On November 1, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported third quarter 2021 financial results and recent portfolio execution (Press release, Kiniksa Pharmaceuticals, NOV 1, 2021, View Source [SID1234594028]).
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"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-1α and IL-1β 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 OSMRβ)
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 subcutaneous dosing in rheumatoid arthritis over 12 weeks.
The pharmacokinetic lead-in of the Phase 2 trial is designed to provide optionality to evaluate the therapeutic potential of KPL-404 across a range of other autoimmune diseases with pathologies believed to be mediated by the CD40-CD154 pathway.
Financial Results
Total net revenue for ARCALYST product sales in the third quarter of 2021 was $12.1 million.
Net loss for the third quarter of 2021 was $30.5 million, compared to a net loss of $43.8 million for the third quarter of 2020.
Total operating expenses for the third quarter of 2021 were $42.8 million, compared to $43.2 million for the third quarter of 2020.
Non-cash, share-based compensation expense for the third quarter of 2021 was $6.2 million, compared to $5.6 million for the third quarter of 2020.
As of September 30, 2021, the company had cash, cash equivalents, and short-term investments of $200.2 million and no debt.
Financial Guidance
Kiniksa expects ARCALYST net revenue for the fourth quarter of 2021 to be between $16.0 million and $17.0 million.
Kiniksa continues to expect that its cash, cash equivalents and short-term investments will fund its current operating plan into 2023.
Upcoming Scientific Conference Presentations
Presentations of new data from several of Kiniksa’s pipeline programs are planned at the upcoming American College of Rheumatology (ACR) Convergence 2021, being held virtually from November 3, 2021 to November 9, 2021. In addition, encore presentations of RHAPSODY data are planned. Details of the pipeline presentations are as follows:
Marc Corbera-Bellalta, Ph.D., University of Barcelona, will give an oral presentation titled, Transcriptomic Changes Induced by Mavrilimumab versus Tocilizumab in ex-vivo Cultured Arteries from Patients with Giant-cell Arteritis.
Sebastian Unizony, MD, Massachusetts General Hospital, will present a poster entitled, Utility of CRP and ESR in the Assessment of Giant Cell Arteritis Relapse in a Phase 2 Trial of Mavrilimumab.
Manoj Samant, Ph.D., Kiniksa Pharmaceuticals, will present a poster entitled, Safety, Tolerability, Pharmacokinetics, Receptor Occupancy, and Suppression of T-cell-Dependent Antibody Response in a Phase 1 Study with KPL-404, an anti-CD40 Monoclonal Antibody.
Kiniksa plans to present details on the RESONANCE registry in pediatric and adult patients with recurrent pericarditis at the American Heart Association (AHA) Scientific Sessions 2021, being held virtually from November 13, 2021 to November 15, 2021. Details of the presentation are as follows:
Sushil Allen Luis, MD, Mayo Clinic, will present a poster entitled, Including the Patient’s Perspective in the Planning of Data Collection in the Recurrent Pericarditis Registry, RESONANCE.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Monday, November 1, 2021 to discuss third quarter 2021 financial results and to provide a corporate update.
Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.