Northwest Biotherapeutics Reports $83.8 Million Net Loss for Fiscal Year 2024

Northwest Biotherapeutics, Inc. reported a net loss of $83.8 million for the fiscal year ending December 31, 2024, compared to a loss of $62.6 million in the previous year. The company’s operating expenses increased to $67.9 million from $57.4 million in 2023, primarily driven by a rise in research and development (R&D) costs, which reached $34.9 million, up from $27.7 million. This increase was attributed to expenses related to the ramp-up of DCVax-Direct production, costs associated with the Marketing Authorization Application (MAA) process, and specialized scientific testing. General and administrative expenses also rose to $33.0 million, largely due to increased legal costs.

In terms of strategic developments, Northwest Biotherapeutics has made significant progress in its clinical and operational activities. The company submitted a Marketing Authorization Application for its lead product, DCVax-L, aimed at treating glioblastoma, and has been actively engaged in the review process with the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The company also completed a 331-patient Phase III trial for DCVax-L, with results published in JAMA Oncology. Additionally, preparations for pediatric brain cancer trials are underway, and the company is exploring potential manufacturing partnerships in the U.S.

Operationally, Northwest Biotherapeutics maintained a stable workforce, ending the year with 25 full-time employees. The company has been focusing on expanding its manufacturing capabilities, particularly at its facility in Sawston, U.K., which has received its first regulatory inspection under the MIA license approved by the MHRA. The facility is expected to produce enough doses for approximately 450 to 500 patients annually. The company is also developing a simplified Grade C lab to enhance production efficiency and reduce costs.

Looking ahead, Northwest Biotherapeutics faces challenges related to funding and market conditions. The company has indicated substantial doubt about its ability to continue as a going concern without securing additional financing. It plans to continue its efforts to raise capital through equity and debt financing to support ongoing operations and clinical trials. The company is also working on reimbursement evaluations for its products, which will be critical for commercialization. Despite these challenges, Northwest Biotherapeutics remains focused on advancing its clinical programs and expanding its market presence.