Humacyte, Inc. (NASDAQ:HUMA) Q4 2022 Earnings Call Transcript

Suraj Kalia: Fair enough. And Laura, finally from my side, I’ll hop back in queue, with JDRF, congratulations on that partnership. The BVP, is that going to involve, I shouldn’t say plain vanilla iPSCs, but are you all going to edit in any genes, knock out any genes, any time lines? Any additional color would be greatly appreciated. Thank you for taking my questions.

Laura Niklason: Yes. So we are focusing on stem cell-derived islets. I mean we’re taking a sort of a multiplexed approach. We’re looking at the potential of using cadaveric native islets as part of the BVP program, but we’re also looking very closely at stem cell-derived islets because, obviously, these — that brings in manufacturability and control of islet supply, which is going to be very important in any commercial setting. We are certainly looking at immune privileged iPS cells. I do not believe we’ve yet shared with the broader investment community what exact types of immune privilege we’re looking at. But I will generally say that as a general rule, overexpressing genes and adding in new stuff into a cell line that’s then going to be therapeutic for a patient is generally a little harder from a regulatory standpoint than taking stuff out.

So in other words, removing genes that might be immunogenic, we anticipate will be an easier path forward rather than overexpressing or adding in new proteins, which might add more regulatory hurdles.

Suraj Kalia: Got it. Thank you.

Operator: Thank you. Our next question comes from the line of Bruce Jackson with The Benchmark Company. Please proceed with your question.

Bruce Jackson: Hi, good morning, and thank you for taking my questions. Quick follow-up on the pre-approval net inspection for manufacturing, is that scheduled yet?

Laura Niklason: Heather, do you want to take that?