Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2023 Earnings Call Transcript

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I will say that as it relates to the Phase II, if I can just editorialize a minute that I think we’re on track to complete the single administration Phase II by the end of 2024. If that data continues to look positive, we’ll present that data in the first pass of that at SNO. We may actually seek a pre-end of Phase II meeting with the FDA to discuss options for.

Sean Lee: Great. That’s all I have and thanks again for taking my questions.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Edward Woo with Ascendiant Capital. Your line is open.

Edward Woo: Yeah, congratulations on the progress. To clarify you said that Cohort 4 the LM trial was the fastest that you were able to get it filled. Is that something that you should expect going forward and does that speed up your time line at all with LM trial?

Norman LaFrance: Hi, Ed. This is Norman. Great question. And the — as I think we’ve discussed previously, there are protocol defined up [Technical Difficulty] that we agreed to with FDA because this is first-in-man intrathecal administration of, obviously, the radio activity. Given the interest that Marc alluded to earlier and a question on an earlier Q&A question, we’re getting a lot of interest on folks for the exact reason Marc mentioned that, first of all, there are really no treatments for this devastating complication. And there really are no significant active investigative trials other than ours. And we’ve gotten a very promising provocative efficacy signal in addition to being a very well-tolerated outpatient treatment.

So the short of it for the Cohorts now five through seven to be continued. We’d expect to enroll at the same rate. With that, we’d expect if there are no DLTs or other safety observations that may call the decision to end in an earlier Cohort, say, Cohort 6 will complete the full dose escalation probably by June of next year. With that, we’ll go to FDA and have an end of Phase I dose escalation and Pre-Phase II meeting and I don’t want to get too forward-looking. But given the current trend of both the safety, tolerability and preliminary efficacy will be in a position to talk to FDA about a Phase II trial that will include it being [Technical Difficulty] leading to an accelerated approval all because LM has no treatment options, is a devastating complication and not a lot of investigative.

At this point, I’ll stop there, and see if you have any other questions.

Edward Woo: Thank you very much. That was very helpful. I wish you guys good luck. Thank you.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jason McCarthy with Maxim Group. Your line is open.

Unidentified Analyst: Hi, guys. It’s Chad on for Jason. Sorry if it was already covered, but I was just wondering what the plans are for implementing CNSide in the LM study given that Biocept has declared bankruptcy, will you still be able to use the platform?

Marc Hedrick: Hi, Chad. Yes. So you’re right. They declared bankruptcy. We’ve been using the test for over a year and I did mention a bit in my prepared remarks, but I’ll expand on those. We didn’t really know what to expect. We started using the trial, the test, but over a year or so of experienced both with our technology and our trial and talking to the investigators, we think there’s a real opportunity with this test. We were concerned about them their solvency over the past year. And that’s why we, frankly, licensed and transferred the technology to ourselves in the weeks before they declared insolvency. So we essentially have a nonexclusive right to use the test for — in our trials with our technology and then we have an option that’s exercisable through the end of next year to gain exclusivity in the area of radiotherapeutics for this test.

So now that they’re gone, and they are gone, they’re no longer operating. We’ll be taking the protocols, the information and the testing kits that we have already acquired and are now in Texas and we’ll begin using the test, not in a CLIA fashion, but just as a research tool, so we can use in the context of our trial. Now with our option based on kind of our ongoing experience, we will actually consider whether we want to exercise that and maybe expand that. But right now, I think, the plan is just to implement it and use it in our trial and frankly CPRIT ought to pay for that as well.

Unidentified Analyst: Okay. Great. Thanks for taking the question and congrats on the progress.

Marc Hedrick: Okay. Thank you.

Operator: Thank you. I’m showing no further questions in the queue. I would now like to turn the call back over to Marc for closing remarks.

Marc Hedrick: Thank you, Tawanda. Thanks, everyone for joining us. Thanks for the good questions. Thanks for your interest in the company and we will be talking to you soon. Have a nice evening. Goodbye.

Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect.

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