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Diamond in the Rough - Humanigen ($HGEN) a little DD
Posted on 2/1/21 at 10:45 am
Posted on 2/1/21 at 10:45 am
Humanigen is a biopharmaceutical company that is heavily focused on their COVID therapeutic Lenzilumab. This antibody has shown in trials to neutralize GM-CSF which is a cytokine that creates hyperinflammation aka "Cytokine Storm." The cytokine storm is triggered by the infection and causes one's immune system to flood the body with inflammatory proteins that can cause severe damage to the lungs and much worse. This LINK goes to their website and has a fantastic video outlining Lenzilumab and why it works.
Humanigen just completed phase 3 trial enrollment and has ramped up manufacturing of Lenz. Biomedical Advanced Research and Development Authority (BARDA) granted very coveted manufacturing space to Humanigen ( LINK). With partners like Gilead and the Mayo Clinic, it's obvious to me that Lenz is the real deal and will be the most viable therapeutic, and I have a great feeling that when the phase 3 trial data is revealed in March they will receive EUA (Emergency Use Authorization) from the government shortly after. It would not surprise me at all if they were acquired by a big name player at some point as well. I need to do some more research but this stock is heavily shorted (most likely by big pharma IMO) and is very overlooked due to vaccine rollouts. The vaccine is only part of the equation... We need life saving therapeutics and Humanigen's Lenzilumab looks to be just that. There is a lot more detailed information out there but hopefully this is a good jumping off point to do your own DD. Best of luck!
Disclosure: I own 1,005 shares and 40 May 2021 $35 calls and have continued buying up the dips.
Humanigen just completed phase 3 trial enrollment and has ramped up manufacturing of Lenz. Biomedical Advanced Research and Development Authority (BARDA) granted very coveted manufacturing space to Humanigen ( LINK). With partners like Gilead and the Mayo Clinic, it's obvious to me that Lenz is the real deal and will be the most viable therapeutic, and I have a great feeling that when the phase 3 trial data is revealed in March they will receive EUA (Emergency Use Authorization) from the government shortly after. It would not surprise me at all if they were acquired by a big name player at some point as well. I need to do some more research but this stock is heavily shorted (most likely by big pharma IMO) and is very overlooked due to vaccine rollouts. The vaccine is only part of the equation... We need life saving therapeutics and Humanigen's Lenzilumab looks to be just that. There is a lot more detailed information out there but hopefully this is a good jumping off point to do your own DD. Best of luck!
Disclosure: I own 1,005 shares and 40 May 2021 $35 calls and have continued buying up the dips.
23
Posted on 2/1/21 at 11:27 am to itsbigmikey
Might be on to something... people like me who have had Covid and may get vaccine can no longer donate their antibodies for plasma infusion.... more people that get vaccinated, less plasma. So they’ll need a drug to help
Wish it was cheaper, seems like speculation has already driven it up
Wish it was cheaper, seems like speculation has already driven it up
This post was edited on 2/1/21 at 11:30 am
Posted on 2/1/21 at 11:31 am to itsbigmikey
Volume coming in on the May $20c for hgen
Posted on 2/1/21 at 12:06 pm to itsbigmikey
Here's a link to a Mayo Clinic case study from November and some snippets. LINK
"In high-risk COVID-19 patients with severe pneumonia, granulocyte-macrophage colony-stimulating factor neutralization with lenzilumab was safe and associated with faster improvement in clinical outcomes, including oxygenation, and greater reductions in inflammatory markers compared with a matched control cohort of patients hospitalized with severe COVID-19 pneumonia. A randomized, placebo-controlled clinical trial to validate these findings is ongoing (NCT04351152)."
"Lenzilumab has been studied across four completed clinical trials in healthy volunteers and patients with asthma, rheumatoid arthritis, and chronic myelomonocytic leukemia.23,24 A total of 113 individuals received lenzilumab in these trials. Lenzilumab was well tolerated with a low frequency and severity of adverse events.23,24"
"In high-risk COVID-19 patients with severe pneumonia, granulocyte-macrophage colony-stimulating factor neutralization with lenzilumab was safe and associated with faster improvement in clinical outcomes, including oxygenation, and greater reductions in inflammatory markers compared with a matched control cohort of patients hospitalized with severe COVID-19 pneumonia. A randomized, placebo-controlled clinical trial to validate these findings is ongoing (NCT04351152)."
"Lenzilumab has been studied across four completed clinical trials in healthy volunteers and patients with asthma, rheumatoid arthritis, and chronic myelomonocytic leukemia.23,24 A total of 113 individuals received lenzilumab in these trials. Lenzilumab was well tolerated with a low frequency and severity of adverse events.23,24"
Posted on 2/1/21 at 12:46 pm to itsbigmikey
I bought some baw
Posted on 2/1/21 at 2:09 pm to itsbigmikey
Stock Twits Link
This guy is confident on $HGEN and has a pretty good track record to prove it. Called $MRNA last February and likes to think $HGEN could be at the same phase in their lifespan that $MRNA was. He is quite the $HGEN pumper but it seems warranted to me. He posts a lot of pertinent info for those interested in the stock
This guy is confident on $HGEN and has a pretty good track record to prove it. Called $MRNA last February and likes to think $HGEN could be at the same phase in their lifespan that $MRNA was. He is quite the $HGEN pumper but it seems warranted to me. He posts a lot of pertinent info for those interested in the stock
Posted on 2/3/21 at 8:33 am to itsbigmikey
Seeking Alpha Link
"Avid Bioservices (NASDAQ:CDMO), up 7% premarket and Humanigen (NASDAQ:HGEN) have entered into a manufacturing services agreement to expand production capacity for lenzilumab, latter's therapeutic candidate in development for COVID-19."
"Under the terms of this cGMP agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen’s regulatory and potential commercial activities."
"This collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization and subsequent BLA later this year."
Ramping production up for potential EUA. Good news.
"Avid Bioservices (NASDAQ:CDMO), up 7% premarket and Humanigen (NASDAQ:HGEN) have entered into a manufacturing services agreement to expand production capacity for lenzilumab, latter's therapeutic candidate in development for COVID-19."
"Under the terms of this cGMP agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen’s regulatory and potential commercial activities."
"This collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization and subsequent BLA later this year."
Ramping production up for potential EUA. Good news.
Posted on 2/4/21 at 10:12 am to itsbigmikey
HGEN is skyrocketing today.
Posted on 2/4/21 at 11:21 am to itsbigmikey
$22.39 looks to be breakout territory
Posted on 3/5/21 at 7:09 am to itsbigmikey
Posted on 3/14/21 at 9:34 am to itsbigmikey
Lenzilumab dd from Humanigen’s website
This a good summary of Lenz. Phase 3 readout within the next 2 weeks. Positive results will most likely lead to EUA and this stock could 3-5x quickly (and maybe a Gilead buyout?). Nothing from my dd leads me to believe the trial will not be successful.
A recent UK study at the Imperial College London has further emphasized the importance of stopping “cytokine storm”
Also, Humanigen just secured an $80,000,000 loan from Hercules Capital to bolster manufacturing of lenz... BEFORE the phase 3 readout. Hmmm, quite a risky move if you aren’t expecting positive results. From business wire:
Anything under $20 is more than solid IMO and I’ve averaged down quite a bit over the last two weeks. Call premiums are high but could pay bigly on positive results. These next two weeks should be interesting!
This a good summary of Lenz. Phase 3 readout within the next 2 weeks. Positive results will most likely lead to EUA and this stock could 3-5x quickly (and maybe a Gilead buyout?). Nothing from my dd leads me to believe the trial will not be successful.
A recent UK study at the Imperial College London has further emphasized the importance of stopping “cytokine storm”
quote:
In an analysis of more than 500 COVID-19 patients across the UK, researchers identified several inflammatory markers in blood which increased within the early stages of COVID-19 in those who went on to become critically ill. One marker in particular, a cytokine called GM-CSF, was found at higher levels in those who later progressed to severe disease, compared to healthy controls or those with influenza, and was found to be almost 10 times higher in those who died from COVID-19.
Also, Humanigen just secured an $80,000,000 loan from Hercules Capital to bolster manufacturing of lenz... BEFORE the phase 3 readout. Hmmm, quite a risky move if you aren’t expecting positive results. From business wire:
quote:
The term loan facility provides working capital to support the production of lenzilumab, strengthens our balance sheet and increases our financial flexibility as we prepare for the potential Emergency Use Authorization and commercial launch of lenzilumab in 2021,” said Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen. The facility consists of a $25 million initial term loan, with up to an additional $55.0 million available for future draws subject to achievement of future milestones and satisfaction of other conditions. The facility provides for an interest-only period and the four-year term is extendable under certain conditions. Loans under the facility are secured by the company’s assets.
Anything under $20 is more than solid IMO and I’ve averaged down quite a bit over the last two weeks. Call premiums are high but could pay bigly on positive results. These next two weeks should be interesting!
Posted on 3/26/21 at 8:59 am to itsbigmikey
Reddit Link
This is a good write up on Humanigen and Lenzilumab. Phase 3 data is coming within a week and positive data is a catalyst for massive upside potential. The window to buy (or short) is closing quickly. GL to all!
This is a good write up on Humanigen and Lenzilumab. Phase 3 data is coming within a week and positive data is a catalyst for massive upside potential. The window to buy (or short) is closing quickly. GL to all!
Posted on 3/29/21 at 8:58 am to itsbigmikey
Heading up after being halted. A lot of volatility!
Posted on 3/29/21 at 9:18 pm to itsbigmikey
I read this thread last night and bought 1000 shares at $21.91 in the pre-market, watched the share price drop a couple dollars when the market opened for regular trading, and thought about doubling down but didn't. Now, of course, I wish I'd added when the share price dropped. I did end up selling for a nice profit at $28.3672. Thank you for the excellent information you posted which got me to read as much additional information as I could about the company, all of which gave me sufficient confidence to make my day trade for 1000 shares.
Posted on 3/31/21 at 8:19 am to itsbigmikey
Business Wire Link
5m share offering at $18.50/share. Raising capital for more production of Lenz (need the money to meet production numbers for EUA application). A good buy opportunity IMO
5m share offering at $18.50/share. Raising capital for more production of Lenz (need the money to meet production numbers for EUA application). A good buy opportunity IMO
Posted on 4/21/21 at 11:02 am to itsbigmikey
Twitter link
This is a strong addition to the team. I'm still adding to my position on dips. Hopefully news of EUA submission will be within the next couple of weeks
quote:
We are pleased to announce the appointment of Adrian Kilcoyne, MD, MBA, MPH, to the newly-created role of Chief Medical Officer. His responsibilities will include the clinical development & regulatory strategy of #lenzilumab and #ifabotuzumab.
quote:
Dr. Kilcoyne brings to Humanigen strong leadership experience from multinational pharmaceutical and biotechnology companies and a strong clinical background in both Internal Medicine and Public Health Medicine. His most recent leadership role was in AstraZeneca, where he served as Vice President of Oncology Global Medical Affairs, Head of Evidence Generation and External Alliances, and previously as Vice President and Head of US Medical Affairs and Health Economics and Outcomes Research. Dr. Kilcoyne oversaw the development and delivery of the fully integrated global evidence strategy across the company’s complete oncology portfolio, including managing development of real-world evidence, epidemiology, biostatistics and data sciences, health economics and outcomes research, payer evidence, medical affairs sponsored research, and investigator research. He also led Global Oncology External Alliances, building strong scientific partnerships to advance patient care.
This is a strong addition to the team. I'm still adding to my position on dips. Hopefully news of EUA submission will be within the next couple of weeks
Posted on 4/28/21 at 9:02 am to itsbigmikey
+15% this week going into EUA application. News of this should happen any day now (It's been 1 month since p3 results have been released).
Posted on 4/29/21 at 10:13 pm to itsbigmikey
I’m upside-down on NLSP... have to hold long. 
Posted on 5/5/21 at 11:19 am to itsbigmikey
Phase 3 results publicized. A lot of skeptics now have their answers!
quote:
Lenzilumab improved the likelihood of SWOV by 54% in the mITT population (HR: 1.54; 95%CI: 1.02-2.31, p=0.041) and by 90% in the ITT population (HR: 1.90; 1.02-3.52, nominal p=0.043) compared to placebo.
Posted on 5/28/21 at 8:20 am to itsbigmikey
Yahoo Finance Link
As expected, the application for EUA was submitted. Management has been on the money with their timelines which makes me feel even more confident in them as an investor. Next catalyst obviously is the (hopeful) approval.
We'll see how the market takes this, but as someone that is long this stock I'm pumped! I'm unwavering in my conviction for this company and believe EUA approval is imminent. Trying to free up some more powder in case we have a sell the news event.
As expected, the application for EUA was submitted. Management has been on the money with their timelines which makes me feel even more confident in them as an investor. Next catalyst obviously is the (hopeful) approval.
We'll see how the market takes this, but as someone that is long this stock I'm pumped! I'm unwavering in my conviction for this company and believe EUA approval is imminent. Trying to free up some more powder in case we have a sell the news event.
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