LONDON and GAITHERSBURG, Md., July 24, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces that it will release its second quarter 2025 financial results and operational highlights before open of U.S. markets on Tuesday, August 12, 2025. Management will host a conference call and webcast at 8:30am EDT/13:30pm BST to discuss the company’s fina ...

LONDON & GAITHERSBURG, Md., July 15, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies and candidates, today announced that the compensation committee of the Company's Board of Directors granted stock option awards to purchase an aggregate of 360,550 shares of its common stock to 60 employees pursuant to the Company’s 2025 Inducement Plan. The stock options ...

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]

Autolus Therapeutics (AUTL) FY Conference June 11, 2025 01:20 PM ET Speaker0 Good afternoon, everyone, and thank you for joining. My name is Rajan Sharma, European pharma and biotech analyst here at Goldman Sachs. I'm very pleased that we have Rob Dolsky, Chief Financial Officer at Autolus. Rob, you so much for joining us. Speaker1 Great to be here. Speaker0 Maybe kind of just to start for people who may be less familiar with the Autolus story, could you just kind of give us an overview of the company, key ...

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]

Core Viewpoint - Autolus Therapeutics plc has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for the approval of its therapy, obecabtagene autoleucel (obe-cel), for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia [1][6]. 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 [9]. - The company has a pipeline of product candidates and has received FDA approval and MHRA authorization for obe-cel [9]. Product Details - Obe-cel is an autologous CD19 CAR T cell therapy designed to target B-cell precursor acute lymphoblastic leukemia [4]. - The therapy has shown a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the pivotal cohort of the FELIX study [2]. - The median response duration for patients treated with obe-cel was 21.2 months, with median event-free survival (EFS) of 11.9 months [2]. Clinical Study Insights - The CHMP recommendation was based on the results of the FELIX study, which was an open-label, multi-center, single-arm study involving adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia [2][10]. - The study enrolled over 100 patients across 30 leading academic and non-academic centers in the U.S., U.K., and Europe [10]. Safety Profile - 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 occurred in 68.5% of patients, with severe cases in 2.4% [3]. Market Context - Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer with approximately 6,000 new cases diagnosed annually in Europe [5]. - Conventional treatments for adult B-ALL have a median overall survival of only eight months, highlighting the need for effective therapies like obe-cel [5]. Regulatory Status - The positive CHMP opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a final decision within approximately two months [6][8]. - Obe-cel has already received FDA approval in November 2024 and MHRA conditional marketing authorization in April 2025 [4][6].

Core Insights - Autolus Therapeutics plc is presenting three abstracts at the upcoming European Hematology Association Congress, focusing on the efficacy of its programmed T cell therapy, obecabtagene autoleucel (obe-cel), for adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) [1] Group 1: Clinical Findings - The oral presentation titled "Can CAR T-cell therapy be a definitive treatment for adult r/r B-ALL without transplant?" indicates that 40% of responders to obe-cel are in ongoing remission without subsequent stem cell therapy, suggesting its potential as a definitive treatment [2] - Another oral presentation discusses the efficacy and safety of obe-cel across different age groups, showing favorable outcomes with low incidence of severe cytokine release syndrome (CRS) and neurotoxicity, indicating a positive benefit-risk profile [3] - A poster presentation highlights the potential of the ALL-Hematotox model to better predict outcomes in patients treated with obe-cel compared to the CAR-Hematotox model, suggesting a need for further analysis [4] 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, utilizing proprietary T cell programming technologies [5] - The company has an FDA-approved product, AUCATZYL, and a pipeline of candidates for treating hematological malignancies and solid tumors [5][7] Group 3: Clinical Trial Information - The FELIX clinical trial of obe-cel enrolled over 100 adult patients with r/r B-precursor ALL, with primary endpoints focused on overall response rate and secondary endpoints including duration of response and safety [6]

[Part I – Financial Information](index=6&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20statements) The company reported its first AUCATZYL product revenue, a $70.2 million net loss, and increased liabilities for Q1 2025, confirming going concern [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets were $746.3 million, liabilities increased to $375.2 million, and equity decreased to $371.1 million as of March 31, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $95,799 | $227,380 | | Marketable securities | $420,776 | $360,643 | | Inventories, net | $14,647 | $4,138 | | Total assets | $746,338 | $782,725 | | **Liabilities & Equity** | | | | Total current liabilities | $66,615 | $60,743 | | Liabilities related to future royalties and milestones, net (non-current) | $253,437 | $244,600 | | Total liabilities | $375,230 | $355,400 | | Total shareholders' equity | $371,108 | $427,325 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Q1 2025 saw first product revenue of $9.0 million, with net loss increasing to $70.2 million from $52.7 million in Q1 2024 Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $8,982 | $— | | License revenue | $— | $10,091 | | **Total revenue, net** | **$8,982** | **$10,091** | | Cost of sales | ($17,951) | $— | | Research and development expenses, net | ($26,734) | ($30,671) | | Selling, general and administrative expenses | ($29,534) | ($18,177) | | **Loss from operations** | **($65,240)** | **($38,757)** | | **Net loss** | **($70,161)** | **($52,690)** | | **Basic and diluted net loss per share** | **($0.26)** | **($0.24)** | [Condensed Consolidated Statements of Changes in Shareholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased to $371.1 million by March 31, 2025, primarily due to a $70.2 million net loss - Total shareholders' equity decreased by **$56.2 million** in Q1 2025, mainly driven by the quarterly net loss of **$70.2 million**[26](index=26&type=chunk) - In Q1 2024, the company raised net proceeds of **$520.6 million** from the issuance of ordinary shares[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $75.6 million in Q1 2025, with $59.5 million used in investing and no financing activities Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($75,565) | ($40,514) | | Net cash used in investing activities | ($59,547) | ($533) | | Net cash provided by financing activities | $— | $561,441 | - The total cash, cash equivalents, and restricted cash decreased by **$131.6 million** during Q1 2025, ending the period at **$97.3 million**[28](index=28&type=chunk)[29](index=29&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Statements](index=12&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Notes detail the company's commercial transition with AUCATZYL, outlining revenue recognition policies and significant royalty liabilities - AUCATZYL (obe-cel) was approved by the FDA on November 8, 2024, for adult r/r B-ALL, with the U.S. commercial launch in January 2025. U.K. MHRA granted conditional marketing authorization in April 2025[32](index=32&type=chunk) - The company recognized its first product revenue of **$9.0 million** in Q1 2025, entirely from the U.S. This revenue is recognized when the product is administered to the patient and is net of estimated gross-to-net deductions[55](index=55&type=chunk)[77](index=77&type=chunk) - Liabilities related to future royalties and milestones from agreements with Blackstone and BioNTech totaled **$258.2 million** as of March 31, 2025. Interest expense accrued on these liabilities was **$10.1 million** for the quarter[125](index=125&type=chunk) - The company has capital commitments of **$16.4 million** for capital expenditures and **$2.9 million** for master supply commitments as of March 31, 2025[143](index=143&type=chunk)[144](index=144&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's commercial transition with AUCATZYL, reporting $9.0 million net product sales and a $70.2 million net loss in Q1 2025 [Recent Developments](index=33&type=section&id=MD%26A_Recent_Developments) Key Q1 2025 developments include AUCATZYL's U.S. launch, U.K. authorization, and progress in obe-cel clinical trials for LN and MS - Reported Q1 2025 net product sales of **$9.0 million** for AUCATZYL[173](index=173&type=chunk) - As of May 7, 2025, **39 U.S. cancer treatment centers** are activated, with over **90%** of U.S. medical lives having secured coverage for AUCATZYL[173](index=173&type=chunk) - The U.K. MHRA granted conditional marketing authorization for AUCATZYL on April 25, 2025[173](index=173&type=chunk) - The company plans to initiate a Phase 2 pivotal trial for obe-cel in lupus nephritis (LN) and a Phase 1 trial in progressive multiple sclerosis (MS) by year-end 2025[173](index=173&type=chunk)[171](index=171&type=chunk) [Results of Operations](index=39&type=section&id=MD%26A_Results_of_Operations) Q1 2025 total revenue decreased to $9.0 million, with new cost of sales, increased SG&A, and decreased R&D, widening the net loss to $70.2 million Comparison of Operations for Three Months Ended March 31 (in thousands) | Item | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total revenue, net | $8,982 | $10,091 | ($1,109) | (11)% | | Cost of sales | ($17,951) | $— | ($17,951) | 100% | | R&D expenses, net | ($26,734) | ($30,671) | $3,937 | (13)% | | SG&A expenses | ($29,534) | ($18,177) | ($11,357) | 62% | | **Net loss** | **($70,161)** | **($52,690)** | **($17,471)** | **33%** | - The decrease in R&D expenses was primarily due to a **$6.1 million** reduction from reallocating IT and support costs and a **$2.0 million** reduction in personnel costs to commercial manufacturing activities (cost of sales and inventory) following FDA approval[222](index=222&type=chunk) - The increase in SG&A expenses was driven by a **$7.9 million** rise in personnel costs from increased headcount and a **$1.7 million** increase in commercial readiness costs[223](index=223&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=MD%26A_Liquidity_and_Capital%20Resources) As of March 31, 2025, the company held $516.6 million in cash and marketable securities, sufficient for twelve months, with significant future capital needs Cash Position (in millions) | Item | March 31, 2025 | | :--- | :--- | | Cash and cash equivalents | $95.8 | | Available-for-sale debt securities | $420.8 | | **Total** | **$516.6** | - The company believes its existing cash and marketable securities will fund operating expenses and capital requirements for at least **twelve months** from the report's issuance date[237](index=237&type=chunk) - Future capital needs will be driven by AUCATZYL commercialization, advancing other product candidates, expanding manufacturing, and hiring additional personnel[236](index=236&type=chunk)[238](index=238&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate and foreign currency fluctuations, with a 1% interest rate change impacting income by $1.0 million - Primary market risks are interest rate and foreign currency exchange risk[252](index=252&type=chunk) - A hypothetical one percentage point change in interest rates would have resulted in a **$1.0 million** change in interest income for Q1 2025[253](index=253&type=chunk) - As of March 31, 2025, approximately **55%** of cash held by the main U.K. subsidiary was in GBP and **40%** in USD. The company recorded a foreign exchange gain of **$1.2 million** in Q1 2025[256](index=256&type=chunk)[257](index=257&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[261](index=261&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended March 31, 2025[262](index=262&type=chunk) [Part II – Other Information](index=45&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, nor is it aware of any pending or threatened actions - As of the filing date, the company is not a party to any material legal proceedings[263](index=263&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) Key risks include government price controls, CMS reimbursement policies delaying AUCATZYL revenue, and international trade policies impacting supply chain and costs - A new CMS policy splits the AUCATZYL dose into two administrations for billing, which may delay the company's and treatment centers' ability to recognize revenue[265](index=265&type=chunk) - International trade policies, including tariffs and sanctions, pose a risk as the company depends on a global supply chain and manufactures all commercial and clinical supplies in the U.K.[267](index=267&type=chunk) - The company's ability to pass on increased costs from tariffs is limited by fixed-price contracts with payors, which could negatively impact profitability[270](index=270&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[274](index=274&type=chunk) [Defaults Upon Senior Securities](index=47&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[275](index=275&type=chunk) [Mine Safety Disclosures](index=47&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[276](index=276&type=chunk) [Other Information](index=47&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during Q1 2025[277](index=277&type=chunk) [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including the 2025 Inducement Plan and officer certifications

Autolus Therapeutics (AUTL) Q1 2025 Earnings Call May 08, 2025 08:30 AM ET Company Participants Amanda Cray - Executive Director - IR & External CommunicationsChristian Itin - CEORob Dolski - CFOJames Shin - Director of Biopharma Equity ResearchMatt Phipps - Group Head - BiotechnologyKarina Rabayeva - VP - Biotech Equity ResearchYifan Xu - Senior Associate - Biotechnology Equity Research Conference Call Participants Gil Blum - Senior AnalystYanan Zhu - Analyst Operator Good day, and thank you for standing b ...