Summary of Zura Bio Limited Conference Call Company Overview - **Company Name**: Zura Bio Limited - **Focus**: Autoimmune inflammatory disorders - **Lead Program**: Tibulizumab, a bispecific antibody targeting IL-17A and BAFF [3][4] Key Points Transition and Leadership - Newly appointed CEO Sandeep Kulkarni emphasizes the transition from an execution-focused company to a data-driven one, with significant readouts expected in the next 12-18 months [4][5] - Kulkarni has been involved with Zura since its founding in 2022 and has a long history with the company [4] Product Pipeline - **Tibulizumab**: - First readout expected in Q4 2023 for hidradenitis suppurativa (HS) [6] - Second readout in the first half of 2027 for systemic sclerosis (SSc) [6] - Unique in its dual targeting mechanism, addressing unmet needs in complex autoimmune disorders [5][6] - **Additional Assets**: - IL-7 receptor antibody (crebankitug) from Pfizer - IL-33 (torudokimab) from Lilly - Focus remains primarily on tibulizumab due to resource constraints [10] Clinical Development Strategy - Emphasis on recruiting the right patients and ensuring high-quality execution of clinical trials [9] - The HS study has been expanded to 225 patients to enhance statistical power, with a primary endpoint of abscess and nodule (AN) count [24][29] - Secondary focus on HiSCR (Hidradenitis Suppurativa Clinical Response) with a target delta of 20%-25% over placebo [31] Mechanism of Action and Efficacy - Tibulizumab combines the properties of two established antibodies, targeting both IL-17 and BAFF, which are implicated in HS and SSc [11][12] - Evidence suggests B-cell involvement in HS, with elevated BAFF levels in lesions, supporting the rationale for targeting this pathway [18][19] Challenges and Considerations - High placebo response rates in HS necessitate careful study design and monitoring [24] - The complexity of SSc presents challenges, but the dual-target approach may offer new therapeutic avenues [36] Future Directions - Zura is exploring additional indications beyond HS and SSc, focusing on areas with significant unmet needs and potential for clinical validation [44][46] - The company is cautious with capital allocation and prioritization of future studies [10][45] Additional Insights - The bispecific nature of tibulizumab is seen as a potential breakthrough in treating autoimmune disorders, which often involve multiple pathways [5][6] - The company is committed to rigorous data quality and monitoring throughout clinical trials to maximize the chances of success [25][26] This summary encapsulates the key points discussed during the conference call, highlighting Zura Bio Limited's strategic focus, product pipeline, and future directions in the context of autoimmune disorder treatment.

February 11, 2026 Nasdaq Ticker: ZURA Forward-looking statements disclaimer Corporate overview Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio's expectations regarding its product candidates and their related benefits, and Zura Bio's beliefs regarding competing product candidates and products both in development and ...

Core Insights - Zura Bio Limited is a clinical-stage biotechnology company focused on developing innovative treatments for serious autoimmune and inflammatory diseases [1][3] - The company will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit on February 11, 2026, and will hold one-on-one investor meetings on the same day [1] Company Overview - Zura is developing dual-pathway antibodies aimed at addressing unmet needs in autoimmune and inflammatory diseases [3] - The company's pipeline includes candidates targeting immune system imbalances to enhance efficacy, safety, and dosing convenience [3] Product Pipeline - Zura's lead product candidate, tibulizumab (ZB-106), is currently in two Phase 2 clinical studies: TibuSHIELD for hidradenitis suppurativa and TibuSURE for systemic sclerosis [4] - Additional candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [4]

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]

Core Viewpoint - Zura Bio Limited is a clinical-stage biotechnology company focused on developing innovative treatments for serious autoimmune and inflammatory diseases, and it has provided business updates along with an outlook for 2026 [1] Business Updates - The company is looking forward to significant developments in 2026, particularly with two potentially transformative readouts for its drug tibulizumab expected within the next 18 months [1]

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].