AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics (Nasdaq: AUTL), a biopharmaceutical company focused on next-generation programmed T cell therapies, has scheduled its second quarter 2025 financial results announcement for August 12, 2025, before U.S. markets open.

The company will host a conference call and webcast at 8:30 AM EDT/1:30 PM BST featuring management's discussion of financial results and a business update. Participants must pre-register to receive dial-in details and a personal PIN for the call. A simultaneous audio webcast and replay will be available on the company's website events section.

Autolus Therapeutics (Nasdaq: AUTL) has received European Commission (EC) marketing authorization for AUCATZYL® (obecabtagene autoleucel) to treat adult patients aged 26 and older with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

The approval is based on the FELIX clinical trial results, where the therapy demonstrated a 76.6% complete response rate in the pivotal cohort (n=94). The median response duration was 21.2 months, with median event-free survival of 11.9 months. Key safety data showed cytokine release syndrome in 68.5% of patients (2.4% grade 3+) and neurotoxicity in 22.8% of patients (7% grade 3+).

This EC authorization follows previous approvals from the FDA and MHRA, covering all 27 EU Member States, Iceland, Norway, and Liechtenstein. In Europe, approximately 6,000 new ALL cases are diagnosed annually, with up to 50% of adult B-ALL patients ultimately relapsing after frontline treatment.

Autolus Therapeutics (Nasdaq: AUTL), a biopharmaceutical company focused on programmed T cell therapies, has granted stock options to 60 employees under its 2025 Inducement Plan. The compensation committee approved options to purchase 360,550 shares at an exercise price of $2.47 per share, matching the July 9, 2025 closing price.

The options have a 10-year term with a four-year vesting schedule: 25% vests after one year, followed by monthly vesting over 36 months. These grants were made as inducement awards in accordance with Nasdaq Listing Rule 5635(c)(4).

Autolus Therapeutics presented extended follow-up data from the FELIX study of obe-cel in relapsed/refractory B-ALL patients at the 2025 EHA Congress. The results showed impressive durability with median response duration of 42.6 months. At 24 months, over 50% of patients maintained remission, with 38% of ongoing responders requiring no additional therapy by month 33. The 24-month probability rates were 43% for Event Free Survival and 46% for Overall Survival. The study demonstrated obe-cel's effectiveness across age groups, with favorable outcomes in both under and over 55-year-old patients. Key factors associated with long-term remission included Philadelphia chromosome-positive disease, earlier obe-cel use, lower disease burden, and ongoing CAR T-cell persistence. No new safety concerns emerged during the extended follow-up period.

Autolus Therapeutics (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company focused on programmed T cell therapies, has announced its participation in three major upcoming investor conferences in June 2025:

• William Blair 45th Annual Growth Stock Conference on June 3 in Chicago (investor meetings)
• Jefferies Global Healthcare Conference on June 5 in New York (fireside chat with CEO Dr. Christian Itin)
• Goldman Sachs 46th Annual Global Healthcare Conference on June 11 in Miami (fireside chat with CFO Rob Dolski)

Webcasts of the fireside chats will be available on the company's website and archived for 90 days after the presentations.

Autolus Therapeutics (NASDAQ: AUTL) has received a positive CHMP opinion recommending EU approval of obecabtagene autoleucel (obe-cel) for treating adult patients (26+) with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The recommendation is based on the FELIX study results, which showed impressive outcomes: 76.6% complete response rate, 21.2-month median response duration, and 11.9-month median event-free survival. The therapy demonstrated favorable safety with low rates of severe cytokine release syndrome (2.4%) and neurotoxicity (7%). This follows FDA approval (November 2024) and MHRA authorization (April 2025). The European Commission's final decision is expected within two months, potentially expanding access across 27 EU member states, Iceland, Norway, and Liechtenstein.

Autolus Therapeutics (Nasdaq: AUTL) presented clinical data updates for obecabtagene autoleucel (obe-cel) at the 2025 EHA Congress. Key findings from the FELIX study in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) patients show:

- 40% of responders maintained remission for ≥3 years without stem cell therapy - Obe-cel demonstrated effectiveness across age groups with favorable remission rates - Low incidence of Grade ≥3 CRS and ICANS complications in both younger and older patients - Factors linked to better outcomes include obe-cel persistence, low disease burden, and earlier treatment - ALL-Hematotox model showed promise in predicting response and safety outcomes

Autolus Therapeutics reported Q1 2025 financial results and key business updates. The company achieved $9.0 million in net product revenue from AUCATZYL®. Notable developments include UK MHRA's conditional marketing authorization for AUCATZYL® for treating adult r/r B-ALL patients. The company has 39 activated centers in the U.S. with coverage for ~90% of U.S. medical lives. Preliminary data from the Phase 1 CARLYSLE trial in SLE showed promising results, with plans for Phase 2 pivotal trials in lupus nephritis and Phase 1 trials in MS by year-end 2025. Financial results show a net loss of $70.2 million for Q1 2025, with cash reserves of $516.6 million. Operating expenses increased due to commercialization activities, with R&D expenses at $26.7 million and SG&A expenses at $29.5 million.

Autolus Therapeutics (NASDAQ: AUTL) has received conditional marketing authorization from the UK MHRA for AUCATZYL® (obecabtagene autoleucel) to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL).

The authorization is based on the FELIX study results, where 127 patients received the treatment. Key findings include:

• 76.6% Complete Response rate in the pivotal cohort
• 21.2 months median response duration
• 11.9 months median event-free survival
• 65.4% and 49.5% event-free survival rates at 6 and 12 months respectively

Safety data showed cytokine release syndrome in 68.5% of patients (2.4% grade 3 or higher) and immune effector cell-associated neurotoxicity in 22.8% of patients (7% grade 3 or higher). The company is currently working with NICE for potential NHS access in England.