Full Press Release Details
Kiniksa Reports Second Quarter 2020 Financial
Results and Highlights Recent Pipeline and Corporate Activity
- July 30, 2020 - Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a
biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients
with significant unmet medical need, today reported second quarter 2020 financial results and highlighted recent pipeline and
"Kiniksa had a brilliant first half of 2020, marked by
statistically significant results from the pivotal Phase 3 study of rilonacept in recurrent pericarditis and the Phase 2a study
of vixarelimab in prurigo nodularis as well as the COVID-19 mavrilimumab data published in The Lancet Rheumatology,"
said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "The second half of the year is also expected
to be catalyst-filled. We are committed to submitting an sBLA to the FDA for rilonacept in recurrent pericarditis this year and
look forward to bringing this potential treatment to patients as soon as possible. Our evaluations of mavrilimumab in severe COVID-19
pneumonia and vixarelimab in prurigo nodularis are also progressing, and we continue to expect data in the fourth quarter from
the mavrilimumab GCA trial and from our anti-CD40 program, KPL-404. We expect the recent capital raises and continued financial
discipline to extend our cash runway into 2023."
Rilonacept (IL-1 and IL-1 cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFR )
Vixarelimab (monoclonal antibody inhibitor of signaling through
KPL-404 (monoclonal antibody inhibitor of signaling between
1 The treatment protocol with the investigational
drug mavrilimumab was conducted by Professor Lorenzo Dagna, MD, FACP, Head, Unit of Immunology, Rheumatology, Allergy and Rare
Diseases IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University in Milan, Italy within a COVID-19 Program
directed by Professor Alberto Zangrillo, Head of Department of Anesthesia and Intensive Care of the Scientific Institute San Raffaele
Hospital and Professor in Anesthesiology and Intensive Care, Universit Vita-Salute San Raffaele.
2 Proforma cash reserves is a non-GAAP measure, please
refer to "Use of Non-GAAP Measures" in this press release for an explanation of our use of this measure.
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 clinical-stage product candidates, rilonacept, mavrilimumab, vixarelimab and KPL-404, are
based on strong biologic rationale or validated mechanisms, target underserved conditions and offer the potential for differentiation.
These pipeline assets are designed to modulate immunological pathways that are implicated across a spectrum of diseases. For more
information, please visit www.kiniksa.com.
Rilonacept is a weekly, subcutaneously-injected, recombinant
fusion protein that blocks interleukin-1 alpha (IL-1 ) and interleukin-1 beta (IL-1 ) signaling. Rilonacept was
discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST for the treatment of CAPS,
specifically Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. Rilonacept for the treatment of deficiency of the
interleukin-1 receptor antagonist (DIRA) is currently pending FDA approval following the submission of an sBLA in June 2020. Rilonacept
in recurrent pericarditis is an investigational drug. The FDA granted Breakthrough Therapy designation to rilonacept for recurrent
pericarditis in 2019 and Orphan Drug designation to rilonacept for pericarditis in 2020.
Important information about ARCALYST (rilonacept) Injection
IL-1 blockade may interfere with immune response to infections.
Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient
develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious
Patients should not receive a live vaccine while taking ARCALYST.
It is recommended that prior to initiation of therapy with ARCALYST patients receive all recommended vaccinations, as appropriate,
including pneumococcal vaccine and inactivated influenza vaccine. In the initial development program for ARCALYST, six serious
adverse reactions were reported by four patients: Mycobacterium intracellular infection, gastrointestinal bleeding and colitis,
sinusitis and bronchitis and Streptococcus pneumoniae meningitis. The most commonly reported adverse reactions associated with
ARCALYST were injection site reaction and upper respiratory tract infection. Patients should be monitored for changes in their
lipid profiles and provided with medical treatment if warranted. Treatment with immunosuppressants, including ARCALYST, may result
in an increase in risk of malignancies. Hypersensitivity reactions associated with ARCALYST administration in clinical studies
have been rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and appropriate therapy
Mavrilimumab is an investigational fully-human monoclonal antibody
that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFR ). 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's lead indication for mavrilimumab is giant cell arteritis (GCA), an inflammatory
disease of medium-to-large arteries. Kiniksa is also evaluating mavrilimumab in COVID-19 pneumonia and hyperinflammation. Additionally,
Kiniksa and Kite, a Gilead company, have a clinical collaboration to evaluate mavrilimumab in combination with Yescarta (axicabtagene
ciloleucel) in patients with relapsed or refractory large B-cell lymphoma.
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.
KPL-404 is an investigational humanized monoclonal antibody
that is designed to inhibit CD40-CD40 ligand (CD40L) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation
and immunoglobulin class switching. Kiniksa believes disrupting the CD40-CD40L interaction is an attractive approach for blocking
T-cell mediated, B-cell driven responses, drivers of multiple autoimmune disease pathologies such as rheumatoid arthritis, Sjogren's
syndrome, Graves' disease, systemic lupus erythematosus and solid organ transplant.
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 expectations for catalysts in the second half of fiscal year 2020; plans and timing
of clinical trial data readouts; plans and timing of submitting a supplemental BLA to the FDA in recurrent pericarditis; our beliefs
about the potential to bring rilonacept as a potential treatment option for patients with recurrent pericarditis; our beliefs about
the mechanisms of action of our product candidates and potential impact of their approach; planned clinical trials and timing thereof,
including a potential dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis and a Phase 2 trial evaluating the
investigational combination of Yescarta (axicabtagene ciloleucel) and mavrilimumab in relapsed or refractory large
B-cell lymphoma; and our projected timeframe for funding our current operating plan with current cash, cash equivalents and short-term
These forward-looking statements are based on management's
current plans, estimates or 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: potential delays or difficulty in enrollment of patients in, and activation or continuation of sites
for, our clinical trials; potential complications in coordinating among requirements, regulations and guidelines of regulatory
authorities across a number of jurisdictions for our global clinical trials; potential amendments to our clinical trial protocols
initiated by us or required by regulatory authorities; potential delays or difficulty in completing our clinical trials, including
as a result of the COVID-19 pandemic; potential for low accrual of events in our clinical trials; potential undesirable side effects
caused by our product candidates; our potential inability to demonstrate safety and efficacy to the satisfaction of applicable
regulatory authorities or otherwise producing negative, inconclusive or commercially uncompetitive results; potential for changes
between final data and any preliminary, interim, top-line or other data we announce; impact of additional data from us or other
companies; our potential inability to replicate in later clinical trials positive results from our earlier pre-clinical and clinical
trials; drug substance and/or drug product shortages; our reliance on third parties as the sole source of supply of the drug substance
and drug products used in our product candidates; our reliance on third parties to conduct our research, pre-clinical studies,
clinical trials, and other trials for our product candidates; substantial existing or new competition; potential 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