CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTOR SUMMARY
This Annual Report on Form 10-K includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing needs and other information that is not historical information. Many of these statements appear, in particular, under the headings “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Forward-looking statements can often be identified by the use of terminology such as “subject to”, “believe,” “anticipate,” “plan,” “expect,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “hope,” “can,” the negatives thereof, variations thereon and similar expressions, or by discussions of strategy. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Examples of such forward looking statements include, but are not limited to statements related to:
| ● | our ability to maintain operations, development programs, preclinical studies, clinical trials and raise capital as a result of the recent coronavirus disease 2019 (“COVID 19”) outbreak; |
| ● | our ability to advance our product candidate and potential future product candidates through, and successfully complete, clinical trials; |
| ● | our ability to recruit sufficient numbers of patients for future clinical trials, and the benefits expected therefrom; |
| ● | our ability to obtain funding for operations, including research funding, and the timing and potential sources of such funding; |
| ● | the initiation, timing, cost, location, progress and success of, strategy and plans with respect to our research and development programs (including research programs and related milestones with regards to next-generation drug candidates and compounds), preclinical studies and clinical trials; |
| ● | the therapeutic benefits, properties, effectiveness, pharmacokinetic profile and safety of our product candidate and potential future product candidates, if any, including the expected benefits, properties, effectiveness, pharmacokinetic profile and safety of our next-generation aniten compounds; |
| ● | our ability to achieve profitability; |
| ● | the grant (“CPRIT Grant”) under the Cancer Prevention and Research Institute of Texas (“CPRIT”) and payments thereunder, including any residual obligations; |
| ● | our use of proceeds from funding and financings; |
| ● | our ability to effectively liquidate Realm (as defined herein), and assume the related obligations; |
| ● | our intended use of proceeds from the acquisition of Realm and the past and future offerings of our securities; |
| ● | our ability to establish and maintain relationships with collaborators with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts; |
| ● | the implementation of our business model and strategic plans, including strategic plans with respect to patent applications and strategic collaborations and partnerships; |
| ● | our ability to identify, develop and commercialize product candidates; |
| ● | our commercialization, marketing and manufacturing capabilities and strategy; |
| ● | our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; |
| ● | our expectations regarding federal, state, provincial and foreign regulatory requirements, including our plans with respect to anticipated regulatory filings; |
| ● | whether we will receive, and the timing and costs of obtaining, regulatory approvals in the United States, Canada and other jurisdictions; |
| ● | the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our product candidate and potential future product candidates, if any; |