PolyPid Ltd. (NASDAQ:PYPD) Q3 2023 Earnings Call Transcript

Roy Buchanan : Okay. That’s actually my next question, the blinded infection rate. Just wondering if you had a sense of it. Is it in line with your expectations going into the trial?

Dikla Czaczkes Akselbrad : So it is in line, but I think that, saying that from our experience, we need to have the first 100 patients to see a trend. Because as you can imagine, as we start recruiting, patients are coming from a handful of centers. And as we start opening the centers, we now have 20. By the end of the year, we will have 40, and beginning of 2024, we expect to have another 10. And with an average recruitment rate of 1.5 patients per center, we will start seeing recruitment rate ramping up pretty quickly. And at that point, where patients are more spread geographically and center-wise, we believe the trend will be much more visible and much more indicative. But for now, we definitely see the infection rate in line with our expectations.

Roy Buchanan : All right, great. Thanks. And maybe could you just elaborate a little bit on the, I guess, cadence of the potential partnering discussions? You mentioned OncoPLEX. Are you actively out there looking to partner OncoPLEX or doing internal work with it to be able to present potential partners? That’s a bit unclear on that. And then just more broadly, just how are you thinking about your capital runway and addressing the need to get to the data? Thanks.

Dikla Czaczkes Akselbrad : So obviously, I can’t say much on the partnering, but maybe to give a bit of coloring on that. So we are, and we said before, we are in discussions on both fronts, the D-PLEX front as well as the platform-related slash oncology program. And we are also doing internal work that is not at this stage requiring heavy investment because obviously our cash is all focused on SHIELD II and getting the program to top line. But we do have an internal program that is more targeting, supporting potential collaboration, what we believe will be needed or what we are hearing from those discussions that is needed in order to promote a potential partnership. And you were also asking about our financial runway. So as we’ve indicated, our cash, you’ve seen that we’ve ended the quarter with over $10 million.

And we’ve indicated that this is sufficient to take us all the way through the end of the first quarter. Obviously, with running the trial full speed ahead, full recruitment rate, so it takes all of that into consideration. I should remind everyone that once we have the top line results from our Phase 3 trial, we have a potential milestone from Advanced Pharma. So this is an immediate milestone that is expected once we have Phase 3 data. And obviously, we are looking at different alternatives on financing the trial. And I must say that what makes us very encouraged is the level of support that our largest shareholder have shown in the past and are showing now.

Roy Buchanan : Great. Thank you.

Operator: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from the line of Raghuram Selvaraju from H.C. Wainwright. Please go ahead. Your line is open.

Raghuram Selvaraju: Thanks very much for taking my questions. Firstly, I was just wondering if it would be possible at all for you to give us an update on the number of patients in SHIELD II who have completed their 30-day follow-up at this time.

Dikla Czaczkes Akselbrad : Right. So, yes, sure, we could do that. As I said in the prepared remark, we have about 50 patients already enrolled, and I would say that around 40 have finished their 30 days.

Raghuram Selvaraju: Also, in the context of partnering discussions, maybe you can just comment a little bit on the extent to which the fact that you have commercial scale-up work already significantly accomplished plays a role in increasing the attractiveness of this asset for potential partners. And if you could give us a sense of what your preferred working arrangement might be in the future with a potential licensee, partner or distributor with respect to the manufacturing. If this is something that you would like to continue to maintain in-house or if it’s something that you anticipate potentially doing tech transfer on in the future.