Core Viewpoint - Zura Bio Limited has appointed Dr. Sandeep Kulkarni as the new CEO, effective January 21, 2026, succeeding Kim Davis, who served as Interim CEO since October 2025 [1][2][3] Leadership Transition - Dr. Kulkarni will also continue his role as a Director of Zura, while Kim Davis will retain her positions as Chief Operating Officer, Chief Legal Officer, and Corporate Secretary [2] - Robert Lisicki, the previous CEO, is resigning effective January 21, 2026, after taking a medical leave of absence [2] Dr. Kulkarni's Background - Dr. Kulkarni has over two decades of experience in biotechnology, investment, entrepreneurship, and medicine, previously serving as co-founder and CEO of Tourmaline Bio [3][5] - His leadership at Tourmaline Bio included guiding the company through its acquisition by Novartis, which was completed in October 2025 [3] Company Strategy and Pipeline - Zura is entering a critical period with two potentially transformative readouts expected over the next 18 months [3] - The lead program, tibulizumab, is a bispecific antibody targeting IL-17 and BAFF pathways, validated in multiple autoimmune diseases, and is among the most advanced in development for such conditions [4][7] - Zura's pipeline includes additional candidates like crebankitug and torudokimab, which have completed Phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [7]

HENDERSON, Nev.--(BUSINESS WIRE)---- $ZURA #TeamZura--Zura Bio Limited (Nasdaq: ZURA) ("Zura†), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory diseases, today reported business updates and updated its outlook for 2026. "We are excited to enter 2026, as we get closer to two potentially transformative readouts over the next 18 months for tibulizumab, starting with ant ...

Group 1 - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 100 points on Monday [1] - DigitalBridge Group Inc announced its acquisition by SoftBank Group for an enterprise value of approximately $4.0 billion, resulting in a 9.9% increase in its shares to $15.30 [1] Group 2 - Eightco Holdings Inc shares surged 29.1% to $2.15 following the announcement of a share buyback program for up to $125 million [2] - Palisade Bio Inc saw an 18.6% increase to $2.55 after Piper Sandler initiated coverage with an Overweight rating and a price target of $25 [2] - Regencell Bioscience Holdings Ltd gained 16.3% to $24.60 [2] - Praxis Precision Medicines Inc surged 13% to $304.00 after receiving Breakthrough Therapy Designation from the FDA for ulixacaltamide [2] - Zura Bio Ltd increased by 13% to $5.26 [2] - Precigen Inc rose 8.6% to $4.52 [2] - Autolus Therapeutics PLC jumped 7.8% to $1.80, with Needham analyst raising the price target from $10 to $11 [2] - LightPath Technologies Inc gained 6.6% to $9.62 [2] - NGL Energy Partners LP surged 6.3% to $9.98 [2] - Six Flags Entertainment Corp increased by 5% to $15.64 [2]

Core Insights - Zura Bio Limited (NASDAQ:ZURA) has shown strong performance over the past three months and is identified as one of the 12 hot penny stocks to invest in currently [1] - Guggenheim has reiterated a "Buy" rating for Zura Bio with a price target of $15, reflecting a bullish outlook amid the progress of the tibulizumab Phase 2 clinical trial [2] Financial Performance - For Q3 2025, Zura Bio reported $139 million in cash, which is expected to fund operations until 2027 [3] - The company experienced an increase in R&D expenses to $11.9 million due to the tibulizumab Phase 2 clinical trial, while G&A expenses decreased to $7.6 million [3] - The net loss for the quarter was $20 million, or $0.21 per share, an improvement from the previous year's loss of $22.9 million, or $0.26 per share [3] Clinical Development - Zura Bio is advancing two Phase 2 studies for tibulizumab: TibuSHIELD for hidradenitis suppurativa and TibuSURE for systemic sclerosis [4] - TibuSHIELD is on track to deliver topline data in Q3 2026, while TibuSURE's data is anticipated in Q4 2026 [4] - Management is focused on patient enrollment and addressing competitive trial recruitment dynamics [4] Company Overview - Zura Bio Limited is a clinical-stage immunology company that develops dual-pathway antibodies targeting autoimmune and inflammatory diseases [5]

Financial Performance - Total assets decreased from $179,533,000 as of December 31, 2024, to $143,935,000 as of September 30, 2025, representing a decline of approximately 19.87%[12] - Net loss attributable to Class A Ordinary Shareholders increased from $22,942,000 in Q3 2024 to $20,037,000 in Q3 2025, indicating a decrease in loss of about 12.6%[14] - The company reported a net loss per share attributable to Class A Ordinary Shareholders of $(0.21) for Q3 2025, compared to $(0.26) for Q3 2024, reflecting an improvement of approximately 19.2%[14] - The Company has incurred operating losses since inception and expects to continue incurring significant operating losses for the foreseeable future[39] - The Company has an accumulated deficit of $207.4 million as of September 30, 2025, and a net loss of $18.0 million for the three months ended September 30, 2025[39] Cash and Cash Equivalents - Cash and cash equivalents decreased from $176,498,000 as of December 31, 2024, to $139,017,000 as of September 30, 2025, a decline of about 21.3%[12] - The cash and cash equivalents at the end of the period were $139,017,000, down from $188,221,000 at the end of September 30, 2024[28] - Cash equivalents as of September 30, 2025, were valued at $135.9 million, down from $170.7 million as of December 31, 2024, indicating a decrease of 20.4%[67] - The Company has significant cash balances exceeding the federally insured limit of $250,000, which could impact its financial condition if access to these funds is restricted[48] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $56,835,000, compared to $39,457,000 for the same period in 2024, reflecting a year-over-year increase of approximately 44.1%[14] - Research and development expenses increased significantly from $6,029,000 in Q3 2024 to $11,948,000 in Q3 2025, a rise of approximately 98.5%[14] - The company reported a net cash used in operating activities of $42,537,000 for the nine months ended September 30, 2025, compared to $17,252,000 for the same period in 2024[28] Shareholder Equity and Shares - As of September 30, 2025, the total shareholders' equity was $109,784,000, with a net loss of $51,475,000 for the period[24] - The number of Class A Ordinary Shares issued and outstanding as of September 30, 2025, was 65,018,058, compared to 65,297,530 as of December 31, 2024, indicating a slight decrease[12] - The Company has authorized 300,000,000 Class A Ordinary Shares and 1,000,000 preferred shares as of March 16, 2023[90] - The Company issued 20,090,128 Class A Ordinary Shares in connection with the April 2024 Private Placement, net of $7.2 million in transaction costs[26] - During the nine months ended September 30, 2025, the Company sold 3,000,000 Class A Ordinary Shares at a price of $1.75 per share, generating net proceeds of $5.1 million[95] Liabilities - The total liabilities remained constant at $25,491,000 as of September 30, 2025, compared to $19,514,000 as of December 31, 2024, indicating no increase in liabilities despite the decrease in assets[12] - As of September 30, 2025, the total accounts payable and accrued expenses amounted to $25.5 million, an increase from $19.5 million as of December 31, 2024, representing a 30.5% increase[70] Clinical Development - The company has one clinical-stage product candidate, tibulizumab (ZB-106), currently in ongoing Phase 2 trials[32] - The Company initiated the TibuSHIELD Phase 2 clinical study in May 2025, evaluating tibulizumab in approximately 180 adults with moderate to severe hidradenitis suppurativa[36] - The Company is actively assessing additional development opportunities within its pipeline, focusing on indications with unmet needs and commercial potential[32] - The Company is evaluating potential therapeutic indications for crebankitug and torudokimab as part of its strategic focus[34] Share-Based Compensation - Share-based compensation expense for the nine months ended September 30, 2025, was $9,755,000, compared to $13,981,000 for the same period in 2024[28] - The total share-based compensation expense for the nine months ended September 30, 2025 was $9,755,000, compared to $13,981,000 for the same period in 2024, reflecting a decrease of approximately 30%[122] - The company recognized $1.3 million in share-based compensation expense related to RSUs for the nine months ended September 30, 2025, down from $1.6 million in 2024[117] - The company recognized $0.3 million in share-based compensation expense related to RSAs for the nine months ended September 30, 2025, consistent with the same period in 2024[118] - The redeemable noncontrolling interest balance was $8.7 million as of September 30, 2025, down from $11.7 million as of December 31, 2024[126] Future Expectations and Regulations - The Company expects to no longer be classified as an emerging growth company effective December 31, 2026[38] - The Company expects to adopt ASU 2024-03 for the year ending December 31, 2027, which will require additional disclosures in financial statements[63] Financing Activities - The total cash flows from financing activities for the nine months ended September 30, 2025, were $5,152,000, compared to $110,697,000 for the same period in 2024[28] - The Company received $56.7 million in net cash proceeds upon the closing of the Business Combination and raised an additional $105.3 million from the sale of Class A Ordinary Shares in April 2024[40] Agreements and Obligations - The Company is obligated to make contingent payments to Lilly, including up to $155 million in development milestone payments and up to $440 million in sales milestone payments based on net sales thresholds for products developed from tibulizumab[78] - The Company has not made a $5.0 million milestone payment to BAFFX17 as of September 30, 2025, which is due upon certain conditions being met[75] - The Company is required to make a one-time payment of $4.5 million to Stone Peach upon FDA acceptance for its Investigational New Drug for tibulizumab, which was recorded in research and development expenses for the year ended December 31, 2024[74] - The Company has not recorded any Pfizer Contingent Payments as of September 30, 2025, as none are due at this time[85] Licensing and Agreements - The Company entered into a license agreement with Lonza Sales AG, resulting in an annual license fee of $0.4 million starting in 2023[87] - The Company has a biologics master services agreement with WuXi Biologics, with fees recognized as research and development expenses as incurred[88] - The Cell Line License Agreement with WuXi Biologics requires royalty payments based on a single-digit percentage of global net sales if manufacturing is done by third parties[89]

Financial Position - Zura Bio reported cash and cash equivalents of $139.0 million as of September 30, 2025, expected to fund operations through 2027[4]. - The Company’s accumulated deficit increased to $207.4 million as of September 30, 2025, compared to $155.9 million at the end of 2024[16]. - Zura Bio's total assets decreased to $143.9 million as of September 30, 2025, from $179.5 million at the end of 2024[16]. Research and Development - Research and Development (R&D) expenses for Q3 2025 were $11.9 million, up from $6.0 million in Q3 2024, reflecting ongoing Phase 2 clinical trials for tibulizumab[7]. - The Company is advancing two Phase 2 clinical trials for tibulizumab, with topline data expected in the second half of 2026 for both trials[4]. - Zura Bio's lead product candidate, tibulizumab, is being evaluated in two Phase 2 studies targeting systemic sclerosis and hidradenitis suppurativa[11]. - The Company continues to monitor timelines and evaluate strategies for its clinical studies in light of competitive patient enrollment and regulatory factors[3]. Operating Expenses - General and Administrative (G&A) expenses decreased to $7.6 million in Q3 2025 from $13.3 million in Q3 2024, primarily due to a one-time non-cash expense in share-based compensation in the previous year[8]. - Total operating expenses for Q3 2025 were $19.5 million, slightly higher than $19.3 million in Q3 2024[18]. Net Loss - Net loss for Q3 2025 was $20.0 million, or $0.21 per share, compared to a net loss of $22.9 million, or $0.26 per share, in Q3 2024[9].

Core Insights - Zura Bio Limited reported its financial results for the third quarter of 2025, highlighting advancements in its clinical programs and a strong cash position [1][4]. Financial Performance - As of September 30, 2025, Zura Bio had cash and cash equivalents of $139.0 million, expected to support operations through 2027 [4][7]. - Research and Development (R&D) expenses for Q3 2025 were $11.9 million, up from $6.0 million in Q3 2024, reflecting ongoing Phase 2 clinical trials for tibulizumab [5]. - General and Administrative (G&A) expenses decreased to $7.6 million in Q3 2025 from $13.3 million in Q3 2024, primarily due to a one-time non-cash expense in share-based compensation in the previous year [6]. - The net loss for Q3 2025 was $20.0 million, or $0.21 per share, compared to a net loss of $22.9 million, or $0.26 per share, for the same period in 2024 [9][17]. Clinical Development Updates - Zura Bio is advancing two Phase 2 studies of tibulizumab, targeting hidradenitis suppurativa (TibuSHIELD) and systemic sclerosis (TibuSURE), with topline data expected in the second half of 2026 [2][8]. - The company is focused on disciplined study execution and patient enrollment to generate meaningful data in these important disease areas [2][3]. Pipeline Overview - Zura Bio's lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies [11]. - Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being assessed for various autoimmune and inflammatory conditions [11].

Core Insights - 2026 is anticipated to be a crucial year for Zura Bio Ltd. (ZURA) as key data readouts for its lead investigational drug, Tibulizumab, are expected to significantly impact the company's strategic direction and market position [1] Company Overview - Zura Bio is a clinical-stage, multi-asset immunology company focused on developing treatments for immune-mediated diseases with unmet medical needs [1] - The lead product candidate, Tibulizumab, is a potential first-in-class dual-pathway biologic targeting cytokines IL-17A and BAFF [1] Clinical Trials - Tibulizumab is currently being evaluated in two global phase 2 studies: TibuSHIELD and TibuSURE [2][6] - TibuSHIELD is assessing Tibulizumab in adults with moderate to severe Hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting approximately 1% of the global population [3][5] - The TibuSHIELD trial, initiated in May 2025, aims to enroll about 180 adults and includes a 16-week efficacy assessment followed by a 12-week safety follow-up [5] - Topline results from the TibuSHIELD trial are expected in Q3 2026 [6] - TibuSURE is evaluating Tibulizumab for systemic sclerosis (SSc), a rare autoimmune disease affecting around 300,000 individuals worldwide [7][8] - The TibuSURE study, initiated in December 2024, plans to enroll roughly 80 participants and includes a 24-week efficacy period [8] - Topline results from the TibuSURE study are anticipated in Q4 2026 [9] Pipeline and Financial Position - Zura Bio has two additional investigational drugs, Crebankitug and Torudokimab, which have completed phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [9] - As of June 30, 2025, Zura Bio had cash and cash equivalents of $154.5 million, projected to support operations until 2027 [10] - Zura Bio made its Nasdaq debut on March 21, 2023, under the ticker symbol "ZURA" following a merger with JATT Acquisition Corp [10] Stock Performance - Over the past year, ZURA's stock has traded between $0.97 and $5.07, closing at $4.17, reflecting a 6.10% increase [11]

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.

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 ...