US Market News
4週前
Zura Bio Expands Leadership Team with Appointment of Muzammil Mustufa as Chief Business OfficerMay 13, 2026 7:30 AM
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 the appointment of Muzammil Mustufa as Chief Business Officer (CBO). Mr. Mustufa will oversee corporate strategy, business development, commercial planning, and investor relations efforts. Mr. Mustufa brings 20 years of diversified pharmaceutical and biotechnology experience to Zura, with extensive experience in immunology, rare disease, and other therapeutic areas. Most recently, he served as Vice President of Corporate Strategy at Amicus Therapeutics, where he played an integral part in the global launch and commercialization strategies of two innovative medicines in orphan diseases. He subsequently led integration planning for Amicus in connection with BioMarin Pharmaceutical Inc.'s $4.8 billion acquisition of the company. Earlier in his career, Mr. Mustufa held roles at GSK plc, The Frankel Group, and The D.E. Shaw Group. "We are thrilled to welcome Muz to Zura as we approach key clinical and corporate milestones for tibulizumab,” said Sandeep Kulkarni, M.D., co-founder and Chief Executive Officer of Zura Bio. “He brings a rare combination of commercial, strategic, and financial acumen that will elevate and complement our leadership team’s capabilities. Muz is the perfect fit for the company as we continue to explore tibulizumab’s potential to redefine treatment across multiple autoimmune indications as well as pursue opportunities to further advance our mission.” "I am excited to be joining Zura and to contribute during what is clearly a defining period for the company,” said Mr. Mustufa. “The science behind tibulizumab — a first- and only-in-class bispecific simultaneously blocking the IL-17 and BAFF pathways — reflects an approach that has the potential to improve outcomes for patients with serious and complex immune system disorders. I look forward to partnering with Sandeep, our talented team, and the Board of Directors as we prepare for our readouts and the company’s next phase of growth." 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/20260513568466/en/ Investor and media inquiries:
ir@zurabio.com Original: Zura Bio Expands Leadership Team with Appointment of Muzammil Mustufa as Chief Business Officer
US Market News
1月前
Zura Bio Reports First Quarter 2026 Financial Results and Recent Corporate UpdatesMay 7, 2026 7:30 AM
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 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. ZURA BIO LIMITED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) March 31, December 31, 2026 2025 (unaudited) Assets Current assets Cash and cash equivalents $ 225,594 $ 109,407 Prepaid expenses and other current assets 1,410 2,903 Total current assets 227,004 112,310 Property and equipment, net 125 126 Other assets 1,512 1,512 Total assets $ 228,641 $ 113,948 Liabilities and Shareholders’ Equity Current liabilities Accounts payable and accrued expenses $ 11,745 $ 12,410 Total current liabilities 11,745 12,410 Total liabilities 11,745 12,410 Commitments and contingencies Shareholders’ Equity Class A Ordinary Shares, $0.0001 par value; 300,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 94,880,710 and 73,680,710 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 9 7 Additional paid-in capital 465,657 326,078 Accumulated deficit (248,770 ) (224,547 ) Total shareholders’ equity 216,896 101,538 Total liabilities and shareholders’ equity $ 228,641 $ 113,948 ZURA BIO LIMITED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except share and per share data) For the Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ 14,746 $ 10,474 General and administrative 10,753 8,780 Total operating expenses 25,499 19,254 Loss from operations (25,499 ) (19,254 ) Other income, net Interest income (1,319 ) (1,817 ) Other expense, net 43 5 Total other income, net (1,276 ) (1,812 ) Loss before income taxes (24,223 ) (17,442 ) Income tax benefit — — Net loss $ (24,223 ) $ (17,442 ) Net loss per share, basic and diluted $ (0.22 ) $ (0.19 ) Weighted-average shares outstanding, basic and diluted 112,222,789 92,964,048 View source version on businesswire.com: https://www.businesswire.com/news/home/20260507541381/en/ Investor and media inquiries:
ir@zurabio.com Original: Zura Bio Reports First Quarter 2026 Financial Results and Recent Corporate Updates
US Market News
3月前
Zura Bio Reports Full Year 2025 Financial Results and Recent Corporate UpdatesMarch 19, 2026 4:05 PM
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
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.
ZURA BIO LIMITED
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
December 31,
December 31,
2025
2024
Assets
Current assets
Cash and cash equivalents
$
109,407
$
176,498
Prepaid expenses and other current assets
2,903
2,246
Total current assets
112,310
178,744
Property and equipment, net
126
91
Other assets
1,512
698
Total assets
$
113,948
$
179,533
Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity
Current liabilities
Accounts payable and accrued expenses
$
12,410
$
19,514
Total current liabilities
12,410
19,514
Total liabilities
12,410
19,514
Redeemable noncontrolling interest
—
11,663
Shareholders’ Equity
Class A Ordinary Shares, $0.0001 par value; 300,000,000 shares authorized as of December 31, 2025 and December 31, 2024; 73,680,710 and 65,297,530 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively
7
7
Additional paid-in capital
326,078
302,705
Accumulated deficit
(224,547
)
(155,897
)
Total Zura Bio Limited shareholders’ equity
101,538
146,815
Noncontrolling interest
—
1,541
Total shareholders’ equity
101,538
148,356
Total liabilities, redeemable noncontrolling interest and shareholders’ equity
$
113,948
$
179,533
ZURA BIO LIMITED
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
For the Years Ended
December 31,
2025
2024
Operating expenses:
Research and development
$
42,082
$
24,401
General and administrative
33,164
30,788
Total operating expenses
75,246
55,189
Loss from operations
(75,246
)
(55,189
)
Other (income)/expense, net:
Interest income
(6,336
)
(7,998
)
Change in fair value of private placement warrants
—
5,240
Other income, net
(260
)
(28
)
Total other (income)/expense, net
(6,596
)
(2,786
)
Loss before income taxes
(68,650
)
(52,403
)
Income tax benefit
—
—
Net loss
(68,650
)
(52,403
)
Adjustment of redeemable noncontrolling interest
831
7,017
Accretion of redeemable noncontrolling interest to redemption value
4,868
—
Deemed dividend on extinguishment of noncontrolling interest and redeemable noncontrolling interest
(36,402
)
—
Net loss attributable to Class A Ordinary Shareholders of Zura
$
(99,353
)
$
(45,386
)
Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted
$
(1.06
)
$
(0.60
)
Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted
94,160,138
75,070,761
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/
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Original: Zura Bio Reports Full Year 2025 Financial Results and Recent Corporate Updates
US Market News
3月前
Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World CongressMarch 5, 2026 6:30 AM
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 that the design of its ongoing Phase 2 TibuSURE clinical trial evaluating tibulizumab (ZB-106) in systemic sclerosis (SSc) has been accepted for poster presentation at the Systemic Sclerosis World Congress, taking place March 5–7, 2026 in Athens, Greece.
The poster, titled “TibuSURE: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis” (Abstract ID 184; Poster P.267), outlines the rationale and design of the global Phase 2 study. No clinical efficacy or safety data will be presented.
Diffuse cutaneous systemic sclerosis (“dcSSc”) is a rare, progressive autoimmune disease characterized by immune activation, vasculopathy and fibrosis affecting the skin and internal organs, including the lungs. Treatment options remain limited, highlighting the need for therapeutic approaches that address multiple drivers of disease biology.
TibuSURE is the first clinical trial designed to evaluate the dual inhibition of interleukin-17A (“IL-17A”) and B-cell activating factor (“BAFF”) in dcSSc. Tibulizumab is an investigational bispecific antibody engineered to simultaneously neutralize IL-17A and BAFF, two cytokines implicated in inflammation, autoimmunity and fibrotic progression in SSc. By targeting complementary immune pathways, tibulizumab represents a differentiated investigational strategy intended to modulate both inflammatory and fibrotic disease processes.
The ongoing global Phase 2 study is expected to enroll approximately 80 adults who will be randomized 1:1 to receive tibulizumab or placebo every four weeks for 24 weeks, followed by a 28-week open-label extension. The primary endpoint is change from baseline in modified Rodnan Skin Score at Week 24. Topline results are currently anticipated in the first half of 2027.
Poster Presentation Details
Poster Number: P.267
Presenting Author: Christopher Denton, M.D., Ph.D., FRCP, Professor of Experimental Rheumatology at University College London
Session Times (Local Athens Time, EET / UTC+2):
Friday, March 6, 2026: 13:20–14:25
Saturday, March 7, 2026: 12:35–13:50
ABOUT TIBULIZUMAB (ZB-106)
Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with hidradenitis suppurativa and systemic sclerosis. Prior to in-licensing by Zura, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis.
Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority.
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 “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Zura’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of Zura’s product candidates; the timing of enrollment, initiation, progress, and results of Zura’s current and future clinical trials, including TibuSURE, including reporting of data therefrom; and Zura’s plans to present the design of its Phase 2 TibuSURE clinical trial at the Systemic Sclerosis World Congress. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Zura’s current or future product candidates will 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, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that modeling data indicating therapeutic potential, or clinical evidence from other drug candidates, will not be replicated in ongoing or future studies or clinical trials involving Zura’s current or future product candidates; the risk that Zura’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Zura anticipates; risks regarding 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; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions on Zura’s business, clinical trials and financial position; and other risks and uncertainties that are described in Zura’s Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its 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 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, and 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260305051263/en/
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Original: Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World Congress
US Market News
3月前
Zura Bio Announces Pricing of $125 Million Public Offering of Class A Ordinary Shares and Pre-Funded WarrantsFebruary 25, 2026 6:30 AM
Business Wire
Zura Bio Limited (Nasdaq: 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 the pricing of its previously announced underwritten public offering of 18,200,000 Class A ordinary shares at a price to the public of $6.25 per share and, in lieu of Class A ordinary shares to certain investors that so choose, pre-funded warrants to purchase 1,800,000 Class A ordinary shares at a price to the public of $6.249 per pre-funded warrant, which equals the public offering price per Class A ordinary share, less the $0.001 exercise price of each pre-funded warrant. In addition, Zura has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 Class A ordinary shares at the public offering price, less underwriting discounts and commissions. All of the Class A ordinary shares and pre-funded warrants are to be sold by Zura.
The gross proceeds to Zura from the offering are expected to be $125 million, before deducting underwriting discounts and commissions and other offering expenses payable by Zura. The offering is expected to close on February 26, 2026, subject to the satisfaction of customary closing conditions.
Leerink Partners, Piper Sandler and Cantor are acting as joint bookrunning managers for the proposed offering. Wedbush PacGrow is acting as lead manager for the proposed offering.
The Class A ordinary shares and pre-funded warrants are being offered by Zura pursuant to a shelf registration statement on Form S-3, as amended (Registration No. 333-281905) that was originally filed with the Securities and Exchange Commission (the “SEC”) on September 3, 2024 and subsequently declared effective by the SEC on September 17, 2024. The offering is being made only by means of a prospectus supplement and accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or via email at syndicate@leerink.com; Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, by telephone at (800) 747-3924, or via email at prospectus@psc.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, via e-mail at prospectus@cantor.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
ABOUT ZURA
Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. The Company’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.
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 “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Zura’s current beliefs and expectations. These forward-looking statements include statements regarding the expected gross proceeds from the offering and the closing date of the offering. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties related to market conditions, the satisfaction of customary closing conditions related to the public offering, and such other risks and uncertainties that are described in Zura’s Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its 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 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 of this release, and 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260225821534/en/
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Original: Zura Bio Announces Pricing of $125 Million Public Offering of Class A Ordinary Shares and Pre-Funded Warrants
US Market News
3月前
Zura Bio Welcomes Accomplished Drug Development Leaders Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., to Board of DirectorsFebruary 23, 2026 6:30 AM
Business Wire
Zura Bio Limited (Nasdaq: ZURA) (“Zura” or the “Company”), 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 the appointments of Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., to its Board of Directors, effective February 21, 2026. As part of this transition, Neil Graham, M.B.B.S., M.D., M.P.H., will step down from the Board effective the same date.
“Mark and Ajay are accomplished immunology executives who have successfully guided innovative biologics from early development through approval and commercialization on a global scale,” said Amit Munshi, Chairman of the Board. “As we advance our Phase 2 programs and evaluate new growth opportunities, their experience will be instrumental. Their decision to join the Board reflects their conviction in our strategy and pipeline.”
“Neil has been a valued member of our Board since the Company’s formative stages,” added Mr. Munshi. “Following his decision to accept a full-time role that limits his ability to continue serving on the Board, we want to express our sincere appreciation for his significant contributions to Zura. Neil has been a critical participant on our R&D Committee, and his insight and dedication have helped shape the Company. We are grateful for his service and wish him continued success in his future endeavors.”
Mark Eisner, M.D., M.P.H.
Dr. Mark Eisner, M.D., M.P.H., is a biotechnology executive with more than 25 years of leadership in clinical development and immunology. He currently serves as Executive Vice President and Chief Medical Officer of Vir Biotechnology, where he oversees clinical development, regulatory sciences, and medical affairs. Previously, he served as Chief Medical Officer at Sonoma Biotherapeutics and FibroGen, and spent nearly 11 years at Genentech/Roche, including as Senior Vice President and Global Head of Product Development for Immunology, Infectious Disease, and Ophthalmology. In that role, he led multinational development programs and global regulatory submissions across major therapeutic areas. Prior to entering industry, Dr. Eisner was Professor of Medicine and Anesthesia at the University of California, San Francisco.
“Successfully advancing innovative biologics requires rigorous clinical strategy and disciplined execution,” said Dr. Eisner. “Zura has taken a data-driven and scientifically grounded approach to development, and I look forward to contributing my experience in guiding programs through critical clinical and regulatory milestones.”
Ajay Nirula, M.D., Ph.D.
Dr. Ajay Nirula, M.D., Ph.D., is a physician-scientist and biotechnology executive with more than two decades of leadership in immunology research and clinical development. He currently serves as Executive Vice President and Head of Research and Development at Recludix Pharma. Previously, Dr. Nirula served as Senior Vice President and Immunology Therapeutic Area Head at Eli Lilly and Company, where he led discovery research and early- and mid-phase clinical development in immunology. During his tenure, he helped establish immunology as a core therapeutic area at Lilly, contributing to four globally approved medicines and advancing more than ten product candidates into clinical development. While at Lilly, he oversaw the development of tibulizumab prior to its licensing to Zura and has subsequently served on Zura’s Scientific Advisory Board, continuing his engagement with the program. Prior to Lilly, Dr. Nirula held leadership roles at Amgen, Biogen Idec, and Merck & Co., advancing programs across multiple immune-mediated diseases.
“Having overseen tibulizumab’s development while at Lilly, I have long believed in the strength of its dual-pathway design,” said Dr. Nirula. “By simultaneously targeting IL-17 and BAFF, Zura’s strategy is designed to address complementary drivers of autoimmune disease, and I’m excited to support the advancement of this dual-pathway bispecific program.”
ABOUT ZURA
Zura is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases with unmet need. The Company’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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260223718399/en/
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Original: Zura Bio Welcomes Accomplished Drug Development Leaders Mark Eisner, M.D., M.P.H., and Ajay Nirula, M.D., Ph.D., to Board of Directors