
Aiming to Harness the DMT Molecule
A bold idea intended to help fight a multi-trillion dollar global problem.
According to the National Institute on Drug Abuse, substance use disorders are expected to cost roughly $600 billion annually in the US alone… One R&D biotechnology company intends to help create a new dimension in addiction treatment.
This biotechnology company is focused on developing psychedelic medicines to treat addiction. Its ambitious agenda revolves around and is supported by:
- An unwavering commitment to significantly improve the odds of beating addiction.
- Pioneering a leading-edge addiction recovery concept intended to harness and optimize the therapeutic potential of the DMT molecule
- The belief that DMT, a psychedelic, may be a powerful treatment for Substance Use Disorders
- Developing a DMT-assisted therapeutic protocol intended to be specifically tailored to address the core mechanisms underlying drug-seeking and using behavior
- A strong scientific advisory board with expertise in psychedelics and behavioural sciences
- Preparing for both pre-clinical and clinical trials, the Company recognizes it is in an early stage of development, which comes with its own challenges and potential opportunities
View our exclusive video on this unique publicly-traded company for more information about its DMT-related treatment concepts and development plans. Feel free to contact us at support@pinnacledigest.com
Disclosure, Compensation, Risks Involved and Forward-Looking Statements:
You must read the following before continuing.
THIS VIDEO AND THE INCLUDED CONTENT ARE NOT INVESTMENT ADVICE OR A RECOMMENDATION TO PURCHASE ANY SECURITY. NOR ARE THEY INTENDED TO PROVIDE A COMPLETE OVERVIEW OF ENTHEON BIOMEDICAL CORP. THE INFORMATION IN THIS VIDEO AND IN THE INCLUDED CONTENT IS NOT A SUBSTITUTE FOR INDEPENDENT PROFESSIONAL ADVICE. SEEK THE ADVICE OF YOUR FINANCIAL ADVISOR AND A REGISTERED BROKER-DEALER BEFORE MAKING ANY INVESTMENT DECISIONS.
Entheon Biomedical Corp. (the “Company” or “Entheon”) is a client and sponsor of PinnacleDigest.com (“Pinnacle Digest” or “Maximus Strategic Consulting Inc.” or “we” or “our”) and has paid for the production and distribution of the included video and content. PinnacleDigest.com produced this video and the included content. Because we are paid by Entheon, and therefore we are not independent reporters, our coverage of Entheon features many of its positive aspects, and not the potential risks to its business or to investing in its stock.
The securities of Entheon are highly speculative due in part to the nature of the Company’s plans/objectives, its early stage of business development (Entheon has not generated any revenue), the new industry it operates in, the substantial existing regulations and uncertainty as to future regulations for psychedelics, and the early stage of its product development, which involves research and development that has uncertain outcomes. Entheon is therefore subject to many of the risks common to early-stage enterprises, including under-capitalization, cash shortages, limitations with respect to personnel, financial, and other resources.
The Company has limited financial resources, and no assurances that sufficient funding, including adequate financing, will be available to advance its objectives. If the Company’s generative commercialization and development programs are successful, additional funds will be required for development of one or more initiatives. The Company may seek such additional financing through debt or equity offerings. Any equity offering will result in dilution to the ownership interests of the Company’s shareholders and may result in dilution to the value of such interests. Failure to obtain additional financing could result in the delay or indefinite postponement of further business development.
There can be no certainty that Entheon will be able to implement successfully the objectives and strategies described in this video and in the included content. A prospective investor should consider carefully the risk factors set out in this disclosure statement and outlined in the Company’s annual and quarterly Management’s Discussion and Analysis, and in other filings made by Entheon with Canadian securities regulatory authorities available at www.sedar.com.
An investment in securities of Entheon should only be made by persons who can afford a significant or total loss of their investment. Entheon’s stock price is volatile, and at times its shares are thinly traded. The value of the Company’s securities may experience significant fluctuations due to many factors, some of which could include operating performance, performance relative to estimates, disposition or acquisition by a large shareholder, failed pre-clinical or clinical trials, a lawsuit against Entheon, the loss or acquisition of a significant customer or business, industry-wide factors, and general market trends. There can be no assurance that an active trading market for Entheon’s common shares will be established and/or sustained.
Negative Operating Cash Flow: Since inception, the Company has had negative operating cash flow and incurred losses. Entheon has not generated any revenue to date. The Company’s negative operating cash flow and losses are expected to continue for the foreseeable future. Entheon does not believe that its existing capital resources are sufficient to enable the Company to complete the development and commercialization of its proposed DMT offerings. We cannot predict when Entheon will reach positive operating cash flow, if ever. Due to the expected continuation of negative operating cash flow, the Company will be reliant on future financings in order to meet its cash needs. There is no assurance that such future financings will be available on acceptable terms or at all. If Entheon is unable to obtain funding on a timely basis, it may be required to significantly curtail one or more of its research or development programs and/or incur financial penalties.
The Company and its business prospects must be viewed against the background of the risks, expenses and problems frequently encountered by companies in the early stages of their development, particularly companies in new and rapidly evolving markets. The regulatory approval process that Entheon will be subject to can be expensive, lengthy, and there are no guarantees Entheon will have any success during its pre-clinical and/or clinical trials.
If Entheon is unable to obtain approval from Health Canada, the FDA, the EMA, or other regulatory agencies, for any of its proposed DMT offerings, or if, subsequent to approval, Entheon is unable to successfully commercialize its proposed DMT offerings, it may not be able to generate sufficient revenue to become profitable or to continue its operations.
Psychedelic Regulatory Risk: Dimethyltryptamine (“DMT”) is currently a Schedule III drug under The Controlled Drugs and Substances Act (Canada) and a Schedule I drug under The Controlled Substances Act (United States) and the UN Convention 1971 (European Union) and is illegal, under each such legislation, to possess without a prescription or an exemption. As of the date hereof, neither Health Canada, the FDA nor the EMA have approved DMT as a drug for any indication.
Psychedelic therapy is a new and emerging industry with substantial existing regulations and uncertainty as to future regulations. There is no assurance the Company will be able to derive meaningful revenue from its investment in psychedelic therapy development, or to pursue that business to the extent proposed in this video and in the included content.
A psychedelic therapeutic solution can unexpectedly fail at any stage of preclinical and clinical development.
Entheon could fail to receive regulatory approval for its product candidates for many reasons, including but not limited to: disagreement with the design or implementation of its clinical trials; failure to demonstrate that a product candidate is safe and effective for its proposed indication; failure of clinical trials to meet the level of statistical significance required for approval; failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; disagreement with Entheon’s interpretation of data from preclinical studies or clinical trials; the insufficiency of data collected from clinical trials of Entheon’s product candidates to support the submission and filing of a submission to obtain regulatory approval; deficiencies in the manufacturing processes or the failure of facilities of collaborators with whom Entheon contracts for clinical and commercial supplies to pass a pre-approval inspection, or changes in the approval policies or regulations that render Entheon’s preclinical and clinical data insufficient for approval.
Do Your Own Due Diligence: All statements in this video and in the included content should be checked and verified by the viewer. This video and the included content may contain technical or other inaccuracies, omissions, or errors, for which Maximus Strategic Consulting Inc., owner of PinnacleDigest.com, assumes no responsibility. PinnacleDigest.com cannot warrant the information contained in this video and in the included content to be exhaustive, complete or sufficient.
Unless otherwise indicated, the market and industry data contained in this video and in the included content is based upon information from industry and other publications and the knowledge of Pinnacle Digest and Entheon. While Pinnacle Digest believes this data is reliable, market and industry data is subject to variations and cannot be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties inherent in any statistical survey. Pinnacle Digest has not independently verified any of the data from third-party sources referred to in this video or in the included content, or ascertained the underlying assumptions relied upon by such sources.
Please be aware and note the date this video was published (March 19, 2021). As a result of the passing of time, the relevancy of the opinions and facts in this video are likely to diminish and may change. As such, you cannot rely on the accuracy and timeliness of the information provided in this video. Since there is no specific guideline as to how long this video may remain relevant, you should consider that it may be irrelevant shortly after its publication date.
In all cases, interested parties should conduct their own investigation and analysis of Entheon, its assets and the information provided in this video and in the included content. Viewers should refer to Entheon’s public disclosure documents found on the SEDAR website (www.sedar.com) before considering investing in the Company. The public disclosure documents will help investors understand Entheon’s objectives and the risks associated with the Company.
The statements and opinions expressed by representatives of Pinnacle Digest are solely those of Pinnacle Digest and not the opinions of Entheon. The statements and opinions expressed by representatives of Entheon are solely those of Entheon and not the opinions of Pinnacle Digest.
Cautionary Note Regarding Forward-Looking Information: This video and the included content contain “forward-looking information” within the meaning of Canadian securities legislation (collectively, “forward-looking statements”). All statements, other than statements of historical fact, that address activities, events or developments that Entheon or Pinnacle Digest believes, expects or anticipates will or may occur in the future are forward-looking statements. Such forward-looking statements also include, but are not limited to, statements regarding: the future financial position, business strategy and objectives, potential mergers and acquisitions, budgets, projected costs and plans of or involving Entheon; future growth predictions for the psychedelics industry, particularly in regard to DMT; expectations for future revenues, earnings, capital expenditures, operating and other costs; Entheon being able to utilize DMT to address addiction and substance use disorders and depression; DMT’s safety and efficacy; Entheon’s ability to conduct operations in a safe, efficient and effective manner; Entheon’s near-term growth predictions; market forecasts and predictions; the nature of potential business acquisitions and partnerships; the timing and the completion of various development projects, including the Company’s proposed product research and development; the Company’s intention to grow its business and operations; the future performance of Entheon; expectations for anticipated cash needs; Entheon being able to manage anticipated and unanticipated events; the expected timing and completion of Entheon’s near-term and long-term objectives; the timing of Entheon’s clinical trials; the regulatory environment and legal framework for administering and developing treatments with psychedelics, particularly with DMT; Entheon having the ability to develop treatments for the future; the novelty of Entheon’s proposed therapeutic treatments; Entheon’s proposed intravenous DMT delivery system; Entheon progressing through and completing its clinical trials; the receipt of any required regulatory approvals; potential future applications for DMT; psychedelics being able to radically change the face of mental health and addiction; Entheon being able to leverage its management team’s expertise; Entheon having the strongest advisory team in the psychedelic industry; Entheon’s ability to harness and optimize the therapeutic potential of the DMT molecule; the competitive advantages of Entheon; the Company entering into new markets; the Company’s ability to scale its business; Entheon being able to obtain necessary financing on acceptable terms; the regulatory environment in which Entheon operates and the expected changes within; the Company’s ability to maintain and expand geographic scope; the Company being able to attract and/or retain key personnel and services; currency exchange and interest rates; the impact of competition; the changes and trends in Entheon’s industry or the global economy, and other statements, estimates or expectations.
Often, but not always, these forward-looking statements can be identified by the use of forward-looking terminology such as “expects”, “expected”, “budgeted”, “targets”, “forecasts”, “intends”, “anticipates”, “scheduled”, “estimates”, “aims”, “will”, “believes”, “projects”, “could”, “would” and similar expressions (including negative variations) which by their nature refer to future events.
By their very nature, forward-looking statements are subject to numerous risks and uncertainties, some of which are beyond Entheon’s control. These statements should not be read or interpreted as guarantees of future performance or results because a number of assumptions and estimates have been made, and they may prove to be incorrect. Forward-looking statements are based on the opinions and estimates of Entheon’s management or Pinnacle Digest at the date the statements are made. In this video and in the included content, assumptions and estimates may have been made regarding, among other things, future demand for the Company’s proposed offerings; Entheon being able to fund its development plans; the anticipated effects and benefits of DMT; future changes in regulations and legislation regarding psychedelic therapy; Entheon being able to secure future financing to meet its growth targets; the efficacy of conventional treatments for substance and alcohol use disorders and depression; future market growth and market trends; competition; Entheon successfully completing its development and growth plans, and doing so on schedule; the potential of Entheon’s DMT treatment plans; Entheon’s ability to scale its operations; the level of expertise within Entheon’s management and advisory teams; economic conditions continuing to show modest improvement in the near to medium future; no material changes to the tax and other regulatory requirements governing the Company; the economic and societal costs that substance and alcohol use disorders impose on Canada and the rest of the world; the competitive environment; the ability of the Company to accurately forecast the timing of business development targets; the ability of the Company to identify, hire, train, motivate, and retain qualified personnel; the ability of the Company to develop, introduce, and implement new offerings; the risks associated with operations; the impact of any potential changes in the laws and regulations in the jurisdictions in which the Company operates; the support and continued support of shareholders of Entheon; Entheon’s ability to obtain FDA, EMA or Health Canada approval, within the time frame required or at all; Entheon’s ability to carry on current and future operations; the ability of the Company to meet current and future obligations; the accuracy and reliability of estimates, projections, forecasts, studies and assessments; the current and future social, economic and political conditions; currency exchange rates; capital costs; the future size of the markets that Entheon intends to service; the business and development impacts of the current global health pandemic on Entheon’s operations, and other assumptions and factors generally associated with the psychedelic therapy industry. We caution all viewers that the foregoing list of assumptions and estimates is not exhaustive.