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.”
Corporate Update
- Kiniksa’s year-end 2022 cash, cash equivalents, and short-term
investments of $190.4 million (unaudited) are expected to fund its
current operating plan into at least 2025.
- Kiniksa’s resources are currently focused on growing its
cardiovascular franchise through ARCALYST sales and mavrilimumab
collaborative study agreements, as well as building an autoimmune
franchise, initially with the clinical trial of KPL-404 in
rheumatoid arthritis.
Portfolio UpdateARCALYST (IL-1α and
IL-1β cytokine trap)
- ARCALYST net product revenue was $39.9 million and $122.5
million for the fourth quarter and full year 2022, respectively
(unaudited).
- Since launch, greater than 800 prescribers have written
ARCALYST prescriptions for recurrent pericarditis, with 22% having
written prescriptions for 2 or more patients.
- As of the end of the fourth quarter of 2022, there was a
greater than 90% payer approval rate of completed patient cases for
recurrent pericarditis.
- As of the end of the fourth quarter of 2022, the average
duration of initial therapy in the commercial setting was
approximately 12 months, and approximately 45% of recurrent
pericarditis patients who had discontinued ARCALYST therapy
restarted treatment.
- As of the end of the fourth quarter of 2022, approximately 5%
of the target 14,000 multiple-recurrent pericarditis patients were
actively on ARCALYST treatment.
- Kiniksa expects to provide
full-year 2023 ARCALYST net product revenue guidance with its
fourth quarter and full-year 2022 financial results.
Portfolio UpdateKPL-404 (monoclonal
antibody inhibitor of CD40-CD154 signaling)
- Kiniksa has completed enrollment of the second and final cohort
of the multiple ascending dose portion of the Phase 2 clinical
trial of KPL-404 in rheumatoid arthritis. Following completion of
this portion of the trial, the proof-of-concept portion will begin.
The company expects data from the trial in the first half of
2024.
Mavrilimumab (monoclonal antibody inhibitor targeting
GM-CSFRα)
- Kiniksa is pursuing collaborative study agreements to evaluate
the potential of mavrilimumab in rare cardiovascular diseases where
the granulocyte macrophage colony stimulating factor (GM-CSF)
mechanism has been implicated.
41st Annual J.P.
Morgan Healthcare ConferenceSanj 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.
About KiniksaKiniksa 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.
About ARCALYSTARCALYST is a weekly,
subcutaneously injected recombinant dimeric fusion protein that
blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β)
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 ABOUT ARCALYST
- ARCALYST may affect your immune system and can lower the
ability of your immune system to fight infections. Serious
infections, including life-threatening infections and death, have
happened in patients taking ARCALYST. If you have any signs of an
infection, call your doctor right away. Treatment with ARCALYST
should be stopped if you get a serious infection. You should not
begin treatment with ARCALYST if you have an infection or have
infections that keep coming back (chronic infection).
- While taking ARCALYST, do not take other medicines that block
interleukin-1, such as Kineret® (anakinra), or medicines that block
tumor necrosis factor, such as Enbrel® (etanercept), Humira®
(adalimumab), or Remicade® (infliximab), as this may increase your
risk of getting a serious infection.
- Talk with your doctor about your vaccine history. Ask your
doctor whether you should receive any vaccines before you begin
treatment with ARCALYST.
- Medicines that affect the immune system may increase the risk
of getting cancer.
- Stop taking ARCALYST and call your doctor or get emergency care
right away if you have any symptoms of an allergic reaction.
- Your doctor will do blood tests to check for changes in your
blood cholesterol and triglycerides.
- Common side effects include injection-site reactions (which may
include pain, redness, swelling, itching, bruising, lumps,
inflammation, skin rash, blisters, warmth, and bleeding at the
injection site), upper respiratory tract infections, joint and
muscle aches, rash, ear infection, sore throat, and runny
nose.
For more information about
ARCALYST, talk to your doctor and see the Product
Information.
About KPL-404KPL-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.
About MavrilimumabMavrilimumab 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-CSFRα). 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 StatementsThis 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.
Every Second Counts! ®
Kiniksa Investor and Media ContactRachel
Frank(339) 970-9437rfrank@kiniksa.com
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