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Chapter 2 The ancillary benefits
In our first quarter 10-Q, the company described current trials of lenzilumab that were all sponsored by partners. The trials focused on CMML, aGvHD, and CAR-T.
In each indication, lenzilumab promises to have demonstrated game-changing improvement, which could lead to long-delayed Regulatory authorizations or approvals. Shareholders and patients will welcome these authorizations and approvals to get lenz into the market. This was, after all, the primary focus of management, prior to 2020.
cowtown jay
@cowtown_jay
I wonder if AZ will show the same interest in lenz or ifab for a vaccine adjuvant or ADC, that they may have shown in the lenz-enhanced CAR-T by Gracell. Mayo is the only other entity that I know who has studied lenz for both covid and CAR-T, why aren't they advocating for us?
This is why I think Novavax really needs Humanigen's lenzilumab as an adjuvant in their prototype vaccine. They currently produce the only protein-based covid vaccine in the US.
AstraZeneca and Janssen both produce adenovirus covid vaccines approved in Europe. I think lenz could work well as an adjuvant in all three vaccines, and it could result in millions of doses of lenz in demand.
I was wondering the same thing, especially with today's volume. I've been trying to convince myself, though, that Humanigen is the buyer. The problem with that is, I don't know who in their right mind would be selling.
And as soon as I finished that last sentence, it hit me. This volume could just represent the continued accumulation of shares in preparation for a stock-for-stock merger.
Maybe for AZ's Vaxzevria?
I didn't know about Vanda suing for denial of fast track.
https://pink.citeline.com/PS146273/US-FDAs-Fast-Track-Designation-Policy-Faces-Unusual-Legal-Challenge#:~:text=Vanda%20Pharmaceuticals%20contends%20the%20agency,the%20designation%20and%20granted%20173.
Interesting case. I'm not sure how it may relate to us. In general, courts recognize the discretionary authority of agencies where it has been granted.
But, willful or criminal negligence is different, and an AG like Ken Paxton in Texas could look into this, if presented with solid reason as to why he should. I think we may have sufficient reason to investigate, if necessary.
Don't be too sure about that, Yooo. Lenz is currently only authorized with an IND status. This could lead to a full Approval of lenz by the FDA and overseas Regulators.
That's exactly right. If lenz is being used as the game-changing therapeutic that dramatically enhanced Gracell's CAR-T (think 24 hour cycle to customize patient treatment compound, versus 6 weeks+), then that should, at a minimum, represent a licensing fee source of revenue for Humanigen.
Congratulations to former Humanigen Board member Kevin Xie and Gracell Biotech.
"AstraZeneca to buy China's Gracell Biotechnologies in $1.2 billion deal
By Urvi Manoj Dugar and Christy Santhosh
December 26, 20237:17 AM CST"
https://www.reuters.com/markets/deals/aztrazeneca-buy-china-based-gracell-biotechnologies-12-bln-deal-2023-12-26/#:~:text=Dec%2026%20(Reuters)%20%2D%20AstraZeneca,world's%20second%2Dlargest%20pharmaceuticals%20market.
My question regarding Gracell has been if lenzilumab has enhanced the safety and efficacy of their CAR-T therapy.
But why the mystery with the delayed filings, and the peek-a-boo with the latest Form 4, including today? Why buy the Baudax shares? Why present at the ASH conference? Potentially bad news doesn't need to be hidden. We're all aware of that potential. I think management, especially because our future course will be tied to other entities and various outcomes, has taken the course they are on to cloak our progress in these multiple areas, until they have been concluded. It's anyone's guess, but this is mine.
Taking a look at Humanigen's latest discussion regarding the nature of our business, we see the following.
"1. Nature of Operations...
The Company’s lead product candidate, lenzilumab, or LENZ®, and its other product candidate, ifabotuzumab (“iFab”), are Humaneered monoclonal antibodies. The Company’s Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target. In addition, the Company believes its Humaneered antibodies offer further important advantages, such as high potency, a slow off-rate and a lower likelihood to induce an inappropriate immune response or infusion related reactions.
The Company is developing lenzilumab in chronic myelomonocytic leukemia (“CMML”), a rare blood cancer, for which the Precision Approach to Chronic Myelomonocytic Leukemia (“PREACH-M”) study is underway, and is continuing its plans for the Risk Adapted Therapy in Acute GvHD (“RATinG”) study in acute graft versus host disease (“aGvHD”) that occurs in patients undergoing bone marrow transplant, as these studies are majority funded by its partners. In April 2023, the Company announced that as of December 31, 2022, eleven subjects had been dosed with lenzilumab and with current standard of care, azacytidine, in the PREACH-M study. Six subjects were evaluable based on at least three months of follow-up, including those with high risk CMML, and all demonstrated clinical benefit. In addition, LENZ appeared to be well-tolerated. The Company anticipates the first patient dosing in the RATinG study to occur in the second quarter of 2023. A leading network of centers, The Mayo Clinics, is currently progressing with an investigator-initiated trial (“IIT”) of lenzilumab in combination with CAR-T therapies."
see pg.8
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923007002/hgen-20230331.htm
Approval to treat CMML was a target objective that, "I don't see how we could: Miss getting an expedited approval to treat CMML from the Australian government, complete with a possible $100M+ Priority Review Voucher..."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172877542
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173383975
Results of that effort were presented at the latest ASH conference.
"All patients (5/5) in INNATE-1 showed 100% response (CR or optimal marrow response resulting in <5% blasts) to AZA/LENZ. Two subjects (2/6) in INNATE-2 demonstrated partial responses or haematological improvement thus far.
Conclusion: CMML is a disorder of profound innate immune activation, driven by GM-CSF and other pro-inflammatory cytokines. Early treatment with LENZ/AZA, a precision immunotherapeutic approach, leads to a) efficacy in INNATE-1 that exceeds historical CR rates for hypomethylating agents1,2; and b) evolving efficacy in INNATE-2, in which pro-inflammatory activity is more robust."
https://ash.confex.com/ash/2023/webprogram/Paper179706.html
This tendency for lenz to perform so well in the early stage of disease progression, when cytokine levels are lower, was also exhibited in the ACTIV-5 trial compared to the LIVE-AIR trial, in my opinion. I also believe that it is accurate to say that lenz, for this indication, could prove to be a preventative, versus just a therapeutic, since CMML is myeloid-driven, and lenz modulates the production of those myeloid cells.
Acute Graft versus Host Disease (aGvHD) was also detailed in Humanigen's10-K as a developmental treatment target, and was included in my list of catalysts and was a target that I did not think we could miss. The first patient patient was dosed in the on-going RATinG study (Risk Adapted Therapy in Acute GvHD) as the company announced in August.
https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Announces-First-Participant-Dosed-in-RATinG-Trial-of-Lenzilumab-for-Early-Treatment-of-Acute-Graft-Versus-Host-Disease-Following-Allogeneic-Stem-Cell-Transplantation/default.aspx#:~:text=The%20RATinG%20trial%2C%20a%20Phase,stem%20cell%20transplant%20(HSCT).
In addition to the PREACH-M and RATinG studies Humanigen disclosed were in development, and which I included as target objectives in our list of catalysts, the company also noted Mayo Clinic was conducting an Investigator Initiated Trial (IIT) of the use of lenz in CAR-T therapy. In addition, we see Gracell also conducting an IIT in the US for their CAR-T platform. And we see label updates for Gilead/Kite's yescarta and tecartus. Together, these CAR-T developments before and following the ASH conference could suggest a critical role for lenz in CAR-T.
https://www.sec.gov/Archives/edgar/data/1826492/000110465923126860/tm2332578d1_ex99-1.htm
I could go on and talk about lenz for covid, or about lenz and ifab as ADC's, but the point of the post was to look at what Humanigen stated were the projects they were working on, and how that progress seems to have progressed.
What I would most like to see for Christmas, or in the week following, is Humanigen's announcement of the recall of their loaned shares, coupled with some news in regards to either regulatory approval, or a business combination or partnerships.
Speaking of interesting clinical trial correlations, here's another reporting similar progress.
U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data
December 21, 2023
https://www.businesswire.com/news/home/20231220595740/en/U.S.-FDA-Approves-Label-Update-for-Kite%E2%80%99s-Yescarta%C2%AE-CAR-T-Cell-Therapy-to-Include-Overall-Survival-Data
When it comes to Yescarta/Tecartus, and the Zuma trials with the different suffixes, I'm totally lost.
We had this from Zuma-19:
ZUMA-19: A Phase 1/2 Study of Axicabtagene Ciloleucel Plus Lenzilumab in Patients With Relapsed or Refractory Large B-Cell Lymphoma
NOVEMBER 15, 2022
https://ashpublications.org/blood/article/140/Supplement%201/10318/489550/ZUMA-19-A-Phase-1-2-Study-of-Axicabtagene
So despite not having a conclusion that I can draw, since I think we pulled out of one of the Zuma trials, I mention this news regarding the FDA approval of the label update, just in case it sheds light on how this treatment progress is being made.
I'd like to know if there are alternative therapies achieving similar results to lenz.
Well, the majority opinion here may be that the latest Form 4, which disappeared briefly again before the market opened today, reflects sells by Dale's entities.
I don't agree with that. I think these shares are being accumulated for transfer to a partner in a stock-for-stock merger agreement. I really hope that is correct, and that the partner proves to be Novavax.
But, a new potential partner's name seems to be developing, perhaps under the same umbrella of companies corroborating with SpringWorks Therapeutics. And we still can't discount that these shares may be going to Baudax/TeraImmune.
I believe either the 10-K or the Q1 10-Q actually mentioned both a possible business combination, as well as partnerships. So if interest in a business combination was re-kindled, we could see shares going to more than just one other entity.
Further, I think the HGEN share price projection could explain the back-and-forth movement of the Form 4.
I second that emotion, Tank.
I see that our latest Form 4 may have been tweaked again this morning. So I hope this thing is good to go.
I'm not selling shares until after lenz gets regulatory approval. So this stock price if frustrating as hell, but it is also irrelevant.
You will see billions in revenue if we get a covid EUA. I think Paxlovid, which was generating about $13B for Pfizer, could lose a substantial part of the therapeutic market to lenz, especially now that studies are showing rebound cases of covid are 10X higher than Pfizer claimed. Their vaccine could also lose market share to Novavax, if their protytype vaccine incorporates a lenz adjuvant.
I think you're smarter than what is reflected in your posts. I hope you will reassess your statements.
You did not document any major mistakes made by management. You stated your opinion that we should have paired with Big Pharma.
I, for one, am a staunch supporter of maintaining our independence, where shareholders will actually be able to feel the effect of billions of dollars in revenue hitting the top line.
Yes, some personal attacks have already started, unless saying that my ego is over the top, and that I'm really bizarre, is not to be taken personally, LOL! Sounds like you're taking online psych classes from WaWa Yooo.
I mean really, when I show you trial data and link peer reviews in support of what management has accomplished, and demonstrate how the ACTIV-5 data was skewed, you come back with some barb about me drinking KoolAide?
There's no excuse for looking at the data, and not concluding that the FDA should have awarded us an EUA. That negligence is permitting the preventable loss of life. Are you seriously condemning management, and defending the FDA?
The trial size was determined with management and the FDA. Compare that trial size to the initial design of ACTIV-5.
"Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform..."
https://clinicaltrials.gov/study/NCT04583969?intr=lenzilumab&rank=2
Or look at the plan for LIVE-AIR.
"Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio."
https://clinicaltrials.gov/study/NCT04351152?intr=lenzilumab&rank=3
If our trial size was too small to qualify, then doesn't that also mean that the ACTIV-5 trial was too small to disqualify? Yes, I know they bumped up the population, but not beyond our trial population.
And what about sabizabulin?
"A total of 204 patients were randomly assigned to treatment..."
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200145
Of course, Veru claimed that, "The mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo." Ridiculous.
Is the new antagonist here another of your plebes? Are you trying to show him how it's done?
I have nothing to compare to Humanigen. The development of lenz for the covid indication, along with the already in-progress cancer application development, coincided with my wife's cancer (and covid?) progression, and it gave me an unimaginable appreciation for what this drug could, and should, be doing to save lives.
My biggest fear is that the worst, by far, is still ahead of us.
I take solace, though, in deeply believing that this management team is as capable of performing as is lenzilumab, and that when regulators are forced to depend on us, Humanigen will be prepared to meet the challenge.
I live in Humaniworld, you're right about that. When I have evidence that demonstrates my conclusions, as I have shown you, then I definitely have more regard for my own opinion, than I do for unsubstantiated contrarian views. Call that ego, if you like. I call it confidence.
I think if anyone can look at the clinical trial results, and the peer reviews, and STILL blame management for not having regulatory approval, then congratulations! You are a model citizen and qualify as a Little Brother for the Big Brother Bureaucrats who seek to control your life, for which they have less concern than they have for their own favor.
I see that you're just stuck on your agenda, and wasting my time. Humanigen's LIVE-AIR trial was a huge success.
Millions of family members have suffered the preventable loss of a loved one, because of the FDA's abuse of their discretionary authority. That remains so today.
Anybody incapable of realizing that, and trying to misdirect responsibility for these losses of human life to management, is not someone worthy of my effort.
Please explain what covid failures got us delisted.
Management should not have to run a new covid trial. It would be too expensive, and there is no reason that requires it.
The FDA claims they wanted to see additional safety and efficacy data for lenz.
I think the PANAMO trial (NCT04333420) of Gohibic may have provided some context for Regulatory consideration of lenz, based on what the government-sponsored ACTIV-5 trial determined.
https://www.fda.gov/media/166823/download?attachment
I think Gohibic may have shown slightly better efficacy in treating late-stage patients than lenz did. But I think lenz showed a better safety profile. These patients are too progressed to have been included in LIVE-AIR, but ACTIV-5 may have inadvertently provided a secondary choice for doctors treating these late-stage patients.
In addition, the PREACH-M trial demonstrated game-changing safety and efficacy of lenz in treating CMML cancer.
And a major question regards the trial Novavax conducted for their prototype covid vaccine. I am eagerly awaiting that trial data, to see if lenz was used in the manner we patented as a vaccine adjuvant.
But aside from additional safety and efficacy data for lenz, the true safety and efficacy of Pfizer's vaccine is showing significantly less efficacy than reported in their trial, and the public, as well as the medical community, is rejecting the continued use of their covid vaccine , as well as Paxlovid.
Necessity, as it has always been, will force the regulatory approval of a re-submitted EUA application for lenz.
I call the linked peer reviews of our successful Phase III trial successful.
But I also call the PREACH-M trial of lenzilumab's treatment of CMML successful. Once this blazes the pathway of regulatory success for lenz, I think the FDA will recognize the futility of trying to save the covid market for Pfizer. In fact, that's already a lost cause, no matter how much lipstick the FDA puts on the mRNA vaccines. The public is not buying the hype.
But, the public will need a real covid vaccine and covid therapeutic. They will need lenz.
We just need to announce some news, and take an interim step back onto the OTC pink venue.
As the ACTIV-5 government-sponsored trial of lenzilumab was announced, I felt that it was nothing more than the commandeering of our successful LIVE-AIR trial results. A simple comparison of the trial designs prove that. Look at the patient inclusion criteria for the two trials.
The government-sponsored ACTIV-5 trial inclusion criteria #6:
"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/study/NCT04583969?intr=Lenzilumab&rank=2
The company-sponsored LIVE-AIR trial 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/study/NCT04351152?intr=Lenzilumab&rank=3
The government excluded room air patients in their trial, and included patients on IMV and ECMO. Humanigen did not intend to treat patients that were as seriously ill as the government included in their trial.
And in case you haven't seen just how successful the LIVE-AIR trial results were, here are the peer reviews from Lancet and Thorax on this page.
https://www.humanigen.com/
I've been here since 2017. I know the company hoped that ACTIV-5 would corroborate our findings. But including patients in such a late-stage of disease progression in their trial, and excluding the room air patients who did so well in the LIVE-AIR trial, only demonstrates that ACTIV-5 was never going to corroborate the LIVE-AIR trial results.
Lenzilumab is going to be a blockbuster drug (generate over $1B in yearly revenue). Pfizer needs that revenue. But we don't need Pfizer, or any other Big Pharma, to capture this market potential. Durrant has already run 5 blockbuster products through the FDA validation process. And Dale is a specialist in the field of T cell memory function, having been published in his post-doctoral work with the Howard Hughes Medical Institute.
I have shown you the proof of what this management team has done. And I have demonstrated the government's effort to safeguard the revenue of their Big Pharma sponsors. Hopefully, facts will persuade you that the NIH and the FDA are the real culprits here, with the deadly abuse of their discretionary authority.
Covid killed 1.2M Americans so far, not including all those who died of covid-related indications. The CDC has just warned that hospitals could become over-whelmed again by the end of this month. That tells me that the mono-valent vaccines the FDA required are not going to work effectively against this new variant in circulation.
Humanigen's management are MBA's, but they are also doctors. They can't turn their backs on covid, and watch millions of people die, who could be saved by lenz. I don't call that royally screwing up. I call that living up to the ideals of their Hippocratic Oath, even if the business side of them could sway them to capture the less worldly beneficial course of treating cancer.
Place the blame where it belongs. The FDA and the NIH are solely responsible for keeping this company, with it's successful, peer-reviewed Phase III trial results, off the market, by abusing their discretionary authority.
Well, the problem with management providing updates, even with FLS notice, is that dumbasses get sucked into joining a Class Action Lawsuit, alleging that the company was misleading them. It doesn't matter that the tort lawyers used the ACTIV-5 government-sponsored trial of late stage patients, to dispute the results of the company-sponsored, peer-reviewed LIVE-AIR trial of early stage patients.
Why isn't the tort lawyer suing Lancet and Thorax, who validated our findings?
Because they know better. The peer-reviewers do not have the discretionary power the NIH and FDA has. They have to scientifically corroborate our reported results, which they did. There is nothing arbitrary about their findings. Like teachers used to tell us on math tests, they have to "show their work."
I was beginning to worry about you, Yooo. It's been 3 weeks since you posted. So, good to know you haven't forgotten about us.
As far as the post you replied to, I was only wondering aloud if lenz may be the common denominator in the success of both trials. Obviously, it was the drug being studied in the PREACH-M trial. But as I said before, I wonder if Kevin resigned from Humanigen's Board, to dedicate his full attention to the IIT of their CAR-T, using lenz as intended by one of our patents, such as this one?
"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"
https://patents.justia.com/assignee/humanigen-inc
I find interesting correlations between the Investigator Initiated Trial (IIT) results that former Board Member Kevin Xie's 'Gracell' just announced, compared to the PREACH-M trial results recently announced for Humanigen's lenzilumab.
Gracell: https://www.sec.gov/Archives/edgar/data/1826492/000110465923126860/tm2332578d1_ex99-1.htm
Humanigen: https://ash.confex.com/ash/2023/webprogram/Paper179706.html
Hello, and welcome to the room, bencozey.
I don't know how you knew there was stock manipulation going on, but then again, it would only be surprising to discover there was no manipulation. So, where are the charges against the brokerages? Don't bother looking. If there are charges, they seldom identify the victimized companies.
What does a serial stock manipulation do the the targeted company? It's usually lethal to the company. Is Humanigen on death's bed? Have you seen the opportunities we have queued up? That certainly signifies management's faith in lenzilumab to me.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173383975
The opportunity to recall our loaned shares is an interesting one, especially if you consider that our float has been reported at 192% of our Outstanding Shares. I've also seen an indication that Humanigen owns 110M of the 119M shares that are Outstanding.
Things aren't always what they appear to be.
The problem is not likely with the low level regulators who have their boots on the ground and are engaged with company staff through constant communication and site inspections. I was engaged with one such site inspector myself, when my staff couldn't provide satisfactory information regarding a process he had observed. He was fully aware of the protocol, and had the competency to accurately determine our compliance.
In the same way, I think our management was sure that we were meeting FDA requirements up until the time we submitted our EUA application. The Lancet and Thorax peer reviews validated the safety and efficacy of lenzilumab. So there was no justifiable reason to deny our EUA application. The FDA knew that. That's why they did not deny the application.
I believe it was just before, or during, the 104 days the FDA sat on our EUA application, that they exercised their discretionary authority to grant themselves a new power, the power to Decline to make a decision. That's what they then did to us. They Declined to make a decision on our EUA, claiming to want additional safety and efficacy data. That decision likely wasn't made by the FDA staff who did the grunt work with management to prepare for a successful submission. It was an arbitrary decision that effectively kept us out of the market, without having to justify their "non-decision."
Now, as we saw in the 'Live Science' article I referenced previously, the medical community is searching for a way to manage inflammation.
https://www.yahoo.com/lifestyle/dont-inflammation-then-youll-die-120009520.html
Lenzilumab has the Method of Action they are searching for. It is locked away from the medical community because of the FDA's abuse of their discretionary authority, using a newly imposed, self-granted power, to Decline to make a regulatory decision on our product.
The more I look at SpringWorks Therapeutics, and the relationship they have with GSK, and many others, the more impressed I am, and the more intrigued I become with the idea of partnering with a forward-moving group of companies, with the track record they are establishing. Even more, I think there could be some group interest in Humanigen's lenz and ifab products.
I sense a lot of potential here, particularly in using lenz as an antibody drug conjugate (ADC).
Look at what SpringWorks is doing in terms of establishing partnerships and collaborations.
https://springworkstx.com/who-we-are/partners-collaborators/
As I recall, the required P-value is .05 or less to show statistical significance. The Hazard Ratio has to be >1.0 (which would indicate the same efficacy as the Standard of Care drug).
During the 104 days that the FDA sat on our EUA, we were showing a Hazard Ratio of ~1.54, a 54% improvement over SOC. In the meantime, Roche submitted an EUA with a Hazard Ratio of 1.44, and had failed to meet the primary endpoint in that trial for about the 3rd time. But they got an EUA for toci, anyway.
The company subsequently provided the establishment of CRP levels as a biomarker. I think that was peer reviewed by Lancet. Humanigen went on to evaluate the LIVE-AIR patients segregated by CRP levels, and demonstrated Hazard Ratios that ranged from 3.0 - 3.4. In yet another lengthy peer review of that data, this one from Thorax, they determined our Hazard Ratio was "only" 2.54.
Toci was awarded an EUA with a Hazard Ratio of ~1.44 because they failed so many trials, that they had established a large database. We were declined an EUA decision, because I'm sure we followed the FDA's guidance in regards to trial size required, but the FDA decided after the fact that they wanted to see more data.
So, millions of people worldwide likely suffered preventable deaths from covid and covid-related indications, since we submitted our EUA application. None of the regulators have been charged with willful or criminal negligence or manslaughter. And we are poised to repeat the process, and allow even more preventable deaths from this new covid variant, which threatens to overwhelm our healthcare system by the end of the month.
Approval can't be arbitrary? We have Hazard Ratios that ranged from 2.5 - 3.4 from our LIVE-AIR trial. Nothing nebulous about the superior results lenz showed in treating covid patients. But the FDA still declined to grant our EUA application. That's what discretionary authority for the FDA allows to happen.
As far as CMML, I think the data I linked in my previous post indicated that current Standard of Care yields a Complete Response rate ranging from 16-21%. I also think that the interim analysis of the PREACH-M study showed a Complete Response rate of 73%. The P-value was 0.02. This reflects my understanding of the data I linked earlier.
I think that level of improvement, complete with establishing biomarkers where there were none, justifies Dr. Thomas' excitement, as well as approval and regulatory incentives, including a PRV, from the Australian regulators.
Last week's presentation to the American Society of Hematology, detailing the patterns of Complete Remission Rates of CMML with Lenzilumab, did not result with the concurrent news of Australian approval, nor of any regulatory awards, such as expedited review or a Priority Review Voucher, that I was hoping to see. Today, there is very little dedicated focus on that topic on the Humanigen investors' X board.
The news was outstanding.
https://ash.confex.com/ash/2023/webprogram/Paper179706.html
The last thing I want to do is to be hopeful about a vaporous catalyst, some opportunity that just doesn't materialize. "I don't see how we could miss" that opportunity to treat CMML patients, even without additional Project Orbis data. To me, this remains one Humanigen's top contenders for regulatory approval.
We just don't learn.
"Hospitals and emergency rooms could be forced to ration care by the end of this month, the Centers for Disease Control and Prevention warned Thursday, saying recent trends in COVID-19 and influenza are now on track to again strain America's health care system."
https://www.yahoo.com/lifestyle/covid-flu-surge-could-strain-155700941.html
"A mysterious respiratory illness among dogs appears to be spreading with cases being reported in two more states."
https://abcnews.go.com/GMA/Living/veterinarians-warn-rising-cases-mystery-dog-illness/story?id=104906650
"‘We Are All Sick’: Infectious Diseases Spread Across Gaza...
While the collapse of Gaza’s health system has made it challenging to track exact numbers, the World Health Organization has reported at least 369,000 cases of infectious diseases since the war began, using data collected from the Gaza Health Ministry and UNRWA, the U.N. agency that cares for Palestinians — a staggering increase from before the war...
The most common diseases raging through Gaza are respiratory infections, Ms. Barkley said, ranging from colds to pneumonia. Even normally mild illnesses can pose grave risks to Palestinians, especially children, older adults and the immunocompromised, given the dire living conditions, she said."
https://www.nytimes.com/2023/12/11/world/middleeast/gaza-health-infectious-disease.html
"Exclusive: US FDA finds control lapses at Moderna manufacturing plant
By Patrick Wingrove
December 15, 2023
Dec 15 (Reuters) - U.S. drug regulators in September found quality control lapses at Moderna’s (MRNA.O) main factory including with equipment used to manufacture drug substance for its COVID-19 vaccine, according to the report obtained by Reuters via a Freedom of Information Act request.
The Sept. 11-21 inspection by the U.S. Food and Drug Administration took place at Moderna’s facility in Norwood, Massachusetts, which is used to manufacture the company’s COVID shot Spikevax..."
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-control-lapses-moderna-manufacturing-plant-2023-12-15/
"Florida’s surgeon general told the FDA that COVID-19 vaccines aren’t safe. The FDA calls that misinformation
Cindy Krischer Goodman, South Florida Sun Sentinel
Fri, December 15, 2023 "
https://www.yahoo.com/news/florida-surgeon-general-told-fda-233900803.html
"The best way to conduct biowarfare is to have your ignorant-ass targeted population further harm themselves with their own medical countermeasures."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173337853
The question is, has our covid Standard of Care, focused predominantly on mRNA vaccines, harmed our innate immune response system, as I suspect that it has?
At least, questions are being asked surrounding this issue.
"Did COVID-19 make us more vulnerable to other illnesses?
Nicole Karlis
Thu, December 14, 2023 at 4:29 AM CST
"...Recent CDC data reports COVID hospitalizations are up 17% and deaths are up 25% from last week...
As Salon has previously reported, severe cases of COVID can trigger a hyperinflammatory response called a "cytokine storm" so intense that it seems to exhaust the T cells and decrease their number. More recently, there has been evidence to suggest this can affect the immune system fighting future infections from both COVID-19 and other diseases as well."
https://www.yahoo.com/news/respiratory-viruses-rise-did-covid-102902780.html
mRNA shots fail to prevent infections. They fail to prevent reinfections. And they fail to imbue an appropriate immune response against future infections.
This can, and should be, avoided. Lenzilumab, used as an adjuvant with a protein-based vaccine, such as Nuvaxovid, can halt this self-inflicted damage to our immune response systems.
I consider Dale's entities to, at least in part, be our financing arm. The share structure was outlined in a filing some years ago, which detailed how corporate insiders would be designated as the nominee owners of Cede shares placed in the accounts, with shares issued to and from the company-controlled beneficial ownership account.
We saw Baudax tried to mask their activity by using merger subs. SpongeTech used certificated shares, originally issued to nominee account holders, who would convert the shares into Cede (digital) form. I was able to identify two such accounts and knew, when the Cede shares in those accounts were converted back into certificate form, that those shares would then be retired. So a company with 2 billion authorized and issued shares, proved that there were a billion shares that could not be certificated, because brokerages could not verify the authenticity of the shares. The corrupt SEC just forced a new Transfer Agent to issue an additional 1 billion shares, and the bankruptcy judge failed to order a list of shareholders, even though that was required in a bankruptcy filing. We got the list, anyway, and the Electronic Blue Sheet trading records, through subpoena power granted to us by the bankruptcy judge.
In all cases above, as the shares were transferred from the companies to the nominees, the transactions would show as buys and sells, when they were actually only transfers of shares between the company-controlled accounts.
That's why in one of my posts, I say, "As our latest Form 4 continues to disappear and reappear, even this morning, we may need to consider who the beneficiary of these shares may be. Baudax is still a contender. But another possibility may be that Novavax will receive these shares in a stock-for-stock merger agreement." I do not accept that our latest Form 4 reflects true sells by Dale's entities. I think those transactions only reflect the accumulation of shares to be transferred in a stock-for-stock merger agreement.
And I discussed our previous recall of loaned shares, and very eagerly anticipate the next recall of our loaned shares. How would that help us, at all, if the company doesn't own the loaned shares?
I have been saying for years that the Form 4's may not be reflecting actual buys and sells.
In fairness, without having access to the Transfer Journal, I can't prove that these shares are just being transferred between company-controlled accounts. But we'll see soon enough, especially if the company recalls their loaned shares, and completes a stock-for-stock merger agreement without issuing new shares.
I have to admit that I don't see what Baudax brings to the table for Humanigen, with the possible exception of inking a deal with TeraImmune before we could. But what secrets lie beneath the surface is anyone's guess. Is there something enticing about their neuro-musculature blocking agent, or an untapped use for Anjeso?
There's got to be something, not just worth buying 500K shares of Baudax, but worth buying those shares WHEN we did, which was when we had (or still have) financial constraints.
I think the real inducement was TeraImmune.
Are we supposed to be surprised by the 8-K Baudax filed this morning?
More importantly, are Durrant, Dale, and TeraImmune's co-founder, Jay Park, surprised?
These are the steps taken to date.
Jay Park accepts a deal to transfer all equity interest of TeraImmune to Baudax in a stock-for-stock acquisition on June 30th, 2023, the last day of Q2.
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
Black Horse acquires 500,000 shares, a 6.9% equity interest of Baudax, on that same date.
https://www.sec.gov/Archives/edgar/data/1178179/000101359423000580/baudax13ga1-07102023.htm
Baudax files a warning 8-K this morning.
"Management has concluded that substantial doubt exists about our ability to continue as a going concern for the next twelve months."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1780097/000119312523293726/d37178d8k.htm
So are Dale, Durrant, and Jay Park SHOCKED by this 8-K?
My opinion is not worth more than yours. But for what it is worth, I see this last step as just a continuation of our carefully-contrived strategy. I hope that this strategy culminates with more fully leveraging our investment in Baudax, and in announcing that we are accepting a stock-for-stock merger agreement, perhaps with Novavax.
But however it turns out, I don't think any of the players are bemoaning the unexpected loss of their equity or investment dollars in less than two quarters from the time they entered into these deals.
An article just published in 'Live Science' concludes with, "Ultimately, what (Dr.) Abdou and others are doing is reframing the way that we see inflammation; not solely as a flaw to be fixed, but rather an incredible force that can be controlled and harnessed for good."
https://www.yahoo.com/lifestyle/dont-inflammation-then-youll-die-120009520.html
To me, the article illustrates the medical communities' search for an immuno-modulator which can already be found in lenzilumab. This long-delayed regulatory authorization is keeping lenzilumab's Method of Action hidden from the medical community that is searching for what lenz offers.
The article demonstrates why I never want to sell out my position in Humanigen. I think the medical community will continue to discover applications for lenz for years to come.