FibroGen, Inc. (NASDAQ:FGEN) Q2 2023 Earnings Call Transcript

I’ll talk about essential other indications and then I think I’ll turn it over to Mark to address the multiple myeloma question. We are, in fact looking at indications to expand into. We have an ongoing translational medicine effort to identify IHC antibodies that we may use to be able to run a BASKET trial in patients from other solid tumors indications where the prevalence of CD46 expression might not be as high, but where we can select patients, who do have that high expression to enter into a trial. These are very early efforts. So, we will hope to out pay you as they progress. And now Mark, I’ll hand it over to you for any additional comments.

Mark Eisner : Well, thanks, John. I mean, I think what we’re – I’m also very excited about the molecule because or the ADC, because it has several potential ways to help patients into really add value to FibroGen. One is, as you said in metastatic castrate-resistant prostate cancer in monotherapy, the other one is an ENZO combo therapy, which is a current ongoing study at UCSF as you mentioned. The other one is either our solid tumors and/or multiple myeloma. So, multiple diseases seem to be driven by CD46. This is a very novel ADC. We have a parallel PET Imaging biomarker strategy that we’re pursuing. So I think there’s a novelty and a deep biology underlying this program that’s very exciting.

Thane Wettig: And I think maybe just to conclude related to the excitement for the Fortis asset is the favorable deal terms with no upfront cash consideration, success-based milestones and the opportunity over a four-year period of evaluation to potentially acquire the company for $80 million in addition to obviously what John and Mark just spoke about, we’re really excited about the opportunity.

Unidentified Analyst: Okay. Thank you. Can I follow up on the first one? Is there any way to extend your exclusivity for roxa when, after your CIA indication gets approved?

Chris Chung : So, how should we be thinking about it? So, there is a fourth amended intellectual property law in China. The law itself was activated to First 2021. At this point in time that regulations have not yet been implemented. So, we are looking at those opportunities with a – I think the decision would come down to what the Chinese company eventually decides to implement.

Unidentified Analyst: Okay. Thank you.

Chris Chung : Welcome

Operator: One moment for our next question. Our next question comes from the line of Yaron Werber of TD Cohen. Please proceed with your question.

Unidentified Analyst: Hi. This is Joyce [Ph] on for Yaron. Thanks so much for taking our question. Maybe just a couple from us. First on the CIA. Can you tell us about your latest thinking around whether this is ultimately going to be a China only strategy? Or if you’re thinking that this is going to come to the U.S. as well. And then, for the LAPIS study, could you just quickly remind us about the potential use of event-free survival as a surrogate for accelerated approval. Thank you.

Thane Wettig: Yeah. Thanks Joyce. Related to CIA, as of right now is a China only opportunity. And Mark, would you like to touch on the question on LAPIS?

Mark Eisner : Yeah, so the question had to do with the primary endpoint of the study, which is overall survival. As we mentioned in an earlier call, we did do an interim analysis for event-free survival as a potential surrogate marker. It was a very high bar analysis. It did not meet that analysis. So we’re continuing the trial for overall survival as the primary endpoint. And we expect that to read out in the first half of next year.

Unidentified Analyst: Okay. Thank you.