4D Molecular Therapeutics Inc To Discuss Topline Interim Data Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Tommy Rearing - Goldman Sachs - Analyst : Thanks for taking our question. This is Tommy on for Salveen. And congratulations on this data. So, for the 2 Phase 3 wet AMD trials, beyond meeting the primary endpoint, what can you lay out, what gives you confidence that it will be compelling for payers and physicians? Could you see any need to see multi-year Phase 3 data for durability to get stakeholders to be comfortable here?

Question: Daniel Giraldo - BofA Global Research - Analyst : Hey, guys, can you hear me now?

Question: Daniel Giraldo - BofA Global Research - Analyst : Okay. Hey, guys, good morning. Thanks for taking my question and thanks for the updates. I was just wondering if you could maybe elaborate a little more on the recently diagnosed patients you had in the trial and maybe if the baseline characteristics kind of compare to what you would expect to see in a larger Phase 3 trial where you would have maybe more variability for treatment-naive patients? And maybe just one clarification for the anti-VEGF response you're looking at. Is that going to be after a single injection of aflibercept? And then, if so, what percent of patients do you expect to get a response after just 1 injection?

Question: Daniel Giraldo - BofA Global Research - Analyst : Yes. I'm just wondering, just based on the baseline characteristics for those patients, how do you think that could extrapolate to a larger trial? Do you think you would expect to see sort of similar baseline characteristics once you start enrolling the Phase 3 where you would -- since you're enrolling treatment-naive patients, you would have more variability in terms of response or anti-VEGF needs for those patients?

Question: Daniel Giraldo - BofA Global Research - Analyst : Great, thanks.

Question: Gina Wang - Barclays - Analyst : Thank you. I have one question regarding the safety and one question regarding the protein biomarker. So, regarding the safety, it looks very clean. And you do have a 2 out of the 71 treatment treated in grade 1 inflammation. So maybe can you give a little bit more color at what time point you did see it's a 1 single timepoint? And what was that single time point when it happened? And any color on the 1 patient that still requires steroid? My second question is regarding the protein biomarker data. I know you only select the patient with less than 20 weeks -- sorry, more than 20 weeks without any rescue injection. What percentage of these patients were injection-free patient -- and also, do you see any correlation regarding the protein expression and the BCVA and CST? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 10, 2025 / 1:00PM, FDMT.OQ - 4D Molecular Therapeutics Inc To Discuss Topline Interim Data Call

Question: Gina Wang - Barclays - Analyst : Thank you.

Question: Mani Foroohar - Leerink Partners - Analyst : Hey, thanks for the question. I guess I have a broader one. Obviously, this is a market with a number of approved products, biosimilars, et cetera. Some attempts to add longer duration/less frequently dosed products, although certainly not in the same duration as a gene therapy approach. For the KOLs more broadly, where do they see 4D-150 fitting into the treatment paradigm initially upon approval and longer term? Is this a place we're primarily going to be looking for new patients that are diagnosed, patients that have a high injection burden, those who are most responsive to anti-VEGF least responsive. Like where and amongst which patients would you initially adopt, and where and amongst which patients would you use long term?

Question: Jonathan Miller - Evercore ISI - Analyst : Hi, guys. Congrats on the data and thanks for taking my question. I'd love to ask more color on the new inclusion criteria details you've given for Phase 3. In particular, I know you flagged that 1 patient in the broader Phase 2 that would have been screened out. But are any of the patients that required injection in the newly diagnosed subset of the Phase 2, would those patients have been screened out by these new inclusion criteria? And then -- yes, and then I have a follow-up.

Question: Jonathan Miller - Evercore ISI - Analyst : And then I'd also like to ask on the supplemental injection criteria. You've added this vision plus anatomy criterion. You've loosened the anatomy-only criterion, I guess. Would you characterize these criteria as tighter or looser versus the Phase 2, first of all? And second of all, are there any patients in the Phase 2 with the old rescue criteria that got a supplemental injection that would not have gotten that injection on the new criteria?

Question: Jonathan Miller - Evercore ISI - Analyst : Excellent, thank you.

Question: Clara Dong - Jefferies - Analyst : Hi, team. Thanks for the presentation and congrats on the update. For the doctors on the call here, when you look at the numbers of injection-free rate and treatment burden reduction from the different patient subgroups, if you have to pick which number is more important for you for making treatment decisions? And also in a broad population here, there were 2 patients had supplemental injections based on investigator discretion. So, wondering whether you could provide some details on whether the decision was based on their vision or atomical change?

Question: Lisa Walter - RBC Capital Markets - Analyst : Great. Thanks for taking our question and congratulations on the data. I'm just curious if you have had an opportunity to share the wet AMD results with any strategics? And if so, what has the feedback been like?