- Topline data from MISSION Phase 2 trial of zetomipzomib for the
treatment of lupus nephritis expected in June 2022, consistent with
previous guidance
- KZR-261 continues to enroll patients with solid tumors in Phase
1 dose-escalation trial
- Company to host virtual Investor and Analyst Day in June
2022
- Cash, cash equivalents and marketable securities totaled $242.6
million as of March 31, 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 first quarter ended March 31,
2022 and provided a business update.
“I want to thank my colleagues at Kezar for their excellent
execution across both of our novel programs so far this year,” said
John Fowler, Kezar’s Co-founder and CEO. “We are excited to present
the topline results from our Phase 2 MISSION trial in lupus
nephritis this June and remain committed to exploring
zetomipzomib’s potential in inflammatory diseases with high unmet
need. Our strengthened balance sheet is key in supporting both of
our programs, including our Phase 1 trial of KZR-261 in solid
tumors.”
Zetomipzomib: Selective Immunoproteasome Inhibitor
MISSION – Phase 2 clinical trial of zetomipzomib (KZR-616) in
patients with lupus nephritis (LN) (NCT03393013)
- In November 2021, Kezar reported interim data from the MISSION
Phase 2 open-label trial in patients with active, proliferative LN.
The interim data showed that, of the five patients who completed
the full 24 weeks of weekly treatment with zetomipzomib 60mg doses,
two achieved partial renal responses (PRRs) and two achieved
complete renal responses (CRRs). The primary efficacy endpoint for
the trial is the number of patients achieving a renal response
measured by a 50% or greater reduction in UPCR at the end of
treatment compared to baseline.
- Kezar reiterates prior guidance and expects to report Phase 2
topline data in June 2022
- An abstract featuring zetomipzomib has been selected for poster
presentation as part of the EULAR Science Exhibit session at the
upcoming Annual European Congress of Rheumatology (EULAR), taking
place June 1-4, 2022, in Copenhagen, Denmark. The virtual
presentation will be available beginning Wednesday, June 1, 2022,
at 2:00 am Eastern Time through July 31, 2022.
- 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, PhD, Vice President, Head of
Biology and Translational Research, Kezar Life Sciences
PRESIDIO – Phase 2 clinical trial of zetomipzomib (KZR-616) in
patients with active dermatomyositis (DM) or polymyositis (PM)
(NCT04033926)
- On May 3, 2022, Kezar reported topline data from the PRESIDIO
Phase 2 clinical trial of zetomipzomib in patients with DM (n=13)
and PM (n=12). 20 of the 25 patients enrolled in the study
completed end-of-treatment (Week 32). Topline results from PRESIDIO
showed that most DM and PM patients saw clinically meaningful
improvements in total improvement score (TIS), but zetomipzomib
demonstrated no significant differentiation from placebo. The
overall safety and tolerability of zetomipzomib was favorable and
consistent with previous results.
- KZR-616-003E (NCT04628936) is an
open-label extension (OLE) study available to patients who
completed 32 weeks in the PRESIDIO trial. Following completion of
PRESIDIO, 18 out of 20 patients enrolled in the OLE. For the first
time, patients have the option to self-administer zetomipzomib in
the OLE. As of the release date, active participation in the OLE
ranged from 2 to 77 weeks, and six patients had discontinued for
reasons unrelated to zetomipzomib. No additional safety or
tolerability issues have been observed, and mean TIS scores have
improved over scores observed at the 32-week conclusion of
PRESIDIO.
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.
Financial Results
- Cash, cash equivalents and marketable securities totaled
$242.6 million as of March 31, 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 first quarter
of 2022 increased by $1.7 million to $11.0 million compared to $9.3
million in the first quarter of 2021. This increase was primarily
related to advancing the KZR-616 clinical program and the KZR-261
Phase 1 clinical trial.
- General and administrative expenses for the first
quarter of 2022 increased by $1.1 million to $4.9 million compared
to $3.8 million in the first quarter of 2021. The increase was
primarily due to an increase in personnel expenses, including
non-cash stock-based compensation.
- Net loss for the first quarter of 2022 was $16.0
million, or $0.26 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 first quarter of 2021.
- Total shares of common stock outstanding were 59.6
million shares as of March 31, 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 8.9 million shares of common stock
at a weighted average exercise price of $7.94 per share as of March
31, 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 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 and 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
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.
Selected Balance Sheets Data
(In thousands)
March 31, 2022
December 31, 2021
(unaudited)
Cash, cash equivalents and marketable
securities
$
242,609
$
208,355
Total assets
251,866
217,933
Total current liabilities
6,978
8,212
Total noncurrent liabilities
12,573
12,845
Total stockholders’ equity
232,315
196,876
Summary of Operations Data (Unaudited in thousands except
share and per share data)
Three Months Ended
March 31,
2022
2021
Operating expenses:
Research and development
$10,944
$9,286
General and administrative
4,934
3,762
Total operating expenses
15,878
13,048
Loss from operations
(15,878
)
(13,048
)
Interest income
108
54
Interest expense
(254
)
―
Net loss
($16,024
)
($12,994
)
Net loss per common share, basic and
diluted
($0.26
)
($0.25
)
Weighted-average shares used to compute
net loss per common share, basic and diluted
60,630,389
51,058,039
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005248/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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