ZURA BIO LIMITED_March 31, 2025

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)



☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025



☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-40598

ZURA BIO LIMITED

(Exact name of Registrant as specified in its Charter)


Cayman Islands	98-1725736
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
1489 W. Warm Springs Rd. #110 Henderson, NV	89014
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (702) 825-9872

Securities registered pursuant to Section 12(b) of the Act:



Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Class A Ordinary Shares	ZURA	The Nasdaq Stock Market LLC (The Nasdaq Capital Market)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of May 5, 2025, the registrant had 61,874,998 Class A Ordinary Shares outstanding

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		Page
	Cautionary Note Regarding Forward-Looking Statements	3
PART I	FINANCIAL INFORMATION	5
Item 1.	Financial Statements	5
	Condensed Consolidated Balance Sheets	5
	Condensed Consolidated Statements of Operations	6
	Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Equity	7
	Condensed Consolidated Statements of Cash Flows	8
	Notes to Unaudited Condensed Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	34
Item 4.	Controls and Procedures	35

PART II	OTHER INFORMATION	36

Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	39
Item 3.	Defaults Upon Senior Securities	39
Item 4.	Mine Safety Disclosures	39
Item 5.	Other Information	39
Item 6.	Exhibits	40
Signatures		41

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our forward-looking statements include, but are not limited to, statements regarding our and our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward- looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

These forward-looking statements are based on the current expectations of Zura Bio Limited (the “Company” or “Zura”) and its management thereof and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. Forward-looking statements are not guarantees of performance. You should not put undue reliance on our forward-looking statements. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to:

●

our expectations regarding our product candidates and their related benefits, and our beliefs regarding competing product candidates and products both in development and approved, may not be achieved;

●

our vision and strategy may not be successful;

●

the timing of key events and initiation of our studies and release of clinical data may take longer than anticipated or may not be achieved at all;

●

expectations regarding the potential general acceptability and maintenance of our product candidates by regulatory authorities, payors, physicians, and patients may not be achieved;

●

we may be unable to attract and retain key personnel;

●

expectations with respect to our future operating expenses, capital requirements and needs for additional financing may not be achieved;

●

we have not completed any clinical trials, and have no products approved for commercial sale;

●

we have incurred significant losses since inception, and expect to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future;

●

we require substantial additional capital to finance our operations, and if we are unable to raise such capital when needed or on acceptable terms, we may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts;

●

we may be unable to renew existing contracts or enter into new contracts;

●

we rely on third-party contract development manufacturing organizations for the manufacture of clinical materials;

●

we rely on contract research organizations, clinical trial sites, and other third parties to conduct our preclinical studies and clinical trials;

●

we may be unable to obtain regulatory approval for our product candidates, and there may be related restrictions or limitations of any approved products;

●

we may be unable to successfully respond to general economic and geopolitical conditions;

●

we may be unable to effectively manage growth;

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●

we face competitive pressures from other companies worldwide;

●

we may be unable to adequately protect our intellectual property rights; and

●

other factors set forth in documents filed, or to be filed, with the Securities and Exchange Commission (the “SEC”).

Additional discussion of the risks, uncertainties and other factors described above, as well as other risks material to our business, can be found under “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report), as supplemented by the risks and uncertainties described in “Risk Factors” Item 1A. Risk Factors in Part II of this Quarterly Report. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. New risk factors emerge from time to time and it is not possible to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other transactions we may execute.

For the reasons described above, we caution you against relying on any forward-looking statements, which should also be read in conjunction with this Quarterly Report and the documents referenced within this Quarterly Report and the other cautionary statements that are included elsewhere in this Quarterly Report and in our public filings, including under “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Forward-looking statements, reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements. We undertake no obligations to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Zura Bio Limited

Condensed Consolidated Balance Sheets

(In thousands, except share data)


	March 31,		December 31,
	2025		2024
	(unaudited)
Assets
Current assets
Cash and cash equivalents	$	170,569	$	176,498
Prepaid expenses and other current assets		1,123		2,246
Total current assets		171,692		178,744
Property and equipment, net		106		91
Other assets		698		698
Total assets	$	172,496	$	179,533

Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity
Current liabilities
Accounts payable and accrued expenses	$	21,092	$	19,514
Total current liabilities		21,092		19,514
Total liabilities		21,092		19,514

Commitments and contingencies (Note 9)

Redeemable noncontrolling interest		11,663		11,663

Shareholders’ Equity
Preferred shares, $0.0001 par value, 1,000,000 authorized as of March 31, 2025 and December 31, 2024; no shares issued and outstanding as of March 31 2025 and December 31, 2024		—		—
Class A Ordinary Shares, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2025 and December 31, 2024; 68,374,998 and 65,297,530 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively		7		7
Additional paid-in capital		311,532		302,705
Accumulated deficit		(173,339)		(155,897)
Total Zura Bio Limited shareholders’ equity		138,200		146,815
Noncontrolling interest		1,541		1,541
Total shareholders’ equity		139,741		148,356
Total liabilities, redeemable noncontrolling interest and shareholders’ equity	$	172,496	$	179,533

See accompanying notes to unaudited condensed consolidated financial statements.

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Zura Bio Limited

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)


	For the Three Months Ended
	March 31
	2025		2024
Operating expenses:
Research and development	$	10,474	$	3,593
General and administrative		8,780		4,786
Total operating expenses		19,254		8,379
Loss from operations		(19,254)		(8,379)
Other (income)/expense, net
Interest income		(1,817)		(1,215)
Change in fair value of private placement warrants		—		606
Other expense (income), net		5		(23)
Total other income, net		(1,812)		(632)
Loss before income taxes		(17,442)		(7,747)
Income tax benefit		—		—
Net loss		(17,442)		(7,747)
Adjustment of redeemable noncontrolling interest from redemption value to carrying value		—		7,017
Net loss attributable to Class A Ordinary Shareholders of Zura	$	(17,442)	$	(730)
Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted	$	(0.19)	$	(0.02)
Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted		92,964,048		46,914,542

See accompanying notes to unaudited condensed consolidated financial statements.

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Zura Bio Limited

Condensed Consolidated Statements of Changes in Redeemable Noncontrolling Interest and Shareholders’ Equity

(Unaudited)

(In thousands, except share data)

For the Three Months Ended March 31, 2025


	Redeemable		Class A			Additional						Total
	Noncontrolling		Ordinary Shares			Paid-in		Accumulated		Noncontrolling		Shareholders’
	Interest		Shares	Amount		Capital		Deficit		Interest		Equity
Balance as of December 31, 2024	$	11,663	65,297,530	$	7	$	302,705	$	(155,897)	$	1,541	$	148,356
Issuance of Class A Ordinary Shares in connection with a sale under the ATM, net of $0.2 million of commissions		—	3,000,000		—		5,093		—		—		5,093
Stock option exercises and restricted stock unit releases		—	77,468		—		90		—		—		90
Share-based compensation		—	—		—		3,644		—		—		3,644
Net loss		—	—		—		—		(17,442)		—		(17,442)
Balance as of March 31, 2025	$	11,663	68,374,998	$	7	$	311,532	$	(173,339)	$	1,541	$	139,741

For the Three Months Ended March 31, 2024

Redeemable

Class A

Additional

Total

Noncontrolling

Ordinary Shares

Paid-in

Accumulated

Noncontrolling

Shareholders’

Interest

Shares

Amount

Capital

Deficit

SEC Form 10-Q filed by Zura Bio Limited