Northwest Biotherapeutics, Inc.

What they do

{ "headline": "Northwest Biotherapeutics is a clinical-stage biotechnology company developing dendritic-cell immune therapies for cancer under its DCVax platform, with a U.K. marketing application for DCVax-L in glioblastoma pending.", "what_they_do": "The company develops personalized immune therapies built on its DCVax platform, which uses activated dendritic cells to mobilize a patient's immune system against cancer. Lead product DCVax-L targets surgically removable solid tumors and has completed a 331-patient international Phase III trial in glioblastoma multiforme; a Marketing Authorization Application was submitted in the U.K. on December 20, 2023. DCVax-Direct, designed for inoperable solid tumors, has completed a 40-patient Phase I trial covering more than a dozen cancer types. Preparations for further trials proceed only as resources permit.", "revenue_drivers": [ { "name": "DCVax-L (lead product, pre-commercial)", "detail": "Not yet approved or marketed; the U.K. MAA filed December 20, 2023 is the nearest potential commercial path. No product revenue is reported from DCVax-L." }, { "name": "Reported annual revenue (unspecified source)", "detail": "Annual revenue was $1.0M in 2021, $1.7M in 2022, $1.9M in 2023, $1.4M in 2024 and $1.4M in 2025; the filings provided do not break this down by product or segment." }, { "name": "Recent quarterly revenue", "detail": "Quarterly revenue was $200,000 (2025-09-30), $672,000 (2025-12-31), $494,000 (2026-03-31) and $807,000 (2026-06-30) — small amounts relative to operating costs." } ], "recent_performance": "Annual revenue was $1.4M in 2025, flat with $1.4M in 2024, while net loss narrowed to $60.2M from $83.8M. Operating cash outflow was $44.8M in 2025 versus $57.0M in 2024. At 2026-06-30 the company reported total assets of $75.9M, total liabilities of $110.7M, shareholders' equity of negative $45.2M, cash and equivalents of just $595,000, and long-term debt of $52.0M. Quarterly revenue in the first half of 2026 was $494,000 and $807,000, and the company recorded a "going concern" audit opinion on its December 31, 2025 financial statements.", "strategy": "Management states that much of its time and resources is devoted to the U.K. MAA review process, working with large teams of consultants, and that it does not plan interim announcements before a regulatory decision. The company acquired Advent BioServices Ltd. on October 24, 2025 as a wholly owned subsidiary to facilitate manufacturing scale-up, and is developing a Grade C lab at its Sawston, U.K. facility that it says would roughly triple current capacity. In the U.S., it completed technology transfer for DCVax-L manufacturing and basic engineering runs and validation, while pursuing lease arrangements for a GMP facility for Kalinski aDC1 products. It is also pursuing U.K. leukapheresis capacity, a second-source manufacturing collaboration, and overseas collaboration discussions including an MOU with a large Saudi Arabian pharmaceutical company. The company presented independent statistical analyses of the Phase 3 glioblastoma data at the British Neuro Oncology Society meeting in July 2026.", "risks": [ { "title": "Going concern", "detail": "Auditors issued a going concern opinion on the December 31, 2025 financial statements, and management said there is substantial doubt about the ability to continue as a going concern — a position the company says it has received for more than a decade." }, { "title": "Need for substantial ongoing funding", "detail": "The company states it will need substantial additional funding on an ongoing basis for trials, patent prosecution, manufacturing build-out and corporate purposes, with no assurance such financing will be available or on acceptable terms." }, { "title": "Regulatory approval uncertainty", "detail": "The DCVax-L U.K. MAA remains under review with no announced outcome; the 10-K states the company has completed one Phase III trial, and any approval failure would leave it without a marketed product." }, { "title": "Persistent losses and cash burn", "detail": "The company reports net cash outflows from operations since inception, a $60.2M net loss in 2025, $44.8M of operating cash outflow in 2025, and only $595,000 of cash and equivalents at 2026-06-30 against $110.7M of total liabilities." } ], "outlook": "Management says it will announce the results of the U.K. MAA review when the regulatory process and decision-making are finished, and is not making interim announcements. It expects the Sawston Grade C lab to roughly triple manufacturing capacity once complete, and continues to pursue a second-source manufacturing collaboration and overseas partnering discussions, including a potential Saudi Arabian collaboration. The 10-K states that trials of DCVax-L in other solid tumors and Phase II preparations for DCVax-Direct will proceed only as resources permit.", "key_facts": [ { "label": "Lead product / status", "value": "DCVax-L for GBM; U.K. MAA submitted December 20, 2023, review ongoing" }, { "label": "Phase III trial size", "value": "331 patients, international, glioblastoma; results published in JAMA Oncology" }, { "label": "2025 financials", "value": "Revenue $1.4M; net loss $60.2M; operating cash flow -$44.8M" }, { "label": "Balance sheet at 2026-06-30", "value": "Assets $75.9M; liabilities $110.7M; equity -$45.2M; cash $595,000; long-term debt $52.0M" } ] }