Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a
biopharmaceutical company with a pipeline of assets designed to
modulate immunological pathways across a spectrum of diseases,
today reported third quarter 2020 financial results and highlighted
recent pipeline and corporate activity.
“Kiniksa continues to execute across its pipeline,” said Sanj K.
Patel, Chief Executive Officer and Chairman of the Board of
Kiniksa. “We are preparing for the commercial launch of rilonacept
in recurrent pericarditis in the first half of 2021, if approved by
the FDA. The primary and secondary efficacy endpoints of the
mavrilimumab Phase 2 trial in giant cell arteritis achieved
statistical significance, further demonstrating the potential broad
utility of the molecule. Additionally, all cohorts have been dosed
in the Phase 1 study of KPL-404, our anti-CD40 program, and we
expect data from the first cohorts this quarter.”
Pipeline
ActivityRilonacept (IL-1α and IL-1β
cytokine trap)
- Kiniksa anticipates the commercial
launch of rilonacept in recurrent pericarditis in the first half of
2021, if approved by the U.S. Food and Drug Administration (FDA)
assuming priority review.- If rilonacept is approved for recurrent
pericarditis by the FDA, Kiniksa will commence the sales and
distribution of rilonacept for the approved indications in the
United States and evenly split profits on sales with Regeneron
Pharmaceuticals, Inc. (Regeneron).-Kiniksa is obligated to pay
regulatory milestones to Regeneron of up to an aggregate of $27.5
million through the potential approval of rilonacept in recurrent
pericarditis.
- Kiniksa expects data from RHAPSODY,
the pivotal Phase 3 clinical trial of rilonacept in recurrent
pericarditis, to be presented at the late-breaking science session
during the American Heart Association (AHA) Scientific Sessions
2020.- Dr. Allan Klein, MD, of Cleveland Clinic and co-principal
investigator for RHAPSODY, will deliver a virtual presentation
entitled RHAPSODY: Rilonacept an IL-1α and IL-1β Trap Resolves
Pericarditis Episodes and Reduces Risk of Recurrence in a Phase 3
Trial of Patients with Recurrent Pericarditis on Monday, November
16, 2020 at 7:34 p.m. Central Time.
Mavrilimumab (monoclonal antibody inhibitor
targeting GM-CSFRα)
- Kiniksa recently announced positive
data from the global Phase 2 clinical trial of mavrilimumab in
giant cell arteritis (GCA).- Both the primary efficacy endpoint of
time-to-first adjudicated GCA flare by Week 26 in all treated
patients (Hazard Ratio = 0.38, p=0.0263) and the secondary
efficacy endpoint of sustained remission at Week 26 in all treated
patients (p=0.0038) were statistically significant. Additionally,
while the trial was not powered for disease cohorts, there was a
consistent trend of efficacy across the new onset and
relapsing/refractory cohorts.
- Kiniksa expects data from the
global Phase 2 clinical trial of mavrilimumab in GCA to be
presented at the late-breaking abstracts session during the
American College of Rheumatology (ACR) Convergence 2020.- Dr. Maria
Cid of Hospital Clínic, University of Barcelona, IDIBAPS and
co-principal investigator for the trial, will deliver a virtual
presentation entitled Mavrilimumab (Anti GM-CSF Receptor α
Monoclonal Antibody) Reduces Risk of Flare and Increases Sustained
Remission in a Phase 2 Trial of Patients with Giant Cell Arteritis
on Monday, November 9, 2020 at 11:30 a.m. Eastern Time.
- Kiniksa announced that the FDA
granted Orphan Drug Designation to mavrilimumab for the treatment
of GCA.
- Kiniksa is evaluating mavrilimumab
in severe COVID-19 pneumonia and hyperinflammation and is enrolling
the Phase 2 portion of a global, randomized, double-blind,
placebo-controlled adaptive design Phase 2/3 clinical trial.
Additionally, data are expected from a randomized, double-blind,
placebo-controlled investigator-initiated study in
the U.S. in the fourth quarter of 2020.
- Kiniksa disclosed the
discontinuation of the clinical collaboration with Kite, a Gilead
company, evaluating mavrilimumab in combination with Yescarta®
(axicabtagene ciloleucel) in relapsed or refractory large B-cell
lymphoma, due to a portfolio strategy review by Kite that impacted
the planned trial.
Vixarelimab
(monoclonal antibody inhibitor of signaling through
OSMRβ)
- Data from the Phase 2a clinical
trial of vixarelimab in prurigo nodularis were presented at the
European Academy of Dermatology and Venereology (EADV) Virtual
Congress.- Dr. Howard Sofen, MD, of the David Geffen UCLA School of
Medicine, delivered a virtual presentation entitled Vixarelimab
Reduced Pruritus, Improved Nodules, and was Well-Tolerated in
Patients with Prurigo Nodularis in a Phase 2a, Randomized,
Double-Blind, Placebo-Controlled Study.
- Kiniksa expects to initiate a
dose-ranging Phase 2b clinical trial of vixarelimab in prurigo
nodularis in the fourth quarter of 2020.
KPL-404 (monoclonal antibody inhibitor of
interaction between CD40 and
CD40L)
- Kiniksa today announced that all
cohorts in the single-ascending-dose Phase 1 clinical trial of
KPL-404 in healthy volunteers have been dosed. All dose escalations
occurred as per protocol with no dose limiting safety findings. The
data to-date support continued clinical development.- The study is
divided into two parts: single doses of KPL-404 0.03 mg/kg, 0.3
mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg intravenous (IV) and single
doses of KPL-404 1 mg/kg or 5 mg/kg subcutaneous.- Pharmacokinetic,
receptor occupancy and T-cell Dependent Antibody Response data from
the first cohorts, including the 3 mg/kg IV dose level, are
expected in the fourth quarter of 2020. Final data and safety
follow-up from all cohorts are expected in the first half of
2021.
- The CD40-CD40 ligand (CD40L)
interaction has been implicated in diseases such as rheumatoid
arthritis, Sjogren’s syndrome, Graves’ disease, systemic lupus
erythematosus and solid organ transplant, where external
proof-of-concept has been previously demonstrated.
Corporate Activity
- In July of 2020, Kiniksa completed
a public offering of 5,952,381 Class A common shares at a
public offering price of $21.00 per share. Concurrent with the
public offering, Kiniksa sold 1,428,572 Class A1 common shares to
certain existing shareholders affiliated with certain of Kiniksa’s
directors at a sale price equal to the price of the public
offering. The aggregate net proceeds to Kiniksa from these
offerings after deducting underwriting discounts and commissions,
private placement fees and other offering costs were approximately
$146.0 million.
Financial Results
- For the third quarter of 2020,
Kiniksa reported a net loss of $43.8 million, compared to a net
loss of $27.1 million for the third quarter of 2019.
- Total operating expenses for the
third quarter of 2020 totaled $43.2 million, compared to $30.4
million for the third quarter of 2019. Non-cash share-based
compensation expense totaled $5.6 million for the third quarter of
2020, compared to $3.8 million for the third quarter of 2019.
- As of September 30, 2020, the
company had cash, cash equivalents and short-term investments of
$364.4 million and no debt.
Financial Guidance
- Kiniksa expects that its cash, cash
equivalents and short-term investments will fund its current
operating plan into 2023.
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 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 across a spectrum of diseases. For more
information, please visit www.kiniksa.com.
About RilonaceptRilonacept is a weekly,
subcutaneously-injected, recombinant fusion protein that blocks
interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β).
Rilonacept was discovered and developed by Regeneron and is
approved by the FDA under the brand name ARCALYST® for the
treatment of Cryopyrin-Associated Periodic Syndromes (CAPS),
specifically Familial Cold Autoinflammatory Syndrome and
Muckle-Wells Syndrome. Rilonacept for the treatment of deficiency
of the interleukin1 receptor antagonist (DIRA) is currently pending
FDA approval following the submission of a Supplemental Biologics
License Application (sBLA) in June 2020. Rilonacept in
recurrent pericarditis is an investigational drug. The FDA granted
Breakthrough Therapy designation to rilonacept for the treatment of
recurrent pericarditis in 2019 and Orphan Drug designation to
rilonacept for the treatment of 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 infections.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 initiated.
About MavrilimumabMavrilimumab is an
investigational fully-human monoclonal antibody that targets
granulocyte macrophage colony stimulating factor receptor alpha
(GM-CSFRα). 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 GCA, a rare inflammatory disease of medium-to-large
arteries. Kiniksa is also evaluating mavrilimumab in COVID-19
pneumonia and hyperinflammation. 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.
About KPL-404KPL-404 is an investigational
humanized monoclonal antibody that is designed to inhibit
CD40-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 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
forwardlooking 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:
plans and timing of clinical trial data readouts; our beliefs about
research, pre-clinical and clinical trial data supporting continued
clinical development; anticipated timing of our potential
commercial launch of rilonacept in recurrent pericarditis, if
approved by the FDA under priority review; planned clinical trials
and timing thereof, including a potential dose-ranging Phase 2b
clinical trial of vixarelimab in prurigo nodularis; regulatory
milestones and related payments under our License Agreement with
Regeneron upon achievement of certain specified events; 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; and our projected timeframe for funding
our current operating plan with current cash, cash equivalents and
short-term investments.
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: 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;
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
applicable regulatory authorities to not accept our BLA or sBLA
filings or to delay or deny approval of any of our product
candidates or to require additional trials to support any such
approval; potential for changes between final data and any
preliminary, interim, top-line or other data from clinical trials
conducted by us or third parties, including from investigator
initiated studies; impact of additional data from us or other
companies; potential inability to replicate in later clinical
trials positive results from earlier pre-clinical and clinical
trials or studies of our product candidates potential in subsequent
clinical trials conducted by us or third parties, including
investigator-initiated studies; 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; 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 our ability to attract and retain qualified
personnel.
These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on August 4, 2020 and our
other reports subsequently filed with the SEC 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 plans, estimates,
or expectations as of the date of this press release. While we may
elect to update such forward-looking statements at some point in
the future, we disclaim any obligation to do so, even if subsequent
events cause our views to change. 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. and Yescarta® is a registered trademark
of Gilead Sciences, Inc., or its related companies.
Every Second Counts!™
Kiniksa Investor and Media ContactMark
Ragosa(781) 430-8289mragosa@kiniksa.com
KINIKSA
PHARMACEUTICALS, LTD. |
CONSOLIDATED
STATEMENTS OF OPERATIONS |
(In
thousands, except share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
|
|
|
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
31,419 |
|
|
$ |
22,014 |
|
|
$ |
74,644 |
|
|
$ |
112,115 |
|
|
|
General and administrative |
|
|
11,799 |
|
|
|
8,432 |
|
|
|
29,821 |
|
|
|
25,267 |
|
|
|
|
|
Total operating expenses |
|
|
43,218 |
|
|
|
30,446 |
|
|
|
104,465 |
|
|
|
137,382 |
|
Loss from operations |
|
|
(43,218 |
) |
|
|
(30,446 |
) |
|
|
(104,465 |
) |
|
|
(137,382 |
) |
Interest income |
|
|
49 |
|
|
|
1,386 |
|
|
|
1,104 |
|
|
|
4,919 |
|
Loss before benefit (provision) for income taxes |
|
|
(43,169 |
) |
|
|
(29,060 |
) |
|
|
(103,361 |
) |
|
|
(132,463 |
) |
Benefit (provision) for income taxes |
|
|
(667 |
) |
|
|
2,002 |
|
|
|
(4,363 |
) |
|
|
2,393 |
|
Net loss |
|
|
|
$ |
(43,836 |
) |
|
$ |
(27,058 |
) |
|
$ |
(107,724 |
) |
|
$ |
(130,070 |
) |
Net loss per share attributable to common shareholders —basic and
diluted |
|
$ |
(0.66 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.80 |
) |
|
$ |
(2.42 |
) |
Weighted average common shares outstanding—basic and diluted |
|
|
65,958,513 |
|
|
|
54,831,308 |
|
|
|
59,754,495 |
|
|
|
53,767,003 |
|
KINIKSA
PHARMACEUTICALS, LTD. |
SELECTED
CONSOLIDATED BALANCE SHEET DATA |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
As of |
|
September
30, |
December
31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
Cash, cash
equivalents, and short-term investments |
$ |
364,395 |
|
|
$ |
233,380 |
|
Working
capital |
|
353,521 |
|
|
|
213,797 |
|
Total
assets |
|
384,413 |
|
|
|
254,534 |
|
Accumulated
deficit |
|
(463,816 |
) |
|
|
(356,092 |
) |
Total
shareholders' equity |
|
358,509 |
|
|
|
225,423 |
|
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