Autolus Therapeutics plc American Depositary Share - AUTL STOCK NEWS

Autolus Therapeutics plc (Nasdaq: AUTL) has announced that it has no past or present business relationships with Silicon Valley Bank, following recent events concerning the bank. Autolus focuses on developing next-generation programmed T cell therapies for cancer treatment, utilizing proprietary T cell programming technologies. The company aims to create targeted, controlled, and effective therapies to combat cancer cells. Autolus is advancing its product pipeline for hematological malignancies and solid tumors, with ongoing clinical trials and a planned submission of a Biologics License Application for its obe-cel program by the end of 2023.

Autolus Therapeutics (AUTL) announced that its treatment, obe-cel, met the primary endpoint in the pivotal Phase 2 FELIX study for relapsed/refractory B-cell Acute Lymphoblastic Leukemia. The company plans to submit a Biologics License Application to the US FDA by year-end 2023, with data updates expected at a medical conference mid-2023. Financially, Autolus reported a net loss of $148.8 million for 2022, an increase from $142.1 million in 2021. Cash reserves stand at $382.8 million, bolstered by a successful fundraising of approximately $163.9 million. The company is positioned for a commercial launch of obe-cel in 2024.

The latest report on Chronic Lymphocytic Leukemia (CLL) market forecasts a robust pipeline of cell therapies, particularly CAR-T therapies, which are projected to capture significant market share by 2031. The report estimates the CLL cell therapy market will reach $2 billion in annual sales across major pharmaceutical markets, with overall CLL market sales peaking at $20.8 billion. The analysis covers the clinical landscape, unmet needs, and future players within the market, emphasizing a shift towards cell therapies for high-risk patients. The report spans 15 major markets, providing insights into disease epidemiology and forecast methodologies.

The CAR-T cell therapy market is poised for significant growth, projected to reach a CAGR of 23% from 2022 to 2035. Over 970 therapies are currently approved or under development, with 25% in late-stage trials. The market's expansion is supported by substantial investments, totaling nearly USD 25 billion, primarily from US-based companies. Non-Hodgkin's lymphoma is expected to dominate the market, capturing 85% of target indications. The report highlights over 38,470 patients enrolled in around 750 clinical trials, indicating robust research and partnership activity.

Autolus Therapeutics plc (Nasdaq: AUTL) will release its fourth quarter and full year 2022 financial results on March 7, 2023, before U.S. markets open. A conference call and webcast for investors will take place at 8:30 am ET, providing insights into financial outcomes and a general business update. Participants are advised to pre-register to obtain dial-in numbers and personal PIN for access. A replay of the webcast will be available on the company’s website following the event.

The global autologous cell therapy market is projected to reach USD 24.31 billion by 2030, growing at a CAGR of 19.4% from 2022. This growth is driven by increasing incidences of diseases such as cancer and neurodegenerative disorders, alongside the lower risk of rejection associated with patient-derived therapies. Notably, the bone marrow segment dominated the market with a 42% share in 2021, while the cancer application segment is expected to grow fastest at 20.7% CAGR. North America led the market with 41% of total revenue in 2021 due to regulatory support and rising cancer cases.

Autolus Therapeutics (Nasdaq: AUTL) announced changes to its Board of Directors effective February 2023. John H Johnson, the non-executive Chairman since September 2021, will not seek re-election to focus on his CEO role at Reaction Biology. Dr. Jay T Backstrom will also step down from the board after serving since August 2020 to concentrate on his position as CEO of Scholar Rock. Both directors contributed during a critical transition period for Autolus, including the successful pivotal FELIX trial for the lead product candidate, obe-cel. The company is now preparing for regulatory approval and commercialization.

Autolus Therapeutics plc (Nasdaq: AUTL) announced a non-exclusive license agreement with Cabaletta Bio, Inc (Nasdaq: CABA) to use Autolus' proprietary RQR8 safety switch in a cell therapy program for autoimmune diseases. This deal includes an upfront payment, potential development milestones, and royalties on sales from products using this technology. Autolus aims to enhance patient outcomes while minimizing treatment risks, highlighting its ability to monetize its technologies and advance its pipeline, complementing previous agreements with Bristol Myers Squibb and Moderna.

Autolus Therapeutics (Nasdaq: AUTL) announced on December 21, 2022, that underwriters have exercised a partial option to buy an additional 6,927,102 American Depositary Shares (ADSs) at $2.00 each. This move will yield roughly $13.9 million in gross proceeds, bringing the total raised from the public offering to approximately $163.9 million. The offering, which closed on December 13, 2022, involved a total of 81,927,102 ADSs sold. Jefferies LLC, William Blair & Company, and Wells Fargo Securities acted as joint bookrunners for the offering.