Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2023 Earnings Call Transcript

So I think, we’ll continue to look not only at the more traditional U.S. governmental grants, but also look at CPRIT as well and in development. That non-dilutive funding allows us to really, to manage our balance sheet in a materially different way than we would otherwise have to. And so it really makes a lot of sense leveraging very experienced team in terms of getting grants, to continue to seek those for the foreseeable couple of years, or so as we hopefully bridge to improved product and revenue.

Edward Woo: Great. Well, congratulations again, and I wish you guys good luck. Thank you.

Marc Hedrick: Thank you.

Operator: Thank you. And now I’ll turn it over to Andrew for any questions.

Andrew Sims: Thanks, Victor. So we have one question, and it’s for Dr. LaFrance. What is the status of the pediatric trial? And when do you expect to start treating patients?

Norman LaFrance: Thanks, Andrew. Great question. As everyone heard, Marc touched on that briefly at the end of his remarks that we had been to FDA, and we’ll be following up with them for submitting the final IND for approval. I would add that FDA has embraced and are very pleased that with Plus and are pursuing the pediatric indications for high-grade glioma and ependymoma. So we have – we already have basically an agreement with FDA for the pediatric protocol. They had some final minor questions, not so much on the pediatric protocol conduct, which like I said, we have their preliminary agreement, but some additional – some GBM data that we’ve generated in adults around asymmetry, all of which is very straightforward. We committed to get that information back to them as we’ve enrolled more Phase 2 adult patients.

We will be getting that data to FDA in the first half of this year, which we hope means, we will beginning and be able to enroll by second half of 2024, our first patients. Importantly, we have our pediatric site – first pediatric site identified, and preparation at that site is well underway and the principal investigators that, that site are already well engaged and partnering with us for that. So peds is on track, and it’s been very well embraced by the agency.

Marc Hedrick: All right. Andrew, any other e-mail questions?

Andrew Sims: That is it tonight, Marc.

Marc Hedrick: Okay. Thank you. All right. I want to thank everybody for joining us. Again, thank you to the investigators and patients and their employees who work so hard, and we’re obviously very excited about where the company is right now. And this is a great road ahead of us in 2024. So, we appreciate your time and your interest, and we’ll look forward to talking to you next time. Thank you, Victor.

Operator: Thank you. Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone, have a great day.