Financial Performance - AUCATZYL net product sales reached $20.9 million in Q2 2025 and $29.9 million for the six months ended June 30, 2025[8] - The company's cash, cash equivalents, and marketable securities totaled $454.3 million as of June 30, 2025[24] - Cost of sales for Q2 2025 was $24.445 million[24] - Research and development expenses, net for Q2 2025 were $27.430 million[24] - Selling, general, and administrative expenses for Q2 2025 were $30.265 million[24] - Loss from operations for Q2 2025 was $61.217 million[24] - Total comprehensive loss for Q2 2025 was $28.949 million[24] AUCATZYL Commercialization and Market Access - 46 treatment centers are authorized for AUCATZYL as of August 12, 2025[8] - Over 90% of total U S medical lives are covered for AUCATZYL[10] Obe-cel Clinical Data and Development - At 3 years of follow-up, 38.4% of responders remain in remission without subsequent treatment[14, 15] - The probability of remaining in remission after 24 months was 54.1% censoring for consolidative SCT[17] - At 24 months, overall survival probability was 46.0%[19] Upcoming Milestones - Initial data from PY01 trial in pediatric ALL is expected in H2 2025[27]

LONDON and GAITHERSBURG, Md., Aug. 12, 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 its operational and financial results for the second quarter ended June 30, 2025. "We are encouraged by AUCATZYL's early launch performance in the U.S., driven by physician enthusiasm for the product profile, unmet need for r/r B-All patients and favorable ma ...

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 ...

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 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]

AUCATZYL Launch and Growth - AUCATZYL achieved net product sales of $9 million in Q1 2025[8] - Approximately 90% of total U S medical lives are covered for AUCATZYL[10] - 39 Treatment Centers Authorized as of 05/07/25[8] - Conditional marketing authorization in the UK received April 25, 2025, with EMA decision expected in H2 2025[12] Obe-cel Development and Potential - Obe-cel demonstrated a high MRD-negative complete remission rate of 94% in r/r adult and pediatric acute B cell lymphoblastic leukemia (ALL) patients[17] - In non-Hodgkin lymphoma, obe-cel showed a high metabolic complete remission rate of 88% in r/r LBCL and 95% in r/r FL[17] - Preliminary CARSLYLE SLE P1 trial data shows 10+ point drop in SLEDAI-2K scores and 3 of 6 patients with renal CRs by month 3[22] Financial Status - The company's cash, cash equivalents, and marketable securities totaled $516 6 million as of Q1 2025[41] - Net product revenue for Q1 2025 was $8 982 million[40] Upcoming Milestones - The company anticipates dosing the first patient in the Phase 2 trial for lupus nephritis by year-end 2025[32] - The company anticipates dosing the first patient in the progressive MS Phase 1 trial by year-end 2025[37]

Core Insights - Autolus Therapeutics plc reported strong initial sales and positive clinical developments for its product AUCATZYL, indicating a promising market entry and potential for future growth [2][4][5] Financial Performance - The company reported Q1 2025 net product revenue of $9.0 million, with a significant increase in patient access and coverage for AUCATZYL in the U.S. [4][8] - Cost of sales for the same period totaled $18.0 million, reflecting the expenses associated with product delivery and patient access programs [9] - Research and development expenses decreased from $30.7 million to $26.7 million year-over-year, primarily due to cost shifts related to commercial manufacturing [10] - Selling, general and administrative expenses increased from $18.2 million to $29.5 million, driven by increased headcount for U.S. commercialization efforts [11] - The net loss for Q1 2025 was $70.2 million, compared to $52.7 million in the same period of 2024, with a basic and diluted net loss per share of $(0.26) [13][18] Product Development and Regulatory Updates - AUCATZYL received conditional marketing authorization from the UK's MHRA for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [4][5] - The company is collaborating with NICE to enhance patient access to AUCATZYL in the UK [2] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) showed promising results, leading to plans for a Phase 2 pivotal trial in lupus nephritis (LN) [5][6] - The company anticipates dosing the first patient in the Phase 2 trial for LN and a Phase 1 trial for progressive multiple sclerosis (MS) by year-end 2025 [12][7] Market and Competitive Position - Autolus has established 39 fully activated treatment centers in the U.S. and secured coverage for approximately 90% of total U.S. medical lives, enhancing market penetration [5] - The company is well-capitalized with cash and cash equivalents totaling $516.6 million as of March 31, 2025, allowing for continued investment in product launches and clinical trials [14][15]

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]

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]