Bio-Path Holdings, Inc. (NASDAQ:BPTH) Q4 2022 Earnings Call Transcript

Jonathan Aschoff: Okay. And lastly, you said you would file that IND for 1003 this year, right?

Peter Nielsen: That’s our goal. We finally — let me just again give the background color on that. What has slowed us down? We’ve done everything for that. We just have that final second species tox study to do. And to do that, we have to have our PK study available. Again specific for that, being able to demonstrate that in fact you have drug substance in the animal. We have a successful PK study that has — method, I’m sorry, that has worked in our other two drugs, has not worked in this third drug and we’ve gone through some analysis. The molecule has a significantly lower melting point than the other two and we think that it may not be durable enough for the chemical additions and steps that go to when you get a plasma from an animal that can’t withstand it.

And so it interrupts the binding, which gives off the signal that detects it. So, we’ve had to come up with another technique for the detection and we have one now. And in fact, this past two weeks, we’ve been interviewing some large CROs that have an acceptable method and they don’t have much of a backlog, which is great on their mass spec side of the business that you need to use with this technique. And so we think we can get that round up and going on with the actual animal study only take two months to test and report. So, we think we can make that IND by the end of the year. But that’s been the trouble. We’ve been all set. It’s just we’ve had to come up with a different technology to be able to detect presence of the substance in the blood serum.

Jonathan Aschoff: Thank you very much, Peter.

Peter Nielsen: You’re welcome.

Operator: And ladies and gentlemen, with that, we’ve reached the end of today’s question-and-answer session. I’d like to turn the floor back over to Peter for any closing remarks.

Peter Nielsen: Thank you again everyone for joining us and for your continued support of Bio-Path. Have a great day. Thank you.

Operator: And ladies and gentlemen, with that we’ll conclude today’s conference call. We do thank you for joining. You may now disconnect your lines.