Full Press Release Details
Reports Fourth Quarter and Full-Year 2019 Financial Results
and Highlights Recent Pipeline Activity
Clinical data readouts expected throughout 2020 for rilonacept, mavrilimumab,
KPL-716 and KPL-404 -
Year-end 2019 cash reserves of $233 million -
- February 26, 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 fourth quarter and full-year 2019 financial results and highlighted recent
"We have the potential to generate data-driven value from
multiple clinical-stage assets in 2020," said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa.
"Near-term, given the anti-pruritic response shown in both cohorts of our KPL-716 Phase 1b study as well as recent external
mechanistic validation, we are enabling an interim readout from our KPL-716 Phase 2a trial in prurigo nodularis. Data are expected
by the end of April."
Rilonacept (IL-1 and IL-1 cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFR )
KPL-716 (monoclonal antibody inhibitor of signaling through
KPL-404 (monoclonal antibody inhibitor of signaling between
Scientific Conference Presentations
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, KPL-716 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 signaling 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 Pharmaceuticals, Inc. (Regeneron) and is approved by the FDA under the
brand name ARCALYST for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which includes
Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. Interleukin-1 (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 tumor necrosis factor (TNF) inhibitors is not
recommended because this may increase the risk of serious infections. Kiniksa exclusively licensed rilonacept from Regeneron
for recurrent pericarditis and certain other indications. Rilonacept in recurrent pericarditis is an investigational drug.
The FDA has granted Breakthrough Therapy designation to rilonacept for recurrent pericarditis.
Mavrilimumab is an investigational fully-human monoclonal
antibody that is designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor (GM-CSFR ).
Kiniksa's lead indication for mavrilimumab is GCA, an inflammatory disease of medium to large arteries. Additionally,
Kiniksa and Kite have a clinical collaboration to evaluate mavrilimumab in combination with Yescarta
(axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma.
KPL-716 is an investigational fully-human monoclonal antibody
that targets oncostatin M receptor beta (OSMR ), which mediates signaling of IL-31 and OSM, two key cytokines implicated in
pruritus, inflammation and fibrosis. Kiniksa believes KPL-716 to be the only monoclonal antibody in development that targets both
pathways simultaneously.
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 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 fiscal year 2020 data readouts; proposed indications for the investigation of our
product candidates; our beliefs about the mechanisms of action of our product candidates and potential impact of their
approach; our clinical trial design; plans and timing to report or present preliminary, interim and final top-line or other
clinical trial data and the potential impact of that data; and our projected timeframe for funding our 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: 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 our clinical trial design; potential for
lower 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 and 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; changes in our operating plan and funding requirements; substantial existing or new competition; 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 November
5, 2019 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 Contact
KINIKSA PHARMACEUTICALS, LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
| Three Months Ended | Years Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 22,886 | $ | 36,122 | $ | 135,001 | $ | 86,597 | ||||||||
| General and administrative | 9,695 | 8,013 | 34,962 | 21,563 | ||||||||||||
| Total operating expenses | 32,581 | 44,135 | 169,963 | 108,160 | ||||||||||||
| Loss from operations | (32,581 | ) | (44,135 | ) | (169,963 | ) | (108,160 | ) | ||||||||
| Interest income | 1,130 | 1,727 | 6,049 | 4,719 | ||||||||||||
| Loss before benefit (provision) for income taxes | (31,451 | ) | (42,408 | ) | (163,914 | ) | (103,441 | ) | ||||||||
| Benefit (provision) for income taxes | (346 | ) | (172 | ) | 2,047 | 214 | ||||||||||
| Net loss | $ | (31,797 | ) | $ | (42,580 | ) | $ | (161,867 | ) | $ | (103,227 | ) | ||||
| Net loss per share attributable to common shareholders -basic and diluted | $ | (0.58 | ) | $ | (0.88 | ) | $ | (2.99 | ) | $ | (3.49 | ) | ||||
| Weighted average common shares outstanding-basic and diluted | 54,887,689 | 48,458,892 | 54,049,477 | 29,547,427 |
KINIKSA PHARMACEUTICALS, LTD.
SELECTED CONSOLIDATED BALANCE SHEET DATA
| As of | ||||||||
| December 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Cash, cash equivalents, and short-term investments | $ | 233,380 | $ | 307,304 | ||||
| Working capital | 213,797 | 271,196 | ||||||
| Total assets | 254,534 | 321,965 | ||||||
| Accumulated deficit | (356,092 | ) | (194,225 | ) | ||||
| Total shareholders' equity | 225,423 | 279,267 |