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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 plc (Nasdaq: AUTL) announced its plan to release third quarter 2021 financial results on November 3, 2021, before U.S. markets open. The company’s management will host a conference call at 8:30 am ET to discuss the financial results and provide a business update. Interested parties can access the webcast through the company’s events section on its website. The call can also be dialed in using provided numbers for U.S. and international callers with a reference conference ID of 6984737.
Autolus Therapeutics has received planning approval to construct a new manufacturing facility in Stevenage, UK, aimed at enhancing global commercial launch capacity for obe-cel (AUTO1). The 70,000 square foot facility will allow for GMP production of approximately 2,000 batches annually, with potential for expansion. The company anticipates pivotal data from the FELIX study in 2022 for treating adult patients with acute lymphoblastic leukemia (ALL). This new facility positions Autolus to secure its place in Europe's growing biotechnology sector.
Autolus Therapeutics (Nasdaq: AUTL) announced the appointment of John H. Johnson as non-executive chairman of its Board of Directors, effective September 15, 2021. Johnson, with over 30 years in the life sciences sector, previously held executive roles at Strongbridge Biopharma and major firms like Eli Lilly and Pfizer. The company is preparing for pivotal data on obe-cel, a CD19 CAR T cell therapy aimed at treating adult acute lymphoblastic leukemia, expected in 2022. This leadership change is seen as pivotal for advancing Autolus' clinical programs.
Novaremed AG has acquired Metys Pharmaceuticals AG in an all-share transaction, expanding its pipeline of non-opioid treatments for chronic pain. The acquisition includes two new development projects, allowing Novaremed to target neuropathic pain, including chemotherapy-induced peripheral neuropathy (CIPN). This move aligns with Novaremed's strategy to lead in non-opioid pain management. Additionally, Andrew J. Oakley has been appointed to the Board of Directors, enhancing the leadership team. Key objectives include advancing clinical studies and seeking further capital for development.
Autolus Therapeutics plc (Nasdaq: AUTL) has announced its participation in three upcoming virtual investor conferences. These events include the Goldman Sachs Eleventh Annual Biotech Symposium on September 7, the Wells Fargo Healthcare Conference on September 10 at 7:30 am ET, and the H.C. Wainwright & Co 23rd Annual Global Investment Conference on September 13 at 7:00 am ET. Audiences can access live audio webcasts of the presentations through the company's website, with archived versions available for a limited time.
Autolus is focused on developing innovative T cell therapies to treat various cancers.
Autolus Therapeutics has reported promising results from the Phase 1 ALLCAR19 clinical trial of its CD19 CAR-T therapy, obe-cel, published in the Journal of Clinical Oncology. The therapy is designed to minimize toxicity while enhancing patient response rates in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). Notably, 85% of participants achieved minimal residual disease negative complete responses at one month, and no patients experienced severe cytokine release syndrome. The company plans to advance obe-cel into the pivotal FELIX study to further evaluate its efficacy.
Autolus Therapeutics (Nasdaq: AUTL) announced that its CAR T cell therapy, obe-cel, has received Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA). This designation acknowledges obe-cel's potential to significantly benefit adult patients with relapsed/refractory B-cell Acute Lymphocytic Leukemia (ALL). The ongoing FELIX Phase 1b/2 study is exploring its efficacy and safety, with promising implications for early access to treatment for patients with high unmet medical needs.
Autolus Therapeutics (Nasdaq: AUTL) reported its Q2 2021 financial results, revealing a net loss of $33.2 million, or $(0.47) per share, an improvement from $(0.62) per share in the prior year. Cash reserves totaled $216.4 million, projected to fund operations into H1 2023. Promising updates on the obe-cel therapy highlighted a 50% event-free survival rate in adult acute lymphoblastic leukemia patients after 24 months and successful outcomes in B-cell non-Hodgkin lymphoma trials. The company anticipates pivotal data from ongoing trials in 2022.
Autolus Therapeutics has entered an exclusive licensing agreement with Moderna for up to four immuno-oncology targets, permitting Moderna to develop and commercialize mRNA therapeutics utilizing Autolus' proprietary binders.
Autolus will receive upfront payments for each licensed target, along with milestone payments for successful commercialization, plus royalties on net sales. This partnership underscores Autolus' innovative positioning in the biopharmaceutical field, particularly in cancer treatment technologies.
Autolus Therapeutics (AUTL) announced the appointment of Dr. Edgar Braendle as Chief Development Officer, effective immediately. His expertise in oncology development is expected to propel the company's lead program, obe-cel, through its pivotal study aimed at treating relapsed/refractory adult Acute Lymphoblastic Leukemia (ALL). Dr. Braendle previously held leadership roles at Sumitomo Dainippon Pharma Oncology and Boston Biomedical. His experience includes managing global oncology programs and a strong background in clinical affairs. Autolus aims to advance its proprietary CAR T cell therapies.