Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q4 2022 Earnings Call Transcript

Roger Song : Great. Thank you for taking the question. Maybe a few ones for the detail. First, for the REVEAL trial, I think you mentioned the biomarker patient seems to be lower, the number of the patients seem to be lower than expected. So just curious what is the expected percentage of the biomarker-driven population will look like in a general population and also given you now have the data set from both trials, any thoughts around how to improve upon the market strategy? I have a follow-up after that. Thank you.

Jacqueline Shea : Okay. Thanks, Roger. I’m going to hand those questions over to Mike. Mike?

Michael Sumner: Yes. So as we presented during the presentation, — when you look at the REVEAL 1 population, the biomarker from an efficacy level was at 65.9%. And in terms of frequency within the 201 patients in the trial, it actually accounted for 33% of those patients. So obviously, when you come on to the REVEAL 2 population, there was a difference that we need to investigate there. And so there was a second — so yes, so in terms of how to improve, I mean, I think that goes back to my previous answer. We need to dig into the data and see what what’s going on in the REVEAL 2 data set. But when you think about — I mean, as Jacque mentioned, it was an investigational biomarker the team only had the REVEAL 1 population to work on. They now have double the amount of data to look for the appropriate signature. So I think there’s a lot more the team can do to really delve into a biomarker signature and see where that leads us once we’ve got our hands on more data.

Roger Song : Got it. Yes, that makes sense. And then so for RRP, can you just remind us what is the criteria for the patient to do surgery given that one of the key endpoints and how consistent the criteria across size and investigation as you want to do a global trial for the later stage development? Thank you.

Jacqueline Shea : Yes. That’s a really good question, Roger. And if you recollect for our Phase 1/2 study, we were actually using multiple sites across the U.S. and we’ve been working and talking closely with KOLs and other investigators as to how we might expand the study to Europe. But I’m going to ask Mike to comment on the criteria for surgery and how variable the disease can be.

Michael Sumner: Yes. So when you look at the sort of surgical intervention in the current trial, we didn’t really specify when and how the patients could receive surgery. It was ultimately a decision between the patient and the treating clinician. As you can imagine, one of the things because surgery is a key indicator of efficacy. We will need to try and standardize that as we move toward a registration trial. And that is going to be one of the discussions that we have with the regulatory bodies. But at present, we’re not in a position that we can disclose what criteria we’re thinking about. But it is an important aspect of how we design the next trial.

Jacqueline Shea : And if I can just add in here. What we’re hearing from patients, what we’re hearing from investigators is — they really are looking for an improvement and a reduction in number of surgeries. That’s the major impact on patients’ lives, and that’s really the thing that will move the needle for patients. So more work to do, more discussions to be had, but we really are focused on surgery.

Operator: Next question is from Yi Chen with H.C. Wainwright. Please go ahead.

Yi Chen : Thank you for taking my questions. First question is the biomarker you’re utilizing in REVEAL 2 and REVEAL 1, is that the only biomarker available? Or there are some other candidate biomarkers?

Jacqueline Shea : Yes, Yi. That’s a really important question. So I’m going to hand over to Mike to talk a bit about our biomarker strategy.