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.
I bumped-up an open bid to add a few more shares today. It was mostly because Dr. Thomas, a co-investigator on the CMML trial, seemed even more enthusiastic in the 'Medscape' interview, than when the company first announced the results to the EHA Congress.
""I was very surprised that the RAS-mutant arm — so, patients that have KRAS, NRAS, or CBL mutations — are just responding beautifully to [lenzilumab], and that really has taken me by surprise,” Thomas said."
But the other reason I added was because Gilead had just the opposite reaction to their trial, using magrolimab. And that opens several doors for lenzilumab. As Durrant said, "These results may create the possibility for lenzilumab development in myelodysplastic leukemias."
I can only imagine the improved morale lenzilumab may bring to cancer health care providers, and patients, where "...treatment options for CMML patients are limited to blood transfusions, hydroxyurea, and supportive care alongside the current standard of care, which includes hypomethylating agents such as azacitidine and decitabine, which have limited response rates of 7% to 18%, with no proven increase in overall survival."
I will be even happier when covid health care providers and patients will also get access to lenz, even if it is for a new variant they haven't seen yet.
Can you tell me where management went wrong by achieving an 8-fold+ improvement in treatment outcomes for Black and African American covid patients? How did they fail in LIVE-AIR by achieving Hazard Ratios of between 2.5 - 3.4?
The CMML and aGvHD studies also used lenz, and we know that data is positive. I hope it results in regulatory approvals from the UK and Australia. Is that because management failed?
The attempted sabotage of our LIVE-AIR trial results by using sicker patients in the ACTIV-5 trial, even those on IMV, still showed improved treatment outcomes, comparable to the outcome achieved by Gohibic, for which they were given an EUA. Is that failed management?
Why is it so hard for you to understand that the reason we have lost $1.3B in market cap is because we threaten the $38B in covid revenue Pfizer is realizing?
The stark reality is, if this corruption is permitted to continue, our ICU's will be too overwhelmed and under-resourced to effectively save us. Stateside Chinese-owned biotech with bio-engineered mice to catch and carry covid? ICU utilization already increasing?
Direct your anger to where it rightly belongs, against the agencies charged with approving this life-saving therapeutic.
LOL !!
Please explain where I went wrong about the RATinG study being conducted across the UK for GvHD by the IMPACT stem cell transplant centers.
To PM, do you have any evidence that those comments were made, or are being made? I'd like to know, if you do.
No, Yooo. I wouldn't be as passionate as I am about this drug and the management of this company, if I was getting paid for my effort.
It should be about time for interim analyses for CMML and Acute GvHD, plus time for news as to whether we resubmitted our covid EUA application to the FDA, with a copy to the MHRA, based on ACTIV-5 supplemental safety and efficacy data, as well as comparable date to Gohibic for stage 6 patients.
So I hope we'll hear news about regulatory progress, as well as news related to our purchase of the Baudax shares, when our 10-Q is released in the next week, or two.
In the meantime, we'll just continue to communicate our thoughts and ideas, as we are now doing.
Word of the day: goad
"He refused to be goaded by their insults."
https://dictionary.cambridge.org/us/dictionary/english/goad
"GM-CSF Inhibitor Lenzilumab Shows Early Promise in CMML
Neil Osterweil
June 19, 2023...
Targeting GM-CSF
'I was very surprised that the RAS-mutant arm — so, patients that have KRAS, NRAS, or CBL mutations — are just responding beautifully to [lenzilumab], and that really has taken me by surprise,' said Daniel Thomas, MD, PhD, from the South Australian Health and Medical Research Institute, Adelaide, Australia, in an interview with Medscape Medical News...''
Thomas is a co-investigator of the ongoing phase 2/3 PREACH-M trial, which is testing a novel strategy of treating CMML with mutations in the RAS pathway with a combination of azacitidine and the investigational antibody lenzilumab, which is a targeted inhibitor of granulocyte-macrophage colony-stimulating factor (GM-CSF).
https://www.medscape.com/viewarticle/993375?form=fpf#vp_1
"In the open label, nonrandomized PREACH-M trial, 72 patients with CMML were enrolled and were assigned to receive 24 monthly cycles of therapy depending on mutational status...
Here at EHA 2023, the investigators reported available data on 10 patients enrolled in the lenzilumab arm and one enrolled in the azacitidine-sodium ascorbate arm.
Among patients in the lenzilumab arm there was a 5.1-fold decrease in monocyte counts (P = .03) and 2.4-fold decrease in blast counts (P = .04) at 12 months of follow-up.
In addition there was a trend toward increased platelet counts over baseline at 12 months, a significant increase in blood hemoglobin concentration (P = .024), a significant reduction in spleen size (P = .03) and a trend toward lower levels of the inflammatory marker C-reactive protein...
Thomas told Medscape that the investigators have been "pleasantly surprised” at how well patients tolerated the monoclonal antibody.
"We haven't had any infusion reactions, we haven't had any pulmonary alveolar proteinosis, we haven't had any fevers from the infusion, from the antibody,” he said."
https://www.medscape.com/viewarticle/993375?form=fpf#vp_2
Thanks to Stocktwits poster paivante69 for referencing the Medscape Medical News article.
"'Fairly shocking': Secret medical lab in California stored bioengineered mice laden with COVID
Thao Nguyen and Saleen Martin, USA TODAY
Updated Tue, August 1, 2023 at 10:36 AM CDT
A monthslong investigation into a rural California warehouse uncovered an illegal laboratory filled with infectious agents, medical waste and hundreds of mice bioengineered "to catch and carry the COVID-19 virus," according to Fresno County authorities.
Health and licensing said Monday that Prestige Biotech, a Chinese medical company registered in Nevada, was operating the unlicensed facility in Reedley, California..."
https://www.yahoo.com/news/fairly-shocking-secret-medical-lab-021812463.html
Good post, Yooo.
But chances are, that management has already bought every share the company has issued. So they know how valuable the company is.
And they know how to unlock that value which, in the short run, has nothing to do with our approval prospects, or projected revenue, or any of the standard business valuations.
They have to hold the brokerages accountable for the number of shares they have put into the market, and are charging clients margin loan interest to borrow. They have not done due diligence to verify the authenticity of those shares they loaned.
But, certain corporate actions, such as a stock split, a change in venue, or a merger, will FORCE an accounting of those shares. And I think we are seeing management take those necessary steps which will result in another short squeeze, propelled even higher, and with sustained price support, if the squeeze is supported with news of regulatory approval for a number of indications, including aGvHD, CMML, and covid.
I find use in Yooo's consistent negativity, to balance the perspective I offer, and give people a fuller view to consider than just my own.
A good example, and there are many, concerns our float. I believe there are 110M more shares in our market than the company has issued. I believe our float is 229M shares, because that number was associated with a reported OS of 595,400,675 shares. And that OS, means to me, that the company will declare a 5:1 forward stock split.
So I believe in those numbers, even with nothing now to substantiate them. But that float would also substantiate what I have been saying for years about our share structure, and how that could give a false impression about insider selling. That is a subject Yooo is absolutely sure about.
In addition, Yooo has often caused me to dig a little deeper on other issues we disagree about, and those have proven to be learning experiences for me, as I find justification for my position.
But you and others do not need to tolerate a room that permits personal attacks, even if they aren't always directed at you. And that needs to stop.
I think lenz retains an advantage over the E7 antibody method of action. Lenz works upstream of E7 by binding GM-CSF. Doing so would eliminate binding the spike proteins of the virus, because the virus would not progress to the point of needing to bind the spike proteins. In addition, it's not just the receptor cells that the virus can target. The virus also shows up in accessory cells, for example.
The lenz/vaccine/anti-viral cocktail will, in my opinion, be so successful, that we will stop the virus prophylactically. That will likely apply to stopping any virus, coronavirus or otherwise, that triggers a hyperactive immune response leading to Cytokine Release Syndrome (CRS).
Also, lenz has already clinically proven it's unmatched ability to prevent and treat cytokine storm in infected patients.
But an additional therapeutic solution, using a different technique to accomplish a similar effect, could be another arrow in the quiver of our therapeutic arsenal, and two is twice as good as one.
Please stop the personal attacks. Now.
Somehow, I thought sharing what I found, just the simple facts, with no expounding, might get through to you, without you finding it necessary to attack me.
LOL !!
I didn't just make up what I posted. It wasn't even a conclusion. I'm just sharing information that I have found.
HGEN.XA ?
So, an ETF with a phytomedical research and biopharmaceutical drug development company?
Targeting Cytokine release syndrome, or CRS...potential to reset the body’s immune system after triggering hyperinflammation. Post-exposure target population...
Interesting find, deserves study.
I wonder if Gilead wishes they had kept a non-exclusive right to use lenzilumab from Humanigen, instead of spending $4.9B on buying Forty Seven, and trying to use magrolimab in 30+ trials.
Maybe management would again license lenz to Gilead, non-exclusively, of course, and maybe for not much more than the $4.9B they spent buying Forty Seven, and maybe not to use for the indications we are pursuing. After all, what are frenemies for?
You posts are like smoke bombs, Yooo, an annoyance, but ultimately impact nothing. If you had tried to understand the obstacles management has to overcome on our, and on patients' behalf, maybe you could have learned something about the REAL issues here, such as OUR VERY LIVES, AND THOSE OF OUR LOVED ONES, are worth nothing compared to the greed of our competitors and regulators.
Ihub Developers. I absolutely HATE the Beta version of this site under development on Ihub. I hope you at least give users the option to continue to use the Classic current version.
1upandaway, have you made Geert aware of lenz over the years that you have been bringing him to our attention?
I sensed Geert was very heavy-hearted over the approaching fulfillment of his assessment of reinfections on those people who have already been infected two times.
If they could get a Novavax or Janssen vaccine, and an IND approval of our lenz cocktail, they may be able to prevent the third infection. At the least, if they become infected, a lenz infusion may save them.
I'd really like to hear from John Hempton about what he replied to Ruby as he did.
Ruby
@flipflapulous
·
Jul 25
Hey
@humanigen
, before you fully go belly up, can you at least release the data?? We've still never seen why we lost our entire investment in you. You owe us something. We may never get our money back, but it would be nice to have some answers.
Sincerely,
Your investors
$HGEN
John_Hempton
@John_Hempton
·
Jul 27
because you were defrauded.
cowtown jay
@cowtown_jay
I think lenz trial data is under regulatory review for covid, CMML, and GvHD approvals or CMA's. Do you disagree? If you accepted Cameron's meeting invitation, did you learn something that convinces you that he has defrauded investors? I'd like to hear your opinion. Thank you.
I think lenz trial data is under regulatory review for covid, CMML, and GvHD approvals or CMA's. Do you disagree? If you accepted Cameron's meeting invitation, did you learn something that convinces you that he has defrauded investors? I'd like to hear your opinion. Thank you.
— cowtown jay (@cowtown_jay) July 30, 2023
"Note: I think I need to look more closely at Acute GvHD. This could be the dark horse winner of lenzilumab's first authorization or approval. Partnership interest. TeraImmune TReg work. Phase 2/3 trial."
It does indeed look like there could be reason to hope for good news regarding the use of lenz in the prevention and treatment of Acute Graft Versus Host Disease.
"Humanigen Announces Clinical Trial Collaboration to
Evaluate Lenzilumab in Acute Graft Versus Host Disease
11/11/2021
Humanigen is supporting the University of Birmingham to conduct a Phase 2/3, potentially registrational, clinical trial at IMPACT stem cell transplant centers across the United Kingdom
The “Risk Adapted Therapy in Acute GvHD”, or “RATinG”, study is expected to begin enrolling in 1H22"
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Announces-Clinical-Trial-Collaboration-to-Evaluate-Lenzilumab-in-Acute-Graft-Versus-Host-Disease-2021.pdf
Humanigen will also advance its plan to study lenzilumab in acute graft versus host disease ("aGvHD") that occurs in patients undergoing bone marrow transplant, which will be the focus of the RATinG study that is expected to enroll its first patient in 3Q22.
https://www.newsfilecorp.com/release/131903/Humanigen-Implements-Strategic-Realignment-of-Pipeline-and-Resources-to-Achieve-Key-Clinical-Milestones
"Continuing to execute the RATinG study for lenzilumab for the early treatment of aGvHD with the goal of reporting a planned interim assessment of the first 20 patients in 2Q23"
https://www.newsfilecorp.com/release/131903/Humanigen-Implements-Strategic-Realignment-of-Pipeline-and-Resources-to-Achieve-Key-Clinical-Milestones
See also the corporate preentation (thru pg 15)
https://ir.humanigen.com/English/events-and-presentations/default.aspx
This could also explain why Humanigen is keen on partnering/combining with PCI, for their services in the UK.
https://pci.com/humanigen-preparations-for-commercialization/
In addition, it appears that the company is moving forward partnering/combining with Baudax/TeraImmune.
"TeraImmune develops cell therapeutics for autoimmune diseases and immune-related disorders. It uses regulatory T (Treg) cells from a donor and makes cells for hemophilia, multiple sclerosis, and graft-versus-host disease from stem cell transplantation, enabling the healthcare industry to suppress unwanted immune reactions without side effects in patients with autoimmune diseases. The company was founded in 2016 and is based in Germantown, Maryland. In June 2023, TeraImmune was acquired by Baudax Bio. The terms of the transactions were not disclosed."
https://www.cbinsights.com/company/teraimmune
Also, this indication could relate to our latest patent
"Method of increasing the efficacy of CAR-T immunotherapy using lenzilumab
Patent number: 11673962
Abstract: Methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject, the method comprising a step of administering a recombinant hGMCSF antagonist to the subject, wherein said administering inhibits or reduces the incidence or the severity of immunotherapy-related toxicity in said subject, are provided. An hGMCSF antagonist for use in methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject also are provided.
Type: Grant
Filed: October 2, 2018
Date of Patent: June 13, 2023
Assignee: HUMANIGEN, INC.
Inventors: Cameron Durrant, Dale Chappell"
Notice the 2018 file date, well before covid.
https://patents.justia.com/assignee/humanigen-inc
Welcome to the room, Timing101. I'm glad you liked my summary, also.
Thank you and good luck to you as well. I really think we're seeing management execute an effective strategy to safeguard us and to force their desired outcome. I was very happy to add here.
That's a risk with this strategy. I have VERY minimal risk by adding at this price point, based on the 8-Jay.
I was able to just about double my position by adding at $0.013755.
I still have a very small number of shares. But I was glad to buy them before Cam and Dale get ready to spring some good news on us.
ZoomLenz . 2 of 2 . Synopsis. Topical Focus on Top Ihub>>Twitter posts
Subject: Market Opportunity
Note: I think I need to look more closely at Acute GvHD. This could be the dark horse winner of lenzilumab's first authorization or approval. Partnership interest. TeraImmune TReg work. Phase 2/3 trial.
"There will be a plethora of indications for lenz once it is approved and becomes known to the medical community. Add to that HGEN005...and ifabotuzumab..."
"Gilead's Magrolimab strikes out as blood cancer treatment...azacitidine..."
"If Gilead is scrapping their late-stage study of magrolimab with azacitidine to treat blood cancer, I wonder how that bodes for the other half dozen or so trials using that drug combination."
"The United States represents 4.23% of the world's population.
US percentage of (covid) cases 15.3%
US percentage of (covid) deaths 16.3%
It doesn't have to be that way, not when products from Humanigen, Novavax, Janssen, and Innovation, may stand ready to be used as components of a real vaccine cocktail."
"When we were naively thinking that LIVE-AIR's phenomenally successful trial outcome would result in an EUA, and could yield a market cap in the $20B range, we had reason to think that...Novavax had attained that level."
"I expect that we will benefit far more without a Gilead alliance...keep away from large market cap entities, and let the shareholders be the beneficiaries of the company's success."
"...valuation will prove far too low as the medical community becomes familiar with the value of lenzilumab's unique method of action."
Subject: Stock Play
"...our float is 229,164,012 shares, which is 192.45% of our 119,080,135 issued share total...Failures to Deliver (FTD's). Do we really want to issue additional shares for that purpose? Or do we just want paid to close out those open positions?"
"I wouldn't be surprised if we were actually under TWO business combination contracts, with PCI and with Baudax."
"Rule 204 Close-out Requirement. Rule 204 requires brokers and dealers that are participants of a registered clearing agency to take action to close out failure to deliver positions. Closing out requires the broker or dealer to purchase or borrow securities of like kind and quantity."
"I'm glad to see the Baudax/TeraImmune slide presentation features Recro staff as members of their Senior Management Team."
"I think a stock split is going to require that ALL shares outstanding be split 5:1. Illegal shorts will have to deliver 5 shares for every 1 they shorted."
"...the float of 229,164,012 was 192.45% of our current OS...So that's 110M shares more in the float, than in the OS."
"I should also consider that PCI Pharma may still be a targeted business combination."
"Baudax investment. It looks like we may have played a major role in financing their acquisition of TeraImmune by buying those 500K shares..."
"Why would we have funded Baudax's acquisition of TeraImmune, if we did not plan to merge with them?"
"I don't know what management's plan is in regards to Failures to Deliver, but I'm glad they are astute enough to manage this situation themselves..."
"less Ihub access to HGEN information...No information is provided on Shares in Issue or Float."
Subject: Influences
"I never understood why Hohneker and Xie were appointed to the board..."
"I don't (want) my taxpayer dollars to provide funding to Pfizer, if they are interfering with lenzilumab's authorization to prevent millions of deaths that their covid vaccines won't save."
"I hope Geert continues to communicate in videos.
But his comments regarding poor projected outcomes starting late this season, or early next season, for twice re-infected covid patients, is ominous."
""How is resigning at the same time, causing a Nasdaq non-conformance for the company, the faithful execution of their obligated Duty of Care?"
Initial "ZoomLenz" post
"Hohneker and Xie joined the BOD at the same time, and resigned on consecutive days."
"I think proof of our sabotage is in evidence already.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169869278
LIVE-AIR only included patients in disease severity scales 4 or 5. ACTIV-5 included patients in disease severity scales 5, 6, and 7."
Mojocash, is your trading platform showing Bid and Ask data as normal, or are you just getting access to that information from a trading ticket?
One of these things is not like the other, on Ihub, anyway. Compare data available to see that we now have less Ihub access to HGEN information. I'll use the Ford data to illustrate.
Price, support, resistance
Ford: https://ih.advfn.com/stock-market/NYSE/ford-motor-F/chart
HGEN: https://ih.advfn.com/stock-market/USOTC/humanigen-HGEN/chart
Note that on the bottom right of the matrices are links for "more quote information." Click on those links, and you get
Ford: https://ih.advfn.com/stock-market/NYSE/ford-motor-F/stock-price
Data displayed includes Shares in Issue and Float
HGEN: https://ih.advfn.com/stock-market/USOTC/humanigen-HGEN/stock-price
No information is provided on Shares in Issue or Float. There is also no longer a link at the bottom right of the matrix, as there still is for Ford, to access "more financial information." Here is the additional data for Ford from that link.
Ford: https://ih.advfn.com/stock-market/NYSE/ford-motor-F/financials
We have trading platforms. We have access to some of the data that Ihub now deprives us of.
But okay, it is what it is, and we can deal with it anyway.
But for the record, it makes more sense to regain Nasdaq listing requirements for two companies, instead of one, in my opinion. Why duplicate the process?
I continue to be impressed with the company's navigation through this process. I didn't know how they were going to reflect $22B worth of FTD's on a term sheet, anyway. LOL!
"Time" is my biggest resource constraint. We've got an unprecedented price explosion and it's hard to wait to see that happen. But the unfolding strategy being enacted has locked our adversary out of action they would have otherwise attacked us with. Brilliant!
This was my first attempt to trade during normal trading hours (for almost everybody but us) on Schwab. TDAmeritrade gave Schwab their trading accounts. I've been able to place trades after hours, even a $100 sell order is accepted. TDA wouldn't have accepted that. So, good and bad on Schwab. But I'll keep E*Trade in mind once I get to see how this goes with Schwab. Just not a good initial impression. Thanks for the suggestion!
I tried to more than double my small position today at $0.0165, which was then the Ask.
The account balance showed my deposit yesterday was Available to Trade on my new Schwab account. But after about 20 minutes of chatting with tech support, he told me that I had to wait till Monday.
The company is not going to forward split shares they did not issue.
I can understand not being too happy.
But, one type of insolvency proceeding is a restructuring, which may include a merger.
https://www.chamberlain-co.co.uk/stages-of-insolvency/
I think this is clearly the path we are on. In evidence of that was our purchase of 500K shares of Baudax Bio on June 30th, which was when Baudax acquired TeraImmune. And TeraImmune also focuses on suppressing immune response, while Baudax has a small CDMO it is associated with. Good framework to build upon.
And no one has mentioned that Humanigen could very well own every share they have issued, which I think they do. I think we are poised to initiate a forward stock split with our merger, and cause a short squeeze.
As you noted, the company is "...exploring all restructuring options..." Why would we have funded Baudax's acquisition of TeraImmune, if we did not plan to merge with them?
Just my opinion, with just enough subtle substantiation for me to comfortably make that conclusion.
"How is resigning at the same time, causing a Nasdaq non-conformance for the company, the faithful execution of their obligated Duty of Care? Can the company seek to enjoin them from resigning, until new Board Members can be appointed? What is their collective liability for this breach of their fiduciary duty?
This is highly suspicious."
While the questions I asked could be legitimate, there could also be a benign explanation. In fact, I hope there is.
I know some of you also post on Twitter. Can any of you tell me who designates the "Top" posts there on Humanigen's investor board? Is it a company representative or associate? I'm going to share this post on Twitter, and if no one here knows who controls that board, maybe someone on Twitter will be able to answer my question.
Uhhhh, no, not spam.
Thanks, Yooo. Here's more.
"On July 24, 2023, Baudax Bio, Inc. (the “Company”) received a determination from the Nasdaq Hearings Panel (the “Panel”) granting the Company’s request for the continued listing of its common stock on The Nasdaq Stock Market (“Nasdaq”), subject to the Company evidencing compliance with all applicable criteria for initial listing on The Nasdaq Capital Market, and certain other interim conditions."
https://www.sec.gov/Archives/edgar/data/1780097/000119312523192792/d538486ddefa14a.htm
The BOD resignations were, "...not the result of disagreements with Humanigen on any matter relating to Humanigen's operations..."
Could be right. Or it could be they disagreed with the Baudax investment. It looks like we may have played a major role in financing their acquisition of TeraImmune by buying those 500K shares, which got as high as $1.40 that day. Stock-for-stock deal, but operating costs will likely be higher for them..
And sacrificing the Nasdaq listing? Maybe we did that, and maybe the Board members resigned, because we are going to form our business combination with Baudax, and there weren't enough Board seats in the deal. They're a small outfit, and also facing delisting, if they can't regain compliance. And the Founder also founded Recro Bio REPH.
"RECRO COMPLETES SEPARATION OF BAUDAX BIO AND BECOMES A DEDICATED CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION
NOVEMBER 21, 2019 4:30PM EST"
https://ir.societalcdmo.com/press-releases/detail/153/recro-completes-separation-of-baudax-bio-and-becomes-a
Limited resources. A small operation. But an established framework, and potential to grow.
Maybe it's just wishful thinking, because to say I've been doing a lot of that would be a huge understatement. But dang! We're on the cusp of turbo-blasting, and I want to see it happen!
Here's the patent information in an easier to read format, including the patent you are bringing to our attention, and which is appreciated.
I don't remember seeing your name here before. So welcome to the room, if this is your first visit.
https://patents.justia.com/assignee/humanigen-inc