Kezar Life Sciences Reports Second Quarter 2023 Financial Results and Provides Business Update
11 8월 2023 - 5:01AM
Business Wire
- PALIZADE global Phase 2b clinical trial evaluating zetomipzomib
in lupus nephritis and PORTOLA Phase 2a clinical trial evaluating
zetomipzomib in autoimmune hepatitis are both open for
enrollment
- KZR-261 dose escalation study continues to progress and display
a favorable safety and tolerability profile
- Cash, cash equivalents and marketable securities totaled $236.6
million as of June 30, 2023
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,
2023 and provided a business update.
“This quarter, we’ve been laser-focused on executing on our
three ongoing clinical trials to validate the broad potential of
our product candidates,” said John Fowler, Kezar’s Co-Founder and
Chief Executive Officer. “Now actively recruiting patients, our
PALIZADE and PORTOLA clinical trials are designed to demonstrate
zetomipzomib’s potential to be a steroid-sparing, immunomodulating
treatment for multiple autoimmune conditions. Our first-in-class
protein secretion inhibitor, KZR-261, continues to demonstrate a
favorable safety and tolerability profile as we proceed with our
dose-escalation study, and represents only the first of several
potential assets generated by our Sec61 translocon inhibition
platform. I commend the Kezar team for their hard work and
unwavering commitment to our mission of delivering novel treatments
to patients fighting difficult-to-treat chronic diseases.”
Zetomipzomib: Selective
Immunoproteasome Inhibitor
PALIZADE – Phase 2b clinical trial of zetomipzomib in patients
with active lupus nephritis (LN) (ClinicalTrials.gov:
NCT05781750)
- PALIZADE is a global, placebo-controlled, randomized,
double-blind Phase 2b clinical trial evaluating the efficacy and
safety of two dose-levels of zetomipzomib in patients with active
LN. Target enrollment will be 279 patients, randomly assigned
(1:1:1) to receive 30 mg of zetomipzomib, 60 mg of zetomipzomib or
placebo subcutaneously once weekly for 52 weeks, in addition to
standard background therapy. Background therapy can, but will not
be mandated to, include standard induction therapy. Over the
initial 16 weeks, there will be a mandatory corticosteroid taper to
5 mg per day or less. End-of-treatment assessments will occur at
Week 53. The primary efficacy endpoint is the proportion of
patients who achieve a complete renal response (CRR) at Week 37,
including a urine protein-to-creatine ratio (UPCR) of 0.5 or less
without receiving rescue or prohibited medications.
PORTOLA – Phase 2a clinical trial of zetomipzomib in patients
with autoimmune hepatitis (AIH) who have not benefited from
standard-of-care treatment (ClinicalTrials.gov: NCT05569759)
- PORTOLA is a placebo-controlled, randomized, double-blind Phase
2a clinical trial evaluating the efficacy and safety of
zetomipzomib in patients with AIH that are insufficiently
responding to standard of care or have relapsed. Target enrollment
will be 24 patients, randomized (2:1) to receive 60 mg of
zetomipzomib or placebo in addition to background corticosteroid
therapy for 24 weeks, with a protocol-mandated steroid taper by
Week 14. The primary efficacy endpoint will measure the proportion
of patients who achieve a complete response measured as
normalization of alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) levels with a successful corticosteroid
taper by Week 24.
MISSION – Completed open-label Phase 2 clinical trial of
zetomipzomib in patients with active LN (ClinicalTrials.gov:
NCT03393013)
- The post-hoc analysis across LN biopsy classes from the
open-label Phase 2 MISSION clinical trial was presented as a poster
presentation at the National Kidney Foundation (NKF) Spring
Clinical Meeting 2023, which took place April 11-15, 2023 in
Austin, Texas.
- The complete MISSION Phase 1b/2 results, along with a post hoc
subgroup analysis in the Phase 2 Hispanic/Latino population, were
presented as a poster presentation at the Pan American League of
Associations for Rheumatology (PANLAR) 2023 Congress, which took
place April 26-29, 2023 in Rio de Janeiro, Brazil.
- The complete MISSION Phase 1b/2 results were presented as an
oral presentation at the LUPUS & KCR 2023 meeting, which took
place May 17-20, 2023 in Seoul, Korea.
- The complete MISSION Phase 2 results, MISSION Phase 2 uCD163
data, and the unmet need of European patients with LN were
presented as poster presentations at the European Alliance of
Associations for Rheumatology (EULAR) 2023 Congress, which took
place May 31 – June 3, 2023 in Milan, Italy.
- The post-hoc analysis of MISSION Phase 2 patients with
nephrotic range proteinuria and the unmet need of European patients
with LN were presented as oral presentations at the 60th European
Renal Association (ERA) Congress, which took place June 15-18, 2023
in Milan, Italy.
Protein Secretion Inhibition
Platform
KZR-261: Broad-Spectrum Sec61 Translocon Inhibitor
KZR-261-101 – Phase 1 clinical trial of KZR-261 in patients with
locally advanced or metastatic solid malignancies
(ClinicalTrials.gov: NCT05047536)
- The Phase 1 clinical trial of KZR-261 is being conducted in two
parts: dose escalation and dose expansion in four tumor-specific
solid tumors and one all-tumor cohort. The study is designed to
evaluate safety and tolerability, pharmacokinetics and
pharmacodynamics, identify a recommended Phase 2 dose and to
explore the preliminary anti-tumor activity of KZR-261 in patients
with locally advanced or metastatic disease.
- The KZR-261 trial is currently enrolling Cohort 7 (40 mg/m2).
Previously, Cohort 1 (1.8 mg/m2) through Cohort 6 (27 mg/m2)
enrolled a total of 24 patients and completed rapid dose escalation
without significant safety concerns.
- To date, KZR-261 has shown dose-proportional exposure and no
signs of accumulation or altered pharmacokinetics with repeated
dosing.
Financial Results
- Cash, cash equivalents and marketable securities totaled
$236.6 million as of June 30, 2023, compared to $276.6 million as
of December 31, 2022. The decrease was primarily attributable to
cash used in operations to advance clinical-stage programs and
preclinical research and development.
- Research and development expenses for the second quarter
of 2023 increased by $9.7 million to $21.0 million compared to
$11.3 million in the second quarter of 2022. This increase was
primarily due to advancing the zetomipzomib clinical program in
multiple indications and the KZR-261 clinical program and an
increase in compensation and personnel related expenses, including
non-cash stock-based compensation expense, as a result of an
increase in headcount.
- General and administrative (G&A) expenses for the
second quarter of 2023 increased by $0.8 million to $5.8 million
compared to $5.0 million in the second quarter of 2022. The
increase was primarily due to an increase in compensation and
personnel related expenses, including non-cash stock-based
compensation, as a result of an increase in headcount.
- Net loss for the second quarter of 2023 was $24.3
million, or $0.34 per basic and diluted common share, compared to a
net loss of $16.2 million, or $0.25 per basic and diluted common
share, for the second quarter of 2022.
- Total shares of common stock outstanding were 72.5
million shares as of June 30, 2023. Additionally, there were
options to purchase 13.0 million shares of common stock at a
weighted-average exercise price of $7.43 per share and 0.4 million
restricted stock units outstanding as of June 30, 2023.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company discovering and developing novel 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 that
has completed 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,
and follow us on LinkedIn, Facebook, Twitter and Instagram.
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,” “can”, “should,” “expect,”
“believe,” “potential” 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, initiation, progress, timing, scope
and results of clinical trials, anticipated therapeutic benefit and
regulatory development of Kezar’s product candidates, 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
unexpected safety or efficacy data observed during clinical
studies, difficulties enrolling and conducting our 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, 2023
December 31, 2022
(unaudited)
Cash, cash equivalents and marketable
securities
$
236,589
$
276,561
Total assets
263,379
299,568
Total current liabilities
13,737
10,997
Total noncurrent liabilities
17,365
18,699
Total stockholders' equity
232,277
269,872
Summary of Operations Data
(In thousands except share and per share
data)
Three Months Ended
Six Months Ended
June 30
June 30
2023
2022
2023
2022
(unaudited)
(unaudited)
Operating expenses:
Research and development
$
20,999
$
11,346
$
39,317
$
22,290
General and administrative
5,785
4,977
11,991
9,911
Total operating expenses
26,784
16,323
51,308
32,201
Loss from operations
(26,784
)
(16,323
)
(51,308
)
(32,201
)
Interest income
2,861
408
5,556
516
Interest expense
(385
)
(272
)
(755
)
(526
)
Net loss
$
(24,308
)
$
(16,187
)
$
(46,507
)
$
(32,211
)
Net loss per common share, basic and
diluted
$
(0.34
)
$
(0.25
)
$
(0.64
)
$
(0.52
)
Weighted-average shares used to compute
net loss per common share, basic and diluted
72,461,850
64,279,634
72,395,410
62,465,092
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version on businesswire.com: https://www.businesswire.com/news/home/20230810849969/en/
Investor Contact: Gitanjali Jain Vice President, Investor
Relations and External Affairs gjain@kezarbio.com
Media Contact: Julia Deutsch Solebury Strategic
Communications jdeutsch@soleburystrat.com
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