Avid Bioservices Inc (CDMO)

[jakedogman1]

Given the new bavi trial is recruiting and the contract between Avid and Oncologie states a milestone payment be made within 30 days. So when is the technical start date? Posted on clinicaltrials.gov on Sept 23.

https://www.clinicaltrials.gov/ct2/show/NCT04099641?term=bavituximab&rank=1

From the contract:
https://www.sec.gov/Archives/edgar/data/704562/000168316818001961/avid_ex1011.htm

Milestone Payments. One-time payments upon the achievement of the milestones (each, a “Milestone” and collectively, the “Milestones”) described in this Section 3.1(b), by wire transfer of immediately available funds within thirty (30) calendar days after the achievement of each such Milestone (each, a “Milestone Payment” and collectively, the “Milestone Payments”):

And we know all 9 milestones have been blanked out for confidentially reasons.. (keep potential acquirers in the dark to stay below radar? ... do another underhanded deal with the rights to the IP?)

So the question is whether starting a phase 2 is a milestone? If so, how much. We know when it is supposed to be paid.

IMO I would call this a milestone likely on the blanked out list. And a material event given zero value is associated with the IP at this time. Mgmt has been sent several emails by several folks pointing out the trial start and importance of the IP to company value and the lack of support thereof.


So by Oct 23 (assuming the start date is milestone date) IMO mgmt will need to disclose milestone payment. The ASM is Oct 9th so we may not hear anything. I would think it would be a topic of discussion at the ASM and I would encourage attendants to ask the tough question. I also think mgmt needs to be aware of the lack of "coverage" of the IP on the cc's.

Doing some research I came across a few articles which included discussions of milestones: Here is a typical example:

https://bioscibd.com/biopharma-milestone-payments/#1

Our definitions of the various financial terms utilized in this analysis are as follows:

Total Development and Regulatory Milestones (Total Dev/Reg) – the total milestone amount to be paid to the licensor through launch in all jurisdictions for the first product indication (sum of 2-12 below);
IND Filing – payment on Investigational New Drug filing, typically with the FDA;
Phase I Start – payment on first human treated in a clinical setting;
Phase II Start – payment on commencement of a human clinical trial to determine safety and preliminary design of additional efficacy studies;
Phase III Start – payment on commencement of a pivotal human clinical trial;
FDA Filing – payment on filing of a New Drug Application with the FDA;
1st Approval – payment(s) on FDA or other 1st major market approval and/or launch;
EU Filing – payment on filing of a marketing approval application in the EU;
Major EU Approval – payment(s) on EU approval, pricing and/or launch;
Japan+ Filing – payment on filing of a marketing approval application in Japan or other Asia;
Japan+ Approval – payment(s) on Japan or other Asia approval and/or launch;
Other Dev Milestones – typically payments on early R&D, toxicology, development candidate designation or license option exercise;