1097264--3/3/2009--ALLOS_THERAPEUTICS

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{condition, economic, financial}

{provision, law, control}

{control, financial, internal}

{acquisition, growth, future}

{regulation, government, change}

{financial, litigation, operation}

{personnel, key, retain}

{property, intellectual, protect}

{loan, real, estate}

{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 pralatrexate (PDX), our lead product candidate. If we are unable to successfully develop and obtain regulatory approval for pralatrexate 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 pralatrexate. 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. Even if pralatrexate meets safety and efficacy endpoints in clinical trials, regulatory authorities may not approve pralatrexate, or we may face post-approval problems that require withdrawal of pralatrexate from the market. Even if we receive regulatory approval for pralatrexate, we will be subject to ongoing regulatory obligations and review. We will need to raise additional capital to support our future operations. If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully develop or commercialize pralatrexate. Budget constraints may force us to delay our efforts to develop pralatrexate for certain indications in favor of developing it for other indications, which may prevent us from commercializing pralatrexate for all desired indications as quickly as possible. If pralatrexate fails to meet safety and efficacy endpoints in clinical trials, it will not receive regulatory approval and we will be unable to market pralatrexate. We may experience delays in our clinical trials that could adversely affect our financial position and our commercial prospects. 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 pralatrexate 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 pralatrexate. 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. 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. 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 pralatrexate. In addition, enforcing our proprietary rights may be expensive and result in increased losses. 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 pralatrexate or otherwise be subject to unfavorable terms. Acceptance of pralatrexate 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. We may not obtain orphan drug exclusivity or we may not receive the full benefit of orphan drug exclusivity even if we obtain such exclusivity. 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 pralatrexate effectively. If our competitors develop and market products that are more effective than pralatrexate, our commercial opportunity will be reduced or eliminated. If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of pralatrexate. 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. and Baker Brothers Life Sciences, L.P. 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. Unstable market conditions may have serious adverse consequences on our business. Our liquidity, capital resources and results of operations may be adversely affected by declines in the value of our investments in marketable securities. 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. Substantial sales of shares may impact the market price of our common stock.

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1097264--3/3/2009--ALLOS_THERAPEUTICS_INC