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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
June 6, 2024
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 June 6, 2024,
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: June 6, 2024
|
ZURA BIO LIMITED |
|
|
|
By: |
/s/ Kim Davis |
|
|
Kim Davis |
|
|
Chief Legal Officer |
Exhibit 99.1
Zura Bio Forms Scientific Advisory Board with
Prominent Specialists in Rheumatology, Dermatology, and Immunology
Henderson, Nev – June 6, 2024 - Zura
Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies
for autoimmune and inflammatory diseases, today announced the formation of a Scientific Advisory Board (SAB) with leading experts from
rheumatology, dermatology, and immunology. The five distinguished founding members of the SAB are Johann Gudjonsson, M.D, Ph.D., Dinesh
Khanna, M.D., M.Sc., Ajay Nirula, M.D., Ph.D., Michael Weinblatt, M.D. and Steven Ziegler, Ph.D.
“With the launch of the SAB, we are strengthening
our commitment to advancing solutions in translational and clinical science across our portfolio,” stated Michael Howell, Ph.D.,
Chief Scientific Officer and Head of Translational Medicine. “We welcome these esteemed advisors whose expertise will enhance our
understanding of targeted pathways and their pivotal role in disease pathogenesis. This understanding will be impactful across our portfolio,
particularly in directing our efforts towards supporting Phase 2 clinical development in systemic sclerosis and hidradenitis suppurativa,
as well as elucidating the roles of BAFF and IL-17A across autoimmune and inflammatory diseases.”
·
Johann Gudjonsson, M.D., Ph.D., is a Professor of Molecular Skin Immunology and Dermatology at the University of Michigan Dermatology
Department and a foremost expert in dermatological science. He leads a National Institutes of Health - funded research group examining
the immunological and genetic drivers of inflammatory skin disease, with projects directed at improving the diagnosis and treatment of
disorders such as atopic dermatitis, cutaneous lupus, hidradenitis suppurativa, lichen planus, psoriasis, and psoriatic arthritis. Since
2008, Dr. Gudjonsson has provided dermatology patient care at the University of Michigan Taubman Center. He is a graduate of the University
of Iceland Medical School and completed his internship and dermatology residency training at the University of Michigan.
· Dinesh Khanna, M.D., M.Sc., is a Professor of Medicine and serves as the Director of the University of Michigan Scleroderma Program.
Guiding a multidisciplinary team of caregivers, scientists, and clinical researchers, Dr. Khanna is dedicated to advancing knowledge about
scleroderma and related conditions. His research interests include developing new patient-reported outcome measures in patients with scleroderma
and leading clinical trials evaluating new treatments for scleroderma. Dr. Khanna received an M.D. from University College of Medical
Sciences and completed a clinical and research rheumatology fellowship and an M.Sc. in Clinical Research from UCLA.
· Ajay
Nirula, M.D., Ph.D., is the Executive Vice President and Head of Research and Development at Recludix Pharma. He was previously a
Senior Vice President and the Immunology Therapeutic Area Head for Eli Lilly & Co, which he joined in 2015. He was responsible for
the company’s research and early clinical development work in immunology. Before his tenure at Lilly, Dr. Nirula held leadership
roles at Amgen and Biogen Idec, contributing to various research programs and regulatory filings across diseases such as rheumatoid arthritis,
systemic lupus erythematosus, multiple sclerosis, psoriasis, and vasculitis. Dr. Nirula received his undergraduate degree in molecular
biology from UC Berkeley, followed by a medical degree from the University of California, Los Angeles (UCLA) School of Medicine, and
a Ph.D. from the University of Texas Southwestern Medical School.
· Michael
Weinblatt, M.D., is the Co-Director of Clinical Rheumatology at Brigham and Women’s Hospital and a Professor of Medicine at
Harvard Medical School. As a recognized authority in rheumatology with 40 years of experience, his clinical interests have been focused
on innovations in rheumatoid arthritis (RA) treatment. Dr. Weinblatt leads the Brigham and Women’s clinical trial program in rheumatology
and was involved in the development of methotrexate for the treatment of RA. Dr. Weinblatt earned an M.D. from the University of Maryland
School of Medicine and has been board certified in rheumatology since 1980.
·
Steven Ziegler, Ph.D., is a Director of External Collaborations and a Member of the Center for Fundamental Immunology at Benaroya
Research Institute (BRI). He is also an Affiliate Professor in the Immunology Department at the University of Washington School of Medicine.
Dr. Ziegler graduated with honors from the University of Michigan in 1979, and in 1984 received his Ph.D. in molecular biology from UCLA.
Following post-doctoral training at the University of Washington, Dr. Ziegler spent five years as a staff scientist at Immunex, followed
by three years as the Director of Immunology/Molecular Biology at Darwin Molecular. He joined BRI as an Associate Member in 1997.
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology
company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. 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 tibulizumab
(ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune
and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.
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 in this release include, but are not limited to, statements regarding Zura Bio’s anticipated proceeds
to be received in the proposed Private Placement, expected timing of closing of the proposed Private Placement and the size, completion
and use of proceeds of the proposed Private Placement, the forecast of cash runway and the Company’s expectations regarding funding,
operating and working capital expenditures, business strategies and objectives, statements related to Zura Bio’s abilities to achieve
anticipated internal readouts and achieve them in expected time periods, Zura Bio’s product candidates, clinical trials and the
design and timing thereof, statements with respect to expected therapeutic potential and statements regarding Zura Bio’s product
candidates ability to proceed into Phase 2 clinical trials. 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 the ability to consummate the
proposed Private Placement and the timing and proceeds thereof; are difficult or impossible to predict and could differ materially from
those expressed or implied in such forward-looking statements. You should carefully consider the risks and uncertainties described in
the “Risk Factors” sections of Zura Bio's 10-K for the year ended December 31, 2023 and other filings with the SEC, including:
Zura Bio’s expectations regarding product candidates and their related benefits; Zura Bio’s beliefs regarding potential benefits
or limitations of competing products both in development and approved; information regarding Zura Bio’s vision and strategy; anticipated
timing of key events and initiation of Zura Bio’s studies and release of clinical data; Zura Bio’s expectations regarding
the general acceptability and maintenance of our products by regulatory authorities, payors, physicians, and patients; Zura Bio’s
ability to attract and retain key personnel; the accuracy of Zura Bio’s future operating expenses, capital requirements and needs
for additional financing; Zura Bio’s ability to obtain funding for operations, including funds that may be necessary to complete
development of our product candidates; the fact that Zura Bio has not completed any clinical trials and has no products approved for commercial
sale; the fact that Zura Bio has incurred significant losses since inception, and it expects to incur significant losses for the foreseeable
future and may not be able to achieve or sustain profitability in the future; Zura Bio’s ability to renew existing contracts; Zura
Bio’s reliance on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio’s
ability to obtain regulatory approval for our products, and any related restrictions or limitations of any approved products; Zura Bio’s
ability to effectively manage growth and competitive pressures from other companies worldwide in the therapies in which Zura Bio competes;
and litigation and Zura Bio’s ability to adequately protect intellectual property rights. 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,
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.
CONTACTS
Megan K. Weinshank
Head of Investor Relations
ir@zurabio.com
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