LONDON - Autolus Therapeutics plc (NASDAQ:AUTL), a biopharmaceutical company focused on T cell therapies for cancer and autoimmune diseases, announced the appointment of Matthias Will, M.D., as its new Chief Development Officer, effective September 30, 2024. Dr. Will brings extensive experience from his previous roles in clinical development and strategic advisory within the pharmaceutical industry.
Dr. Will's career includes tenure as Chief Medical Officer at Dren Bio, Inc., where he led clinical team expansion and the submission of two Investigational New Drug applications for hematologic cancer treatments. His prior positions also include Vice President of Clinical Development at CRISPR Therapeutics and roles at CytomX Therapeutics (NASDAQ:CTMX) Inc., Gilead Sciences, Inc. (NASDAQ:GILD), and Novartis (SIX:NOVN) Oncology. Additionally, Dr. Will has provided strategic consulting for pharmaceutical clients with McKinsey & Company.
CEO of Autolus, Dr. Christian Itin, expressed confidence in Dr. Will's ability to steer the company's development organization, particularly as Autolus prepares to commercialize its first product, obe-cel, for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia (B-ALL).
Obe-cel (Obecabtagene autoleucel) is an investigational CD19 chimeric antigen receptor (CAR) T cell therapy. Designed to improve upon current CD19 CAR T cell therapies, obe-cel has shown a reduced toxicity profile and improved persistence in clinical trials, leading to high levels of durable remissions in B-ALL patients. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 16, 2024, for obe-cel, with regulatory submissions also accepted by the EMA in April 2024 and an MAA submitted to the UK's MHRA in July 2024.
Autolus is also evaluating obe-cel in a Phase 1 clinical trial for B-cell non-Hodgkin lymphoma (B-NHL) in collaboration with University College London.
The forward-looking statements in the press release reflect the company's aspirations and are subject to risks and uncertainties that could significantly impact actual future results. These include the progression of clinical programs, the results and timing of clinical trials, and product candidate approvals.
This news article is based on a press release statement from Autolus Therapeutics plc.
In other recent news, Autolus Therapeutics plc has secured £18.5 million to improve its Nucleus facility in Stevenage, U.K. The funding will be used for the creation of additional clean rooms for product manufacturing, with the improvement works following a mutually agreed timeline. In the clinical realm, Autolus reported promising data from its FELIX Phase 1b/2 study, which examines the efficacy of obe-cel, a novel CAR T-cell therapy, for adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia. The study showed a remission rate of 90% in the low tumor burden group and 75% in the high tumor burden group. In financial analysis, Truist Securities maintained a Buy rating on Autolus, with minor revisions to the projected market penetration for Obe-cel. Additionally, Wells Fargo reiterated its Overweight rating on Autolus Therapeutics. At the company's Annual General Meeting, all nine resolutions were approved, including the adoption of 2023 financial statements and the re-election of several directors. The shareholders also endorsed the Directors' remuneration report and re-appointed Ernst & Young LLP as the company's auditors.
InvestingPro Insights
As Autolus Therapeutics plc (NASDAQ:AUTL) welcomes Dr. Matthias Will to guide its development strategy, investors are keenly watching the company’s financial health and market potential. With a market capitalization of approximately $1.03 billion, Autolus holds more cash than debt on its balance sheet, a positive sign for stakeholders gauging the company's solvency and risk profile.
InvestingPro data indicates that Autolus has experienced a revenue growth of 40.22% in the last twelve months as of Q2 2024, suggesting an expanding market presence. This aligns with the InvestingPro Tip that analysts anticipate sales growth in the current year, which may be fueled by the company's promising clinical trials and potential product commercialization.
However, it's important to note that Autolus is not yet profitable, with analysts not expecting profitability this year. The company's stock price movements have also been quite volatile, which could be a consideration for risk-averse investors. These financial metrics and analyst insights can offer valuable context as Autolus advances its clinical programs and moves closer to potential product approvals.
For those seeking more in-depth analysis, there are additional InvestingPro Tips available at https://www.investing.com/pro/AUTL, providing further insights into Autolus’s financial performance and market outlook.
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