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2 KEZAR LIFE SCIENCES Kezar Reports Third Quarter Financial Results and Provides Business Update November 9 , 2021 • Target enrollment met in the MISSION Phase 2 trial evaluating KZR - 616 for lupus nephritis • First patient dosed in Phase 1 trial of KZR - 261 for the treatment of advanced solid tumor malignancies • Company to host virtual Investor and Analyst Day on Monday , November 15 , 2021 , at 4:30 p.m. ET to discuss KZR - 616 , including MISSION interim results , and KZR - 261 • New credit facility provides up to $ 50 million of available funding SOUTH SAN FRANCISCO , Calif .-- ( BUSINESS WIRE ) -- Kezar Life Sciences , Inc. , ( Nasdaq : KZR ) , a clinical - stage biotechnology company discovering and developing breakthrough treatments for immune - mediated and oncologic disorders , today reported financial results for the third quarter ended September 30 , 2021 and provided a business update . " Excellent progress continues across our programs , as we reached target enrollment in both of our Phase 2 trials with KZR - 616 and announced our first patient dosed with KZR - 261 . Achieving full enrollment in our MISSION and PRESIDIO studies is an important milestone for KZR - 616 as a potentially differentiated treatment option for patients suffering from lupus nephritis , dermatomyositis and polymyositis . We look forward to sharing interim results from MISSION at our upcoming event this month , with topline results from both studies expected in the second quarter of 2022 , " said John Fowler , Kezar's Co - founder and Chief Executive Officer . Clinical Highlights & Updates KZR - 616 : Selective Immunoproteasome Inhibitor MISSION - Phase 2 clinical trial in patients with lupus nephritis ( LN ) ( NCT03393013 ) • Kezar's upcoming Investor and Analyst Day , scheduled for Monday , November 15 , 2021 , at 4:30 p.m. ET / 1 : 30 p.m. PT , will include a presentation featuring interim MISSION data , as well as a presentation from Samir V. Parikh , MD , Associate Professor of Medicine , Nephrology , The Ohio State University Wexner Medical Center . • The MISSION Phase 2 open - label trial in patients with active , proliferative LN has reached target enrollment of 20 subjects . The primary efficacy endpoint for the trial is the number of patients with a 50 % reduction in urine protein / creatine ratio ( UPCR ) after 24 weeks of treatment when compared to baseline . • Kezar expects to report topline data in the second quarter of 2022 . PRESIDIO - Phase 2 clinical trial in patients with active dermatomyositis ( DM ) or polymyositis ( PM ) ( NCT04033926 ) • The PRESIDIO Phase 2 , placebo controlled , cross - over trial of KZR - 616 in DM and PM has completed target enrollment of 24 subjects . The primary efficacy endpoint for the trial is the mean change from start to end of KZR - 616 treatment in the Total Improvement Score ( TIS ) , which ranges from 0 to 100 . • Kezar expects to report topline data in the second quarter of 2022 . • The PRESIDIO open - label extension study is available for patients completing the PRESIDIO trial , which evaluates KZR - 616 for up to a maximum of 96 weeks ( NCT04628936 ) . KZR - 261 : Protein Secretion Inhibitor KZR - 261-101- Phase 1 clinical trial in patients with locally advanced or metastatic solid malignancies ( NCT05047536 ) • In August , Kezar announced an IND submission for KZR - 261 for the treatment of advanced solid malignant tumors , and in October , the first patient was dosed in its Phase 1 clinical trial . • KZR - 261 is a novel , broad - spectrum , anti - tumor agent that acts through direct interaction and inhibition of the Sec61 translocon . • The Phase 1 clinical trial of KZR - 261 will be conducted in two parts : dose escalation in subjects with locally advanced or metastatic solid malignancies for whom no therapeutics are available and dose expansion in subjects with selected tumor types . The trial will assess safety and tolerability , including determination of a recommended Phase 2 dose , evaluate pharmacokinetics and pharmacodynamics , and explore the preliminary anti - tumor activity .