[Form 8-K Filing Details](index=1&type=section&id=Form%208-K%20Filing%20Details) This section details the administrative information of the Form 8-K filing, including registrant identification and securities registration [Registrant Information and Filing Context](index=1&type=section&id=Registrant%20Information%20and%20Filing%20Context) This section outlines the registrant's identification, report date, registered securities, and emerging growth company status for the Form 8-K filing - The report date is **August 12, 2025**, filed by Autolus Therapeutics plc[1](index=1&type=chunk) Registered Securities | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :---------------------------------------------------------- | :---------------- | :---------------------------------------- | | American Depositary Shares, each representing one ordinary share, nominal value $0.000042 per share | AUTL | The Nasdaq Global Select Market | | Ordinary shares, nominal value $0.000042 per share* | * | The Nasdaq Stock Market LLC* | - The registrant is **not indicated as an emerging growth company**[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Conditions](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Conditions) This item reports Autolus Therapeutics plc's financial results for the quarter ended June 30, 2025, and a corporate update announced via press release - On **August 12, 2025**, Autolus Therapeutics plc announced its financial results for the quarter ended **June 30, 2025**, and provided a corporate update[5](index=5&type=chunk) - A copy of the press release is furnished as **Exhibit 99.1** and incorporated by reference[5](index=5&type=chunk) - This information is furnished, not deemed 'filed' for Section 18 of the Exchange Act, and not incorporated by reference in other filings unless expressly set forth[6](index=6&type=chunk) [Item 7.01 Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) This item discloses the use of an updated corporate presentation for the company's Q2 2025 results conference call - The Company will utilize an updated corporate presentation during its conference call on **August 12, 2025**, to discuss **Q2 2025** results[7](index=7&type=chunk) - A copy of the corporate presentation is furnished as **Exhibit 99.2** to this Current Report on Form 8-K[7](index=7&type=chunk) - Similar to Item 2.02, this information is furnished and not deemed 'filed' for Section 18 of the Exchange Act[8](index=8&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, including the referenced press release and corporate presentation Exhibits | Exhibit No. | Description of Exhibit | | :------------ | :-------------------------------------- | | 99.1 | Press release dated August 12, 2025 | | 99.2 | Corporate Presentation dated August 12, 2025 | | 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURES) This section contains the official signature confirming the due authorization and submission of the report - The report was signed by **Christian Itin, Ph.D., Chief Executive Officer** of Autolus Therapeutics plc, on **August 12, 2025**[12](index=12&type=chunk)

Core Insights - Autolus Therapeutics plc reported strong early performance for its product AUCATZYL in the U.S., driven by physician enthusiasm and favorable market access, with a net product revenue of $20.9 million for Q2 2025 and $29.9 million for the first half of 2025 [2][4][8] - The company received conditional marketing authorizations for AUCATZYL in the UK and EU, and is focusing on market access strategies in various countries [4][5] - Autolus is advancing its pipeline with ongoing clinical trials for obe-cel in pediatric ALL, systemic lupus erythematosus, lupus nephritis, and progressive multiple sclerosis, with key data expected in the second half of 2025 [2][7][11] Financial Performance - For Q2 2025, Autolus reported a net loss of $47.9 million, an improvement from a net loss of $58.3 million in the same period in 2024, with a basic and diluted net loss per share of $(0.18) compared to $(0.22) [13][19] - Total revenue for the first six months of 2025 was $29.9 million, with a cost of sales amounting to $24.4 million for Q2 2025 [4][9] - Research and development expenses decreased to $27.4 million from $36.6 million year-over-year, while selling, general, and administrative expenses increased to $30.3 million from $21.9 million [10][11] Product Development and Pipeline - AUCATZYL is designed for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) and has shown promising long-term remission data [4][23] - The company is on track to initiate a Phase 2 pivotal trial in lupus nephritis and a Phase 1 trial in progressive multiple sclerosis by the end of 2025 [4][11] - Preliminary data from the Phase 1 CARLYSLE study in systemic lupus erythematosus is expected to be presented at a medical conference later this year [2][7] Market Access and Regulatory Updates - AUCATZYL has secured coverage for over 90% of total U.S. medical lives, enhancing patient access [5] - The UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission (EC) granted conditional marketing authorizations for AUCATZYL, although market entry in Germany is currently on hold [5][4] - The company plans to address the preliminary Appraisal Consultation Decision (ACD) from NICE, which recommended against funding for AUCATZYL in the UK [5]

Core Viewpoint - Autolus Therapeutics plc is set to release its second quarter 2025 financial results and operational highlights on August 12, 2025, before the U.S. markets open [1]. Group 1: Financial Results Announcement - The company will host a conference call and webcast at 8:30am EDT/13:30pm 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, manufacturing, and delivering 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 controlled T cell therapies aimed at effectively recognizing and eliminating target cells [3]. - Autolus has a marketed therapy, AUCATZYL, and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3].

Core Viewpoint - Autolus Therapeutics has received marketing authorization from the European Commission for AUCATZYL® (obecabtagene autoleucel) to treat adult patients aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][7]. Group 1: Clinical Study and Approval - The European Commission's approval is based on the FELIX study, which demonstrated a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of 94 patients [2][9]. - The median response duration for all infused patients was 21.2 months, with a median event-free survival (EFS) of 11.9 months; the estimated 6- and 12-month EFS rates were 65.4% and 49.5%, respectively [2][9]. Group 2: Safety and Adverse Reactions - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3][33]. - Cytokine release syndrome (CRS) occurred in 68.5% of patients, with Grade 3 or higher events in 2.4% [3][33]. - Immune effector cell-associated neurotoxicity syndrome (ICANS) developed in 22.8% of patients, with Grade 3 or higher in 7% [3][33]. Group 3: Market Potential and Company Strategy - The CEO of Autolus, Dr. Christian Itin, emphasized that AUCATZYL represents a significant new treatment option for physicians treating adult r/r B-ALL patients, and the company is evaluating market entry opportunities in EU countries [4][11]. - Autolus is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, with AUCATZYL being part of its marketed therapy portfolio [11]. Group 4: Background on B-ALL - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer, with approximately 6,000 new cases diagnosed annually in Europe; up to 50% of adult B-ALL patients will ultimately relapse [6]. - Conventional treatments for r/r ALL have a median overall survival of only eight months, highlighting the need for new therapeutic options [6].

Core Viewpoint - Autolus Therapeutics has received marketing authorization from the European Commission for AUCATZYL (obecabtagene autoleucel), a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [1][7]. Group 1: Clinical Study and Approval - The European Commission's approval is based on the FELIX study, which demonstrated a 76.6% complete response rate in the pivotal cohort of 94 patients [2][9]. - The median response duration for all infused patients was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. - The estimated 6- and 12-month event-free survival rates were 65.4% and 49.5%, respectively [2]. Group 2: Safety and Adverse Reactions - The most common non-laboratory Grade 3 or higher adverse reactions included unspecified infections (32%), febrile neutropenia (24%), and bacterial infectious disorders (11%) [3]. - Cytokine release syndrome (CRS) occurred in 68.5% of patients, with 2.4% experiencing Grade 3 or higher events [3]. - Immune effector cell-associated neurotoxicity syndrome (ICANS) developed in 22.8% of patients, with 7% experiencing Grade 3 or higher [3]. Group 3: Market Potential and Company Strategy - The CEO of Autolus, Dr. Christian Itin, emphasized that AUCATZYL represents a significant new treatment option for adult r/r B-ALL patients, and the company is evaluating market entry opportunities in EU countries [4]. - Autolus is focused on developing next-generation T cell therapies and has a pipeline of product candidates for various cancers and autoimmune diseases [11]. Group 4: Disease Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [6]. - Up to 50% of adult patients with B-ALL will ultimately relapse, and conventional treatments have a median overall survival of only eight months [6].

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 [3] - Autolus has a marketed therapy named AUCATZYL and a pipeline of candidates for treating hematological malignancies, solid tumors, and autoimmune diseases [3] Stock Option Awards - The compensation committee of Autolus granted stock option awards to purchase a total of 360,550 shares to 60 employees under the 2025 Inducement Plan [1] - The exercise price for the options is set at $2.47 per share, matching the closing price of Autolus' common stock on July 9, 2025 [2] - Each option has a ten-year term and vests over four years, with 25% vesting on the one-year anniversary and the remainder vesting in 36 equal monthly installments, contingent on continued service [2]

Core Insights - Autolus Therapeutics plc announced updated long-term data from the FELIX study of its programmed T cell therapy, obecabtagene autoleucel (obe-cel), for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) [1][2] - The data will be presented at the European Hematology Association Congress in Milan, Italy, from June 12-15, 2025 [1] Efficacy and Safety - At a median follow-up of 32.8 months, 38.4% of responders remained in ongoing remission without subsequent therapy, showing a slight decrease from 40% at 21.5 months [3] - The 24-month probability of Event Free Survival was reported at 43%, while Overall Survival was at 46%, indicating a long-term plateau in outcomes [3] - No new safety signals or Grade ≥3 secondary malignancies were observed during the extended follow-up, suggesting a favorable safety profile for obe-cel [3][6] Patient Demographics and Treatment Outcomes - Obe-cel treatment demonstrated deep and durable remissions across different age groups, with low incidence of Grade ≥3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5] - The multivariate analysis indicated that factors such as Philadelphia chromosome-positive disease and lower disease burden at lymphodepletion were associated with higher remission rates [4] Clinical Trial Background - The FELIX clinical trial is a Phase 1b/2 study that enrolled over 100 adult patients with r/r B-precursor ALL across 30 leading centers in the US, UK, and Europe [9] - The primary endpoint was overall response rate, with secondary endpoints including duration of response and safety [9] Company Overview - Autolus Therapeutics is focused on developing next-generation T cell therapies for cancer and autoimmune diseases, with obe-cel being FDA approved and MHRA licensed [8]

Summary of Autolus Conference Call Company Overview - Autolus is a biotechnology company focused on autologous CAR T cell therapies, with its lead program, ObiCell (now branded as Alcatsol), recently approved in the U.S. in November 2022 [4][5][6] - The company is in the launch phase for Alcatsol in the U.S. and is undergoing regulatory processes in the U.K. and Europe [4][5] Key Differentiation and Clinical Data - ObiCell's unique design allows for a "fast on, fast off" mechanism, leading to lower levels of high-grade adverse events such as ICANS and CRS, which are common in CAR T therapies [5][6] - Clinical studies show a plateau in event-free survival and overall survival curves, with about 40% of patients remaining in remission without additional therapy [7] - The company has built a unique manufacturing facility in the U.K. to support commercial capacity for CAR T delivery [8][9] Market Launch and Performance - In Q1, Autolus reported $9 million in revenue, with a significant portion logged as deferred revenue [23] - The onboarding of treatment centers has exceeded expectations, with over 40 centers activated and a target of 60 by year-end, aiming for 90% coverage of addressable patients [24][36] - The company has achieved over 90% coverage of total medical lives in terms of access and reimbursement [25] Challenges and Considerations - Potential impacts of tariffs and most favored nation pricing in the U.S. are being monitored, with the company actively planning for various scenarios [16][19] - Discussions with European health authorities regarding pricing and reimbursement are ongoing, with a focus on the German market initially [46][47] Future Pipeline and Expansion - Autolus is exploring additional indications for ObiCell, including lupus nephritis and multiple sclerosis, with plans for pivotal studies [11][59] - The company is also conducting a pediatric trial for acute lymphoblastic leukemia (ALL) and aims for label expansion based on the data [48][50] Financial Outlook and Investment Thesis - The company targets a gross margin of 15% to 20% of U.S. sales as production volume increases [43] - The investment case for Autolus emphasizes execution of the launch, reliable product delivery, and potential growth in the autoimmune space, despite current market challenges [63][64] Conclusion - Autolus is positioned to leverage its unique CAR T therapy and manufacturing capabilities, with a strong focus on expanding its market presence and addressing unmet medical needs in both oncology and autoimmune diseases [64][65]

Group 1 - The article discusses the importance of staying updated on stocks in the biotech, pharma, and healthcare industries, highlighting key trends and catalysts that influence market valuations [1] - Autolus Therapeutics plc (NASDAQ: AUTL) was previously covered with a bullish outlook due to an upcoming PDUFA date, indicating potential positive developments for the company [1] - The investing group Haggerston BioHealth offers resources for both novice and experienced biotech investors, including sales forecasts and financial analyses for major pharmaceutical companies [1] Group 2 - The article emphasizes the expertise of Edmund Ingham, a biotech consultant with over five years of experience in the sector, who has produced detailed reports on more than 1,000 companies [1]

Summary of Autolus Therapeutics (AUTL) 2025 Conference Call Company Overview - **Company**: Autolus Therapeutics - **Product**: Ocatsil (formerly ObiCell) - **Approval Date**: November 8, 2024 - **Indication**: Approved for patients with relapsed/refractory Acute Lymphoblastic Leukemia (ALL) in the adult population - **Unique Selling Point**: First CAR T therapy approved without a Risk Evaluation and Mitigation Strategy (REMS) obligation, indicating a strong safety profile [4][5] Key Achievements and Launch Strategy - **Launch Progress**: Initiated launch at the end of 2024, currently has 40 active centers, expecting to reach 60 by year-end, providing approximately 90% patient access across the US [5][6] - **Market Access**: Achieved about 90% of lives covered, ensuring reimbursement for patients interested in therapy [6] - **Support Services**: Emphasized the importance of qualifying centers and providing comprehensive support, including training, product management, and patient support [7][8] Manufacturing and Quality Control - **Manufacturing Facility**: Located in the UK, underwent rigorous inspections by MHRA and FDA, allowing for high control over manufacturing processes [8] - **Quality Metrics**: Approximately 5-6% of manufactured products were out of specification during pivotal studies, indicating a low failure rate [29] Product Safety and Efficacy - **Adverse Events**: Reported low rates of high-grade cytokine release syndrome (2%) and neurological toxicities (7%), significantly lower than other T cell-mediated therapies [15][16] - **Dosing Strategy**: Tailored dosing based on tumor burden, allowing for better management of adverse events and improved patient tolerability [12][14] Financial Performance and Revenue Guidance - **Q1 Sales**: Reported $9 million in sales for Q1 2025, with cautious optimism about future revenue growth due to increasing center openings and physician adoption [19][24] - **Revenue Guidance**: Company refrained from providing specific revenue guidance, citing the complexity of launch dynamics and the need for more data over the next three quarters [19][24] Future Opportunities and Trials - **Expansion of Indications**: Plans to expand indications to pediatric ALL and autoimmune diseases, with ongoing trials and discussions with regulatory agencies [34][38] - **Lupus Nephritis Trials**: Focus on patients with advanced lupus nephritis, planning a pivotal study in the second half of 2025 [41][46] - **Multiple Sclerosis Exploratory Study**: Investigating the potential of CAR T cells to cross the blood-brain barrier for treating progressive multiple sclerosis [46][48] Regulatory Considerations - **Single Arm Trials**: Regulatory agencies may consider single-arm trials for high medical need settings, provided there is a high treatment effect and sufficient safety data [51][55] Upcoming Milestones - **Key Data Releases**: Anticipated updates from ongoing studies at upcoming conferences, including EHA and ASH, with a focus on leukemia and lupus nephritis [57] Conclusion - **Overall Sentiment**: The company expressed confidence in its product's safety and efficacy, with a strong focus on execution and market penetration as it navigates the complexities of launching a new CAR T therapy [10][24]