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].

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]

AUCATZYL Launch and Expansion - Autolus' AUCATZYL received FDA approval on November 8, 2024, triggering a $30 million milestone payment from Blackstone[12] - As of March 19, 2025, 33 treatment centers are authorized for AUCATZYL, covering over 60% of the target patient population, with a goal to reach approximately 60 centers covering 90% by the end of 2025[12, 23] - Over 85% of total U S medical lives are covered for AUCATZYL[22] - The anticipated payor mix for AUCATZYL is approximately 60% commercial and 40% government/other[23] Obe-cel Development - The FELIX trial data for obe-cel was published in the New England Journal of Medicine in December 2024[12] - The FELIX trial showed an overall remission rate of 77% in all patients, 75% in morphological disease, 96% in measurable residual disease, and 71% in isolated extramedullary disease[13] - In the FELIX trial, the estimated 6- and 12-month overall survival rates were 80 3% and 61 1%, respectively, with a median OS of 15 6 months[19, 20] - Regulatory decisions from MHRA and EMA regarding obe-cel are expected in H2 2025[12] Financial Performance - Autolus' cash, cash equivalents, and marketable securities totaled $588 023 million for FY 2024, compared to $239 566 million for FY 2023[35] - Total revenue, net, for FY 2024 was $10 120 million, compared to $1 698 million for FY 2023[35] - The net loss for FY 2024 was $(220 844) million, compared to $(208 383) million for FY 2023[35]

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 [25] - Loss from operations for the year ending December 31, 2024, was $241.4 million, compared to $179.7 million for 2023 [26] - Net loss was $220.7 million for the year ended December 31, 2024, compared to $208.4 million for the same period in 2023 [27] Business Line Data and Key Metrics Changes - Cost of sales totaled $11.4 million following the BLA approval for Obicel, representing the cost of commercially available plant capacity [26] - Research and development expenses increased to $138.4 million for the year ended December 31, 2024, from $130.5 million in 2023, driven by increases in employee salaries and manufacturing costs [27] - Selling, general, and administrative expenses rose to $101.1 million for the year compared to $46.7 million in 2023, primarily due to increased salaries and employee-related costs [27] Market Data and Key Metrics Changes - As of March 19, 2025, 33 centers were authorized to deliver Ocassol, expected to reach approximately 60 centers by the end of the year, covering about 60% of the target patient population in the U.S. [12][13][20] - The product was included in the NCCN guidelines shortly after clinical results were published, enhancing confidence in its commercial use [12] Company Strategy and Development Direction - The primary objective for 2025 is to execute a successful commercial launch of Ocassol and explore opportunities for expanding its utility in additional indications [7][8] - The company plans to hold 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 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's safety profile and its potential for outpatient administration, contingent on physician experience and patient suitability [35][36] - The company noted a strong dynamic in the activation of treatment centers, driven by physician interest and patient need [34] - Management highlighted the importance of ongoing data collection and analysis to support the product's positioning and adoption in the market [66] Other Important Information - The company received a $30 million milestone payment from Blackstone following FDA approval and made a regulatory milestone payment of GBP 10 million [28] - The manufacturing facility is operational and is expected to reliably deliver products to treatment centers [22] Q&A Session Summary Question: Can you provide any color on the initial demand or the book of orders for Ocassol? - Management noted a positive dynamic around center activation, driven by interest and patient need, but stated a fuller picture would be provided in the Q1 update [34] Question: What is the ramp-up plan for the authorized centers? - Management indicated a steady trajectory for onboarding centers, with expectations for gradual growth throughout the year [41][42] Question: Can you comment on the spread of time from site activation to treating the first patient? - Management stated that the time varies significantly based on patient suitability and center readiness, with some centers achieving quick onboarding [50] Question: What is the sentiment among prescribers regarding the need for subsequent therapy after using Ocassol? - Management indicated that initial experiences suggest a low percentage of patients require subsequent stem cell transplants, which resonates positively with physicians [55] Question: What has been the manufacturing success rate and turnaround time for Ocassol? - Management reported that production experiences are aligning well with clinical study data, providing reassurance for future batches [57]

Financial Results Announcement - Autolus Therapeutics plc announced its financial results for the year ended December 31, 2024, during a conference call on March 20, 2025[5] - The press release detailing the financial results is included as Exhibit 99.1[9] Corporate Presentation - The company provided an updated corporate presentation alongside the financial results, which is available as Exhibit 99.2[7]

Core Insights - Autolus Therapeutics achieved significant milestones in 2024, including FDA approval and commercial launch of AUCATZYL, a CAR T therapy for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) [2][5] - The company is focused on expanding its commercial launch and advancing its clinical pipeline in 2025, with plans to enter new markets and invest in the obe-cel opportunity [2][4] Financial Performance - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $588.0 million, up from $239.6 million in 2023, primarily due to a strategic collaboration with BioNTech [8] - The net loss for the year ended December 31, 2024, was $220.7 million, compared to a loss of $208.4 million in 2023, with a basic and diluted net loss per share of $(0.86) [12][18] - Research and development expenses increased to $138.4 million from $130.5 million in 2023, while selling, general, and administrative expenses rose significantly to $101.1 million from $46.7 million [10][11] Product Development and Regulatory Updates - AUCATZYL was approved by the FDA on November 8, 2024, and is progressing well in the U.S. commercial launch with 33 authorized treatment centers as of March 19, 2025 [4][5] - The company expects marketing authorizations for obe-cel from the MHRA and EMA in the second half of 2025 [4][6] - Initial data from the Phase 1 trial in systemic lupus erythematosus (SLE) will be presented at an R&D event on April 23, 2025 [7][20] Clinical Trials and Pipeline - The pivotal Phase 1b/2 FELIX clinical trial of obe-cel demonstrated high rates of durable responses with low incidence of severe immune-related toxicity [5][9] - Autolus is also advancing early-stage pipeline programs, including AUTO8 and AUTO6NG, with updates planned for the upcoming R&D event [10][20] Market Access and Coverage - Patient access to AUCATZYL is strong, with coverage secured for over 85% of total U.S. medical lives, and the company aims to authorize 60 treatment centers by the end of 2025 [5][8] - The National Comprehensive Cancer Network (NCCN) has included AUCATZYL in its Clinical Practice Guidelines for the treatment of adult patients with relapsed/refractory B-ALL [5]

Core Insights - Autolus Therapeutics plc is set to release its fourth quarter and full year 2024 financial results on March 20, 2025, before the US markets open [1] - A conference call and webcast will be held on the same day at 8:30 am EDT/12:30 pm GMT to discuss the financial results and provide a business update [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 T cell programming technologies to create targeted and controlled T cell therapies aimed at effectively recognizing and eliminating target cells [3] - Autolus has an FDA-approved product, AUCATZYL, and is developing a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3]