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ZURA

Zura BioC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-11
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Investor releaseQuarter not tagged2026-08-11

Zura Bio Reports Second Quarter 2026 Financial Results and Recent Corporate Updates

Business Wire
TibuSHIELD enrollment complete, exceeding initial enrollment target with 247 participants randomized in HS; topline data expected Q4 2026 TibuSURE enrollment complete, exceeding initial enrollment target with 91 participants randomized in SSc; topline data expected H1 2027 Zura plans to initiate a Phase 2 study for tibulizumab in polymyalgia rheumatica (PMR) by year-end 2026 Cash and cash equivalents of $205.1 million as of June 30, 2026, which is expected to fund planned operations through at least the end of 2028 HENDERSON, Nev., August 11, 2026--(BUSINESS WIRE)--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 announced financial results for the second quarter ended June 30, 2026, and provided recent corporate updates. "The second quarter was marked by strong execution across our tibulizumab programs, with enrollment now complete in both TibuSHIELD and TibuSURE—each exceeding its initial enrollment target—underscoring growing conviction in dual IL-17 and BAFF inhibition," said Sandeep Kulkarni, M.D., Chief Executive Officer of Zura. "We are excited to nominate polymyalgia rheumatica as the third indication for tibulizumab, a debilitating disorder with high unmet need and important evidence supporting the roles of both IL-17 and BAFF. With cash expected to fund planned operations through at least the end of 2028, we believe we are well positioned—operationally, financially, and scientifically—as we approach our first topline readout in the fourth quarter of this year." PROGRAM UPDATES Tibulizumab (ZB‑106) Zura has completed enrollment in both Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17 (IL-17) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis, and announced plans to initiate a Phase 2 study in a third indication for tibulizumab by year end 2026. TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adults with hidradenitis suppurativa (HS) has completed and exceeded enrollment, with 247 participants. Topline data are anticipated in the fourth quarter of 2026. TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adults with SSc has completed and exceeded…Read full document

TibuSHIELD enrollment complete, exceeding initial enrollment target with 247 participants randomized in HS; topline data expected Q4 2026 TibuSURE enrollment complete, exceeding initial enrollment target with 91 participants randomized in SSc; topline data expected H1 2027 Zura plans to initiate a Phase 2 study for tibulizumab in polymyalgia rheumatica (PMR) by year-end 2026 Cash and cash equivalents of $205.1 million as of June 30, 2026, which is expected to fund planned operations through at least the end of 2028 HENDERSON, Nev., August 11, 2026--(BUSINESS WIRE)--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 announced financial results for the second quarter ended June 30, 2026, and provided recent corporate updates. "The second quarter was marked by strong execution across our tibulizumab programs, with enrollment now complete in both TibuSHIELD and TibuSURE—each exceeding its initial enrollment target—underscoring growing conviction in dual IL-17 and BAFF inhibition," said Sandeep Kulkarni, M.D., Chief Executive Officer of Zura. "We are excited to nominate polymyalgia rheumatica as the third indication for tibulizumab, a debilitating disorder with high unmet need and important evidence supporting the roles of both IL-17 and BAFF. With cash expected to fund planned operations through at least the end of 2028, we believe we are well positioned—operationally, financially, and scientifically—as we approach our first topline readout in the fourth quarter of this year." PROGRAM UPDATES Tibulizumab (ZB‑106) Zura has completed enrollment in both Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17 (IL-17) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis, and announced plans to initiate a Phase 2 study in a third indication for tibulizumab by year end 2026. TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adults with hidradenitis suppurativa (HS) has completed and exceeded enrollment, with 247 participants. Topline data are anticipated in the fourth quarter of 2026. TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adults with SSc has completed and exceeded enrollment, with 91 participants. Topline data are anticipated in the first half of 2027. NEXUS-PMR (PMR) — new indication: Zura has selected PMR as the third indication for tibulizumab. PMR is a common inflammatory rheumatic disease of older adults characterized by disabling bilateral shoulder and hip-girdle pain and stiffness, for which treatment options beyond long-term glucocorticoids remain limited. Over 700,000 people live with PMR today in the United States and the standard of care leaves most patients steroid-dependent, with a median time to permanent discontinuation of glucocorticoids of approximately six years. Zura believes tibulizumab's combined inhibition of IL‑17 and BAFF may provide greater and more durable therapeutic benefit relative to other agents that only block a single pathway. Zura has engaged with the U.S. Food and Drug Administration (FDA) and received feedback that was constructive and supportive of the Company's proposed development strategy. Incorporating this feedback, Zura plans to initiate a Phase 2 study, NEXUS-PMR, evaluating tibulizumab in adult participants with PMR by year end 2026. Tibulizumab is an investigational compound and has not been approved for marketing by the FDA or any other regulatory authority. Additional Clinical Stage Product Candidates In addition to tibulizumab, Zura is continuing its evaluation of potential development approaches for torudokimab (ZB‑880) and crebankitug (ZB‑168), informed by current clinical and translational evidence and ongoing assessment of the evolving competitive landscape. SECOND QUARTER 2026 FINANCIAL RESULTS Cash Position As of June 30, 2026, Zura had cash and cash equivalents of $205.1 million. Zura expects that its existing cash and cash equivalents are sufficient to support planned operations through at least the end of 2028. Research and Development (R&D) Expenses R&D expenses were $20.7 million for the second quarter of 2026, compared to $8.7 million for the same period in 2025. The increase was primarily driven by the advancement of Zura’s Phase 2 tibulizumab clinical programs. General and Administrative (G&A) Expenses G&A expenses were $8.6 million for the second quarter of 2026, compared to $9.4 million for the same period in 2025. The decrease was primarily due to lower expense in professional fees. Net loss for the second quarter of 2026 was $26.3 million, or $0.21 per share, compared to $16.0 million, or $0.17 per share, for the same period in 2025. ABOUT ZURA Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura’s lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa (HS), and TibuSURE, a study in systemic sclerosis (SSc). Additional product candidates torudokimab (ZB-880) and crebankitug (ZB-168) have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. FORWARD-LOOKING STATEMENTS Any statements contained in this press release that do not describe historical facts may constitute "forward‑looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "anticipate," "believe," "continue," "could," "designed to," "expect," "goal," "intend," "may," "outlook," "plan," "potential," "should," "will," and similar expressions, and are based on Zura’s current beliefs and expectations. These forward‑looking statements include, but are not limited to, statements regarding the development and potential therapeutic benefits of Zura’s product candidates; the initiation, timing, progress, design and results of Zura’s current and future clinical trials, including the anticipated reporting of data therefrom; the potential to expand Zura’s product candidates into additional indications; Zura's interactions and engagement with the FDA, and the outcome of any related feedback on Zura's development strategy; Zura's evaluation of potential development approaches for its product candidates; the sufficiency of Zura’s cash resources and projected cash runway; and other statements that are not historical facts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward‑looking statements. Risks and uncertainties that may cause actual results to differ materially include, but are not limited to: uncertainties inherent in the development of therapeutic product candidates, such as the risk that one or more of Zura’s current or future product candidates may not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Zura’s current or future product candidates; the risk that prior results, including signals of safety, activity or durability of effect observed in preclinical studies or earlier clinical trials, may not be replicated or may not continue in ongoing or future studies or clinical trials; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, may not be predictive of results in Zura’s current or future clinical trials; the risk that Zura’s product candidates or procedures in connection with their administration may not have the safety or efficacy profiles anticipated; risks related to the accuracy of Zura’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; uncertainties related to the timing and outcome of the regulatory approval process; unexpected litigation or other disputes; the impact of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties described in Zura’s Annual Report on Form 10‑K for the year ended December 31, 2025, and other filings with the Securities and Exchange Commission. Any forward‑looking statements speak only as of the date of this press release and are based on information available to Zura as of the date hereof. Zura assumes no obligation to, and does not intend to, update any forward‑looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260811021983/en/ Contacts Investor and media inquiries:[email protected]

Investor releaseQuarter not tagged2026-05-07

Zura Bio Reports First Quarter 2026 Financial Results and Recent Corporate Updates

Business Wire
Continuing advancement of two Phase 2 studies evaluating tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic sclerosis (SSc) (TibuSURE), with both trials on track to meet anticipated timelines Strengthened leadership team with key executive and Board appointments Completed an underwritten public offering in February 2026, resulting in gross proceeds of approximately $144 million to support advancement of its pipeline Cash and cash equivalents of $225.6 million as of March 31, 2026, which is expected to fund planned operations through at least the end of 2028 HENDERSON, Nev., May 07, 2026--(BUSINESS WIRE)--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 announced financial results for the first quarter ended March 31, 2026, and provided recent corporate updates. "We entered the second quarter with a strengthened balance sheet and strengthened team, reflecting growing conviction in bispecific approaches and increased appreciation for IL‑17 and BAFF biology" said Sandeep Kulkarni, M.D., Chief Executive Officer of Zura. "We believe we are well positioned—operationally, financially, and scientifically—as we approach anticipated tibulizumab readouts starting later this year." PROGRAM UPDATES Tibulizumab (ZB‑106) During the first quarter of 2026, Zura continued to advance its two ongoing Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17 (IL-17) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis. TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adult participants with HS is ongoing, with enrollment of approximately 225 patients on track. Topline data are anticipated in the fourth quarter of 2026. TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with enrollment of approximately 80 patients on track. Topline data are anticipated in the first half of 2027. Additionally, Zura is conducting a disciplined evaluation of potential new indications for tibulizumab. Additional Clinical Stage Product Candidates In addition to tibulizumab, Zura is continuing its evaluation of potential development approaches for tor…Read full document

Continuing advancement of two Phase 2 studies evaluating tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic sclerosis (SSc) (TibuSURE), with both trials on track to meet anticipated timelines Strengthened leadership team with key executive and Board appointments Completed an underwritten public offering in February 2026, resulting in gross proceeds of approximately $144 million to support advancement of its pipeline Cash and cash equivalents of $225.6 million as of March 31, 2026, which is expected to fund planned operations through at least the end of 2028 HENDERSON, Nev., May 07, 2026--(BUSINESS WIRE)--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 announced financial results for the first quarter ended March 31, 2026, and provided recent corporate updates. "We entered the second quarter with a strengthened balance sheet and strengthened team, reflecting growing conviction in bispecific approaches and increased appreciation for IL‑17 and BAFF biology" said Sandeep Kulkarni, M.D., Chief Executive Officer of Zura. "We believe we are well positioned—operationally, financially, and scientifically—as we approach anticipated tibulizumab readouts starting later this year." PROGRAM UPDATES Tibulizumab (ZB‑106) During the first quarter of 2026, Zura continued to advance its two ongoing Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17 (IL-17) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis. TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adult participants with HS is ongoing, with enrollment of approximately 225 patients on track. Topline data are anticipated in the fourth quarter of 2026. TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with enrollment of approximately 80 patients on track. Topline data are anticipated in the first half of 2027. Additionally, Zura is conducting a disciplined evaluation of potential new indications for tibulizumab. Additional Clinical Stage Product Candidates In addition to tibulizumab, Zura is continuing its evaluation of potential development approaches for torudokimab (ZB‑880) and crebankitug (ZB‑168), informed by current clinical and translational evidence and ongoing assessment of the evolving competitive landscape. CORPORATE HIGHLIGHTS In January 2026, Zura appointed Sandeep Kulkarni, M.D., as Chief Executive Officer. In February 2026, Zura appointed Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., to its Board of Directors. Dr. Eisner, is a seasoned biotechnology executive with over 25 years of leadership in clinical development and immunology and recently served as Executive Vice President and Chief Medical Officer of Vir Biotechnology. Dr. Nirula, is an accomplished physician-scientist and immunology leader who currently serves as president, and head of research and development at Recludix. He previously served as Senior Vice President and Immunology Therapeutic Area Head at Eli Lilly. In February 2026, Zura closed an underwritten public offering of Class A ordinary shares and pre-funded warrants to purchase Class A ordinary shares, resulting in gross proceeds of approximately $144 million, before deducting underwriting discounts, commissions, and offering expenses. The proceeds are expected to support continued advancement of the Company’s pipeline and broader strategic development initiatives. FIRST QUARTER 2026 FINANCIAL RESULTS Cash Position As of March 31, 2026, Zura had cash and cash equivalents of $225.6 million. Zura expects that its existing cash and cash equivalents are sufficient to support planned operations through at least the end of 2028. Research and Development (R&D) Expenses R&D expenses were $14.7 million for the first quarter of 2026, compared to $10.5 million for the first quarter of 2025. The increase was primarily driven by the continued advancement of Zura’s Phase 2 tibulizumab clinical programs. General and Administrative (G&A) Expenses G&A expenses were $10.8 million for the first quarter of 2026, compared to $8.8 million for the first quarter of 2025. The increase was primarily due to an increase in compensation expense, including share-based compensation and professional fees to support the Company’s growth and advancement of its clinical programs. Net Loss Net loss for the first quarter of 2026 was $24.2 million, or $0.22 per share, compared to $17.4 million, or $0.19 per share, for the same period in 2025. ABOUT ZURA Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura’s lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa (HS), and TibuSURE, a study in systemic sclerosis (SSc). Additional product candidates torudokimab (ZB-880) and crebankitug (ZB-168) have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. FORWARD-LOOKING STATEMENTS Any statements contained in this press release that do not describe historical facts may constitute "forward‑looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "anticipate," "believe," "continue," "could," "designed to," "expect," "goal," "intend," "may," "outlook," "plan," "potential," "should," "will," and similar expressions, and are based on Zura’s current beliefs and expectations. These forward‑looking statements include, but are not limited to, statements regarding the development and potential therapeutic benefits of Zura’s product candidates; the timing, progress, design and results of Zura’s current and future clinical trials, including the anticipated reporting of data therefrom; the potential to expand Zura’s product candidates into additional indications; the sufficiency of Zura’s cash resources and projected cash runway; and other statements that are not historical facts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward‑looking statements. Risks and uncertainties that may cause actual results to differ materially include, but are not limited to: uncertainties inherent in the development of therapeutic product candidates, such as the risk that one or more of Zura’s current or future product candidates may not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Zura’s current or future product candidates; the risk that prior results, including signals of safety, activity or durability of effect observed in preclinical studies or earlier clinical trials, may not be replicated or may not continue in ongoing or future studies or clinical trials; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, may not be predictive of results in Zura’s current or future clinical trials; the risk that Zura’s product candidates or procedures in connection with their administration may not have the safety or efficacy profiles anticipated; risks related to the accuracy of Zura’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; uncertainties related to the timing and outcome of the regulatory approval process; unexpected litigation or other disputes; the impact of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties to be described in Zura’s Annual Report on Form 10‑K for the year ended December 31, 2025, and other filings with the Securities and Exchange Commission. Any forward‑looking statements speak only as of the date of this press release and are based on information available to Zura as of the date hereof. Zura assumes no obligation to, and does not intend to, update any forward‑looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507541381/en/ Contacts Investor and media inquiries: [email protected]

Investor releaseQuarter not tagged2026-03-20

Zura Bio Reports Full Year 2025 Financial Results and Recent Corporate Updates

Business Wire
Advancing two Phase 2 studies evaluating tibulizumab in hidradenitis suppurativa (HS) and systemic sclerosis (SSc) Topline data expected from the Phase 2 TibuSHIELD study in HS in the fourth quarter of 2026 and from the Phase 2 TibuSURE study in SSc in the first half of 2027 Cash and cash equivalents of $109.4 million as of December 31, 2025 Completed an underwritten public offering in February 2026 for gross proceeds of approximately $144 million; post‑financing cash and cash equivalents expected to support planned operations through at least the end of 2028 HENDERSON, Nev., March 19, 2026--(BUSINESS WIRE)--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 financial results for the full year ended December 31, 2025, and provided recent corporate updates. "2025 was a year of strong execution for Zura, marked by meaningful progress across our Phase 2 programs and a disciplined focus on advancing our clinical strategy," said Sandeep Kulkarni, M.D., co‑founder and Chief Executive Officer of Zura Bio. "We enter 2026 with momentum, supported by a strengthened balance sheet and a focused plan to advance tibulizumab, our lead program and a potential first‑ and only‑in‑class bispecific antibody targeting the interleukin‑17 and B‑cell activating factor pathways. With multiple anticipated Phase 2 data readouts ahead, including topline data from our TibuSHIELD study expected in the fourth quarter of 2026, we believe Zura is well positioned as we move into an important phase of clinical execution and value creation." CORPORATE HIGHLIGHTS AND ANTICIPATED MILESTONES Tibulizumab (ZB‑106) Hidradenitis suppurativa (HS) – Phase 2 TibuSHIELD The Phase 2 TibuSHIELD clinical study evaluating tibulizumab in adult participants with HS is ongoing. To enhance statistical power, Zura expanded planned enrollment to 225 participants. Topline data are anticipated in the fourth quarter of 2026. Systemic sclerosis (SSc) – Phase 2 TibuSURE The Phase 2 TibuSURE clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with topline data anticipated in the first half of 2027. Additional Clinical Stage Product Candidates In addition to tibulizumab, Zura is continuing t…Read full document

Advancing two Phase 2 studies evaluating tibulizumab in hidradenitis suppurativa (HS) and systemic sclerosis (SSc) Topline data expected from the Phase 2 TibuSHIELD study in HS in the fourth quarter of 2026 and from the Phase 2 TibuSURE study in SSc in the first half of 2027 Cash and cash equivalents of $109.4 million as of December 31, 2025 Completed an underwritten public offering in February 2026 for gross proceeds of approximately $144 million; post‑financing cash and cash equivalents expected to support planned operations through at least the end of 2028 HENDERSON, Nev., March 19, 2026--(BUSINESS WIRE)--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 financial results for the full year ended December 31, 2025, and provided recent corporate updates. "2025 was a year of strong execution for Zura, marked by meaningful progress across our Phase 2 programs and a disciplined focus on advancing our clinical strategy," said Sandeep Kulkarni, M.D., co‑founder and Chief Executive Officer of Zura Bio. "We enter 2026 with momentum, supported by a strengthened balance sheet and a focused plan to advance tibulizumab, our lead program and a potential first‑ and only‑in‑class bispecific antibody targeting the interleukin‑17 and B‑cell activating factor pathways. With multiple anticipated Phase 2 data readouts ahead, including topline data from our TibuSHIELD study expected in the fourth quarter of 2026, we believe Zura is well positioned as we move into an important phase of clinical execution and value creation." CORPORATE HIGHLIGHTS AND ANTICIPATED MILESTONES Tibulizumab (ZB‑106) Hidradenitis suppurativa (HS) – Phase 2 TibuSHIELD The Phase 2 TibuSHIELD clinical study evaluating tibulizumab in adult participants with HS is ongoing. To enhance statistical power, Zura expanded planned enrollment to 225 participants. Topline data are anticipated in the fourth quarter of 2026. Systemic sclerosis (SSc) – Phase 2 TibuSURE The Phase 2 TibuSURE clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with topline data anticipated in the first half of 2027. Additional Clinical Stage Product Candidates In addition to tibulizumab, Zura is continuing to evaluate potential future development strategies for crebankitug (ZB‑168) and torudokimab (ZB‑880), informed by available clinical and translational data and by the evolving competitive landscape. 2026 UPDATES SUBSEQUENT TO YEAR END Leadership Updates In January 2026, Zura appointed Sandeep Kulkarni, M.D., as Chief Executive Officer. In February 2026, Zura appointed Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., to its Board of Directors. Balance Sheet Strengthening In February 2026, Zura closed an underwritten public offering of Class A ordinary shares and pre‑funded warrants to purchase Class A ordinary shares, resulting in gross proceeds of approximately $144 million, before deducting underwriting discounts, commissions, and offering expenses. FINANCIAL RESULTS FOR FULL YEAR 2025 Cash Position Cash and cash equivalents were $109.4 million as of December 31, 2025, compared to $176.5 million as of December 31, 2024. Cash Runway (Pro-Forma Post‑Financing) Based on its current operating plans, and after giving effect to the completion of the February 2026 public offering, Zura believes that its existing cash and cash equivalents are sufficient to support planned operations through at least the end of 2028. Research and Development (R&D) Expenses R&D expenses were $42.1 million for the year ended December 31, 2025, compared to $24.4 million for the year ended December 31, 2024. The increase was primarily driven by continued advancement of Zura’s Phase 2 tibulizumab clinical programs, including increased payments to contract research organizations and contract development and manufacturing organizations. The increase was partially offset by the reversal of a $5.0 million accrued obligation following the December 29, 2025 BAFFX17 Settlement and Release Agreement. General and Administrative (G&A) Expenses G&A expenses were $33.2 million for the year ended December 31, 2025, compared to $30.8 million for the year ended December 31, 2024. The increase was primarily due to higher costs to support the Company’s continued growth and advancement of its Phase 2 tibulizumab clinical programs. Net Loss Net loss was $68.7 million for the year ended December 31, 2025, compared to $52.4 million for the year ended December 31, 2024. Net Loss Attributable to Class A Ordinary Shareholders Net loss attributable to Class A ordinary shareholders was $99.4 million, or $(1.06) per basic and diluted share, compared to $45.4 million, or $(0.60) per share, for the year ended December 31, 2024. ABOUT ZURA Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. Zura’s pipeline includes product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura’s lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies in adults: TibuSHIELD, a study in hidradenitis suppurativa (HS), and TibuSURE, a study in systemic sclerosis (SSc). Additional product candidates crebankitug (ZB-168) and torudokimab (ZB-880) have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. FORWARD-LOOKING STATEMENTS Any statements contained in this press release that do not describe historical facts may constitute "forward‑looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "anticipate," "believe," "continue," "could," "designed to," "expect," "goal," "intend," "may," "outlook," "plan," "potential," "should," "will," and similar expressions, and are based on Zura’s current beliefs and expectations. These forward‑looking statements include, but are not limited to, statements regarding the development and potential therapeutic benefits of Zura’s product candidates; the timing, progress, design and results of Zura’s current and future clinical trials, including the reporting of data therefrom; the timing and potential to expand Zura’s product candidates into additional indications; the sufficiency of Zura’s cash resources and projected cash runway; and other statements that are not historical facts. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such forward‑looking statements. Risks and uncertainties that may cause actual results to differ materially include, but are not limited to: uncertainties inherent in the development of therapeutic product candidates, such as the risk that one or more of Zura’s current or future product candidates may not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Zura’s current or future product candidates; the risk that prior results, including signals of safety, activity or durability of effect observed in preclinical studies or earlier clinical trials, may not be replicated or may not continue in ongoing or future studies or clinical trials; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, may not be predictive of results in Zura’s current or future clinical trials; the risk that Zura’s product candidates or procedures in connection with their administration may not have the safety or efficacy profiles anticipated; risks related to the accuracy of Zura’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; uncertainties related to the timing and outcome of the regulatory approval process; unexpected litigation or other disputes; the impact of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties to be described in Zura’s Annual Report on Form 10‑K for the year ended December 31, 2025, and other filings with the Securities and Exchange Commission. Any forward‑looking statements speak only as of the date of this press release and are based on information available to Zura as of the date hereof. Zura assumes no obligation to, and does not intend to, update any forward‑looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260319990599/en/ Contacts Megan K. Weinshank Head of Corporate Affairs [email protected]

Investor releaseQuarter not tagged2025-11-13

Zura Bio Reports Third Quarter 2025 Financial Results and Recent Corporate Updates

Business Wire
Continued advancement of two Phase 2 clinical trials evaluating tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic sclerosis (SSc) (TibuSURE), with topline data expected in the second half of 2026. Reported $139.0 million in cash and cash equivalents as of September 30, 2025, which is expected to fund planned operations through 2027. HENDERSON, Nev., November 13, 2025--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and pipeline updates. "Both tibulizumab studies advanced during the quarter," said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. "We continue to focus on disciplined study execution and patient enrollment across these important disease areas, with the aim of generating meaningful data." PROGRAM UPDATES Tibulizumab During the third quarter of 2025, Zura Bio continued to advance its two ongoing Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17A (IL-17A) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis. TibuSHIELD (HS): The Phase 2 clinical trial in adults with HS progressed as planned. Topline data are expected in the third quarter of 2026. TibuSURE (SSc): The Phase 2 clinical trial in adults with SSc continued to advance during the quarter. Topline data are expected in the fourth quarter of 2026. The Company continues to monitor timelines and evaluate strategy for both studies in light of the competitive landscape for patient enrollment and other external factors, including those that may impact regulatory matters and overall study execution. THIRD QUARTER 2025 FINANCIAL RESULTS Cash Position As of September 30, 2025, Zura Bio had cash and cash equivalents of $139.0 million. The Company anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses were $11.9 million for the third quarter of 2025, compared to $6.0 million for the same period in 2024, primarily reflecting continued advancement of the tibulizumab Phase 2 clinica…Read full document

Continued advancement of two Phase 2 clinical trials evaluating tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic sclerosis (SSc) (TibuSURE), with topline data expected in the second half of 2026. Reported $139.0 million in cash and cash equivalents as of September 30, 2025, which is expected to fund planned operations through 2027. HENDERSON, Nev., November 13, 2025--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported financial results for the third quarter ended September 30, 2025, and provided recent corporate and pipeline updates. "Both tibulizumab studies advanced during the quarter," said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. "We continue to focus on disciplined study execution and patient enrollment across these important disease areas, with the aim of generating meaningful data." PROGRAM UPDATES Tibulizumab During the third quarter of 2025, Zura Bio continued to advance its two ongoing Phase 2 studies of tibulizumab, a bispecific antibody designed to neutralize interleukin-17A (IL-17A) and B-cell activating factor (BAFF), key mediators of inflammation and fibrosis. TibuSHIELD (HS): The Phase 2 clinical trial in adults with HS progressed as planned. Topline data are expected in the third quarter of 2026. TibuSURE (SSc): The Phase 2 clinical trial in adults with SSc continued to advance during the quarter. Topline data are expected in the fourth quarter of 2026. The Company continues to monitor timelines and evaluate strategy for both studies in light of the competitive landscape for patient enrollment and other external factors, including those that may impact regulatory matters and overall study execution. THIRD QUARTER 2025 FINANCIAL RESULTS Cash Position As of September 30, 2025, Zura Bio had cash and cash equivalents of $139.0 million. The Company anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses were $11.9 million for the third quarter of 2025, compared to $6.0 million for the same period in 2024, primarily reflecting continued advancement of the tibulizumab Phase 2 clinical trials. General and Administrative (G&A) Expenses G&A expenses were $7.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024, driven mainly by a one-time non-cash expense in share-based compensation in the third quarter of 2024. Net Loss Net loss for the third quarter of 2025 was $20.0 million, or $0.21 per share, compared to $22.9 million, or $0.26 per share, for the same period in 2024. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. 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. 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; Zura Bio’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to Zura Bio’s development programs, including its product candidates and the potential benefits thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof. 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 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 approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by Zura Bio’s Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025, June 30, 2025 and September 30, 2025 and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics 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, 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 update any forward-looking statements, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251113296574/en/ Contacts Megan K. Weinshank Head of Corporate Affairs [email protected]

Investor releaseQuarter not tagged2025-08-14

Zura Bio Reports Second Quarter 2025 Financial Results and Recent Corporate Updates

Business Wire
Initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe hidradenitis suppurativa (HS) in Q2 2025 Continued progress in the Phase 2 TibuSURE clinical study evaluating tibulizumab in adults with systemic sclerosis (SSc) Appointed new executive and board leadership to support ongoing growth and development Reported $154.5 million in cash and cash equivalents as of June 30, 2025; expected to fund planned operations through 2027 HENDERSON, Nev., August 14, 2025--(BUSINESS WIRE)--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. "The second quarter of 2025 marked continued progress across our clinical programs and organizational goals," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We advanced our Phase 2 clinical study in systemic sclerosis and initiated a second Phase 2 clinical study in hidradenitis suppurativa. We also welcomed a new Chief Financial Officer as well as a new member of our board of directors, who bring valuable experiences and perspectives. As we look ahead, we remain focused on executing our strategy with discipline and care." PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Hidradenitis suppurativa In the second quarter of 2025, Zura Bio initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. A topline data readout is anticipated in the third quarter of 2026. Systemic sclerosis The Company also continued to advance TibuSURE, a global Phase 2 clinical study evaluating tibulizumab in adults with SSc. A topline data readout is anticipated in the fourth quarter of 2026. Crebankitug Zura Bio continues to conduct preclinical and translational research on crebankitug to explore its potential in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer therapeutic benefit. The Company is collaborating with academic researchers to guide future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respirat…Read full document

Initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe hidradenitis suppurativa (HS) in Q2 2025 Continued progress in the Phase 2 TibuSURE clinical study evaluating tibulizumab in adults with systemic sclerosis (SSc) Appointed new executive and board leadership to support ongoing growth and development Reported $154.5 million in cash and cash equivalents as of June 30, 2025; expected to fund planned operations through 2027 HENDERSON, Nev., August 14, 2025--(BUSINESS WIRE)--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. "The second quarter of 2025 marked continued progress across our clinical programs and organizational goals," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We advanced our Phase 2 clinical study in systemic sclerosis and initiated a second Phase 2 clinical study in hidradenitis suppurativa. We also welcomed a new Chief Financial Officer as well as a new member of our board of directors, who bring valuable experiences and perspectives. As we look ahead, we remain focused on executing our strategy with discipline and care." PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Hidradenitis suppurativa In the second quarter of 2025, Zura Bio initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. A topline data readout is anticipated in the third quarter of 2026. Systemic sclerosis The Company also continued to advance TibuSURE, a global Phase 2 clinical study evaluating tibulizumab in adults with SSc. A topline data readout is anticipated in the fourth quarter of 2026. Crebankitug Zura Bio continues to conduct preclinical and translational research on crebankitug to explore its potential in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer therapeutic benefit. The Company is collaborating with academic researchers to guide future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases. The Company continues to monitor external clinical data from ongoing IL-33/ST2-targeted programs in asthma and chronic obstructive pulmonary disease, including Phase 2b and Phase 3 trials. An additional IL-33/ST2 data readout is expected in 2026. These findings may help inform future development plans for torudokimab. CORPORATE HIGHLIGHTS In May 2025, Dan Becker, M.D., Ph.D. joined the Board of Directors, bringing a strong background in immunology and biotechnology. In July 2025, Eric Hyllengren was appointed as Chief Financial Officer. With more than 20 years of experience in financial leadership within the life sciences sector, Mr. Hyllengren will help guide the Company’s financial and operational planning. SECOND QUARTER 2025 FINANCIAL RESULTS Cash Position As of June 30, 2025, Zura Bio had cash and cash equivalents of $154.5 million. The Company anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses were $8.7 million for the second quarter of 2025, compared to $5.5 million for the same period in 2024. The increase of $3.2 million was primarily related to our continued advancement of our Phase 2 clinical studies evaluating tibulizumab in SSc and HS. Specifically, we incurred a $3.3 million increase in costs related to our SSc and HS clinical studies driven by an increase in contract research organization (CRO) expenses. These increases were partially offset by a $1.3 million reduction in manufacturing costs for our product candidates. R&D compensation costs increased by $0.7 million, reflecting additional headcount to support the growing development organization. General and Administrative (G&A) Expenses G&A expenses were $9.4 million for the second quarter of 2025, compared to $6.2 million for the same period in 2024. The $3.2 million year-over-year increase was primarily driven by a $2.0 million increase in compensation costs to support the expansion of administrative functions and a $1.2 million increase in external spend related to organizational growth as we continue to advance our clinical development programs. Net Loss Net loss for the second quarter of 2025 was $16.0 million, or $0.17 per share, compared to $10.3 million, or $0.17 per share, for the same period in 2024. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet needs. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two separate Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. 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; Zura Bio’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives; and expectations with respect to Zura Bio’s development program, including its product candidates and the potential clinical benefits thereof, data readouts, regulatory matters, clinical studies and the design and timing thereof. 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 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 approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct its preclinical studies and clinical studies; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by Zura Bio’s Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2025 and June 30, 2025, and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, including the conflict between Russia and Ukraine and the Israel-Hamas war and sanctions related thereto, international trade policies, including tariffs, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems, and changes in regulations, 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, 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 update any forward-looking statements, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250814431219/en/ Contacts Megan K. Weinshank Head of Corporate Affairs [email protected]

Investor releaseQuarter not tagged2025-05-08

Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates

Business Wire
Advanced the Phase 2 TibuSURE clinical trial evaluating tibulizumab in adults with systemic sclerosis (SSc) Continued preparations for the planned Phase 2 trial evaluating tibulizumab in adults with hidradenitis suppurativa (HS), expected to initiate in Q2 2025 Strengthened the team with a strategic appointment to support clinical execution and organizational growth $170.6 million in cash and cash equivalents with cash runway anticipated through 2027 HENDERSON, Nev., May 08, 2025--(BUSINESS WIRE)--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 progress across our clinical and operational priorities," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We continued advancing trial efforts for our Phase 2 TibuSURE trial for adults with SSc, and progressed preparations for the initiation of a second Phase 2 study in HS. Recent additions to our clinical team have further strengthened our ability to grow and execute with care. We believe we are well-positioned to move our programs forward thoughtfully and purposefully." PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Systemic sclerosis In the first quarter of 2025, Zura Bio continued to advance its ongoing Phase 2 TibuSURE trial evaluating tibulizumab in adults with SSc. Hidradenitis suppurativa In the first quarter of 2025, Zura Bio received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for HS, supporting the planned initiation of its Phase 2 clinical trial in adults with HS in the second quarter of 2025. Crebankitug Zura Bio continues to explore the potential of crebankitug in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer clinical benefits with commercial potential. The Company is conducting translational research and engaging with academic collaborators to inform future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases and monitoring external clinical data in areas…Read full document

Advanced the Phase 2 TibuSURE clinical trial evaluating tibulizumab in adults with systemic sclerosis (SSc) Continued preparations for the planned Phase 2 trial evaluating tibulizumab in adults with hidradenitis suppurativa (HS), expected to initiate in Q2 2025 Strengthened the team with a strategic appointment to support clinical execution and organizational growth $170.6 million in cash and cash equivalents with cash runway anticipated through 2027 HENDERSON, Nev., May 08, 2025--(BUSINESS WIRE)--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 progress across our clinical and operational priorities," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We continued advancing trial efforts for our Phase 2 TibuSURE trial for adults with SSc, and progressed preparations for the initiation of a second Phase 2 study in HS. Recent additions to our clinical team have further strengthened our ability to grow and execute with care. We believe we are well-positioned to move our programs forward thoughtfully and purposefully." PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Systemic sclerosis In the first quarter of 2025, Zura Bio continued to advance its ongoing Phase 2 TibuSURE trial evaluating tibulizumab in adults with SSc. Hidradenitis suppurativa In the first quarter of 2025, Zura Bio received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for HS, supporting the planned initiation of its Phase 2 clinical trial in adults with HS in the second quarter of 2025. Crebankitug Zura Bio continues to explore the potential of crebankitug in immune-mediated diseases where dual inhibition of interleukin-7 (IL-7) and thymic stromal lymphopoietin (TSLP) may offer clinical benefits with commercial potential. The Company is conducting translational research and engaging with academic collaborators to inform future development decisions. Torudokimab Zura Bio is evaluating the potential role of torudokimab in inflammatory and respiratory diseases and monitoring external clinical data in areas such as asthma and chronic obstructive pulmonary disease to inform its development strategy. CORPORATE HIGHLIGHTS In the first quarter, Zura Bio appointed Kate Dingwall as Senior Vice President of Development Operations. Ms. Dingwall brings extensive experience in patient-centered trial design, recruitment strategies, and clinical optimization and is expected to help advance the Company’s pipeline and lead execution across current and future clinical programs. FIRST QUARTER 2025 FINANCIAL RESULTS Cash Position As of March 31, 2025, Zura Bio had cash and cash equivalents of $170.6 million. Zura Bio anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses R&D expenses for the first quarter of 2025 were $10.5 million, compared to $3.6 million for the first quarter of 2024. The increase was primarily driven by increases of $3.7 million for contract research organization (CRO) costs and $2.1 million for manufacturing costs for our product candidates, as well as $0.6 million for cash and non-cash compensation costs for personnel in research and development functions as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. General and Administrative (G&A) Expenses G&A expenses for the first quarter of 2025 were $8.8 million, compared to $4.8 million for the first quarter of 2024. The increase was primarily due to a $2.6 million increase in cash and non-cash compensation costs for personnel in executive and administrative functions and our board of directors, as well as a $1.2 million increase in professional fees to support our growing organization as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS. Net Loss Net loss for the first quarter of 2025 was $17.4 million, or $0.19 per share, compared to $7.7 million, or $0.02 per share, for the same period in 2024. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company developing novel antibodies for autoimmune and inflammatory diseases. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in TibuSURE, a Phase 2 clinical trial in adults with systemic sclerosis. It is also expected to enter a separate Phase 2 clinical trial in adults with hidradenitis suppurativa in the second quarter of 2025. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com. 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; Zura Bio’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to Zura Bio’s development program, including its product candidates and the potential clinical benefits and commercial potential thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof; 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 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 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 clinical benefits, and Zura Bio’s beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, including the conflict between Russia and Ukraine and the Israel-Hamas war and sanctions related thereto, international trade policies, including tariffs, inflation, increased interest rates, uncertain global credit and capital markets and disruptions in banking systems, 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, 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 update any forward-looking statements, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250508227131/en/ Contacts Megan K. Weinshank Head of Corporate Affairs [email protected]

Investor releaseQuarter not tagged2025-03-25

Zura Bio Reports Full Year 2024 Financial Results and Recent Corporate Updates

Business Wire
Achieved key milestones in 2024 that enhanced our leadership team, strengthened our financial position, and progressed our clinical pipeline Initiated the Phase 2 TibuSURE trial in adults with systemic sclerosis (SSc) Completed a $112.5 million private placement financing in April 2024, contributing to a total of $176.5 million in cash and cash equivalents, as of December 31, 2024 Cash runway anticipated through 2027, supporting operations and funding anticipated tibulizumab data readouts in SSc and hidradenitis suppurativa (HS) HENDERSON, Nev., March 25, 2025--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2024 financial results and recent corporate updates. "In 2024, we reached key milestones that reinforced our financial foundation, expanded our leadership team, and advanced our clinical pipeline, highlighting our commitment to establishing a leading presence in immunology," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We remain dedicated to developing treatments for patients with severe autoimmune and inflammatory diseases. In 2025, we look forward to building on this progress with continued advancements, including our TibuSURE Phase 2 study for SSc and the anticipated launch of a Phase 2 study for HS in Q2." CORPORATE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Systemic sclerosis In December 2024, Zura Bio advanced its clinical pipeline by initiating the Phase 2 TibuSURE trial in SSc. Hidradenitis suppurativa In September 2024, a third-party Contract Research Organization was selected to oversee and conduct the Phase 2 clinical program for HS. Zura Bio holds an active Investigational New Drug with the U.S. Food and Drug Administration, allowing the clinical trial to proceed. Zura Bio plans to initiate a Phase 2 trial for the treatment of adults with HS in the second quarter of 2025. Crebankitug Zura Bio is exploring potential therapeutic applications where IL-7/TSLP inhibition may provide meaningful clinical and commercial benefits. Ongoing translational medicine research and collaborations with key opinion leaders aim to enhance the understanding of its clinical potential. Torudokimab Zura Bio is monitoring external Phase 2 and Phase 3 I…Read full document

Achieved key milestones in 2024 that enhanced our leadership team, strengthened our financial position, and progressed our clinical pipeline Initiated the Phase 2 TibuSURE trial in adults with systemic sclerosis (SSc) Completed a $112.5 million private placement financing in April 2024, contributing to a total of $176.5 million in cash and cash equivalents, as of December 31, 2024 Cash runway anticipated through 2027, supporting operations and funding anticipated tibulizumab data readouts in SSc and hidradenitis suppurativa (HS) HENDERSON, Nev., March 25, 2025--(BUSINESS WIRE)--Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today reported full year 2024 financial results and recent corporate updates. "In 2024, we reached key milestones that reinforced our financial foundation, expanded our leadership team, and advanced our clinical pipeline, highlighting our commitment to establishing a leading presence in immunology," said Robert Lisicki, Chief Executive Officer of Zura Bio. "We remain dedicated to developing treatments for patients with severe autoimmune and inflammatory diseases. In 2025, we look forward to building on this progress with continued advancements, including our TibuSURE Phase 2 study for SSc and the anticipated launch of a Phase 2 study for HS in Q2." CORPORATE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES Tibulizumab Systemic sclerosis In December 2024, Zura Bio advanced its clinical pipeline by initiating the Phase 2 TibuSURE trial in SSc. Hidradenitis suppurativa In September 2024, a third-party Contract Research Organization was selected to oversee and conduct the Phase 2 clinical program for HS. Zura Bio holds an active Investigational New Drug with the U.S. Food and Drug Administration, allowing the clinical trial to proceed. Zura Bio plans to initiate a Phase 2 trial for the treatment of adults with HS in the second quarter of 2025. Crebankitug Zura Bio is exploring potential therapeutic applications where IL-7/TSLP inhibition may provide meaningful clinical and commercial benefits. Ongoing translational medicine research and collaborations with key opinion leaders aim to enhance the understanding of its clinical potential. Torudokimab Zura Bio is monitoring external Phase 2 and Phase 3 IL-33/ST2 data in asthma and chronic obstructive pulmonary disease to inform its development strategy. Corporate Highlights In January 2024, Kiran Nistala, MBBS, PhD, a rheumatologist and immunologist, joined as Chief Medical Officer and Head of Development, further strengthening our clinical and scientific leadership. In April 2024, Robert Lisicki was appointed Chief Executive Officer and played a key role in securing $112.5 million through an oversubscribed private placement, supported by leading life sciences-focused institutional investors. In June 2024, a Scientific Advisory Board was established, composed of leading specialists in rheumatology, dermatology, and immunology. In June 2024, data from two abstracts on tibulizumab in Sjögren’s syndrome and rheumatoid arthritis were presented at the Annual European Congress of Rheumatology. In August 2024, the Company successfully completed a warrant exchange, simplifying its capital structure. In September 2024, the Company established an "at-the-market" (ATM) program, providing increased financial flexibility. FULL YEAR 2024 FINANCIAL RESULTS Cash Position Cash and cash equivalents were $176.5 million as of December 31, 2024, as compared to $99.8 million as of December 31, 2023. Zura Bio anticipates that its existing cash and cash equivalents should be sufficient to support operations as currently planned through 2027. Research and Development (R&D) Expenses Research and development expenses were $24.4 million for the year ended December 31, 2024, a decrease of $19.6 million compared to $44.0 million for the year ended December 31, 2023. The decrease was primarily due to $27.2 million related to the acquisition of tibulizumab from Eli Lilly and Company ("Lilly") during the year ended December 31, 2023. This decrease was partially offset by a $4.5 million milestone payment in 2024 related to the Lilly license for tibulizumab and an increase of $2.9 million for cash-based compensation expenses for personnel in R&D functions and an increase of $2.0 million of costs incurred for consulting services for our product candidates. General and Administrative (G&A) Expenses General and administrative expenses were $30.8 million for the year ended December 31, 2024, an increase of $12.2 million compared to $18.6 million for the year ended December 31, 2023. The increase was primarily due to $8.3 million in compensation costs, including a one-time non-cash stock-based compensation expense of $5.9 million and a $2.4 million increase in cash and non-cash compensation costs for personnel in executive and administrative functions, as well as a $2.9 million increase in professional fees, driven by $1.6 million in fees related to the warrant exchange. Net Loss Net Loss was $45.4 million or $0.60 per share for the year ended December 31, 2024, compared to $69.2 million or $2.09 per share for the year ended December 31, 2023. 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. 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 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; Zura Bio’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to Zura Bio’s development program, including its product candidates and the potential benefits thereof, data readouts, regulatory matters, clinical trials and the design and timing thereof; 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 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 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 approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the "Risk Factors" section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2024 and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics 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, 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 update any forward-looking statements, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250325942559/en/ Contacts Megan K. Weinshank Head of Corporate Affairs [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook