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.
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.
The Authorized Shares is 225M, and 119,080,135 of those shares are issued and Outstanding.
At one time, I think management was contemplating a 5:1 forward split. We may still see something like that. For example, maybe Taran will offer 5 shares of their stock, for every one share of HGEN stock, and end up with an OS of 595,400,675 shares. That OS was reported for us, at one time.
Any news will result in more than enough to pay off our Unsecured Creditors, and have this bankruptcy discharged. Remember, after TLD, I was able to sell shares at an average price of ~$28 (x 119,080,135 = a Market Cap of $3.3B, even without the spike of a recall of the loaned shares, or news regarding CMML).
We're dealing with the US government owning a sizable chunk of Moderna, and the ECB and German government heavily invested in Pfizer, plus these governments are providing the majority of the Regulatory Agencies' operating expenses, with government scientists also earning royalties from these companies.
So I agree that the best move is to look to Australia for the approval of lenz to treat CMML.
Management has more ice water in their veins than we do. I think it represents nothing less than stone cold resolve, and means that we will succeed.
"Myelodysplastic syndrome (MDS) is a group of cancers that affect the bone marrow and blood. In MDS, immature blood cells in the bone marrow don't develop normally and instead die or become unhealthy. This can lead to a buildup of defective cells over time, which can cause problems like anemia, leukopenia, and thrombocytopenia."
https://www.mayoclinic.org/diseases-conditions/myelodysplastic-syndrome/symptoms-causes/syc-20366977#:~:text=In%20a%20healthy%20person%2C%20bone,%2Dclotting%20platelets%20(thrombocytopenia).
I will not be surprised if lenzilumab is being used in the treatment of MDS in Mayo Clinic's Investigator Initiated Trial (IIT). And I think our CMO, Dr. Michael W Schuster, could be aiding Mayo in their IIT. This is his area of expertise.
https://doctors.stonybrookmedicine.edu/provider/Michael+W+Schuster/2250408
Humanigen, Inc., paid off their loan from Hercules Capital, about $25M, as I recall, to prevent Hercules from gaining control of the IP, as the book value of the company plummeted.
Thank you very much for providing that information, which did include Board of Director fees for Cheryl and all of the other Board members. But that is not the document I was looking for. I'll post it, when I see it again.
I don't think there is necessarily anything adversarial involved. I did, initially. But Kevin Xie probably coordinated the integration of lenz into the highly enhanced CAR-T platform used by Gracell, and I suspect they are paying license fees to us. I think the BOD resignations were scripted, and designed to disqualify us from NASDAQ. It was in the KBIO playbook.
The recall of my car, which has now been at the dealership for about a month, is going to cost me thousands to repair, and I need good financial news, not more of the same surprises I've been dealing with.
Management's Objection regarding claims on account of Equity Interest was not what I had hoped it would be. Here is a list of the claimants, in this regard, in case you haven't seen it.
start on pg 19/26
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1079544&projectCode=HUM&docketNumber=254&source=DM
I mention it because I did not see Cheryl Buxton's name on it. But the list I saw did mention John Hohneker and Kevin Xie. Now, I see none of the three.
https://www.streetinsider.com/Board+Changes/Humanigen+%28HGEN%29+Announces+Resignations+of+Three+Directors%2C+Company+Now+not+Compliant+with+Nasdaq+Rules/21941128.html
Maybe I need SG44's eyes on this, or maybe I need to finish my first cup of coffee. But I think there has to be another version of the list somewhere.
I just find it a little curious. I still believe that we will have a successful conclusion by the time additional information relative to the co-exclusive licensing deal between Sanofi and Novavax is made known.
"...some non existent illegal hidden share scheme."
If a distribution is allowed to existing equity account holders, the identity of those holders will be determined "...(as reflected by DTC and/or the Debtor’s official register of holders of common stock)."
see Allowance, pg 52/85
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1089767&projectCode=HUM&docketNumber=309&source=DM
I was right to note the significance of the reported float of 192% of our Outstanding Shares, and to assume that total came from the Transfer Agent.
Even the latest version of our antagonist recognizes that there are more shares in our market, than issued by the company, if he thinks we have someone holding 110M shares, and there are another 36M shares out there somewhere.
I'm in the process of reading today's Order issued by the bankruptcy court judge. Taking a break for dinner, so here is the link.
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1089767&projectCode=HUM&docketNumber=309&source=DM
Without regulatory approval, or news of a partnership, etc., we're where we are.
Yes, I did.
Actually, dlog, there was data in that regard, which I suspected, at the time, was from our Transfer Agent, to the NASDAQ Hearing Panel.
I mention the following should it be worth doing so.
"To me, part of the reason for investing here has always been a stock play, such (as) they executed previously DBA Kalobios."
I've never considered the PPS as reflective of the value of the stock. The value I have always considered was based on the projected value, when management recalls their loaned shares. It is for this reason that I have maintained open sell orders priced at $200.
Therefore, it is not mere ownership of shares that constitute my Equity Claim. My equity claim is based on a stated float that was reported at 192% of the Outstanding Shares, and knowing that excess shares in the market will have to be bought-in, in the event of a recall of the loaned shares, or a merger.
see pgs 4-5/26
"A. Equity Claims
13. The Debtor objects to the Equity Claims identified on Exhibit A to the Proposed Order because such claims relate solely to the mere ownership of equity security interests in the Debtor (as opposed to a claim arising from such ownership). Therefore, the Equity Claims do
not constitute a “claim” within the meaning of section 101(5) of the Bankruptcy Code. "
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1079544&projectCode=HUM&docketNumber=254&source=DM
Having said the above, I recognize that no recall of the loaned shares has yet been issued, nor has a merger been announced. However, management has to maintain control of a possible distribution to equity holders, even if motion is made to convert the bankruptcy to CH7.
I don't know what you're talking about, but neither do you. And you're certainly not in position to determine the validity of the claims against the company. The chief invalid claim is that the ACTIV-5 trial did not corroborate the results of the LIVE-AIR trial. The truth is, the ACTIV-5 trial was designed to fail, and failure to meet the endpoint of that trial of late-stage patients, had nothing to do with the successful treatment of the early-stage LIVE-AIR patients. And the class action tort lawyers who brought suit against the company were totally derelict in their duty.
Your reply failed to address the issue I presented in my post. What does that information mean to you?
My concern was in regards to the Liquidation Trustee having sole discretion to declare a distribution to existing equity holders. It seems to me that Humanigen management shares that concern, and their objection still appears to be on tomorrow's docket. I think they intend to safeguard claims of equity interest accounts, not only on shareholders' behalf, but on Humanigen's behalf, as well, since I think they control ~90% of our Outstanding Shares.
https://document.epiq11.com/document/getdocumentbycode?docId=4343828&projectCode=HUM&source=DM
"Docket # 254
Filed May 03 2024
First Omnibus Objection to Claims //Debtor's First Omnibus Objection (Non-Substantive) to Claims on Account of Equity Interests. Filed by Humanigen, Inc.. Hearing scheduled for 6/13/2024 at 10:00 AM at US Bankruptcy Court, 824 Market St., 6th Fl., Courtroom #1, Wilmington, Delaware. Objections due by 5/17/2024. (Attachments: # (1) Notice # (2) Exhibit 1 # (3) Exhibit 2) (Forshay, Shannon)
Case Number 24-10003 Humanigen, Inc."
4th tab
https://dm.epiq11.com/case/humanigen/dockets
Always best to remain up to date. But prior to the years I spent here, I spent years in another company, where the SEC totally abused their discretionary authority, as they likely did here, and as NIAID/NIH, and the FDA definitely did. And the much more extensive research I did in the other company showed just cause to a judge to grant me subpoena power, which I used. So time I don't have to spend in the weeds, because of research from people like you, is very much appreciated.
So I assume the Omnibus Hearing and the Governmental Bar Date, whatever those are, are likewise delayed.
Like I see you did, I credited US-JUSTICE for his valid points, but he then tends to get sidewise in keeping with what I suspect is his agenda, and it only diminishes whatever credibility he had. The government's abuse of discretionary authority is one thing, when the SEC uses it to fund recipients of government largesse from the Treasury Dept. The abuse of discretionary authority by NIAID, the NIH, and the FDA, causes the preventable loss of life, and that is a worthy cause to fight.
I really appreciate when other stockholders, such as SorcererGuru44, contribute valuable research. I've been following this company since 2015, invested since it became Humanigen in 2017, and I have previously said that I have had my fill of legal boilerplate. I'll take the CliffNotes version, with links, anytime.
I wish there was news. I've been wishing for news ever since we filed our topline data from the LIVE-AIR trial in March of 2021, just one year after covid hit our shores. That was an incredible achievement, especially for a small-cap biotech. Lenz could have saved the lives of many who were lost; it could have improved the quality of life in patients that couldn't be saved; and it could also have improved the quality of life of those of us who invested here. I think management is steadfast in their effort to achieve success, and I owe them support in their quest.
That's actually good to know, SorcererGuru44. Sanofi may not be quite ready to spinoff until next quarter, which, as you said, "...may or may not mean anything to us."
Appreciate your research.
Management dutifully reported the clinical safety and efficacy results of lenz in treating/preventing CMML in the PREACH-M study, as well as the outstanding Hazard Ratio of 2.54, as determined by the Thorax peer review of the LIVE-AIR trial for covid.
The IP was devalued by the NIAID/NIH ACTIV-5/BET-B trial design and orchestrated results.
https://ir.humanigen.com/English/news/news-details/2022/Humanigen-Receives-Preliminary-Topline-Data-From-NIHNIAID-Study-of-Lenzilumab-in-ACTIV-5BET-B/default.aspx
So the issue is not my claiming an overstated value of the IP in the billions. That was, is, and will be the value.
You have shown no interest in the real issue that decimated the value of this life-saving therapeutic, nor in the willful/criminal negligence of the NIAID/NIH and FDA, which continues to permit the preventable loss of life. I don't understand why you wouldn't want to give this issue serious attention, and quit wasting your ability.
I actually believe that our likelihood of success is MORE realistic now than it has ever been. Sanofi is a behemoth, and 100% capable of meeting all of our manufacturing and other CMC requirements. Even more, they have 77 projects in their active pipeline, to include therapeutic development for:
Immunology & Inflammation
Neurology
Oncology, and
Rare Diseases
I think lenz could be market-dominant in all these areas.
So there are numerous opportunities for lenz to enhance or replace the therapeutics that are already in these many clinical trials. Some of these trials are for the same indications that lenz, and Ifab, are already being developed for, such as AML, (CMML for us) GvHD, and solid tumors.
https://www.sanofi.com/en/our-science/our-pipeline
And I'm hoping that Dubovsky can help us capture foreign regulatory approval and commercialization of lenz for covid through the vast network Novavax has worldwide. In fact, Novavax is current with domestic competitors for the 2024-2025 vaccine year, and they will again have the only non-mRNA vaccine in the US.
So when the Milestone Events were amended to be significantly expanded, I think much of this increased opportunity will stem from our role in the Sanofi/Novavax entity that will follow Sanofi's spinoff.
I eagerly await a Press Release in these matters, and I look forward to the recall of our loaned shares
"If overseas traders who are aware of the potential for Lenz approval aren’t trying to buy shares, it kinda tells you all ya need to know."
Doesn't that logic equally apply to sellers, such that:
If overseas traders who are aware of the potential for Lenz approval aren’t trying to sell shares, it kinda tells you all ya need to know?
I don't think that investor sentiment can adequately be reflected on the Expert Market, where Bid/Ask information is not displayed.
I don't want to downplay the situation we are now in, which is being placed in liquidation status, versus reorganization status. I don't know who the Liquidating Trustee is. No do I know if this is a management-supported defensive tactic. But I don't accept that he has unfettered authority to use "sole discretion," as is reported. An offer of Taran shares, for HGEN shares, for example, should prompt the judge to disallow liquidation. And more, the announcement of regulatory approval of lenz to treat or prevent CMML and/or aGvHD, should result in more than enough funds for management to fully meet obligations to the Unsecured Creditors, and result in the discharge of this case from the bankruptcy court.
Anything less than a distribution to existing equity holders, this close to our success, would transcend a mere travesty of justice. It would be illegal under the circumstances I just described.
Thank you for the link, SG44. So, it appears that there will be an Omnibus Hearing on Tuesday, and the Governmental Bar Date is set the day before my open sell orders expire on July 2. I don't want to see those orders expire.
I really don't know what that means, and I would much rather see those actions mooted by whatever course of action management might be implementing. But I will say that I continue to sense, everyday, that management is working with Sanofi on their spin-off, and that we could be looking at a partnership with Novavax in association with the Sanofi spin-off.
I'm fully aware that the SEC has sealed the records in their case against Dale's entities, and I hope he prevailed in the Court of Appeals. I mean, really, management spelled out their share structure, to include the use of company insiders as nominee account holders, in an SEC filing. I knew as soon as I read the filing what they were doing, and why they were doing it. It was because management knew that the SEC would not protect them, and they had to have a plan to defend themselves, which they did very well.
"Based on the asset disclosure it doesn't appear there is nearly enough $ to reach us."
I think lenzilumab may prove to be the biggest blockbuster drug ever to hit the market. That is not a new conclusion, nor is it based on news that management has kept under wraps. Lenzilumab's astounding safety and efficacy was duly reported in the topline data of their LIVE-AIR trial, which showed a Hazard Ratio of 1.54, which was a 54% improvement over standard of care.
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Reports-Positive-Phase-3-Topline-Results-Demonstrating-That-Lenzilumab-Improves-Survival-Without-Need-for-Mechanical-Ventila-O9C2T.pdf
Just based on the release of the topline data, with the 54% improvement over placebo and standard of care, the market reacted so favorably that I was able to sell shares for as much as $27.78 and $29.07 on March 29, 2021.
"Highlights over the past year include:
Lenzilumab in COVID-19 patients
Completed the LIVE-AIR study, which showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54% greater relative likelihood of survival without the need for invasive mechanical ventilation compared with patients receiving standard of care and placebo.
Positive results of the LIVE-AIR study were published in The Lancet Respiratory Medicine, https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00494-X/fulltext. The Lancet publication concluded that lenzilumab treatment of patients with COVID-19 can improve the likelihood of survival without the need for mechanical ventilation, with a safety profile comparable to placebo..."
https://www.sec.gov/Archives/edgar/data/1293310/000121465922003320/ex99_1.htm
Here again, we see management reporting the peer-reviewed results published in Lancet. But in addition to the topline data, and the Lancet peer-review, the company reported the publication of a second peer-review in Thorax. This was on using CRP as a biomarker, and it showed that the early use of lenz in hospitalized and hypoxic covid pneumonia patients showed that "... baseline CRP <150 mg/L (HR: 2.54; 95% CI 1.46 to 4.41; p=0.0009)."
https://thorax.bmj.com/content/78/6/606
Personally, I think our market has greatly expanded to include treatment of non-hospitalized covid pneumonia patients. I base this on the Thorax peer review, which concluded:
"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)." (Info is in paragraph just above Table 3).
We're seeing reports now that Pfizer and Moderna provide 70 - 80% of the FDA's operating revenue, and that NIH and NIAID scientists are receiving royalties from these manufacturers. Here is four year old data from the FDA acknowledging this practice.
"About 55 percent, or $3.2 billion, of FDA’s budget
is provided by federal budget authorization. The
remaining 45 percent, or $2.7 billion, is paid for
by industry user fees."
https://www.fda.gov/media/143704/download#:~:text=authorization%20funds%20about%2062%20percent,%40fda.hhs.gov.
That's why lenz, with an 8-fold improvement in treatment outcomes, when administered early to patients with CRP levels <41 mg/L, can't get regulatory approval, and consequently, millions of covid patients have, or will, suffer preventable deaths. This collusion and graft is what happens when executive agency bureaucrats have "discretionary authority," which I think should be rescinded.
Lenz was intended as a cancer drug before covid came along, and an effective CMML cancer drug is what lenz has proven to be.
Humanigen Presents Promising New Hematologic Data from PREACH-M Trial for Chronic Myelomonocytic Leukemia Treatment at the 2023 European Hematology Association Congress
— Humanigen, Inc. (@humanigen) June 9, 2023
Full Story: https://t.co/mXv7opGRkr
@humanigen $HGEN #HGEN #Humanigen #Chemicals #Pharmaceutical #Medical
What YOU don't understand is the design of the company's share structure, where company insiders were merely the nominee share holders. They held shares for the beneficial owner. Transactions reflecting buys and sells amongst Dale's entities, were actually just reflecting the transfer of shares between the entities.
The company provided the 'locates,' meaning they agreed to loan the shares. They have a right to recall those loaned shares. Brokers will be forced to buy-in their short sellers.
To me, part of the reason for investing here has always been a stock play, such they executed previously DBA Kalobios. Does this sound familiar?
"KaloBios has been surging since Shkreli bought a 70% stake in the company earlier in November, rescuing it from insolvency. The company had announced just a week earlier that it was winding down operations because it was running out of cash while developing two potential cancer drugs."
https://www.marketwatch.com/story/kalobios-short-sellers-facing-squeeze-as-ceo-shkreli-says-will-no-longer-lend-stock-2015-11-27
alternate source:
https://moxreports.com/kbio-infinity-squeeze/
I have seen no reason to think that the company will not achieve certain strategic objectives, associated with Australian regulatory approval to treat CMML, perhaps with the addition of Filip Dubovsky to work with our new entity and with the Sanofi spin-off. I also believe Humanigen may control ~90% of their Outstanding Shares.
But to be sure, we appear to be in a precarious situation. However, I just don't believe that we are. I will believe that until management tells us differently.
Thank you, SorcererGuru44.
I see that the last sentence on page 38/70 still contains the following.
"Pursuant to the Combined Plan and Disclosure Statement, the Liquidating Trustee, in its sole discretion, may establish the Existing Equity Interests Record Date should there be a Distribution to Holders of Allowed Existing Equity Interests."
https://document.epiq11.com/document/getdocumentbycode?docId=4343564&projectCode=HUM&source=dm
The section for Treatment of Existing Equity Holders that you quoted also notes, a few paragraphs after the information you quoted, the following.
"Allowance: Existing Equity Interests held by Holders thereof as
of the Existing Equity Interests Distribution Record Date (which
such date may be established by the Liquidating Trustee in its sole
and absolute discretion) shall be Allowed Existing Equity
Interests under the Combined Plan and Disclosure Statement (as
reflected by DTC and/or the Debtor’s official register of holders
of common stock)."
I suspect there is going to be a significant difference in the number of shares reported by the DTC, versus the number of shares reported by the company's Transfer Agent.
We'll see how things transpire. It could get interesting if the company requests to have their shares in certificate form. However, you did source the material I was waiting for, and I very much appreciate your post.
Contrary to what I've been reading about myself, I am not paid to post. I've said that before, but it evidently bears repeating. I've also said repeatedly that I am retied, and living on a fixed income, and sometimes unexpected repairs, etc., have to be put off. So at the earliest possible time, if good news is on our horizon, I want to hear it. My open sell orders will expire in about two weeks. As I look at the pieces that have to be put into play for our success, I'm seeing what think are key components coming together. I know that lenz will be hugely successful, and I want to see existing equity holders, including management, receive the reward we deserve.
Once again, thank you for sourcing the important information you provided. Well done!
Hello and welcome to the room, SorcererGuru44. Can you link a source for material you quoted? I'm not seeing a new filing. Do you have a Pacer account?
"...the question is why is cowtown who probably paid to post every day here?"
You have no clue how important lenz will be to the world.
Here again, I agree with a part of what you say. The SEC gave the crooks the playground to rip off the public. But I disagree that there are no share loans. You know that can't be right, because you recognize (from somewhere - me?) that a single entity owns 110M shares. So if Humanigen controls about 90% of their OS, then management aren't the crooks, and my only question is whether Taran, or the Humanigen/Taran entity, will benefit by the forced covering, whether prompted by a merger, or by a recall of the loaned shares, or both.
I think the SEC tried to squash this situation, especially if the NIH owns so much of Moderna. If so, will this bankruptcy judge allow Humanigen's assets to be transferred to the US Treasury? Or will he order those funds to be returned to Humanigen and the injured shareholders? More often than not, judges recognize the discretionary authority of the executive branch agencies. But, in this case, the judge may recognize a conflict of interest in the agencies, and disallow the discretionary authority to convert our funds to the Treasury Department.
"Currently, my primary hope is to see Cameron's leadership in action. Do you have any insights or observations in this regard?"
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173637404
Stay tuned. I think he has set the stage.
I agree that the shares are, "... useless and worthless with the information that is available today..." and that there is a single entity, "...who still owns 110 million shares." The meaning of that entire dynamic will change with a Press Release, which I am eagerly anticipating. I think you picked a bad time to come back.
"... 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)."
I don't see why a distribution to existing equity holders should not be declared. The Unsecured Creditors are looking forward to the amended plan which will increase the number and amount of payments they will receive. These Milestone Payments are based on regulatory approval which seems likely to first come from Australia as the result of our PREACH-M trial for CMML.
With the progress management has made, I truly don't see how existing equity holders could fail to be rewarded.
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.
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.