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KEZAR LIFE SCIENCES Kezar Life Sciences Reports First Quarter Financial Results and Provides Business Updates May 12 , 2021 • KZR - 616 clinical development in three severe autoimmune diseases is advancing with several data readouts expected in 2021 and 2022 • KZR - 261 IND submission expected mid - 2021 , with Phase 1 trial in solid tumors expected to initiate before year - end • Cash , cash equivalents and marketable securities of $ 142 million as of March 31 , 2021 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 announced its first quarter 2021 financial results and corporate highlights . " Last quarter saw excellent execution by the Kezar team across both of our programs . We look forward to sharing data this June from the completed Phase 1b portion of the MISSION study of KZR - 616 in SLE patients , followed by an interim review of the Phase 2 portion of MISSION in LN patients in the fourth quarter . Our conviction continues to deepen that immunoproteasome inhibition has the potential to be a powerful , differentiated treatment approach for patients with autoimmune diseases , " said John Fowler , Kezar's Co - founder and Chief Executive Officer . " In addition , we are on track to submit an IND for KZR - 261 , our first - in - class protein secretion inhibitor , in mid - 2021 and commence a Phase 1 study in solid tumors shortly thereafter . " Clinical Highlights & Updates KZR - 616 : Selective Immunoproteasome Inhibitor MISSION - Phase 1b / 2 clinical trial in patients with systemic lupus erythematous ( SLE ) and lupus nephritis ( LN ) , respectively ( NCT03393013 ) • The last patient from the MISSION Phase 1b completed treatment in February 2021 , and final clinical data from this 25 - week safety and tolerability study of up to 75 mg weekly of KZR - 616 in 47 patients with SLE will be presented during the European Congress of Rheumatology ( EULAR 2021 ) in June . • The amended Phase 2 open - label portion of the MISSION trial in patients with active , proliferative lupus nephritis opened for enrollment in August 2020 and is actively recruiting . The primary efficacy endpoint for the trial is the proportion of patients achieving a renal response measured by a 50 % or greater reduction in urine protein to creatinine ratio ( UPCR ) at six months . • Interim data are expected in late 2021 , and topline data are expected in the first half of 2022 . PRESIDIO - Phase 2 clinical trial in patients with dermatomyositis ( DM ) and polymyositis ( PM ) ( NCT04033926 ) • The PRESIDIO Phase 2 , placebo controlled cross - over trial of KZR - 616 in DM and PM is actively enrolling . Additionally , a 12 - month open - label extension study is open to patients completing the 32 - week placebo - controlled trial ( NCT04628936 ) . o Topline data are expected in the first half of 2022 . Protein Secretion Program • KZR - 261 is a first - in - class protein secretion inhibitor which targets the Sec61 translocon and has demonstrated broad anti - tumor activity in preclinical models of both solid and hematologic malignancies . • Pending successful completion of drug product manufacturing , submission of an Investigational New Drug ( IND ) application for KZR - 261 is anticipated in mid - 2021 . The Phase 1 clinical trial will evaluate pharmacokinetics , safety , and tolerability in patients with solid tumors as well as preliminary signs of efficacy in tumor - specific expansion cohorts . The trial is expected to commence shortly after the IND becomes effective . • Two abstracts featuring Kezar's small molecule inhibitors of the Sec61 translocon were presented in April during the American Association of Cancer Research ( AACR ) 2021 Virtual Annual Meeting . Corporate Update • In May 2021 , Kezar was recognized as a winner of the 2021 Bay Area Best Places to Work , an awards program presented by the San Francisco Business Times and the Silicon Valley Business Journal . Financial Results • Cash , cash equivalents and marketable securities totaled $ 142.3 million as of March 31 , 2021 , compared to $ 140.4 million as of December 31 , 2020. The increase in cash , cash equivalents and marketable securities was primarily