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Zura's Make-or-Break Year Ahead: Will TibuSHIELD And TibuSURE Trials Deliver Or Disappoint?
RTTNews· 2025-10-07 12:44
2026 could be a pivotal year for Zura Bio Ltd. (ZURA), with key data readouts for its lead investigational drug expected to significantly influence the company's strategic direction and market position.Zura is a clinical-stage, multi-asset immunology company advancing treatments for immune-mediated diseases where there is an unmet medical need. Its lead product candidate is Tibulizumab, a potential first-in-class dual-pathway biologic designed to target cytokines IL-17A and BAFF. Tibulizumab is currently b ...
Zura Bio (ZURA) 2025 Conference Transcript
2025-09-04 19:45
Summary of Zura Bio Conference Call Company Overview - Zura Bio is a publicly traded company listed on NASDAQ since April 2023, having raised $200 million and in-licensed three bispecific monoclonal antibodies [2][49] - The lead asset, tibulizumab, is an anti-IL-17 B-cell activating factor antagonist currently enrolling in two Phase II studies for systemic sclerosis and hidradenitis suppurativa, with top-line data expected in Q3-Q4 of next year [2][49] Core Points and Arguments Lead Program: Tibulizumab - Tibulizumab targets both IL-17 and B-cell activating factor, with a unique combination therapy approach expected to yield robust results [4][10] - The drug has a higher affinity for IL-17A and IL-17AF compared to other IL-17 inhibitors, which may provide a therapeutic advantage [4][22] - The Phase II TibuSHIELD study is designed to measure the change in AN count as the primary endpoint, with secondary endpoints including HiSCR scores and impact on draining tunnels [11][34] Efficacy and Comparisons - The efficacy of tibulizumab is compared to other IL-17 inhibitors, with expectations of a broader and deeper response in patients, particularly in reducing draining tunnels associated with hidradenitis suppurativa [15][22] - The company aims to differentiate tibulizumab from existing treatments by addressing unmet needs in the market, particularly for patients who have not previously been exposed to biologics [6][16] Financial Position and Future Outlook - As of the end of Q2, Zura Bio had $155 million in cash, sufficient to fund both Phase II studies and operations through 2027, with a projected burn rate peaking at $15 million per quarter [49][50] - The company anticipates strong investor interest if the Phase II data is robust, which could lead to favorable financing opportunities for Phase III studies [50][55] Industry Context - The discussion highlights the competitive landscape of IL-17 inhibitors, with tibulizumab positioned to potentially outperform existing therapies by targeting both IL-17 and B-cell pathways [3][27] - The company is also exploring other pipeline programs, including a combination therapy for asthma, which may provide additional growth opportunities [39][40] Important but Overlooked Content - The potential for tibulizumab to address the complexities of systemic sclerosis, where IL-17A is a significant driver of inflammation and fibrosis, is emphasized [28][34] - The company is cautious about setting specific efficacy targets until all Phase II data is available, indicating a strategic approach to market positioning [15][19] - The importance of understanding the right dosing and therapeutic range for tibulizumab is highlighted, with ongoing studies to optimize these parameters [23][24] This summary encapsulates the key points discussed during the conference call, providing insights into Zura Bio's strategic direction, product development, and financial outlook.
Zura Bio (ZURA) Earnings Call Presentation
2025-09-02 22:00
Forward Looking Statements Disclaimer 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 the negatives of such terms and similar expressions ...
Zura(ZURA) - 2025 Q2 - Quarterly Report
2025-08-14 12:25
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40598 ZURA BIO LIMITED (Exact name of Registrant as specified in its Charter) Cayman Islands 98-1725736 (State ...
Zura(ZURA) - 2025 Q2 - Quarterly Results
2025-08-14 12:20
Exhibit 99.1 Zura Bio Reports Second Quarter 2025 Financial Results and Recent Corporate Updates HENDERSON, Nev. – (BUSINESS WIRE) – August 14, 2025 – Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs, today reported financial results for the second quarter ended June 30, 2025, and provided recent corporate updates. Torudokimab Zura Bio ...
Zura Bio (ZURA) 2025 Conference Transcript
2025-06-04 20:10
Summary of Zura Bio Conference Call Company Overview - Zura Bio was formed as a private company in 2022 and went public in 2023 [2][3] - The company has in-licensed three novel bispecific antibodies [3] Key Objectives and Achievements - The CEO outlined three objectives: secure two new INDs, initiate two phase two trials, and raise sufficient funds for these trials [3] - Successfully secured IND for systemic sclerosis and initiated the study in December 2024 [4] - IND cleared for hidradenitis suppurativa in March 2025, with the study activated [4] Lead Asset: Tipalizumab - Tipalizumab is a quadrivalent bispecific antibody that inhibits IL-17 and BAF [5] - The unique quadrivalent structure allows binding to IL-17, BAF, or both without requiring dual engagement [7] Phase Two Programs Systemic Sclerosis - Affects approximately 300,000 individuals globally with a ten-year mortality rate of 50% [8] - No advanced line agent approved for the disease; existing therapies provide modest effects [9] - Phase two trial will measure the change in modified Rodnan Skin Score and explore lung function [10] - Previous studies (e.g., Brodalumab) showed robust responses in skin scores, indicating potential for Tipalizumab [12] Hidradenitis Suppurativa - A challenging disease with around 300,000 patients in the US; existing treatments have modest benefits [17][18] - The need for higher efficacy therapies remains unmet [21] - Emerging data suggests a combinatory approach using IL-17 and B cell inhibition could improve outcomes [23] Clinical Trial Design and Expectations - Phase two trial for systemic sclerosis will have 80 participants and is expected to complete enrollment by Q1 2026, with top-line data by Q4 2026 [15] - The trial for hidradenitis suppurativa is expected to provide top-line data in Q3 2026 [29] - Both trials include a loading dose to achieve therapeutic levels quickly [30] Financial Position - The company has a strong cash position, expected to last through 2027, providing a buffer for post-data catalyst activities [32] Conclusion - Zura Bio is positioned uniquely in the biotech landscape with promising drug candidates and a solid financial foundation, aiming to validate its hypotheses in systemic sclerosis and hidradenitis suppurativa [33]
Zura(ZURA) - 2025 Q1 - Quarterly Report
2025-05-08 10:55
(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Cayman Islands 98-1725736 (State or other jurisdiction of incorporation or organization) 1489 W. Warm Springs Rd. #110 Henderson, NV 89014 (I.R.S. Employer Identification No.) (Address of principal executive offices) (Zip Code) For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SE ...
Zura(ZURA) - 2025 Q1 - Quarterly Results
2025-05-08 10:50
Exhibit 99.1 Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates 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 ...
Zura(ZURA) - 2024 Q4 - Annual Results
2025-03-25 10:50
Financial Position - Zura Bio reported cash and cash equivalents of $176.5 million as of December 31, 2024, up from $99.8 million as of December 31, 2023, indicating a significant increase of 76.8%[9]. - Zura Bio's total assets increased to $179.5 million as of December 31, 2024, compared to $100.8 million in 2023, indicating strong growth in the company's financial position[18]. - Zura Bio completed a $112.5 million private placement financing in April 2024, contributing to a total cash position that supports operations through 2027[6]. Expenses - Research and development expenses decreased to $24.4 million for the year ended December 31, 2024, down 44.5% from $44.0 million in 2023, primarily due to a one-time acquisition cost in the previous year[10]. - General and administrative expenses rose to $30.8 million in 2024, an increase of 65.5% compared to $18.6 million in 2023, driven by higher compensation and professional fees[11]. - The total operating expenses for 2024 were $55.2 million, a decrease from $62.6 million in 2023, reflecting improved cost management[20]. Net Loss - The net loss for the year ended December 31, 2024, was $45.4 million, or $0.60 per share, a reduction from a net loss of $69.2 million, or $2.09 per share, in 2023[12]. Clinical Development - Zura Bio initiated the Phase 2 TibuSURE trial for systemic sclerosis (SSc) in December 2024, marking a key milestone in its clinical pipeline[4]. - The company plans to launch a Phase 2 trial for hidradenitis suppurativa (HS) in Q2 2025, further expanding its clinical research efforts[7]. - The company established a Scientific Advisory Board in June 2024, enhancing its clinical and scientific leadership capabilities[13].
Down -35.58% in 4 Weeks, Here's Why You Should You Buy the Dip in Zura Bio Limited (ZURA)
ZACKS· 2025-01-24 15:36
Group 1 - Zura Bio Limited (ZURA) has experienced a significant downtrend, with a stock decline of 35.6% over the past four weeks, indicating strong selling pressure [1] - The stock is currently in oversold territory, with an RSI reading of 29.75, suggesting a potential reversal in trend [5] - Wall Street analysts have raised earnings estimates for ZURA, with a consensus EPS estimate increase of 8.9% over the last 30 days, indicating a positive outlook for the company's earnings [6] Group 2 - ZURA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which further supports the potential for a turnaround [7] - The RSI is a commonly used technical indicator for identifying oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - The upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, reinforcing the potential for ZURA's stock to recover [6]