Core Viewpoint - The article expresses a positive sentiment towards cell therapy companies, particularly Autolus Therapeutics, highlighting the author's bullish stance on the company's potential in the biotech sector [1]. Company Analysis - Autolus Therapeutics is identified as a key player in the cell therapy market, with the author advocating for its potential based on scientific analysis and clinical trial evaluations [1]. Industry Insights - The article emphasizes the importance of understanding the science behind biotech investments, suggesting that informed analysis can help investors navigate the complexities of the industry [1].

[Corporate Information](index=1&type=section&id=Corporate%20Information) This section provides an overview of the company's filing status, voluntary reporting choices, and a cautionary note on forward-looking statements. [Filing Details](index=1&type=section&id=Filing%20Details) Autolus Therapeutics plc filed its Form 10-Q quarterly report for the period ended June 30, 2025, registered in England and Wales, classified as a non-accelerated filer and smaller reporting company, voluntarily filing as a U.S. domestic issuer - The company voluntarily files its Form 10-Q quarterly report as a U.S. domestic issuer, despite being exempt as a "foreign private issuer"[8](index=8&type=chunk)[39](index=39&type=chunk) Company Filing Status | Status | Option | | :--- | :--- | | Large Accelerated Filer | ☐ | | Accelerated Filer | ☐ | | Non-Accelerated Filer | ☒ | | Smaller Reporting Company | ☒ | | Emerging Growth Company | ☐ | - As of August 11, 2025, the company had **266,141,411** ordinary shares issued and outstanding, including shares in the form of ADSs[5](index=5&type=chunk) [Explanatory Note](index=3&type=section&id=Explanatory%20Note) Autolus Therapeutics plc, as a "foreign private issuer," is exempt from filing Form 10-Q under the Exchange Act but has voluntarily chosen to file this report - The company, as a "foreign private issuer," is exempt from filing Form 10-Q but has voluntarily chosen to do so[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This report contains numerous forward-looking statements regarding the company's strategy, future financial condition, operations, R&D costs, management plans, and objectives, cautioning investors about significant risks and uncertainties that could cause actual results to differ materially - Forward-looking statements cover the therapeutic potential of AUCATZYL/obe-cel, market acceptance, regulatory approvals, commercialization, R&D plans, future financing needs, intellectual property protection, and market size and growth potential[16](index=16&type=chunk) - The company cautions investors that forward-looking statements involve known and unknown risks, uncertainties, and assumptions, including macroeconomic events, clinical trial results, regulatory approval timing, market acceptance, financing capabilities, and competition, which could cause actual results to differ materially from expectations[17](index=17&type=chunk) [Part I – Financial Information](index=6&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations. [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20statements) This section presents Autolus Therapeutics plc's unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, statements of changes in shareholders' equity, statements of cash flows, and detailed notes, offering a comprehensive view of the company's financial position, operating performance, and cash flows [Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024 (Unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030,%202025%20and%20December%2031,%202024%20(Unaudited)) The condensed consolidated balance sheets present the company's financial position, showing changes in assets, liabilities, and equity between June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheets Key Data (Thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets:** | | | | Cash and cash equivalents | **$123,825** | **$227,380** | | Marketable securities | **$330,454** | **$360,643** | | Total current assets | **$574,250** | **$660,929** | | Total assets | **$720,981** | **$782,725** | | **Liabilities:** | | | | Total current liabilities | **$68,151** | **$60,743** | | Total liabilities | **$374,517** | **$355,400** | | **Shareholders' Equity:** | | | | Accumulated deficit | **$(1,217,302)** | **$(1,099,224)** | | Total shareholders' equity | **$346,464** | **$427,325** | - As of June 30, 2025, the company's cash and cash equivalents decreased by approximately **45.5%**, and marketable securities decreased by approximately **8.4%** compared to December 31, 2024[20](index=20&type=chunk) - As of June 30, 2025, the company's total assets decreased by approximately **8%**, total liabilities increased by approximately **5.4%**, and shareholders' equity decreased by approximately **18.9%**[20](index=20&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(Unaudited)) The condensed consolidated statements of operations and comprehensive loss detail the company's financial performance, including revenue, expenses, and net loss, for the three and six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss Key Data (Thousands of USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | **$20,923** | **$—** | **$29,905** | **$—** | | License revenue | **$—** | **$—** | **$—** | **$10,091** | | Total net revenue | **$20,923** | **$—** | **$29,905** | **$10,091** | | Cost of sales | **$(24,445)** | **$—** | **$(42,396)** | **$—** | | Research and development expenses, net | **$(27,430)** | **$(36,612)** | **$(54,164)** | **$(67,283)** | | Selling, general and administrative expenses | **$(30,265)** | **$(21,903)** | **$(59,799)** | **$(40,080)** | | Operating loss | **$(61,217)** | **$(58,929)** | **$(126,457)** | **$(97,686)** | | Net loss | **$(47,917)** | **$(58,272)** | **$(118,081)** | **$(110,962)** | | Net loss per share, basic and diluted | **$(0.18)** | **$(0.22)** | **$(0.44)** | **$(0.43)** | - In the second quarter and first half of 2025, the company recognized product net revenue for the first time, totaling **$20.9 million** and **$29.9 million**, respectively, primarily from AUCATZYL sales in the U.S[23](index=23&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) - In the first half of 2025, net research and development expenses decreased by **19%** year-over-year, while selling, general and administrative expenses increased by **49%**[23](index=23&type=chunk) [Condensed Consolidated Statements of Changes in Shareholders' Equity for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(Unaudited)) The condensed consolidated statements of changes in shareholders' equity illustrate the movements in capital stock, additional paid-in capital, accumulated other comprehensive loss, and accumulated deficit for the periods presented Condensed Consolidated Statements of Changes in Shareholders' Equity Key Data (Thousands of USD) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Ordinary shares outstanding | **266,137,837** | **266,121,689** | | Additional paid-in capital | **$1,562,774** | **$1,555,593** | | Accumulated other comprehensive loss | **$862** | **$(29,174)** | | Accumulated deficit | **$(1,217,302)** | **$(1,099,224)** | | Total shareholders' equity | **$346,464** | **$427,325** | - As of June 30, 2025, the company's total shareholders' equity was **$346.5 million**, a decrease from **$427.3 million** as of December 31, 2024, primarily due to an increased accumulated deficit and changes in accumulated other comprehensive loss[26](index=26&type=chunk) - In the first half of 2025, the company increased additional paid-in capital by **$4.305 million** due to share-based compensation expense and recognized **$18.968 million** in other comprehensive income[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024 (Unaudited)](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(Unaudited)) The condensed consolidated statements of cash flows provide an overview of cash generated from or used in operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Cash Flows Key Data (Thousands of USD) | Cash Flow Type | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | **$(148,346)** | **$(91,597)** | | Net cash provided by (used in) investing activities | **$36,368** | **$(1,374)** | | Net cash used in (provided by) financing activities | **$(768)** | **$559,362** | | Effect of exchange rate changes | **$9,273** | **$233** | | Net (decrease) increase in cash, cash equivalents, and restricted cash | **$(103,473)** | **$466,624** | | Cash, cash equivalents, and restricted cash at end of period | **$125,332** | **$706,959** | - Net cash used in operating activities significantly increased to **$148.3 million** in the first half of 2025, primarily due to net loss and increases in accounts receivable and inventory[32](index=32&type=chunk)[261](index=261&type=chunk) - Net cash provided by investing activities turned into a **$36.4 million** inflow in the first half of 2025, mainly from maturities and redemptions of marketable securities, offsetting equipment purchases and security acquisitions[32](index=32&type=chunk)[263](index=263&type=chunk) - Net cash used in financing activities was **$0.768 million** in the first half of 2025, compared to a **$559.4 million** inflow in the same period of 2024, primarily due to significant proceeds from the BioNTech agreement and ADS offerings in 2024[32](index=32&type=chunk)[264](index=264&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Statements](index=13&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) These notes provide essential disclosures and additional information to the unaudited condensed consolidated interim financial statements, clarifying accounting policies, estimates, and significant events [Note 1. Nature of the Business](index=13&type=section&id=Note%201.%20Nature%20of%20the%20Business) Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T-cell therapies for cancer and autoimmune diseases, with its lead product AUCATZYL approved in the U.S., UK, and EU, and first commercially sold in the U.S. in January 2025 - The company's core business is developing next-generation programmed T-cell therapies for cancer and autoimmune diseases[36](index=36&type=chunk) - AUCATZYL (obecabtagene autoleucel, obe-cel) received FDA approval on November 8, 2024, for adult relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) and was first commercially launched in the U.S. in January 2025[36](index=36&type=chunk) - AUCATZYL received conditional marketing authorization from the UK MHRA in April 2025 and marketing authorization from the European Commission in July 2025[36](index=36&type=chunk) - The company anticipates continued operating losses and significant additional capital requirements to support AUCATZYL commercialization and other product candidate development[38](index=38&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=13&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the significant accounting policies followed in preparing the unaudited condensed consolidated interim financial statements, including U.S. GAAP basis, U.S. dollar presentation, emphasis on going concern assumption, use of estimates, product revenue deduction estimation, and the impact of recently issued accounting pronouncements - The company's financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (U.S. GAAP) and presented in U.S. dollars[40](index=40&type=chunk) - The company has incurred continuous losses since inception, with an accumulated deficit of **$1.217 billion** as of June 30, 2025, but expects existing cash and marketable securities to fund operations for at least the next 12 months[45](index=45&type=chunk) - Significant uncertainty exists in estimating product revenue net deductions, such as rebates and chargebacks, for which the company uses the expected value method and updates estimates regularly based on actual claims and current information[47](index=47&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) - The company adopted ASU 2024-01 and ASU 2024-02 on January 1, 2025, with no material impact on financial statements, and is currently evaluating the impact of ASU 2025-01, ASU 2024-03, and ASU 2023-09[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk) [Note 3. Revenue](index=18&type=section&id=Note%203.%20Revenue) This note details the company's product and license revenue recognition. In the first half of 2025, the company recognized its first product net revenue of **$29.9 million**, primarily from AUCATZYL sales in the U.S. License revenue was zero in the first half of 2025, compared to **$10.1 million** in the same period of 2024, mainly from the BioNTech license and option agreement Product Revenue, Net (Thousands of USD) | Region | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | United States | **$20,923** | **$—** | **$29,905** | **$—** | | Total | **$20,923** | **$—** | **$29,905** | **$—** | - Following FDA approval of AUCATZYL on November 8, 2024, the company began recognizing product net revenue in the first half of 2025[79](index=79&type=chunk)[80](index=80&type=chunk) License Revenue (Thousands of USD) | Region | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Europe | **$—** | **$—** | **$—** | **$10,091** | | Total | **$—** | **$—** | **$—** | **$10,091** | - The **$10.1 million** license revenue recognized in the first half of 2024 was entirely from the BioNTech license and option agreement, with no license revenue in the first half of 2025[86](index=86&type=chunk)[90](index=90&type=chunk) - The company is eligible for up to **$32.0 million** in milestone payments and low single-digit percentage net sales royalties from BioNTech, which were fully constrained and excluded from the transaction price as of June 30, 2025, and 2024[91](index=91&type=chunk) [Note 4. Interest Expense, Net](index=20&type=section&id=Note%204.%20Interest%20Expense,%20Net) This note discloses the composition of the company's interest expense. In the second quarter and first half of 2025, net interest expense was **negative $6.8 million** and **$3.3 million**, respectively, primarily impacted by cumulative catch-up adjustments for liabilities related to future royalties and milestones Interest Expense, Net (Thousands of USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Accretion of interest expense on liabilities related to future royalties and milestones, net | **$10,681** | **$10,169** | **$20,819** | **$18,559** | | Cumulative catch-up adjustment | **$(17,525)** | **$—** | **$(17,525)** | **$10,870** | | Other interest expense | **$15** | **$5** | **$20** | **$14** | | Total interest expense | **$(6,829)** | **$10,174** | **$3,314** | **$29,443** | - Net interest expense was **negative $6.8 million** and **$3.3 million** in the second quarter and first half of 2025, respectively, a significant decrease from the prior year, primarily due to negative cumulative catch-up adjustments for liabilities related to future royalties and milestones[96](index=96&type=chunk) [Note 5. Net Loss Per Share](index=20&type=section&id=Note%205.%20Net%20Loss%20Per%20Share) This note presents the calculation of the company's basic and diluted net loss per share. Due to net losses in all reported periods, potentially dilutive securities, such as unvested restricted stock units, stock options, and warrants, are excluded from diluted net loss per share calculations due to their anti-dilutive effect Net Loss Per Share (Thousands of USD, except per share amounts) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss | **$(47,917)** | **$(58,272)** | **$(118,081)** | **$(110,962)** | | Weighted-average ordinary shares outstanding, basic and diluted | **266,141,411** | **266,025,783** | **266,134,021** | **255,131,873** | | Net loss per share, basic and diluted | **$(0.18)** | **$(0.22)** | **$(0.44)** | **$(0.43)** | - As the company is in a net loss position, all potentially dilutive securities, including unvested restricted stock units, stock options, and warrants, are excluded from diluted net loss per share calculations due to their anti-dilutive effect[99](index=99&type=chunk)[100](index=100&type=chunk) [Note 6. Fair Value Measurements](index=21&type=section&id=Note%206.%20Fair%20Value%20Measurements) This note describes the company's fair value measurement methods for financial assets, primarily using market participant assumptions and categorized into three levels based on observable and unobservable inputs. As of June 30, 2025, most cash equivalents and marketable debt securities' fair values are determined through active market quotes (Level 1) or observable inputs (Level 2) - The company classifies and measures financial assets using fair value hierarchy (Level 1, Level 2, Level 3) to maximize the use of observable inputs[101](index=101&type=chunk)[102](index=102&type=chunk) Fair Value of Financial Assets as of June 30, 2025 (Thousands of USD) | Asset Class | Total Estimated Fair Value | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | **Cash Equivalents:** | | | | | | Money market funds | **$87,546** | **$87,546** | **$—** | **$—** | | Commercial paper | **$3,966** | **$—** | **$3,966** | **$—** | | UK government securities | **$20,640** | **$—** | **$20,640** | **$—** | | **Marketable Securities:** | | | | | | Commercial paper | **$37,777** | **$—** | **$37,777** | **$—** | | Corporate debt securities | **$123,740** | **$—** | **$123,740** | **$—** | | UK government securities | **$149,501** | **$—** | **$149,501** | **$—** | | U.S. Treasury bills | **$19,436** | **$19,436** | **$—** | **$—** | | **Total** | **$442,606** | **$106,982** | **$335,624** | **$—** | - As of June 30, 2025, the fair value of most of the company's cash equivalents and marketable debt securities is determined using active market quotes (Level 1) or observable inputs (Level 2), with no Level 3 assets[103](index=103&type=chunk) [Note 7. Marketable Securities: Available-For-Sale Debt Securities](index=22&type=section&id=Note%207.%20Marketable%20Securities:%20Available-For-Sale%20Debt%20Securities) This note provides details on the company's available-for-sale debt securities, including their amortized cost, unrealized gains/losses, and fair value. As of June 30, 2025, the company held **$330.0 million** in available-for-sale debt securities, mostly maturing within one year, with 42 securities in an unrealized loss position, though the company does not intend to sell and expects to recover principal and interest Available-For-Sale Debt Securities as of June 30, 2025 (Thousands of USD) | Security Type | Remaining Contractual Maturity | Amortized Cost | Unrealized Gains | Unrealized Losses | Estimated Fair Value | | :--- | :--- | :--- | :--- | :--- | :--- | | Commercial paper | Within 1 year | **$37,782** | **$—** | **$(5)** | **$37,777** | | Corporate debt securities | Within 1 year | **$110,579** | **$14** | **$(50)** | **$110,543** | | UK government securities | Within 1 year | **$149,436** | **$67** | **$(2)** | **$149,501** | | U.S. Treasury bills | Within 1 year | **$14,390** | **$23** | **$—** | **$14,413** | | Corporate debt securities | 1 to 5 years | **$13,196** | **$12** | **$(11)** | **$13,197** | | U.S. Treasury bills | 1 to 5 years | **$5,010** | **$13** | **$—** | **$5,023** | | **Total** | | **$330,393** | **$129** | **$(68)** | **$330,454** | - As of June 30, 2025, the company held 42 available-for-sale debt securities in an unrealized loss position, totaling **$68 thousand** in unrealized losses, but does not intend to sell and expects to recover principal and interest[110](index=110&type=chunk)[112](index=112&type=chunk) [Note 8. Inventories, Net](index=24&type=section&id=Note%208.%20Inventories,%20Net) This note presents the composition and net value of the company's inventories. As of June 30, 2025, net inventories significantly increased to **$23.9 million** from **$4.1 million** on December 31, 2024, primarily due to substantial growth in consumables, raw materials, and work-in-progress. In the first half of 2025, the company recorded a **$3.2 million** inventory reserve Inventories, Net (Thousands of USD) | Inventory Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Consumables | **$7,439** | **$2,026** | | Raw materials | **$8,203** | **$1,956** | | Work-in-progress | **$6,474** | **$16** | | Finished goods | **$1,827** | **$140** | | **Total Inventories, Net** | **$23,943** | **$4,138** | - As of June 30, 2025, net inventories significantly increased to **$23.9 million**, primarily reflecting increased commercial manufacturing for AUCATZYL[114](index=114&type=chunk) - In the first half of 2025, the company recorded a **$3.2 million** inventory reserve, reflecting estimated obsolescence and lower market value[114](index=114&type=chunk) [Note 9. Prepaid Expenses and Other Current Assets](index=24&type=section&id=Note%209.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note presents the composition of the company's prepaid expenses and other current assets. As of June 30, 2025, the total was **$67.9 million**, largely consistent with December 31, 2024, with R&D tax credit receivables remaining the largest component Prepaid Expenses and Other Current Assets (Thousands of USD) | Asset Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | R&D tax credit receivables | **$41,836** | **$38,242** | | Prepaid expenses | **$13,069** | **$15,212** | | VAT receivables | **$5,221** | **$5,996** | | Deferred costs | **$2,860** | **$2,320** | | Accrued interest income | **$1,969** | **$2,566** | | Other tax receivables | **$1,719** | **$—** | | Other receivables | **$665** | **$491** | | Lease and lease deposit receivables | **$538** | **$930** | | Other assets | **$—** | **$1,571** | | **Total Prepaid Expenses and Other Current Assets** | **$67,877** | **$67,328** | - As of June 30, 2025, R&D tax credit receivables totaled **$41.8 million**, representing the largest component of prepaid expenses and other current assets[115](index=115&type=chunk) [Note 10. Property and Equipment, Net](index=25&type=section&id=Note%2010.%20Property%20and%20Equipment,%20Net) This note presents the composition of the company's net property and equipment. As of June 30, 2025, net property and equipment significantly increased to **$66.5 million** from **$49.6 million** on December 31, 2024, primarily due to increased investment in construction in progress Property and Equipment, Net (Thousands of USD) | Asset Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Lab equipment | **$47,012** | **$41,728** | | Office equipment | **$6,908** | **$6,330** | | Furniture and fixtures | **$2,597** | **$2,359** | | Leasehold improvements | **$15,442** | **$14,116** | | Construction in progress | **$36,233** | **$19,638** | | Less: Accumulated depreciation | **$(41,725)** | **$(34,618)** | | **Total Property and Equipment, Net** | **$66,467** | **$49,553** | - As of June 30, 2025, construction in progress significantly increased to **$36.2 million**, serving as the primary driver for the growth in net property and equipment[117](index=117&type=chunk) - Depreciation expense for the first half of 2025 was **$4.1 million**, an increase from **$3.7 million** in the same period of 2024[117](index=117&type=chunk) [Note 11. Intangible Assets, Net](index=25&type=section&id=Note%2011.%20Intangible%20Assets,%20Net) This note presents the composition of the company's net intangible assets. As of June 30, 2025, net intangible assets totaled **$12.9 million**, primarily comprising licensed intellectual property and software licenses. Amortization expense for the first half of 2025 was **$0.6 million**, with an expected annual amortization of **$1.2 million** for the next five years Intangible Assets, Net (Thousands of USD) | Asset Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Licensed intellectual property | **$13,713** | **$12,535** | | Software licenses | **$50** | **$—** | | Less: Accumulated amortization | **$(830)** | **$(162)** | | **Total Intangible Assets, Net** | **$12,933** | **$12,373** | - Amortization expense for the first half of 2025 was **$0.6 million**, with an expected annual amortization of **$1.2 million** for the next five years[118](index=118&type=chunk) [Note 12. Accrued Expenses and Other Liabilities](index=25&type=section&id=Note%2012.%20Accrued%20Expenses%20and%20Other%20Liabilities) This note presents the composition of the company's accrued expenses and other liabilities. As of June 30, 2025, the total was **$51.4 million**, a slight decrease from **$52.3 million** on December 31, 2024, with compensation and benefits and R&D costs remaining the primary components Accrued Expenses and Other Liabilities (Thousands of USD) | Liability Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Compensation and benefits | **$17,792** | **$19,681** | | Research and development costs | **$11,516** | **$13,372** | | Professional services | **$7,017** | **$9,075** | | Manufacturing accruals | **$7,004** | **$6,075** | | VAT accruals | **$4,256** | **$3,594** | | Other liabilities | **$2,148** | **$479** | | Rebates, chargebacks, and returns | **$1,633** | **$—** | | **Total Accrued Expenses and Other Liabilities** | **$51,366** | **$52,276** | - As of June 30, 2025, compensation and benefits and research and development costs remain the primary components of accrued expenses and other liabilities[119](index=119&type=chunk) - A new **$1.6 million** liability for rebates, chargebacks, and returns reflects related deductions following product sales[119](index=119&type=chunk) [Note 13. Shareholders' Equity](index=26&type=section&id=Note%2013.%20Shareholders'%20Equity) This note details the composition and changes in the company's shareholders' equity. As of June 30, 2025, the total number of ordinary shares was **266,137,837**. In February 2024, the company raised approximately **$520 million** in net proceeds through an underwritten offering and a private placement to BioNTech - As of June 30, 2025, the company had **266,137,837** ordinary shares issued and outstanding[20](index=20&type=chunk)[26](index=26&type=chunk) - In February 2024, the company raised **$326.8 million** in net proceeds from an underwritten offering of **58,333,336** ADSs[123](index=123&type=chunk) - In February 2024, the company raised **$193.8 million** in net proceeds from a private placement of **33,333,333** ADSs to BioNTech[124](index=124&type=chunk) [Note 14. Share-Based Compensation](index=26&type=section&id=Note%2014.%20Share-Based%20Compensation) This note discloses detailed information on the company's share-based compensation. In the first half of 2025, total share-based compensation expense was **$7.16 million**, primarily allocated to selling, general and administrative expenses and research and development expenses. As of June 30, 2025, unrecognized stock option compensation expense was **$19.0 million**, expected to be recognized over 3.19 years Share-Based Compensation Expense (Thousands of USD) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | **$1,528** | **$1,048** | **$2,526** | **$1,498** | | Selling, general and administrative expenses | **$2,309** | **$1,887** | **$4,041** | **$3,723** | | Cost of sales | **$468** | **$—** | **$614** | **$—** | | Capitalized to intangible assets, net/property and equipment, net | **$(12)** | **$—** | **$(21)** | **$(2)** | | **Total Share-Based Compensation Expense** | **$4,293** | **$2,935** | **$7,160** | **$5,219** | - Total share-based compensation expense for the first half of 2025 was **$7.16 million**, an increase from **$5.2 million** in the same period of 2024[126](index=126&type=chunk) - As of June 30, 2025, unrecognized stock option compensation expense was **$19.0 million**, expected to be recognized over a weighted-average vesting period of **3.19 years**[130](index=130&type=chunk) [Note 15. Liabilities Related to Future Royalties and Milestones, Net](index=27&type=section&id=Note%2015.%20Liabilities%20Related%20to%20Future%20Royalties%20and%20Milestones,%20Net) This note details the changes and composition of the company's liabilities related to future royalties and milestones. As of June 30, 2025, the total liability was **$251.0 million**, primarily from collaboration agreements with Blackstone and BioNTech. In the first half of 2025, accrued interest expense for this liability was **$20.8 million**, partially offset by a **$17.5 million** cumulative catch-up adjustment Liabilities Related to Future Royalties and Milestones, Net (Thousands of USD) | Metric | Amount | | :--- | :--- | | Balance as of December 31, 2024 | **$248,100** | | Accretion of interest expense | **$20,819** | | Cumulative catch-up adjustment | **$(17,525)** | | Revenue share payments | **$(763)** | | **Balance as of June 30, 2025** | **$250,631** | - As of June 30, 2025, net liabilities related to future royalties and milestones totaled **$251.0 million**, with a current portion of **$6.0 million** and a non-current portion of **$244.6 million**[134](index=134&type=chunk) - In the first half of 2025, accrued interest expense for this liability was **$20.8 million**, with a negative cumulative catch-up adjustment of **$17.5 million**[134](index=134&type=chunk)[135](index=135&type=chunk) - The imputed interest rates for the Blackstone collaboration agreement liability and BioNTech liability are **15.80%** and **28.70%**, respectively[143](index=143&type=chunk) [Note 16. Leases](index=29&type=section&id=Note%2016.%20Leases) This note provides information on the company's operating leases as a lessee. In the first half of 2025, total lease cost was **$5.174 million**. As of June 30, 2025, the weighted-average remaining lease term was **16.1 years**, and the weighted-average discount rate was **8.17%** Lease Costs (Thousands of USD) | Lease Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Operating lease cost | **$2,136** | **$2,087** | **$4,308** | **$4,185** | | Variable costs | **$256** | **$484** | **$752** | **$1,028** | | Short-term lease costs | **$99** | **$103** | **$114** | **$204** | | **Total Lease Costs** | **$2,491** | **$2,674** | **$5,174** | **$5,417** | - As of June 30, 2025, the weighted-average remaining lease term for operating leases was **16.1 years**, with a weighted-average discount rate of **8.17%**[148](index=148&type=chunk) Operating Lease Liability Maturities as of June 30, 2025 (Thousands of USD) | Year | Amount | | :--- | :--- | | 2025 | **$1,577** | | 2026 | **$9,763** | | 2027 | **$9,142** | | 2028 | **$8,359** | | 2029 | **$6,285** | | Thereafter | **$84,697** | | **Total Lease Payments** | **$119,823** | | Less: Imputed interest | **$(55,288)** | | **Present Value of Lease Liabilities** | **$64,535** | [Note 17. Commitments and Contingencies](index=30&type=section&id=Note%2017.%20Commitments%20and%20Contingencies) This note discloses the company's licensing agreements, contractual obligations, capital commitments, key supply commitments, and legal proceedings and indemnification agreements. Following EU marketing approval for AUCATZYL in July 2025, the company triggered an **$8.2 million** regulatory milestone payment. As of June 30, 2025, the company had **$13.0 million** in capital expenditure commitments and **$3.5 million** in reagent and consumable purchase commitments - In July 2025, the company received EU marketing approval for AUCATZYL, triggering a regulatory milestone payment of **£6.0 million** (approximately **$8.2 million**) payable under the UCLB license agreement[150](index=150&type=chunk) - As of June 30, 2025, the company had **$13.0 million** in capital expenditure commitments and **$3.5 million** in Miltenyi Biotec GmbH reagent and consumable purchase commitments, expected to occur within one year[155](index=155&type=chunk)[156](index=156&type=chunk) - The company is not currently involved in any material legal proceedings and has not established any contingent reserves for liabilities[159](index=159&type=chunk) - The product option in the BioNTech license and option agreement was not exercised, and therefore no amounts were recognized[157](index=157&type=chunk) [Note 18. Segment Reporting](index=32&type=section&id=Note%2018.%20Segment%20Reporting) This note provides the company's segment reporting information, where its business is managed as a single operating and reportable segment. As of June 30, 2025, most of the company's long-lived assets are located in the UK. This note also provides a summary of revenue and segment loss by geographic region - The company manages its operations and business as a single operating and reportable segment, focusing on the development and commercialization of CAR T-cell therapies[53](index=53&type=chunk) Geographic Distribution of Long-Lived Assets (Thousands of USD) | Region | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | United Kingdom | **$124,493** | **$104,160** | | United States | **$593** | **$891** | | **Total Long-Lived Assets** | **$125,086** | **$105,051** | Summary of Segment Loss (Thousands of USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | **$20,923** | **$—** | **$29,905** | **$—** | | License revenue | **$—** | **$—** | **$—** | **$10,091** | | Cost of sales | **$(24,445)** | **$—** | **$(42,396)** | **$—** | | Research and clinical development | **$(16,069)** | **$(10,854)** | **$(29,120)** | **$(15,971)** | | Operating loss | **$(61,217)** | **$(58,929)** | **$(126,457)** | **$(97,686)** | | Net loss | **$(47,917)** | **$(58,272)** | **$(118,081)** | **$(110,962)** | [Note 19. Related Party Transactions](index=32&type=section&id=Note%2019.%20Related%20Party%20Transactions) This note discloses the company's related party transactions with Blackstone and BioNTech. As of June 30, 2025, the carrying value of the Blackstone collaboration agreement liability was **$212.6 million**, and the BioNTech liability was **$38.0 million** - Blackstone and BioNTech are related parties due to holding over **10%** of the company's voting securities or having the right to nominate directors[167](index=167&type=chunk)[170](index=170&type=chunk) - As of June 30, 2025, the carrying value of the Blackstone collaboration agreement liability was **$212.6 million**, and the BioNTech liability was **$38.0 million**[169](index=169&type=chunk)[171](index=171&type=chunk) - In the first half of 2025, the Blackstone collaboration agreement liability generated **$1.5 million** in cumulative non-cash interest expense and cumulative catch-up adjustments, along with **$0.5 million** in revenue share payments[169](index=169&type=chunk) - In the first half of 2025, the BioNTech liability generated **$1.8 million** in cumulative interest expense and cumulative catch-up adjustments, along with **$0.3 million** in revenue share payments[171](index=171&type=chunk) [Note 20. Subsequent Events](index=33&type=section&id=Note%2020.%20Subsequent%20Events) This note discloses significant events subsequent to the financial statement issuance date of August 12, 2025. In July 2025, the European Commission approved AUCATZYL for marketing, but the company has paused commercialization in Germany and anticipates no EU sales in 2025 and 2026. Additionally, BioNTech's manufacturing and commercial services agreement option expired unexercised in August 2025 - In July 2025, the European Commission approved AUCATZYL for marketing, but the company has paused commercialization in Germany and anticipates no EU sales in 2025 and 2026[173](index=173&type=chunk) - In August 2025, BioNTech's Manufacturing and Commercial Services Agreement (MCSA) option expired unexercised[174](index=174&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's detailed discussion and analysis of the company's financial condition and operating results, covering an overview, recent developments, components of operations, financial performance comparison, liquidity and capital resources, critical accounting policies, and the impact of recent accounting pronouncements. The company recognized product revenue for the first time in the first half of 2025 but still faces ongoing losses and financing needs [Overview](index=34&type=section&id=Overview) This overview summarizes the company's business as an early commercial-stage biopharmaceutical entity, highlighting its accumulated deficit and current financial resources - The company is an early commercial-stage biopharmaceutical company focused on developing next-generation programmed T-cell therapies for cancer and autoimmune diseases[179](index=179&type=chunk) - As of June 30, 2025, the company reported a net loss of **$47.9 million** and an accumulated deficit of **$1.2173 billion**[180](index=180&type=chunk) - As of June 30, 2025, the company held **$123.8 million** in cash and cash equivalents and **$330.5 million** in marketable securities, expected to fund operations for at least the next 12 months[181](index=181&type=chunk) [Recent Developments](index=35&type=section&id=Recent%20Developments) Recent developments include AUCATZYL's commercialization progress in the U.S., regulatory approvals in the UK and EU with market access challenges, and advancements in obe-cel clinical trials for lupus nephritis and multiple sclerosis - AUCATZYL's commercialization in the U.S. is progressing well, with **46** cancer treatment centers fully activated and over **90%** patient coverage as of August 12, 2025[188](index=188&type=chunk) - The UK MHRA has granted conditional marketing authorization for AUCATZYL, but NICE's preliminary recommendation is not to fund it, prompting the company to pursue patient access in the UK[188](index=188&type=chunk) - The European Commission has granted marketing authorization for AUCATZYL, but the company has paused commercialization in Germany and anticipates no EU sales in 2025 and 2026[188](index=188&type=chunk) - Latest long-term data from the FELIX study show a median duration of response of **42.5 months**, **24-month event-free survival of 43%**, and **overall survival of 46%** for r/r B-ALL patients[183](index=183&type=chunk) - Preliminary Phase 1 clinical trial data for obe-cel in lupus nephritis (LN) support progression to a pivotal Phase 2 study, with the first patient dosing planned by the end of 2025[189](index=189&type=chunk) - The company plans to advance obe-cel into clinical development for progressive multiple sclerosis (MS), with the first patient dosing in a Phase 1 clinical trial anticipated by the end of 2025[185](index=185&type=chunk) [Components of Our Results of Operations](index=35&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details the key components influencing the company's operating results, including product and license revenue recognition, cost of sales, research and development expenses, and selling, general, and administrative expenses [Product Revenue, Net](index=35&type=section&id=Product%20Revenue,%20Net) The company recognizes product revenue under ASC 606 when the product is delivered to and administered by authorized treatment centers, and the customer's right to cancel or return expires. Starting in the second quarter of 2025, CMS policy codes and bills AUCATZYL's therapeutic dose as two separate administrations, with the company recognizing **50%** of revenue after each administration - The company recognizes product revenue upon delivery to and administration by authorized treatment centers, when the customer's right to cancel or return expires[187](index=187&type=chunk) - Starting in the second quarter of 2025, CMS policy codes and bills AUCATZYL's therapeutic dose as two separate administrations, with the company recognizing **50%** of revenue after each administration[190](index=190&type=chunk) - Product revenue, net, is reduced by estimated rebates, chargebacks, patient travel assistance, and patient out-of-pocket assistance[191](index=191&type=chunk) [License Revenue](index=36&type=section&id=License%20Revenue) The company recognizes license revenue under ASC 606, including non-refundable upfront license fees, future commercial license options, milestone payments, and royalties. Revenue recognition depends on the nature of performance obligations in the contract and whether they are satisfied at a point in time or over time - License revenue recognition involves identifying performance obligations, determining their distinctiveness, measuring the transaction price, allocating the transaction price, and recognizing revenue as performance obligations are satisfied[199](index=199&type=chunk) - If an intellectual property license is deemed distinct from other performance obligations, non-refundable upfront fees are recognized as revenue when the license is transferred to the licensee[200](index=200&type=chunk) - Contingent research milestone payments are considered variable consideration and are included in the transaction price only to the extent that a significant reversal of cumulative revenue recognized is not probable[203](index=203&type=chunk)[204](index=204&type=chunk) [Cost of Sales](index=38&type=section&id=Cost%20of%20Sales) Cost of sales includes manufacturing costs, personnel-related expenses, external manufacturing fees, allocated facility costs, depreciation, third-party royalties, and other costs incurred to bring inventory to its saleable location and condition. For newly launched products, cost of sales does not include full manufacturing costs until initial pre-launch raw material inventory is depleted - Cost of sales includes raw materials, personnel-related expenses, external manufacturing fees, facility costs, depreciation, third-party royalties, and inventory-related costs[208](index=208&type=chunk) - Certain manufacturing costs incurred prior to AUCATZYL's approval were expensed as R&D, resulting in lower initial cost of sales and a positive impact on cost of sales as a percentage of net sales[209](index=209&type=chunk) [Research and Development Expenses](index=38&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses include costs related to product candidate development, partially offset by UK R&D tax credits. These expenses cover clinical trials, preclinical studies, manufacturing, personnel-related costs, external professional services, laboratory materials, and licensing fees. The company anticipates a significant increase in R&D expenses in the coming years - Research and development expenses include CRO agreement fees, clinical trial material manufacturing, personnel-related expenses, external professional services, laboratory materials, and licensing fees[215](index=215&type=chunk) - The company anticipates a significant increase in research and development expenses in the coming years to support clinical development and regulatory filings for product candidates[213](index=213&type=chunk) - Successful development and commercialization of R&D activities are highly uncertain, influenced by factors such as clinical trial results, regulatory approvals, manufacturing capabilities, intellectual property protection, and competition[216](index=216&type=chunk)[217](index=217&type=chunk) [U.K. Research and Development Tax Credits](index=39&type=section&id=U.K.%20Research%20and%20Development%20Tax%20Credits) The company benefits from UK government R&D tax incentive schemes, including the Small and Medium-sized Enterprise (SME) scheme and the Research and Development Expenditure Credit (RDEC) scheme. However, effective January 1, 2025, the company will no longer qualify for the SME scheme and will transition to the merged RDEC regime - The company benefits from UK R&D tax credits, including the SME scheme and RDEC scheme, which are recognized as a reduction in research and development expenses[218](index=218&type=chunk)[219](index=219&type=chunk) - The SME scheme allows for cash refunds on trading losses from qualifying R&D activities, with the refund rate reduced to **18.6%** after April 1, 2023, and **27%** for R&D intensive companies[220](index=220&type=chunk) - Effective January 1, 2025, the company will no longer qualify for the SME scheme and will transition to the merged RDEC regime, which can generate up to **16.2%** net cash benefit for loss-making companies[224](index=224&type=chunk)[222](index=222&type=chunk) [Selling, General and Administrative Expenses](index=40&type=section&id=Selling,%20General%20and%20Administrative%20Expenses) Selling, general and administrative expenses primarily include compensation, benefits, and share-based compensation for executive, finance, legal, and other administrative personnel, as well as facility costs, patent application fees, and professional services. The company anticipates continued growth in these expenses with increased headcount and commercial operations preparation - Selling, general and administrative expenses primarily include employee compensation, benefits, share-based compensation, facility costs, patent fees, and professional services[225](index=225&type=chunk) - The company anticipates increased selling, general and administrative expenses in the future due to increased headcount and sales and marketing preparations for AUCATZYL[226](index=226&type=chunk) [Other Income, Net](index=40&type=section&id=Other%20Income,%20Net) Other income, net, primarily comprises sublease income and gains or losses from lease terminations - Other income, net, primarily consists of sublease income and gains or losses from lease terminations[228](index=228&type=chunk) [Foreign Exchange Gains (Losses), Net](index=40&type=section&id=Foreign%20Exchange%20Gains%20(Losses),%20Net) Foreign exchange gains (losses), net, primarily arise from currency translation adjustments on transactions denominated in foreign currencies - Foreign exchange gains (losses), net, primarily result from currency translation adjustments on transactions denominated in foreign currencies[229](index=229&type=chunk) [Interest Income](index=40&type=section&id=Interest%20Income) Interest income primarily relates to interest on cash, cash equivalents, and available-for-sale debt securities, net of amortization or accretion of premiums or discounts on debt security purchases and sales - Interest income primarily derives from investments in cash, cash equivalents, and available-for-sale debt securities[230](index=230&type=chunk) [Interest Expense, Net](index=40&type=section&id=Interest%20Expense,%20Net) Net interest expense primarily includes interest expense from the amortization of liabilities related to future royalties and milestones under collaboration agreements with Blackstone and BioNTech, using the effective interest method. The company quarterly assesses the present value of future payments and adjusts interest expense based on changes in estimates - Net interest expense primarily arises from the amortization of liabilities related to future royalties and milestones under the Blackstone and BioNTech collaboration agreements[231](index=231&type=chunk) - The company quarterly assesses the present value of future payments and makes cumulative catch-up adjustments to interest expense based on changes in estimates[231](index=231&type=chunk) [Income Tax Expenses](index=40&type=section&id=Income%20Tax%20Expenses) The company is subject to corporate income taxes in the UK, U.S., Germany, and Switzerland. Due to the nature of its business, the company has incurred losses since inception. Income tax expense primarily reflects amounts payable or receivable in the UK and U.S - The company is subject to corporate income taxes in the UK, U.S., Germany, and Switzerland, and has incurred losses since its inception[232](index=232&type=chunk) - As of December 31, 2024, the company had **$545.6 million** in cumulative tax loss carryforwards in the UK and has recognized a full valuation allowance against its UK deferred tax assets[233](index=233&type=chunk) - The company may benefit from the UK "patent box" regime, which allows profits generated from patented products or patents to be taxed at an effective rate of **10%**[234](index=234&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025, and 2024, detailing changes in revenue, expenses, and net loss [Comparison of Three Months Ended June 30, 2025 and 2024](index=41&type=section&id=Comparison%20of%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) In the second quarter of 2025, the company recognized its first product net revenue of **$20.9 million**, with operating loss slightly increasing to **$61.2 million**. R&D expenses decreased by **25%** due to IT infrastructure and personnel reallocation. Selling, general and administrative expenses grew by **38%** due to increased headcount and commercial operations costs. Net interest expense significantly decreased due to valuation adjustments Comparison of Operating Results for the Three Months Ended June 30, 2025 and 2024 (Thousands of USD) | Metric | 2025 | 2024 | Change | Percentage Change | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | **$20,923** | **$—** | **$20,923** | **100%** | | Total net revenue | **$20,923** | **$—** | **$20,923** | **100%** | | Cost of sales | **$(24,445)** | **$—** | **$(24,445)** | **100%** | | Research and development expenses, net | **$(27,430)** | **$(36,612)** | **$9,182** | **(25)%** | | Selling, general and administrative expenses | **$(30,265)** | **$(21,903)** | **$(8,362)** | **38%** | | Operating loss | **$(61,217)** | **$(58,929)** | **$(2,288)** | **4%** | | Interest income | **$5,234** | **$9,656** | **$(4,422)** | **(46)%** | | Interest expense, net | **$(6,829)** | **$10,174** | **$17,003** | **(167)%** | | Net loss | **$(47,917)** | **$(58,272)** | **$10,355** | **(18)%** | - Product net revenue for the second quarter of 2025 was **$20.9 million**, compared to zero in the same period of 2024, primarily from AUCATZYL sales in the U.S[236](index=236&type=chunk) - Net research and development expenses decreased by **$9.2 million (25%)**, primarily due to reallocation of IT infrastructure and personnel to commercial manufacturing activities and lower clinical trial costs, partially offset by reduced UK R&D tax credits[239](index=239&type=chunk) - Selling, general and administrative expenses increased by **$8.4 million (38%)**, primarily due to increased headcount, higher IT infrastructure and facility costs, and increased commercialization readiness costs[240](index=240&type=chunk) - Net interest expense decreased by **$17.0 million**, primarily due to negative cumulative catch-up adjustments resulting from changes in valuation assumptions for the Blackstone collaboration agreement and BioNTech license and option agreement[243](index=243&type=chunk) [Comparison of Six Months Ended June 30, 2025 and 2024](index=43&type=section&id=Comparison%20of%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) In the first half of 2025, total net revenue significantly increased by **196%** to **$29.9 million**, primarily driven by AUCATZYL product sales. Operating loss increased by **29%** to **$126.5 million**. Net R&D expenses decreased by **19%**, while selling, general and administrative expenses grew by **49%**. Net interest expense significantly decreased due to valuation adjustments Comparison of Operating Results for the Six Months Ended June 30, 2025 and 2024 (Thousands of USD) | Metric | 2025 | 2024 | Change | Percentage Change | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | **$29,905** | **$—** | **$29,905** | **100%** | | License revenue | **$—** | **$10,091** | **$(10,091)** | **(100)%** | | Total net revenue | **$29,905** | **$10,091** | **$19,814** | **196%** | | Cost of sales | **$(42,396)** | **$—** | **$(42,396)** | **100%** | | Research and development expenses, net | **$(54,164)** | **$(67,283)** | **$13,119** | **(19)%** | | Selling, general and administrative expenses | **$(59,799)** | **$(40,080)** | **$(19,719)** | **49%** | | Operating loss | **$(126,457)** | **$(97,686)** | **$(28,771)** | **29%** | | Interest income | **$11,371** | **$16,589** | **$(5,218)** | **(31)%** | | Interest expense, net | **$(3,314)** | **$(29,443)** | **$26,129** | **(89)%** | | Net loss | **$(118,081)** | **$(110,962)** | **$(7,119)** | **6%** | - Product net revenue for the first half of 2025 was **$29.9 million**, compared to zero in the same period of 2024, primarily from AUCATZYL sales in the U.S[246](index=246&type=chunk) - Net research and development expenses decreased by **$13.1 million (19%)**, primarily due to reallocation of IT infrastructure and personnel to commercial manufacturing activities, partially offset by reduced UK R&D tax credits and increased clinical trial costs[250](index=250&type=chunk) - Selling, general and administrative expenses increased by **$19.7 million (49%)**, primarily due to increased headcount, higher IT infrastructure and facility costs, and increased commercialization readiness costs[251](index=251&type=chunk) - Net interest expense decreased by **$26.1 million (89%)**, primarily due to cumulative catch-up adjustments resulting from changes in valuation assumptions for the Blackstone collaboration agreement and BioNTech license and option agreement[254](index=254&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$123.8 million** in cash and cash equivalents and **$330.5 million** in marketable securities, expected to fund operations for at least the next 12 months. The company has incurred continuous losses since inception and will require substantial additional capital to support AUCATZYL commercialization and product candidate development - As of June 30, 2025, the company held **$123.8 million** in cash and cash equivalents and **$330.5 million** in marketable securities[259](index=259&type=chunk) - The company expects its existing cash and marketable securities to be sufficient to fund operations for at least the next 12 months[266](index=266&type=chunk) - The company has incurred continuous losses since inception, with an accumulated deficit of **$1.2173 billion** as of June 30, 2025, and will require substantial additional capital in the future[256](index=256&type=chunk)[257](index=257&type=chunk) - Future capital requirements will be influenced by factors such as AUCATZYL commercialization, other product candidate development, regulatory approvals, manufacturing, sales, marketing, distribution costs, and intellectual property maintenance[265](index=265&type=chunk)[269](index=269&type=chunk) - The company plans to raise capital through equity offerings, R&D tax credits, licensing agreements, or strategic collaboration agreements[267](index=267&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=48&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section updates the company's critical accounting policies and significant judgments and estimates, particularly regarding the expected rebate and chargeback percentages for product revenue deductions. Due to AUCATZYL's recent launch and limited actual claims data, the company uses the expected value method for estimation, emphasizing the inherent uncertainty and judgment - The company uses the expected value method to estimate expected rebate and chargeback percentages for product revenue deductions, which considers the probability of rebates or chargebacks applying to sales[272](index=272&type=chunk) - Estimating rebate and chargeback percentages is judgmental due to the time lag between sales and the determination of actual amounts[274](index=274&type=chunk) - As of June 30, 2025, total product revenue deductions for the six months amounted to **$2.1 million**, with **$1.6 million** recorded in accrued expenses and other current liabilities[276](index=276&type=chunk) - A **10%** increase or decrease in the estimated rebate and chargeback percentages payable to government or governmental agencies would result in a **$0.6 million** decrease or increase in product net revenue[277](index=277&type=chunk) [Contractual Obligations](index=48&type=section&id=Contractual%20Obligations) As of June 30, 2025, the company's contractual obligations and commitments have not materially changed from those disclosed in the annual report - As of June 30, 2025, the company's contractual obligations and commitments have not materially changed from those disclosed in the annual report[278](index=278&type=chunk) [Recent Accounting Pronouncements Not Yet Adopted](index=48&type=section&id=Recent%20Accounting%20Pronouncements%20Not%20Yet%20Adopted) This section refers to recently issued accounting pronouncements not yet adopted, whose potential impact on the company's financial condition and operating results is disclosed in Note 2 to the financial statements - Descriptions of recently issued accounting pronouncements not yet adopted are disclosed in Note 2 to the financial statements[279](index=279&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=49&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section discloses the company's market risks, primarily interest rate fluctuation risk and foreign currency exchange rate risk. The company manages interest rate risk by investing surplus cash in interest-bearing savings, money market funds, and marketable securities, and minimizes foreign exchange risk by maintaining cash levels in various currencies [Interest Rate Risk](index=49&type=section&id=Interest%20Rate%20Risk) The company's interest rate sensitivity is primarily influenced by changes in U.S. and UK bank rates, affecting its cash, cash equivalents, marketable securities, and certain liabilities - The company's interest rate sensitivity is primarily influenced by changes in U.S. and UK bank rates[281](index=281&type=chunk) - As of June 30, 2025, the company held **$123.8 million** in cash and cash equivalents and **$330.5 million** in marketable securities[281](index=281&type=chunk) - A hypothetical one percentage point sustained change in interest rates over a reporting period would result in a **$1.2 million** increase in interest income for the second quarter and first half of 2025[281](index=281&type=chunk) - The Blackstone collaboration agreement liability has a fixed effective interest rate and is not subject to interest rate fluctuations; the BioNTech liability's effective interest rate may fluctuate due to the discretionary nature of certain contractual payments[282](index=282&type=chunk) [Foreign Currency Exchange Risk](index=49&type=section&id=Foreign%20Currency%20Exchange%20Risk) The company's foreign exchange risk primarily relates to fluctuations in foreign currency-denominated cash, cash equivalents, and liabilities held by its UK operating subsidiary - The company's foreign exchange risk primarily relates to fluctuations in the value of foreign currency-denominated cash, cash equivalents, and liabilities related to future royalties and milestones held by its principal UK operating subsidiary[283](index=283&type=chunk) - As of June 30, 2025, most of the company's cash and cash equivalents were held by its UK subsidiary, with approximately **54%** denominated in GBP and approximately **44%** in USD[284](index=284&type=chunk) - In the second quarter and first half of 2025, the company recorded foreign exchange gains of **$1.5 million** and **$2.7 million**, respectively[285](index=285&type=chunk) - The company currently does not engage in currency hedging activities but may consider using forward foreign exchange contracts and swap agreements to manage risk in the future[287](index=287&type=chunk) [Item 4. Controls and Procedures](index=50&type=section&id=Item%204.%20Controls%20and%20Procedures) This section describes the company's evaluation of disclosure controls and procedures and changes in internal control over financial reporting. As of June 30, 2025, the company's management, including the Chief Executive Officer and Chief Financial Officer, assessed and concluded that its disclosure controls and procedures were effective. There were no material changes in internal control over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=50&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The company maintains disclosure controls and procedures to ensure timely and accurate recording, processing, summarization, and reporting of information required under the Exchange Act - The company maintains disclosure controls and procedures designed to ensure that information required to be disclosed under the Exchange Act is timely recorded, processed, summarized, and reported[288](index=288&type=chunk) - As of June 30, 2025, the company's Chief Executive Officer and Chief Financial Officer assessed and concluded that its disclosure controls and procedures were effective[289](index=289&type=chunk) [Changes in Internal Control over Financial Reporting](index=50&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section confirms that there were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025 - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025[290](index=290&type=chunk) [Part II – Other Information](index=50&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) This section covers legal proceedings, risk factors, equity security sales, defaults, mine safety disclosures, other information, a

Financial Data and Key Metrics Changes - In Q2 2025, net product revenue was $20.9 million, up from $9 million in Q1 2025, indicating strong momentum in the product launch [14][6] - The net loss for Q2 2025 was $47.9 million, reduced from a loss of $58.3 million in Q2 2024 [17] - Cash, cash equivalents, and marketable securities totaled $454.3 million at the end of Q2 2025, down from $588 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - Product sales for the first six months of the launch reached $29.9 million, with a total of 46 centers authorized for the use of Ocatsol [6][7] - Cost of sales in Q2 2025 was $24.4 million, which includes costs for products delivered but not yet administered [15] - Research and development expenses decreased to $27.4 million in Q2 2025 from $36.6 million in the same period in 2024 [16] Market Data and Key Metrics Changes - The company has achieved 90% total US medical lives covered and aims to reach over 60 authorized centers by year-end [7] - The company does not expect EU sales in 2025 and 2026 due to limited resources and the need for economically viable market access [9] Company Strategy and Development Direction - The company is focused on expanding the use of Ovicell beyond adult patients with relapsed-refractory ALL and is making progress in autoimmune diseases [12][20] - The company is taking a disciplined approach to market access in Europe, evaluating country by country for economically viable launches [9][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the product's reception and the potential for increased patient enrollment as administrative adjustments are resolved by Q4 [8][30] - The company plans to release updated data from its Phase I study at the ACR meeting in October and expects to dose the first patients in several upcoming studies [20][98] Other Important Information - The company received conditional marketing authorization in the UK and from the European Commission, with ongoing market access discussions [8][9] - The company is broadening real-world experience in the US to support market access conversations elsewhere [9] Q&A Session Summary Question: What is the status of the Germany launch? - Management indicated that market access methodologies in Europe are challenging, particularly for CAR T programs, and emphasized a methodical approach to launching in different countries [24][26] Question: How will revenue recognition change with the split reimbursement? - The CFO clarified that revenue recognition has shifted to a 50/50 split between the first and second administration, with expectations for enrollment and sales to accelerate post-implementation [28][29] Question: What is the feedback from the US community regarding the product? - Management reported very positive feedback, with early reorder activity from treatment centers indicating strong acceptance [38] Question: What is the timeline for the UK and Germany launches? - Management expects potential launches in the UK by early next year, contingent on favorable negotiations, while Germany's timeline remains uncertain [65][66] Question: How many patients were treated in Q2? - Management did not provide specific numbers but indicated that the revenue can be backtracked based on therapy costs [90] Question: What is the expected data release for the lupus Phase II trial? - Management stated that it is premature to provide a timeline for data from the lupus nephritis study, as patient enrollment is just beginning [99]

Financial Performance - AUCATZYL net product sales reached $20.9 million in Q2 2025 and $29.9 million for the six months ended June 30, 2025[8] - The company's cash, cash equivalents, and marketable securities totaled $454.3 million as of June 30, 2025[24] - Cost of sales for Q2 2025 was $24.445 million[24] - Research and development expenses, net for Q2 2025 were $27.430 million[24] - Selling, general, and administrative expenses for Q2 2025 were $30.265 million[24] - Loss from operations for Q2 2025 was $61.217 million[24] - Total comprehensive loss for Q2 2025 was $28.949 million[24] AUCATZYL Commercialization and Market Access - 46 treatment centers are authorized for AUCATZYL as of August 12, 2025[8] - Over 90% of total U S medical lives are covered for AUCATZYL[10] Obe-cel Clinical Data and Development - At 3 years of follow-up, 38.4% of responders remain in remission without subsequent treatment[14, 15] - The probability of remaining in remission after 24 months was 54.1% censoring for consolidative SCT[17] - At 24 months, overall survival probability was 46.0%[19] Upcoming Milestones - Initial data from PY01 trial in pediatric ALL is expected in H2 2025[27]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 12, 2025 Autolus Therapeutics plc (Exact name of registrant as specified in its Charter) England and Wales 001-38547 Not applicable (State or other jurisdiction of (Commission File Number) WASHINGTON, D.C. 20549 FORM 8-K (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane London W12 7FP United Kingdom (Ad ...

Core Insights - Autolus Therapeutics plc reported strong early performance for its product AUCATZYL in the U.S., driven by physician enthusiasm and favorable market access, with a net product revenue of $20.9 million for Q2 2025 and $29.9 million for the first half of 2025 [2][4][8] - The company received conditional marketing authorizations for AUCATZYL in the UK and EU, and is focusing on market access strategies in various countries [4][5] - Autolus is advancing its pipeline with ongoing clinical trials for obe-cel in pediatric ALL, systemic lupus erythematosus, lupus nephritis, and progressive multiple sclerosis, with key data expected in the second half of 2025 [2][7][11] Financial Performance - For Q2 2025, Autolus reported a net loss of $47.9 million, an improvement from a net loss of $58.3 million in the same period in 2024, with a basic and diluted net loss per share of $(0.18) compared to $(0.22) [13][19] - Total revenue for the first six months of 2025 was $29.9 million, with a cost of sales amounting to $24.4 million for Q2 2025 [4][9] - Research and development expenses decreased to $27.4 million from $36.6 million year-over-year, while selling, general, and administrative expenses increased to $30.3 million from $21.9 million [10][11] Product Development and Pipeline - AUCATZYL is designed for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) and has shown promising long-term remission data [4][23] - The company is on track to initiate a Phase 2 pivotal trial in lupus nephritis and a Phase 1 trial in progressive multiple sclerosis by the end of 2025 [4][11] - Preliminary data from the Phase 1 CARLYSLE study in systemic lupus erythematosus is expected to be presented at a medical conference later this year [2][7] Market Access and Regulatory Updates - AUCATZYL has secured coverage for over 90% of total U.S. medical lives, enhancing patient access [5] - The UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) granted conditional marketing authorizations for AUCATZYL, although market entry in Germany is currently on hold [5][4] - The company plans to address the preliminary Appraisal Consultation Decision (ACD) from NICE, which recommended against funding for AUCATZYL in the UK [5]

Core Viewpoint - Autolus Therapeutics plc is set to release its second quarter 2025 financial results and operational highlights on August 12, 2025, before the U.S. markets open [1]. Group 1: Financial Results Announcement - The company will host a conference call and webcast at 8:30am EDT/13:30pm BST to discuss the financial results and provide a general business update [2]. - Participants are required to pre-register to receive dial-in numbers and a personal PIN for accessing the conference call [2]. Group 2: Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing, manufacturing, and delivering next-generation T cell therapies for cancer and autoimmune diseases [3]. - The company utilizes proprietary and modular T cell programming technologies to create targeted and controlled T cell therapies aimed at effectively recognizing and eliminating target cells [3]. - Autolus has a marketed therapy, AUCATZYL, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3].

LONDON and GAITHERSBURG, Md., July 21, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, announces today that the European Commission (EC) has granted marketing authorization for AUCATZYL® (obecabtagene autoleucel or "obe- cel") for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemi ...

LONDON and GAITHERSBURG, Md., July 21, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, announces today that the European Commission (EC) has granted marketing authorization for AUCATZYL (obecabtagene autoleucel or "obe-cel") for the treatment of adult patients, 26+, with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ...

Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing, manufacturing, and delivering next-generation programmed T cell therapies for cancer and autoimmune diseases [3] - The company utilizes proprietary and modular T cell programming technologies to create targeted and controlled T cell therapies [3] - Autolus has a marketed therapy named AUCATZYL and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3] Stock Option Awards - The compensation committee of Autolus granted stock option awards to purchase a total of 360,550 shares to 60 employees under the 2025 Inducement Plan [1] - The exercise price for the options is set at $2.47 per share, matching the closing price of Autolus' common stock on July 9, 2025 [2] - Each option has a ten-year term and vests over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 equal monthly installments, contingent on continued service [2]