Add IND for Dr. P. Kalinski for aDC1 platform to FDA in 2nd Q which is about to finish in 6 weeks. We are very close. It means we can start the trial. It could be Ovarian cancer trial.
• Kalinski technology clinical trial preparations advancing An updated trial design and IND package for an initial clinical trial involving the Company’s licensed Kalinski technology were completed during the first quarter. The lead medical institution for the clinical trial has been determined, and the IND package has been submitted to the Institutional Review Board (IRB) at that institution. The Company anticipates submission to the FDA during the second quarter.
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Northwest Biotherapeutics – Q1 2026 Highlights. For the quarter ended March 31, 2026, Northwest Biotherapeutics reported significant operational and financial improvements compared with Q1 2025. The Company continues to focus on advancing its regulatory, manufacturing, and commercialization initiatives while maintaining disciplined expense management.
• Net loss improved substantially year-over-year Q1 2026 net loss was approximately $3.1 million, compared with a net loss of approximately $19.6 million in Q1 2025, representing an approximately 84% improvement year-over-year.
• Revenue increased year-over-year NWBO recorded approximately $494,000 in total revenue during Q1 2026, primarily from research services revenue, compared with approximately $375,000 in Q1 2025, representing an increase of approximately 31.7%.
• UK property development initiative progressing The Company owns a 17-acre parcel of land on the edge of Sawston, UK, located across the road from the Company’s manufacturing facility and adjacent to existing residential neighborhoods. The Company owns unencumbered fee title to the property. Due to a pressing housing shortage in the region, the Local Council is conducting a review of land and zoning in the area. Although the property is not currently zoned for residential development, its location adjacent to residential areas may make it highly valuable if rezoned. During the first quarter, the Company worked with a team of advisers to develop and submit an application for rezoning of the property as part of the Local Council review process.
• Progress in spoofing litigation settlement discussions On April 30, 2026, the Company and one of the lesser defendants in the Canaccord spoofing litigation agreed to resolve the Company’s claims through a confidential settlement. The parties notified the Court accordingly. Settlement funds are currently being held in escrow while the Company continues discussions with additional lesser defendants regarding potential resolutions. The Company anticipates that the escrowed funds will be released following completion of those discussions.
• Litigation settlement gain recorded The Company recognized a $2.25 million litigation settlement gain related to a Delaware legal action.
• Operating expenses reduced significantly Research and development expenses declined to approximately $4.9 million in Q1 2026, compared with approximately $8.4 million in Q1 2025. General and administrative expenses were reduced to approximately $6.5 million, compared with approximately $9.3 million in the prior-year period.
• UK Strategic Advisor engaged As previously reported, the Company engaged a new Strategic Advisor, Dr. Annalisa Jenkins. Dr. Jenkins has extensive experience in big pharma, biotech and medical innovation, and is a recognized key opinion leader in the UK and globally. Dr. Jenkins will advise and help the Company advance the development of its DCVax cancer vaccines. The Company believes that Dr. Jenkins’ experience, advice and involvement will be a valuable resource.
• Kalinski technology clinical trial preparations advancing An updated trial design and IND package for an initial clinical trial involving the Company’s licensed Kalinski technology were completed during the first quarter. The lead medical institution for the clinical trial has been determined, and the IND package has been submitted to the Institutional Review Board (IRB) at that institution. The Company anticipates submission to the FDA during the second quarter.
• UK clinic development advancing As previously reported, the Company established a clinic arrangement with the London Welbeck Hospital in the Harley Street medical district in London. During the first quarter, the Company secured a contractor and proceeded with the clinic buildout. The clinic will include two leukapheresis units, each capable of conducting two procedures per day, for a total capacity of up to four patients per day. The clinic may also offer extended hours and weekend operations. The Company noted that there is a general shortage of leukapheresis capacity in the UK, and such procedures are required for both T cell products and dendritic cell products. The buildout is anticipated to be completed by June, and the Company is pursuing applications for the required licenses.
• Strengthened liquidity position As of March 31, 2026, the Company reported approximately $1.8 million in cash and cash equivalents. In addition, on May 12, 2026, Northwest Biotherapeutics entered into a commercial agreement with another party for financing in the amount of $7 million. Key financing terms include: – No repayments required during the first 8 months – Repayments begin January 11, 2027 – 10% original issue discount (OID) – 8% interest rate – 22-month term