cowtown jay
1 hour ago
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 โCompanyโ) entered into a collaboration and license agreement (the โCollaboration and License Agreementโ) with Sanofi Pasteur Inc. (โSanofiโ) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Companyโs current standalone COVID-19 vaccine products, including the Companyโs NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (โCOVID Mono Productsโ)..."
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.
cowtown jay
1 day ago
A Covid Mono vaccine? Do we already have the therapeutic form with lenz?
"On May 10, 2024, Novavax, Inc. (the โCompanyโ) entered into a collaboration and license agreement (the โCollaboration and License Agreementโ) with Sanofi Pasteur Inc. (โSanofiโ) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Companyโs current standalone COVID-19 vaccine products, including the Companyโs NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (โCOVID Mono Productsโ)..."
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.
cowtown jay
3 days ago
"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.
cowtown jay
5 days ago
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.
ZenNavigator54
5 days ago
taran or the owner of taran is also the 90% owner of hgenq shares or the controlling shareholder of hgenq. that is why hgenq didn't object to selling taran lenzi ip for nothing.
main reason no bids from other pharma companies, they usually don't bid on assets with a lien on it, which was the promissory not to hgeneq shareholders.
if the hgenq shares are dissolved and liquidated, taran no longer owes hgenq shareholders anything and the promissory not is void and invalid if the company no longer exist. a dead money has no legal status in the courts and can no longer sue taran. if the company is liquidated and dissolved
any lawsuit by former hgenq shareholders would be a separate civil case which takes years and may not have a case. and case denied by omnibus hearing. there is no case for hgenq shareholders to sue taran. you have the courts and SEC working against minority hgenq shareholders you cannot sue them and basically screwed. legally the controlling shareholder of hgenq sold assets for nothing. to taran or himself. these guys know the legal system to screw shareholders in this stock scam, they got everything paid off , you know what I mean.
ZenNavigator54
5 days ago
taran didn't even have to give hgenq shreholders anything or that schmuck insurance or the promissory not. legally, the fake creditors committee owns the company. technically. it's like that fake baloney lawsuit the guilliani was sued for 'defamation ' for llike $100 million and he declares bankruptcy so he doesn't have to pay a dime of that lawsuit. same with Trumps conviction of 'rape' there is no rape. it was consensual sex and stormy daniels was an escort. there is no shame what Trump did, who cares if Trump as 5 mistresses they were consenting and willing females. back in the good old days, rich guys like Trump would have 5 wives, nine lives, alright. mormons can have 10 wives but the gov't banned polygamy like its some kind of 'crime' the status of man was how many wives he had..but gov't banned it.
ZenNavigator54
5 days ago
At this moment based on the legal facts. shareholders own no assets and even the promissory not of payment to hgenq shareholders can be voided if the shares are liquidated and dissolved. to get any money from taran, shareholders would have to file another civil case against taran, in a civil case. taran legally doesn't owe hgenq any compensation with the stolen ip asset they paid nothing for. but that is for juror to decide, the chapter 11 court or judge doesn't care about civil case or criminality charges by the SEC, it's not his job but based on chapter 11 processes, technically, the assets are sold and hgenq shareholder no longer own the ip lenzi patents and entitled to nothing. and no compensation based on chapter 11 law.
cowtown jay
6 days ago
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.
cowtown jay
1 week ago
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.
cowtown jay
1 week ago
"...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 Novavaxโs Directors Up for Election at its 2024 Annual Meeting"
https://www.sec.gov/Archives/edgar/data/1000694/000092189524001044/dfan14a11882nvax_05062024.htm
cowtown jay
1 week ago
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.
cowtown jay
1 week ago
At last report, Humanigen had several sponsored clinical trials of lenzilumab in progress.
"The Company is developing lenzilumab in chronic myelomonocytic leukemia (โCMMLโ), a rare blood cancer, for which the Precision Approach to Chronic Myelomonocytic Leukemia (โPREACH-Mโ) study is underway, and is continuing its plans for the Risk Adapted Therapy in Acute GvHD (โRATinGโ) study in acute graft versus host disease (โaGvHDโ) 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 (โADCโ), 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.
cowtown jay
2 weeks ago
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.