Kezar Life Sciences Reports Third Quarter 2022 Financial Results and Provides Business Update
November 10 2022 - 4:01PM
Business Wire
- Presented positive complete results from the MISSION Phase 2
trial evaluating zetomipzomib in patients with lupus nephritis at
ASN’s Kidney Week 2022 Annual Meeting
- Received FDA clearance of IND for zetomipzomib for the
treatment of autoimmune hepatitis
- Cash, cash equivalents and marketable securities totaled $290.4
million as of September 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 third quarter ended September
30, 2022 and provided a business update.
“In the third quarter, the team at Kezar continued its tradition
of strong execution across our clinical and portfolio development
plans,” said John Fowler, Kezar’s Co-founder and Chief Executive
Officer. “Supported by the results from the MISSION study, our
conviction remains high that zetomipzomib has the potential to be a
non-immunosuppressive, steroid-sparing treatment for patients with
lupus and lupus nephritis. In addition, our recently announced
development plan in autoimmune hepatitis underscores our belief
that zetomipzomib can help patients across a diverse range of
autoimmune diseases. In parallel, we are excited by progress in our
protein secretion inhibition platform and look forward to our SITC
poster presentation tomorrow on KZR-540, an oral small molecule
that selectively blocks PD-1 expression.”
Zetomipzomib: Selective
Immunoproteasome Inhibitor
MISSION – Phase 2 clinical trial of zetomipzomib in patients
with active lupus nephritis (LN) (NCT03393013)
- Kezar presented positive complete results for the 37-week Phase
2 MISSION clinical trial at the American Society of Nephrology’s
(ASN) Kidney Week 2022 Annual Meeting.
- 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 (EOT), with a safety follow up period and
completion of the study at Week 37 (EOS). Patients in the MISSION
Phase 2 clinical trial received zetomipzomib without induction
therapy, which represents a difference from other recently
published clinical 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 MISSION Phase 2 clinical trial, 17 of 21 enrolled
patients reached end-of-treatment at Week 25 and end-of-study at
Week 37:
- ORRs were achieved in 11 of 17 patients (64.7%) at EOT. This
benefit occurred with a 53% mean reduction of background
corticosteroid use.
- During the safety follow up period, clinical responses
deepened, and ORRs increased to 16 patients (94.1%) at Week 29 and
15 patients (88.2%) at EOS. Of these responders, 12 patients
(70.6%) also reached a UPCR of 0.7 or less at EOS.
- CRRs were achieved in 6 of 17 patients (35.3%) at EOT,
including a UPCR of 0.5 or less, stable eGFR, daily
prednisone/prednisone equivalent dose of 10 mg or less, and no use
of prohibited medication.
- During the safety follow up period, an additional patient
achieved a CRR, with the total CRRs increasing to 7 patients
(41.2%) at both Week 29 and EOS.
- Key measurements of SLE disease activity were reduced and key
biomarkers of SLE improved. There was no evidence of early rebound
of inflammation following discontinuation of zetomipzomib.
- Kezar will also present the complete MISSION data set at the
upcoming American College of Rheumatology (ACR) Convergence 2022,
which is taking place November 10 – 14, 2022 in Philadelphia, PA.
The ACR poster presentation details are available here.
PORTOLA – Phase 2 clinical trial of zetomipzomib in patients
with autoimmune hepatitis (AIH) who have not benefited from
standard-of-care treatment (NCT05569759)
- In October 2022, Kezar received clearance of its
Investigational New Drug (IND) application from the U.S. Food and
Drug Administration for zetomipzomib for the treatment of AIH. AIH
is a rare, chronic disease in which the immune system attacks the
liver and causes inflammation and tissue damage, severely impacting
patients’ physical health and quality of life.
- The PORTOLA trial (KZR-616-208) is a randomized, double-blind,
placebo-controlled Phase 2a clinical trial evaluating the safety
and efficacy of zetomipzomib in patients with AIH that are
insufficiently responding to standard of care or have relapsed. The
target enrollment will be 24 patients, who will be randomly
assigned (2:1) to receive either zetomipzomib or placebo in
addition to background corticosteroid therapy for 24 weeks and
includes 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.
Protein Secretion
Inhibition
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.
KZR-540 – Kezar will introduce promising preclinical data on
KZR-540, an oral small molecule inhibitor that selectively blocks
PD-1 expression via inhibition of the Sec61 translocon, on November
11, 2022 at the Society for Immunotherapy of Cancer’s (SITC) 37th
Annual Meeting in Boston, MA. KZR-540 illustrates that the Sec61
translocon can be selectively inhibited for specific anti-tumor
effects and validates Sec61 inhibition as a platform for additional
new chemical entities.
- Details for the SITC poster presentation are as follows:
- Title: KZR-540 is a novel oral small molecule inhibitor
of Sec61 cotranslational translocation that potently and
selectively blocks PD-1 expression (#422)
- Category: Checkpoint Blockade Therapy
- Date/Time: November 11, 2022 from 9 AM – 8:30 PM ET
- Presenter: Cristina Delgado-Martin, Senior Scientist,
Biology
Financial Results
- Cash, cash equivalents and marketable securities totaled
$290.4 million as of September 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 in operations to advance clinical-stage programs and
preclinical research and development.
- Research and development expenses for the third quarter
of 2022 increased by $3.4 million to $13.9 million compared to
$10.5 million in the third quarter of 2021. This increase was
primarily due to an increase in personnel-related expenses
including non-cash stock-based compensation because of headcount
growth, and higher research and clinical development expenses, to
advance the zetomipzomib clinical programs and the KZR-261 Phase 1
clinical trial.
- General and administrative expenses for the third
quarter of 2022 increased by $1.0 million to $5.0 million compared
to $4.0 million in the third quarter of 2021. The increase was
primarily due to an increase in personnel-related expenses
including non-cash stock-based compensation.
- Net loss for the third quarter of 2022 was $17.8
million, or $0.25 per basic and diluted common share, compared to a
net loss of $14.5 million, or $0.28 per basic and diluted common
share, for the third quarter of 2021.
- Total shares of common stock outstanding were 68.4
million shares as of September 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, 0.4 million
outstanding restricted stock units and options to purchase 9.6
million shares of common stock at a weighted-average exercise price
of $8.12 per share as of September 30, 2022.
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 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,”
“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, 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, the performance of audit and
verification procedures, 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,
2022
December 31,
2021
(unaudited)
Cash, cash equivalents and marketable
securities
$290,383
$208,355
Total assets
304,770
217,933
Total current liabilities
9,595
8,212
Total noncurrent liabilities
11,987
12,845
Total stockholders' equity
283,188
196,876
Summary of Operations Data
(In thousands except share and per share
data)
Three Months Ended
Nine Months Ended
September 30
September 30
2022
2021
2022
2021
(unaudited)
(unaudited)
Operating expenses:
Research and development
$13,860
$10,527
$36,150
$29,154
General and administrative
5,067
3,972
14,978
11,402
Total operating expenses
18,927
14,499
51,128
40,556
Loss from operations
(18,927
)
(14,499
)
(51,128
)
(40,556
)
Interest income
1,390
37
1,906
138
Interest expense
(310
)
—
(836
)
—
Net loss
($17,847
)
($14,462
)
($50,058
)
($40,418
)
Net loss per common share, basic and
diluted
($0.25
)
($0.28
)
($0.76
)
($0.78
)
Weighted-average shares used to compute
net loss per common share, basic and diluted
72,153,952
52,048,563
65,730,202
51,674,063
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version on businesswire.com: https://www.businesswire.com/news/home/20221110005886/en/
Investor: 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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