-
Strategic realignment to focus capital resources on clinical projects and reduce workforce by approximately 41%
-
Expanded cash runway to fund PALIZADE global Phase 2b clinical trial evaluating zetomizomib in lupus nephritis; topline data expected in mid-2026
-
Co-founder and Board Director Dr. Christopher Kirk appointed CEO
South San Francisco, California, October 3, 2023(BUSINESS WIRE)–Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing breakthrough treatments for immune-mediated and oncological diseases, today announced that it has initiated a strategic reorganization plan to prioritize long-term growth and focus its resources on clinical-stage projects. This strategic adjustment is expected to expand working capital to fund Kezar’s Phase 2b clinical trial PALIZADE in lupus nephritis.
Actions to prioritize clinical programs and implement cost-saving measures are expected to extend Kezar’s cash runway until late 2026. These efforts will focus resources to obtain important clinical data for zetomizomib in lupus nephritis and autoimmune hepatitis and KZR-261 in solid tumors. All research and drug discovery activities have been suspended while Kezar explores strategic collaboration alternatives for its protein secretion platform and preclinical programs. Kezar expects to have preliminary data from the Phase 1 clinical trial of KZR-261 in 2024, topline data from the Phase 2a clinical trial of PORTOLA 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 anticipates reducing the number of planned expansion cohorts to conserve cash resources while continuing to evaluate safety and biologic activity in ongoing trials.
John Fowler will resign as CEO on November 7, 2023, and Dr. Christopher Kirk will resign effective November 7, 2023. has been appointed CEO. Dr. Kirk is a co-founder and board member and previously served as Kezar’s President and Chief Scientific Officer from March 2015 to April 2023. Mr. Fowler will continue to serve as a member of Kezar’s Board of Directors. Additionally, Noreen Roth Henig, MD, will resign as chief medical officer on October 6, 2023. Zung To, senior vice president of clinical development operations, will be responsible for clinical trial execution and 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 and extend our runway to critical data,” said John Fowler points, especially the readouts from the PALIZADE trial.” Kezar Co-Founder and CEO. “I would like to thank Dr. Henig for his contributions to the company over the past three years and express my enthusiasm for Dr. Kirk’s leadership of Kezar’s growth. I will be leaving the company and look forward to supporting the company’s success in the coming years.” Fowler added “It is extremely difficult to part ways with so many talented members of the Kezar team who have been instrumental in getting us to where we are today. I want to thank each of the departing employees for their dedication to our mission.”
Dr. Kirk added, “I am excited to return to Kezar as CEO and lead us through the next chapter as we focus on zetomizomib and KZR-261 clinical programs. I believe in immunoproteasome inhibition as a therapeutic potential and is committed to developing zetomizomib for the treatment of lupus nephritis and other autoimmune diseases.” Dr. Kirk continued, “I am also grateful to John for his exceptional leadership over eight years and look forward to serving on our Board of Directors Members continue to work with him.”
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel treatments for immune-mediated diseases. Zetomipzomib is a selective immunoproteasome inhibitor currently being evaluated in a Phase 2b clinical trial in lupus nephritis and a Phase 2a clinical trial in autoimmune hepatitis. The product candidate also has the potential to treat a variety of chronic immune-mediated diseases. Kezar’s oncology product candidate, KZR-261, targets the Sec61 translocon and protein secretion pathway and 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 connect on LinkedIn, Facebook, Twitter and Instagram.
Cautionary Note Regarding 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 that refer to future events, conditions or circumstances or Expressions) 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 may result in Kezar’s clinical development plans, future results or performance could 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 regarding the Company’s financial condition and cash runway, the timing and amount of future operating expenses, A statement of the design, progress, timing, scope and results of the clinical trials, the expected timing of disclosure of clinical trial results, the timing and results of strategic collaboration alternatives, the likelihood of data supporting future development and the likelihood of regulatory approval of Kezar’s product candidates nature. Many factors could cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, lower than expected clinical trial site activation or enrollment rates, anticipated or existing competitive changes in the regulatory environment, uncertainty and timing of the regulatory approval process, the adequacy of Kezar’s capital and other resources; and unexpected litigation or other disputes. Kezar’s filings with the Securities and Exchange Commission discuss the potential for actual Other factors could cause results to differ from those expressed or implied by the forward-looking statements in this press release, including the “risk factors” contained therein. Kezar does not undertake to update any forward-looking statements contained herein to reflect changes in expectations, except as required by law. obligations even if new information becomes available.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231003874621/en/
Contact information
Investor contact information:
Geetanjali Jainism
Vice President of Investor Relations and External Affairs
Kozar Life Sciences
gjain@kezarbio.com
Media contact information:
Will Zassadeny
evoke canal
will.zasadny@evokegroup.com