AKAO 2017 Annual Report

96 Plan of Operations and Future Funding Requirements We expect to incur substantial expenditures in the foreseeable future for research, development and potential commercialization of our product candidates. Specifically, we have incurred and we expect to continue to incur substantial expenses in connection with our clinical development of plazomicin and C-Scape, the advancement of our research and development programs and the preparation for commercialization of plazomicin. Management expects that, based on its current operating plans, our existing cash, cash equivalents and short-term investments will enable us to fund our current planned operations for at least the next twelve months from the issuance date of this report. We anticipate that we will need to raise substantial additional financing in the future to fund our operations, including enabling us to commercially launch plazomicin. We may obtain additional financing through public or private equity offerings, debt financings, a credit facility, government contracts and/or strategic collaborations. Additional financing may not be available to us when we need it or it may not be available to us on acceptable terms, if at all. Our ability to obtain debt financing may be limited by covenants we have made under our loan and security agreement with Silicon Valley Bank and our pledge to Silicon Valley Bank of substantially all of our assets, other than our intellectual property, as collateral. The negative pledge in favor of Silicon Valley Bank with respect to our intellectual property under the loan and security agreement could further limit our ability to obtain additional debt financing. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. The amount and timing of our future financing requirements will depend on many factors, including: • the size and timing of revenues from approved products like plazomicin (when approved); • the size, timing and type of the nonclinical and clinical studies that we decide to pursue in the development of our product candidates, including plazomicin and C-Scape; • the type, number, costs and results of the product candidate development programs which we are pursuing or may choose to pursue in the future; • the rate of progress and cost of clinical trials we may commence, preclinical studies and other discovery and research and development activities; • the costs associated with developing a plazomicin IVD assay to support therapeutic drug monitoring; • the timing of, and costs involved in, seeking and obtaining FDA and other regulatory approvals, including any supplemental applications relating to our NDA for plazomicin; • our ability to enter into additional collaboration, licensing or other arrangements and the terms and timing of such arrangements; • the costs of preparing, filing, prosecuting, maintaining and enforcing any patent claims and other intellectual property rights, including litigation costs and the results of such litigation; • the emergence of competing technologies and other adverse market developments; • the resources we devote to marketing, and, if approved, commercializing our product candidates; • the scope, progress, expansion, and costs of manufacturing our product candidates; • our ability to enter into additional government contracts, or other collaborative agreements, to support the development of our product candidates and development efforts; and • the costs associated with being a public company.