Core Viewpoint - Autolus Therapeutics has received marketing authorization from the European Commission for AUCATZYL® (obecabtagene autoleucel) to treat adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][7]. Group 1: Clinical Study and Approval - The European Commission's approval is based on the FELIX study, which demonstrated a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of 94 patients [2][9]. - The median response duration for all infused patients was 21.2 months, with a median event-free survival (EFS) of 11.9 months; the estimated 6- and 12-month EFS rates were 65.4% and 49.5%, respectively [2][9]. Group 2: Safety and Adverse Reactions - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3][33]. - Cytokine release syndrome (CRS) occurred in 68.5% of patients, with Grade 3 or higher events in 2.4% [3][33]. - Immune effector cell-associated neurotoxicity syndrome (ICANS) developed in 22.8% of patients, with Grade 3 or higher in 7% [3][33]. Group 3: Market Potential and Company Strategy - The CEO of Autolus, Dr. Christian Itin, emphasized that AUCATZYL represents a significant new treatment option for physicians treating adult r/r B-ALL patients, and the company is evaluating market entry opportunities in EU countries [4][11]. - Autolus is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, with AUCATZYL being part of its marketed therapy portfolio [11]. Group 4: Background on B-ALL - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer, with approximately 6,000 new cases diagnosed annually in Europe; up to 50% of adult B-ALL patients will ultimately relapse [6]. - Conventional treatments for r/r ALL have a median overall survival of only eight months, highlighting the need for new therapeutic options [6].

Core Viewpoint - Autolus Therapeutics has received marketing authorization from the European Commission for AUCATZYL (obecabtagene autoleucel), a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][7]. Group 1: Clinical Study and Approval - The European Commission's approval is based on the FELIX study, which demonstrated a 76.6% complete response rate in the pivotal cohort of 94 patients [2][9]. - The median response duration for all infused patients was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. - The estimated 6- and 12-month event-free survival rates were 65.4% and 49.5%, respectively [2]. Group 2: Safety and Adverse Reactions - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3]. - Cytokine release syndrome (CRS) occurred in 68.5% of patients, with 2.4% experiencing Grade 3 or higher events [3]. - Immune effector cell-associated neurotoxicity syndrome (ICANS) developed in 22.8% of patients, with 7% experiencing Grade 3 or higher [3]. Group 3: Market Potential and Company Strategy - The CEO of Autolus, Dr. Christian Itin, emphasized that AUCATZYL represents a significant new treatment option for adult r/r B-ALL patients, and the company is evaluating market entry opportunities in EU countries [4]. - Autolus is focused on developing next-generation T cell therapies and has a pipeline of product candidates for various cancers and autoimmune diseases [11]. Group 4: Disease Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [6]. - Up to 50% of adult patients with B-ALL will ultimately relapse, and conventional treatments have a median overall survival of only eight months [6].

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]

Core Insights - Autolus Therapeutics plc announced updated long-term data from the FELIX study of its programmed T cell therapy, obecabtagene autoleucel (obe-cel), for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) [1][2] - The data will be presented at the European Hematology Association Congress in Milan, Italy, from June 12-15, 2025 [1] Efficacy and Safety - At a median follow-up of 32.8 months, 38.4% of responders remained in ongoing remission without subsequent therapy, showing a slight decrease from 40% at 21.5 months [3] - The 24-month probability of Event Free Survival was reported at 43%, while Overall Survival was at 46%, indicating a long-term plateau in outcomes [3] - No new safety signals or Grade ≥3 secondary malignancies were observed during the extended follow-up, suggesting a favorable safety profile for obe-cel [3][6] Patient Demographics and Treatment Outcomes - Obe-cel treatment demonstrated deep and durable remissions across different age groups, with low incidence of Grade ≥3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5] - The multivariate analysis indicated that factors such as Philadelphia chromosome-positive disease and lower disease burden at lymphodepletion were associated with higher remission rates [4] Clinical Trial Background - The FELIX clinical trial is a Phase 1b/2 study that enrolled over 100 adult patients with r/r B-precursor ALL across 30 leading centers in the US, UK, and Europe [9] - The primary endpoint was overall response rate, with secondary endpoints including duration of response and safety [9] Company Overview - Autolus Therapeutics is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, with obe-cel being FDA approved and MHRA licensed [8]

Summary of Autolus Conference Call Company Overview - Autolus is a biotechnology company focused on autologous CAR T cell therapies, with its lead program, ObiCell (now branded as Alcatsol), recently approved in the U.S. in November 2022 [4][5][6] - The company is in the launch phase for Alcatsol in the U.S. and is undergoing regulatory processes in the U.K. and Europe [4][5] Key Differentiation and Clinical Data - ObiCell's unique design allows for a "fast on, fast off" mechanism, leading to lower levels of high-grade adverse events such as ICANS and CRS, which are common in CAR T therapies [5][6] - Clinical studies show a plateau in event-free survival and overall survival curves, with about 40% of patients remaining in remission without additional therapy [7] - The company has built a unique manufacturing facility in the U.K. to support commercial capacity for CAR T delivery [8][9] Market Launch and Performance - In Q1, Autolus reported $9 million in revenue, with a significant portion logged as deferred revenue [23] - The onboarding of treatment centers has exceeded expectations, with over 40 centers activated and a target of 60 by year-end, aiming for 90% coverage of addressable patients [24][36] - The company has achieved over 90% coverage of total medical lives in terms of access and reimbursement [25] Challenges and Considerations - Potential impacts of tariffs and most favored nation pricing in the U.S. are being monitored, with the company actively planning for various scenarios [16][19] - Discussions with European health authorities regarding pricing and reimbursement are ongoing, with a focus on the German market initially [46][47] Future Pipeline and Expansion - Autolus is exploring additional indications for ObiCell, including lupus nephritis and multiple sclerosis, with plans for pivotal studies [11][59] - The company is also conducting a pediatric trial for acute lymphoblastic leukemia (ALL) and aims for label expansion based on the data [48][50] Financial Outlook and Investment Thesis - The company targets a gross margin of 15% to 20% of U.S. sales as production volume increases [43] - The investment case for Autolus emphasizes execution of the launch, reliable product delivery, and potential growth in the autoimmune space, despite current market challenges [63][64] Conclusion - Autolus is positioned to leverage its unique CAR T therapy and manufacturing capabilities, with a strong focus on expanding its market presence and addressing unmet medical needs in both oncology and autoimmune diseases [64][65]

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - Autolus Therapeutics plc (NASDAQ: AUTL) was previously covered with a bullish outlook due to an upcoming PDUFA date, indicating potential positive developments for the company [1] - The investing group Haggerston BioHealth offers resources for both novice and experienced biotech investors, including sales forecasts and financial analyses for major pharmaceutical companies [1] Group 2 - The article emphasizes the expertise of Edmund Ingham, a biotech consultant with over five years of experience in the sector, who has produced detailed reports on more than 1,000 companies [1]

Summary of Autolus Therapeutics (AUTL) 2025 Conference Call Company Overview - **Company**: Autolus Therapeutics - **Product**: Ocatsil (formerly ObiCell) - **Approval Date**: November 8, 2024 - **Indication**: Approved for patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) in the adult population - **Unique Selling Point**: First CAR T therapy approved without a Risk Evaluation and Mitigation Strategy (REMS) obligation, indicating a strong safety profile [4][5] Key Achievements and Launch Strategy - **Launch Progress**: Initiated launch at the end of 2024, currently has 40 active centers, expecting to reach 60 by year-end, providing approximately 90% patient access across the US [5][6] - **Market Access**: Achieved about 90% of lives covered, ensuring reimbursement for patients interested in therapy [6] - **Support Services**: Emphasized the importance of qualifying centers and providing comprehensive support, including training, product management, and patient support [7][8] Manufacturing and Quality Control - **Manufacturing Facility**: Located in the UK, underwent rigorous inspections by MHRA and FDA, allowing for high control over manufacturing processes [8] - **Quality Metrics**: Approximately 5-6% of manufactured products were out of specification during pivotal studies, indicating a low failure rate [29] Product Safety and Efficacy - **Adverse Events**: Reported low rates of high-grade cytokine release syndrome (2%) and neurological toxicities (7%), significantly lower than other T cell-mediated therapies [15][16] - **Dosing Strategy**: Tailored dosing based on tumor burden, allowing for better management of adverse events and improved patient tolerability [12][14] Financial Performance and Revenue Guidance - **Q1 Sales**: Reported $9 million in sales for Q1 2025, with cautious optimism about future revenue growth due to increasing center openings and physician adoption [19][24] - **Revenue Guidance**: Company refrained from providing specific revenue guidance, citing the complexity of launch dynamics and the need for more data over the next three quarters [19][24] Future Opportunities and Trials - **Expansion of Indications**: Plans to expand indications to pediatric ALL and autoimmune diseases, with ongoing trials and discussions with regulatory agencies [34][38] - **Lupus Nephritis Trials**: Focus on patients with advanced lupus nephritis, planning a pivotal study in the second half of 2025 [41][46] - **Multiple Sclerosis Exploratory Study**: Investigating the potential of CAR T cells to cross the blood-brain barrier for treating progressive multiple sclerosis [46][48] Regulatory Considerations - **Single Arm Trials**: Regulatory agencies may consider single-arm trials for high medical need settings, provided there is a high treatment effect and sufficient safety data [51][55] Upcoming Milestones - **Key Data Releases**: Anticipated updates from ongoing studies at upcoming conferences, including EHA and ASH, with a focus on leukemia and lupus nephritis [57] Conclusion - **Overall Sentiment**: The company expressed confidence in its product's safety and efficacy, with a strong focus on execution and market penetration as it navigates the complexities of launching a new CAR T therapy [10][24]

Core Viewpoint - Autolus Therapeutics plc has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of its therapy, obecabtagene autoleucel (obe-cel), for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][6]. Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases [9]. - The company has a pipeline of product candidates and has received FDA approval and MHRA authorization for obe-cel [9]. Product Details - Obe-cel is an autologous CD19 CAR T cell therapy designed to target B-cell precursor acute lymphoblastic leukemia [4]. - The therapy has shown a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of the FELIX study [2]. - The median response duration for patients treated with obe-cel was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. Clinical Study Insights - The CHMP recommendation was based on the results of the FELIX study, which was an open-label, multi-center, single-arm study involving adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia [2][10]. - The study enrolled over 100 patients across 30 leading academic and non-academic centers in the U.S., U.K., and Europe [10]. Safety Profile - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3]. - Cytokine release syndrome occurred in 68.5% of patients, with severe cases in 2.4% [3]. Market Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [5]. - Conventional treatments for adult B-ALL have a median overall survival of only eight months, highlighting the need for effective therapies like obe-cel [5]. Regulatory Status - The positive CHMP opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a final decision within approximately two months [6][8]. - Obe-cel has already received FDA approval in November 2024 and MHRA conditional marketing authorization in April 2025 [4][6].

Core Insights - Autolus Therapeutics plc is presenting three abstracts at the upcoming European Hematology Association Congress, focusing on the efficacy of its programmed T cell therapy, obecabtagene autoleucel (obe-cel), for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) [1] Group 1: Clinical Findings - The oral presentation titled "Can CAR T-cell therapy be a definitive treatment for adult r/r B-ALL without transplant?" indicates that 40% of responders to obe-cel are in ongoing remission without subsequent stem cell therapy, suggesting its potential as a definitive treatment [2] - Another oral presentation discusses the efficacy and safety of obe-cel across different age groups, showing favorable outcomes with low incidence of severe cytokine release syndrome (CRS) and neurotoxicity, indicating a positive benefit-risk profile [3] - A poster presentation highlights the potential of the ALL-Hematotox model to better predict outcomes in patients treated with obe-cel compared to the CAR-Hematotox model, suggesting a need for further analysis [4] Group 2: Company Overview - Autolus Therapeutics plc is an early commercial-stage biopharmaceutical company focused on developing next-generation T cell therapies for cancer and autoimmune diseases, utilizing proprietary T cell programming technologies [5] - The company has an FDA-approved product, AUCATZYL, and a pipeline of candidates for treating hematological malignancies and solid tumors [5][7] Group 3: Clinical Trial Information - The FELIX clinical trial of obe-cel enrolled over 100 adult patients with r/r B-precursor ALL, with primary endpoints focused on overall response rate and secondary endpoints including duration of response and safety [6]

[Part I – Financial Information](index=6&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20statements) The company reported its first AUCATZYL product revenue, a $70.2 million net loss, and increased liabilities for Q1 2025, confirming going concern [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets were $746.3 million, liabilities increased to $375.2 million, and equity decreased to $371.1 million as of March 31, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $95,799 | $227,380 | | Marketable securities | $420,776 | $360,643 | | Inventories, net | $14,647 | $4,138 | | Total assets | $746,338 | $782,725 | | **Liabilities & Equity** | | | | Total current liabilities | $66,615 | $60,743 | | Liabilities related to future royalties and milestones, net (non-current) | $253,437 | $244,600 | | Total liabilities | $375,230 | $355,400 | | Total shareholders' equity | $371,108 | $427,325 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Q1 2025 saw first product revenue of $9.0 million, with net loss increasing to $70.2 million from $52.7 million in Q1 2024 Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $8,982 | $— | | License revenue | $— | $10,091 | | **Total revenue, net** | **$8,982** | **$10,091** | | Cost of sales | ($17,951) | $— | | Research and development expenses, net | ($26,734) | ($30,671) | | Selling, general and administrative expenses | ($29,534) | ($18,177) | | **Loss from operations** | **($65,240)** | **($38,757)** | | **Net loss** | **($70,161)** | **($52,690)** | | **Basic and diluted net loss per share** | **($0.26)** | **($0.24)** | [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased to $371.1 million by March 31, 2025, primarily due to a $70.2 million net loss - Total shareholders' equity decreased by **$56.2 million** in Q1 2025, mainly driven by the quarterly net loss of **$70.2 million**[26](index=26&type=chunk) - In Q1 2024, the company raised net proceeds of **$520.6 million** from the issuance of ordinary shares[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $75.6 million in Q1 2025, with $59.5 million used in investing and no financing activities Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($75,565) | ($40,514) | | Net cash used in investing activities | ($59,547) | ($533) | | Net cash provided by financing activities | $— | $561,441 | - The total cash, cash equivalents, and restricted cash decreased by **$131.6 million** during Q1 2025, ending the period at **$97.3 million**[28](index=28&type=chunk)[29](index=29&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Statements](index=12&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Notes detail the company's commercial transition with AUCATZYL, outlining revenue recognition policies and significant royalty liabilities - AUCATZYL (obe-cel) was approved by the FDA on November 8, 2024, for adult r/r B-ALL, with the U.S. commercial launch in January 2025. U.K. MHRA granted conditional marketing authorization in April 2025[32](index=32&type=chunk) - The company recognized its first product revenue of **$9.0 million** in Q1 2025, entirely from the U.S. This revenue is recognized when the product is administered to the patient and is net of estimated gross-to-net deductions[55](index=55&type=chunk)[77](index=77&type=chunk) - Liabilities related to future royalties and milestones from agreements with Blackstone and BioNTech totaled **$258.2 million** as of March 31, 2025. Interest expense accrued on these liabilities was **$10.1 million** for the quarter[125](index=125&type=chunk) - The company has capital commitments of **$16.4 million** for capital expenditures and **$2.9 million** for master supply commitments as of March 31, 2025[143](index=143&type=chunk)[144](index=144&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's commercial transition with AUCATZYL, reporting $9.0 million net product sales and a $70.2 million net loss in Q1 2025 [Recent Developments](index=33&type=section&id=MD%26A_Recent_Developments) Key Q1 2025 developments include AUCATZYL's U.S. launch, U.K. authorization, and progress in obe-cel clinical trials for LN and MS - Reported Q1 2025 net product sales of **$9.0 million** for AUCATZYL[173](index=173&type=chunk) - As of May 7, 2025, **39 U.S. cancer treatment centers** are activated, with over **90%** of U.S. medical lives having secured coverage for AUCATZYL[173](index=173&type=chunk) - The U.K. MHRA granted conditional marketing authorization for AUCATZYL on April 25, 2025[173](index=173&type=chunk) - The company plans to initiate a Phase 2 pivotal trial for obe-cel in lupus nephritis (LN) and a Phase 1 trial in progressive multiple sclerosis (MS) by year-end 2025[173](index=173&type=chunk)[171](index=171&type=chunk) [Results of Operations](index=39&type=section&id=MD%26A_Results_of_Operations) Q1 2025 total revenue decreased to $9.0 million, with new cost of sales, increased SG&A, and decreased R&D, widening the net loss to $70.2 million Comparison of Operations for Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $8,982 | $10,091 | ($1,109) | (11)% | | Cost of sales | ($17,951) | $— | ($17,951) | 100% | | R&D expenses, net | ($26,734) | ($30,671) | $3,937 | (13)% | | SG&A expenses | ($29,534) | ($18,177) | ($11,357) | 62% | | **Net loss** | **($70,161)** | **($52,690)** | **($17,471)** | **33%** | - The decrease in R&D expenses was primarily due to a **$6.1 million** reduction from reallocating IT and support costs and a **$2.0 million** reduction in personnel costs to commercial manufacturing activities (cost of sales and inventory) following FDA approval[222](index=222&type=chunk) - The increase in SG&A expenses was driven by a **$7.9 million** rise in personnel costs from increased headcount and a **$1.7 million** increase in commercial readiness costs[223](index=223&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=MD%26A_Liquidity_and_Capital%20Resources) As of March 31, 2025, the company held $516.6 million in cash and marketable securities, sufficient for twelve months, with significant future capital needs Cash Position (in millions) | Item | March 31, 2025 | | :--- | :--- | | Cash and cash equivalents | $95.8 | | Available-for-sale debt securities | $420.8 | | **Total** | **$516.6** | - The company believes its existing cash and marketable securities will fund operating expenses and capital requirements for at least **twelve months** from the report's issuance date[237](index=237&type=chunk) - Future capital needs will be driven by AUCATZYL commercialization, advancing other product candidates, expanding manufacturing, and hiring additional personnel[236](index=236&type=chunk)[238](index=238&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate and foreign currency fluctuations, with a 1% interest rate change impacting income by $1.0 million - Primary market risks are interest rate and foreign currency exchange risk[252](index=252&type=chunk) - A hypothetical one percentage point change in interest rates would have resulted in a **$1.0 million** change in interest income for Q1 2025[253](index=253&type=chunk) - As of March 31, 2025, approximately **55%** of cash held by the main U.K. subsidiary was in GBP and **40%** in USD. The company recorded a foreign exchange gain of **$1.2 million** in Q1 2025[256](index=256&type=chunk)[257](index=257&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[261](index=261&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2025[262](index=262&type=chunk) [Part II – Other Information](index=45&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened actions - As of the filing date, the company is not a party to any material legal proceedings[263](index=263&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) Key risks include government price controls, CMS reimbursement policies delaying AUCATZYL revenue, and international trade policies impacting supply chain and costs - A new CMS policy splits the AUCATZYL dose into two administrations for billing, which may delay the company's and treatment centers' ability to recognize revenue[265](index=265&type=chunk) - International trade policies, including tariffs and sanctions, pose a risk as the company depends on a global supply chain and manufactures all commercial and clinical supplies in the U.K.[267](index=267&type=chunk) - The company's ability to pass on increased costs from tariffs is limited by fixed-price contracts with payors, which could negatively impact profitability[270](index=270&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[274](index=274&type=chunk) [Defaults Upon Senior Securities](index=47&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[275](index=275&type=chunk) [Mine Safety Disclosures](index=47&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[276](index=276&type=chunk) [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2025[277](index=277&type=chunk) [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including the 2025 Inducement Plan and officer certifications