Kezar Life Sciences Reports First Quarter 2023 Financial Results and Provides Business Update
12 May 2023 - 6:01AM
Business Wire
- PALIZADE Phase 2b clinical trial evaluating zetomipzomib in
lupus nephritis on track to initiate in first half of 2023
- KZR-261 dose escalation study continues to progress; the dose
expansion study expected to initiate in second half of 2023
- Cash, cash equivalents and marketable securities totaled $257.7
million as of March 31, 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 first quarter ended March 31,
2023 and provided a business update.
“This quarter, Kezar continued to make meaningful progress on
its clinical strategy. We remain focused on actively exploring
zetomipzomib’s promise in lupus nephritis and autoimmune hepatitis,
in addition to advancing our protein secretion inhibitor pipeline,
showcasing our ability to discover and develop first in class small
molecule therapeutics against novel targets,” said John Fowler,
Kezar’s Co-Founder and Chief Executive Officer. “To that end, we
recently presented the trial design for PALIZADE, our Phase 2b
clinical trial of zetomipzomib in lupus nephritis, and provided an
encouraging early update from our Phase 1 oncology study of
KZR-261, our Sec61 translocon inhibitor. We look forward to
continued strong execution in our programs and are excited to share
results from our KZR-261 dose escalation trial in the second half
of this year.”
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, and the end-of-study assessments will occur at Week 57.
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. PALIZADE is on track to
initiate in the first half of 2023.
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 60mg 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)
- An abstract featuring post-hoc analysis across LN biopsy
classes from the open-label Phase 2 MISSION clinical trial was
presented at the National Kidney Foundation (NKF) Spring Clinical
Meeting 2023, which took place April 11-15, 2023 in Austin,
Texas.
- An abstract featuring complete MISSION Phase 1b/2 results,
along with a post hoc subgroup analysis in the Phase 2
Hispanic/Latino population, was presented at the Pan American
League of Associations for Rheumatology (PANLAR) 2023 Congress,
which took place April 26-29, 2023 in Rio de Janeiro, Brazil.
- An abstract featuring complete MISSION Phase 1b/2 results has
been selected for oral presentation at the upcoming LUPUS & KCR
2023 meeting, taking place May 17-20, 2023 in Seoul, Korea.
- Three abstracts featuring complete MISSION Phase 2 results,
MISSION Phase 2 uCD163 data, and the unmet need of European
patients with LN have been selected for poster presentations at the
upcoming European Alliance of Associations for Rheumatology (EULAR)
2023 Congress, taking place May 31 – June 3, 2023 in Milan,
Italy.
- Two abstracts featuring post-hoc analysis of MISSION Phase 2
patients with nephrotic range proteinuria and the unmet need of
European patients with LN will be presented as focused oral
presentations at the 60th European Renal Association (ERA)
Congress, taking 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. Kezar plans to
initiate the dose expansion study in the second half of 2023, with
topline data expected starting mid-2024.
- The KZR-261 trial is currently enrolling Cohort 6 (27 mg/m2).
To date, KZR-261 has shown dose-proportional exposure and no signs
of accumulation or altered pharmacokinetics with repeated dosing.
There have been no consistent patterns of safety signals. Kezar
plans to report safety and dose escalation data from this trial in
the second half of 2023.
Financial Results
- Cash, cash equivalents and marketable securities totaled
$257.7 million as of March 31, 2023, compared to $276.6 million as
of December 31, 2022. The decrease was primarily attributable to
cash used to advance clinical-stage programs and preclinical
research and development.
- Research and development expenses for the first quarter
of 2023 increased by $7.4 million to $18.3 million compared to
$10.9 million in the first 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 related personnel costs, including
non-cash stock-based compensation expense, attributable to higher
headcount to support the progression of the company’s programs and
drug discovery.
- General and administrative (G&A) expenses for the
first quarter of 2023 increased by $1.3 million to $6.2 million
compared to $4.9 million in the first quarter of 2022. The increase
was primarily due to an increase in legal and professional services
and an increase in compensation and related personnel costs,
including non-cash stock-based compensation expense as a result of
an increase in headcount and salaries.
- Net loss for the first quarter of 2023 was $22.2
million, or $0.31 per basic and diluted common share, compared to a
net loss of $16.0 million, or $0.26 per basic and diluted common
share, for the first quarter of 2022.
- Total shares of common stock outstanding were 70.8
million shares as of March 31, 2023. Additionally, there were
outstanding pre-funded warrants to purchase 1.6 million shares of
common stock at an exercise price of $0.001 per share, 0.5 million
outstanding restricted stock units and options to purchase 12.5
million shares of common stock at a weighted-average exercise price
of $7.83 per share as of March 31, 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.
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,”
“plans,” “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)
March 31, 2023
December 31, 2022
(unaudited)
Cash, cash equivalents and marketable
securities
$
257,671
$
276,561
Total assets
284,180
299,568
Total current liabilities
13,644
10,997
Total noncurrent liabilities
18,046
18,699
Total stockholders' equity
252,490
269,872
Summary of Operations Data
(In thousands except share and per share
data)
Three Months Ended
March 31
2023
2022
(unaudited)
Operating expenses:
Research and development
$
18,318
$
10,944
General and administrative
6,206
4,934
Total operating expenses
24,524
15,878
Loss from operations
(24,524)
(15,878)
Interest income
2,695
108
Interest expense
(370)
(254)
Net loss
$
(22,199)
$
(16,024)
Net loss per common share, basic and
diluted
$
(0.31)
$
(0.26)
Weighted-average shares used to compute
net loss per common share, basic and diluted
72,328,231
60,630,389
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version on businesswire.com: https://www.businesswire.com/news/home/20230511005766/en/
Investors: Gitanjali Jain Vice President, Investor
Relations and External Affairs gjain@kezarbio.com
Media: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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