Canaccord Fireside Chat & pelareorep's approval in mBC
If anyone cares to listen to the call, Matt Coffey clearly states at timestamp 23:10 that ONCY has 2 randomized clinical studies woth pelareorep + pacilitaxel (IND-213 & Bracelet-1) that were both ststistically significant and the ONCY thinks that this is the path to pelareorep's enhanced approval.
And in terms of life-cycle management Coffey ststed that ONCY should also be looking at combinations with ADCs and and CDK4/6 inhibitors. And "by all means ONCY will be looking at combinations with ADCs" - which brings Pfizer back into the picture, alongside Roche, Merck, and other companies with ADCs either on the market or in development.
Futhermore, the AWARE-1 study in brand new mBC patients showed that combination of pelareorep + Tecentriq resulted in a "phenominal increase" in CellTiL which gives a better benefit in overall survival (OS) and that the earlier one can use the pelareorep/Tecentriq combination in mBC patients, the better the benefit that would be dervived.
Lastly at timestamp 24:20 Kirl Look commented on the US15 Million Offering and what was particular "exciting" was that this was the first time that a "strategic helathcare investor" was involved in an ONCY offering and also took a "sizable portion of that raise". He went on to say "That was the first time that we saw that type of interest coming our way and in a pretty tough financing market". Look then stated that ONCY was pleased with that outcome and feel confident in ONCY's funding that will take the company beyond 12 months and the company can "getting moving on the Precision Promise opportunity" and continue to push the breast cancer opportunity forward, as Matt discussed."
In short, ONCY will be seeking to achieve the quick approval of pelareorep in the treatment of ER+/HER2- mBC in combination with paclitaxel, soon after the company files for an adaptive Phase 3 study that would include the 2 completed Phase 1/2 mBC studies that were statstically signficant and which achieved the FDA's asks, as earlier discussed.