Humanigen Inc (HGENQ)

[cowtown jay]

"Based on the asset disclosure it doesn't appear there is nearly enough $ to reach us."

I think lenzilumab may prove to be the biggest blockbuster drug ever to hit the market. That is not a new conclusion, nor is it based on news that management has kept under wraps. Lenzilumab's astounding safety and efficacy was duly reported in the topline data of their LIVE-AIR trial, which showed a Hazard Ratio of 1.54, which was a 54% improvement over standard of care.

https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Reports-Positive-Phase-3-Topline-Results-Demonstrating-That-Lenzilumab-Improves-Survival-Without-Need-for-Mechanical-Ventila-O9C2T.pdf

Just based on the release of the topline data, with the 54% improvement over placebo and standard of care, the market reacted so favorably that I was able to sell shares for as much as $27.78 and $29.07 on March 29, 2021.

"Highlights over the past year include:

Lenzilumab in COVID-19 patients

Completed the LIVE-AIR study, which showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for invasive mechanical ventilation compared with patients receiving standard of care and placebo.

Positive results of the LIVE-AIR study were published in The Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext. The Lancet publication concluded that lenzilumab treatment of patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile comparable to placebo..."

https://www.sec.gov/Archives/edgar/data/1293310/000121465922003320/ex99_1.htm

Here again, we see management reporting the peer-reviewed results published in Lancet. But in addition to the topline data, and the Lancet peer-review, the company reported the publication of a second peer-review in Thorax. This was on using CRP as a biomarker, and it showed that the early use of lenz in hospitalized and hypoxic covid pneumonia patients showed that "... baseline CRP <150 mg/L (HR: 2.54; 95% CI 1.46 to 4.41; p=0.0009)."

https://thorax.bmj.com/content/78/6/606

Personally, I think our market has greatly expanded to include treatment of non-hospitalized covid pneumonia patients. I base this on the Thorax peer review, which concluded:

"Exploratory analysis for the effect of lenzilumab on SWOV was conducted by the CRP baseline quartile. Response to lenzilumab was observed in the first through third quartiles of baseline CRP with the greatest lenzilumab treatment effect observed in the first quartile (CRP <41 mg/L; HR: 8.20; 95% CI 1.74 to 38.69; p=0.0079)." (Info is in paragraph just above Table 3).

We're seeing reports now that Pfizer and Moderna provide 70 - 80% of the FDA's operating revenue, and that NIH and NIAID scientists are receiving royalties from these manufacturers. Here is four year old data from the FDA acknowledging this practice.

"About 55 percent, or $3.2 billion, of FDA’s budget
is provided by federal budget authorization. The
remaining 45 percent, or $2.7 billion, is paid for
by industry user fees."

https://www.fda.gov/media/143704/download#:~:text=authorization%20funds%20about%2062%20percent,%40fda.hhs.gov.

That's why lenz, with an 8-fold improvement in treatment outcomes, when administered early to patients with CRP levels <41 mg/L, can't get regulatory approval, and consequently, millions of covid patients have, or will, suffer preventable deaths. This collusion and graft is what happens when executive agency bureaucrats have "discretionary authority," which I think should be rescinded.

Lenz was intended as a cancer drug before covid came along, and an effective CMML cancer drug is what lenz has proven to be.

Humanigen Presents Promising New Hematologic Data from PREACH-M Trial for Chronic Myelomonocytic Leukemia Treatment at the 2023 European Hematology Association Congress

Full Story: https://t.co/mXv7opGRkr

@humanigen $HGEN #HGEN #Humanigen #Chemicals #Pharmaceutical #Medical

— Humanigen, Inc. (@humanigen) June 9, 2023

Regulatory approval from Australia for lenz to treat or prevent CMML will be the first key to fully meet the financial obligations to Unsecured Creditors, and provide for a distribution to existing equity holders, who will benefit even far more, as the loaned shares are recalled.