64 • obtain, maintain, expand, protect and enforce our intellectua t l property portfol f io; • attract, hire and retain qualified personnel; • experience any delays or encounter other issues related to our operations; • meet the requirements and demands of being a public company; and • defend against any product liability claims or other lawsuits related to our products. Our prior losses and expected future losses have had and will continue to have an adverse effe f ct on our stockholders’ equity and working capi a tal. In any particular quarter or quarters, our operating results could be below the expectations of securities analysts or investors, which could cause our stock price to decline. Drug developm l ent is a high i ly uncertai t n i undertaki t ng i and involves a substantia t l degr e ee of risk i .k We have never generated any n revenue from product sales, and we may a never generate revenue or be profita f ble. l We have no products approved for commercial sale and have not generated any revenue from product sales. We do not anticipate generating any revenue from product sales until afte f r we have successful f ly completed clinical development and received regulatory approval for the commercial sale of a product candidate, if ever. Our ability to generate revenue and achieve profita f bi a lity depends significantly on many factors, including: • successful f ly completing research and preclinical and clinical development of our product candidates; • obtaining regulatory approvals and marketing authorizations for product candidates for which we successful f ly complete clinical development and clinical trials; • developing a sustainabl a e and scalable manufact f ur t ing process for our product candidates, as well as establ a ishing and maintaining commercially viable suppl u y relationships with third parties that can provide adequate products and services to suppor u t clinical activities and any commercial demand for our product candidates; • identifying, assessing, acquiring and/or developing new product candidates; • negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; • launching and successful f ly commercializing product candidates for which we obtain regulatory r and marketing approval, either by collaborating with a partner or, if launched independently, by establ a ishing a sales, marketing and distribution infrastructur t e; • obtaining and maintaining an adequate price for our product candidates, both in the United States and in foreign countries where our products are commercialized; • obtaining adequate reimbursement for our product candidates from payors; • obtaining market acceptance of our product candidates as viable treatment options; • addressing any competing technological and market developments; • maintaining, protecting, expanding and enforcing our portfol f io of intellectua t l property rights, including patents, trade secrets and know-how; and • attracting, hiring and retaining qualifie f d personnel. Because of the numerous risks and uncertainties associated with drug r development, we are unabl a e to predict the timing or amount of our expenses, or when we will be able to generate any meaningful f revenue or achieve or maintain profita f bi a lity, if ever. In addition, our expenses could increase beyond our current expectations if we are required by the FDA or foreign regulatory r agencies, to perform studi t es in addition to those that we currently anticipate, or if there are any delays in any of our or our future collaborators’ clinical trials or the development of any of our product candidates. Even if one or more of our product candidates is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate and on-going compliance effo f rts.