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– Clinical data readouts expected throughout 2020 for rilonacept, mavrilimumab, KPL-716 and KPL-404 –
– Operating plan funded into 2H 2021; no current plan to raise additional capital prior to delivering clinical data readouts –
– Final rilonacept Phase 2 data to be presented at the American Heart Association Scientific Sessions 2019 –
– First subject dosed in first-in-human trial of KPL-404 –
HAMILTON, Bermuda, Oct. 28, 2019 (GLOBE NEWSWIRE) -- 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 third quarter 2019 financial results and highlighted recent corporate and pipeline activity.
“We expect 2020 to be a pivotal year for Kiniksa,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Our resources are focused on the lead indications for our clinical-stage assets and we expect clinical data readouts from each of them in 2020, including pivotal Phase 3 data for rilonacept in recurrent pericarditis, Phase 2 data for mavrilimumab in giant cell arteritis and Phase 2a data for KPL-716 in prurigo nodularis. Importantly, our projected cash runway extends into the second half of 2021 and we do not anticipate raising additional capital before delivering these clinical milestones.”
Rilonacept (IL-1α and IL-1β cytokine trap)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
KPL-716 (monoclonal antibody inhibitor of signaling through OSMRβ)
KPL-404 (monoclonal antibody inhibitor of signaling between CD40 and CD40L)
KPL-045 (monoclonal antibody inhibitor of the CD30L co-stimulatory molecule)
Third Quarter 2019 Financial Results
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 has a pipeline of product candidates across various stages of development, focused on autoinflammatory and autoimmune conditions. For more information, please visit www.kiniksa.com.
Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1α (IL-1α) and interleukin 1β (IL-1β) 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. 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. Kiniksa exclusively licensed rilonacept from Regeneron for recurrent pericarditis and certain other indications. Rilonacept in recurrent pericarditis is an investigational drug.
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. Kiniksa’s lead indication for mavrilimumab is GCA, an inflammatory disease of medium-large arteries.
KPL-716 is an investigational fully-human monoclonal antibody that targets OSMRβ, 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-CD40L interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching. 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 Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren’s Syndrome and Grave’s Disease.
KPL-045 is an investigational fully-human monoclonal antibody that is designed to inhibit CD30-CD30L interaction, a co-stimulatory signal involved in activating and sustaining memory T-cells.
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; plans and timing to advance our product candidates; proposed indications for the investigation of our product candidates; plans and timing to report or present preliminary, interim and final top-line clinical trial, pre-clinical and other data; expected cash, cash equivalents and short-term investments at fiscal year-end 2019; expected timeframe for funding our operating plan with current cash, cash equivalents and short-term investments; and our having no current plans to raise additional capital prior to delivering our anticipated 2020 clinical trial data readouts.
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 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 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” data we announce; impact of additional data from us or other companies; our potential inability to replicate in later pre-clinical and clinical trials positive results from our earlier pre-clinical and clinical trials; drug substance and/or drug product shortages caused by issues at our third-party manufacturers’ facilities; our reliance on certain 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; changes in the capital markets; market reaction to our anticipated 2020 clinical trial data readouts; 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 August 13, 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.
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Kiniksa Investor and Media Contact
|KINIKSA PHARMACEUTICALS, LTD.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Research and development||$||22,014||$||20,644||$||112,115||$||50,475|
|General and administrative||8,432||5,515||25,267||13,550|
|Total operating expenses||30,446||26,159||137,382||64,025|
|Loss from operations||(30,446||)||(26,159||)||(137,382||)||(64,025||)|
|Loss before benefit for income taxes||(29,060||)||(24,537||)||(132,463||)||(61,033||)|
|Benefit for income taxes||2,002||131||2,393||386|
|Net loss per share attributable to common shareholders —basic and diluted||$||(0.49||)||$||(0.51||)||$||(2.42||)||$||(2.62||)|
|Weighted average common shares outstanding—basic and diluted||54,831,308||48,183,424||53,767,003||23,174,841|
|KINIKSA PHARMACEUTICALS, LTD.|
|SELECTED CONSOLIDATED BALANCE SHEET DATA|
|September 30,||December 31,|
|Cash, cash equivalents, and short-term investments||$||258,745||$||307,304|
|Working capital (1)||240,780||271,196|
|Total shareholders' equity||251,911||279,267|
|(1) We define working capital as current assets less current liabilities.|
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