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Warrants [Member]

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM8-K

 

 

 

CURRENT REPORT

PURSUANT TO SECTION 13OR15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

May 8, 2025

Date of Report (Date of earliest event reported)

 

 

 

Zura Bio Limited

(Exact name of registrant as specified in its charter)

 

Cayman Islands   001-40598   98-1725736
(State or other jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

1489 W. Warm Springs Rd. #110

Henderson, NV 89014

(Address of principal executive offices,

including zip code)

 

(702) 825-9872

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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, par value $0.0001 per share   ZURA   The Nasdaq Stock Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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. ¨

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On May 8, 2025, Zura Bio Limited (“ZURA”, the “Company”) issued a press release announcing its first quarter 2025 financial results. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated herein by reference.

 

The information in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any Company filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits

 

(d) Exhibits.

 

Exhibit
No.
  Description
99.1   Press Release dated May 8, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  ZURA BIO LIMITED
   
Date: May 8, 2025 By: /s/ Kim Davis
    Kim Davis
    Chief Legal Officer

 

 

 

EX-99.1 2 tm2514121d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates

 

· Advanced the Phase 2 TibuSURE clinical trial evaluating tibulizumab in adults with systemic sclerosis (SSc) 
· Continued preparations for the planned Phase 2 trial evaluating tibulizumab in adults with hidradenitis suppurativa (HS), expected to initiate in Q2 2025 
· Strengthened the team with a strategic appointment to support clinical execution and organizational growth 
· $170.6 million in cash and cash equivalents with cash runway anticipated through 2027 

 

HENDERSON, Nev. – (BUSINESS WIRE) – May 8, 2025 – Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio” or the “Company”), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates. 

 

“The first quarter of 2025 reflected steady progress across our clinical and operational priorities,” said Robert Lisicki, Chief Executive Officer of Zura Bio. “We continued advancing trial efforts for our Phase 2 TibuSURE trial for adults with SSc, and progressed preparations for the initiation of a second Phase 2 study in HS. Recent additions to our clinical team have further strengthened our ability to grow and execute with care. We believe we are well-positioned to move our programs forward thoughtfully and purposefully.” 

 

PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES 

 

Tibulizumab 

 

Systemic sclerosis  

 

In the first quarter of 2025, Zura Bio continued to advance its ongoing Phase 2 TibuSURE trial evaluating tibulizumab in adults with SSc. 

 

Hidradenitis suppurativa 

 

In the first quarter of 2025, Zura Bio received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for HS, supporting the planned initiation of its Phase 2 clinical trial in adults with HS in the second quarter of 2025. 

 

Crebankitug 

 

Zura Bio continues to explore the potential of crebankitug in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer clinical benefits with commercial potential. The Company is conducting translational research and engaging with academic collaborators to inform future development decisions. 

 

Torudokimab 

 

Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases and monitoring external clinical data in areas such as asthma and chronic obstructive pulmonary disease to inform its development strategy. 

 

 


 

 

 

CORPORATE HIGHLIGHTS 

 

In the first quarter, Zura Bio appointed Kate Dingwall as Senior Vice President of Development Operations. Ms. Dingwall brings extensive experience in patient-centered trial design, recruitment strategies, and clinical optimization and is expected to help advance the Company’s pipeline and lead execution across current and future clinical programs. 

 

FIRST QUARTER 2025 FINANCIAL RESULTS 

 

Cash Position 

 

As of March 31, 2025, Zura Bio had cash and cash equivalents of $170.6 million. Zura Bio 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 for the first quarter of 2025 were $10.5 million, compared to $3.6 million for the first quarter of 2024. The increase was primarily driven by increases of $3.7 million for contract research organization (CRO) costs and $2.1 million for manufacturing costs for our product candidates, as well as $0.6 million for cash and non-cash compensation costs for personnel in research and development functions as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. 

 

General and Administrative (G&A) Expenses  

 

G&A expenses for the first quarter of 2025 were $8.8 million, compared to $4.8 million for the first quarter of 2024. The increase was primarily due to a $2.6 million increase in cash and non-cash compensation costs for personnel in executive and administrative functions and our board of directors, as well as a $1.2 million increase in professional fees to support our growing organization as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. 

 

Net Loss  

 

Net loss for the first quarter of 2025 was $17.4 million, or $0.19 per share, compared to $7.7 million, or $0.02 per share, for the same period in 2024. 

 

ABOUT ZURA BIO 

 

Zura Bio is a clinical-stage, multi-asset immunology company developing novel antibodies for autoimmune and inflammatory diseases. 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 TibuSURE, a Phase 2 clinical trial in adults with systemic sclerosis. It is also expected to enter a separate Phase 2 clinical trial in adults with hidradenitis suppurativa in the second quarter of 2025. 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. These 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 program, including its product candidates and the potential clinical benefits and commercial potential thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof; expectations with respect to development programs, data readouts and product candidates of other parties. 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 clinical 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 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, including the conflict between Russia and Ukraine and the Israel-Hamas war and sanctions related thereto, international trade policies, including tariffs, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems, 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 

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                  
                 
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  

 

 


 

 

 

ZURA BIO LIMITED 

CONSOLIDATED STATEMENTS OF OPERATIONS 

(In thousands, except share and per share data) 

unaudited

 

    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  

 

CONTACTS 

 

Megan K. Weinshank 

Head of Corporate Affairs 

ir@zurabio.com