Full Press Release Details
Pharmaceuticals Provides Corporate and Portfolio Update
ARCALYST (rilonacept) Q4 2022 and full-year 2022 net product revenue of $39.9 million and $122.5 million, respectively
2 of 3 cohorts enrolled in KPL-404 Phase 2 trial in rheumatoid arthritis; data expected in 1H 2024 -
reserves expected to fund operations into at least 2025 -
BERMUDA - January 9, 2023 - Kiniksa
Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of immune-modulating assets designed
to target a spectrum of cardiovascular and autoimmune diseases, today provided a corporate and portfolio update.
"Kiniksa continues to optimize
its portfolio and is well-positioned for both near- and long-term growth. We plan to advance our cardiovascular franchise through continued
ARCALYST commercial execution in recurrent pericarditis and the pursuit of collaborative study agreements with mavrilimumab. Additionally,
we are building an autoimmune franchise initially through the clinical trial of KPL-404, our CD40 antagonist, in rheumatoid arthritis,"
said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "These efforts are supported by our profitable ARCALYST collaboration,
non-dilutive capital from recent out-licensing transactions, and continued financial discipline. This combination provides cash runway
into at least 2025 and allows for continued capital allocation to our existing programs as well as synergistic opportunities."
ARCALYST (IL-1 and IL-1
KPL-404 (monoclonal antibody inhibitor
of CD40-CD154 signaling)
Mavrilimumab (monoclonal antibody
inhibitor targeting GM-CSFR )
41st Annual J.P. Morgan
Healthcare Conference
Sanj K. Patel, Chief Executive Officer
and Chairman of the Board of Kiniksa will provide a corporate presentation at the 41st Annual J.P. Morgan Healthcare
Conference today, Monday, January 9, 2023, at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time). A live webcast of Kiniksa's presentation
will be accessible through the Investors & Media section of the company'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 of immune-modulating assets, ARCALYST, KPL-404, and mavrilimumab, are
based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions,
and offer the potential for differentiation. 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.
SAFETY INFORMATION ABOUT ARCALYST
more information about ARCALYST, talk to your doctor and see the Product Information.
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.
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 giant cell arteritis achieved
their primary and secondary endpoints with statistical significance. Kiniksa is evaluating the development of mavrilimumab in rare cardiovascular
diseases where the GM-CSF mechanism has been implicated.
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 plan to (i) advance our cardiovascular franchise through continued ARCALYST commercial execution in recurrent
pericarditis and the pursuit of collaborative study agreements with mavrilimumab and (ii) build an autoimmune franchise, initially with
the clinical trial of KPL-404 in rheumatoid arthritis; our expectation that (i) the proof-of-concept portion of the Phase 2 clinical
trial of KPL-404 in rheumatoid arthritis will begin after completion of the multiple ascending dose portion of such trial, and (ii) we
will report data from such Phase 2 clinical trial in the first half of 2024; our pursuit of collaborative study agreements to evaluate
the potential of mavrilimumab in rare cardiovascular diseases where the GM-CSF mechanism has been implicated; our expectation to provide
full-year 2023 ARCALYST net product revenue guidance with our fourth quarter and full-year 2022 financial results; our expectation about
our cash reserves funding our current operating plan into at least 2025; our beliefs about the mechanisms of action of our product candidates
and potential impact of their approach, including that using KPL-404 to disrupt the CD40-CD154 interaction is an attractive approach
to address multiple autoimmune disease pathologies; and our belief that all of our product candidates offer the potential for differentiation.
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 material, important ancillary product 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 any subsequent pandemic and measures taken in response to such pandemics 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 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.
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