Core Viewpoint - The investment thesis for Autolus Therapeutics plc (AUTL) remains cautiously optimistic despite market and company-specific risks associated with launching another CD19 cell therapy [1] Company Analysis - Autolus Therapeutics is focused on developing CD19 cell therapies, which are part of a competitive market landscape [1] - The company has faced challenges typical of the biotech sector, particularly in clinical trials and regulatory approvals [1] Industry Context - The broader biotech industry is characterized by high risks and potential rewards, particularly in the area of cell therapies [1] - There is a growing interest in the science behind biotech investments, emphasizing the importance of due diligence for investors [1]

Core Insights - Autolus Therapeutics plc is participating in the Jefferies Global Healthcare Conference in London, with CEO Dr. Christian Itin scheduled to present on November 18, 2025 [1]. 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 aimed at effectively recognizing and eliminating target cells [3]. - Autolus has a marketed therapy named AUCATZYL and is developing a pipeline of product candidates for hematological malignancies, solid tumors, and autoimmune diseases [3]. Event Details - A webcast of the fireside chat will be available on the company's website, with a replay archived for 90 days post-presentation [2].

Financial Performance - For the three months ended September 30, 2025, the company incurred a net loss of $79.1 million, compared to a net loss of $82.1 million for the same period in 2024, with an accumulated deficit of $1,296.4 million as of September 30, 2025[180]. - Product revenue, net for the three months ended September 30, 2025, was $21.1 million, a 100% increase compared to $0 in the same period in 2024[233]. - Total revenue, net for the three months ended September 30, 2025, reached $21.2 million, reflecting a 100% increase from $0 in the prior year[232]. - Net loss for the three months ended September 30, 2025, was $79.1 million, a 4% improvement from a net loss of $82.1 million in the same period in 2024[232]. - Product revenue, net for the nine months ended September 30, 2025, was $51.0 million, with no product revenue in the same period in 2024[244]. - Total revenue, net for the nine months ended September 30, 2025, was $51.1 million, a 406% increase from $10.1 million in 2024[243]. - Net loss for the nine months ended September 30, 2025, was $197.2 million, a 2% increase from a net loss of $193.1 million in 2024[243]. Revenue and Expenses - Cost of sales for the three months ended September 30, 2025, was $28.6 million, with no cost of sales recognized in the same period in 2024[234]. - Cost of sales for the nine months ended September 30, 2025, was $71.0 million, with no cost of sales recognized in the same period in 2024[246]. - Research and development expenses, net decreased by $12.4 million to $27.9 million for the three months ended September 30, 2025, a 31% reduction from $40.3 million in 2024[236]. - Research and development expenses, net decreased by $25.5 million to $82.1 million for the nine months ended September 30, 2025, from $107.6 million for the same period in 2024, primarily due to reallocations to cost of sales and a decrease in clinical trial costs[248]. - Selling, general and administrative expenses increased by $9.0 million to $36.3 million for the three months ended September 30, 2025, a 33% increase from $27.3 million in 2024[237]. - Selling, general and administrative expenses increased by $28.7 million to $96.1 million for the nine months ended September 30, 2025, from $67.4 million for the same period in 2024, driven by higher salaries and commercial costs[249]. Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $86.1 million and marketable securities of $281.3 million, which are expected to fund operations for at least the next twelve months[181]. - Net cash used in operating activities was $216.2 million for the nine months ended September 30, 2025, compared to $168.3 million for the same period in 2024[258]. - As of September 30, 2025, the company had cash and cash equivalents of $86.1 million and available-for-sale debt securities of $281.3 million[257]. Product Development and Regulatory Approvals - The company achieved activation of 60 cancer treatment centers in the United States by November 12, 2025, meeting its target prior to year-end[183]. - AUCATZYL received conditional marketing authorization from the UK MHRA in April 2025, and discussions with NICE for reimbursement are ongoing[183]. - The FDA granted regenerative medicine advanced therapy designation to obe-cel for pediatric patients with r/r B-ALL in October 2025[183]. - The company plans to advance obe-cel into initial clinical development for progressive multiple sclerosis, with the first patient dosed in the Phase 1 BOBCAT trial in October 2025[184]. - The company anticipates no EU sales of AUCATZYL in 2025 and 2026, as the launch in Germany is currently on hold[183]. - The company’s translational programs with University College London continue to support its early-stage pipeline development[192]. Tax and Regulatory Matters - The company has accumulated tax losses for carry forward in the United Kingdom of $545.6 million as of December 31, 2024, with a full valuation allowance against the net deferred tax asset due to uncertain recoverability[230]. - The company may benefit from the United Kingdom "patent box" regime, allowing profits from patents to be taxed at an effective rate of 10% if revenues are generated in the future[231]. - The company has been advised that sales of its obe-cel CAR T therapy in the UK will be considered exempt from VAT, affecting the amount of VAT reclaimed[212]. - The company is subject to state government Medicaid and TriCare programs requiring rebates to be paid to participating state and local government entities[271]. - Pricing on AUCATZYL is extended below list price to entities under the 340B Program, with chargebacks based on the difference between acquisition cost and program price[272]. Accounting and Compliance - The company has experienced increased expenses associated with being a public company, including compliance costs with Nasdaq and SEC requirements[224]. - The company recognizes external development costs based on the progress of specific tasks, including expenses for clinical trials and manufacturing scale-up[209]. - The company recognizes revenue from sales-based royalties at the later of when related sales occur or when the performance obligation is satisfied[204]. - The company tracks direct research and development expenses on a program-by-program basis, primarily consisting of external costs[210]. - There have been no material changes to the company's contractual obligations and commitments as of September 30, 2025[276]. - Recent accounting pronouncements that may impact financial position and results of operations are disclosed in the quarterly report[277]. - The company is considered a "smaller reporting company" and is not required to provide certain market risk disclosures[278].

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025 [29] - Deferred revenue at the end of Q3 was $7.6 million, compared to $2.1 million in Q2 2025, indicating a healthy backlog of products ready for infusion [29] - The net loss for Q3 2025 was $79.1 million, reduced from a loss of $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - AUCATZYL achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of the year [8][29] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-ALL was approximately 15% before AUCATZYL's commercialization, increasing to around 20% within the 60 treatment centers currently active [10] Company Strategy and Development Direction - The company aims to drive market share in adult ALL, improve margins, and expand beyond ALL into pediatric ALL and other indications [8][33] - The focus is on optimizing operations and leveraging investments in infrastructure to enhance efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and the potential for growth in the CAR-T market [5][10] - The company is preparing for upcoming data presentations at ASH and expects to initiate pivotal studies in lupus nephritis and pediatric ALL [33] Other Important Information - The company has made key leadership changes to strengthen its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [35][37] Question: What is the competitive positioning for obe-cel in pediatric patients? - The focus is on high-risk pediatric patients who currently have limited options, with a strong safety and efficacy profile for obe-cel [39][41] Question: Can you provide insights on the Q3 performance and expectations for Q4? - Management indicated that Q3 performance was impacted by CMS reimbursement policy changes, but they expect a healthy amount of deferred revenue for Q4 [46][50] Question: What are the growth opportunities in the CAR-T market? - The majority of patients are not yet receiving CAR-T therapy, presenting significant growth opportunities within existing treatment centers [58][60] Question: What data is expected at ASH? - Key data points will include pediatric ALL study results and expanded data from the CARLYSLE study, focusing on safety and efficacy [68][70]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025, with deferred revenue increasing to $7.6 million from $2.1 million in Q2 2025 [28][29] - Cost of sales for Q3 2025 totaled $28.6 million, while research and development expenses decreased to $27.9 million from $40.3 million in the same period of 2024 [29][30] - Selling, general, and administrative expenses rose to $36.3 million from $27.3 million in Q3 2024, resulting in a loss from operations of $71.6 million compared to $67.9 million in Q3 2024 [30][31] - The net loss for Q3 2025 was $79.1 million, reduced from $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - The launch of AUCATZYL in the U.S. achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of 2025 [8][28] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9][10] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-cell ALL was approximately 20% within the 60 treatment centers currently active, indicating substantial growth potential [10][56] - The company aims to expand its geographic footprint and minimize travel distances for patients to access therapy [9] Company Strategy and Development Direction - The company is focusing on driving market share in ALL, improving margins, and expanding beyond ALL into pediatric ALL, lupus nephritis, and progressive multiple sclerosis [8][19] - The management is optimizing operations and leveraging investments made in infrastructure to drive efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and interest in investigator-sponsored trials [5][6] - The company anticipates significant growth opportunities in the CAR-T market and is preparing for upcoming data presentations at ASH [10][32] Other Important Information - The company has made key leadership changes to enhance its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] - The company is well-capitalized with $367.4 million in cash and marketable securities as of September 30, 2025, to support its commercialization efforts [31] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [34][35] Question: What is the competitive positioning for OB/Cell in pediatric patients? - The focus is on high-risk pediatric patients who are not eligible for CAR-T therapy, emphasizing the product's good safety and efficacy profile [37][38] Question: Can you provide insights on the Q3 performance and expected trends for Q4? - Management indicated that the Q3 performance was impacted by CMS reimbursement policy changes, but a healthy amount of deferred revenue suggests a positive outlook for Q4 [44][46] Question: What are the expected data presentations at ASH? - Key data points from the pediatric ALL study and the Carlyle study will be presented, focusing on safety, efficacy, and long-term outcomes [66][68]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025. Deferred revenue increased to $7.6 million from $2.1 million in Q2 2025, indicating a healthy backlog of products ready for infusion [28][29]. - Cost of sales for Q3 2025 totaled $28.6 million, while research and development expenses decreased to $27.9 million from $40.3 million in Q3 2024. Selling, general, and administrative expenses rose to $36.3 million from $27.3 million in the same period [29][30]. - The net loss for Q3 2025 was $79.1 million, reduced from a loss of $82.1 million in Q3 2024. Cash, cash equivalents, and marketable securities totaled $367.4 million, down from $588 million at the end of December 2024 [31][32]. Business Line Data and Key Metrics Changes - The launch of AUCATZYL in the U.S. achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of the year. The company has established 60 treatment centers, achieving over 90% patient access for U.S. covered lives [6][7][28]. - The manufacturing success rate is above 90%, and the company is focusing on optimizing operations and driving efficiencies [5][7]. Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-cell ALL is approximately 20% within the 60 treatment centers, indicating significant growth potential as the majority of patients are still not receiving CAR-T therapy [8][58]. - The company is expanding its pipeline with ongoing studies in pediatric ALL, lupus nephritis, and progressive multiple sclerosis, indicating a strategic focus on diversifying its product offerings [6][18]. Company Strategy and Development Direction - The company aims to drive market share in adult ALL, improve margins, and expand beyond ALL into other indications. There is a focus on building relationships with treatment centers to enhance product uptake [4][6][33]. - The management is optimistic about the growth potential in the CAR-T market and is leveraging data collected from the initial launch phase to optimize processes and drive efficiencies [5][8]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and the establishment of a reliable product delivery system [4][5]. - The company anticipates key data points from ongoing trials to be presented at the ASH conference, which could further validate its product offerings and market position [33][70]. Other Important Information - The company has made significant leadership changes, appointing new key members to enhance its operational capabilities and drive future growth [10][11]. - The management emphasized the importance of innovation in manufacturing and market access to serve a larger patient population [16]. Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [35][36]. Question: How does the competitive positioning for Obe-cel in pediatric patients compare to adults? - The focus is on high-risk pediatric patients who are not eligible for CAR-T therapy, with a strong safety and efficacy profile expected to drive interest [39][40]. Question: What drove the flat performance in Q3 compared to Q2? - The flat performance was influenced by a CMS reimbursement policy change that affected patient enrollment, but deferred revenue indicates a healthy pipeline for Q4 [46][50]. Question: Can you provide insights on CAR-T share growth and the competitive landscape in autoimmune diseases? - The company sees significant growth potential in CAR-T therapy as many patients are still untreated, and it believes it is well-positioned in the competitive landscape of autoimmune diseases [57][63]. Question: What data is expected at the ASH conference? - The company will present data from the pediatric ALL study and the Carlyle study, focusing on safety, efficacy, and long-term outcomes [69][70].

Financial Performance - AUCATZYL achieved net product sales of $21.1 million in Q3 2025[10] - Total revenue for Q3 2025 was $21.194 million[55] - Revenue for the nine months ended September 30, 2025, reached $51.0 million[11] - The company reported a total comprehensive loss of $84.9 million in Q3 2025[55] - As of September 30, 2025, the company's cash position was $367.4 million[56] AUCATZYL Launch and Market Access - AUCATZYL has been launched in the US, with strong initial execution in relapsed/refractory B-ALL (r/r B-ALL)[7] - The company has established 60 authorized treatment centers[14] - AUCATZYL has achieved patient access for over 90% of U S covered lives, exceeding initial expectations[14] - CAR T market share in relapsed/refractory disease in 2024 is approximately 15%[15] Obe-cel Expansion and Pipeline - The company is exploring the potential of obe-cel in new indications beyond adult B-ALL, including pediatric ALL, lupus nephritis, and multiple sclerosis[7] - In a Phase 1 study of obe-cel in Systemic Lupus Erythematosus (SLE), 83.3% (5/6) of patients achieved DORIS (Definition of Remission in SLE)[40] - In the SLE study, 50% (3/6) of patients achieved CRR (complete renal response)[40]

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): November 12, 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 (I.R.S. Employer Identification No.) The Mediaworks 191 Wood Lane London W12 7FP United Kingdom (Address of principal exec ...

Core Insights - Autolus Therapeutics plc reported operational and financial results for Q3 2025, highlighting progress in the launch of AUCATZYL and plans for future growth in various therapeutic areas [1][2][5] Financial Performance - The company achieved net product revenue of $21.1 million for Q3 2025, with a deferred revenue balance of $7.6 million as of September 30, 2025 [4][12] - Cost of sales for the quarter totaled $28.6 million, while research and development expenses decreased from $40.3 million to $27.9 million compared to the same period in 2024 [13][14] - Selling, general and administrative expenses increased from $27.3 million to $36.3 million, primarily due to higher employment-related costs [15] - The net loss for Q3 2025 was $79.1 million, a slight improvement from a net loss of $82.1 million in Q3 2024 [17] Product and Pipeline Updates - AUCATZYL is gaining traction in the market, with over 60 treatment centers activated in the U.S. and coverage for more than 90% of U.S. medical lives [5][6] - Data from the ROCCA Consortium will be presented at the ASH Annual Meeting, showcasing real-world outcomes for AUCATZYL in adult patients with relapsed/refractory acute lymphoblastic leukemia [5][6] - The company is advancing obe-cel into pivotal studies for pediatric ALL and severe lupus nephritis, with promising early data [4][9] Leadership and Operational Changes - Autolus has strengthened its leadership team to support the next phase of growth, appointing Cintia Piccina as U.S. Chief Commercial Officer and Miranda Neville as Chief Technical Officer [8][16] - The company aims to optimize business operations and enhance market growth through strategic planning and operational excellence [11][16] Future Outlook - Autolus is well-capitalized with cash and cash equivalents totaling $367.4 million as of September 30, 2025, to support the commercialization of obe-cel and ongoing clinical trials [18][19] - The company anticipates significant data presentations at upcoming conferences, including initial clinical data from the CATULUS trial and longer-term follow-up from the CARLYSLE trial [11][12]

Core Insights - The third-quarter 2025 reporting cycle for the Medical sector, which includes pharma/biotech and medical device companies, is nearing completion [1] Earnings Performance - Major pharmaceutical companies like Amgen, Novo Nordisk, and Pfizer reported earnings, with Amgen and Pfizer showing strong results and raising their EPS outlook for 2025, while Novo Nordisk faced weaker-than-expected results and reduced its full-year guidance due to slower growth in its GLP-1 portfolio [2] - As of November 5, nearly 82% of companies in the Medical sector, representing 92% of the sector's market capitalization, reported quarterly earnings, with approximately 92% beating earnings estimates and around 84% exceeding revenue expectations. Year-over-year earnings rose over 4%, while revenues increased nearly 11%, with overall expected increases of 3.0% in earnings and 10.5% in sales compared to the previous year [3] Potential Earnings Surprises - Four biotech companies—Alto Neuroscience, Autolus Therapeutics, Ascendis Pharma, and Immuneering—are highlighted as likely to deliver earnings beats based on their positive Earnings ESP and solid Zacks ranks [4][10] - Alto Neuroscience has an Earnings ESP of +16.41% and a Zacks Rank 2, with a consensus estimate for a loss of 66 cents per share [7] - Autolus Therapeutics has an Earnings ESP of +22.30% and a Zacks Rank 2, with a consensus estimate for a loss of 23 cents per share [11] - Ascendis Pharma has an Earnings ESP of +34.28% and a Zacks Rank 3, with a consensus estimate for a loss of 41 cents per share [13] - Immuneering has an Earnings ESP of +21.62% and a Zacks Rank 3, with a consensus estimate for a loss of 37 cents per share [15]