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.
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.
Autolus Therapeutics (Nasdaq: AUTL) presented promising updates on its clinical trials at the ASH Annual Meeting. In the ALLCAR19 trial, 35% of adult relapsed/refractory B-ALL patients achieved sustained complete remission after three years without additional therapy. The AUTO1/22 trial showed an 83% MRD negative complete response rate in challenging pediatric B-ALL cases, with no antigen-negative relapses. Additionally, AUTO4 demonstrated sustained metabolic complete remissions in peripheral T-cell lymphoma patients. Full data from the pivotal FELIX trial is expected in mid-2023.
Autolus Therapeutics plc (Nasdaq: AUTL) announced the pricing of a public offering of 75 million American Depositary Shares (ADSs) at $2.00 each, totaling $150 million in gross proceeds. The offering, set to close on December 13, 2022, includes a 30-day option for underwriters to purchase an additional 11.25 million ADSs. The proceeds will support the development of its next-generation T cell therapies targeting cancer treatment. Jefferies LLC, William Blair, and Wells Fargo Securities are the joint bookrunners for this offering.
Autolus Therapeutics plc (Nasdaq: AUTL) has initiated an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing one ordinary share. The company plans to grant underwriters a 30-day option to purchase up to 15% of the ADSs sold at the public offering price. The offering is subject to market conditions and no assurance can be given regarding its completion or terms. Jefferies LLC, William Blair & Company, and Wells Fargo Securities are the joint bookrunners. The securities are offered under an effective shelf registration statement with the SEC.
Autolus Therapeutics (AUTL) has secured two milestone payments of $35 million each from Blackstone Life Sciences, totaling $70 million, due to positive interim results from the pivotal FELIX Phase 2 trial of their CAR T cell therapy, obecabtagene autoleucel (obe-cel). The first payment was received earlier than expected due to the trial meeting its primary endpoint. The second payment follows the successful demonstration of the manufacturing process for obe-cel. Autolus aims to submit a Biologics License Application to the FDA by the end of 2023.