Kodiak(KOD)2020-05-13 05:51Financial Data and Key Metrics Changes - As of the end of Q1 2020, the company reported over 24.4 million, including non-cash expenses of approximately 6 million, indicating a strong financial position to support operations into 2022 [15][9] Business Line Data and Key Metrics Changes - The company plans to conduct two Phase 3 studies in Diabetic Macular Edema (DME) and one study in wet Age-related Macular Degeneration (AMD), along with one study in Retinal Vein Occlusion (RVO) and one in non-proliferative Diabetic Retinopathy (NPDR) [19][47] - The DAZZLE study has enrolled 245 patients as of May 8, 2020, with a robust recruitment rate prior to the pandemic [32][33] Market Data and Key Metrics Changes - The company is observing a shift in patient enrollment dynamics due to COVID-19, with a noted decline in overall ophthalmology outpatient visits but an increase in visits for anti-VEGF therapy [29][30] - The company expects to begin patient recruitment activities at certain sites in Europe in Q2 2020, contingent on local COVID-19 conditions [36] Company Strategy and Development Direction - The company aims for a single Biologics License Application (BLA) covering key retinal indications by 2022, with a focus on optimizing pivotal study designs and engaging with regulators [10][18] - The strategic shift to focus on DME studies is driven by the higher prevalence and unmet need in this area compared to RVO [22][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing operations despite COVID-19, noting minimal disruption and continued patient enrollment in clinical trials [13][14] - The company remains committed to its 2022 Vision and is utilizing the additional time to enhance pivotal study plans [18][39] Other Important Information - The company has made significant additions to its Board of Directors, enhancing its expertise in pharmaceutical development and financial management [41] - The company received full registration of its trademarks with the U.S. Patent and Trademark Office, reinforcing its brand recognition in retinal disease treatment [42] Q&A Session Summary Question: How does the company view competition from additional biosimilars in the retinal market? - Management believes that KSI-301's differentiated profile will allow it to capture market share, even in the presence of biosimilars, by offering a better treatment option for patients [78][81] Question: What is the confidence level regarding the completion of enrollment for the AMD study? - Management noted that enrollment rates were robust prior to the pandemic and expect an increase as conditions improve, with a focus on maintaining a balanced approach to U.S. and ex-U.S. patient recruitment [92][94] Question: How sustainable is the current monthly burn rate? - The company indicated that the $6 million monthly burn rate is sustainable in the short term, but it will increase as new pivotal studies are initiated [114]