Cybin Company Presentation

P r i v a t e & C o n f i d e n t i a l 35 Limited Products The Company and the Resulting Issuer is heavily reliant on the productionand distributionof psychedelics, nutraceuticalsand related products. If they do not achieve sufficient market acceptance, it will be difficult for the Resulting Issuer to achieve profitability. The Resulting Issuer’s revenue will be derived almost exclusively from sales of psychedelic and nutraceutical based products, and the Company and the Resulting Issuer expect that its psychedelic and nutraceutical based products will account for substantially all of its revenue for the foreseeable future. If the psychedelic and nutraceutical market declines or psychedelics and nutraceuticals fail to achieve substantially greater market acceptance than it currently enjoys, the Resulting Issuer will not be able to grow its revenues sufficiently for it to achieve consistent profitability. Even if products to be distributed by the Resulting Issuer conform to international safety and quality standards, sales could be adversely affected if consumers in target markets lose confidence in the safety, efficacy, and quality of psychedelic and nutraceutical based products. Adverse publicity about psychedelic and nutraceutical based products that the Resulting Issuer sells may discourage consumers from buying products distributed by the Resulting Issuer. Limited Marketing and Sales Capabilities The Company and the Resulting Issuer will, for the immediate future, have limited marketing and sales capabilities, and there can be no assurance that it will be able to develop or acquire these capabilities at the level needed to produce and deliver for sale, through industry partners, its products in sufficient commercial quantities. Further, there can be no assurance that the Resulting Issuer, either on its own or through arrangements with other industry participants, will be able to develop or acquire such capabilities on a cost-effective basis, or at all. Finally, there can be no assurance that the Resulting Issuer’s industry partners will be able to market or sell the Resulting Issuer’s products in compliance with requisite regulatory protocols or on a cost-effective basis. The Resulting Issuer’s dependence upon third parties for the production,and marketing or sale, as applicable, of the Resulting Issuer’s products could have a material adverse effect on the Resulting Issuer’s business, financial conditionand results of operations. No Assurance of Commercial Success The successful commercialization of the Resulting Issuer’s products will depend on many factors, including, the Resulting Issuer’s ability to establish and maintain working partnerships with industry participants in order to market its products, the Resulting Issuer’s ability to supply a sufficient amount of its products to meet market demand, and the number of competitors within each jurisdiction within which the Resulting Issuer may from time to time be engaged. There can be no assurance thatthe Resulting Issuer or its industry partners will be successful in their respective efforts to develop and implement, or assist the Resulting Issuer in developing and implementing, a commercialization strategy for the Resulting Issuer’s products. No Profits or Significant Revenues The Company and the Resulting Issuer have no history upon which to evaluate its performance and future prospects. The Resulting Issuer’s proposed operations are subject to all the business risks associated with new enterprises. These include likely fluctuations in operating results as the Resulting Issuer makes significant investments in research, development and product opportunities, and reacts to developments in its market, including purchasing patterns of customers, and the entry of competitors into the market. The Resulting Issuer will only be able to pay dividends on any shares once its directors determine that it is financially able to do so. The Company and the Resulting Issuer cannot make any assurance that it will be profitable in the next three (3) years or generate sufficient revenues to pay dividends to the holders of the common shares in the capitalof the Resulting Issuer (the “Resulting Issuer Shares”). Reliance on Third Parties for Clinical Development Activities The Company and the Resulting Issuer rely and will continue to rely on third parties to conduct a significant portion of its preclinical and clinical development activities. For example, clinical development activities include trial design, regulatory submissions, clinical patient recruitment, clinical trial monitoring, clinical data management and analysis, safety monitoring and project management. If there is any dispute or disruption in its relationship with third parties, or if it is unable to provide quality services in a timely manner and at a feasible cost, the Resulting Issuer’s active development programs will face delays. Further, if any of these third parties fails to perform as the Resulting Issuer expects or if their work fails to meet regulatory requirements, the Resulting Issuer’s testing could be delayed, cancelled or rendered ineffective. Risks Related to Third Party Relationships The Company and the Resulting Issuer intend to enter into strategic alliances with third parties that the Company believes will complement or augment its proposed business or will have a beneficial impact on the Resulting Issuer. Strategic alliances could present unforeseen integration obstacles or costs, may not enhance the Resulting Issuer’s business, and may involve risks that could adversely affect the Resulting Issuer, including significant amounts of management time that may be diverted from operations in order to pursue and complete such transactions or maintain such strategic alliances. Future strategic alliances could result in the incurrence of additional debt, costs and contingent liabilities, and there can be no assurance that future strategic alliances will achieve, or that the Resulting Issuer’s existing strategic alliances will continue to achieve, the expected benefits to the Resulting Issuer’s business or thatthe Resulting Issuer will be able to consummate future strategic alliances on satisfactory terms, or at all. Any of the foregoing could have a material adverse effect on the Resulting Issuer’s business, financial conditionand results of operations. In addition to the foregoing, the success of the Resulting Issuer’s business will depend, in large part, on the Resulting Issuer’s ability to enter into, and maintain collaborative arrangements with various participants in the psychedelic and nutraceutical industry. There can be no assurance that the Resulting Issuer will be able to enter into collaborative arrangements in the future on acceptable terms, if at all. There can be no assurance that such arrangements will be successful, that the parties with which the Resulting Issuer has or may establish arrangements will adequately or successfully perform their obligations under such arrangements, that potential partners will not compete with the Resulting Issuer by seeking or prioritizing alternate, competitor products. The termination or cancellation of any such collaborative arrangement or the failure of the Resulting Issuer and/or the other parties to these arrangements to fulfill their obligations could have a material adverse effect on the Resulting Issuer’s business, financial condition and results of operations. In addition, disagreements between the Resulting Issuer and any of its industry partners could lead to delays or time consuming and expensive legal proceedings, which could have a material adverse effect on the Resulting Issuer’s business, financial conditionand results of operations. Reliance on Contract Manufacturers The Company has, and the Resulting Issuer will have, limited manufacturing experience and rely on contract manufacturing organizations (“CMOs”) to manufacture its product candidates for preclinical studies and clinical trials. The Company relies, and the Resulting Issuer will rely, on CMOs for manufacturing, filling, packaging, storing and shipping of drug product in compliance with current Good Manufacturing Practices (“cGMP”) regulations applicable to its products. Health Canada ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with cGMP regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of a drug product. There can be no assurances that CMOs will be able to meet the Resulting Issuer’s timetable and requirements. The Company has not contracted with alternate suppliers for drug substance production in the event that the current provider is unable to scale up production, or if it otherwise experiences any other significant problems. If the Resulting Issuer is unable to arrange for alternative third-party manufacturing sources on commercially reasonable terms or in a timely manner, the Resulting Issuer may be delayed in the development of its product candidates. Further, CMOs must operate in compliance with cGMP and failure to do so could result in, among other things, the disruption of product supplies. The Resulting Issuer’s dependence upon third parties for the manufacture of its products may adversely affect its profit margins and its abilityto develop and deliver products on a timely and competitive basis. Commercial Scale Product Manufacturing The Resulting Issuer’s products will be manufactured in small quantities for preclinical studies and clinical trials by third party manufacturers. In order to commercialize its product, the Resulting Issuer needs to manufacture commercial quality drug supply for use in registration clinical trials. Most, if not all, of the clinical material used in phase 3/pivotal/registration studies must be derived from the defined commercial process including scale, manufacturing site, process controls and batch size. If the Resulting Issuer has not scaled up and validated the commercial production of its product prior to the commencement of pivotal clinical trials, it may have to employ a bridging strategy during the trial to demonstrate equivalency of early stage material to commercial drug product, or potentially delay the initiation or completion of the trial until drug supply is available. The manufacturing of commercial quality product may have long lead times, may be very expensive and requires significant efforts including, but not limited to, scale-up of production to anticipated commercial scale, process characterization and validation, analytical method validation, identification of critical process parameters and product quality attributes, and multiple process performance and validation runs. If the Resulting Issuer does not have commercial drug supply available when needed for pivotal clinical trials, the Resulting Issuer’s regulatory and commercial progress may be delayed, and it may incur increased product development costs. This may have a material adverse effect on the Resulting Issuer’s business, financial conditionand prospects, and may delay marketing of the product. Safety andEfficacy of Products Before obtaining marketing approval from regulatory authorities for the sale of the Resulting Issuer’s product candidates, the Resulting Issuer must conduct preclinical studies in animals and extensive clinical trials in humans to demonstrate the safety and efficacy of the product candidates. Clinical testing is expensive and difficult to design and implement, can take many years to complete and has uncertain outcomes. The outcome of preclinical studies and early clinical trials may not predict the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety profiles, notwithstanding promising results in earlier trials. The Company does not know whether the clinical trials it may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any of its product candidates in any jurisdiction. A product candidate may fail for safety or efficacy reasons at any stage of the testing process. A major risk the Resulting Issuer faces is the possibility thatnone of its product candidates under development will successfully gain market approval from Health Canada, the FDA or other regulatory authorities, resulting in the Resulting Issuer being unable to derive any commercial revenue from them after investing significant amounts of capitalin their development. RISK FACTORS