- Announced positive topline results from the MISSION Phase 2
Trial evaluating zetomipzomib for the treatment of patients with
lupus nephritis
- Appointed Nick Mordwinkin, Pharm.D., Ph.D. as Chief Business
Officer
- Cash, cash equivalents and marketable securities totaled $306.8
million as of June 30, 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 second quarter ended June 30,
2022 and provided a business update.
“The second quarter was tremendously productive for Kezar,
during which we achieved key clinical milestones, strengthened our
balance sheet, and added great talent to our leadership team,
marking a major step in our growth,” said John Fowler, Kezar’s
Co-founder and Chief Executive Officer. “We shared exciting
positive topline results from our MISSION Phase 2 study evaluating
zetomipzomib in LN patients, and our Phase 1 trial in solid tumors
with our novel protein secretion inhibitor, KZR-261 is progressing
as planned. We look forward to continued momentum across the
company for the rest of 2022 and providing further updates in the
coming months.”
Zetomipzomib: Selective Immunoproteasome Inhibitor
MISSION – Phase 1b/2 clinical trial of zetomipzomib (KZR-616) in
patients with systemic lupus erythematosus with and without active
lupus nephritis (LN) (NCT03393013)
- In June 2022, Kezar reported topline results from the
open-label MISSION Phase 2 clinical trial evaluating zetomipzomib
in patients with active LN.
- During the 24-week treatment period, patients received 60 mg of
zetomipzomib subcutaneously once weekly (first dose of 30 mg) in
addition to stable background therapy. End-of-treatment assessments
occurred at Week 25, with completion of study at Week 37. Patients
in the MISSION Phase 2 clinical trial received zetomipzomib without
induction therapy, which represents a difference from other
recently published trials in LN. The primary efficacy endpoint for
the trial was the proportion of patients achieving an overall renal
response (ORR), measured as a 50% or greater reduction in urine
protein to creatinine ratio (UPCR) at end of treatment. A key
secondary efficacy endpoint was the number of patients with a
complete renal response (CRR), measured as an absolute reduction in
proteinuria values to a UPCR of 0.5 or less, with preserved renal
function (eGFR), and corticosteroid use of 10 mg or less
prednisone/prednisone equivalent and no use of prohibited
medication.
- In the Phase 2 topline analysis, 17 of 21 patients enrolled in
the trial reached end of treatment:
- 11 of 17 patients (64.7%) achieved an ORR measured as a 50% or
greater reduction in UPCR at end of treatment compared to baseline,
the primary efficacy endpoint of the clinical trial.
- 6 of 17 patients (35.2%) achieved a CRR of 0.5 UPCR or less,
with all other protocol definitions satisfied.
- Treatment benefit of zetomipzomib was maintained or deepened
following the end of treatment, based on assessments at Week 29.
- 16 of 17 patients (94.1%) reached an ORR at Week 29, and 6
patients maintained a CRR.
- Patients’ mean daily prednisone background dosage was reduced
from 19.2 mg at baseline to 9.1 mg at week 25 and was further
reduced at Week 29.
- Also in June, Kezar presented a poster featuring zetomipzomib
as part of the EULAR Science Exhibit session at the Annual European
Congress of Rheumatology (EULAR) in Copenhagen, Denmark.
- POS0715: Treatment of SLE Patients with Zetomipzomib (KZR-616),
a Selective Inhibitor of the Immunoproteasome, Results in
Circulating Gene Expression, Protein Level, and Immune Cell
Phenotypic Changes with Potential Correlations to Clinical
Response, presented by Andrea Fan, Ph.D., Vice President, Head of
Biology and Translational Research, Kezar Life Sciences.
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)
- KZR‑261 is a novel, broad-spectrum agent that acts through
direct interaction and inhibition of the Sec61 translocon. In
preclinical studies, KZR-261 has been shown to induce a direct
anti-tumor effect as well as modulate the tumor microenvironment,
including enhancing anti-tumor immune responses.
- The Phase 1 clinical trial of KZR-261 is being conducted in two
parts: dose escalation and dose expansion in subjects with selected
tumor types. The trial is designed to evaluate safety and
tolerability, pharmacokinetics and pharmacodynamics, as well as to
explore the preliminary anti-tumor activity of KZR-261 in patients
with locally advanced or metastatic disease.
- At the American Association of Cancer Research (AACR) 2022
Annual Meeting, held in April 2022 in New Orleans, LA, Kezar
presented data on its proprietary small molecule inhibitors of the
Sec61 translocon, specifically KZR-834, a working analog of
KZR-261.
Appointment of Chief Business Officer
- In July 2022, Nick Mordwinkin, Pharm.D., Ph.D., was appointed
as Chief Business Officer. Dr. Mordwinkin brings over a decade of
experience in leadership, corporate development and strategic
partnership roles in the healthcare industry. Dr. Mordwinkin will
be responsible for shaping and overseeing the Company’s business
development strategy.
Financial Results
- Cash, cash equivalents and marketable securities totaled
$306.8 million as of June 30, 2022, compared to $208.4 million as
of December 31, 2021. The increase was primarily attributable to
net proceeds from the issuance of common stock under the
“at-the-market” Sales Agreement with Cowen and Company, LLC, net of
cash used by the company in operations to advance its
clinical-stage programs and preclinical research and
development.
- Research and development expenses for the second quarter
of 2022 increased by $2.0 million to $11.3 million compared to $9.3
million in the second quarter of 2021. This increase was primarily
related to advancing the zetomipzomib clinical programs and the
KZR-261 Phase 1 clinical trial.
- General and administrative expenses for the second
quarter of 2022 increased by $1.3 million to $5.0 million compared
to $3.7 million in the second quarter of 2021. The increase was
primarily due to an increase in personnel expenses, including
non-cash stock-based compensation and an increase in professional
services.
- Net loss for the second quarter of 2022 was $16.2
million, or $0.25 per basic and diluted common share, compared to a
net loss of $13.0 million, or $0.25 per basic and diluted common
share, for the second quarter of 2021.
- Total shares of common stock outstanding were 68.3
million shares as of June 30, 2022. Additionally, there were
outstanding pre-funded warrants to purchase 3.8 million shares of
common stock at an exercise price of $0.001 per share and
outstanding options to purchase 9.2 million shares of common stock
at a weighted-average exercise price of $8.05 per share as of June
30, 2022.
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 1 clinical trials provide evidence that zetomipzomib exhibits
a favorable safety and tolerability profile for development in
severe, chronic autoimmune diseases.
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 KZR-261 and the Inhibition of Protein Secretion
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.
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 a Phase 2 clinical trial in lupus nephritis. 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, anticipated regulatory development of Kezar’s
product candidates, the preliminary nature of topline 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 topline data,
delays in cleaning and verifying clinical trial data, unexpected
safety or efficacy data observed during clinical studies, 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.
Selected Balance Sheets Data
(In thousands)
June 30, 2022
December 31, 2021
(unaudited)
Cash, cash equivalents and marketable
securities
$306,838
$208,355
Total assets
317,502
217,933
Total current liabilities
7,853
8,212
Total noncurrent liabilities
12,285
12,845
Total stockholders' equity
297,364
196,876
Summary of Operations Data
(In thousands except share and per share
data)
Three Months Ended
Six Months Ended
June 30
June 30
2022
2021
2022
2021
(unaudited)
(unaudited)
Operating expenses:
Research and development
$11,346
$9,341
$22,290
$18,627
General and administrative
4,977
3,668
9,911
7,430
Total operating expenses
16,323
13,009
32,201
26,057
Loss from operations
(16,323
)
(13,009
)
(32,201
)
(26,057
)
Interest income
408
47
516
101
Interest expense
(272
)
—
(526
)
—
Net loss
($16,187
)
($12,962
)
($32,211
)
($25,956
)
Net loss per common share, basic and
diluted
($0.25
)
($0.25
)
($0.52
)
($0.50
)
Weighted-average shares used to compute
net loss per common share, basic and diluted
64,279,634
51,904,701
62,465,092
51,483,709
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version on businesswire.com: https://www.businesswire.com/news/home/20220811005451/en/
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
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