Geron Corporation (NASDAQ:GERN) Q4 2022 Earnings Call Transcript

Joel Beatty: Thank you for taking the questions. First one is, are you able to share any feedback from FDA on their openness to filing with the priority review?

John Scarlett: Sure, I will take that really quickly, and then Faye can add if she has anything. Joel, it’s Chip. FDA generally does not give any insights. And generally, we should rarely ask regarding insights into priority versus standard review. The answer would almost always be that’s a review issue. As you know, they first have to look at the NDA submission and accept it for filing, and that generally takes 60 days. And then at the time that they accept it for filing if they do, then that’s when they tell us whether we will have a priority or a standard review. All we said about it, that I recall is, that we expect to request a priority review, which is based on our current regulatory designations with Fast Track and so forth. So, that’s pretty much all I know that we can say. Faye, did I leave out anything from your perspective?

Faye Feller: Thanks Chip. That was pretty comprehensive. I don’t have anything to add.

Joel Beatty: Okay. Great. That’s helpful. And then my other question, when you discuss the IMerge Phase 3 data with payers, are there any drugs that come up with comps with regards to the value that’s provided to patients?

John Scarlett: Anil, do you want to address that?

Anil Kapur: Sure. So, the question around the payer feedback is extremely positive. I think the drugs start continue to come up are obviously Reblozyl, Inqovi, but then the lower-risk MDS landscape. But our entire discussions are focused on our value proposition of both the efficacy profile, the totality of benefit and what it would mean for the payers within their value proposition. So, as of right now, these discussions are extremely favorable, and this data is being received well.

Joel Beatty: Great. Thank you.

Operator: Your next question comes from the line of Gil Blum with Needham. Your line is now open.

Gil Blum: Hi everyone. Good afternoon. So, maybe one for Anil. How important do you think long transfusion independence data will be for effective payer coverage? And do you expect longer TIs to matter more to payers, i.e., waiting on additional IMerge data to really have a broader picture? Thank you.

Anil Kapur: Thanks for the question. I think the durability of the TI data is extremely important, both in the U.S. as well as in Europe. This point has repeatedly come up from payers as well as clinicians to showcase the durability of TI. And the most important metric being measured from their perspective is the 24-week TI data. The fact that we have 1 year TI data on top of that, which is pretty unprecedented in this landscape, is extremely favorable to us. And in addition, the totality of benefit in terms of both reductions in transfusion burdens as well as the fact that we go across both subgroups, all of these points are being extremely well received, and we expect it to be in a very favorable position as we move forward towards the launch.

Gil Blum: Thank you. Very helpful. And a quick one for Olivia, it seems like you are going to have quite significant cash burn this year. I mean in my own calculations, I have some of your clinical study costs going away. So, how do you think that this is going to be? Is this mostly OpEx going to SG&A and sales force ramp up? Thank you.