BB,
Very kind words, thank you. Eight years of conviction earns you the right to understand what you own, and you clearly do.
You are correct that Linda Powers’ laser focus right now is DCVax-L for operable tumors. That discipline is exactly what gets a platform through regulatory approval. You do not try to be everything at once. You pick the indication with the strongest data, the clearest regulatory path, and the most urgent unmet need, and you execute. That is what DCVax-L represents and that is the right near-term focus. And you are right that approval is the key that unlocks everything else. Linda Powers said exactly that at the December annual meeting: “everything else is facilitated by getting the first approval.”
What I think is worth appreciating is just how much of the treasure chest is already staged and ready to unlock when that key turns.
At that same annual meeting, Linda Powers confirmed the first company-sponsored trial using the Kalinski portfolio is already determined. It is an ovarian cancer combination trial with a conditioning regimen, a dendritic cell component, and a third agent. That is CKM + alphaDC1 + checkpoint blockade moving from academic research into NWBO’s own clinical program. She said the lead institutions are “jumping up and down.” A Pittsburgh manufacturing group is being built principally to manufacture Kalinski’s DC products. DCVax-Direct Phase 2 is manufacturing-ready for a below-the-neck solid tumor, IND section partially written, lead institutions in the US and UK on board. Compassionate use is expanding in 2026 to most solid tumor types including DCVax-Direct, not just DCVax-L for brain cancer. These are not plans for someday. These are programs staged and waiting for the key to turn.
Now consider what happened in the span of four days last week:
On April 29, Kalinski delivered a public lecture describing alphaDC1-educated T cells as potentially better than both CAR-T and TIL, with quantitative data on dual-key recognition at two-hundred-fold enhanced sensitivity. That is not a theoretical future product. That is a paid NWBO consultant presenting clinical-grade data to a CE-credited professional audience.
On May 2, the DePuyt/Mailliard/Kalinski single-cell paper identified the manufacturing innovation (Cluster E sorting) that makes the T cell product consistently reproducible across patients. Surface markers for GMP-compliant sorting are identified. The science is not ten years away. The science published last week.
The CKM clinical data already exists: two completed trials at Roswell Park, 78% favorable pathologic response in neoadjuvant TNBC, published in JITC 2023 and 2024.
I think what Linda Powers built is not a company with one product now and a treasure chest for later. It is a company with one product in the regulatory pipeline now and a treasure chest whose contents are staged, staffed, and scientifically validated, waiting for that first approval to unlock them. The gap between approval and the next product may be shorter than any of us expected.
We have all been patient for a long time. And our patience is about to be rewarded on more than one front.
Cheers.
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