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Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon Biomedical Announces Recruitment Underway in EBIQ-101 Clinical Study

Entheon ID(TM) Clinical Study to Assess the Effect of Ketamine on Neurological Activity as Measured by EEG

Vancouver, British Columbia–(Newsfile Corp. – November 10, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced today that recruitment has begun for the clinical research study with Heading Health LLC (“Heading Health”) as institution and Dr. Steve Levine, MD, as principal investigator to determine the electro-neurophysiologic effects of ketamine.

Entheon recently announced its sponsorship of the study, which will gather electroencephalogram (EEG) biomarker data and patient experience insight from individuals receiving ketamine therapy, and now confirms that enrolment has begun. The study population will be composed of participants who have been diagnosed with treatment-resistant Major Depressive Disorder and have been determined to have a medically appropriate indication for intramuscular ketamine treatment. The participants are also willing to wear an EEG headset which will measure brainwave patterns.

This study serves as the research foundation for two divisions of the company, Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data.

EBIQ-101, an Open Label Observational Study, will observe the EEG pattern of participants being treated with intramuscular ketamine. The data collected will be used to inform the understanding of brain activity changes in response to ketamine. In addition, genetic markers across participants will be compared, with data on impact of genetic markers and response to ketamine also being analyzed.

Based on the two hypotheses being tested, that the clinical response to drug treatment can be accurately assessed during ketamine administration, and EEG changes can predict long term response to drug treatment Entheon intends to develop a framework of understanding for characterizing the psychedelic drug state of patients and to research phenotypes associated with particular addictions and mental health disorders.

“The initiation of EBIQ-101 study is a landmark occasion for Entheon’s ID™ and Entheon IQ™ programs,” said Timothy Ko, Chief Executive Officer of Entheon. “We believe that personalized medicine is the future of psychedelic psychiatry, and that EEG and genetic-based biomarkers will add much needed layers of data insight which can be used to improve patient care.”

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Heading Health LLC

Founded in Austin, Texas, Heading Health delivers mental healthcare which is high quality, affordable and accessible. A comprehensive set of evidence-based, insurance covered therapeutics and technologies are available through Heading, including Spravato (esketamine), Transcranial magnetic stimulation (TMS), telepsychiatry and Intramuscular (IM) ketamine.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
joe@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
eglassen@blueskycommunications.com

Cautionary Note on Forward-Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to a strategic investment, the performance of such investment and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the design and commencement of the study of the electroneurophysiologic effects of ketamine, the effects of ketamine, obtaining regulatory approvals, subject enrollment, obtaining meaningful data, if at all, and the outcome of the study. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.

Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release

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Insurance coverage for ketamine therapy

Novamind Secures Insurance Coverage for Ketamine from Four Major Payors

One of the biggest hurdles of making psychedelic therapy accessible to all will be getting the treatment covered by insurance.

That’s why we’re excited to share that Novamind (NM) has secured coverage for ketamine treatments from four major health insurance providers: Blue Cross Blue Shield, the University of Utah, PEHP Health & Benefits and MBA Benefit Administrators!

The company’s Chief Medical Officer says that this a promising signal that insurance providers are interested in more effective mental health treatments as research emerges.

Novamind has also opened a call center dedicated to insurance verification to ensure that patients are approved and reimbursed as quickly as possible.

PDF of article

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Delic Corp Acquisition Of Ketamine Wellness Centers Is Complete

Delic Corp Acquisition Of Ketamine Wellness Centers Is Complete

Delic Completes Acquisition of Ketamine Wellness Centers (KWC), Becomes Largest Psychedelic Wellness Chain in United States

National Presence Across 10 States Provides Millions with Access to New Medicines and Treatments for a Variety of Health Conditions Twelve Operational Today, 15 Additional Clinics to Open within 18 Months. Kevin Nicholson, CEO of KWC, Promoted to Chief Operating Officer for Delic Corp

VANCOUVER, BRITISH COLUMBIA – November 9, 2021 – Delic Holdings Corp. (“Delic” or the “Company”) (CSE: DELC) (OTCQB: DELCF) (FRA: 6X0) (Original Source), a leader in new medicines and treatments for a modern world, today announced the official, completed acquisition of Ketamine Wellness Centers Arizona LLC (“KWC”), becoming the largest chain of wellness centers providing ketamine treatments in the U.S. KWC is a limited liability corporation formed under the laws of Arizona, which operates 10 ketamine infusion treatment clinics, across Arizona, Colorado, Florida, Illinois, Minnesota, Nevada, Texas, Utah, and Washington. Delic paid USD$3,293,933 and issued 241,258.50 multiple voting shares. With the close of this transaction, Delic’s consolidated revenue run rate is $11MM.

Transaction Highlights:

  • This acquisition establishes Delic as the largest ecosystem of mental health clinics in the United States.
  • KWC has been operating profitably and expanding significantly with 2020 revenues in excess of USD$3.5MM, on track for USD$4.5MM in 2021. This brings Delic’s pro forma annualized revenue to in excess of USD$8 million.
  • Delic has been focused on opening locations in secondary cities with considerable demand, in an effort to provide access to the most patients.
  • Delic expects to drive considerable patients to KWC through its media platform and build on the existing national leadership position already in place.
  • Established history of providing FDA-approved ketamine infusion services: The management team at KWC has been in business for 6 years expanding services throughout the United States.
  • Management expertise: The acquisition of KWC will add a team of 60+ medical professionals and ‎employees bringing a wealth of industry ‎experience and knowledge to Delic.

Over the last six years, the team at KWC has expanded across the country, from Arizona to Florida, while overseeing 60,000 treatments delivered to date and generating 2020 revenue of USD$3.5MM, trending toward USD$4.5MM in 2021. Prior to this Transaction, KWC has grown without taking outside capital. KWC will operate under the Delic umbrella, under the direction and guidance of Kevin Nicholson, CEO of KWC and the new Chief Operating Officer for Delic Corp. In this new role, Nicholson will focus on the growth and expansion of the psychedelic wellness clinics for the company.

KWC adds to Delic’s existing portfolio of two clinics operated by Ketamine Infusion Centers LLC (“KIC”) in California and Arizona, cementing its position as the leading and largest wellness provider in the country. Delic expects to open 15 additional clinics across the country over the coming 18 months, further expanding access to millions who can benefit from new medicines and treatments for a variety of mental health conditions and adds to their position as a central hub of education, media, and cultural conversations around these new medicines and treatments. With a recent successful private placement of $7MM, Delic is actively scouting new locations in cities with a growing patient base.

Matt Stang, co-founder and CEO of Delic commented, “We are thrilled to officially welcome the KWC team to the Delic family and cement our place as the largest network of treatment clinics in the U.S. With the addition of KWC, we can now reach millions of people suffering from various mental health conditions who have lost hope of finding effective, affordable treatments. As more treatments, such as MDMA and psilocybin, become FDA-authorized for medical use, we have the potential to help millions more people through the clinics.”

“On behalf of the entire KWC team, we are very excited about officially becoming a part of the Delic family,” said Nicholson. “They are an industry leader and uphold the highest standards in developing new, science-backed medicines and treatments and making them more accessible to a wider group of people. With the full support of Delic behind us, KWC will be on an accelerated path to growing our network of clinics throughout the U.S. and bringing more effective, affordable treatments to communities. They will also help us increase awareness of the clinics significantly and drive up patient counts.”

Delic is committed to addressing the mental health crisis by increasing access to science-backed benefits for all and reframing the psychedelic conversation. The company does this through an umbrella of related owned and operated businesses to support scaling the impact and reach of treatment, including 1) the largest and most accessible network of physical clinics to administer effective treatments, 2) a licensed lab to develop IP, R&D and innovative high quality and safe product lines, and 3) trusted media and e-commerce platforms and in-person events to market the services directly to patients and consumers and gain data.

Transaction Summary

Under the terms of the Merger Agreement, Delic acquired all of the membership interests of KWC through a reverse triangular merger between KWC and a wholly-owned subsidiary of Delic. (the “Transaction“) for an aggregate purchase price of USD$10,000,000. Delic issued multiple voting shares in the capital of Delic (“Consideration Shares“) to the members of KWC (the “Members“), having an aggregate value of USD$5,000,000, less a holdback equal to USD$1,000,000, at a price per Consideration Share of US $0.1658 (being the ten trading day volume weighed average trading price (“VWAP“) of the Consideration Shares on the Canadian Securities Exchange (the “Exchange“) as of November 3, 2021). Delic further satisfied the purchase price by paying to the Members, an amount equal to USD$5,000,000 in cash consideration with approximately US$3,293,933 paid on the closing date, US$296,541 to be paid on forgiveness of a loan to KWC from The Health Resources and Services Administration,   USD$750,000 to be paid on the date that is 12 months following the closing date, and the final USD$750,000 to be paid on the date that is 24 months following the closing date.

In addition, the Members are eligible to receive additional Consideration Shares upon each new clinic opened by KWC that posts three consecutive months of profitability and minimum revenue of USD$135,000, during those three months, such additional Consideration Shares to have an aggregate value of USD$100,000 per clinic opening, based on a price per share equal to the 10 trading day VWAP of the Consideration Shares on the Exchange immediately prior to the date such milestone is achieved. The milestones are subject to an aggregate cap of 30 new clinic milestones or USD$3,000,000 in additional Consideration Shares.

The Members have agreed that any Consideration Shares issued will be ‎subject to a contractual hold ‎‎period, with 10% of the share consideration to be released on the date that is six months and one day following closing, ‎and 15% ‎released every six months thereafter over a period ‎of 36 months. In addition, Members have agreed to enter into voting support agreements with Delic having a term of two years, pursuant to which the Members will ‎vote as directed by the board of directors of ‎Delic, subject to customary carve-outs.

About Ketamine Wellness Centers

Ketamine Wellness Centers (KWC) is the largest ketamine therapy provider in the United States with 10 clinic locations serving communities across eight states. Since 2011 KWC has been a trusted leader in bringing IV ketamine therapy into mainstream health care. KWC has provided over 60,000 treatments to clinically eligible patients, from young adults to seniors, in addition to developing specialized programs for veterans and first responders. The KWC team, including a core group of physicians, psychologists, clinicians, and executives, is dedicated to providing value-based, personalized, clinically controlled ketamine infusion care for people suffering from treatment-resistant depression, anxiety, PTSD, OCD and chronic pain. KWC’s scalable business and treatment model is designed for further rapid expansion along with breakthrough innovations in effective therapies and services.

About Delic Corp, Inc.

Delic is a leader in new medicines and treatments for a modern world, improving access to health benefits across the country and reframing the conversation on psychedelics. The company owns and operates an umbrella of related businesses, including the largest chain of psychedelic wellness clinics in the country, including Ketamine Infusion Centers and Ketamine Wellness Centers; the only licensed entity by Health Canada to exclusively focus on research and development of psilocybin vaporization technology, Delic Labs; the premier psychedelic wellness event, Meet Delic; and trusted media and e-commerce platforms Reality Sandwich and Delic Radio. Delic is backed by a team of industry and cannabis veterans and a diverse network, whose mission is to provide education, research, high-quality products, and effective treatment options to the masses. 

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.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities ‎in the United States. The securities have not been and will not be registered ‎under the United States ‎Securities Act of 1933, as amended (the “U.S. Securities Act“), or any state ‎securities laws and may not be offered or ‎sold within the United States unless registered under the U.S. ‎Securities Act and applicable state securities laws or an ‎exemption from such registration is available.‎

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: potential benefits of the Transaction; anticipated continued growth in the health and wellness sector (and, in particular, related to psychedelics); the ability of Delic to successfully achieve business ‎objectives, including opening 15 additional clinics over 18 months, ‎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. Such risks and other factors may include, but are not limited to:  incorrect assessment of the value and potential benefits of the Transaction; direct and indirect material adverse effects from the COVID-19 pandemic; inability to obtain future financing on suitable terms; failure to obtain required regulatory and other approvals; risks inherent in the psychedelic treatment sector; changes in applicable laws and regulations; and failure to comply with applicable laws and regulations.

In addition, in connection with the forward-looking ‎information and forward-looking statements contained in this press ‎release, Delic has made certain ‎assumptions. These assumptions include, but are not limited to: the potential impact of the announcement or consummation of milestone payments 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.‎

Media & Investor Relations Contact

Rich Rodriguez

rich@deliccorp.com 

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Try psychedelic therapy at home in these states

Origin Therapeutics Portfolio Company TripSitter Expands to Eight Additional States

TripSitter Clinic Corp. now offers at-home ketamine therapy in 10 states!

The company, which is part of Origin Therapeutics’ portfolio, expanded its services to eight new states: Arizona, Colorado, Michigan, Washington, Florida, New York, Ohio, and Virginia, in addition to California and Illinois.

Patients can receive a prescription for oral ketamine after a virtual consultation a physician. They can then take the medication at home with virtual guidance, followed by therapy sessions.

Another company, My Ketamine Home, offers similar services in Texas, Florida, and California.

PDF of article

 

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Why ketamine is so effective at preventing suicide

Ketamine rapidly improves cognitive function, making those in suicidal crisis less likely to harm themselves

Researchers have known for years that ketamine can reduce depression symptoms and suicidal ideation in as little as 24 hours, but a recent study helps us understand why it’s so beneficial.

The study showed that a single dose of ketamine rapidly improved cognitive function, problem-solving abilities, and distorted thinking in suicidal patients.

“Being able to think more clearly can make someone feel less suicidal,” explains Ravi. N. Shah, MD, one of the researchers.

Ketamine was more effective than Midazolam, a benzodiazepine used as a sedative for surgeries. After the dose, suicidal ideation was diminished for up to 6 weeks.

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MINDCURE Provides Update on Studies and Clinical Trials

MINDCURE Provides Update on Studies and Clinical Trials

VANCOUVER, BC, Nov. 4, 2021 /CNW/ – Mind Cure Health Inc. (CSE: MCUR) (OTCQX: MCURF) (FRA: 6MH) (“MINDCURE” or the “Company”), a leader in advanced proprietary technology and research for psychedelics, is pleased to provide an operational progress update on the strategic initiatives of its operating segments – MINDCURE Research and MINDCURE Technology.

MINDCURE Research:

Synthetic Ibogaine Production Update
In March 2021, MINDCURE announced the initiation of chemical synthesis routes for the production of fully synthetic ibogaine. In July 2021, the Company applied for patents on two routes to full chemical synthesis and initiated the production of Good Laboratory Practice (“GLP”) ibogaine leading to the production of Good Manufacturing Practice (“GMP”) ibogaine in order to scale and manufacture a global supply of fully synthetic ibogaine. MINDCURE is currently on schedule and expects to have GLP supply available for research partners beginning in Q2 of 2022.

Pre-Clinical Update
MINDCURE confirms that it is preparing to ship ibogaine drug material to its pre-clinical research partner. The material will initially be used for broad cardiac and neurologic screens, with the potential to conduct in-depth behavioral studies. This program has been identified as MSYNTH-001, and the Company expects results from the first studies during the first quarter of 2022.

In addition to advancing the scale of its synthetic ibogaine program, MINDCURE continues to explore options for drug pipeline expansion. Two candidate selection programs are currently underway, known internally as MC-106 and MC-808. The Company will provide further information on these programs in the second quarter of 2022.

Clinical Trial Update
MINDCURE has completed its draft research protocol for the use of MDMA and psychotherapy to treat female sexual hypoactive desire disorder, known as The Desire Project. The Company expects a pre-IND meeting with the FDA to be scheduled in the first quarter of 2022 and for its Phase 2 trial to begin by the third quarter of 2022. Further, site initiation and initial screening are planned for March 2022, with recruitment and enrollment to follow.

“We are proud to report that MINDCURE’s core research programs are progressing rapidly, showcasing our disciplined commitment to advancing MINDCURE’s drug research and commercial production programs. Concurrently, we maintain a focus on identifying opportunities to expand our drug development pipeline,” said Kelsey Ramsden, President & Chief Executive Officer of MINDCURE.

MINDCURE Technology:

Digital Platform iSTRYM Update
The Company released the minimum viable product (“MVP”) of its digital therapeutics (DTx) technology, iSTRYM, into partner clinics across North America in August. MINDCURE is pleased to announce that it has exceeded its previously announced target and timeline of 10 clinics by the end of 2021. The Company has already partnered with 20 ketamine clinics in nine states in the US and three provinces in Canada and plans to expand to the broader mental health market in 2022.

In addition, MINDCURE will begin full commercial deployment to all partner clinics in early 2022, with expansion plans to the UK and Europe by the fourth quarter of 2022.

In addition to its recently announced letter of intent with Awakn Life Sciences Corp. to distribute their Ketamine for Alcohol Use Disorder (“AUD”) protocol in North America via iSTRYM, MINDCURE will expand its selection of existing ketamine protocols with an additional MINDCURE developed protocol in the first quarter of 2022. The Company is continuing on its path toward becoming a leader in the distribution of best-in-class therapy protocols for both partners and providers.

Observational Study Update
MINDCURE is pleased to announce that its Integration Protocol Research Study is complete. As previously announced in March 2021, unconditional ethics approval from Veritas IRB was received for the study. The data has been amassed and findings incorporated into the MVP of iSTRYM. As a next step, the Company’s research partners will submit findings for publication. Understanding integration protocols and practices is an important part of providing best-in-class care specific to psychedelic medicines in practice.

Corporate Update

MINDCURE has further engaged Sandstone Media LLC (“Sandstone”) to provide a broad range of product and brand awareness, marketing and media services, including message development, content creation, social media, advertising, marketing and retargeting, which may include related investor relations services. Sandstone will be paid up to USD$375,000 for the execution and management of the campaign.

Lastly, the Company has granted a total of 30,000 stock options to certain employees pursuant to the terms of the Company’s long term incentive plan (“Plan”). The stock options are exercisable at a price of $0.33 per share and subject to the terms of the Plan.

About MINDCURE
Mind Cure Health (“MINDCURE”) is a life sciences company focused on innovating and commercializing new ways to promote healing and improve mental health. The company is developing digital therapeutics technology and researching psychedelic compounds to support access to safe, evidence-based psychedelic-assisted therapies globally.  Learn more at mindcure.com, and follow us on LinkedIn, Facebook, Twitter, and Instagram.

On Behalf of the Board of Directors
Kelsey Ramsden, President & CEO
Phone: 1-888-593-8995

Forward-Looking Information
Certain information presented in this news release may constitute “forward-looking information” within the meaning of applicable securities laws regarding MINDCURE and its business. Forward-looking information generally can be identified by the use of terms and phrases such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “feel”, “intend”, “may”, “plan”, “predict”, “project”, “subject to”, “will”, “would”, and similar terms and phrases.

Forward-looking information is based on a number of key expectations and assumptions made by management of MINDCURE, including, without limitation: the COVID-19 pandemic impact on the Canadian economy and MINDCURE’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect MINDCURE’s business; the Company will develop its products as expected and that they will attain the outcomes anticipated; there will be a demand for MINDCURE’s products in the future; no unanticipated expenses or costs arise; MINDCURE will be able to continue to identify products that make them ideal candidates for providing solutions for treating mental health; that strategic partnerships entered by the Company will create the opportunities and outcomes anticipated; that MINDCURE will advance wellness worldwide; that trading on the OTCQX will attract additional investment and provide additional liquidity for shareholders.

Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. Forward-looking information inherently entails known and unknown risks and uncertainties about the future and actual results and involves significant risks and uncertainties and should not be read as a guarantee of future performance or results as actual results may differ materially from those expressed or implied in such forward-looking information. Those risks and uncertainties include, among other things, risks related to: successful clinical studies relating to ibogaine and the Desire Project, successfully synthesizing and manufacturing of ibogaine, the successful development, integration and deployment of iSTRYM, the successful development of appropriate Ketamine protocols, and acquiring adequate protection of any IP developed. Although MINDCURE has attempted to identify important factors that could cause actual results, performance or achievements to differ materially from those described in forward-looking information presented, there may be other factors that cause results, performance or achievements to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements as no forward-looking information can be guaranteed.

Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and MINDCURE does not undertake any obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events, or otherwise.

The CSE has neither approved nor disapproved the contents of this press release and the CSE does not accept responsibility for the adequacy or accuracy of this release.

For further information

MINDCURE Investor Relations

investors@mindcure.com

1-888-593-8995

Media Inquiries

Annie Graf / Kristin Cwalinski

KCSA Strategic Communications

mindcure@kcsa.com

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Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Awakn Life Sciences Announces The Findings From Phase II A/B Study Are To Be Published In American Journal Of Psychiatry

Worlds’s First Controlled Study To Investigate Ketamine-Assisted Psychotherapy

TORONTO, CANADA, November 4, 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announced today that the ‘Ketamine in the Reduction of Alcoholic Relapse’ (KARE) psychotherapy intervention study, which was the first controlled study in the world to investigate ketamine-assisted psychotherapy, will be published in the American Journal of Psychiatry later this year. The study was conducted by University of Exeter (UoE) and led by Prof. Celia Morgan, Professor of Psychopharmacology at UoE and Awakn’s Head of Ketamine-assisted psychotherapy for addiction. Awkan has acquired the rights to this research.

The findings, which will be shared in detail in the journal, are a very exciting step forward in the treatment of alcohol use disorder and for the wider psychedelic industry in general. The phase II a/b trial had four groups, ketamine with and without therapy, and placebo administered with and without therapy.

Professor Morgan commented “We are delighted that the findings are to be published in the American Journal of Psychiatry. This new approach looks set to revolutionise the treatment of alcohol use disorder. We are excited to partner with Awakn for the next steps in the journey of ketamine-assisted therapy into a licensed treatment for this group of patients with limited treatment options.”

With ketamine already a licenced medicine, the phase II a/b results allow Awakn to deliver the KARE treatment in its clinics in the UK and Europe immediately and through its licencing partnerships outside of these territories. The University of Exeter and Awakn are investigating how best to move this research forward to a pivotal phase III trial, which ultimately would allow it to be delivered ‘on label’, meaning it could be adopted by public health systems and covered by insurers.

Following the study, Dr. Morgan’s research team also interviewed participants in the trial and published an analysis of their experiences in the journal Frontiers in Psychiatry entitled, “This Is Something That Changed My Life: A Qualitative Study of Patients’ Experiences.” A brief selection of quotes from the paper below, show the life-changing effect the treatment had on them and crucially how it changed their relationship with alcohol.

It helped family wise, relationship wise, in every, every single avenue of my life, It’s changed it.

I wouldn’t be here now if it wasn’t for it. I can definitely say that.

I feel I have much less desire to drink now than I used to. And I think what it is, I actually, I think I enjoy it less now”

“I think before the trial all my life was sort of focused around alcohol. I was either drinking it at home or selling it to students or working in an event where there was alcohol, the alcohol was a focus of it. So it was sort of everything and then afterwards, it just sort of stopped.

Chief Executive Officer of Awakn, Anthony Tennyson commented; “This is a very exciting moment for ketamine-assisted psychotherapy. For so many people who are suffering from alcohol addiction, for whom the current treatments just aren’t working, a successful phase II a/b trial and a unified ambition to progress this forward to a pivotal trial, gives real hope to those seeking a better and healthier future.”

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company with clinical operations, developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn’s team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver these evidence backed psychedelic therapies in clinics in the UK and Europe and through licensing partnerships globally.

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Notice Regarding Forward Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as “forward-looking statements”). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company’s future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “continues”, “forecasts”, “projects”, “predicts”, “intends”, “anticipates”, “targets” or “believes”, or variations of, or the negatives of, such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will” be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company’s public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company’s and Awakn’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World:
ROAD Communications
Paul Jarman / Anna Ramsey

Awakn@roadcommunications.co.uk

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Braxia Scientific Graduates First Cohort of Medical Professionals From Psilocybin-Assisted Therapy Training Program; Ready to Start Health Canada Approved Psilocybin Clinical Trial

Braxia Scientific Graduates First Cohort of Medical Professionals From Psilocybin-Assisted Therapy Training Program; Ready to Start Health Canada Approved Psilocybin Clinical Trial

TORONTO, ONTARIO November 2, 2021 – Braxia Scientific Corp. (“Braxia”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 496), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, is excited to announce the completion of the training program for psilocybin-assisted clinical therapy by its first multi-disciplinary cohort of 20 qualified therapists from diverse psychiatry and psychotherapy backgrounds.

This program was implemented by the Braxia Institute, the Company’s training centre focused on advancing psychiatric clinical practice and health services of ketamine and psychedelic treatment therapy. Through this program, the Company is able to develop, train, and support qualified, independent medical physicians, psychologists and psychotherapists skilled in best practices to implement safe and effective psilocybin-assisted therapy for patients with depression.

Trainees experienced and learned, through pre-readings, didactic teaching, peer teaching, group discussion and simulations, which provided important background on the use of psilocybin for treating depression and practical considerations for providing psilocybin-assisted psychotherapy. All the enrolled therapists were also required to complete a practicum component, in which medical professionals gained experience in administering psilocybin-assisted therapy for participants with depression as part of an upcoming Health Canada-approved clinical trial.

“Braxia Scientific would like to extend congratulations to this pioneering group graduating our training program,” said Dr. Roger McIntyre, CEO of Braxia Scientific.

“Psilocybin-assisted therapy is a rapidly growing and evolving area of interest for medical professionals, clinicians and patients with multiple mental health conditions, including treatment-resistant depression. Combining the effects of psilocybin with the support of psychotherapy from a qualified and trusted therapist allows a patient to process the psilocybin experience with the therapist, providing the basis for a better treatment outcome.”

Participants in the Braxia Institute training program came from diverse therapy backgrounds, allowing them to leverage their various areas of expertise to co-create guidelines and best practices. This co-creation is also a parallel process with the therapy itself, as (i) psilocybin-assisted therapy relies on a personal journey with minimal top-down direction from the therapist, and (ii) structured therapies, such as cognitive behavioural therapy (CBT), provide more explicit direction and transfer of skills and knowledge from the therapist to the patient.

Through this program, the therapists will be fully competent to perform psilocybin-assisted therapy in upcoming clinical trials conducted by Braxia Scientific and its subsidiaries, evaluating the safety and efficacy of psilocybin in depression. The Company anticipates that, pending regulatory approval of psilocybin, therapists would also be trained to implement psychedelics in clinical practice.

“As mental health professionals, we continually strive to deliver innovative treatment options that will result in better outcomes in persons affected by depression and related disorders,” said Dr. McIntyre.

“We are encouraged to see the growing number of clinical studies focused on demonstrating that psilocybin, and potentially other psychedelics, may be safe and effective in treating people with mental health conditions, and we are focused on providing healthcare professionals with the training, competencies and practical experience to address the need for safe, legal and affordable access to high-quality psilocybin-assisted therapy as regulatory approval is sought for these innovative treatments.”

About Braxia Scientific Corp.
Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based mental disorders such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”
Dr. Roger S. McIntyre
Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:
Braxia Scientific Corp.
Tel: 416-762-2138
Email: info@braxiascientific.com
Website: www.braxiascientific.com

 

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

 

Forward-looking Information Cautionary Statement
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. 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, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

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. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. 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.

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PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

  • Completing IND-enabling studies with novel microneedle patch for ketamine, psilocybin, MDMA, LSD, and DMT.
  • Expanding research in evaluating ibogaine and mescaline.
  • Aiming for FDA Phase 1 and 2 clinical studies in Q2-2022.
  • Discussing partnership opportunities for delivering psychedelics with MicroDose-MN™ and MacroDose-MN™ patches.
TORONTO, November 1, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today provides an update on the ongoing research studies with its novel microneedle (“MN”) patch as a next generation delivery technology for psychedelics, including ketamine, psilocybin, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).

The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.

Research results with MicroDose-MN™ for psilocybin and LSD will be made available in November 2021, followed by results with MDMA and DMT in December 2021.  Research results with MacroDose-MN™ for ketamine and KETABET™ will be made available in December 2021.  Current research results are very encouraging; therefore, the Company has decided to expand research to include ibogaine and mescaline, prepare IND applications with the FDA for Phase 1 and 2 clinical studies in Q2-2022, and discuss partnership opportunities with specialty pharmaceutical companies seeking a novel and validated delivery system for psychedelics targeting specific indications and desired pharmacokinetic profiles.

PharmaTher is proceeding with its IND-enabling studies and manufacturing scale-up for cGMP microneedle patches for its expected clinical studies in 2022.  The MicroDose-MN™ and MacroDose-MN™ patches can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are nearing completion of our research programs in validating the utility of our microneedle patch delivery technologies for psychedelics, derisking our plans in advancing the completion of our IND-enabling studies to support future clinical studies and partnering opportunities,” said Fabio Chianelli, CEO of PharmaTher.  “As we look forward to announcing our research results, our focus continues to expand our ketamine-based product pipeline and advance our microneedle patch programs to unlock significant value and return on investment for long-term revenue potential through our products and our future partners.”

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is 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. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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A new tool to understand the brain

Kernel’s Brain-Imaging Helmet Approved For Clinical Trial On Patients Using Ketamine

An LA-based company called Kernel developed a brain-imaging helmet that can track what actually happens in the brain during a psychedelic trip.

The device, called Kernel Flow, was just approved by the FDA to be used in a ketamine trial sponsored by Cybin (CYBN).

Researchers will use the helmet to measure the neurological activity of 15 patients during a ketamine therapy session compared to baseline activity.

Kernel Flow is much less expensive than other brain-imaging tools and allows the patients to move freely during the session.

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