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MindMed Announces the Start of the First-Ever Clinical Trial Combining MDMA and LSD

BASEL, Switzerland, Jan. 20, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company, announced today the start of the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body. The trial will be conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland.

If administered in combination with LSD, MDMA may increase positive subjective drug effects, including positive mood and empathy, and reduce the negative emotions and anxiety that are sometimes associated with LSD – producing an overall more positive experience.

MindMed is undertaking a Phase 1 clinical trial to evaluate if MDMA, when balanced and used in combination with LSD, can help offset some of the known potential unpleasant effects of LSD that occur in therapy or clinical settings. MindMed is interested in understanding how to balance both MDMA and LSD in a cohesive way to create better patient outcomes, and develop more advanced psychedelic assisted therapies, as MindMed expands both its R&D and commercial drug development pipeline. The study is anticipated to take around one year to complete.

President of MindMed, Dr. Miri Halperin Wernli added, “I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts. It is like a gateway to a multidimensional universe.‌”

The Phase 1 double-blind, placebo-controlled, 4-period crossover design study officially began this week and will assess subjective and autonomic effects aiming to determine the qualitative emotional differences between a combined MDMA and LSD experience, a pure LSD experience and a pure MDMA experience, versus a placebo.

LSD in other Phase 1 clinical trials has demonstrated an acute subjective effect on the serotonin 5-HT2A receptor stimulation, leading to ego dissolution and neuroplasticity. These properties of LSD are thought to have therapeutic effects on patients suffering from mental disorders. However, in some instances unpleasant effects can occur in therapy, causing distress to the subject through acute anxiety.

If MindMed finds the Phase 1 trial results promising, it will work with expert clinicians to undertake patient studies with treatments combining MDMA and LSD for various potential indications and mental disorders. With its recent capital raise resulting in a total of CAD $237.2m (USD $183.8m) raised to date and the essential addition of Robert Barrow as Chief Development Officer, MindMed is well positioned to capitalize on research advancements resulting from groundbreaking studies such as this.

More details on the clinical trial can be found here: https://clinicaltrials.gov/ct2/show/NCT04516902

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 Adds Chief Development Officer with FDA Phase 2 Psilocybin Clinical Trial Experience

Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer

NEW YORK, Jan. 14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow, an accomplished pharmaceutical executive, as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

In his most recent position, Mr. Barrow served as Director of Drug Development & Discovery at the Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs in psychedelics. At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA.

MindMed Co-CEO J.R. Rahn said, “Rob has been an integral advisor to MindMed on Project Lucy and in preparing our meetings with the FDA, and we are honored he is now joining us on the senior leadership team. We are excited to attract such top tier talent from the psychedelic drug development community. The entire MindMed team is looking forward to exploring potential additional programs evaluating psilocybin and other psychedelics backed by Rob’s recent experience and expertise gaining a breakthrough therapy designation at FDA for a psychedelic assisted therapy.”

MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare.  In joining MindMed, I look forward to delivering on this potential and working to further build and progress MindMed’s pipeline of clinical development programs, offering hope to millions of people suffering from addiction and mental health disorders.”

Robert Barrow Bio:

Mr. Barrow is an accomplished pharmaceutical executive and clinical pharmacologist with over a decade of experience leading drug development programs in a variety of disease areas. Mr. Barrow previously served as Director of Drug Development & Discovery at Usona Institute, where he oversaw preclinical, clinical and regulatory development efforts for all of Usona’s development programs. Prior to joining Usona, Mr. Barrow served as Chief Operating Officer of Olatec Therapeutics where he oversaw the execution of numerous early- and late-stage clinical trials in the fields of analgesics, rheumatology, immunology and cardiovascular disease. In addition, he has been responsible for the design and execution of preclinical research programs for new molecular entity drugs in CNS conditions such as multiple sclerosis, Alzheimer’s Disease and Parkinson’s Disease. Mr. Barrow holds a Masters degree in Pharmacology from The Ohio State University and a Bachelor of Science degree from Wake Forest University, where he graduated summa cum laude.

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 Expands Psychedelic Microdosing Division, Adds Groundbreaking Study Evaluating LSD Microdosing Through Next-Gen Digital Clinical Markers

MindMed to Commence Groundbreaking LSD Microdosing Study Evaluating Benefits on Neuroplasticity, Sleep, Cognitive Enhancement Variables and Immune System Response on the Human Body

NEW YORK, Jan. 12, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced an innovative randomized placebo-controlled study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood, neuroplasticity markers, emotion regulation, quality of life, and immune system response.

The  study will provide an additional research pathway for MindMed’s psychedelic Microdosing Division and will immediately integrate with MindMed’s plans in digital therapeutics through its newly formed Albert unit for digital medicine. The new study will be conducted in collaboration with Dr. Kim Kuypers of Maastricht University in the Netherlands, a global, leading authority on the microdosing of psychedelics.

Dr. Kuypers said, “I am excited about this new study which combines a variety of measures ranging from self-reporting and cognitive tasks to health and sleep parameters, bringing us closer to the mechanism of action behind the claimed benefits of microdosing.”

In order to advance the scientific understanding of microdosing for clinical purposes, the randomized placebo-controlled study will specifically measure the effects of microdoses of LSD on neuroplasticity markers such as BDNF plasma levels, as well as on various sleep measures, mood, cognitive performance, emotion regulation, quality of life, and immune system response. MindMed is integrating innovative digital tracking devices and software into the study to better assess LSD’s effects on various digital clinical markers on the human body.

MindMed’s President and Head of Clinical, Dr. Miri Halperin Wernli, commented on the groundbreaking new study saying, “Over the past 15 years there has been growing interest in psychedelic microdosing and its potential enhancing effects on the human body. We now aim to use digital medicine techniques to expand the measurements enabling us to track and understand cognitive performance, various behavioral variables, productivity, and mood indicators. We believe that such measurements may offer an efficient way of determining a response loop for better understanding how microdosing can affect the human body. With this study we are seeking to gather scientific and controlled data that we hope will contribute to the discovery of potential therapeutic applications for these psychedelics microdosing paradigms as innovative treatment modalities.”

In addition to this study, MindMed’s Microdosing Division under the leadership of Dr. Halperin Wernli is undertaking a commercial Phase 2a Adult ADHD clinical trial evaluating microdoses of LSD. Dr. Kim Kuypers and Dr. Matthias Liechti will serve as principal investigators for the initial clinical trial of this commercial program.

About MindMed

MindMed is a leading 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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As the Focus on Psychedelic Stocks Increases, So Do the Valuations

Published at Real Money

By Debra Borchardt

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Stocks quotes in this article: CMPS, MMEDF, CLXPF, MYCOF, CGC

With so many new IPOs and companies launching in the psychedelic industry it’s important to fully evaluate the major factors of success or failure in the industry. There are various steps that companies take to have a drug approved and to successfully complete them it takes years and tens of millions of dollars. The further ahead a company moves in the approval process, the more valuable the company becomes, and that is why there is so much excitement for Compass Pathways (CMPS) . Institutional and retail investors are in a frenzy to get a position. The company is in Phase 2b and has received a “Breakthrough Therapy” designation from the FDA, meaning that their therapy has the potential to be more effective than available medications.

Currently there are only a handful of companies that have:

  • Access to psychedelic compounds
  • A clear idea of the disorder they are targeting, also known as drug indication
  • Are actively running a clinical trial.

It’s important for investors to be mindful of the stage a company is in and to fully evaluate if a company they are investing in has the potential to be successful.

The only companies that have Phase 2 clinical trials now are Compass Pathways, Mind Medicine (MMEDF) , Cybin Inc. (CLXPF)  , and Mydecine Innovations Group (MYCOF) . Here’s an analysis of these biotech players and we highlight the most undervalued company in the industry.

What is the Drug Discovery Process?

The drug development process being undertaken is to ensure these treatments are safe and effective for consumption.

  1. The drug is investigated and screened tested on animals to prove safety (can be skipped since psilocybin has been proven safe and effective)
  2. Investigational drug application to FDA and Health Canada is submitted that includes, drug composition, formulation and manufacturing process
  3. Clinical Trial Plan including selection of location
  4. Recruitment of volunteers
  5. Analysis of findings and submission
  6. Approved to move to next Phase in larger population

Psychedelic Companies with Phase 2 Trials Valuation Comparison

Biotechnology companies are hard to value as it’s hard to predict success of clinical trials. Biotech companies are unique types of investments that can either pay off handsomely or end with a complete loss of capital. One of the best ways to value a company is by looking at the size of the addressable market and estimating the potential market penetration.

The reason Compass Pathways is leading the charge in psychedelics is they have a drug that is more effective than anything available, has a total addressable market of 16 million adults, and can upend this entire market as a whole.

What key parameters to look for valuing biotech companies?

  1. Experienced Science team
  2. Experienced Management Team
  3. Intellectual property protection
  4. Large addressable market
  5. Potential Market Penetration Possible
  6. Access to patients
  7. Access to active ingredients
  8. Unique R&D Capabilities
  9. Scientific Community Collaborations

Compass Pathways

COMPASS Pathwaysoperates as a mental health care company in the UK and the U.S. It develops COMP360, a psilocybin formulation, which is in Phase IIb clinical trial to treat patients with treatment-resistant depression. The company is currently the most valuable and most well-known company in the industry and has raised over $250 million since its inception.

Current Market Cap: $1.57 Billion

Drug in development: COMP360 Psilocybin for Depression

Indication: Treatment Resistant Depression

Total Addressable Market: $1.12 billion by 2024

Stage: Phase 2B

Location: Multiple sites globally

Mind Medicine Inc.

Mind Medicine, also known as MindMed, is a neuro-pharmaceutical company that discovers, develops and deploys psychedelic inspired medicines to improve health, promote wellness and alleviate suffering. The company’s immediate priority is to address the opioid crisis by developing a non-hallucinogenic version of the psychedelic ibogaine. In addition, the company has established a microdosing division to conduct clinical trials of LSD microdosing for adult ADHD. The company has also added MDMA to its R&D pipeline to explore MDMA’s potential to treat mental health disorders.

Current Market Cap: $977 Million

Drugs in development: LSD for Adult ADHD, LSD for Suicide Headaches, Ibogaine for Addiction

Indication: Various

Total Addressable Market: Unknown but the largest of all studied companies

Stage: Phase 2a

Location: Multiple sites globally

Cybin Inc.

Cybin is a life sciences company advancing psychedelic pharmaceutical treatments for various psychiatric and neurological conditions. Cybin is developing technologies and delivery systems, aiming to improve bioavailability, to potentially achieve the desired medicinal effects of psychedelics at low dosage levels. The new delivery systems are expected to be studied through clinical trials to confirm safety and efficacy.

Current Market Cap: $203 Million

Drug in development: Sublingual Psilocybin Delivery Mechanism for Depression

Indication: Major Depressive Disorder

Total Addressable Market: $5.8 billion by 2025

Stage: Phase 2 A

Location: University of West Indies Jamaica

Mydecine Innovations Group

Mydecine Innovations Group is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing well-being. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.

Mydecine was the first company to offer CGMP naturally sourced psilocybin and recently made history again by making the first legal export of Magic Mushrooms. Mydecine has a big focus on intellectual property and is utilizing genome technology (editing plants like what GW Pharma did in Cannabis) under the leadership of Rob Roscow the ex-Canopy Growth (CGC) head of genetics and at Mydecine’s U.S. and Canadian laboratories. The company now has over 20 kilos of psilocybin mushrooms – most in the industry – and has active ingredients for their trials at a fraction of the cost that Compass Pathways or Cybin ever can with their synthetic drugs.

Current Market Cap: $56 Million

Drug in development: Naturally Sourced Psilocybin

Indication: PTSD

Total Addressable Market: $10.6 B by 2026

Stage: Phase 2 A

Location: Multiple Sites Globally

As illustrated above, by making side by side comparisons of companies that are in Phase 2 trial studies, investors can quickly see the size of the addressable audience and the market cap of the company. This makes it easier to see if there is a stock that might have more room for upside than others. As the focus on psychedelic stocks increases, so do the valuations. There is concern that some company valuations have gotten ahead of themselves and investors may want to take that into consideration before hitting the buy button.

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MindMed Closes Upsized Financing of CAD $92.1m (USD $72.7m) to Meet High Investor Demand

Bolsters Cash on Hand to CAD $183.0m (USD $144.4m)

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

TORONTO, Jan. 7, 2021 /CNW/ — Mind Medicine (MindMed) Inc. (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ) (“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 Underwriters’ over-allotment option (the “Offering”). In connection with the Offering, the Company issued 20,930,000 units of the Company (the “Units”) at a price per Unit of CAD $4.40 (the “Issue Price”) for gross proceeds of approximately CAD $92.1m. The Offering was conducted by Canaccord Genuity Corp. (the “Lead Underwriter”), along with Eight Capital and CIBC Capital Markets (collectively, the “Underwriters”).

As announced on December 14, 2020, MindMed originally entered into an agreement with the Lead Underwriter to raise gross proceeds of CAD $50.0m and agreed to increase the size of the Offering to CAD $80.0m on December 15, 2020 due to outsized investor demand. In connection with the filing of MindMed’s final prospectus on December 31, 2020, CIBC Capital Markets was also added to the offering.

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. Since the founding of Mind Medicine, Inc. in May 2019, MindMed has now raised a total of approximately CAD $237.2m (USD $183.8m) in investment capital before fundraising and deal expenses, making it one of the leaders in the psychedelic medicine industry in its ability to finance its innovative R&D, a new digital therapeutics division and a growing clinical trial pipeline.

MindMed Co-Founder & Co-CEO, J.R. Rahn said “We are extremely pleased to have the continued support of our Lead Underwriter, Canaccord Genuity, as well as Eight Capital and CIBC Capital Markets as syndicate members. Financing is critical to the fast-growing psychedelic medicine industry as we seek to pioneer a new paradigm and therapeutic asset class for the millions suffering from mental illness and addiction globally.”

The Company intends to use the net proceeds of the Offering for investment in its digital medicine division, for further investments in its LSD experiential therapy program for anxiety disorders (“Project Lucy”), its development of a non-hallucinogenic version of the psychedelic substance ibogaine to address the opioid crisis (“Project Layla”), and its LSD micro-dosing trials for adult ADHD, as well as for general working capital and corporate purposes.

Further Details of Offering

In connection with the Offering, the Company issued 20,930,000 Units of the Company at the Issue Price for gross proceeds of approximately CAD $92.1m.

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 $5.75 until January 7, 2024. 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 $9.00 per Subordinate Voting Share for the preceding five 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.WR”, subject to the final approval of the NEO.

Subscriptions by insiders of the Company accounted for approximately $1,320,000 of the gross proceeds of the Offering. Participation by insiders in the Offering is exempt from the valuation and minority shareholder approval requirements of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) by virtue of the exemptions contained in Sections 5.5(a) and 5.7(1)(a) of MI 61-101.

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 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 Neo Exchange Inc. 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.

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.

Media Contact: mindmed@150bond.com

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2020 Was A Year of Historic Firsts That Set the Stage for the Psychedelic Renaissance

Published at Microdose

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The world undoubtedly faced unforeseen challenges last year in the wake of the Coronavirus pandemic. However, we as a society also witnessed psychedelic medicine make unprecedented progress in 2020. From Mydecine’s first psilocybin extraction to Compass Pathways debuting on the NASDAQ, 2020 had no shortage of exciting developments on the psychedelic medicine front. Together, this massive progress has set the stage for the psychedelic renaissance with much more to come in 2021. Here is a list of all the historic firsts that psychedelic medicine had in 2020.

First Psychedelic

Mydecine Innovations Group Completed First Legal Psilocybin Extraction & International Export

The innovative team at Mydecine completed the first legal psilocybin extraction in 2020. They were also the first to export these mushrooms internationally. From the press release:

“[Myedecine 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.”

This historic milestone sets an extraordinary precedent for psilocybin science and psychedelic medicine as a whole.

Mindleap Launches First Psychedelics Focused Telehealth Platform

The psychedelic renaissance is bringing forth an exciting new age of digital therapeutics and telehealth platforms. At the forefront of this movement is Mindleap Health, a subsidiary of the Myedicine group, that launched the world’s first telehealth platform for psychedelic integration.

From the press release:

“Mindleap was founded with the goal of enhancing the wellbeing of millions of people that struggle with mental health problems. By combining traditional telemedicine with mood and behavior analytics, the Mindleap platform offers a powerful set of tools for managing mental healthcare.”

The robust platform allows users to browse vetted and experienced specialists and easily schedule appointments and purchase mental health services.

There are benefits for the healthcare providers too. From the release:

“Specialists on Mindleap benefit from the platform’s full freedom to manage their virtual practice on their terms; setting their own prices and choosing the hours they work each week (with no minimums or maximums).”

As the psychedelic renaissance continues to progress, so will the diverse and robust arena of digital therapeutics. Such progress stands to benefit the entire field of healthcare, a promising thing to look forward to.

Compass Pathways’ Leads the Way as the First Psychedelics Company To IPO on the NASDAQ

Being the first psychedelic company to debut on the NASDAQ is a really big deal, and that’s exactly what the Peter Thiel-backed dynamo, Compass Pathways (ticker: CMPS), managed to do. The team at Compass listed a $100 million dollar IPO for psilocybin-based therapy. With millions of people suffering from depression across the globe, the team at Compass is poised to make a massive impact on mental health treatment with psilocybin therapy. Their debut on the NASDAQ sets a major precedent for psychedelic stocks and the emerging renaissance overall.

Field Trip Launched the First Psychedelics app & Opened Psychedelic-Enhanced Therapy Centers

The progressive team at Field Trip Health launched the first psychedelics app, Trip, that “allows people from anywhere in the world to access tools that support self-exploration and consciousness expansion through meditation, breathwork and more.” In addition to expanding their digital offerings, the progressive team at Field Trip also opened psychedelic-enhanced therapy centers in Canada and the United States. Their most recent center, which currently offers ketamine-assisted psychotherapy, opened up in Chicago, Illinois.

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Mydecine Innovations Group Launched First Ever Psilocybin Clinical Trials with Veterans

Originally based out of Denver, Mydecine (CSE: MYCO) launched the first ever psilocybin-based clinical trials for treatment of war veteran PTSD. Indeed, after buying NeuroPharm Inc. in the summer of 2020, Mydecine went ahead to proceed with these clinical trials. The clinical trials also hoped to treat PTSD among EMS and first responders, and this noble effort reached Phase 2A of the clinical process. Those who have been in space for quite some time will recall that PTSD is usually coupled with subsequent depression and/or substance use disorder – which are also indications which psilocybin may treat effectively.

MindMed Announces First-Ever Clinical Trial Combining MDMA and LSD

You read correctly – Mind Medicine (NEO: MMED), the leading psychedelic pharmaceutical company championed by Shark Tank’s Kevin O’Leary, announced the first ever clinical trial exploring the therapeutic benefits of combining MDMA and LSD. This combination, once dubbed as “candy flipping” in the underground psychedelic scene, is now being explored with clinical prowess for the first time. In the original announcement of this trial, MindMed explained that MDMA may negate the negative effects of LSD (or other classical psychedelics, for that matter). This move is quite genius considering that some of the unpleasant side effects of LSD (e.g., a considerably strange “come up,” subsequent panic, etc.) would be easily replaced by the well-studied euphoria induced by MDMA.

Psychedelic Pioneers at Numinus Team Up With MAPS to Conduct Groundbreaking MDMA-assisted Psychotherapy Trial for PTSD

The psychedelic pioneers at Numinus, one of the best known players in the space, teamed up with with MAPS last year and announced a collaboration agreement regarding an open-label trial of MDMA-assisted psychotherapy for PTSD. The dynamic psychedelic company also completed their first legal psilocybin harvest in October of 2020–another huge first for the team and the psychedelic renaissance overall.

You can learn more about the exciting developments from the Numinus team by checking out this PsyCap recap from their Psychedelic Capital presentation here.

Fireside Project, a San Francisco-based nonprofit organization, is launching a psychedelic peer support hotline — the first of its kind.

Though the news of psychedelic therapy advances is exhilarating and fun to watch, the actual psychedelic therapy sessions are quite challenging. Part of what makes psychedelics such a powerful adjunct to psychotherapy is their ability to bring difficult (but necessary for healing) conversations to the forefront of one’s psyche. Likewise, some can be especially off-put by induced hallucinatory effects. Luckily, the first ever psychedelic peer support hotline will be available to the public in 2021. Launched by Fireside Project, a San Francisco-based non profit, the hotline is meant to walk folks through these challenging and sometimes outright scary psychedelic experiences. This is a huge step up for the harm reduction movement, as psychedelic experiences are most powerful when done safely. The hotline (1-833-2FIRESIDE) is slated to begin April 14, 2021, and run 24/7. What a fantastic contribution to the modern drug user’s arsenal of safe protocols.

UK Company, Small Pharma, Secures Approval for World’s First DMT Clinical Trial

One of the larger firsts this previous year was one felt on an international level – the world’s first regulatory-approved patient clinical trial using N,N-dimethyltryptamine (DMT). Executed by UK neuropharmaceutical company Small Pharma, this announcement debuted Dec. 10, 2020. Like most companies in this space, their focus on psychedelics is in pursuit of alleviating clinical mental health symptoms. DMT has considerably shorter (and more controllable) duration than other psychedelics, which brings about unique therapeutic applications. This is partially why Canadian biotech company Entheon Biomedical is pursuing DMT in treatment of substance use disorder.

Mindmed is the First Psychedelic Company to Go Public & Trade on the NEO Exchange

After a fantastic pre-IPO round for MindMed, featuring the aforementioned Kevin O’Leary and also Bruce Linton (prolific investor and former CEO of Canopy Growth), the company became the first psychedelic organization to go public. Subsequently, MindMed started trading on the NEO exchange under the ticker symbol MMED. The company’s historic pre-IPO round raised a whopping $24 million (of course, we’d later see them reap in significantly more capital). Furthermore, upon being listed on the NEO exchange, MindMed sold over 14 million shares. It is precisely this kind of news that draws in more investors towards emerging psychedelic companies period.

Mindbloom is the First Company to do an “At Home” Virtual Ketamine Treatment

Amid a horrific heightening of the COVID-19 pandemic, NY-based mental health company MindBloom offered remote-enabled ketamine therapy to struggling homebound individuals. This is an especially important service for two reasons: first, the mental health crisis increased amongst U.S. citizens once social distancing (e.g., stay at home orders, consequential closing of workplaces) was implemented. Folks were stuck at home, and because of this, existing mental health symptoms were exacerbated which were otherwise regulated by a change of scenery and the comfort of in-person relationships. MindBloom’s ketamine therapy sessions helped such individuals. Second, existing in person mental health care facilities were no longer ethically able to have patients come in. Some of this nation’s most depressed members deeply depended on the care of a mental health professional, and in the face of losing that care, MindBloom provided a safe virtual alternative.

The Conscious Fund Launched the World’s First Psychedelic Job Board

Time and time again, the psychedelic community may subconsciously take the lesser discussed roles of psychedelic medicine for granted. Indeed, headlines consistently remind us of mover-shaker CEOs and investors in the space, but likewise, the industry runs thanks to the therapists, project managers, media associates and other employees of psychedelic medicine. The Conscious Fund (the leading global early-stage venture fund for psychedelics) helped many fulfill these roles in the summer of 2020, when they launched the world’s first psychedelic industry job board. The premise and usefulness of this job board is summarized perfectly in their initial announcement of the job board:

“Even with a global downturn, the psychedelic medicine industry is booming and creating an entirely new range of exciting opportunities and career paths across roles in science, manufacturing, finance, operations, and professional services. However, despite this exciting growth, we noticed there was an information gap between professionals looking to enter the space and companies looking to access global talent. We decided to fix that.”

The DPV Launched the World’s First Psychedelic Video Museum

Cleverly announced on April 16, the day Albert Hoffman first accidentally tripped on LSD, The Daily Psychedelic Video announced their launch of the world’s first psychedelic video museum. For those who missed it, Daily Psychedelic Video (DPV) has spent the last decade making and posting fantastic psychedelic visuals for the public to enjoy. They doubled down on this and created a psychedelic video museum, featuring 700 DPV videos and 45 different themed exhibits (e.g., sixties psychedelia, psychedelic activism, psychedelic hip hop, etc.). Readers are encouraged to check out the DPV museum ASAP, for it truly represents our juncture in time – the intersection of technology and psychedelia.

The University of Aukland Launched the World’s First Randomized Controlled Clinical Trial of LSD Microdosing

Despite the growing interest and positive testimonies regarding microdosing worldwide, the law still makes it quite difficult to study microdosing’s efficacy. But in 2020, the University of Aukland launched the world’s first randomized and controlled clinical trial pertaining to microdosed LSD. The trial involved 40 male volunteers who agreed to take sub psychedelic LSD dosage “every fourth morning” of their daily schedule. We ought to say thank you to psychedelic academic figures like Dr. Suresh Muthukumaraswamy for pioneering such studies, especially in New Zealand, where the drug has spent many decades as a strongly prohibited substance.

A Scientific First: How Psychedelics Bind to Key Brain Cell Receptor

For the first time, scientists solved the high-resolution structure of these compounds when they are actively bound to the 5-HT2A serotonin receptor on the surface of brain cells. This discovery is already leading to the exploration of more precise compounds that could eliminate hallucinations but still have strong therapeutic effects. Psilocybin – the psychedelic compound in mushrooms – has already been granted breakthrough status by the FDA to treat depression.

Oregon is First State to Legalize Psilocybin

Those who didn’t keep up with psychedelic industry news certainly heard about the following 2020 groundbreaking moment, as it pertains to cognitive liberty more broadly, and came at a time of high political tension. On Nov. 3, Oregon passed measure 109 – a legislative measure that legalized psilocybin for therapeutic application. Likewise, this news was coupled with the passing of measure 110, which decriminalized small possession of all drugs in general. Taken together, this news shows a remarkably progressive attitude towards drugs and drug usage in Oregon, and we can only hope the rest of the world follows suit.

First Psychedelic

A Terrific Way to Enter 2021

The psychedelic medicine renaissance triumphed above what many have called the worst closer to a decade in modern history. Beyond public health obstacles, the industry overcame financial downfall, which is evident by some of these aforementioned “firsts.” Equally important, 2020 set the stage clinically, which means this well funded machine can now explore even more neuro-based treatments for trauma, addiction, depression, and other psychological issues plaguing society. We look forward to covering all the victories to come in the new year and would like to thank the people who made this previous year possible.

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MindMed Files Final Prospectus In Connection With Bought Deal Equity Financing

FINANCING TO SUPPORT THE DEVELOPMENT OF MINDMED’S DIGITAL MEDICINE DIVISION AND PSYCHEDELIC INSPIRED MEDICINES AND EXPERIENTIAL THERAPIES

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

TORONTO, Jan. 4, 2021 /CNW/ — Mind Medicine (MindMed) Inc. (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ) (“MindMed” or the “Company“) is pleased to announce that further to its previously announced offering (the “Offering“), it has filed a final short form prospectus (the “Prospectus“) with the securities commissions or similar authorities in each province of Canada, other than Québec. Pursuant to the amended and restated underwriting agreement among the Company, Canaccord Genuity Corp. (the “Lead Underwriter“), Eight Capital (“Eight“) and CIBC Capital Markets (together with the Lead Underwriter and Eight, the “Underwriters“), the Underwriters have agreed to purchase 18,200,000 units of the Company (the “Units“), on a “bought deal” basis, at a price per Unit of CAD$4.40 (the “Issue Price“) for gross proceeds of CAD$80,080,000.

The Company 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 CAD$12,012,000 will be raised pursuant to the Offering and the aggregate proceeds of the Offering will be CAD$92,092,000.

Each Unit will be comprised of one subordinate voting share of the Company (each, a “Subordinate Voting Share“) and one-half of one Subordinate Voting Share purchase warrant (each whole warrant, a “Warrant“). Each Warrant shall entitle the holder thereof to purchase one Subordinate Voting Share at an exercise price of CAD$5.75, for a period of 36 months following the closing of the Offering. 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$9.00 per Subordinate Voting Share for the preceding five 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 Company intends to use the net proceeds of the Offering for investment in its digital medicine division, for further investments in its LSD experiential therapy program for anxiety disorders (“Project Lucy“), its development of a non-hallucinogenic version of the psychedelic ibogaine to address the opioid crisis (“Project Layla“), and its LSD micro-dosing trials for adult ADHD, as well as for general working capital and corporate purposes.

The Offering is scheduled to close on or about January 7, 2021 and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals.

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.

The Prospectus containing important information relating to these securities has been filed with securities commissions or similar authorities in each province of Canada, other than Québec and may be subject to amendment. A copy of the Prospectus can be obtained under the Company’s corporate profile on SEDAR at www.sedar.com.

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 Neo Exchange Inc. 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.

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.

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The Year In Review For Psychedelic Drug Stocks: 2020

Published at PsychedelicStockWatch.com.

By Jeff Nielson

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In 2020, the psychedelic drug industry burst onto the radar of investors. As psychedelic drug research exploded and new capital has flooded into this sector, a vibrant core of public companies has commenced trading.

Still other pubcos have either added a psychedelics component to their business model or simply rebranded the entire company. Psychedelic drugs became the most important story in life sciences in 2020.

As investors look ahead to 2021, Psychedelic Stock Watch is looking back. We have prepared a 2020 Report Card for the psychedelic drug industry, measuring its development in 5 key categories.

Here is the Psychedelic Stock Watch 2020 review.

Stock performance:  A

After a subdued summer for psychedelic stocks, the industry caught fire in September with the Compass Pathways IPO. A new NASDAQ listing and the nearly $150 million raised by Compass for its IPO financing provided an instant credibility boost for these new public companies.

See: Compass Pathways Files For NASDAQ Listing: Psychedelics Game-Changer

Several stocks went vertical. Investors who got in early had a number of multi-bagger opportunities.

The Compass IPO was the initial catalyst driving this rally. But fueling upward momentum was a rapid-fire series of new financings that injected ~$500 million into the sector – in just the last 3 ½ months of 2020.

Raising capital:  A+

Drug development is expensive. Taking a single drug through the clinical trials process can cost in excess of $100 million – and consume several years of time.

Even building and operating a network of psychedelics-assisted treatment clinics requires robust infusions of capital. As the psychedelic drug industry was getting off the ground, many investors were justifiably skeptical as to whether the industry could attract sufficient capital.

As we reach the end of 2020, those doubts have evaporated.

We’ve seen companies (public and private) close on several nine-figure financings.

We saw one company (MindMed) go to capital markets with new offerings three times in just the last quarter. Each financing was at a dramatically higher unit price (CAD$1.05 –> CAD$1.90 –> CAD$4.40) and each one was oversubscribed.

Indeed, virtually every new psychedelics private placement in the fourth quarter was oversubscribed, as institutions and high net-worth investors engaged in a feeding frenzy.

Psychedelic drug R&D:  A

Psychedelic Stock Watch is assigning the industry an “A” for its progress in psychedelic drug R&D in 2020. But many readers may see even that high grade as being too low.

As we end the year, one psychedelic drug clinical trial is moving into (final) Phase 3 testing. MAPS’ MDMA-assisted psychotherapy for the treatment of PTSD has commenced this stage of the clinical trials process – with early indications strongly pointing toward a successful result.

Based on earlier promising results (and an urgent need), the FDA has granted Breakthrough Therapy Designation to this research, further streamlining the clinical trial process.

Numerous other psychedelics-based clinical trials are at various stages of a Phase 2 trial.

Among the public companies beginning or engaged in Phase 2 clinical trials involving psychedelics are: Compass Pathways, MindMed Inc, Cybin Corp, and Mydecine Innovations Group. Indeed, MindMed itself has three drug R&D initiatives in or beginning Phase 2 trials.

Of equal importance are the clinical results emerging from these drug trials.

Compass Pathways’ Phase 2 clinical trial for treatment-resistant depression has also received Breakthrough Therapy Designation, due to the strong results from its own research.

We are currently in the midst of a Mental Health Crisis, with stress-related disorders like depression, addiction, anxiety and PTSD afflicting over 1 billion people globally. Much of the reason why this has become a crisis is the appalling standard of care for many of these conditions.

Addiction therapy is a revolving-door failure. Rehab, release, relapse, repeat.

Front-line drugs to treat depression (antidepressants) are dangerous and addictive. And their efficacy is little better than that of sugar pills. Roughly two-thirds of Americans exhibiting symptoms of depression don’t even seek treatment.

Meanwhile, clinical testing on psychedelics-based therapies is consistently yielding spectacular success rates for addiction, depression and PTSD.

MAPS’ MDMA-assisted psychotherapy for PTSD has been generating positive results for ~90% of patients being treated. Conversely, roughly two-thirds of U.S. veterans being treated for PTSD by the Department of Defense express dissatisfaction with the current standard of care.

The Department of Defense has become a major booster of psychedelic drug research – and has itself contributed $10s of millions for research funding.

Why no “A+” for psychedelic drug R&D in 2020?

One simple reason: no psychedelic drug completed the clinical trial process in 2020. But we could easily see this occur in 2021 – earning the sector an even higher letter-grade next year.

Media/public opinion: A+

Most psychedelic drugs are illegal, and have been strictly prohibited for ~50 years. Through nearly all of this time, the mainstream media has demonized any/all usage of these substances.

Why are we reminding readers of these facts?

Because if we look around today at public attitudes and what is being written in the media about these drugs, visitors from a distant planet would never guess that these drugs are still (mostly) illegal.

In the medical community, a Renaissance has taken place regarding psychedelics-based research. A long-and-growing list of physicians are banging the drum for the medicinal potential of these drugs – including many of the brightest minds in medicine.

See: The Psychedelics Revolution: It’s No Longer BAD To Feel GOOD

Among the general public, there are two parallel tracks of interest that are both seeing exponential increases in support:

  • Gaining access to psychedelic medicines to elevate the standard of care for many mental health disorders.
  • “Biohacking” with these substances (generally via microdosing) as a new health-and-wellness trend to significantly improve quality of life and/or career performance.

Despite 50 years of anti-psychedelics propaganda (by government and media) fears/phobias toward these drugs are rapidly dissipating.

Most surprising, however, has been the change in media attitudes and coverage of psychedelic drugs.

The anti-drug propaganda is gone. It has been replaced by in-depth, fact-based coverage of psychedelics and psychedelic drug R&D, with mainstream media coverage universally positive.

Psilocybin Sessions: Psychedelics could help people with addiction and anxiety (CBS News, August 2020)

We can no longer ignore the potential of psychedelic drugs to treat depression (The Guardian, June 2020)

Psychedelic Drugs Like LSD and Magic Mushrooms Linked to Transformative Experiences, Feeling Connected With Others (Newsweek, January 2020)

The mainstream media still regularly smears the (legal) cannabis industry with archaic propaganda that has been completely discredited. But these same large corporations have turned over the proverbial “new leaf” when it comes to how they cover psychedelic drugs.

In turn, the consistently positive optics being projected on psychedelics by the media can only have a beneficial effect on political and regulatory attitudes toward psychedelic drugs.

Regulatory thaw:  B

In 2020, the psychedelic drug industry has addressed – and essentially eliminated – investor doubts in several key areas. When it comes to stock performance, capital raising, drug R&D and public opinion, the psychedelic drug industry couldn’t look any stronger as 2020 comes to a close.

Yet one area of doubt remains: the decriminalization/legalization of these substances and subsequently creating a regulatory framework for these emerging drugs.

Considerable progress has been made this year.

Several U.S. cities have decriminalized psychedelic drugs. In the recent U.S. election, the state of Oregon not only broadly decriminalized psychedelic drugs, it has legalized psilocybin for medicinal use.

In Canada, progress began a little later but is moving even faster – much like we saw with cannabis legalization.

It started at the beginning of August, when Health Canada granted “medical exemptions” to allow medicinal psilocybin use for four terminally-ill patients.

Subsequently, Health Canada has expanded these medical exemptions for psilocybin use for patients. More importantly, it has granted several psychedelics therapists permission to personally use these substances to help refine treatment.

In the space of a few months, Health Canada has gone from being cautiously receptive toward the medicinal use of psilocybin to moving clearly and methodically to broaden medicinal usage in Canada.

One observer with a strong interest in these developments is Doug Drysdale, CEO of Cybin Corp. Cybin is one of the public companies that is well-advanced into formal clinical trials with its psilocybin-based R&D.

Drysdale estimates that psilocybin-based therapies will start to be approved (as they emerge from these clinical trials) in roughly a two-year time frame. And he sees psilocybin legalization (at least in Canada) as a real possibility over the same time-horizon.

While the psychedelic drug industry earns a solid “B” for regulatory progress in 2020, the sector is still at the beginning of a long road.

Better days ahead for psychedelic stocks

As good as 2020 was for the psychedelic drug industry, expectations for 2021 are even higher. The half-billion in fresh capital that was raised in roughly the last quarter of 2020 is sufficient to drive plenty of growth in this industry in the first half of 2021.

Major industry catalysts loom for early 2021.

More companies will be going public. New investment capital will continue to flood into the industry. Regulatory progress should accelerate. And several psychedelic drugs should get much closer to the drug approval finish line in 2021.

Also, two dimensions of the industry that were just starting to gain prominence in 2020 will be squarely in the spotlight for investors in 2021.

DISCLOSURE: The writer holds shares in MindMed Inc, Numinus Wellness, Cybin Corp and Mind Cure Health. Mind Cure Health is a client of Psychedelic Stock Watch.

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MindMed Files Preliminary Prospectus In Connection With Bought Deal Equity Financing

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

TORONTO, Dec. 21, 2020 /CNW/ — Mind Medicine (MindMed) Inc. (NEO: MMED) (OTCQB: MMEDF) (DE: MMQ) (“MindMed” or the “Company“) is pleased to announce that further to its previously announced offering (the “Offering“) on December 14 and December 15, 2020, it has filed a preliminary short form prospectus (the “Preliminary Prospectus“) with the securities commissions or similar authorities in each province of Canada, other than Québec. Pursuant to the underwriting agreement among the Company, Canaccord Genuity Corp. (the “Lead Underwriter“) and Eight Capital (together with the Lead Underwriter, the “Underwriters“), the Underwriters have agreed to purchase 18,200,000 units of the Company (the “Units“), on a “bought deal” basis, at a price per Unit of CAD$4.40 (the “Issue Price“) for gross proceeds of CAD$80,080,000.

The Company 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 CAD$12,012,000 will be raised pursuant to the Offering and the aggregate proceeds of the Offering will be approximately CAD$92,092,000.

Each Unit will be comprised of 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 shall entitle the holder thereof to purchase one Subordinate Voting Share at an exercise price of CAD$5.75, for a period of 36 months following the closing of the Offering. 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 $9.00 per Subordinate Voting Share for the preceding 5 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 Company intends to use the net proceeds of the Offering for investment in its digital medicine division, for further investments in its experiential therapy program for anxiety disorders (“Project Lucy“), its development of a non-hallucinogenic version of the psychedelic ibogaine to address the opioid crisis (“Project Layla“), and its LSD micro-dosing trials for adult ADHD, as well as for general working capital and corporate purposes.

The Offering is scheduled to close on or about January 5, 2020 and is subject to certain conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the Neo Exchange Inc. and the applicable securities regulatory authorities.

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.

The Preliminary Prospectus containing important information relating to these securities has been filed with securities commissions or similar authorities in each province of Canada, other than Québec. The Preliminary Prospectus is still subject to completion or amendment. A copy of the Preliminary Prospectus can be obtained under the Company’s corporate profile on SEDAR at www.sedar.com. There will not be any sale or any acceptance of an offer to buy the securities until a receipt for the final short form prospectus has been issued.

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 Neo Exchange Inc. 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.

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.

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2020: A Year In Review for the Psychedelic Renaissance

Published at Microdose.com.

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By Gaurav Dubey

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2020 has indeed brought forth unforeseen challenges into the world due to the global coronavirus pandemic. However, this year has also seen monumental victories for psychedelic medicine–a radical new hope for a brighter future. The current state of mental healthcare, which has been starkly exposed due to the pandemic, is seriously insufficient.There is a significant need for new and better mental health treatments now more than ever before.

Fortunately, between the groundbreaking clinical research into psychedelic medicine at leading universities and institutions and the incredible amount of capital flowing into the space, one thing is clear: psychedelics are making a massive comeback. Here are some of the major highlights and victories witnessed by the psychedelic renaissance in this otherwise challenging year.

psychedelic renaissance research development science
psychedelic renaissance research development science
psychedelic renaissance research development science

Groundbreaking Research Into Psychedelic Medicine Pushes Policy Reform Ahead

2020 Has Been A Really Big Year for Magic Mushrooms

Robust clinical research has been the backbone of the modern psychedelic renaissance, and 2020 certainly had its share of exciting developments here. Leading institutions such as Johns Hopkins, NYU and the Imperial College of London have conducted historic trials demonstrating the efficacy of drugs like psilocybin, the active ingredient in magic mushrooms, for end-of-life anxiety and severe treatment resistant depression.

Fascinating research by renowned scientists like Robin Carhart Harris utilizes fMRI technology to uncover the mysterious mechanisms in the brain that characterize the beneficial effects of psilocybin therapy. The below diagram by Carhart-Harris shows increased brain connectivity and communication while under the influence of magic mushrooms and has become a hallmark of psychedelic science in 2020.

this is your brain on mushrooms robin carhart harris psilocybin brain connectivity

Communication between brain networks in people given psilocybin (right) or a non-psychedelic compound (left).

The dynamic group at Mydecine, which includes Carhart-Harris and Dr. Rakesh Jetly, are also spearheading trials investigating psilocybin for PTSD in veterans. Their recent speaker series featured their all-star science team and explored many of these important topics.

Such trials have been so profound that earlier this year, Canada’s Health Minister Patty Hajdu, in response to Therapsil’s advocacy efforts, approved the first four Canadian’s for psilocybin assisted psychotherapy. This has since been expanded to include non-terminally ill Canadian patients–-a genuine testament of Hajdu’s dedication to progressive drug policy. Canada isn’t the only one embracing psychedelics, however.

The state of Oregon recently made history by legalizing psilocybin assisted psychotherapy and decriminalizing small amounts of all drugs. This is a huge move by Oregon that sets a strong precedent for other states in the US who also wish to embrace and reintegrate psychedelics into society.

psychedelic renaissance research development science

MAPS Successful Trials Mean MDMA Assisted Psychotherapy is on the Horizon

The Multidisciplinary Association of Psychedelic Studies, also known as MAPS, have spearheaded trials investigating MDMA-assisted psychotherapy for PTSD with remarkable success. After raising $30 million in non-profit donations for these trials, they are now currently in phase 3 trials and have paired with the team at Numinus to help bring the treatment to market. Their partnership with Numinus aims to expand upon the phase 3 trials going on in the US by conducting trials in Canada if they gain approval. MDMA has now received “breakthrough therapy” status by the FDA, allowing its trials to be expedited. In a time where traditional mental health treatments are failing, this is hugely significant. As this important data continues to pour out of the world’s top research institutions, drug policy is expected to continue to align with science and data.

psychedelic renaissance research development science

Great Minds Connected Despite Lockdowns to Share Big Ideas

While the lockdown may have kept us indoors, that didn’t stop the psychedelic community from virtually connecting and sharing big ideas. In fact, Microdose, in conjunction with The Conscious Fund, hosted the world’s largest virtual psychedelic conference in April, shortly after lockdowns began. The Microdose team carried this momentum into future events, including their monthly Psychedelic Capital conference series and their insightful molecular masterclasses, such as The Ketamine Conference and The Mushroom Conference.

By convening the most influential voices in the field of psychedelic medicine, Microdose helps foster communication and creativity in this emerging space. Event sponsors included major players in the space, including MagicMed Industries, Psygen, The Wake Network and many more.

Despite global lockdowns preventing live conferences, the psychedelic community took the internet by storm to share ideas and spark important conversations. Indeed, the public is becoming increasingly interested in the promise of these powerful medicines. Additionally, investor interest is at an all time high, with major financings and deals in the sector.

psychedelic renaissance research development science

Psychedelics Are Winning Big With Major Players Drawing Serious Investment Interest

Money tends to follow efficacy in biotech and pharmaceutical investing, and psychedelics have certainly exhibited incredible efficacy. Indeed, 2020 has witnessed several companies IPO, crazy stock surges and some major financings. In fact, in just the last week, psychedelic company MindMed upsized to an $80 million bought deal, MagicMed Industries closed an upsized $8.1 million dollar deal, and Tryp Therapeutics has launched their IPO and are now trading on the Canadian Stock Exchange (CSE: TRYP).

Billionaire Peter Thiel-backed psychedelic pioneers, Compass Pathways (NASDAQ: CMPS), were the first psychedelic company to debut on the NASDAQ this year. They are certainly leaders in the space and have helped establish a powerful precedent for psychedelic medicine. Additionally, their immense commitment to research is a powerful indicator of their teams success.

All signs certainly point towards a bright and lucrative future for psychedelic medicine and the companies leading the charge.

psychedelic renaissance research development science

Celebrating and Thanking the Forerunners of Psychedelic Medicine

2020 has seen an enormous amount of headlines, clinical breakthroughs, and financial successes within the psychedelic medicine field. Likewise, this year has seen a dramatic increase in event attendees, investor capital, and general indicators of mainstream curiosity. That being said, we ought to enter the new year in gratitude for those who positioned us to have these conversations. Thank you to Imperial College London, John Hopkins, NYU, Drug Science, and all the other organizations who fought this decade-plus uphill battle for us. Thank you Matthew W. Johnson, Rolland R. Griffiths, David Mokler, Robin Carhart Harris, and all the researchers dedicating their lives to understanding the gnosis of these compounds. Let’s end this year and begin the new one with an emphasis on the working class, corporate social responsibility, and evidence-based exploration of psychoactive drugs.

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