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At this point, is management a little cocky? YES.
Should they be? YES.
Why should management be a little cocky? Because I think Humanigen, using the J&J and Novavax vaccines, is going to demonstrate that the lenz/vaccine/anti-viral compound is so effective that it should be the Standard of Care for covid prevention.
You know, JA3, we can't discount one other consideration, which I mentioned some time ago. It may be that we could get licensing deals with Novavax and J&J, to use the lenz cocktail with their traditional vaccines. But our business combination could still be the assumption of Partners Group's interest in PCI Pharma. Like you said, we're getting tired, and I have been remiss in the continued consideration of this possibility.
Expanding upon our existing partnership with PCI, and getting commitments from J&J and Novavax to use the lenz cocktail, could lead to an opportunity for management to split our stock, as I think they want to do, and to either resume the existing Controlled Equity Offering, or to add to it. We all know that management needs to fund operations until we see revenue following the authorization of lenz, and the lenz cocktail.
I'd like to be wrong about our business combination. I would prefer that it would be with a J&J subsidiary, instead of a Novavax subsidiary. Hopefully, it will be. The only reasons for that are, that it would be better-received by investors, and it may draw upon a deeper resource pool for Durrant, due to his previous association with J&J. Either way, I think we will strike deals with both J&J and Novavax, in terms of using the lenz cocktail with their traditional vaccines.
It's unfortunate that this paradigm shift could be costly to Moderna. But I don't think lenzilumab's method of action is compatible with their, and with Pfizer's, mRNA vaccines.
I think we are about to see Humanigen to begin dealing from a long-delayed, but now unquestionable position of strength.
And where will they begin to flex their muscles? I think management will prioritize taking down the illegal short sellers, who have criminally decimated our share price for years.
Next, management will take market share away from Pfizer, who has likely abused their regulatory influence to deprive Humanigen of having any of the market share we should have attained.
Thirdly, management will highlight the adverse medical, economic, and societal consequences of the regulatory pathway Regulators have paved for their corporate sponsors. Humanigen will shift the covid prevention and treatment paradigm.
Then, it will be time for a coffee break.
Love the priorities, guys!
Thanks, Chaplain. I've been keeping an eye on the vaccine makers going through the process here:
https://newsfilter.io/
And I now see back-filled short volume being reported, too.
http://shortvolumes.com/?t=HGEN
I think it's entirely possible that we will strike some type of deal with both J&J (Janssen) AND Novavax. Neither of their covid vaccines are mRNA-based. We may be looking at a merger agreement with a subsidiary of one company, and a licensing agreement with the other. But either way, I think we will shut down both the Pfizer and the Moderna covid vaccine markets. And the country, and the world, will have the basis to establish a virulent response protocol.
We could put a stop to continued covid mutations, ASSUMING that these variants aren't also the result of gain of function manipulation. And I have no reason to think that is beyond a possibility. When in history have we ever seen so many mutations, so quickly?
I don't doubt it for a minute.
I don't know of any lenz cocktail trials being done, either. But I hope a study has been done. At least, I think we should know the covid reinfection rate from patients in the LIVE-AIR and ACTIV-5 trials. The earlier lenz is administered, the better.
But we didn't administer lenz as early as we could. We waited until patients were diagnosed with covid pneumonia, and hospitalized in disease severity scales 4 or 5 (or 3, 4, or 5, using the WHO scale).
Administering lenz within minutes of asymptomatic individuals being vaccinated could, in my opinion, have totally prevented covid infection. Isn't that what vaccines are supposed to do? This may very well be yet another example of why we patented the use of lenz to make treatments more effective.
We represent a possible existential threat to Pfizer and Moderna, to whom covid is being counted upon to generate billions in revenue every year. Humanigen has to be careful about what they say, especially about their vaccines and their political influence. Once the superiority of lenz, and the lenz cocktail, is clinically proven and authorized, whether here or abroad, then management can tout our products with factual evidence in support of what they say. We're half way to that point. We have proof of safety and efficacy, we just don't have verification in terms of regulatory authorization or approval.
Management's historical record of presentations and commentary in their SEC filings are what I draw upon to form my opinions. I feel fairly good about knowing what's going on, based on that. Not everything I say is going to be accurate. It's just my opinion and conclusions, and to hit, or miss, points, should be expected.
It is absolutely THRILLING to think about the possibilities for our future that the lenz cocktail represents.
Thank you, dlog. But I appreciate the freedom to voice my honest assessment of what management is trying to accomplish, without being constrained, as I would be working for the company. It means a lot to me to see lenz get approved for covid prevention and treatment. And I find it very gratifying when my comments receive consideration.
They're doctors, in addition to being MBA's. They HAD TO focus their effort on treating covid pneumonia, as covid has killed almost 7 million people in the last three years. They have done everything they needed to do to get regulatory approval for this treatment. My only question now is whether they are going to wait for Australian approval of lenz to treat CMML, before they resubmit their covid EUA application to the FDA.
Maybe there are some Big Pharma competitors that think Humanigen is too small to handle a covid product that has that big of a bang for the buck.
But there are other vaccine makers who may recognize that using their vaccine in a cocktail with lenz and an anti-viral, could enable them to take market share away from Pfizer and Moderna. Maybe those smaller vaccine makers also recognize that this cocktail would negate the need for perpetual trials, because lenz is variant-agnostic. And if the anti-viral being used in this cocktail is brilacidin, then their vaccine may be used to prevent both upper and lower respiratory tract infections, AND, the cocktail may be able to treat, not only new strains and variants of SARs-CoV-2, but other TYPES of coronavirus, as well, such as SARS and MERS.
I think Humanigen is rightly focused on using their patented lenz/vaccine/anti-viral cocktail, and thereby expanding our patient population by using lenz as a covid preventative, as well as a treatment for covid pneumonia.
Well, it's been three weeks now since any short volume has been reported.
http://shortvolumes.com/?t=HGEN
I think that's because management has done as much as they can to take loanable shares out of the market. But still, somebody once again claims to have 1.3M loanable shares available today, at a reduced fee.
https://iborrowdesk.com/report/HGEN
This continued criminal decimation of our share price has to be met with an effective deterrent. Management has a plan to initiate that deterrence, and that plan needs to be executed, because it's of vital importance to the company to get a fair price for the shares they will sell in an equity offering.
The investment community needs to be enticed by news of the company's transition from being sustained by equity offerings, to being revenue-funded.
We know that CMML treatment, especially with the promise of a Priority Review Voucher, could provide significant revenue. We have reason to believe, with the patent grant for CAR-T enhancement, that Mayo Clinic may have achieved success in using lenz in their Investigator Initiated Trial. We have other partners testing lenz to treat other indications.
But, we also see improved outcomes in the designed-to-fail ACTIV-5 trial, which could lead to an EUA for lenz to treat covid pneumonia, based on our LIVE-AIR augmented results.
I didn't think it could get any better than that. But it has. The lenz/vaccine/anti-viral cocktail, with polyclonal antibodies, could likely become the standard of care in covid prevention. And I have hope that our merger partner is a vaccine manufacturer, and that Humanigen will financially benefit from the use of lenz in an expanded patient population for us, to include the use of lenz as a prophylaxis with the vaccine. Using lenz with FDA approved vaccines may be the vehicle that leads to authorization and approvals worldwide, to use lenz not only as part of a prevention, but as a treatment for infected patients, as well.
Based on the overall study. of the 215 lenz-treated patients who completed the ACTIV-5 trial, the death rate was 14.4%. This includes one death because there was not enough lenz on site.
Of the 196 placebo patients who completed the ACTIV-5 trial, the death rate was 19.4%.
Both groups had received remdesivir.
https://clinicaltrials.gov/study/NCT04583969?intr=lenzilumab&rank=2&tab=results
That's not statistically significant? What is that (seriously), about 25% fewer deaths? Seems like it's significant to me, especially since ACTIV-5 included patients who were intubated or on IMV.
As previously noted, ACTIV-5 did not include patients on room air, either. But ACTIV-5 showed improvement even in treating patients whom we did not intend to treat with lenz.
I hope the additional safety and efficacy data has been resubmitted for our EUA application, based on the LIVE-AIR trial.
Study results I would REALLY like to see would be covid reinfection rates of lenz-treated patients. Even moreso, I would like to see any study data that may have been done on preventing covid infection in samples or of indivuals who had received the lenz cocktail.
It would be a lot funnier, if we weren't so close to having insufficient money to fund our operation. Yeah, we've got a lot of catalysts, but we need to trigger one.
Can you imagine Dale and Cameron buying shares in the open market that they know don't exist? Buying 127M shares that have not been delivered, and not reporting FTD's. Man, did they really do that?
All I can say is that it looks that way to me in my Humaniworld.
Yeah, I guess you could say that.
Fee Available Updated
40.9 % 450,000 2023-06-21 12:45:03
40.9 % 450,000 2023-06-21 12:30:04
40.9 % 550,000 2023-06-21 12:15:04
14.6 % 550,000 2023-06-21 12:00:03
14.6 % 550,000 2023-06-21 11:45:03
14.6 % 550,000 2023-06-21 11:30:04
14.6 % 550,000 2023-06-21 11:15:04
(Thanks to Elisa2Summer, Stocktwits)
https://iborrowdesk.com/report/HGEN
I don't use margin, so I don't pay attention to this site, or know anything about the data.
The company has not split the stock yet, which would certainly be reportable if they had. I have been saying for some time that I expect they will declare a 5:1 forward split. But I think they will first resume the Controlled Equity Offering. Very likely, they will also announce a Public Offering.
I think the appearance of an increased amount of float was to demonstrate to the Nasdaq appeals panel that the company did, in fact, have control of 127M shares of their stock. The Nasdaq appeals panel would likely not accept a screen shot from the company's ledger in this regard. They would want verification from our Transfer Agent, and I think we saw that when they reported a float of 229M shares.
To me, restricting those phantom shares so they could not be loaned, AND declaring a 5:1 forward stock split, is the reason why I have shares offered at $100 per share, and plan to offer even more at $200 per share, once Schwab let's me. We could get one hell of a squeeze (but if the squeeze comes after the stock split, those prices would have to be divided by 5).
We have seen the float fluctuate from 102M up to 229M, then back to the current 110M. The increase and the decrease both happened in overnight time frames. I pointed them out when I saw them. It is certainly a possible explanation for what we see on the short volume website.
"... I would certainly not be opposed to seeing us use Innovation's brilacidin..." in our lenz cocktail.
"Innovation Pharmaceuticals Provides Update on U.S. Patent Applications Covering Use of Brilacidin in Inflammatory Bowel Diseases, Coronaviruses and Fungal Diseases
WAKEFIELD, MA / June 21, 2023 Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced the United States Patent and Trade Office (USPTO), on June 6, 2023, granted a patent..."
https://www.globenewswire.com/news-release/2023/06/21/2691932/0/en/Innovation-Pharmaceuticals-Provides-Update-on-U-S-Patent-Applications-Covering-Use-of-Brilacidin-in-Inflammatory-Bowel-Diseases-Coronaviruses-and-Fungal-Diseases.html
I don't think they simply stopped reporting. Shortvolumes.com is still reporting, as we see in looking at CYDY.
"The short sale volume percent (not short interest) for stock ticker CYDY is 49.99% on Jun 20, 2023..."
http://shortvolumes.com/?t=cydy
I think the shares being loaned were under management's control, and they either moved those shares to a cash account, or they restricted the shares. Either way, those shares could not be loaned any longer.
I wrote a post on this subject last week, and that post is noted on the Humanigen Twitter message board.
https://twitter.com/search?q=humanigen&src=typed_query
I only keep an eye on the short volume, dlog. That ground to a stop on June 1st, and no short volume has been reported since then.
http://shortvolumes.com/?t=hgen
The reason for my derision at this early attempt to systemize an annual "fall campaign" for covid vaccine formulation, is that both the regulators and the vaccine makers know better than to do this. They know that they are causing the virus to mutate to the point where yet more new vaccines will be required. They tolerate the covid and covid-associated deaths being at elevated levels. They welcome the waning efficacy of their vaccines, because they know that will stimulate demand for them to make new vaccines. They justify this systemization by recognizing that they are ultimately saving lives.
They just don't internalize the fact that even more covid and covid-associated deaths could be avoided, because they don't have ability to save those additional lives.
But Humanigen has that ability, with their lenz variant-agnostic cocktail. I'll be happy to see a bolus dose of the cocktail coming to an ER or infusion center near you.
The other vaccine manufacturer that could benefit from a partnership with Humanigen is J&J. It doesn't look like their covid vaccine is even available in the US.
As far as a subsidiary, they've got 250 of them. I doubt that they are all listed. There might be a merger partner candidate in there somewhere. Who even knows if Humanigen wants a vaccine partner?
Humanigen is going to put a stop to this silly parade of vaccine manufacturers marching in step behind the fife and drums of the WHO and the FDA, as they belt out their covid prevention tune using a single flat note.
Humanigen's patented lenzilumab cocktail for the prevention of covid is going to cause a fundamental change, representing a paradigm shift in how to prevent covid infection against any variant or strain, known or unknown. I believe we will be joined in that endeavor by partnering with Novavax.
The time is nigh.
That would void any business combination. They can't take us private, and offer our merger partner a platform to list on Nasdaq.
Besides, the value of this company is astronomical if we and our partner can collaborate on a plan to capture the covid prevention market, and if Humanigen can save covid patients without causing the virus to mutate, or allowing patients to get re-infected.
Allow me to go from memory.
Our OS is 119, 080, 135.
Briefly, Ihub reflected an OS of 595,400,675.
That OS is 5 times higher than our current OS. That is why I suspect we will see a 5:1 forward split. Of course, this would be non-dilutive, but it may create some shares the company could sell to short sellers.
The company advised that our merger partner could get a number of shares that represented twice our current OS, or 238,160,270 shares (2 x 119,080,135).
238,160,270 shares for our partner / 595,400,675 post split OS = 40% ownership.
Thank you for your interest. I appreciate the questions.
I appreciate you sharing your thoughts on the subject.
But Durrant and Dale have scalpels, and know how to use them.
What a treat it has been for me to try to understand what these brilliant men have been doing scientifically, financially, and commercially.
But if I recall correctly, the KBIO squeeze was effectuated after the loanable shares were restricted or removed from the market.
They need to increase the share supply to force short covering at some point in this century. Once the air shares have been vacuumed out of our market, if they want to reduce our OS from 595.4M, they can.
In what way do you think things could get wild?
We're out of time to mollycoddle in some type of pipe dream. I have expressed my serious assessment of our pathway to success.
There is the possibility that the company may offer the cocktail to other vaccine makers, and it is only my bias that rules out that possibility. I just don't think that's true, even if it is just the opposite of what we did in using lenz for CAR-T. Besides, if my assessment is correct, those Big Pharma vaccine makers are going to become our competitors.
I continue to hope, everyday, that the company will announce their going-forward game plan, even before tomorrow's open. Whatever that game plan proves to be, I hope that management will be able to capture the real value of lenz, to the utmost benefit of patients and shareholders.
And speaking of shareholder value, a 5:1 forward split may negate the need to file a prospectus to sell more than we have available on our open shelf registration. It could depend on how much trial work may have been done by Novavax and Humanigen, using the lenz cocktail, in some part of world where the Novavax vaccine has been approved.
I do realize, though, how far I am out on the limb. I just don't think there is time to worry about that.
Those could have been shares being transferred to our partner.
You didn't miss it, friend. Management has not yet released the name of our merger partner.
The essential consideration is our lenz/vaccine/anti-viral patent.
METHODS FOR TREATING CORONAVIRUS INFECTION AND RESULTING INFLAMMATION-INDUCED LUNG INJURY
Publication number: 20230109208
Filed: March 8, 2021
Publication date: April 6, 2023 (Most recent date)
https://patents.justia.com/assignee/humanigen-inc
Knowing that the cocktail has been developed, and that it incorporates a vaccine, I looked at which vaccine makers represented the most benefit for us.
I also considered our business combination strategy. What could possibly be worth giving up 40% of our business?
To me, it makes the most sense to sacrifice that much of our business only to an entity that we co-owned, in partnership with the vaccine maker, in whom we will have an ownership stake, stock-for-stock, through a subsidiary.
Novavax wholly owns two subsidiaries. They could lose both of those, and their core business, if they can't correct their course. This is an opportunity for them to make that course correction. It's also an opportunity for us to expand our patient population by using their vaccine as an activating agent to trigger lenz.
Big Pharma vaccine makers want to bury us, not contribute to our success. Novavax needs us, and this is a great opportunity for both companies.
I've previously been more circumspect in talking about Novavax as our prospective partner, but all signs point to them, in my opinion.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172108878
The FDA and the WHO have got it wrong. Requiring vaccine manufacturers to produce variant-specific vaccines will only result in the covid virus continuing to mutate, and in the systemization of a revenue-producing. more lethal response to a perpetually evolving form of covid.
The management teams at Humanigen and Novavax are about to shift the covid prevention and treatment paradigms in a joint collaboration and merger deal. As I said, "What SHOULD happen is that the lenz/vaccine/anti-viral cocktail should be the standard of care (SOC) for covid prevention. At the least, until that truth becomes self-evident, the lenz cocktail should be extended to family members of infected patients as a post-exposure prophylaxis. It should likewise be extended to seniors and those who are immuno-compromised as a pre-exposure prophylaxis."
People may think that lenz is too expensive to use as a covid prophylaxis. But that does not seem to be true for CMML treatment, or for CAR-T neuro-toxicity and CRS prevention, nor to prevent adverse events associated with aGvHD transplants. And the cost benefit of using lenz prohylactically with a vaccine and anti-viral has to be considered. How much money can be saved by preventing/sharply reducing re-infections, or by avoiding non-stop clinical trials required by covid mutations?
I am very excited by, and very thankful for, the business combination our management team has been working on to achieve this covid prevention paradigm shift. The US government recently ordered 1.5M additional doses of the Novavax vaccine. As the lenz cocktail gets integrated into use, it will likely result in our market dominance, and ensure that the world is prepared with a virulent response plan.
It's imperative that Humanigen raises cash immediately. The most expeditious way may be to simply resume our Controlled Equity Offering, which would meet our short term requirements. But those requirements include cash needed to fund the partner in our business combination, as they will apparently trade on the HGEN ticker (or we will change our ticker, and both entities will trade on a new ticker). HMNV?
In that regard, it looks like management may slip out of their modular management role, and assume operational control, in whole or in part, of a brick and mortar vaccine manufacturing operation. I think that's why we saw the Part III amended 10-K. That 10-K/A also discussed the proposed business combination, and noted that we will be pursuing additional financing.
It's worth noting that we entered into in this proposed business combination before we engaged SC&H.
Events are unfolding at a much broader scale. I'm only looking at the event in which management may have the greatest role in facilitating.
News of a business combination with a wholly-owned subsidiary of Novavax may catalyze enough investor interest to make the resumed Controlled Equity Offering successful. Or it may not.
Another possibly incentivizing development may have been signalled by the recent patent grant for CAR-T enhancement. Mayo Clinic has continued work on that, I assume with products in addition to Tecartus and Yescarta (drug names?). Anyway, news in that regard could be positive. As could news from other partners working on aGvHD or CMML. And it could be those partnerships that SC&H has been working with.
There are plenty of opportunities to entice investor interest, and possibly lead to a fully-subscribed Public Offering.
Most of all, though, I hope we end up in a business combination with the Novavax subsidiary, based on authorization to use lenz for covid. That is where lenz could do the most amount of good in terms of saving lives and generating revenue.
Remember when a vaccine was defined as a preparation that would safeguard people from a specific disease?
I think Novavax is about to restore that definition, in a joint collaboration with Humanigen, which will see Novavax assume a 40% interest in Humanigen through a wholly-owned subsidiary, and in which Humanigen will jointly own the subsidiary with Novavax through a merger.
A caveat is required. I have seen no studies on the covid reinfection rate in lenz-treated patients. That astounds me, because if the reinfection rate is negligible, that would be blockbuster news.
But would Humanigen sacrifice 40% of the company, without assurance that lenz, used with the Novavax vaccine, would cost-justify their investment and merger?
I don't understand why contracting a lower respiratory tract infection, such as mononucleosis (Epstein-Barr), could imbue a learned immune response against future viral infection, that could last a lifetime, but that covid does not imbue that same learned response by the human immune system.
I contracted a serious case of mono in my late teens, over 50 years ago, and I was hospitalized for several days. And Epstein-Barr virus was detected in my blood again a few months ago.
I suspect that what really happened was that I was infected with covid, and my immune system reacted as it had learned to do when I had mono.
But the question is, why the variance in the body's apparent inability to learn an appropriate immune response to covid? I have been hoping to see some data from lenz-treated patients regarding reinfection rates. If lenz works as I think it does, that reinfection rate ought to be neglible. At the least, there should be a very statistically significant reduction in reinfection.
But why covid reinfections in non-lenz-treated patients? I have to suspect that it is due to mass vaccinations, forcing the covid virus to continually mutate.
This is why I am excited about Humanigen's development of our lenz/vaccine/anti-viral product. I'm particularly excited to see the cocktail used with the Novavax protein-based vaccine, versus the mRNA vaccines.
I think the lenz cocktail could stop the covid virus from mutating, because the virus is not attacked by lenz, it is just prevented from binding to GM-CSF and attaching to receptor cells.
In addition, the immune system could learn how to respond to future covid infection, because the virus will not have mutated from what it was.
Your response takes no notice of my mentioning the, "...singularly essential..." role lenz has in developing "a proactive virulent response plan." Our trial investigators, and informed shareholders, can understand that role. But lenz would not be able to fulfill that role, if it wasn't for this management team demonstrating lenzilumab's capability.
It would be very difficult to overstate the value lenz has, and can continue to have. So I think management's contributions will prove priceless...not worthless. (And trust me, priceless and worthless are antonyms, not synonyms).
Novavax just issued a PR saying:
"PR NEWSWIRE
Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall"
https://newsfilter.io/latest/fda-approvals
They're up 1.3% today on the excellent news.
We're up 6 - 20% with no PR.
I think both valuations simply reflect that regulators feel empowered to abuse their discretionary authority with impunity.
But this is a big world. It is not prepared with a proactive virulent response plan, as lenz is singularly essential to develop, preferably in an exclusive collaboration with Novavax.
Novavax recently announced:
"U.S. Government and Novavax Extend Partnership, Securing Up to 1.5 Million Additional Doses of Novavax' COVID-19 Vaccine
Feb 13, 2023"
https://ir.novavax.com/2023-02-13-U-S-Government-and-Novavax-Extend-Partnership,-Securing-Up-to-1-5-Million-Additional-Doses-of-Novavax-COVID-19-Vaccine
What SHOULD happen is that the lenz/vaccine/anti-viral cocktail should be the standard of care (SOC) for covid prevention. At the least, until that truth becomes self-evident, the lenz cocktail should be extended to family members of infected patients as a post-exposure prophylaxis. It should likewise be extended to seniors and those who are immuno-compromised as a pre-exposure prophylaxis.
Whether we close red or green, today or any day, is totally irrelevant.
I initiated a small position soon after HGEN was formed in 2017.