Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) Q4 2022 Earnings Call Transcript

Thomas Smith: Understood. Super helpful. Thanks DA. I appreciate the color and looking forward to the data presentations tomorrow.

David-Alexandre Gros: Thanks, Tom.

Operator: The next question comes from Matt Kaplan with Ladenburg Thalmann. Please proceed.

Matt Kaplan: Hey guys. Thanks for taking the questions. Just a quick follow-up on Phase Ib. Now with your first three data points coming out tomorrow, should we expect additional data as this is an open-label study during the course of the remainder of the year? Or will you just report data after you finish enrollment after the end of the study?

David-Alexandre Gros: Thanks, Matt. Appreciate the question. We plan on continuing to share data from the study over time. As we continue to get more patients and as we continue to get longer term data, we will share them with both you and investors more broadly. We will aim to do so at some of the larger conferences during the year.

Matt Kaplan: Okay. Great. Thanks.

David-Alexandre Gros: So that’s €“ that will be true probably later on this year as well as in future years. What’s exciting is it’s over time, this population of up to 12 participants will allow us to generate significant data.

Matt Kaplan: And then in terms of the expected timeline, you’re alluding to this a little bit for the BESTOW Phase II study that you’re going to start, I guess, middle of this year. Can you give us a sense in terms of how that enrollment should track?

David-Alexandre Gros: So we expect that enrollment to take about a year and a half from the enrollment of the first patient. And then there would be a year to data since we’re following the patients out a year, that’s the last patient out, it would be a year later.

Matt Kaplan: Thank you. And I guess maybe a question for Steve. I guess given the recent ALS AdComs for a different product and the AdComs, the committee there, really looking like they would accept the light chain as a biomarker for efficacy. What are your thoughts on that for tegoprubart in ALS and kind of next studies there?

Steven Perrin: Yes. They seem to reopen in receptive to NFL changes, but albeit not required. We didn’t see it in the MLX study as an example. And yet they went ahead and approved it based on more traditional endpoints of ALSFRS. I think all studies are now incorporating it into their study designs. It’s unclear at this point how long you have to go to really be confident that you’ll see changes. It certainly appears you have to go at least six months. But most people are now incorporating that into their studies and we would certainly incorporate NFL into our future studies as well.

Matt Kaplan: All right. Well, thanks for taking the questions and look forward to tomorrow’s data presentation.

Steven Perrin: Thanks, Matt.

David-Alexandre Gros: Thanks, Matt.

Operator: The next question comes from Rami Katkhuda with LifeSci Capital. Please proceed.

Rami Katkhuda: Hey guys. Congrats on the update and thanks for taking my questions as well. Can you touch upon how quickly eGFR typically stabilizes post kidney transplantation? Is it €“ is eGFR, I guess at earlier time points like month one or three consistent with values at 12 months and beyond?

David-Alexandre Gros: Rami, thanks for the question. Steve?

Steven Perrin: Yes. Hi, Rami. Great question. Yes. It does appear as if €“ once the organ stabilizes that eGFR levels out around 90 days and beyond are very predictive and similar to what one would see at six months or 12 months. They tend to get fairly stable by that period of time. After transplant, like immediately after transplant in the first 30 to 60 days, they are shifting and they bounce around a little bit as the organ settles in, but certainly by three months it does appear they’re fairly stable at that point.

David-Alexandre Gros: And it takes at least four weeks for the organs to really in grafts.