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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
December 4, 2023
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) 757-6133
(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 |
Warrants, each whole warrant exercisable for one Class A Ordinary Share at an exercise price of $11.50 per share |
|
ZURAW |
|
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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
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 7.01. | Regulation FD Disclosure. |
On December 4, 2023,
Zura Bio Limited issued the press release attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.
The information set forth in
this Item 7.01 is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits
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.
Date: December 4, 2023
|
ZURA BIO LIMITED |
|
|
|
By: |
/s/ Kim Davis |
|
|
Kim Davis |
|
|
Chief Legal Officer |
Exhibit 99.1
Zura Bio Announces Two Immunology Abstracts Presented at the World Allergy Congress in Bangkok
Henderson, Nev – December 4, 2023
- Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a multi-asset clinical-stage biotechnology company focused on developing
novel medicines for immune and inflammatory disorders, today announced two abstracts were accepted and presented at World Allergy
Congress (WAC), held December 1 – 3, 2023 in Bangkok, Thailand. The abstracts highlight Zura Bio’s informative research
for ZB-168, an anti-IL-7Rα monoclonal antibody with potential across a broad set of indications where the IL-7 or TSLP pathways
may be involved, and ZB-880 (torudokimab), a fully human, high affinity monoclonal antibody that neutralizes IL-33 and also has potential
for a broad range of indications.
“Introducing Zura Bio’s ZB-168 and
ZB-880 at World Allergy Congress is an opportunity to share the unique science behind these assets. ZB-168 uniquely inhibits both IL-7
and TSLP, while ZB-880 prevents IL-33 mediated-activation of ST2-dependent and independent inflammation. The unique biology of our assets
may give us access to a broad range of biology applicable in a number of autoimmune and inflammatory diseases,” said Michael
Howell, Ph.D., Chief Scientific Officer and Head of Translational Science at Zura Bio. “We believe these could have applicability
in the dermatological, rheumatological, gastrointestinal and respiratory spaces, and we are very excited about taking these development
programs forward.”
Details are as follows:
Abstract: WAC23-0180
Title: Biomarker analysis identifies subset of atopic dermatitis
patients that respond to IL-33 blockade
Authors: Michael Howell, Ph.D., Jackson Cabell, Brandon
Walsh, Ph.D., Someit Sidhu, M.D., Christopher Cabell, M.D.
Abstract: WAC23-0179
Title: ZB-168 potently inhibits thymic stromal lymphopoietin
mediated Inflammation
Authors: Christopher Cabell, M.D., Javier Cote-Sierra, Ph.D.,
Karl Deacon, Ph.D., Someit Sidhu, M.D., Michael Howell, Ph.D.
Full session details can be accessed via the
WAC program.
About Zura Bio
Zura Bio is a multi-asset clinical-stage biotechnology
company focused on developing novel medicines for immune and inflammatory disorders. Currently, Zura Bio is developing three assets which
have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for ZB-106 (tibulizumab),
ZB-168, and ZB-880 (torudokimab) with a goal of demonstrating their efficacy, safety, and dosing convenience in immune and inflammatory
disorders, including systemic sclerosis, hidradenitis suppurativa, and other novel indications with unmet needs.
About ZB-106 (tibulizumab)
ZB-106 (tibulizumab) is a potential first-in-class,
anti-IL-17 and anti-BAFF dual antagonist that Zura Bio plans to develop for the treatment of systemic sclerosis and hidradenitis suppurativa.
ZB-106 is an IgG-scFv bispecific dual-antagonist antibody engineered by the fusion of Taltz® (ixekizumab) and tabalumab that neutralizes
IL-17A and BAFF. ZB-106 has been assessed in two Phase 1b studies completed in rheumatoid arthritis and Sjögren's syndrome. The safety
profile to date appears to be acceptable, with no new findings relative to known IL-17 and BAFF inhibitors. Chronic toxicology studies
have been completed with no adverse drug-related findings. Phase 2 clinical trials of ZB-106 in systemic sclerosis and hidradenitis suppurativa
are planned to initiate 2H-2024.
About ZB-168
ZB-168 is a fully human, high affinity monoclonal
antibody that binds and neutralizes the IL-7 receptor chain (“IL-7R”) alpha. IL-7Rα sits at the nexus of two key immune
pathways (IL-7 and TSLP), thus inhibiting IL-7Rα has the potential to block activation through both of these pathways. As a result,
we believe ZB-168 could be therapeutically beneficial in a broad set of indications where the IL-7 or TSLP pathways may be involved. ZB-168
has been assessed in Phase 1/1b clinical studies in Type 1 diabetes and multiple sclerosis. Safety and pharmacokinetics were evaluated
and the safety profiles from these studies support further development. A Phase 2 clinical trial of ZB-168 in alopecia areata is planned
to initiate in 2024.
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” 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 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 and circumstances are
difficult or impossible to predict and will differ from assumptions. You should carefully consider the risks and uncertainties
described in the “Risk Factors” sections of Zura Bio’s recent filings with the SEC. These filings would
identify and address other important risks and uncertainties that could cause actual events and results to differ materially from
those contained in the forward-looking statements. Many of these factors are outside Zura Bio’s control and are difficult to
predict. Many factors could cause actual future events to differ from the forward-looking statements in this communication,
including but not limited to: (1) the outcome of any legal proceedings that may be instituted against Zura Bio; (2) volatility in
the price of Zura Bio’s securities; (3) the ability of Zura Bio to successfully conduct research and development activities,
grow and manage growth profitably, maintain relationships with customers and suppliers, and retain key employees; (4) the ongoing
costs relating to operating as a public company; (5) changes in the applicable laws or regulations; (6) the possibility that Zura
Bio may be adversely affected by other economic, business, and/or competitive factors; (7) the risk of downturns and a changing
regulatory landscape in the highly competitive industry in which Zura Bio operates; (8) the potential inability of Zura Bio to raise
additional capital needed to pursue its business objectives or to achieve efficiencies regarding other costs; (9) the enforceability
of Zura Bio’s intellectual property, including its patents, and the potential infringement on the intellectual property rights
of others, cyber security risks or potential breaches of data security; and (10) other risks and uncertainties described in the
registration statement on Form S-1 filed with the SEC on June 14, 2023, and such other documents filed by Zura Bio
from time to time with the SEC. These risks and uncertainties may be amplified by the COVID-19 pandemic 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, including projections, 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 publicly provide revisions or updates to any forward-looking statements, whether as a result of new information,
future developments or otherwise, or should circumstances change, except as otherwise required by securities and other applicable
laws.
Contact
Megan K. Weinshank
Head of Investor Relations
info@zurabio.com
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