AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics (Nasdaq: AUTL) presented clinical data on obecabtagene autoleucel (obe-cel) for relapsed/refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL) at the SOHO Annual Meeting 2024. The FELIX Phase Ib/II study utilized a tumor burden (TB)-guided dosing strategy, resulting in high CAR T-cell expansion and manageable adverse events.

Key findings:

• 94% of patients received two planned doses
• Overall remission rates: 90% (low TB) and 75% (high TB)
• Peak expansion reached after Dose 2 in both groups
• 50% TB increase associated with 1.754-fold Cmax increase and 2.068-fold AUC0-28days increase

The data support the TB-guided dosing approach in adult r/r B-ALL, highlighting obe-cel's differentiation based on its unique binding properties.

Autolus Therapeutics (NASDAQ: AUTL) reported Q2 2024 financial results and provided business updates. Key highlights include:

1. On track for potential US commercial launch of obe-cel with FDA PDUFA date of November 16, 2024.

2. MAA submitted to MHRA in UK for obe-cel in r/r adult B-ALL.

3. FELIX Phase 2 data showed durable responses, with 40% of patients in ongoing remission without subsequent stem cell transplant.

4. Cash position of $705.9 million as of June 30, 2024.

5. Total operating expenses increased to $58.9 million in Q2 2024 from $44.4 million in Q2 2023.

6. Net loss of $58.3 million for Q2 2024, compared to $45.6 million in Q2 2023.

7. Basic and diluted net loss per share of $0.22 for Q2 2024.

Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company focused on developing next-generation programmed T cell therapies, has announced its plans to release second quarter 2024 financial results and operational highlights. The release is scheduled for Thursday, August 8, 2024, before US markets open. Following the release, the company will host a conference call and webcast at 8:30 am EDT/1:30 pm BST to discuss the financial results and provide a general business update. Interested participants are advised to pre-register for the conference call to receive dial-in numbers and a personal PIN. An audio webcast and replay will also be available on the events section of Autolus' website.

Autolus Therapeutics (Nasdaq: AUTL) will present three clinical updates on the therapy obecabtagene autoleucel (obe-cel) for relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) at the European Hematology Association (EHA) Congress from June 13-16, 2024. Key data from the FELIX study indicate a 78% overall response rate (ORR) with median follow-up of 21.5 months, stabilizing long-term survival rates around 40%. Additional findings suggest the effectiveness of INO-containing bridging therapy and the sensitivity of ddPCR in monitoring CAR T persistence.

The median event-free survival (EFS) was 11.9 months and overall survival (OS) was 23.8 months, with 12-month EFS and OS rates at 49.5% and 61.1%, respectively. INO-containing therapies showed reduced bone marrow disease and minimized risks without increasing liver toxicity, while ddPCR proved more sensitive in monitoring CAR T-cell levels compared to flow cytometry.

Autolus Therapeutics announced longer-term follow-up and additional data from the pivotal Phase 1b/2 FELIX study of obe-cel for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). Presented at ASCO 2024, the data revealed that 40% of patients remain in remission without further therapy, showing potential long-term survival benefits. Median overall survival (OS) was 23.8 months, and median event-free survival (EFS) was 11.9 months. The FDA BLA submission has a target action date of November 16, 2024. The results support obe-cel as a standalone therapy with CAR T persistence linked to improved outcomes.

Autolus Therapeutics (NASDAQ: AUTL) reported its Q1 2024 financial results, highlighting key developments and financial metrics. The company is progressing with its regulatory review processes for obe-cel in relapsed/refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) with the FDA and European Medicines Agency (EMA). Key milestones include longer follow-up data from the FELIX Phase 2 trial, initial data from the CARLYSLE Phase 1 trial for Systemic Lupus Erythematosus (SLE) expected by late 2024, and the strategic CAR T cell therapy collaboration with BioNTech. Financially, the company reported cash and cash equivalents totaling $758.5 million as of March 31, 2024. Operating expenses were $38.8 million, with a net loss of $52.7 million for the quarter.

Autolus Therapeutics (Nasdaq: AUTL) announced the publication of three abstracts for the upcoming 2024 European Hematology Association (EHA) Congress, set for June 13-16, 2024. The studies focus on obecabtagene autoleucel (obe-cel) for treating relapsed/refractory B-Cell acute lymphoblastic leukemia. Key presentations include:

- An oral presentation by Dr. Claire Roddie on survival rates and CAR-T cell persistence in the FELIX study.

- A poster by Dr. Jae H. Park discussing the effects of inotuzumab-containing bridging therapy.

- Another poster by Dr. Claire Roddie on the sensitivity of droplet digital PCR and flow cytometry in measuring CAR-T cell kinetics.

Autolus Therapeutics plc, a biopharmaceutical company, has delayed its first quarter 2024 earnings release and conference call. The company will file a Form 12b-25 for an extension to file its Quarterly Report on Form 10-Q. The earnings release and call scheduled for May 14, 2024, are canceled, with the Q1 2024 10-Q expected to be filed by May 20, 2024. The conference call is rescheduled to May 17, 2024, for discussing financial results.