Disc Medicine Inc EOP2 Meeting for Bitopertin in EPP Transcript

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

Question: Thomas Smith - Leerink Partners LLC - Analyst : Hey guys. Good morning. Thanks for taking our questions and congrats on the great regulatory updates here. We had a couple questions if first can you provide a little more color on how the FDA is getting comfortable with the use of PPIX reductions as a surrogate endpoint to support accelerated approval. Is this more on the basis of the literature or the data you presented publicly from Aurora, Beacon or maybe data from those studies that we haven't seen yet? And then secondly, can you elaborate on what remains to be hashed out with FDA during the Q1 meeting? And can you comment on your level of confidence that you'll be able to move forward with the accelerated approval pathway versus the traditional pathway that you've been guiding to historically?

Question: Thomas Smith - Leerink Partners LLC - Analyst : Great. That's super helpful. Yeah, I appreciate the color there. And then just one other question on the Apollo trial, you mentioned you're more than 80% powered with the plans. 150 patients can you just elaborate on what you're assuming for treatment effect and, and placebo response in these patients? Thanks.

Question: Thomas Smith - Leerink Partners LLC - Analyst : Got it. That makes sense. Okay. Thanks for taking the questions. Congrats. Again, on the update. Thanks. So.

Question: Roger Song - Jefferies Group LLC - Analyst : Thanks, Big congrats for the regulatory update and then thank you for taking your question. So maybe the first one, I do want to just confirm and clarify in terms of the accelerated approval path. Just get, can you confirm you don't need any additional clinical data from additional clinical trial including safety exposure and then the efficacy. So you for the one Q this update is really, really hashing out some of the detail for the confirmatory study not related to the the package you need for the accelerator approval. Thank you first.

Question: Roger Song - Jefferies Group LLC - Analyst : Great super clear. And then so given you're about to get to the approval soon, much sooner than initially expected. So, can you just give us some of the comments around the market opportunity, particularly around this clinically meaningful sunlight exposure improvement compared to placebo? How you compare to other Epp either approved or pipeline development, how you think Bitopertin can be can become the future standard of care for this population? Thank you.

Question: Roger Song - Jefferies Group LLC - Analyst : Got it. Thank you.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Hi, good morning, everybody. Congrats on these updates. Great to hear that this drug could potentially be on the market a lot quicker than a lot of us anticipated. So, wanted to ask you some questions specific to the Apollo trial. You did a great job for us at [EHA] this year, essentially demonstrating why the placebo responded the way it did and clearly showing the effects of the drug are quite clear once you hit that PPIX reduction of 20% to 30%. So based on the trends that we saw at four months. I was hoping you can comment on what your expectation would be up to six months here. Would you expect that delta to continue separating between the two groups? Even if the data looks pretty stable from drug arm again? Just what are your expectations with a little bit longer data set here?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay. Thank you so much. And my last question is I know when you have these discussions around confirmatory trials, the FDA of course, wants to see evidence or a clear path to show that you're very serious about conducting the trial in a good amount of timing. So regardless whether this ends up being a confirmatory study or if you run as a regular phase 3 study, can you give us some expectations for enrollment of this study? And you know, your confidence in telling the FDA, why you'll be able to successfully complete such a trial if you go under accelerated approval. Thanks again, everyone.

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay, great. Thanks so much. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, IRON.OQ - Disc Medicine Inc EOP2 Meeting for Bitopertin in EPP

Question: David Nierengarten - Wedbush Securities - Analyst : Hey, thanks for taking the question. Maybe this is a minor detail, but the average monthly total time between 10 and 18:00 hours after six months, obviously, we have a change of seasons, it's getting darker right now in the northern hemisphere. Are you, you know, correcting for that and, and it kind of rolling starts and in different geographies' or, or how are you making sure that there's actually sunlight until 6 p.m. Thanks.

Question: David Nierengarten - Wedbush Securities - Analyst : Okay. And then maybe if I could squeeze one more in, maybe getting ahead of ourselves here. But would we get any updates on commercial preps? Assuming you have a, an agreement with the FDA? This is a accelerated approval pathway. Would we get that in Q1 or you? How are you thinking about that scenario? Thanks.

Question: Danielle Brill - Raymond James Financial, Inc. - Analyst : Hi there. Good morning. And let me add, I'm able to develop, I guess first, just to be clear, is there anything left to align with the agency regarding the accelerated approval path? Or are you just need to iron out details around Apollo and then I have a couple of Follow ups.

Question: Danielle Brill - Raymond James Financial, Inc. - Analyst : Okay, great. That's helpful. And then I guess what's the rate limiting step then to filing. Is this getting Apollo up and running [CMC] or is it something else? And then just curious during your, your discussions with the agency, there were any aspects of your proposed trial design that they were not supportive of? Thank you.

Question: Danielle Brill - Raymond James Financial, Inc. - Analyst : Okay. Thank you so much.

Question: Jeffrey Hung - Morgan Stanley - Analyst : Congratulations on the progress and thanks for taking my questions for, Accelerator Accelerated Approval. Has the FDA given any indication if there's a specific percent reduction in PPIX that they would look for and then I have a follow up.

Question: Jeffrey Hung - Morgan Stanley - Analyst : Great. Thanks. And then what is your current thinking on the bar for success on the primary end point for Apollo? Are you just looking for statistically significant difference or is there a specific amount of time that would be considered clinically meaningful for that month?

Question: Jeffrey Hung - Morgan Stanley - Analyst : All right, great. Thank you so much.

Question: Evan Seigerman - BMO Capital Markets - Analyst : Hi, guys. Thanks so much for taking my question on the, you know, on your interactions with the FDA. Can you characterize what they want to see in terms of enrollment for the Apollo trial? I know a lot of a lot of debated around what you know, underway means when it comes to enroll, but any color there would be great. And then secondarily, you know, it's really great to see that alignment on approvability, but maybe talk about the feedback you've gotten from payers in terms of driving access. You know, and how that has helped align and inform the design of the Apollo trial. Basically, what do payers want to see from this trial? So that they can be comfortable providing access to this drug? Thank you, guys.

Question: Evan Seigerman - BMO Capital Markets - Analyst : And yeah, kind of.Like the commercial side of things now that you have a trial underway or, you know, Apollo design essentially kind of underway. What do they want to see?

Question: Evan Seigerman - BMO Capital Markets - Analyst : Great. Thank you.

Question: Greg Harrison - Scotiabank - Analyst : Hey, good morning, congrats on the update and thanks for taking our question. Just thinking about in, in the case of an accelerated approval. And, and depending on priority review, it looks like you could be on the market maybe near the end of next year, early 26. First is, is that possible? And then in that case, you know, how would you ramp up your commercial capabilities to prepare for launch much sooner than previously anticipated? And, and where are you at so far with, with patient identification and other aspects of, of launch prep?

Question: Greg Harrison - Scotiabank - Analyst : Great. Thanks so much. And congrats again, .

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Hi, good morning and, and congrats on the Harves and thanks for taking the questions. I think. Will you noted that in Apollo there is going to be some mechanism I think to, I don't, I don't think you said stratify but to adjust or account for patients' baseline, sunlight tolerance, which, which makes sense. I'm just curious if you could discuss that in a little bit more detail to just provide some color for, for how that mechanism will work.

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : So, will this be done on an individual patient basis or sort of, will it be sort of done on a, on a population basis? And I guess it's because the endpoint itself is not the change right relative to baseline still. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. NOVEMBER 04, 2024 / 1:00PM, IRON.OQ - Disc Medicine Inc EOP2 Meeting for Bitopertin in EPP

Question: Douglas Tsao - H.C. Wainwright & Co - Analyst : Okay, great. Thank you very much. And congrats on the progress.