Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The Title 42 protection/restriction (depending on how you look at it) has ended.
So hopefully, what I had said earlier can no longer be somehow considered off-topic.
"There is another potentiality for AG Paxton and Governor Greg Abbott to be concerned about with the pending expiration of Title 42. I mentioned it earlier.
"Another Mysterious Balloon Is Being Tracked by U.S. Officials
The balloon was first spotted last week over Hawaii. U.S. Officials are now reportedly watching as it heads toward Mexico...
The U.S. military has reportedly been tracking the balloon since late last week and has deemed the object as no threat to air traffic or national security, and claims that the balloon isn’t emitting or receiving any signals. Sources told NBC News that the balloon is free-floating under its own power and is moving slowly toward Mexico."
https://gizmodo.com/spy-balloon-china-hawaii-flying-object-1850392558
The balloon doesn't have to traverse US airspace to spread a pathogen across America, when there are millions of foreign nationals in Mexico preparing to cross our southern border when Title 42 ends, at virtually the same time as the national pandemic emergency ends. The balloon could drop canisters of pathogens designed to open at a certain elevation, and then just continue on its merry way."
We've had reports from various universities around the world that they were able to weaponize the covid virus to yield as much as an 80% kill rate.
We've seen balloons used in our history to disseminate pathogens.
There is no known treatment option for a covid virus that is that virulent. Lenz is the best potential therapeutic solution should a lethal variant begin to circulate. Governments should stockpile lenz for the protection of their citizens, societies, and economies.
I didn't see where you were getting that. Now I do.
Have you compared that to the ownership reports I previously linked from the SEC?
https://www.sec.gov/cgi-bin/own-disp?action=getissuer&CIK=0001293310&type=&dateb=&owner=include&start=80
I'm not sure that MarketBeat contradicts what I said about this earlier. If it does, show me.
Are you sure that you provided the link you intended to provide? It doesn't support what you said.
I don't know if you have followed my discussions about the design of our share structure, using Cede shares issued to insiders, through nominee accounts, and not for the beneficial use of the insiders, but that might factor into what I hope we will see soon.
I pointed out that the insider trading record I had earlier linked reflected what most people consider insider sells. But I pointed our that the insiders did not directly own the shares designated as sold. In fact, I don't think these shares were sold, at all. I think they were just transferred to the nominee. And if so, then it could be these shares that will be issued to our business partner.
Man, I hope that is true.
The 10-Q we could be seeing tonight or perhaps tomorrow will likely reflect that our ACTIV-5 trial results were submitted for quality control review on April 13th. But unless the company waited to finalize the 10-Q until the trial results were made available, which was just made two days ago, we'll probably also see a Press Release about the tentative results.
We could also see a Press Release announcing that our business combination was finalized, and completed by more fully utilizing the capability of the shares already in the market, thereby maintaining shareholders' degree of ownership. I think that is possible, anyway.
Dr. Jayadevan makes a good point.
"Death isn't the only outcome from COVID-19, that's a foolish thing to believe. There are so many other known parameters that are being ignored, which will continue to accumulate as the virus circulates again and again."
And we have seen several things that support the doctor's statement, especially this phenomenon of "excess deaths" and increases in covid-associated indications.
The article did fail, though, to point out that we are powerless to treat not only a new variant, but especially a new covid strain. (I won't even get into a weaponized version of the virus, and the need to be prepared for that).
I really hope that we will begin to see data about the reinfection rate of lenz-treated patients. The virus could still enter the airway of lenz-treated patients, but if it can't bind to GM-CSF, it will just pass through the body without harm. At least, that's the information I would like to see.
Your initial entry on the message board was to support 'Preciouslife1,' who was supporting me. So that's a good indication of what motivates you, and it indicates your good character.
If I should be proven right about what is to transpire, the good news is that we will maintain majority control of our destiny with 60% ownership. It may even enable me to acquire another 10% increase to my modest holdings next week (but I would be thrilled if share price is too high for me to afford more shares). And we have to also remember that our company will have a larger and expanded opportunity, to perhaps treat inflammation therapeutically once drug-free intervention becomes ineffective (if our partner is currently making "Relief Factor"), which has been suggested on a couple of occasions. I don't know if Promedev can be considered a pharmaceutical company, but perhaps so. Whoever the partner proves to be, we will have an equity interest in them, so this isn't just a decrease in our ownership of Humanigen, it is also an increase in our ownership of a new entity.
Thank you for the link, JA3.
Quality Control has not been completed, but the results are presented based on patients in ordinal scales 5 and 6 at baseline. I was hoping to see why patients in ordinal scale 7 were included in the trial, but the only reason I could see for that may have been to report the results of the first Secondary Outcome: "Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score."
The Primary Outcome was "Proportion of Participants Alive and Without Mechanical Ventilation Through Day 29 in Participants With Baseline Ordinal Score of 5 or 6, C-reactive Protein (CRP)<150mg/L and Age <85 Years"
Results showed the P-value was only 0.691, and the Odds Ratio was 1.13.
The first Secondary Outcome of patients Alive and Without Mechanical Ventilation Through Day 29 in Participants With Any Baseline Ordinal Score showed:
P-Value 0.378, and the Odds Ratio was 1.24.
Odds Ratios above 1.0 favors Remdesivir plus Lenzilumab. But these results, though positive, are not statistically significant.
Technically, not statistically significant.
But in my view, these top endpoints showing positive results, when demonstrated in patients who were as much as 3 grades higher on the ordinal disease progression scale than the LIVE-AIR patients, and all of whom required supplemental oxygen at randomization, confirms the clinical benefit of lenz even beyond the P-value and Odds Ratio designations.
I hope that things like the cytokine levels demonstrate similar benefit, but interpreting that data is beyond my paygrade.
I'm not seeing any dilution happening. All I see is the existing shares trading hands. How are you seeing 50% dilution?
Yesterday, I fell victim to a pattern I have seen going on here, and I actually anticipated what happened. But that doesn't really make it any easier to tolerate. So I really appreciate your kind comments, oakhill3.
It's sad that this company, and this management team, and lenzilumab, should be attacked by orchestrated negative commentary. But I hope TX AG Paxton becomes aware of this pattern, and addresses the issue.
"We have executed a non-binding letter of intent and are engaged in exclusive negotiations relating to a proposed business combination with a privately held biopharmaceutical company (the "Partner Company"). The proposed terms for the business combination contemplate a tax-free stock-for-stock merger, as a result of which we would issue shares of our capital stock to stockholders of the Partner Company which are expected to represent roughly two times the number of our currently outstanding shares of common stock."
https://www.marketscreener.com/quote/stock/HUMANIGEN-INC-25805137/news/HUMANIGEN-INC-MANAGEMENT-S-DISCUSSION-AND-ANALYSIS-OF-FINANCIAL-CONDITION-AND-RESULTS-OF-OPERATION-43386924/
Our current number of Outstanding Shares is 119.1M. Two times this number is 238.2M shares for our prospective business combination. These two numbers equals an OS of 357.3 M. The company would need even more shares for a Controlled Equity Offering.
We haven't seen a prospectus or other filing regarding an increase in our OS for an equity offering. So how are we going to proceed?
I think we'll forward split at 5:1. There is a revised OS already showing on the Ihub financial section for Humanigen which aligns perfectly with this thesis. It reflects Shares Outstanding of 595,400,675. Divide this number by 5 equals 119.08, our current OS. The shares then available for a Controlled Equity Offering would be the difference between 595.4M - 357.3M = 238.1M shares.
The forward split would drop our share price from $0.17 to $0.034. To meet all of the Nasdaq listing standards, we need a minimum bid price pf $1.00. So we need news. We have several catalysts, to include Long Covid, government stockpiling, CMML, GvHD, asthma/arthritis partnerships, regulatory approval or authorization based on the ACTIV-5 Final Report or interim analysis of the CMML data, etc.
We were previously selling for over $30 per share with much less short term potential. We lost a major opportunity by the FDA/NIAID/NIH delays getting us into the Covid market. On the other hand, the products that got the covid revenue we should have been earning are useless now. And Covid is still the third leading cause of death in the US, with a market that could be all ours, especially if lenz could be used prophylactically.
https://www.webmd.com/covid/news/20230417/covid-remains-leading-cause-of-death-us
I have no idea of how feasible this scenario is. It just makes sense to me.
Hi, stevedazs. Welcome to the room, and thank you for your comment.
I think you picked a great time to make an entry here. Some time ago, we had a 1:5 reverse stock split. At the time, I was holding some of my shares, and flipping the rest, and the reverse split caused me to quit flipping, because I had so fewer shares, it wasn't worth it to scalp a small profit. I'm going to look forward to resuming that strategy, if it works out that way.
Thank you, Chaplain.
Things will change soon, if the Ihub financial section on Humanigen is any indication. And I have always found them to be the first to report such changes, well ahead of the brokerages.
The table is set for the first course of our long-awaited bounty, and I can't wait to see what's on the menu. I am expecting news every day now.
Hi, Chaplain. I always appreciate hearing from you.
I don't have anyone blocked. I'd prefer to challenge any comments I disagree with, so that others don't develop what I think are misperceptions.
Some days, like today, I'm not very successful in defending myself, though I try to meet TOS requirements. I just feel doubly bad, because it affects what I tweet from here to Twitter also (which anyone can do that has a Twitter account, and that would be fine with me). I don't tweet everything, because I'm self-conscious about taking up too much space in Twitter, which takes about 80% of the available posting space, to just present the first line of text, before the link brings Twitter users to Ihub.
That's not supported by the evidence I just provided.
The insider transaction report from the SEC website reflects that from June - August of 2021, insiders were selling shares that they indirectly owned.
I have long noted the design of our share structure, which involves shares held in Cede form, in nominee accounts, for the beneficial owner. The evidence reported does not indicate that insiders were selling shares that they owned directly.
The report also reflects that insider transactions since Sept of 2021 have all been acquisitions, with the exception of some stock options that were returned, because the option price to buy was above the then-market price of the shares.
https://www.sec.gov/cgi-bin/own-disp?action=getissuer&CIK=0001293310&type=&dateb=&owner=include&start=0
The PPS is a reflection of the short volume, which typically represents the majority of our total volume, as well as the delay in getting FDA approval for lenzilumab, which has been held up pending the Final Report of the ACTIV-5 trial from NIAID/NIH.
If you want to continue to claim that the LIVE-AIR trial results, as well as the Lancet and Thorax peer-reviews, are 100% false in reporting lenzilumab's safety and efficacy, then nothing I can say is going to change your mind.
What needs to be updated? Where is your dang proof that what was reported by the company, and Lancet, and Thorax, is inaccurate?
In the past, I have had a confrontation with a previous Texas governor's staff member that literally came to blows. (I won, LOL, and I don't think either of us got seriously hurt).
So even if you don't like Paxton (I don't have a problem with him), if he's going to look at trial designs and reported outcomes, I hope he looks at not only those conducted on Big Pharma's behalf, but also at those trials and outcomes from Big Pharma's small-cap competitors. Texas Medicaid funds should not be used in government-sponsored trials that are designed to fail products of small-cap companies that threaten Big Pharma revenues, especially if this corruption results in a significant and preventable loss of patients' lives, as ACTIV-5 did.
Can you source the LIVE-AIR data that fell short of what Mayo reported from their case cohort study, please?
I didn't see this coming, guys. When TDAmeritrade reports our float at :
Float 104.8M
I don't expect that it is really less than 46M, if I'm right.
I'm trying to stay mentally engaged by this process of understanding Humaniworld. Y'all are messing with an old guy's mental health here, LOL!
Just the opposite of a strategy I would have anticipated...again, if I'm right.
LOL!! Perhaps. Or is it prescience?
Why have I started to think my shares are going to be worth $0.034, and that I won't be unhappy about that?
The company never intended to license lenz strictly to Gilead, nor should they limit their exposure to the CAR-T market.
Cushy jobs? More like culture shock, most likely. These guys believe in "do no harm." Yet, they have had front row seats to what is probably the largest criminal negligence in history (I'm being generous by not calling it negligent homicide).
I hope TX AG Paxton really does scrutinize Big Pharma's 90% + efficacy claims, similar to lenzilumab's 92% efficacy going all the way back to Mayo Clinic's case cohort study, and that he takes note not only of how the field-tested Big Pharma drugs proved worthy of nothing more than shelf space, while lenzilumab was kept off the market by the FDA's newly-created, self-awarded power to Decline to make a decision on certain covid products that were not developed by Big Pharma. This, even when lenzilumab continued to demonstrate unparalleled efficacy, still noted by the NIH in their Covid Treatment guidelines, before they were unable to find statistical significance in lenzilumab's preliminary topline data.
Our insiders have never issued themselves Preferred Shares. So I'll be watching that. It's a possibility, and it may even serve a benign function, in terms of control, if such shares are issued.
Also, I would love to be partnered with a CDMO, which could give us greater control of our manufacturing process, where we aren't forced to pay millions of dollars for product the supplier was not able to provide. This would also re-establish our CMC compliance.
It's not an option that will serve us better than if the FDA had granted our EUA, which they should have done. They have literally cost us a billion dollars + in damage, in addition to letting millions of people die, that lenz could have saved, and still could save going forward.
So, the business combination is a viable strategy, and much better than any other option, in my opinion. Durrant and Dale hopefully maintain operating control of Humanigen, we'll likely get lenz commercialized, and we have a great pipeline of products to bring to market.
I think our new OS, once it's reported, will be enough to provide for the stock-for-stock exchange in our business combination, and also allow enough shares to be sold to give the company about $200M from an equity offering. I confess that I think it's pretty petty for our partner to insist that we can provide for ourselves financially in the short run, especially if they end up with 2/3 ownership of Humanigen, but if their own current share price is higher than ours, that has to be factored into the cost/benefit analysis. How much of an ownership interest will we be getting in the partner?
And it sure would be nice if the partner proved to be PCI, and had the manufacturing capacity to give us CMC compliance.
I'm looking forward to the details I hope we'll see tonight, and going forward. For all I know, this may prove to be related to an entity treating asthma and/or arthritis.
I've seen the reported float change, so it is obvious that news is pending. But we have several catalysts, between the ACTIV-5 Final Report, the CMML trial status, the partnership, and our regulatory status. I can't see, however, that news on any of those fronts should only result in a temporary share price of just $2.
No, Yooo, management has never misrepresented the capability of lenz to treat covid, and the LIVE-AIR trial, as well as the Lancet and Thorax peer-reviews, confirm lenzilumab's efficacy.
And far from covering up facts, I am exposing them as clearly and factually as I can.
If you get covid, and the doctors don't give you lenz when you're hypoxic, or mild/moderately ill, but then want you take it when you're on mechanical ventilation or ECMO, THEN you have a right to be mad, as the surviving ACTIV-5 patients should be, or as the families of the deceased ACTIV-5 patients should be. Their lives were degraded or sacrificed to sabotage lenz, and to safeguard vaccine revenues. Those doctors and trial investigators should loose their right to practice...at least.
Gone are the days when written statements can be corrected with a pencil eraser or white-out, when business dynamics evolve, and course changes have to be made.
Following the information you cited from NIH, which referenced our Hazard Ratio of 2.54, according to Lancet, the company announced that ACTIV-5 did not meet statistical significance in the primary endpoint. Somehow.
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Receives-Preliminary-Topline-Data-From-NIHNIAID-Study-of-Lenzilumab-in-ACTIV-5BET-B-2022.pdf
The company then announced a strategic realignment. "As part of this realignment, Humanigen expects to signicantly reduce its go-forward, cash-based operating
expenses including elimination of ongoing lenzilumab manufacturing, (significant) reduction in other R&D costs." The company shifted focus to treating other indications, such as CMML and GvHD.
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Implements-Strategic-Realignment-of-Pipeline-and-Resources-to-Achieve-Key-Clinical-Milestones-2022.pdf
It is false to contend that management touted lenz for covid after that. You are misrepresenting management's guidance.
My own assessment is that there will be enough positive data in the ACTIV-5 Final Report to justify a resubmission of our EUA application based on the LIVE-AIR trial, which was, as I have shown, a trial based on the early treatment of covid patients, not those late-stage patients on IMV and ECMO, as included by NIAID/NIH.
Where do you see management touting lenz for covid? They're not. Positive ACTIV-5 results, with perhaps a large platform study group or partner taking an interest in including lenz in a covid study, is all that management has said about this market.
I, on the other hand, maintain what I have said previously, which is that both governments and management will do what they are forced to do about covid, which is far from a "NON event."
If a new covid strain, or possibly even just a new covid variant, should begin to circulate, it could leave us defenseless. It reminds me of a lyric from a song I sang in church with my son.
"When you come to the place that I'm all you have,
then you'll find I'm all you need."
Yooo, we are totally unprepared for a new covid, which is inevitable. I showed recently that Dr. Birx and Dr. Fauci are now saying the same thing. We HAVE TO be prepared with an effective solution, and lenz is simply all there is, and all that is required, if administered early, and perhaps, prophylactically.
Thinking a little more about it, I think these could be shares for the stock-for-stock deal with our prospective partner. If so, it is fewer shares than I was expecting. But to close the deal with our partner, we had to give them a platform for registering their shares on Nasdaq. And it is likely that the extension granted to us by the delisting Appeal gave our partner the reassurance to finalize their agreement with us.
I'd much rather hear that the company requests a trading halt before Monday's opening, pending news. That could give us a chance to capitalize on a short squeeze. But regardless, I get a sense of forward movement, and I am happy about that, however it develops.
Elsewhere, we see:
Market Cap $ 18.47M
Shares in Issue 119.08M
Float 229.16M
https://ih.advfn.com/stock-market/NASDAQ/humanigen-HGEN/stock-price
This is a lot more believable, since we haven't seen a prospectus yet.
But still, this updated presentation opens up yet another option to consider, which is the exposure of a large uncovered short position, which pretty much lines up with the data we have been tracking regarding the majority of our trading is from short sells.
Above this premature release of data, and what it means, at the least it suggests to me that CH7 is possibly off the table.
"Again with talk of dilution." Speaking of...
"Market Cap $ 17,850,112
Shares Outstanding 595,400,675
Float 229,164,012"
https://ih.advfn.com/stock-market/NASDAQ/humanigen-HGEN/financials
Too much tequila on Cinco de Mayo? Or too early to have just awakened? Or news pending?
So, in their Covid treatment guidelines, NIH recognizes the "significant improvement" lenz showed in the primary endpoint.
But, their preliminary topline data of ACTIV-5 shows a lack of statistical significance in the primary endpoint.
Hmmm.
"Based on the patient inclusion criteria, the LIVE-AIR patients were conservatively in ordinal scales 4 or 5 of the WHO's disease severity scale."
Unfortunately, I can't be conservative by reducing the ordinal scale range of patients in the LIVE-AIR trial.
I have to say that LIVE-AIR patients were in ordinal scales 3, 4, and 5.
And that ACTIV-5 patients were in ordinal scales 5, 6, and 7.
This is due to two facts. One fact being the NIH Covid-19 Treatment Guidelines, which recognized that, "Data from a double-blind randomized controlled trial of lenzilumab did show a significant improvement in the primary endpoint of ventilator-free survival through Day 28 among those who received the GM-CSF inhibitor..." and that, "...the lenzilumab and mavrilimumab studies primarily included patients on room air or low-flow oxygen and excluded patients receiving mechanical ventilation."
https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/gm-csf-inhibitors/
And secondly, the company had reported that ~60% of the LIVE-AIR patients were on room air +. Plus what, I don't recall the degree of supplemental oxygen.
I made a big deal about this previously, as I think I should have.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169869278
Further evidence of the sustained reduction in cytokine levels is all that I want to see from this sham of a trial. It should certainly be all we need for an EUA or foreign approval.
Evidence that ACTIV-5 was designed to sabotage the reported results of the LIVE-AIR trial is clear and irrefutable.
Let me use the WHO's COVID-19 disease severity scale to illustrate my point. It's not the scale I used some years ago in illustrating my point, but it is close enough to avoid my spending hours of time to search my posting history. Besides, LIVE-AIR did not specify the numerical clinical scale of disease progression for the trial patients, they merely described the disease progression. ACTIV-5 used a numeric designation, in addition to a description.
"The WHO scale is an 8-point ordinal scale ranging from ambulatory (1 = asymptomatic, 2 = mild limitation in activity) to hospitalized with mild to moderate disease (3 = room air, 4 = nasal cannula or facemask oxygen), hospitalized with severe disease (5 = high-flow nasal cannula or noninvasive positive pressure ventilation, 6 = intubation and mechanical ventilation, 7 = intubation and mechanical ventilation and other signs of organ failure [hemodialysis, vasopressors, extracorporeal membrane oxygenation]), and death (score of 8).
https://www.acpjournals.org/doi/10.7326/m20-3905#:~:text=The%20WHO%20scale%20is%20an,cannula%20or%20noninvasive%20positive%20pressure
Let's look now at the relevant portion of the LIVE-AIR patient inclusion criteria.
"SpO2 ≤ 94% on room air and/or require low-flow supplemental oxygen and/or require high-flow oxygen support or NIPPV
Hospitalized, not requiring invasive mechanical ventilation during this hospitalization"
https://clinicaltrials.gov/ct2/show/NCT04351152?term=lenzilumab&draw=2&rank=3
Based on the patient inclusion criteria, the LIVE-AIR patients were conservatively in ordinal scales 4 or 5 of the WHO's disease severity scale.
Turning now to look at the relevant portion of the ACTIV-5 patient inclusion criteria.
"Illness of any duration, and requiring, just prior to randomization, supplemental oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) (ordinal score 5, 6, or 7)."
https://clinicaltrials.gov/ct2/show/NCT04583969?term=lenzilumab&draw=2&rank=4
There could be a difference between baseline ordinal scale condition, versus condition at the time of randomization. But in this case, I think we can be submissive of that possibility. Patients on IMV or ECMO were eligible for inclusion in ACTIV-5, as shown by the testing site from UT San Antonio.
https://lsom.uthscsa.edu/infectious-diseases/clinical-trial/bet-activ-5/
The link below is for me. It will save me time if I have to further address this issue.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext
Again with talk of dilution.
"I don't think the company intended to sell shares after April 5, 2021."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170094120
We really did, dlog. All of the back-and-forth discussions and guidance from the FDA, only for the FDA to hide behind a Decline determination announced after, what was it? 104 days?
I look at pictures and videos of Marsha, and the thought that lives, to this day, are still being needlessly lost...and even more incredibly, that we have less defense now than we did...I mean, what's it going to take for this country to safeguard itself?
Just the opposite is true. Do you think NIH/NIAID would have commandeered our LIVE-AIR trial if it wasn't worth billions in revenues to their Big Pharma sponsors?
There ought to be a Temporary Use Authorization (TUA), specifically for small companies who have successfully completed and peer-reviewed a Phase III trial, and then are selected (really, 'subjected' is a better descriptive) for further study by NIH/NIAID.
Small companies likely put most of their limited resources into achieving a successful trial. It is imperative that they be allowed to start a revenue stream by selling their product. The FDA should no longer be allowed to shirk their decision-making function behind a Decline determination, which just places an undue financial burden on companies who are deprived of revenue by not being able to sell their product. And NIAID/NIH should not be allowed to change trial parameters as they did here.