UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 17, 2022, Kezar Life Sciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year and quarter ended December 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information provided under this Item 2.02 in this Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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KEZAR LIFE SCIENCES, INC. |
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Dated: |
March 17, 2022 |
By: |
/s/ Marc L. Belsky |
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Marc L. Belsky |
Exhibit 99.1
Kezar Reports Fourth Quarter and Year-End 2021 Financial Results and Provides Business Update
SOUTH SAN FRANCISCO, Calif. – (BUSINESS WIRE) – March 17, 2022 – Kezar Life Sciences, Inc., (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided a business update.
“In 2021, we made significant progress in each of our programs, achieving target enrollment in both of our Phase 2 trials with zetomipzomib, sharing positive interim results from our MISSION Phase 2 study, and launching a Phase 1 trial in solid tumors with our novel protein secretion inhibitor, KZR-261,” said John Fowler, Kezar’s Co-founder and Chief Executive Officer. “We look forward to continued momentum across the company in 2022, including the presentation of topline results from the MISSION and PRESIDIO trials in the second quarter and preparing for the exciting next phase of development with our first-in-class immunoproteasome inhibitor, zetomipzomib.”
Zetomipzomib Assigned as Nonproprietary Name for KZR-616
The International Nonproprietary Name (INN) of zetomipzomib has been selected as the proposed nonproprietary name for KZR-616. The established suffix “-ipzomib” is being utilized to convey the compound’s mode of action to selectively inhibit the immunoproteasome.
KZR-616: Selective Immunoproteasome Inhibitor
MISSION – Phase 2 clinical trial of KZR-616 in patients with lupus nephritis (LN) (NCT03393013)
PRESIDIO – Phase 2 clinical trial of KZR-616 in patients with active dermatomyositis (DM) or polymyositis (PM) (NCT04033926)
KZR-261: Protein Secretion Inhibitor
KZR-261-101– Phase 1 clinical trial of KZR-261 in patients with locally advanced or metastatic solid malignancies (NCT05047536)
Board Appointment
Courtney Wallace, a strategic business development executive, was appointed to Kezar’s Board of Directors in December 2021, bringing over a decade of business experience in healthcare.
Financial Results
About Zetomipzomib (KZR-616)
Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1a and 1b clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases. Phase 2 trials are underway in multiple severe autoimmune diseases.
About KZR-261
KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.
About Lupus Nephritis
Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.
About Dermatomyositis and Polymyositis
Dermatomyositis (DM) and Polymyositis (PM) are two of the five types of autoimmune myositis diseases. Both are chronic, debilitating, inflammatory autoimmune myopathies that are distinguished by inflammation of the muscles as well as the skin (in DM). Approximately 30,000 to 120,000 people in the United States are living with these severe and progressive inflammatory myopathies that are characterized by marked morbidity and associated mortality. While debilitating muscle weakness is the hallmark of these myopathies, including compromised muscles of respiration, other internal organ system dysfunctions can be equally disabling. The aim of treatment for these diseases is to suppress inflammation, increase muscle strength and prevent long-term damage to muscles and extramuscular organs; however, treatment options are limited for DM, and there are currently no approved treatments for PM.
About Inhibition of Protein Secretion
Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders. The company is pioneering first-in-class, small-molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets. Zetomipzomib, its lead development asset, is a selective immunoproteasome inhibitor being evaluated in Phase 2 clinical trials in lupus nephritis, dermatomyositis and polymyositis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. KZR-261 is the first anti-cancer clinical candidate from the company’s platform targeting the Sec61 translocon and the protein secretion pathway. An open-label dose-escalation Phase 1
clinical trial of KZR-261 to assess safety, tolerability and preliminary tumor activity in solid tumors is underway. For more information, visit www.kezarlifesciences.com.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “expect,” “believe” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, progress, timing, scope and results of clinical trials, the anticipated regulatory development of Kezar’s product candidates, the anticipated timing of disclosure of interim and topline data from clinical trials, the anticipated approval of the nonproprietary name of KZR-616, the preliminary nature of interim data, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including the performance of audit and verification procedures on interim and topline data, delays in cleaning and verifying clinical trial data, unexpected safety or efficacy data observed during clinical studies, clinical trial site data collection and reporting, the impacts of the COVID-19 pandemic and other global events on the company’s business and clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Kezar assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
KEZAR LIFE SCIENCES, INC. |
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Selected Balance Sheets Data |
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(In thousands) |
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December 31, 2021 |
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December 31, 2020 |
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Cash, cash equivalents and marketable securities |
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$ 208,355 |
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$ 140,447 |
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Total assets |
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217,933 |
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151,842 |
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Total current liabilities |
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8,212 |
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6,442 |
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Total noncurrent liabilities |
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12,845 |
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4,422 |
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Total stockholders’ equity |
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196,876 |
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140,978 |
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Summary of Operations Data
(in thousands except share and per share data)
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2021 |
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2020 |
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2021 |
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2020 |
Operating expenses: |
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Research and development |
$9,781 |
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$8,117 |
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$38,935 |
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$30,981 |
General and administrative |
4,322 |
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2,951 |
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15,724 |
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11,969 |
Total operating expenses |
14,103 |
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11,068 |
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54,659 |
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42,950 |
Loss from operations |
(14,103) |
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(11,068) |
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(54,659) |
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(42,950) |
Interest expense |
(159) |
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- |
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(159) |
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Interest income |
50 |
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127 |
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188 |
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1,208 |
Net loss |
($14,212) |
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($10,941) |
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($54,630) |
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($41,742) |
Net loss per common share, basic and diluted |
($0.25) |
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($0.22) |
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($1.04) |
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($0.95) |
Weighted-average shares used to compute net loss per common share, basic and diluted |
55,979,764 |
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50,080,283 |
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52,759,335 |
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44,004,190 |
Gitanjali Jain
Vice President, Investor Relations and External Affairs
650-269-7523
gjain@kezarbio.com
Liza Sullivan
Argot Partners
212-600-1902
kezar@argotpartners.com