Company reports Q1 2025 AUCATZYL® net product revenue of $9.0 millionU.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization for AUCATZYL® for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL)Encouraging preliminary data reported in Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE); planned Phase 2 pivotal clinical trial in lupus nephritis (LN) and Phase 1 clinical trial in prog ...

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 ...

Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advanc ...

Company outlined potential for value creation driven by obe-cel across multiple B cell driven malignancies and autoimmune diseases, including acute lymphoblastic leukemia (ALL), lupus nephritis (LN) and multiple sclerosis (MS)Preliminary data in initial six patient cohort treated in Phase 1 trial in systemic lupus erythematosus (SLE) support progressing obe-cel into a planned Phase 2 pivotal study in lupus nephritis; first patient expected to be dosed in Phase 2 trial by year-end 2025Company plans to advanc ...

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].

LONDON, April 02, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces that the Company will participate in the 24th Annual Needham Virtual Healthcare Conference. Autolus Chief Executive Officer Dr. Christian Itin will present in a Fireside Chat on Wednesday, April 9, 2025 at 9:30am EDT / 14:30pm BST. A webcast of the fireside chat will be available ...

LONDON, April 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announced that the Company will host an R&D investor event on Wednesday, April 23, 2025 at 8:30am EDT / 13:30pm BST. The live event will be held in New York City. To inquire about in-person attendance please email: susan@sanoonan.com. Amanda Cray +1 617-967-0207 a.cray@autolus.com About Au ...

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].

Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities at year-end 2024 totaled $588 million, up from $239 million at the end of 2023, primarily due to a collaboration with BioNTech and equity financing [27][28] - Loss from operations for the year ending December 31, 2024, was $241.4 million, compared to $179.7 million for 2023 [28] - Net loss was $220.7 million for the year-end December 31, 2024, compared to $208.4 million for the same period in 2023 [30] Business Line Data and Key Metrics Changes - Cost of sales totaled $11.4 million following the BLA approval for obe-cel, representing costs associated with commercially available plant capacity [28] - Research and development expenses increased to $138.4 million for the year ending December 31, 2024, compared to $130.5 million in 2023, driven by increases in employee salaries and manufacturing costs [29] - Selling, general, and administrative expenses increased to $101.1 million for the year, compared to $46.7 million for the same period in 2023, primarily due to increased headcount for commercialization activities [29] Market Data and Key Metrics Changes - As of March 19, 2025, 33 centers were authorized to deliver AUCATZYL, expected to reach approximately 60% of the target patient population in the U.S. [13][21] - The company aims to have approximately 60 centers ready to deliver AUCATZYL by the end of the year [14] Company Strategy and Development Direction - The primary objective for 2025 is to execute a successful commercial launch for AUCATZYL and explore additional indications for obe-cel [8][10] - The company is planning an R&D event on April 23, 2025, to outline future growth opportunities [9] - The company is also moving through regulatory steps in the UK and Europe, with expected decisions in the second half of 2025 [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's safety profile and its potential for outpatient administration, depending on physician experience and patient suitability [41][42] - The company noted a strong interest from centers to activate and deliver the product, indicating a positive dynamic in the launch [39] - Management highlighted the importance of ongoing experience with the product to build confidence among physicians [42] Other Important Information - The company received a $30 million milestone payment from Blackstone following FDA approval and made a regulatory milestone payment of GBP10 million [31][32] - The manufacturing facility is operational and is expected to reliably deliver products to centers [23] Q&A Session Summary Question: Initial demand and outpatient administration for AUCATZYL - Management noted a positive dynamic around center activation and interest in outpatient administration based on safety data [39][41] Question: Ramp-up of authorized centers and impact of tariffs - Management expects a steady ramp-up of centers, driven by individual center capabilities, and noted uncertainty regarding potential tariffs [48][53] Question: Time from site activation to first patient treatment - The time varies significantly, with some centers quickly treating patients while others may experience delays [60] Question: Manufacturing success rate and BioNTech's decision on AUTO6NG - Initial production experience mirrors clinical studies, and BioNTech's option on AUTO6NG will be exercised after pivotal study results [71][72] Question: SLE data context and resource allocation for launch - Upcoming SLE data will focus on product properties, safety, and B-cell depletion, with resources primarily directed towards service support for centers [78][85] Question: Treatment adoption among centers and sales guidance - Both experienced and new centers are adopting the treatment, and the company will not provide sales guidance due to multiple variables affecting sales trajectories [91][110]