Page 1

KINIKSA Kiniksa Pharmaceuticals Reports Third Quarter 2021 Financial Results and Recent Portfolio Execution November 1 , 2021 - Q3 2021 ARCALYSTⓇ ( rilonacept ) net revenue of $ 12.1 million- - ARCALYST prescribed by more than 200 physicians for recurrent pericarditis since approval - - Data from Phase 3 trial of mavrilimumab in COVID - 19 - related ARDS expected in Q1 2022 - - Data from Phase 2b trial of vixarelimab in prurigo nodularis expected in 2H 2022 - - Conference call and webcast scheduled for 8:30 am ET today - HAMILTON , Bermuda , Nov. 01 , 2021 ( GLOBE NEWSWIRE ) -- Kiniksa Pharmaceuticals . Ltd. ( Nasdaq : KNSA ) ( “ Kiniksa " ) , a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases , today reported third quarter 2021 financial results and recent portfolio execution . " We are delighted with the ARCALYST launch performance in recurrent pericarditis . The continued momentum underscores the dedication of our first - rate team as well as the unmet need for patients with this debilitating disease , " said Sanj K. Patel , Chairman and Chief Executive Officer of Kiniksa . " In addition to our ongoing commercial efforts , we are executing on our clinical - stage pipeline . Mavrilimumab demonstrated potentially best - in - class mortality reduction in a Phase 2 study in non - mechanically ventilated patients with COVID - 19 - related ARDS , and Phase 3 data are on track for the first quarter of 2022. We are also conducting a dose - ranging Phase 2b study of vixarelimab in prurigo nodularis with data expected in the second half of 2022. Furthermore , we expect to initiate a Phase 2 proof - of - concept trial of KPL - 404 in rheumatoid arthritis by the end of 2021. " Portfolio Execution ARCALYST ( IL - 1a and IL - 1ẞ cytokine trap ) • ARCALYST net revenue for the third quarter of 2021 was $ 12.1 million . • More than 200 physicians have prescribed ARCALYST for recurrent pericarditis since approval . • More than 90 % of completed patient enrollment cases for recurrent pericarditis were approved for coverage . • Kiniksa has achieved broad access for its recurrent pericarditis target population in the United States , with greater than 190 million lives receiving favorable coverage . • Two thirds of ARCALYST prescriptions for recurrent pericarditis have been written for 12 months of therapy . • Recent data from the ongoing Phase 3 clinical trial of ARCALYST in recurrent pericarditis ( RHAPSODY ) showed median duration of continuous ARCALYST therapy at the 1 - year anniversary of the Long - Term Extension portion of the trial of approximately 20 months . Mavrilimumab ( monoclonal antibody inhibitor targeting GM - CSFRα ) • Mavrilimumab has demonstrated broad utility across multiple indications including COVID - 19 - related acute respiratory distress syndrome ( ARDS ) and giant cell arteritis ( GCA ) . • Kiniksa expects data from the Phase 3 clinical trial of mavrilimumab in hospitalized non - mechanically ventilated patients with COVID - 19 - related ARDS in the first quarter of 2022 . • The primary efficacy endpoint for the Phase 3 trial is the proportion of patients alive and without mechanical ventilation at Day 29. A key secondary efficacy endpoint is mortality at Day 29 . • Phase 2 clinical data in hospitalized non - mechanically ventilated patients with COVID - 19 - related ARDS showed mavrilimumab reduced the risk of mechanical ventilation or death by 65 % versus placebo at Day 29 . Vixarelimab ( monoclonal antibody inhibitor of signaling through OSMRẞ ) • Kiniksa expects data from the dose - ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the second half of 2022 . • The primary efficacy endpoint for the Phase 2b trial is the percent change from baseline in the weekly - average Worst - Itch Numeric Rating Scale ( WI - NRS ) at Week 16 . KPL - 404 ( monoclonal antibody inhibitor of signaling between CD40 and CD154 ) • Kiniksa plans to initiate a Phase 2 clinical trial of KPL - 404 in rheumatoid arthritis in the fourth quarter of 2021 . • The Phase 2 trial is designed to evaluate the efficacy , dose response , pharmacokinetics , and safety of chronic