AUTOLUS THERAPEUTICS PLC Stock Price, News & Analysis

Autolus Therapeutics plc (Nasdaq: AUTL) has received RMAT designation from the FDA for its lead gene therapy, obe-cel, designed for adult patients with relapsed/refractory B-Acute Lymphocytic Leukemia (ALL). This designation recognizes the therapy's potential to fulfill unmet medical needs and facilitates the drug development process. obe-cel has also received PRIME and ILAP designations in Europe. The ongoing FELIX Phase 2 trial aims to enroll 140 patients across multiple centers. This milestone underscores the importance of obe-cel in addressing critical treatment gaps in adult B-ALL.

Autolus Therapeutics plc (Nasdaq: AUTL) will report its Q1 2022 financial results and operational highlights on May 5, 2022, before U.S. markets open. A conference call and webcast will follow at 8:30 am ET/1:30 pm BST for management to discuss the results and provide a business update. Investors can access the presentation and call via Autolus' website or by dialing provided numbers for U.S. and international listeners. The call will be available for replay for one week.

Autolus Therapeutics (AUTL) has received Orphan Medical Product Designation from the European Medicines Agency for its CAR T therapy, obe-cel, aimed at treating acute lymphoblastic leukemia (ALL). This milestone follows a similar designation from the FDA in 2019. The designation offers benefits such as fee reductions and ten years of market exclusivity post-approval. Ongoing clinical trials for obe-cel focus on its efficacy and safety in adult ALL patients, with first Phase 2 data expected later this year, indicating progress in addressing urgent treatment needs.

Autolus Therapeutics plc (Nasdaq: AUTL) announced participation in three notable investor conferences: the Wells Fargo Annual Biotech Forum on April 12-13, the 21st Annual Needham Virtual Healthcare Conference on April 14 at 8:45 am ET, and the 14th Kempen Life Sciences Conference on April 21, with timing to be confirmed. Management will present, and audio webcasts will be available live and archived on the company’s website. Autolus focuses on developing advanced T cell therapies targeting cancer, with a diverse pipeline aimed at treating hematological malignancies and solid tumors.

Autolus Therapeutics plc (Nasdaq: AUTL) reported its financial results for Q4 and full-year 2021 on March 10, 2022. The company secured a $150M collaboration with Blackstone Life Sciences, with potential additional milestone payments of $100M. Notable clinical data from its obe-cel therapy displays a favorable safety profile. Autolus has cash reserves of $310.3M, extending its financial runway into 2024, despite a net loss of $142.1M for the year, a slight improvement over 2020. Key clinical milestones are anticipated in 2022 for therapies targeting various cancers.

Autolus Therapeutics (Nasdaq: AUTL) announced a publication in BioTechniques detailing a novel technology for controlled expression of gene modules, crucial in T cell therapy for cancer treatment. This method allows for very low expression levels of toxic genes, enhancing safety while maintaining efficacy. By utilizing a translational readthrough mechanism, the technology improves CAR T cell therapies targeting solid tumors, specifically allowing controlled IL-12 release without systemic toxicity. This innovation aims to maximize anti-tumor activity while minimizing risks to patients.

Autolus Therapeutics plc (Nasdaq: AUTL) will announce its fourth quarter and full year 2021 financial results and operational highlights on March 10, 2022, before U.S. market open. The management team will host a conference call at 8:30 am ET to discuss the results and provide a business update. Interested parties can access the call via webcast, with a replay available for one week afterward. This event marks a critical opportunity for investors to evaluate the company’s performance in the clinical-stage biopharmaceutical sector focused on T cell therapies.

Engitix has successfully closed a $54m Series A financing round, co-led by Netherton Investments and new investor Dompé farmaceutici S.P.A. The collaboration with Dompé includes a multi-year strategic partnership to advance Engitix's drug discovery efforts in fibrosis and cancer. Dompé will provide access to its AI-driven Exscalate platform while Engitix retains control over its assets. The funding will enhance Engitix's internal pipeline and expand its operations significantly.

Autolus Therapeutics plc (Nasdaq: AUTL) announces the retirement of CFO Andrew J. Oakley on March 31, 2022, transitioning to a non-executive director role while remaining an advisor until March 2023. Dr. Lucinda Crabtree, currently SVP of Finance, will succeed him. Oakley highlighted the company's strong financial position following a deal with Blackstone Life Sciences, allowing for strategic advancement of its lead candidate, obe-cel. Crabtree brings extensive financial experience and previously oversaw major public offerings for Autolus.