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Bullish Outlook on Zura Bio Limited (ZURA) Amid Tibulizumab Phase 2 Clinical Trial Progress
Yahoo Finance· 2025-11-29 06:26
Core Insights - Zura Bio Limited (NASDAQ:ZURA) has shown strong performance over the past three months and is identified as one of the 12 hot penny stocks to invest in currently [1] - Guggenheim has reiterated a "Buy" rating for Zura Bio with a price target of $15, reflecting a bullish outlook amid the progress of the tibulizumab Phase 2 clinical trial [2] Financial Performance - For Q3 2025, Zura Bio reported $139 million in cash, which is expected to fund operations until 2027 [3] - The company experienced an increase in R&D expenses to $11.9 million due to the tibulizumab Phase 2 clinical trial, while G&A expenses decreased to $7.6 million [3] - The net loss for the quarter was $20 million, or $0.21 per share, an improvement from the previous year's loss of $22.9 million, or $0.26 per share [3] Clinical Development - Zura Bio is advancing two Phase 2 studies for tibulizumab: TibuSHIELD for hidradenitis suppurativa and TibuSURE for systemic sclerosis [4] - TibuSHIELD is on track to deliver topline data in Q3 2026, while TibuSURE's data is anticipated in Q4 2026 [4] - Management is focused on patient enrollment and addressing competitive trial recruitment dynamics [4] Company Overview - Zura Bio Limited is a clinical-stage immunology company that develops dual-pathway antibodies targeting autoimmune and inflammatory diseases [5]
Zura(ZURA) - 2025 Q3 - Quarterly Report
2025-11-13 11:32
Financial Performance - Total assets decreased from $179,533,000 as of December 31, 2024, to $143,935,000 as of September 30, 2025, representing a decline of approximately 19.87%[12] - Net loss attributable to Class A Ordinary Shareholders increased from $22,942,000 in Q3 2024 to $20,037,000 in Q3 2025, indicating a decrease in loss of about 12.6%[14] - The company reported a net loss per share attributable to Class A Ordinary Shareholders of $(0.21) for Q3 2025, compared to $(0.26) for Q3 2024, reflecting an improvement of approximately 19.2%[14] - The Company has incurred operating losses since inception and expects to continue incurring significant operating losses for the foreseeable future[39] - The Company has an accumulated deficit of $207.4 million as of September 30, 2025, and a net loss of $18.0 million for the three months ended September 30, 2025[39] Cash and Cash Equivalents - Cash and cash equivalents decreased from $176,498,000 as of December 31, 2024, to $139,017,000 as of September 30, 2025, a decline of about 21.3%[12] - The cash and cash equivalents at the end of the period were $139,017,000, down from $188,221,000 at the end of September 30, 2024[28] - Cash equivalents as of September 30, 2025, were valued at $135.9 million, down from $170.7 million as of December 31, 2024, indicating a decrease of 20.4%[67] - The Company has significant cash balances exceeding the federally insured limit of $250,000, which could impact its financial condition if access to these funds is restricted[48] Operating Expenses - Total operating expenses for the nine months ended September 30, 2025, were $56,835,000, compared to $39,457,000 for the same period in 2024, reflecting a year-over-year increase of approximately 44.1%[14] - Research and development expenses increased significantly from $6,029,000 in Q3 2024 to $11,948,000 in Q3 2025, a rise of approximately 98.5%[14] - The company reported a net cash used in operating activities of $42,537,000 for the nine months ended September 30, 2025, compared to $17,252,000 for the same period in 2024[28] Shareholder Equity and Shares - As of September 30, 2025, the total shareholders' equity was $109,784,000, with a net loss of $51,475,000 for the period[24] - The number of Class A Ordinary Shares issued and outstanding as of September 30, 2025, was 65,018,058, compared to 65,297,530 as of December 31, 2024, indicating a slight decrease[12] - The Company has authorized 300,000,000 Class A Ordinary Shares and 1,000,000 preferred shares as of March 16, 2023[90] - The Company issued 20,090,128 Class A Ordinary Shares in connection with the April 2024 Private Placement, net of $7.2 million in transaction costs[26] - During the nine months ended September 30, 2025, the Company sold 3,000,000 Class A Ordinary Shares at a price of $1.75 per share, generating net proceeds of $5.1 million[95] Liabilities - The total liabilities remained constant at $25,491,000 as of September 30, 2025, compared to $19,514,000 as of December 31, 2024, indicating no increase in liabilities despite the decrease in assets[12] - As of September 30, 2025, the total accounts payable and accrued expenses amounted to $25.5 million, an increase from $19.5 million as of December 31, 2024, representing a 30.5% increase[70] Clinical Development - The company has one clinical-stage product candidate, tibulizumab (ZB-106), currently in ongoing Phase 2 trials[32] - The Company initiated the TibuSHIELD Phase 2 clinical study in May 2025, evaluating tibulizumab in approximately 180 adults with moderate to severe hidradenitis suppurativa[36] - The Company is actively assessing additional development opportunities within its pipeline, focusing on indications with unmet needs and commercial potential[32] - The Company is evaluating potential therapeutic indications for crebankitug and torudokimab as part of its strategic focus[34] Share-Based Compensation - Share-based compensation expense for the nine months ended September 30, 2025, was $9,755,000, compared to $13,981,000 for the same period in 2024[28] - The total share-based compensation expense for the nine months ended September 30, 2025 was $9,755,000, compared to $13,981,000 for the same period in 2024, reflecting a decrease of approximately 30%[122] - The company recognized $1.3 million in share-based compensation expense related to RSUs for the nine months ended September 30, 2025, down from $1.6 million in 2024[117] - The company recognized $0.3 million in share-based compensation expense related to RSAs for the nine months ended September 30, 2025, consistent with the same period in 2024[118] - The redeemable noncontrolling interest balance was $8.7 million as of September 30, 2025, down from $11.7 million as of December 31, 2024[126] Future Expectations and Regulations - The Company expects to no longer be classified as an emerging growth company effective December 31, 2026[38] - The Company expects to adopt ASU 2024-03 for the year ending December 31, 2027, which will require additional disclosures in financial statements[63] Financing Activities - The total cash flows from financing activities for the nine months ended September 30, 2025, were $5,152,000, compared to $110,697,000 for the same period in 2024[28] - The Company received $56.7 million in net cash proceeds upon the closing of the Business Combination and raised an additional $105.3 million from the sale of Class A Ordinary Shares in April 2024[40] Agreements and Obligations - The Company is obligated to make contingent payments to Lilly, including up to $155 million in development milestone payments and up to $440 million in sales milestone payments based on net sales thresholds for products developed from tibulizumab[78] - The Company has not made a $5.0 million milestone payment to BAFFX17 as of September 30, 2025, which is due upon certain conditions being met[75] - The Company is required to make a one-time payment of $4.5 million to Stone Peach upon FDA acceptance for its Investigational New Drug for tibulizumab, which was recorded in research and development expenses for the year ended December 31, 2024[74] - The Company has not recorded any Pfizer Contingent Payments as of September 30, 2025, as none are due at this time[85] Licensing and Agreements - The Company entered into a license agreement with Lonza Sales AG, resulting in an annual license fee of $0.4 million starting in 2023[87] - The Company has a biologics master services agreement with WuXi Biologics, with fees recognized as research and development expenses as incurred[88] - The Cell Line License Agreement with WuXi Biologics requires royalty payments based on a single-digit percentage of global net sales if manufacturing is done by third parties[89]
Zura(ZURA) - 2025 Q3 - Quarterly Results
2025-11-13 11:30
Financial Position - Zura Bio reported cash and cash equivalents of $139.0 million as of September 30, 2025, expected to fund operations through 2027[4]. - The Company’s accumulated deficit increased to $207.4 million as of September 30, 2025, compared to $155.9 million at the end of 2024[16]. - Zura Bio's total assets decreased to $143.9 million as of September 30, 2025, from $179.5 million at the end of 2024[16]. Research and Development - Research and Development (R&D) expenses for Q3 2025 were $11.9 million, up from $6.0 million in Q3 2024, reflecting ongoing Phase 2 clinical trials for tibulizumab[7]. - The Company is advancing two Phase 2 clinical trials for tibulizumab, with topline data expected in the second half of 2026 for both trials[4]. - Zura Bio's lead product candidate, tibulizumab, is being evaluated in two Phase 2 studies targeting systemic sclerosis and hidradenitis suppurativa[11]. - The Company continues to monitor timelines and evaluate strategies for its clinical studies in light of competitive patient enrollment and regulatory factors[3]. Operating Expenses - General and Administrative (G&A) expenses decreased to $7.6 million in Q3 2025 from $13.3 million in Q3 2024, primarily due to a one-time non-cash expense in share-based compensation in the previous year[8]. - Total operating expenses for Q3 2025 were $19.5 million, slightly higher than $19.3 million in Q3 2024[18]. Net Loss - Net loss for Q3 2025 was $20.0 million, or $0.21 per share, compared to a net loss of $22.9 million, or $0.26 per share, in Q3 2024[9].
Zura Bio Reports Third Quarter 2025 Financial Results and Recent Corporate Updates
Businesswire· 2025-11-13 11:30
Core Insights - Zura Bio Limited reported its financial results for the third quarter of 2025, highlighting advancements in its clinical programs and a strong cash position [1][4]. Financial Performance - As of September 30, 2025, Zura Bio had cash and cash equivalents of $139.0 million, expected to support operations through 2027 [4][7]. - Research and Development (R&D) expenses for Q3 2025 were $11.9 million, up from $6.0 million in Q3 2024, reflecting ongoing Phase 2 clinical trials for tibulizumab [5]. - General and Administrative (G&A) expenses decreased to $7.6 million in Q3 2025 from $13.3 million in Q3 2024, primarily due to a one-time non-cash expense in share-based compensation in the previous year [6]. - The net loss for Q3 2025 was $20.0 million, or $0.21 per share, compared to a net loss of $22.9 million, or $0.26 per share, for the same period in 2024 [9][17]. Clinical Development Updates - Zura Bio is advancing two Phase 2 studies of tibulizumab, targeting hidradenitis suppurativa (TibuSHIELD) and systemic sclerosis (TibuSURE), with topline data expected in the second half of 2026 [2][8]. - The company is focused on disciplined study execution and patient enrollment to generate meaningful data in these important disease areas [2][3]. Pipeline Overview - Zura Bio's lead product candidate, tibulizumab (ZB-106), is being evaluated in two Phase 2 clinical studies [11]. - Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being assessed for various autoimmune and inflammatory conditions [11].
Zura's Make-or-Break Year Ahead: Will TibuSHIELD And TibuSURE Trials Deliver Or Disappoint?
RTTNews· 2025-10-07 12:44
Core Insights - 2026 is anticipated to be a crucial year for Zura Bio Ltd. (ZURA) as key data readouts for its lead investigational drug, Tibulizumab, are expected to significantly impact the company's strategic direction and market position [1] Company Overview - Zura Bio is a clinical-stage, multi-asset immunology company focused on developing treatments for immune-mediated diseases with unmet medical needs [1] - The lead product candidate, Tibulizumab, is a potential first-in-class dual-pathway biologic targeting cytokines IL-17A and BAFF [1] Clinical Trials - Tibulizumab is currently being evaluated in two global phase 2 studies: TibuSHIELD and TibuSURE [2][6] - TibuSHIELD is assessing Tibulizumab in adults with moderate to severe Hidradenitis suppurativa (HS), a chronic inflammatory skin disease affecting approximately 1% of the global population [3][5] - The TibuSHIELD trial, initiated in May 2025, aims to enroll about 180 adults and includes a 16-week efficacy assessment followed by a 12-week safety follow-up [5] - Topline results from the TibuSHIELD trial are expected in Q3 2026 [6] - TibuSURE is evaluating Tibulizumab for systemic sclerosis (SSc), a rare autoimmune disease affecting around 300,000 individuals worldwide [7][8] - The TibuSURE study, initiated in December 2024, plans to enroll roughly 80 participants and includes a 24-week efficacy period [8] - Topline results from the TibuSURE study are anticipated in Q4 2026 [9] Pipeline and Financial Position - Zura Bio has two additional investigational drugs, Crebankitug and Torudokimab, which have completed phase 1/1b studies and are being evaluated for various autoimmune and inflammatory conditions [9] - As of June 30, 2025, Zura Bio had cash and cash equivalents of $154.5 million, projected to support operations until 2027 [10] - Zura Bio made its Nasdaq debut on March 21, 2023, under the ticker symbol "ZURA" following a merger with JATT Acquisition Corp [10] Stock Performance - Over the past year, ZURA's stock has traded between $0.97 and $5.07, closing at $4.17, reflecting a 6.10% increase [11]
Zura Bio (ZURA) 2025 Conference Transcript
2025-09-04 19:45
Summary of Zura Bio Conference Call Company Overview - Zura Bio is a publicly traded company listed on NASDAQ since April 2023, having raised $200 million and in-licensed three bispecific monoclonal antibodies [2][49] - The lead asset, tibulizumab, is an anti-IL-17 B-cell activating factor antagonist currently enrolling in two Phase II studies for systemic sclerosis and hidradenitis suppurativa, with top-line data expected in Q3-Q4 of next year [2][49] Core Points and Arguments Lead Program: Tibulizumab - Tibulizumab targets both IL-17 and B-cell activating factor, with a unique combination therapy approach expected to yield robust results [4][10] - The drug has a higher affinity for IL-17A and IL-17AF compared to other IL-17 inhibitors, which may provide a therapeutic advantage [4][22] - The Phase II TibuSHIELD study is designed to measure the change in AN count as the primary endpoint, with secondary endpoints including HiSCR scores and impact on draining tunnels [11][34] Efficacy and Comparisons - The efficacy of tibulizumab is compared to other IL-17 inhibitors, with expectations of a broader and deeper response in patients, particularly in reducing draining tunnels associated with hidradenitis suppurativa [15][22] - The company aims to differentiate tibulizumab from existing treatments by addressing unmet needs in the market, particularly for patients who have not previously been exposed to biologics [6][16] Financial Position and Future Outlook - As of the end of Q2, Zura Bio had $155 million in cash, sufficient to fund both Phase II studies and operations through 2027, with a projected burn rate peaking at $15 million per quarter [49][50] - The company anticipates strong investor interest if the Phase II data is robust, which could lead to favorable financing opportunities for Phase III studies [50][55] Industry Context - The discussion highlights the competitive landscape of IL-17 inhibitors, with tibulizumab positioned to potentially outperform existing therapies by targeting both IL-17 and B-cell pathways [3][27] - The company is also exploring other pipeline programs, including a combination therapy for asthma, which may provide additional growth opportunities [39][40] Important but Overlooked Content - The potential for tibulizumab to address the complexities of systemic sclerosis, where IL-17A is a significant driver of inflammation and fibrosis, is emphasized [28][34] - The company is cautious about setting specific efficacy targets until all Phase II data is available, indicating a strategic approach to market positioning [15][19] - The importance of understanding the right dosing and therapeutic range for tibulizumab is highlighted, with ongoing studies to optimize these parameters [23][24] This summary encapsulates the key points discussed during the conference call, providing insights into Zura Bio's strategic direction, product development, and financial outlook.
Zura Bio (ZURA) Earnings Call Presentation
2025-09-02 22:00
Forward Looking Statements Disclaimer This communication includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believe," "predict," "potential," "continue," "strategy," "future," "opportunity," "would," "seem," "seek," "outlook" and the negatives of such terms and similar expressions ...
Zura(ZURA) - 2025 Q2 - Quarterly Report
2025-08-14 12:25
Financial Performance - Total current assets decreased from $178,744 thousand as of December 31, 2024, to $156,985 thousand as of June 30, 2025, representing a decline of approximately 12.1%[13] - Total operating expenses for the three months ended June 30, 2025, were $18,062 thousand, an increase of 53.5% compared to $11,759 thousand for the same period in 2024[15] - Net loss attributable to Class A Ordinary Shareholders for the three months ended June 30, 2025, was $15,993 thousand, compared to a net loss of $12,666 thousand for the same period in 2024, reflecting a 26.5% increase in losses[15] - As of June 30, 2025, the company reported a net loss of $33.4 million, compared to a net loss of $18.1 million for the same period in 2024, indicating an increase in losses of approximately 84% year-over-year[31] - The company has incurred operating losses since inception and may never become profitable, highlighting the ongoing financial challenges[41] Cash and Liquidity - Cash and cash equivalents decreased from $176,498 thousand as of December 31, 2024, to $154,490 thousand as of June 30, 2025, a reduction of approximately 12.4%[13] - Cash and cash equivalents decreased to $154.5 million as of June 30, 2025, from $176.5 million at the beginning of the period, reflecting a net decrease of $22.0 million[31] - The company expects to continue incurring significant operating losses for the foreseeable future, with liquidity sufficient to fund operations over the next twelve months[41] - The Company has significant cash balances exceeding the federally insured limit of $250,000, which poses a risk to its financial condition if access to these funds is lost[51] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $19,178 thousand, up from $9,132 thousand for the same period in 2024, indicating a growth of 109.5%[15] - The company initiated the TibuSHIELD Phase 2 clinical study in May 2025, evaluating tibulizumab in approximately 180 adults with moderate to severe hidradenitis suppurativa[38] - The company is developing tibulizumab (ZB-106), a bispecific dual-antagonist antibody targeting interleukin-17A and BAFF, currently in Phase 2 trials[35] - The company has initiated TibuSURE, a global Phase 2 clinical study for tibulizumab in adults with systemic sclerosis, involving approximately 80 participants[38] Shareholder Equity and Shares - Shareholders' equity decreased from $148,356 thousand as of December 31, 2024, to $127,446 thousand as of June 30, 2025, a decline of approximately 14.1%[13] - The weighted-average Class A Ordinary Shares used in computing net loss per share increased from 74,947,369 for the three months ended June 30, 2024, to 94,289,954 for the same period in 2025[15] - The company raised a total of $105.3 million in net cash proceeds from the sale of Class A Ordinary Shares and pre-funded warrants in April 2024[42] - In April 2025, the Company sold 3 million Class A Ordinary Shares at a price of $1.75 per share under the ATM, resulting in net proceeds of $5.1 million[92] - As of June 30, 2025, a total of 50,230,383 shares are reserved for issuance, including shares issuable upon exercise of pre-funded warrants and options[93] - The Company has issued pre-funded warrants with an exercise price of $0.001 per share, totaling 30,384,348 outstanding as of June 30, 2025[98] - The Company completed a warrant exchange on August 12, 2024, issuing 2,064,082 Class A Ordinary Shares in exchange for public warrants and 1,718,108 Class A Ordinary Shares for private placement warrants[101] Milestone Payments and Obligations - The Company is obligated to make development milestone payments up to an aggregate of $155.0 million and sales milestone payments up to $440.0 million based on net sales thresholds for products developed from tibulizumab[76] - The Company has a right to receive up to $69 million in future development and regulatory milestone payments from Pfizer, along with sales milestone payments up to $525 million[82] - The Company is obligated to make milestone payments to Lilly totaling up to $155 million and sales milestone payments up to $440 million based on net sales thresholds of products developed from the licensed compound[80] - As of June 30, 2025, no Lilly Contingent Payments are due and will not be recorded in the financial statements until they are due[80] Share-Based Compensation - The total share-based compensation expense for the three months ended June 30, 2025 was $3.732 million, compared to $2.926 million for the same period in 2024[119] - The Company had approximately $19.5 million of unrecognized share-based compensation expense related to options, expected to be recognized over a weighted average period of 3.1 years[119] - The Company granted 4,824,440 share options during the six months ended June 30, 2025, with options outstanding increasing to 16,883,380 as of June 30, 2025[107] - The weighted average grant date fair value of options granted during the six months ended June 30, 2025 was $0.96, down from $2.83 in 2024[110] Legal and Regulatory Matters - The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims[120] - The Company expects no material impact from the tax law changes enacted on July 4, 2025, as it analyzes the tax effects for Q3 2025[126] - The Company is currently evaluating the impact of ASU 2023-09 on its income tax disclosures, which is expected to result in considerable changes[62] Other Financial Information - The Company recorded $0.3 million in other income for R&D Credits received in May 2025, and filed an additional claim for $1.0 million that was not received as of June 30, 2025[58] - The Company recorded expenses for Defined Contribution Plans of $0.1 million for Q2 2025, compared to $41,000 in Q2 2024, reflecting a significant increase[125] - Stone Peach requested to exercise a Put Option to sell 50% of its Series Seed Preferred Shares in Z33 for $5.0 million on July 14, 2025[127] - The Company granted inducement awards for options to purchase 890,950 Class A Ordinary Shares to newly hired employees in July 2025[128] - In July 2025, the Company issued 2,888,952 Class A Ordinary Shares related to the exercise of 1,682,000 2023 Pre-Funded Warrants and 1,206,952 2024 Pre-Funded Warrants[129]
Zura(ZURA) - 2025 Q2 - Quarterly Results
2025-08-14 12:20
Financial Position - Zura Bio reported cash and cash equivalents of $154.5 million as of June 30, 2025, expected to fund operations through 2027[8]. - The total assets as of June 30, 2025, were $157.8 million, down from $179.5 million as of December 31, 2024[20]. - The accumulated deficit increased to $189.3 million as of June 30, 2025, compared to $155.9 million at the end of 2024[20]. Operating Expenses - Research and Development (R&D) expenses increased to $8.7 million in Q2 2025, up from $5.5 million in Q2 2024, primarily due to advancements in clinical studies[10]. - General and Administrative (G&A) expenses rose to $9.4 million in Q2 2025, compared to $6.2 million in Q2 2024, driven by increased compensation and external spending[11]. - For the three months ended June 30, 2025, total operating expenses were $18,062 million, an increase from $11,759 million in the same period of 2024, representing a 53.5% increase[22]. - Research and development expenses for the three months ended June 30, 2025, were $8,704 million, up from $5,539 million in 2024, reflecting a 56.5% increase[22]. - General and administrative expenses increased to $9,358 million for the three months ended June 30, 2025, compared to $6,220 million in 2024, marking a 50.5% increase[22]. Net Loss - The net loss for Q2 2025 was $16.0 million, or $0.17 per share, compared to a net loss of $10.3 million, or $0.17 per share, in Q2 2024[12]. - The net loss for the three months ended June 30, 2025, was $15,993 million, compared to a net loss of $10,329 million in the same period of 2024, indicating a 55.0% increase in losses[22]. - The net loss attributable to Class A Ordinary Shareholders of Zura for the three months ended June 30, 2025, was $15,993 million, compared to $12,666 million in 2024, a 26.0% increase[22]. - The net loss per share attributable to Class A Ordinary Shareholders of Zura for the three months ended June 30, 2025, was $0.17, unchanged from the same period in 2024[22]. Clinical Studies - Zura Bio initiated the TibuSHIELD Phase 2 clinical study for tibulizumab in moderate to severe hidradenitis suppurativa in Q2 2025, with topline data expected in Q3 2026[4]. - The company continued its Phase 2 TibuSURE clinical study for systemic sclerosis, with topline data anticipated in Q4 2026[5]. - The company is conducting preclinical research on crebankitug and evaluating torudokimab for potential therapeutic benefits in immune-mediated diseases[6][7]. Other Financial Metrics - Total other income, net for the three months ended June 30, 2025, was $(2,069) million, compared to $(1,430) million in 2024, reflecting a 45.0% increase in other losses[22]. - Loss from operations for the three months ended June 30, 2025, was $(18,062) million, compared to $(11,759) million in 2024, a 53.5% increase in operational losses[22]. - The company reported an interest income of $(1,717) million for the three months ended June 30, 2025, down from $(2,196) million in 2024, a decrease of 21.8%[22]. Shareholder Information - Weighted-average Class A Ordinary Shares used in computing net loss per share for the three months ended June 30, 2025, were 94,289,954, compared to 74,947,369 in 2024, an increase of 25.8%[22]. - Zura Bio appointed a new Chief Financial Officer and a new board member to support ongoing growth and development[8].
Zura Bio (ZURA) 2025 Conference Transcript
2025-06-04 20:10
Summary of Zura Bio Conference Call Company Overview - Zura Bio was formed as a private company in 2022 and went public in 2023 [2][3] - The company has in-licensed three novel bispecific antibodies [3] Key Objectives and Achievements - The CEO outlined three objectives: secure two new INDs, initiate two phase two trials, and raise sufficient funds for these trials [3] - Successfully secured IND for systemic sclerosis and initiated the study in December 2024 [4] - IND cleared for hidradenitis suppurativa in March 2025, with the study activated [4] Lead Asset: Tipalizumab - Tipalizumab is a quadrivalent bispecific antibody that inhibits IL-17 and BAF [5] - The unique quadrivalent structure allows binding to IL-17, BAF, or both without requiring dual engagement [7] Phase Two Programs Systemic Sclerosis - Affects approximately 300,000 individuals globally with a ten-year mortality rate of 50% [8] - No advanced line agent approved for the disease; existing therapies provide modest effects [9] - Phase two trial will measure the change in modified Rodnan Skin Score and explore lung function [10] - Previous studies (e.g., Brodalumab) showed robust responses in skin scores, indicating potential for Tipalizumab [12] Hidradenitis Suppurativa - A challenging disease with around 300,000 patients in the US; existing treatments have modest benefits [17][18] - The need for higher efficacy therapies remains unmet [21] - Emerging data suggests a combinatory approach using IL-17 and B cell inhibition could improve outcomes [23] Clinical Trial Design and Expectations - Phase two trial for systemic sclerosis will have 80 participants and is expected to complete enrollment by Q1 2026, with top-line data by Q4 2026 [15] - The trial for hidradenitis suppurativa is expected to provide top-line data in Q3 2026 [29] - Both trials include a loading dose to achieve therapeutic levels quickly [30] Financial Position - The company has a strong cash position, expected to last through 2027, providing a buffer for post-data catalyst activities [32] Conclusion - Zura Bio is positioned uniquely in the biotech landscape with promising drug candidates and a solid financial foundation, aiming to validate its hypotheses in systemic sclerosis and hidradenitis suppurativa [33]