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Autolus Therapeutics plc reports news on its commercial-stage biopharmaceutical business developing, manufacturing and delivering next-generation programmed T cell therapies. Updates center on AUCATZYL (obecabtagene autoleucel, or obe-cel), product revenue, manufacturing capacity, gross margin plans and the company’s acute lymphoblastic leukemia business.
Company announcements also cover clinical programs using obe-cel and related T cell therapy candidates in pediatric relapsed/refractory acute lymphoblastic leukemia, lupus nephritis and progressive multiple sclerosis. Other recurring items include financial results, operational efficiency actions, investor presentations, Nasdaq inducement equity grants and ADR-related public-company disclosures.
Autolus Therapeutics (NASDAQ: AUTL) announced the online publication of three abstracts for the upcoming American Society of Hematology Annual Meeting in December 2022. These abstracts will highlight the clinical data of three therapies: obe-cel in B-ALL and B-NHL, AUTO1/22 in pediatric ALL, and AUTO4 in T-Cell Lymphoma. CEO Dr. Christian Itin emphasized obe-cel's promising safety and efficacy profile, showing potential in long-term remission for B-ALL patients. The presentations are set for December 11 and 12, providing updated data for clinical trials.
Autolus Therapeutics plc (Nasdaq: AUTL) announced its Q3 2022 operational and financial results, highlighting several strategic progress points. The pivotal FELIX Phase 2 trial for obe-cel in relapsed/refractory adult ALL is on track for a Q4 2022 update. The commercial manufacturing facility in the UK is scheduled for completion in Q4 2022. Financially, cash decreased to $163.1 million, while the net loss expanded to $42.8 million compared to $34.0 million in Q3 2021. The company expects future pipeline updates at the upcoming ASH Annual Meeting in December 2022.
Autolus Therapeutics (Nasdaq: AUTL) will announce its Q3 2022 financial results and operational highlights on November 3, 2022, prior to the U.S. market opening. Management will hold a conference call at 8:30 am ET to discuss these results and provide updates on the company’s business. Participants are encouraged to pre-register for access details. Autolus is focused on developing next-generation programmed T cell therapies for cancer treatment, utilizing proprietary technologies for targeting and eliminating cancer cells in hematological malignancies and solid tumors.
Autolus Therapeutics plc (Nasdaq: AUTL) announces that Moderna has exercised its option to license proprietary binders for an undisclosed immuno-oncology target. This exercise follows a previous agreement granting Moderna options on four targets. Autolus has received an option exercise fee and stands to gain from development and commercial milestone payments, as well as royalties on net sales of products derived from this collaboration. This partnership underscores Autolus' capabilities in innovative cell programming technologies aimed at treating cancer.
Autolus Therapeutics has entered a strategic agreement with Bristol Myers Squibb to incorporate its proprietary RQR8 safety switch into selected cell therapy programs targeting cancer treatments. This agreement includes an upfront payment, potential option exercise fees, development milestone payments, and royalties on net sales of products utilizing the RQR8 switch. The RQR8 technology enhances safety in cell therapies, allowing for controlled elimination of cells experiencing severe side effects. This partnership aims to improve patient outcomes and represents a significant advancement in the field of advanced cell therapies.
Scholar Rock has appointed Dr. Jay Backstrom as CEO-Elect, effective September 20, 2022. With over 30 years of biopharmaceutical leadership, he previously held roles at Acceleron and Celgene, contributing to drug development and approval processes. Nagesh Mahanthappa will serve as interim CEO during the transition until October 20, 2022. Dr. Backstrom aims to advance the company’s clinical programs targeting spinal muscular atrophy and oncology, emphasizing growth milestones and innovative therapy approaches.
Pyramid Biosciences has appointed Dr. Nushmia Khokhar as the new Chief Medical Officer to lead the company's clinical pipeline advancements. Dr. Khokhar, previously with Umoja Biopharma and Autolus Therapeutics, brings extensive experience in oncology clinical development. The CEO, Brian Lestini, expressed confidence in her leadership during this growth phase. Dr. Khokhar's background includes significant roles at Johnson & Johnson, where she directed successful clinical trials for cancer therapies. Pyramid Biosciences focuses on creating precision therapies for serious diseases.
Autolus Therapeutics announced its Q2 2022 operational and financial results, highlighting significant advancements in its clinical pipeline. The company received RMAT designation from the FDA for obe-cel in April 2022 and continues to progress in the pivotal Phase 2 FELIX trial for r/r ALL. Financially, Autolus reported a net loss of $42.1 million and operating expenses of $46.5 million for the quarter. Cash reserves decreased to $216.4 million, extending the runway into 2024. Initial results from the FELIX trial are anticipated in Q4 2022.
Autolus Therapeutics plc (Nasdaq: AUTL) will release its second quarter 2022 financial results and operational highlights before the U.S. market opens on August 4, 2022. A conference call and webcast will be held at 8:30 am ET/1:30 pm BST to discuss these results and provide a business update. Participants must pre-register to receive dial-in information. The webcast will also be available for replay in the events section of Autolus' website.
Autolus Therapeutics plc (Nasdaq: AUTL) will announce its Q2 2022 financial results and operational highlights on August 4, 2022, prior to the U.S. market opening. A conference call and webcast featuring management will occur at 8:30 am ET to discuss the results and provide an update on the company's business. Participants can pre-register for the call to receive dial-in numbers and PINs. The audio webcast will also be accessible on the company's website.