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Cybin Completes Acquisition of Phase 1 DMT Study from Entheon Biomedical

Cybin Completes Acquisition of Phase 1 DMT Study from Entheon Biomedical

07/11/2022

— Expected to accelerate clinical development pathway of CYB004 for the potential treatment of anxiety disorders by nine months —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that, through its wholly-owned subsidiary Cybin IRL Limited, it has completed the acquisition of a Phase 1 N,N-dimethyltryptamine (“DMT”) study (the “Acquisition”) from Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon”). This DMT study, which is the largest to date, is expected to accelerate the clinical development path of CYB004, Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders, by approximately nine months. The Company previously announced details of the Acquisition on June 7, 2022.

“With the closing of this transaction we are well on our way to advancing CYB004 through Phase 1 development and gathering essential safety and dosing optimization data that will inform the clinical path forward for this important molecule,”said Doug Drysdale, Chief Executive Officer of Cybin. “Cybin now has multiple clinical-stage programs ongoing that we believe will contribute significantly to a greater understanding of the potential of psychedelics to provide therapeutic relief to patients who suffer with a variety of mental health issues.”

The Company paid a purchase price of CDN$1,000,000 in relation to the Acquisition. Up to an additional CDN$480,000 is payable for consulting services to be provided by Entheon for up to twelve months following the closing of the Acquisition. In connection with the Acquisition, Cybin IRL Limited has also entered into a data license agreement with Entheon that permits Entheon to access certain data to support the Entheon IQ program.

About the CYB004-E Study
The CYB004-E study is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of a target-controlled intravenous infusion of DMT in healthy smokers.

Primary Objectives:

  • evaluate the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes;
  • characterize the PK of a single dose DMT administered continuously over 90 minutes;
  • characterize the PD of a single dose DMT administered continuously over 90 minutes; and,
  • establish the minimum DMT dose required to produce a psychedelic effect.

Pending results from the CYB004-E study, Cybin plans to evaluate CYB004 delivered via intravenous (“IV”) and via inhalation to determine the clinical path forward. Based on preclinical results reported by Cybin in April 2022, inhaled CYB004 demonstrated:

  • approximately 2000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability;
  • approximately 41% improved bioavailability compared with inhaled DMT;
  • approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend therapeutic window; and,
  • rapid onset of effect and similar low variability equivalent to IV DMT.

CYB004 is a new chemical entity for which a patent was issued by the U.S. Patent and Trademark Office in February 2022. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT. The composition of matter patent is expected to expire in 2041 before consideration of any patent term extensions.

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe,” “expect,” “aim,” “intend,” “plan,” “continue,” “will,” “may,” “would,” “anticipate,” “estimate,” “forecast,” “predict,” “project,” “seek,” “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders, the Company’s expectation that the Acquisition will accelerate the CYB004 timeline and the Company’s expectations and objectives regarding the results of the CYB004-E study.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the year ended March 31, 2022 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

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Cybin Acquires DMT Clinical Study from Entheon Biomedical

Cybin Acquires DMT Clinical Study from Entheon Biomedical

06/07/2022

— Acquisition of largest Phase 1 DMT study conducted to date is expected to accelerate CYB004 program timeline by nine months —

— Phase 1 study evaluating pharmacokinetics/pharmacodynamics of DMT currently underway and will inform clinical path forward —

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that, through its wholly-owned subsidiary Cybin IRL Limited, it has entered into an agreement to acquire a Phase 1 N,N-dimethyltryptamine (“DMT”) study (the “Acquisition”) from Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon”) to accelerate the clinical development path for CYB004, Cybin’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.

The Phase 1 EBRX-101 study, now named CYB004-E, is being conducted in the Netherlands at the Centre for Human Drug Research, a leading independent foundation specializing in innovative early-stage clinical drug research, in 50 healthy volunteers who smoke tobacco – making it the largest Phase 1 DMT clinical study conducted to date. Pending the close of the Acquisition, the CYB004-E study is expected to yield essential safety and dosing optimization data and will replace Cybin’s planned pilot study for CYB004 that was expected to commence in the third quarter of 2022. Entheon will continue to support the CYB004-E study and act as external consultants to Cybin.

“The most precious commodity in drug development is time and acquiring this robust Phase 1 study already underway potentially accelerates the CYB004 development program by approximately nine months. The PK findings from the CYB004-E study should also help to inform the clinical path forward for this innovative and proprietary molecule,” said Doug Drysdale, Chief Executive Officer of Cybin. “This transaction also provides Cybin with access to a world-class research foundation and the privilege to work with the Entheon team, who offer a wealth of knowledge and expertise in this psychedelic class.”

The purchase price of the Acquisition is $1,000,000 (CAD), a portion of which will be a deposit with the balance payable on closing of the Acquisition. Up to an additional $480,000 (CAD) is payable for consulting services to be provided by Entheon for up to twelve months following the closing of the Acquisition. Pursuant to the Acquisition the Company will also enter into a data license agreement with Entheon that will permit Entheon to access certain data to support the Entheon IQ program. The Company expects the Acquisition to close within 30 days, subject to the completion of certain conditions and obtaining all necessary approvals.

“With our recent IND filing for CYB003, we are quickly becoming a multi-program clinical-stage company with four sponsored human trials underway in 2022. This is especially meaningful to our work to bring our innovative psychedelic-based therapies to people in need as quickly as possible. This is a truly exciting time for Cybin,” concluded Drysdale.

About the CYB004-E Study

The CYB004-E study is an adaptive, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) of a target-controlled intravenous infusion of DMT in healthy smokers.

Primary Objectives:

  • Evaluate the safety of increasing doses of a single dose continuous DMT infusion over 90 minutes;
  • Characterize the PK of a single dose DMT administered continuously over 90 minutes;
  • Characterize the PD of a single dose DMT administered continuously over 90 minutes; and
  • Establish the minimum DMT dose required to produce a psychedelic effect.

Pending results from the CYB004-E study, Cybin plans to evaluate CYB004 delivered via intravenous (“IV”) and via inhalation to determine the clinical path forward. Based on preclinical results reported by Cybin in April 2022, inhaled CYB004 demonstrated:

  • Approximately 2000% improved bioavailability compared with orally administered DMT, which is known to have limited to no oral bioavailability;
  • Approximately 41% improved bioavailability compared with inhaled DMT;
  • Approximately 300% longer duration of effect when compared with IV DMT, indicating potential to extend therapeutic window; and
  • Rapid onset of effect and similar low variability equivalent to IV DMT.

CYB004 is a new chemical entity for which a patent was issued by the U.S. Patent and Trademark Office in February 2022. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT. The composition of matter patent is expected to expire in 2041 before consideration of any patent term extensions.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders, the anticipated timeline for closing the Acquisition, the Company’s expectation that the Acquisition will accelerate the CYB004 timeline, and the Company’s expectations and objectives regarding the results of the study.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investor & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
irteam@cybin.com – or – media@cybin.comSource: Cybin Inc.

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Predict which psychedelics are right for you

Entheon Biomedical Announces Expanded Psychedelics Genetic Test Panel & New Clinical Research Platform

Ketamine therapy for depression seems promising, but how do you know if it’s right for you?

About 30% of people have a genetic variant that impairs the secretion of BDNF, a protein that promotes the growth of neurons.

Since ketamine works by increasing the release of BDNF, people with this gene variant may have a decreased response to the antidepressant effects of ketamine therapy.

HaluGen just expanded its Psychedelics Genetic Test Kit to test for the gene variant! It also tells you how sensitive you’re to classical psychedelics and if you are at risk for schizophrenia, bipolar disorder, or psychosis.

Use code “DAILYMUSHROOM” to get 10% off HaluGen’s Psychedelics Genetic Test!

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Join our virtual Mental Health Town Hall

We’re collaborating with experts at Entheon Biomedical (ENBI) to bring you a special virtual event on February 3rd. 

Here’s what you can expect to learn:

  • The latest psychedelic research on mental health and addiction
  • How psychedelics can be used for personal development
  • All things microdosing
  • Where the industry is headed
  • Answers to all your burning questions

You’ll hear insights and stories from:

  • Timothy Ko, CEO and Founder of Entheon
  • Dr. Andrew Greenshaw, Scientific Advisor to Entheon and Professor of Psychiatry and Neuroscience at the University of Alberta
  • David Mayoh, Communications Manager at Entheon
  • Thomas Hartle, the first Canadian to receive psilocybin therapy
  • And more

Now is your chance to get your questions answered by industry experts and connect with fellow members of the Daily Mushroom Community. We can’t wait to see you there. Register for free here.

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Take this test before your first ayahuasca retreat

Entheon Biomedical Announces Expanded Psychedelics Genetic Test Panel

HaluGen Life Sciences expanded its psychedelic DNA test – it can now assess how your body metabolizes LSD, MDMA and ayahuasca. 

The kit tests for a CYP2D6 gene mutation, which can cause metabolism of the drugs to take up to twice as long. This could lead to longer, more intense trips and adverse reactions. 

Thankfully, the mutation is only present in 5-10% of people!

Entheon Biomedical

PDF of article

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Psychiatrist and Addiction Researcher, Dr. Henry Kranzler Joins Entheon Advisory Board

Psychiatrist and Addiction Researcher, Dr. Henry Kranzler Joins Entheon Advisory Board

Vancouver, British Columbia–(Newsfile Corp. – December 1, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, is pleased to announce that Dr. Henry Kranzler, Professor of Psychiatry and Director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine, has been appointed to Entheon’s Advisory Board.

Dr. Kranzler’s research centres on the genetics and pharmacological treatment of substance dependence, with a particular emphasis on targeted addiction medicine. He is also a member of the editorial board of three peer-review journals and the editor of Alcoholism: Clinical and Experimental Research. His work currently focuses on the molecular genetics of substance dependence and the personalized treatment of alcohol, opioid, and nicotine use disorders using a pharmacogenetic approach.

Dr. Kranzler is affiliated with multiple hospitals in the Philadelphia area, including the Hospital of the University of Pennsylvania, Philadelphia Veterans Affairs Medical Center, and Penn Presbyterian Medical Center. He received his medical degree from Rutgers Robert Wood Johnson Medical School and has been a practicing psychiatrist for 35 years. With a specialization in addiction and psychopharmacology, Dr. Kranzler is experienced in genetics of addiction, pharmacotherapy of alcohol dependence, and pharmacogenetics of heavy drinking.

“As alcohol use disorder is one of Entheon’s target indications, Dr. Kranzler’s specialization in this field, along with his extensive research background, will strengthen our knowledge base related to pharmacogenetics,” said Timothy Ko, Chief Executive Officer of Entheon.

About Entheon Biomedical Corp.

Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N,N-dimethyltryptamine (“DMT”) as the pharmacological benchmark; 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. 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.

On Behalf of the Board of Directors,

“Timothy Ko”
Timothy Ko, CEO

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 the engagement and advisory services of Dr. Henry Kranzler as ” Advisor” 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 Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. 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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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