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We probably just checked-off another requirement of the Nasdaq Appeals Panel.
The reason I started to look at Kohlberg and Mubadala was to see what kind of connection either had to Pfizer. Were they being influenced to delay the business combination, in order to cause us to miss this Appeals Panel requirement?
Luckily, our management planned for such contingency, and successfully executed Plan B (if that is what it was). You have no idea, no appreciation of, just had many deadly tentacles that management must avoid, if Humanigen, Janssen, Novavax, and possibly Innovation, are going to snatch the tens of billions of annual revenue dollars out of the ill-deserving, bloated hands of the Favored Ones.
Here's a factual basis I can comment on, based again on the 10-K, regarding the business combination and financing.
"Accordingly, we cannot provide any assurance that we will effect the proposed business combination and related financing transactions. If we are unable to complete the proposed transactions or identify and complete another strategic or financing transaction in the first half of 2023, we may elect or be required to pursue a reorganization or seek other protection under the federal bankruptcy code.
pg 5
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923004512/hgen-20221231.htm
So, we have management telling us in the 10-K that, if a secondary strategic transaction is required, as it may have been, that we needed to move on that by June 30th.
June 30th is when Baudax Bio finalized their acquisition of TeraImmune.
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
June 30th is also when Black Horse acquired 500K shares of Baudax Bio. See the 13-G.
"June 30, 2023
(Date of Event which Requires Filing of this Statement)"
https://www.sec.gov/Archives/edgar/data/1178179/000101359423000580/baudax13ga1-07102023.htm
There is tremendous synergy between what Humanigen has been doing with SAHMRI, and to the related efforts between Baudax and TeraImmune. This could be the right platform to bring our CMML treatment into the market, if the treatment has been approved in Australia and possibly included in Project Orbis. Regulatory approval of lenz to treat CMML could prompt Humanigen to forward split their stock at 5:1.
I pay attention to what management communicates. They told us, "Accordingly, we cannot provide any assurance that we will effect the proposed business combination and related financing transactions. If we are unable to complete the proposed transactions or identify and complete another strategic or financing transaction in the first half of 2023, we may elect or be required to pursue a reorganization or seek other protection under the federal bankruptcy code."
pg. 5
https://www.sec.gov/ix?doc=/Archives/edgar/data/1293310/000121465923004512/hgen-20221231.htm
I have said, many times, that I want to have a basis for my "dream theories." I can handle being wrong about something, as long as I have a justifiable reason for my conclusion.
I think that the supportive data that can be harvested from the ACTIV-5 final report, coupled with the CMML study findings, and including our possibly comparable results to Gohibic in treating stage 6 patients (ACTIV-5 treated stage 5 AND 6 patients), that the FDA may find enough safety and efficacy data to make a favorable decision on approving a resubmitted EUA application.
But that will trash Pfizer's tens of millions of annual revenue dollars, especially if lenz is used with traditional vaccines. That would destroy the case of the mRNA proponents, in addition to taking market share away from Pfizer and Moderna in the US.
So I can see a pathway to our success even without the business combination, but only if the FDA is fair in awarding us an EUA. And as far as financing, I haven't seen more than what I estimate about $1M raised.
But management has said we needed to complete the business combination, and raise enough money to fund the combined company until a revenue stream is started.
We haven't announced any news about progress on the regulatory front, either here or in Australia, and we haven't even resumed our Controlled Equity Offering, let alone added to it, or announced a Public Offering. Nor can we capitalize on a 5:1 forward stock split, without news to entice investor buying.
The company has also not acknowledged any Humanigen connection to the Black Horse entities' investment in Baudax Bio. Their recent acquisition and business combination with TeraImmune could represent exactly the opportunity to compliment our effort with SAHMRI in CMML and hematology oncology.
I think I'm at a point right now, in early Q3, where I don't have enough substantiation to support my conviction in this company's success.
At the same time, and especially after Black Horse's investment in Baudax Bio, I have never been more excited and confident in our immediate and spectacular turn-around, which I think will enable me to fill an open sell order at almost 100X my invested capital, if I were to sell out at that level, which I don't plan to do.
But again, I pay attention to what management communicates. I've been severely disappointed every week recently where news has not been announced. But I am hopeful that the Baudax investment will be announced as a Humanigen transaction designed to maximize the work we have been doing with SAHMRI in Australia. And I hope this news will enable us to execute a 5:1 forward stock split, forcing a short squeeze.
Going back to Ajinomoto and Catalent, and then Avid, Lonza, Thermo Fisher, Cenexi, PCI Pharma, etc.,..any relationship we've had with a CDMO has left me somewhat unsettled. My manufacturing management background biased me against the modular management concept, in which we relied on Contract Development and Manufacturing Organizations (CDMO's), but, in my opinion, we didn't have any boots on the ground controlling the manufacture of our product.
So I hope that our intended partner in our business combination is PCI Pharma, and that we can conclude negotiations, and perhaps end up with an equity stake in a company that could become our product manufacturer, and more.
Whether there is any intent on using PCI Pharma in this capacity, or not, I couldn't say. But our success can't be held hostage. There are other CDMO's, and perhaps Cenexi is still a possibility. We need a Plan B, if not as a business combination candidate, then at least as a CDMO.
I fully support dedicating up to 40% of the company to a business combination into an entity that we will co-own, if that means we have ownership rights over the manufacture of our product. If the Baudax investment leads to Recro, that could also be our key to a CDMO foothold.
I think that management has amazing foresight, and I'm not used to seeing them at an impasse, which I hope they can overcome.
dlog, what makes you so sure that these prices aren't going to last?
We're two weeks past the possible financial end of our rope.
The company seems focused on a possible problem in concluding our business combination. I just don't understand that. What's so "Mission Critical" about closing the deal with PCI, or whoever it is?
Why does the company seem to prioritize the UK, over the EU?
All I know is, that another week bites the dust.
I can continue to construct a successful outcome, with the multiple opportunities I see before us. But I would really like any input, from anyone, that might lead to the development of an understanding in regards to the possible problem with our business combination, and the consequences of not reaching an agreement.
From what we have been told, we have too little time, and too little money, to continue to watch the weeks slip away, without popping the cork, and toasting our success.
There was a problem posting this on Twitter. I thought it may have been due to a report I had filed earlier in the day, regarding the posting, 10 years ago, of pictures of naked women by someone with a nick-name very similar to mine, and it looks like someone on that board thought it was me. I'm not a prude, but a stock message board, including female posters, should not be subjected to that, and I certainly didn't want them to think I had posted those.
"Report
·
July 13, 2023
We received your report for sensitive media
View Rule
Cowtown Jay
@Cowtownjay
What’s next
Our team and technology will review your report. If we find a rule violation, we’ll let you know what actions we’re taking.
What’s our process?
Context matters. We consider the following factors when enforcing our rules (this isn’t a complete list):
Does the reported content target people because of their identity?
How severe is this violation?
Was the report submitted by the person being targeted?
Creating duplicate reports will not accelerate our process."
Anyway, it seems that my posting ability has been restored, and I'm satisfied with that
So, NOW that the US Government is no longer paying for vaccines, Becerra gets his name in print to warn the private sector about price gouging? Where the heck has he been while vaccine makers have left the US market and found standard marketing authorizations overseas, that they didn't get here?
We've already done the clinical and economic benefit analyses of using lenz to treat hospitalized covid patients in both the US and in England.
https://www.tandfonline.com/doi/pdf/10.1080/13696998.2022.2030148
https://www.dovepress.com/getfile.php?fileID=79968
In some patient populations, the marginal cost savings have more than exceeded the $10K price of lenz. How much more can be saved if the lenz cocktail is administered with the traditional vaccines, and hospitalizations of these patients are almost entirely avoided?
No, thank you once again for bringing value to the discussion here, JA3.
I don't think you can call my post an update. It's more like what I see when I look out the window of my house in Humaniworld. For all I know, the company could announce tomorrow that we have run out of money.
I get some reassurance from sharing posts on Twitter, but we'll see if that continues. It may not.
The 6.9% ownership stake just assumed in Baudax Bio may be unrelated to Humanigen, and all 500K shares may be beneficially owned by Dale. But the share structure is exactly the design as Humanigen has. It will allow Dale, as the managing member and control person of the accounts, to reallocate the shares between the funds, and the companies, and open up charges of "insider selling" when no such sells were even made, despite Form 4's to the contrary.
https://www.sec.gov/Archives/edgar/data/1178179/000101359423000580/baudax13ga1-07102023.htm
But the acquisition could ultimately enhance the hematology oncology work we have been doing with our partner in Australia in treating CMML, as well as with our aGvHD and CAR-T partners, and may ultimately provide a US-based exchange for entering the CMML market here.
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
Ampersand, dlog, makes a world of difference.
Hey, Chaplain, I wonder if brilacidin is estimated to generate 10% of the revenue realized from a lenz cocktail.
I'm not much for TA.
But it wouldn't surprise me to see a chart saying that we would be oversold at 50 cents.
And that's why, I'm not much for TA.
"Last 5 days short percent 51.46%"
http://shortvolumes.com/?t=hgen
And you think announcing something significant can really pop our price up to over 50 cents? That much??!!!!
Thank you, steve, I appreciate that. But when it comes to lenz, I'm addicted to a drug that I've never had.
Thank you, eb.
But I still think a piece of PCI Pharma remains an objective for the company, as well. Janssen could alleviate the pressure to a degree, but even they have been playing musical CDMO's. And in Europe, PCI only appears to have been engaged with Spain and Germany. That's not much EU presence, and I have to wonder where Cenexi may fit in, if we can't work out a deal with Kohlberg and Mubadala, the majority owners of PCI.
I wonder if TeraImmune was the privately owned biotech that Humanigen was interested in. And I wonder if their acquisition by Baudax explains the ownership stake in Baudax taken by Black Horse, etc. Is this a blueprint for what we may see?
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
If it relates to Humanigen, I suppose we will see a PR about it.
If it doesn't legally relate to Humanigen, but we run out of funds, that could get sticky.
But I think the company has largely refocused on the use of lenz for covid, as it is likely more expeditious to generate revenue through the use of lenz in cocktails using the Janssen and Novavax vaccines.
Then, we can return our attention to the imperative of using lenz as a therapeutic to treat covid pneumonia.
Actually, it looks like several of Dale's entities are involved. But Baudax is not a privately held pharmaceutical company, so it may not be related to Humanigen at all, at least not yet. But the timing is certainly curious.
https://www.sec.gov/edgar/browse/?CIK=0001178179
Thank you for the heads-up, shurtha2000. I found this filed most recently.
"COVID cases in Japan continue to rise, situation serious in Okinawa
Friday, July 7...
The head of Tokyo Center for Infectious Disease Control and Prevention, Kaku Mitsuo, said a rapid spread of infections in Okinawa has strained its healthcare system.
He warned that medical institutions in Tokyo could also be overwhelmed if current infections, mainly seen among young people, spread to the elderly.
He called on medical institutions to prepare before the situation worsens...
Meanwhile, US pharmaceutical companies Pfizer and Moderna filed for Japanese government approval for the use of their vaccines against the Omicron XBB.1.5 coronavirus subvariant.
The health ministry plans to roll out vaccines to protect people aged five or older against XBB.1-related subvariants through booster shots starting in September."
https://www3.nhk.or.jp/nhkworld/en/news/20230707_34/
And this:
"Okinawa's COVID surge accompanied by other viral infections in children
Friday, June 30...
Pediatric hospitals are becoming overstretched. The Nanbu Medical Center & Children's Medical Center says its eight pediatric intensive care units were all occupied as of Thursday...
Pediatrician Cho Yoshiaki, "says outbreaks of children's viral infections normally occur seasonally. He added that it is rare to have outbreaks of several types at the same time. Cho says he has seen dual coronavirus and RS virus cases. He says that the viruses are showing no signs of being contained at the moment."
https://www3.nhk.or.jp/nhkworld/en/news/20230630_23/
So the game plan is to roll out the XBB.1.5 mRNA vaccines, starting in about two months, and hope for the best. And what therapeutics are being directed to treat infected patients, since there are no signs of being able to contain the virus presently?
If the company owns as many shares as they have issued, how much more can be reinvested?
And we have unmatched strength with lenz, and with the lenz cocktail. Unmatched, as in Pfizer losing tens of billions of annual revenue dollars.
The two non-mRNA vaccine makers in the US market have both recently been upgraded from conditional to standard marketing authorization by the EU, meaning they don't need to be re-authorized for five years. Janssen gave up on the US market, and Novavax was blessed to use as a last resort in the US, if an mRNA vaccine can't be provided.
In my previous post, I said, "Between the ACTIV-5 and the PREACH-M trial results, I've got to believe that the FDA will be forced to conclude that, with the previously-reported LIVE-AIR stellar results, that there is sufficient data to approve the resubmission of our EUA application." I should know better. They've already taken 10 days off our 52 days to regain Nasdaq compliance. And I'm not sure if Humanigen is even considering the EU for approval.
I'm most hopeful for CMML approval in Australia, and either a forward stock split, or a PRV, to be announced with news of that approval.
If Humanigen can meet Nasdaq listing standards after that, then it will be game-over the clique of mRNA, Big Pharma regulatory advocates. We have 21 days in both July and August to regain compliance, and maybe less time than that to start a revenue stream.
I think ACTIV-5 demonstrated that lenz may have had slightly better late-stage covid treatment results than Gohibic did, who did not treat stage 6 patients. But still, if Gohibic deserved an EUA, then it is likely that so do we.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-gohibic-vilobelimab-injection-treatment-covid-19
Between the ACTIV-5 and the PREACH-M trial results, I've got to believe that the FDA will be forced to conclude that, with the previously-reported LIVE-AIR stellar results, that there is sufficient data to approve the resubmission of our EUA application, especially now that there are no approved mAbs to treat hospitalized covid patients, and that the FDA has been encouraging mAb development for this indication. Regulatory approval, whether from the FDA or from Australian regulators, may be just the type of news we need to declare a 5:1 forward stock split, and cause a massive short squeeze. If there are also IND treatment results regarding the use of lenz prophylactically, in a cocktail with an anti-viral, polyclonal antibodies, and with the Novavax vaccine, we could also be looking at an actual prevention of covid infection.
I mention this, as to me, this greatly reduces the importance of concluding a business combination.
BUT, I don't think management would agree with that assessment. I think management sees a tremendous advantage by partnering, with PCI, for example. And I could see reluctance on the part of PCI, if they are being asked to give up 238M shares of their company, in exchange for 238M shares of Humanigen's stock, with a total dollar value of $7.145M (at $0.03 per share, post-split price). But, if Humanigen's market cap increases to $8.5B (if the lenz cocktail is used with Janssen and Novavax vaccines), we would be looking at a share price of $14.27, or a total dollar value of almost $3.4B for PCI/our stake.
And THAT'S got me excited, if management seems eager for this business combination, knowing the potential value of the stock dedicated to this business combination. Or...perhaps management is negotiating for an upper dollar limit for the stock going to PCI. So I'll be curious to see what this huge value could be for us, by combining the companies.
Two of my most favorite cities in the world.
Thank you, eb. I always have something to learn from you.
Thanks for the response. It feels like we've been waiting since that term was coined. But if I could have a chance to live in the 1500's, I would split my time between Rome and Florence, and between being around Da Vinci and Michelangelo. I'm sure they would be bemused.
What are you hearing, dlog? Did we lose a wheel today?
Thank you for the info, eb! You gave me a whole different perspective than what I got looking online after I received the email from the NIH on the study. Still, this was one of the first human studies on how mitochondrial function impacts immune cells, and I have been shocked at the experience of having my energy totally escape in an instant, with no advance warning and no control over it. I think lenz provides a restorative effect to the immune system, in addition to regulating the immune response, so I thought it may be worth looking into.
"I would want lenz to treat the residual inflammation I have, which still prevents me from wearing my cowboy boots, because I can't get them on. And I think lenz is going to be like WD-40, and doctors will find all kinds of applications for it. Maybe it will also have an effect on the chronic fatigue I can't shake."
It's interesting to see the following:
"Researchers find weaker immune response to viral infections in children with mitochondrial disorders."
https://www.nih.gov/news-events/news-releases/researchers-find-weaker-immune-response-viral-infections-children-mitochondrial-disorders
"Mitochondrial syndrome
A disorder that occurs when structures that produce energy for a cell malfunction.
A common factor among mitochondrial diseases is that the mitochondria are unable to completely burn food and oxygen to generate energy, which is essential for normal cell function..."
https://www.google.com/search?q=what+are+mitochondrial+disorders%3F&oq=what+are+mitochondrial+disorders%3F&aqs=chrome..69i57j0i22i30l2j0i390i650l2.2007082905j0j15&sourceid=chrome&ie=UTF-8
I just find it interesting that I wondered if lenz might alleviate my chronic fatigue, and now I see an NIH study linking the immune system to a failure to generate energy. I thought Dale might be interested as it involves B cells.
Chronic fatigue is a common symptom of those suffering from Long Covid.
The design of our share structure makes it impossible to take the Form 4's at face value.
All you need to know is that our OS changed by 127M shares overnight. First, it increased that much, then it decreased that much.
That signifies to me that the company had control of that number of shares, which was higher than the number of shares they issued.
If the company now has control of all the shares they issued, that's all that matters.
Actually, I'm bullish to see $100 - $200 pre-split, or $20 - $40 post-split.
The $14.27 equates to an $8.5B market cap, I just think we'll run past that on a squeeze.
I think it's swagger city time. Time to announce the completion of our business combination, and the licensing agreements with Janssen and Novavax. And if we eventually get a CMA for the EU,*** I think there is another vaccine maker, or two, that would also like to license the lenz cocktail for their vaccines, too.
Looking for regulatory authorization/approval. Maybe even a PRV.
*** Scratch that "eventually" part. Could happen fairly soon.
https://novavax.investorroom.com/2023-07-06-Novavaxs-Nuvaxovid-TM-Receives-Full-Marketing-Authorization-in-the-EU-for-the-Prevention-of-COVID
Thanks poster Don Ford
Our market cap used to be about $1.3B, just in anticipation of a covid EUA. And just in anticipation of being used as a covid pneumonia treatment.
If we can be used with the Janssen and Novavax vaccines in a cocktail designed to prevent the initial infection of covid, a conservative market cap of $8.5B is possible, in my opinion, and that would come to $14.27 per share, post-split price.
Not at all. They need to maintain a minimum bid price of $1.00, and achieve a Market Value of Listed Securities of $35M. They have until August 21st to meet those requirements.
There are several catalysts that could enable us to maintain listing standards, including the completion of our business combination, approval of an EUA for covid, and Authorization for CMML, licensing agreements with Janssen and Novavax, etc.
By the way, Bill, welcome to the room, and thank you for joining us.
It will be in the 3 cent range, just going by dividing the current price by 5.
But, the real reason for the split, in my opinion, is to force a short squeeze, making short sellers deliver about 550M more shares than exists. I've got a sell order in just under $10, and another sell order already in place for $100. Schwab won't let me enter a sell order for $200 yet.
But I'll have to divide those prices by 5, if Schwab doesn't do it for me automatically.
Oh, gosh, really?
If management declares a 5:1 forward split, the OS will go up 5X...
and the number of shares in our accounts will also go up 5X.
That IS a fact.
Where's the dilution?
I'm a shareholder, not a soothsayer. So of course I'm just expressing my informed opinion.
If I knew facts in advance, I would never have had the opportunity to make your acquaintance, because I wouldn't be on a message board trying to support management's effort in getting authorization and approval for a drug I believe will bring about a treatment paradigm shift.
That would kind of take the challenge out of it for me. I think I like the grunt work better.
A forward split would be non-dilutive, as I have told you before, and as you just don't seem to understand.
This management team is on the verge of wresting a significant chunk of Pfizer's tens of billions of annual covid revenue away from them.
And please, explain to me how management could have sold all their shares, yet the company appears to be in control of all the 119M shares they have issued.
You may briefly have a chance to buy shares in the three cent range, if you're prepared and lucky. But I hope that possibility doesn't materialize.
Authorized or approved vaccines and mAbs
Types of COVID-19 Vaccines Available
COVID-19 vaccine vials
Vaccines authorized by the U.S. Food and Drug Administration (FDA) currently include:
Pfizer-BioNTech and Moderna COVID-19 vaccines which are mRNA vaccines.
Novavax COVID-19 vaccine which is a protein subunit vaccine.
J&J/Janssen COVID-19 vaccine, a viral vector vaccine, has expired and is no longer available for use in the United States as of May 6, 2023.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/overview-COVID-19-vaccines.html
Find out more about the COVID-19 vaccines approved for use in the UK, including their ingredients:
Moderna (Spikevax) COVID-19 vaccine on GOV.UK
Pfizer/BioNTech (Comirnaty) COVID-19 vaccine on GOV.UK
Novavax (Nuvaxovid) COVID-19 vaccine on GOV.UK
Sanofi and GSK (VidPrevtyn Beta) COVID-19 vaccine on GOV.UK
https://www.nhs.uk/conditions/covid-19/covid-19-vaccination/about-covid-19-vaccination/
EU’s vaccine portfolio
The Commission has so far given eight conditional marketing authorisations for the vaccines developed by BioNTech and Pfizer, Moderna, AstraZeneca, Janssen Pharmaceutica NV, Novavax, Valneva, Sanofi and GSK and HIPRA respectively, following the European Medicines Agency’s (EMA) positive assessment of their safety and efficacy. Several other vaccines are at different stages of assessment by the EMA.
(we know that Novavax and Janssen have been upgraded to 'standard' marketing authorizations)
https://commission.europa.eu/strategy-and-policy/coronavirus-response/safe-covid-19-vaccines-europeans_en
Anti-SARS-CoV-2 Monoclonal Antibodies That Have Received Emergency Use Authorizations
Four anti-SARS-CoV-2 mAb products (bamlanivimab plus etesevimab, casirivimab plus imdevimab, sotrovimab, and bebtelovimab) have received Emergency Use Authorizations (EUA) from the Food and Drug Administration (FDA) for the treatment of outpatients with mild to moderate COVID-19. However, they are not currently authorized for use in the United States because the dominant Omicron subvariants are not expected to be susceptible to these products.
https://www.covid19treatmentguidelines.nih.gov/therapies/antivirals-including-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
The worldwide state of preparedness for covid prevention and treatment is woefully inadequate. A new strain of covid, in a world where we have seen covid weaponized to achieve as much as a >80% kill rate, could result in far more than the 7 million deaths we have seen to date.
Are regulators going to wake up to this menacing threat before it is too late? Heck, even Boy Scouts know to "Be Prepared."
In the US, we have the potential to prepare, if the FDA grants our EUA from results of the LIVE-AIR trial, now supplemented by the ACTIV-5 trial data.
An approval of lenz in Australia, to treat CMML, would be additional evidence of safety and efficacy.
It's just incredible, in a world so ill-prepared for a virulent strain of covid, that the variant-agnostic lenz isn't already saving lives, as no other mAb can do, and as no other other vaccine-enhancement is even under development.
It seems to me that Janssen has the infrastructure and service capability to function for us in a broader scope, if we are having difficulty with PCI Pharma. They may not have the scale we were looking for, but I wanted to see more focus on the EU than the UK, anyway.
There may be a crucial function we need PCI for, that I am not aware of.
But I like focus being placed on executing a stock split, not diverted by an issue with PCI.
I don't think anything is more important than executing the stock split, which I was hoping to see tomorrow, or the next day, or...
I hope we can legitimately re-focus on the stock split as our highest priority.
Are Kohlberg and Mubadala mucking up negotiations between Humanigen and Partners Group? How feasible would it be to re-engage with Cenexi? They seem to have a wider EU footprint, and the EU seems to be much more accommodating than either the PfDA or UK. Novavax is under the gun here, just as Humanigen is.
I hope that is far from the case. And I hope we really are ready to squeeze the trigger on a stock split.
I know. The closer we get to success, the harder it is to wait another day. I'm certainly feeling that way.