Full Press Release Details
Kiniksa Pharmaceuticals
Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Corporate Update
collaboration achieved profitability in Q4 2021 -
ARCALYST full-year 2022 net revenue expected to be $115 - $130 million -
Strategic collaboration with Huadong Medicine to develop and commercialize ARCALYST and mavrilimumab in the Asia Pacific Region (excluding
Conference call and webcast scheduled for 8:30 am ET today -
- February 22, 2022 - 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 fourth quarter
and full-year 2021 financial results and provided a corporate update.
"The successful launch of ARCALYST in recurrent pericarditis
has been marked by continuous growth in prescriber adoption, expansion in payer coverage, and strong patient adherence," said Sanj
K. Patel, Chairman and Chief Executive Officer of Kiniksa. "In 2022, we anticipate continued robust commercial execution and the
further advancement of our clinical-stage pipeline. We expect data from the Phase 2b study of vixarelimab in prurigo nodularis in the
second half of this year and will continue to enroll the Phase 2 trial of KPL-404 in rheumatoid arthritis. Our collaboration with Huadong
Medicine provides non-dilutive capital and the opportunity to accelerate the development of ARCALYST and mavrilimumab in areas complementary
to our existing autoinflammatory cardiovascular business."
ARCALYST (IL-1 and IL-1 cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFR )
Vixarelimab (monoclonal antibody inhibitor
of signaling through OSMR )
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)
Upcoming Scientific Conference
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Tuesday, February 22, 2022, to discuss fourth
quarter and full-year 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
8145539. 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.
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 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 www.kiniksa.com.
ARCALYST is a weekly, subcutaneously
injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1 beta (IL-1 ) signaling.
ARCALYST was discovered by Regeneron and is approved by the U.S. Food and Drug Administration (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. The European Commission granted Orphan Drug Designation
to ARCALYST for the treatment of idiopathic pericarditis in 2020.
IMPORTANT SAFETY INFORMATION
For more information
about ARCALYST, talk to your doctor and see the Product Information.
Mavrilimumab is an investigational
fully human monoclonal antibody that blocks activity of GM-CSF by specifically binding to the alpha subunit of the GM-CSF receptor (GM-CSFR ).
Phase 2 clinical trials of mavrilimumab in rheumatoid arthritis and GCA achieved their primary and secondary endpoints with statistical
significance. Kiniksa is evaluating development of mavrilimumab in cardiovascular diseases where the GM-CSF mechanism has been implicated.
Vixarelimab is an investigational
fully human monoclonal antibody that targets oncostatin M receptor beta (OSMR ), 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.
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
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: the multi-product collaboration
between Kiniksa and Huadong Medicine, including anticipated milestone and royalty payments under the collaboration; our expectation
that ARCALYST net revenue for full-year 2022 will be between $115 million and $130 million; our expectation that we will have
continued robust commercial execution and further advancement of our clinical-stage pipeline in 2022; our expectation about our
year-end cash reserves funding our current operating plan into 2024; expected timing of data from the dose-ranging Phase 2b clinical
trial of vixarelimab in prurigo nodularis in the second half of 2022; our expectation that we will continue to enroll the Phase 2
trial of KPL-404 in rheumatoid arthritis in 2022; our expectations regarding our next steps for mavrilimumab; 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 and that
using KPL-404 to disrupt the CD40-CD154 interaction is an attractive approach to address multiple autoimmune disease pathologies;
our belief that all of our product candidates offer the potential for differentiation; and our plans to present at any future
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; delays or difficulty in completing our
clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data
from clinical trials; our inability to replicate results 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, delay or deny approval
of any of our product candidates or require additional data or trials to support approval; 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 product used in our products
and product candidates; our reliance on Regeneron as the sole manufacturer of ARCALYST; raw materials, important ancillary products and
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, 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