RE: CDX28 Dec 2020 11:54
Hi DCB, the loan was applied for a long time ago and certainly before Eli labs re-opened and in a "worst case" scenario, IE how much funding would be required to take everything to Phase 1/2a clinical trials. The wording in the circular is IF, Eli could have licenced the work 2 years ago with Hemo before any pre-clinical work was done if they wanted, plenty of small pharma get bought out at a much earlier stage than this.
In terms of that Β£5mil, that refers to: IND-enabling pre-clinical studies, that is In Vivo and In Vitro testing, that is what Eli and Hemogenyx have been doing for the past 2-3 years plus further stages of profiling the drugβs effect on DNA, critical organ systems , safety pharmacology, and toxicity (tests on rodent and nonrodent).
Basically if Hemogenyx go it alone and dont licence to Eli and Eli dont inlicence the work done with them to Hemogenyx then Vlad has to go and re-do all the testing then draw up and get approval for the clinical trials etc alone.
He would have to start from the base antibodies that he licenced years ago from the university and use none of the materials produced while working with Eli which very well could take 5mil.
If Eli Lilly licence CDX the IND enabling studies are largely done, they will have to, if not already done, test for toxicity on non mice, IE monkeys, they may have to submit to a third party lab for sign off on safety but really you have to expect that a company as big as Eli have the capability to inhouse all of this. Much of that Β£5m has already been spent over the years at the expense of Eli Lilly, which makes walking away even less likely, but also explains why they will want the best deal possible for them as they have footed the bill to this point.
Fundamentally though you have to look at the Loan as Vlad saying : Eli, either you licence from us, or you licence to us and take a cut OR with this loan we have enough to start from scratch and bring CDX to clinical trials alone. Its not a case that Hemogenyx need the Loan to enable them to licence to Eli lilly, 100% not the case. Had Covid not shut the labs and Eli not forced to mothball work with CDX back in March, late April they would have selected the antibody and the licencing period would have finished by the summer.