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Galzus Research

05/02/25 8:27 PM

#765620 RE: Doc logic #763186

Honestly, while it's still in this era of pilot studies and single-institution trials, it's very difficult to see the tissue agnostic story being meaningful.

I do agree that the preclinical foundation is interesting, and that a tissue-agnostic role is not impossible. But you can't have paid to the history of immunotherapy without seeing this kind of hype build and then face reality. Back in 2014, when nivo and pembro were lighting the world on fire, it was a question of "which cancers can NOT be treated by immune checkpoint inhibitors?"

The answer ended up being a lot of them, and for reasons we still are working on figuring out. You'd think it was the PD-L1-high cancers. Nope, that doesn't predict it. Then it was the tumor mutational burden high cancers, which works great as biomarker, until it doesn't (as published in the NEJM in recent years).

The "soon to be recognized" ability to ramp up production is one speculation, and certainly a necessary step to achieving revenue that justifies even the current valuation.

And the remarks on the NHS funding would put me much further into the weeds than my editors will allow me to go. Massively speculative notion that the NHS has any awareness of, let alone enthusiasm for, any specific treatment being considered for approval.

The more speculation that needs to come true for the thesis to make sense, the less it makes sense. Right now, everything remains up in the air. NWBO has no cash, so I don't know how they will fund their launch. I am not willing to bet that a partner is waiting in the wings.

We don't know if approval is assured. I feel and have stated that it's basically a lock, but my opinion doesn't matter to the regulators. But approval wouldn't be a surprise ala Provenge back in the day, so I think there's a reality check coming for the "substantial price increase." My analysis states this perspective outright, that it would not be a surprise to me to see the valuation decline when NWBO actually has to successfully launch a drug.