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Numinus and Syreon Provide Psilocybin Compassionate Access Trial Update

Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage

VANCOUVER (March 2, 2021) – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies (PAP), and Syreon Corporation (Syreon), a global contract research organization with expertise in conducting clinical trials across a broad range of diseases, are pleased to share that significant progress has been made in the single-arm, open-label compassionate access* trial of Psilocybin-Research Intervention with Motivational Enhancement (PRIME) for substance use disorders. Currently in the development stage, the PRIME study will assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy.

The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. The study will take place in Vancouver and will enroll 30 individuals with opioid, stimulant and/or alcohol use disorders. Syreon is leading the trial as Clinical Research Organization (CRO) with Numinus as the trial sponsor.

Numinus is pleased to share that several key milestones have been met since the trial was announced in November. The protocol is now finalized, having gone through two rounds of external expert peer review by a leading psychedelic research foundation. The overall structure selected for this protocol is consistent with current best practices developed internationally for psilocybin-assisted treatment. The psilocybin administration will occur in the context of a behavioural intervention consisting of motivational enhancement therapy, which is a structured counseling approach based on principles of motivational psychology and is designed to produce rapid, internally motivated change.

“Syreon is pleased to partner with Numinus to conduct this ground-breaking study in substance use disorders,” says Paul Keown, founder and CEO of Syreon. “These are among the most complex and challenging areas of modern healthcare, with enormous clinical and societal consequences. Psilocybin is a promising new therapy for personalized care in this field, and Numinus and Syreon combine the deep medical knowledge and broad trial expertise required for expert research in this expanding area of natural bioactive therapeutics.”

Numinus is also proud to announce the appointment of several key members to the study, including Dr. Lindsay Mackay, MD, CCFP, a clinician-scientist and addictions specialist who has been selected as Principal Investigator. Dr. Mackay is a graduate of the British Columbia Centre on Substance Use, NIDA-funded International Collaborative Addictions Medicine Research Fellowship, and has extensive experience in the exploration of psychedelics and novel therapies as treatments for mental health and addictions. Elena Argento, PhD, MPH, has been appointed Co-Principal Investigator. Argento works collaboratively with the BC Centre on Substance Use to conduct and lead innovative research and interventions in response to the overdose crisis and is a Postdoctoral Researcher at the University of British Columbia.

While psilocybin remains a restricted substance in Canada, the evolving regulatory landscape has shown the potential to enable greater accessibility to psilocybin-assisted psychotherapy, particularly in light of Health Canada’s recent announcement of its intention to revise the Special Access Programme (SAP). The PRIME trial is expected to contribute to the growing interest in expanding access to psilocybin-assisted treatments.

“We have made important progress to develop the framework and a team of experts to conduct this compassionate access trial that will contribute meaningful insights to treatment methods for individuals with opioid, stimulant and/or alcohol use disorders,” said Dr. Evan Wood, Chief Medical Officer, Numinus.

Several new objectives are underway in preparation for the implementation phase, with Syreon, as CRO, initiating study materials. Numinus will continue the ongoing establishment of physical, technical, and human resource infrastructure to support the Compassionate Access trial, with the aim of enabling wider delivery through the SAP, if approved.

*Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” (Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation.

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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.

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

About Syreon Corporation
Syreon provides a full suite of adaptive clinical trials, health economics and outcomes research ensuring safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.

Syreon partners with an elite portfolio of global pharmaceutical corporations and early-stage biotech companies to speed the evaluation of new therapies and improve health outcomes. Its expert research services identify precise therapeutic needs, rapidly evaluate new health interventions, monitor clinical use and define optimal economic value in today’s competitive health environment.

Syreon scientists have contributed to many groundbreaking innovations, from the first blockbuster signal inhibitors, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, stem cell therapeutics and other recent initiatives in precision medicine.

Syreon’s head offices in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, providers, purchasers and payers. Our services through all phases of study planning, operation, analysis and reporting ensure safe, effective and value-driven clinical use.

www.syreon.com

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, 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. 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.

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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Mydecine Innovations: Unlocking Fungi’s Pharmacological and Nutraceutical Healing Properties

Published at The Dales Report

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By Benjamin A. Smith

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Mydecine Innovations: Unlocking Fungi’s Pharmacological and Nutraceutical Healing Properties

In the world of early-stage psychedelic investing, leadership matters. With future revenue streams uncertain and developmental roadmaps being devised from scratch, innovation and management competency are high on the list of investor considerations. Enter Mydecine Innovations, whose A-to-Z psilocybin research model rivals or exceeds many larger market cap peers in the sector.

What Does Mydecine Do?

Above all else, Mydecine is an industry leader in the study of mycology, or the branch of biology concerned with the study of fungi—including its genetic and biochemical properties. Throughout history, mycology research has led to the development of important antibiotic drugs such as penicillin, streptomycin, and tetracycline, as well as cholesterol-lowering statin drugs. While it’s possible the company might back into a similar non-core discovery, the company is targeting different therapeutic areas altogether.

Mydecine is somewhat of a paradox in that it is both operationally diverse, yet has a very simple mission statement. Through its vertically-integrated operations, it aims to become a leader in the cultivation, processing, product development, and research and development of various strains of mushroom and fungi from all around the world; to unlock the full potential of fungi in both pharmacological and nutraceutical domains. Thus, Mydecine is in a unique position of being able to monetize an array of pharmaceutical and CPG pathways—specifically relating to mental health and wellness applications.

On the clinical side, Mydecine is best known for its upcoming international Phase 2A study that will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at various clinical sites across three continents in an effort to establish the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.

Although Mydecine’s trial is objectively behind Compass Pathways’ Phase 2b psilocybin-assisted therapy study for treatment-resistant depression, it is perhaps the most comparable psilocybin assisted-therapy based study among Compass’ competitors trading on the public markets. The companies are targeting different indications, however, depression and its many subsets share intertwining affinities.

Mydecine is also sponsoring an important study to determine whether microdosing leads to changes in novelty perception or pattern recognition. The study titled: “Neurocognitive Effects of Low Dose Psychoactive Substances” will take place at Australia’s Macquarie University and will helping to build a database library to help the company understand microdosing works. Such understanding will help build a foundation for future intellectual property development and clinical trial design.

Scientific Advisory Board member Dr. David Erritzoe has previously helped execute a large-scale microdosing study co-sponsored by the National Institute for Health Research at Imperial College of London.

Mydecine Research & Development/IP

Mydecine has the ability to oversee all areas of drug development—from the production of Psilocybe mushrooms to its synthesis to product commercialization and distribution. Central to this vertically-integrated strategy is the company’s seven patent pending applications representing multiple layers of protection on its drug development pipeline and technology assets.

By developing a greater understanding of the therapeutic properties of fungi-based compounds, Mydecine is creating novel intellectual property around specialized mental wellness solutions. Spearheaded by Chief Scientific Officer Rob Roscow, its patent portfolio is designed to unlock innovative medication design and distribution pathways, accurate dosable formulations and emerging developments for increased use of psilocybin in a medical setting.

Central to this strategy is Mydecine’s industry-leading psychedelics telemedicine platform, which is an instrumental part of its assisted-therapy support system.

The company recently announced that it has filed a provisional patent for its Mindleap Health technology platform in both The United States Patent and Trademark Office (USPTO) and the Canadian Intellectual Property Office. The app combines mood, emotion and habit tracking allowing users to purchase and receive virtual mental health coaching from an international network of specialists.

Can Psychedelic-Focused Telemedicine Apps Take A Bite From The Apple?

With the global telemedicine market worth an estimated USD 41.4 billion (2019) and expected to grow at a CAGR of 15.1% until 2027, Mydecine is seeking to protect this first-mover application. With web/mobile based delivery model expected to witness significant growth in the coming years, the Mindleap app offers direct access-to-care delivery solutions. It’s perhaps an underappreciated asset which should provide supplementary value along Mydecine’s assisted-therapy delivery chain.

On the research & development side, 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. The Mydecine Center of Mycology (MYCOM) features a 7500 sq. ft mycology lab, full-scale commercial fungi cultivation capabilities, mass spectrometer equipment… the works. It is here that Mydecine will attempt to unlock the science behind the mushroom, and parlay its research into new intellectual property, psilocybin and nutraceutical formulations. Longer term, the company has devised a planned expansion to research psilocybin under DEA licensure as regulations allow.

In Canada, Mydecine has established an R&D partnership with Applied Pharmaceutical Innovation (API) through the Alberta Faculty Of Pharmacy And Pharmaceutical Sciences out of the University of Alberta. The relationship provides Mydecine with many tangible benefits, including:

  • Access to a full cGMP certified pharmaceutical manufacturing facility
  • Ability to import/export, extract, and analyze psychedelic medicine with full government approval through Health Canada Schedule 1 Substances and Drugs Dealer’s License
  • Access to a wide range of world-class scientific researchers
  • Artificial intelligence capabilities to identify biosynthesis pathways for medicine discovery, optimize targeted medicine delivery systems and to design marketable medicinal compounds

Whether through organic developmental research or through collaborations at major universities, Mydecine is committed like no other when it comes to understanding fungi in pharmacological and nutraceutical contexts. The bet for investors is that its heavy R&D emphasis will eventually translate into mental wellness therapies and applications that can be monetized in many diverse ways.

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Psychedelic Special Task Force – Report on Psychedelics

Numinus and MAPS reach trial milestone

In a first-of-its-kind trial in Canada, Numinus Wellness (CSE: NUMI) has partnered with MAPS Public Benefit Corporation to collaborate for research on MDMA-assisted therapy. The “single-arm, open-label, compassionate access 1” trial has met several key milestones to enter a pre-implementation stage.

Aiming to expand access and treatment options to patients with PTSD, these significant developments will help gain better understanding of psychedelic-assisted psychotherapies as viable, safe, and necessary.

Who’s who?

  • Eight Numinus therapists working on this trial graduated in November 2020 from Part B of the MAPS-standardized MDMA therapist training program.
  • Dr. Devon Christie, Medical & Therapeutic Services Director at Numinus, was trained in this program and will serve as both the trial’s Principal Investigator and as a therapist.
  • MAPS Public Benefit Corporation, a subsidiary of MAPS, was formed to develop healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics.

Neither the FDA or Health Canada have approved this therapy just yet. The safety and efficacy of MDMA-assisted psychotherapy are still under investigation.

NYU Langone and MindMed launch psychedelic center

Operating with an endorsement by NYU Langone’s Department of Psychiatry, the one-of-a-kind health center continues to advance progress in psychedelic medicine through their Psychedelic Medicine Research Training Program.

The program will support development of early-career faculty members and post-doctoral fellows to become independent investigators in the field of psychedelic medicine. Treatment models & training programs developed at the center will scale psychedelic medicines into mainstream adoption by psychiatrists & therapists in America.

They have a lot going on.

Research at the center has and still focuses on the treatment of advanced cancer-related psychiatric and existential distress, addiction, major depression and PTSD.

  • Phase II clinical trial nearing completion to examine the use of psilocybin in treating alcohol use disorder, and developing a Phase II/III trial.
  • Phase II study from 2016 is now in Phase III development, with a funding proposal under review with the National Cancer Institute.
  • Recruitment underway for Phase II study to evaluate the efficacy of psilocybin in the context of “set and setting” therapy for individuals with major depressive disorder.
  • Recently completed a Phase III study on the safety and efficacy of psychotherapy utilizing MDMA for treatment of severe PTSD, and began recruitment for a second Phase III study.
  • Other studies are examining the use of psychedelics for disorders including chronic pain, end-of-life psychotherapy, opioid & tobacco addiction, and more.

Philanthropic efforts have kept the momentum going.

Major philanthropic support from donors have enabled medical breakthroughs and totaled over $10 million in support for studies at NYU Langone.

  • MindMed (OTCM: MMEDF) leads the way with $5 million contribution.
  • Scientist & philanthropist Carey Turnbull: $1 million
  • Private investor Alan Fournier: $2 million
  • President of the Usona Institute, Bill Linton: $1 million
  • Other significant donors include the George Sarlo Foundation, Cody Swift of the Riverstyx Foundation and Dr. Bronner’s Soaps.

Massachusetts is looking to decriminalize all drugs

It’s clear that current drug enforcement regulations are creating an unjust number of arrests and prosecutions in fragile communities. That’s why lawmakers introduced legislation in Massachusetts aiming to end the state’s war on drugs, which has disproportionately targeted racial minorities.

The statewide bill HD.3439 was introduced on Friday to challenge current criminal penalties for the possession of controlled substances in Section 34. These efforts come alongside bills SD.2248 and HD.3829 that aim to solve racial injustice and evaluate the impact of these new regulations.

What are they trying to pass?

  • Remove criminal penalties for possession of all drugs.
  • Legalize and regulate psychedelic substances, including possession, consumption, transportation, and sale of entheogenic plants and fungi.
  • Establish a 21-person task force to conduct studies on entheogenics.
  • Civil fine of up to $50, or submitting to screening for health and economic evaluation in order to provide services to the individual rather than an economic punishment.
  • Completion of this screening won’t be deemed as an admission of criminal charges.
  • Failure to pay the fine won’t incur penalties or incarceration.

What’s up with this “task force”?

  • They will develop recommendations:
    • On how to legalize psychedelic substances “in a manner that maximizes equitable access and sustainable manufacture of these plants.”
    • Regarding “pardons, parole, diversion, expungement, and equity measures” for people with prior criminal records due to possession, or distribution of these substances.

These recommendations will be used to draft legislation to be put into effect no later than June 2022.

UC San Diego researchers are exploring psychedelics to treat phantom limb pain

Imagine losing a limb yet still experiencing chronic pain out of thin air. The phenomena, known as ‘phantom limb’ is a commonly debilitating sensation that a limb is still physically there, because the brain interprets it as such.

The result is lingering pain with no effective solution for up to 80% of the world’s 40 million amputees (according to WHO).

Study Details

Timothy Furnish, MD, clinical professor of anesthesiology at UC San Diego School of Medicine had this to say:

  • The clinical trial will enroll 30 amputees suffering from phantom pain to receive 25 milligrams of psilocybin; another 30 will receive a placebo (niacin).

The trial will assess pain and psychological functioning, including magnetic resonance imaging.

Awakn announces AUD study results

The world’s first MDMA clinical trial addressing alcohol use disorder (AUD) has now provided definitive, promising results. The outcome of the study conducted by Awakn Life Sciences: all patients tolerated the treatment well, and with no adverse reactions. Further trials will now ensue.

  • Dr. Ben Sessa, Chief Medical Officer at Awakn, conducted the Bristol Imperial MDMA in Alcoholism (BIMA) trial.
  • The study evaluated patients’ drinking behavior, quality of life and psycho-social functioning.
  • Phase IIb study in the UK will now proceed. It will be a double-blind, placebo-controlled clinical trial to further investigate safety and efficacy of MDMA.

This is a really big deal.

  • The first clinical research study using MDMA-assisted psychotherapy to treat any addiction, and it was totally successful! Improvements by all measures were clinically observed.
  • Currently available treatments are greatly ineffective, with a high rate of relapse.
  • Alcohol abuse is the most prevalent substance disorder in the world, and one of the top 5 causes of disease and disability in Europe.
  • In the UK, alcohol is the leading cause of diseases for over 20% of the adult population.
  • It’s expected that the COVID-19 pandemic will make matters worse.

Report Readout

Frontier Acquisition Corp, a special purpose acquisition company (SPAC) sponsored by German investor Christian Angermayer, a major backer of COMPASS, will launch biotech SPAC in the U.S.

Mindset landed an international contract to develop and manufacture synthetic psilocybin.

Mind Cure adds global technology leader Robert C. Hill to Board of Directors.

Edmonton psychiatry professor founding new company by studying psychedelic effects on mental health.

Columbia professor turns heads with bold statements on his recreational use of drugs.

Psychedelic drug therapy now offered at Calgary clinic to treat depression, anxiety, PTSD.

Universal Ibogaine Inc. announces appointment of Dr. Rami Batal as Chief Executive Officer.

PharmaTher to collaborate with Terasaki Institute for Novel Microneedle Delivery of Psychedelic Pharmaceuticals.

Therapists could be influencing mystic, spiritual experiences and meaning while patients are on psychedelics.

Entheon Biomedical and Science in Action received ethics approval for in vivo non-GLP toxicology study of DMT.

Hawaii bill dies in session, opposed by the state Department of Health as well as county police departments.

Field Trip Health secures $50 million offering of common shares with Bloom Burton Securities Inc.

DEA gives green light for Psilera’s mission to study new DMT and psilocybin treatments for central nervous system disorders.

Optimi Health Corp goes public, completing a $20.7 million IPO.

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Delic To Acquire Complex Biotech Discovery Ventures LTD

VANCOUVER,BC, Feb. 25, 2021 /CNW/ – Delic Holdings Inc. (“DELIC” or the “Company“) (CSE: DELC) (OTCQB: DELCF), a psychedelic wellness-focused company, is pleased to announce it has executed a definitive share purchase agreement (the “Agreement“) to acquire all of the issued and outstanding shares in the capital of Complex Biotech Discovery Ventures (“CBDV“), a licensed psilocybin and cannabis research laboratory focused on extraction, analytical testing, and chemical process development (the “Transaction“). Founded by award-winning chemist, Dr. Markus Roggen, and UBC Professor, Glenn Sammis, CBDV supports the psychedelic industry with high precision chemical analytics and metabolomic identification. Following the Transaction, CBDV expects to change its name to “DELIC Labs”.

Transaction Highlights

  • The acquisition of CBDV will further establish DELIC as a diversified psychedelics organization: The addition of CBDV will allow DELIC to add scientific-based research and analytics to its product offerings. CBDV recently received its Section 56 Exemption granted by Health Canada, enabling CBDV to focus on research and intellectual property development with psilocybin.
  • Building an Intellectual Property (“IP”) portfolio: CBDV plans to use its analytical tools for psychedelic mushroom compounds that advance clinical ‎and end-user testing. Development of psilocybin analogs that could be used in future medical ‎treatments.
  • Enhanced exposure of CBDV to drive growth: DELIC expects to drive customers to CBDV through its media platform, allowing CBDV to expand its current customer base and potential product offerings.
  • History of profitability: CBDV has a history of profitability, with a focus on extraction optimization, analytical testing, and chemical process development to advance the cannabis and psilocybin industry. Current and past customers are well-established global enterprises who require the cutting-edge cannabis and soon, psilocybin research, which CBDV provides services to.
  • Management expertise. Dr. Roggen, who will remain as an employee of CBDV following closing of the Transaction, brings a wealth of knowledge and industry experience to DELIC, in a critically important and evolving space.

Matt Stang, Founder and CEO of DELIC, commented, “Joining forces with CBDV is a foundational transaction for DELIC. Science and research is the backbone of the psychedelic renaissance and adding the talent, know-how and expertise of CBDV will bear fruit both now and in the years to come. The fact that the company has a world-class team, history of profitability, more than 50 blue chip clients, and is on track for significant growth, makes this a compelling acquisition for DELIC and one that makes it a pillar of the Company. Going forward, with the discussions we currently have in place with the many entrepreneurs worldwide within the DELIC ecosystem, we see an opportunity to potentially commercialize this science in the near term.”

CBDV is one of a handful of licensed research psilocybin labs in Canada and has an aggressive plan to build out a suite of novel compounds and delivery methods for the industry. The company is also a leading cannabis analytical and research company boasting clients that include some of the largest brands in the world. CBDV intends to apply for its dealer’s license, to eventually commercialize its psilocybin research and associated IP.

Dr. Roggen, CEO of CBDV, stated “This is a very exciting moment for us at CBDV. Partnering with DELIC was an easy choice. The combination will allow us to use their platform to share our findings with the psychedelic and medical community while also gaining new clients on the cannabis front. It’s a great opportunity to work in tandem with the DELIC team to help these new age treatments become accessible for all.”

Matt Stang continues, “The DELIC ecosystem will benefit greatly from the IP that will come out of CBDV. As new jurisdictions start to decriminalize and legalize psilocybin, we feel we will have the IP that everyone will want. On top of that, our roots in cannabis are deep and we feel we can direct significant revenue in our network towards CBDV’s cannabis business.”

Transaction Summary

Under the terms of the Agreement, DELIC will acquire all of the issued and outstanding shares in the capital of CBDV. The purchase price will be satisfied through the issuance of subordinate voting shares in the capital of DELIC (the “Consideration Shares“) equal in value to CAD $7,000,000 (the “Purchase Price“), to be issued at a price per share equal to the higher of: (a) the ten (10) trading day volume weighted average trading price (“VWAP“) of the Consideration Shares on the Canadian Securities Exchange (or such other recognized stock exchange upon which the Consideration Shares are listed for trading) (the “Exchange“) in the ten (10) trading days immediately prior to the date of the Agreement, and (b) the maximum discount under the policies of the Exchange applicable to the closing price of the Consideration Shares on the Exchange on the trading day immediately prior to the closing date. The Consideration Shares issued to the sellers of CBDV will be subject to certain contractual hold periods. In addition, each of the sellers of CBDV will enter into voting support agreements with a two-year term, pursuant to which they will agree to vote their Consideration Shares as directed by the board of directors of DELIC, subject to certain customary exclusions.

In addition, pursuant to the Agreement, for so long as Dr. Roggen holds not less than 10% of the shares in DELIC, and at least for the first two years following closing of the Transaction, DELIC agrees to appoint one nominee of Dr. Roggen to the board of directors of DELIC. In the ‎event Dr. Roggen ceases to have nomination rights pursuant to the foregoing, Dr. Roggen shall use ‎commercially reasonable efforts to cause his nominee to resign immediately. ‎

Dr. Roggen has agreed to execute an employment agreement with DELIC upon closing of the Transaction. In addition, Dr. Roggen and DELIC will enter into an earn-out agreement on closing (the “Earn Out Agreement“). Pursuant to the Earn Out Agreement, Dr. Roggen will be eligible to earn additional consideration for completing the Transaction of up to CAD$3,000,000, to be paid in Consideration Shares, subject to achievement of certain milestones. The milestone payments are as follows and will be based on the ten (10) trading day VWAP of the ‎Consideration Shares on the ‎Exchange in the ten (10) trading days prior to the ‎date the respective milestone.

The closing of the Transaction is subject to customary closing conditions, including necessary third-party consents and approvals, including approval of the Exchange, if required.

About DELIC
DELIC Always Expanding. In All Ways.

DELIC was formed in 2019 to address the growing interest in psychedelic wellness backed by science. DELIC was the ‎first psychedelic umbrella platform and is currently a trusted source for those interested in ‎psychedelic culture, psychedelic clinics, and more. ‎DELIC’s offerings include “Reality Sandwich”, a free public education platform providing psychedelic guides, news and ‎culture, “Meet Delic”, the first ever psychedelic wellness summit, and “The Delic”, an e-commerce lifestyle brand. ‎For more information, check out www.deliccorp.com.

The Canadian Securities Exchange ‎has neither approved nor disapproved the contents of this news release and does not accept responsibility ‎for the adequacy or accuracy of this release.‎

Forward-Looking Information and Statements

This press release contains certain “forward-looking information” within the meaning of applicable ‎Canadian securities ‎legislation and may also contain statements that may constitute “forward-looking ‎statements” within the meaning of ‎the safe harbor provisions of the United States Private Securities ‎Litigation Reform Act of 1995. Such forward-looking ‎information and forward-looking statements are not ‎representative of historical facts or information or current ‎condition, but instead represent only the ‎Company’s beliefs regarding future events, plans or objectives, many of ‎which, by their nature, are ‎inherently uncertain and outside of DELIC’s control. Generally, such forward-looking ‎information or ‎forward-looking statements can be identified by the use of forward-looking terminology such as ‎‎”plans”, ‎‎”expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, ‎‎‎”anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may ‎contain ‎statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be ‎taken”, “will continue”, ‎‎”will occur” or “will be achieved”. The forward-looking information and forward-‎looking statements contained herein ‎may include, but are not limited to, closing of the Transaction, the growth and business of CBDV, potential earn out payments, anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics), the continued emergence of psychedelics from stigmas, the ability of the Company to maintain sensible messaging, the ability of the Company to avoid dogmatic practices and binary rhetoric‎, the ability of DELIC to successfully achieve business ‎objectives, ‎and expectations ‎for other economic, ‎business, and/or competitive factors.‎

By identifying such information and statements in this manner, DELIC is alerting the reader that ‎such ‎information and statements are subject to known and unknown risks, uncertainties and other factors ‎that may cause ‎the actual results, level of activity, performance or achievements of DELIC to be ‎materially different from those ‎expressed or implied by such information and statements. In addition, in ‎connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, DELIC has made certain ‎assumptions. Among the key factors that could cause actual ‎results to differ materially from those projected in the ‎forward-looking information and statements are the ‎following:‎ the ability to consummate the Transaction; the ability to satisfy the conditions to closing of the Transaction on the proposed terms and schedule; the potential impact of the announcement or consummation of the acquisition on ‎relationships, ‎including with regulatory bodies, employees, suppliers, customers and competitors; ‎changes in general economic, ‎business and political conditions, including changes in the financial ‎markets; changes in applicable laws; compliance ‎with extensive government regulation; and the diversion of management time on the Transaction.

Should one or more of these risks, uncertainties or other factors materialize, or should assumptions ‎underlying the ‎forward-looking information or statements prove incorrect, actual results may vary ‎materially from those described ‎herein as intended, planned, anticipated, believed, estimated or ‎expected.‎

Although DELIC believes that the assumptions and factors used in preparing, and the expectations ‎contained ‎in, the forward-looking information and statements are reasonable, undue reliance should not ‎be placed on such ‎information and statements, and no assurance or guarantee can be given that such ‎forward-looking information and ‎statements will prove to be accurate, as actual results and future events ‎could differ materially from those anticipated ‎in such information and statements. The forward-looking ‎information and forward-looking statements contained in this ‎press release are made as of the date of ‎this press release, and DELIC does not undertake to update any ‎forward-looking information ‎and/or forward-looking statements that are contained or referenced herein, except in ‎accordance with ‎applicable securities laws. All subsequent written and oral forward- looking information and ‎statements ‎attributable to DELIC or persons acting on its behalf is expressly qualified in its entirety by this ‎‎notice.‎

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Lobe Sciences to Present at Psychedelic Capital Virtual Investor Conference

Vancouver, British Columbia–(Newsfile Corp. – February 24, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) announces that Philip Young, CEO and Director, and Maghsoud Dariani, Chief Science Officer will be presenting on Thursday, February 25th, 2021 at 5:45 pm EST at “The Gold Standard in Psychedelic Investment, Psychedelic Capital Virtual Investment Conference”, a platform showcasing the top companies, latest IPOs, newest opportunities, and deepest industry insights.

 

As a presenting sponsor, the Company will connect directly with some of the earliest moving investors in the psychedelic industry and reach an audience of 2,000+ investors. Presentations are 30 minutes in length, with 10 minutes allocated to a one- on-one Q&A session with the audience.

Investors can register to the event using the following link: https://microdose.buzz/shop/psychedelic-capital/psychedelic-capital-feb-2021/

 

Recent Company highlights & topics to be discussed include:

 

  • Executed definitive agreement for the $32,000,000 sale of Cowlitz Cannabis Assets;
  • The successful completion and testing of the proof-of-concept prototype of Lobe’s proprietary nasal mist device;
  • Pre-clinical study of psilocybin plus NAC for treatment of PTSD and mTBI with the University of Miami;
  • The appointment of Philip Young as CEO and Director;
  • The closing of an upsized $3,445,847 non-brokered private placement;
  • The appointment of Jonathan Gilbert as Executive

 

About Lobe Sciences Ltd.

 

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

2/24/2021 2:10:00 PM

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Core One Labs Finalizes Deal to Acquire Ketamine Infusions Centers of Texas, Entering the US Market for Psychedelic Treatments

Vancouver, British Columbia, Canada – February 23, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) a research and technology company focused in life sciences and on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy is pleased to announce it has entered into a definitive agreement to acquire (the “Transaction”) Ketamine Infusion Centers of Texas Inc. (KICT), a US based health and wellness Ketamine Clinic. The Transaction is the first health and wellness operation for the Company in the United States.

The acquisition of KICT allows the company to establish a roster of patients in Texas for psychedelic assisted psychotherapy utilizing our novel delivery system and API grade psilocybin, upon legalization.

KICT was established to address the growing problem of depression and other mental health issues that plague society. KICT’s goal is to be known as a center of excellence in the management of treatment-resistant depression. KICT strives to achieve this by providing unparalleled and individualized care based on the uniqueness of each of its patients. KICT offers Ketamine treatments to individuals suffering from depression, bipolar disorder, post-traumatic stress disorder and obsessive-compulsive disorder. KICT combines their medical expertise with their passion to help patients reach optimal levels of health and vitality through intravenous therapy services and wellness programs.
Ketamine clinics are on the cutting edge of mental health and addictions medicine and with over 100 Ketamine clinics operating in the US, its increasing use in the treatment of depression, anxiety, OCD, and PTSD, represents a significant paradigm shift.

Ketamine, a Schedule III substance under the U.S. Controlled Substances Act, is garnering significant acceptance, and is supported by a growing body of research, for its affective use in the treatment of mood disorders and addictions. In addition to Ketamine, the psychotropic compound, psilocybin, is also witnessing increased support as an alternative medicine, and various cities in the United States, including Denver, Colorado, Oakland and Santa Cruz, California, Ann Arbor, Michigan as well as Somerville, Massachusetts have decriminalized its use. In the state of Oregon, legislators have gone so far as to legalize psilocybin outright.

This rapid shift of regulations on psychedelics is very promising for the field of mental health and addictions, and the Company foresees many opportunities for growth and advancement.

A new market study by Data Bridge Market Research indicates that the legal U.S. psychedelic drug market is projected to grow at 16.3% CAGR during the period of 2020 to 2027 noting that the market is expected to reach approximately $6.8 billion by 2027, up from $2 billion in 2019. In addition, the report highlights the growing acceptance of psychedelic drugs for treating depression, along with the increasing prevalence of depression and mental disorders as significant factors driving such growth.

“I am very excited about establishing a footprint in the US through the acquisition of KICT. Their world-class team of physicians with years of experience in delivering psychedelic and wellness treatments at KICT will be a great addition to our Core One Team. We intend to collaborate with the KICT team as we move our IP and patentable psilocybin process forward with our team at Vocan. Our goal is to expand into several new locations in the US this year, where decreased regulations surrounding psychedelics have created a rapidly growing market.” stated Joel Shacker CEO of the Company.

Acquisition Details

On February 18, 2021, the Company entered into a purchase agreement (the “Definitive Agreement”) to acquire KICT. Pursuant to the Definitive Agreement, the Company will (i) issue 210,000 common shares of the Company (the “Consideration Shares”) to the current interest holders of KICT in exchange for all of their interests in KICT (the “Transaction”). The Company also anticipates paying a finder’s fee of 21,000 common shares to a third-party who introduced the Transaction to the Company (the “Finder’s Shares”). The Consideration Shares are subject to a voluntary pooling arrangement, which will prevent the holders thereof from trading the shares until February 14, 2022 . The Finder’s Shares will be subject to a four-month hold from the date of issuance pursuant to the policies of the Canadian Securities Exchange.
Closing of the Transaction is subject to a number of conditions typical for a transaction of this nature, and readers are cautioned that completion of the Transaction cannot be completed unless such conditions are satisfied.

The Company is at arms-length from KICT and its interest holders. The Transaction will not constitute a fundamental change for the Company, nor is it expected to result in a change of control of the Company, within the meaning of applicable securities laws and the policies of the Canadian Securities Exchange.

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

Core One Labs Inc.
Joel Shacker
Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:
info@core1labs.com
1-866-347-5058

Cautionary Disclaimer Statement:

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

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with 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 Labs does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One Labs believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One Labs does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Aion Therapeutic Opening the First International Treatment Center for Psychedelic Psychiatry in Jamaica; Hires Leading Psychiatrist as Medical Director

Toronto, Ontario–(Newsfile Corp. – February 23, 2021) – Aion Therapeutic Inc. (CSE: AION) (“Aion Therapeutic” or the “Company“) announced today the opening of the Aion International Center for Psychedelic Psychiatry in Jamaica. The Center will initially specialize in the use of psilocybin for the treatment of addiction (tobacco, alcohol, and other drug misuse), depression and anxiety associated with life-threatening illnesses, treatment-resistant depression, and major depressive disorder (MDD). In addition, the Center will be studying the effectiveness of psilocybin as a new therapy for opioid addiction, Alzheimer’s disease, post-traumatic stress disorder (PTSD), and anorexia nervosa.

The U.S. Food and Drug Administration (FDA) recently designated psilocybin therapy as a “breakthrough therapy” for the treatment of MDD. “MDD is a substantial public health concern, affecting more than 300 million individuals worldwide. Depression is the number one cause of disability, and the relative risk of all-cause mortality for those with depression is 1.7 times greater than the risk for the general public. In the United States, approximately 10% of the adult population has been diagnosed with MDD in the past 12 months, and the yearly economic burden of MDD is estimated to be $210 billion.”[1] “Across the 36 largest countries in the world, in the absence of scaled-up treatment, it is projected that more than 12 billion days of lost productivity (equivalent to more than 50 million years of work) are attributable to depression and anxiety disorders every year, at an estimated cost of US $925 billion. Assuming the same distribution of costs across lower-income and higher-income countries holds for all other countries (representing 20% of the world’s population), the global cost per year is $1.15 trillion.”[2]

The Medical Director of the Aion International Center for Psychedelic Psychiatry is Winston De La Haye, M.D., M.P.H, D.M., I.C.A.P. Dr. De La Haye is Deputy Dean in the Faculty of Medical Sciences, The University of the West Indies (UWI), Mona, Jamaica and a Consultant General and Addiction Psychiatrist at the University Hospital of the West Indies (UHWI). He completed his MD (Cum Laude) at the University of Pecs in Hungary, his Postgraduate Degree in Psychiatry at the UWI, his Masters in Public Health (Cum Laude) and a Fulbright Fellowship in Substance Abuse at the Johns Hopkins University (JHU). He is an Internationally Certified Addiction Professional and a Global Master Trainer of Trainers in the Treatment of Substance Use Disorders.

Dr. De La Haye is a Past Chief Medical Officer in the Ministry of Health and Wellness in Jamaica, Member of the Medical Council of Jamaica, Member of the International Society for Substance Use Professionals (ISSUP), Past President of the Medical Association of Jamaica, Past President of the Jamaica Psychiatric Association, Past President of the Jamaica Fulbright Alumni Association, Past Chairman of the Bellevue Hospital Board of Management, and Past Deputy Chairman of the National Council on Drug Abuse in Jamaica.

Dr. De La Haye established the Medicinal Cannabis Unit in the Ministry of Health and Wellness (MOHW) in July 2017, supervising the registration of over 80 medicinal cannabis products in Jamaica. He is also a former Captain in the Jamaica Defense Force.

Dr. De La Haye stated, “We need all available and effective products for the treatment of patients with mental illness. Psychedelic Psychiatry has the potential to change the lives of millions of patients, reducing their disability and improving their quality of life.” Dr. De La Haye continued, “As a Johns Hopkins Alumnus, it is our intention to follow the best treatment protocols like those being established at Johns Hopkins Center for Psychedelic and Consciousness Research.”

Aion International Center for Psychedelic Psychiatry, in addition to treating patients, looks forward to collaborating with The UWI and other Tertiary Institutions in Jamaica in the research and development of cutting edge, effective and safe products for treating patients with mental illness. We also recognize the importance of regulating the Psychedelic Industry and look forward to working closely with the MOHW in Jamaica as they move towards setting up this very important regulatory body.

Dr. Stephen Barnhill, Executive Chairman of Aion Therapeutic, stated, “We’re very excited to be opening the first International Center for Psychedelic Psychiatry in Jamaica. The Center is unique in our ability to treat patients with both psilocybin and medical cannabis combination therapies currently being produced at Aion Therapeutic in conjunction with our licensed medical cannabis partner Apollon Therapeutics Jamaica, Ltd. We are establishing treatment protocols and dosing schedules for international expansion and export when and where the legal use of these products continues to expand globally.” Dr. Barnhill continued, “We are honored to have Dr. Winston De La Haye, with his significant expertise in addiction medicine as the Medical Director for the treatment facility.”

Mr. Graham Simmonds, Executive Vice Chair and CEO of Aion Therapeutic, stated, “This is a very exciting time for the Company as we now embark on treating patients and further advancing our science and research with another excellent doctor added to our team.” He added, “Our team, led by Dr. Barnhill, has been working tirelessly over the past six months in advancing our research, developing our formulations, patent protecting these formulations and preparing an operating plan for treating patients with additional medical conditions including cancer, inflammatory conditions, viral disorders and obesity. We will have updates with further details on our approach to expanding our treatment markets and managing our intellectual property portfolio released shortly. I commend them for this important milestone and we look forward to seeing further advancements from this world-class team we now have in place.”

The offices of Aion International Center for Psychedelic Psychiatry will soon be opened for seeing both Jamaican and international patients. In addition, we are planning a grand opening celebration in the very near future. The grand opening date will be based on the lifting of the COVID-19 restrictions.

About Aion Therapeutic Inc.

Aion Therapeutic Inc. (formerly, Osoyoos Cannabis Inc.) has a joint-venture agreement with a private, vertically-integrated licensed producer under the Cannabis Act (Canada) to offer contract tolling extraction services to third-party businesses. Additionally, the Company recently acquired 1196691 B.C. Ltd. d/b/a “PCAI Pharma” (www.pcai.ca) and its wholly-owned subsidiary AI Pharmaceuticals Jamaica Limited, a private corporation incorporated and operating under the laws of Jamaica. The business of AI Pharma involves, research and development, treatment, data mining and state-of-the-art artificial intelligence (machine learning) techniques, focused on the development of combinatorial pharmaceuticals, nutraceuticals and cosmeceuticals utilizing compounds from cannabis (cannabinoids), psychedelic mushrooms (psilocybin), fungi (edible mushroom), natural psychedelic formulations (Ayahuasca), and other medicinal plants in a legal environment for this type of discovery. In addition, the Company is creating a strong international intellectual property portfolio related to their discoveries.

For further information, please contact:

Investor Relations & Financial Media
Integrity Media Inc.
team@integritymedia.com
Toll Free: (888) 216-3595
www.IntegrityMedia.com

Aion Therapeutic Inc.
Graham Simmonds
Executive Vice Chair & CEO
(416) 843-2881

DISCLAIMER & READER ADVISORY

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “may”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to the parties. The material factors and assumptions include regulatory and other third-party approvals; licensing and other risks. The forward-looking information contained in this release is made as of the date hereof and the parties are not obligated 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 laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.

[1]The Journal of Clinical Psychiatry. 2015;76(2):155-162
[2] Lancet Psychiatry 3: 415-24

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/75204

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Lobe Sciences to Present at Virtual One2One Investor Forum

Vancouver, British Columbia–(Newsfile Corp. – February 22, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) announces that Philip Young, CEO and Director, will be interviewed on Tuesday, February 23rd, 2021 at 1:00 pm EST by broadcast journalist Christine Corrado of Proactive Investors, a leading multi-media news organization, investor portal and events management business with offices in New York, Sydney, Toronto, Frankfurt, and London.

 

The Virtual One2One Investor Forum invitation will be sent to Proactive’s 20,000 YouTube subscribers and will be broadcasted internationally. The audience will consist of high-net-worth investors, fund managers, private client brokers and analysts. Lobe’s presentation will be followed by a Q&A session and it will be published online.

Recent Company highlights & topics to be discussed include:

 

The successful completion and testing of the proof-of-concept prototype of its proprietary nasal mist device

 

Pre-clinical study of psilocybin plus NAC for treatment of PTSD and mTBI with the University of Miami

 

The appointment of Philip Young as CEO and Director

 

The closing of an upsized $3,445,847 non-brokered private placement

 

The appointment of Jonathan Gilbert as Executive Chairman

 

Executed LOI for CAD$23 million sale of certain assets related to Cowlitz County Cannabis Cultivation Inc.

About Lobe Sciences Ltd.

 

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

2/22/2021 2:09:00 PM

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Truffle Talk with Joshua Bartch of Mydecine Innovations Group

Published at Truffle Report

By Emily Jarvie

‍

Josh Bartch Mydecine

‍

  • Mydecine Innovations Group co-founder and CEO Joshua Bartch speaks to Truffle Report about the company’s psychedelics research program.
  • Mydecine’s lead program is focused on psilocybin and the treatment of post-traumatic stress disorder (PTSD).
  • Bartch says the company will be listed on three senior stock exchanges over the coming months.

At a time when he was looking for the next big industry, entrepreneur Joshua Bartch was attracted to the world of fungi by its unique compounds. “Diversification is incredibly important. With fungi, you can pursue oil remediation, break down plastic, and solve a lot of the world’s problems,” Bartch tells Truffle Report.

Along with geneticist Robert Roscow and hemp consultant Damon Michaels, Bartch co-founded biotechnology and life sciences company Mydecine Innovations Group to develop psychedelic-assisted therapies. “Our focus is the unique compounds that can promote health and wellness, and psychedelic compounds that can address unmet needs in the mental health arena,” Bartch says of the Colorado-based company.

Prior to becoming the CEO of Mydecine, Bartch had worked in the cannabis industry in Denver, Colorado starting in 2009. When recreational cannabis was legalized in the state in 2014, he launched Cannabase, a technology platform that connected standalone cultivators and retailers which was acquired 16 months later by Helix GCS. After selling significant professional and private cannabis-related assets, Bartch moved into mergers and acquisitions (M&A) and investing which ultimately led him to the psychedelics space.

Mydecine Conducting Clinical Trials on Psilocybin and PTSD

Bartch tells Truffle Report that Mydecine’s lead program is focused on the use of psilocybin and psilocybin-like compounds in conjunction with strict psychotherapy protocols for the treatment of post-traumatic stress disorder (PTSD), particularly among veteran populations. “In the United States alone, a veteran commits suicide every 72 minutes. That’s over 22 a day,” Bartch says.

“For whatever reasons, there’s been complacency with the current treatment models that maybe work half the time for half the population. Currently, there is not a single pharmaceutical drug that is manufactured for PTSD. Everything is borrowed, off-label, such as selective serotonin reuptake inhibitors (SSRIs) and Prozac which are incredibly dangerous drugs and are really ineffective for the treatment of PTSD because they carry side effects like suicide.”

Bartch says Mydecine has been working off a body of evidence from the 1950s and 60s which showed one to three macrodoses of psilocybin treatments, accompanied by strict psychotherapy protocols, had a success rate in excess of 75 percent in eliminating PTSD. “What is exciting for us is we are dealing with very ineffective band-aids that carry incredible negative side effects and we are able to replace it was a non-addictive, non-invasive treatment that has no known long-term side effects and can essentially act as a cure with one to three treatments combined with psychotherapy protocols,” he says.

Mydecine is ready to conduct Phase 2A clinical trials revolving around the use of psilocybin to treat PTSD, however, the trials have been put on hold due to COVID-19. “We have approved test sites at Leiden University in the Netherlands, the University of Western Ontario and the University of Alberta in Canada, and we are about to announce three very prominent veterans-focused sites in the United States,” Bartch says. He adds that the trial is expected to begin in the next few months once restrictions around COVID-19 allow it to proceed. “We don’t want to start the trial and then have to stop. To stop and restart could be very expensive and from a pure data standpoint is not the best,” he says.

Exclusive Partnership Sets Mydeceine Apart

Bartch says Mydecine’s exclusive access to a full cGMP pharmaceutical manufacturing facility at the University of Alberta was one way the company differentiated itself from others in the psychedelics space. “We have the ability to go from A to Z and turn a concept into reality,” Bartch tells Truffle Report. “Through the University of Alberta, which is covered by a Health Canada dealer’s licence, we have the ability to cultivate, extract, and isolate compounds which we can sell commercially. We can provide that active pharmaceutical ingredient (API) for our clinical trials to drastically lower the cost of our API or leverage our ability to produce these compounds, which can be used on humans, to participate in other studies we think are interesting or hold potential. To leverage that in exchange for shared data is advantageous.”

He adds that Mydecine supports the work of organizations exploring the medical potential of psychedelics in a responsible manner, such as through the passage of Measure 109 in Oregon. While Mydecine cannot take part in this state-based program itself, Bartch says the company supported the cause because it believes public acceptance of psychedelics is a significant barrier. “We don’t support the recreational use of psychedelics in any instance at all because we think it is a completely different substance to THC and it holds a higher medical potential to change the way mental health is being treated. Anything that is done responsibly that will better educate the public we think is a great thing for the industry,” he says.

Listing of Mydecine on Three Senior Stock Exchanges Underway

Mydecine is currently in the process of being listed on three senior stock exchanges: the NEO exchange in Canada, the London Securities Exchange (LSE) in the United Kingdom, and NASDAQ in the United States. The company is currently listed on the Canadian Securities Exchange (CSE) under the ticker symbol MYCO, on OTC Markets (OTC) in the United States under MYCOF, and on the Frankfurt Securities Exchange (FSE) under 0NFA.

Bartch tells Truffle Report he expects the first of the three new listings to be finalized will be the NEO exchange listing. “We believe that we will be trading on the NEO exchange within the next 30 days, around the first or second week of March,” he says. For the LSE, Bartch says Mydecine’s preliminary prospectus will be completed within the next few weeks. For the NASDAQ, Mydecine has been appointed a reviewer and Bartch says he expects the company will be listed in the next four to six months. “We continue to check boxes off,” Bartch says. “We have a couple of initiatives in the company that I can’t talk about now but the market should react accordingly and that should get us over the price requirement if not there could be additional capital raising to meet that requirement,” he says.

Being included in Horizons ETFs Managements’ first psychedelic stock ETF which began trading on the NEO Exchange in January is an honour, Bartch says. “The ETF was incredibly beneficial for the industry as a whole,” he says. “We would have been incredibly disappointed if we weren’t included because we feel we are an industry leader. As some of the initiatives we are working on come to light, we expect our percentage in the ETF will increase as we grow as a company.”

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Lobe Sciences Successfully Completes Proof-of-Concept of Proprietary Nasal Mist Device

Proprietary spray delivers micro doses of psilocybin or N-acetylcysteine for treatment of PTSD and traumatic brain injury

 

Vancouver, British Columbia–(Newsfile Corp. – February 18, 2021) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company“) announced today the completion and testing of the proof-of-concept prototype of its proprietary nasal mist device. As announced on December 3, 2020, the Company engaged VisionWorks Engineering of San Diego, CA to complete this first phase of development. Lobe’s nasal mist device delivers “micro doses” of pharmaceutical agents such as a psilocybin and N-acetylcysteine (“NAC“) at preselected dosages.

Philip Young, CEO of Lobe states “Advancing through the initial development and testing of our innovative nasal mist device will position Lobe as the leader in the delivery of effective therapeutics to treat patients suffering from mild traumatic brain injury, post-traumatic stress disorder, and other mental health conditions. We intend to further the development of this device leading to commercialization. Completing the development of this device will enable the patients to easily treat themselves where they live and work.”

During the first phase of development of the device, a test platform was built. The platform was then used to quantify key characteristics of the actuator, atomizer, and control system. The testbed was also used to refine the mist volume, quality, and spray pattern. The results reflect a clear path for delivering precise doses of drugs to the upper region of the nasal cavity. The completion of the prototype phase is an important milestone towards the ultimate goal of developing effective delivery methods for commercialization.

Lobe holds several provisional patent applications, including the nasal mist device entitled “Device and Method for the Treatment of Traumatic Brain Injuries and Post-Traumatic Stress Disorder“. Once completed, the device design will allow for the precise control and delivery of medicines through the nasal cavity directly to the olfactory bulb for faster and more efficient uptake of psilocybin and other medicines that target the brain.

About Lobe Sciences Ltd.

 

Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.

2/18/2021 2:08:00 PM