Kiniksa Pharmaceuticals Reports Third Quarter 2021 Financial Results and Recent Portfolio Execution – GlobeNewswire

| Source: Kiniksa Pharmaceuticals, Ltd. Kiniksa Pharmaceuticals, Ltd.
– 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-1α and IL-1β cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)
KPL-404 (monoclonal antibody inhibitor of signaling between CD40 and CD154)
Financial Results
Financial Guidance
Upcoming Scientific Conference Presentations
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 A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.
About Kiniksa
Kiniksa is a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s portfolio of assets, ARCALYST, mavrilimumab, vixarelimab and KPL-404, are based on strong biologic rationale or validated mechanisms, target underserved conditions, and offer the potential for differentiation. These assets are designed to modulate immunological pathways across a spectrum of diseases. For more information, please visit
ARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha and interleukin-1 beta signaling. ARCALYST was discovered by Regeneron and is approved by the FDA for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug designation to ARCALYST for the treatment of pericarditis in 2020.
Important Information About ARCALYST Injection
About Mavrilimumab
Mavrilimumab is an investigational fully human monoclonal antibody that blocks activity of granulocyte macrophage colony stimulating factor (GM-CSF) by specifically binding to the alpha subunit of the GM-CSF receptor. Mavrilimumab was dosed in over 550 patients with rheumatoid arthritis through Phase 2b clinical studies in Europe and achieved prospectively defined primary endpoints of efficacy and safety. Kiniksa is evaluating mavrilimumab in GCA, and the Phase 2 clinical trial achieved both the primary and secondary efficacy endpoints with statistical significance. Kiniksa continues to evaluate mavrilimumab in COVID-19-related ARDS. The FDA granted Orphan Drug designation to mavrilimumab for the treatment of GCA in 2020.
About Vixarelimab
Vixarelimab is an investigational fully human monoclonal antibody that targets oncostatin M receptor beta (OSMRβ), which mediates signaling of interleukin-31 (IL-31) and oncostatin M (OSM), two key cytokines implicated in pruritus, inflammation, and fibrosis. Kiniksa believes vixarelimab to be the only monoclonal antibody in development that targets both pathways simultaneously. Kiniksa’s lead indication for vixarelimab is prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules. The FDA granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020.
About KPL-404
KPL-404 is an investigational humanized monoclonal antibody that is designed to inhibit CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 interaction is an attractive approach to address multiple autoimmune disease pathologies. Kiniksa owns or controls the intellectual property related to KPL-404.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our beliefs about the future commercial demand for ARCALYST; expected timing and design of our clinical trials, including (i) the timing of data from the Phase 3 portion of our clinical trial for mavrilimumab in COVID-19-related ARDS in the first quarter of 2022, (ii) the initiation of our Phase 2 proof-of-concept trial of KPL-404 in rheumatoid arthritis by the end of 2021 and (iii) the timing of data from the dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the second half of 2022; our belief that KPL-404 has broad utility across multiple indications; our beliefs about the mechanisms of action of our product candidates and potential impact of their approach, including that vixarelimab is the only monoclonal antibody in development that targets both interleukin-31 (IL-31) and oncostatin M (OSM) pathways simultaneously; our belief that all of our product candidates offer the potential for differentiation; our ability to execute on our clinical stage pipeline; our expectations regarding ARCALYST net revenue for the fourth quarter of 2021; our plans to present at any future medical conferences; and our expectations about our cash reserves funding our current operating plan into 2023.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; amendments to our clinical trial protocols initiated by us or required by regulatory authorities; delays or difficulty in completing our clinical trials, including as a result of the ongoing COVID-19 pandemic; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials conducted by us or third parties; our inability to replicate in later clinical trials the positive final data from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings or to delay or deny approval of, or emergency use authorization for, any of our product candidates or to require additional data or trials to support any such approval or authorization; delays, difficulty or inability to successfully execute on our commercial strategy for ARCALYST; our reliance on third parties as the sole source of supply of the drug substance and drug products used in our products and product candidates; our reliance on Regeneron as the sole manufacturer of ARCALYST; raw materials, drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; the impact of the COVID-19 pandemic and measures taken in response to the pandemic on our business and operations as well as the business and operations of our manufacturers, CROs upon whom we rely to conduct our clinical trials, and other third parties with whom we conduct business or otherwise engage, including the FDA and other regulatory authorities; changes in our operating plan and funding requirements; and existing or new competition.
These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”), including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
Every Second Counts!®
Kiniksa Investor and Media Contact
Rachel Frank
(339) 970-9437
[email protected]