Full Press Release Details
Third Quarter 2025 Financial Results and Recent Corporate Updates
- (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.
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."
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.
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.
2025 FINANCIAL RESULTS
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.
Development (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.
Administrative (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.
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.
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.
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
For more information,
please visit www.zurabio.com.
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.
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.
CONDENSED CONSOLIDATED
| 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 | ||||
| Liabilities, Redeemable Noncontrolling Interest and Shareholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued expenses | $ | 25,491 | $ | 19,514 | ||||
| Total current liabilities | 25,491 | 19,514 | ||||||
| Total liabilities | 25,491 | 19,514 | ||||||
| Commitments and contingencies (Note 9) | ||||||||
| Redeemable noncontrolling interest | 8,660 | 11,663 | ||||||
| Shareholders' Equity | ||||||||
| Preferred shares, $0.0001 par value, 1,000,000 shares authorized as of September 30, 2025 and December 31, 2024; no shares issued and outstanding as of September 30, 2025 and December 31, 2024 | - | - | ||||||
| Class A Ordinary Shares, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2025 and December 31, 2024; 65,018,058 and 65,297,530 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | 7 | 7 | ||||||
| Additional paid-in capital | 315,608 | 302,705 | ||||||
| Accumulated deficit | (207,372 | ) | (155,897 | ) | ||||
| Total Zura Bio Limited shareholders' equity | 108,243 | 146,815 | ||||||
| Noncontrolling interest | 1,541 | 1,541 | ||||||
| Total shareholders' equity | 109,784 | 148,356 | ||||||
| Total liabilities, redeemable noncontrolling interest and shareholders' equity | $ | 143,935 | $ | 179,533 |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
except share and per share data)
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 11,948 | $ | 6,029 | $ | 31,126 | $ | 15,161 | ||||||||
| General and administrative | 7,571 | 13,290 | 25,709 | 24,296 | ||||||||||||
| Total operating expenses | 19,519 | 19,319 | 56,835 | 39,457 | ||||||||||||
| Loss from operations | (19,519 | ) | (19,319 | ) | (56,835 | ) | (39,457 | ) | ||||||||
| Other (income)/expense, net: | ||||||||||||||||
| Interest income | (1,526 | ) | (2,461 | ) | (5,060 | ) | (5,872 | ) | ||||||||
| Change in fair value of private placement warrants | - | 3,866 | - | 5,240 | ||||||||||||
| Other expense/(income), net | 47 | (22 | ) | (300 | ) | (47 | ) | |||||||||
| Total other (income)/expense, net | (1,479 | ) | 1,383 | (5,360 | ) | (679 | ) | |||||||||
| Loss before income taxes | (18,040 | ) | (20,702 | ) | (51,475 | ) | (38,778 | ) | ||||||||
| Income tax benefit | - | - | - | - | ||||||||||||
| Net loss | (18,040 | ) | (20,702 | ) | (51,475 | ) | (38,778 | ) | ||||||||
| Accretion of redeemable noncontrolling interest to redemption value | (2,828 | ) | (2,240 | ) | (2,828 | ) | (4,577 | ) | ||||||||
| Adjustment of redeemable noncontrolling interest | 831 | - | 831 | 7,017 | ||||||||||||
| Net loss attributable to Class A Ordinary Shareholders of Zura | $ | (20,037 | ) | $ | (22,942 | ) | $ | (53,472 | ) | $ | (36,338 | ) | ||||
| Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted | $ | (0.21 | ) | $ | (0.26 | ) | $ | (0.57 | ) | $ | (0.52 | ) | ||||
| Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted | 94,564,632 | 87,335,667 | 93,941,675 | 69,778,401 |
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