Tryp Therapeuatics (TRYPF) Coverage Report

Regulatory risk . Tryp’s drug candidates that are based on the PFN™ program will be subject to controlled substance laws and regulations in the territories where the drug will be marketed and failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect the results of their business operations, both during clinical development and post approval, and their financial condition. Therapeutic candidates containing controlled substances are subject to DEA regulations relating to manufacturing, storage, distribution, and physician prescription procedures. They are subjected to DEA registration and inspection of facilities, state-controlled substances laws, prior to approval of each of our research sites for clinical trials. If they experience delays in the enrollment of patients in their clinical trials, their receipt of necessary regulatory approvals could be delayed or prevented. In addition, during the review process of drugs that are based on their PFN™ program, and prior to approval, the FDA and/or other regulatory bodies may require additional data, including with respect to whether those drugs have abuse potential. This may delay approval and any potential rescheduling process. The potential reclassification of psilocybin and psilocin in the United States could create additional regulatory burdens on their operations and negatively affect their results of operations. Even if their drug candidates receive regulatory approval in the United States, they may never receive approval outside of the United States. Intellectual property risks. Tryp may not be successful in obtaining or maintaining rights to drug candidates through acquisitions and in- licenses. If they fail to comply with obligations in the agreements under which they in-license intellectual property and other rights from third parties or otherwise experiences disruptions to their business relationships with their licensors, they could lose intellectual property rights that are important to the business. Tryp may not be able to protect their proprietary or licensed technology in the marketplace. Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and their patent protection for licensed patents, licensed pending patent applications and potential future patent applications and patents could be reduced or eliminated for non-compliance with these requirements. Any claims or lawsuits relating to infringement of intellectual property rights brought by or against Tryp will be costly and time consuming and may adversely affect their business, financial condition, and results of operations. Changes in U.S. patent law could diminish the value of patents in general, thereby impairing Tryp’s ability to protect their drug candidates or, upon any approval, drug products. Tryp may not be able to protect their intellectual property rights throughout the world and may be unable to adequately prevent disclosure of trade secrets and other proprietary information. Tryp may be subject to claims that their employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties. Tryp may also be subject to claims challenging the inventorship of any patents they may own in the future and other intellectual property. If Tryp does not obtain additional protection under the Hatch-Waxman Amendments and similar foreign legislation extending the terms of their licensed patents and any future patents they may own, their business, financial condition and results of operations may be materially and adversely affected. Commercialization risks. Tryp’s drug candidates that are based on our PFN™ program contain controlled substances, the use of which may generate public controversy. Adverse publicity or public perception regarding psilocybin or our current or future investigational therapies using psilocybin may negatively influence the success of these therapies. If any of their drug candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected drugs. The pharmaceutical industry is intensely competitive and involves a high degree of risk. If they are unable to compete effectively with existing drugs, new treatment methods and new technologies, Tryp or their partners, if any may be unable to successfully commercialize any drug candidates that they develop. Any collaboration arrangement that Tryp may enter in the future may not be successful, which could adversely affect their ability to develop and commercialize their current and potential future drug candidates. If they are unable to enter into agreements with third parties to sell and market their drug candidates, it may be necessary to develop their own commercial organization. If Tryp fails to retain current members of the management, or to attract and keep additional key personnel, they may be unable to successfully develop or commercialize our drug candidates. Operational risks. The company may engage in strategic transactions that could impact liquidity, increase expenses, and present significant distractions to management. As COVID-19 continues to be present and spread around the globe, the company may experience additional disruptions that could severely impact business and clinical trials. The directors and officers may have conflicts of interest with the company. The company has limited operating history may make it difficult for an investor to evaluate the success of the company’s business to date and to assess the company’s future viability. The company’s executive officers, directors and certain significant shareholders will continue to own a substantial number of Common Shares and, as a result, may be able to exercise control over the company, including the outcome of shareholder votes. STOCK RATING DEFINITIONS Buy: The stock’s return is expected to exceed 12.5% over the next twelve months. Neutral: The stock’s return is expected to be plus or minus 12.5% over the next twelve months. Sell: The stock’s return is expected to be negative 12.5% or more over the next twelve months. Investment Ratings are determined by the ranges described above at the time of initiation of coverage, a change in risk, or a change in target price. At other times, the expected returns may fall outside of these ranges because of price movement and/or volatility. Such interim deviations from specified ranges will be permitted but will become subject to review. Michael Higgins 212.409.2074 Tryp Therapeutics, Inc. (TRYPF) Page 43