Disc Medicine Inc Type C Meeting for Bitopertin in EPP Conference Call Transcript

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

Question: Roger Song - Jefferies - Analyst : Thanks. Congrats for the regulatory update and thanks for taking our questions. Maybe two quick ones from us. The first one is to relate to the coprimary point given this is the news to the confirmatory study. Just curious about the statistics, how you split off to make sure both endpoint will be hit in order to have a positive confirmatory study. And then I have a follow up regarding your confirmatory study enrollment. Thank you.

Question: Roger Song - Jefferies - Analyst : Great. Thanks for the clarification. And then in terms of the confirmatory study enrollment, I think you used the word well underway. Believe that's the communication with the FDA. Just curious about the pay -- the sites in the US, any guidance around what percentage of the clinical sites will REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 21, 2025 / 1:00PM, IRON.OQ - Disc Medicine Inc Type C Meeting for Bitopertin in EPP Conference Call coming from the US or the enrollment will come from the US so we can understand a little bit better. How much the enrollment needed for the US patient in the confirmatory study? Thank you.

Question: Roger Song - Jefferies - Analyst : Excellent. Thank you. That's it from us. Congrats again.

Question: Carolina Ibanez - Stifel - Analyst : Hello, good morning. Congratulations on the update. And team this is Carolina Ibanez for Ben Burnett. Thank you for taking our questions. First, we were wondering what are your plans on commercial readiness this year?

Question: Carolina Ibanez - Stifel - Analyst : Okay, thank you. That's very helpful. And the second part of a previous question of the 150 patients, you are planning to recruit for the APOLLO, what's the proportion of adolescent patients you are targeting to enroll to support approval also for this patient population? And then do you expect the person also to have a similar profile in adolescents than in adults, both in terms of efficacy and safety?

Question: Carolina Ibanez - Stifel - Analyst : Okay. That's appreciated.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Hi, good morning. And congrats on all of these final alignments in place. I had two questions about the commercial opportunity. First, in rare diseases, we often see that the patient communities are quite close amongst each other. And I know that this is a community that is indeed that case, they have the different sauna scans and events to kind of meet as a community in a safe space. So I wanted to ask for a launch, how much do you think is going to need to be dictated by physicians calling their patients to say, hey, there's a new therapy on board versus patients just being aware of what's going on in the landscape both through their patient advocacy groups, as well as their friendships and connections that they have in the group.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Thank you for that. And then are there any rare disease comps that you can point that you're potentially framing about a similar cadence and size of the market opportunity for what you believe can be ahead as well.

Question: Kristen Kluska - Cantor Fitzgerald & Co. - Analyst : Great. Thanks very much.

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Hi guys, Malcolm Hoffman on for Evan. I wanted to start with a question with the AURORA and BEACON studies being tested in Australia and Europe and now APOLLO adding European and Canadian patients. How is this team working to ensure enrollment proceeds swiftly for these Canadian and European sites and centers of excellence that the team may not have previously worked with? Thanks.

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Appreciate it. Thanks guys.

Question: Douglas Tsao - H.C. Wainwright - Analyst : Hi, good morning. Thanks for taking the questions. Just for the first on APOLLO, I just want to confirm for the co primary end points. Will these be evaluated separately and each need to be hit or will it be a responder analysis for the two end points? PPIX reduction, sunlight exposure together and then I have a follow up?

Question: Douglas Tsao - H.C. Wainwright - Analyst : Okay.

Question: Douglas Tsao - H.C. Wainwright - Analyst : Okay, great. And then just I know you've talked about it but any updated thoughts in terms of pursuing pediatrics with Bitopertin, below adolescence. Obviously, as you noted, they represent a pretty meaningful, commercial opportunity. Has that topic come up in any of your subsequent conversations with the agency? Thank you.

Question: Douglas Tsao - H.C. Wainwright - Analyst : Okay. And John just that's helpful. So John, just to confirm, so that would likely come, well, after completion of APOLLO.

Question: Douglas Tsao - H.C. Wainwright - Analyst : Okay, great. Thank you very much.

Question: Jeffrey Hung - Morgan Stanley - Analyst : Thanks for digging my questions. In your meeting, did FDA give an indication if there are specific differences in each of the co primary endpoints that they would look for or is it just that sig and then I have a follow up?

Question: Jeffrey Hung - Morgan Stanley - Analyst : Okay. And then now you have more feedback from FDA. Can you just talk about the powering assumptions for APOLLO, what are you expecting for the treatment and placebo response rates? Thanks.

Question: Jeffrey Hung - Morgan Stanley - Analyst : Thank you.

Question: Rami Katkhuda - LifeSci Capital - Analyst : Hey guys, congrats on the update. Two quick questions for me as well. Maybe first, can you speak a bit more on how you plan to stratify patients in APOLLO to minimize potential confounding factors is the kind of the same things we've seen in BEACON and AURORA. And then secondly, can you remind us where you stand in terms of CMC, given the advanced timelines to commercialization with Bitopertin? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 21, 2025 / 1:00PM, IRON.OQ - Disc Medicine Inc Type C Meeting for Bitopertin in EPP Conference Call

Question: Rami Katkhuda - LifeSci Capital - Analyst : Got it. Thanks so much.

Question: Teraesa Vitelli - Scotiabank - Analyst : Good morning. This is Teraesa Vitelli on for Greg Harrison. Congrats on all the updates and thanks for taking our questions. Could you talk about your plans for regulatory filing outside of the US? And is that something that we should look for post read out of APOLLO or is there any potential to accelerate on that front as well? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JANUARY 21, 2025 / 1:00PM, IRON.OQ - Disc Medicine Inc Type C Meeting for Bitopertin in EPP Conference Call

Question: Teraesa Vitelli - Scotiabank - Analyst : Great. Thank you.