Kezar Life Sciences(KZR) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities totaled $157.5 million as of June 30, 2020, compared to $78.2 million as of December 31, 2019, primarily due to net proceeds from public offerings [37] - Net loss for Q2 2020 was $9.5 million or $0.22 per share, compared to a net loss of $8.7 million or $0.46 per share for Q2 2019 [39] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2020 increased by $200,000 to $7.1 million compared to $6.9 million in Q2 2019, mainly due to advancing the protein secretion pre-clinical program [38] - General and administrative expenses for Q2 2020 increased by $300,000 to $2.7 million compared to $2.4 million in Q2 2019, primarily due to increased personnel expenses [38] Market Data and Key Metrics Changes - The company is focusing on the development of KZR-616 for severe autoimmune diseases and KZR-261 for solid tumors, with ongoing clinical trials impacted by COVID-19 [11][14] Company Strategy and Development Direction - The company aims to pioneer small molecule approaches against novel targets, with a focus on KZR-616 and KZR-261, to address severe autoimmune diseases and cancers [14][41] - The strategy includes reevaluating clinical development plans in light of new data and the ongoing pandemic, with a commitment to patient safety and effective treatment [12][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their drug candidates and the ongoing commitment to advancing clinical programs despite challenges posed by COVID-19 [9][41] - The company is well-capitalized with a strong balance sheet, providing a runway to achieve its goals [15][37] Other Important Information - The MARINA study has been withdrawn due to a lack of patient enrollment and the need for protocol amendments [30] - The company plans to submit an IND for KZR-261 in Q1 2021 and initiate a first-in-human clinical trial shortly thereafter [34][55] Q&A Session Summary Question: What factors contributed to better tolerability on Cohort 2c? - Better tolerability was due to a combination of moving to a lyophilized formulation, step-up dosing, and supportive measures for patients [43] Question: Does the new formulation make the drug more stable? - The new formulation does not change stability but simplifies the formulation by removing an excipient that could cause adverse reactions [45] Question: When can we expect another update from the Stage 1b MISSION study? - An interim update is expected by the end of the year, with initial data anticipated in the first half of 2021 [50] Question: How has the PRESIDIO timeline been impacted by COVID-19? - Enrollment has slowed, pushing the completion timeline from the end of 2021 to mid-2022, but data integrity is not expected to be affected [51] Question: What is the rationale for the 50% reduction in proteinuria as a primary endpoint? - A 50% reduction in proteinuria is a standard measure of renal response based on past clinical trials [58] Question: Why was the MARINA study withdrawn? - The study was withdrawn due to a high screening failure rate and the need for a more inclusive protocol [59][77]