risks and uncertainties that could cause actual results and MindMed’s plans and objectives to differ materially from those expressed in the forward-looking information. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in the United States. The securities of the Company will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons except in certain transactions exempt from the registration requirements of the U.S. Securities Act)

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Benzinga – Psyched: Canada Allows Psilocybin Use For Healthcare Pros, UK Begins DMT Trials, Cybin To Purchase Adelia

Psyched: Canada Allows Psilocybin Use For Healthcare Pros, UK Begins DMT Trials, Cybin To Purchase Adelia

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Canada Allows Professionals In Training To Use Psilocybin

The Canadian Health Minister Patty Hajdu has allowed 17 healthcare professionals to possess and use psilocybin to conduct professional training in psilocybin-assisted therapy.

The decision, announced Tuesday, marks the latest step in Canada’s path towards the legalization of psilocybin.

Since August 2020, Canada’s Health Minister has granted 14 exemptions to access psilocybin therapy, mainly for patients dealing with end-of-life distress.

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“Health Canada now rightfully acknowledges that clinician experience with psychedelic medicines is an important part of their training. Therapists having psychedelic experience are able to more deeply empathize with patients and understand their experience,” said Bruce Tobin, founder and Board Chair of TheraPsil, a nonprofit working for patient access to psilocybin in Canada.

The UK To Begin First-Ever Clinical Trials On DMT For Depression

The Imperial College of London, in partnership with neuropharmaceutical research company Small Pharma, have been granted approval from UK authorities to begin clinical trials on the hallucinogenic drug DMT for the treatment of depression.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) gave the green light to begin the trials, which are expected to start in January 2021, The Guardian reported.

The trials will mark the first time that DMT is studied in the treatment of clinical depression. The institutions stated that the essays will be based on recent clinical research on psilocybin.

In its initial phase, 32 healthy volunteers will be given DMT in order to understand the minimum dose needed to achieve a psychedelic effect. After that, the drug will be administered to 36 separate patients, who have been diagnosed with clinical depression.

The parties still await Home Office approval given the scheduled condition of the drug. DMT remains illegal in the UK as in most countries around the globe.

Cybin to Acquire Adelia Therapeutics for $15.7M

This week, Canadian psychedelics company Cybin (NEO: CYBN) signed a definitive agreement to acquire 100% Adelia Therapeutics, a biopharmaceutical company focused on the development of proprietary psychedelic derivatives.

The purchase was done through an all-stock transaction of CA$20.1 million (approximately $15.7 million).

“Adelia’s focus on creating novel therapeutics, including novel delivery methods and innovative therapeutic regimens can support our goal of creating therapies that result in faster onset of action, smoother pharmacokinetic profiles, shorter treatment durations, and reduced side effects,” said Cybin CEO Doug Drysdale.

With the purchase, which is part of Cybin’s expansion strategy through M&A, the company expects to develop a novel drug discovery platform with efficient drug delivery aimed at enhancing dosing control and developing a potential novel treatment regimen.

This Week’s Milestone Round

The Usona Institute, a Wisconsin-based nonprofit focused on psychedelics research published a new method of synthesis for 5-MeO-DMT, a psychedelic compound closely related to DMT, which is naturally produced by the Sonoran Desert toad.

The novel method emphasizes scalability, controllability, and reproducibility in order to support production of the compound for clinical research. According to Usona, previous synthetic routes did not achieve these goals.

Field Trip Health (CSE:FTRP) (OTCQB:FTRPF) announced a new private offering of CA$15 million ($11.7 million) to close on or about January 5, 2021. The company is offering 3,333,333 units (comprising one share and one-half of a common share purchase warrant) at a price of CA$4.50 per Unit. On Friday December 11, Field Trip stock closed at CA$5.60.

MindMed (NEO: MMED) (OTCQB:MMEDF) announced the closing of its last offering, for gross proceeds of CA$34.5 million ($27 million).

More companies are also looking at clinical research on DMT. On Wednesday, Entheon Biomedical (CSE:ENBI), a Canadian company focused on studying DMT’s medicinal potential, announced closing a drug-supply agreement with Psygen Labs Inc.

Entheon will receive DMT for future formulation, preclinical and clinical research, aimed at  post-approval commercialization of the drug. The company expects to start clinical trials on DMT by late 2021, in association with the Centre for Human Drug Research in the Netherlands.

Biotech company BetterLife Pharma (CSE:BETR) (OTCQB:BETRF), is entering the psychedelics space with the signage of an agreement to acquire Transcend Biodynamics, in an all-stock transaction of CA$10 million ($7.8 million).

Transcend is researching BOL-148, a derivative of LSD that is touted to offer several of the same therapeutic actions -like treating cluster headaches- without the psychedelic effect.

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MindMed Closes Upsized Financing of CAD $34.5m, Gross Proceeds Raised Since Company Founding Now Total CAD $121.4m (USD $94.8m)

Post-Financing Cash Reserves of CAD $85m (USD $66.4m) to Enable Advancement of Digital Therapeutics Division and Growing Clinical Trial Pipeline

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

TORONTO, Dec. 11, 2020 /CNW/ — Mind Medicine (MindMed) Inc. (NEO: MMED, OTCQB: MMEDF) (“MindMed” or the “Company”) is pleased to announce that it has closed its previously announced bought deal short form prospectus offering, including the exercise in full of the underwriter’s over-allotment option (the “Offering”). In connection with the Offering, the Company issued 18,170,000 units of the Company (the “Units”) at a price per Unit of CAD $1.90 (the “Issue Price”) for gross proceeds of CAD $34,523,000. The Offering was conducted by Canaccord Genuity Corp., as lead underwriter, and Eight Capital.

Each Unit comprises one subordinate voting share of the Company (a “Subordinate Voting Share”) and one-half of one Subordinate Voting Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one Subordinate Voting Share at an exercise price of CAD $2.45 until December 11, 2023. If, at any time following the closing of the Offering, the daily volume weighted average trading price of the Subordinate Voting Shares on the NEO Exchange Inc. is greater than CAD $4.00 per Subordinate Voting Share for the preceding 10 consecutive trading days, the Company may, upon providing written notice to the holders of Warrants, accelerate the expiry date of the Warrants to the date that is at least 30 days following the date of such written notice. The Warrants will be listed for trading on the facilities of the NEO Exchange Inc. (the “NEO”) under the symbol “MMED.WA”, subject to the final approval of the NEO.

Since the founding of Mind Medicine Inc. in May 2019, MindMed has now raised a total of CAD $121.4m (USD$94.8m) in investment capital before fundraising and deal expenses.

MindMed Co-Founder & Co-CEO, J.R. Rahn said, “The COVID-19 pandemic has made it clearer than ever that the current global mental healthcare system demands more comprehensive solutions to address multiple mental health and addiction crises around the world. This successful upsized financing from investors offers further validation that psychedelic medicines are being viewed as a promising new frontier in mental health treatments. As we advance and design this new treatment paradigm in mental health and addiction, we believe that interlacing digital therapeutics alongside regulated psychedelic drug development through rigorous science at the FDA and other regulatory bodies will be integral to advancing the potential healing of millions of patients globally.”

The Company intends to use the net proceeds of the Offering for investment in its digital medicine division, additional microdosing research and development as well as general working capital and corporate purposes, including to further fund its ongoing programs.

Post-financing, the Company now has cash reserves of CAD $85m (USD $66.4m) to enable development of its digital medical division Albert and continued progress of its clinical trial pipeline of psychedelic inspired medicines and experiential therapies.

With Albert, the Company aims to build an integrated digital platform to improve patient safety, outcomes, and clinical trial design. By pairing digital tools, such as wearables and the latest in machine learning, with psychedelic assisted therapies, MindMed can optimize and better understand the patient journey and therapeutic outcomes from pre-care through to after-care.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

About MindMed

MindMed is a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and experiential therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including Psilocybin, LSD, MDMA, DMT and an Ibogaine derivative, 18-MC. The MindMed team brings extensive biopharmaceutical experience to the Company’s groundbreaking approach to developing the next generation of psychedelic inspired medicines and experiential therapies.

MindMed trades on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in the United States under the symbol MMEDF and in Germany under the symbol MMQ. For more information: http://www.mindmed.co/

Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the intended use of proceeds of the Offering, the listing of the Warrants on the NEO,  the Company’s cash reserves and the effects thereof, and the Company’s intended future business plans and operations, including the development of psychedelic inspired medicines and experiential therapies. There are numerous risks and uncertainties that could cause actual results and MindMed’s plans and objectives to differ materially from those expressed in the forward-looking information. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

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Benzinga – Imperial College Of London To Study Illegal Psychedelic Compound In First-Ever Clinical Trial

Clinical trials on the hallucinogenic drug DMT for the treatment of depression are expected to start in January.

According to The Guardian, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) gave the green light to the Imperial College of London, in partnership with neuropharmaceutical research company Small Pharma, to begin the trials.

DMT, a strong, short-acting hallucinogenic compound, remains illegal in the UK as in most countries around the globe. It is best known as the active ingredient in ayahuasca, a hallucinogenic drink traditionally used as a spiritual medicine in shamanic ceremonies among indigenous communities in South America.

Studying DMT for Depression

This would be the first time DMT is studied in the treatment of clinical depression.

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The institutions stated that the essays will be based on recent clinical research on psilocybin, the active psychedelic compound in magic mushrooms.

In its initial phase, 32 healthy volunteers will be given DMT in order to understand the minimum dose needed to achieve a psychedelic effect. After that, the drug will be administered to 36 separate patients, who have been diagnosed with clinical depression.

The parties still await Home Office approval given the scheduled condition of the drug.

DMT vs Psilocybin: Small Pharma CEO Peter Rands said that DMT’s intense, short-acting psychedelic effect could become a viable alternative to psilocybin treatment in cases where patients cannot participate in the long sessions required by the latter.

A typical psilocybin “trip” will last between two to four hours. In a medical setting, that’s accompanied by four more hours of psychotherapy in order to integrate the experience into the patient’s life.

DMT typically has an onset and offset time of just 15 to 30 minutes, allowing for faster sessions within the long-term treatment.

More Research Is On Its Way: Earlier this year, New York-based MindMed (MEO: MMED) (OTCQB:MMEDF) announced it will begin studying DMT’s correct dosing and duration in a Phase 1 clinical trial conducted in collaboration with University Hospital Basel in Switzerland.

More companies are also looking at clinical research on DMT.

On Wednesday, Entheon Biomedical (CSE:ENBI), a Canadian company focused on studying DMT’s medicinal potential, closed a drug-supply agreement with Psygen Labs Inc.
Entheon will receive DMT for future formulation, preclinical and clinical research, aimed at  receiving post-approval commercialization of the drug. The company expects to start clinical trials on DMT by late 2021, in association with the Centre for Human Drug Research in the Netherlands.

Photo by cottonbro from Pexels.

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Psychedelic Quick Hits: Havn Life, MindMed, Mydecine

Published at GreenMarketReport.com

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Mydecine Innovations

Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) announced that it has completed its first commercial harvest of 20 kilograms of psilocybin mushrooms at its research and cultivation facility in Jamaica. The company said it is now preparing to export the harvest to its Canadian cGMP Facility which has a Health Canada schedule 1 Dealer’s License attached to it, allowing for legal import.

“We are pleased to announce the completion of our first commercial harvest of natural psilocybin mushrooms,” said Joshua Bartch, CEO and Chairman of Mydecine. “There is more research needed on these compounds in order to better understand the entourage effect experienced by patients which has shown dramatically effective results compared to single-molecule synthetic psilocybin in preliminary studies. As the industry grows, the need for naturally occurring psilocybin and access to large quantities of these molecules will be paramount and we are excited to be the first to advance this movement at scale.”

Mydecine said that its final product will be made available for purchase by other licensed institutions and companies conducting clinical research into the efficacy of these compounds to treat various health conditions including anxiety, addiction, depression and PTSD. Portions of the harvest will also be used for Mydecine’s proprietary genetic, pharmacology, and clinical research. The clinical use will be for the studies and developing protocols of psilocybin-assisted psychotherapy to treat PTSD in veterans and other frontline workers.

MindMed

Mind Medicine Inc. (NEO: MMED) (OTCQB: MMEDF) has filed a final short form prospectus with the securities commissions or similar authorities in each province of Canada, other than Québec with regards to a previously announced bought deal. The company’s underwriters have agreed to purchase 15,800,000 units of MindMed, on a “bought deal” basis, at a price per Unit of $1.90 for gross proceeds of $30,020,000.

The company said it has also granted the Underwriters an over-allotment option to purchase up to an additional 15% of the Units at the Issue Price, exercisable in whole or in part, at any time on or prior to the date that is 30 days following the closing of the Offering. If this option is exercised in full, an additional $4,503,000 will be raised pursuant to the Offering and the aggregate proceeds of the Offering will be $34,523,000.The Offering is scheduled to close on or about December 11, 2020.

Havn Life

Havn Life Sciences Inc. (CSE:HAVN) has signed a Memorandum of Agreement with the international veteran’s organization, Heroic Hearts Project. Heroic Hearts is a registered 501(c)(3) nonprofit organization founded in the United States that connects military veterans struggling with mental trauma, to psychedelic therapy options including ayahuasca, psilocybin, and ketamine. Heroic Hearts also provides support and professional counseling to these veterans throughout the process. These veterans typically have tried all the available resources offered by the Department of Veteran Affairs with limited success leaving them with very few options. Heroic Hearts currently has branches across the United States, Canada, and the United Kingdom.

“This collaboration between Havn Life and Heroic Hearts has the potential to make an extraordinary impact on the mental health and wellness of military veterans,” said Susan Chapelle, EVP of Research and Development at Havn Life. “Under the agreement, Havn Life will supply products and compounds to be used in Heroic Hearts’ future clinical studies that will investigate the effects of low-dosage psychedelic compounds on veterans suffering from emotional trauma and PTSD. This progressive research will help develop clinical trial formulations to aid in the recovery of PTSD and other trauma-related disorders. We look forward to working closely with veterans and others with military backgrounds.”

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Psychedelics: FDI’s next trip?

By Seth O’Farrell

Published at FDIIntelligence.com

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Psilocybin-based therapies are gaining ground in the US, sparking investment in the sector

The past few months has seen a flurry of activity to do with psychedelics in North America: US cities and states have legalised psilocybin, and biotech psychedelic-assisted therapy companies have started to raise institutional capital and establish R&D centres overseas.

In November, the state of Oregon decriminalised the possession of all drugs and legalised the use of psilocybin – the naturally occurring compound found in “magic mushrooms” – for medical treatment. This comes as biotech companies developing psilocybin therapy, such as Compass Pathways, look to raise capital funding through IPOs.

On both sides of the Atlantic, guided therapy using psilocybin as a conduit is gaining ground, while investor interest is surging. Psychedelics stocks are fast becoming a hot topic in the biotech sector.

The business potential is not lost on investors. In 2017, the UK’s Centre for Mental Health estimated that mental health problems at work had cost the country £34.6bn, up from £26bn 10 years earlier. Global predictions for the financial cost of mental health run to trillions. With Covid-19 exacerbating the rates of anxiety, depression and addiction, it is little wonder that capital is coming to the rescue.

Indeed, it follows that companies large and small are expanding their operations. Greenfield investment tracker fDi Markets recorded two projects in this sector this year. Despite concurrent legalisation efforts, how companies court investors and acquire regulatory approval remains delicate, however.

Canadian company Mydecine, which develops and produces drugs from mushrooms, has opened a lab in Denver focused on the medical applications of mushrooms of non-psychedelics and is awaiting DEA approval.

“We think that the US is an amazing marketplace,” says Mydecine chief executive Josh Bartch, adding that the decriminalisation in Oregon and lobbying efforts in Washington DC have led to a “wave of acceptance” and “mindset changes”.

Covid-19 fallout

In the wake of the pandemic and the second lockdown restrictions across Europe and North America, concerns around mental health and wellbeing are only likely to become more pronounced.

Mr Bartch expects a surge in post-traumatic stress disorder and a spike in substance abuse, for which psilocybin is a unique treatment. “People will be actively seeking out more progressive, innovative and less harmful solutions,” he says.

For J.R. Rahn, CEO and founder of MindMed, a Toronto-based psychedelic medicine biotech company, being federally compliant and distancing oneself from the legalisation path are essential to attracting institutional capital.

He fears that legalisation efforts may ignore the needs of the patients who are suffering, and so priority must be given to the patients before any debate on legalisation.

“Right now, let’s solve the acute problem that tens of millions of Americans are jobless and are probably going to have high rates of mental illness and addiction,” Mr Rahn says. “The whole legalisation thing has the ability to threaten what we’re doing in the therapeutic space.Our objective is not for you to have a better Phish concert. Our objective is to solve the underlying cause of your anxiety or addiction.”

MindMed opened a research and development centre in Basel earlier this year, attracted by the research going on in Switzerland and the infrastructure that is already in place to conduct clinical trials there.

“There is a huge Swiss legacy on psychedelics,” he says, which goes all the way back to Basel-born chemist Albert Hofmann’s discovery of LSD.

Humanitarian opportunity

It is hard not to make comparisons with the evolution of the cannabis industry over the past 10 years, whereby legal changes have aligned with public acceptance to create a billion-dollar medical industry. Legalisation efforts in the US have removed much of the stigma attached to alternative, psychoactive medicine, and the country’s opioid crisis led to greater openness regarding plant-based alternatives.

Ronan Levy, co-founder and executive chairman of Canadian psychedelic therapeutics company Field Trip Health, which recently expanded operations to the Netherlands, insists that this is distinct from the popularisation of cannabis-inspired medicine in both mission and scope.

“The cannabis industry was driven more through political grassroots activism,” he says. The difference here is that this surge of interest has been triggered by the research coming out of Baltimore’s Johns Hopkins University and Imperial College, London.

“This is not only an incredible business opportunity but an incredible humanitarian opportunity,” Mr Levy asserts. “Research shows that people who have psychedelic therapies have increased creativity and empathy.”

In a divided world, he adds, humanity is evolving in a positive way as the psychedelics industry begins to flourish.