Financial Data and Key Metrics Changes - The company reported recognized revenue of $9 million for Q1 2025, marking a strong start for the U.S. launch of Ocassel [8][42] - Cost of sales totaled $18 million, which includes costs for all commercial products delivered to authorized treatment centers [44] - The net loss for Q1 2025 was $70.2 million, compared to a net loss of $52.7 million for the same period in 2024 [46] Business Line Data and Key Metrics Changes - The company aims to increase the number of centers authorized to deliver Ocassel from 39 to approximately 60, targeting 90% access to patients across the U.S. [11] - Research and development expenses decreased to $26.7 million from $30.7 million in the same period in 2024, primarily due to cost shifts following the approval of Ocassel [44] Market Data and Key Metrics Changes - As of April 1, CMS published codes for inpatient and outpatient use for Ocassel, formalizing reimbursement for patients on government programs [9][43] - The company is preparing for market expansion in the UK and Europe, having received conditional marketing authorization from the MHRA in the UK [12] Company Strategy and Development Direction - The company plans to expand its market share for CAR T products and is exploring opportunities in acute lymphoblastic leukemia and pediatric populations [12][14] - The strategy includes a fast-to-market approach for lupus nephritis, focusing on a refractory patient population with a clear objective endpoint [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial momentum seen in Q1 and expects this to carry into the second quarter [10] - The company is well-capitalized with $516.6 million in cash and equivalents, which supports ongoing commercialization efforts [46][52] Other Important Information - The company is evaluating the implications of the April 1 coding update on revenue recognition policies [57] - The safety profile of Ocassel is favorable, with no high-grade cytokine release syndrome observed in patients [19] Q&A Session Summary Question: Can you clarify the revenue recognition for Ocassel? - Management confirmed that revenue recognition for Q1 was based on patients receiving both doses, and they are evaluating the implications of the new coding update [54][56] Question: What is the potential exposure to UK or pharma-specific tariffs? - Management noted that blood products are typically exempt from tariffs, but the final impact remains uncertain pending government announcements [60][62] Question: Can you provide details on the cost of goods sold (COGS) for the quarter? - Management indicated that the majority of COGS is driven by the cost of products sold and those delivered but not yet booked as sales, with smaller contributions from patient assistance programs [71][73] Question: What is the median turnaround time for manufacturing success? - Management reported that the turnaround time is tracking towards the target of 16 days, consistent with previous trials [86]

Financial Data and Key Metrics Changes - The company reported recognized revenue of $9 million for Q1 2025, marking a strong start for the U.S. launch of Ocassel [7][42] - Cost of sales totaled $18 million, which includes costs for all commercial products delivered to authorized treatment centers [43][44] - Research and development expenses decreased to $26.7 million from $30.7 million in the same period in 2024, primarily due to cost shifts following Ocassel's approval [44] - Selling, general, and administrative expenses increased to $29.5 million from $18.2 million in the same period in 2024, driven by increased headcount for U.S. commercialization [45] - The net loss for Q1 2025 was $70.2 million, compared to $52.7 million for the same period in 2024 [46] Business Line Data and Key Metrics Changes - The company is focusing on expanding the number of centers authorized to deliver Ocassel therapy from 39 to approximately 60, aiming for 90% patient access across the U.S. [9][11] - The company is also planning to present key updates based on long-term follow-up from the FELIC study, which is expected to provide encouraging data for Ocassel [10] Market Data and Key Metrics Changes - As of April 1, CMS published codes for Ocassel, formalizing reimbursement for patients on government programs, which is expected to enhance market access [7][43] - The company has received conditional marketing authorization from the MHRA in the UK and is engaging with NICE for reimbursement processes [11] Company Strategy and Development Direction - The company aims to increase the number of treatment centers and expand market share for CAR T products, with a focus on geographic expansion into the UK and Europe [11][12] - The company is exploring the utility of its products in earlier stages of treatment and in pediatric populations, with plans for investigator-sponsored trials [13][14] - The company is also looking into opportunities beyond acute lymphoblastic leukemia, targeting a broader range of B cell malignancies and autoimmune diseases [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial momentum seen in Q1 and expects this to carry into Q2 [8] - The company is well-capitalized with $516.6 million in cash and equivalents, which is expected to support the launch and commercialization of its products [46][52] - Management highlighted the importance of medical need in regulatory assessments and the potential for accelerated access to therapies [66] Other Important Information - The company is preparing for updates and data presentations for various studies, including the Carlyle study for lupus nephritis and a phase I study for progressive MS [47][48] - The company is also evaluating the implications of recent coding updates on revenue recognition policies [56] Q&A Session Summary Question: Revenue recognition for Ocassel and impact of coding update - Management confirmed that revenue recognition for Q1 was based on patients receiving both doses, and they are evaluating the implications of the April 1 coding update on revenue recognition [54][56] Question: Potential exposure to tariffs - Management noted that blood products are typically exempt from tariffs, and the customs value used for tariff calculations is linked to manufacturing costs rather than product sales [61][62] Question: Manufacturing turnaround time and success rate - Management indicated that the turnaround time is tracking towards the target of 16 days, and while it is premature to discuss success rates, initial results indicate good quality products [87][88]

AUCATZYL Launch and Growth - AUCATZYL achieved net product sales of $9 million in Q1 2025[8] - Approximately 90% of total U S medical lives are covered for AUCATZYL[10] - 39 Treatment Centers Authorized as of 05/07/25[8] - Conditional marketing authorization in the UK received April 25, 2025, with EMA decision expected in H2 2025[12] Obe-cel Development and Potential - Obe-cel demonstrated a high MRD-negative complete remission rate of 94% in r/r adult and pediatric acute B cell lymphoblastic leukemia (ALL) patients[17] - In non-Hodgkin lymphoma, obe-cel showed a high metabolic complete remission rate of 88% in r/r LBCL and 95% in r/r FL[17] - Preliminary CARSLYLE SLE P1 trial data shows 10+ point drop in SLEDAI-2K scores and 3 of 6 patients with renal CRs by month 3[22] Financial Status - The company's cash, cash equivalents, and marketable securities totaled $516 6 million as of Q1 2025[41] - Net product revenue for Q1 2025 was $8 982 million[40] Upcoming Milestones - The company anticipates dosing the first patient in the Phase 2 trial for lupus nephritis by year-end 2025[32] - The company anticipates dosing the first patient in the progressive MS Phase 1 trial by year-end 2025[37]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 8, 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) (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane London W12 7FP United Kingdom (Addres ...

Core Insights - Autolus Therapeutics plc reported strong initial sales and positive clinical developments for its product AUCATZYL, indicating a promising market entry and potential for future growth [2][4][5] Financial Performance - The company reported Q1 2025 net product revenue of $9.0 million, with a significant increase in patient access and coverage for AUCATZYL in the U.S. [4][8] - Cost of sales for the same period totaled $18.0 million, reflecting the expenses associated with product delivery and patient access programs [9] - Research and development expenses decreased from $30.7 million to $26.7 million year-over-year, primarily due to cost shifts related to commercial manufacturing [10] - Selling, general and administrative expenses increased from $18.2 million to $29.5 million, driven by increased headcount for U.S. commercialization efforts [11] - The net loss for Q1 2025 was $70.2 million, compared to $52.7 million in the same period of 2024, with a basic and diluted net loss per share of $(0.26) [13][18] Product Development and Regulatory Updates - AUCATZYL received conditional marketing authorization from the UK's MHRA for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [4][5] - The company is collaborating with NICE to enhance patient access to AUCATZYL in the UK [2] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) showed promising results, leading to plans for a Phase 2 pivotal trial in lupus nephritis (LN) [5][6] - The company anticipates dosing the first patient in the Phase 2 trial for LN and a Phase 1 trial for progressive multiple sclerosis (MS) by year-end 2025 [12][7] Market and Competitive Position - Autolus has established 39 fully activated treatment centers in the U.S. and secured coverage for approximately 90% of total U.S. medical lives, enhancing market penetration [5] - The company is well-capitalized with cash and cash equivalents totaling $516.6 million as of March 31, 2025, allowing for continued investment in product launches and clinical trials [14][15]

UK Medicines and Healthcare products Regulatory Agency (MHRA) authorisation based on FELIX clinical trial of obecabtagene autoleucel in adult patients with r/r B-ALL1AUCATZYL® licensed from MHRA under ‘conditional marketing authorisation’, meaning that the MHRA will review new efficacy and safety information at least once every year1 Investors, US and UK National, Medical and Industry media only LONDON, April 25, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage bio ...

Core Insights - Autolus Therapeutics plc is advancing its development pipeline, particularly focusing on the expansion of its programmed T cell therapy, obe-cel, into autoimmune diseases such as lupus nephritis (LN) and multiple sclerosis (MS) [1][2][5] Development Plans - The company aims to establish a potential registrational path for obe-cel in LN, supported by insights from key opinion leaders in the field [2][3] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) indicate a strong rationale for progressing to a pivotal Phase 2 study, with the first patient expected to be dosed by the end of 2025 [5][6] Clinical Data - In the Phase 1 CARLYSLE trial, three out of six patients achieved complete renal response by month three, and all patients showed normalization of complement levels by month one [6] - The trial reported no dose-limiting toxicities or severe neurotoxicity, with only mild cytokine release syndrome observed in some patients [6] Future Trials - Autolus plans to initiate a Phase 1 trial for obe-cel in progressive forms of MS, with the first patient expected to be dosed by year-end 2025 [5][6] - The company has aligned with the U.S. FDA on the Phase 2 trial design and anticipates further data presentation at a medical conference in the second half of 2025 [6] Regulatory Updates - Autolus is awaiting notifications from the UK MHRA and EU EMA regarding the approval of obe-cel for adult patients with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL) in 2025 [7][11] - The company is actively launching AUCATZYL, its FDA-approved product, with 38 centers fully activated as of April 2025 [11][13] Market Potential - The company believes that obe-cel represents a significant opportunity for value creation across multiple B cell-driven malignancies and autoimmune diseases, addressing substantial unmet medical needs [3][5]

Core Insights - Autolus Therapeutics plc is advancing its development pipeline, particularly focusing on the expansion of its programmed T cell therapy, obe-cel, into autoimmune diseases such as lupus nephritis (LN) and multiple sclerosis (MS) [1][2][5] Development Plans - The company aims to establish a potential registrational path for obe-cel in LN, supported by insights from key opinion leaders in the field [2][3] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) indicate a strong rationale for progressing to a pivotal Phase 2 study, with the first patient expected to be dosed by year-end 2025 [5][6] Clinical Data - In the CARLYSLE trial, three out of six patients achieved complete renal response by month three, and all patients showed normalization of complement levels by month one [6] - The trial reported no dose-limiting toxicities or severe neurotoxicity, with only mild cytokine release syndrome observed in some patients [6] Regulatory and Market Updates - Autolus is aligned with the U.S. FDA on the Phase 2 trial design and anticipates dosing the first patient in this trial before the end of 2025 [6] - The company expects notifications regarding regulatory approvals for obe-cel in the UK and EU in Q2 and H2 2025, respectively [11] Anticipated News Flow - Key upcoming milestones include notifications from the UK MHRA and EU EMA regarding approval for obe-cel in relapsed/refractory adult acute lymphoblastic leukemia (ALL) in Q2 and H2 2025, respectively [7] - Initial data from the pediatric ALL trial and the presentation of the Phase 1 CARLYSLE trial at a medical conference are also expected in H2 2025 [7] Financial and Commercial Strategy - The launch of AUCATZYL, an FDA-approved product for adult patients with relapsed or refractory B-ALL, is progressing with 38 centers activated as of April 2025 [11] - The company is leveraging its proprietary manufacturing and commercial infrastructure to maximize the value of its assets, particularly obe-cel [3][11]

Core Viewpoint - Autolus Therapeutics plc is set to release its first quarter 2025 financial results and operational highlights on May 8, 2025, before the US markets open [1]. Group 1: Financial Results Announcement - The company will host a conference call and webcast at 8:30 am EDT/13:30 pm 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 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 highly active T cell therapies [3]. - Autolus has an FDA-approved product, AUCATZYL, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3].

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 highly active T cell therapies [3] - Autolus has an FDA-approved product, AUCATZYL, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3] Upcoming Events - Autolus will participate in the 24th Annual Needham Virtual Healthcare Conference [1] - CEO Dr. Christian Itin is scheduled to present in a Fireside Chat on April 9, 2025, at 9:30 AM EDT / 14:30 PM BST [1] - A webcast of the presentation will be available on the company's website and archived for 90 days [2]