Cybin Company Presentation

P r i v a t e & C o n f i d e n t i a l 37 Biotechnology and Pharmaceutical Market Competition The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. The Resulting Issuer’s competitors include large, well-established pharmaceutical companies, biotechnology companies, and academic and research institutions developing therapeutics for the same indications the Resulting Issuer is targeting and competitors with existing marketed therapies. Many other companies are developing or commercializing therapies to treat the same diseases or indications for which the Resulting Issuer’s product candidates may be useful. Although there are no approved therapies that specifically target opioid addiction, some competitors use therapeutic approaches that may compete directly with the Resulting Issuer’s product candidates. Many of the Resulting Issuer’s competitors have substantially greater financial, technical and human resources than the Resulting Issuer does and have significantly greater experience than the Resulting Issuer in conducting preclinical testing and human clinical trials of product candidates, scaling up manufacturing operations and obtaining regulatory approvals of products. Accordingly, the Resulting Issuer’s competitors may succeed in obtainingregulatory approval for products more rapidly than the Resulting Issuer does. The Resulting Issuer’s abilityto compete successfully will largely depend on: • the efficacy and safety profile of its product candidates relative to marketed products and other product candidates in development; • the Resulting Issuer’s abilityto develop and maintain a competitive position in the product categories and technologies on which it focuses; • the time it takes for the Resulting Issuer’s product candidates to complete clinical development and receive marketing approval; • the Resulting Issuer’s abilityto obtainrequired regulatory approvals; • the Resulting Issuer’s abilityto commercialize any of its product candidates thatreceive regulatory approval; • the Resulting Issuer’s abilityto establish, maintainand protect intellectual property rights related to its product candidates; and • acceptance of any of the Resulting Issuer’s product candidates thatreceive regulatory approval by physicians and other healthcare providers and payers. Competitors have developed and may develop technologies that could be the basis for products that challenge the discovery research capabilities of products the Resulting Issuer is developing. Some of those products may have an entirely different approach or means of accomplishing the desired therapeutic effect than the Resulting Issuer’s product candidates and may be more effective or less costly than its product candidates. The success of the Resulting Issuer’s competitors and their products and technologies relative to the Resulting Issuer’s technological capabilities and competitiveness could have a material adverse effect on the future preclinical studies and clinical trials of the Resulting Issuer’s product candidates, including its ability to obtain the necessary regulatory approvals for the conduct of such clinical trials. This may further negatively impact the Resulting Issuer’s abilityto generate future product development programs using psychedelic inspired compounds. If the Resulting Issuer is not able to compete effectively against its current and future competitors, the Resulting Issuer’s business will not grow, and its financial conditionand operations will substantially suffer. Further, there can be no assurance that potential competitors of the Resulting Issuer, which may have greater financial, cultivation, production, sales and marketing experience, and personnel and resources than the Resulting Issuer, are not currently developing, or will not in the future develop, products and strategies that are equally or more effective and/or economical as any products or strategies developed by the Resulting Issuer or which would otherwise render the Resulting Issuer’s business, products and strategies, as applicable, ineffective, or obsolete. Increased competition by larger and better financed competitors could materially and adversely affect the business, financial conditionand results of operations of the Resulting Issuer. Reliance on Key Executives and Scientists The loss of key members of the Resulting Issuer’s staff, could harm the Resulting Issuer. The Resulting Issuer does not have employment agreements with all members of its staff, although such employment agreements do not guarantee their retention. The Resulting Issuer also depends on its scientific and clinical collaborators and advisors, all of whom have outside commitments that may limit their availability to the Resulting Issuer. In addition, the Resulting Issuer believes that its future success will depend in large part upon its ability to attract and retain highly skilled scientific, managerial, medical, manufacturing, clinical and regulatory personnel, particularly as the Resulting Issuer expands its activities and seeks regulatory approvals for clinical trials. The Resulting Issuer enters into agreements with its scientific and clinical collaborators and advisors, key opinion leaders and academic partners in the ordinary course of its business. The Resulting Issuer also enters into agreements with physicians and institutions who will recruit patients into the Resulting Issuer’s clinical trials on its behalf in the ordinary course of its business. Notwithstanding these arrangements, the Resulting Issuer faces significant competition for these types of personnel from other companies, research and academic institutions, government entities and other organizations. The Resulting Issuer cannot predict its success in hiring or retaining the personnel it requires for continued growth. The loss of the services of any of the Resulting Issuer’s executive officers or other key personnel could potentiallyharm its business, operating results or financial condition. Employee Misconduct The Resulting Issuer is exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include failures to comply with Health Canada and the FDA regulations, provide accurate information to Health Canada and the FDA, comply with manufacturing standards the Resulting Issuer has established, comply with federal and provincial healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to the Resulting Issuer. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing, and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to the Resulting Issuer’s reputation. If any such actions are instituted against the Resulting Issuer, and the Resulting Issuer is not successful in defending itself or asserting its rights, those actions could have a substantial impact on the Resulting Issuer’s business and results of operations, including the imposition of substantial fines or other sanctions. Business Expansion and Growth The Company has in the past and the Resulting Issuer may in the future seek to expand its pipeline and capabilities by acquiring one or more companies or businesses, entering into collaborations, or in-licensing one or more product candidates. Acquisitions, collaborations and in-licenses involve numerous risks, including, but not limited to substantial cash expenditures, technology development risks, potentially dilutive issuances of equity securities, incurrence of debt and contingent liabilities, some of which may be difficult or impossible to identify at the time of acquisition, difficulties in assimilating the operations of the acquired companies, entering markets in which the Resulting Issuer has limited or no direct experience, and potential loss of the Resulting Issuer’s key employees or key employees of the acquired companies or businesses. The Company has experience in making acquisitions, entering collaborations and in-licensing product candidates; however, the Company cannot provide assurance that any acquisition, collaboration or in-license will result in short-term or long-term benefits to it. The Resulting Issuer may incorrectly judge the value or worth of an acquired company or business or in-licensed product candidate. In addition, the Resulting Issuer’s future success would depend in part on its ability to manage the rapid growth associated with some of these acquisitions, collaborations and in-licenses. The Company and the Resulting Issuer cannot provide assurance that it would be able to successfully combine its business with that of acquired businesses, manage a collaboration or integrate in-licensed product candidates. Furthermore, the development or expansion of the Resulting Issuer’s business may require a substantial capitalinvestment by the Resulting Issuer. Negative Results of External Clinical Trials or Studies From time to time, studies or clinical trials on various aspects of biopharmaceutical products are conducted by academic researchers, competitors or others. The results of these studies or trials, when published, may have a significant effect on the market for the biopharmaceutical product that is the subject of the study. The publication of negative results of studies or clinical trials or adverse safety events related to the Resulting Issuer’s product candidates, or the therapeutic areas in which the Resulting Issuer’s product candidates compete, could adversely affect its share price and the Resulting Issuer’s abilityto finance future development of its product candidates, and its business and financial results could be materially and adversely affected. Product Liability The Company currently does not carry any product liability insurance coverage. Even though the Company is not aware of any product liability claims at this time, its business exposes itself to potential product liability, recalls and other liability risks that are inherent in the sale of food products. The Company and the Resulting Issuer can provide no assurance that such potential claims will not be asserted against it. A successful liabilityclaim or series of claims brought against the Resulting Issuer could have a material adverse effect on its business, financial condition and results of operations. Although the Company intends to obtain adequate product liability insurance, it cannot provide any assurances that it will be able to obtain or maintain adequate product liability insurance of on acceptable terms, if at all, or that such insurance will provide adequate coverage against potential liabilities. Claims or losses in excess of any product liability cover that may be obtained by the Resulting Issuer could have a material adverse effect on its business, financial conditionaland results of operations. Some of our agreements with third parties might require us to maintain product liabilityinsurance. If we cannot obtainacceptable amounts of coverage on commercially reasonable terms in accordance with the terms set forth in these agreements, the corresponding agreements would be subject to termination, which could have a material adverse impact on our operations. RISK FACTORS