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Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

Clearmind Medicine Launches Study for Binge Eating with The Hebrew University Using its Proprietary MEAI Compound

‍Focus on the discovery and development of novel therapeutic strategies to treat obesity and its related metabolic disorders

TORONTO, Nov. 24, 2021 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (CSE: CMND, FSE: CWY0, OTC Pink: CMNDF), (“Clearmind” or the “Company”), a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, is pleased to announce it has signed an agreement to fund a new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory, to evaluate the Company’s proprietary compound, MEAI’s direct effect on binge eating including food and water intakes as well as activity and metabolic parameters.

The study, which will be overseen by Prof. Joseph (Yossi) Tam, D.M.D., Ph.D., head of the Obesity and Metabolism Laboratory and Associate Professor of Pharmacology at the Hebrew University’s Institute for Drug Research, will focus on testing the potential of MEAI to treat binge eating and related behaviors, and will support the discovery and development of novel therapeutic strategies to safely treat obesity and its associated metabolic disorders.

Increasingly prevalent in developed nations, the conditions of being overweight and obese are a serious health concern as they contribute to so many other conditions, including heart disease, stroke, type 2 diabetes, fatty liver disease, and certain types of cancers, some of the leading causes of preventable, premature death in the US. The Center for Disease Control and Prevention estimates that about 74% of adults in the US are overweight1 and over 40% are considered obese2. According to a recent study published in 2020, this phenomenon is also accompanied with the high and rising costs of obesity to the US Health Care system at an estimated annual medical cost for the full non-institutionalized population of adults, in 2013, equaling $342.2 billion.

Adi Zuloff-Shani, Ph.D., CEO of Clearmind, commented on the announcement, “The medical community has yet to establish an effective therapeutic or preventative treatment for obesity, despite its increasing prevalence and severe negative impacts on the medical and economic health of people around the world. Clearmind has been able to demonstrate the positive influence MEAI has on binge behavior with regard to alcohol use, and our preliminary research indicates it may have a similar effect on metabolic disorders.”

Prof. Tam added, “I have spent my career exploring the biological mechanisms underlying obesity and the metabolic syndrome, intending to develop an effective drug therapy. After viewing the early data on MEAI, I am optimistic that this compound has the potential to be a building block for a real solution and look forward to working with the Clearmind team to advance our shared objective.”

The first phase of the three-stage study will focus on assessing the direct effect of MEAI on food and water intakes as well as its ability to modulate activity and metabolic parameters.

Following the initial screening, the study will evaluate MEAI’s efficacy as a therapeutic metabolic agent on a high-fat diet-induced obese mouse model, by measuring MEAI’s potential to treat obesity, hepatic injury, glycemic and hormonal imbalance. Lastly MEAI’s binge eating and drinking mitigating properties will be determined by comparison of cumulative food and sucrose preference, respectively.

About Clearmind Medicine Inc.

Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of four patent families. The first, “Binge Behavior Regulators”, has been granted in the U.S., Europe, China and India, with pending divisional applications in Europe and the U.S. The second, “Alcohol Beverage Substitute”, has been approved for a European patent, with pending applications in the U.S., China and India. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on the Canadian Securities Exchange under the symbol “CMND“, the Frankfurt Stock Exchange under the symbol “CWYO” and on the OTC Pink under the symbol “CMNDF“.

For further information, please contact:
Investor Relations,
Email: invest@clearmindmedicine.com
Telephone: (778) 400-5347
General Inquiries,
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Such statements include discussion of the new research and development project with the Hebrew University of Jerusalem’s Obesity and Metabolism Laboratory and the benefits of product candidate. There is no certainty that any of these events will occur. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances.

Investing into early-stage companies inherently carries a high degree of risk, and investment into securities of the Company shall be considered highly speculative.

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

Neither the Canadian Securities Exchange (the “CSE”) nor its Regulation Services Provider (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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Mydecine Signs LOI with Maya to Co-Develop a Novel Prescription Digital Therapeutic Platform Aiming to Further Increase Safety, Efficacy, and Accessibility of Psychedelic-Assisted Treatments

Mydecine Signs LOI with Maya to Co-Develop a Novel Prescription Digital Therapeutic Platform Aiming to Further Increase Safety, Efficacy, and Accessibility of Psychedelic-Assisted Treatments

DENVER, Dec. 22, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NF.F) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, announced today that the Company has signed an LOI (letter of intent) with Maya. Together, the two companies plan to co-develop a novel digital therapeutics (DTx) platform. This platform would allow Mydecine to enhance treatment effectiveness by pairing the DTx with the Company’s existing digital health platform, Mindleap Health (“Mindleap”), alongside the Company’s medication-based treatments to create a trifecta approach.

This collaborative partnership aims to enhance Mindleap’s digital platform by collecting and computing unique data to create more personalized treatments for patients. Once the new DTx platform is complete, physicians could prescribe the new digital therapeutic in addition to Mydecine’s drug and therapy protocols or as a standalone option. The Company believes this will improve the efficacy of current treatment options by personalizing them to the patient and making them more accessible.

Maya is a purpose-built platform enabling real-world data and research to optimize outcomes and industry standards by enhancing safety, reducing the cost of care, increasing IP equity, and informing regulation of psychedelic-based therapy. Maya’s clinically validated surveys, biometric tracking, and protocol customization combined with Mindleap’s telemedicine, exclusive digital content, and community features will allow both companies to accelerate the development and commercialization of a novel DTx platform.

Both companies will pursue rigorous studies to achieve FDA Section 510(k) clearance upon software integration and a comprehensive regulatory assessment. This clearance will allow the DTx platform to be registered and used as a medical device to allow patients to receive insurance reimbursement coverage for treatments on the platform. This developing partnership with Maya will enable both companies to create standalone evidence-based software as a medical device DTx platform. In addition, the current smoking cessation clinical trial Mydecine is conducting in partnership with Johns Hopkins University, and Mindleap’s current consumer-facing offerings, will not be altered or affected.

“The technology integration of the two software platforms is aimed at enhancing Mindleap’s medical capabilities to more quickly and efficiently develop a personalized prescription-based digital therapeutic that will not only complement Mydecine’s smoking cessation treatment but eventually for all primary and ancillary indications the Company is targeting. We believe Digital Therapeutics is the next big wave in healthcare. We feel confident that once our DTx platform is complete, Mydecine will be on the cutting-edge and well-ahead of the competition. Creating and integrating a DTx will be equally as valuable as the drug discovery and therapeutic protocols that the Company currently has under development. The new platform will provide improved adherence to treatment protocols, patient experience, biometric insights, and post-approval insurance reimbursements,” commented Damon Michaels, Mydecine Co-Founder, Director, and COO.

The global digital therapeutics market size is estimated to be $4.20 billion in 2021 and expects to reach $10.62 billion in 2025 at a CAGR of 26.1%. Digital therapeutics, particularly those that a physician prescribes instead of releasing directly to consumers, allow biotech companies to enhance treatments using modern technology. This partnership will enable Mydecine to accelerate the launching of new features using a market-leading technology partner.

David Champion, Founder, and CEO of Maya, commented, “Digital therapeutics are starting to transform how biotech companies approach clinical development and healthcare delivery. Our team is excited to develop a prescription DTx tool to initially aid in smoking cessation along with Mydecine’s researchers and Mindleap’s technology team.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO: MYCO) (OTC: MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise, focusing on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

About Mindleap Health
Mindleap Health Inc. is a wholly-owned subsidiary of Mydecine. Mindleap’s virtual healthcare platform offers technology solutions to allow people to improve their mental health and wellbeing. The Mindleap platform provides remote telemedicine services for mental health coaching through its international network of mental health specialists along with mental health tracking and analytics. The Mindleap platform brings convenience, improves access to treatments, and can lead to more personal breakthroughs. In addition, Mindleap’s proprietary platform is designed to provide professional support and personalized treatment for every user. The company’s mission is to upgrade mental health by simplifying, modernizing, and improving access to mental health treatments for millions of people worldwide.

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Learn more at: https://www.mindleap.com.

About Maya
The Maya platform empowers psychedelic practitioners to map care journeys and improve health outcomes comprehensively. Maya’s global community of providers, participants, and researchers chart a knowledge base to advance safe and accessible psychedelic practices. Maya is a Colorado Public Benefit Corporation (PBC), which means its team members, advisors, investors, and supporters are aligned to prioritize purpose over profit. In addition, Maya is laying the foundations of a global environment for psychedelic healthcare to scale safely and effectively with specialized therapy software solutions.

Learn more at: https://www.mayahealth.com.

For more information, please contact:

Media Contact:
Morgan Kervitsky, Director of Marketing
+1 (720) 277-9879
pr@mydecineinc.com

Investor Relations:
+1 (720) 277-9879
corp@mydecineinc.com

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 specific 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 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 protect and enforce its intellectual property adequately, the Company’s ability to bring its products to commercial production, the 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, other factors may cause effects 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. 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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Tryp Therapeutics Announces Fiscal Year 2021 Financial Results and Reports on Corporate Highlights

Tryp Therapeutics Announces Fiscal Year 2021 Financial Results and Reports on Corporate Highlights

SAN DIEGO – December 22, 2021 – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp” or the “Company“), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today the filing of its audited financial statements for the fiscal year ending August 31, 2021 and reported on corporate highlights from 2021. Complete financial statements along with related management discussion and analysis can be found in the System for Electronic Document Analysis and Retrieval, the electronic filing system for the disclosure documents of issuers across Canada, at www.SEDAR.com.

Clinical Development

Tryp achieved several significant development milestones in 2021 as the Company advanced its psilocybin-based drug programs across multiple chronic pain disorders and other indications:

  • The formation of a collaboration with the Chronic Pain & Fatigue Research Center at the University of Michigan Medical School to conduct a Phase 2a clinical trial for fibromyalgia, which is expected to be one of the first Phase 2 studies evaluating the efficacy of a psychedelic compound for the indication.
  • The approval from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2a study in fibromyalgia at the University of Michigan.
  • The filing of an Investigational New Drug (IND) application to the FDA for Tryp’s Phase 2a study in binge eating disorder in collaboration with the University of Florida.
  • A collaboration with Fluence to support the design and implementation of innovative psychotherapy to be used in combination with Tryp’s psilocybin-based drug compounds.
  • The completion of psychotherapy training with Fluence Training for Phase 2a study in binge eating disorder at the University of Florida.

Product Development

By furthering Tryp’s manufacturing capabilities and establishing critical partnerships for its proprietary TRP-8803 drug product, the Company accomplished several important objectives in 2021:

  • The filing of a provisional patent in March 2021 for Tryp’s proprietary drug product, TRP-8803, that includes a novel formulation and unique route of administration aimed at improving the patient experience.
  • Formalized partnerships with the University of Michigan and the University of Wisconsin-Madison to further the development of TRP-8803.
  • Commenced a research collaboration with Calvert Labs to complete preclinical studies for TRP-8803.
  • Solidified collaborations with Curia and Alcami for the manufacturing of active pharmaceutical ingredient (API) and drug products for TRP-8803.

Management and Advisors

The Company succeeded in attracting high quality management team members and scientific advisors in 2021, creating a best-in-class team within psychedelic drug development:

  • The appointment of Robin Carhart-Harris, Ph.D. as Chairman of Tryp’s Scientific Advisory Board (SAB) and the additions to the SAB of Daniel Clauw, M.D. — a world-leading expert in fibromyalgia and other nociplastic pain indications — and Joel Castellanos, M.D. from UC San Diego. Dr. Carhart-Harris is the leading researcher of psychedelics for medical use.
  • The appointment of Greg McKee as Chairman and Chief Executive Officer in April 2021. The Company also appointed Luke Hayes as Chief Financial Officer in March 2021. Both bring more than 20 years of experience in life science, finance, and investment activities.

Commenting on the Company’s progress, Chairman and CEO Greg McKee said, “This has been a banner year for Tryp Therapeutics as we accelerated our drug development activities and led the extension of psychedelics into chronic pain and other indications. Despite the headwinds that the biotech capital markets have faced in 2021, we have great optimism as we continue to advance a robust slate of clinical milestones in 2022 and beyond.”

Financial Results

The Company’s total assets as of August 31, 2021, were C$4.1 million, including C$3.7 million in cash. Net and comprehensive losses for the twelve months ended August 31, 2021, were C$8.3 million.

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and other indications. The Company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and overeating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and route of administration to improve the patient experience. For more information, please visit www.tryptherapeutics.com.

Investor Inquiries:

Joseph Green

Edison Group

investors@tryptherapeutics.com

Media Inquiries:

Abby Berger
KCSA Strategic Communications
TRYP@KCSA.com

1-833-811-8797

Forward-Looking Information

Certain information in this news release constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans,” “targets,” “expects” or “does not expect,” “is expected,” “an opportunity exists,” “is positioned,” “estimates,” “intends,” “assumes,” “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,” “will” or “will be taken,” “occur” or “be achieved.” In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information, including expectations for the Company’s progress in 2022. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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Optimi Health Receives Dealers License Inspection and Introduces Quality Assurance Department

Optimi Health Receives Dealers License Inspection and Introduces Quality Assurance Department

VANCOUVER, BC (December 21, 2021) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional as well as novel psychedelic compounds focused on the health and wellness sector, is pleased to announce a facility inspection under the auspices of Health Canada has commenced concurrent with today’s announcement regarding the implementation and inauguration of an internal control department focused on Quality Assurance efforts aimed at ensuring GMP standards are fully integrated and maintained at all times, post facility certification and commissioning.

As previously noted (news release Dec 7, 2021), the Princeton, BC mushroom facility has been purpose-built to meet globally recognized GMP standards as part of the Company’s aim to develop a world-class seed-to-sale research and commercial production facility designed to compete at the very highest level of product excellence.

Since December of 2020, the Company has invested over CAD$8.5 million in completing its state-of-the-art facilities in full compliance with Health Canada’s Directives and all regional, provincial, and federal security, design and building standards. Optimi believes that the completion of the physical inspection by Health Canada, subject to any comments or concerns, paves the way for Dealers License certification early in the new year.

Alongside the installation of operational and laboratory research equipment and final exterior fittings, the Company is rapidly moving towards an operational posture including the commencement of human resource plans for phase one departmental activation. The first additions to the operations team comes with today’s announcement introducing the buildout of Optimi’s Quality Assurance department with the appointment of Department Head, Mr. Raphael Moxam and QA Manager, Farkhanda Saifullah Khowaja, Ph.D.

Quality Assurance in a controlled growing environment requires extensive knowledge of specialized agronomy as well as operational considerations such as (but not limited to), environmental considerations and monitoring systems (i.e.: ventilation, humidity), fertilizer, nutrient composition, product care & handling, facility cleanliness, pest control, irrigation, and related systems. The department will oversee both quality control (QC) and quality assurance (QA) and compliance with Health Canada’s QA guidelines pertaining to business, production, facility, security, storage, packaging, labeling as well as establishing and enforcing GAP, GMP, HACCP standards for the Mushroom program. The team will develop, update, audit and maintain Standard Operating Procedures (SOP) and Quality Manuals ensuring continuous compliance with regulations and our own commitment to pure, high-quality products.

The Company’s goal and ambition towards becoming the leading producer and supplier of GMP certified medicinal and psychedelic mushrooms strains starts with Quality Assurance and Mr Moxam and Ms. Khowaja have the necessary expertise to execute. Mr. Moxam previously served as the Senior Quality Assurance Officer at DSM-Dietary Nutritional Products (DNP) and Process Chemist II (Pharmaceutical-cGMP) at Apotex Pharmachem Inc. During this period, he worked as liaison with government regulatory bodies, and implemented safety and quality standards for products. In these roles, he was responsible for developing equipment qualification, process validation, Quality Systems including SOP, recall procedures, HACCPs, and quality assurance of raw materials and products, for pharmaceutical drugs and fish oil products. He is experienced in the development of effective preventative actions, optimizing production processes to decrease the chance of out-of-specifications conditions, trouble shoot out-of-specifications and production equipment monitoring failures, and reviewed and/or approved laboratory equipment qualifications and validated analytical test methods. Mr Moxam earned his B.Sc. Chemistry at McMaster University, Hamilton, Ontario.

Ms. Khowaja previously served over 5 years at a Cannabis Cultivation Facility utilizing environmentally controlled automated systems with credentials approved by Health Canada for Quality Assurance Person (worked as Independent Contractor for responsibilities of QC/QA Supervisor, Production Manager, and leading R&D related activities). She gained hands-on knowledge of BioTrackTHC software, this comes under the category of ERP system for operational and business activities and keeping complete and auditable batch records from seed to sale. Ms. Khowaja has the proven ability to obtain security clearances. Ms. Khowaja earned her Ph.D. in Plant Molecular Genetics at the University of Aberdeen, U.K., M.Sc. in Plant Biotechnology, Wye College, University of London, U.K. and B.Sc. in Plant Breeding, Sindh Agriculture University, Tando Jam, Pakistan.

Optimi COO Bryan Safarik notes, “As we near facility completion and certification, the activity level on-site is shifting dramatically from construction to detailed preparations for commercial efforts to commence. To say it is exciting is such an understatement. Years of effort, millions of dollars and so much planning are materializing before our eyes. Even so, the real work is just about to begin. With this shift comes new attention to processes, procedures and policies that will form the basis for our future success. I’m delighted to have the opportunity to introduce our new Quality Assurance department and can’t wait to get started working with Raphael and Farkhanda. Their experience and attention to detail is developmentally critical to our ability to deliver the highest quality products in our sector. This is of extreme importance to us as we are 100% committed to delivering the finest all-natural products to our future customers.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: 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 Company’s potential Nasdaq listing, 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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Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

Levitee Labs Announces Strategic Partnership with LiveRx Research Group to Provide Equitable Access to Hepatitis C Care throughout Alberta, Canada

  • Treatment for Hepatitis C Virus (HCV) is effective in over 95% of infected patients, yet remains disproportionately unavailable to certain patient groups across Canada.
  • Levitee Clinics and Levitee Pharmacies will work collaboratively with LiveRx to create easily accessible patient-centric HCV care, impacting currently under-served patient groups, including those with mental health conditions such as substance use disorders.
  • The partnership involves Levitee Labs promoting and implementing the LiveRx test and treat program, providing HCV screening and treatment, in addition to communications on optimal care strategies through the Levitee Labs’ portfolio of companies.

VANCOUVER, BC, CANADA, December 20th, 2021 /CNW/ – Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the “Company” or “Levitee”), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, today announces a new strategic collaboration with the LiveRx Research Group (“LiveRx”) for testing, treating, and curing HCV in Alberta.

LiveRx is a project led by Dr. Mark G. Swain, Head of the Division of Gastroenterology and Hepatology at the University of Calgary and funded by The Alberta Innovates Partnership for Research and Innovation in the Health System (PRIHS) funding program. LiveRx is dedicated to addressing inequities in the current specialist referral-based HCV care model.

Levitee Labs and LiveRx will work jointly to create an equitable, patient-centric HCV care model that facilitates shifting HCV care from specialist treatment centers in urban centers to easily accessible clinics and pharmacies across the province.

As part of the collaboration agreement, Levitee Labs will implement the LiveRx HCV test and treat program at its Levitee Clinics and Levitee Pharmacies across Alberta from January 2022 through January 2024.

The following activities will be part of the collaboration with LiveRx:

  • Conducting HCV screening and testing for Levitee Clinics patients.
  • Including patients identified with HCV who are within the Levitee Clinics care program as part of the LiveRx HCV eradication research program.
  • Undertaking HCV treatment for appropriate HCV-infected individuals through a Levitee-linked pharmacy with full support of LiveRx where available.
  • Promoting the LiveRx program at Levitee Clinics and Levitee Pharmacies sites.
  • Communicating regularly with the LiveRx Research Group to assess implementation successes, challenges, and further needs, and make mutually agreed upon changes where appropriate.

In Canada, it is estimated that 250,000 Canadians are living with chronic HCV and thousands of new cases are diagnosed each year1. 44% of those infected are unaware of their HCV status2; symptoms can take two weeks to six months to appear, and most people will not develop symptoms3. If left untreated, HCV can progress over time to serious liver damage and is associated with a range of systemic health problems, decreased quality of life, and increased healthcare costs4. The North American HCV drug market was valued at USD$3.7 billion as of 2018.5

“HCV infects up to 1% of Canadians and can lead to dire complications, such as liver cancer and irreversible liver scarring, for which there are limited treatment options,” commented Dr. Mark G. Swain. “What’s disheartening is that current HCV treatments can safely cure more than 95% of these infected individuals, but access to these therapies are disproportionately unavailable to priority populations, an obstacle that we are optimistic we can overcome by modifying the standard of care through work with companies like Levitee Labs.”

“As I am an expert in HCV care, we are thrilled to be working with Dr. Swain and his team with the common goal of eradicating HCV in Alberta,” commented Noha ElSayed, B.Sc.Pharm, APA, Executive Director, Levitee Clinics and Levitee Pharmacies, Alberta Region. “By combining resources and implementing a non-judgmental practice to testing and community-based approach to treatment, we can make a meaningful impact on healthcare from both personal and provincial perspectives.”

Sources:

1. The Canadian Network on Hepatitis C Blueprint Writing Committee and Working Groups. Blueprint to inform hepatitis C elimination efforts in Canada. Montreal, QC: Available at: https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed on: July 21, 2021.
2. Public Health Agency of Canada. Report on Hepatitis B and C in Canada: 2017.  Centre for Communicable Disease and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada; 2019. Available at: https://www.canada.ca/en/services/health/publications/diseases-conditions/report-hepatitis-b-c-canada-2017.html. Accessed on: July 21, 2021.
3. CATIE. The epidemiology of hepatitis C in Canada. Available at: https://www.catie.ca/the-epidemiology-of-hepatitis-c-in-canada-0. Accessed on: July 21, 2021
4. The Canadian Network on Hepatitis C Blueprint Writing Committee and Working Groups. Blueprint to inform hepatitis C elimination efforts in Canada. Montreal, QC: Available at: https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed on: July 21, 2021.5. https://www.fortunebusinessinsights.com/industry-reports/hepatitis-c-drug-market-101562

About the LiveRx Research Group

LiveRx Research Group is a medical research project led by Dr. Mark G. Swain, Head of the Division of Gastroenterology and Hepatology at the University of Calgary and funded by The Alberta Innovates Partnership for Research and Innovation in the Health System funding program (PRIHS) from 2021-2024. The project is focused on tackling the challenge of inequitable access to Hepatitis C Virus care in Alberta.

LiveRx believes the current model of specialist care leaves many Albertans unable to access proper testing or treatment. LiveRx follows a 5-part strategy to bring hepatitis C virus screening, treatment and cures to Albertans. LiveRx utilizes a novel approach, based on partnerships between pharmacists and community-based organizations, to deliver hepatitis C virus support to Albertans. For further information about LiveRx please visit: www.epicore.ualberta.ca/liverx

About Levitee Labs 

Levitee is establishing itself as a leader in the integrative wellness space. Through leveraging an M&A regimen that focuses on the centralization of complementary integrative wellness assets, Levitee aims to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies.

The Company’s current portfolio of assets includes: Levitee Clinics™, a group of five operating addiction and pain treatment clinics in Alberta; Levitee Pharmacies™, three pharmacies operating in Alberta specialized in filling prescriptions for patients with substance use disorders, mental health conditions, and chronic pain; BlockMD, the first technology company in Alberta to receive provincial approval for electronic-prescriptions in the addiction treatment space; and Earth Circle Organics, a direct-to-consumer and wholesaler of supplements and superfood products with 180+ SKUs in its product lineup across three brands. Further information about Levitee is available on its website at www.leviteelabs.com.

Investor and Corporate Communications: 

Pouya Farmand, CEO & Co-Founder

+1 833-381-8660

ir@leviteelabs.com

Media Contact: 

Olivia Belcher-Coward, Marketing & Communications Manager

media@leviteelabs.com

Forward-Looking Statements

This news release contains certain statements that may constitute forward-looking information under applicable securities laws. All statements, other than those of historical fact, which address activities, events, outcomes, results, developments, performance, or achievements that Levitee anticipates or expects may or will occur in the future (in whole or in part) should be considered forward-looking information. Such information may involve, but is not limited to, statements respecting Levitee’s business plans and proposed products, and the benefits derived from mushroom-infused products; the acquisitive growth potential of Levitee once acquisitions are completed; the expectation that Levitee will continue to execute its accretive acquisition program, and the contribution of such program to Levitee’s future growth potential; and Levitee’s objective to transform mental health and addiction treatments through the integration of psychedelic medicines and therapies. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or statements formed in the future tense or indicating that certain actions, events or results “may”, “could”, “would”, “might” or “will” (or other variations of the forgoing) be taken, occur, be achieved, or come to pass. These statements and other forward-looking information are based on assumptions made by Levitee based on currently available competitive, financial and economic data and operating plans, strategies or beliefs as of the date of this news release as well as management’s current expectations or beliefs regarding future growth, results of operations, future capital (including the amount, nature and sources of funding thereof) and expenditures. These assumptions may also be based on information obtained from third-party industry analysts and other third-party sources. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Levitee as of the date such statements are made, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to risks associated with the following: Levitee’s limited history of operations; ability to secure additional financing; negative cash flow from operating activities since inception; regulatory requirements; changes in consumer preferences; supply of raw materials; reliance on a limited number of products; brand awareness; the ability to develop, market and produce new products; dependence on certain key senior managers; reliance on third parties for manufacturing and packaging; potential product liability claims and product recalls; and significant competition. For additional information regarding these risks, please see the risk factors identified and reported in Levitee’s public filings under its SEDAR profile at www.sedar.com. Any and all forward-looking information contained in this press release is expressly qualified by this cautionary statement. Readers are cautioned not to place undue reliance on forward-looking statements or information. The forward-looking information is made as of the date of this news release, and Levitee assumes no obligation to publicly update or revise such forward-looking information, except as required by applicable securities laws. The CSE (operated by CNSX Markets Inc.) has neither approved nor disapproved of the contents of this press release and accepts no responsibility for the adequacy or accuracy hereof.

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Two esteemed doctors join CB Therapeutics in its exploration of innovative approaches to the production of novel psychedelics and cannabinoids so researchers can address the unmet needs of patient communities

Two esteemed doctors join CB Therapeutics in its exploration of innovative approaches to the production of novel psychedelics and cannabinoids so researchers can address the unmet needs of patient communities

SAN DIEGO, Dec. 20, 2021 (GLOBE NEWSWIRE) — CB Therapeutics today announces the appointments of Dr. Stephen Wright and Dr. Brian Barnett to its newly formed Medical Advisory Board.

Dr. Wright has more than 30 years of experience in medicines development, having worked on both sides of the Atlantic in large and small pharmaceutical companies. He was Chief Medical Officer and a Main Board Director of GW Pharmaceuticals from 2004 up to the company’s successful listing on NASDAQ and the development of Epidiolex, which is now heading for blockbuster status. He is currently Senior Medical Adviser to Compass Pathways. Dr. Wright has a Master’s degree in Social and Political Science from the University of Cambridge and is qualified in Medicine (MB BS) at The Royal London Hospital. His other higher degrees include an MD from The University of Cambridge and a Diploma in Pharmaceutical Medicine. He is a Fellow of the Royal College of Physicians of Edinburgh, is a Fellow of the Royal Society of Medicine and was elected to Fellow of the Faculty of Pharmaceutical Medicine in 2000. In addition, he holds a diploma in Pharmaceutical Business Management from The Wharton School at The University of Pennsylvania.

“I believe that the therapeutic potential of cannabinoids has not yet been fully explored and am excited by the innovative approach that CB Therapeutics is taking to the production of novel cannabinoids in particular,” said Wright. “This should allow for the investigation of the value of novel cannabinoids in so far unexplored areas of high unmet medical need and avoid some of the pitfalls associated with other production methods. It is a privilege to be working with CB Therapeutics.”

Dr. Barnett is co-Director of the Cleveland Clinic Center for Interventional Psychiatry. He and his team treat patients who have not responded to standard psychiatric treatments with both established and innovative modalities such as intravenous ketamine and electroconvulsive therapy, and transcranial magnetic stimulation. Dr. Barnett’s research covers a wide range of topics, including catatonia, the efficacy of ketamine in treatment-resistant depression, and psychiatry’s relationship with emerging psychedelic-assisted therapies. Dr. Barnett also writes about psychiatry for the public, and his works have been published in national publications such as STAT, The Wall Street Journal, The Washington Post, and HuffPost.

“I look forward to collaborating with CB Therapeutics in the development of innovative psychedelic treatments for patients with mental health conditions and addictions who have been failed by existing interventions,” said Barnett.

About CB Therapeutics

CB Therapeutics produces high-value molecules, compounds, and rare ingredients from simple sugars utilizing yeast and the process of fermentation. CB Therapeutics’ expertise in synthetic genomics and bio-engineering has significantly advanced its proprietary production platform of microorganisms, enzymes, and production processes. After more than four years of research and development, the CB Therapeutics team can produce a broad range of phytochemicals faster, utilizing fewer resources, at greater yields, and with more purity, consistency, and efficiency than competing platforms. Its 16,000 sq. ft. fully-licensed commercial batch facility in southern California includes research labs, advanced bioreactor systems production facility with off-gas analysis, and coupling to analytical equipment (HPLC, LC-MS) for streamlined process development and cost-effective fermentations. In addition to this, the new facility also includes an extensive suite of micro-scale, bench-top, and large-scale bioreactor systems to optimize the production of a broad range of fermentation-based production applications.

Contact Information

Media Contact:
Alana Armstrong
Alan Aldous Communications Inc.
Email: alana@alanaldous.com

Partnership Inquiries:
Sher Ali Butt
CEO, CB Therapeutics
Email: sher@cbthera.com

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atai Impact Establishes the atai Fellowship Fund in Psychedelic Neuroscience with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics

atai Impact Establishes the atai Fellowship Fund in Psychedelic Neuroscience with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics

atai Impact’s first major initiative will support promising academics in researching the therapeutic potential of psychedelic compounds to address unmet needs in mental health

The Fund aims to help unlock the mysteries of the brain, improve the treatment of mental health conditions and positively change the future of brain health through psychedelic research

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across this world-class teaching hospital

NEW YORK and BERLIN, Dec. 16, 2021 (GLOBE NEWSWIRE) — atai Impact, the recently launched philanthropic program of atai Life Sciences (Nasdaq: ATAI) (“atai”), today announced its first major initiative, the establishment of the atai Fellowship Fund in Psychedelic Neuroscience (“atai Fellowship Fund”) in collaboration with Massachusetts General Hospital’s (MGH) Center for the Neuroscience of Psychedelics.

atai Impact was launched in October 2021 by atai Life Sciences, a clinical-stage biopharmaceutical company, to harness the power of innovative mental health approaches for positive social change. atai Impact is committed to advancing education, expanding access, and supporting the wider ecosystem of mental health care, with an initial focus on psychedelics.

The $2 million atai Fellowship Fund will facilitate further research into the potential of psychedelics to address unmet patient needs in mental health and support promising graduate students in furthering their professional careers in this emerging field.

Massachusetts General Hospital was selected as the ideal partner for the atai Fellowship Fund due to its global reputation as a leading academic medical center and position as the largest teaching hospital of Harvard Medical School. This Fellowship builds on existing collaborations between atai Life Sciences and the Center for Neuroscience of Psychedelics, announced in January 2021, to accelerate discovery of the mechanisms underlying the therapeutic effects of psychedelic agents.1

Fellows will have access to MGH’s cutting-edge resources and expertise in neuroimaging technologies, cognitive neuroscience, cellular and molecular neurobiology, and clinical trial design. The Fund will enable them to pursue the discovery, optimization, and translation of novel experimental psychedelic neurotherapeutics. The ultimate objective of the Fund will be to investigate and unlock the potential of psychedelics to improve brain health and reduce the burden of mental health conditions, which affect over a billion people worldwide.2

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across key departments of Massachusetts General Hospital, including Neurology, Psychiatry and Radiology. Fellows will be equipped to explore a variety of therapies and neurotherapeutics, and their potential to address key mental health needs, in a world-class educational environment.

“We are very proud to kick off the atai Impact initiatives with such an important contribution to drive robust psychedelic medicine research and to do so with the eminent team at Massachusetts General Hospital,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences.

“Through the atai Impact Fellowship Fund, we are excited to be fostering the next generation of neuro-innovators. We look forward to the future findings of their research, and its important contribution to the emerging psychedelic renaissance and the future of global mental health care.”

“The current development of psychedelics as psychiatric therapeutics is the beginning, not the end of the story,” said Jerrold F. Rosenbaum, MD, Director, Center for the Neuroscience of Psychedelics at Massachusetts General Hospital.

“These agents are forerunners to a future of novel compounds that will depend on the advance of science to lead to deeper understanding of the underlying neuroscience to deliver enhanced and more precise treatments. For this we need a new generation of scientists and for this goal, the atai Fellowship will be an essential contribution.”

About atai Impact

atai Impact was launched by atai Life Sciences, in October 2021, to harness the power of innovative mental health approaches for positive social change.

The key pillars of atai Impact’s activities are: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis.

The establishment of atai Impact is based on atai Life Sciences’ position that harmonization across commercial and non-profit entities represents the best path forward to address all aspects of the escalating global mental crisis.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

References:

  1. atai Life Sciences to Collaborate with Massachusetts General Hospital to Accelerate Discovery of Mechanisms Underlying Therapeutic Effects of Psychedelic Agents. [Press Release] https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-collaborate-massachusetts-general-hospital. Published January 26, 2021. Accessed November 12, 2021.
  2. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release (including without limitation, the atai Impact program and any other future philanthropic endeavors by atai) that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, and in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

For atai Impact:
Email: Impact@atai.life

For atai:
Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

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Ketamine One Reports Strong 1Q22 Financial Results

Ketamine One Reports Strong 1Q22 Financial Results

Revenues Reached Just Under $2.0 Million for the Quarter Ended October 31, 2021

VANCOUVER, British Columbia, Dec. 16, 2021 (GLOBE NEWSWIRE) — KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that it has filed its financial results for the quarter ended October 31, 2021, which is the first quarter of the Company’s 2022 fiscal year ending July 31, 2022, the highlights of which are included in this news release. The full set of Consolidated Financial Statements and Management Discussion and Analysis can be viewed by visiting the Company’s website at www.ketamine.one or its profile page on SEDAR at www.sedar.com.

Financial Highlights (all amounts expressed in Canadian Dollars unless otherwise noted)

  • Revenue for the quarter ended October 31, 2021 reached $1,989,752, as compared to $nil for the same period of the prior year, which was primarily due to transitioning from an investment issuer to a single-purpose company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, while the Company’s wholly owned contract research organization, KGK Science Inc., also secured a significant amount of new business in the form of four contracts with third party clinical research and regulatory service clients;
  • Gross profit for the quarter ended October 31, 2021 was $594,411, as compared to $nil for the same period of the prior year, due to the aforementioned reasons;
  • Net loss for the quarter ended October 31, 2021 was $9,225,769, as compared to net loss of $605,810 reported for the same period of the prior year, primarily due to share based payments of $6,156,242, service fees of $941,567 and general and administrative expenses of $691,760; and
  • Total assets for the quarter ended October 31, 2021 decreased by 13% to $19,079,056 from $21,921,195 for the period ended July 31, 2021, which was mainly attributable to a decreased in cash and cash equivalents.

Management Commentary

“We are pleased with Ketamine One’s financial results for the first quarter of the 2022 fiscal year, as revenue during the three-month period ending October 31st exceeded that for all of the 2021 fiscal year. It’s a great way to start the fiscal year and I am grateful for the keen efforts of our employees across all of our subsidiaries and to our sage advisors as well,” said Adam Deffett, Interim CEO of Ketamine One. “Ketamine One continues to execute on its plan to become a leader in mental health across North America. Our businesses, including KGK Science and IRP Health, are growing in multiple ways and we are optimistic about the financial performance of the Company for the remainder of the fiscal year as we nurture our existing industry partnerships, cultivate new ones and explore other opportunities as they arise,” added Mr. Deffett.

Subsequent Highlighted Events (all amounts expressed in Canadian Dollars unless otherwise noted)

  • Virtual Mental Healthcare Platform in Partnership With iHealthOX: On November 4, announced that it had entered into a telehealth and virtual health partnership to increase accessibility and service offerings to its patients (the “Telehealth Strategy”). In order to better address the needs of patients as well as incorporate the Telehealth Strategy across its portfolio of mental health clinics, contract research capabilities and its focus on digital therapeutics, the Company had also announced the launch of a new patient-facing website at www.ketamine.one/patients/home.
  • Intention to Submit Draft Registration Statement for Proposed U.S. Initial Public Offering: On November 9, announced that it intended to confidentially submit a draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission (the “SEC”) relating to a potential initial public offering (“IPO”) of its common shares in the United States. The IPO is expected to be for up to USD 20 Million of Ketamine One’s common shares and is currently expected by Company management to occur in the first half of 2022. The number of common shares to be offered, the use of proceeds, and the price range for the proposed IPO have not yet been determined.
  • IRP Health Opened Two New Veteran-Focused Clinics: On November 16, announced that its wholly owned subsidiary, IRP Health Ltd. (“IRP” or the “Subsidiary”), opened its Comox Valley and Ottawa clinics (the “Two Clinics”). As previously announced, the Two Clinics are veteran-focused facilities and multidisciplinary in nature. To date, IRP has successfully performed over 10,000 unique treatments for past or present personnel of the Canadian Armed Forces and the Royal Canadian Mounted Police (“RCMP”), as well as first responders including firefighters, law enforcement officers, paramedics and emergency medical technicians.
  • KGK Science Helps Client Receive New Dietary Ingredient Status from U.S. FDA: On December 2, announced that its wholly owned contract research organization, KGK Science Inc., successfully assisted its client, Hofseth Biocare ASA (HBC.OL) (“HBC”), to receive New Dietary Ingredient status from the United States Food and Drug Administration for its patented CalGo® and OmeGo® branded products. HBC is a leading manufacturer and marketer of unique and innovative marine-derived calcium, protein, collagen, and lipid nutritional supplements.
  • Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD: Also on December 2, announced that it entered into a collaborative partnership with Cognetivity Neurosciences Ltd. (CSE: CGN; OTCQB: CGNSF; FWB: 1UB) (“Cognetivity”) to study and develop assessments for depression and post-traumatic stress disorder (“PTSD”). In the initial stage of the partnership, Cognetivity and Ketamine One will partner on two separate clinical studies, one for depression and the second for PTSD. Protocols for both studies have received Institutional Review Board approval and patient recruitment is expected to occur in early 2022. Ketamine One’s wholly owned subsidiary, KGK Science Inc., will lead the study, while Cognetivity will lead the analysis.
  • Adds Seattle Location To US Clinical Network: On December 8, announced that it had been engaged by Dr. Tami Meraglia to establish a ketamine infusion clinic in Seattle, Washington. The new clinic will operate as Seattle Ketamine Infusions (“SKI” or the “Clinic”) and be located at 311 West Republican Street. Dr. Meraglia is focused on the areas of personalized intravenous treatments and is also a national best-selling author and frequent media guest regarding total health and wellness topics. Ketamine One will provide training, protocol development, and ongoing support for the Clinic, with the first patient treatments expected at SKI in early 2022.
  • Termination of NY Ketamine acquisition: On December 13, the Company announced that it and NY Ketamine Medical Practice, PLLC (“NY Ketamine”) had mutually agreed to terminate the letter of intent previously announced on April 5, 2021 pursuant to which the Company was working to acquire NY Ketamine. Ketamine One remains active in evaluating the acquisition of clinic assets in several US states and is focused on growing its network of existing clinics across North America.
  • Departure of CMO: On December 13, the Company announced that its Chief Medical Officer, Dr. Mark Kimmins, has departed the organization.
  • Appointment of New CFO: On December 14, the Company announced that Joe Ramelli was appointed as Ketamine One’s new Chief Financial Officer (“CFO”) effective December 14, 2021, subject to the final acceptance of the NEO Exchange. Ketamine One’s former CFO, Peter Nguyen, amicably agreed to depart the Company and also resigned from the Company’s Board of Directors effective December 13, 2021.

Outlook (excerpt from Ketamine One’s Management Discussion & Analysis For the Period Ended October 31, 2021 and 2020)

Ketamine One is dedicated to becoming a leader in clinical offerings of ketamine-enhanced treatments across North America. We have acquired 15 clinics across North America, with letters of intent signed for an additional clinic. We are building the critical infrastructure needed to provide breakthrough and life-changing mental wellness treatments through existing clinics, experienced professionals and advanced technology.

Ketamine One will be utilizing first-of-its-kind wearable technologies to track key vitals before, during, and after psychedelic-assisted therapies. Our technology aims to empower patients in their wellness journey and provide clinicians with data to improve outcomes. Building objective data around the patient experience by measuring physical signals and responses will allow us to refine and adjust our processes, while providing great opportunities to advance psychedelic therapy research.

KGK Science, a wholly owned Ketamine One subsidiary, has helped hundreds of companies with custom designed clinical trials and claim substantiation strategies over the past 23 years. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of industry experts, KGK Science is a leader in premium clinical research. The company has extensive experience in pharmaceuticals, cannabis, natural health products, and more recently psychedelics.

ABOUT KETAMINE ONE

KetamineOne Capital Limited (formerly Myconic Capital Corp.) is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. It is working to provide the critical infrastructure needed to develop and deliver breakthrough mental health treatments. Currently, Ketamine One has a network of clinics across North America, with plans to further consolidate the highly fragmented industry. KGK Science Inc. is the Company’s wholly-owned contract research division, which places it at the forefront of premium clinical research based on the subsidiary’s history and extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic medicine industries. As a collective enterprise, Ketamine One is dedicated to helping solve the growing need for safe and accessible mental health therapy.

On behalf of:

KETAMINE ONE

“Adam Deffett“
Adam Deffett, Interim CEO

For further information, please contact:

Nick Kuzyk, Investor Relations
Tel: 1-844-PHONE-K1 (1-844-746-6351)
Email: IR@ketamine.one
Web: www.ketamine.one
Twitter: @KetamineOne

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.

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atai Impact Establishes the atai Fellowship Fund in Psychedelic Neuroscience with Massachusetts General Hospital’s Center for the Neuroscience of Psychedelics

atai Impact’s first major initiative will support promising academics in researching the therapeutic potential of psychedelic compounds to address unmet needs in mental health

The Fund aims to help unlock the mysteries of the brain, improve the treatment of mental health conditions and positively change the future of brain health through psychedelic research

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across this world-class teaching hospital

NEW YORK and BERLIN, Dec. 16, 2021 (GLOBE NEWSWIRE) — atai Impact, the recently launched philanthropic program of atai Life Sciences (Nasdaq: ATAI) (“atai”), today announced its first major initiative, the establishment of the atai Fellowship Fund in Psychedelic Neuroscience (“atai Fellowship Fund”) in collaboration with Massachusetts General Hospital’s (MGH) Center for the Neuroscience of Psychedelics.

atai Impact was launched in October 2021 by atai Life Sciences, a clinical-stage biopharmaceutical company, to harness the power of innovative mental health approaches for positive social change. atai Impact is committed to advancing education, expanding access, and supporting the wider ecosystem of mental health care, with an initial focus on psychedelics.

The $2 million atai Fellowship Fund will facilitate further research into the potential of psychedelics to address unmet patient needs in mental health and support promising graduate students in furthering their professional careers in this emerging field.

Massachusetts General Hospital was selected as the ideal partner for the atai Fellowship Fund due to its global reputation as a leading academic medical center and position as the largest teaching hospital of Harvard Medical School. This Fellowship builds on existing collaborations between atai Life Sciences and the Center for Neuroscience of Psychedelics, announced in January 2021, to accelerate discovery of the mechanisms underlying the therapeutic effects of psychedelic agents.1

Fellows will have access to MGH’s cutting-edge resources and expertise in neuroimaging technologies, cognitive neuroscience, cellular and molecular neurobiology, and clinical trial design. The Fund will enable them to pursue the discovery, optimization, and translation of novel experimental psychedelic neurotherapeutics. The ultimate objective of the Fund will be to investigate and unlock the potential of psychedelics to improve brain health and reduce the burden of mental health conditions, which affect over a billion people worldwide.2

Fellows will be selected with a focus on diversity, equity and inclusion and mentored by leading scientists from across key departments of Massachusetts General Hospital, including Neurology, Psychiatry and Radiology. Fellows will be equipped to explore a variety of therapies and neurotherapeutics, and their potential to address key mental health needs, in a world-class educational environment.

“We are very proud to kick off the atai Impact initiatives with such an important contribution to drive robust psychedelic medicine research and to do so with the eminent team at Massachusetts General Hospital,” said Florian Brand, Chief Executive Officer and Co-founder of atai Life Sciences.

“Through the atai Impact Fellowship Fund, we are excited to be fostering the next generation of neuro-innovators. We look forward to the future findings of their research, and its important contribution to the emerging psychedelic renaissance and the future of global mental health care.”

“The current development of psychedelics as psychiatric therapeutics is the beginning, not the end of the story,” said Jerrold F. Rosenbaum, MD, Director, Center for the Neuroscience of Psychedelics at Massachusetts General Hospital.

“These agents are forerunners to a future of novel compounds that will depend on the advance of science to lead to deeper understanding of the underlying neuroscience to deliver enhanced and more precise treatments. For this we need a new generation of scientists and for this goal, the atai Fellowship will be an essential contribution.”

About atai Impact

atai Impact was launched by atai Life Sciences, in October 2021, to harness the power of innovative mental health approaches for positive social change.

The key pillars of atai Impact’s activities are: advancing education, expanding access, and supporting the wider ecosystem of mental health care. atai Impact has an initial focus on the psychedelics sector, given its emerging potential in tackling the growing mental health crisis.

The establishment of atai Impact is based on atai Life Sciences’ position that harmonization across commercial and non-profit entities represents the best path forward to address all aspects of the escalating global mental crisis.

About atai Life Sciences

atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders.

atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders.

atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

References:

  1. atai Life Sciences to Collaborate with Massachusetts General Hospital to Accelerate Discovery of Mechanisms Underlying Therapeutic Effects of Psychedelic Agents. [Press Release] https://ir.atai.life/news-releases/news-release-details/atai-life-sciences-collaborate-massachusetts-general-hospital. Published January 26, 2021. Accessed November 12, 2021.
  2. Rehm J, Shield KD. Global Burden of Disease and the Impact of Mental and Addictive Disorders. Curr Psychiatry Rep. 2019;21(2):10. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release (including without limitation, the atai Impact program and any other future philanthropic endeavors by atai) that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, and in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information

For atai Impact:
Email: Impact@atai.life

For atai:
Media Contact:
Camilla Dormer
VP, Communications, atai Life Sciences
Email: camilla@atai.life

Investor Contact:
Chad Messer
VP, Investor Relations, atai Life Sciences
Email: chad@atai.life

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Mindset Pharma to Participate in Citi’s Psychedelic Drug Call Series on January 6th

Mindset Pharma to Participate in Citi’s Psychedelic Drug Call Series on January 6th

TORONTO, Dec. 15, 2021 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that it will participate in Citi’s Psychedelic Drug Call Series to be held virtually on Thursday, January 6, 2022.  

Neena Bitritto-Garg, Citi’s Biotech analyst, will host James Lanthier, CEO of Mindset, and Joseph Araujo, CSO of Mindset, for a fireside chat at 10:00 a.m. ET.

For more information about the event, please contact your appropriate Citi representative directly.

Additionally, Mindset’s management team will be available to participate in investor and partnering meetings surrounding the 40th Annual J.P. Morgan Healthcare Conference to be held January 10-12, 2022, in San Francisco, CA. To schedule a one-on-one meeting, please send an email to KCSA Strategic Communications at MindSet@kcsa.com.

About Mindset Pharma
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds.

For further information on Mindset, please visit our website at www.mindsetpharma.com.

For more information, please contact:

Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788

Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com

Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094

‍Forward-Looking Information

This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized bywords such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.