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Fantastic!
Not enough people understand the ‘variant agnostic’ benefit of lenzilumab. I anticipate the FDA will finally see the light.
FDA should take these new variants into consideration as part of the risk with not giving Lenz an EUA. The scale should tip towards Lenz where reward is greater than the risk. And hopefully additional data does the same.
Good summary. I am confident despite the stock price.
Buyouts happen. Like you, I think Cameron is poised to go that route. Lenzilumab is proven and the proof strengthens daily if you consider the ongoing trials to have similar results as the P3. A larger biotech may be looking at Humanigen and saying, we can acquire them, put a turbo charger on Lenz trials and bring a BLA to the finish line.
For MHRA to be working as close with management as they are this late in the process is highly positive. Dialogue is a good sign. But I think the UK could consume 100k doses alone. Therefore $1 Billion revenue is accessible for 2022.
In summary, I think we are bound to get MHRA and we are bound to be acquired. But I think the price will be higher than you anticipate.
On Humanigen website there is a tab called ‘Compassionate Use’. Might be worthwhile pursuing. My best to your mother.
In January, my mother was in the hospital and endured a drastic case of septic shock. She ended up losing some limbs. I have wondered if Lenz may have assisted in her system to ‘correct’ itself and make it through rather than for extremities to start shutting down while the core fought it.
$8.00 seems pity considering where we were prior to FDA holding pattern designation. But, I would be happy to see it. Too much happening in UK and EU for there not to be a strong momentum upwards. Not to mention the US has still not figured out how lenz could save many issues the hospitals are now faced with (ie: lack of beds for patients - not just those with Covid).
He does say later in the clip that the combined study group is roughly 1,000. But that was a general statement of the number of Lenz trials to date.
Given that the video was made a week before being released there were moments where Cameron seemed more careful than before about giving too much pending information.
We have much to look forward to in the coming weeks. The peer review should make for some good conversation. Leading up to the MHRA decision will also bring some positive movement for the stock price. And if approved in the UK, maybe the FDA will be inspired to finally give Lenz the nod.
I am surprised they have not PRed the MHRA submission yet. Durrant was very adamant it would be well before month end. Two days is not “well-before.”
I did notice through the three recent presentations, Cameron became less enthused that it would be before month end. We’ll see.
With no revenue dollar amounts in a PR, all it does is give the shorts (of which there are more than I can remember) a timeframe to exit.
Another, more favorable catalyst might be the ‘partnership’ CD was referring to in the presentation.
And, I replayed a half dozen times the part where CD talks about ifab, I read into it as something happening sooner than anyone expects.
Only one brokerage has the PT less than $9. All other analysts have PTs slightly lower than when the company was waiting for EUA response. That says, there is a delay in the expected earnings, but it shows confidence that EUA will eventually be granted. The one firm that has PT below $9 is the least involved with Humanigen. Plus, they have always been a bit shady in my opinion.
Yes, I do hope the request for additional data was real and not just another FDA standard response.
FDA probably does not take into consideration corporation financial health into their decision making process. Large companies certainly have an edge in so many ways. Sadly, innovative smaller companies that may have the next best product are hindered and have a more difficult hill to climb.
I agree about not waiting for NIH to conclude before reapplying for EUA. It tells me the FDA feedback is such that it won’t take much to push over the finish line.
It also doesn’t hurt that distance is being established from the vaccination decisions peculiarly made at the same time as Lenz was declined. Whether direct or indirect, one has to consider the political pressure the FDA was faced with at the time the decision was made.
$20/share is not an acceptable buyout amount. Especially for merely an FDA request for additional data. There is still a large unmet market (sadly). Real value of HGEN has potential for being multiple times $20. I’ll be patient.
Yes, my thoughts exactly. A sooner response from the FDA would have kept HGEN in a much more viable position. I hope CD goes back to them with the new data and says they put the lenz supply chain in jeopardy by delaying a response. If FDA truly wants a therapeutic for COVID symptoms they need to act quickly before further disruption in supply.
Will cash need to be raised if CMA is granted? I anticipate a CMA would bridge to a possible EUA approval. If that is the case, we would not need to raise cash differently.
“Cash Runway”: based on the slides from both recent presentations, HGEN had cash and cash equivalents of $120M as of June 30. Q2 manufacturing was $57M. The unknown is Q3 manufacturing expenditure. Any guesses on what that might be? And any guesses on what the non-manufacturing spend will be until approval? CD said they intend to “extend the runway.” This can be interpreted in multiple ways. Thoughts?
LOL! I see that!
I, too, believe that the market cap of HGEN is at rock bottom. The ‘decline’ of the recent EUA application is merely temporary. Cash expenditure will need to be managed, but I feel we can get UK decision or retry EUA without much dilution, if any. Would like management to confirm.
I received an email from Fidelity offering an “opportunity” to loan my shares out at an unspecified interest rate. HGEN shares must be scarce.
Is the FDA in a vacuum? EUA can be approved, modified or retracted at anytime. Why not approve and allow the drug to be used? What is the hold up?
Perfectly explained. Tired of the “Dale selling” excuse for HGEN stock price.
Or is someone a buried short or hedge fund and doesn’t want the information made public? Both ends of the spectrum can be at play here.
Who sent the private messages? Nothing was wrong with your post. Public information.
I would be very curious what conversations are taking place within the FDA. If the EUA is stalled for political reasons, it must be frustrating. If it is stalled because of pure bureaucratic reasons, it must be embarrassing. If Lenz EUA is stalled because of FDA being in big pharma’s pocket, it’s criminal. I’m sure minions within the system who know of Lenz’s potential to save lives would love to share an opinion.
Don, my thoughts exactly. I’ll take an extra 10 days if we can qualify for a BLA.
Crazy how disrespected CDMO is considering the potential of HGEN and ongoing HALO growth. Need news.
Delta variant slides.
Is it possible this PR was to reassure the FDA that Lenz will be available to the US even if the UK pulls the trigger first? Seems like it to me by the statement of allocating product.
As has been discussed previously, EUA will be a catalyst for sales announcements. Without the revenue numbers HGEN will continue to be vulnerable to price manipulation.
July 15 for EUA
UK will commit on July 9. They have less politics involved and a much greater need - as of today.
All the others will swing in within July 25.
Me as well Scooter. What good would EUA approval be without any sales.
The big question for me is who hits the buzzer first? US or UK?
EUA will probably be the first domino to fall. But revenue PR’s are what it takes to move and sustain price.
Exactly Jay. It’s complicated, but I believe PIT has nailed it. Chappell is likely being advised to make this sale. It was planned out well in advance and will, in the end, potentially save him millions in taxes.
In fact, the financing done in March(?) when we were all confused as to why the company would not just do a shelf is probably part of the overall picture. It’s all being set up for a fantastic catalyst like...say...EUA approval and a BARDA contract.
Great deductions PITrader. One other very positive indicator of Chappell selling to just below 20% is that the company has no immediate future plans to dilute the pool. Had they done that, Chappell’s holdings would have naturally dropped below 20%.
IMHO, this is very positive news. Those who are treating it otherwise are either taking advantage on the short side or buying the very inexpensive shares under cover of the sale. July is HGEN’s month!
Nice move. Lots of analyst support for CDMO these days. They smell when things are brewing on the positive side of business. Looking forward to whatever it is!
Also, is JPM still in business? The have done nothing to the $21 PT. Must be on vacation or asleep at the wheel. They look like fools!
Credit Suisse is likely “getting in the game” with this move. Once EUA is approved they can raise the PT as needed. I’m just glad to see more coverage.
The question is, did they do this because they recently became aware of Humanigen’s potential or was it merely brought on because of being added to the Russell a few weeks back?
One would think HGEN will gain additional coverage in the coming weeks.
The numbers he gave, if priced at $10k per dose, are astounding.
Getting some very good clarification on capacities, markets and other breakthrough infections.