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Yeah, that wouldn't be cool. But the subject of how I think the share structure is designed is actually one that I have been discussing ever since I saw it laid out in a filing some years ago. This is only your 5th post on this board, so you may not be familiar with the history of these discussions. I will only say the purpose of the design may be in the realization phase now. If I see a contra-indication, I'll say so. But on the other hand, if I see additional confirmation, I won't say anything.
I wouldn't be saying now, either, if I hadn't earlier raised a possible concern. And I am only saying that I no longer have that possible concern.
Long Time StockHOLDER, Trying To Average Down, BUT...
Every time I Think The Bottom Is In And I'm About To Buy A Chunk,
I See The PPS Drop Again... <sigh>
Surely, There Is At Least A Bounce Coming?
But Hopefully, One Of The HGEN Pipeline Is Still Promising?
It Would Be Great To See New All Time Highs,
But Getting Out Of This Penny PPS Area And Back Into The "Dollars"
Would Be A Great Start!!!
Glta Bulls, Watchers, & StockHOLDERS!
hes just messing with you mr c
im waiting for .0001 before i dump my shares if its any help
What’s the concern and how the heck have they “alleviated it”? You’re not even saying anything, explain the concern and the supposed alleviation
I've raised a possible concern recently. That concern is being alleviated. I appreciate that management is responsive.
No, they just expect us to after making tens of millions. Explain why not. What is this defense plan that the company is enacting? Revenue is years away without an FDA approved product, so without a major partner announcement, a buyout, or insider purchase with multiple failures hanging over head then the stock is dead in the water
I don't think they have to buy a single share.
I can say it now. I've seen some confirmation that allows me to say that if I was an insider, I wouldn't do anymore to support the share price than management has been doing. A finite amount of investment dollars is not going to prevail against an infinite number of shares available.
But there is a powerful defense to the continued decimation of our share price, and I think management has begun the process of enacting that defense. If I'm right, and I don't see how I could be wrong, then I just want to thank management in advance. Good job, guys!
So please explain the MOA to me, no time to go searching right now. I have a chronic inflammatory condition and take the low dose naltrexone protocol for it too.
I recently had an exacerbation of a chronic condition and went to the ER... was admitted and given a PCR test. They told me I had COVID and suggested Remdesivir, but wouldn't let me have my NAC.
I told the Dr. that .he must be aware that a PR test is not a diagnostic test, and NO - I did not have COVID.
I signed out AMA and went home and took my NAC and guaifenesin for the congestion. I got better.
NAC!!! YES, I talk NAC to people almost as much as I do Vitamin D. People NEED to know about it and use it... DAILY. (and I have no medical background.....but I did stay at a Holiday Inn Express one time.)
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Protect Your Respiratory System
NAC (N-acetyl-L-cysteine) helps prevent viruses and bacteria from adhering to the lining of the lungs. Data show that NAC reduces excess airway mucus, lowers inflammation, supports pulmonary function, and inhibits infectious colonization.
Scientifically reviewed by: Dr. Gary Gonzalez, MD, in May 2022. Written by: Roberta Stanton.
N-acetyl-L-cysteine is an amino acid derivative that breaks down excess mucus in air passages.
Used by physicians for decades, N-acetyl-L-cysteine has a wide variety of benefits, especially helping to protect the lungs and airways of the respiratory tract.
Known by many as NAC, N-acetyl-L-cysteine has been shown to reduce the number of harmful pathogens, including bacteria and viruses.1-6
Clinical studies have shown that NAC can help treat or prevent worsening of chronic bronchitis and acute respiratory distress syndrome, an often fatal complication in patients with pneumonia or other severe lung infections.7-12
In patients with chronic obstructive pulmonary disease (COPD), N-acetyl-L-cysteine has been associated with lower rates of exacerbations (periods of worsening of symptoms) and fewer days spent in the hospital.4,13-18
Most individuals gain benefits from using 600 mg to 1,800 mg/day in divided dosages.
What Is N-Acetyl-L-Cysteine?
N-acetyl-L-cysteine (NAC) is a precursor of L-cysteine, the amino acid cells need to produce one of the most powerful antioxidants in the body, glutathione.19,20
Found in every cell in the body, glutathione fights the oxidative stress that is closely associated with many age-related chronic diseases.21
But scientists have found that N-acetyl-L-cysteine does much more than this. It also protects the respiratory system from a number of different pathogens and diseases.
Controlling Excess Mucus
Healthy lungs have a built-in cleaning and protection system.
A small amount of mucus is secreted to coat the walls of the airways. This mucus traps inhaled particles, many of which can be irritants, infectious, or worse. Then, tiny projections called cilia on the surface of cells lining the airways sweep away the mucus and trapped particles, keeping airways clear and protecting the lungs from potential pathogens.
Many conditions, from allergies to infection to lung disease, can cause this system to become dysfunctional, leading to the secretion of large amounts of mucus.22
When excess mucus accumulates, it becomes sticky and hard to remove, leading to difficulty breathing. This complicates many lung conditions, including bronchitis, emphysema, asthma, cystic fibrosis, and lung infections.22
Doctors have been using inhaled N-acetyl-L-cysteine to reduce mucus since the 1960s.23 It breaks down mucus secretions, making them less dense and sticky.
N-acetyl-L-cysteine also reduces the thickness of the mucus.3 It does this by reacting with bonds within the mucus proteins and thinning the mucus.4,24
This helps clear the airways and makes it easier for the cilia to sweep away mucus and trapped particles.3
Reducing Oxidative Stress
N-acetyl-L-cysteine is a highly effective precursor to the antioxidant glutathione, which reduces oxidative stress and free-radical tissue damage.3,4,24
Taken orally, NAC is rapidly absorbed and distributed throughout the body, where it provides the building blocks for cells to produce their own glutathione.
N-acetyl-L-cysteine is also a direct antioxidant itself. Even before conversion into glutathione, it scavenges free radicals that could otherwise cause damage.4
Oxidative stress is a common contributor to many disorders of the respiratory system, from infection to chronic obstructive pulmonary disease (COPD), disorders of the lungs that cause difficulty breathing.4
By bolstering antioxidant reserves, and thus reducing oxidative stress, N-acetyl-L-cysteine offers powerful protection to the lungs.
For example, in COPD such as emphysema, oxidative stress in the lungs contributes to inflammation, abnormal constriction of the airways, fluid in the lungs, excess mucus secretion, and other tissue damage.4 N-acetyl-L-cysteine reduces oxidative stress and the damage it does while also reducing mucus volume and thickness.
Stopping Infectious Pathogens
N-acetyl-L-cysteine has been shown to reduce the number of harmful pathogens, including bacteria and viruses.
In the case of harmful bacteria, N-acetyl-L-cysteine makes it hard for them to gain a foothold and cause infection.
In vitro experiments show that N-acetyl-L-cysteine prevents bacteria from adhering to cells lining the airways.5,6
One of the ways it accomplishes this is by disrupting biofilms, slimy coverings that many disease-causing bacteria form around themselves. These films prevent immune cells from recognizing and gaining access to the bacteria. They also make it difficult for antibiotics, antibodies, and other helpful compounds to get to the bacteria.
N-acetyl-L-cysteine blocks the formation of biofilms and destroys existing ones, impeding the ability of bacteria to survive in the airways.2,3
The protection from pathogens also extends to viruses.
One cell study evaluated respiratory syncytial virus .Normally, this virus invades the cells lining the airways, growing rapidly and causing damage to the structure of the airways.
But treatment with N-acetyl-L-cysteine blocks the reproduction of the virus while restoring the normal structure and function of the cells lining the airways.1
Reducing Harmful Inflammation
By preventing free-radical damage, reducing pathogen colonization, and other mechanisms, N-acetyl-L-cysteine decreases harmful inflammation, which contributes to the symptoms of most respiratory disorders.
Preclinical studies show that N-acetyl-L-cysteine reduces the production of pro-inflammatory compounds and decreases the production of compounds that initiate fibrosis in the lung tissue, scarring that makes it difficult for the lungs to work properly.25-27
Respiratory Tract Disorders
N-acetyl-L-cysteine has shown success in treating a number of different respiratory conditions.
Chronic bronchitis is longstanding inflammation in the airways of the lungs caused by irritation and tissue damage. It’s common in smokers but can also be caused by secondhand smoke, air pollution, and other inhaled irritants.
Several human studies have shown that oral intake of N-acetyl-L-cysteine reduces exacerbations (worsening or flare-ups) of chronic bronchitis and significantly improves symptoms.11,12
Chronic obstructive pulmonary disease (COPD) refers to disorders of the lungs that restrict airflow in the lungs, making it hard to breathe. It includes chronic bronchitis, emphysema, and severe asthma.28,29
Oxidative stress, inflammation, and excessive secretion of airway-clogging mucus play major roles in these conditions. Knowing that N-acetyl-L-cysteine helps prevent or treat all three of these problems, scientists have tested it to treat COPD.
In COPD patients, N-acetyl-L-cysteine use has been associated with clinical improvements. These include lower rates and decreased severity of exacerbations, and fewer days spent in the hospital for COPD exacerbations.4,13-18
Acute respiratory distress syndrome (ARDS) is a form of severe lung inflammation that causes fluid to leak into the lungs, preventing oxygen from getting into the body.
It occurs in critical illness, particularly in patients suffering from pneumonia or other serious lung infections. It often requires mechanical ventilation and typically results in a high mortality rate.
Animal studies show that N-acetyl-L-cysteine protects the lungs from injury and leads to significant improvements.30,31 In clinical studies, patients with acute respiratory distress syndrome who were given N-acetyl-L-cysteine had shorter intensive-care-unit stays, and clinical improvements.7-10
Summary
N-acetyl-L-cysteine (NAC) is a precursor to the antioxidant glutathione. It helps prevent harmful oxidative damage and reduces inflammation.
In the lungs and airways of the respiratory tract, it reduces and thins excess mucus secretion and could help prevent colonization by harmful bacteria and viruses.
Through these mechanisms and more, N-acetyl-L-cysteine supports healthy respiratory function and provides protection against lung diseases, including acute respiratory distress syndrome, infections, and chronic obstructive pulmonary diseases like bronchitis and emphysema.
Most individuals gain benefits from using 600 mg to 1,800 mg/day of N-acetyl-L-cysteine in divided dosages.
If you have any questions on the scientific content of this article, please call a Life Extension® Wellness Specialist at 1-866-864-3027.
References
1. Mata M, Sarrion I, Armengot M, et al. Respiratory syncytial virus inhibits ciliagenesis in differentiated normal human bronchial epithelial cells: effectiveness of N-acetylcysteine. PLoS One. 2012;7(10):e48037.
2. Blasi F, Page C, Rossolini GM, et al. The effect of N-acetylcysteine on biofilms: Implications for the treatment of respiratory tract infections. Respir Med. 2016 Aug;117:190-7.
3. Kalyuzhin OV. Effect of N-acetylcysteine on mucosal immunity of respiratory tract. Ter Arkh. 2018 Apr 19;90(3):89-95.
4. Santus P, Corsico A, Solidoro P, et al. Oxidative stress and respiratory system: pharmacological and clinical reappraisal of N-acetylcysteine. COPD. 2014 Dec;11(6):705-17.
5. Zheng CH, Ahmed K, Rikitomi N, et al. The effects of S-carboxymethylcysteine and N-acetylcysteine on the adherence of Moraxella catarrhalis to human pharyngeal epithelial cells. Microbiol Immunol. 1999;43(2):107-13.
6. Riise GC, Qvarfordt I, Larsson S, et al. Inhibitory effect of N-acetylcysteine on adherence of Streptococcus pneumoniae and Haemophilus influenzae to human oropharyngeal epithelial cells in vitro. Respiration. 2000;67(5):552-8.
7. Bernard GR. N-acetylcysteine in experimental and clinical acute lung injury. Am J Med. 1991 Sep 30;91(3C):54S-9S.
8. Bernard GR, Wheeler AP, Arons MM, et al. A trial of antioxidants N-acetylcysteine and procysteine in ARDS. The Antioxidant in ARDS Study Group. Chest. 1997 Jul;112(1):164-72.
9. Zhang Y, Ding S, Li C, et al. Effects of N-acetylcysteine treatment in acute respiratory distress syndrome: A meta-analysis. E xp Ther Med. 2017 Oct;14(4):2863-8.
10. Lu X, Ma Y, He J, et al. N-acetylcysteine for adults with acute respiratory distress syndrome: a meta-analysis of randomized controlled trials. Hong Kong J Emerg Me. 2019;26(5):288-98.
11. Cazzola M, Calzetta L, Page C, et al. Influence of N-acetylcysteine on chronic bronchitis or COPD exacerbations: a meta-analysis. Eur Respir Rev. 2015 Sep;24(137):451-61.
12. Wei J, Pang CS, Han J, et al. Effect of Orally Administered N-Acetylcysteine on Chronic Bronchitis: A Meta-analysis. Adv Ther. 2019 Dec;36(12):3356-67.
13. Pela R, Calcagni AM, Subiaco S, et al. N-acetylcysteine reduces the exacerbation rate in patients with moderate to severe COPD. Respiration. 1999 Nov-Dec;66(6):495-500.
14. Poole PJ, Black PN. Preventing exacerbations of chronic bronchitis and COPD: therapeutic potential of mucolytic agents. Am J Respir Med. 2003;2(5):367-70.
15. Sadowska AM, Verbraecken J, Darquennes K, et al. Role of N-acetylcysteine in the management of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):425-34.
16. Stey C, Steurer J, Bachmann S, et al. The effect of oral N-acetylcysteine in chronic bronchitis: a quantitative systematic review. Eur Respir J. 2000 Aug;16(2):253-62.
17. Sutherland ER, Crapo JD, Bowler RP. N-acetylcysteine and exacerbations of chronic obstructive pulmonary disease. COPD. 2006 Dec;3(4):195-202.
18. Tse HN, Raiteri L, Wong KY, et al. High-dose N-acetylcysteine in stable COPD: the 1-year, double-blind, randomized, placebo-controlled HIACE study. Chest. 2013 Jul;144(1):106-18.
19. Salamon S, Kramar B, Marolt TP, et al. Medical and Dietary Uses of N-Acetylcysteine. Antioxidants (Basel). 2019 Apr 28;8(5).
20. Sansone RA, Sansone LA. Getting a Knack for NAC: N-Acetyl-Cysteine. Innov Clin Neurosci. 2011 Jan;8(1):10-4.
21. Available at: https://www.sciencedirect.com/topics/neuroscience/glutathione . Accessed October 2, 2020.
22. Available at: https://www.webmd.com/lung/mucus-in-chest-overview#1. Accessed October 2, 2020.
23. Walsh TS, Lee A. N-acetylcysteine administration in the critically ill. Intensive Care Med. 1999 May;25(5):432-4.
24. Aldini G, Altomare A, Baron G, et al. N-Acetylcysteine as an antioxidant and disulphide breaking agent: the reasons why. Free Radic Res. 2018 Jul;52(7):751-62.
25. Cu A, Ye Q, Sarria R, et al. N-acetylcysteine inhibits TNF-alpha, sTNFR, and TGF-beta1 release by alveolar macrophages in idiopathic pulmonary fibrosis in vitro. Sarcoidosis Vasc Diffuse Lung Dis. 2009 Jul;26(2):147-54.
26. Gosset P, Wallaert B, Tonnel AB, et al. Thiol regulation of the production of TNF-alpha, IL-6 and IL-8 by human alveolar macrophages. Eur Respir J. 1999 Jul;14(1):98-105.
27. Pinar Karapinar S, Ulum YZ, Ozcelik B, et al. The effect of N-acetylcysteine and calcium hydroxide on TNF-alpha and TGF-beta1 in lipopolysaccharide-activated macrophages. Arch Oral Biol. 2016 Aug;68:48-54.
28. Available at: https://medlineplus.gov/copd.html . Accessed October 6, 2020.
29. Available at: https://acaai.org/asthma/types-asthma/asthma-copd-overlap Accessed October 6, 2020.
30. Kao SJ, Wang D, Lin HI, et al. N-acetylcysteine abrogates acute lung injury induced by endotoxin. Clin Exp Pharmacol Physiol. 2006 Jan-Feb;33(1-2):33-40.
31. Su CF, Kao SJ, Chen HI. Acute respiratory distress syndrome and lung injury: Pathogenetic mechanism and therapeutic implication. World J Crit Care Med. 2012 Apr 4;1(2):50-60.
Good afternoon all long-suffering longs! Well, at least, one thing is very consistent with Humanigen, that is every day at his yearly Lows!!!
I gather that the forces that are against the security will eventually bring it down to
.00001 per share, and they will rename the company Phoenix, Enterprises, and we shall rise from the ashes like a phoenix in flight all the way up to $40 per share!
…. And then we wake up!
I figured as such
I think it's great that NAC works well for you. But the reason to prioritize lenz is that it will prevent hyper-inflammation, leading to cytokine storm.
After decades of use, I see recent news regarding FDA guidance for considering NAC as a dietary supplement.
https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-final-guidance-enforcement-discretion-certain-nac-products
They are really on the ball at the FDA.
Yes, lenz does reduce inflammation. But it is a GM-CSF inhibitor.
The problem with this is the definition of "vaccinated". I have found that this definition often includes a time lag that excludes toxic side effects.
I took NAC 600mg 3x per day prior to 2019 and pulmonary symptoms from chemically damaged lungs almost disappeared. I either went off of or severely reduced all pulmonary meds.
When suffering from probable COVID late 2019-early 2020 1200mg every 2-3 hours kept me alive.
IMO a more proximate solution should be considered first.
Lenz MOA is inflammation reduction, right?
But it has been my personal experience that NAC does the same thing...
When hospitalized for lung issues and alleged COVID recently, I was not allowed to use NAC and signed out AMA.
Yet in late 2019 early 2020 I went to the ER four times without diagnosis and NAC supplementation kept me alive.
I was well aware of the risks.. I was denied effective medication (NAC) and offered life threatening medication (Remedisivir)
The Johns Hopkins covid map does not break down deaths for vaccinated vs unvaccinated patients.
I found some information from the CDC that might answer your question here.
https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e2.htm
I am more interested in reinfections of patients who received lenz.
Good to see you again, Xena.
I can only guess that with a comorbidity of lung damage, they wanted you to be aware of the risks.
Critical question: How many of those are vaccinated lives?
I have chemically damaged lungs. I went to the ER recently for an exacerbation. I tested positive for COVID per PCR. PCR is NOT a diagnostic test, but still, I was asked to approve administration of Remdesivir.
Really???
https://www.mayoclinic.org/drugs-supplements/remdesivir-intravenous-route/side-effects/drg-20503608
I think this may answer the question, "What are frenemies for?" Drive the target's stock price down, cause the company to be snowballed with litigation, then present a lowball offer that many shareholders will want the company to accept.
The best thing management did, after the successful Phase III, was to secure our intellectual property.
The reason we have such a high float is the biggest question I wonder about. When you take Durrant's comments about a partnership as something to remember from his last presentation, having so much liquidity is a potential positive. But that is if the company and insiders have a majority beneficial ownership of the shares. In support of that possibility is paying off the Hercules loan.
If we have maintained controlling interest, we'll be fine.
Hi CJ, I bought a lot at .02-.025 and should have bought more at that price … HGEN at .17 is either a huge bargain steal, or in a death spiral … Lenzilumab is an efficacious and effective drug and the value of the company on the immoral and corrupt market is way below even cash ….
I watch them daily, Chaplain. They're on my watchlist.
The exact same with IPIX & Brilicidin drug that also got bamboozled by FDA DURING HEIGHT OF CV19
B-COVID Meeting NIAID'S Criteria For Development As Antiviral
Small Molecule/Antivirals
"NIAID will evaluate and advance new drug candidates to the stage of being late Phase 2-ready. One existing program through which NIAID will develop safe and effective antivirals is the Antiviral Program for Pandemics (APP). The APP will focus on antivirals that directly act against viral targets
,specifically for RNA viruses. Antivirals of interest will have broad use in the outpatient setting, reducing viral burden in the early stages of infection [**] .
As part of the APP, NIAID will establish Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern. The centers will initially focus on novel, oral antivirals for SARS-CoV-2 and other coronaviruses [***] ..."
https://www.niaid.nih.gov/sites/default/files/pandemic-preparedness-plan.pdf
"
.. Brilacidin has been shown not to target the Spike S1 and Spike RBD regions of SARS-CoV-2, acting instead through dual-acting neutralizing and blocking antiviral properties, able to target virus and host."
https://www.ipharminc.com/press-release/2022/6/23/innovation-pharmaceuticals-reports-brilacidin-inhibits-omicron-delta-gamma-and-alpha-sars-cov-2-variants-based-on-in-vitro-testing-by-nihniaid-sponsored-and-rutgers-university-researchers
" [**] If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study’s primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
https://www.ipharminc.com/press-release/2022/3/7/innovation-pharmaceuticals-reports-additional-findings-based-on-review-of-brilacidin-phase-2-covid-19-trial-results-and-compassionate-use-cases
" [***] Brilacidin has now been tested in vitro in seven SARS-CoV-2 strains (Omicron, Delta, Gamma, Alpha, Italian, Washington, Wuhan) and three human coronavirus (H-CoV) strains (OC43, 229E, and NL63), in addition to MERS-CoV and SARS-CoV-1. Brilacidin has consistently inhibited all coronaviruses tested,..."
https://www.ipharminc.com/press-release/2022/6/23/innovation-pharmaceuticals-reports-brilacidin-inhibits-omicron-delta-gamma-and-alpha-sars-cov-2-variants-based-on-in-vitro-testing-by-nihniaid-sponsored-and-rutgers-university-researchers
>>> Monkeypox is a viral zoonotic disease caused by infection with monkeypox virus. Monkeypox virus is an enveloped double-stranded DNA virus from the Ortho-poxvirus genus in the family Poxviridae. It shares the same genus with the variola virus which causes smallpox, the vaccinia virus which was used for the development of smallpox vaccine, cowpox virus, and camel pox virus. Known as a less lethal and infectious relative of the smallpox virus, monkeypox has developed into two strains, namely the Central African strain, and the West African strain. Although infections with Central African strain have been known to be more severe and transmissible, the spread of monkeypox virus had been limited to tropical rainforest regions of Central and West Africa until 2003. Since then, although the virus was occasionally exported to other areas, it was quickly contained.
No he isn’t. This company is going bankrupt and I am a shareholder probably longer than you
“Pleasure to support management” shut up with your nonsense and stop being a sycophant. I own this company and it is going bankrupt because of management
It's always a pleasure to support management and this miracle drug, Chaplain.
The REAL truth is that the potential for lenz is grossly understated. Just like inhibiting CCR-5 was a cure for HIV, so is inhibiting GM-CSF a potential cure for covid, and a host of other inflammation indications. And if we can link a mutation in HLA-B27 to the onset of covid, we may be able to use lenz prophylactically.
CJ, THANKS AGAIN … YOU ARE STATING TRUTH UNLIKE THE NEW RESIDENT FEAR MONGERER … NOTHING LIKE RUBBING SALT INTO PEOPLES WOUNDS LIKE A SADISTIC EGOMANIACAL PERSON WOULD DO ….. I DO NOT KNOW WHY ANYONE DOES NOT HAVE HIM ON IGNORE
What was overstated?
And let's take another look at this issue of selling shares prior to the EUA denial.
"The company also announced the public offering of 5 million shares with a closing date of April 5, 2021. In addition, they paused the controlled equity offering.
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Pricing-of-Public-Offering-of-Five-Million-Shares-of-Common-Stock/default.aspx
The company submitted an EUA application in May of 2021, the month following the public offering.
https://ir.humanigen.com/English/news/news-details/2021/-Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19/default.aspx
And we waited. And continued to build inventory and deplete the cash we had raised with the public offering. Management was forced to resume the controlled equity offering in August of 2021, due to the FDA delay regarding our EUA application.
https://www.sec.gov/Archives/edgar/data/1293310/000121465921008540/p812211424b5.htm
It took the FDA 104 days to finally announce the Decline of our EUA. But management could not have very well tapered production when they were expecting an EUA approval. There were only three weeks left in the Third Quarter before the FDA finally announced their Decline decision in Sept of 2021.
https://ir.humanigen.com/English/news/news-details/2021/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients/default.aspx
Had the FDA's decision been favorable and timely, we would not have had to resume the controlled equity offering."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169675432&txt2find=resumed%20controlled%20equity%20offering
Additional data from the ACTIV-5 patients who were in ordinal scale 5 could be added to a re-submission of an EUA application. That is sufficient data to confirm a survival endpoint.
The lowest Hazard Ratio I have seen was about 2.54 from the Thorax peer review. That is an outstanding result!
They did overstate it. Which is why they sold tens of millions worth of shares prior to EUA denial. I’m filing a report with the SEC and possibly joining the lawsuit this coming month. These guys deserve to be in jail. Give it up on Covid. A large IIT trial is years away from completion and no one will care about Covid by then. Cam, Dale, and Tim are scammers.
I ask again for a moderator to pin Humanigen's Covid-19 Resource Page.
https://www.humanigen.com/covid-19-1
This link provides the documented evidence of the company's accomplishments.
On the other side of the coin are tort lawyers' claims that the company violated the Securities Exchange Act of 1934. Here is a representative sample of what they state in their Class Action Alert.
https://flashalert.me/?symbol=HGEN&source=PR&referer=https://twitter.com/&url=https://www.globenewswire.com/news-release/2022/09/20/2519552/32719/en/Humanigen-Inc-Class-Action-Alert-Shareholders-with-Losses-in-Humanigen-Inc-HGEN-Are-Urged-to-Contact-Robbins-LLP-for-Information-About-Their-Rights.html&s3=HGEN/2022-09-20/12-10-18_000000/glob/b5d47280b778d04d823bc68147611edf/Humanigen-Inc-Class-Action-Alert-Shareholders-with-Losses-in-Humanigen-Inc-HGEN-Are-Urged-to-Contact-Robbins-LLP-for-Information-About-Their-Rights.html
"In May 2021, Humanigen submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization ("EUA") for lenzilumab for the treatment of patients hospitalized with COVID-19."
Keep in mind the EUA Application, "...follows positive results from the LIVE-AIR Phase 3 clinical trial evaluating the ability of lenzilumab to improve the likelihood of survival without ventilation (SWOV) in newly hospitalized COVID-19 patients.
https://s28.q4cdn.com/539885110/files/doc_news/Humanigen-Submits-Application-to-FDA-for-Emergency-Use-Authorization-for-Lenzilumab-in-COVID-19-2021.pdf
The company's Covid-19 resource page lists various studies on the value in targeting GM-CSF and and CRP levels, in addition to peer reviews.
The Class Action Alert continues with, "On September 9, 2021, Humanigen announced that the FDA had rejected the lenzilumab EUA, advising that "in its letter, [the] FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19."
The EUA application was declined, not rejected, as claimed in the Class Action Alert. "FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients
9/8/2021
FDA has committed to working with Humanigen in the development of lenzilumab and has invited Humanigen to submit additional data as it becomes available. NIH’s ACTIV-5/BET-B study is expected to provide further data that may support a new EUA request " The FDA did not reject the EUA. They only indicated that they wanted to see more data.
https://s28.q4cdn.com/539885110/files/doc_news/FDA-has-declined-Humanigens-Emergency-Use-Authorization-EUA-Request-for-Lenzilumab-in-Hospitalized-COVID-19-Patients-2021.pdf
The Class Action Alert continues. "Then, on July 13, 2022, Humanigen disclosed that lenzilumab had failed to show statistical significance on the primary endpoint of the ACTIV-5/BET-B study."
There's no need to rehash the points I made about ACTIV-5 using a more severe primary endpoint, tested against late stage covid patients, instead of the newly hospitalized covid patients tested in LIVE-AIR. I pointed these issues out previously.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169869278
But I would like to add that NIAID's ACTT trial on remdesivir not only tested patients on room air, their patients needed to have laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction collected < 72 hours prior to randomization. So these were newly infected patients.
inclusion criteria 5:
https://clinicaltrials.gov/ct2/show/NCT04280705
How likely was it, in the ACTIV-5 trial, to have patients progress to ordinal scales 6 or 7 within 72 hours of testing positive for covid? Maybe that is possible, but what is the norm?
In any event, the NIH/NIAID ACTIV-5 trial is no reflection of the LIVE-AIR trial. Our results are not diminished from what we reported, and what the peer-reviews confirmed. The Class Action is without merit, and Humanigen has every reason to expect that a review of ACTIV-5's patients in ordinal scale 5 should provide at least some additional confirmatory data to LIVE-AIR.
The covid "superdodger" post Preciouslife1 linked to start this thread is about research at UCSF designed to answer the question, "So why haven't these (exposed) people caught COVID?"
The lead researcher looking into this question is immunogeneticist Jill Hollenbach. She "... and her colleagues at UCSF have been studying people who test positive COVID but show no symptoms. "Not even a sniffle or a scratchy throat," she says. "So they are entirely asymptomatic."
After analyzing DNA from more than 1,400 people, they identified a mutation that helps a person clear out SARS-CoV-2 so fast that their body doesn't have a chance to develop symptoms.
The mutation occurs in a gene called HLA, which is critical during the earliest stages of infection."
Hollenbach doesn't disclose which Human leukocyte antigen (HLA) was mutated, but I think it may be HLA-B27. "HLA-B27 is a blood test to look for a protein that is found on the surface of white blood cells... (HLAs) are proteins that help the body's immune system tell the difference between its own cells and foreign, harmful substances. They are made from instructions by inherited genes."
While in our 20's, both my brother and I contracted Reiter's Syndrome. "Reactive arthritis, also called Reiter's syndrome, is the most common type of inflammatory polyarthritis in young men. It is sometimes the first manifestation of human immunodeficiency virus infection. An HLA-B27 genotype is a predisposing factor in over two thirds of patients with reactive arthritis."
https://www.aafp.org/pubs/afp/issues/1999/0801/p499.html#:~:text=Reactive%20arthritis%2C%20also%20called%20Reiter's,of%20patients%20with%20reactive%20arthritis.
I'm just trying to understand what lenz does. Why might it be an important drug in treating arthritis? More importantly, is a potential Big Pharma partner looking at lenz as a possible cure for arthritis?
Additionally, what does an arthritis drug have to do with treating coronaviruses, including mono? And the answer appears to be that both indications are associated with human immunodeficiency virus infection.
https://www.medrxiv.org/content/10.1101/2022.06.21.22276660v1
https://www.cdc.gov/epstein-barr/index.html
So I ask again, how many lenz patients have suffered breakthrough covid infections?
Ok sure, I’m invested probably longer than most of you in this company. Some of what you guys are saying is fairy tales though and obviously conjecture to give hope when there is little at this point in the near term. I’m just facing reality, and my points were spot on. This company has no near-term revenue potential. You’re just desperate for some hope and willfully ignoring reality to make yourself feel better about the situation. This blows for everyone, but some of the false hope and possibilities being listed aren’t even close to realistic. Company will have no revenue for at least another year or two. IIT trials for Car-T and Covid will just be us giving away our expiring inventory for someone else to take future revenues with no money coming in from those for a very long time. Cam’s best hope was to sell a priority review voucher from one of the orphan indications. I’m not pinning my hopes and dreams to that. This thing is dead for now. Insider buys or a straight buyout were the only near-term hope and now we’re in blackout until November. The company is hovering at $0.19 cents with no close prospects and no revenue. Without a Hail Mary saving play this will continue to linger, dilute, and eventually reverse split so it can fall further. It sucks, but that’s the truth. If I am wrong then please tell me what money we have coming into the company in the near term, I’ll wait…….
When the next covid strain hits, especially if the mutated virus is more severe, take your pick from the therapeutic of your choice.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=167307578&txt2find=evusheld
Good morning, Chaplain.
I was extremely interested in the article you linked, and even more interested as it may pertain directly to me.
But first, since the article regards gene editing through CRISPR technology (which went into the formulation of lenz, by the way), let me say that I consider CRISPR's capability to be a two-edged sword. It can be used constructively, as we know, such as to help inhibit GM-CSF. But what can be used constructively also has the potential to be used destructively. So when I see the covid virus mutate to the point where accessory proteins begin mutating, targeting the immune response system, I become suspicious, especially from a biological warfare perspective.
But, on the very positive side, by drawing a parallel to the cure for HIV, being achieved through CRISPR gene editing, the article notes that this technology, "...led to the first – and only – way to cure a person of HIV."
The science behind lenz is why many of us are invested here. And when I say that lenz is the only option to actually treat covid patients, I'm hoping that lenz will truly prove to be, "...the first - and only - way to cure a person of..." covid. And management paying off the Hercules loan, and releasing liens on our intellectual property, signals that they are very aware of what they have, and the licensing revenue they could generate until lenz is approved.
Now, as far as your linked article may relate to me, due to things such as my smoking, and my weight (now over 200 pounds) on my 5'10" frame, I remain covid-free, despite being a model covid victim. And I am now being treated for peripheral artery disease (PAD), which is another reason I hope lenz will be there for me. So, am I a covid "superdodger?"
Or is it likely I'm covid-free because I am pretty much a hermit?
Or...
is it because I was diagnosed with mononucleosis (mono) again? The first infection was when I was about 18, and I was hospitalized for it. This was a shocking diagnosis, especially with my hermitic lifestyle . I don't feel sick at all, beyond fatigue (and now pain from PAD).
Your linked article states, "This summer, Hollenbach and her colleagues demonstrated that, with a specific mutation in HLA, some people have T cells that are already pre-programmed to recognize and fight off SARS-CoV-2. So there's no delay in generating COVID-specfic weaponry. It's already there.
"Your immune response and these T cells fire up much more quickly [than in a person without the HLA mutation]," Hollenbach says. "So for lack of a better term, you basically nuke the infection before you even start to have symptoms."
But here's the kicker. For the HLA mutation to work (and for you to have these pre-armed T cells), you first had to have been infected with another coronavirus.
Most of us have been exposed to some common cold coronavirus at some point in life," she explains. And we all generate T cells to fight off these colds. But if you also have this mutation in your HLA, Hollenbach says, then just by mere luck, these T cells you make can also fight off SARS-CoV-2."
So I decided to research for a connection between mono and covid, and I found this.
"Infectious Mononucleosis Complicated With COVID-19."
It is a case study of a 4 year old, but it does illustrate a mono/covid link. I'll be excited to discuss this with my vascular surgeon on Monday. I am having a procedure done then. But, I would be greatly relieved to confirm that my being covid-free may be related to my previous mono infection. And the surgeon is very interested in topics like this, and in lenzilumab.
https://journals.lww.com/pidj/Fulltext/2022/07000/Infectious_Mononucleosis_Complicated_With_COVID_19.27.aspx
So obviously, I found your linked article very informative, and thank you for sharing it.
The point is, WE know what we are doing and the associated risk/reward. Your attempt to "educate" us is not sincere and you make it obvious.
If the Reddit Army would just show up on Monday, that would solve some of our problems with the share price and the shorters! This is so painful to watch, but it's the gamble we all took.
Just telling it like it is. No one wants this, but it’s the truth of the situation. You just don’t want to hear it is all. Stop looking for confirmation bias to make you feel better and give you hope that might not be there
Jay, she is only a month old so it is obvious she knows N o t h i n g. I assume some try to get kicks from trying to destroy something, anything.
Mr nobody has no idea what she is talking about. Jay does know what he is talking about. Imo
MR C, you’re such a breath of foul air, so positive, edifying and instilling hope to shareholders! Sad that some take pleasure in running down companies and people …… joyous weekend all even the mr c …
Wow……this is a deluded stretch. They will absolutely want to see the data from NIH to confirm Live-Air data, but aside from safety it means nothing to other trials except a Covid IIT, which is years away from completion if starting at all. Live-Air had a different endpoint from ACTIV and if it was going to be stopped at any point then it would have been stopped or approved back in 2020/2021 when Covid was hot and scary. We don’t even know where Covid will be at the end of a large IIT a year or two down the road. Asthma and arthritis are not happening. They were just padding the presentation and rehashing old data. Arthritis and Asthma have plenty of exploratory molecules in this class and even if pursued are years away as well. I know you want this thing to work, but it’s probably not happening. If it does then it’s definitely not soon. We’re talking years to pull themselves out of this hole. No insider buying is a clear signal to the market that nothing good is coming.
I doubt that there are many patients who are happy with whatever asthma or arthritis drug they are taking. I'm not. So a therapeutic that can alleviate symptoms far better than what is currently available would be widely welcomed.
With our LIVE-AIR results being as stellar as they are, no BP is going to lend any credence to the findings of ACTIV-5. They are going to recognize the NIH/NIAID folly for what it is.
All BP needs to do is to model the LIVE-AIR trial design, and a DSMB would halt the trial at an interim review, and recommend FDA approval.
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Humanigen, Inc. is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, we believe that we have the ability to transform CAR-T therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. Clinical correlative analysis and pre-clinical in vivo evidence points to GM-CSF as the key initiator of the inflammatory cascade resulting in CAR-T therapy’s side-effects. Pre-clinical in vivo data on the neutralization of GM-CSF using antibody or gene KO indicates that it is not required for CAR-T cell activity. Our strategy is to continue to pioneer the use of GM-CSF neutralization and GM-CSF gene knockout technologies to improve efficacy and prevent or significantly reduce the serious side-effects associated with CAR-T therapy.
We believe that our GM-CSF pathway science, assets and expertise create two technology platforms to usher in next-generation CAR-T therapies. Lenzilumab, our proprietary Humaneered® anti-GM-CSF immunotherapy, has the potential to be used in combination with any FDA-approved or development stage CAR-T therapy, as well as in combination with other cell therapies such as HSCT, to make these treatments safer and more effective. In addition, our GM-CSF knockout gene-editing platform has the potential to create next-generation CAR-T therapies that may inherently avoid any efficacy/toxicity linkage, thereby potentially preserving the benefits of the CAR-T therapy while altogether avoiding its serious and potentially life-threatening side-effects.
The company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. The company is also developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, T cell engaging, and immunotherapy treatments to break the efficacy/toxicity linkage including the prevention and/or treatment graft-versus-host disease (GvHD) in patients undergoing allogeneic HSCT. The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline.
June 15, 2020
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
https://clinicaltrials.gov/ct2/show/NCT04351152
Anti-GM-CSF antibodies expected to show better effect in Covid-19 than cytokine-specific targets
July 27, 2020
https://discoverysedge.mayo.edu/2021/06/22/cancer-to-covid-19/
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