NorthWest Biotherapeutics Inc (NWBO)

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Clean room "C" per latest update NWBO Q10

NOTES TO CONDENSED CONSOLIDATED STATEMENTS
(d) Technology Transfer: Clean Room Implementation.
After the choice of system (TFF vs commercial) and the choice of product composition are decided, development of new SOPs and transfer of production into the clean rooms. This includes pre-clean room engineering runs, establishment of critical quality attributes, and process performance qualifications. For technology transfer into the clean rooms, each employee operator individually must pass 3 consecutive and successful aseptic process simulations in the clean room and also 3 consecutive and successful PQQ runs at scale in the clean room; microbial analysis (sterility, endotoxin, mycoplasma all need to pass); growth promotion tests; validation of all equipment used after being placed in the clean room; validation of all cell analysis assays used via flow cytometry and validation of the fill and finish protocols. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.
As of September 30, 2025, this milestone had been completed but had not yet been paid. The Company had an accrued liability of $0.5 million as of September 30, 2025 related to this milestone.
(e) New IMPD and New IND.
Draft a new IMPD (Investigational Medicinal Product Dossier) for the revised DCVax-Direct product composition and production process, containing all changes to the manufacturing system, reagents and product composition, processes, sources and/or Mechanism of Action vs. those used in the prior DCVax-Direct program. Also draft a new IND (CMC section), for the first clinical trial with the new manufacturing process and new product composition. Obtain the first approval or clearance of the new IND by a regulator. Milestone payment of £0.35 million (approximately $0.5 million) upon completion.
As of September 30, 2025, this milestone had not been fully completed. Advent had completed the new IND CMC section (comprising part of this milestone) but the new IND had not yet been submitted to and approved by regulators (comprising the other part of this milestone). The Company had an accrued liability of $0.4 million as of September 30, 2025 related to this milestone.
The following table summarizes total research and development costs from Advent for the three and nine months ended September 30, 2025 and 2024, respectively (in thousands).

It looks like NWNO had completed the clean room "C" but additional (e) New IMPD and New IND. and are hopefully completed soon?