24 Failure of a product candidate may occur at any stage of preclinical or clinical development, and, because our product candidates and our ABC Platform are in development, there is a relatively higher risk of failure and we may never succeed in developing marketable products or generating product revenue. Further, we may not be successful f in our effo f rts to further develop our product candidates in time to meet the current and identifie f d market opportunity. We are not permitted to market or promote any of our product candidates before we receive regulatory r approval from the FDA or comparable foreign regulatory r authorities, and we may never receive such regulatory r approval for any of our product candidates. Each of our product candidates is in various stages of development and will require significant additional clinical development, management of preclinical, clinical, and manufac f turing activities, regulatory r approval, adequate manufactur t ing suppl u y, a commercial organization, and significant marketing effo f rts before we generate any revenue from product sales, if at all. Any clinical studi t es that we may conduct may not demonstrate the effi f cacy and safety necessary to obtain regulatory r approval to market our product candidates. If the results of our on-going or future clinical studi t es are inconclusive with respect to the effi f cacy of our product candidates or if we do not meet the clinical endpoints with statistical significance or if there are safety concerns or adverse events associated with our product candidates, we may be prevented or delayed in obtaining marketing approval for our product candidates. If any of our product candidates successfully completes clinical trials, we generally plan to seek regulatory r approval to market our product candidates in the United States, the EU, and in additional foreign countries where we believe there is a viable commercial opportunity. We have never commenced, compiled or subm u itted an application seeking regulatory r approval to market any product candidate in any jurisdiction. We may never receive regulatory r approval to market any product candidates even if such product candidates successful f ly complete clinical trials, which would adversely affe f ct our viability. To obtain regulatory r approval in countries outside the United States, we must comply with numerous and varying regulatory r requirements of such other countries regarding safety, effi f cacy, chemistry, r manufact f ur t ing and controls, clinical trials, commercial sales, pricing, and distribution of our product candidates. We may also rely on our collaborators or partners to conduct the required activities to suppor u t an appl a ication for regulatory r approval, and to seek approval, for one or more of our product candidates. We cannot be sure that our collabor a ators or partners will conduct these activities successful f ly or do so within the timeframe we desire. Even if we (or our collabor a ators or partners) are successful f in obtaining approval in one jurisdiction, we cannot ensure that we will obtain approval in any other jurisdictions. If we are unabl a e to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations could be negatively affe f cted. Even if we receive regulatory r approval to market any of our product candidates, we cannot assure you that any such product candidate will be successful f ly commercialized, widely accepted in the marketpl t ace or more effe f ctive than other commercially availabl a e alternatives. That approval may be for indications, dosage and administration or patient populations that are not as broad as intended or desired or may require labe a ling that includes significant use or distribution restrictions or safety warnings. We may also be required to perform additional or unanticipated clinical studi t es to obtain approval or be subj u ect to additional post-marketing testing requirements to maintain regulatory r approval. In addition, regulatory r authorities may withdraw their approval of a product or impose restrictions on its distribution, such as in the form of a modified Risk Evaluation and Mitigation Strategy, or REMS. The failure to obtain timely regulatory r approval of product candidates, any product marketing limitations or a product withdrawal would negatively impact our business, results of operations and financial condition. Investment in biopharmaceutical product development involves significant risk that any product candidate will fail to demonstrate adequate effi f cacy or an acceptabl a e safety profile f , gain regulatory r approval, and become commercially viable. We cannot provide any assurance that we will be able to successful f ly advance any of our product candidates through the development process or, if approved, successful f ly commercialize any of our product candidates. We may a encounter t substantia t l delays a in our clin l ical trials,s or may a not be ablel to conduct or complete our clin l ical trials on the time i lines we expe x ct,t if at all. l Clinical testing is expensive, time consuming, and subj u ect to uncertainty. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. We cannot be sure that subm u ission of an IND application or a clinical trial application, or CTA, will result in the FDA, European Medicines Agency, or EMA or any other regulatory r authority as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could suspend or terminate such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our future clinical trials may not be successful. For example, in July 2023 we announced a business decision to wind-down development of tarcocimab afte f r certain of our trials did not meet their primary r effi f cacy endpoints. Events that may prevent successful f or timely initiation or completion of clinical trials include: • inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to suppor u t the initiation or continuation of clinical trials; • delays in reaching a consensus with regulatory r agencies on study t design;