10 We also plan to initiate a Phase 2 randomized controlled clinical study of KSI-301 in DME patients in the U.S. and E.U. We also expect this study to evaluate the non-inferiority of KSI-301 administered on an every 12 week or less frequent dosing schedule versus EYLEA administered on its every 8-week (labeled) regimen (after five loading doses). We plan to initiate dosing in this study by the end of 2019 or early 2020. We additionally plan to initiate two Phase 2 studies in China, one in wet AMD and one in DME, and we are planning for these studies to have the same clinical design frameworks as our U.S./EU studies. We filed the regulatory pre-IND package to China’s Center for Drug Evaluation in January 2019, and we hope to file the IND in China in the first half of 2019 and initiate dosing in the second half of 2019. Our Strategy Our goal is to become a leading biopharmaceutical company focused on developing and commercializing therapeutics for the treatment of ophthalmic diseases. The key elements of our strategy are: • Complete clinical development of KSI-301 for wet AMD and DR. We are devoting a significant portion of our resources and business efforts to the manufacture and clinical development of KSI-301 for retinal vascular diseases. We anticipate initiating a Phase 2 wet AMD study of KSI-301 in the U.S. and EU in the second quarter of 2019 to evaluate the non-inferiority of intravitreal KSI-301 administered as infrequently as every 20-weeks versus EYLEA. The FDA has indicated this study, KSI-CL-102, if successful, can be supportive of a marketing application for KSI- 301. We are thus designing and intend to execute this Phase 2 study as a pivotal study. We also plan to initiate a Phase 2 clinical trial of KSI-301 in the U.S. and EU in DME patients and are formulating our strategy for evaluating KSI-301 in earlier Diabetic Retinopathy, or DR. We also plan to initiate two Phase 2 studies in China, one in wet AMD and one in DME, and we are planning for these studies to have the same clinical design frameworks as our U.S. and EU studies. We plan to perform an administrative interim analysis of our Phase 2 data after approximately 200 patients (100 on KSI-301 and 100 on EYLEA) have been treated for approximately 6 months, to evaluate the KSI-301 Q20W (once every 20 weeks), Q16W (once every 16 weeks), and Q12W (once every 12 weeks) durability proportion. We expect to undertake this administrative interim analysis in either or both of the global or China Phase 2 studies. We may use the results of this interim analysis to inform future activities related to KSI-301. In parallel to our Phase 2 programs, we have expanded the scope of our Phase 1 study into a Phase 1b open label design to evaluate the safety and treatment effect of sequential doses of KSI-301 in approximately 50 patients with retinal vascular disease including wet AMD, DME, and RVO. • Establish market acceptance of KSI-301 in wet AMD and diabetic eye disease. We believe that if KSI-301 is approved and is shown to have comparable efficacy and improved durability to other anti-VEGF therapies, it will compete favorably with other marketed products for retinal vascular disease. In addition, we believe KSI-301 may potentially expand the market reach to patients not currently on approved standard of care therapies or not currently on therapy at all. • Seek to expand the use of KSI-301 in DR beyond DME. We intend to explore the use of KSI-301 in the treatment of all subtypes of DR patients. Currently marketed anti-VEGFs are used primarily to treat late and advanced manifestations of DR, particularly DME. We believe that the potential for improved durability of KSI-301 could not only improve the standard of care but also expand the patient population that receives anti-VEGF therapy to include patients with less severe forms of DR for whom frequent injections may be a barrier to adoption. • Commercialize KSI-301 with our own specialty sales force. KSI-301 is wholly-owned by us. If KSI-301 receives marketing approval, we plan to commercialize it in the United States with our own focused, specialty sales force. We believe that retinal specialists in the United States, who perform most of the medical procedures involving retinal diseases, are sufficiently concentrated that we will be able to effectively promote KSI-301 with a sales and marketing group of fewer than 200 people. We expect to explore collaboration, distribution or other marketing arrangements with one or more third parties to commercialize KSI-301 in markets outside the United States. • Advance the development of our other ABC product candidates. We intend to continue deploying capital to selectively develop our own portfolio of product candidates based on our ABC Platform (including bispecific inhibitors such as KSI-501). We may partner with biotechnology and pharmaceutical companies to further develop our ABC Platform and product candidates. • Discover and develop future product candidates for areas of unmet need. We intend to continue our discovery efforts and deepen our pipeline of medicines for high-prevalence ophthalmic diseases. We may opportunistically in-license or acquire the rights to complementary products, other product candidates and technologies to aid in the treatment of a range of ophthalmic diseases, principally diseases of the retina.