Zura Bio Ltd

Previous wording

In May 2025, we initiated TibuSHIELD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in participants with moderate to severe hidradenitis suppurativa (“HS”). Enrollment in TibuSHIELD is complete, exceeding the initial enrollment target with 247 participants. The study is designed to assess the safety, tolerability, and efficacy of tibulizumab in the relevant patient population. The study will evaluate tibulizumab over a 32-week period, which includes a 16-week efficacy assessment period followed by a 16-week optional open-label extension (“OLE”). The primary endpoint of the study is the percent change from baseline in total abscess and nodule (“AN”) count at week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at week 16. Topline results are expected to be available in the fourth quarter of 2026.

Current wording

In May 2025, we initiated TibuSHIELD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in participants with moderate to severe hidradenitis suppurativa (“HS”). Enrollment in TibuSHIELD is complete, exceeding the initial enrollment target with 247 participants. The study is designed to assess the safety, tolerability, and efficacy of tibulizumab in the relevant patient population. The study will evaluate tibulizumab over a 32-week period, which includes a 16-week placebo-controlled efficacy assessment period followed by a 16-week optional open-label extension (“OLE”). The primary endpoint of the study is the percent change from baseline in total abscess and inflammatory nodule (“AN”) count at week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at week 16. Topline results are expected to be available in the fourth quarter of 2026.

Previous wording

In December 2024, we initiated TibuSURE, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in participants with early diffuse cutaneous systemic sclerosis. Enrollment in TibuSURE is complete, exceeding the initial enrollment target with 91 participants. The study is designed to assess the safety, tolerability, and efficacy of tibulizumab in the relevant patient population. The study will evaluate tibulizumab over a 52-week period, which includes a 24-week efficacy period followed by a 28-week optional OLE. The primary endpoint is the modified Rodnan Skin Score. Key efficacy endpoints include lung disease, assessed by quantitative high-resolution computed tomography and forced vital capacity; physical function, measured by the Health Assessment Questionnaire-Disability Index; and the revised Combined Response Index in Systemic Sclerosis. Topline results are expected to be available in the first half of 2027.

Current wording

In December 2024, we initiated TibuSURE, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in participants with early diffuse cutaneous systemic sclerosis (“SSc”). Enrollment in TibuSURE is complete, exceeding the initial enrollment target with 91 participants. The study is designed to assess the safety, tolerability, and efficacy of tibulizumab in the relevant patient population. The study will evaluate tibulizumab over a 52-week period, which includes a 24-week placebo-controlled efficacy period followed by a 28-week optional OLE. The primary endpoint is change from baseline in the modified Rodnan Skin Score. Key efficacy endpoints include lung involvement, assessed by quantitative high-resolution computed tomography and forced vital capacity; physical function, measured by the Health Assessment Questionnaire-Disability Index; and the revised Combined Response Index in Systemic Sclerosis. Topline results are expected to be available in the first half of 2027.

Previous wording

We have a limited operating history. Since our inception, our operations have focused on organizing and staffing our company, business planning, raising capital, and entering into collaboration agreements for conducting manufacturing, clinical trials and other research and development activities. Our lead product candidate is in the clinical testing stage; however, prior to the initiation of TibuSHIELD and TibuSURE in May 2025 and December 2024, respectively, we had not conducted any clinical trials. We do not have any product candidates approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through private and public equity financings, having raised aggregate gross proceeds of approximately $421.5 million as of the date hereof.

Current wording

Since our inception, our operations have focused on organizing and staffing our company, business planning, raising capital, and entering into collaboration agreements for conducting manufacturing, clinical trials and other research and development activities. Our lead product candidate is in the clinical testing stage; however, prior to the initiation of TibuSHIELD and TibuSURE in May 2025 and December 2024, respectively, we had not conducted any clinical trials. We do not have any product candidates approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through private and public equity financings, having raised aggregate gross proceeds of approximately $421.5 million as of the date hereof.

Previous wording

Since our inception, we have incurred significant operating losses. Our net loss for the three and six months ended June 30, 2026 was $26.3 million and $50.5 million, respectively. As of June 30, 2026, we had an accumulated deficit of $275.1 million. We anticipate that our expenses will increase significantly in connection with our ongoing and future activities, as we:

Current wording

Since our inception, we have incurred significant operating losses. Our net loss for the three and nine months ended September 30, 2026 was $25.8 million and $76.4 million, respectively. As of September 30, 2026, we had an accumulated deficit of $300.9 million. We anticipate that our expenses will increase significantly in connection with our ongoing and future activities, as we:

Previous wording

In February 2026, we sold 21,200,000 Class A Ordinary Shares (the “Shares”), par value $0.0001 per share, at a price to the public of $6.25 per share, along with pre-funded warrants (the “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 represents the per share public offering price for the Shares less the $0.001 exercise price of each Pre-Funded Warrant (the “February 2026 Equity

Current wording

In February 2026, we sold 21,200,000 Class A Ordinary Shares (the “Shares”), par value $0.0001 per share, at a price to the public of $6.25 per share, along with pre-funded warrants (the “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 represents the per share public offering price for the Shares less the $0.001 exercise price of each Pre-Funded Warrant (the “February 2026 Equity Offering”). The net proceeds from the February 2026 Equity Offering were approximately $134.6 million after deducting underwriting discounts and commissions and offering expenses.

Previous wording

On April 26, 2023, our consolidated subsidiary ZB17 LLC entered into a license agreement with Lilly, to develop, manufacture and commercialize tibulizumab.

Current wording

On April 26, 2023, our consolidated subsidiary ZB17 entered into a license agreement with Eli Lilly and Company ("Lilly"), to develop, manufacture and commercialize tibulizumab.

Previous wording

We are obligated to make payments to Lilly (a) for 4 development milestone payments up to an aggregate of $155.0 million, and sales milestone payments up to an aggregate of $440.0 million based on respective thresholds of net sales of products developed from tibulizumab; (b) over a multi-year period (twelve years, or upon the later expiration of regulatory exclusivity of tibulizumab in a country) for an annual earned royalty at a marginal royalty rate in the mid-single digits to low-double digits, with increasing rates depending on net sales in the respective calendar year, based on a percentage of sales within varying thresholds for a certain period of years (collectively, the “2023 Lilly Contingent Payments”). As of June 30, 2026, none of the 2023 Lilly Contingent Payments are due and accordingly will not be recorded in our financial statements until they are due.

Current wording

We are obligated to make payments to Lilly (a) for 4 development milestone payments up to an aggregate of $155.0 million, and sales milestone payments up to an aggregate of $440.0 million based on respective thresholds of net sales of products developed from tibulizumab; and (b) over a multi-year period (twelve years, or upon the later expiration of regulatory exclusivity of tibulizumab in a country) for an annual earned royalty at a marginal royalty rate in the mid-single digits to low-double digits, with increasing rates depending on net sales in the respective calendar year, based on a percentage of sales within varying thresholds for a certain period of years (collectively, the “2023 Lilly Contingent Payments”). As of September 30, 2026, none of the 2023 Lilly Contingent Payments are due and accordingly will not be recorded in our financial statements until they are due.

Previous wording

On December 8, 2022, our consolidated subsidiary, Z33 Bio Inc. (“Z33”), entered into a license agreement with Lilly to develop, manufacture, and commercialize torudokimab.

Current wording

On December 8, 2022, our consolidated subsidiary, Z33, entered into a license agreement with Lilly to develop, manufacture, and commercialize torudokimab.

Previous wording

We are obligated to make payments to Lilly for (a) 10 commercial, development and regulatory milestone payments up to an aggregate of $155.0 million and sales milestone payments up to an aggregate of $440.0 million based on respective thresholds of net sales of products developed from the licensed molecule; and (b) an annual earned royalty at a marginal royalty rate in the mid-single to low-double digits, with increasing royalty percentage rates based on Net Sales in the respective calendar year, based on a percentage of sales within varying thresholds for a certain period of the year (collectively, the “2022 Lilly Contingent Payments”). As of June 30, 2026, none of the 2022 Lilly Contingent Payments are due and accordingly will not be recorded in our financial statements until they are due.

Current wording

We are obligated to make payments to Lilly for (a) 10 commercial, development and regulatory milestone payments up to an aggregate of $155.0 million and sales milestone payments up to an aggregate of $440.0 million based on respective thresholds of net sales of products developed from the licensed compound; and (b) an annual earned royalty at a marginal royalty rate in the mid-single to low-double digits, with increasing royalty percentage rates based on net sales in the respective calendar year, based on a percentage of sales within varying thresholds for a certain period of the year (collectively, the “2022 Lilly Contingent Payments”). As of September 30, 2026, none of the 2022 Lilly Contingent Payments are due and accordingly will not be recorded in our financial statements until they are due.

Previous wording

On March 22, 2022, we entered into a license agreement and a Series A-1 Subscription and Shareholder’s Agreement (collectively, the “Pfizer Agreement”) with Pfizer to develop, manufacture, and commercialize crebankitug.

Current wording

On March 22, 2022, we entered into a license agreement and a Series A-1 Subscription and Shareholder’s Agreement with Pfizer to develop, manufacture, and commercialize crebankitug.

Previous wording

•a $4.8 million increase in costs for tibulizumab that was not specific to an indication, primarily driven by increased drug manufacturing costs;

Current wording

•a $2.3 million increase in costs for tibulizumab that was not specific to an indication, primarily driven by increased drug manufacturing costs;

Previous wording

•a $2.1 million increase in compensation, including share-based compensation, primarily driven by increased personnel in research and development functions.

Current wording

•a $2.3 million increase in compensation, including share-based compensation, primarily driven by increased personnel in research and development functions;

Previous wording

•a $2.7 million and $2.8 million increase in costs as we advance our Phase 2 clinical trials evaluating tibulizumab in adults with HS and SSc, respectively, driven by costs incurred for CRO fees to support the conduct of our clinical trials; and

Current wording

•a $0.9 million increase in costs as we continue execution of our Phase 2 clinical trials evaluating tibulizumab in adults with HS and SSc, driven by costs incurred for CRO fees to support the conduct of our clinical trials.

Previous wording

Interest income increased by $0.2 million for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. This is primarily due to a higher cash balance for the second quarter of 2026 due to the proceeds from the February 2026 Equity Offering.

Current wording

Interest income increased by $0.2 million for the three months ended September 30, 2026 as compared to the three months ended September 30, 2025. This is primarily due to a higher cash balance for the third quarter of 2026 due to the proceeds from the February 2026 Equity Offering.

Previous wording

•a $6.1 million and $3.2 million increase in costs as we advance our Phase 2 clinical trials evaluating tibulizumab in adults with HS and SSc, respectively, driven by costs incurred for CRO fees to support the conduct of our clinical trials;

Current wording

•a $7.4 million and $2.9 million increase in costs as we continue execution of our Phase 2 clinical trials evaluating tibulizumab in adults with HS and SSc, respectively, driven by costs incurred for CRO fees to support the conduct of our clinical trials;

Previous wording

•a $4.0 million increase in costs for tibulizumab that was not specific to an indication, which was also driven by increased personnel; and

Current wording

•a $5.8 million increase in costs for tibulizumab that was not specific to an indication, primarily driven by increased drug manufacturing costs;

Previous wording

•a $3.3 million increase in compensation, including share-based compensation, driven by increased personnel in research and development functions.

Current wording

•a $5.5 million increase in compensation, including share-based compensation, driven by increased personnel in research and development functions; and

Previous wording

General and administrative expenses increased by $1.2 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025. The increase was primarily due to an increase in compensation expenses, including share-based compensation, for personnel in executive and administrative functions and our board of directors, and an increase in professional fees to support our growing organization as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS.

Current wording

General and administrative expenses increased by $2.9 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025. The increase was primarily due to an increase in compensation expenses, including share-based compensation, for personnel in executive and administrative functions and our board of directors, and an increase in professional fees to support our growing organization as we continue execution of our Phase 2 tibulizumab trials in SSc and HS and initiate evaluation in PMR.

Previous wording

Interest income decreased by $0.3 million for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025. This is primarily due to lower interest rates, as well as a lower cash balance for the majority of the first quarter of 2026, as the proceeds from the February 2026 Equity Offering were not received until the end of February.

Current wording

Interest income decreased by $0.1 million for the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025. This is primarily due to lower interest rates, as well as a lower cash balance for the majority of the first quarter of 2026, as the proceeds from the February 2026 Equity Offering were not received until the end of February.

Previous wording

Other income, net increased by $0.6 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025, primarily due to the receipt of an R&D Credit during the six months ended June 30, 2026.

Current wording

Other income, net increased by $0.6 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily due to the receipt of an R&D Credit during the nine months ended September 30, 2026.

Previous wording

Since our inception, we have not reached successful commercialization of our product candidates or generated any revenue and we expect to continue to incur significant operating losses for the foreseeable future. We will require ongoing financing in order to continue our research and development activities and may never become profitable. As of June 30, 2026, we had cash and cash equivalents of $205.1 million. We have funded our operations primarily through private and public equity financings, having raised aggregate gross proceeds of approximately $421.5 million as of the date hereof.

Current wording

Since our inception, we have not reached successful commercialization of our product candidates or generated any revenue and we expect to continue to incur significant operating losses for the foreseeable future. We will require ongoing financing in order to continue our research and development activities and may never become profitable. As of September 30, 2026, we had cash and cash equivalents of $187.7 million. We have funded our operations primarily through private and public equity financings, having raised aggregate gross proceeds of approximately $421.5 million as of the date hereof.

Previous wording

To date, we have not generated revenue from any source, including the commercial sales of our approved drug products, and we do not expect to generate revenue from the commercial sales of our approved drug products for at least the next few years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be adversely affected. We do not know when, or if, we will generate any revenue from the commercial sale of our approved drug products, and we do not expect to generate revenue from the commercial sales of our approved drug products unless and until we obtain regulatory approval of, and commercialize, our product candidates.

Current wording

To date, we have not generated revenue from any source, including the commercial sales of any approved drug products, and we do not expect to generate revenue from the commercial sales of our product candidates for at least the next few years. If we fail to complete the development of our product candidates in a timely manner or fail to obtain their regulatory approval, our ability to generate future revenue will be adversely affected. We do not know when, or if, we will generate any revenue from the commercial sale of our product candidates, and we do not expect to generate revenue from the commercial sales of our product candidates unless and until we obtain regulatory approval of, and commercialize, our product candidates.

Previous wording

Net cash used in operating activities increased by $12.7 million to $39.8 million for the six months ended June 30, 2026 compared to the six months ended June 30, 2025. This was primarily due to an increase in our net loss of $17.1 million, which is driven by an increase in our operating costs.

Current wording

Net cash used in operating activities increased by $16.8 million to $59.3 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This was primarily due to an increase in our net loss of $24.9 million, which is driven by an increase in our operating costs.

Previous wording

Net cash used in investing activities for each of the six months ended June 30, 2026 and 2025 was de minimis.

Current wording

Net cash used in investing activities for each of the nine months ended September 30, 2026 and 2025 was de minimis.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 was $135.6 million, which related primarily to net proceeds from the February 2026 Equity Offering, after underwriters’ fees and discounts. Cash provided by financing activities for the six months ended June 30, 2025 was $5.1 million, which primarily related to net proceeds, after placement agent commissions, from the sale of Class A Ordinary Shares under our ATM.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 was $137.6 million, which related primarily to net proceeds from the February 2026 Equity Offering, after underwriters’ fees and discounts. Net cash provided by financing activities for the nine months ended September 30, 2025 was $5.2 million, which primarily related to net proceeds, after placement agent commissions, from the sale of Class A Ordinary Shares under our ATM.

Previous wording

In July 2023, we entered into a cell line license agreement (the “Cell Line License Agreement”) with WuXi Biologics and its Affiliates (“WuXi Biologics”) for certain of WuXi Biologics’ know-how, cell line, and biological materials (the “WuXi Biologics Licensed Technology”) to manufacture, have manufactured, use, sell and import certain products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). If we manufacture all of our commercial supplies of bulk drug product for WuXi Biologics Licensed Products with a manufacturer other than WuXi Biologics or its affiliates, we are required to make royalty payments to WuXi Biologics in an amount equal to a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer (the “Royalty”). If we manufacture part of our commercial supplies of the WuXi Biologics Licensed Products with WuXi Biologics or its affiliates, then the Royalty will be reduced accordingly on a pro rata basis. The Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon three months’ prior written notice and its payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by us that remains uncured for 30 days after written notice, or (iii) by WuXi Biologics if we fail to make a payment and such failure continues for 30 days after receiving notice of such failure. As of June 30, 2026, there are no payments currently due under the Cell Line License Agreement.

Current wording

In July 2023, we entered into a cell line license agreement (the “Cell Line License Agreement”) with WuXi Biologics and its Affiliates (“WuXi Biologics”) for certain of WuXi Biologics’ know-how, cell line, and biological materials (the “WuXi Biologics Licensed Technology”) to manufacture, have manufactured, use, sell and import certain products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). If we manufacture all of our commercial supplies of bulk drug product for WuXi Biologics Licensed Products with a manufacturer other than WuXi Biologics or its affiliates, we are required to make royalty payments to WuXi Biologics in an amount equal to a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer (the “Royalty”). If we manufacture part of our commercial supplies of the WuXi Biologics Licensed Products with WuXi Biologics or its affiliates, then the Royalty will be reduced accordingly on a pro rata basis. The Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon three months’ prior written notice and our payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by us that remains uncured for 30 days after written notice, or (iii) by WuXi Biologics if we fail to make a payment and such failure continues for 30 days after receiving notice of such failure. As of September 30, 2026, there are no payments currently due under the Cell Line License Agreement.

Previous wording

•exemptions from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements, and an exemption from compliance with the requirements of the Public Company Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s report on financial statements.

Current wording

•exemptions from the requirements of holding non-binding advisory votes on executive compensation or golden parachute arrangements, and an exemption from compliance with the requirements of the Public Company

Previous wording

We are also a “smaller reporting company” as defined under the Securities Act and Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may continue to be a smaller reporting company so long as either (i) the market value of Class A Ordinary Shares held by non-affiliates is less than $250.0 million or (ii) our annual revenue was less than $100.0 million during the most recently completed fiscal year and the market value of Class A Ordinary Shares held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report and have reduced disclosure obligations regarding executive compensation, and, similar to emerging growth companies, if we are a smaller reporting company under the requirements of (ii) above, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

Current wording

We are also a “smaller reporting company” as defined under the Securities Act and Securities Exchange Act of 1934, as amended (the “Exchange Act”). We may continue to be a smaller reporting company so long as either (i) the market value of Class A Ordinary Shares held by non-affiliates is less than $250.0 million or (ii) our annual revenue was less than $100.0 million during the most recently completed fiscal year and the market value of Class A Ordinary Shares held by non-affiliates is less than $700.0 million. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our 2025 Annual Report and have reduced disclosure obligations regarding executive compensation, and, similar to emerging growth companies, if we are a smaller reporting company under the requirements of (ii) above, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.