LONDON: In a company announcement, Autolus Therapeutics plc (Nasdaq: AUTL), a trailblazer in programmed T cell therapies, has released its operational and financial results for the year ending December 31, 2023. The company, which is in the clinical stage, revealed a cash reserve of $239.6 million, a notable decrease from the previous year’s $382.4 million.

Despite the reduction in cash, Autolus has reported a surge in total operating expenses, reaching $179.7 million for 2023, up from $143.4 million in 2022. This increase is attributed to the expansion of operations, including the launch of a new commercial manufacturing facility, milestone payments, and a rise in employee compensation.

Research and development (R&D) expenses have also climbed from $117.4 million to $130.5 million, driven by the aforementioned operational expansions and a reduction in U.K. R&D tax credits. Autolus has adjusted its financial reporting to reflect R&D tax credits as a deduction in R&D expenses rather than an income tax benefit, resulting in a decrease of $19.5 million and $24.6 million for the years 2023 and 2022, respectively.

General and administrative costs have not been spared, witnessing an increase from $31.9 million to $46.7 million, primarily due to the growth in workforce to support pre-commercialization efforts.

The net loss for shareholders has deepened to $208.4 million for 2023, a significant jump from $148.8 million in the previous year. The net loss per share has settled at $(1.20), showing an improvement from $(1.57) in 2022.

Looking ahead, Autolus is optimistic about its financial stability, bolstered by funds from a strategic alliance with BioNTech, private placements, and equity financing. These resources are expected to fully support the launch and commercialization of obe-cel for relapsed/refractory adult acute lymphoblastic leukemia (ALL) and propel the development of its pipeline, including pivotal studies of obe-cel in autoimmune diseases.

“We’re delighted to be starting 2024 in such a strong financial position; our recently announced strategic alliance with BioNTech, coupled with two equity financing transactions, raised gross proceeds of $600 million. Combined with our 2023 ending cash of $240 million, this enables us to drive the full launch and commercialization of obe-cel in r/r adult ALL and establish Autolus as a potential leader in the delivery of CAR T therapy to patients with autoimmune diseases,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

“2023 was a transformational year for the Company. Our lead program, obe-cel, demonstrated strong data in B-ALL in the pivotal FELIX study, we fully validated our commercial manufacturing facility, The Nucleus, to support our regulatory submissions and we submitted our first BLA for obe-cel to the United States Food and Drug Administration (FDA) in November, with a PDUFA target action date of November 16, 2024. We also just submitted an MAA to the European Medicines Agency (EMA).”

“Beyond B-ALL, we see a significant opportunity for obe-cel in autoimmune disease. Our Phase 1 dose confirmation trial in refractory SLE is now open for enrollment. We believe obe-cel’s clinical profile, together with our commercial product delivery base and infrastructure, will help to drive an accelerated and differentiated expansion in autoimmune diseases and we look forward to sharing initial data from the study in late 2024.”

“For now, we remain fully focused on preparing for a potential obe-cel launch and successfully transitioning Autolus to a commercial stage company. Pre-commercial and product delivery activities are well underway, and we are on track to make obe-cel available to B-ALL patients as soon as possible, following a potential approval.”

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