Humanigen Inc (HGENQ)

[MWM]

The next article I wanted to discuss for the "Biotech Analysis Central Stock Insight Series" is a biotech by the name of Humanigen Inc. (OTC:HGEN). The reason why I want to go over this stock next is because it has cancer data that will be presented at the upcoming 62nd Annual ASH Meeting. Specifically, the company will present data from a study using its GM-CSF inhibitor drug Lenzilumab along with Gilead Sciences (GILD) drug Yescarta to treat patients with relapsed/refractory diffuse Large B-Cell lymphoma (DLBCL). The basic premise that you should know is that Lenzilumab inhibits GM-CSF in the patient's body, which is believed to control inflammatory response. It is believed, based on a preclinical model, that combining this drug along with Yescarta can improve upon safety issues with a CAR-T like Yescarta. Meaning to handle/reduce cytokine release syndrome (CRS) and any other toxicity associated with CAR-T. The presentation of phase 1 data will happen at ASH December 6, 2020. From there, this sets up multiple catalysts in 2021. You have the phase 1b/2 ZUMA-19 study results due by the 1st half of 2021. Then, you have phase 2 results set to be released by the 2nd half of 2021. Speaking of GM-CSF drug Lenzilumab targeting cancer, there are two other highly important clinical programs. One indication is dealing with early intervention of patients who go through a transplant and are at high risk/intermediate risk for steroid refractory acute Graft versus Host Disease ((aGvHD)). The other indication deals with lowering cytokine release syndrome (CRS) and inflammation of ARDS in patients with Covid-19. The company has a phase 3 study ongoing for treating the inflammation that occurs in Covid-19 patients. That is, to reduce inflammation and reduce hospital stay due to the disease. Humanigen has even already spoken with the FDA as part of Operation Warp speed and has data coming out in Q1 of 2021. The biotech's monoclonal antibody targeting GM-CSF has a lot of potential and can potentially help patients in a few key areas.


Conclusion Of Marketplace Article
The Final Verdict is that Humanigen is a good long-term biotech to own. I think the 90% powering of the phase 3 Covid-19 study is a good thing and has been somewhat de-risked based on the interim analysis done. I think the mechanism of action has been proven in terms of reducing CRS, Cytokine storm, inflammatory response of the immune system and neurological toxicities. Upcoming results from several studies should confirm these findings. The upcoming readout at the ASH 2020 medical conference will also be important for Humanigen. That's because the implications of improving safety or efficacy of CAR-T will be huge. That means Lenzilumab could be applied to many CAR-Ts targeting a host of NHL indications. With the global market opportunity for non-Hodgkin Lymphoma (NHL) reaching $10.8 billion by 2025, the potential is endless. As far as the Covid-19 program goes, I think there is great potential to help patients. One of the main ways is by reducing hospital stay and reducing inflammation of these patients with respect to their lungs. I have talked about the need for a therapy that covers acute respiratory distress syndrome (ARDS), which happens in severely ill covid-19 patients. They have to be put on a ventilator and have a longer hospital stay. There is no guarantee, but Lenzilumab has the potential to become a first-line treatment option for these patients in the hospital setting. The best part of all is that Humanigen only has a market cap of $492 million, which IMO is very low. Why is that? Well, the potential with improving CAR-T alone could revalue the entire pipeline for the biotech. More importantly, it is believed by the company that it could earn $1 billion or more in revenues for an approved Covid-19 treatment. This assumes that they can price Lenzilumab at about $10,000 per treatment course. I believe that if all works out in the pipeline, this stock should be trading much higher in the coming months with the potential it has

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