1097264--2/27/2008--ALLOS_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{provision, law, control}

{control, financial, internal}

{regulation, government, change}

{acquisition, growth, future}

{financial, litigation, operation}

{property, intellectual, protect}

{condition, economic, financial}

{personnel, key, retain}

{regulation, change, law}

We have a history of net losses and an accumulated deficit, and we may never generate revenue or achieve or maintain profitability in the future. Our near-term prospects are substantially dependent on PDX, our lead product candidate. If we are unable to successfully develop and obtain regulatory approval for PDX for the treatment of patients with relapsed or refractory PTCL, our ability to generate revenue will be significantly delayed. We cannot predict when or if we will obtain regulatory approval to commercialize our product candidates. If our product candidates, including PDX, fail to meet safety and efficacy endpoints in clinical trials, they will not receive regulatory approval, and we will be unable to market them. We may experience delays in our clinical trials that could adversely affect our financial position and our commercial prospects. While we have negotiated a special protocol assessment with the FDA relating to our PROPEL trial, this agreement does not guarantee any particular outcome from regulatory review of the trial or the product, including any regulatory approval. We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed. Reports of adverse events or safety concerns involving our product candidates or in related technology fields or other companies' clinical trials could delay or prevent us from obtaining regulatory approval or negatively impact public perception of our product candidates. Due to our reliance on contract research organizations and other third parties to conduct our clinical trials, we are unable to directly control the timing, conduct and expense of our clinical trials. Even if our product candidates meet safety and efficacy endpoints in clinical trials, regulatory authorities may not approve them, or we may face post-approval problems that require withdrawal of our products from the market. Even if we receive regulatory approval for our product candidates, we will be subject to ongoing regulatory obligations and review. Budget constraints may force us to delay our efforts to develop certain product candidates in favor of developing others, which may prevent us from commercializing all product candidates as quickly as possible. If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully develop or commercialize our product candidates. If we are unable to effectively protect our intellectual property, we will be unable to prevent third parties from using our technology, which would impair our competitiveness and ability to commercialize our product candidates. In addition, enforcing our proprietary rights may be expensive and result in increased losses. We do not have manufacturing facilities or capabilities and are dependent on third parties to fulfill our manufacturing needs, which could result in the delay of clinical trials, regulatory approvals, product introductions and commercial sales. We may explore strategic partnerships that may never materialize or may fail. If we enter into one or more strategic partnerships, we may be required to relinquish important rights to and control over the development of our product candidates or otherwise be subject to unfavorable terms. Acceptance of our products in the marketplace is uncertain, and failure to achieve market acceptance will limit our ability to generate revenue and become profitable. The status of reimbursement from third-party payors for newly approved health care drugs is uncertain and failure to obtain adequate coverage and reimbursement could limit our ability to generate revenue. Health care reform measures could adversely affect our business. If we fail to comply with healthcare fraud and abuse laws, we could face substantial penalties and our business, operations and financial condition could be adversely affected If we are unable to develop adequate sales, marketing or distribution capabilities or enter into agreements with third parties to perform some of these functions, we will not be able to commercialize our products effectively. If our competitors develop and market products that are more effective than ours, our commercial opportunity will be reduced or eliminated. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. We are currently involved in a securities class action litigation, which could harm our business if management attention is diverted or the claims are decided against us. Our success depends on retention of our President and Chief Executive Officer, Chief Medical Officer and other key personnel. We cannot guarantee that we will be in compliance with all potentially applicable regulations. If our internal controls over financial reporting are not considered effective, our business and stock price could be adversely affected. If we do not progress in our programs as anticipated, our stock price could decrease. Warburg Pincus Private Equity VIII, L.P. ("Warburg") and Baker Brothers Life Sciences, L.P. ("Baker") each control a substantial percentage of the voting power of our outstanding common stock. Anti-takeover provisions in our charter documents and under Delaware law could discourage, delay or prevent an acquisition of us, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management. We have adopted a stockholder rights plan that may discourage, delay or prevent a merger or acquisition that is beneficial to our stockholders. The market price for our common stock has been and may continue to be highly volatile, and an active trading market for our common stock may never exist. We are required to recognize stock-based compensation expense relating to employee stock options, restricted stock, and stock purchases under our Employee Stock Purchase Plan, and the amount of expense we recognize may not accurately reflect the value of our share-based payment awards. Further, the recognition of stock-based compensation expense will cause our net losses to increase and may cause the trading price of our common stock to fluctuate. Substantial sales of shares may impact the market price of our common stock.

Full 10-K form ▸

1097264--2/27/2008--ALLOS_THERAPEUTICS_INC