911216--9/29/2008--PALATIN_TECHNOLOGIES

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{cost, regulation, environmental}

{investment, property, distribution}

{control, financial, internal}

{interest, director, officer}

{acquisition, growth, future}

{personnel, key, retain}

{provision, law, control}

We expect to continue to incur substantial losses over the next few years and we may never become profitable. We need to raise additional funds and expect that we will need to continue to raise funds in the future, and funds may not be available on acceptable terms, or at all. Our independent registered public accounting firm has expressed doubt about our ability to continue as a going concern, which may hinder our ability to obtain future financing. Based upon the recent price of our common stock on the American Stock Exchange (the AMEX), even if we are able to raise additional capital it is likely that our existing stockholders will experience substantial dilution. We have a limited operating history upon which to base an investment decision. Development and commercialization of our product candidates involves a lengthy, complex and costly process and we may never successfully develop or commercialize any product. The regulatory approval process is lengthy, expensive and uncertain, and may prevent us from obtaining the approvals we require. In order to reintroduce NeutroSpec to the market, we will be required to conduct extensive clinical trials of NeutroSpec, and may not be able to obtain regulatory approval. If any approved product does not achieve market acceptance, our business will suffer. We rely on third parties to conduct clinical trials for our product candidates and their failure to timely perform their obligations could significantly harm our product development. The results of our clinical trials may not support our product claims. Production and supply of our product candidates depend on contract manufacturers over whom we have no control. We are subject to extensive regulation in connection with the laboratory practices and the hazardous materials we use. Contamination or injury from hazardous materials used in the development of our products could result in a liability exceeding our financial resources. We have no experience in marketing, distributing and selling products and will substantially rely on our marketing partners to provide these capabilities. We do not control the development of compounds licensed to third parties and, as a result, we may not realize a significant portion of the potential value of any such license arrangements. Competing products and technologies may make our proposed products noncompetitive. Our ability to achieve significant revenues from the sale of our future products will depend, in part, on the ability of healthcare providers to obtain adequate reimbursement from Medicare, Medicaid, private insurers and other healthcare payers. We could lose our rights to NeutroSpec, which could adversely affect our potential revenues. If we fail to adequately protect or enforce our intellectual property rights or secure rights to patents of others, the value of our intellectual property rights would diminish. If we are unable to keep our trade secrets confidential, our technologies and other proprietary information may be used by others to compete against us. We may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits. We are highly dependent on our management team, senior research professionals and third-party contractors and consultants, and the loss of their services could materially adversely affect our business. Stockholders may experience dilution from the exercise of outstanding options and warrants and the vesting of restricted stock units. Our stock price is, and we expect it to remain, volatile, which could limit investors ability to sell stock at a profit. Anti-takeover provisions of Delaware law and our charter documents may make potential acquisitions more difficult and could result in the entrenchment of management. We do not intend to pay cash dividends in the foreseeable future. We have broad discretion over the use of available cash and may not realize an adequate return.

Full 10-K form ▸

911216--9/29/2008--PALATIN_TECHNOLOGIES_INC