- Strategic restructuring extends cash runway to fund PALIZADE
global Phase 2b clinical trial evaluating zetomipzomib in lupus
nephritis
- Collaboration and license agreement with Everest Medicines to
develop and commercialize zetomipzomib in Greater China, South
Korea and Southeast Asia
- Kezar Co-Founder and Board Director, Christopher Kirk, Ph.D.,
appointed as Chief Executive Officer
- Cash, cash equivalents and marketable securities totaled $218.2
million as of September 30, 2023
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage
biotechnology company developing breakthrough treatments for
immune-mediated and oncologic disorders, today reported financial
results for the third quarter ended September 30, 2023 and provided
a business update.
“During the third quarter, we made important progress in
streamlining our operations and sharpening our focus on the
zetomipzomib and KZR-261 programs,” said Christopher Kirk, Ph.D.,
co-founder and Chief Executive Officer of Kezar. “Our progress has
been bolstered by a strategic collaboration and license agreement
with Everest Medicines to develop and commercialize zetomipzomib in
China, South Korea and Southeast Asia. Looking ahead, our strategic
realignment and strong balance sheet provide cash runway to reach
and extend beyond important clinical inflection points over the
next three years for both our immunology and oncology
programs.”
Corporate Update
Christopher Kirk, Ph.D. was appointed and began serving as
Kezar’s Chief Executive Officer on November 7, 2023. Dr. Kirk is a
co-founder and member of the Board of Directors and previously
served as Kezar’s President and Chief Scientific Officer. John
Fowler, co-founder and departing CEO, will continue serving as a
member of the Board of Directors. In addition, Kezar recently
announced a strategic restructuring to prioritize long-term growth
and focus resources on its clinical-stage programs. Actions to
prioritize clinical programs and implement cost saving measures are
expected to extend Kezar’s cash runway into late 2026. These
measures will focus resources on achieving important clinical data
readouts for zetomipzomib in lupus nephritis (LN) and autoimmune
hepatitis and KZR-261 in solid tumors. All research and drug
discovery activities have been paused, and Kezar is exploring
strategic alternatives for its protein secretion platform and
preclinical programs. Kezar anticipates initial data from its
KZR-261 Phase 1 clinical trial in 2024, topline data from its
PORTOLA Phase 2a clinical trial in mid-2025 and topline data from
its PALIZADE Phase 2b clinical trial mid-2026.
Zetomipzomib: Selective
Immunoproteasome Inhibitor
Collaboration with Everest Medicines:
In September 2023, Kezar entered into a collaboration and
license agreement with Everest Medicines to develop and
commercialize zetomipzomib in Greater China, South Korea and
Southeast Asia. Everest Medicines is joining Kezar on PALIZADE, a
global, placebo-controlled Phase 2b clinical trial evaluating
zetomipzomib in patients with active LN, and will contribute their
local regulatory and clinical trial expertise to potentially
accelerate enrollment in these geographies. In addition to
PALIZADE, Kezar and Everest Medicines have the opportunity to
collaborate on future clinical trials and indications for the
continued development of zetomipzomib.
Clinical Development:
PALIZADE – Phase 2b clinical trial of zetomipzomib in patients
with active 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.
PRESIDIO Open-Label Extension (OLE) – Dr. Rohit Aggarwal, M.D.,
an investigator at the University of Pittsburgh, will present
results from the OLE portion of the Phase 2 PRESIDIO trial in
patients with dermatomyositis (DM) and polymyositis (PM) showing
zetomipzomib demonstrates long-term safety and tolerability without
signs of immunosuppression at the American College of Rheumatology
(ACR) Convergence 2023, which is taking place November 10 – 15,
2023, in San Diego, Calif.
MISSION – Kezar will present an encore poster presentation of
the results from the open-label Phase 2 MISSION trial of
zetomipzomib in LN at the upcoming 25th Asia-Pacific League of
Associations for Rheumatology (APLAR) Congress, which is taking
place December 7 – 11, 2023, in Thailand.
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 tumor-specific solid
tumors. 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 8 (60 mg/m2).
Previously, Cohort 1 (1.8 mg/m2) through Cohort 7 (40 mg/m2)
enrolled a total of 29 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.
Protein Secretion
Platform
Kezar presented results around the quantitative proteomic
profiling of KZR-540, an oral small molecule inhibitor that
selectively blocks PD-1 expression via inhibition of the Sec61
translocon, at the Society for Immunotherapy of Cancer’s (SITC)
38th Annual Meeting which took place November 1– 5, 2023 in San
Diego, CA. KZR-540 demonstrates that the Sec61 translocon can be
selectively inhibited for specific anti-tumor effects and validates
Sec61 inhibition as a platform for selective down-regulation of
high-value targets. The poster presentation was made by David Bade,
Ph.D., Senior Scientist at Kezar.
Financial Results
- Cash, cash equivalents and marketable securities totaled
$218.2 million as of September 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.
- Revenue for the third quarter of 2023 was $7.0 million
resulting from the upfront payment under the collaboration and
license agreement with Everest Medicines.
- Research and development expenses for the third quarter
of 2023 increased by $9.8 million to $23.7 million compared to
$13.9 million in the third 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
third quarter of 2023 increased by $3.7 million to $8.8 million
compared to $5.1 million in the third quarter of 2022. The increase
was primarily due to an increase in legal and professional service
expense in connection with the collaboration and license agreement
with Everest and 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 third quarter of 2023 was $23.1
million, or $0.32 per basic and diluted common share, compared to a
net loss of $17.8 million, or $0.25 per basic and diluted common
share, for the third quarter of 2022.
- Total shares of common stock outstanding were 72.7
million shares as of September 30, 2023. Additionally, there were
options to purchase 13.3 million shares of common stock at a
weighted-average exercise price of $2.76 per share and 0.3 million
restricted stock units outstanding as of September 30, 2023.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company developing novel treatments for immune-mediated and
oncologic disorders. Zetomipzomib, a selective immunoproteasome
inhibitor, is currently being evaluated in a Phase 2b clinical
trial for lupus nephritis and a Phase 2a clinical trial for
autoimmune hepatitis. This product candidate also has the potential
to address multiple chronic immune-mediated diseases. Kezar’s
oncology product candidate, KZR-261, targeting the Sec61 translocon
and protein secretion pathway, is being evaluated in an open-label
dose-escalation Phase 1 clinical trial to assess safety,
tolerability and preliminary tumor activity in solid tumors. 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,” “anticipate” 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
company’s financial position and cash runway, the timing and amount
of future operating expenses, the design, initiation, progress,
timing, scope and results of clinical trials, collaboration on
clinical trials and development of zetomipzomib in additional
indications, the potential acceleration of enrollment 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 clinical trial site activation or
enrollment rates that are lower than expected, unexpected safety or
efficacy data observed during clinical studies, difficulties
enrolling and conducting our clinical trials, disputes or failure
to perform under the collaboration and license agreement, 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)
September 30, 2023
December 31, 2022
(unaudited)
Cash, cash equivalents and marketable
securities
$
218,205
$
276,561
Total assets
249,326
299,568
Total current liabilities
16,672
10,997
Total noncurrent liabilities
16,660
18,699
Total stockholders' equity
215,994
269,872
Summary of Operations Data
(In thousands except share and per share
data)
Three Months Ended
Nine Months Ended
September 30
September 30
2023
2022
2023
2022
(unaudited)
(unaudited)
Collaboration revenue
$
7,000
$
—
$
7,000
$
—
Operating expenses:
Research and development
23,738
13,860
63,055
36,150
General and administrative
8,789
5,067
20,780
14,978
Total operating expenses
32,527
18,927
83,835
51,128
Loss from operations
(25,527
)
(18,927
)
(76,835
)
(51,128
)
Interest income
2,820
1,390
8,376
1,906
Interest expense
(396
)
(310
)
(1,151
)
(836
)
Net loss
$
(23,103
)
$
(17,847
)
$
(69,610
)
$
(50,058
)
Net loss per common share, basic and
diluted
$
(0.32
)
$
(0.25
)
$
(0.96
)
$
(0.76
)
Weighted-average shares used to compute
net loss per common share, basic and diluted
72,681,645
72,153,952
72,491,870
65,730,202
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231113750324/en/
Investor Contact: Gitanjali Jain Vice President, Investor
Relations and External Affairs Kezar Life Sciences, Inc.
gjain@kezarbio.com
Media Contact: Will Zasadny Evoke Canale
will.zasadny@evokegroup.com
Kezar Life Sciences (NASDAQ:KZR)
Historical Stock Chart
From Apr 2024 to May 2024
Kezar Life Sciences (NASDAQ:KZR)
Historical Stock Chart
From May 2023 to May 2024