– Rilonacept advancing toward pivotal Phase 3 clinical trial in 2H 2018 following recent End-of-Phase 2 communication with FDA –
– KPL-716 single-dose Phase 1a/1b Last Subject Last Visit achieved; clinical trial data expected in Q3 2018 –
– Mavrilimumab advancing toward Phase 2 clinical trial in 2H 2018; ex-U.S. IMPD/CTA filings ongoing; pre-IND meeting scheduled with FDA –
– Completed initial public offering raising $155.5 million in net proceeds –
HAMILTON, Bermuda, Aug. 06, 2018 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today reported second quarter 2018 financial results and pipeline progress.
“We have made significant progress in driving our portfolio forward,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We plan to continue the positive momentum in the second half of the year with Phase 1a/1b data from KPL-716, the initiation of a pivotal Phase 3 trial for rilonacept in recurrent pericarditis and the initiation of a Phase 2 trial for mavrilimumab in giant cell arteritis.”
Second Quarter 2018 and Recent Pipeline Progress
Rilonacept (IL-1α and IL-1β cytokine trap)
KPL-716 (monoclonal antibody inhibitor of signaling through OSMRβ)
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)
KPL-045 (monoclonal antibody inhibitor of the CD30L co-stimulatory molecule)
KPL-404 (monoclonal antibody inhibitor of the CD40 co-stimulatory receptor)
Second Quarter 2018 Financial Results
About Kiniksa
Kiniksa is a clinical-stage 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, currently focused on autoinflammatory and autoimmune conditions. For more information, please visit www.kiniksa.com.
About Rilonacept
Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling. Rilonacept was approved by the FDA for the treatment of cryopyrin-associated periodic syndrome (CAPS), which includes cold auto-inflammatory syndrome and Muckle-Wells syndrome, and has been commercially available in the U.S. from Regeneron Pharmaceuticals, Inc. for this indication since 2008. Kiniksa’s lead indication for rilonacept is recurrent pericarditis, which is a recurring painful inflammation of the pericardium.
About Mavrilimumab
Mavrilimumab is an investigational fully-human monoclonal antibody that antagonizes GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor. Kiniksa’s lead indication for mavrilimumab is giant cell arteritis, an inflammatory disease of blood vessels.
About KPL-716
KPL-716 is an investigational fully-human monoclonal antibody that targets oncostatin M receptor beta (OSMRβ), which mediates signaling of IL-31 and oncostatin M (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.
About KPL-045
KPL-045 is an investigational fully-human monoclonal antibody that is designed to inhibit the CD30-CD30 ligand interaction, a co-stimulatory signal involved in activating and sustaining memory T-cells.
About KPL-404
KPL-404 is an investigational humanized monoclonal antibody that is designed to inhibit the CD40-CD40 ligand interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching. Kiniksa obtained a license to conduct research and development on KPL-404 from Primatope Therapeutics, Inc. in 2017 and has an exclusive option to acquire all outstanding capital stock of Primatope, which, subject to extension and the payment of specified extension fees, is exercisable until January 2019.
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 strategy and momentum, plans and timing for initiation of new clinical trials, potential designs of our new clinical trials, proposed indications for the investigation of our product candidates, plans and timing to report clinical trial data, timing for the initiation of clinical trial sites, plans and timing for the submission of investigational new drug and other applications and submissions to regulatory authorities, and plans and timing to advance additional pipeline programs into clinical trials.
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: our potential inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential delays or difficulty in enrollment of patients, which could delay or prevent the clinical development of our product candidates; potential undesirable side effects caused by our product candidates; our dependence on pre-clinical and clinical development conducted by third parties prior to our acquisition of our product candidates; our inability to replicate in later clinical trials positive results from pre-clinical studies or generate any human data demonstrating efficacy; potential for changes between final data and any interim “top-line” and preliminary data we announce; our reliance on third parties to manufacture our product candidates; 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 active pharmaceutical ingredient, drug product, and drug substance 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; we face substantial competition; and our ability to attract and retain qualified personnel.
These and other important factors discussed under the caption “Risk Factors” in our final prospectus filed with the Securities and Exchange Commission (“SEC”) on May 24, 2018 relating to our Registration Statement on Form S-1, and our other reports 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 estimates 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.
Every Second Counts!™
Kiniksa Investor and Media Contact
Mark Ragosa
(781) 430-8289
[email protected]
KINIKSA PHARMACEUTICALS, LTD. | |||||||||||||||||
SELECTED CONSOLIDATED BALANCE SHEET DATA | |||||||||||||||||
(In thousands) | |||||||||||||||||
(Unaudited) | |||||||||||||||||
As of | |||||||||||||||||
June 30, | December 31, | ||||||||||||||||
2018 | 2017 | ||||||||||||||||
Cash, cash equivalents, and short-term investments | $ | 359,190 | $ | 45,555 | |||||||||||||
Working capital | 340,725 | 29,674 | |||||||||||||||
Total assets | 365,129 | 47,492 | |||||||||||||||
Accumulated deficit | (127,239 | ) | (90,998 | ) | |||||||||||||
Total shareholders' equity (deficit) | 341,799 | (89,708 | ) | ||||||||||||||
KINIKSA PHARMACEUTICALS, LTD. | ||||||||||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||||||||||
(In thousands, except share and per share amounts) | ||||||||||||||||||||||||
(Unaudited) | ||||||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development | $ | 17,200 | $ | 9,272 | $ | 29,831 | $ | 12,417 | ||||||||||||||||
General and administrative | 4,327 | 2,120 | 8,036 | 4,022 | ||||||||||||||||||||
Total operating expenses | 21,527 | 11,392 | 37,867 | 16,439 | ||||||||||||||||||||
Loss from operations | (21,527 | ) | (11,392 | ) | (37,867 | ) | (16,439 | ) | ||||||||||||||||
Interest income | 1,066 | 153 | 1,371 | 226 | ||||||||||||||||||||
Loss before provision for income taxes | (20,461 | ) | (11,239 | ) | (36,496 | ) | (16,213 | ) | ||||||||||||||||
Benefit (provision) for income taxes | 202 | 36 | 255 | 70 | ||||||||||||||||||||
Net loss and comprehensive loss | $ | (20,259 | ) | $ | (11,203 | ) | $ | (36,241 | ) | $ | (16,143 | ) | ||||||||||||
Net loss per share attributable to common shareholders—basic and diluted | $ | (0.97 | ) | $ | (6.69 | ) | $ | (3.09 | ) | $ | (10.47 | ) | ||||||||||||
Weighted average common shares outstanding—basic and diluted | 20,787,288 | 1,673,500 | 11,735,578 | 1,541,691 | ||||||||||||||||||||
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