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LONDON - The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorization for Autolus Therapeutics plc’s AUCATZYL® (obecabtagene autoleucel), a treatment for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). This decision, announced today, is based on the outcomes of the FELIX clinical trial. According to InvestingPro data, Autolus Therapeutics (NASDAQ: AUTL), currently valued at $370 million, holds more cash than debt on its balance sheet, positioning it well for the commercial launch.
AUCATZYL® is a chimeric antigen receptor (CAR) T cell therapy, which has been engineered to have a fast-off rate to reduce excessive activation of the programmed T cells. The therapy was created by Autolus, a biopharmaceutical company focused on developing programmed T cell therapies for cancer and autoimmune diseases, with its scientific and manufacturing base in the UK.
The pivotal FELIX study demonstrated a Complete Response/Complete Response with Incomplete Hematological Recovery (CR/CRi) rate of 76.6% in the cohort of patients who received at least one infusion of obecabtagene autoleucel. The median response duration was 21.2 months, with median event-free survival (EFS) at 11.9 months. However, the treatment was associated with significant adverse reactions, including infections and cytokine release syndrome. With the company’s next earnings report due on May 1, InvestingPro analysts have revised their earnings expectations upward, suggesting growing confidence in the company’s commercial prospects.
MHRA’s conditional authorization requires an annual review of new efficacy and safety information. This kind of authorization is typically granted for treatments that address an unmet medical need or offer a major therapeutic advantage in serious diseases where comprehensive clinical data is still being gathered.
Dr. Claire Roddie, Lead investigator of the FELIX study, expressed optimism that the treatment could soon become accessible to eligible patients through the National Health Service (NHS), pending the completion of an assessment by the National Institute for Health and Care Excellence (NICE).
This authorization marks a milestone for Autolus, which has submitted obecabtagene autoleucel for appraisal by NICE in the fourth quarter of 2024, aiming to secure access for eligible patients in England. Acute lymphoblastic leukemia is an aggressive cancer with approximately 765 new cases diagnosed annually in the UK. Current survival rates for adult patients with r/r ALL are poor, with median overall survival of eight months under conventional treatments. Financial data from InvestingPro shows impressive revenue growth of 496% in the last twelve months, though the stock remains undervalued according to InvestingPro’s Fair Value analysis. The company’s strong liquidity position, with a current ratio of 10.88, provides substantial runway for commercialization efforts. For deeper insights into Autolus’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
The information for this article is based on a press release statement from Autolus Therapeutics plc.
In other recent news, Autolus Therapeutics has reported a net loss of $220.7 million for the fourth quarter of 2024, a rise from the previous year’s loss of $208.4 million. Despite the increased loss, the company bolstered its cash reserves significantly to $588 million, aided by a $600 million collaboration with BioNTech and equity financing. Autolus is actively expanding its reach, with 33 U.S. treatment centers now authorized to administer its therapy, Aucatzyl, exceeding its initial target of 30 centers. This expansion potentially covers around 60% of the U.S. patient population for adult relapsed or refractory B-cell Acute Lymphoblastic Leukemia. Analysts from Truist Securities and Mizuho Securities have reiterated their positive outlook on Autolus, maintaining price targets of $11 and $12, respectively, while acknowledging strong demand and expansion efforts. Truist Securities, however, has adjusted its price target for Autolus from $11 to $10 due to refined financial projections. The company is also anticipating key developments in 2025, including approval decisions for Aucatzyl in the UK and Europe and initial pediatric data. Additionally, Autolus is preparing to share data on its systemic lupus erythematosus trial at an upcoming research and development event.
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