Cybin Company Presentation

P r i v a t e & C o n f i d e n t i a l 36 Clinical Testing and Commercializing Product Candidates The Company cannot predict whether any clinical trials will begin as planned, will need to be restructured, or will be completed on schedule, or at all. The Resulting Issuer’s product development costs will increase if it experiences delays in clinical testing. Significant clinical trial delays could shorten any periods during which the Resulting Issuer may have the exclusive right to commercialize its product candidates or allow its competitors to bring products to market before the Resulting Issuer, which would impair the Resulting Issuer’s abilityto successfully commercialize its product candidates and may harm its financial condition,results of operations and prospects. The commencement and completion of clinical trials for the Resulting Issuer’s productsmay be delayed for a numberof reasons, includingbutnot limited, to: • failure by regulatory authorities to grant permission to proceed or placing clinical trials on hold; • suspension or terminationof clinical trials by regulators for many reasons, including concerns about patientsafety or failure of the Resulting Issuer’s CMOs to comply with cGMP requirements; • any changes to the Resulting Issuer’s manufacturing process that may be necessary or desired, delays or failure to obtainclinical supply from CMOs of the Resulting Issuer’s products necessary to conduct clinical trials; • product candidates demonstrating a lack of safety or efficacy during clinical trials, reports of clinical testing on similar technologies and products raising safety or efficacy concerns; • clinical investigators not performing the Resulting Issuer’s clinical trials on their anticipated schedule, dropping out of a trial, or employing methods not consistent with the clinical trial protocol, regulatory requirements or other third parties not performing data collection and analysis in a timely or accurate manner; • failure of the Resulting Issuer’s contract research organizations to satisfy their contractualduties or meet expected deadlines; • inspections of clinical trial sites by regulatory authorities; • regulatory authorities or ethics committees finding regulatory violations thatrequire the Resulting Issuer to undertake corrective action, resulting in suspension or termination of one or more sites or the imposition of a clinical hold on the entire study; • one or more regulatory authorities or ethics committees rejecting, suspending or terminating the study at an investigational site, precluding enrollment of additionalsubjects, or withdrawing its approval of the trial; or • failure to reach agreement on acceptable terms with prospective clinical trial sites. The Resulting Issuer’s product development costs will increase if it experiences delays in testing or approval or if the Resulting Issuer needs to perform more or larger clinical trials than planned. Additionally, changes in regulatory requirements and policies may occur, and the Resulting Issuer may need to amend study protocols to reflect these changes. Amendments may require the Resulting Issuer to resubmit its study protocols to regulatory authorities or ethics committees for re-examination, which may impact the cost, timing or successful completion of thattrial. Delays or increased product development costs may have a material adverse effect on the Resulting Issuer’s business, financial conditionand prospects. Completion of Clinical Trials As the Resulting Issuer’s product candidates advance from preclinical testing to clinical testing, and then through progressively larger and more complex clinical trials, the Resulting Issuer will need to enroll an increasing number of patients that meet its eligibility criteria. There is significant competition for recruiting patients in clinical trials, and the Resulting Issuer may be unable to enroll the patients it needs to complete clinical trials on a timely basis or at all. The factors that affect the Resulting Issuer’s ability to enroll patients are largely uncontrollable and include, but are not limited to the size and nature of the patient population, eligibility and exclusion criteria for the trial, design of the clinical trial, competition with other companies for clinical sites or patients, perceived risks and benefits of the product candidate, and the number, availability,location and accessibility of clinical trial sites. Natureof Regulatory Approvals The Resulting Issuer’s development and commercialization activities and product candidates are significantly regulated by a number of governmental entities, including Health Canada and the FDA. Regulatory approvals are required prior to each clinical trial and the Resulting Issuer may fail to obtain the necessary approvals to commence or continue clinical testing. The Resulting Issuer must comply with regulations concerning the manufacture, testing, safety, effectiveness, labeling, documentation, advertising, and sale of products and product candidates and ultimately must obtain regulatory approval before it can commercialize a product candidate. The time required to obtain approval by such regulatory authorities is unpredictable but typically takes many years following the commencement of preclinical studies and clinical trials. Any analysis of data from clinical activities the Resulting Issuer performs is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. Even if the Resulting Issuer believes results from its clinical trials are favorable to support the marketing of its product candidates, Health Canada, the FDA or other regulatory authorities may disagree. In addition,approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. The Company and the Resulting Issuer have not obtained regulatory approval for any product candidate and it is possible that none of its existing product candidates or any future product candidates will ever obtain regulatory approval. The Resulting Issuer could fail to receive regulatory approval for its product candidates for many reasons, including, but not limited to 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, or deficiencies in the manufacturing processes or the failure of facilities of CMOs with whom the Resulting Issuer contracts for clinical and commercial supplies to pass a pre-approval inspection. A regulatory authority may require more information, including additional preclinical or clinical data to support approval, which may delay or prevent approval and the Resulting Issuer’s commercialization plans, or we may decide to abandon the development program. If the Resulting Issuer were to obtain approval, regulatory authorities may approve any of its product candidates for fewer or more limited indications than the Resulting Issuer request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Moreover, depending on any safety issues associated with the Resulting Issuer’s product candidates thatgarner approval, Health Canada, the FDA or other regulatory authorities may impose a risk evaluation and mitigationstrategy, thereby imposing certain restrictions on the sale and marketabilityof such products. Achieving Publicly AnnouncedMilestones From time to time, the Resulting Issuer may announce the timing of certain events it expects to occur, such as the anticipated timing of results from its clinical trials. These statements are forward-looking and are based on the best estimates of management at the time relating to the occurrence of such events. However, the actual timing of such events may differ from what has been publicly disclosed. The timing of events such as initiation or completion of a clinical trial, filing of an application to obtain regulatory approval, or announcement of additional clinical trials for a product candidate may ultimately vary from what is publicly disclosed. See “Commercial Scale Product Manufacturing”, “Safety and Efficacy of Products”, “Clinical Testing and Commercializing Product Candidates”, “Completion of Clinical Trials”, and “Nature of Regulatory Approvals” as discussed under this heading “Risk Factors” for further disclosure of risks and events that may affect the timing of certain events the Resulting Issuer may announce. The Company and the Resulting Issuer undertake no obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise, except as otherwise required bylaw. Any variation in the timing of previously announced milestones could have a material adverse effect on the business plan, financial condition or operating results and the future trading price of the Resulting Issuer Shares. Unfavourable Publicity or Consumer Perception The Company believes the psychedelic industry is highly dependent upon consumer perception regarding the safety, efficacy and quality of psychedelic products. Consumer perception of the Resulting Issuer’s psychedelic products can be significantly influenced by scientific research or findings, regulatory investigations, litigation, media attention and other publicity regarding the consumption of psychedelics. There can be no assurance that future scientific research, findings, regulatory proceedings, litigation, media attention or other research findings or publicity will be favourable to the psychedelic industry or any particular product, or consistent with earlier publicity. Future research reports, findings, regulatory proceedings, litigation, media attention or other publicity that are perceived as less favourable than, or that question, earlier research reports, findings or publicity could have a material adverse effect on the demand for the Resulting Issuer’s psychedelic products and the business, results of operations, financial condition and cash flows of the Resulting Issuer. The Resulting Issuer’s dependence upon consumer perceptions means that adverse scientific research reports, findings, regulatory proceedings, litigation, media attention or other publicity, whether or not accurate or with merit, could have a material adverse effect on the Resulting Issuer, the demand for the Resulting Issuer’s psychedelic products, and the business, results of operations, financial condition and cash flows of the Resulting Issuer. Further, adverse publicity reports or other media attention regarding the safety, efficacy and quality of psychedelic products in general, or the Resulting Issuer’s psychedelic products and services specifically, or associating the consumption of truffles with illness or other negative effects or events, could have such a material adverse effect. Such adverse publicity reports or other media attention could arise even if the adverse effects associated with such products resulted from consumers’ failure to consume such products legally, appropriatelyor as directed. The psilocybin industry is highly dependent upon consumer perception regarding the medical benefits, safety, efficacy and quality of the psilocybin distributed for medical purposes to such consumers. There can be no assurance that future scientific research or findings on the medical benefits, viability, safety, efficacy and dosing of psilocybin or isolated constituents, regulatory proceedings, litigation,media attentionor other research findings or publicity will be favourable to the industry or the Resulting Issuer or any particular product, or consistent with earlier publicity. RISK FACTORS

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