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"And there are a host of other indications, including asthma, arthritis, malaria, Long Covid, etc., that I think will far surpass anyone's expectations."
"Pfizer's Paxlovid fails as 15-day treatment for long COVID, study finds
By Michael Erman
June 7, 2024
June 7 (Reuters) - A 15-day course of Pfizer's (PFE.N), opens new tab COVID-19 antiviral treatment Paxlovid did not relieve symptoms of long COVID, according a study by Stanford University researchers.
Currently, there are no proven treatments specifically for long COVID in which a host of symptoms can last for many months after initial coronavirus infection."
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizers-paxlovid-fails-15-day-treatment-long-covid-study-finds-2024-06-07/#:~:text=June%207%20(Reuters)%20%2D%20A,study%20by%20Stanford%20University%20researchers.
Yes, in part, and as I have previously made clear, some of my conclusions, particularly in regards to Novavax, have no basis in fact, and simply reflect a blaringly obvious solution to the unmet needs of both Humanigen and Novavax, as only they can meet for each other with such a high degree of success. I am highly confident in what Dubovsky can contribute toward our international approval and usage of lenz.
My pinned post, which reflects the last communication from Humanigen, focuses on our opportunities as otherwise noted in my post. And I think Sanofi will enable our ability to penetrate the market beyond covid and into oncology and hematology.
I have read and studied the material on Humanigen over the years, just as I read and studied my college textbooks. No relevant communication with management, other than that, except for conveying my appreciation of management, as I am doing now, because I think they are entirely worthy of shareholder support. Hopefully, we'll all have the financial reward they have worked to provide for us, and many more shareholders will share my appreciation of them after that gain is realized.
Diego, I think management may have secured a revenue stream through licensing fees from Gracell, Mayo Clinic, Novavax, Sanofi, our PREACH-M and aGvHD partners. and others TBA, that will pay the $44M to our unsecured creditors, and negate the reason to remain in bankruptcy. How management wants to capitalize on the recall of their loaned shares remains to be seen and is irrelevant to me. And there are a host of other indications, including asthma, arthritis, malaria, Long Covid, etc., that I think will far surpass anyone's expectations. The Do or Die bankruptcy hearing is scheduled next week, on the 13th. If I have overstated our potential, it's because you sincerely asked if I thought there was something that could move the stock price. But even a more limited version of our opportunities could prove sufficient to successfully exit our CH11 proceeding.
It just makes no sense to raise the subject of an expanded program to meet Milestone Events without Humanigen capitalizing on their share structure and offering some type of distribution to existing equity holders, chiefly the company.
You're a good man, eb, and I appreciate your continued support. But the amended Asset Purchase Agreement was probably the best news we could have received. I look forward to hearing from Michael North on how Taran and Humanigen may be integrated, and I suspect that Filip Dubovsky may have a key role in the expansion of our Milestone Events, which I think will shock the investment community...and the short sellers who have bet against us. Also, I credited Dubovsky for a possible role in the Pfizer covid trial, but Michael Shuster is who I should have credited. I hope this is our last week in purgatory.
As I indicated in the link I provided, the date for the Combined Hearing is June 13th.
I'm fully aware of the warning that existing shareholders may not receive a distribution from the Liquidating Trustee.
But I am convinced that the co-exclusive licenses held by Sanofi and Novavax, will prove to be a game-changer for Humanigen shareholders. I actually think Novavax has received funds they can use to pay their licensing fee to Taran, which could fully satisfy the Unsecured Creditors, and that Taran will possibly offer an exchange of equities to Humanigen shareholders.
There is just not enough information for me to speculate on whether Sanofi will also provide licensing fees to Taran, and how Humanigen shares may be converted to Taran shares, nor how to tell what the outcome will be of a possible combination of Sanofi, Novavax, Humanigen, and Taran.
But, in light of the warning about potentially no distribution to Humanigen shareholders, coupled with my commitment to have a reasonable basis for my conclusions, I am saying that I expect a successful conclusion to our CH11.
Novavax just hit another new 52 week high of $22.24 today.
Novavax just eliminated the possibility of recipients topping-out on awards granted to them under their 2015 Stock Plan. This will positively impact Dubovsky, who I think we'll see named as our Chief of Development. Their June 13th Stockholders Meeting coincides with our June 13th Combined Hearing.
"AMENDMENT TO PROXY STATEMENT DATED APRIL 29, 2024, FOR THE NOVAVAX, INC. 2024 ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 13, 2024."
https://www.sec.gov/Archives/edgar/data/1000694/000110465924068426/tm2416428d1_defa14a.htm
See pg 3, The Combined Hearing
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Well, Novavax did end up making a 52 week high yesterday. I'm hopeful that they will be using lenz as a vaccine enhancement, and that we see them make an all-time high, which would be over $300 per share, and maybe result in filling my open sell orders at $200 before the orders expire early in July.
"... it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders."
As I recall, it is the SEC that proposes which Bankruptcy Trustee they want. In my previous experience, the Trustee and the bankruptcy judge discussed the rampant naked shorting of the victimized company that was forced into bankruptcy, and decided not to accumulate a required list of the victimized shareholders, just due to the excessive scope of the problem. Subsequently, the SEC entered into a Settlement Agreement with the Bankruptcy Trustee to deregister the shares, which required the judge's approval.
We obtained the required list of NOBO/OBO shareholders by subpoena. We also argued against the Settlement Agreement, and the judge denied that Agreement.
My point is that Bankruptcy Trustees have a vested interest in accommodating the SEC, by whom they are recommended as Trustees. I think that presents a conflict of interest, and the Trustees should be nominated by a disinterested party (the Consumer Financial Protection Agency, for example). A second point is that shareholders have significant power that can be granted to them by the judge.
I've been reticent speak too much since Liquidation was declared, and that guidance was provided to advise shareholders that no distribution to them was anticipated.
However, it is evident that Humanigen's circumstances have changed (or are changing), to the point where I expect that a distribution will be made to existing equity holders. We see support in that regard by the amended Asset Purchase Agreement, which will significantly expand the Milestone Events, and payments to the Unsecured Creditors.
We see Dubovsky altering his career path from Novavax's President of R&D, as we see Sanofi begin their spin-off, at the same time that we see both companies acknowledge their co-exclusive licensing agreement, which I suspect will be for lenz. I think it is these changes that will ignite the significantly expanded Milestone Events, and will also trigger Humanigen's recall of their loaned shares.
I see Gilead trading near 52 week lows today, while Novavax is trading near 52 week highs.
I suspect this illustrates why management did not want to give Gilead exclusive rights to use lenz. Rather, if I'm right, we'll see that lenz is the product co-exclusively licensed to Sanofi and Novavax. And hopefully, Dubovsky has helped to demonstrate that lenz improves the efficacy of azacitidine in treating, or preventing, Myelodysplastic cancers, perhaps significantly beyond what he and Pfizer demonstrated in their trials.
Of course, we know that Gilead gave up on their effort in this regard, after spending almost $5B to buy magrolimab, which failed to show improved efficacy, and in fact, resulted in increased mortality.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174481489
If North knows what he is getting into by establishing communications with investors and key shareholders of Humanigen's stalking horse bid winner, then he must know about Taran's strategy going forward, and believe that there is sufficient value to warrant the investment he will be soliciting.
And, since our bankruptcy judge has kept us in a CH11 proceeding, he should be equally informed about Humanigen's prospects and strategy as it relates to shareholder value.
Existing equity holders were excluded from voting on the Combined Plan and Disclosure Statement. However, it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders. The Declaration of a Record Date would not adversely affect the superior claim holders in any way. In fact, it could add value to their claims, if certain Causes of Action are implemented.
Existing equity holders should be permitted to Object to an arbitrary denial of our Preservation of Rights. I see no reason why the judge, rather than the Liquidating Trustee, should not retain the authority to Declare a Record Date, if requested by the Debtor.
There may be something we could learn from Sanofi's acquisition of Inhibrx, Inc. I see some similarities in the set-up of the acquisition. It's beyond my pay grade.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524150383/d843856dex991.htm
Hello, D
First of all, let me say that I appreciate your continued consideration of my posts. The issue of how the bankruptcy concludes, in my opinion, should now consider whether Humanigen still meets bankruptcy parameters, especially in regards to liquidation. I don't think they do. I think we should see our status changed from liquidation, back to reorganization, from which we should emerge with our share structure intact.
Something else I have long believed is that we are engaged in biowarfare. I view the illegal mass migration of non-Europeans into the US in support of that claim. That claim is also reinforced by the tens of thousands of Chinese nationals who have entered our country illegally. These immigrants are not susceptible to the covid strains designed based on national DNA databases. A good discussion of this topic is based on an interview by Matthew Smith of Doug Casey, in which they note a Deagel study which projects the US population to decline by as much as 200M by 2025.
"Research into Disease X also requires gain-of-function utilization, to possibly produce another novel coronavirus, which I think could be the Pangolin Coronavirus GX_P2V..."
More recent discussion suggests that "Disease X" could actually prove to be a version of H5N1 bird flu, which could be, or will become, genetically modified. Dr. Kelly Victory, one of my favorites, conducted an excellent interview of Dr. Brian Hooker, PhD, on this subject of "H5N1 Bird Flu: New Pandemic Gets New mRNA Vaccine," starting at minute marker 09:30 in the following video.
It begs the question, since Humanigen has no secured debt obligations; no non-tax priority claims; and the unsecured creditors are voting to approve the amended APA in anticipation of a rigorous response toward accomplishing Milestone Events, then why shouldn't the CH11 bankruptcy be discharged with the share structure absorbed, as the company emerges from this reorganization?
An old skeptical challenge to such a Phoenix re-emergence of life, would be to ask, "How did this happen? Did the company discover a cure for cancer or something?" And the answer is likely yes, for cancers such as CMML.
It could be the butterfly effect. But my long-standing, pro-bias toward Novavax has me convinced that they and Humanigen have such mutual benefit by partnering, that Filip may very well slip into a Chief position with the Taran/Humanigen entity.
But I'm even more excited about the amended Asset Purchase Agreement, where it was indicated that, "...The settlement amended the APA to, among other things, significantly expand the events that will trigger the contingent “Milestone Payments” and increase the amount of those payments under the APA."
end of 2nd para, pg 4/5
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
About two weeks later, we got a little mixed messaging in Doc 253, where it was noted that no distribution to shareholders was anticipated, but that same paragraph concluded with the potential of a Record Date being declared, exactly for a Distribution to shareholders (which I think could be for shares of Taran, equal to the number of our Humanigen shares).
see 1st para, pg 3
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Is Filip Dubovsky retiring as Novavax's President of R&D, after recent patent grants, including some that were Granted in February and March, 2024?
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924064680/tm2415419d1_8k.htm
https://patents.justia.com/assignee/novavax-inc
Will he be joining in the Sanofi spin-off company, perhaps merged with the Humanigen/Taran entity, and Novavax?
"Michael North
Co-Founder, CEO; Chairman of Galaxy Magnesium
1mo
I have agreed to serve Taran Therapeutics as Strategy Advisor. Taran is a leader in the field of monocolonal antibody therapies, and I provide communications with prospective investors and key stakeholders. I work directly with the chief executives of the company, Cameron Durrant and Michael Schuster, helping to formulate its mission, vision, and long-term investment strategy. This is especially meaningful to me, because of my long commitment to the life sciences, specifically to making fundamental therapies that penetrate to root causes widely available."
https://www.linkedin.com/posts/michaelnorth_i-have-agreed-to-serve-taran-therapeutics-activity-7183247229166534657-j50L
Michael W Schuster, MD
Hematology Oncology, Hematology
https://doctors.stonybrookmedicine.edu/provider/Michael+W+Schuster/2250408
Schuster seems to have had a role in the following Pfizer clinical trial
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
https://clinicaltrials.gov/study/NCT04842604?intr=NCT02367456.&rank=1
"T cells, cancer and immunity"
I've only listened to the first half, so far, of this latest video posted by Dr. John Campbell, in which he and Professors Angus Dalgleish and Robert Clancy are discussing 'T cells, cancer and immunity.'
You'll have to check Youtube for Dr. Campbell's video for "T cells, cancer and immunity." I can't get the link to work.
To me, listening to the three of these gentlemen is the next best thing to listening to an investor presentation from Dale or Durrant. Without knowing it, I think John, Gus, and Robert are actually talking about the Methods Of Action for Humanigen's Lenzilumab and Ifab. At the least, I always feel that I develop a better understanding of the role I anticipate that our products will play, as we gain regulatory approval and authorization, and gain CMC and commercialization from partners such as Sanofi and Novavax.
"The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax."
Today, Shah Capital filed an Amended 13D for their Novavax holdings.
"Item 4. Purpose of Transaction.
Item 4 is hereby amended to add the following:
On May 20, 2024, the Reporting Persons announced that in light of recent developments at the Issuer, they have determined to withdraw their preliminary proxy statement and campaign against the re-election of the Class II directors at the Issuer’s upcoming annual meeting. The Reporting Persons have long advocated for the Issuer to explore potential strategic partnership opportunities and believe that the Issuer’s recent announcement of its entry into a co-exclusive licensing agreement with Sanofi is a long-awaited step in the right direction."
https://www.sec.gov/Archives/edgar/data/1000694/000119380524000687/e663637_sc13da-novavax.htm
Sanofi, one of Humanigen's oldest shareholders (going back to Kalobios) has announced their intention to spin-off their healthcare division, and they and Novavax have acquired co-exclusive licenses to...use lenz as a vaccine enhancement? I believe so.
There are several developments I was hoping Humanigen would have expanded upon last week, because they all point to the likelihood of our success. And even more than news regarding regulatory approval, which would qualify as a Milestone Event, I especially anticipate the recall* of the company's loaned shares, with that news.
Particularly interesting is the filing of The Official Committee of Unsecured Creditors of Humanigen, Inc. Initial estimates were that this group could receive from
about $172K - $8.5M.
"The Creditors’ Committee initially objected to
the sale to Taran (the “Sale”) but ultimately reached a settlement with the Debtor and Taran
pursuant to which certain terms of the Sale and the APA were amended as described on the record
at the hearing before the Bankruptcy Court on February 14, 2024. The settlement amended the
APA to, among other things, significantly expand the events that will trigger the contingent
“Milestone Payments” and increase the amount of those payments under the APA."
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
Achieving a Milestone Event, in and of itself, would enable Humanigen to pay the full $44.1M owed to the Unsecured Creditors, and open the door to the restoration of financial reward for shareholders.
*Shareholder value will be greatly enhanced by Humanigen's recall of the loaned shares. I had news of a different type of recall myself, from my auto manufacturer. But, my out-of-pocket expense is going to be several thousands of dollars to repair my car. Not the type of recall I was hoping for.
The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax. Novavax filed the following in this regard.
"Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”),
ii) A sole license to develop and commercialize combination products containing a potential combination of the Company’s COVID-19 vaccine and Sanofi’s seasonal influenza vaccine (“COVID and influenza Combination Products” or “CIC Products”),
iii) A non-exclusive license to develop and commercialize combination products containing both the Company’s COVID-19 vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID Mono Products, CIC Products, and Other Combination Products (“Licensed COVID-19 Products”), and
iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include the Company’s Matrix-MTM adjuvant (as described below, the “Adjuvant Products”).
Under the Collaboration and License Agreement, the Company will receive a non-refundable upfront payment of $500 million. In addition, the Company will also be eligible to receive development, tech transfer, launch, and sales milestone payments totaling up to $700 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products. In addition, the Company is eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
It's a shame, Chaplain. We just keep seeing new effects of the damage caused by the virus, AND, caused by the medical countermeasures to the virus, as seen in this young lady's case.
Better HEALTH, a whole lot more WEALTH, and no more STEALTH.
Thanks, Chaplain. I'm pretty sure that management submitted lenz for consideration in treating long covid. I hope lenz will be authorized for it. It's not just for the pain and the chronic fatigue, I'm concerned plaque will become more inflamed, and further lead to restricted blood flow and more clotting, especially with a long stent in my left leg. Lenz has shown how it makes therapeutics more effective, and I think it will likewise lead to improving a variety of indications.
"This biological decrease in energy is specific to those with PEM and not seen in other chronic illnesses."
I have to disagree. In addition to Long Covid, I think this post-exertional malaise (PEM) is also caused by mitochondrial issues associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). I was hoping that lenz would have demonstrated success in treating Long Covid, and that it would help me with ME/CSF. I'm still hopeful.
https://www.newsbreak.com/news/3336545657202-long-covid-can-destroy-your-ability-to-exercise-or-do-simple-tasks-now-we-may-know-why?_f=app_share&s=i16&pd=0EVqRbCy&lang=en_US&send_time=1715800027&trans_data=%7B%22platform%22%3A0%2C%22cv%22%3A%2224.19.0.27%22%2C%22languages%22%3A%22en%22%7D
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392668/
Chances are that I misinterpreted the meaning of the 'Covid Mono vaccine,' and that mono, in this sense, means monovalent.
"On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”)..."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
But the term "co-exclusive license" poses the question, who is the licensor? I think Taran will be revealed as the licensor.
I received the proxy material this morning from my broker, even though it is assumed that I would vote against the Combined Plan and the Disclosure Statement. The hearing has been set for June 13th, 2024.
The Hearing will not interfere with Taran's licensing the use of the patented vaccine enhancement, using lenz, to Novavax and Sanofi.
Nor will the Hearing derail progress in the various on-going clinical trials for CMML, aGvHD, and Mayo Clinic's CAR-T. In fact, success in these trials will cause a sharp increase in price for shares of Humanigen, (or the merged entity with Taran), and will result in the company's recall of their loaned shares.
"No new CMML medications with novel mechanisms of action have been approved in over 30 years..."
A Covid Mono vaccine? Do we already have the therapeutic form with lenz?
"On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”)..."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
I did not take a covid vaccine, and took comfort in my contracting mono (mononucleosis, or Epstein Barr virus,) as a teenager, to provide antibodies from T cell memory. I did have a blood test which detected EBV.
But aside from the name distinction, the symptoms of chronic fatigue and inflammation (I still can't wear my cowboy boots), seem to be very similar for EBV and Long Covid (and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
https://www.cdc.gov/me-cfs/about/index.html#:~:text=People%20with%20ME%2FCFS%20have,concentrating%2C%20pain%2C%20and%20dizziness.
This insidious virus demands the authorization and approval of lenz. Some of us would prefer not to be fodder for the goal of depopulating the world until it is our time to do so.
The important thing is that you got a green checkmark, instead of the signature shit-faced (have you seen his profile pic, very appropriate) 💩🤡 emojis you got for a previous post. Good job!
"What would it take to monetize these Milestone Events? It would take receiving a BLA from the FDA for CMML, and related indications in the US. I think Sanofi, with their deep pipeline of oncology products and processes, would be an excellent partner for us in oncology, once they complete the spin-off of their healthcare division in the coming months."
Sanofi, one of Humanigen's first shareholders, issued four Press Releases in between April 17th - May 2nd, 2024.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524129331/d793882d6k.htm
And as we know, Sanofi is planning to spin-off their healthcare division. So, a lot going on there. Did they overlook something?
"Novavax and Sanofi Announce Co-exclusive Licensing Agreement to Co-commercialize COVID-19 Vaccine and Develop Novel COVID-19-Influenza Combination Vaccines
May 10, 2024
>Agreement provides individuals with broader access to a protein-based non-mRNA adjuvanted COVID-19 vaccine through combined commercial strength, from 2025 onwards
>Provides Novavax with cash and an equity investment totalling approximately $1.2 billion (upfront payment of $500 million and up to $700 million in additional development, regulatory and launch milestones), plus tiered royalties
>Novavax is entitled to additional launch and sales milestone opportunities of up to $200 million, plus mid-single digit royalties, for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax's Matrix-M™ adjuvant technology
>Accelerates potential for development of a novel COVID-19-Influenza combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially offering individuals enhanced convenience and protection"
https://ir.novavax.com/press-releases/2024-05-10-Novavax-and-Sanofi-Announce-Co-exclusive-Licensing-Agreement-to-Co-commercialize-COVID-19-Vaccine-and-Develop-Novel-COVID-19-Influenza-Combination-Vaccines
These developments have enabled Novavax to remove their 'going concern' warning. "Liquidity and Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern within one year after the date that the financial statements are issued and contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business."
see pg 7
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000100069424000031/nvax-20240331.htm
I'm hoping for news this week that Humanigen's patented methodology was used to enhance Nuvaxovid, and that we will see our restructuring completed with a discharged CH11, and some type of licensing, partnering, or a business combination announced.
Unless Dale lost his Appeal, Humanigen is positioned to enter into a stock-for-stock merger with Taran. If Dale lost his Appeal, Taran could just outright buy Humanigen's shares. I don't think it's likely that Dale lost his Appeal, or Durrant would have submitted a Tender Offer, instead of an Asset Purchase Agreement.
You're not recognizing the value of Humanigen owning ~90% of the shares they issued, leaving a float of 192% of our OS. If lenz is gaining market access, whether through authorization or approval, or through its IND use by Gracell and Novavax, that news, announced with the Taran merger, will be the trigger for Humanigen to recall their loaned shares.
That really does promise to be good news for Taran and Durrant!
But, it would be far better for them to trade Taran shares for Humanigen shares, as I think they will. It makes no sense for Taran to deal themselves out of the recall of Humanigen's shares. I hope Durrant announces the stock-for-stock merger now.
"Novavax shares soar on license deal with Sanofi at lofty valuation
By Sriparna Roy
May 10, 2024"
https://www.reuters.com/business/healthcare-pharmaceuticals/frances-sanofi-covid-19-vaccine-deal-with-novavax-statement-2024-05-10/
I am obviously very happy about this announcement, as these two companies have been the subjects of several of my posts. Now if we could only confirm that the efficacy of the Novavax vaccine was indeed enhanced by Humanigen's patented methodology.
Lenzilumab's sabotage was done by the design of the NIAID/NIH ACTIV-5 clinical trial. All the while, billions of Genetically Modified Organisms (GMO's, aka 'vaccines,') were administered to the populations mainly of the US, the UK, and Australia. mRNA vaccines were not administered in China.
Lenz will gain market access through it's ability to prevent CMML, and to enhance CAR-T and protein-based covid vaccines.
I don't care whether it was the covid trial, or the CMML study, seasoned clinical trial investigators were SHOCKED by how quickly, safely, and effectively lenz saved the lives of severely ill patients. I'm specifically talking about Mayo Clinic's Dr. Claudia Libertin, in the video-taped trial review meeting with fellow investigators on the covid LIVE-AIR trial, as well as Dr. Daniel Thomas, Clinical Hematologist, Royal Adelaide Hospital, Associate Professor, Adelaide Medical School, The University of Adelaide, who presented the interim results of the CMML study.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext (I can't access the video archive)
https://medicalresearch.com/cancer-_-oncology/preach-m-trial-humanigen-study-evaluates-lenzilumab-and-azacitidine-for-cmml/#:~:text=The%20preliminary%20results%20from%20the,cells%20with%20RAS%2Dpathway%20mutations.
Lenz is practically miraculous. That was evidenced by the reactions of the clinical trial investigators (no, there are not "lots of drugs" that cause those reactions from the investigators) , and confirmed by both the Lancet and Thorax peer-reviews.
So yes, lenz works. Will lenz be approved? Yes, by necessity only. Regulators have a vested interest in saving the covid market for Pfizer and Moderna, and for their share of royalties from the approval of these products.
"However, in our breaking investigation, we found hundreds of millions of dollars in payments also flow the other way. These are royalty payments from third-party payers (think pharmaceutical companies) back to the NIH and individual NIH scientists."
NOTE: I do NOT advocate for Fauci's assassination.
https://www.sammyboy.com/threads/fauci%E2%80%99s-royalties-and-the-350-million-royalty-payment-stream-hidden-by-nih.321335/
Management is ALL about getting regulatory approval, even if overseas, and saving patients' lives, as well as rewarding shareholders.
"...the rich live and poor die because they cannot afford the anti-viral drugs. FDA would not approve these drugs."
Actually, we ARE seeing a change in the FDA's view towards drugs like lenzilumab.
I mentioned previously that Invivyd received an EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA. "The immunobridging pathway for COVID-19 treatment is enabled by data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype monoclonal antibody (mAb), for the treatment of COVID-191 and data from the ongoing CANOPY Phase 3 clinical trial of pemivibart for PrEP of COVID-19. The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible. "
https://www.globenewswire.com/news-release/2024/05/07/2876606/0/en/Invivyd-to-Pursue-Rapid-Immunobridging-Pathway-to-Potential-EUA-for-Treatment-of-COVID-19-in-Moderately-to-Severely-Immunocompromised-People-Based-on-U-S-FDA-Feedback.html
I think this change simply reflects the FDA's recognition that having no viable treatment therapeutic for covid 19 is untenable.
Equally untenable is failure to utilize lenz to enhance non-mRNA vaccines. The EU challenged, but then quickly accepted the enhanced performance results of the latest Novavax covid vaccine. But Novavax is, rightfully, also under investor pressure to capitalize on this opportunity.
"Shah Capital Launches Campaign Urging Stockholders to Vote AGAINST the Re-Election of All of Novavax’s Directors Up for Election at its 2024 Annual Meeting"
https://www.sec.gov/Archives/edgar/data/1000694/000092189524001044/dfan14a11882nvax_05062024.htm
The earliest patent application for developing humanized antibodies was filed in 2015. The patent was granted to Humanigen in 2021.
More recently, another patent was filed in 2018, and granted to Humanigen in 2020. The following month, another patent was granted for CAR-T use. There were other patent grants, as well.
So it appears lenz has met your requirement of, "...any new drug needs at least 5-10 years of data," based on the 2015 and 2018 patent filings, which were granted.
Lenz wasn't in a Phase III trial, it had completed it, and successfully met the primary endpoint. I normally provide links, but you have shown me that such substantiation means nothing to you.
Lenz was sold to whom "for nothing?" Our CEO. And we know that preparations have been made for Taran to issue stock. Why? For a stock-for-stock merger?
I agree that lenz has multiple use applications. I consider it like WD-40, but I like your analogy to baking soda, as well.
And I know you realize that neither Pfizer, Moderna, nor mRNA technology have as much data history that lenz has, but they are authorized.
And perhaps you further realize that the mRNA vaccines are CAUSING injuries and excess deaths?
But Humanigen's success is on the horizon.
At last report, Humanigen had several sponsored clinical trials of lenzilumab in progress.
"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 addition, we have the following. Mayo Clinic, whose trial investigators led Humanigen's successful LIVE-AIR trial for the treatment of hospitalized and hypoxic covid patients, is also conducting an Investigator Initiated Trial..."of lenzilumab in combination with CAR-T therapies. We are also developing iFab, an EpAh-3 targeted monoclonal antibody, currently in Phase 1 development, as part of an antibody drug conjugate (“ADC”), for certain solid tumors."
see pg 14
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923007002/hgen-20230331.htm
More on Mayo Clinic's CAR-T program can be found here, which includes a 7 minute video.
https://www.mayoclinic.org/departments-centers/car-t-cell-therapy-program/home/orc-20404317
None of the above is speculative. In addition, we know that the interim analysis of the PREACH-M trial showed outstanding results for CMML.
"The additional data demonstrate that in all 10 participants with at least three months of treatment with both lenzilumab and azacitidine, blood monocyte count decreased fivefold (P=0.03), the percentage of blast cells and pro-monocytes decreased more than twofold (P=0.04), and C-reactive protein decreased more than threefold (P=NS) with improvements noted after both 3 months and 6 months of this combination treatment. These results suggest lenzilumab may normalize hematologic and inflammatory aberrations in CMML and improve the condition of participants. All ten evaluable participants had a rapid clinical response."
https://ir.humanigen.com/English/news/news-details/2023/Humanigen-Presents-Promising-New-Hematologic-Data-from-PREACH-M-Trial-for-Chronic-Myelomonocytic-Leukemia-Treatment-at-the-2023-European-Hematology-Association-Congress/default.aspx
Also, Mayo Clinic's Dr. Zelalem Temesgen also led Humanigen's effort to establish CRP as a biomarker, to identify which covid patients would benefit the most by being treated with lenz. The Thorax peer review of those results confirmed the following. "Exploratory analysis for the effect of lenzilumab on SWOV was conducted by the CRP baseline quartile. Response to lenzilumab was observed in the first through third quartiles of baseline CRP with the greatest lenzilumab treatment effect observed in the first quartile (CRP <41 mg/L; HR: 8.20; 95% CI 1.74 to 38.69; p=0.0079)..."
https://thorax.bmj.com/content/78/6/606
Those are facts which should have forced regulatory authorization or approval. Instead, the FDA conducted a study of late-stage patients, beyond the treatment scope management intended, and failed to meet the primary endpoint in that trial, which the class action lawyers negligently used as the basis for their suit against the company.
Regardless, I am looking forward to seeing if lenz is being used by Novavax to enhance their covid vaccine. On October 15th of last year, the EU delayed approval of the vaccine. "The Financial Times, which first reported the news, said the EMA had questions on the potency of the vaccine's latest version, and that it is seeking to ensure its characteristics will be the same across different production sites."
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-delays-approval-novavaxs-revised-covid-vaccine-ft-2023-10-15/
By the end of the month, the EU approved the vaccine.
"Novavax's Updated COVID-19 Vaccine Now Approved in the EU
October 31, 2023...
Approval was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants."
https://ir.novavax.com/press-releases/2023-10-31-Novavaxs-Updated-COVID-19-Vaccine-Now-Approved-in-the-EU
What better vaccine enhancement than lenz could have so quickly caused the 180 by the EU, for multiple variants, and imbued a T cell response with a high level of potency and dependable replication?
For that matter, will Mayo discover similar increases in lenziulmab's safety and efficacy in their ITT for CAR-T, as Gracell may have? And will Mayo, as well as Sanofi, find success in using Ifab as an antibody drug conjugate (ADC) in their cancer tumor treatment programs?
Humanigen has never been stronger than we are now, and we have never been closer to success. Incredible performance and execution by management.
You're very welcome, eb. But my explanation is actually quite sanitized, with an underlying deep and dangerous tale relating to serious criminal activity. I fully understand why management designed our share structure as they did, to mask their accumulation of shares. And I wanted to highlight DJT's experience recalling their loaned shares, to illustrate the importance of excellent news (regulatory approval, restructuring) to add share price momentum to our next recall. I saw some activity that suggests to me that Humanigen could be ready to proceed with executing their game plan. At least, I really hope that's what it means. It could just mean that there is a new normal, which would be fine, if this signals starting our new beginning.
By the way, without the approval of the Emergency Rule Change, the US equity market would have crashed in three days.
One of Sanofi's three new independent Directors is John Sundy. "Between 2014 and 2021, he held several management positions including Senior Vice President at Gilead Sciences..."
https://www.sanofi.com/en/media-room/press-releases/2024/2024-02-22-18-02-50-2833994
Sundy's tenure at Gilead was during the time of our collaboration with them.
"Kite and Humanigen Announce Clinical Collaboration to Evaluate Investigational Combination of Yescarta® (Axicabtagene Ciloleucel) with Lenzilumab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
-- Phase 1/2 Multi-Center Clinical Trial to Begin Enrolling in Q4 2019 --
The objective of this study is to determine the effect of lenzilumab on the safety of Yescarta. Kite will act as the sponsor of this study and will be responsible for its conduct."
https://www.gilead.com/news-and-press/press-room/press-releases/2019/5/kite-and-humanigen-announce-clinical-collaboration-to-evaluate-investigational-combination-of-yescarta-axicabtagene-ciloleucel-with-lenzilumab-in-r
As I recall, Humanigen refused to sign an exclusivity agreement for Gilead's use of lenz, so Gilead ended up buying Forty Seven for $4.9B, only to have to suspend patient enrollment in a clinical trial due to lack of magrolimab's efficacy.
https://www.gilead.com/news-and-press/press-room/press-releases/2020/3/gilead-to-acquire-forty-seven-for-49-billion
https://www.biospace.com/article/gilead-suspends-patient-enrollment-for-troubled-magrolimab-in-solid-tumor-trials/#:~:text=In%20July%202023%2C%20Gilead%20announced,satisfied%20the%20criteria%20for%20futility.
I could get into Sanofi's agreement with AstraZeneca, who acquired our former board member Kevin Xie's Gracell, but you guys can look into it if you're interested.
Restructurings sure can get complicated.