Replies to post #31044 on Humanigen Inc (fka HGENQ)

[cowtown jay]

I always get confused when I have so many windows opened, so I can see I have made some mistakes. But you get the idea, until the corrections are made.

I wanted to see how this compared to our being told that we will have some lenz available for sale this summer, with the bulk appearing in the fall or winter. That guidance appears to be pretty accurate.

[cowtown jay]

Our potential preparedness. Corrected.

Based on 4-6 months for facilities to come up to speed, and

6-8 months to grow the cells and fill the vials.

1. Catalent
agreement signed July 16, 2020
come up to speed Nov 2020 - Jan 21
grow cells and fill vials May 21 - Sept 21

https://www.catalent.com/catalent-news/humanigen-expands-partnership-with-catalent-biologics-to-manufacture-investigational-covid-19-therapeutic-candidate-lenzilumab/

2. Lonza
agreement signed September 15, 2020
come up to speed Jan 21 - March 21
grow cells and fill vials July 21 - Nov 21

https://www.businesswire.com/news/home/20200914005914/en/Humanigen-and-Lonza-Announce-Collaboration-to-Expand-Manufacturing-of-Humanigens-COVID-19-Therapeutic-Candidate-Lenzilumab

3. Thermo-Fisher
agreement signed Sep 23, 2020
come up to speed Jan 21 - Mar 21
grow cells and fill vials July 21 - Nov 21

https://www.fiercepharma.com/manufacturing/humanigen-thermo-fisher-reach-agreement-to-scale-up-manufacturing-monoclonal-antibody

4. Avid Bioservices
agreement signed Feb. 3, 2021
come up to speed June 21 - Aug 21
grow cells and fill vials Dec 21 - Apr 22

https://www.pharmtech.com/view/avid-bioservices-enters-manufacturing-agreement-with-humanigen-for-lenzilumab

5. Chime Biologics
agreement signed May 17, 2021
come up to speed Sept 21 - Nov 21
grow cells and fill vials Mar 22 - July 22

https://www.biospace.com/article/releases/humanigen-and-chime-biologics-enter-into-manufacturing-agreement-for-covid-19-therapeutic-candidate-lenzilumab/

Timelines provided by Humanigen's Tim Morris and/or Ken Trbovich. These guidelines encompass the complete timeline for the production of lenzilumab, from start to finish. So I am not mentioning the CDMO's who were contracted to provide fill/finish, as that time is already factored in.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164586056

So currently, we could have filled vials available from three of our CDMO's by the end of this month, in the best case scenario.

But, again in the best case scenario, we may not get filled vials from the other two CDMO's until Dec 2021, and then March 2022, the beginning of winter, and the end of winter. In between, we may see an additional batch from Catalent in Nov.

That's a real challenge for the production planner and the Sales Manager, if we have to go from the end of this month until November before we see additional production completion.

I have to think that the sophisticated demand model the company has developed is raising a red flag, and certainly indicating zero tolerance when it comes to any disruption of our production.

So I think we have two reasons for publicly stating our need for a timely EUA. As discussed, revenue requirements are one reason, since we planned on about $169M in R&D expense for the last 3 quarters (classified as R&D expense instead of inventory until EUA).

And in addition, and in the face of the uptick in developing Covid cases, we could be looking at several months before our finished goods can get replenished.

Avid should be coming up to speed next month. That would give us the opportunity to increase purchases from four CDMO's which could yield additional finished goods production by Jan 21, in the best case, if we have revenue coming in to pay for that production.