-- Continued advancement of two Phase 2 clinical trials evaluating
tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic
sclerosis (SSc) (TibuSURE), with topline data expected in the second half
of 2026.
-- Reported $139.0 million in cash and cash equivalents as of September
30, 2025, which is expected to fund planned operations through 2027.
HENDERSON, Nev.--(BUSINESS WIRE)--November 13, 2025--
Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and pipeline updates.
"Both tibulizumab studies advanced during the quarter," said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. "We continue to focus on disciplined study execution and patient enrollment across these important disease areas, with the aim of generating meaningful data."
PROGRAM UPDATES
Tibulizumab
During the third quarter of 2025, Zura Bio continued to advance its two ongoing Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17A (IL-17A) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis.
-- TibuSHIELD (HS): The Phase 2 clinical trial in adults with HS
progressed as planned. Topline data are expected in the third quarter of
2026.
-- TibuSURE (SSc): The Phase 2 clinical trial in adults with SSc continued
to advance during the quarter. Topline data are expected in the fourth
quarter of 2026.
The Company continues to monitor timelines and evaluate strategy for both studies in light of the competitive landscape for patient enrollment and other external factors, including those that may impact regulatory matters and overall study execution.
THIRD QUARTER 2025 FINANCIAL RESULTS
Cash Position
As of September 30, 2025, Zura Bio had cash and cash equivalents of $139.0 million. The Company anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027.
Research and Development (R&D) Expenses
R&D expenses were $11.9 million for the third quarter of 2025, compared to $6.0 million for the same period in 2024, primarily reflecting continued advancement of the tibulizumab Phase 2 clinical trials.
General and Administrative (G&A) Expenses
G&A expenses were $7.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024, driven mainly by a one-time non-cash expense in share-based compensation in the third quarter of 2024.
Net Loss
Net loss for the third quarter of 2025 was $20.0 million, or $0.21 per share, compared to $22.9 million, or $0.26 per share, for the same period in 2024.
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs. The Company's pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients.
Zura Bio's lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.
For more information, please visit www.zurabio.com.
FORWARD-LOOKING STATEMENTS
This communication includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believe," "predict," "potential," "continue, " "strategy," "future," "opportunity," "would," "seem," "seek," "outlook, " "goal," "mission," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. Forward-looking statements in this release include, but are not limited to, statements regarding: Zura Bio's forecasts, including with respect to its cash resources; Zura Bio's expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to Zura Bio's development programs, including its product candidates and the potential benefits thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on, by an investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability.
Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related benefits, and Zura Bio's beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by Zura Bio's Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025 and September 30, 2025 and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to update any forward-looking statements, except as required by law.
ZURA BIO LIMITED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
September 30, December 31,
2025 2024
--------------- ----------------
(unaudited)
Assets
Current assets
Cash and cash equivalents $ 139,017 $ 176,498
Prepaid expenses and other current
assets 3,275 2,246
---------- ---------
Total current assets 142,292 178,744
Property and equipment, net 131 91
Other assets 1,512 698
---------- ---------
Total assets $ 143,935 $ 179,533
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