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I was in a bit of a hurry in writing a couple of posts yesterday. I had a doctor's appointment at 3pm. I should have followed-up my comment about the 10-Q with what I had posted previously about needing to see Notice of Effectiveness statements from Gracell and Baudax for their registration statements.
Those notices appeared today for both companies.
https://www.sec.gov/cgi-bin/browse-edgar?company=gracell&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
https://www.sec.gov/cgi-bin/browse-edgar?company=baudax&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
So my expectations remain intact.
By the way, Gracell's fireside chat with Jefferies can be viewed here.
https://wsw.com/webcast/jeff290/grcl/1841840
Kevin kept his comments directed to their therapeutic. We'll have to hear from management in regards to the the potential performance of lenz.
I've seen the Electronic Blue Sheet trading records of other financial firms that did the same thing Citadel has done. What a joke.
I want to see the 10-Q before Gracell makes their presentations to Jefferies and Cantor, starting tomorrow. But I am assuming that their CAR-T enhancement is due to lenz. It may not be, in which case, I will have to reset my expectations.
"The SEC’s order finds that the inaccurate marks resulted from a coding error in Citadel Securities’s automated trading system..."
That's BS. This is standard operating procedure for violating RegSHO.
It's been awhile since I saw the 595,400,675 OS number, which was exactly 5X higher than our current OS, leading me to conclude that management was going to declare a 5:1 forward stock split.
I think the stock split , in itself, would cause a short covering of shares that were sold, but not delivered. I don't think management is reporting Failures to Deliver yet. We did, however, see that they reported 229M shares in the float. That's 110M shares more than they issued.
Short sellers are going to be SOL, well beyond just getting margin calls, because I fully suspect management is going to recall all their loaned shares.
On top of that, the absolutely stellar performance of lenz in treating CMML, and covid, could result in regulatory authorizations and/or approvals, with the promise of even more good news in enhancing CAR-T safety and efficacy, and that could cause a stampede of buying interest.
I have historically pointed out supportive evidence for what I reported above. There are reasons for my claims.
I was hoping we would see the 10-Q today, one day ahead of associated news. But maybe the 10-Q and news will be released tomorrow, instead, concurrently. I hope so, man.
I tried to place a buy at $0.002, in case we forward split at 5:1. I guess my money STILL hasn't baked enough in Schwab's oven, so I couldn't place the order. I'm hoping we have a business combination agreement, with a partner who may want US market access without using ADR's. I'll try again tomorrow.
Intended link to text
https://www.congress.gov/bill/117th-congress/senate-bill/1348/text
"AbbVie terminates deal with I-Mab to develop cancer drug
Reuters
Fri, September 22, 2023...
AbbVie's decision to scrap the deal comes after it pulled the plug on an early-stage study in August last year that was testing lemzoparlimab in combination with two other drugs for treating two types of blood cancers, myelodysplastic syndrome and acute myelocytic leukemia."
https://www.yahoo.com/news/abbvie-terminates-deal-mab-develop-210910326.html
Former DNI John Ratcliffe has been pretty forth-coming on this issue.
Here is the format of S.1348, specifying certain events at WIV that Scalise put into the House subcommittee's record.
https://www.congress.gov/bill/117th-congress/senate-bill/1348/all-info
Combining the political pushback that is developing, the increased hypervirulence and anti-biotic resistance of certain emerging infections, 2020 levels of Covid detected in wastewater sampling, and additional safety and efficacy in support of LIVE-AIR results, we may very well see our EUA approved, not only overseas, but in the United States, as well.
I have been consistent in my self-determined opinion that federal agencies, such as the FDA and the NIH, abused their discretionary authority to the point where the FBI or the HHS Inspector General (IG) needed to investigate the issues.
Earlier this year, we saw this from the IG.
"Federal watchdog finds problems with NIH oversight of grant funding bat virus research in China
5 JAN 2023...
NIH had concluded that these studies did not qualify as “gain-of-function” research that requires a special HHS review because the hybrid viruses weren’t expected to be more dangerous to mammals than the starting viruses. But it stipulated that EcoHealth should “immediately” report any unexpected growth of the hybrid viruses to NIH.
NIH has faulted EcoHealth for failing to promptly report this unexpected growth in some experiments...
OIG recommends that WIV—but not EcoHealth—be debarred from receiving NIH funding in the future, a step NIH supports but noted must be made by an HHS debarment official. A recent congressional spending bill bars any 2023 funding to WIV."
https://www.science.org/content/article/federal-watchdog-finds-problems-nih-oversight-grant-funding-bat-virus-research-china
My "self-determined opinion" wasn't formulated by anything Tucker said. It isn't reflective of any desire we have to tear down government agencies. We simply want those agencies to be free from the influence from Big Pharma, or political ideology. I have clearly demonstrated, from the patient inclusion criteria for the LIVE-AIR and ACTIV-5 trials, that the spectacular results of the LIVE-AIR trial were obtained from early-stage patients, including a majority who were on room air and in WHO ordinal scales 3, 4, and 5; while the ACTIV-5 trial included late-stage patients only, in disease severity scales of 5, 6, and 7 (point 8 on the scale is death). I think it is fair to conclude that the NIH trial was designed to fail, and had no intention to collaborate the results of the company-sponsored trial.
The system is broken, and as a result, millions of lives have been, or could be, needlessly lost. These are preventable deaths that lenz will avoid, if authorized.
I'm glad that you're still here.
I have rock solid conviction in our immediate and continued success.
Hi, dlog. Did you guys hear anything from Gracell's presentation to Stifel Wednesday? I'm wondering if it concerned lenz, as I think it may have.
But, we've got opportunities on Tues and Wed to learn more in this regard. I'm hopeful for a good week.
A $1M per patient treatment cost, and the treatment is ineffective for 30% of the treated patients.
Sounds like a job for lenzilumab.
But surely not, right? How could lenz possibly eliminate most of the treatment cost, and also improve the complete response rate for patients, when Humanigen's stock price it teetering on one cent?
Dare I to think that this unrealized potential presents promise almost beyond comprehension? Could share price be transient, yet result in lenzilumab demonstrating results that are robust and durable?
This is just about one of the many active opportunities for lenz. I'm here for the realization of all of lenzilumab's opportunities.
And political power is not a factor for this indication. Nor does Big Pharma regulatory influence come into play. When a product is as good as lenz, it can't be denied for everything, and forever.
While I have previously recognized lenzilumab's potential to enhance CAR-T efficacy as it may relate to TeraImmune, I think Gracell's CAR-T technology expands on that, and illustrates a broader scope for lenz in CAR-T.
The list of catalysts I'm anticipating doesn't note CAR-T enhancement, that now likely warrants being included in my list of catalysts. I'll add it now.
>CAR-T enhancement
>Our merger with Baudax
>The resubmission of our EUA application to the FDA with copy to MHRA in UK
>Tentative regulatory approval for lenz to treat CMML, granted by Australia's Therapeutic Goods Administration
>A finding to continue the study of lenz based on results from the first 20 patients in the aGvHD trial, which could prove to be a cure for certain cancers
>The declaration of a 5:1 forward stock split, depending perhaps on concluding a planned business combination.
>The recall of our loaned shares.
But when you KNOW what to expect from Regulators (not a damn thing, until they must), and you KNOW how revolutionary this drug will be (in both the covid and cancer markets), it presents unparalleled life-changing, as well as life-saving, opportunity. I think management is just quietly taking advantage of this opportunity, ahead of the recall of their loaned shares.
I wonder if Humanigen had a role in the Investigator Initiated CAR-T study of the Gracell platform. And we may also have invested Humanigen funds for the Baudax/TeraImmune acquisition. I suspect investment firms could be queued-up for a private offering. And with the Jefferies and Cantor investor presentations, maybe we will see a controlled equity offering, as well. Shares could become available if the company announces a 5:1 forward stock split, and if we also deplete our open shelf registration for $80M+.
I was able to add at $0.01, and at $0.0098.
Yes, that amazing improvement was discovered as a result of an Investigator Initiated IND clinical "FasT CAR" trial in the US. I'm hopeful that lenz was the Investigational New Drug that was used.
https://www.gracellbio.com/pipeline/
I don't know how Gracell's presentation to the Stifel 2023 Immunology and Inflammation Virtual Summit was received yesterday. The webcast wasn't archived. But the Jefferies and Cantor presentations scheduled for Tuesday and Wednesday will be available to review.
https://ir.gracellbio.com/news-events/events-and-presentations
I am hopeful that we will see our second quarter 10-Q by the 25th, before next week's presentations. If we can soon see news regarding the approval of lenz for CMML in Australia, followed-up with this news of our CAR-T enhancement, and possibly including TReg news from TeraImmune, that would be amazing!
Yes, I think I caught a bad case of chutzpah from management. It's obvious they are afflicted with it. Why else, with all the negativity about being demoted to Pink Limited listing status, would management echo my sentiment about the "good reason" for being so positioned? I love these guys.
"I think there is a very good reason that the second quarter 10-Q has been held up, taking us to Pink Limited listing status. If, as I suspect, the company recalls their loaned shares (which I think comes to 110M shares), short sellers, forced into buying by this recall, will have a very, very hard time of buying that volume of shares on this venue."
'"Will you walk into my parlour?" said the Spider to the Fly."
https://www.poetrybyheart.org.uk/poems/the-spider-and-the-fly
Double digit gains from a fraction of a penny in share price movement are as tempting, as they are dangerous.
No short volume reported in almost two months here:
http://shortvolumes.com/?t=HGEN
And with what I think is an impending recall of loaned shares, what could possibly go wrong for short sellers, betting against Humanigen's success?
Regarding T cells becoming exhausted, that is an issue being addressed by Gracell with their FasTCAR platform. Gracell filed an F-3 Registration statement in this regard last month.
"Company Overview
We are a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies to address major industry challenges and fulfill unmet medical needs in the treatment of cancer. We aim to develop next-generation, transformational CAR-T cell therapies to broaden the use of this potent treatment modality across a wide range of disease indications in hematological malignancies, solid tumors and beyond.
Our pioneering platforms, FasTCAR and TruUCAR, are designed to provide significant advantages as highlighted below:
•
FasTCAR. With FasTCAR, we are able to deliver younger, less exhausted T cells for autologous cell therapies with enhanced activities and next-day manufacturing versus the industry norm of one to six weeks. FasTCAR is designed to address the most pressing challenges associated with autologous therapies, such as lengthy manufacturing time, suboptimal cell quality, high therapy cost and poor T cell fitness."
See Prospectus Summary, page 1.
https://www.sec.gov/Archives/edgar/data/1826492/000110465923094883/tm2324412-1_f3.htm
It's interesting to think that not only does lenz improve the efficacy of treatment therapeutics, but perhaps that extends to improving the efficacy of the treatment method.
I really appreciate that, eb. Thank you.
How would you know how far from reality my posts are? The reality is something I'd really like to know. Let me know if my starting to think that it is unrealistic to think that Gracell may enter into a partnership agreement with us.
Why ask me? I think they have a lot of things going, as I told you before, and they could be anywhere.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172790011
Maybe so, Yooo. But for anyone who is considering making an investment, or whether or not to sell their existing shares, it may be relevant to their decision.
It's interesting to note that Gracell does have a US Phase Ib/2 IND study on-going for their "FasT CAR" program.
https://ir.gracellbio.com/static-files/318a2250-ad01-4a5b-8f93-fdf5a96088ad
Over the next 9 days, the first of three investor conferences Gracell will participate in is scheduled in two days.
"Stifel 2023 Immunology and Inflammation Virtual Summit
Fireside Chat: Wednesday, September 20th at 10:15 am ET
Presenter: Dr. Kevin Xie, Chief Financial Officer
Location: Virtual"
https://ir.gracellbio.com/news-events/events-and-presentations
I mention that for what it is worth because I think there is enough reason to do so, and it may be worth consideration for the next couple of days.
"COVID levels are so high, they’re hovering near 2020’s initial peak, as the WHO urges those at high risk to take any booster they can get their hands on"
Erin Prater
Sat, September 16, 2023
The reported headline, as well as some of the content in the article, is so surprising, and some of it makes so little sense, that I almost didn't post the link. But there is some input from Eric Topol, so I'm making the post.
https://finance.yahoo.com/news/covid-levels-high-hovering-near-094500374.html
"... I looked at the Baudax filings the day before Ed resigned, to see if there was a clue provided."
Maybe the clue I was looking for regarding Ed can be found in Gracell's Press Release.
"I wonder if our 10-Q and news will dim Gracell's spotlight, or if lenz (will) have a role in their news." It seems like they may need a top level Commercialization officer, and would certainly benefit by Ed's hands-on experience with lenz for CAR-T.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172819198
I actually think lenz is better than a vaccine.
Yet, here we are with vaccines for everybody, starting at the age of 6 months.
Standard of care should be an infusion of lenz, with an activating agent, such as used in the traditional vaccines.
It makes far more sense to program an appropriate immune response to a respiratory infection, whether it is viral, fungal, parasitic, or bacterial in nature.
We're not there, yet. Lenz may be there, but we're not.
We'll take each victory as it comes. We know that the CMML trial data is revolutionary. Combine that with the recall of our loaned shares, and our success will be manifested. As far as I'm concerned, that is nothing more than a factual assessment of our situation.
Those aren't just your thoughts, Friend, many of us probably feel the same way you do.
And contrary to my feeling that lenz is some kind of vaccine, I don't feel that way at all. I think it could become part of a vaccine, when used with the Novavax or Janssen traditional vaccines, an anti-viral, and perhaps with the polyclonal antibodies we mentioned in our patent.
Nonetheless, I think we do pose a significant threat to the mRNA vaccine market. Again, I wish I had data on covid pneumonia reinfections for those patients who had lenz. I suspect reinfections of lenz patients to be negligible, AT MOST. You did not note the role of T cell memory imbued by lenz, which could prevent the progression of any future covid infection. And in that case, rather than lenz providing many more living people to be vaccinated, I think that market will diminish to the point that lenz could be used as a treatment for any covid cases that do develop.
I agree with you that the government wants their citizens to rely on them for virtually every aspect of their lives, and that lenz will remove a large degree of that control when it comes to healthcare. But look around. We're seeing unusual presentments of various types of infections, to include fungal and bacterial infections, in addition to viral. Not only that, we're seeing hypervirulent and antibiotic-resistant strains of some of these infections. This passive-aggressive bio-war will evolve to the point where it will become necessary to effectively combat these infections.
Lenz will earn it's stripes in fighting CMML and related cancers. The only reason we'll be permitted to do that is because decades have passed without Big Pharma being able to provide a solution. We are showing that progress now, and I have to think our effort will result in regulatory approval in Australia. I also think MHRA may then decide to grant lenz Conditional Marketing Authorization for covid, as well as CMML.
"Necessity" has always been one of the required components for our success. Government interference has hindered us. But ironically, the adversarial actions of other governments may force the hand of our government to protect their citizens. We've got to make our 535 national legislators rescind discretionary authority from government agencies. They should be required to follow the laws as written, and any deviation should require a full vote of both Houses to be permitted.
I find what the Item 5.02 DOESN'T say, more curious than what it does say. There was none of the language expected when announcing the departure of a Chief officer of the company. I was so curious that I looked at the Baudax filings the day before Ed resigned, to see if there was a clue provided. There was none that I could see.
The catalysts that can propel us forward are in place and active. There's no denying how effective lenz has shown to be in CMML and covid. Nothing is going to erase lenzilumab's demonstrated performance.
I just don't want any corporate actions undertaken to delay our reward. More importantly, I don't want any more regulatory inaction to delay our reward.
I'm sorry to see that, JA3. Ed has always struck me as being as real asset to the company, willing to serve in whatever way he can, whether it was assisting Cenexi (as I recall) in establishing a European distribution and commercialization network, or writing press releases for Investor Relations. I wish him well.
The tenths of a penny that our share price fluctuates is meaningful to you. I get that.
But the daily data that interests me is the following CMML trial data. especially for the Primary Endpoint, and Secondary Endpoints 4, 5, 6, and 7, all of which should have reportable data by now.
"Primary outcome [1] To assess the frequency of complete response (CR) and partial response (PR) at any point during the first 12 cycles of active therapy according to Savona Criteria. (composite outcome)
Timepoint [1] Any point during the first 12 cycles
Secondary outcome [1] Overall survival (as measured by medical records/follow-up.)
Timepoint [1] 2 years from Cycle 1, Day 1
Secondary outcome [2] Progression-free survival (as measured by medical records/follow-up)
Timepoint [2] 2 years from cycle 1, day 1
Secondary outcome [3] The proportion of participants who derive a clinical benefit according to Savona Criteria
Timepoint [3] The proportion of participants who derive a clinical benefit at any point during the 24 cycles of active therapy. This will be evaluated at the conclusion of study.
Secondary outcome [4] Assessment of the impact of treatment on physical capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [4] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [5] Toxicity evaluation, both haematological and non-haematologic for both arms of the study by assessment of adverse event reporting and test results.
(Composite outcome)
Tests include blood tests and bone marrow tests. Toxicity will also be evaluated by asking participants about their health at every visit.
Timepoint [5] Throughout the 24 cycles of active therapy. (Assessed throughout as serious adverse events reported immediately). Participants will be asked about their health at every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Blood tests will be collected every visit (baseline, cycle 1 days 1, 2, 4, 7, 15 & 22 and then day 1 of each cycle (maximum of 24 cycles). Bone marrow tests will be collected after 3, 6, 12 & 24 cycles of treatment.
Secondary outcome [6] Assessment of the impact of treatment on functional capacity by serial assessment of Multidimensional Geriatric Assessment.
Timepoint [6] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal.
Secondary outcome [7] Assessment of the impact of treatment on social wellbeing by serial assessment of quality of life questionnaires.
Timepoint [7] At baseline, Cycles 3, 6. 9, 12, 18, 24 and Early withdrawal."
https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380941&isReview=true
Former Board member Kevin Xie will be on familiar stomping grounds on behalf of Gracell and their, "potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors and autoimmune diseases."
https://www.globenewswire.com/news-release/2023/09/14/2743346/0/en/Gracell-Biotechnologies-to-Participate-in-Three-Upcoming-Investor-Conferences.html
I wonder if our 10-Q and news will dim Gracell's spotlight, or if lenz have a role in their news.
I wonder if our interest in TeraImmune, through Baudax, is reflective of Moderna's interest in collaboration with Immatics NV. I've got to look at what TeraImmune and Immatics are doing, in comparison to each other. Immatics does have a simple 5 minute video illustration of their effort to develop the right T cell receptors to target cancer immunotherapies.
https://immatics.com/ See "Our mission"
FYI: "Regarding oncology, Moderna announced on Monday a multi-year collaboration with biotechnology company Immatics NV, on a variety of products, including antibodies produced through mRNA and cancer vaccines."
https://finance.yahoo.com/news/moderna-covid-shots-grow-revenue-105341755.html
This just sounds like the Treg work TeraImmune is doing, as well what our latest CAR-T patent is advancing.
"Method of increasing the efficacy of CAR-T immunotherapy using lenzilumab
Patent number: 11673962
Abstract: Methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject, the method comprising a step of administering a recombinant hGMCSF antagonist to the subject, wherein said administering inhibits or reduces the incidence or the severity of immunotherapy-related toxicity in said subject, are provided. An hGMCSF antagonist for use in methods of inhibiting or reducing the incidence or the severity of immunotherapy-related toxicity in a subject also are provided.
Type: Grant
Filed: October 2, 2018
Date of Patent: June 13, 2023
Assignee: HUMANIGEN, INC.
Inventors: Cameron Durrant, Dale Chappell"
https://patents.justia.com/assignee/humanigen-inc
Quite the contrary. It looks like I've got 10 sell orders at price-specific levels that are pre-programmed. I'd probably have to re-enter them if we get a ticker change and/or a forward stock split.
You share price post was actually helpful today. I had to go to the doctor's office, Dollar General, post office, etc., this morning, and forgot to log back into the trading platform after I got home, until I saw your post.
I don't think I'm going to have a chance to add more shares. I think great CMML news will be announced before I can buy more shares. I'm excited!
I have been writing about the catalysts I have been eagerly awaiting for some time now.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172790011
The longer I write about them, the closer they come to fruition.
Ultimately, I run the risk of stepping on the news of the fulfillment of some of those goals. I don't want to do that.
That honor rightfully belongs to management.
I hope people will recognize the significance of these fungal and bacterial infections present in patients with covid viral infection. This seems very suspicious to me.