Oncolytics Biotech Inc. (NASDAQ:ONCY) Q1 2023 Earnings Call Transcript

I’m not saying we aren’t, but one thing that could be done is look at that in the lifecycle management to try and find maybe the patients who would have that kind of a response and therefore be able to tell, say, look, for these patients with this profile we think they’ll respond and talk to the payers that way. Matt, anything else from your perspective there?

Matt Coffey: No. I think that’s fantastic. I really think it becomes a very important figure in lifecycle management. I’m not sure it’s as important for what the Phase 3 looks like because we really do want to capitalize on the 213 results and then expand those hopefully with BRACELET into a Phase 3 opportunity. Tom, did you want to talk a little bit about what a study would likely look like?

Thomas Heineman: Yes. Sure, Matt. So with the comments of Matt and Andrew in mind, I think the study design will be – will be comparatively straightforward. We would envision a two-arm study with a Paclitaxel control arm and then a Paclitaxel plus pelareorep with or without avelumab investigational arm. And we would then obviously power it appropriately for an overall survival endpoint and perhaps a PFS endpoint depending on how things play out. But we – but I think the overall design would be pretty straightforward two-arm study.

Matt Coffey: Thank you, John.

John Newman: Okay, great. Thank you.

Operator: Thank you. Next question will be from Louise Chen at Cantor Fitzgerald. Please go ahead.

Louise Chen: Hi. Congratulations on all the progress this quarter, and thanks for taking my question. So I wanted to make sure I heard you right when you said that BRACELET-1 was not powered for stat sig and if not, what do you want to see to consider this a successful trial or what do you expect to see? And then secondly, can you elaborate more on the CAR T opportunity and what that means for you? And last question I had for you is on your cash runway, what positive inflection points does that bring you through? Thank you.

Matt Coffey: Thanks Louise. Tom, do you want to take the first question, Andrew the second, and Kirk the third?

Thomas Heineman: Sure. Well, the first question was, I’m sorry, say that again please.

Louise Chen: Yes. So did I hear you right in that, you did not power BRACELET…

Thomas Heineman: For the powering, yes. Yes. So the BRACELET study is a randomized study. So the patients are randomized between the arms. However, it was not powered to allow a formal statistical comparison. So what we – what we will look for in that study as a – as criteria for success are numerical differences between the groups in the key – in the primary endpoint, which is objective response rate as well as any other efficacy endpoints. As we mentioned, we will be reporting the progression-free survival results, but the overall survival results are not mature enough to report at this time. So we will be looking for numerical differences and then obviously we can one can conclude based on the magnitude of those differences.

But keep in mind also that this study is not a standalone study in that it is the first two arms of this study, which are the Paclitaxel versus Paclitaxel plus pelareorep are basically recapitulating the former IND study in which we saw the strong survival benefit. So this is from an efficacy perspective will largely be a confirmatory study to provide additional confidence and to de-risk the program further.

Matt Coffey: Opportunity in CAR T, Andrew, do you want to talk a little bit about how we would look at sales and royalty in that particular environment and how across, this could potentially work across platforms?