708717--10/14/2008--ALFACELL

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{property, intellectual, protect}

{control, financial, internal}

{loan, real, estate}

{personnel, key, retain}

{acquisition, growth, future}

{product, market, service}

{cost, regulation, environmental}

{provision, law, control}

{cost, operation, labor}

{stock, price, operating}

We are highly dependent on achieving success in the clinical testing, regulatory approval, and commercialization of ONCONASE and our other compounds currently under development. If we fail to obtain the necessary regulatory approvals, we will not be allowed to commercialize ONCONASE and our business will be harmed. We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future. We do not have a current source of product revenue and may never be profitable. We will need additional financing to continue operations, which may not be available on favorable or acceptable terms, if it is available at all. Budget constraints may force us to delay our efforts to develop certain drug product candidates in favor of developing others, which may prevent us from commercializing all drug product candidates as quickly as possible. Competition in the biopharmaceutical field is intense and subject to rapid technological change. Our principal competitors have substantially greater resources to develop and market products that may be superior to ours. Our stock price has been and is likely to continue to be volatile, and an investment in our common stock could decline in value. The trading market for our common stock may be limited if we are unable to continue listing our common stock on the Nasdaq Capital Market. We are and will be dependent upon third parties for manufacturing our products. If these third parties do not devote sufficient time and resources to our products our revenues and profits may be adversely affected. Because we do not have in-house marketing, sales or distribution capabilities, we have contracted with third parties and expect to contract with third parties in the future for these functions and we will therefore be dependent upon such third parties to market, sell and distribute our products in an effort to generate revenues. Our lack of operating experience may cause us difficulty in managing our growth. Our proprietary technology and patents may offer only limited protection against infringement and the development by our competitors of competitive products. We may be sued for infringing on the intellectual property rights of others. If we lose key management personnel or are unable to attract and retain the talent required for our business, our business could be materially harmed. If we are unable to obtain favorable reimbursement for our product candidates, their commercial success may be severely hindered. Our product candidates may not be accepted by the market. Material weaknesses or deficiencies in our internal control over financial reporting could harm stockholders and business partners confidence in our financial reporting, our ability to obtain financing, and other aspects of our business. Our investments could lose market value and consequently harm our ability to fund continuing operations. We handle hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. We could also be liable for damages, penalties, or other forms of censure if we are involved in a hazardous waste spill or other accident. We may be sued for product liability. Our incorporation documents may delay or prevent the removal of our current management or a change of control that a stockholder may consider favorable. Events with respect to our share capital could cause the price of our common stock to decline. stockholders to recover against Armus Harrison Co., or AHC, may be limited because we have not been able to obtain the reissued reports of AHC with respect to the financial statements included in our Form 10-K, nor have we been able to obtain AHC s consent to the use of such report herein.

Full 10-K form ▸

708717--10/14/2008--ALFACELL_CORP