GNPX 2017 Annual Report

45 Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. In addition, our expenses could increase if we are required by the FDA to perform studies or trials in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our drug candidates. The amount of future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. We have a limited operating history and we expect a number of factors to cause our operating results to fluctuate on an annual basis, which may make it difficult to predict our future performance. We are a clinical stage gene therapy company with a limited operating history. Our operations to date have been limited to conducting clinical and preclinical research. We have not yet obtained any regulatory approvals for any of our drug candidates. Consequently, any predictions made about our future success or viability may not be as accurate as they could be if we had a longer operating history or approved products on the market. Our operating results are expected to significantly fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Factors relating to our business that may contribute to these fluctuations include: • any delays in regulatory review and approval of our current and potential product candidates in clinical development, including our ability to receive approval from the FDA for Oncoprex; • delays in the commencement, enrollment and timing of clinical trials; • the success of our clinical trials through all phases of clinical development; • potential side effects of our current and potential product candidates that could delay or prevent approval or cause an approved drug to be taken off the market; • our ability to obtain additional funding to develop product candidates; • our ability to identify and develop additional drug candidates beyond Oncoprex; • competition from existing products or new products that continue to emerge; • the ability of patients or healthcare providers to obtain coverage or sufficient reimbursement for our products; • our ability to adhere to clinical trial requirements directly or with third parties such as contract research organizations, or CROs; • our dependency on third-party manufacturers to manufacture our products and key ingredients; • our ability to establish or maintain collaborations, licensing or other arrangements, particularly with MD Anderson; • our ability to defend against any challenges to our intellectual property including, claims of patent infringement; • our ability to enforce our intellectual property rights against potential competitors; • our ability to secure additional intellectual property protection for our drug candidates in development and associated technologies; • our ability to attract and retain key personnel to manage our business effectively; and • potential product liability claims. Accordingly, the results of any historical quarterly or annual periods should not be relied upon as indications of future operating performance. Risks Related to Development and Commercialization of Our Current and Potential Product Candidates Our success depends greatly on the success of our development of Oncoprex for the treatment of non-small cell lung cancer, and our pipeline of product candidates beyond this lead indication is extremely early stage and limited. At this time we are actively pursuing development of only one product candidate, Oncoprex for non-small cell lung cancer. Therefore, we are dependent on the success of Oncoprex in the near term. We cannot provide you any assurance that we will be able to successfully advance Oncoprex through the development process, or that any development problems we experience in the future will not cause significant delays or unanticipated costs, or that such development problems can be solved. We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process or transferring that process to commercial partners, or developing or validating product release assays in a timely manner, which may prevent us from completing our clinical