FibroGen, Inc. (NASDAQ:FGEN) Q3 2023 Earnings Call Transcript

John Hunter: Yeah, thanks for the question. Just with regards to going into earlier lines, there, the endelutamide combo study that’s being run as an investigator sponsored trial at UCSF does open the possibility of going into a first line setting if that is positive. So, we are following that carefully to see what those results look like and then we would make a decision, I think, based on those results. Just with regards to the percentage of patients who we expect to be positive, we have a pretty limited data set at this point regarding, expression by IHC for patients that either do or do not express CD46. We do think that the PET biomarker will give us much better data on that and really kind of guide our thinking, but based on the data that we have in hand right now, we’ve been estimating between 50% and 70% of the patients with metastatic castration resistant prostate cancer will be CD46 positive, but I do want to stress that we are looking to acquire more data points to sort of firm that number up.

And we won’t be enriching in the Phase 2 trial. We’re going to be assessing the patients ahead of treatment with our CD3246 or our CD46 and then once the efficacy results are in, then we’ll do a correlation with the PET positivity and in the efficacy results.

UnidentifiedAnalyst: Got it. Thank you. And just a quick follow up. Just thinking more broadly, kind of your strategy for this, for this potential acquisition during these next four year period, you have obviously success in this MCRPC trial will be important, but, do you have any plans to assess this indication or this, sorry, asset and other indications in the next four years?

Thane Wettig: Yeah, we do. We’ve got — we’ve got the plans to do a tumor expansion trial as well and it’s just a matter of determining exactly when the right time is to do that tumor expansion trial, whether we go ahead and pull the trigger on it earlier or wait until we see some sort of an efficacy signal in the Phase two trial. We’ll just — we’ll make that call at some point in the future. But yeah, there’s there are definitely plans and you heard John speak about multiple myeloma in his remarks as well.

Operator: Thank you. I’ll now hand the call back over to CEO, Thane Wettig for any closing remarks.

Thane Wettig: Well, thanks, everybody. We appreciate your participation in today’s investor call and your interest in FibroGen. Enjoy the rest of your day. Thank you.

Operator: Ladies and gentlemen, thank you for participating. This concludes today’s program and you may now disconnect.