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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.
Some things never change, shajelly. Crucial to our success is Humanigen's plan to recall their loaned shares, which we see that Trump Media (DJT ticker) attempted in a completely amateurish fashion.
The problem comes exactly from my effort to focus on Penson Financial for their role in the SpongeTech market, which led to an Emergency Rule Change the SEC had to approve to transfer Penson's accounts to Apex Clearing.
"I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change
The Exchange proposes to temporarily suspend the requirements of Exchange Rule 2.6 and related Exchange rules concerning the approval of new Members?[3] of the Exchange in order to approve Apex Clearing Corporation, f/k/a Ridge Clearing and Outsourcing Solutions, Inc. (“Apex Clearing”) as an Exchange Member, subject to Apex Clearing complying with Exchange Rules for a new Member within 30 calendar days of the date that Apex Clearing is provisionally approved as an Exchange Member. The Exchange is also proposing to accept Apex Clearing's assumption of all of the existing clearing agreements and arrangements currently in effect between Penson Financial Services Inc. (“PFSI”) and various other Exchange Members by execution of a global agreement thereto."
https://www.federalregister.gov/documents/2012/06/11/2012-14072/self-regulatory-organizations-bats-exchange-inc-notice-of-filing-and-immediate-effectiveness-of-a
On the plus side for Trump Media, they do have people who understand what is happening, at least to an appreciable extent.
"“I believe quick action is necessary to protect retail shareholders, identify wrongdoers, and determine whether any laws including [Racketeer Influenced and Corrupt Organizations Act] statutes and tax evasion laws have been violated,” wrote CEO Devin Nunes, who on April 24 first asked top House Republicans to probe short selling of Trump Media stock.
Nunes, in a letter dated Wednesday, wrote that the committees should seek documents and testimony from the eight firms that he named: Apex Clearing, Clear Street, Cobra Trading, Cowen and Company, Curvature Securities, StoneX Securities, TradePro and Velocity Clearing."
https://www.cnbc.com/2024/05/02/djt-trump-media-ids-firms-for-house-short-selling-probe.html
My question is, does Nunes know that the House members he is asking for quick action, may be rightfully included as RICO defendants? They empowered Apex Clearing by the Emergency Rule Change they approved.
These are the minefields that Humanigen's management have to contend with. They did so successfully as Kalobios, and they are even better positioned to succeed now.
"and you need to let the judge know how much you are billing the clients."
Why bother? In your same post, you said, "...hgenq owns no assets." If so, then you're saying the judge is too dumb to convert the case to a CH7, which he should do, if Humanigen is worthless.
But not only do we see the CH11 continued, we see just the opposite of a 'worthless' determination of Humanigen's value. We see additional value recognized.
"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."
I think the company owns about 90% of the shares they have issued, and subsequently loaned. And just like shares investors are holding, the price of those shares will spike considerably when Milestone Events are reached, and we advance our restructuring, in conjunction with a recall of our loaned shares.
I have no relationship with the company or insiders, and I don't post for pay. Millions of preventable deaths, and millions more excess deaths, can be avoided when lenz is used as a vaccine enhancement, or as a therapeutic in lieu of 3+ mRNA jabs. The insiders, the judge, and the creditors know more than we do, and they seem to be seeing increased value, as do I.
Interesting find, Chaplain, and also coincides with a related study just published in the NIH Library on the subject of atherosclerosis. This could mean that I might be a candidate for a cohort study of lenz.
"Tuesday, April 30, 2024
Scientists find cancer-like features in atherosclerosis, spurring opportunity for new treatment approaches"
https://www.nih.gov/news-events/news-releases/scientists-find-cancer-features-atherosclerosis-spurring-opportunity-new-treatment-approaches
"Atherosclerosis, platelets and thrombosis in acute ischaemic heart disease"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3760546/#:~:text=In%20advanced%20atheromatous%20plaques%2C%20high,thrombosis%20and%20its%20clinical%20complications.
"AstraZeneca admits for first time in court documents its COVID vaccine can cause TTS (Thrombosis with Thrombocytopenia Syndrome)"
https://www.breezyscroll.com/world/astrazeneca-admits-for-first-time-in-court-documents-its-covid-vaccine-can-cause-tts/amp/
I'm looking forward to how prospective partners may use lenzilumab. For instance, I see that Novavax states they, "Demonstrated our variant strain change capabilities, updating our vaccine to the XBB.1.5 variant for the 2023-2024 vaccination season." Was their ability to accommodate variant strain changes accomplished by enhancing their vaccine with our variant-agnostic lenz?
see pg 4/162 "COVID-19 Clinical and Strain Change"
https://www.sec.gov/Archives/edgar/data/1000694/000100069424000026/novavax2023annualreport-fi.pdf
Also, I'm particularly interested in what role lenz could play in treating or preventing malaria.
"Based on the conclusions reached in the aforementioned studies, we gather that cytokines are important modulators of the immune response in malaria. Dysregulation of the cytokine network in severe malaria is linked to parasite and host factor variations. We have found that many of the cytokines involved in malaria (TNF-a, IFN-?, IL-4, and IL-10) play a double role, as a friend or as an enemy. Proinflammatory cytokines control parasite multiplication and promote parasite clearance. However, elevated levels of proinflammatory cytokines such as TNF-a, IL-6, or IL-8 may be markers of severe malaria. TGF-ß is probably the most important regulatory cytokine that limits the inflammatory process in malaria. Maintaining a balance between proinflammatory and anti-inflammatory cytokines is essential, and disrupting this molecular harmony can lead to unfavorable disease evolution. A better understanding on the cytokine's involvement in malaria pathogenesis could provide the basis for the discovery of novel diagnostic markers and indicators of disease progression and severity, as well as the foundation for the development of new malaria vaccines."
See the Conclusions:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8592744/#:~:text=Proinflammatory%20cytokines%20control%20parasite%20multiplication,the%20inflammatory%20process%20in%20malaria.
Prospective partner Sanofi's Global Health Unit plans to, "...provide access to a broad portfolio of medicines in 40 countries with the highest unmet medical needs. To that end the GHU created Impact, a unique not-for-profit brand with 30 standard-of-care medicines produced by Sanofi, some of which are considered essential by the World Health Organization (WHO). The Impact medicines cover a wide range of therapeutic areas including diabetes, cardiovascular disease, tuberculosis, malaria and cancer."
See pg 11, "Corporate Social Responsibility update at the end of the Q1 2024"
https://www.sec.gov/Archives/edgar/data/1121404/000112140424000011/pressreleaseq12024english.htm
Sanofi's product pipeline also includes objectives for treating other indications, such as asthma, which could also be an application for lenz.
I think these are exciting times for Humanigen, and I look forward to my open sell order being filled at $200, in the short squeeze we will have when management recalls their loaned shares.
Speaking of Durrant's Amendment to the Milestone Events, Novavax also filed an Amendment to their Articles of Incorporation.
https://www.sec.gov/Archives/edgar/data/1000694/000100069424000013/0001000694-24-000013-index.htm
And Sanofi really seems to be getting things ready for their spinoff.
https://www.sec.gov/Archives/edgar/data/1121404/000112140424000011/pressreleaseq12024english.htm
I think either, or both, of these companies represent potential partnerships for Humanigen.
Welcome to the room, and to Ihub, TimelessOasis72. Don't pay any attention to the emojis.
I'm sorry that I can't answer your question. I opted out of the class action. But I would be the first to join a lawsuit against the class action lawyers.
Besides, I think lenz may be demonstrating just how widely it will be accepted into the market, well beyond the covid and oncology indications, where lenz has clinically proven its first-in-class safety and efficacy. I'm glad to see this success being factored into a more rapid and expanded amended version of the Milestone Events. I think that's a truly exciting development, yet it gets absolutely no recognition of its significance by shareholders. I'm sure, though, that investor sentiment will improve sharply, once details of our opportunity are spelled out, letter-by-letter, by management.
Thanks for posting!
The time was, when talk about waning was taken for granted to refer to a vaccine's efficacy over even short periods of time. Now, waning refers to the body's immune response, in terms of less effective antibodies being produced. But, are there any serious proponents advocating for a third mRNA jab, especially in light of all the serious adverse events apparently resulting from a third jab?
The only serious option is to use lenz in lieu of a third mRNA jab.
"Exploratory analysis for the effect of lenzilumab on SWOV (Survival Without Ventilation, primary endpoint) 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).
see pg 3/11, next to the last paragraph:
https://thorax.bmj.com/content/thoraxjnl/78/6/606.full.pdf
"I don't get this need creditor approval to liquidate hgenq for what?"
Friday's filing by Durrant of Exhibit A was in regards to the, "...monetizing and distributing contingent assets such as the Milestone Payments..." This amendment obviously reflects a belief that either Durrant, the Creditors, or all of them, anticipate either a BLA or foreign regulatory approval of lenz. That's what it would take to monetize the Milestone Payments.
Again:
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
I know. It was 92%, and I think the shares they sold to DTG may have dropped them down to 89%.
Humanigen's most valuable resource is management's holding of ~90% of the company's Outstanding Shares. I built a database capable of tracking Cede shares. I will give it to management, or I will do the data entry myself, if they give me the Transfer Agent's journal. I would not charge them for that service. I would sign a Non-Disclosure Agreement, as well, to protect shareholders' identities. I would only want to report on the number of shares in circulation. The data I compiled previously was solid, and showed just cause for enabling me to subpoena the Electronic Blue Sheets from FINRA, which I did. Also, if there was any question in regards to the ownership of the shares in the SEC's case against Dale's entities, this database would provide a clear trail of possession. My motivation for the work I did previously was to prove the SEC's culpability. That would be true in this case, as well, except the cast of despicable characters would be expanded to include NIAID, the NIH, the CDC, and the FDA, and their intentional roles in permitting each and every preventable death, including my wife's. All management has to do is ask.
I hope the recall of Humanigen's loaned shares does happen. I can't accept that the existing HGEN shares will just somehow dissolve. I suspect the shares will be transferred to Taran in a stock-for-stock purchase. Not only do I think that needs to happen, Durrant can use the windfall profits from a short squeeze to further his reorganization objectives.
"DiegoRiv_
@diegaturp
·
9h
Isn't it going to disappear?"
cowtown jay
@cowtown_jay
·
51m
I wonder if Taran will issue 119,080,135 shares, and then offer HGEN a stock-for-stock buyout. Or might Taran issue 595,400,650 shares, and offer HGEN a 1:5 stock buyout. That could also allow 238,160,270 shares for a second stock-for-stock merger.
Consider the Milestone Events:
+First (1st) FDA approval of a BLA
relating to Lenzilumab for CMML in
the United States, provided such
approval is granted within five (5)
years following the Closing Date.
The next three (3) FDA approvals of
a BLA relating to Lenzilumab for any
follow-on indication to CMML in the
United States provided such
approval(s) is granted within seven
(7) years following the Closing Date.
First (1st) Regulatory Approval of
any HGEN Product for a particular
Therapeutic Indication for
Lenzilumab in the United Kingdom,
Germany, France, Italy, Spain or
Australia (each, an “Approved
Country”), provided such approval is
granted within five (5) years
following the Closing Date."
There are a few other Milestone Events related to various net sales totals.
The Milestone Events can be seen on pages 55 and 56/95, linked here.
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1061258&projectCode=HUM&docketNumber=155&source=DM
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.
In other parts of the world, Regulatory approval of lenz from any Approved Country would qualify as a Milestone Event. I think SAMHRI will be of invaluable assistance to us in Australia.
How likely is it that Humanigen will get Regulatory authorization or approval to qualify for these Milestone Events?
The Creditors' Committee must think that not only is this likely, Humanigen may even accomplish more than currently indicated.
"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."
page 4/5
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
Any news of regulatory authorization or approval, or news regarding our restructuring, will signal Humanigen to recall their loaned shares.
"The US government, in my opinion, is keeping lenz out of the covid market, to safeguard their Moderna investment, and misplaced faith in mRNA technology."
If that is true, as I firmly believe that it is, you must ask yourself how that could possibly have come about.
This authority for the US Government to interfere with the commercial development of covid vaccines, and to curtail the development of safe and effective therapeutics to combat covid, was vested in NIAID, when it was decided to resume the manufacture of bioweapons. In fact, Fauci got a 68% pay raise to resume the development of bioweapons, and their counter-measures.
Additional funding of gain function research began to be provided by other agencies and entities. The largest of these is the United States Agency for International Development ("USAID").
If you don't want to keep and study the entire video, watch it from minute marks 35 - 45:24
Ep. 16 RFK Jr. explains Ukraine, bio-labs, and who killed his uncle pic.twitter.com/RMr5VZVqSM
— Tucker Carlson (@TuckerCarlson) August 14, 2023
" I immediately remembered that Japan has a unique non-inflammatory diet and that this may account for the difference."
The US has 4.2% of the world's population, yet accounts for 17.4% of all covid deaths.
https://www.worldometers.info/world-population/
https://www.worldometers.info/coronavirus/
The Chinese collected national DNA databases, and it was reported that this was to aid in the design of a virus specifically targeting particular nations, such as the US.
I can see diet and obesity impacting covid cases differently from country to country, but not to this extent. However, I totally agree about the third mRNA jab "wrecking" the immune response system, which is why I want to see if lenz can help to restore the immune system in these vaccinees.
Howdy, mates! Or should I say 'G,day, partners?'
"Hi Jay Booth, Aka Cowtown Jay,
There's been an update on Taran Pharma (Europe) Ltd in the last 24 hours:
Shareholders/Group Structure"
The only new filing I see from the four companies I track (Humanigen, Baudax, Novavax, and Sanofi), is from an upset an investment firm holding Novavax. The comments provided by the investment firm are legitimate, and actually reflect why I feel that Novavax really needs to use lenz as their vaccine enhancement, if the company is going to survive.
https://www.sec.gov/Archives/edgar/data/1000694/000139834424007144/fp0087987-1_ex992.htm
Recent studies indicate that Novavax has an advantage in booster antibody durability. That's a plus, especially as mRNA booster antibodies are degrading, and becoming less effective. And it is becoming evident that Serious Adverse Events are presenting after a third mRNA booster.
I hope that Humanigen and Novavax can partner, and take the majority of the US covid market, currently captured by Moderna.gov (US govt), and PfDA (Pfizer/BioNtech and their German govt and European bank ownership).
eb is correct, oldstocks. I moved out of Fort Worth in 2008, but just across the county line, where it is still possible to buy land, and the taxes are significantly lower.
Welcome to the room, oldstocks, and thank you for your post.
I can't say that you ARE reading it wrong, sosjtb.
"As soon as practicable after payment in full of, or reserve for, all other Allowed Claims, the Liquidating Trust shall
pay to each holder of an Allowed Subordinated Claim or an Allowed Existing Equity Interest its pro rata share of any
remaining amounts in the Liquidating Trust subject to the terms and conditions of this Combined Plan and Disclosure
Statement, the Liquidating Trust Agreement, and the Bankruptcy Code. No distribution to Class 4 (Subordinated
Claims) or Class 5 (Existing Equity Interests) is anticipated."
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1074462&projectCode=HUM&docketNumber=226&source=DM
p 33/65
But, you certainly COULD BE reading it wrong.
"As soon as practicable after payment in full of, or reserve for, all other Allowed Claims, the Liquidating Trust shall
pay to each holder of an Allowed Subordinated Claim or an Allowed Existing Equity Interest its pro rata share of any
remaining amounts in the Liquidating Trust subject to the terms and conditions of this Combined Plan and Disclosure
Statement, the Liquidating Trust Agreement, and the Bankruptcy Code. No distribution to Class 4 (Subordinated
Claims) or Class 5 (Existing Equity Interests) is anticipated...
there is no assurance that the Liquidating Trust will be successful in prosecuting any Cause of Action or generate sufficient
proceeds from the Causes of Action for Distribution. "
p 33/65 p 35/65
The case remains a CH11, and the recall of the loaned shares, especially if Novavax purchases the lenz/vaccine cocktail, or we combine/partner/merge through Taran into Sanofi, and get regulatory approval from Australia, perhaps with a PRV, we could easily see Ed Dowd announce a target price of $67 for our shares.
"The new Humanigen may be stronger than I expected."
At one point, I actually questioned why the CH11 bankruptcy would be necessary. If Humanigen owns 110M of the 119M shares they have issued, and if our float of 229M shares is 192% of our OS, that could only mean that Humanigen has loaned the excess shares in our market. If so, Humanigen would be positioned to issue a recall of their loaned shares, and cause an even more massive short squeeze than they did as Kalobios.
I see no change in those circumstances.
I think Humanigen has held off recalling their loaned shares, until news, such as in regards to regulatory approval or authorization of lenzilumab, or news regarding a business combination/merger/partnership, was ready to be announced. This extended delay caused the financial constraints that forced the CH11 (as the US regulators tried to force us out of business, and protect their financial investment in Moderna, and promote their mRNA ideology, in my opinion).
I really think that Novavax may have used lenz as an enhancement in their prototype vaccine. I also think that Sanofi graduated, as Gracell did, from Humanigen's incubation of their their products, used with lenz for enhanced safety and efficacy. And I note how this CH11 is nearing completion as Sanofi prepares to spin-off their healthcare division, and the PREACH-M trial results are placed for regulatory approval in Australia, perhaps with a Priority Review Voucher worth ~$100M.
The only things that have changed are:
We may have partnership interests from Novavax, PREACH-M (and/or Sanofi), and Gracell (and perhaps AstraZeneca), exerting authorization approval of lenz from Regulators (probably overseas).
We have no secured debt obligations.
We have non-debtor Humanigen subsidiaries prepared for possible merger use in the UK, Australia, and the Republic of Ireland.
And we have shocking safety and efficacy failures, to include vaccine injuries and excess deaths, caused by the standard of care currently in use.
I'm very optimistic, and I believe that Humanigen has never been stronger than we are now.
First of all, thank you for sharing that link, GURUBK. I'd certainly like to see our equity tied again to the IP rights, even if just by exclusive license. But I just don't think that this is going to happen solely by acquisition. Fine with me, if it does. The new Humanigen may be stronger than I expected. I just thought, and still think, that we'll see a merger, business combination, or partnerships factor into our new course, as well.
I'm interpreting an entirely different vibe, dlog. It seems that antibodies derived from vaccine-induced infection are weakening, and at the same time, the virulence of the next coronavirus to circulate, will be significantly worse than any strain or type that we have seen so far.
If so, then most of the covid that lenz will have to fight will be vaccine-induced, AND more deadly, unless the FDA prohibits mRNA vaccines, and authorizes lenz, before the next variant begins to circulate. I am very curious to see if lenz will be capable of restoring the the immune response in this scenario.
I think it would be naive to think that Moderna, with the $2.5B US government investment in their company, has (..."nothing to do with our company"). The US government, in my opinion, is keeping lenz out of the covid market, to safeguard their Moderna investment, and misplaced faith in mRNA technology.
There's a reason the charges the UK wants to file regarding the forced acceptance of mRNA vaccines, include charges of murder. I hope TX AG Ken Paxton also files criminal charges against Pfizer, Moderna, Lancet, Thorax, NIAID, the NIH, the CDC, and the FDA.
Easy come, easy go.
"Moderna has scored $2.48 billion in R&D and supply funding from the U.S. government for its program."
https://www.fiercepharma.com/pharma/after-nearly-1b-research-funding-moderna-takes-1-5b-coronavirus-vaccine-order-from-u-s
"Moderna halts plans to build Kenya vaccine plant as Covid shot demand plunges
PUBLISHED THU, APR 11 2024...
The biotech company said it has not received any vaccine orders for Africa since 2022 and has taken more than $1 billion in losses and write-downs related to the cancellation of previous orders from the continent.
https://www.cnbc.com/2024/04/11/moderna-halts-kenya-vaccine-plant-plans-as-covid-shot-demand-plunges.html
The lack of demand for mRNA covid vaccines in Africa is noteworthy.
"This study shows that the highest number of cases per million population was recorded in Europe, while the trend of new cases is lowest in Africa. The mortality rates in different continents were as follows: North America 4.57%, Europe 3.74%, South America 3.87%, Africa 3.49%, Oceania and Asia less than 2%."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157209/#:~:text=Results%3A%20This%20study%20shows%20that,cases%20is%20lowest%20in%20Africa.
It's frustrating to me, as a US citizen, to see our tax dollars squandered in support of deadly mRNA vaccine development. It's even more frustrating to me, as a US investor in Humanigen, to see Lenzilumab side-lined from the opportunity of being used as a covid traditional-vaccine-enhancement and therapeutic treatment, despite Lenzilumab's superior safety and efficacy peer-reviewed trial results.
I was glad to hear Dr. Kelly Victory interview Ed Dowd recently. Ed is a former portfolio manager at Blackrock, and I believe they may still maintain a position with Humanigen.
I've come to enjoy reading clinical trial reviews, and following the logic the trial investigators use in writing their findings. But Ed opened a new perspective on the logic he uses to make investment decisions, such as in biotech (continuing with Humanigen)? I like the way in which Ed explained his estimation of excess deaths, which brought a sharp focus on the astounding increase in excess deaths in the younger population. And another thing I really like is that he didn't just focus on covid. He noted the developments in neurological and cancer indications, as well.
I think lenz has tremendous opportunities in preventing and/or treating all three indications. I've been saying that for several years. And I really appreciated hearing a financial guy express his conclusions in this regard.
Regarding Dr. McCullough's congressional testimony about a lack of recommended covid treatment protocols, we know that in 2021, the NIH did recognize the substantial improvement lenzilumab demonstrated in treating hospitalized covid patients.
""Preliminary data from a double-blind, placebo-controlled randomized trial of lenzilumab did show a significant improvement in the primary endpoint of ventilator-free survival through Day 28 among those who received the GM-CSF inhibitor."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165682015
Since then, and as now, there has been no justification for the US and UK Regulators to negligently permit thousands of preventable deaths every week. Those deaths should be added to the number of "excess deaths" due to the mRNA vaccines, because keeping lenz off the market is only to protect the covid profits from the Pfizer and Moderna mRNA vaccines (and the financial investments in those companies made by the US and German governments).
"Sanofi needs to spin-off their healthcare sector, and we saw the S-8 regarding the Securities to be offered to employees in employee benefit plans filed today."
Other Sanofi news hitting the wire today was in regards to their on-going trial to treat Parkinson's Disease.
"A Type 2 diabetes medication called lixisenatide appeared to slow the progression of Parkinson's disease symptoms in a small, mid-stage trial funded by the French Ministry of Health and others, the New England Journal of Medicine reported on Thursday."
https://www.morningstar.com/news/marketwatch/20240404312/diabetes-medication-appears-to-slow-progress-of-parkinsons-disease-in-french-backed-trial
Loss of motor control completely changes the quality of life for affected patients. I hope lenz may have a role in improving the efficacy of Sanofi's lixisenatide.
If, by some miracle, certain of the conclusions I have drawn develop as I surmised, then the counter-parties to those events need to complete their tasks, in addition to Humanigen doing the same. Baudax needs to complete their CH11, and hopefully sell Tera-Immune to us. Novavax may need to get additional regulatory approval or authorization to use lenz as their prototype vaccine enhancement. Sanofi needs to spin-off their healthcare sector, and we saw the S-8 regarding the Securities to be offered to employees in employee benefit plans filed today.
Humanigen has never been stronger that we are now. And the world will be a better place as we step into our rightful covid and oncology positions.
And no CH7. So the bankruptcy court judge does not agree with your assessment of Humanigen's prospects and future. The company is restructuring, under CH11. Give it a minute.
Sanofi filed an S-8 securities Registration Statement today. I think Sanofi may be our most-tenured shareholder, and that their oncology market could be enhanced by lenzilumab, such as we have seen in CMML. Sanofi previously announced plans to spin-off their healthcare sector, and I am excited about the partnership opportunity this could provide to Humanigen/Taran.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524086673/d803515ds8.htm
The filing notes that, "The information required by Item 1 and Item 2 of Part I of Form S-8 is omitted from this filing..."
The type of information withheld, if I am reading the prospectus instructions correctly, can be found on pages 5-7 in the following link.
https://www.sec.gov/files/forms-8.pdf
You're missing the point I was making, which is that worldwide, the majority of the covid vaccines are non-mRNA-based, and I think they represent a large market for our patented method of vaccine enhancement. There is nothing "off-topic" about that, even if some staff of government agencies, such as NIH or USAMRIID, continue to promote mRNA vaccines, which pose increased risk of deadly consequences, not only to this generation, but to the unborn of the next, as well.
"What do these companies have to do with HGEN?"
Most vaccine manufacturers don't use mRNA technology, they use traditional methodology, and incorporate an inactive form of the virus, for example. That's what Novavax does, and they are the only non-mRNA vaccine manufacturer authorized in the US.
The majority of the overseas vaccine manufacturers should be candidates to use lenz as an enhancement to their vaccines. We patented the process for this application, as I've shown before.
"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
It is not accurate to consider the subject of vaccine enhancement as "off topic." Quite the contrary, vaccine enhancement is THE MAIN OPPORTUNITY I am hoping to see Humanigen capture.
The only argument the antagonists have is always centered around the fact that none of the developments I fully expect to see realized have, as yet, come to pass. Instead, there is, "Not a peep from management."
I haven't seen anything disproven that was in the Top Line Data of the LIVE-AIR trial. Not only were those trial results verified by the Lancet peer-review, they were bolstered by the Thorax peer-review, based upon patient stratification by CRP levels.
I would link, for the 100th time, Humanigen's home page, with access to the Lancet and Thorax peer reviews, but I am now getting an error message trying to do so.
"Looks like this domain isn't
connected to a website yet"
https://www.humanigen.com/
All the tabs associated with the home page are accessible (Other, News, Events, etc).
https://ir.humanigen.com/English/news/default.aspx
I wonder if the Home page is getting a facelift.
And what? Am I supposed to be worried about that? That's the nature of postulating, based upon the reasoning of what is observed.
People are entirely free to think what they will, or to not think about Humanigen, at all, if that's what they want to do. But to me, it's a big deal to suffer the abuse of discretionary authority, by the very government intended to prevent the abuse of their citizens. By all means, that is true in the financial sense, where the SEC routinely ignores illegality by everyone, except for the alleged violations by the principals of the victimized companies.
But in a profoundly worse sense, as I learned here, agencies such as NIAID, the NIH, and the FDA, intentionally abuse their discretionary authority, with full knowledge of the immoral loss of life that would be prevented, were these agencies to discharge their duties faithfully. And, "...every day that goes by (I am right)," about families suffering the needless loss of a loved one.
Our share structure was designed to counteract the naked shorting of our shares, and to severely punish the perpetrators, even in the absence of fiduciary duty by the SEC. This defensive mechanism will result in the recall of Humanigen's loaned shares, or, it may be effected simply by a merger. Regardless, it should not even be a contingency for which management had to plan, and meticulously execute over a period of years. Our management has fought more battles than we'll ever know about, perhaps like in regards to our venture in Wuhan.
I think pieces are continuing to fall into place, which may include Tera-Immune, Novavax, and Sanofi, plus mergers or partnerships, including those based on the PREACH-M and RATiNG trials. Of course I'd like to know WHEN these developments will occur. But I have no reason to waste my time writing posts about how meaningless these developments will be to Humanigen.