Humanigen Inc (HGENQ)

[cowtown jay]

The Lenzilumab Partnership Framework


I have never seen a company structure itself in the way that Humanigen is proceeding. But I have never seen a developmental company almost immediately required to be fully operational, either. And that is what we have here. I find it most interesting and educational to witness this unfolding before our eyes.

Humanigen has revealed how they will be structured. They provided this blueprint in their Business Development plan.

"Key areas we are looking for in Lenzilumab partners are:

Partners:

Multinational, Regional or Domestic Pharmaceutical or Biotechnology Company


Territories:

Global, Regional and Countries such as People’s Republic of China, Latin America, Russia, India and certain other Asia-Pacific countries are available for discussion


Product:

Lenzilumab (currently 10mg/ml filled into a 10ml vial)


Indications:

Treatment of hypoxic hospitalized COVID-19 pneumonia patients; treatment and prevention of CAR-T CRS and neurotoxicity and improvement in CAR-T efficacy


Clinical development:

Partner to complete required clinical development suitable for registration in the Territory


Regulatory:

Partner to submit for approval in the territory for the Indication. Partner is free to reference EUA, BLA and any other approvals


Manufacturing:

Ideally partner will have experience in the manufacturing of mAbs and will complete the tech transfer of the process (to cGMP standard) from our current CMO’s. If no manufacturing capability exist, partner may find a suitable CMO to supply Product. Alternatively, Partner may be able to purchase Product from Humanigen.


Commercialization:

Partner will need to have existing commercial infrastructure to commercialize and distribute lenzilumab to hospitals and other relevant institutions."

https://www.humanigen.com/business-development

Now we can start filling in the blanks. Start with the most recent development, that with Eversana for "Commercialization."

Did you notice the incredible terms of this deal? "EVERSANA will serve as the Company’s end-to-end commercial partner, providing the Company with a full suite of services in connection with the potential launch of lenzilumab. EVERSANA’s services initially will comprise marketing, market access and field solution services, and may expand to other areas including patient services, compliance services, professional services, data and analytics, and health economics outcome research, as may be negotiated by the parties and set forth in statements of work delivered in accordance with the Agreement."

What is the laying of this foundation going to cost Humanigen? "EVERSANA has agreed to defer its fees pending the Company’s receipt of an emergency use authorization (“EUA”) from the U.S. Food and Drug Administration for lenzilumab for hospitalized and hypoxic COVID-19 patients."

https://www.sec.gov/Archives/edgar/data/1293310/000121465921000503/s1102108k.htm

Then, we have our manufacturing partnerships with Thermo Fisher, Catalent, and Lonza. We could go on and on, filling in the blanks with KPM/Telcon, IMPACT, Kite, etc.

How is all of this possible? The scope is massive. The feat, of going from developmental stage to fully functioning on a global basis, in a matter of MONTHS, is almost unbelievable!

I don't think it would have been possible if Humanigen executives were not working closely with the Department of Defense in executing their Cooperative Research and Development Agreement (CRADA) with the US Government.

I think it's time I start closing out other positions and start re-investing the proceeds in additional shares of HGEN. I have not seen this degree of preparation by any of the other biotechs I am holding, and our time is drawing nigh.