Zura Bio Reports Full Year 2023 Financial Results, Business Highlights, and Appoints Robert Lisicki as Chief Executive Officer
- Successful Nasdaq listing and leadership team buildout were key milestones in 2023.
- Appointment of Robert Lisicki as CEO highlights Zura Bio's commitment to strategic development.
- Cash position of $99.8 million expected to support operations until 2026.
- Plans to initiate a Phase 2 study for tibulizumab in systemic sclerosis in 2H 2024.
- Expansion of the Board of Directors and Executive leadership team to fortify business operations.
- Raised $145 million in 1H 2023 and completed a $80 million financing round in April 2023.
- Joined the Russell 2000® and Russell 3000® Indexes in June 2023.
- Net loss for the year ended December 31, 2023, was $60.4 million.
- Net loss increased to $60.4 million in 2023 compared to $25.7 million in 2022.
- R&D expenses increased to $44.0 million in 2023, primarily due to manufacturing and license acquisition costs.
- G&A expenses rose to $18.6 million in 2023, driven by personnel compensation and professional services.
- The increase in expenses may impact the company's financial performance.
Insights
The recent financial report from Zura Bio indicates a strategic positioning within the biotechnology sector, specifically in the domain of immunology and inflammation. The company's capital raise of approximately $145 million in the first half of 2023, including a significant Business Combination Agreement and subsequent Nasdaq listing, has fortified its financial standing. This capital infusion is pivotal for supporting the company's clinical pipeline, particularly the progression of tibulizumab into Phase 2 trials for systemic sclerosis—a chronic autoimmune disease characterized by fibrosis of the skin and internal organs.
From an industry perspective, the transition to Phase 2 trials is a critical juncture, often referred to as 'proof-of-concept' studies. These trials are designed to provide preliminary evidence on the effectiveness of a drug, which can significantly impact a company's valuation if the results are positive. The dual-action mechanism of tibulizumab, targeting both IL-17A and BAFF, represents a novel therapeutic approach that could differentiate it from other treatments if clinical efficacy is demonstrated.
The company's reported cash position, sufficient to fund operations into 2026, offers a buffer against the need for immediate further financing, which is often a concern for investors in the biotech industry due to the high costs associated with drug development. The R&D expenses reflect a substantial investment in manufacturing and licensing, which are necessary steps in preparing for later-stage trials and potential commercialization.
Zura Bio's financial health, as evidenced by its year-end cash position of $99.8 million, showcases a strong balance sheet that is likely to reassure investors of the company's operational sustainability in the medium term. The substantial increase in R&D expenses year-over-year aligns with the company's strategic focus on advancing its clinical assets. It is important to note that such increases are common in the biotech industry as companies transition from preclinical to clinical stages.
However, the reported net loss of $60.4 million, a more than twofold increase from the previous year, reflects the aggressive investment in the company's pipeline and may raise questions about the long-term profitability and risk profile of the company. Investors typically scrutinize G&A expenses and the reported $18.6 million, up from $3.5 million the previous year, indicates significant investment in human capital and professional services to support the company's growth.
While the appointment of a new CEO with a strong background in drug development and commercial operations could signal a strategic shift towards commercial readiness, it is also indicative of the company's stage of evolution. Leadership changes at this level can have a significant impact on investor confidence and the company's strategic direction, especially as it approaches critical clinical milestones.
The initiation of Phase 2 trials for tibulizumab represents a significant milestone for Zura Bio in the competitive landscape of systemic sclerosis treatments. The therapeutic potential of tibulizumab, given its dual-pathway inhibition, could position it favorably in the market if clinical outcomes are positive. The anticipation of this trial, along with the readiness of other clinical assets such as ZB-168 and torudokimab, suggests a robust pipeline that could cater to various autoimmune and inflammatory conditions.
Market dynamics for autoimmune treatments are heavily influenced by the efficacy and safety profiles of drugs. Tibulizumab's novel mechanism could meet an unmet need in systemic sclerosis, a market where limited effective treatments are available. Moreover, the company's strategic development and scientific planning, as evidenced by partnerships and research agreements, indicate a proactive approach to understanding disease mechanisms and potential therapeutic targets.
Investors often look for companies with a clear strategic vision and the capability to execute on their development plans. Zura Bio's expansion of its board and executive team, along with its strategic research collaborations, suggests an alignment of its operational capabilities with its long-term strategic goals. This alignment is important for building investor confidence in the company's ability to deliver on its promises and navigate the complex regulatory and competitive landscape of the biotech industry.
- Significant 2023 milestones highlighted by successful Nasdaq listing, leadership team buildout, formation of strategic development and scientific plan
- On track to initiate Phase 2 study evaluating tibulizumab (ZB-106) for the treatment of systemic sclerosis (SSc) in 2H 2024
- Appointment of CEO, Robert Lisicki, underscores Zura Bio’s commitment to building leading immunology company as we prioritize excellence in strategic development and scientific planning
- Outgoing Founder and CEO, Someit Sidhu, M.D., will continue as a Board Director to leverage institutional knowledge and provide continued support
-
Cash position as of December 31, 2023 totaling
$99.8 million
“Throughout 2023, Zura Bio achieved significant milestones by successfully listing on Nasdaq, broadening our portfolio of differentiated clinical-stage immunology and inflammation assets, and building our management team. These accomplishments have firmly established a robust operational framework for our business that is underpinned by a cash runway expected to fund operations into 2026,” stated Someit Sidhu, M.D., Founder and CEO of Zura Bio, “We remain focused on initiating a Phase 2 clinical trial evaluating our lead asset, tibulizumab, in systemic sclerosis in the second half of 2024. This involves effective management of our development and manufacturing partners, the thoughtful selection of a contract research organization, and communications with regulatory authorities. Concurrently, we're advancing ZB-168 and torudokimab towards Phase 2 readiness while closely monitoring external readouts expected in 2024.”
Zura Bio has appointed Robert Lisicki as CEO, effective April 8, 2024, succeeding Dr. Sidhu, who remains actively involved in the Company as a non-independent Director of the Board. The Company will expand its Board membership to ten, which includes Mr. Lisicki’s role as a Director of the Board. Mr. Lisicki joined Zura Bio in January 2024 as President and Chief Operating Officer.
Dr. Sidhu continued, "On behalf of the Management Team and Board, I am pleased to welcome Robert as the Chief Executive Officer. Robert brings a wealth of industry leadership experience complemented by expertise in drug development and commercial operations. With his proven track record of excellence, he is the right individual to lead Zura Bio as our lead asset enters Phase 2 development. I will work closely with Robert to transition CEO responsibilities and remain actively involved as a Director."
IMPORTANT UPCOMING ANTICIPATED EVENTS FOR ZURA BIO
Tibulizumab (ZB-106): Zura Bio plans to initiate a Phase 2 trial of tibulizumab for the treatment of systemic sclerosis in 2H 2024. Tibulizumab is a tetravalent dual-antagonist antibody engineered by the fusion of TALTZ® (ixekizumab) and tabalumab that neutralizes IL-17A and BAFF.
ZB-168: Zura Bio plans to conduct necessary CMC and regulatory activities to prepare ZB-168, an anti-IL-7Rα inhibitor, for Phase 2 readiness. Additionally, the Company is actively monitoring Phase 2 IL-7R external catalysts in ulcerative colitis, atopic dermatitis, and alopecia areata, along with additional TSLP-driven catalysts.
Torudokimab (ZB-880): Zura Bio plans to conduct necessary CMC and regulatory activities to prepare torudokimab, an anti-IL-33 antibody, for Phase 2 readiness in allergy or respiratory-related indications. Additionally, the Company is monitoring Phase 2 and Phase 3 external catalysts in asthma and chronic obstructive pulmonary disease.
BUSINESS AND FINANCIAL HIGHLIGHTS
-
Raised approximately
$145 million -
In March 2023, successfully closed a Business Combination Agreement (BCA) with JATT Acquisition Corp., resulting in approximately
$65 million -
In April 2023, completed
$80 million
-
In March 2023, successfully closed a Business Combination Agreement (BCA) with JATT Acquisition Corp., resulting in approximately
-
Enhanced and expanded the Board of Directors and Executive leadership team to fortify business operations and ensure readiness for clinical trials in 2024.
- In April 2023, appointed Michael Howell, Ph.D. as the Chief Scientific Officer and Head of Translational Medicine.
- In November 2023, appointed Arnout Ploos van Amstel to the Board of Directors.
- In January 2024, appointed Kiran Nistala, M.B.B.S., Ph.D. as the Chief Medical Officer and Head of Development.
- In March 2024, appointed Robert Lisicki to CEO, effective April 8, 2024.
- Joined the Russell 2000® and Russell 3000® Indexes in June 2023.
- Entered into a sponsored research agreement with Benaroya Research Institute in September 2023 to further characterize the pivotal role of Interleukin-7 receptor alpha (IL-7Rα) in Thymic Stromal Lymphopoietin (TSLP) and Interleukin-7 (IL-7) signaling pathways.
- Presented results from two abstracts at the World Allergy Congress in December 2023, highlighting the Company’s informative research for ZB-168 and torudokimab.
Cash and cash equivalents: Cash and cash equivalents were
Research and Development (R&D) expenses: R&D expenses were
General and Administrative (G&A) expenses: G&A expenses were
Net loss: Net loss for the year ended December 31, 2023 was
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-168, and torudokimab 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 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.
ZURA BIO LIMITED |
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CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
December 31, |
|
December 31, |
||||
|
|
2023 |
|
2022 |
||||
Assets |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
99,806 |
|
|
$ |
1,567 |
|
Prepaid expenses and other current assets |
|
|
1,037 |
|
|
|
209 |
|
Total current assets |
|
|
100,843 |
|
|
|
1,776 |
|
Deferred offering costs |
|
|
— |
|
|
|
3,486 |
|
Total assets |
|
$ |
100,843 |
|
|
$ |
5,262 |
|
|
|
|
|
|
||||
Liabilities, Redeemable Noncontrolling Interest, Convertible Preferred Shares, and Shareholders’ Equity (Deficit) |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable and accrued expenses |
|
$ |
20,302 |
|
|
$ |
4,428 |
|
Note payable |
|
|
— |
|
|
|
7,756 |
|
Research and development license consideration liability |
|
|
— |
|
|
|
2,634 |
|
Total current liabilities |
|
|
20,302 |
|
|
|
14,818 |
|
Private placement warrants |
|
|
990 |
|
|
|
— |
|
Total liabilities |
|
|
21,292 |
|
|
|
14,818 |
|
|
|
|
|
|
||||
Commitments and contingencies (Note 12) |
|
|
|
|
||||
|
|
|
|
|
||||
Redeemable noncontrolling interest |
|
|
18,680 |
|
|
|
10,000 |
|
|
|
|
|
|
||||
Convertible preferred shares |
|
|
|
|
||||
Series A-1 convertible preferred shares, |
|
|
— |
|
|
|
12,500 |
|
|
|
|
|
|
||||
Shareholders’ Equity (Deficit): |
|
|
|
|
||||
Preferred Shares, |
|
|
— |
|
|
|
— |
|
Class A Ordinary Shares, |
|
|
4 |
|
|
|
— |
|
Additional paid-in capital |
|
|
162,820 |
|
|
|
— |
|
Accumulated deficit |
|
|
(103,494 |
) |
|
|
(32,056 |
) |
Total Zura Bio Limited shareholders’ equity (deficit) |
|
|
59,330 |
|
|
|
(32,056 |
) |
Noncontrolling interest |
|
|
1,541 |
|
|
|
— |
|
Total shareholders’ equity (deficit) |
|
|
60,871 |
|
|
|
(32,056 |
) |
Total liabilities, redeemable noncontrolling interest, convertible preferred shares, and shareholders’ equity (deficit) |
|
$ |
100,843 |
|
|
$ |
5,262 |
|
ZURA BIO LIMITED |
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CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
(In thousands, except share and per share data) |
||||||||
|
|
|
|
For the Period from |
||||
|
|
|
|
January 18, 2022 |
||||
|
|
For the Year Ended |
|
(date of inception) to |
||||
|
|
December 31, |
|
December 31, |
||||
|
|
2023 |
|
2022 |
||||
Operating expenses: |
|
|
|
|
||||
Research and development |
|
$ |
43,999 |
|
|
$ |
23,689 |
|
General and administrative |
|
|
18,639 |
|
|
|
3,473 |
|
Total operating expenses |
|
|
62,638 |
|
|
|
27,162 |
|
Loss from operations |
|
|
(62,638 |
) |
|
|
(27,162 |
) |
Other expense/(income), net: |
|
|
|
|
|
|
||
Other expense, net |
|
|
(17 |
) |
|
|
23 |
|
Interest income |
|
|
(2,186 |
) |
|
|
(8 |
) |
Dividend income |
|
|
(1,392 |
) |
|
|
— |
|
Change in fair value of private placement warrants |
|
|
(724 |
) |
|
|
— |
|
Change in fair value of note payable |
|
|
2,244 |
|
|
|
156 |
|
Total other expense/(income), net |
|
|
(2,075 |
) |
|
|
171 |
|
Loss before income taxes |
|
|
(60,563 |
) |
|
|
(27,333 |
) |
Income tax benefit |
|
|
— |
|
|
|
— |
|
Net loss before redeemable noncontrolling interest |
|
|
(60,563 |
) |
|
|
(27,333 |
) |
Net loss attributable to redeemable noncontrolling interest |
|
|
203 |
|
|
|
1,595 |
|
Net loss |
|
|
(60,360 |
) |
|
|
(25,738 |
) |
Accretion of redeemable noncontrolling interest to redemption value |
|
|
(7,220 |
) |
|
|
(6,652 |
) |
Deemed contribution from redeemable noncontrolling interest |
|
|
9,212 |
|
|
|
— |
|
Deemed dividend to redeemable noncontrolling interest |
|
|
(10,875 |
) |
|
|
— |
|
Net loss attributable to Class A Ordinary Shareholders of Zura |
|
$ |
(69,243 |
) |
|
$ |
(32,390 |
) |
Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted |
|
$ |
(2.09 |
) |
|
$ |
(141.97 |
) |
Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted |
|
|
33,064,036 |
|
228,148 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20240328129564/en/
Megan K. Weinshank
Head of Investor Relations
IR@zurabio.com
Lee M. Stern
Meru Advisors
lstern@meruadvisors.com
Source: Zura Bio Limited
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