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Numinus Wellness To Acquire Neurology Centre of Toronto, Plans to Create Centre for Psychedelic Neurology

NCT’s treatment of neurological disorders combined with Numinus’ leadership in psychedelic-assisted therapy will offer opportunity to treat a range of chronic neurological conditions and common concurrent mental health challenges

VANCOUVER (July 6, 2021) – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, is pleased to announce that the Company has agreed to acquire the Neurology Centre of Toronto (“NCT”) pursuant to a purchase agreement dated July 2, 2021. Numinus and NCT founder Dr. Evan Lewis plan to expand NCT into a comprehensive clinical neurology treatment centre with a unique specialization in the application of psychedelics in the field of neurology.

Numinus will pay $300,000 in cash and $200,000 in Numinus shares upon closing and future performance-based payments totaling up to $500,000 in Numinus shares to complete the transaction. The transaction is subject to a number of conditions, including the approval of the TSX Venture Exchange. As of the date hereof, Numinus and NCT management have completed their due diligence. The Company anticipates that the acquisition of NCT will be completed by the end of August 2021.

Transaction Highlights:

  • Numinus to acquire a fully operational neurology centre with 13 doctors, 8 allied health staff, nurse practitioners and physician assistants. Gross revenues for the centre grew more than 25% to approximately $1 million for the year ended December 31, 2020, while net revenue grew 25% to $454,000 for the same period.
  • NCT offers experience managing patients with common neurological conditions and associated chronic psychological disorders for whom there is potential to benefit from psychedelic-assisted psychotherapy.
  • NCT’s expertise in clinical neurology and associated mental health disorders will be integrated with Numinus’ leadership in psychedelic-assisted psychotherapy to establish the field of psychedelic neurology, to develop strategies and treatments for those with select neurological and concurrent disorders.
  • NCT and Numinus plan to establish the first centre for excellence in psychedelic neurology, comprising highly specialized neurology experts with an understanding of how psychedelics can safely and positively impact patients with neurologic illnesses and associated mental health challenges.
  • Numinus to leverage and grow NCT’s information technology-based virtual rapid access care model to streamline and scale pathways for patients to access psychedelic-assisted psychotherapies.
  • Dr. Lewis, recognized for advancing the use of medical cannabis to treat complex neurologic disorders, will join Numinus as VP, Psychedelic Neurology Services upon completion of the acquisition.

“Our collaboration with Numinus represents an important evolution in patient care for individuals suffering from common neurological illnesses and challenges that are often associated with chronic mental health conditions,” said Dr. Lewis, a neurologist and clinical neurophysiologist who founded NCT in 2017. “While today’s treatments help many patients, a significant number continue to suffer and, we believe, may be helped by psychedelic-assisted psychotherapy.”

Currently, therapies for common neurological disorders such as concussion, migraine and cluster headache, neuropathic pain syndromes and chronic epilepsy have limitations, especially when these disorders are associated with chronic psychological challenges. The need to develop novel therapies that address both medical and psychological components of neurological diseases may be substantial and the potential impact could be significant.

Numinus and NCT are coming together to explore and develop applications of psychedelic-assisted therapies to reduce patient suffering and enable greater opportunities for healing. Current research shows that psychedelic medications such as psilocybin and MDMA open new pathways in the brain that, in conjunction with professional therapy, can treat a host of mental health disorders.

“This acquisition represents an exciting opportunity for NCT and Numinus to combine medical, clinical and academic expertise to help create a new discipline and ultimately a centre for excellence in psychedelic neurology,” said Dr. Evan Wood, Chief Medical Officer, Numinus. “In doing so, this collaborative discipline could potentially make a transformative difference for many patients.”

In addition, NCT has developed a virtual rapid access model for patient intake and evaluation that is efficient, team-based and readily modifiable to support specialized programs across various disciplines. The rapid access model is cost-effective, supports and streamlines patient care, reduces wait lists, addresses some barriers to care, and has scale potential. NCT and Numinus will explore how this innovative model can support the development and delivery of efficient, patient-centered psychedelic-assisted psychotherapy.

“I continue to be humbled by the quality of people joining Numinus and acting with us on our ambition to help people heal and be well,” said Payton Nyquvest, Numinus CEO and Chair. “The acquisition of NCT reflects our thoughtful expansion strategy to add clinics that offer revenue-generating services, accretive assets and innovative leadership that maintains our position at the forefront of client care and psychedelic-assisted therapy.”

All of NCT’s staff – including medical doctors, nurses, physician assistants, occupational therapists, psychotherapists, physiotherapists, nutritionists and administrative staff – are expected to remain with Numinus post transaction closing.

For more on the acquisition from Numinus CEO Payton Nyquvest, Dr. Evan Wood and Dr. Evan Lewis, please review this short video:

About Dr. Evan Lewis

Dr. Evan Cole Lewis, MD, FRCPC, CSCN EEG Diplomate, is a pediatric neurologist and clinical neurophysiologist with expertise in epilepsy, epilepsy surgery, electroencephalography and virtual medicine. He is considered an innovative leader in the use of cannabinoids for neurological disorders in adults and children.

Dr. Lewis is an Adjunct Assistant Professor at the University of Toronto and a Fellow of the Royal College of Physicians of Canada. He obtained his MD from the University of Ottawa and trained as a pediatric neurologist at the Children’s Hospital of Eastern Ontario. He completed fellowships in both clinical neurophysiology and epilepsy at Nicklaus Children’s Hospital and Toronto’s Hospital for Sick Children. Dr. Lewis was a staff neurologist, clinical neurophysiologist and the Director of the Epilepsy Fellowship Training Program at the Hospital for Sick Children between 2015 and 2016.

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On behalf of the board of Numinus Wellness Inc.

Payton Nyquvest

President, Chief Executive Officer and Chair

About Numinus

Numinus Wellness (TSX-V: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus Wellness model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance abuse. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice, and building the foundation for a healthier society.

Learn more at numinus.ca, and follow us on Facebook, Twitter, and Instagram.

About NCT

NCT is a multi-disciplinary, community-based neurology clinic centrally located in midtown Toronto. NCT utilizes a model of care that brings together neurologists, neurology-related specialists and allied health practitioners to address the complex conditions that affect patients’ health and well-being. Our team assesses a wide range of neurologic conditions and provides specialty care in the areas of epilepsy, concussion, brain injury, multiple sclerosis, headache & migraine and the treatment of neurologic disorders with medical cannabis. NCT strives to deliver comprehensive neurologic care organized around its core values of patient-centred care, collaboration, community, health equity and innovation that focuses on transforming the lives of our patients.

Forward-Looking Statements
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 of psychedelic therapies, due to inconsistent public opinion, perception of the medical-use of psychedelics, 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; 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.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information:

May Lee

Communications Manager

Numinus

may@numinus.ca

For media inquiries:

Catherine Snider

Kaiser & Partners

catherine.snider@kaiserpartners.com

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This Canadian psychedelic drug company is working on a vaccine for depression

“Diagnosing, preventing and treating diseases of the central nervous system is at the core of our focused corporate strategy.”

Vancouver-based MYND Life Sciences is exploring whether depression and other central nervous system disorders can be treated with novel psychedelic drugs, including psilocybin. In January, the company announced a collaborative research agreement with the University of British Columbia on major depressive disorder.“We have an opportunity to improve the wellness and quality of life of people suffering from depression, anxiety and addiction and this agreement helps set the foundation for the development of novel therapies utilizing psilocybin and other related compounds,” said Dr. Lyle Oberg, MYND’s chief executive officer.MYND is now one step closer to that goal after signing a licensing agreement with private vaccine developer Eyam.

The Letter of Intent, announced last month, gives MYND an exclusive license with respect to Eyam’s proprietary technologies for applications to central nervous system vaccines.This agreement with Eyam will allow MYND to access yet another cutting edge technology with the development of vaccines that have the ability to prevent neurological disorders such as major depressive disorder, by stopping the neuro-inflammatory process before it starts,” explains Dr. Oberg.MYND is working to develop a suite of central nervous system disorder treatment protocols, including diagnostic capacity with blood markers, treatment with specific psilocybin and other psychedelic analogs, and immunoprotection.

The company is also working on methods for treating or delaying Alzheimer’s disease and related forms of dementia.“Diagnosing, preventing and treating diseases of the central nervous system is at the core of our focused corporate strategy,” Dr. Oberg said last month. “Alzheimer’s disease affects millions of people around the globe and remains a catastrophic condition without a cure.”

Regina Leader-Post, July 3, 2021.

https://leaderpost.com/cannabis-news/psychedelics/this-canadian-psychedelic-drug-company-is-working-on-a-vaccine-for-depression

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HAVN LIFE SCIENCES SIGNS FINISHED GOODS SUPPLY AGREEMENT WITH ALLIED HEALTH

The Agreement will utilize HAVN Life’s fully integrated supply chain model, from the growing of psilocybin through to extraction, compounding, and encapsulation

Vancouver, BC – HAVN Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “HAVN Life”), a biotechnology company pursuing standardized extraction of psychoactive compounds and the development of natural healthcare products, is thrilled to announce it has entered into a supply agreement (the “Supply Agreement”) with Allied Health (OTCQB: ALID), an innovator in the cannabis and psychedelics space, integrating medical research, cultivation and processing, and proprietary products and natural health product distribution.

Allied Health is in the process of developing Psilonex™ RX Capsules, a proprietary formulation of psilocybin, cordyceps, lion’s mane, vitamin B, and other ingredients that will be available to their patient cohort, including more than 300 veterans, police, fire, and ambulance personnel struggling with PTSD and related mental health issues. Allied Health is currently seeking a Section 56 special access exemption for their patient cohort for the use of Psilonex™ RX Capsules, with continued research and data gathering planned for future product development.

“We are beyond excited to welcome Allied Health to our growing list of supply partners,” says HAVN Life CEO, Tim Moore. “With a supply partner roster that includes Revive Therapeutics, The Heroic Hearts Project, Health Tech Connex, ATMA and now Allied Health, we are demonstrating industry support in our business model as an end-to-end supply chain for psychedelic compounds. With plans underway to have our Vancouver facility fully licenced and operational in the near future, this new aspect of production will be a tremendous revenue opportunity for us,” he adds.

Pursuant to the Supply Agreement, Allied Health will have access to the Company’s full range of psychedelic compounds and APIs, cultivated at the Company’s facility in Jamaica, which opened this May. This Supply Agreement is a major milestone, marking the completion of HAVN Life’s vision of a fully integrated supply chain model, from the growing of psilocybin, through to extraction, compounding and finally to encapsulation.

Allied Health’s decision to use naturally derived psilocybin in their Psilonex™ RX Capsules underscores the growing patient preference for plant-based products over synthetic ones. By partnering with another industry innovator, HAVN Life further consolidates its position as an integral supply chain provider in respect of naturally-derived psychedelics for clinical providers and researchers around the globe.

With the recent news that California is moving toward decriminalizing psychedelics through Senate Bill 519 – Controlled substances: decriminalization of certain hallucinogenic substances, the growing demand for clinical and therapeutic use of psychedelic compounds is undeniable, and highlights HAVN Life’s unique position as a source of safe and standardized products.

Any transactions to be completed pursuant to the Supply Agreement, including any supply of psilocybin thereunder, will be subject to compliance with any and all applicable laws and regulations, including those of Health Canada.

On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About HAVN Life Sciences Inc.

HAVN Life Sciences is a Canadian biotechnology company pursuing standardized extraction of psychoactive compounds, the development of natural health products, and innovative mental health treatment to support brain health and enhance the capabilities of the mind. Learn more at: havnlife.com and follow us on Facebook, Twitter, Instagram and Youtube.

Connect

Investor Relations
ir@havnlife.com
(604) 687-7130

Facebook: @havnlife
Twitter: @havnlife
Insta: @havn.life
LinkedIn: @Havn Life
Youtube: @HavnLife

Media Contact
savi@emergence-creative.com
(647) 896-8078

 

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OPTIMI HEALTH SUPPORTS PATIENT-FOCUSED PSILOCYBIN ADVOCACY BY THERAPSIL

VANCOUVER, BC (June 29, 2021) — Optimi Health Corp. (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a vertically integrated developer of mushroom products is pleased to announce it has initiated corporate support as one of TheraPsil’s first Core Spore Supporters through a generous donation and ongoing advocacy to the TheraPsil Coalition (“TheraPsil”) in support of their continued national initiatives aimed at increasing patient access to psilocybin.

Based in Victoria, British Columbia and established in 2019, TheraPsil is a non-profit coalition of healthcare professionals, patients, and advocates dedicated to obtaining legal access to psilocybin-assisted psychotherapy for Canadians in medical need. TheraPsil has facilitated precedent-setting and tangible progress in the fight for compassionate access to psilocybin therapy in Canada. It has helped Canadians suffering from end-of-life distress through advocacy efforts resulting in ‘section 56 exemptions’ granted directly from the Minister of Health, Patty Hadju, beginning on August 4th, 2020. These first exemptions represent a milestone event as the first instance of psilocybin being approved for patients since 1974 when it was made a controlled substance in Canada. TheraPsil has now successfully supported 31 patients in five Canadian provinces to gain access to legal, psilocybin-assisted psychotherapy.

Psilocybin-assisted psychotherapy is the professionally guided use of psilocybin in combination with psychotherapy. According to TheraPsil, research and anecdotal evidence has shown that psilocybin therapy can improve the quality of life and end-of-life care for individuals experiencing anxiety, depression, and hopelessness as a result of a life-threatening diagnosis.

The primary services of TheraPsil are patient-rights advocacy, assessment, and referral – connecting patients with exemptions with therapists trained in psilocybin assisted therapy. To this end, TheraPsil recognizes the importance of developing a pool of suitably trained and trusted clinical associates for referral purposes, and subsequently has created a training curriculum as the required context in which trainees may legally use psilocybin as part of their professional training. After 100 days of advocacy, on December 1st, 19 Healthcare Practitioners were granted their section 56 exemptions by Health Canada to legally consume psilocybin in the course of training. On March 1st, 2021 TheraPsil launched the beta-version of their training program, and to date, four training cohorts across the country have been launched with five more set to launch in the next three months.

Spencer Hawkswell, CEO of TheraPsil notes, “Natural psilocybin has been used for thousands of years, and now the science and medicinal benefits of psilocybin-assisted therapy are being proven not just on the clinical side, but in real settings with patients, delivering real life-changing results. Greater access to psilocybin therapy to reduce Canadian’s suffering is needed, and we are grateful for Optimi’s support of our on-going initiatives to facilitate compassionate access to patients in medical need across the nation, alongside professional training, public education and research.”

TheraPsil is a non-profit, Canadian organization that relies on donations to continuously advocate for Canadians in medical need. Every dollar donated will help TheraPsil advocate for psilocybin regulations in Canada through public education, research, and patient advocacy. Individuals interested in supporting the legalization of psilocybin therapy in Canada can support their current online fundraiser by clicking here. Corporate donors who are interested in becoming one of TheraPsil’s Core Spore Supporters are encouraged to reach out to TheraPsil’s Development Officer, Robyn Broekhuizen at Robyn@therapsil.ca.

Optimi Health’s Chairman JJ Wilson states, “Compassionate care for patients seeking relief from end-of-life situations is an ever-growing need. Patients living with on-going anxiety, depression, and related traumas deserve timely access to both the medicine and the therapeutic support. The philosophy behind TheraPsil is certainly in line with our views of all-natural human optimization as we aim to bring consistent dosing to natural psilocybin upon receipt of our dealer’s license. We are proud to support their upcoming efforts and hope the growing number of Optimi followers will take a moment to support their cause by visiting the TheraPsil website to consider how you too might help the efforts of this excellent organization.”

On Behalf of the Board of Directors, Optimi Health Corp.

Mike Stier
President, Chief Executive Officer and Director

ABOUT OPTIMI (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://optimihealth.ca/

FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

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Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans

Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans
Mydecine is well-funded to advance its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001

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By Uttara Choudhury

Mydecine Innovations Group Inc (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) is the first company to treat post-traumatic stress disorder (PTSD) and smoking cessation with the natural form of psilocybin (MYCO – 001).

The Denver, Colorado-based biotech is gearing up to launch a Phase 2A clinical trial on psilocybin-assisted psychotherapy to treat PTSD in veterans. Mydecine hopes to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting.

“We are waiting for final approval on our Investigational New Drug before launching our Phase 2A PTSD clinical study in the late third quarter, or early fourth quarter,” Mydecine co-founder and CEO Joshua Bartch told Proactive in an interview.

Psilocybin is a tryptamine that binds to serotonin receptor 5-HT2A in the brain. At certain doses, the psilocybin elicits profound changes in consciousness and has great potential in treating mental health disorders.

Mydecine is well-funded to grow its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001.

Roth Capital recently initiated coverage on Mydecine with a ‘Buy’ rating and a C$3 price target, citing the “blockbuster potential” of MYCO – 001 for PTSD peaking at “$3 billion five years after introduction (2027).”

Mydecine has identified four patentable lead drug candidates which include MYCO – 001, a pure psilocybin from natural fungal sources; MYCO – 003, a psilocybin-based formula with reduced anxiety potential; and MYCO – 004, a patch delivered tryptamine compound.

A serial entrepreneur, Bartch co-founded the Cannabase.io cannabis wholesale platform which was acquired by Helix TCS.

Proactive sat down with CEO Bartch to learn about Mydecine’s clinical calendar and how it is leading the charge in psilocybin and psychedelic-assisted therapeutics.

Proactive: What is Mydecine’s value proposition and why should investors care?

Mydecine has a very unique approach — we are focused on first and second-generation therapeutics derived from psychedelic molecules. The reason why this is important is our paths to approval. We have both short and long-term goals on that path and obviously the infrastructure to support both initiatives.

In our first generation, we are already in a Phase 2A PTSD and a late-stage addiction study. There’s our MYCO–001, a pure psilocybin from natural fungal sources. For the first time, a company has been able to take a natural fungal source, extract the psilocybin and take it down to 99.9% purity so it is analogous to the synthetic versions of the COMP360 products that are out in the market in clinical studies. But remember we are pulling it from a natural source, so we have full freedom to operate without infringing on any patents.

We have novel approaches to our second generation of medicines. We address things like controllability, reducing the experience time down to a more controllable hour or two depending on the indications — safety rails and we look at things like shelf stability. Psilocybin has a single molecule — it is not oxygen stable. We’ve been able to address that problem. As a single molecule psilocybin is also not skin permeable, but we’ve tailored a molecule to permeate the skin through unique fast delivery mechanisms, while making the uptick time and controllability more accurate.

By acquiring NeuroPharm and Mindleap Health, Mydecine has increased its assets and diversified into telehealth. Will acquisitions be a part of your growth strategy?

There’s definitely going to be a number of M&A transactions and consolidations as the industry progresses. You have a company like Mydecine that is well along its journey to the NASDAQ. We’ve raised tens of millions of dollars and have very solid infrastructure globally with approved clinical sites. With our exclusive partnership with Applied Pharmaceutical Innovation and the University of Alberta, we can literally go from A-to-Z on drug development with full cGMP certified pharmaceutical manufacturing capabilities on-site and in-house as well. You are going to start to see this divide between new companies that have smaller balance sheets, but potentially good IP. And later stage companies like Mydecine that have larger balance sheets and are further along in their market journey who will be able to acquire a number of these companies.

What is the kind of work that is being done at the Mydecine Center of Mycology?  

Our functional mushroom research happens in Denver, Colorado at our 7,500 square feet advanced mycology lab. This world-class lab is built around exploring medicinal mushrooms and the vast array of fungi medicinal compounds, which could potentially cure some of life’s biggest problems. We are looking at mushrooms like cordyceps, Lion’s Mane, reishi and others. We are breaking them down to the molecular level and developing unique IP around different genetics and compounds.

Our Chief Scientific Officer Robert Roscow is a well-known geneticist and worked at Canopy Growth and Ebbu where he ran their genetics division. He was the first to use CRISPR/Cas9 technology on the cannabis plant to isolate different character traits. We are doing the same thing with functional mushrooms and medicinal mushrooms, looking at what are the compounds of interest in these mushrooms.

You are evaluating PTSD, addiction, depression, anxiety, and other mental health conditions. Where are you with your clinical trials?  

In regard to PTSD, we have multiple global test sites — three in the US, three in Canada, which are all very well-known and prolific, and then there are two in Europe. We are carrying out clinical trials in three continents for the Phase 2A study of psychedelic treatments for PTSD in veterans and EMS personnel to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting. We are waiting for final approval on our Investigational New Drug enabling studies before launching our Phase II PTSD clinical study this year.

We are taking the value that is currently present in natural molecules, such as the psilocybin molecule in MYCO-001, and adding in patentable safety features. MYCO – 001 is likely to be used at mid to late-stage clinical trials. In addition, we have a later stage addiction study that we will be launching later this year, or early next year.

So, you have an advanced clinical program calendar?

That is definitely a yes!

Mindleap is the only digital health platform that combines traditional telehealth with psychedelic medicine and mood, emotion, behavior tracking and analytics. Tell us about Mindleap.

We have invested significant time, money, and resources in Mindleap. We appointed William Cook as the interim CEO. At Raytheon, Cook designed the Patriot missile system software parameters for the US Army. He is a systems architect by profession and has a Master’s degree in marriage and family therapy. A West Point grad, Cook has been involved in massive builds and also has artificial intelligence expertise.

We have revamped Mindleap’s capabilities. At its core Mindleap was aimed at solving the issues that you have with psychedelic-assisted psychotherapy. You are looking at protocols that have tens of hours of psychotherapy associated with a single treatment. This is not accessible to everyday people as you have a limited number of locations/ketamine clinics where people can actually go and get treatments.

But when you look at the protocols, nine-tenths of the equation are therapy interactions between patient and therapist without any substance taken. These are interactions pre-and post-experience, and you have one or three possibly under the influence of a substance throughout the whole protocol. So, to be able to administer the treatments — seven, eight, or nine-tenths of the equation remotely — through a HIPAA-compliant telehealth app with trained professionals versed in the protocols is incredibly advantageous.

Mindleap 2.0 is set to launch in the coming weeks with more robustness to the platform. We have an educational platform that will share videos from top professionals, as well as audio clips with experts discussing what are psychedelics, how do they interact with our brains, what are the safety profiles of different substances, and what are the success rates? These are open questions and people don’t have easy access to professional advice.

Now you have this community-based app that individuals can go on for a low monthly subscription rate. They can not only access groups, and information, but find yoga, meditation, breathwork therapy classes, and ancillary services that promote overall mental health. We are incredibly excited about the overall product that we’ve been able to deliver.

Where do you see the psychedelic therapeutics industry five years from now, and what does this mean for your company?

You are going to see incredible advancement in the science behind these molecules and FDA approvals on a number of molecules for different indications — actually see real life treatments for individuals that have been suffering for ages with really no viable solution. We hope to be one of those making significant progress on clinical trials and the regulatory front.

Separately, one of the biggest hurdles to adoption is public acceptance of psilocybin and psychedelics. You’re looking at a substance that’s been taboo and is talked about as a party drug. However, when you look at the safety profiles of these substances, comparatively speaking to serotonin reuptake inhibitors (SSRI), a class of drugs that are typically used as antidepressants, they’re not even in the same ballpark in terms of their safety profile. Studies have shown that psilocybin and MDMA have no long-lasting effects.

Patients are also looking at one to three psychedelic-assisted therapy sessions to round out the whole protocol, compared to taking a pill every day of their lives. Most importantly, it is a curative solution, a very different proposition from popping a pill every day and feeling maybe better, maybe not! It’s a matter of time before the FDA grants approval for psychoactive compounds and psilocybin to be used therapeutically. Then you will see them enter the mainstream with profound implications for psychiatry and the treatment of mental disorders and addiction.

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Field Trip Health Ltd. Reports Fiscal Fourth Quarter and Full Year 2021 Financial Results

  • Field Trip completes FY2021 as the largest vertically integrated psychedelics company positioned to be a leader in the emerging industry
  • Continues to leverage its early mover opportunity by investing in its drug development strategy and the build out of a globally recognized brand of psychedelic-assisted therapy centers
  • Closed FY2021 with $111,817,443 in unrestricted cash and cash equivalents, funds held in trust and short-term investments after successfully completing two bought deal offerings for gross proceeds of $115 million
  • Development of FT-104, a novel psychedelic molecule with pending patents, continues to progress with GMP production underway in preparation for Phase 1 studies
  • 6 Field Trip Health centers have commenced operations and are in early stages of ramp up to break-even; Q4 2021 patient services revenues grew by 66% over previous quarter to $526,435
  • Construction completed in Amsterdam, NL and construction underway on locations in San Diego CA, Seattle WA, Washington DC and Fredericton NB and, new leases have been signed for Field Trip Health centers in Stamford CT, Austin TX and Vancouver BC and construction will be commencing in San Carlos CA shortly
  • Field Trip is pleased to announce, due to the diversified demand coming from different patient demographic groups, an expansion of its offerings to include group Ketamine Assisted Psychotherapy (“KAP”) and group ongoing therapy for patients who complete the program.

TORONTO, June 24, 2021 (GLOBE NEWSWIRE) — Field Trip Health Ltd. (TSX: FTRP; FTRP.WT; OTCQX: FTRPF) (“Field Trip”), a leader in the development and delivery of psychedelic therapies, reported its fiscal year end results for the three and twelve months ended March 31, 2021. All results are reported under International Financial Reporting Standards (“IFRS”) and in Canadian dollars, unless otherwise specified.

Key Highlights and Developments During Fiscal Fourth Quarter 2021

During the fiscal fourth quarter, Field Trip continued to execute on its FT-104 drug development strategy and the buildout of a globally recognized brand of psychedelic-assisted therapy clinics, positioning it as an early mover in the emerging psychedelics industry, which could be a $100 billion market according to Canaccord Genuity. The Company anticipates that interest in, and demand for, psychedelic therapies will continue to rapidly expand over the coming years, and the clinic network will remain a pivotal asset to validate clinical outcomes in real setting.

On January 5, 2021, the Company closed its previously announced bought deal offering (the “January BD Offering”) and issued 4,448,200 Units at a price per Unit of $4.50 for gross proceeds of $20,016,900. Each Unit comprised one common share (“Common Share”) of the Company and one-half of one Common Share purchase warrant (each whole Common Share purchase warrant, a “Warrant”). Each Warrant entitles the holder thereof to purchase one Common Share (a “Warrant Share”) at an exercise price of $5.60 per Warrant Share until July 5, 2022. The Warrants commenced trading on the CSE under the symbol “FTRP.WT on January 5, 2021.

On March 17, 2021 the Company completed a bought deal offering (the “March BD Offering”) resulting in the issuance of 14,661,499 Common Shares of the Company at a price of $6.50 per Common Share for gross proceeds of $95,299,744. In consideration of the services rendered by the underwriters in connection with the March BD Offering, the Company paid a cash commission equal to $4,961,472 and issued 865,303 compensation warrants (the “Compensation Warrants”). Each Compensation Warrant is exercisable to acquire one Common Share at an exercise price of $6.50 per Compensation Share until March 17, 2023 The lead investor in the Offering was Soleus Capital with additional participation by Avidity Partners, Sphera Funds, Pura Vida Investments, Jennison Associates and other healthcare specialized institutional investors.

As at March 31, 2021 Field Trip had unrestricted cash and cash equivalents, funds held in trust and short-term investments of $111,817,443.

Operational Highlights

On January 7, 2021, the Company announced, subject to completion of a final site inspection, that its Toronto clinic has been selected as a trial location for a MAPS-sponsored study on the safety, feasibility and preliminary outcomes of MDMA-assisted therapy to treat eating disorders (the “Eating Disorder Study”), including Anorexia Nervosa. Field Trip will be hosting MAPS-trained therapists who will be providing MDMA-assisted therapy to an initial cohort of individuals suffering from Anorexia Nervosa, and collecting safety, feasibility and preliminary outcome data. Field Trip also announced that it is becoming a financial supporter of MAPS, committing to making an annual contribution of $50,000. Site selection is conducted independently by MAPS Public Benefit Corporation and is unaffected by charitable contributions to MAPS.

On January 26, 2021, Field Trip announced the opening of a location in Atlanta, GA. The opening of the Atlanta clinic represents Field Trip’s fifth operating location and the first in 2021.

On January 28, 2021, the Company announced that its common shares were approved for trading on the OTCQX® Best Market (“OTCQX”) retaining its current symbol FTRPF. At the time, Field Trip’s Common Shares and Warrants continued to trade on the CSE.

On February 9, 2021, Field Trip announced the official opening of the Field Trip Natural Products Limited Research and Development Laboratory for Psychedelic Fungi in Mona, Jamaica (the “Jamaica Facility”). The Jamaica Facility, which opened as part of Field Trip’s previously announced strategic partnership with the University of West Indies, is the world’s first legal research and cultivation facility dedicated exclusively to psilocybin-producing mushrooms and other plant-based psychedelics. The work at the new facility will leverage the research and development efforts that have been conducted by Field Trip at a temporary facility at UWI since January 2020, and will be broad-ranging, from genetics, breeding and cultivation work on many of the 180+ plus recorded species of psilocybin-producing mushrooms, to developing analytical methods for quality control, identification of novel molecules, as well as extractions and formulations for drug development purposes.

Joseph del Moral, Field Trip’s CEO, said, “Through our strategic and expeditious execution of our business plan in fiscal 2021, Field Trip has emerged as one of the foremost players in the psychedelics sector. Among other accomplishments, we commenced development work on, and filed provisional patent applications for, FT-104, our next-generation, psychedelic molecule. The pre-clinical studies suggest that FT-104 is a strong 5HT2A receptor agonist that can be delivered with high bioavailability and will produce a reliably short-duration of psychedelic experience in the range of two to four hours. This is approximately half the duration of psilocybin. We completed significant optimization and scale-up of the chemistry and GMP-compliant production is scheduled, as well as furtherance of the pre-clinical data package needed for human clinical studies.”

Dr. Ryan Yermus, Field Trip’s Chief Clinical Officer added: “In addition to our drug development work, we opened four Field Trip Health Centers during the year, with our fifth and sixth locations in Atlanta and Houston opening subsequent to year end, with more locations underway. The strategic importance of the clinics is to enable us to collect large amounts of data on clinical outcomes associated with the set, setting and therapeutic protocols of psychedelic therapies, to innovate new models of care and to identify areas of unmet need in psychedelics.

“We are also excited to be launching new therapeutic programs to increase patient access and clinical outcomes, including continuing therapy for patients who have completed KAP treatments, as well as group KAP offerings. These new offerings, along with other initiatives currently in development, reflect some of the insights generated from being an early mover with scale in a real-world clinical setting,” added Dr. Yermus.

Mr. del Moral said, “These initiatives have laid the groundwork for the business to scale in fiscal 2022, including the anticipated launch of Phase 1 clinical trials for FT-104, and the continued rollout of our Field Trip Health Centers. Since launching these clinics, we’ve demonstrated the remarkable success of our therapies with many of our patients reporting substantially improved depression and anxiety scores which has enabled us to generate a Net Promoter Score (NPS)* amongst patients who have completed our therapies of +66. We have a strong cash position to facilitate the execution of our strategic plan and are confident that our deeply integrated platform, which combines drug and product development, psychedelic-assisted therapies and technology-enabled virtual care solutions, will enable us to further our mission to bring psychedelic-based treatments to a broader audience.”

*NPS is a universally recognized metric for measuring customer loyalty. Field Trip’s score of +66 is based on patient feedback scores ranging from 0 to 10 for how likely they are to recommend Field Trip to their friends and colleagues. According to Survey Monkey’s global benchmark data, which accounts for the NPS of more than 150,000 organizations, the average NPS score is +32.

Subsequent Developments

On May 4, 2021, the Company announced the opening of its fifth location in the United States (and sixth overall) in the city of Houston, TX. The Houston location is the second Field Trip Health center to open in calendar year 2021. Field Trip also announced that it has entered into leases and has commenced, or will soon commence, construction to build Field Trip Health centers in San Diego, CA, San Carlos, CA, Seattle, WA, Washington DC and Fredericton, NB.

On May 6, 2021, Field Trip announced that its Common Shares became eligible for electronic clearing and settlement through The Depository Trust Company (“DTC”) in the United States. DTC is a subsidiary of The Depository Trust & Clearing Corporation, a United States company that manages the electronic clearing and settlement of publicly-traded companies. Securities that are eligible to be electronically cleared and settled through DTC are considered “DTC eligible.” This electronic method of clearing securities speeds up the receipt of stock and cash and thus accelerates the settlement process for investors and brokers, enabling the stock to be traded over a wider selection of brokerage firms.

On May 20, 2021, the Company announced the appointment of former US Senate Majority Leader Tom Daschle as a Special Advisor to the Company. Senator Daschle is one of the longest serving Senate Democratic leaders in history and one of only two to serve twice as both Majority and Minority Leader. In 1978, he was elected to the U.S. House of Representatives, where he served eight years. In 1986, he was elected to the U.S. Senate and was chosen as Senate Democratic Leader in 1994. Senator Daschle is also the Founder and CEO of the Daschle Group, a Public Policy Advisory of Baker Donelson and a legal and government affairs firm that advises clients on a broad array of economic, policy and political issues.

On June 7, 2021 Field Trip’s Common Shares and Warrants commenced trading on the Toronto Stock Exchange (“TSX”) under the ticker symbols “FTRP” and “FTRP.WT” respectively. The Common Shares continue to trade on the OTCQX market under the symbol “FTRPF”. In connection with the TSX listing, Field Trip’s Common Shares and Warrants were delisted from the Canadian Securities Exchange (“CSE”). In conjunction with its TSX listing, the Company announced that it has bolstered its Board of Directors with the appointments of Barry Fishman and Ellen Lubman. Mr. Fishman is an accomplished business leader and Board Director with proven success in strategy development, performance enhancement and public company governance, with an expansive global network and deep pharmaceutical knowledge. Ms. Lubman brings nearly 20 years of experience in corporate and business development, portfolio strategic planning, financial strategy and investor relations through leadership roles in small biotech and large pharma, starting her career as a Wall Street equity research analyst.

On June 8, 2021, the Company announced that it had applied to list its Common Shares on the NASDAQ Stock Market (“NASDAQ”). In advance of an anticipated listing on NASDAQ, Field Trip will file a Registration Statement with the United States Securities and Exchange Commission. The listing of Common Shares on NASDAQ remains subject to the review and approval of the listing application and the satisfaction of all applicable listing and regulatory requirements, as well as effectiveness of the registration statement. Field Trip will continue to maintain the listing of its Shares on the Toronto Stock Exchange under the symbol “FTRP”.

The Company also announced that it anticipates being able to commence Phase 1 human trials for FT-104 and expects to have 20 Field Trip Health centers operating or under construction by the end of December 2021, including its existing and announced locations in New York, NY, Toronto, ON, Los Angeles, CA, Chicago, IL, Houston, TX, Atlanta, GA, San Diego, CA, San Jose, CA, Seattle, WA, Washington, DC, Fredericton, NB and Amsterdam, NL.

Financial Highlights

For our fourth fiscal quarter ended March 31, 2021, we earned patient services revenues of $526,435 from our Toronto, New York, Santa Monica, Chicago and Atlanta clinics, a 66% increase over our third fiscal quarter patient services revenues of $316,329. Net loss for our fourth fiscal quarter of $7,950,590 was primarily due to general and administration expenses of $4,636,669, research and development expenses of $871,955, sales & marketing expenses of $675,068, patient services expenses of $586,328, depreciation and amortization of $539,321, occupancy costs of $433,279 and realized foreign exchange loss of $532,656. Net loss for our prior year’s fourth fiscal quarter of 2020 of $891,240 was primarily due to general and administration expenses of $1,062,141, sales and marketing expenses of $165,737, depreciation and amortization of $127,048 and research and development costs of $112,079, partially offset by a realized foreign exchange gain of $690,579.

For the fiscal year ended March 31, 2021, we earned patient services revenues of $960,655 from our Toronto, New York, Santa Monica, Chicago and Atlanta clinics, despite a temporary closure in Toronto from March to May 2020 and Chicago and Atlanta contributing revenues only beginning March 2021. We expect to scale our revenue as the number of patients treated at our locations increases, and with the addition of our Houston location, which just began treating patients in May 2021.

Net loss of $23,117,607 was primarily due to general and administration expenses of $11,161,893, research and development expenses of $3,417,690, listing expenses of $2,180,142 relating mainly to the Transaction, sales and marketing expense of $1,630,223, patient services expense of $1,544,328, realized foreign exchange loss of $1,578,142, depreciation and amortization of $1,394,404 and occupancy costs of $897,391. Net loss for the period ended March 31, 2020 of $2,628,324 was primarily due to general and administration expenses of $2,310,076, occupancy costs of $317,476, sales and marketing expenses of $305,710, research and development costs of $193,192 and depreciation and amortization of $146,320, partially offset by a realized foreign exchange gain of $667,526.

Selected Consolidated Financial Information

The following table sets forth selected financial information derived from the Company’s unaudited condensed interim financial statements for the three and twelve months ended March 31, 2021 and periods March 31, 2020, prepared in accordance with IAS 34 in a manner consistent with the Company’s annual audited financial statements.  The following information should be read in conjunction with the financial statements and management’s discussion and analysis, which are available on the Company’s website at www.fieldtriphealth.com and under the Company’s SEDAR profile at www.sedar.com.

3 months ended 3 months ended Fiscal Year Ended Period from April 2,
2019 (Date of
Incorporation) to
March 31, 2021 March 31, 2020 March 31, 2021 March 31, 2020
$ $ $ $
Revenue
  Patient services 526,435 1,000 960,655 1,000
  Other revenue – – 240 –
526,435 1,000 960,895 1,000
Operating Expenses
  General and administration 4,636,669 1,062,141 11,161,893 2,310,076
  Occupancy costs 433,279 94,624 897,391 317,476
  Sales and marketing 675,068 165,737 1,630,223 305,710
  Research and development 871,955 112,079 3,417,690 193,192
  Depreciation and amortization 539,321 127,048 1,394,404 146,320
  Patient services 586,328 9,403 1,544,328 9,403
7,742,620 1,571,032 20,045,929 3,282,177
Other Income (Expenses)
  Finance expense (74,214 ) (16,360 ) (252,259 ) (19,907 )
  Other expense (611,158 ) 695,152 (1,600,172 ) 672,760
  Listing expense (49,033 ) – (2,180,142 ) –
Net Loss (7,950,590 ) (891,240 ) (23,117,847 ) (2,628,324 )
Net Loss per Share – Basic and Diluted (0.18 ) (0.05 ) (0.70 ) (0.26 )
Cash and cash equivalents 38,469,057 9,590,758
Funds held in trust 795,516 –
Restricted cash 588,041 100,000
Short-term investments 72,552,870 –
Other Receivables 813,761 203,112
Total Assets 126,450,005 12,541,095
Total Non-Current Financial Liabilities 6,426,484 1,078,334

Conference Call

The Company will conduct a conference call and webcast to review its results the following day, Friday, June 25, 2021 at 8:00 am ET. To access the call, please dial 1-877-407-9716 or 1-201-493-6779 and provide conference ID 13720523. A live webcast of the conference call can be accessed via the Events and Presentations section of the Field Trip Health Investor Relations website or via the following link: http://public.viavid.com/index.php?id=145259

For those unable to attend the live call, a telephonic replay will be available until Friday, July 9, 2021. To access the replay of the call dial 1-844-512-2921 or 1-412-317-6671 and provide conference ID 13720523. An archived copy of the webcast will be available on the Events and Presentations section of the Field Trip Health Investor Relations website after the conclusion of the call.

About Field Trip Health Ltd.

Field Trip is a global leader in the development and delivery of psychedelic therapies. With our Field Trip Discovery division leading the development of the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics and our Field Trip Health division building centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools that will enable massive scale, we help people in need with a simple, evidence-based way to heal and heighten engagement with the world.

Learn more at https://www.meetfieldtrip.com, https://www.fieldtriphealth.com and https://www.fieldtriphealth.nl.

Follow us on Twitter and Instagram: @fieldtriphealth

To receive company updates about Field Trip and to be added to the email distribution list please sign up here.

For further information, contact Ronan Levy, Executive Chairman and a Director at Field Trip, at 1 (833) 833-1967.

Cautionary Note Regarding Forward-Looking Information 

This release includes forward-looking information within the meaning of Canadian securities laws regarding Field Trip and its business. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such statements are based on the current expectations and views of future events of the management of Field Trip, and are based on assumptions and subject to risks and uncertainties. Although the management of Field Trip believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the companies, including risks regarding listing of our common shares on NASDAQ, the timing and results of its research and development programs, the opening of additional clinics, the COVID-19 epidemic, the medical clinic industry, market conditions, economic factors, management’s ability to manage and to operate the business and the equity markets generally. Although Field Trip has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Field Trip does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Neither the Toronto Stock Exchange, nor its Regulation Services Provider, nor the OTC Markets have approved the contents of this release or accept responsibility for the adequacy or accuracy of this release.

Media contacts:
Rachel Moskowitz
Autumn Communications
202-276-7881
press@fieldtriphealth.com

Nick Opich / McKenna Miller
KCSA Strategic Communications
212-896-1206 / 347-487-6197
press@fieldtriphealth.com

Investor contacts:
Elizabeth Barker
KCSA Strategic Communications
212-896-1203
ebarker@kcsa.com

SOURCE Field Trip Health Ltd.

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MYND Life Sciences Expands Intellectual Portfolio to Target Alzheimer’s disease and related forms of Dementia with Chemical Subclasses of Psilocybin Analogues

VANCOUVER, BC, June 23, 2021 /CNW/ – MYND Life Sciences Inc. (CSE: MYND) (“MYND“) a drug research and development company focused on novel psychedelic drug development, diagnostic approaches and pharmaceuticals, is pleased to announce it has expanded its intellectual property portfolio for diseases of the central nervous system, including methods for treating or delaying Alzheimer’s disease and related forms of dementia.

MYND’s research team has shown significant progress in advancing its proprietary technologies that may impact central nervous system diseases including Alzheimer’s disease and other forms of dementia by possibly delaying or in some instances potentially reversing the progress of these forms of diseases. MYND has bolstered its novel drug discovery pipeline by commencing preclinical testing of chemical subclasses of psilocybin analogues with the goal to enter clinical trials to treat Alzheimer’s disease and other related forms of dementia.

“Our preclinical research is uncovering new therapeutic approaches and we plan to exhaustively explore these new leads for treating Alzheimer’s disease and other dementias,” stated Dr. Wilf Jefferies, MYND’s Chief Science Officer.

The World Health Organization estimates that between 44 and 50 million people worldwide are suffering from Alzheimer’s disease or related forms of dementia. That includes approximately six million Americans and nearly one million Canadians suffering from dementias.

“Diagnosing, preventing and treating diseases of the central nervous system is at the core of our focused corporate strategy,” said Dr. Lyle Oberg, CEO of MYND Life Sciences. “Alzheimer’s disease affects millions of people around the globe and remains a catastrophic condition without a cure. MYND’s intellectual property holdings have recently been expanded to address unmet needs in treating Alzheimer’s disease that may create significant value for MYND shareholders.”

For more information and to subscribe to the Company’s mailing list, please visit https://myndsciences.com/contact/

ABOUT MYND LIFE SCIENCES

MYND Life Sciences is a medicine biotech company focused on neuro-pharmaceutical drug development. The Company is advancing medicinal substances through rigorous science and clinical trials.

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information 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 state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release.  

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

SOURCE Mynd Life Sciences Inc.

For further information: CONTACT INFORMATION: Dr. Lyle Oberg, CEO, Email: ir@myndsciences.com, Web: www.myndsciences.com

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Roth Initiates Coverage On Mydecine Innovations With A 9x Price Target

By Shadd Dales

Investors of Mydecine Innovations Group (NEO: MYCO)(OTCMKTS: MYCOF) received a pleasant surprise Tuesday morning, drawing coverage from a firm that is making itself known in the psychedelics industry. Roth Capital Partners (RCP), a privately-owned investment banking firm dedicated to the smallcap public market—bestowed an eye-opening price target that instantly captured the market’s attention.

RCP initiated coverage on Mydecine with a “Buy” Rating and C$3.00 price target, which is a 916.94% premium to MYCO’s closing price of $0.295/share before market open on June 22. Not only did RCP recommend that investors buy Mydecine, it is projecting the company to rise 9-fold within the next twelve months. Quite the conviction call for a company in deep penny-stock territory in a sector which has been sputtering.

In its research note, the investment bank cites numerous catalysts to support its investment thesis, including:

• Mydecines ability to be the first psychedelic company to potentially use psilocybin to the PTSD and smoking cessation markets worldwide

• Mydecine plans to initiate and complete advanced clinical trials in PTSD (currently in Phase 2A) and smoking cessation with potential milestone achievements upcoming within 18-24 months

• Blockbuster potential for smoking cessation, in which research compound MYCO-001 could be introduced to the U.S. market in 2026; with a very small peak market penetration of 0.5%, the drug could have the potential to achieve approximately $2.5B in sales by 2031

Valuation

Roth’s 12-month price target of C$3/share is determined by calculating the after-tax, risk-adjusted net present value (NPV) of possible future cash flows from MYCO–001 projects. In their estimate, the probability-adjusted, fully taxed (21%) NPV (15%) of anticipated cash flows through 2035 is $1.1 billion, (US$2.50/share or C$3/share), matching its 12-month price objective.

Of course, Roth’s projections come with numerous forward-looking assumptions that are far from conclusive. The price target uses anticipated cash flows from a drug that hasn’t cleared Phase 2 trials, faces competing therapeutic research and won’t be on the market for another five years, at minimum.

But it also underscores the incredible rewards that wait for those that break through. Mydecine, engaged in Phase 2 trials and with target compounds selected, has a strong inferred risk/reward profile according to Roth. The market seemingly agrees, pushing Mydecine higher +16.95% on Tuesday on its best volume in six weeks.

TDR will have further coverage as events warrant.

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Mydecine to Participate in the ROTH Virtual Healthcare Private Company Forum on June 28th

DENVER, June 23, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, today announced that Josh Bartch, CEO of Mydecine, will participate in the ROTH Healthcare Private Company Forum to be hosted virtually on Monday, June 28, 2021.

Mr. Bartch will speak on the panel titled Next Wave of Psychedelic Drug Developers at 11:00 a.m. ET. To attend, register here.

For more information about the ROTH conference, or to schedule a one-on-one meeting with Mydecine management, please contact KCSA Strategic Communications at MYCO@kcsa.com.

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

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

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

For more information, please contact:

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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MindMed Receives FDA Type C Meeting Response for Project Lucy Phase 2b Clinical Trial

MindMed Finalizes Clinical Development Approach for LSD Targeting Generalized Anxiety Disorder as Initial Indication

MindMed (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), a leading clinical stage psychedelic medicine company, announces receipt of Type C Meeting Responses from FDA leading to the finalization of the Company’s clinical development approach for Project Lucy by selecting Generalized Anxiety Disorder as an initial indication. MindMed is on target to formally submit its Investigational New Drug (IND) application for Project Lucy in Q3 2021 and expects to launch its Phase 2b clinical trial shortly thereafter in Q4 2021.

As an extension of the positive pre-IND meeting held with the FDA in December 2020, MindMed sought further agreement from the FDA on the Company’s clinical approach for the development of LSD in the treatment of anxiety disorders. In line with positive FDA feedback, MindMed will pursue the treatment of Generalized Anxiety Disorder as its first indication. The clinical development program is scheduled to advance in late 2021 with the launch of Study MMED008, which is a Phase 2b dose-optimization study of LSD in approximately 200 patients diagnosed with Generalized Anxiety Disorder. This study, with clinical sites mainly in the United States, will assess improvements in anxiety symptoms following a single administration of LSD and will be the catalyst to select a final dose to be taken forward into Phase 3 pivotal clinical trials.

“We are excited by the productive discussion with the FDA to date and by the finalization of MindMed’s clinical approach to advance LSD in the treatment of anxiety disorders, beginning with a Phase 2b clinical trial for Generalized Anxiety Disorder. This approach both provides a clear regulatory pathway to advance LSD to possible approval and leverages the vast experience of Dr. Liechti and our UHB collaborators, including the Phase 2 clinical trial studying LSD in patients with anxiety.” said Rob Barrow, Chief Development Officer of MindMed. “Further, the results of this Phase 2b dose optimization study we believe could significantly advance our scientific understanding of both the clinical effects of LSD and the underlying mechanisms of action that predict clinical response.”

Generalized Anxiety Disorder is a chronic, often debilitating mental health disorder that affects approximately 6% of US adults in their lifetimes. Symptoms of Generalized Anxiety Disorder include excessive anxiety and worry that persists for over six months, which can lead to significant impairments in social, occupational and other functioning, according to the National Institute of Mental Health (NIMH). While there is substantial diagnostic overlap between Generalized Anxiety Disorder, Major Depressive Disorder and other major mental health disorders, there has been very little innovation focused on the treatment of Generalized Anxiety Disorder in the past several decades.

MindMed Chief Medical Officer Dr. Dan Karlin said: “Anxiety is a universal feature of the human experience. At times, we all anticipate potentially uncomfortable and unfortunate future events. Aversive anticipation is a central and and distressing feature of daily life for many. Worse still is the lurking awareness of our own mortality, and the existential dread that this knowledge can carry with it. Though depression syndromes, in particular Major Depressive Disorders, have been a major focus of drug development activity in recent decades, we see anxiety as being both core to the suffering of many diagnosed with depression, and a symptom that cuts across a number of other psychiatric disorders.”

At present, most anxiolytics are oriented toward suppression of the conscious experience of anxiety. Existing medications are taken in anticipation of one’s future anxiety, as a reaction to a contemporaneous sense of heightened anxiety, and in anxiety’s most acute manifestation, to avert panic attacks.

“In studying the treatment of Generalized Anxiety Disorder through Project Lucy, MindMed hopes to help patients address the underlying sources of their anxieties to produce meaningful, sustained improvement across all aspects of their lives,” said MindMed Chief Medical Officer Dr. Dan Karlin.

About MindMed
MindMed is a clinical-stage 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 MindMed’s approach to developing the next generation of psychedelic inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

Forward-Looking Statements
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is 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 “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes statements regarding the timing of the submission of the IND, the timing of the launch of the Phase 2b clinical trial, the ability to determine a final dose for a future Phase 3 clinical trial or that a future Phase 3 clinical trial will occur, that there is or will be a clear regulatory pathway to LSD approval, that the Company’s knowledge of the product or dosage will be advanced by the Phase 2b study, the ability of the Company to produce a product to address underlying sources of anxiety and improve the lives of those suffering from GAD and, if such a product is developed, that it will have the desired effects. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. 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 and does not assume any obligation to update this forward-looking information.

Media Contact: mindmed@150bond.com