Humanigen Inc (fka HGENQ)

[cowtown jay]

Chief Medical Advisor. Even better.

"New Head of MAHA Revealed as He Lays Bare Radical Plan to Transform US Health… And Ban Covid Shots + More

Daily Mail reported:

A newly appointed health advisor to the Trump-aligned Make America Healthy Again (MAHA) initiative has unveiled a bold plan to overhaul the nation’s health. British cardiologist Dr. Aseem Malhotra, a long-time ally of MAHA leaders like health secretary Robert F. Kennedy Jr. and NIH head Dr. Jay Bhattacharya, has joined the movement as Chief Medical Advisor."

https://publichealthpolicyjournal.com/new-head-of-maha-revealed-as-he-lays-bare-radical-plan-to-transform-us-health-and-ban-covid-shots-more/

It is still crucial that Bobby uses his Inspector General's staff, even if the position itself isn't yet filled, to address aspects related to willful or criminal negligence, possibly in regards to certain of the previous members of the ACIP and Big Pharma.

[cowtown jay]

"I had quit following the bankruptcy case because I think the issue is largely moot for the effect it will have on shareholders going forward."

By that comment, I mean that I think almost all the heavy lifting necessary for a successful resolution to the bankruptcy case has already been done by GS working with Geoff Winkler (I hid a Chair in the boardman closet for Geoff, just in case).

[cowtown jay]

💙The definitive evidence for Regulatory Approval of Lenzilumab is presented by the trial doctors who conducted the company-sponsored LIVE-AIR trial. Those results are presented and discussed by the trial investigators in the following 36 minute video. It should be noted that the first 10 minutes of the video discusses a case cohort study conducted by Mayo Clinic, as a pre-cursor to implementing the Phase III trial by Humanigen. Select the option to watch the video on Youtube.

[cowtown jay]

The problem with "true placebo control" was best illustrated by LIVE-AIR trial investigator Dr. Claudia Libertin. She noted how one of her patients did not require supplemental oxygen just as the Delta Wave was hitting. The very next day, however, that patient required NIPPV, as I recall.

If Humanigen's management was interested in bolstering Lenzilumab's reported efficacy, they could have used a standard placebo at their clinical trial testing sites. They chose, instead, to let the testing sites use their Standard of Care in the control group, which was often dexamethasone and remdesivir. So. the reported Hazard Ratio ultimately determined by Thorax peer review, of 2.54 overall, was based on improvement over SOC, not a placebo.

This isn't Gold Standard performance, like Bobby is looking for...this is platinum. Place the prevention and treatment of cytokine storm into the care of Humanigen, the company designed for that purpose, along with our partners.

[RitonavirCYP3A4]

Great dates to look forward to:
🏛️ Criminal Case – United States v. Chappell (24-CR-243, D.N.J.)
• Status Conference:
• Scheduled for June 16, 2025, at 2:00 PM ET
• Location: Camden, NJ, Courtroom 4A, before Judge Karen M.?Williams ?

?

⚖️ Civil Case – SEC v. Dale B. Chappell et al. (23-civ-03769, D.N.J.)
• This case is proceeding in District Court and subject to the Third Circuit’s July 9, 2024 ruling affirming the SEC’s asset freeze ?.
• No additional hearing or motion schedule has been publicly announced yet by the SEC or court. The SEC listing (LR-26206) simply confirms charges and jurisdiction, without specifying further court dates ?.

[cowtown jay]

As unequivocable as Lenzilumab's safety and efficacy was proven to be, most comprehensively in the Thorax peer review of the LIVE-AIR trial, the even more value of lenz may be the untold backside contribution I expect lenz will show toward lowering excess deaths and in preventing future cases of covid and covid-related pneumonia reinfections.

The approach Bobby is taking is going to unveil the full effect of lenz-enhanced covid and CIC products, compared to other vaccine platforms.

While I understand the concerns outlined in the article linked below, a quick resolution, to include the four years of covid treatment history, is actually REQUIRED for an accurate assessment of America's covid response and future direction.

https://www.yahoo.com/news/covid-crusader-writes-open-letter-234500979.html

[cowtown jay]

I see nothing standing in the way of our unparalleled and historic success, especially as our American Health Care leaders live up to the expectations I have of them.

Posted by: cowtown jay
"I think the only way Bobby can comply with the decision of the Advisory Committee on Immunization Practices (ACIP), is to dismiss all of the current Committee members, and appoint his own ACIP staff, if there is any reason to even have this Committee.

Jay Booth
@booth37337·
May 1"

"RFK Jr. Fires All 17 Members of CDC’s Vaccine Advisory Board
Story by Janet H. Cho

“Today, we are taking a bold step in restoring public trust by totally reconstituting the Advisory Committee for Immunization Practices (ACIP),” he wrote."

https://www.msn.com/en-us/news/politics/rfk-jr-fires-all-17-members-of-cdc-s-vaccine-advisory-board/ar-AA1Go9e6?ocid=msedgdhp&pc=HCTS&cvid=b0a33cbc5c954ec183f88696fa812f70&ei=7

[sosjtb]

"We"'meaning HGEN cusip holders don't have any patents. We have debt far exceeding cash or revenue. That means we have nothing but a tax write off. Those who now own the patents will benefit  from them being used in Brilacidin if that's the case.
Our total loss in this investment is to the benefit of those who absconded with the only thing left of value here and were probably able to capitalize on that at our expense.
You and I and all HGEN shareholders get nothing  from this Jay.

[cowtown jay]

"Regulatory messaging over the last week or two has been atrocious."

However, the newly-initiated FDA-related podcasts are helpful, in terms of message clarification or re-statement.

[eb0783]

Thanks for sharing, Jay. I also have some IPIX. Good to know.

[cowtown jay]

Several years ago, I mentioned that I kept a small number of shares in IPIX so that my trading platform would keep me updated on share price. I wanted to keep an eye on them because I thought their Brilacidin anti-viral may be used by Humanigen in our lenz/vaccine cocktail.

Today, IPIX poster 'frenchbroad' posted this.

"New patents who include Brilacidin for 2025 = 9:
https://worldwide.espacenet.com/patent/search?q=brilacidin"

Several of our covid patents are in the link she provided.

[cowtown jay]

Patents for the NIH's Dr. Matthew Memoli, and NIAID's Dr. Jeffery Taubenberger:

"A large investment in older technology

The vaccine technology in HHS’s new initiative uses inactivated whole-virus vaccines, an older approach that delivers an entire virus that’s been chemically tweaked so it can’t infect human cells. The project comes from work being driven by Dr. Matthew Memoli, the NIH’s principal deputy director, and Dr. Jeffery Taubenberger, acting director of NIAID."

Note the File and Publication/Patent dates.

https://patents.justia.com/search?q=+Matthew+Memoli

https://patents.justia.com/search?q=Jeffery+Taubenberger

[cowtown jay]

The pansies are in bloom along Laissez Faire Avenue in Regulatory Overlook. But despite the focus on appearance, order has been lost and direction has been sacrificed.

The post I'm replying to, concerning Jay Bhattacharya's statement about the paradigm shift represented by Generation Gold Standard, shows Jay's lack of understanding the roots of this paradigm shift, but it focuses accurately on our destination. And Humanigen's Lenzilumab is the most critical component needed to reach that destination.

Regulatory messaging over the last week or two has been atrocious. I just want to bring the focus back to the contributions that lenz will enable Novavax and Sanofi, our prospective partners, to make, in the way Jay outlines.

[cowtown jay]

I wouldn't mind seeing Dr. Aseem Malhotra named to replace Christi Grimm as the Inspector General for HHS, if that's possible. I can see Bobby holding onto the CDC Director function, even though it may be going to Susan Monarez, for some reason. But that IG slot should be running hot already. There's a lot to do, and Aseem is well aware of the problems we're facing.

[cowtown jay]

I guess I was getting the July time frame from Doc 356.

"The Claims Objection Deadline is extended for the Liquidating Trust to object to
Claims through and including July 7, 2025."

https://document.epiq11.com/document/getdocumentbycode?docId=4430358&projectCode=HUM&source=DM

There were subsequent filings, however, that I had quit following, and that support your September deadline.

I had quit following the bankruptcy case because I think the issue is largely moot for the effect it will have on shareholders going forward.

[SorcererGuru44]

All of the liquidating trust extensions have been filed through September, so I anticipate it to take at least that long.

July would be nice though.

[cowtown jay]

From the recesses of my disturbed mind. I think it relates to a deadline the liquidating trustee has. Please correct me if I'm wrong. Otherwise, I'll look up the Epic site myself.

[SorcererGuru44]

Where are you gathering the July time frame from?

[cowtown jay]

I think management will continue to pursue the covid opportunities by having consolidated operations into what was our Australian subsidiary. We'll know the details when our bankruptcy case concludes in July.

[VanGan]

I think Humanigen/Novavax/Sanofi will bind together, and own the Covid and the CIC vaccine markets exclusively.

If there is any further Lenz development in Covid, it will be through Taran. Humanigen was liquidated in the bankruptcy. Taran owns the rights to Lenz now.

I'm just going by what Taran is posting on their website (not the Pacific Royalties site). They seem more focused on oncology rather than Covid.

[cowtown jay]

Taran's website, which is not that new, says this about their market for covid.

"Many public health professionals are convinced that a new serious variant of the original COVID-19 source, will eventually emerge through mutation. By the end of 2023, a total of 772 million people worldwide had contracted COVID and its variants, and a new milestone was passed — 7 million fatalities worldwide (over 1.2 million in the US).

As of this writing (April 2023), people continue to die each day from COVID-19 and its mutations. Source: World Health Organization

Only disciplined application of monoclonal antibody therapies has kept these numbers from being much larger.

When — not if — a new outbreak occurs, Taran will be among the first with the experience and resources to begin addressing that need quickly."

I've referenced that passage before. It is written by Pacific Royalties. Find them linked on "The Opportunity" tab of Taran's site.

http://www.pacificroyalties.com/resources/taran-therapeutics/

I think Humanigen/Novavax/Sanofi will bind together, and own the Covid and the CIC vaccine markets exclusively.

[VanGan]

I'll be honest, I am not sure if Taran (Durrant's new company) plans to initiate any new Covid trials with lenz. Everything on their website seems to be pointing to oncology as the primary area of focus.

https://www.tarantherapeutics.com/the-products

Lenzilumab (LENZ) is a monoclonal antibody currently in a Phase 2/3 trial in Australia for Chronic Myelomonocytic Leukemia (CMML), with published findings presented at an invited oral presentation on CMML at the American Society of Hematology meeting in San Diego in December 2024, showing a CR (Complete Response) and either an mCR (marrow Complete Response) or an oMR (optimal Marrow Response) of 85% in the aggregate (whether assessed by the IWG or Savona criteria) compared to 7-21% cited in literature for standard of care. LENZ was well-tolerated and not associated with serious adverse events, consistent with the clinical experience in hundreds of patients in other studies at a similar dose or higher.

US, UK and European trials are planned in CMML, and potentially in AML, MDS, autoinflammation, CHIP and oncology treatment-associated myeloid neoplasms. A Phase 3 study protocol has been signed off by FDA focused on increasing the effectiveness of CAR-T therapies for cancer. Mayo Clinic is in discussion with the company to lead this potential registration study. LENZ has an established safety profile and a Chemistry, Manufacturing, and Controls (CMC) package.

[cowtown jay]

Here's information on one of the patents Humanigen filed which reflects management's intention to enhance the Novavax covid vaccine, in my opinion.

"METHODS FOR TREATING CORONAVIRUS INFECTION AND RESULTING INFLAMMATION-INDUCED LUNG INJURY
Publication number: 20230109208
Abstract: The present invention provides methods for treating a subject infected with 2019 coronavirus (SARS-CoV-2) comprising administering to the subject a therapeutically effective amount of a GM-CSF antagonist or a therapeutically effective amount of a GM-CSF antagonist and a second drug, including an anti-viral agent, an anti-SARS-CoV-2 vaccine, and serum containing human polyclonal antibodies to SARS-CoV-2.
Type: Application
Filed: March 8, 2021
Publication date: April 6, 2023
Applicant: HUMANIGEN, INC.
Inventors: Cameron DURRANT, Dale CHAPPELL"

https://patents.justia.com/assignee/humanigen-inc

Note the File date of March 2021.

This adds context to three events in May 2021:

1. The pre-print demonstrating Lenzilumab's safety and efficacy in the LIVE-AIR trial

2. Humanigen's request for an EUA, and

3. The NIH's decision to withhold the incidences of myocarditis associated with the mRNA vaccines

[cowtown jay]

Welcome to Ihub and to the room, VanGan. And thank you for the informative postings.

[VanGan]

This abstract on lenzilumab was presented at the ASH Conference in December. It appears Taran is planning to initially focus Lenz development on CMML.

https://ashpublications.org/blood/article/144/Supplement%201/1006/530879/Durable-Responses-Observed-in-Chronic

Introduction: Chronic myelomonocytic leukemia (CMML) is a rare cancer orchestrated by granulocyte-macrophage colony-stimulating factor (GM-CSF), a pro-inflammatory cytokine that drives leukemic monocyte proliferation. Standard of care (SOC) for CMML treatment includes azacitidine (AZA), with a complete response (CR) rate of 16-21%. The PREcision Approach to CHronic Myelomonocytic Leukemia (PREACH-M; ACTRN12621000223831) trial investigates novel CMML therapies directed by molecular profiling. Lenzilumab(LENZ; Taran Therapeutics, Short Hills, NJ) a proprietary Humaneered® first-in-class monoclonal antibody with best-in-class off-rate and affinity that neutralizes GM-CSF. PREACH-M interim results show that LENZ/AZA improves hematologic parameters, decreases spleen size, and dampens pro-inflammatory responses in CMML with RAS-pathway mutations. This report details the objective clinical responses from an interim analysis of the first 20 subjects who completed at least three months LENZ/AZA treatment.

[VanGan]

Taran Therapeutics has a new website

We are a life sciences company pioneering therapies for hematology/oncology and chronic inflammation. Our leading drug candidate, Lenzilumab (LENZ), is in a Phase 2/3 trial for Chronic Myelomonocytic Leukemia (CMML), with an initial response rate more than twice standard of care in early findings. Our vision is to save the lives of patients facing this devastating disease.

They also confirm that they now own all the assets previously owned by Humanigen:

On February 20, 2024, Taran Therapeutics, a private Delaware C-corp, acquired the assets of Humanigen, Inc., A NASDAQ-listed company, in a Chapter 11 bankruptcy sale overseen by the court in Delaware and Judge Brendon Shannon, who signed off on the sale. Humanigen had pursued development of Lenzilumab (LENZ), a monoclonal antibody, as a therapy for rheumatoid arthritis, asthma, CMML, acute GvHD, as a companion therapy to CAR-T, and more recently for COVID-19. Despite a promising trial in COVID, LENZ did not receive Emergency Use Authorization in COVID and Humanigen could not continue as a going concern.

Taran now owns all rights to three drugs, including LENZ, a promising monoclonal antibody with two on-going, funded Phase 2/3 trials for often-fatal conditions that currently lack adequate therapies. The Mayo Clinic is planning to initiate a third Phase 3 trial. Taran also plans three additional trials. LENZ shows promise in hematology/oncology and chronic inflammation. It could be commercialized in certain territories for a form of leukemia in 2026.

Thanks to the investments already made under the prior ownership, LENZ now has a well-established and excellent safety profile at a sunk cost of approximately $300 million. In addition, extensive Chemistry, Manufacturing, and Controls (CMC) work was completed and inventorymanufactured at a sunk cost of approximately $200 million. In addition, Taran acquired two other monoclonal antibodies in the bankruptcy sale. These promising drugs could be developed, partnered, or divested.

[SorcererGuru44]

Friendly reminder to all those visiting: Humanigen no longer exists, has no IP, their shares have been cancelled by FINRA, and thus do not exist. Your previous shares will remain visible in your trading accounts until the bankruptcy has concluded in its entirety. If you filed a claim, they have begun payout.

Pay no attention to speculation, disinformation around trials, partnerships, and like.

Anyone searching for information can find all relevant material surrounding the bankruptcy and sale of assets here: https://dm.epiq11.com/case/humanigen/info

If you are so inclined:
Dale's indictment can be found here: https://www.justice.gov/criminal/media/1392191/dl?inline
and here: https://www.justice.gov/criminal/criminal-vns/case/united-states-v-dale-chappell
Victim impact statement form is here: https://www.justice.gov/criminal/media/1392186/dl?inline
and can be emailed here: [e-mail]

That is all. Cheers 👋

[cowtown jay]

Why let a forced covering of 110M shares go to waste, especially when our OS is only 119M shares? Why waste time re-creating a shareholder base that meets Nasdaq requirements? Management has a hungry shareholder to feed with an appetite for $200 per share for half of his holdings.

Do you really not see how this is coming all together?

[sosjtb]

Newly issued shares intact? Why would they? They would just grant themselves new shares standing on the grave of the company they killed. 
It ain't happening...

[cowtown jay]

Will Sanofi's milestone payment to Novavax, based on the FDA's Approval of the Novavax covid vaccine, also result in an Advanced Purchase Agreement (APA), and/or a partnership agreement, between Novavax and Humanigen? Will that, in itself, be enough to convince the bankruptcy court judge of Humanigen's viability as a going concern, with the newly-issued shares intact?

Or will we see Humanigen ask for a full regulatory approval of lenz, based on our EUA submitted in May of 2021, and the IND patient treatment record over the last four years? Will that data result in a joint merger into a new entity with a subsidiary of Sanofi?

[cowtown jay]

"CBS News chief medical correspondent Dr. Jon LaPook, for example, asked Kennedy whether he approved the HHS cuts that helped states address infectious disease, mental health, addiction and childhood vaccination..." and other programs that went poof.

https://www.msnbc.com/rachel-maddow-show/maddowblog/pressed-answers-rfk-jr-comes-short-capitol-hill-testimony-rcna206981

or

https://www.msn.com/en-us/health/other/maddow-blog-pressed-for-answers-rfk-jr-comes-up-short-during-capitol-hill-testimony/ar-AAhi1EPMXF?ocid=msedgntp&pc=HCTS&cvid=da39a68c0bc14ec6993cb44df016f67c&ei=17

I can't fault Bobby for being unaware of DOGE acts, to the point where he can be conversant regarding all of the activity that is going on.

My only problem with Bobby is his thinking he is knowledgeable about a subject, when in fact he is unaware of new information. To be fair, there is no clinical data publicly available that verifies the safety and efficacy of Humanigen's lenz/vaccine cocktail (other than IND-obtained data). But we know how effectively lenz seems to have enhanced Gracell's CAR-T.

And even if the public at-large doesn't know how safe and effective Lenzilumab is as a covid therapeutic, management used the four months from May - September 2021, as we awaited the FDA 's determination of our EUA request, to present the LIVE-AIR trial data.

I believe that lenz is truly part of the HHS/NIH's Generation Gold Standard for Covid and Covid/Influenza Vaccines. I hope the agencies and Novavax (and Humanigen and Sanofi?) can come to terms in the Postmarketing Commitment, leading to the upfront Approval(s) associated with this PMC.

[cowtown jay]

I think we have a course change dead-ahead. It's past due for us. But it could be too early for others. Screw others, except for our prospective commercial partners. In two weeks, it will be four years since we submitted our EUA application, which the FDA sat on for four months, before announcing that they were going to Decline a review of our submission.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

https://ir.humanigen.com/English/news/news-details/2021/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients/default.aspx

I'm trying to be optimistic about Generation Gold Standard, but it's hard to trust government agencies, even though I think the new Regulatory Cadre is just what we need, as long as they take no prisoners.

It is likely that the private sector is just moving far faster than the public sector.

[Diego Rivas]

What?

[cowtown jay]

Le poof? I don't think so.

[cowtown jay]

The FDA's news site (https://newsfilter.io/) is currently linking to an article from Reuters regarding "Novavax says talks with FDA on COVID vaccine approval ongoing calming investor fears
By Sriparna Roy
May 8, 2025"

What I found most exciting in the article was this. ""The company wants to convert the vaccine's emergency authorization granted in 2022 into a full approval that would allow for expanded use and help it compete against shots from rivals."

https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-swings-profit-lower-expenses-related-covid-shots-2025-05-08/

Novavax filed their EUA request on January 31, 2022.

https://ir.novavax.com/press-releases/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine

Humanigen filed our EUA application on May 28, 2021, three days after the FDA asserted their self-granted authority to Decline to review most of the active or new EUA requests.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

And just as a reminder, with the cancer trials Humanigen had in-process, the FDA was aware of Lenzilumab's (lenz's) safety and efficacy, and was quick to grant IND Authorization of lenz to treat covid within weeks of the pandemic on April 2, 2020.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

If the FDA's Makary wants clinical use data of a lenz-enhanced Novavax covid or a Sanofi CIC vaccine, lenz data for covid is available since April 2, 2020

At least, data since our EUA was Declined should be considered, as Novavax is asking for consideration of their data since they requested their EUA.

How long is it going to take the regulatory cadre to wake up to the fact that the US is left with no alternative protein-based vaccine under regulatory review for Approval?

[cowtown jay]

Marty, please, you have to be aware of how your own comments serve to exasperate the very failures of the FDA that you lament.

Let me share my perspective on what you said here: “We have a bit of a public trust problem,” Makary said. “I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

I passionately agree with you that there is a public trust problem in the FDA. Let me get case specific here as it relates to my investment in Humanigen, and my faith in their Lenzilumab (lenz) leading drug candidate. The void in our safety and efficacy data is because the FDA Declined to review our EUA request. My comments at the time were as follows.

"Posted by: cowtown jay
In reply to: None
Date: 01/10/2025 05:59:07 PM
Post #: 43,649 of 43,854
Vigilant Fox,

The FDA granted IND (corrected) authorization to treat covid for Humanigen's Lenzilumab on April 2, 2020, just weeks after the pandemic started. So by May of 2021, it is likely they had full knowledge of the outstanding safety and efficacy lenz demonstrated under this IND authorization.

https://ir.humanigen.com/English/news/news-details/2020/FDA-Approves-Emergency-IND-Use-of-Humanigens-Lenzilumab-for-Compassionate-Use-in-COVID-19-Patients/default.aspx

Management communicated with the FDA during this year-long process, and the FDA knew the company was prepared to request an EUA based on their LIVE-AIR Phase III trial to treat hospitalized and hypoxic patients with covid pneumonia.

What did the FDA do? On May 25, 2021, "...The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:...As noted in the guidance, for the remainder of the current pandemic, the FDA may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency as described in the agency’s guidance, “Emergency Use Authorization Vaccines to Prevent COVID-19.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-25-2021

Three days later, May 28, 2021, "Humanigen Submits Application to FDA for Emergency Use Authorization for Lenzilumab in COVID-19." The FDA Declined to make a decision on our EUA application, based on their newly self-granted power to Decline to make a decision.

https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx

Lenz has the ability to program an appropriate immune response, which is also variant-agnostic. This poses a threat to a multi-billion dollar annuity revenue stream Big Pharma, who are major providers of government agencies' operating budgets, and grantors of royalties to government agencies' scientists, all currently enjoy."

https://investorshub.advfn.com/boards/manage_msg.asp?message_id=175649690

In addition, NIAID and the NIH conducted a "confirmatory" ACTIV-5 Bet B study of lenz. I voiced my opinion of that in expressing my reason for wanting no part of the litigation brought against the company in the Class Action suit.

"Re: [External]Exclusion from Litigation


Jay Booth

From:
[e-mail]
To:
Ann Cavanaugh

Sat, Feb 3 at 6:15 PM

Dear Ms. Cavanaugh.

Your instruction that I must send a letter by mail, and that I must provide transaction details in Humanigen securities, to be excluded from litigation, impose requirements that I don't feel well enough to comply with. I will simply comply with page 2 of the Notice of Pendency:

"DO NOTHING Get no payment."

I strongly disagree with the Lead Counsel, as I have publicly declared in the following.

cowtown jay

Re: bencozey post# 41218

Tuesday, December 19, 2023 7:38:43 PM

Post#
41220
of 41817 Go
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.

Humanigen, Inc.

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."

Thank you,
Jay Booth

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173768831

But, the government's deadly abuse of their discretionary authority doesn't stop there.

The FDA evidently told Humanigen's management that they were unlikely to approve the EUA. Keep in mind that the FDA ultimately Declined to even review the EUA application, despite positive peer reviews of the LIVE-AIR trial by both Lancet and Thorax publications. The FDA got the SEC and the DOJ to file charges for selling shares in the company despite the bogus concerns of the FDA, (except for the devastation it would cause their sponsors, Moderna and Pfizer).

"According to the SEC’s complaint, between June and August 2021, Chappell and Durrant sold Humanigen stock while in possession of material nonpublic information that the U.S. Food and Drug Administration was unlikely to approve Emergency Use Authorization (EUA) for Humanigen’s newly developed COVID-19 drug, lenzilumab."

https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

Do the right thing, Marty. Fill the data void you recognize by ordering your agency to Authorize or Approve lenz based on a review of the company's EUA request in 2021, and review the Lancet and Thorax peer reviews. Humanigen, it's shareholders, and patients, deserve the benefit of the paradigm shift lenz has facilitated as part of Generation Gold Standard, which I think it is. Approve the Novavax vaccine in accordance with the postmarketing commitment.

[cowtown jay]

Vinay fits the mold I like.

"In a recent blog post on the Substack platform, Prasad said the CDC "should ABSOLUTELY remove COVID-19 from the Childhood Immunization schedule. If it stays, it shows the United States is a corrupt country," citing the lack of randomized trial evidence for use of the vaccines in children...

In another post, Prasad criticized media coverage of Marks' departure and called him "one of the most dangerous, opens new tab, pro-pharma regulators of the 21st century."

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-names-agency-critic-vinay-prasad-top-vaccine-official-2025-05-06/

Although I like this cadre, I'm pissed about pausing the (lenz-enhanced?) Novavax covid vaccine Approval. No matter how short the pause, Humanigen has been waiting since Sept 2021 for the regulatory approval of lenz. I want to see these guys direct their passion for fairness to getting lenz Approved.

[cowtown jay]

It would aid the FDA's Makary to fulfill Novavax's upfront regulatory Approval, in accordance with the Postmarketing Commitment, if Taran could announce regulatory approval of lenz to treat CMML. For that matter, if Makary needs ammunition to suppress opposition to Novavax's Approval, he could look to his own agency to make a decision on Humanigen's Lenzilumab's regulatory status. The FDA Declined to review our successful LIVE-AIR trial data. Do Makary and Administration officials have any clue about how safe and effective the variant-agnostic Lenzilumab is?

The FDA's failure to even review our LIVE-AIR trial data in September 2021, was a travesty to patient care that is now 3 1/2 years old.

https://s28.q4cdn.com/539885110/files/doc_news/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients-2021.pdf

[cowtown jay]

Summary
The U.S. FDA has appointed Vinay Prasad as the director of its Center for Biologics Evaluation & Research.
Prasad has been a critic of FDA leadership, COVID-19 vaccine mandates, & the pharmaceutical industry.
He will oversee the regulation of biologic drugs, vaccines, gene therapies, & blood supply.
Prasad succeeds Peter Marks, who was involved in the approval of COVID-19 vaccines & left the agency in March.
The announcement led to a drop in biotech stocks, including an 11% fall in Moderna's shares & a 20% decrease in smaller gene therapy developers.
Prasad has criticized the inclusion of COVID-19 vaccines in the Childhood Immunization schedule due to lack of randomized trial evidence.
RBC Capital Markets analyst Brian Abrahams described Prasad as an "anti-establishment physician" critical of various industry practices.
Prasad's appointment received support from FDA Commissioner Marty Makary & others who praised his skills & expertise.
Prasad previously worked at the University of California, San Francisco & holds a medical degree from the University of Chicago.
Link to original article

https://newsfilter.io/

[cowtown jay]

"Sanofi conservatively (inaccurately) estimates that this CIC vaccine will result in a 56% increase in demand for their existing flu vaccine. I think that is under-stated, and in terms of the covid component of this CIC vaccine, it will be 100% of the US covid market, as Pfizer and Moderna will lose their EUA authorizations, once the triumvirate of Humanigen/Sanofi/Novavax have attained their full regulatory approvals."

My comments seem rather prescient in light of this latest news from the HHS in regards to, "... the development of a universal flu vaccine...(and)...A similar paradigm has unfolded for Covid-19 vaccines..."

https://www.yahoo.com/news/hhs-touts-universal-flu-coronavirus-210630297.html

BUT WE NEED TO BEWARE.

The linked article notes the role of BARDA in this development. We had agreements with them and with CRADA in which we detailed our development of lenz.

[cowtown jay]

In previous posts, I mentioned,

"Jay Booth
@booth37337
·
Apr 27
I will be disappointed if the new NIH covid treatment guideline does not just simply recommend the single Approved (lenz-enhanced?) Novavax covid vaccine. Further, since this is a real vaccine, in the traditional sense of the word, and since lenz is variant-agnostic, I don't

Jay Booth
@booth37337
·
Apr 27
think we need to signify "covid years" going forward. At least, this represents my expectation of these gentlemen, and my belief in their desire and ability to make this happen."

Humanigen Inc (fka HGENQ) : "And with Jay Bhattacharya now appointed... https://t.co/1ct5ynkxIu via @Investors_Hub

— Jay Booth (@booth37337) April 26, 2025

I noted also that this one-and-done approach should apply to Sanofi's Covid-Influenza-Combination (CIC) vaccine.

Hold that thought.

A few hours ago, I saw this article.

"HHS touts universal flu, coronavirus vaccine initiative while casting doubt on future of seasonal Covid-19 shots
Meg Tirrell and Brenda Goodman, CNN
Thu, May 1, 2025

The US Department of Health and Human Services said Thursday that it aims to accomplish within four years a scientific feat that hasn’t been achieved for the past 45: the development of a universal flu vaccine that could protect against multiple virus strains with pandemic potential, including H5N1 avian influenza.

“Generation Gold Standard is a paradigm shift,” National Institutes of Health Director Dr. Jay Bhattacharya said in a statement on the new initiative. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats – not just today’s, but tomorrow’s as well – using traditional vaccine technology brought into the 21st century.”

HHS said the project, being developed in-house at the National Institute of Allergy and Infectious Diseases, is targeting US Food and Drug Administration approval of universal influenza vaccines in 2029, with human clinical trials scheduled to start next year. The Wall Street Journal first reported that it will be funded with $500 million from the Biomedical Advanced Research and Development Authority, a figure confirmed by a spokesperson for HHS...

A similar paradigm has unfolded for Covid-19 vaccines since they were first authorized in the height of the pandemic at the end of 2020. HHS’s new initiative also aims to develop universal coronavirus vaccines that could provide protection against not just the virus that causes Covid-19 – SARS-CoV-2 – but its cousins SARS-CoV-1 and MERS-CoV.

A large investment in older technology
The vaccine technology in HHS’s new initiative uses inactivated whole-virus vaccines, an older approach that delivers an entire virus that’s been chemically tweaked so it can’t infect human cells. The project comes from work being driven by Dr. Matthew Memoli, the NIH’s principal deputy director, and Dr. Jeffery Taubenberger, acting director of NIAID."

https://www.yahoo.com/news/hhs-touts-universal-flu-coronavirus-210630297.html

It may be worth noting that before Bobby fired her, Fauci's wife was, "...a top bioethicist at the National Institutes of Health..."

https://www.allsides.com/news/2025-04-03-0819/public-health-fauci-s-wife-nih-bioethicist-who-never-probed-ethics-wuhan

So maybe I wasn't too far off the mark, and it may really be possible for the triumvirate of Humanigen/Novavax/Sanofi to own the covid AND flu markets with the only FDA-Approved vaccines.

[cowtown jay]

We're a month past due on a PDUFA deadline which we know is going to reflect the Approval of what is likely to be the Lenzilumab-enhanced Novavax covid vaccine. And I fully understand the profound consequences which are inevitable subsequent to this Approval.

But shareholders and patients have paid a MUCH HIGHER price for this Approval than is conscionable already. There is no excuse for ignoring the fact that the Humanigen and Novavax management teams are working feverishly in front of this approval, despite the fact that their effort should be in conformance to the POSTMARKETING Commitment made with the FDA.

Marty, people are still suffering preventable covid and covid-related death every day, despite the fact that managements' efforts should now be under the auspices of an FDA Approval of this product, which will save these lives that are being lost.

[cowtown jay]

That's a possibility. But, with SpongeTech, which was heavily naked shorted, I subpoenaed Electronic Blue Sheet trading records from FINRA, and successfully identified the brokerages responsible. Dale was likely aware of my effort, since I made that disclosure here.

I also made it clear that I was aware of the design of our share structure here. Dale could have modified his exit strategy, if he was concerned about my effort to hold government agencies responsible for the abuse of their discretionary authority, which may have exposed his activity.

Instead, I saw exactly what I told you repeatedly that I expected to see, the misinterpretation of the Form 4's.

We should have received EUA approval from the FDA in September of 2021, when the FDA Declined to review our submission. This unjust abuse of the FDA's discretionary authority may have placed management, and the company, in a precarious financial position, entrapping them when they raised cash by equity financing upon releasing the LIVE-AIR trial results. But, management will be multi-billionaires once we're FDA- Approved. They've earned it.

[dloggold]

They may not get the clink but will be enjoined from public companies which is why they stole the best patent for their private enjoyment 

[dloggold]

Or is was an effort to conceal fraud

[cowtown jay]

I didn't see the original indictment, only the second one. However, I have seen no criminal charge filed against Durrant or relief defendants in the civil case.

DOJ charge:
https://www.justice.gov/usao-nj/pr/former-executive-new-jersey-pharmaceutical-company-charged-38-million-insider-trading

SEC charge:
https://www.sec.gov/enforcement-litigation/litigation-releases/lr-26206

I have noted repeatedly that the design of the share structure, as reflected in an SEC filing, recognized that certain insiders were designated as nominee account holders for the beneficial ownership of some shares they merely held in their accounts, but did not own, and that the Form 4's would not be an accurate reflection of transactions reportedly made by those insiders. In my opinion, it was a defensive tactic to guard against the SEC's refusal to safeguard companies against naked shorting.

[cowtown jay]

“We have a bit of a public trust problem,” Makary said. “I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data.”

In a statement, HHS affirmed Makary’s comments: “Using the COVID pandemic as an eternal justification for blanket approvals of new products will not happen under the leadership of Commissioner Makary.”

Additionally, the Trump administration is seeking for the drug manufacturer Novavax to commit to conducting a new clinical trial on its coronavirus vaccine after it gets approved. The company’s shot has been available under emergency use authorization and is the only vaccine that uses a more traditional protein base instead of messenger RNA - an appealing option to some who have reactions to mRNA shots.

The FDA was on track to grant full approval to the vaccine April 1, according to two people familiar with the matter who spoke on the condition of anonymity to share internal deliberations. Top Trump FDA officials told agency regulators to pause the approval, these sources said - which some vaccine experts say amounts to political interference into decisions typically made by career staff tasked with reviewing the data.

“To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies,” Makary wrote Saturday in a post on X.

Is a Lenzilumab enhancement, complete with an anti-viral and with added polyclonal antibodies, what defines the Novavax vaccine under review, as a new product versus their Authorized vaccine?

https://patents.justia.com/assignee/humanigen-inc

https://www.yahoo.com/news/rfk-jr-require-shift-vaccines-004638181.html

[bencozey]

BK waiting for some management to go to jail and stock to be finally removed from accounts as it is worthless

[Diego Rivas]

I have been disconected from this stock for a long time, could you bring me up to speed on the news please?

[cowtown jay]

That's not it, but thanks, anyway.