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]

Core Insights - Autolus Therapeutics plc will host an R&D investor event on April 23, 2025, to discuss updates on its clinical pipeline and expansion plans [1][2] Group 1: 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 [4] - The company utilizes proprietary T cell programming technologies to create targeted and effective therapies [4] - Autolus has an FDA-approved product, AUCATZYL, and is developing additional candidates for hematological malignancies, solid tumors, and autoimmune diseases [4] Group 2: Upcoming Event Details - The R&D investor event will take place in New York City at 8:30am EDT / 13:30pm BST [1] - The company will present initial data from the CARLYSLE Phase 1 trial in systemic lupus erythematosus and discuss plans for expansion in autoimmune diseases [2] - A webcast of the presentation will be available on the company's website, with a replay archived for 90 days [3]

Autolus will present an update on clinical pipeline programs, including plans to expand the obe-cel opportunity. The Company expects to report initial data in six patients from the ongoing CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE), announce development plans for expansion in autoimmune diseases, and provide a brief update of the ongoing commercial launch of AUCATZYL®. LONDON, April 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (NASDAQ:AUTL), an early commercial-stage biopharmaceut ...

Financial Performance - For the years ended December 31, 2024 and 2023, the company incurred net losses of $220.7 million and $208.4 million, respectively, with an accumulated deficit of $1,099.2 million as of December 31, 2024[661]. - The company has not generated revenue from commercial product sales, with total revenue primarily from license agreements during the year ended December 31, 2024[677]. - License revenue increased to $10.1 million for the year ended December 31, 2024, compared to $1.7 million in 2023, representing a 496% increase[715]. - Total revenue for 2024 was $10.1 million, up from $1.7 million in 2023, marking a 496% increase[714]. - Interest income surged to $32.4 million in 2024, up from $13.5 million in 2023, reflecting a 140% increase[721]. - Interest expense, net decreased significantly to $9.3 million in 2024 from $45.1 million in 2023, a reduction of 79%[722]. - Net cash used in operating activities was $206.3 million in 2024, compared to $145.6 million in 2023[726]. Cash and Capital Resources - The company has cash and cash equivalents of $227.4 million and marketable securities of $360.6 million as of December 31, 2024, expected to fund operations for at least the next twelve months[662]. - The company raised an aggregate of $1.7 billion from various capital sources since its inception in 2014 through December 31, 2024[724]. - The company expects significant additional capital requirements to fund operations until it can generate substantial revenue from product sales[723]. - As of December 31, 2024, the company has cash and cash equivalents of $227.4 million and available-for-sale debt securities of $360.6 million, which are expected to fund operating expenses for at least twelve months[734]. - The unconditional purchase obligations for capital expenditures totaled $17.5 million, expected to be incurred within one year[738]. - The company has operating lease obligations of $52.6 million under non-cancellable leases for laboratory and office properties in the UK and the US as of December 31, 2024[736]. Research and Development - The company expects substantial increases in research and development expenses over the next few years due to higher personnel costs and additional clinical trials[691]. - Research and development expenses rose by $7.9 million to $138.4 million in 2024, a 6% increase from $130.5 million in 2023[717]. - The company recognizes external development costs based on the progress of specific tasks, primarily involving fees paid to outside consultants and CROs[690]. - The company is planning to present initial data from the ongoing Phase 1 dose confirmation study ("CARLYSLE") in refractory SLE patients on April 23, 2025[665]. Commercialization and Regulatory Approvals - AUCATZYL was approved by the FDA on November 8, 2024, for treating adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, with 33 centers authorized as of March 19, 2025[664]. - The company expects to complete authorization of 60 treatment centers by the end of 2025, covering approximately 90% of the target U.S. patient population[664]. - The company anticipates significant commercialization expenses related to product manufacturing, sales, marketing, and distribution, depending on the commercialization strategy for AUCATZYL and other product candidates[734]. - The company expects to incur significant commercialization expenses if regulatory approval is received for other product candidates, which may require additional capital for in-licenses or acquisitions[735]. Agreements and Collaborations - The License Agreement with BioNTech includes potential future payments of up to $582.0 million, including milestone payments and royalties on net sales of licensed products[667]. - BioNTech made an initial payment of $10.0 million under the License Agreement, with additional milestone payments of up to $32.0 million possible[668]. - Under the Blackstone Collaboration Agreement, the company is set to receive up to $150 million, including an upfront payment of $50 million and milestone payments based on clinical achievements[740]. - BioNTech has made an upfront payment of $40 million to support the clinical development of obe-cel, with additional milestone payments of up to $100 million based on regulatory achievements[742]. Tax and Regulatory Considerations - Accumulated tax losses for carry forward in the U.K. amounted to $545.6 million at December 31, 2024, and $418.1 million at December 31, 2023[711]. - The U.K. "patent box" regime allows profits from patented products to be taxed at an effective rate of 10% if the company generates profits in the future[712]. - The SME regime allows for a cash rebate of up to 33.35% of qualifying R&D expenditure incurred prior to April 1, 2023, decreasing to 18.6% thereafter[697]. - Under the RDEC program, tax credits for qualifying R&D expenditure incurred prior to April 1, 2023, are granted at a headline rate of 13%, increasing to 20% from April 1, 2023[698]. - The company may face restrictions on tax relief for subcontracted R&D activities incurred outside the U.K. starting from April 1, 2024[699]. Risks and Uncertainties - The successful development and commercialization of product candidates is highly uncertain, with significant risks and costs associated with clinical trials and regulatory approvals[693]. - The company’s future funding requirements are uncertain and may increase significantly due to various factors, including the costs of clinical trials and commercialization efforts[735]. - The company has experienced increased expenses associated with being a public company, including compliance costs with Nasdaq and SEC requirements[703]. Financial Management and Investment Policy - The company is exposed to credit risk primarily from available for sale debt securities and cash and cash equivalents[760]. - Cash and cash equivalents are held with multiple counterparties, monitored for credit ratings regularly[760]. - The investment policy limits investments to certain types of instruments, including available for sale debt securities and money market funds[760]. - Restrictions are placed on maturities and concentration by type and issuer, specifying minimum credit ratings for all investments[760]. - The average credit quality of the portfolio is maintained according to the investment policy[760].