Because the successful development of Seelos' product candidates is uncertain, Seelos is unable to precisely estimate the actual funds Seelos will require to develop
and potentially commercialize them. In addition, Seelos may not be able to generate sufficient revenue, even if Seelos is able to commercialize any of its product candidates, to become
Given Seelos' lack of current cash flow, Seelos will need to raise additional capital; however, it may be unavailable to Seelos or, even if capital is obtained,
may cause dilution or place significant restrictions on Seelos' ability to operate its business.
Since Seelos will be unable to generate sufficient, if any, cash flow to fund its operations for the foreseeable future, Seelos will need to seek additional equity or
debt financing to provide the capital required to maintain or expand its operations.
There can be no assurance that Seelos will be able to raise sufficient additional capital on acceptable terms or at all. If such additional financing is not available on
satisfactory terms, or is not available in sufficient amounts, Seelos may be required to delay, limit or eliminate the development of business opportunities and its ability to achieve its business
objectives, its competitiveness, and its business, financial condition and results of operations may be materially adversely affected. In addition, Seelos may be required to grant rights to develop
and market product candidates that it would otherwise prefer to develop and market itself. Seelos' inability to fund its business could lead to the loss of your investment.
Seelos' future capital requirements will depend on many factors, including, but not limited to:
- the scope, rate of progress, results and cost of its clinical trials, preclinical studies and other related activities;
- its ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
- the timing of, and the costs involved in, obtaining regulatory approvals for any of its current or future product candidates;
- the number and characteristics of the product candidates it seeks to develop or commercialize;
- the cost of manufacturing clinical supplies, and establishing commercial supplies, of its product candidates;
- the cost of commercialization activities if any of its current or future product candidates are approved for sale, including marketing, sales and distribution
- the expenses needed to attract and retain skilled personnel;
- the costs associated with being a public company;
- the amount of revenue, if any, received from commercial sales of its product candidates, should any of its product candidates receive marketing approval;
- the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing possible patent claims, including litigation costs and the outcome of any
If Seelos raises additional capital by issuing equity securities, the percentage ownership of its existing stockholders may be reduced, and accordingly these stockholders
may experience substantial dilution. Seelos may also issue equity securities that provide for rights, preferences and privileges senior to those of its common stock. Given Seelos' need for cash
and that equity issuances are the most common type of fundraising for similarly situated companies, the risk of dilution is particularly significant for Seelos' stockholders.
Seelos' product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or commercialization or have other
significant adverse implications on Seelos' business, financial condition and results of operations.
Undesirable side effects observed in clinical trials or in supportive preclinical studies with Seelos' product candidates could interrupt, delay or halt their
development and could result in the denial of regulatory approval by the FDA, the EMA or comparable foreign authorities for any or all targeted indications or adversely affect the marketability
of any such product candidates that receive regulatory approval. In turn, this could eliminate or limit Seelos' ability to commercialize its product candidates.
Seelos' product candidates may exhibit adverse effects in preclinical toxicology studies and adverse interactions with other drugs. There are also risks associated with
additional requirements the FDA, the EMA or comparable foreign authorities may impose for marketing approval with regard to a particular disease.
Seelos' product candidates may require a risk management program that could include patient and healthcare provider education, usage guidelines, appropriate
promotional activities, a post-marketing observational study, and ongoing safety and reporting mechanisms, among other requirements. Prescribing could be limited to physician specialists or
physicians trained in the use of the drug, or could be limited to a more restricted patient population. Any risk management program required for approval of Seelos' product candidates could
potentially have an adverse effect on Seelos' business, financial condition and results of operations.