Cybin Company Presentation

P r i v a t e & C o n f i d e n t i a l 39 Management of Growth The Resulting Issuer may be subject to growth-related risks, including capacity constraints and pressure on its internal systems and controls. The ability of the Resulting Issuer to manage growth effectively will require it to continue to implement and improve its operational and financial systems and to expand, train and manage its employee base. The inability of the Resulting Issuer to deal with this growth may have a material adverse effect on the Resulting Issuer’s business, financial condition, results of operations and prospects. Novel Coronavirus – “COVID-19” The outbreak of the novel strain of coronavirus, specifically identified as “COVID-19”, has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. These measures, including the implementation of travel bans, self-imposed quarantine periods and social distancing, have caused material disruption to businesses globally resulting in an economic slowdown. Global equity markets have experienced significant volatility and weakness. Governments and central banks have reacted with significant monetary and fiscal interventions designed to stabilize economic conditions. The duration and impact of the COVID19 outbreak is unknown at this time, as is the efficacy of the government and central bank interventions. It is not possible to reliably estimate the length and severity of these developments and the impact on the financial results and condition of the Resulting Issuer and its operating subsidiaries in future periods. However, depending on the length and severity of the pandemic, COVID-19 could impact the Resulting Issuer’s operations, could cause delays relating to approval from Health Canada, the FDA and equivalent organizations in other countries, could postpone research activities, and could impair the Resulting Issuer’s ability to raise funds depending on COVID-19s effect on capital markets. To the knowledge of the Resulting Issuer’s management as of the date hereof, COVID-19 does not present, at this time, any specific known impacts to the Resulting Issuer in relation to the Resulting Issuer’s plan of distribution and use of proceeds related to the offering, nor to the timelines, business objectives or disclosed milestones related thereto. The Resulting Issuer relies on third parties to conduct and monitor the Resulting Issuer’s pre-clinical studies and clinical trials. However, to the knowledge of Resulting Issuer’s management, the ability of these third parties to conduct and monitor pre-clinical studies and clinical trials has not been and is not anticipatedto be impacted by COVID-19. The Resulting Issuer is not currently aware of any changes in laws, regulations or guidelines, including taxand accounting requirements, arising from COVID-19 which would be reasonably anticipatedto materially affect the Resulting Issuer’s business. Risks Related to Intellectual Property Trade Secrets The Company relies, and the Resulting Issuer will rely, on third parties to develop its products and as a result, must share trade secrets with them. The Company seeks to protect its proprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, collaborative research agreements, consulting agreements or other similar agreements with its collaborators, advisors, employees and consultants prior to beginning research or disclosing proprietary information. These agreements typically restrict the ability of the Resulting Issuer’s collaborators, advisors, employees and consultants to publish data potentially relating to its trade secrets. Its academic and clinical collaborators typically have rights to publish data, provided that the Resulting Issuer is notified in advance and may delay publication for a specified time in order to secure any intellectual property rights arising from the collaboration. In other cases, publication rights are controlled exclusively by the Resulting Issuer, although in some cases the Resulting Issuer may share these rights with other parties. The Resulting Issuer may also conduct joint research and development programs which may require it to share trade secrets under the terms of research and development collaboration or similar agreements. Despite the Resulting Issuer’s efforts to protect its trade secrets, the Resulting Issuer’s competitors may discover its trade secrets, either through breach of these agreements, independent development or publication of information. A competitor’s discovery of the Resulting Issuer’s trade secrets may impair its competitive position and could have a material adverse effect on its business and financial condition. Patent Law Reform As is the case with other biotechnology and pharmaceutical companies, the Resulting Issuer’s success is heavily dependent on intellectual property rights, particularlypatents. Obtainingand enforcing patents in the biopharmaceutical industry is a technologically and legally complex process, and obtaining and enforcing biopharmaceutical patents is costly, time consuming and inherently uncertain. Recent patentreform legislation could increase the uncertainties and costs surrounding the prosecution of the Resulting Issuer’s and its licensors’ or collaborators’ patent applicationsand the enforcement or defense of the Resulting Issuer or its licensors’ or collaborators’ issued patents. Patent Litigation and Intellectual Property The Company has applied for a provisional patent application but there can be no assurance that it or a successor application will issue into a valid patent. Such failure to issue could have a material adverse effect on the Resulting Issuer. In the event that a patent issued to the Resulting Issuer is challenged, any of Resulting Issuer’s patents may be invalidated (although at this time the Resulting Issuer does not have any issued patents). The Resulting Issuer could also become involved in interference or impeachment proceedings in connection with one or more of its patents or patent applicationsto determine priority of invention. Patent litigation is becoming widespread in the pharmaceutical industry and the Resulting Issuer cannot predict how this will affect its efforts to form strategic alliances, conduct clinical testing, or manufacture and market any of its product candidates that it may successfully develop. If the Resulting Issuer becomes involved in any litigation, interference, impeachment or other administrative proceedings, it will likely incur substantial expenses and the efforts of its technical and management personnel will be significantly diverted. The Resulting Issuer cannot make any assurances that it will have the financial or other resources necessary to enforce or defend a patent infringement or proprietary rights violation action. Moreover, if the Resulting Issuer’s products infringe patents, trademarks or proprietary rights of others, it could, in certain circumstances, become liable for substantial damages, which also could have a material adverse effect on the business of the Resulting Issuer, its financial condition and results of operation. Patent litigation is less likely during development as many jurisdictions contain exemptions from patent infringement for the purpose of obtaining regulatory approval of a product. Where there is any sharing of patent rights either through co-ownership or different licensed “fields of use”, one owner’s actions could lead to the invalidity of the entire patent. If the Resulting Issuer is unable to avoid infringing the patent rights of others, the Resulting Issuer may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Such results could have a material adverse effect on the Resulting Issuer. Regardless of the outcome, patent litigation is costly and time consuming. In some cases, the Resulting Issuer may not have sufficient resources to bring these actions to a successful conclusion, and, even if the Resulting Issuer is successful in these proceedings, it may incur substantial costs and divert management time and attentionin pursuing these proceedings, which could have a material adverse effect on the Resulting Issuer. Any infringement or misappropriation of the Resulting Issuer’s intellectual property could damage its value and limit its ability to compete. In addition, the Resulting Issuer’s ability to enforce and protect its intellectual property rights may be limited in certain countries outside the U.S., which could make it easier for competitors to capture market position in such countries by utilizing technologies that are similar to those developed or licensed by the Resulting Issuer. Competitors may also harm the Resulting Issuer’s sales by designing products that mirror the capabilities of its products or technology without infringing on its intellectual property rights.If the Resulting Issuer does not obtain sufficient protection for its intellectual property, or if it is unable to effectively enforce its intellectual property rights, its competitiveness could be impaired, which would limit its growth and future revenue. The Resulting Issuer may also find it necessary to bring infringement or other actions against third parties to seek to protect its intellectual property rights. Litigation of this nature, even if successful,is often expensive and time- consuming to prosecute and there can be no assurance that the Resulting Issuer will have the financial or other resources to enforce its rights or be able to enforce its rights or prevent other parties from developing similar technology or designing around its intellectual property. The Company is not aware of any infringement by it of any person's or entity's intellectual property rights. In the event that products sold by the Resulting Issuer are deemed to infringe upon the patents or proprietary rights of others, the Resulting Issuer could be required to modify its products or obtain a license for the manufacture and/or sale of such products or cease selling such products. In such event, there can be no assurance that the Resulting Issuer would be able to do so in a timely manner, upon acceptable terms and conditions, or at all, and the failure to do any of the foregoing could have a material adverse effect upon the Resulting Issuer’s business. If the Resulting Issuer’s products or proposed products are deemed to infringe or likely to infringe upon the patents or proprietary rights of others, the Resulting Issuer could be subject to injunctive relief and, under certain circumstances, become liable for damages, which could also have a material adverse effect on the Resulting Issuer’s business and its financial condition. Protection of Intellectual Property The Resulting Issuer will be able to protect its intellectual property from unauthorized use by third parties only to the extent that the Resulting Issuer’s proprietary technologies, key products and any future products are covered by valid and enforceable intellectual property rights including patents or are effectively maintained as trade secrets and provided the Resulting Issuer has the funds to enforce its rights, if necessary. Third-Party Licenses A substantial number of patents have already been issued to other biotechnology and pharmaceutical companies. To the extent that valid third-party patent rights cover the Resulting Issuer’s products or services, the Resulting Issuer or its strategic collaborators would be required to seek licenses from the holders of these patents in order to manufacture, use or sell these products and services and payments under them would reduce the Resulting Issuer’s profits from these products and services. The Resulting Issuer is currently unable to predict the extent to which it may wish or be required to acquire rights under such patents, the availability and cost of acquiring such rights and whether a license to such patents will be available on acceptable terms or at all. There may be patents in the U.S. or in foreign countries or patents issued in the future thatare unavailableto license on acceptable terms. The Resulting Issuer’s inabilityto obtain such licenses may hinder or eliminate its abilityto manufacture and market its products. Further, if the Resulting Issuer obtainsthird-partylicenses but fails to pay annual maintenance fees, development and sales milestones, or it is determined that the Resulting Issuer does not use commercially reasonable efforts to commercialize licensed products, the Resulting Issuer could lose its licenses which could have a material adverse effect on its business and financial condition. RISK FACTORS