Zura Bio (ZURA) 2025 Conference June 04, 2025 03:10 PM ET Speaker0 All right, good to go. All right, everyone. Thank you so much for coming to the Jefferies Healthcare Conference. And I'd like to warmly welcome the CEO of Zura Bio, Robert Lisicki. Speaker1 Thank you very much for that introduction. And I'd like to, on behalf of Zura Bio, just extend my regards and thanks to Jeffries for the invitation today and the chance to share what I think is a very exciting update on Zura Bio and the company. Just as a ...

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Cayman Islands 98-1725736 (State or other jurisdiction of incorporation or organization) 1489 W. Warm Springs Rd. #110 Henderson, NV 89014 (I.R.S. Employer Identification No.) (Address of principal executive offices) (Zip Code) For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SE ...

Exhibit 99.1 Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates HENDERSON, Nev. – (BUSINESS WIRE) – May 8, 2025 – Zura Bio Limited (Nasdaq: ZURA) ("Zura Bio" or the "Company"), a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases, today reported financial results for the first quarter ended March 31, 2025, and provided recent corporate updates. "The first quarter of 2025 reflected steady ...

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]

Financial Performance - The net loss attributable to Class A Ordinary Shareholders for the three months ended September 30, 2024, was $22,942,000, compared to a loss of $8,270,000 for the same period in 2023, representing an increase in loss of approximately 177.5%[15]. - For the three months ended September 30, 2023, the net loss was $20.702 million, compared to a net loss of $8.270 million for the same period in the previous year[18]. - As of September 30, 2024, total shareholders' equity was $154.587 million, with an accumulated deficit of $142.272 million[19]. - As of September 30, 2024, the company reported a net loss of $20.7 million for the three months and $38.8 million for the nine months, with an accumulated deficit of $142.3 million[122]. Assets and Liabilities - As of September 30, 2024, the company reported total current assets of $188,975,000, a significant increase from $100,843,000 as of December 31, 2023, representing an increase of approximately 87%[11]. - The company reported a total liability of $18,244,000 as of September 30, 2024, down from $21,292,000 as of December 31, 2023, indicating a decrease of about 14.4%[12]. - The company’s total shareholders' equity increased to $154,587,000 as of September 30, 2024, from $60,871,000 as of December 31, 2023, representing an increase of approximately 154.0%[13]. - The total assets of the company as of September 30, 2024, were $189,071,000, up from $100,843,000 as of December 31, 2023, reflecting an increase of approximately 87.2%[11]. Cash Flow and Financing - The company had cash and cash equivalents of $188.221 million as of September 30, 2023, up from $103.859 million at the beginning of the period[28]. - Cash provided by financing activities for the nine months ended September 30, 2024 was $110.7 million, consisting of $62.5 million from Class A Ordinary Shares issuance and $50.0 million from Pre-Funded Warrants[180]. - The company raised a total of $10.0 million from the sale of convertible preferred stock, $7.6 million from a promissory note, $56.7 million from a business combination, and $80.0 million from an April 2023 private placement[121]. - The company completed an April 2024 Private Placement, issuing 18,732,301 Class A Ordinary Shares at $3.108 per share, raising approximately $108.3 million[79]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $19,319,000, compared to $10,187,000 for the same period in 2023, reflecting an increase of approximately 90.0%[15]. - General and administrative expenses rose by $7.1 million to $13.3 million for the three months ended September 30, 2024, reflecting a 114% increase year-over-year[154]. - Research and development expenses for the nine months ended September 30, 2024, were $15,161,000, compared to $37,079,000 for the same period in 2023, showing a decrease of approximately 59.1%[15]. - Research and development expenses increased by $2.1 million to $6.0 million for the three months ended September 30, 2024, representing a 52% increase compared to the same period in 2023[153]. Shareholder Equity and Shares - The company issued 20,090,128 Class A Ordinary Shares in connection with an April 2024 private placement, raising $55.221 million after $7.2 million in transaction costs[19]. - The company had 65,293,530 Class A Ordinary Shares outstanding as of September 30, 2024[19]. - The total number of shares issuable upon exercise of options to purchase Class A Ordinary Shares increased from 5,681,471 as of September 30, 2023, to 9,318,906 as of September 30, 2024[47]. - The company authorized 300,000,000 Class A Ordinary Shares and 1,000,000 preferred shares as of March 16, 2023[74]. Future Obligations and Risks - The company is obligated to make future milestone payments to Lilly totaling up to $155 million and sales milestone payments up to $440 million under the 2022 and 2023 Lilly Licenses[70]. - The company has not yet conducted any clinical trials and has no product candidates approved for sale, with no revenue generated from product sales[121]. - The company may need to rely on additional financing to achieve its business objectives, as adequate financing may not be available on acceptable terms[176]. - The company has not included future milestone or royalty payments in its financial obligations due to their uncertain timing and amounts[189]. Management and Corporate Structure - A CEO transition was approved, with Robert Lisicki set to take over from founder Someit Sidhu effective April 8, 2024[143]. - The Company completed a business combination on March 20, 2023, resulting in the establishment of Zura Bio Limited as the new holding company[30]. - The business combination has been accounted for as a reverse recapitalization, with Legacy Zura as the accounting acquirer[31]. Regulatory and Compliance - The Company’s future product candidates require FDA approvals, and there is no assurance that any will receive necessary approvals[39]. - The Company’s financial statements are prepared in accordance with U.S. GAAP and may not be comparable to those of other public companies due to its emerging growth status[34]. - The company qualifies as a "smaller reporting company" under the Securities Act and Exchange Act, with a market value of Class A Ordinary Shares held by non-affiliates being less than $250 million[196].

Financial Performance - Cash and cash equivalents totaled $188.2 million as of September 30, 2024, up from $99.8 million as of December 31, 2023, indicating a significant increase of 88.4%[7] - The net loss for Q3 2024 was $22.9 million, or $0.26 per share, compared to a net loss of $8.3 million, or $0.18 per share, for the same period in 2023[10] - The accumulated deficit increased to $142.3 million as of September 30, 2024, from $103.5 million as of December 31, 2023[17] Expenses - Research and development expenses for Q3 2024 were $6.0 million, an increase of 50% compared to $4.0 million for the same period in 2023[8] - General and administrative expenses rose to $13.3 million in Q3 2024, up 114.5% from $6.2 million in Q3 2023, primarily due to a one-time non-cash expense of $5.3 million in share-based compensation[9] Clinical Trials - The Phase 2 clinical trial for tibulizumab in systemic sclerosis is expected to initiate in Q4 2024, with the protocol finalized in September 2024[3] - A third-party CRO has been selected to oversee the Phase 2 clinical program for tibulizumab in hidradenitis suppurativa, with trial initiation anticipated in Q2 2025[3] Capital Structure - The company completed a warrant exchange program in August 2024, simplifying its capital structure[6] - An "at-the-market" (ATM) program is in place as of September 2024, providing increased financial flexibility for the company[6] Assets - The total assets as of September 30, 2024, were $189.1 million, compared to $100.8 million as of December 31, 2023[15]

Financial Performance - The company reported a net loss of $10.3 million for the three months ended June 30, 2024, and $18.1 million for the six months ended June 30, 2024, with an accumulated deficit of $121.6 million as of June 30, 2024[107]. - The net loss attributable to ordinary shareholders was $13.4 million for the six months ended June 30, 2024, a decrease of $41.3 million (76%) compared to the same period in 2023[144]. - The company incurred a net loss before redeemable noncontrolling interest of $18.1 million for the six months ended June 30, 2024, compared to a net loss of $43.8 million for the same period in 2023[164][165]. - The net loss attributable to Ordinary Shareholders of the Company was $12.7 million for the three months ended June 30, 2024, a decrease of $21.4 million (48%) compared to the prior year[134]. Revenue and Sales - The company has not generated any revenue from product sales and has a limited operating history focused on business planning and raising capital[106]. - The company has not generated any revenue since inception and does not expect to do so for at least the next few years[157]. Capital and Financing - The company raised a total of $112.5 million in gross proceeds from the April 2024 Private Placement, issuing 18,732,301 Class A Ordinary Shares and pre-funded warrants[111]. - The company generated approximately $56.7 million in net proceeds from the Business Combination completed on March 20, 2023[110]. - As of June 30, 2024, the company had cash and cash equivalents of $188.4 million, funded through various financing activities including a $112.5 million private placement[155]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $105.3 million, a decrease of 15.9% from $125.4 million in the same period of 2023[166][167]. Expenses - Research and development expenses decreased by $22.7 million (80%) to $5.5 million for the three months ended June 30, 2024, primarily due to a $27.2 million expense related to an IPR&D license acquisition in the prior year[134][136]. - General and administrative expenses increased by $0.5 million (10%) to $6.2 million for the three months ended June 30, 2024, driven by higher compensation and professional fees[137]. - The Company anticipates a substantial increase in research and development expenses as it continues to develop product candidates and manufacturing processes[131]. - General and administrative expenses increased by $2.5 million (29%) for the six months ended June 30, 2024, mainly due to a $2.0 million increase in compensation-related expenses[148]. - Total operating expenses decreased by $21.5 million (52%) for the six months ended June 30, 2024, compared to the same period in 2023[144]. Future Outlook - The company plans to raise substantial additional capital in the future to support ongoing clinical development and operational needs[131]. - Future operations are dependent on the ability to finance cash requirements for ongoing research and development activities[156]. - The company anticipates ongoing increases in expenses related to research and development and administrative costs as it seeks marketing approval for product candidates[158]. Agreements and Obligations - The company is obligated to make development milestone payments to Lilly of up to $155.0 million and sales milestone payments of up to $440 million based on net sales thresholds for products developed from ZB-106[117]. - The company entered into a license agreement with Lilly for the exclusive rights to develop, manufacture, and commercialize a bispecific antibody, ZB-106, with an initial payment of $5.0 million made during the six months ended June 30, 2024[114]. - The company entered into a Lonza License agreement, which includes potential annual payments of up to middle six-figure amounts per sublicense and royalties of up to low-single digit percentages of net sales[169]. - A master services agreement with WuXi Biologics was established in July 2023, obligating the company to pay service fees as specified in each work order[170]. Operational Changes - The company has incurred significant operating losses since inception and anticipates expenses will increase significantly as it advances preclinical and clinical development of product candidates[107]. - The company has a new CEO, Robert Lisicki, effective April 8, 2024, following a transition from founder Someit Sidhu[123]. - The Company commenced an exchange offer for outstanding IPO warrants, offering 0.30 Class A ordinary shares for each warrant tendered[124]. - The Exchange Offer and Consent Solicitation resulted in 6,703,428 public warrants (approximately 97.2%) and 4,080,580 private placement warrants (approximately 69.0%) being validly tendered[125]. - The Company issued 3,235,184 Class A ordinary shares in exchange for 10,784,008 IPO warrants, with a mandatory exchange ratio of 0.27 Class A ordinary shares for each remaining IPO warrant[126]. Economic Impact - Macroeconomic conditions, including geopolitical conflicts and inflation, continue to impact the Company's business and may materially affect future results[127]. - Cash used in operating activities for the six months ended June 30, 2024, was $11.6 million, compared to $8.4 million for the same period in 2023, reflecting an increase of 38.1%[164][165]. - Cash used in investing activities for the six months ended June 30, 2024, was $5.0 million, slightly lower than $5.8 million in the same period of 2023[166]. Non-Cash Charges - Non-cash charges for the six months ended June 30, 2024, included $6.7 million, primarily from share-based compensation of $5.3 million[164]. Company Classification - The company remains classified as an "emerging growth company" and a "smaller reporting company," allowing it to take advantage of reduced disclosure requirements[177][179].

Financial Performance - Net loss for Q2 2024 was $12.7 million, or $0.17 per share, compared to a net loss of $44.9 million, or $1.31 per share, in Q2 2023[5] - Net loss attributable to Class A Ordinary Shareholders of Zura was $12,666,000, a reduction of 71.8% from $44,900,000 in 2023[13] - Net loss per share attributable to Class A Ordinary Shareholders was $0.17, significantly improved from $1.31 in the prior year[13] - Loss from operations for June 2024 was $11,759,000, compared to $33,905,000 in 2023[13] - The company reported a loss before income taxes of $(10,329,000), down from $(34,025,000) in 2023[13] Cash and Investments - Zura Bio reported cash, cash equivalents, and investments of $188.4 million as of June 30, 2024, up from $99.8 million as of December 31, 2023[3] - The company raised approximately $112.5 million in gross proceeds from a private placement in April 2024, expected to support operations through 2027[3] - Zura Bio's total assets increased to $189.5 million as of June 30, 2024, compared to $100.8 million as of December 31, 2023[12] Research and Development - Research and Development (R&D) expenses decreased to $5.5 million in Q2 2024, down from $28.2 million in the same period in 2023, primarily due to a $27.2 million expense related to the acquisition of tibulizumab in Q2 2023[4] - Research and development expenses amounted to $5,539,000, down from $28,230,000 in the previous year[13] - The company anticipates utilizing external data readouts to inform the initial indication selection for crebankitug by the end of 2024[7] - Zura Bio expects to initiate Phase 2 studies for tibulizumab in systemic sclerosis (SSc) in Q4 2024 and in hidradenitis suppurativa (HS) in Q2 2025[1] Operating Expenses - General and Administrative (G&A) expenses increased to $6.2 million in Q2 2024, compared to $5.7 million in Q2 2023[5] - Total operating expenses for June 2024 were $11,759,000, a decrease of 65.3% compared to $33,905,000 in 2023[13] - Total other income/expense, net was $(1,430,000), compared to $120,000 in the previous year[13] - Interest income for the period was $(2,196,000), with no interest income reported in the prior year[13] Corporate Developments - Zura Bio established a Scientific Advisory Board in June 2024, comprising leading experts in rheumatology, dermatology, and immunology[2] - The company completed a warrant exchange program in August 2024 to simplify its capital structure[2]

Financial Performance - Cash and cash equivalents decreased to $89.8 million as of March 31, 2024, from $99.8 million as of December 31, 2023[4]. - Net loss for Q1 2024 was $7.7 million, an improvement from a net loss of $9.6 million in the same period of 2023[9]. - Total operating expenses for Q1 2024 were $8.4 million, compared to $7.7 million in Q1 2023[20]. Funding and Cash Runway - Zura Bio raised approximately $112.5 million in an oversubscribed private placement, providing a cash runway through 2027[3]. - The projected cash runway supports operations through 2027, factoring in the recent private placement[5]. Research and Development - Research and Development (R&D) expenses for Q1 2024 were $3.6 million, a decrease of $1.3 million compared to $4.9 million in Q1 2023[7]. - The company is on track to initiate Phase 2 studies for tibulizumab in systemic sclerosis (SSc) in Q4 2024 and hidradenitis suppurativa (HS) in Q2 2025[5]. - Zura Bio is developing three assets that are Phase 2 ready, targeting autoimmune and inflammatory diseases[13]. Administrative Expenses and Leadership - General and Administrative (G&A) expenses increased to $4.8 million in Q1 2024, up from $2.8 million in Q1 2023, primarily due to increased personnel costs[8]. - The company appointed Robert Lisicki as CEO and Kiran Nistala as CMO, enhancing its leadership team[6].