Undesirable side effects involving Seelos' product candidates may have other significant adverse implications on Seelos' business, financial condition and results of
operations. For example:
- Seelos may be unable to obtain additional financing on acceptable terms, if at all;
- Seelos' collaborators may terminate any development agreements covering these product candidates;
- if any development agreements are terminated, Seelos may determine not to further develop the affected product candidates due to resource constraints and may
not be able to establish additional collaborations for their further development on acceptable terms, if at all;
- if Seelos were to later continue the development of these product candidates and receive regulatory approval, earlier findings may significantly limit their
marketability and thus significantly lower Seelos' potential future revenues from their commercialization;
- Seelos may be subject to product liability or stockholder litigation; and
- Seelos may be unable to attract and retain key employees.
In addition, if any of Seelos' product candidates receive marketing approval and Seelos or others later identify undesirable side effects caused by the product:
- regulatory authorities may withdraw their approval of the product, or Seelos or Seelos' partners may decide to cease marketing and sale of the product
- Seelos may be required to change the way the product is administered, conduct additional clinical trials or preclinical studies regarding the product, change the
labeling of the product, or change the product's manufacturing facilities; and
- Seelos' reputation may suffer.
Any of these events could prevent Seelos from achieving or maintaining market acceptance of the affected product and could substantially increase the costs and
expenses of commercializing the product, which in turn could delay or prevent Seelos from generating significant revenues from the sale of the product.
Seelos' efforts to discover product candidates beyond Seelos' current product candidates may not succeed, and any product candidates Seelos
recommends for clinical development may not actually begin clinical trials.
Seelos intends to use its technology, including its licensed technology, knowledge and expertise to develop novel drugs to address some of the world's most
widespread and costly central nervous system, respiratory and other disorders, including orphan indications. Seelos intends to expand its existing pipeline of core assets by advancing drug
compounds from current ongoing discovery programs into clinical development. However, the process of researching and discovering drug compounds is expensive, time-consuming and
unpredictable. Data from Seelos' current preclinical programs may not support the clinical development of its lead compounds or other compounds from these programs, and Seelos may not
identify any additional drug compounds suitable for recommendation for clinical development. Moreover, any drug compounds Seelos recommends for clinical development may not
demonstrate, through preclinical studies, indications of safety and potential efficacy that would support advancement into clinical trials. Such findings would potentially impede Seelos' ability to
maintain or expand Seelos' clinical development pipeline. Seelos' ability to identify new drug compounds and advance them into clinical development also depends upon Seelos' ability to fund
its research and development operations, and Seelos cannot be certain that additional funding will be available on acceptable terms, or at all.
Delays in the commencement or completion of clinical trials could result in increased costs to Seelos and delay Seelos' ability to establish strategic
Delays in the commencement or completion of clinical trials could significantly impact Seelos' drug development costs. Seelos does not know whether planned
clinical trials will begin on time or be completed on schedule, if at all. The commencement of clinical trials can be delayed for a variety of reasons, including, but not limited to, delays related
- obtaining regulatory approval to commence one or more clinical trials;
- reaching agreement on acceptable terms with prospective third-party contract research organizations ("CROs") and clinical trial sites;
- manufacturing sufficient quantities of a product candidate or other materials necessary to conduct clinical trials;
- obtaining institutional review board approval to conduct one or more clinical trials at a prospective site;
- recruiting and enrolling patients to participate in one or more clinical trials; and
- the failure of Seelos' collaborators to adequately resource Seelos' product candidates due to their focus on other programs or as a result of general market