Humanigen Inc (HGENQ)

[cowtown jay]

I'm always glad to hear from you, eb. I appreciate your opinions very much.

To me, the priorities are saving lives, and generating revenue, at the earliest time possible.

Consider the following.

A paper published by Lancet on the role of GM-CSF in covid cases noted, "The (LIVE-AIR) study population had lower baseline C-reactive protein (CRP) concentrations than the cohorts..." of some of the large platform studies. "Exploratory sensitivity analyses suggested greater benefit of lenzilumab in patients with CRP concentrations less than the median value of 79 mg/L; further study of a CRP-guided approach, possibly targeting patients with lower CRP concentrations, earlier in their disease course, or of a different disease phenotype, could therefore be warranted."

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00539-7/fulltext

The peer review of our CRP biomarker study noted, " In the
phase three LIVE-AIR trial, lenzilumab an anti-GM-CSF
monoclonal antibody, improved the likelihood of survival
without ventilation (SWOV) in COVID-19, with the
greatest effect in participants having baseline CRP below
a median of 79 mg/L.

https://thorax.bmj.com/content/thoraxjnl/early/2022/07/05/thoraxjnl-2022-218744.full.pdf

As I pointed out previously, the ACTIV-5 trial only included patients that were receiving supplemental oxygen. So they did not include patients on room air, which LIVE-AIR did.

Inclusion criteria #6

https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4

Now look at chart #9 from our Jefferies presentation. Minute mark 12:38

https://wsw.com/webcast/jeff240/hgen/1826850

It indicates that the approximate dividing line between patients on room air with SpO2~<94%, compared to those needing low flow oxygen, was a CRP level of 75mg/L.

So the company-sponsored trial patients had a median 79mg/L CRP, but ACTIV-5 didn't select patients unless they had at least a 75mg/L CRP level (approximately). I think NIAID has to test patients on room air, with SpO2 levels of less than or equal to 94%. Durrant needs to push for this. No, really, he has to demand this. Otherwise, I don't think that selecting a trial population consisting of sicker patients is a reasonable and customary confirmatory trial practice, and that NIAID has forfeited their indemnification from the company.

Our financial security is at stake, and patients' lives are at stake. Higher a lawyer.