Kiniksa Pharmaceuticals, Ltd. (KNSA)
19.85 0.00 (0.00%)
After hours: 4:15PM EST
Chart Events
Performance Outlook
| Previous Close | 19.57 |
| Open | 19.25 |
| Bid | 19.83 x 1000 |
| Ask | 19.99 x 800 |
| Day's Range | 19.10 - 20.35 |
| 52 Week Range | 10.30 - 28.67 |
| Volume | 486,373 |
| Avg. Volume | 351,239 |
| Market Cap | 1.351B |
| Beta (5Y Monthly) | 0.02 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -2.38 |
| Earnings Date | Nov 05, 2020 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 34.00 |
Fair Value
Related Research
- GlobeNewswire
Kiniksa Highlights Corporate Priorities and Expected 2021 Milestones
\- PDUFA goal date of March 21, 2021 for rilonacept in recurrent pericarditis - \- Data from Phase 2 portion of mavrilimumab Phase 2/3 trial in severe COVID-19 pneumonia and hyperinflammation expected in 1H 2021 - \- Final Phase 1 KPL-404 data expected in 1H 2021 -HAMILTON, Bermuda, Jan. 11, 2021 (GLOBE NEWSWIRE) -- 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 highlighted its corporate priorities and expected 2021 milestones. Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa will provide further detail in a corporate presentation at the Virtual 39th Annual J.P. Morgan Healthcare Conference today, Monday, January 11, 2021 at 4:30 p.m. Eastern Time.“2020 was marked by significant progress across our entire pipeline, setting the stage to build long-term value across our portfolio,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Moving forward, 2021 has the potential to be a transformational year for Kiniksa with multiple catalysts expected across our pipeline, notably with the potential commercial launch of rilonacept in recurrent pericarditis in the first half of the year. As we focus on our launch readiness preparations, our commitment to bringing novel therapies to patients with unmet need remains at the core of our goals.”Expected 2021 MilestonesRilonacept (IL-1α and IL-1β cytokine trap) * Kiniksa’s Prescription Drug User Fee Act (PDUFA) goal date for rilonacept in recurrent pericarditis is March 21, 2021, as assigned by the U.S. Food and Drug Administration (FDA) upon the acceptance of the supplemental Biologics License Application (sBLA), with priority review. If approved by the FDA, Kiniksa expects the potential commercial launch of rilonacept in recurrent pericarditis in the first half of 2021 and consequently would evenly split profits on sales of all approved indications in the United States, including cryopyrin-associated periodic syndromes (CAPS) and deficiency of IL-1 receptor antagonist (DIRA), with Regeneron Pharmaceuticals, Inc. (Regeneron). Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα) * Kiniksa plans to provide next steps for the development of mavrilimumab, including for giant cell arteritis (GCA), in the first half of 2021. * Kiniksa is conducting a Phase 2/3 clinical trial in severe COVID-19 pneumonia and hyperinflammation. The company expects to provide data from the Phase 2 portion of the trial in the first half of 2021.Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ) * Kiniksa is conducting a Phase 2b dose-ranging trial of vixarelimab in prurigo nodularis. The Phase 2b trial is expected to enroll approximately 180 patients experiencing severe pruritus. Patients will be randomized to receive vixarelimab or placebo subcutaneously (SC) once-monthly. KPL-404 (monoclonal antibody inhibitor of signaling between CD40 and CD40L) * Full receptor occupancy through Day 29 shown in preliminary Phase 1 data from the single-ascending dose clinical trial of KPL-404 in healthy volunteers at the 3 mg/kg intravenous (IV) dose. This corresponded with complete suppression of the T-cell Dependent Antibody Response (TDAR) to keyhole limpet hemocyanin (KLH) through Day 29. * The data to-date support further evaluation in patients, including potential monthly IV or SC administration. Kiniksa expects final data and safety follow-up from all cohorts in the first half of 2021.Financial Guidance Kiniksa ended 2020 with approximately $323 million in cash, cash equivalents and short-term investments (unaudited). The company expects that these cash reserves will fund its current operating plan into 2023.Presentation at the Virtual 39th Annual J.P. Morgan Healthcare Conference Kiniksa will webcast its corporate presentation at the Virtual 39th Annual J.P. Morgan Healthcare Conference today, Monday, January 11, 2021 at 4:30 p.m. Eastern Time. A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website (www.kiniksa.com). A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference.About Kiniksa 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 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 Rilonacept Rilonacept is a weekly, subcutaneously-injected, recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) 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, and DIRA. 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 Mavrilimumab Mavrilimumab 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 characterized by severely pruritic skin nodules. The FDA granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020.About KPL-404 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 and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD40L interaction is an attractive approach for multiple autoimmune disease pathologies such as rheumatoid arthritis, Sjogren’s syndrome, Graves’ disease, systemic lupus erythematosus and solid organ transplant. Kiniksa owns or controls the intellectual property related to KPL-404.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 belief that progress made across our pipeline in 2020, has set the stage to build long-term value across our portfolio; our belief that 2021 has the potential to be a transformational year for Kiniksa; expected multiple catalysts across our pipeline in 2021; the potential commercial launch of rilonacept in recurrent pericarditis in the first half of the year, if approved by the FDA; expected timing of data from clinical trials, including expected data from the Phase 2 portion of the adaptive design Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation in the first half of 2021, next steps for the development of mavrilimumab, including for giant cell arteritis (GCA), in the first half of 2021, and final data from the single-ascending-dose Phase 1 clinical trial of KPL-404 in healthy volunteers in the first half of 2021; our belief that KPL-404 has the potential to address a broad range of autoimmune diseases; our beliefs about the mechanisms of action of our product candidates and potential impact of their approach, including our beliefs that vixarelimab is the only monoclonal antibody in development that targets both interleukin-31 (IL-31) and oncostatin M (OSM) pathways simultaneously; that KPL-404’s disruption of the CD40-CD40L interaction is an attractive approach for multiple autoimmune disease pathologies; our belief that all of our product candidates offer the potential for differentiation; and expectation about our cash reserves funding our current operating plan into 2023.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: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; 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 changes between final data and any preliminary, interim, top-line or other data from clinical trials conducted by us or third parties; our inability to replicate in later clinical trials the positive final data from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; impact of additional data from us or other companies; potential undesirable side effects caused by our product candidates; our 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; our reliance on third parties as the sole source of supply of the drug substance and drug products used in our product candidates and to manufacture our product candidates; drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; the 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 existing or new competition.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, 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 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.ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc.Every Second Counts!™Kiniksa Investor and Media Contact Mark Ragosa (781) 430-8289 mragosa@kiniksa.com
- GlobeNewswire
Kiniksa Pharmaceuticals to Present at 39th Annual J.P. Morgan Healthcare Conference
HAMILTON, Bermuda, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 4:30 p.m. Eastern Time. A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will be available on Kiniksa’s website for 14 days following the conference.About Kiniksa 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 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.Every Second Counts!™ Kiniksa Investor and Media Contact Mark Ragosa (781) 430-8289 mragosa@kiniksa.com
- GlobeNewswire
Kiniksa Announces Data from U.S. Investigator-Initiated Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation
\- Early signal of efficacy with trends toward lower mortality and shorter duration of mechanical ventilation in patients treated with mavrilimumab – \- Data from the Phase 2 portion of Kiniksa’s adaptive design Phase 2/3 clinical trial expected in 1H 2021 -HAMILTON, Bermuda, Dec. 22, 2020 (GLOBE NEWSWIRE) -- 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 announced data from the investigator-initiated placebo-controlled study of mavrilimumab in patients with severe COVID-19 pneumonia and hyperinflammation. Enrollment in the study was closed early to focus on Kiniksa’s registrational development program in the same patient population.“The data showed encouraging trends of reduced mortality and duration of mechanical ventilation in patients treated with mavrilimumab, especially when considering that many patients in this placebo-controlled study had already been treated with remdesivir and/or corticosteroids,” said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. “These data are comparable to the data from the open-label treatment protocol reported in June of 2020. We believe the totality of these two data sets supports continued evaluation of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation.”The investigator-initiated study was a randomized, double-blind, placebo-controlled study across a consortium of U.S. academic sites, including Cleveland Clinic, University of Cincinnati, and Virginia Commonwealth University, designed to evaluate the efficacy and safety of mavrilimumab versus placebo on top of standard of care therapy in patients with severe COVID-19 pneumonia and hyperinflammation. The study enrolled 40 patients with severe COVID-19 pneumonia (all patients presented with pneumonia and hypoxia: all patients required supplemental oxygen, 50% of patients required non-invasive ventilation, none required mechanical ventilation at baseline; median PaO2/FiO2 ratio 137) and hyperinflammation (median C-reactive protein 13.1 mg/dL). Concomitant medications at baseline included corticosteroids (65% of patients) and remdesivir (75% of patients). Patients were randomized 1:1 to a single intravenous (IV) infusion of mavrilimumab 6mg/kg (n=21) or placebo (n=19) and were followed for at least 60 days.Data showed an early signal of efficacy, with trends toward clinical improvement as well as lower mortality and shorter duration of mechanical ventilation in patients treated with mavrilimumab on top of corticosteroids, including dexamethasone, and/or remdesivir. * There was a 20.5% relative increase in the primary efficacy endpoint, the proportion of patients alive and off supplemental oxygen at Day 14 (mavrilimumab: 57.1% [n=21]; placebo: 47.4% [n=19]; nominal p=0.536). * There was a 20.7% relative increase in the secondary efficacy endpoint, the proportion of patients alive and without respiratory failure at Day 28 (mavrilimumab: 95.2%; placebo: 78.9%; nominal p=0.172). * There was 1 death (4.8%) in the mavrilimumab arm by Day 28, compared to 3 deaths (15.8%) in the placebo arm (nominal p=0.222). By Day 60 there was 1 death (4.8%) in the mavrilimumab arm, compared to 4 deaths (21.1%) in the placebo arm (nominal p=0.108). * While the percentage of patients who progressed to mechanical ventilation was similar between treatment arms (mavrilimumab: 23.8% [n=5]; placebo: 21.1% [n=4]), the median (interquartile) duration of mechanical ventilation was shorter in the mavrilimumab arm (12 [9.0, 18.0] days) compared to the placebo arm (17 [11.0, 24.5] days). Additionally, 4 of the 5 patients who progressed to mechanical ventilation in the mavrilimumab arm had recovered by Day 28, whereas all patients in the placebo arm who progressed to mechanical ventilation had died by Day 28. * There was no difference in serious adverse events between the mavrilimumab arm and the placebo arm. “In the context of the evolving standard of care, the data from this trial in severe COVID-19 pneumonia and hyperinflammation are encouraging,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “While vaccination is expected to be the mainstay of COVID-19 prevention, we believe there will remain an unmet need for effective therapeutics to treat patients who develop severe hyperinflammation. I look forward to the results of the larger Kiniksa-sponsored trial of mavrilimumab in this patient population.”Kiniksa is enrolling the Phase 2 portion of an adaptive design, placebo-controlled Phase 2/3 clinical trial in severe COVID-19 pneumonia and hyperinflammation. The company expects data from the Phase 2 portion of the trial in the first half of 2021.About the Investigator-Initiated Placebo-Controlled Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation in the U.S. The investigator-initiated Phase 2 trial was a randomized, double-blind, placebo-controlled study in the U.S. designed to evaluate the efficacy and safety of mavrilimumab versus placebo on top of standard of care therapy in the treatment of severe COVID-19 pneumonia and hyperinflammation. Standard of care therapy included, but was not limited to, anti-viral treatment and/or supportive care. The trial enrolled 40 patients across a consortium of academic sites, including Cleveland Clinic, University of Cincinnati, and Virginia Commonwealth University. Patients were randomized 1:1 to mavrilimumab to a single IV infusion of mavrilimumab 6 mg/kg or placebo. The primary endpoint was the proportion of patients alive and off of supplemental oxygen at Day 14. For more information, refer to ClinicalTrials.gov Identifier: NCT04399980.About Kiniksa’s Phase 2/3 Clinical Trial Protocol of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation Kiniksa’s Phase 2/3 clinical trial protocol is a global, randomized, double-blind, placebo-controlled study encompassing 2 phases of development (Phase 2 and Phase 3). The Phase 2 portion of the trial is expected to enroll approximately 160 patients and is intended to evaluate the efficacy and safety of 2 dose levels of mavrilimumab relative to placebo in patients who have tested positive for COVID-19 and have x-ray/CT evidence of bilateral pneumonia, active or recent fever, and clinical laboratory results indicative of hyperinflammation. The Phase 3 portion is expected to enroll approximately 420 patients and is intended to confirm Phase 2 efficacy and safety findings. In both Phase 2 and Phase 3, patients are expected to be enrolled into 2 cohorts: Cohort 1 will include non-intubated, hospitalized patients who require supplemental oxygen to maintain SpO2 ≥ 92%, (i.e., non-mechanically ventilated patients); and Cohort 2 will include hospitalized patients for whom mechanical ventilation was recently initiated within 48 hours prior to randomization (i.e., ventilated patients). Following screening, enrolled patients in each cohort will be randomized 1:1:1 to receive a single IV infusion of mavrilimumab 6mg/kg or 10 mg/kg or placebo (Day 1). The primary efficacy endpoint for the Phase 2 portion of the trial for Cohort 1 is the proportion of patients alive and without respiratory failure (defined as the need for high flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation) at Day 29 and for Cohort 2 is the mortality rate by Day 29. There will be a seamless transition in enrollment of patients in both cohorts between the Phase 2 and Phase 3 portions of the trial. For each cohort, once the last patient in Phase 2 is enrolled, all subsequent patients will be considered Phase 3 patients. Once the last patient in Phase 2 completes Day 29, primary efficacy and safety analyses of the Phase 2 data will be conducted. Following demonstration of efficacy and safety in Phase 2, the Phase 3 portion of the trial will be continued/completed. For more information, refer to ClinicalTrials.gov Identifier: NCT04447469.About Mavrilimumab Mavrilimumab is an investigational fully-human monoclonal antibody that targets 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 Kiniksa 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 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.Forward-Looking Statements The information contained in 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 beliefs about the data from investigator initiated study showing encouraging trends of reduced mortality and duration of mechanical ventilation in patients treated with mavrilimumab as well as an early signal of efficacy; assessment as to the data from the investigator initiated study being comparable to the data from the open-label treatment protocol reported in June; our belief that the totality of the data supporting continued evaluation of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation; the timing of data from the Phase2 portion of our adaptive design, placebo-controlled Phase 2/3 clinical trial of mavrilimumab in severe COVID-19 pneumonia and hyperinflammation; our belief that there will remain an unmet need for effective therapeutics to treat patients who develop severe hyperinflammation even with vaccination expected to be the mainstay of COVID-19 prevention; our Phase 2/3 clinical trial designs, including the seamless transition in enrollment of patients in both cohorts between the Phase 2 and Phase 3 portions of the trial; and the potential for all of our clinical stage product candidates to offer differentiation.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: the impact of additional data from us, or other companies; the potential inability to replicate in later clinical trials encouraging or positive results from earlier investigator initiated treatment protocols and studies for mavrilimumab in severe COVID-19 pneumonia and hyperinflammation in later clinical trials; the evolving standard of care for the treatment of patients who develop severe COVID-19 pneumonia and hyperinflammation; the potential for undesirable side effects to be caused by mavrilimumab; changes to our clinical trial protocol; case rates of severe COVID-19 pneumonia and hyperinflammation in various geographies; our reliance on third parties to manufacture our product candidates and conduct our clinical trials; meetings with the Food and Drug Administration; the potential impact of the COVID-19 pandemic and measures taken in response to the pandemic; changes in our operating plan and funding requirements; 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, 2020 and our other reports subsequently filed with or furnished to 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 mragosa@kiniksa.com
