TORONTO, March 22, 2021 /CNW/ – Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company“) is pleased to announce that in connection with its previously announced bought deal public offering, the Company and Canaccord Genuity Corp., as sole bookrunner and lead underwriter (the “Lead Underwriter“), on behalf of a syndicate of underwriters (together with the Lead Underwriter, the “Underwriters“), have agreed to increase the size of the offering. The Company will now issue an aggregate of 10,000,000 units of the Company (each, a “Unit“) at a price of $0.75 per Unit (the “Issue Price“) for aggregate gross proceeds to the Company of $7,500,000 (the “Offering“).
Each Unit shall consist of one common share in the capital of Mindset (each, a “Common Share“) and one Common Share purchase warrant of Mindset (each, a “Warrant“). Each Warrant shall entitle the holder thereof to acquire one Common Share at an exercise price of $1.10 per Common Share for a period of thirty-six (36) months from the Closing Date (as defined herein).
The Company has granted the Underwriters an option (the “Over-Allotment Option“) to purchase up to an additional 1,500,000 Units (the “Over-Allotment Units“) at the Issue Price, to cover over-allotments, if any, and for market stabilization purposes. The Over-Allotment Option is exercisable at any time, in whole or in part, for a period of thirty (30) days after and including the Closing Date (as defined herein), which, if exercised in full, would result in additional gross proceeds of $1,125,000 to the Company.
As consideration for their services to be provided in connection with the Offering, the Underwriters will receive a cash commission equal to 7.0% of the gross proceeds of the Offering and such number of broker warrants of the Company (the “Underwriters’ Warrants“) as is equal to 7.0% of the number of Units sold pursuant to the Offering. Each Underwriters’ Warrant shall entitle the holder thereof to acquire one Unit at the Issue Price for a period of thirty-six (36) months from the Closing Date (as defined herein).
The Units (including the Over-Allotment Units issuable upon exercise of the Over-Allotment Option) will be offered by way of a short form prospectus to be filed in all Provinces of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions. The Offering is expected to close on or about April 8, 2021 (the “Closing Date“), and is subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and other approvals, including the approval of the Canadian Securities Exchange and the applicable regulatory authorities.
The net proceeds of the Offering will be used for the expansion of Mindset’s current pipeline of propriety compounds, further pre-clinical testing of its current compounds, advancement of Mindset’s psilocybin synthesis process, formulation development chemistry and for general working capital purposes.
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 Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin along with its own proprietary compounds. www.mindsetpharma.com
Forward-Looking Information
This news release contains statements and information that, to the extent that they are not historical fact, may constitute “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information is typically, but not always, identified by the use of words such as “will”, “intends”, “scheduled”, “to be” and “may be” and similar words, including negatives thereof, or other similar expressions concerning matters that are not historical facts. Forward-looking information in this news release includes, but is not limited to, statements regarding: the filing of the short form prospectus in each of the provinces of Canada (except Québec); the completion of the Offering, the intended use of the net proceeds therefrom, and the anticipated closing date thereof; that the Units may be offered in jurisdictions outside of Canada. Such forward-looking information is based on various assumptions and factors that may prove to be incorrect, including, but not limited to, factors and assumptions with respect to: the ability of the Company to complete the Offering on acceptable terms or at all; the receipt of all necessary regulatory and other approvals or consents; the ability of the Company to successfully implement its strategic plans and initiatives and whether such strategic plans and initiatives will yield the expected benefits; approvals and authorizations from regulatory authorities, and the timing thereof. Although the Company believes that the assumptions and factors on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that it will prove to be correct or that any of the events anticipated by such forward-looking information will transpire or occur, or if any of them do so, what benefits the Company will derive there from. Actual results could differ materially from those currently anticipated due to a number of factors and risks including, but not limited to: conditions in the psychedelic pharmaceutical industry; fluctuations in market conditions, including in securities markets; economic factors; the risk that the Offering will not be completed as anticipated or at all, including the risk that the Company will not receive the approvals necessary in connection with the Offering; the ability of management to execute its business strategy, objectives and plans; and the impact of general economic conditions and the COVID-19 pandemic in Canada. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
TORONTO, March 22, 2021 /CNW/ – Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company“) is pleased to announce that it has entered into an agreement with Canaccord Genuity Corp., as sole bookrunner and lead underwriter (the “Lead Underwriter“) pursuant to which the Lead Underwriter has agreed, on behalf of a syndicate of underwriters (together with the Lead Underwriter, the “Underwriters“), to purchase, on a “bought deal” basis pursuant to the filing of a short form prospectus, an aggregate of 6,670,000 units of the Company (each, a “Unit“) at a price of $0.75 per Unit (the “Issue Price“) for aggregate gross proceeds to the Company of $5,002,500 (the “Offering“).
Each Unit shall consist of one common share in the capital of Mindset (each, a “Common Share“) and one Common Share purchase warrant of Mindset (each, a “Warrant“). Each Warrant shall entitle the holder thereof to acquire one Common Share at an exercise price of $1.10 per Common Share for a period of thirty-six (36) months from the Closing Date (as defined herein).
The Company has granted the Underwriters an option (the “Over-Allotment Option“) to purchase up to an additional 1,000,500 Units (the “Over-Allotment Units“) at the Issue Price, to cover over-allotments, if any, and for market stabilization purposes. The Over-Allotment Option is exercisable at any time, in whole or in part, for a period of thirty (30) days after and including the Closing Date (as defined herein), which, if exercised in full, would result in additional gross proceeds of $750,375 to the Company.
As consideration for their services to be provided in connection with the Offering, the Underwriters will receive a cash commission equal to 7.0% of the gross proceeds of the Offering and such number of broker warrants of the Company (the “Underwriters’ Warrants“) as is equal to 7.0% of the number of Units sold pursuant to the Offering. Each Underwriters’ Warrant shall entitle the holder thereof to acquire one Unit at the Issue Price for a period of thirty-six (36) months from the Closing Date (as defined herein).
The Units (including the Over-Allotment Units issuable upon exercise of the Over-Allotment Option) will be offered by way of a short form prospectus to be filed in all Provinces of Canada, except Quebec, pursuant to National Instrument 44-101 – Short Form Prospectus Distributions. The Offering is expected to close on or about April 8, 2021 (the “Closing Date“), and is subject to certain conditions including, but not limited to, the receipt of all necessary regulatory and other approvals, including the approval of the Canadian Securities Exchange and the applicable regulatory authorities.
The net proceeds of the Offering will be used for the expansion of Mindset’s current pipeline of propriety compounds, further pre-clinical testing of its current compounds, advancement of Mindset’s psilocybin synthesis process, formulation development chemistry and for general working capital purposes.
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 Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin along with its own proprietary compounds. www.mindsetpharma.com
Forward-Looking Information
This news release contains statements and information that, to the extent that they are not historical fact, may constitute “forward-looking information” within the meaning of applicable securities legislation. Forward-looking information is typically, but not always, identified by the use of words such as “will”, “intends”, “scheduled”, “to be” and “may be” and similar words, including negatives thereof, or other similar expressions concerning matters that are not historical facts. Forward-looking information in this news release includes, but is not limited to, statements regarding: the filing of the short form prospectus in each of the provinces of Canada (except Québec); the completion of the Offering, the intended use of the net proceeds therefrom, and the anticipated closing date thereof; that the Units may be offered in jurisdictions outside of Canada. Such forward-looking information is based on various assumptions and factors that may prove to be incorrect, including, but not limited to, factors and assumptions with respect to: the ability of the Company to complete the Offering on acceptable terms or at all; the receipt of all necessary regulatory and other approvals or consents; the ability of the Company to successfully implement its strategic plans and initiatives and whether such strategic plans and initiatives will yield the expected benefits; approvals and authorizations from regulatory authorities, and the timing thereof. Although the Company believes that the assumptions and factors on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that it will prove to be correct or that any of the events anticipated by such forward-looking information will transpire or occur, or if any of them do so, what benefits the Company will derive there from. Actual results could differ materially from those currently anticipated due to a number of factors and risks including, but not limited to: conditions in the psychedelic pharmaceutical industry; fluctuations in market conditions, including in securities markets; economic factors; the risk that the Offering will not be completed as anticipated or at all, including the risk that the Company will not receive the approvals necessary in connection with the Offering; the ability of management to execute its business strategy, objectives and plans; and the impact of general economic conditions and the COVID-19 pandemic in Canada. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FRA:0NFA) Continues to Advance Research & Development Initiatives in the Field of Natural Medicines
Prior to his monumental comeback at the age of 54, former World Heavyweight Boxing Champion Mike Tyson was delivered a message from a frog.
More precisely, he received the message from a psychedelic sourced from the venomous Colorado River Toad, also known as the Sonoran Desert Toad, known as 5-MeO-DMT (aka “5-MeO” or “frog venom”).
“I took the [5-MeO-DMT] and the medicine told me to get into shape,” Tyson said to USA Today.[1] “It really blew my mind. It told me to come back and start getting in shape.”
With the help of the psychedelic, Tyson lost more than 100 pounds for a major exhibition bout against Roy Jones Jr.—his first fight in 15 years.
Said to be more transcendent and less visual than its plant-based cousin DMT, 5-MeO-DMT can be a stronger experience for some.
Most 5-MeO trips are kept to under an hour, and require far smaller dose sizes than other psychedelics.
But even more impressive is the fast-acting psychedelic’s potential, which researchers at Johns Hopkins have discovered can bring about improvements in depression and anxiety.[2]
The potential for psychedelics to treat mental health issues is truly on the precipice of a major breakout—especially as acceptance of this once taboo form of treatment begins to make its way into mainstream medicine conversations.
Tyson is not alone, being among elite athletes who have looked to psychedelics to turn their life around.
Former Los Angeles Lakers star Lamar Odom successfully used the psychedelic drugs ketamine and ibogaine to combat his drug addiction[3]—crediting the drugs with saving his life.
There are other success stories, including those of NHL Enforcers Riley Cote[4] and Daniel Carcillo,[5] former NFL player Kerry Rhodes,[6] and former UFC MMA Fighters Ian McCall[7] and Dean Lister,[8] utilizing previously taboo treatments such as ayahuasca, ketamine, ibogaine, psilocybin, MDMA, and now 5-MeO-DMT.
Now these treatments are shifting from anecdotal to potential alternative medicinal reality, with the advent of clinical trials being advanced by some of the world’s top psychedelic and mental health professionals, including doctors, scientists, and molecular researchers.
Some analysts are projecting the psychedelics medicine industry to reach $6.85 billion by 2027.[9] As psychedelic companies gain acceptance within the investment community, there is an opportunity to review these companies in a new light.
Recently, a new psychedelics ETF began trading in January, and others are emerging to meet the demand, with two surpassing the US$1 billion market cap threshold.
Highlighted within this group of psychedelic companies is one company underpinned by thought leaders in medicine and science, warranting further due diligence and review: Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).
The company recently announced and closed a bought deal financing of C$17.25 million, announced uplisting to the NASDAQ, and was just included in the inaugural psychedelics-inspired ETF.
With several clinical trials announced in 2020 and early 2021, including involvement with the first lab-based study co-sponsored by the National Institute for Health Research at Imperial College of London, and a Phase 2A clinical study on PTSD in veterans, EMS, and front-line workers, Mydecine continues to approach research and development with cautious optimism as their programs develop.
7 Reasons Why We’re Watching Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA)
World-Renowned Medical and Scientific Advisory is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems.
Exclusive Access to a Full cGMP Certified Pharmaceutical Manufacturing Facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada.
Operates Out of a State-of-the-Art Mycology Lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms
Seven Patent Pending Applications That Represent Thousands of Inventions with multiple layers of protection on the company’s proprietary medical development pipeline.
Proprietary Digital Health Platform, Mindleap, allows Mydecine to generate revenue in the fast-growing US$41.4 billion telemedicine market
Numerous Clinical Trials are currently underway, including a Phase 2A clinical trial on PTSD in Veterans, EMS, and Front Line Workers, a First-of-its-Kind Microdose Study, and Preclinical Animal Work for a Late-State Addiction Study aiming at a Mechanistic Understanding of Psilocybin.
Numerous Novel Next Generation Drugs Under Development:Mydecine is currently developing numerous novel next generation drugs for the treatment of various indications to improve upon the first generation of psychedelic medicines
Combatting the Mental Health Crisis with Psychedelics
COVID-19 is taking its toll on all of us, including rising deaths of despair[10] and an urgent mental health crisis among health workers.[11]
A recent study that screened 402 survivors of COVID-19 found that 55% presented a clinical score for at least one mental disorder, including anxiety (42%), insomnia (40%), depression (31%), PTSD (28%), and OCD (20%).[12]
Anxiety disorders are the most common mental illness in the US, affecting 40 million adults—or 18.1% of the population every year.[13]
Sadly, only 36.9% of those suffering receive treatment, and MORE THAN HALF of people who take antidepressants never get relief.[14]
In cases of Veterans with PTSD, several patients are put on SSRIs, however, only 20-30% of patients achieve complete remission.[15]
SOMETHING needs to change.
Thankfully, we’re witnessing what’s being deemed a “Paradigm Shift in Psychiatric Research and Development.”[16]
That paradigm shift is coming from PSYCHEDELICS.
Now, we’re seeing mainstream coverage being given to the novel mental health approach on 60 Minutes,[17]Forbes,[18]Fox Business,[19]NPR,[20] and Today.[21]
A new wave of mental health sufferers are turning towards small doses of psychedelics, known as “micro-dosing”, to cope with depression and anxiety,[22] or even to achieve higher levels of concentration and creativity,[23] as experts are saying that “legalization is inevitable” for treatments involving psilocybin and other psychedelic treatments.
Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is establishing psychedelic-based therapies, and addressing the unmet needs of high-risk constituents.[24]
The concept is to assist those who have been failed by the current regime of SSRIs and other established antidepressants.
Mydecine’s(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) ongoing research to date includes clinicals using psilocybin therapy for PTSD[25] (which has been featured in FORBES[26]), a clinical trial initiative with leading European Research Institute Leiden University Medical Center of the Netherlands,[27] and the first lab-based study of established microdosers at Macquarie University in Australia.[28]
An Evolving Industry Gaining Traction
While therapists are looking at innovative therapies to treat patients, the investment communities within Wall Street and Silicon Valley are also investigating new ways to approach the psychedelic sector. [29]
Naysayers of whether this type of “new medicine” could ever get mainstream acceptance were silenced, when Compass Pathways (backed by ATAI Life Sciences AG), received FDA breakthrough therapy designation on a psilocybin treatment, perhaps better known as the active medical ingredient in magic mushrooms.[30]
ATAI has raised more than US$100 million from major investors such as PayPal co-founder Peter Thiel—and later this year, they are expected to go public at a valuation of US$1-2 billion.[31]
Mydecine continues to expand its technical platforms and outreach with its available and downloadable app: MindLeap.
Through its proprietary Mindleap platform, Mydecine is also giving practitioners the ability to aid their patients better through telehealth abilities and an AI-powered progress monitoring program.
Mindleap is an after-care smart app platform that not only connects patients with their therapists, but also can significantly improve upon monitoring progress, provide follow-up treatment, and give patients other beneficial activities such as meditation, breathing work, and yoga instruction.
Mindleap currently has over 60 specialists with thousands of downloads to date, and is available on both iOS and Android devices.
Comparing Mental Health Psychedelic Stocks
At the end of 2020, the first-ever Psychedelics ETF was announced, which includes 17 companies in the US and Canada, and began trading on January 26, 2021, under the ticker PSYK on the NEO exchange. Announced among and included in that group of 17 was Mydecine Innovations Group Inc. (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA).
Let’s take a look at some of the other Big Pharma/Mental Health Medicine Stocks.
*Market cap and share price taken from Yahoo Finance on March 9, 2021
As you can see, Mydecine(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) is already far along in the licensing process when compared to its peers.
Economic Advantages from Mushroom Research
Out of all of Mydecine’s advantages in the field of developing new medicines, perhaps its largest is its relationship with the University of Alberta, which holds an 11-year-old aged Schedule I license to research, develop, and produce a number of unique APIs (Active Pharmaceutical Ingredients) from their naturally-sourced cGMP psychedelic extracts.
Through this partnership, Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has established the World’s First Natural-Sourced cGMP Psilocybin supply for Global Research, Sales, and Distribution.[35]
Currently, scientists are paying $7,000 to $10,000 per gram[36] for synthetic mushroom ingredients—whereas MYCO can legally derive and produce the real organic version of the same ingredients for significantly lower than what is currently available.
Mydecine’s Upcoming Timeline
Mydecine’s Thought Leadership
Mydecine(CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) has assembled a talented team of thought leaders, whose accomplishments include:
100+ published peer-reviewed studies/papers
World-class team coming from Pfizer, Novartis, Yale, Imperial College, and Canadian, US, and EU Militaries
Proven medical development and approval experience
30+ years of combined psychedelic industry experience
Joshua Bartch, Director, CEO & Co-Founder Bartch’s entrepreneurial career took off in 2009 when he co-founded AudioTranscriptionist.com and founded the Denver-based dispensary, Doctors Orders. Following these ventures, Mr. Bartch founded a boutique investment firm that operated throughout the US and Canadian markets. In 2014, Bartch co-founded Cannabase.io, the USA’s most significant legal and sophisticated pot wholesale platform. In 2015, Cannabase.io was acquired by Helix TCS.
Damon Michaels, Director, COO & Co-Founder Prior to joining MIG, Michaels was consulting for various hemp businesses through his company, Emerald Baron. Before that, he served as GM for the leading multi-platform cannabinoid research and technology firm based in Colorado called ebbu, which was acquired by Canopy Growth for CA$429 million in November 2018. Michaels developed a national snowboard brand with his team, was one of four entrepreneurs who created Colorado’s first-ever glass recycling company, and was on the business development team for a Google Ventures Company.
Robert Roscow, MA – CSO & Co-Founder With expertise in genomics, evolution, and molecular biology, Roscow has previously worked at both Canopy Growth and ebbu, where he ran the genetics divisions. He has filed multiple patents and holds numerous publications under his belt, including Nature and Rolling Stone.
Professor Eric Vermetten MD, Ph.D. Colonel, an internationally recognized leader in the treatment of PTSD and other mental disorders and an active Colonel of the Dutch military. He is also professor of Medical-Biological and Psychiatric Aspects of Psychotrauma, LUMC/University of Leiden. The chair was established by Arq Psychotrauma Research and the Dutch Ministry of Defense. Eric Vermetten is an active clinical psychiatrist at the MGGZ in Utrecht (Military Mental Health care). From 1991 he has been linked to several universities as a researcher, including Stanford University, Yale University, and Emory University.
Dr. Vermetten has published over 300 articles and book chapters on topics ranging from large longitudinal studies following soldiers’ deployments to innovative approaches to treatment. He continues to be a leader within the international psych traumatology community within NATO and beyond.
Dr. Rakesh Jetly, OMM, CD, MD, FRCPC is currently the Head of the Centre of Excellence on Mental Health in Ottawa, Ontario, and an associate professor of psychiatry at Dalhousie University, and the University of Ottawa. He has published numerous articles in professional journals and presents nationally and internationally on such topics as post-traumatic stress disorder and operational psychiatry.
Carl Castro is the research director for the USC Center for Innovation and Research on Veterans and Military Families. Castro has authored more than 150 scientific articles and reports in numerous areas and currently serves as chair of a NATO research group on military mental health training. He serves as an advisor for several Department of Defense research panels focused on psychological health.
7 Investment Highlights of Mydecine Innovations Group Inc. (CSE:MYCO) (OTCQB:MYCOF) (FRA: 0NFA)
Management, research teams, partners (military, scientists, researchers) and one of the original senior marketing executives that launched Red Bull in the US
Substances Dealer’s Licenses from Health Canada that allow Mydecine (CSE:MYCO) (OTC:MYCOF) (FSE: 0NFA) the ability to cultivate, import, export, extract, and commercialize psilocybin and other functional mushroom products.
Technology and Analytics from the Mindleap platform that’s connected to clinics across the globe, providing TONS of data that’s privacy protected, and can improve upon the AI capabilities of this state-of-the-art telemedicine service.
Equipped for industry leading research through 7,500 sq ft Colorado Lab
Access to Top 15 Global Research through the University of Alberta.
Low-cost cultivation that’s capable of deriving APIs from mushrooms at a cost of pennies per gram when scientists are currently paying $7,000-$10,000 per gram for synthetically derived ingredients, giving HUGE leverage to complete clinical studies.
First-of-its-Kind clinical trials (featured in Forbes), with a current pipeline of 8 studies lined up through 2021, through 7 different respected research institutions.
Toronto, Ontario–(Newsfile Corp. – March 17, 2021) – Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company“), a drug discovery and development company focused on developing next generation psilocybin-inspired medicines and related technologies, is pleased to announce that it has received confirmation of eligibility from The Depository Trust Company (“DTC“) for electronic settlement and transfer of its common shares in the United States. The Company’s common shares are currently listed and posted for trading on the OTCQB® Venture Market (the “OTCQB“) under the symbol “MSSTF” and will continue to trade on the Canadian Securities Exchange under the symbol “MSET” as well as on the Frankfurt Stock Exchange under the symbol “9DF”.
DTC is a subsidiary of the Depository Trust & Clearing Corporation and manages the electronic clearing and settlement of publicly traded companies. DTC eligibility incorporates an electronic method of clearing securities that speeds up the receipt of stock and cash. This reduces costs and accelerates the settlement process for investors and brokers, allowing the stock to be traded over a much wider selection of brokerage firms by coming into compliance with their clearing and settlement requirements.
James Lanthier, CEO of Mindset commented, “DTC eligibility will provide current and prospective shareholders of Mindset with a reliable, cost-efficient, and timely method for clearing and settlement of Mindset’s common shares. With the Company’s common shares being DTC eligible, we expect this to lead to greater liquidity and execution speeds, as well as Mindset’s common shares being accessible to an even broader range of investors.”
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin along with its own proprietary compounds. www.mindsetpharma.com
Forward-Looking Information
This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided, and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. For a description of the risks and uncertainties facing the Company and its business and affairs, readers should refer to the Company’s Management’s Discussion and Analysis. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change, unless required by law. The reader is cautioned not to place undue reliance on forward-looking information.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Toronto, Ontario–(Newsfile Corp. – March 15, 2021) – Mindset Pharma Inc. (CSE:MSET) (FSE: 9DF)(“Mindset” or the “Company“) is pleased to announce that it has filed a sixth provisional patent application with the United States Patent and Trademark Office. This most recent patent application covers a comprehensive range of novel N,N-Dimethyltryptamine (“DMT“) and 5-methoxy-N,N-dimethyltryptamine (“5-MeO-DMT“) analogs, their related chemical process synthesis, composition of matter and therapeutic uses.
Both 5-MeO-DMT and DMT possess unique pharmacodynamic and pharmacokinetic properties compared to other clinically studied psychedelics, including a shorter duration of action, which may help reduce the amount of time a patient would spend in the clinic during psychedelic-assisted psychotherapy. 5-MeO-DMT and DMT’s potency at the 5HT1A receptor in addition to the 5HT2A receptor is unique compared to psilocybin and further increases the breadth of pharmacological diversity of Mindset’s proprietary compounds. The Mindset scientific advisory board believes that strategic structural modifications to DMT and 5-MeO-DMT could reduce toxicity and metabolic liabilities, resulting in an improved and safer psychedelic therapeutic.
Dr. Malik Slassi, a member of Mindset’s scientific advisory board noted, “We are very excited to add yet another psychedelic asset to our drug discovery and development program. This novel family of DMT and 5-MeO-DMT derivatives significantly expands the diversity of our patent-pending next generation psychedelic drug portfolio, bringing the total number of chemically distinct and differentiated chemical scaffolds of patent-pending compounds advancing through our drug discovery and development program to six. In parallel, we continue to make steady progress through our preclinical stages, generating highly promising data through in vitro characterization and animal experiments of our new drug candidates. We anticipate announcing lead compound(s) for investigational new drug-enabling studies from Mindset’s new drug families 1 and 2 shortly, as described in the Company’s press release of February 10, 2021.”
James Lanthier, CEO of Mindset, added, “Given the breadth of clinical indications that psychedelic drugs demonstrate efficacy in treating, we anticipate future clinical applications for a diversity of optimized psychedelic medications, tailored to a range of medical use cases. DMT and 5-MeO-DMT exhibit unique pharmacological and pharmacokinetic profiles, and we believe that optimized analogs have the potential to play a significant role in the future of psychedelic-inspired medicine. We look forward to sharing additional updates around bothour new drug program as well as our manufacturing process program shortly.”
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. www.mindsetpharma.com
Forward-Looking Information This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. For a description of the risks and uncertainties facing the Company and its business and affairs, readers should refer to the Company’s Management’s Discussion and Analysis. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change, unless required by law. The reader is cautioned not to place undue reliance on forward-looking information.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
Vancouver, British Columbia, Canada – March 12, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) announces that it has completed the acquisition (the “Transaction”) of all of the outstanding share capital of Bluejay Mental Health Group Inc. (“Bluejay” or “Bluejay Mental Health”) effective March 11, 2021.
One of Bluejay Mental Health’s assets is a specialty medical clinic located in Langley, British Columbia, which has an integrated telehealth platform enabling medical providers to deliver quality care, diagnosis and treatments to patients remotely using a secure telecommunications platform.
The acquisition of Bluejay Mental Health, will allow the Company to broaden its patient network, incorporate a proven telehealth model that uses measured and meaningful data to integrate clinical data with real world evidence, and allow product development and a full service digital mental health platform capable of launching and commercializing psychedelic assisted therapies and medicines at scale to patients.
The specialty clinic was founded in 2011 and is a pioneer in the medical cannabis industry. To date, Bluejay has assessed over 77,000 patients in Canada for the appropriateness of alternative medical treatments for symptoms such as chronic pain anxiety and post-traumatic stress disorder (PTSD). With a network of over a thousand referring physicians from across Canada, Bluejay will help the Company improve efficiencies and optimize patient access to up and coming psychedelic treatments. Bluejay’s clinic was one of the first medical clinics to assist patients in receiving alternative health treatments in the form of cannabis prescriptions, and has the knowledgeable personnel to navigate the complex legislation surrounding psychedelic treatments.
Bluejay’s mission is to help patients return to a fully functioning life, through patient research and providing the most up to date and relevant education for patients and healthcare professionals. Bluejay clinic conducts assessments and creates plans that meet the patients’ specific needs and is tailored on an ongoing basis. Bluejay maximizes the patient experience with up-to-date products and services available in the medical cannabis industry. Its focus on mental health healing has led to its current focus on providing up and coming treatments in psychedelic medicines.
Bluejay has been a leading educator and has extensive knowledge about cannabinoid therapy working with thousands of patients and cultivators. Additionally, the clinic has been a leading educator of doctors and patients on cannabis regulations, and treatment protocols. The combined knowledge base of its team allows Bluejay to collaborate and find solutions for even the most complex cases. Historically, the clinic assessed patients from all across Canada for their eligibility into Health Canada’s Access to Cannabis for Medical Purposes Regulations program.
Bluejay has also formulated proprietary beverage blends using non-psychedelic, functional mushrooms, which it intends on making commercially available after obtaining a natural health product number (NPN) from Health Canada for its products. If the applications are accepted by Health Canada’s regulatory review process, Bluejay will be able to launch natural health products in Canada containing the herbal and fungi formulations described in the Natural and Non-prescription Health Products application. Currently Bluejay has formulated blends utilizing turkey tail and loins mane mushroom extract. Blujay’s three blends are proprietary in nature and include Energy Blend, Relax Blend and our Focus Blend.
“Bluejay’s extensive patient and physician outreach, experience in navigating the regulatory environment when it comes to treatments for patients opens the door for Core One’s future developments in psychedelic medicines in Canada. There are very few clinics that rival Bluejay’s experience in working with Health Canada to establish best practice treatment plans in the alternative health space,” stated Joel Shacker, CEO of the Company.
Transaction Structure
The Transaction was completed pursuant to a share purchase agreement among the Company, Bluejay and the shareholders of Bluejay (the “Definitive Agreement”) dated March 11, 2021. Pursuant to the Definitive Agreement, and in consideration for the acquisition of Bluejay, Core One issued (i) 9,150,000 common shares (the “Consideration Shares”); and (ii) 6,000,000 common share purchase warrants (the “Consideration Warrants”) entitling the holders to acquire a further 6,000,000 common shares of Core One for $0.05 per share.
1,650,000 of the Consideration Shares are subject to a voluntary pooling arrangement from which:
(a) ten (10%) percent will be released upon completion of the Transaction;
(b) a further thirty (30%) percent will be released on June 11, 2021;
(c) a further thirty (30%) percent will be released on September 11, 2021; and
(d) a further thirty (30%) percent will be released on December11,2021.
The Company is at arms-length from Bluejay and its shareholders. The Transaction neither constitutes a fundamental change nor a change of business for the Company, nor has it resulted in a change of control of the Company within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange. In connection with the completion of the Transaction, the Company has issued 200,000 common shares split evenly between two arms-length third-parties who assisted with facilitating the Transaction.
About Core One Labs Inc.
Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.
Core One Labs Inc.
Joel Shacker
Chief Executive Officer
FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058
Cautionary Disclaimer Statement:
The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.
In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.
TORONTO, March 11, 2021 /CNW/ – NEW WAVE HOLDINGS CORP. (the “Company” or “New Wave”) (CSE: SPOR) (FWB: 0XM2) (OTCPK: TRMNF) an investment issuer that provides capital and support services, announces that N2 Logics Inc. (“N2”), an entity in which New Wave owns a significant interest, has signed an agreement to work alongside Dr. Elizabeth Goldspink on multiple upcoming ventures.
New Wave Holdings Logo (CNW Group/New Wave Holdings Corp.)
Following the partnership agreement commencing on March 22nd, 2021, N2 Logics and Dr. Goldspink are set to collaborate on several developments in the upcoming months. The e-commerce and digital marketing company plans to roll out its own line of functional mushroom products in the UK before this summer, which are currently being developed by Dr. Goldspink. N2 Logics is anticipating positive sales growth with the addition of this mushroom collection to its existing products, with a 18% increase in projected revenue following its launch.
As part of the partnership, N2 Logics will be using their Bloom Botanics brand to leverage sales of Dr. Goldspink’s Papillex & AHCC® by Papillex supplements via its ecommerce site and Amazon. The recently announced Northern Ireland grace period extension will allow N2 Logics to streamline product distribution throughout the UK and across Europe from one location.
Dr. Goldspink is a Toronto-based Naturopathic Doctor and a prominent Health & Wellness Entrepreneur who is frequently featured as a wellness expert on CityTV’s “CityLine”. Dr. Goldspink studied mind body medicine at Harvard Medical School, under Dr. Herbert Benson, MD, who is the world leader in the study, advancement, and clinical practice of mind/body medicine. She writes for various print and online publications, including Integrative Healthcare Practitioners (IHP), and formulates natural health products (NHP’s) for various innovative companies.
“We’re thrilled to be working with an accomplished and distinguished naturopathic doctor such as Dr. Elizabeth Goldspink,” commented Willie Tsang, CEO of New Wave. “She has a wealth of knowledge and experience in the natural health care and wellness sphere, and her expertise will contribute significantly to the growth and development of our company as we continue to evolve. We look forward to working closely with her on a number of upcoming projects, which we’re confident will result in successful outcomes that will be mutually beneficial.”
“Mushrooms are the future of wellness and I am excited to help make pure, transparent, and therapeutic blends accessible to the people who will benefit from them. I am looking forward to collaborating with New Wave on multiple ventures,” said Dr. Elizabeth Goldspink.
ABOUT NEW WAVE HOLDINGS CORP.
New Wave Holdings Corp. (CSE: SPOR, FWB: 0XM2, OTCPK: TRMNF) is an investment issuer focused on the burgeoning nutraceutical and psychedelic sector and support for adaptive and progressive health and wellness products and therapies. New Wave subsidiaries contain various health and beauty products within its portfolio of non-psychoactive plants and fungi as it continues to expand its product distribution through vertical integration to provide end to end solutions while capturing a high margin business model.
Investors interested in connecting with New Wave Holdings can learn more about the company and contact the team at http://newwavecorp.com.
ABOUT Papillex™ Papillex™ is a company that offers a clinically-researched, nutrient-rich supplement that is designed to support the immune system in response to HPV. Papillex™ optimizes natural immunity and replaces key nutrients that have been found to be missing and low in people with persistent HPV symptoms. Additionally, Papillex™ also offers a medicinal mushroom product from the mycelium of shiitake mushrooms called AHCC®, which is backed by over 20 human clinical studies. AHCC® has been demonstrated to help the human body better respond to HPV and other viral infections.
ABOUT N2 LOGICS INC. The N2 team brings over 10 years of experience in the field of online E-commerce and digital marketing, they utilize established and true methodologies to attract high quality traffic online through lead generation and conversion optimization. Based on the current digital marketing needs, they focus on world class tactics and digital optimization to provide return on investments. Uniquely positioned with New Wave, N2 will have the ability to grow globally while developing and discovery various products within the industry.
Investors interested in connecting with N2 can learn more about the company and contact the team at http://www.n2logics.com
ABOUT BLOOM BOTANICS E-COMMERCE PLATFORM Bloom Botanics a highly innovative E-commerce platform that was formed when a collective of E-commerce experts from the UK, Ireland and the North American Cannabis and Cannabis Accessory industry realised there was a significant opportunity to create Bloom Botanics to carry an impressive range of various of CBD and mushroom based products and continue to aggressively increase its presence in this space from a product and geographical basis. The Bloom Botanics team currently consists of industry experts from 6 different European countries and will be looking to expand that team and its expertise moving forward.
Investors interested in connecting with Bloom Botanics can learn more about the company and contact the team at https://bloombotanics.co.uk
Information relating to Bloom Botanics, contained in this news release was provided by Bloom Botanics and/or its agent and has not been independently verified by the Company. The Company does not take responsibility for the accuracy of such information.
The CSE has not in any way passed on the merits of the Acquisition, and neither has approved nor disapproved the contents of this press release. Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.
FORWARD-LOOKING INFORMATION DISCLAIMER
Certain statements contained in this news release may constitute forward–looking information, including but not limited to, applicable regulatory approval in connection with the Acquisition, the closing of the Acquisition, expansion of operations, size and quality of future tournaments and projections regarding attendance at future events. Forward–looking information is often, but not always, identified by the use of words such as “anticipate”, “plan”, “estimate”, “expect”, “may”, “will”, “intend”, “should”, and similar expressions. Forward–looking information involves known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those anticipated in such forward–looking information. The Company’s actual results could differ materially from those anticipated in this forward–looking information as a result of competitive factors and competition for investment opportunities, challenges relating to operations in international markets, transaction execution risk, changes to the Company’s strategic growth plans, and other factors, many of which are beyond the control of the Company. The Company believes that the expectations reflected in the forward–looking information are reasonable based on current expectations and potential investment pipeline, but no assurance can be given that these expectations will prove to be correct and such forward–looking information should not be unduly relied upon. Any forward–looking information contained in this news release represents the Company’s expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward–looking information whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.
NEW YORK, March 10, 2021 /PRNewswire/ — DemeRx IB, Inc. (DemeRx), an atai Life Sciences (atai) platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), today announced the company has approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to commence subject enrollment in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002).
Ibogaine is a naturally-occurring psychedelic product isolated from a West African shrub that has demonstrated rapid and sustained efficacy in treating OUD. This regulatory approval comes as a break-through for patients seeking to end their intractable cycle of drug dependence.
The Phase 1 portion of the MHRA approved trial will be conducted at the Manchester clinical unit of MAC Clinical Research (MAC), one of Europe’s largest clinical development organizations. MAC’s extensive good clinical practice experience, expertise and infrastructure will provide a platform for what is hoped to be a successful and significant trial.
“Our clinical trial authorization is a critical milestone,” said Dr. Deborah Mash, CEO and President of DemeRx. “Stage 1 of the study will provide assessment of safety through the evaluation of ibogaine’s potential adverse effects before we move to the proof-of-concept efficacy portion of our study in patients who seek to detoxify from opioids”.
“This approval allows DemeRx to progress clinical research beyond the previously published uncontrolled studies with ibogaine into well-designed, controlled studies in support of regulatory processes,” said Srinivas Rao, Chief Scientific Officer and Co-founder of atai Life Sciences. “With the initiation of this trial, we start a journey towards understanding the potential of DMX-1002, in-line with regulatory bodies. We are optimistic for the future of DMX-1002 in treating OUD – this is a great step forward for DemeRx.”
“Timing could not be more important as the world faces an ever-growing opioid epidemic. Current treatment options are not highly effective; approximately 75% of patients undergoing OUD therapy experience relapse within one year of treatment,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences. “This approval allows DemeRx to initiate this well-designed protocol to advance our understanding of how DMX-1002 may provide patients with a potentially transformative therapy, where currently the industry has developed few treatment solutions.”
About the Phase 1/2a clinical trial approval
The approval for a Phase 1/2a clinical trial will enable DemeRx to study DMX-1002 in recreational drug users before the start of Stage 2 in opioid-dependent patients. Before the start of Stage 2, the trial will pause to allow MHRA to review human safety data together with nonclinical study results.
About DemeRx, Inc. & DMX-1002
DemeRx, Inc. is a Miami-based clinical stage pharmaceutical company focused on developing ibogaine and noribogaine for the treatment of OUD. DemeRx’s mission is to advance the development of potential treatments for OUD in order to prevent patient suffering, provide better treatment retention, and decrease illegal opioid use.
DemeRx is developing DMX-1002 for the treatment of OUD. DMX-1002 is a GMP drug product manufactured for human use.
Company Contacts:
Deborah C Mash PhD
CEO & Founder, DemeRx Inc.
Phone: +1(305)753-2175
Email: dmash@demerx.com
Matthias Luz MD
Executive Vice President & Chief Medical Officer
Email: mluz@demerx.com
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai is headquartered in Berlin, with offices in New York. For more information, please visit www.atai.life.
Highlights include continued progress with phase IIb psilocybin therapy clinical trial, launch of first Centre of Excellence, and expansion of Discovery Center
Phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD) on track to report data by end of 2021
First Centre of Excellence, a research facility and innovation lab, established at Sheppard Pratt (Baltimore, Maryland, US)
Discovery Center expanded into network of world-leading scientists developing new optimised psychedelic compounds
Conference call today at 1.00pm GMT (8.00am ET)
COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2020 and gave an update on recent progress across its business.
George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “Mental health is an urgent crisis and this has only been exacerbated by the COVID-19 pandemic. At COMPASS we remain committed to transforming mental health care and helping patients who are suffering and aren’t helped by existing treatments. Our phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression is actively recruiting and we plan to report data from this trial at the end of the year. We are also continuing preclinical research into new indications, new compounds and new technologies, working with partners through our Centre of Excellence, our Discovery Center, and a number of investigator-initiated studies, as well as developing a strong team.”
Business highlights
Continued progress with phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression (TRD)
– On track to report data end of 2021
– New site added in London, UK, bringing trial to 22 sites in 10 countries
– Working closely with all sites to assess the ongoing COVID-19 situation and COMPASS will always prioritise the safety of patients and teams
– Paper on therapist training programme published in Frontiers in Psychiatry in February, setting out formal and scalable methodology for psychological support in psilocybin therapy
– Breakthrough Therapy designation awarded by US FDA in 2018
Signal-generating, exploratory psilocybin therapy research underway in a range of indications
– COMPASS has the right to exclusively license new IP generated through these investigator-initiated studies
Launch of first Centre of Excellence at Sheppard Pratt, Baltimore
– Centres of Excellence are research facilities and innovation labs that COMPASS anticipates will model the ”clinic of the future”, showcasing the most advanced thinking in science, therapy, technology and design
– Centres of Excellence should generate evidence to shape therapy models in mental health care, train and certify therapists, conduct clinical trials including proof-of-concept studies, and prototype digital solutions to improve patient experience
– Initial research focused on COMP360 psilocybin therapy, which is already being used in two investigator-initiated studies looking at severe treatment-resistant depression and bipolar type II depression
Expansion of Discovery Center in the US
– Discovery Center expanded beyond initial sponsored research agreement with University of the Sciences (Philadelphia, PA) to include collaborations with world-leading scientists from laboratories at UC San Diego, School of Medicine, and Medical College of Wisconsin, in a virtual network
– Focus on development of new optimised psychedelic compounds targeting the 5-HT2A receptor
– COMPASS is exclusive licensee for all new compounds generated
Financial highlights
Net loss for the three months ended 31 December 2020 was $18.8 million, or $0.52 loss per share (after including non-cash share-based compensation expense of $1.4 million), compared with $7.6 million, or $0.90 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $0.8 million)
The net loss for the 12 months ended 31 December 2020 was $60.3 million, or $3.55 loss per share (after including non-cash share-based compensation expense of $18.0 million), compared with $19.6 million, or $2.62 loss per share, during the same period in 2019 (after including non-cash share-based compensation expense of $3.3 million)
Research & development expenses (R&D) were $4.5 million for the three months ended 31 December 2020, compared with $4.6 million during the same period in 2019. R&D expenses were $23.4 million for the 12 months ended 31 December 2020, compared with $12.6 million during the same period in 2019, reflecting increased investment in the ongoing phase IIb COMP360 psilocybin therapy clinical programme for TRD
General and administrative expenses (G&A) were $7.0 million for the three months ended 31 December 2020, compared with $2.8 million during the same period in 2019. Of the increase, $0.5 million was related to share-based compensation expenses. G&A expenses were $28.0 million for the 12 months ended 31 December 2020, compared with $8.6 million during the same period in 2019. Of this increase, $10.2 million was related to share-based compensation expenses
Cash and cash equivalents were $190.3 million as of 31 December 2020, compared with $196.5 million at 30 September 2020
Conference call
The COMPASS Pathways management team will host a conference call at 1.00pm GMT (8.00am ET) on 9 March 2021. The call can be accessed by dialling (833) 665-0659 from the United States, +1 (914) 987-7313 internationally, and 0800 028 8438 from the UK, followed by the conference ID: 5558345.
The call will also be webcast on the investors section of the COMPASS Pathways website (ir.compasspathways.com) and archived for 30 days.
About COMPASS Pathways
COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, US. Our vision is a world of mental wellbeing.
Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, COMPASS’s business strategy and goals, and COMPASS’s expectations regarding its ongoing preclinical work and clinical trials, including the timing of the release of clinical data. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: preclinical and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.
Numinus Bioscience adds research space, enhances contract services, accelerates IP development and increases psychedelic supply capacity
VANCOUVER (March 9, 2021) – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a global leader in supporting and expanding the safe, accessible and evidence-based use of psychedelic-assisted psychotherapies (PAP), is pleased to announce plans to significantly expand its psychedelics research laboratory by late 2021.
A 7,500-square-foot expansion will be developed and housed in an existing Numinus-leased building adjacent to the current lab. The expansion announcement comes days after Numinus received amendments to its federal licence under Canada’s Controlled Drugs and Substances Act to allow the possession, production, assembly, sale, export and/or delivery of a variety of psychedelics including Ketamine, LSD, Mescaline, N,N-Dimethyltryptamine (DMT), N-Methyl-3,4, methylenedioxyamphetamine (MDMA), Psilocin and Psilocybin.*
“Our investment in an expanded lab marks a key milestone for Numinus and provides the necessary foundation for therapeutics development and research infrastructure to advance psychedelic-assisted psychotherapy in Canada and around the world,” said Sharan Sidhu, Science Officer and General Manager for Numinus Bioscience, the Company’s laboratory division and a pioneer in psychedelic research and development.
Added Sidhu: “When complete, the facility will enhance our IP and partnerships strategy, generate more revenue through analytics testing for psychedelics and other contract services, and increase our supply of consistent, safe and effective psychedelics for clinical use and trials undertaken by academic, not-for-profit and for-profit entities.”
The current lab is conducting innovative work in areas such as Psilocybe mushroom cultivation and extraction, formulation studies and a genotypically verified spore bank and tissue culture library. The expanded facility will accelerate this work and add several psychedelic substances and capabilities to contract lab services, increase capacity for high-throughput psychedelics testing and enhance research and development activities in a wide array of psychedelics.
While Numinus Bioscience develops infrastructure, systems and processes at the expansion site, contract and research work will continue uninterrupted at the Company’s current Health Canada-licensed laboratory facility.
Lab to receive $1.2 million in new equipment
The current laboratory facility recently took possession of next-generation analytical equipment including the Orbitrap Exploris 120 Mass Spectrometer, a state-of-the-art high-resolution mass spectrometry instrument that supports research to optimize the cultivation, harvest and extraction of Psilocybe mushrooms and implement discovery of unknowns and interactions in several psychedelic botanicals in addition to mushrooms. The lab expects to soon receive additional instrumentation, representing a total investment of $1.2 million, to support innovation and development of intellectual property related to Psilocybe mushrooms and standardized test methods for a range of psychedelics.
*Please see news release Regulator approvals place Numinus lab at the forefront of global psychedelics research, March 4, 2021.
Note
The safety and efficacy of psychedelic-assisted psychotherapy is currently under investigation. It has not yet been approved by Health Canada or the U.S. FDA, does not work for everyone, and carries risks even in therapeutic settings. These statements are no guarantee of future Health Canada or FDA approval or availability of psychedelic-assisted psychotherapy. These statements necessarily involve known and unknown risks and uncertainties, which may cause actual outcomes to differ materially from projections.
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About Numinus
Numinus Wellness Inc. (TSXV:NUMI) is a health care and research company creating psychedelic-centred solutions to treat mental illness, substance abuse and trauma.
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal.
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use and adult-use marijuana industry, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company’s goals to develop and implement partnerships with research organizations and other key players in the integrative mental health industry; the Company’s ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; the approval and/or success of compassionate access clinical trials; the cultivation and harvest of psilocybe mushrooms; and the availability of trained personnel and medical professionals. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
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