Zura Bio Reports Second Quarter 2024 Financial Results and Recent Business Highlights
-- Presented data for tibulizumab at EULAR 2024, highlighting the
potential relevance of dual-inhibition of both IL-17A and BAFF in
autoimmune and inflammatory diseases
-- Expect to initiate Phase 2 studies evaluating tibulizumab for the
treatment of systemic sclerosis (SSc) in 4Q 2024 and hidradenitis
suppurativa (HS) in 2Q 2025
-- Strengthened management and advisory team with appointment of Robert
Lisicki as CEO & formation of Scientific Advisory Board
-- Cash, cash equivalents and investments of $188.4 million as of June 30,
2024, including $112.5 million from private placement executed in April
2024, anticipated to support operations as currently planned through
2027
HENDERSON, Nev.--(BUSINESS WIRE)--August 13, 2024--
Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio"), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported its second quarter 2024 financial results, and recent business highlights.
"We have made meaningful progress on our key development programs this quarter. Highlights include selecting our CRO for the Phase 2 clinical program in SSc and advancing study start-up activities to ensure timely execution for both SSc and HS. Additionally, the tibulizumab data presented at EULAR highlighted our dual-inhibition approach and target engagement. We are eager to demonstrate the broad potential of tibulizumab as we plan to advance into Phase 2 studies for SSc this year and for HS in the first half of 2025," said Robert Lisicki, CEO of Zura Bio. "We are also excited to have established a Scientific Advisory Board, composed of leading experts in rheumatology, dermatology, and immunology. We remain committed to our mission of expanding treatment options for patients living with autoimmune disease."
RECENT BUSINESS AND FINANCIAL HIGHLIGHTS
-- Completed a warrant exchange program to simplify the capital structure
in August 2024.
-- Presented data on the tibulizumab program at EULAR 2024, highlighting
the potential relevance of dual inhibition of both IL-17A and BAFF in
autoimmune and inflammatory diseases in June 2024.
-- Key findings from a randomized, double-blind, placebo-controlled
Phase 1 study of tibulizumab in Sjogren's syndrome include
increased serum levels of total IL-17A and BAFF following
tibulizumab administration, reflecting target engagement.
-- Key findings from a preclinical study of tibulizumab in a
rheumatoid arthritis model demonstrate a reduction in inflammation
through the combined inhibition of IL-17A and BAFF, compared to
the control group (p<0.05).
-- Broadened expertise with appointment of Robert Lisicki as CEO in April
2024 and formation of a Scientific Advisory Board (SAB) comprised of
leading experts in rheumatology, dermatology, and immunology in June
2024.
-- Appointed Robert Lisicki as Chief Executive Officer and as a
director on the Company's Board of Directors, succeeding founding
CEO Dr. Someit Sidhu, who remains on the Board of Directors.
-- The five 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.
-- Raised approximately $112.5 million in gross proceeds from a private
placement in April 2024, with such proceeds expected to:
-- Support the accelerated development of tibulizumab, including
the planned Phase 2 clinical study in SSc with an open-label
extension, and the initiation of a Phase 2 study in HS.
-- Extend the cash runway through 2027.
-- ZB-168 was assigned the International Nonproprietary Name $(INN)$
"crebankitug."
-- Launched a new Zura Bio corporate website at www.zurabio.com in July
2024.
Cash and cash equivalents: Cash and cash equivalents were $188.4 million as of June 30, 2024, as compared to $99.8 million as of December 31, 2023. Zura Bio anticipates that its existing cash and cash equivalents and investments should be sufficient to support operations as currently planned through 2027.
Research and Development (R&D) expenses: R&D expenses were $5.5 million for the second quarter of 2024, a decrease of $22.7 million compared to $28.2 million for the same period in 2023. The decrease was primarily due to $27.2 million related to the acquisition of tibulizumab from Eli Lilly and Company ("Lilly") during the three months ended June 30, 2023. This decrease was partially offset by an increase of $1.5 million in expenses related to compensation for personnel in R&D functions including share-based compensation and an increase of $2.3 million of costs incurred for consulting services and manufacturing of product candidates, in addition to an increase of $0.7 million for an annual milestone payment related to the 2023 Lilly License incurred during the three months ended June 30, 2024.
General and Administrative (G&A) expenses: G&A expenses were $6.2 million for the first quarter of 2024, an increase of $0.5 million compared to $5.7 million for the same period in 2023. The increase was primarily due to increases of $0.4 million in expenses related compensation for personnel in executive and administrative functions including share-based compensation, as well as an increase of $0.1 million in professional fees for legal and accounting costs incurred related to ongoing operations as a public company, as well as travel and office expenses.
Net loss: Net loss for the second quarter of 2024 was $12.7 million or $0.17 per share compared to $44.9 million or $1.31 per share for the same period in 2023.
RECENT AND UPCOMING ANTICIPATED MILESTONES
Tibulizumab, a humanized bispecific dual antagonist antibody that neutralizes both IL-17A and BAFF, is expected to enter Phase 2 clinical development for the treatment of SSc and HS.
-- In the second quarter of 2024, Zura Bio received Type B feedback from
the US FDA and expects to initiate a Phase 2 clinical study in SSc in the
fourth quarter of 2024.
-- In July 2024, Zura Bio entered into a start-up agreement with a
third-party CRO to manage and conduct the Phase 2 clinical program in
SSc.
-- A second Phase 2 clinical study in patients with HS is expected to
initiate in the second quarter of 2025.
Crebankitug, also known as ZB-168, is a high-affinity, fully human monoclonal antibody that neutralizes the IL-7 receptor alpha (IL-7R<ALPHA>) chain, potentially blocking the immune pathways of IL-7 and thymic stromal lymphopoietin $(TSLP)$. Zura Bio is monitoring external read-outs of other companies relating to IL-7R inhibitors in conditions such as ulcerative colitis (UC), atopic dermatitis (AD), and alopecia areata $(AA)$. Zura Bio expects to utilize data from anticipated external readouts to help inform its initial indication selection for crebankitug by the end of 2024, with ongoing indication planning for other potential areas of unmet need.
Torudokimab is a fully human, high affinity monoclonal antibody that neutralizes IL-33, preventing ST2-dependent and ST2-independent (e.g., RAGE) inflammation. Zura Bio is actively monitoring Phase 2 and Phase 3 IL-33 external data releases from other companies related to asthma and chronic obstructive pulmonary disease.
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), crebankitug (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, " "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, and Zura Bio's expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to data readouts and the timing thereof; Zura Bio's product candidates, clinical trials and the design and timing thereof, statements with respect to the potential of product candidates; and expectations with respect to Zura Bio's development program, including clinical trials and the timing thereof, and 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
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