Kezar Life Sciences Announces Strategic Restructuring to Prioritize Clinical-Stage Assets and Extend Financial Runway and Appoints Christopher Kirk, Ph.D. as Chief Executive Officer
03 Outubro 2023 - 5:10PM
Business Wire
- Strategic realignment to focus capital resources on clinical
programs and reduce workforce by approximately 41%
- Cash runway extended to fund PALIZADE global Phase 2b clinical
trial evaluating zetomipzomib in lupus nephritis; topline data
expected mid-2026
- Co-Founder and Board Director, Christopher Kirk, PhD, appointed
as Chief Executive Officer
Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage
biotechnology company developing breakthrough treatments for
immune-mediated and oncologic disorders, today announced it has
initiated a strategic restructuring program to prioritize long-term
growth and focus its resources on its clinical-stage programs. The
strategic realignment is expected to extend operating capital to
fund PALIZADE, Kezar’s Phase 2b clinical trial in lupus
nephritis.
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 to achieve important
clinical data readouts for zetomipzomib in lupus nephritis and
autoimmune hepatitis and KZR-261 in solid tumors. All research and
drug discovery activities have been paused, and Kezar will explore
strategic partnering 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 autoimmune hepatitis (AIH)
in mid-2025 and topline data from PALIZADE in mid-2026.
Kezar will reduce its workforce by approximately 41% to optimize
capital allocation and align with strategic priorities. Kezar is
also evaluating its Phase 1 clinical trial of KZR-261 in solid
tumors and expects to reduce the number of planned expansion
cohorts to conserve cash resources while it continues to evaluate
safety and biologic activity in the ongoing trial.
John Fowler will be resigning from his role as Chief Executive
Officer effective November 7, 2023, and Christopher Kirk, Ph.D. has
been appointed as Chief Executive Officer. Dr. Kirk is a co-founder
and member of the Board of Directors and previously served as
Kezar’s President and Chief Scientific Officer from March 2015 to
April 2023. Mr. Fowler will continue as a member of Kezar’s Board
of Directors. In addition, Noreen Roth Henig, M.D., will be
stepping down as Chief Medical Officer effective October 6, 2023.
Zung To, SVP, Clinical Development Operations, will assume
responsibilities for clinical trial execution and will oversee
development operations.
“These difficult but necessary decisions to streamline our
operations and align resources around our clinical programs should
put us on a path to long-term success, extending our runway past
key data points, particularly the readout for our PALIZADE trial,”
said John Fowler, Kezar’s Co-Founder and Chief Executive Officer.
“I would like to thank Dr. Henig for her contributions to the
company over the last three years and express my enthusiasm for Dr.
Kirk’s leadership of Kezar moving forward. I am leaving the company
in great hands, and I look forward to supporting the company’s
success in the years to come.” Fowler added, “It’s incredibly
difficult to part ways with so many talented members of our Kezar
team who were instrumental to getting us where we are today. I want
to thank every one of our departing employees for their dedication
to our mission.”
Dr. Kirk added, “I am very excited to be returning to Kezar as
CEO to lead us through this next chapter as we focus on the
zetomipzomib and KZR-261 clinical programs. I’m convinced of the
therapeutic potential of immunoproteasome inhibition and am
committed to the development of zetomipzomib for the treatment of
lupus nephritis and other autoimmune disorders.” Dr. Kirk
continued, “I am also grateful for the eight years of tremendous
leadership John has provided and look forward to continue to work
with him as a member of our Board.”
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical
company developing novel treatments for immune-mediated 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 “anticipate”, “may,” “will,” “should,”
“expect,” “believe”, “plan” 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,
progress, timing, scope and results of clinical trials, the
anticipated timing of disclosure of results of clinical trials, the
timing and results of strategic partnering alternatives, the
likelihood data will support future development, 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, clinical trial site activation or
enrollment rates that are lower than expected, changes in expected
or existing competition, changes in the regulatory environment, the
uncertainties and timing of the regulatory approval process, the
sufficiency of Kezar’s capital and other resources; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231003874621/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
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