Fulcrum Therapeutics Inc Q2 2024 Earnings Call Transcript

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

Question: Corinne Johnson - Goldman Sachs - Analyst : Maybe first for the work that you're doing to validate reachable workspace for the agency, has the agency specified like specific metrics that are most important or the magnitude of changes like the change or the benefit they'd like to see? Or are they just asking for like general proof that the reachable workspace is beneficial? And then are there multiple analyses that they requested them? Do they all sort of have to go in the same direction? And then my other question in terms of the cash runway guidance you just provided into '27, what specific like clinical milestones and then commercial activity?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Good morning everybody. Thanks for all the transparency and extra guidance today. So, on reachable workspace, we've been getting a lot of questions just because another company also had data on this. And to your point, given it really is a new endpoint hasn't been previously used for approval. Wondering now that we have two data sets supporting the endpoint if this helps, in your opinion, derisk this endpoint for this disease?

Question: Kristen Kluska - Cantor Fitzgerald - Analyst : Okay. Appreciate that. And then assuming that the trial is successful, when you plan to meet with the FDA, can you just remind us, first, what the safety data set is including from the previous company that had studies in other indications. And then second, how much open-label extension data you're going to have from Phase 2 at that point to add on to the pool of evidence? Thanks so much, again.

Question: Joseph Schwartz - Leerink Partners - Analyst : Thanks for the update sorry. So, I was wondering a couple of things on pociredir first and then losmapimod. Can you talk a little bit more about why it's taking longer to proceed with the Cohort 3 group of patients for pociredir, is it the IRB level? Is it enrollment? Can you give us any clear progress update? And maybe talk about what initiatives you have to accelerate things? And then I have a question on losmapimod? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JULY 31, 2024 / 12:00PM, FULC.OQ - Q2 2024 Fulcrum Therapeutics Inc Earnings Call

Question: Joseph Schwartz - Leerink Partners - Analyst : Yes. That was helpful color on pociredir. So as far as losmapimod goes, I was wondering if you could talk about the output that will emerge from the work define the minimally clinically relevant difference on the RWS. Is this just one single number? Is it a range which might provide more context? And how do you feel about the ability of losmapimod to provide a benefit, which exceeds whatever you define as the MCD?

Question: Dae Gon Ha - Stifel - Analyst : Good morning. Thanks for taking my question. I'll stick my two questions with the losmapimod side of things. Specifically, on powering, so maybe a question for Iain. So, the first question is, you previously talked about powering for REACH as having benefited from the over enrollment. I think it was 96% to show 10% placebo-adjusted RSA. Just to clarify, was this just for the FSHD type one or inclusive of type two? And now that you do have the type 2 baseline characteristics disclosed, like what would that powering be, if any, different from the original one? And then second question on powering as well. Just curious, have you guys done additional sensitivity analysis around sort of the evolving resolve natural history data? And what might that mean for the powering of REACH? Thanks so much.

Question: Gregory Renza - RBC Capital Markets - Analyst : Yes. Alex and team, congrats on the progress. We're looking forward to the data in October. Alex, just on losmapimod, as you touched a bit about upon payer engagement, maybe just give us a glimpse of what that engagement will and has been looking like what do you see as the potential tailwinds from the potential data package and losmapimod's profile? Maybe what do you foresee as some of the greatest challenges when it comes to establishing the value proposition and assuming that the data cards flip as you foresee?

Question: Gregory Renza - RBC Capital Markets - Analyst : That's helpful. Maybe related and as Alan has provided some detail on your runway. Just how are you coordinating the urgency about the planning for building a commercial organization when it comes to the leadership in such a capability and slotting that with respect to the data coming?

Question: Matthew Biegler - Oppenheimer - Analyst : We were curious if in your discussions with the FDA they'd ever asked for more data around the losmapimod's mechanism of action. As you mentioned, AVIDITY had some biomarker DUX4 reduction. clinically. I know preclinically you showed that, but you hadn't been able to clinically. So, I'm just kind of curious if you'd be open to rerunning archived biopsies from ReDUX using maybe a more sensitive assay if the FDA wanted you to? Or if not, if you think, really, at this point, the FDA is only concerned with validating the RWS tool?

Question: Matthew Biegler - Oppenheimer - Analyst : Okay. That makes sense. And maybe just squeeze one on the REACH 3 guidance. Is this a revision or just more fine-tuning from the prior guidance, which was year-end? And if it's a revision, kind of what are some of the factors driving that fit faster cadence going from year-end to now end of October.