Odonate (ODTC) Risk Analysis

Since our inception, we have invested substantially all of our capital resources in the development of tesetaxel, which we initially are developing for the treatment of metastatic breast cancer ("MBC"). Tesetaxel currently is the subject of three studies in MBC, including a multinational, multicenter, randomized, Phase 3 study in patients with MBC, known as CONTESSA. We cannot assure you that the U.S. Food and Drug Administration ("FDA"), the European Commission or any other regulatory authority will approve tesetaxel for marketing. Our ability to generate revenue and our future success depend in large part on the success of CONTESSA, the approval of tesetaxel, the nature of any potential requirements for post-approval studies and the successful commercialization of tesetaxel, if approved. Delays in obtaining regulatory approval for tesetaxel would, among other consequences, require further development expenditures, delay the launch of tesetaxel and impact our ability to raise additional capital, all of which would have a material adverse effect on our business and financial condition.

CONTESSA and any other clinical studies of our product candidates that we may conduct in the future may be delayed or halted for various reasons, including: - insufficient financial resources;- insufficient supplies of drug product to treat the patients in the studies;- failure of patients to enroll in the studies at the rate we expect;- ineffectiveness of our product candidates;- patients experiencing unexpected side effects or other safety concerns being raised during treatment;- changes in governmental regulations or administrative actions;- failure to conduct studies in accordance with required clinical practices;- inspection of clinical study operations or study sites by the FDA or other regulatory authorities, resulting in a clinical hold;- political unrest at foreign clinical sites;- a shutdown of the U.S. government, including the FDA; or - natural disasters, public health crises or other catastrophic events impacting any of our clinical sites. If studies are delayed or halted, we may incur significant additional expenses, and the potential approval of our product candidates may be delayed, which would have a material adverse effect on our business and financial condition.

Clinical testing is expensive, can take many years to complete and its outcome is inherently uncertain. Failure can occur at any time during the clinical study process. The results of nonclinical studies and early clinical studies of our product candidates may not be predictive of the results of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent clinical studies. For example, the safety or efficacy results generated to date in our clinical studies do not ensure that later clinical studies will demonstrate similar results. There is a high failure rate for pharmaceutical product candidates proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy, despite having progressed through nonclinical studies and initial clinical studies. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies. Moreover, nonclinical and clinical data often are susceptible to varying interpretations and analyses. We do not know whether any clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates.