Entheon Biomedical Provides Corporate Update on Studies and Clinical Trials

October 27, 2021 8:00 AM EDT | Source: Entheon Biomedical Corp.

Vancouver, British Columbia--(Newsfile Corp. - October 27, 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, is pleased to provide an update on its operations and progress on its strategic initiatives.

Observational Study Update

Entheon is pleased to announce that its observational study assessing the neurophysiological effects of ketamine is progressing as planned. Approval of the observational study was received on October 22, 2021 from the Internal Review Board and site initiation has been completed with patient recruitment to begin shortly. In partnership with Heading Health, LLC ("Heading Health"), this clinical trial will use electroencephalography (EEG) and genetic screening to investigate biomarkers associated with ketamine treatment for major depressive disorder. Study results will further advance Entheon's biomarker program for characterizing various drug states and mental health disorders.

In addition, an agreement has been signed with Wavepaths Ltd. ("Wavepaths"), a company that collaborates with world-class artists to develop adaptive music for use during psychedelic therapy. Pursuant to the agreement, Wavepaths will provide Entheon with audio for ketamine therapy sessions conducted at Heading Health as part of the observational study. The Wavepaths' audio tracks will be used to control EEG variables related to patient-selected music typically used during treatment. This data set may serve as a baseline which Entheon will build on to explore the impact of music on therapeutic outcomes in subsequent studies.

Pre-Clinical Update

Furthermore, Entheon confirms that DMT drug material from Psygen Labs Inc. has been shipped to Entheon's Israeli pre-clinical research partners, Science in Action and Pharmaseed Ltd. This material will be used for both an in vivo acute toxicity study as well as behavioral assays related to alcohol-use disorder. Results of these studies are expected in Q4 of 2021.

Clinical Trial Update

The Scientific Review Committee at the Centre for Human Drug Research has conducted a review and risk analysis of the clinical study, with input from the Scientific Advice Board, and has endorsed Entheon's clinical study protocol for submission to the medical ethics committee. The Company expects that its Phase 1 human trial will now begin in Q1 of 2022. Site initiation and initial screening are planned for January, with recruitment and enrollment to follow shortly thereafter.

"We are happy to report that Entheon's core research programs are progressing steadily with the cooperation of our partners and our shared commitment to advancing Entheon's biomarker-enabled drug development platform," said Timothy Ko, Chief Executive Officer of Entheon.

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.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615

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

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141

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 timeline relating to submission of the Company's IMPD, the development of the Company's protocol, the Company's planned clinical trial, results of trials and studies, receipt of GMP drug material, the expected collaboration to take place with Wavepaths, the commencement of certain pre-clinical studies and the expected timeline for results and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company, including, but not limited to, assumptions relating to the continued impact and status of COVID on the Company's personnel and planned research activities, that general economic and political conditions will remain the same, that the Company will be able to prepare the submission and complete site initiation and initial screening within the time frame expected, that preclinical studies will be completed within the timeframes expected, the expected results from the collaboration with Wavepath, stability in applicable law and regulations. 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, a rise in the number of COVID cases globally, an adverse impact of COVID on the research activities of the Company and its research partners, the inability to prepare the IMPD submission within the time frame expected, difficulties in subject enrollment, initial screening or site initiation, delays to the Company's planned clinical trial timeline as a result of other unknown uncertainties and adverse changes to applicable law and regulations. 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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