In addition, once a clinical trial has begun, it may be suspended or terminated by Seelos, Seelos' collaborators, the institutional review boards or data safety monitoring
boards charged with overseeing Seelos' clinical trials, the FDA, the EMA or comparable foreign authorities due to a number of factors, including:
- failure to conduct the clinical trial in accordance with regulatory requirements or clinical protocols;
- inspection of the clinical trial operations or clinical trial site by the FDA, the EMA or comparable foreign authorities resulting in the imposition of a clinical
- unforeseen safety issues; or
- lack of adequate funding to continue the clinical trial.
If Seelos experiences delays in the completion or termination of any clinical trial of its product candidates, the commercial prospects of Seelos' product candidates will
be harmed, and Seelos' ability to commence product sales and generate product revenues from any of Seelos' product candidates will be delayed. In addition, any delays in completing Seelos'
clinical trials will increase Seelos' costs and slow down its product candidate development and approval process. Delays in completing Seelos' clinical trials could also allow Seelos' competitors
to obtain marketing approval before Seelos does or shorten the patent protection period during which Seelos may have the exclusive right to commercialize its product candidates. Any of these
occurrences may harm Seelos' business, financial condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of
clinical trials may also ultimately lead to the denial of regulatory approval of Seelos' product candidates.
Results of earlier clinical trials may not be predictive of the results of later-stage clinical trials.
The results of preclinical studies and early clinical trials of product candidates may not be predictive of the results of later-stage clinical trials. Product
candidates in later stages of clinical trials may fail to show the desired safety and efficacy results despite having progressed through preclinical studies and initial clinical trials. Many companies
in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to adverse safety profiles or lack of efficacy, notwithstanding promising results in earlier
studies. Similarly, Seelos' future clinical trial results may not be successful for these or other reasons.
This product candidate development risk is heightened by any changes in the planned clinical trials compared to the completed clinical trials. As product candidates are
developed through preclinical to early to late stage clinical trials towards approval and commercialization, it is customary that various aspects of the development program, such as
manufacturing and methods of administration, are altered along the way in an effort to optimize processes and results. While these types of changes are common and are intended to optimize
the product candidates for late stage clinical trials, approval and commercialization, such changes carry the risk that they will not achieve these intended objectives.
Any of these changes could make the results of Seelos' planned clinical trials or other future clinical trials Seelos may initiate less predictable and could cause Seelos'
product candidates to perform differently, including causing toxicities, which could delay completion of Seelos' clinical trials, delay approval of its product candidates, and/or jeopardize Seelos'
ability to commence product sales and generate revenues.
If Seelos experiences delays in the enrollment of patients in its clinical trials, Seelos' receipt of necessary regulatory approvals could be delayed or
Seelos may not be able to initiate or continue clinical trials for Seelos' product candidates if Seelos is unable to locate and enroll a sufficient number of eligible
patients to participate in these trials as required by the FDA or other regulatory authorities. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors,
including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical trials and
clinicians' and patients' perceptions as to the potential advantages of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the
indications Seelos is investigating.
If Seelos fails to enroll and maintain the number of patients for which the clinical trial was designed, the statistical power of that clinical trial may be reduced, which would
make it harder to demonstrate that the product candidate being tested in such clinical trial is safe and effective. Additionally, enrollment delays in Seelos' clinical trials may result in increased
development costs for Seelos' product candidates, which would cause the value of Seelos to decline and limit its ability to obtain additional financing. Seelos' inability to enroll a sufficient
number of patients for any of its current or future clinical trials would result in significant delays or may require Seelos to abandon one or more clinical trials altogether.
Seelos intends to rely on third parties to conduct its preclinical studies and clinical trials and perform other tasks. If these third parties do not successfully
carry out their contractual duties, meet expected deadlines, or comply with regulatory requirements, Seelos may not be able to obtain regulatory approval for or commercialize its
product candidates and its business, financial condition and results of operations could be substantially harmed.