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So here is some speculation on what I think may happen over the next few weeks to months.
I anticipate the peer review being published before Christmas and MHRA approving or denying Lenzilumab around the same time. I am leaning towards MHRA approval with 70/30 odds at this point. Peer review is almost guaranteed to be very positive based on what we already know and what has been discussed by the Mayo Clinic and others.
Then comes the ACTIV-5 data in 3-4 months.
Personally I think that if peer review is as positive as we all are pretty sure it will be, and MHRA issues approval, our stock price should be back in the high teens to low twenties with these two positive catalysts and we will be fielding buyout offers prior to the ACTIV-5 data release.
This would be the perfect time for acquisition. Validation on the science and validation on commercialization, but not so much that our new value makes us less desirable for acquisition.
Companies that would be interested in my opinion include, but are not limited to, Abbvie, Gilead, GlaxoSmithKline and Pfizer.
All four are in the CAR-T space and of course Pfizer has two covid drugs, the vaccine and now the oral pill.
GSK is developing a second gen covid vaccine and is currently in the market for acquiring companies in the covid and specialty medicine space.
Abbvie's Humira, which has come out of patent, now has competition in the form of biosimilars as well as new biologics, and they are looking for new paths to future revenue with CAR-T being a big part of that plan.
Gilead already has history with HGEN through the KITE collaboration that was terminated early this year.
What would we see as a buyout price?
I would think that 3-5 billion would be in the ballpark if we see UK regulatory approval and positive peer review.
Personally I think that given what we know about Humanigen that a buyout has always been the end game. Cameron Durrant has been down this path several times now and the way the company is structured backs up that notion in my opinion.
In summary: Lenzilumab has a bright future in CAR-T alone and covid commercialization will only increase the potential for a near term buyout. These next few months should be very interesting to say the least.
That's assuming quite a bit but let's say you're right. They also have 55 million in additional credit available and the loan is interest only for 18 months.
Worst case we see an ATM offering but they definitely have quite some time before that would be needed, and I would bet they are hoping to hold out till it's actually needed for manufacturing after EUA, MHRA or BLA. Any dilution would be far more palatable in that case.
The wording is also interesting regarding the EUA rejection.
It states that additional data is needed and that it can be supplied from both studies. That may mean that they do not need to resubmit an EUA application. This is conjecture on my part and I will be emailing IR and asking if that is actually the case.
MHRA is also moving forward and could be approved before EUA especially with more data coming in from the expanded NIH study.
If it's true that an EUA does not need to be applied for again then that would definitely make me nervous as a short, as it could come without warning.
All in all the presentation was very positive in my opinion.
You do realize that the current cash outflow is due to manufacturing which will now be at least partially suspended? I mean that's not only common sense it's what management has stated.
You do realize that HGEN gets added to the Russell Micro Cap, Russell 3000 and Russell 2000 this coming Friday right?
If we were going to hit 16 it most likely would have been yesterday on quad witching day. Just like on 3/19.
The fact we held above 18 is actually quite bullish. Gotta remember that the stock offering a few months ago was at 18.50, and it wasn't retail that bought up those shares.
That being said anything is possible with HGEN I suppose, but unless EUA is denied it is unlikely to say the least.
It was a scheduled sale of less than 3% of his holdings. He still has 13.5 million shares. It's literally insignificant.
You know what is significant?
Inclusion in the Russell 3000 and Russell Micro Cap today and by automatic extension also the Russell 2000, which means ETF's and mutual funds will have to buy.
$500 is a stretch, as that would be a 30 billion dollar market cap. 10-20 billion when Lenzilumab also gets approval for CAR-T therapy? Sure.
3-5 billion MC on EUA approval? Yeah that's possible. A buyout offer in the 5-10 billion range? Sure not too much of a stretch. With the Indian Delta Variant becoming a huge problem we will see more hospitalizations soon.
Yeah we are talking easily 10-20 times current market cap in revenue over the next two years. He also mentioned how they expect covid-19 to have somewhere around 500k breakthrough cases a year that require hospitalization for the foreseeable future.
All this without the CAR-T side of things being added to the equation.
I got in $AMV in January for $3.17 so I did hit a ten bagger and have no real regrets. Coulda been a twenty bagger if I had waited till today but that's perfectly okay with me, as I had no illusions about AMC's eventual upcoming crash. AMC is not GME and it certainly isn't HGEN.
I really like this company and see a bright future for it and those of us who have invested. I do wish I had waited to sell my $AMC however LOL. It did go into $HGEN so it will be fine in the end. Cheers!
And it's 25%-35% in many rural and "red" areas as I pointed out. Children under 12 aren't eligible for now and will be a reservoir along with all the anti-vaxxers for the virus to mutate and stick around for a long time to come. Most adults who want a vaccine have gotten it so the numbers aren't going to drastically improve at this point.
Throw in the probable need for boosters, and using the yearly flu shot percentage as an example, we will probably see 50% of eligible people getting boosters this fall/winter.
We don't have enough data yet on the Indian variant and hospitalizations as it has only just gotten here. But early data shown that both Pfizer and Moderna are less effective against it and that it is considerably more contagious, 60 percent more contagious according to an article I read today.
And over 600k people have died here with the supposed best healthcare in the world. The point is that the new mutation is going to ensure this continues to spread, not that India will be buying the drug, although they probably will stockpile some for national security reason same as every other country.
One other point people seem to be missing is that this drug is not only covid-19 variant agnostic, it is pathogen agnostic, meaning research has already shown that it will be effective against cytokine storms brought on by other diseases.
Influenza can kill the same way and we could see a new flu at any time.
You don't seem too see the big picture here, but that's okay, smart money does see it and they are loading up.
How many pandemics have you experienced? You think you are an expert on something you've never experienced before this past year?
When the cost of the drug is less that the hospital stay, that changes the math quite a bit.
I take Humira for Crohn's and arthritis. Without it I would not be able to participate at all in life and run my tax paying business. I am sure you are aware how much humira has made for Abbvie.
Just read that a 33 year anti-vax Colorado police officer died of covid last Wednesday.
Covid-19 isn't going anywhere especially in countries/areas with anti-vaxxers.
Deep red states are averaging around 35% vaccination rate and people have basically stopped getting vaccines in many areas, particularly rural counties with poor healthcare systems.
Everyone who wants one has already gotten it. My friend runs the next county overs health department and they are at 25% and he has shut down the program because no one new was showing up. This is a county with over 120k people.
With the new variants making the vaccine only 70% effective as well, it means we aren't anywhere near done with this.
We need an effective treatment for severe covid. In India they are seeing youngish people (30's-50's) die within 2-3 days where it had been days to weeks.
HGEN is literally the only drug that treats the cytokine storm and it is a literal lifesaver.