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related topics |
{product, candidate, development} |
{product, liability, claim} |
{financial, litigation, operation} |
{stock, price, share} |
{provision, law, control} |
{property, intellectual, protect} |
{stock, price, operating} |
{control, financial, internal} |
{personnel, key, retain} |
{product, market, service} |
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We have a history of losses, and we anticipate that we will continue to incur losses in the future.
Our committed equity financing facility with Kingsbridge may not be available to us. If we elect to make a draw down, we may be required to make additional blackout or other payments to Kingsbridge, which may result in dilution to our stockholders.
In April 2009, we initiated an internal review of matters pertaining to our quality, vendor oversight and regulatory compliance systems, practices and procedures relating to the conduct of clinical trials sponsored by us. While we believe that the actions taken by us in connection with this review have substantially improved our systems, practices and procedures, we cannot assure you that these measures will fully prevent any future quality, vendor management or regulatory compliance issues.
We may fail to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates or those that are in-licensed.
Our product candidates have not completed clinical trials, and may never demonstrate sufficient safety and efficacy in order to do so.
We depend heavily on our executive officers, directors, and principal consultants and the loss of their services would materially harm its business.
Our industry is highly competitive, and its products may become technologically obsolete.
We have licensed in rights to ZYBRESTAT, OXi4503 and other programs from third parties. If our license agreements terminate, we may lose the licensed rights to its product candidates, including ZYBRESTAT and OXi4503, and we may not be able to continue to develop them or, if they are approved, market or commercialize them.
We depend extensively on our patents and proprietary technology, and we must protect those assets in order to preserve our business.
If third parties on which we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize its product candidates.
Our products may result in product liability exposure, and it is uncertain whether our insurance coverage will be sufficient to cover all claims.
Our products are subject to extensive government regulation, which results in uncertainties and delays in the progress of our products through the clinical trial process.
We have no manufacturing capacity, and have relied and expect to continue to rely on third-party manufacturers to produce its product candidates.
Our restated certificate of incorporation, our amended and restated by-laws, our stockholder rights agreement and Delaware law could deter a change of our management which could discourage or delay offers to acquire it.
The uncertainty associated with pharmaceutical reimbursement and related matters may adversely affect our business.
The price of our common stock is volatile, and is likely to continue to fluctuate due to reasons beyond its control.
Full 10-K form ▸
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