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ECNP 2022 | Barriers to psychedelic research

Ellen James, PhD, Director of Research and Development, Small Pharma, London, UK, comments on the resurgence of psychedelic research in the mental health field. A large body of literature is accumulating to support the potential of psychedelic compounds in treating depression and other mental health conditions. With growing media attention and public awareness, some of the stigma surrounding psychedelic research is diminishing, but many hurdles remain. Dr James highlights the additional challenges created by the schedule 1 status of psychedelic drugs. Schedule I drugs are defined as drugs thought to have no therapeutic value and a high potential for abuse. This status imposes strict limits on who can store and supply these agents, hindering research. With the growing evidence to support the value of psychedelic-based therapy for psychiatric conditions, the appropriateness of their schedule 1 grouping is being questioned. This interview took place at the 35th European College of Neuropsychopharmacology (ECNP) Congress 2022 in Vienna, Austria.

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Cautionary Notes

The information contained in this video has been prepared by Small Pharma Inc. and its affiliates (“Small Pharma” or the “Company”) and contains information pertaining to the business and operations of the Company. The information contained in this video: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data as well as third party information from other sources; (b) does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate an investment in the Company; (c) is not to be considered as a recommendation by the Company that any person make an investment in the Company; and (d) is for information purposes only and shall not constitute an offer to buy, sell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful...

The information contained in this video has been prepared by Small Pharma Inc. and its affiliates (“Small Pharma” or the “Company”) and contains information pertaining to the business and operations of the Company. The information contained in this video: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data as well as third party information from other sources; (b) does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate an investment in the Company; (c) is not to be considered as a recommendation by the Company that any person make an investment in the Company; and (d) is for information purposes only and shall not constitute an offer to buy, sell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Where any opinion or belief is expressed in this video, it is based on certain assumptions and limitations and is an expression of present opinion or belief only. The third-party information has not been independently verified. While Small Pharma may not have verified the third-party information, it believes that it obtained the information from reliable sources and has no reason to believe it is not accurate in all material respects. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information in this video. Small Pharma disclaims and exclude all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way out of or in connection with the information in this video, its accuracy, completeness or by reason of reliance by any person on any of it. This video should not be construed as legal, financial or tax advice to any individual, as each individual’s circumstances are different.

This video is for informational purposes only and should not be considered a solicitation or recommendation to purchase, sell or hold a security. This video does not constitute an offering memorandum or an offer or solicitation in any province or territory of Canada, in the United Kingdom, in the United States, or any other jurisdiction in which an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Treatment Claims

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

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Forward-Looking Information

Certain information set forth in this video, together with any supplements and any other information that may be furnished to prospective investors by the Company in connection therewith, contains “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities legislation (referred to herein as forward-looking statements). Except for statements of historical fact, certain information contained herein constitutes forward-looking statements which include but are not limited to statements related to activities, events or developments that the Company expects or anticipates will or may occur in the future, statements related to the Company’s business strategy objectives and goals, and management’s assessment of future plans and operations which are based on current internal expectations, estimates, projections, assumptions and beliefs, which may prove to be incorrect. Such forward-looking statements include but are not limited to statements regarding: the offering terms of the Company’s securities, the potential of any therapy programs, and any milestones listed by the Company. Forward-looking statements can often be identified by the use of words such as “may”, “will”, “could”, “would”, “anticipate”, ‘believe”, expect”, “intend”, “potential”, “estimate”, “scheduled”, “plans”, “planned”, “forecasts”, “goals” and similar expressions or the negatives thereof. Forward looking statements are neither historical facts nor assurances of future performance. Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such information is provided, and forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements

Risk Factors

There are a number of risk factors that could cause future results to differ materially from those described herein. A discussion of the principal risk factors relating to the Company’s operations and business appear in the filing statement of the Company dated April 23, 2021, which is publicly available on the Company’s profile on www.sedar.com. Additional risks and uncertainties, including those that the Company is not aware of currently, or that it currently deems immaterial, may also adversely affect the Company’s business or any investment therein. All of the forward-looking statements made in this video are qualified by these cautionary statements and other cautionary statements or other factors contained herein. Although management believes that the expectations conveyed by forward-looking statements herein are reasonable based on information available on the date such forward-looking statements are made, 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 such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The forward-looking statements contained herein are presented for the purposes of assisting viewers in understanding the Company’s plan, objectives and goals and may not be appropriate for other purposes. The reader is cautioned not to place undue reliance on forward-looking statements.

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