Awesome! Glad to hear they were talking about severe asthma

Gonna miss the calls today, please post updates. I'll be looking forward to enrollment and EUA updates for sure. Plus maybe some Car-T magic they are willing to share. Hope they touch on NIH study as well.

All of this on the heels of ASH last week which seemed like a huge coming out party for Lenz in Car-T. The news is finally catching up with the science, and to top it all off you have a Top Notch Leadership Team running the show along with great partnerships & collaborations. This baby is about to go nuclear!

CART Cell Toxicities: New Insight into Mechanisms and Management

Company has said in the past that NIH results would combine for BLA. Specifically because we are in a urgent need for therapeutics and if results were outstanding I could envision a scenario where they might decide to combine both studies to get an EUA rolling sooner. If Lenz is performing the way we have been showing leading up to this I think there could be a necessary need to get the EUA Stamp to increase production like Scott Gottlieb mentioned yesterday that we need a Stockpile of reserves for the other 2 EUA'd MAB'S and that it could take months, this could be the light we are waiting on with OWS + BARDA support. Exciting times ahead, very exciting! Good Luck

They are planning an interim readout at 50% and if study completion is still estimated for Jan 8th we could be getting ready to hear of interim read coming from there in addition to 75% in Phase III.

ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19

Updated adding more sites and targeting Jan 8th primary completion


https://clinicaltrials.gov/ct2/history/NCT04583969?A=7&B=8&C=Side-by-Side#StudyPageTop

Oh yeah, HGEN has massive potential to run like crazy here.

I hear ya, we have known it's coming for a long time, and if it happens or not tomorrow one thing we both know is that it is definitely coming soon.

Does anybody else think that it is interesting that until this AM we had no advance notice of tomorrow's conference's, and just today we get the PR? Something pretty exciting could be coming. Let's Go, Let's Go, Let's Go

Cytokine Storm?? What if there was a Company called The Cytokine Storm Company? Oh yeah, that's HGEN & Lenzilumab! Good thing they are already in Trials and proving efficacy enroute to an early 2021 BLA. I'm ready, are You?

There was a substantial jump right at closing. Seems like news must be coming with the way it reacted at closing and after hours. Let's go Baby!

I am going to be busy tomorrow during conferences. Will somebody on here let me know if they get rich!

There is some decent after hours volume happening today, and not the typical garbage

https://www.nasdaq.com/market-activity/stocks/hgen/after-hours-trades

Did you turn the printer back on finally? Engineer this Train North, please.

Available supply may play a big role in they stop at 75% or go for full enrollment. I am not sure how much supply is currently available so if it is limited would it make sense to just keep plugging along to hit 515 while supply is being generated in the background? I know the goal is 100K doses in 2021 but wonder how much is ready for deployment currently? Probably started 2020 with enough supply for Car-T Trials and not much surplus to begin.

Lenzilumab has a clear and immediate need in Severe/Critical Patient population to save lives and help free up ICU beds for the next man up. I am also hopeful that the BLA will open doors to treating Mild/Moderate Patients to keep them from progressing to ICU beds. And while Lenzilumab is busy stomping out Covid related Cytokine Storms, it will also be busy making Car-T more efficacious hopefully opening doors to more Patients in need there as well as taking on GVHD in 2021. The future is looking very bright in The Cytokine Storm Fight!

We are gonna find out if were stopping at 390 or going to 515. Depending on pace of enrollment the past month I am torn on if we go for EUA or finish to full enrollment. Both options have big upside, on one hand if EUA can be achieved I wonder if it will be rushed to get into more Hospitals now as needs are extremely high. On the other hand completion might provide more strength in achieving BLA. Regardless we have strong & capable leadership to guide us here and I trust whatever decision they make and will be happy holding either way. Sometime in Q-1 we will be talking about both EUA & BLA as facts no matter the decision, and Vaccines or not The Entire World needs a viable therapeutic so the needs for Lenz in Hospitals will continue for quite sometime.


Scott Gottlieb wrote an opinion piece in WSJ about how MAB's will need to produce oversupply as an insurance policy. HGEN has talked National Stockpile in previous presentations, and I think this will be an important part of 2021 for Lenzilumab.

Antibody therapies were our best bet to lower the Covid death rate this fall, but our stockpile wasn’t enough. We need to change that, writes @ScottGottliebMD https://t.co/MziRbNDMc4

— Wall Street Journal Opinion (@WSJopinion) December 14, 2020

I'm ready, let's go HGEN!

Both interviews were excellent! Thanks guys for finding and sharing them. We are in a really strong position with regard to Covid. It is also very exciting listening to both Dale and Cameron discussing Car-T and GVHD. Why we continue to trade at such a low valuation is beyond me, other than what has been repeated by many that someone is holding us back. We will either be purchased or explode north one day, and I feel that day is coming soon. We are invested here with very smart Institutions, they know what we don't and they choose to get in early. Cameron on a previous interview mentioned that he hoped we could be covered by as many as 5 analysts in December, and that should further cement the confidence in HGEN.

Nice work Jay! Nothing wrong with grabbing some profits and improving your overall position over here. I call that a victory and just in time for our victory lap that starts hopefully very, very soon.

I believe you are correct with regards to placing a value on what HGEN is worth. Early 2021 is going to bring allot of clarity into Lenz's potential. New income will spur further testing in other areas, and that potential with the current leadership team is very interesting.

$5 Billion Market Cap would put us at just under $100 per share. An easy 10 bagger from here in the $10 range, and not totally unrealistic.

Crazy right? Part of me would love to hear that we have turned down offers from suitors, and that HGEN wants to stay independent. What a powerful message that would send regarding where the company feels like it is headed.

Looks like our friends at Gilead went shopping again. Could HGEN be next?

Gilead Sciences Buys a New Hepatitis Delta Virus Treatment

https://www.fool.com/investing/2020/12/10/gilead-sciences-buys-a-new-hepatitis-delta-virus-t/

BARDA, Operation Warp Speed and NIH all seem to be fine with current study parameters. I doubt they would be wasting their time if they didn't see the potential benefits in Lenzilumab.

Reuters Philippines EUA Article dated 12/02

This article does not specifically mention Lenz or HGEN, but it is regarding Philippines EUA rules. Also wouldn't a Lenz EUA in Philippines or Korea mention the "Korea + Philippines rights with KPM/Telcon" ?

https://www.marketwatch.com/press-release/humanigen-executes-licensing-agreement-for-lenzilumabtm-in-covid-19-with-kpm-techtelcon-rf-pharmaceutical-for-south-korea-and-the-philippines-2020-11-03

Be curious to see how Phase III Patients stack up against NIH's ACTIV-5 Trials. One thing is for sure, and that is both Trials absolutely need to be filled quickly. Let's Go!

Let's Go, Let's Go, Let's Go! I'd love to see it confirmed, we know it's coming, but it would be nice to see it.

Seabiscuit for the Win! HGEN is about to have a Ripsnorter of a Q-1 with EUA, BLA, Car-T Data, and now data from Glioblastoma Trial in Australia and potentially NIH Data, and GVHD Trial details starting. There is a whole lot to be excited about in the next 6 months or less.

Sometimes I think the World has lost it's damn mind. We skipped a most critical step in shoring up viable therapeutics and rushed into Vaccine Madness on Day 1. Vaccines are obviously very important, but it seems like all the Media want's to sell is Homeruns and Hail Mary's when we all know Defense wins Championships.

Hopefully soon we will see this thing rocketing north, big time

The KB004 study is at full enrollment, Study completion in March 2021. Q-1 2021 could be full of HUGE news, CAR-T, EUA & BLA for Covid and positive data in Glioblastoma, and also GVHD should be kicking off soon as well.

A Trial of KB004 in Patients With Glioblastoma - Updated today on Clinical Trials website

https://clinicaltrials.gov/ct2/history/NCT03374943?A=5&B=6&C=Side-by-Side#StudyPageTop





https://clinicaltrials.gov/ct2/show/NCT03374943?id=NCT04351152+OR+NCT04314843+OR+NCT03374943+OR+NCT04534725+OR+NCT04583969&draw=2&rank=5&load=cart

follow links below

$HGEN

Thursday, December 10, 2020, at 7:00 p.m. ET, 6:00 p.m. CT

Dr. Badley will be talking to the White House Coronavirus Task Force about monoclonal antibodies. Dr. Birx will be on the panel with him... https://t.co/4MFZDsM2Oe pic.twitter.com/KJ0N5a3ZWE

— Exhausted-Rebuttals (@MosaicTheory101) December 8, 2020

$HGEN 2 @MayoClinic heavyweights will be talking with Dr. Birx on Monoclonal antibodies. @MayoProceedings @MayoClinic is basically spearheading the phase 3 Lenzilumab trials... this could be a diamond in the rough that could put lenz on the national media very soon... pic.twitter.com/qRLmPiGB41

— Exhausted-Rebuttals (@MosaicTheory101) December 8, 2020

Severe & Critical calling out Anti GM-CSF as a possible treatment is huge, we are getting more recognition as a Cytokine Storm Stopper! Go Lenz Go!

That is very interesting! I'd love to have an early X-Mas. There are still concerns/issues with Vaccines and the public's acceptance and that means Lenz could be playing cleanup for quite sometime so the sooner it reaches more Hospitals, especially rural facilities the better. Not sure supply is anywhere near demand, but the EUA and with Operation Warp Speed already involved hopefully means they will find a way to increase production and delivery to more places sooner.