27 Drug- r related side effe f cts could affe f ct patient recrui r tment, the ability of enrolled patients to complete the study t and/or result in potential product liabi a lity claims. We may not be able to maintain insurance coverage at a reasonabl a e cost or in sufficient amounts to protect us against losses due to liability. A successful f product liabi a lity claim or series of claims brought against us could cause our stock price to decline and, if judgments exceed our insurance coverage, could adversely affe f ct our results of operations and business. In addition, regardless of merit or eventual outcome, product liabi a lity claims may result in impairment of our business reputation, withdrawal of clinical trial participants, costs due to related litigation, distraction of management’s attention from our primary business, initiation of investigations by regulators, subs u tantial monetary awards to patients or other claimants, the inability to commercialize our product candidates and decreased demand for our product candidates, if approved for commercial sale. Additionally, if one or more of our product candidates receives marketing approval, and we or others later identify undesirabl a e side effe f cts or adverse events caused by such products, a number of potentially significant negative consequences could result, including but not limited to: • regulatory r authorities may withdraw approvals of such product; • regulatory r authorities may require additional warnings on the labe a l; • we may be required to change the way the product is administered or conduct additional clinical trials or post- approval studi t es; • we may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effe f cts for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; • we could be sued and held liabl a e for harm caused to patients; and • our reputation may suffer. Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations, and prospects. We may a encounter t diffi i culties enrolling patie t ntst in our clin l ical trials,s and our clin l ical developm l ent activitie t s couldl thereby b be delayed a or othe t rwise adverse r ly affe f cted t .d The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including: • the size and nature of the patient population; • the patient eligibility criteria defined in the protocol, including certain highly-specific f criteria related to stage of disease progression, which may limit the patient populations eligible for our clinical trials to a greater extent than competing clinical trials for the same indication that do not have such patient eligibility criteria; • the size of the study t population required for analysis of the trial’s primary r endpoints; • the proximity of patients to a trial site; • the effe f cts of health epidemics, including the resulting shelter-in-place, travel or similar restrictions; • the design of the trial; • new safety events may cause physicians to decrease patient enrollment in our current or planned studi t es; • our ability to recrui r t clinical trial investigators with the appropriate competencies and experience; • competing clinical trials for similar therapies or targeting patient populations meeting our patient eligibility criteria; • clinicians’ and patients’ perceptions as to the potential advantages and side effe f cts of the product candidate being studi t ed in relation to other availabl a e therapies and product candidates; • our ability to obtain and maintain patient consents; and • the risk that patients enrolled in clinical trials will not complete such trials, for any reason.