AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

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.

Autolus Therapeutics (Nasdaq: AUTL) presented updates on its development pipeline and expansion plans in autoimmune diseases at an R&D investor event. The company highlighted the potential of obe-cel across multiple B cell driven malignancies and autoimmune diseases.

Key developments include:

• Preliminary data from Phase 1 CARLYSLE trial in six SLE patients showed promising results, with three patients achieving complete renal response by month three
• Plans to initiate Phase 2 pivotal study in lupus nephritis by year-end 2025
• Expansion into progressive multiple sclerosis (MS) with first patient dosing in Phase 1 trial expected by year-end 2025
• AUCATZYL US launch progressing with 38 centers fully activated
• Regulatory reviews ongoing in EU and UK, with MHRA decision expected in Q2 2025 and EMA in H2 2025

Autolus Therapeutics (Nasdaq: AUTL), an early commercial stage biopharmaceutical company focused on programmed T cell therapies, has scheduled its Q1 2025 financial results announcement for May 8, 2025, before US markets open. The company will host a conference call and webcast at 8:30 am EDT/13:30 pm BST to discuss financial performance and provide a business update. Participants must pre-register to receive dial-in details and a personal PIN for the conference call. A simultaneous audio webcast and replay will be available on the company's website events section.

Innate Pharma (Nasdaq: IPHA) has announced plans to transform its corporate governance structure, proposing to shift from an executive board/supervisory board model to a CEO/board of directors structure at its Annual General Meeting on May 22, 2025.

Under the proposed changes, Irina Staatz-Granzer, current Supervisory board Chairwoman, would become Chairwoman of the board of Directors, while Jonathan Dickinson, current Executive board Chairman, would be appointed CEO. The new board would include eight members, with two new additions: Christian Itin, CEO of Autolus, and Marty J. Duvall, a veteran biotech executive.

Three current board members, including co-founder Hervé Brailly, Gilles Brisson, and Jean-Yves Blay, will not join the new board. This transformation aims to simplify governance and align with international standards, reflecting the company's response to investor feedback.