AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics (Nasdaq: AUTL) reported its Q4 and full year 2024 results, highlighting the successful US commercial launch of AUCATZYL® following FDA approval on November 8, 2024. The company has authorized 33 treatment centers as of March 19, 2025, covering approximately 60% of target US patients, with over 85% of US medical lives securing coverage.

Financial highlights include cash position of $588.0 million as of December 31, 2024, up from $239.6 million in 2023. The company reported a net loss of $220.7 million for 2024, with loss per share of $(0.86). Operating expenses increased with R&D at $138.4 million and SG&A at $101.1 million.

Key developments include MHRA and EMA marketing authorization decisions expected in H2 2025, initial dosing of six patients in Phase 1 SLE trial, and the company's manufacturing facility now FDA and MHRA licensed for commercial supply with 2,000+ batch capacity per year.

Autolus Therapeutics (Nasdaq: AUTL), an early commercial stage biopharmaceutical company focused on programmed T cell therapies, has scheduled its Q4 and full year 2024 financial results announcement for March 20, 2025, before US markets open.

The company will host a conference call and webcast at 8:30 am EDT/12:30 pm GMT where management will present financial results and provide a business update. Participants must pre-register to receive dial-in numbers and a personal PIN for the conference call. A simultaneous audio webcast and replay will be available on the company's website events section.

Autolus Therapeutics (Nasdaq: AUTL), a commercial-stage biopharmaceutical company focused on programmed T cell therapies, has announced its participation in two upcoming investor conferences in Miami, FL.

The company will attend the Jefferies Biotech on the Beach Summit on March 11, 2025, where management will host investor meetings. Additionally, CEO Dr. Christian Itin will deliver a fireside chat presentation at the Leerink Global Biopharma Conference on March 12, 2025, at 8:40am EDT / 12:40pm GMT.

A webcast of the fireside chat will be accessible through the company's website's 'Events' page, with a replay available for 90 days post-presentation.

Autolus Therapeutics (AUTL) announced multiple presentations at the 2025 Tandem Meetings, showcasing new data for their AUCATZYL® therapy. The presentations include an updated health economic cost model comparing adverse events costs versus other CAR-T therapies, demonstrating reduced healthcare costs due to shorter duration and lower incidence of CRS and ICANS.

Key findings include: a risk-stratification model for hematotoxicity to identify patients likely to benefit from obe-cel treatment; economic advantages of obe-cel over brexu-cel due to lower Grade 3/4 adverse events; superior outcomes of obe-cel versus standard of care therapies in matched External Control Arm studies; and strong correlation between deep molecular remission and better clinical outcomes, with 84% of responders achieving MRD <10-6 leukemic cells.

Autolus Therapeutics (Nasdaq: AUTL) has provided significant business updates and an overview of its 2025 milestones. The company is actively progressing with the commercial launch of AUCATZYL® (obecabtagene autoleucel or 'obe-cel'), with 24 treatment centers fully authorized as of January 10th, 2025, and plans to reach 30 centers by the end of January 2025 and 60 by the end of the year.

Notably, the National Comprehensive Cancer Network® (NCCN) has included AUCATZYL® in its Clinical Practice Guidelines in Oncology for treating adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This endorsement follows FDA approval on November 8, 2024, and publication of the FELIX trial data in the New England Journal of Medicine.

Autolus plans to expand its clinical development program into autoimmune diseases, with initial data from the CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) expected in Q1 2025. The company will provide further updates at an R&D investor event on April 23, 2025, in New York City.

Marketing authorization submissions for obe-cel are under regulatory review in the European Union and the United Kingdom, with potential approvals expected in the second half of 2025. Other anticipated milestones include initial data from the PY01 trial in pediatric ALL and a Phase 1 SLE trial presentation at a medical conference in H2 2025.

Autolus Therapeutics (NASDAQ: AUTL) presented clinical data updates at ASH 2024, featuring one oral and three poster presentations about obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

The FELIX trial demonstrated that obe-cel treatment achieved deep molecular remission in 84% of responders, correlating with improved event-free survival and overall survival. The study showed that lower tumor burden at lymphodepletion yielded the best survival benefits.

Additional findings revealed that bridging therapies were effective with obe-cel, maintaining its expansion and persistence. The treatment showed low incidence of severe adverse events, potentially reducing healthcare resource utilization costs. A new CAR-HEMATOTOX risk score was identified as a useful tool for patient risk stratification.

Autolus Therapeutics published data from the FELIX study of obe-cel in The New England Journal of Medicine, showing promising results for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia treatment. The study demonstrated a 76.6% overall response rate in the pivotal cohort, with a median follow-up of 20.3 months. The treatment showed low immune-related toxicity, with Grade ≥3 CRS and ICANS observed in only 2.4% and 7.1% of patients respectively. The 12-month event-free survival rate was 49.5%. Obe-cel was recently approved by the FDA as AUCATZYL® and is under review by EU and UK regulators.

Autolus Therapeutics announces FDA approval of AUCATZYL® (obecabtagene autoleucel) for adult B-cell Acute Lymphoblastic Leukemia treatment, ahead of the target PDUFA date. The approval triggers a $30 million milestone payment from Blackstone. Q3 2024 financial results show cash position of $657.1 million, with operating expenses of $67.9 million and net loss of $82.1 million. Marketing authorizations are under review with MHRA and EMA. The company appointed Matthias Will as Chief Development Officer and expects initial data from SLE Phase 1 study in Q1 2025.

Autolus Therapeutics announces FDA approval of AUCATZYL® for treating adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). The approval is based on the FELIX clinical trial, where 63% of evaluable patients achieved overall complete remission, with 42% achieving complete remission within 3 months. The median duration of remission was 14.1 months. Notably, AUCATZYL is the first CAR T therapy approved without requiring a REMS program, showing low levels of Cytokine Release Syndrome (3% Grade 3) and manageable ICANS (7% Grade ≥3). The therapy will be manufactured at Autolus' Nucleus facility in Stevenage, UK, with Cardinal Health handling U.S. distribution.