Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I didn't try to attend the Novavax shareholders' meeting this morning, since I'm not a shareholder. So I'll have to wait 24 hours to see if relevant news was reported.
"NOVAVAX, INC.'s meeting has concluded. A replay will be available in 24 hours at: www.virtualshareholdermeeting.com/NVAX2024"
https://central.virtualshareholdermeeting.com/vsm/web?pvskey=NVAX2024
The agenda appeared pretty mundane. But they did make note of a Proxy Statement relevant to stockholders as of May 3rd.
https://novavax.widen.net/s/zdd7jdmbbj/2024-proxy-statement
So, no news from Novavax until after our Hearing today.
DTG, the only thing that I can't figure out is why the reorganization bankruptcy was changed to a liquidating bankruptcy, but one in which a distribution may be made to existing equity holders. I can only assume that we have one too many pieces to the puzzle, and that we'll end up with shares in Taran, as the licensor of lenz to Sanofi and Novavax, and that we may merge with Novavax, and perhaps become a subsidiary of Sanofi. That would at least explain why we don't need the Humanigen shell.
Maybe, and hopefully, we'll get news tomorrow.
I hope once we see these game changing announcements come along, that they will include the CDNO stock. It would be incredible to see us brought back from the dead even though I remain skeptical. That would be Awesome!!! I am still rooting for you Jay in that you end up being right about everything.
Leukemia patient, 17 year old Dazelle Peters, who had also suffered Acute Graft versus Host Disease, died Monday after being denied lung transplants because she was not vaccinated.
Dazelle was the embodiment of the patient populations in the RATinG and PREACH-M clinical trials sponsored by our IMPACT and SAHMRI partners. Lenzilumab may have saved the life of this beautiful young lady.
As JFK said, a rising tide lifts all boats. This might explain an increased interest in Humanigen.
As Zack's Equity Research noted, "Investors Heavily Search Novavax, Inc. (NVAX): Here is What You Need to Know
Zacks Equity Research
Mon, Jun 10, 2024...
Novavax (NVAX) is one of the stocks most watched by Zacks.com visitors lately...Shares of this vaccine maker have returned +104.6% over the past month versus the Zacks S&P 500 composite's +3.3% change...For the current quarter, Novavax is expected to post earnings of $1.13 per share, indicating a change of +94.8% from the year-ago quarter. The Zacks Consensus Estimate has changed +241.6% over the last 30 days...The consensus earnings estimate of $0.37 for the current fiscal year indicates a year-over-year change of +106.8%. This estimate has changed +144.5% over the last 30 days."
https://finance.yahoo.com/news/investors-heavily-search-novavax-inc-130016966.html
Novavax further provides FLS cautions as follows. "... (Our) and Sanofi’s ability to successfully implement its partnership, including the ability to transition key processes and effect technology transfers, Novavax’s and Sanofi’s ability to successfully develop or commercialize any vaccines or vaccine candidates, our ability to successfully and timely manufacture, distribute, or market our updated COVID-19 vaccine including as a single dose vial or pre-filled product presentation for the 2024-2025 vaccination season, our plans to sell our COVID-19 vaccine for the 2024-2025 vaccination season under Emergency Use Authorization; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials; challenges or delays in obtaining regulatory authorization for our product candidates, including our updated COVID-19 vaccine in time for the 2024-2025 vaccination season in the U.S. and in foreign jurisdictions to meet APA commitments or for future COVID-19 variant strain changes, our COVID-19-Influenza combination vaccine candidate and our stand-alone influenza vaccine candidate; manufacturing, distribution or export delays or challenges; our substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling and PCI Pharma Services for finishing our COVID-19 vaccine and the impact of any delays or disruptions in their operations on the delivery of customer orders..."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924068875/tm2416490d1_8k.htm
I didn't know that Novavax had a business relationship with PCI Pharma, but I knew of Humanigen's relationship with PCI. I also see Cenexi being mentioned in other posts, and I know we also had a business relationship with them. The closer we get to Novavax's stockholder meeting tomorrow, which is also when we will hear about the bankruptcy court's decision regarding our expanded and increased Asset Purchase Agreement, and a possible distribution to existing equity holders of Humanigen shares, the more optimistic I become.
I hope to see two game-changing announcements from Humanigen this week, or in the near term. One announcement may be in regards to further utilizing our notice of patent allowance for the enhancement of CAR-T immunotherapy.
https://www.pennystockdream.com/blog/hgen-up-3217-after-hours-after-receiving-notice-of-allowance-for-patent-application
I actually think that Gracell and Mayo Clinic are already benefitting from this CAR-T enhancement, and I hope that Sanofi will bring this to market not only for their platforms, but for our partner, the South Australian Health and Medical Research Institute ("SAHMRI"), also.
""Expansion of the PREACH-M study is a critical next step in our realignment strategy. Associate Professor Thomas is a world expert in CMML and program leader for Blood Cancers at SAHMRI. SAHMRI is a leader in precision medicine that assists patients in finding the proper treatment for their cancer," commented Cameron Durrant, Chairman and CEO of Humanigen. "Lenzilumab was discovered in Australia, so it is only fitting that we leverage the wealth of local knowledge that exists for lenzilumab as we continue clinical development."
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-and-SAHMRI-Announce-Expansion-of-the-PREACH-M-Study-of-Lenzilumab-in-CMML/default.aspx
The second announcement I'm looking forward to will be after the Novavax stockholder meeting on the 13th, which coincides with our bankruptcy hearing detailing the expanded Milestone Event triggers and payments.
Chris Cuomo interviews Dr. Robert Redfield on the many ways Long Covid presents. The gist of the discussion is summarized in the last 8 minutes of the video. I share this video because I think we are only beginning to understand just how much we really don't understand, if that makes sense to you. This lack of understanding frustrates me to no end. The frustration started in 2020 as my wife's condition deteriorated, and there was no no appreciation of how lenz could improve her brain functioning. And the frustration continues as I look at the swelling in my right foot and calf, despite taking an anti-coagulant and blood thinner, which I think lenz could improve by reducing the inflammation.
Man, I'm looking forward to getting lenz into the hands of the medical community, where the real discovery can begin.
Yes, Humanigen is still around, and there is a bankruptcy court Hearing scheduled in 3 days, on the 13th, in this matter,
see page 3, para 7
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
A few of my recent posts on this subject reflect my optimism and have had hundreds of views accumulated on the X platform. Perhaps this is the result of Michael North communicating with prospective Humanigen/Taran investors. After all, there are significant movements of Sanofi and Novavax, and I suspect we will figure into the evolving structures of these companies.
Is HGEN still around? Didn't they go bankrupt? I am behind in my news.
"And there are a host of other indications, including asthma, arthritis, malaria, Long Covid, etc., that I think will far surpass anyone's expectations."
"Pfizer's Paxlovid fails as 15-day treatment for long COVID, study finds
By Michael Erman
June 7, 2024
June 7 (Reuters) - A 15-day course of Pfizer's (PFE.N), opens new tab COVID-19 antiviral treatment Paxlovid did not relieve symptoms of long COVID, according a study by Stanford University researchers.
Currently, there are no proven treatments specifically for long COVID in which a host of symptoms can last for many months after initial coronavirus infection."
https://www.reuters.com/business/healthcare-pharmaceuticals/pfizers-paxlovid-fails-15-day-treatment-long-covid-study-finds-2024-06-07/#:~:text=June%207%20(Reuters)%20%2D%20A,study%20by%20Stanford%20University%20researchers.
Yes, in part, and as I have previously made clear, some of my conclusions, particularly in regards to Novavax, have no basis in fact, and simply reflect a blaringly obvious solution to the unmet needs of both Humanigen and Novavax, as only they can meet for each other with such a high degree of success. I am highly confident in what Dubovsky can contribute toward our international approval and usage of lenz.
My pinned post, which reflects the last communication from Humanigen, focuses on our opportunities as otherwise noted in my post. And I think Sanofi will enable our ability to penetrate the market beyond covid and into oncology and hematology.
I have read and studied the material on Humanigen over the years, just as I read and studied my college textbooks. No relevant communication with management, other than that, except for conveying my appreciation of management, as I am doing now, because I think they are entirely worthy of shareholder support. Hopefully, we'll all have the financial reward they have worked to provide for us, and many more shareholders will share my appreciation of them after that gain is realized.
you realize there is no evidence for your claims , it's completely made up in your head yes? thats unless you have information that nobody else has, trying to contact these guys is like trying to find an outhouse in Antarctica so i highly doubt you have spoken to anyone.
i guess vaccine shaming has been forgotten and forgiven.
john nash would be proud
Diego, I think management may have secured a revenue stream through licensing fees from Gracell, Mayo Clinic, Novavax, Sanofi, our PREACH-M and aGvHD partners. and others TBA, that will pay the $44M to our unsecured creditors, and negate the reason to remain in bankruptcy. How management wants to capitalize on the recall of their loaned shares remains to be seen and is irrelevant to me. And there are a host of other indications, including asthma, arthritis, malaria, Long Covid, etc., that I think will far surpass anyone's expectations. The Do or Die bankruptcy hearing is scheduled next week, on the 13th. If I have overstated our potential, it's because you sincerely asked if I thought there was something that could move the stock price. But even a more limited version of our opportunities could prove sufficient to successfully exit our CH11 proceeding.
It just makes no sense to raise the subject of an expanded program to meet Milestone Events without Humanigen capitalizing on their share structure and offering some type of distribution to existing equity holders, chiefly the company.
What do you mean with our last week in purgatory? You mean something could move the stock price?
You're a good man, eb, and I appreciate your continued support. But the amended Asset Purchase Agreement was probably the best news we could have received. I look forward to hearing from Michael North on how Taran and Humanigen may be integrated, and I suspect that Filip Dubovsky may have a key role in the expansion of our Milestone Events, which I think will shock the investment community...and the short sellers who have bet against us. Also, I credited Dubovsky for a possible role in the Pfizer covid trial, but Michael Shuster is who I should have credited. I hope this is our last week in purgatory.
Hang in there Jay. You have been through it before and I'm sure no one here understands what you see here. Keep it going; I love your determination.
nothing is happening
As I indicated in the link I provided, the date for the Combined Hearing is June 13th.
I'm fully aware of the warning that existing shareholders may not receive a distribution from the Liquidating Trustee.
But I am convinced that the co-exclusive licenses held by Sanofi and Novavax, will prove to be a game-changer for Humanigen shareholders. I actually think Novavax has received funds they can use to pay their licensing fee to Taran, which could fully satisfy the Unsecured Creditors, and that Taran will possibly offer an exchange of equities to Humanigen shareholders.
There is just not enough information for me to speculate on whether Sanofi will also provide licensing fees to Taran, and how Humanigen shares may be converted to Taran shares, nor how to tell what the outcome will be of a possible combination of Sanofi, Novavax, Humanigen, and Taran.
But, in light of the warning about potentially no distribution to Humanigen shareholders, coupled with my commitment to have a reasonable basis for my conclusions, I am saying that I expect a successful conclusion to our CH11.
What meeting on June 13th? No notice went out. Company is done
Novavax just hit another new 52 week high of $22.24 today.
Can someone make me a summary of what is going on and what could happen with $HGEN?
Novavax just eliminated the possibility of recipients topping-out on awards granted to them under their 2015 Stock Plan. This will positively impact Dubovsky, who I think we'll see named as our Chief of Development. Their June 13th Stockholders Meeting coincides with our June 13th Combined Hearing.
"AMENDMENT TO PROXY STATEMENT DATED APRIL 29, 2024, FOR THE NOVAVAX, INC. 2024 ANNUAL MEETING OF STOCKHOLDERS TO BE HELD ON JUNE 13, 2024."
https://www.sec.gov/Archives/edgar/data/1000694/000110465924068426/tm2416428d1_defa14a.htm
See pg 3, The Combined Hearing
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Well, Novavax did end up making a 52 week high yesterday. I'm hopeful that they will be using lenz as a vaccine enhancement, and that we see them make an all-time high, which would be over $300 per share, and maybe result in filling my open sell orders at $200 before the orders expire early in July.
"... it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders."
As I recall, it is the SEC that proposes which Bankruptcy Trustee they want. In my previous experience, the Trustee and the bankruptcy judge discussed the rampant naked shorting of the victimized company that was forced into bankruptcy, and decided not to accumulate a required list of the victimized shareholders, just due to the excessive scope of the problem. Subsequently, the SEC entered into a Settlement Agreement with the Bankruptcy Trustee to deregister the shares, which required the judge's approval.
We obtained the required list of NOBO/OBO shareholders by subpoena. We also argued against the Settlement Agreement, and the judge denied that Agreement.
My point is that Bankruptcy Trustees have a vested interest in accommodating the SEC, by whom they are recommended as Trustees. I think that presents a conflict of interest, and the Trustees should be nominated by a disinterested party (the Consumer Financial Protection Agency, for example). A second point is that shareholders have significant power that can be granted to them by the judge.
I've been reticent speak too much since Liquidation was declared, and that guidance was provided to advise shareholders that no distribution to them was anticipated.
However, it is evident that Humanigen's circumstances have changed (or are changing), to the point where I expect that a distribution will be made to existing equity holders. We see support in that regard by the amended Asset Purchase Agreement, which will significantly expand the Milestone Events, and payments to the Unsecured Creditors.
We see Dubovsky altering his career path from Novavax's President of R&D, as we see Sanofi begin their spin-off, at the same time that we see both companies acknowledge their co-exclusive licensing agreement, which I suspect will be for lenz. I think it is these changes that will ignite the significantly expanded Milestone Events, and will also trigger Humanigen's recall of their loaned shares.
I see Gilead trading near 52 week lows today, while Novavax is trading near 52 week highs.
I suspect this illustrates why management did not want to give Gilead exclusive rights to use lenz. Rather, if I'm right, we'll see that lenz is the product co-exclusively licensed to Sanofi and Novavax. And hopefully, Dubovsky has helped to demonstrate that lenz improves the efficacy of azacitidine in treating, or preventing, Myelodysplastic cancers, perhaps significantly beyond what he and Pfizer demonstrated in their trials.
Of course, we know that Gilead gave up on their effort in this regard, after spending almost $5B to buy magrolimab, which failed to show improved efficacy, and in fact, resulted in increased mortality.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174481489
If North knows what he is getting into by establishing communications with investors and key shareholders of Humanigen's stalking horse bid winner, then he must know about Taran's strategy going forward, and believe that there is sufficient value to warrant the investment he will be soliciting.
And, since our bankruptcy judge has kept us in a CH11 proceeding, he should be equally informed about Humanigen's prospects and strategy as it relates to shareholder value.
Existing equity holders were excluded from voting on the Combined Plan and Disclosure Statement. However, it was the Combined Plan and Disclosure Statement that vested sole discretion into the Liquidating Trustee to declare a Record Date for a Distribution to Existing Equity Holders. The Declaration of a Record Date would not adversely affect the superior claim holders in any way. In fact, it could add value to their claims, if certain Causes of Action are implemented.
Existing equity holders should be permitted to Object to an arbitrary denial of our Preservation of Rights. I see no reason why the judge, rather than the Liquidating Trustee, should not retain the authority to Declare a Record Date, if requested by the Debtor.
There may be something we could learn from Sanofi's acquisition of Inhibrx, Inc. I see some similarities in the set-up of the acquisition. It's beyond my pay grade.
https://www.sec.gov/Archives/edgar/data/1121404/000119312524150383/d843856dex991.htm
“in which they note a Deagel study which projects the US population to decline by as much as 200M by 2025. “
That’s 2/3rds of the US population in the next 6 months, I’m guessing that was written wrong?
Hello, D
First of all, let me say that I appreciate your continued consideration of my posts. The issue of how the bankruptcy concludes, in my opinion, should now consider whether Humanigen still meets bankruptcy parameters, especially in regards to liquidation. I don't think they do. I think we should see our status changed from liquidation, back to reorganization, from which we should emerge with our share structure intact.
Something else I have long believed is that we are engaged in biowarfare. I view the illegal mass migration of non-Europeans into the US in support of that claim. That claim is also reinforced by the tens of thousands of Chinese nationals who have entered our country illegally. These immigrants are not susceptible to the covid strains designed based on national DNA databases. A good discussion of this topic is based on an interview by Matthew Smith of Doug Casey, in which they note a Deagel study which projects the US population to decline by as much as 200M by 2025.
"Research into Disease X also requires gain-of-function utilization, to possibly produce another novel coronavirus, which I think could be the Pangolin Coronavirus GX_P2V..."
More recent discussion suggests that "Disease X" could actually prove to be a version of H5N1 bird flu, which could be, or will become, genetically modified. Dr. Kelly Victory, one of my favorites, conducted an excellent interview of Dr. Brian Hooker, PhD, on this subject of "H5N1 Bird Flu: New Pandemic Gets New mRNA Vaccine," starting at minute marker 09:30 in the following video.
It begs the question, since Humanigen has no secured debt obligations; no non-tax priority claims; and the unsecured creditors are voting to approve the amended APA in anticipation of a rigorous response toward accomplishing Milestone Events, then why shouldn't the CH11 bankruptcy be discharged with the share structure absorbed, as the company emerges from this reorganization?
An old skeptical challenge to such a Phoenix re-emergence of life, would be to ask, "How did this happen? Did the company discover a cure for cancer or something?" And the answer is likely yes, for cancers such as CMML.
That’s interesting.
It could be the butterfly effect. But my long-standing, pro-bias toward Novavax has me convinced that they and Humanigen have such mutual benefit by partnering, that Filip may very well slip into a Chief position with the Taran/Humanigen entity.
But I'm even more excited about the amended Asset Purchase Agreement, where it was indicated that, "...The settlement amended the APA to, among other things, significantly expand the events that will trigger the contingent “Milestone Payments” and increase the amount of those payments under the APA."
end of 2nd para, pg 4/5
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
About two weeks later, we got a little mixed messaging in Doc 253, where it was noted that no distribution to shareholders was anticipated, but that same paragraph concluded with the potential of a Record Date being declared, exactly for a Distribution to shareholders (which I think could be for shares of Taran, equal to the number of our Humanigen shares).
see 1st para, pg 3
https://reorgdocumentlibrary.broadridge.com/Client/Client?data=0524/N03355/444863/c
Yeah it’s the butterfly effect .
Is Filip Dubovsky retiring as Novavax's President of R&D, after recent patent grants, including some that were Granted in February and March, 2024?
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924064680/tm2415419d1_8k.htm
https://patents.justia.com/assignee/novavax-inc
Will he be joining in the Sanofi spin-off company, perhaps merged with the Humanigen/Taran entity, and Novavax?
"Michael North
Co-Founder, CEO; Chairman of Galaxy Magnesium
1mo
I have agreed to serve Taran Therapeutics as Strategy Advisor. Taran is a leader in the field of monocolonal antibody therapies, and I provide communications with prospective investors and key stakeholders. I work directly with the chief executives of the company, Cameron Durrant and Michael Schuster, helping to formulate its mission, vision, and long-term investment strategy. This is especially meaningful to me, because of my long commitment to the life sciences, specifically to making fundamental therapies that penetrate to root causes widely available."
https://www.linkedin.com/posts/michaelnorth_i-have-agreed-to-serve-taran-therapeutics-activity-7183247229166534657-j50L
Michael W Schuster, MD
Hematology Oncology, Hematology
https://doctors.stonybrookmedicine.edu/provider/Michael+W+Schuster/2250408
Schuster seems to have had a role in the following Pfizer clinical trial
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
https://clinicaltrials.gov/study/NCT04842604?intr=NCT02367456.&rank=1
"T cells, cancer and immunity"
I've only listened to the first half, so far, of this latest video posted by Dr. John Campbell, in which he and Professors Angus Dalgleish and Robert Clancy are discussing 'T cells, cancer and immunity.'
You'll have to check Youtube for Dr. Campbell's video for "T cells, cancer and immunity." I can't get the link to work.
To me, listening to the three of these gentlemen is the next best thing to listening to an investor presentation from Dale or Durrant. Without knowing it, I think John, Gus, and Robert are actually talking about the Methods Of Action for Humanigen's Lenzilumab and Ifab. At the least, I always feel that I develop a better understanding of the role I anticipate that our products will play, as we gain regulatory approval and authorization, and gain CMC and commercialization from partners such as Sanofi and Novavax.
Its a great price.
Does anyone have any idea as to why almost 458,000 shares of Humanigen traded today ? The stock is valued at .000 and change - so what's the point ?? Thanks for any illumination you can provide.
"The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax."
Today, Shah Capital filed an Amended 13D for their Novavax holdings.
"Item 4. Purpose of Transaction.
Item 4 is hereby amended to add the following:
On May 20, 2024, the Reporting Persons announced that in light of recent developments at the Issuer, they have determined to withdraw their preliminary proxy statement and campaign against the re-election of the Class II directors at the Issuer’s upcoming annual meeting. The Reporting Persons have long advocated for the Issuer to explore potential strategic partnership opportunities and believe that the Issuer’s recent announcement of its entry into a co-exclusive licensing agreement with Sanofi is a long-awaited step in the right direction."
https://www.sec.gov/Archives/edgar/data/1000694/000119380524000687/e663637_sc13da-novavax.htm
Sanofi, one of Humanigen's oldest shareholders (going back to Kalobios) has announced their intention to spin-off their healthcare division, and they and Novavax have acquired co-exclusive licenses to...use lenz as a vaccine enhancement? I believe so.
There are several developments I was hoping Humanigen would have expanded upon last week, because they all point to the likelihood of our success. And even more than news regarding regulatory approval, which would qualify as a Milestone Event, I especially anticipate the recall* of the company's loaned shares, with that news.
Particularly interesting is the filing of The Official Committee of Unsecured Creditors of Humanigen, Inc. Initial estimates were that this group could receive from
about $172K - $8.5M.
"The Creditors’ Committee initially objected to
the sale to Taran (the “Sale”) but ultimately reached a settlement with the Debtor and Taran
pursuant to which certain terms of the Sale and the APA were amended as described on the record
at the hearing before the Bankruptcy Court on February 14, 2024. The settlement amended the
APA to, among other things, significantly expand the events that will trigger the contingent
“Milestone Payments” and increase the amount of those payments under the APA."
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1075977&projectCode=HUM&docketNumber=235&source=DM
Achieving a Milestone Event, in and of itself, would enable Humanigen to pay the full $44.1M owed to the Unsecured Creditors, and open the door to the restoration of financial reward for shareholders.
*Shareholder value will be greatly enhanced by Humanigen's recall of the loaned shares. I had news of a different type of recall myself, from my auto manufacturer. But, my out-of-pocket expense is going to be several thousands of dollars to repair my car. Not the type of recall I was hoping for.
The "significant expansion" of Milestone Events, beyond those regarding the partner-sponsored clinical trials for CMML, aGvHD, and CAR-T, could come from Sanofi and/or Novavax. Novavax filed the following in this regard.
"Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On May 10, 2024, Novavax, Inc. (the “Company”) entered into a collaboration and license agreement (the “Collaboration and License Agreement”) with Sanofi Pasteur Inc. (“Sanofi”) pursuant to which Sanofi received:
i) A co-exclusive license to commercialize with the Company all of the Company’s current standalone COVID-19 vaccine products, including the Company’s NuvaxovidTM prototype COVID-19 vaccine and NuvaxovidTM updated COVID-19 vaccine, and updated versions that address seasonal variants throughout the world (“COVID Mono Products”),
ii) A sole license to develop and commercialize combination products containing a potential combination of the Company’s COVID-19 vaccine and Sanofi’s seasonal influenza vaccine (“COVID and influenza Combination Products” or “CIC Products”),
iii) A non-exclusive license to develop and commercialize combination products containing both the Company’s COVID-19 vaccine and one or more non-influenza vaccines (“Other Combination Products” and together with the COVID Mono Products, CIC Products, and Other Combination Products (“Licensed COVID-19 Products”), and
iv) A non-exclusive license to develop and commercialize other vaccine products selected by Sanofi that include the Company’s Matrix-MTM adjuvant (as described below, the “Adjuvant Products”).
Under the Collaboration and License Agreement, the Company will receive a non-refundable upfront payment of $500 million. In addition, the Company will also be eligible to receive development, tech transfer, launch, and sales milestone payments totaling up to $700 million in the aggregate with respect to the Licensed COVID-19 Products and royalty payments on Sanofi’s sales of such licensed products. In addition, the Company is eligible to receive development, launch, and sales milestone payments of up to $200 million for each of the first four Adjuvant Products and $210 million for each Adjuvant Product thereafter, and royalty payments on Sanofi’s sales of all such licensed products."
https://www.sec.gov/ix?doc=/Archives/edgar/data/1000694/000110465924060444/tm2414089d1_8k.htm
It's a shame, Chaplain. We just keep seeing new effects of the damage caused by the virus, AND, caused by the medical countermeasures to the virus, as seen in this young lady's case.
Better HEALTH, a whole lot more WEALTH, and no more STEALTH.
Thanks, Chaplain. I'm pretty sure that management submitted lenz for consideration in treating long covid. I hope lenz will be authorized for it. It's not just for the pain and the chronic fatigue, I'm concerned plaque will become more inflamed, and further lead to restricted blood flow and more clotting, especially with a long stent in my left leg. Lenz has shown how it makes therapeutics more effective, and I think it will likewise lead to improving a variety of indications.
"This biological decrease in energy is specific to those with PEM and not seen in other chronic illnesses."
I have to disagree. In addition to Long Covid, I think this post-exertional malaise (PEM) is also caused by mitochondrial issues associated with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). I was hoping that lenz would have demonstrated success in treating Long Covid, and that it would help me with ME/CSF. I'm still hopeful.
https://www.newsbreak.com/news/3336545657202-long-covid-can-destroy-your-ability-to-exercise-or-do-simple-tasks-now-we-may-know-why?_f=app_share&s=i16&pd=0EVqRbCy&lang=en_US&send_time=1715800027&trans_data=%7B%22platform%22%3A0%2C%22cv%22%3A%2224.19.0.27%22%2C%22languages%22%3A%22en%22%7D
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7392668/
https://share.newsbreak.com/6wpl3vck LONG COVID EFFECTS
Followers
|
327
|
Posters
|
|
Posts (Today)
|
6
|
Posts (Total)
|
43265
|
Created
|
01/31/13
|
Type
|
Free
|
Moderators DTGoody cowtown jay |
Humanigen, Inc. is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, we believe that we have the ability to transform CAR-T therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. Clinical correlative analysis and pre-clinical in vivo evidence points to GM-CSF as the key initiator of the inflammatory cascade resulting in CAR-T therapy’s side-effects. Pre-clinical in vivo data on the neutralization of GM-CSF using antibody or gene KO indicates that it is not required for CAR-T cell activity. Our strategy is to continue to pioneer the use of GM-CSF neutralization and GM-CSF gene knockout technologies to improve efficacy and prevent or significantly reduce the serious side-effects associated with CAR-T therapy.
We believe that our GM-CSF pathway science, assets and expertise create two technology platforms to usher in next-generation CAR-T therapies. Lenzilumab, our proprietary Humaneered® anti-GM-CSF immunotherapy, has the potential to be used in combination with any FDA-approved or development stage CAR-T therapy, as well as in combination with other cell therapies such as HSCT, to make these treatments safer and more effective. In addition, our GM-CSF knockout gene-editing platform has the potential to create next-generation CAR-T therapies that may inherently avoid any efficacy/toxicity linkage, thereby potentially preserving the benefits of the CAR-T therapy while altogether avoiding its serious and potentially life-threatening side-effects.
The company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. The company is also developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, T cell engaging, and immunotherapy treatments to break the efficacy/toxicity linkage including the prevention and/or treatment graft-versus-host disease (GvHD) in patients undergoing allogeneic HSCT. The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline.
June 15, 2020
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
https://clinicaltrials.gov/ct2/show/NCT04351152
Anti-GM-CSF antibodies expected to show better effect in Covid-19 than cytokine-specific targets
July 27, 2020
https://discoverysedge.mayo.edu/2021/06/22/cancer-to-covid-19/
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |