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So two catalysts that could come at any time are publication with peer review and the announcement that all modules have been submitted to MHRA.
Durrant said yesterday that the last module would be submitted to MHRA by the end of September and perhaps much sooner. Much sooner than the end of September almost has to be tomorrow. Monday is Sept 27th. That is not much sooner than the end of September. So I'm hoping for a press release tomorrow morning announcing that the last module has been submitted to MHRA and that lenz is officially on the clock.
It's a positive development that they'll be submitting again for the EUA before the ACTIV-5 data comes. Sounds like the FDA might have had a change of heart. Or the 60 day data is excellent. Maybe stat sig on mortality at 60 days?
Register for the Oppenheimer Fall Healthcare Summit
https://wsw.com/webcast/oppenheimer16/register.aspx?conf=oppenheimer16&page=hgen&url=https://wsw.com/webcast/oppenheimer16/hgen/2752454
Starts at 2:05pm EST
Here are some lenzilumab science-related articles for those wanting to do some due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage.
Covid
https://www.bbc.com/news/health-56352128
https://immunology.sciencemag.org/content/6/57/eabg9873
https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30267-8/fulltext
https://www.nature.com/articles/s41586-021-03569-1
https://www.pharmaceutical-technology.com/news/humanigen-lenzilumab-improves-survival/
CAR-T
https://www.nature.com/articles/s41408-021-00459-7
https://www.nature.com/articles/s41421-021-00255-4
https://www.targetedonc.com/view/lenzilumab-plus-axi-cel-achieves-responses-in-100-of-patients-with-dlbcl-with-limited-toxicity-in-small-study
https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities
It could take that long. But everything can happen much quicker if the FDA wants. The FDA has said that additional data can be submitted as it becomes available. The NIH sees data from the ACTIV-5 in real time. My guess is that lenz won't need to go through the entire application process again. Remdesivir's DSMB recommended an EUA to the FDA 5 days after the interim review's data was unblinded. The FDA gave the EUA 2 days later. It took the FDA 105 days to make its EUA decision for lenz. It must have been a very difficult decision. It may not take much to nudge them to approve.
XBI is down 4% now. It is killing HGEN.
Here are some lenzilumab science-related articles for those wanting to do some due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage.
Covid
https://www.bbc.com/news/health-56352128
https://immunology.sciencemag.org/content/6/57/eabg9873
https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30267-8/fulltext
https://www.nature.com/articles/s41586-021-03569-1
https://www.pharmaceutical-technology.com/news/humanigen-lenzilumab-improves-survival/
CAR-T
https://www.nature.com/articles/s41408-021-00459-7
https://www.nature.com/articles/s41421-021-00255-4
https://www.targetedonc.com/view/lenzilumab-plus-axi-cel-achieves-responses-in-100-of-patients-with-dlbcl-with-limited-toxicity-in-small-study
https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities
Here are some lenzilumab science-related articles for those wanting to do some due diligence. Lenzilumab is a GM-CSF inhibitor. The "M" in GM-CSF is macrophage.
Covid
https://www.bbc.com/news/health-56352128
https://immunology.sciencemag.org/content/6/57/eabg9873
https://directorsblog.nih.gov/2021/04/13/mapping-severe-covid-19-in-the-lungs-at-single-cell-resolution/
https://www.nature.com/articles/s41586-021-03569-1
https://www.pharmaceutical-technology.com/news/humanigen-lenzilumab-improves-survival/
CAR-T
https://www.nature.com/articles/s41408-021-00459-7
https://www.nature.com/articles/s41421-021-00255-4
https://www.targetedonc.com/view/lenzilumab-plus-axi-cel-achieves-responses-in-100-of-patients-with-dlbcl-with-limited-toxicity-in-small-study
https://www.healio.com/news/hematology-oncology/20210422/lenzilumab-before-cart-induces-high-response-rates-without-severe-toxicities
Two new pr releases:
Baird presentation documents
https://s28.q4cdn.com/539885110/files/doc_presentations/2021/September/Baird-9-14v2.pdf
Baird webcast
https://kvgo.com/baird-2021-global-healthcare-conference/humanigen-sept-2021
Below is the link to today's Wainwright conference with Durrant. Not much is said in this link but he speaks again later in the call. Yesterday's Baird presentation with Durrant was private and still hasn't been posted anywhere. Hopefully, the Baird presentation gets posted to the internet soon.
https://streamable.com/5t5hh8
It says 60% enrolled. 60% of 550 patients is 330 patients. The ACTIV-5 is enrolling super quickly. All 550 patients could be enrolled sometime in October.
So it seems the ACTIV-5 trial is enrolling to 550 patients or 400 patients in the primary endpoint of CRP<150mg/L and <85yo, whichever comes first.
VeryJerry
6m
$HGEN
interesting update to the enrollment number for NIH trial - total trial now up to 550, 60% enrolled to date. And for the first time we see that NIH is targeting specifically 400 in the <150 CRP which is likely the number needed to power the recently updated primary endpoint. It’s possible the trial could conclude early if the trial increases its enrollment in this subgroup at a higher rate than the rest of the population.
One silver lining of the share price crash is that some CAR-T focused investors will be buying in. Many were likely intrigued by the excellent phase I CAR-T data but weren't interested in a Covid stock. For better or worse, HGEN's share price has been tied to Covid. HGEN's current share price is a bargain even when the Covid indication isn't included. The CAR-T investors will be long-term investors who won't worry about the day-to-day share price fluctuations. They won't even consider selling for at least a couple of years. And they'll be more mature investors who won't shoot themselves in the foot by harassing government scientists.
Humanigen Announces Participation and Presentation at Multiple Conferences in September
https://ir.humanigen.com/English/news/news-details/2021/Humanigen-Announces-Participation-and-Presentation-at-Multiple-Conferences-in-September/default.aspx
BURLINGAME, Calif.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced that management will present and participate at multiple virtual investor conferences in September 2021. Details of the conferences are as follows:
Baird Global Healthcare Conference
Cameron Durrant, Chairman & CEO, will provide a corporate update at 5:30pm EDT on September 14, 2021. Access is limited, by the host of the conference, on an invitation only basis. Please contact your Baird representative for information on how to access the meeting.
H.C. Wainwright 23rd Annual Global Investment Conference
Cameron Durrant, Chairman & CEO participated in a panel to discuss “Best Practices Planning for the Next Pandemic”, which was pre-recorded and will be available starting at 12pm EDT on September 15, 2021.
Webcast: https://journey.ct.events/view/df4da74c-0a2c-499c-a5be-13f994a0d28f
Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Presentation date: September 22, 2021
Presentation time: 2:05 ET
Webcast: Webcast link: https://wsw.com/webcast/oppenheimer16/hgen/2752454
The webcast will be archived for 90 days under the Investor Relations section of the company’s website at www.humanigen.com.
Cantor Global Healthcare 2021
Presentation date: September 27, 2021
Presentation time: 4:40 ET
Webcast link: https://wsw.com/webcast/cantor12/hgen/2064020
The webcast will be archived for 90 days under the Investor Relations section of the company’s website at www.humanigen.com.
Seems strange that the primary outcome would be limited to those with a CRP<150mg/L and <85yo but that they'd still include those with CRP>150mg/L or >85yo into the trial. Possibly the clinical trials website hasn't been updated completely?
Here is what the clinical trials site said on July 8th for the primary outcome: