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

Summary of Zura Bio Conference Call Company Overview - Zura Bio is a publicly traded company listed on NASDAQ since April 2023, having raised $200 million and in-licensed three bispecific monoclonal antibodies [2][49] - The lead asset, tibulizumab, is an anti-IL-17 B-cell activating factor antagonist currently enrolling in two Phase II studies for systemic sclerosis and hidradenitis suppurativa, with top-line data expected in Q3-Q4 of next year [2][49] Core Points and Arguments Lead Program: Tibulizumab - Tibulizumab targets both IL-17 and B-cell activating factor, with a unique combination therapy approach expected to yield robust results [4][10] - The drug has a higher affinity for IL-17A and IL-17AF compared to other IL-17 inhibitors, which may provide a therapeutic advantage [4][22] - The Phase II TibuSHIELD study is designed to measure the change in AN count as the primary endpoint, with secondary endpoints including HiSCR scores and impact on draining tunnels [11][34] Efficacy and Comparisons - The efficacy of tibulizumab is compared to other IL-17 inhibitors, with expectations of a broader and deeper response in patients, particularly in reducing draining tunnels associated with hidradenitis suppurativa [15][22] - The company aims to differentiate tibulizumab from existing treatments by addressing unmet needs in the market, particularly for patients who have not previously been exposed to biologics [6][16] Financial Position and Future Outlook - As of the end of Q2, Zura Bio had $155 million in cash, sufficient to fund both Phase II studies and operations through 2027, with a projected burn rate peaking at $15 million per quarter [49][50] - The company anticipates strong investor interest if the Phase II data is robust, which could lead to favorable financing opportunities for Phase III studies [50][55] Industry Context - The discussion highlights the competitive landscape of IL-17 inhibitors, with tibulizumab positioned to potentially outperform existing therapies by targeting both IL-17 and B-cell pathways [3][27] - The company is also exploring other pipeline programs, including a combination therapy for asthma, which may provide additional growth opportunities [39][40] Important but Overlooked Content - The potential for tibulizumab to address the complexities of systemic sclerosis, where IL-17A is a significant driver of inflammation and fibrosis, is emphasized [28][34] - The company is cautious about setting specific efficacy targets until all Phase II data is available, indicating a strategic approach to market positioning [15][19] - The importance of understanding the right dosing and therapeutic range for tibulizumab is highlighted, with ongoing studies to optimize these parameters [23][24] This summary encapsulates the key points discussed during the conference call, providing insights into Zura Bio's strategic direction, product development, and financial outlook.

Forward Looking Statements Disclaimer This communication includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believe," "predict," "potential," "continue," "strategy," "future," "opportunity," "would," "seem," "seek," "outlook" and the negatives of such terms and similar expressions ...

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]

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].

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]

Financial Performance - Total assets as of March 31, 2025, were $172.5 million, a decrease from $179.5 million as of December 31, 2024[12] - Operating expenses for the three months ended March 31, 2025, were $19.3 million, compared to $8.4 million for the same period in 2024, representing a 130% increase[14] - Net loss for the three months ended March 31, 2025, was $17.4 million, compared to a net loss of $7.7 million for the same period in 2024, indicating a 126% increase in losses[14] - Cash and cash equivalents decreased to $170.6 million as of March 31, 2025, from $176.5 million at the end of 2024, reflecting a decrease of $5.9 million[22] - The Company has an accumulated deficit of $173.3 million as of March 31, 2025, and a net loss of $17.4 million for the three months ended March 31, 2025[34] - The Company reported a net loss of $7.7 million for the three months ended March 31, 2024, indicating a year-over-year increase in losses[34] Research and Development - Research and development expenses for the three months ended March 31, 2025, were $10.5 million, significantly higher than $3.6 million for the same period in 2024, marking a 192% increase[14] - The company is currently developing tibulizumab (ZB - 106), with a global Phase 2 study initiated in December 2024, targeting approximately 80 participants[28] - The Company has two key product candidates: Crebankitug (ZB-168) and Torudokimab (ZB-880), targeting immune and inflammatory disorders[32] - The Company is obligated to make milestone payments to Lilly totaling up to $155.0 million for development and $440.0 million for sales based on net sales thresholds for tibulizumab[63] Shareholder Equity and Financing - The company raised $5.1 million from the issuance of Class A Ordinary Shares in connection with a sale under the ATM, net of commissions[23] - The Company raised $56.7 million in net cash proceeds from the Business Combination and an additional $105.3 million from the April 2024 Private Placement[35] - In Q1 2025, the Company sold 3,000,000 Class A Ordinary Shares at $1.75 per share, generating net proceeds of $5.1 million[77] - As of March 31, 2025, a total of 47,219,119 shares are reserved for issuance, including options and warrants[78] - The maximum number of Class A Ordinary Shares that may be issued under the Employee Stock Purchase Plan (ESPP) is 4,029,898, plus additional shares from the Equity Incentive Plan[87] Liabilities and Obligations - Total liabilities as of March 31, 2025, were $21.1 million, unchanged from December 31, 2024[12] - The total accounts payable and accrued expenses increased to $21.1 million as of March 31, 2025, up from $19.5 million as of December 31, 2024[57] - The Company has incurred operating losses since inception and may never become profitable[34] - The Company is obligated to make future payments to Pfizer totaling up to $69.0 million for development milestones and $525.0 million for sales milestones[70] - The Company is obligated to make milestone payments to Lilly totaling up to $155.0 million for development and $440.0 million for sales based on net sales thresholds for tibulizumab[63] Share-Based Compensation - The Company reported a share-based compensation expense of $3.6 million for the three months ended March 31, 2025, compared to $2.4 million for the same period in 2024[23] - The total share-based compensation expense for the three months ended March 31, 2025, was $3.644 million, compared to $2.409 million for the same period in 2024, representing a 51.1% increase[98] - As of March 31, 2025, there was approximately $21.7 million of total unrecognized share-based compensation expense related to options granted, expected to be recognized over a weighted average period of 3.1 years[98] - The Company granted 3,572,790 share options during the three months ended March 31, 2025, with a weighted average exercise price of $1.20[91] - The fair value of share options granted during the three months ended March 31, 2025, was estimated at $0.97 per option, compared to $2.91 for the same period in 2024[93] - As of March 31, 2025, the Company had 15,687,069 options outstanding with a weighted average exercise price of $2.50 and an intrinsic value of $4.096 million[91] Regulatory and Compliance - The company qualifies as a "smaller reporting company" and is exempt from certain regulatory requirements, including auditor attestation under Section 404 of the Sarbanes-Oxley Act[176] - The company has reduced disclosure obligations regarding executive compensation in periodic reports and proxy statements[177] - The company is exempt from holding non-binding advisory votes on executive compensation or golden parachute arrangements[177] - The company is not required to comply with Public Company Accounting Oversight Board requirements related to critical audit matters in auditor reports[177] Licensing and Agreements - The Company entered into a license agreement with Lilly for an exclusive license to develop and commercialize tibulizumab, a bispecific antibody[58] - As part of the 2023 Lilly License, the Company granted Stone Peach a call right to purchase 4.99% of ZB17's equity for $1.0 million, with a noncontrolling interest balance of $1.5 million as of March 31, 2025[59] - Stone Peach will receive an annual payment starting at $0.6 million, increasing by 10% annually, as long as the Company maintains its license for tibulizumab[60] - A one-time payment of $4.5 million is due to Stone Peach upon FDA acceptance of the IND for tibulizumab, recorded in R&D expenses for the year ended December 31, 2024[61] - The Lonza License requires an annual fee of $0.4 million, recorded in accounts payable as of March 31, 2025[73]

Financial Performance - Zura Bio reported a net loss of $17.4 million, or $0.19 per share, for Q1 2025, compared to a net loss of $7.7 million, or $0.02 per share, in Q1 2024[12][22]. - Total operating expenses for Q1 2025 were $19.3 million, compared to $8.4 million in Q1 2024[22]. - Zura Bio's accumulated deficit increased to $173.3 million as of March 31, 2025, compared to $155.9 million at the end of 2024[20]. Research and Development - Research and Development (R&D) expenses increased to $10.5 million in Q1 2025 from $3.6 million in Q1 2024, primarily due to higher contract research organization costs and manufacturing costs[10]. - The Phase 2 TibuSURE trial for tibulizumab in adults with systemic sclerosis (SSc) is ongoing, with preparations for a second Phase 2 trial in hidradenitis suppurativa (HS) expected to initiate in Q2 2025[3][4][7]. - The company is exploring the potential of crebankitug in immune-mediated diseases and evaluating torudokimab for inflammatory and respiratory diseases[5][6]. Administrative Expenses - General and Administrative (G&A) expenses rose to $8.8 million in Q1 2025, up from $4.8 million in Q1 2024, driven by increased compensation costs and professional fees[11]. Cash Position - As of March 31, 2025, Zura Bio had cash and cash equivalents of $170.6 million, with a cash runway anticipated through 2027[9][7]. - The total assets of Zura Bio as of March 31, 2025, were $172.5 million, down from $179.5 million as of December 31, 2024[20]. Organizational Changes - The company appointed Kate Dingwall as Senior Vice President of Development Operations to enhance clinical execution and organizational growth[8].

Financial Position - Zura Bio reported cash and cash equivalents of $176.5 million as of December 31, 2024, up from $99.8 million as of December 31, 2023, indicating a significant increase of 76.8%[9]. - Zura Bio's total assets increased to $179.5 million as of December 31, 2024, compared to $100.8 million in 2023, indicating strong growth in the company's financial position[18]. - Zura Bio completed a $112.5 million private placement financing in April 2024, contributing to a total cash position that supports operations through 2027[6]. Expenses - Research and development expenses decreased to $24.4 million for the year ended December 31, 2024, down 44.5% from $44.0 million in 2023, primarily due to a one-time acquisition cost in the previous year[10]. - General and administrative expenses rose to $30.8 million in 2024, an increase of 65.5% compared to $18.6 million in 2023, driven by higher compensation and professional fees[11]. - The total operating expenses for 2024 were $55.2 million, a decrease from $62.6 million in 2023, reflecting improved cost management[20]. Net Loss - The net loss for the year ended December 31, 2024, was $45.4 million, or $0.60 per share, a reduction from a net loss of $69.2 million, or $2.09 per share, in 2023[12]. Clinical Development - Zura Bio initiated the Phase 2 TibuSURE trial for systemic sclerosis (SSc) in December 2024, marking a key milestone in its clinical pipeline[4]. - The company plans to launch a Phase 2 trial for hidradenitis suppurativa (HS) in Q2 2025, further expanding its clinical research efforts[7]. - The company established a Scientific Advisory Board in June 2024, enhancing its clinical and scientific leadership capabilities[13].

Group 1 - Zura Bio Limited (ZURA) has experienced a significant downtrend, with a stock decline of 35.6% over the past four weeks, indicating strong selling pressure [1] - The stock is currently in oversold territory, with an RSI reading of 29.75, suggesting a potential reversal in trend [5] - Wall Street analysts have raised earnings estimates for ZURA, with a consensus EPS estimate increase of 8.9% over the last 30 days, indicating a positive outlook for the company's earnings [6] Group 2 - ZURA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which further supports the potential for a turnaround [7] - The RSI is a commonly used technical indicator for identifying oversold stocks, with a reading below 30 typically indicating oversold conditions [2] - The upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, reinforcing the potential for ZURA's stock to recover [6]