These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we presently believe that the expectations reflected in the forward-looking statements are reasonable based on facts currently known to us, the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements may not be achieved or occur at all. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Annual Report or to reflect the occurrence of any unanticipated events. Comparisons of results for current and any prior periods are not intended to express any future trends on indications of future performance, unless expressed as such, and should only be viewed as historical data.
Risk Factor Summary
The risks described in the section titled “Risk Factors” immediately following this summary could impact our ability to realize the full benefits of our strengths or execute all or part of our strategy. Some of the more significant risks described in “Risk Factors” include the following:
| ● | We are a preclinical stage biopharmaceutical company with a history of financial losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability. We will need to raise substantial additional funds to advance development of potential product candidates and our discovery platform, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize our potential future product candidates. |
| ● | The potential product candidates related to our IMM-BCP-01 and IMM-ONC-01 programs are in the research stage, have not progressed to IND-enabling toxicology testing and have never been tested in human subjects. We may be unable to advance any potential product candidates through clinical development, obtain regulatory approval and ultimately commercialize any of our product candidates, or we may experience significant delays in doing so. We face additional risks related to the development, manufacture and potential commercialization of IMM-BCP-01 given the uncertainties associated with the COVID-19 pandemic, including potential supply-chain and regulatory issues. |
| ● | We may not be successful in our efforts to use and expand our discovery engine to build a pipeline of product candidates. |
| ● | Our approach to developing and identifying our therapeutic product candidates is novel and unproven and may not result in marketable products. |
| ● | The effects of health epidemics, including the ongoing COVID-19 pandemic, in regions where we, or the third parties on which we rely, have business operations could adversely impact our business, including our research studies and anticipated clinical trials. |
| ● | Given our collaboration with the United States Department of Defense, we face risks related to government funded awards. If the U.S. Department of Defense were to eliminate, reduce or delay funding from these awards, this would have a significant negative impact on our IMM-BCP01 program. |
| ● | Clinical development includes a lengthy and expensive process with an uncertain outcome; therefore, if we progress to clinical trials, results of our earlier studies may not be predictive of future trial results. |
| ● | If third parties on which we intend to rely to manufacture our product and assist with other research and development activities do not perform as contractually required, fail to satisfy regulatory or legal requirements, |