Good morning and welcome to the Fulcrum Therapeutics Third Quarter 2019 Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of the call. I would now like to turn the call over to Peter Thomson, Vice President, Finance and Accounting at Fulcrum. Please proceed.

Good morning. Welcome to Fulcrum’s third quarter 2019 conference call. We issued a press release earlier today reviewing our third quarter 2019 results and business updates which will be covered on this call. A replay of today’s call will be available on the investors and media section of our website. After our prepared remarks, we will open the call for Q&A. Before we begin, I’d like to mention that our call will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about our future expectations and plans, clinical development timelines, and financial projections. I encourage you to review our filings with the Securities and Exchange Commission including without limitation, our most recent quarterly report on form 10-Q which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future, but we are not taking on an obligation to do so. With that, I will turn the call over to Robert Gould, Fulcrum President and Chief Executive Officer.

Thank you, Peter. Good morning, everyone, and welcome to our quarterly financial and corporate update call. Joining me today with prepared remarks is Bryan Stuart, our Chief Operating Officer; Owen Wallace, our Chief Scientific Officer; and Diego Cadavid, our Head of Clinical Development are also with us and will be available for questions. Today, I’d like to begin with an overview of our programs and our strategy. At Fulcrum, we aim to discover and develop therapeutics to treat genetically defined rare diseases by addressing their root cause. Given that a large number of rare genetic diseases have known mechanistic root causes, we believe there’s a significant opportunity to address a wide spectrum of these diseases. During the past quarter, we have made great progress in advancing our pipeline. We initiated two Phase 2 studies for our lead program with losmapimod, the most advanced clinical program in the industry for patients with facioscapulohumeral muscular dystrophy or FFHD. Our second program, FTX-6058 moved into IND-enabling studies with a goal to treat patients with select hemoglobinopathies including sickle cell disease and beta-thalassemia. Both of these programs were identified by Fulcrum’s proprietary product engine. The significant progress of each of these is powerful and tangible evidence of our approach to treat genetically defined diseases. As we have advanced clinically, we continue to evolve and strengthen our team. In September, we announced the appointment of Pamela Strode as Senior Vice President, Regulatory Affairs and Quality Assurance. Pam comes to Fulcrum with deep experience from large and small biopharma companies where she has led regulatory affairs and quality assurance across multiple therapeutic areas. Importantly, she has experience working with regulatory agencies to develop and advance therapies for rare diseases with unmet need. Before I review the progress in FSHD and hemoglobinopathies, I’d like to highlight our…

Thank you, Robert. Good morning everyone and thank you for joining us today. Let me turn to our third quarter financial results which we reported in detail in our press release issued this morning. First, we ended the third quarter of 2019 in a strong financial position with $101.6 million in cash and cash equivalents. Based on our current operating plans, we continue to expect that our existing cash balance will fund our operating and capital expenditure requirements into the third quarter of 2021. Looking at our operating expenses, research and development expenses for the third quarter of 2019 were approximately $13.5 million, representing an increase of $6.5 million, compared to the third quarter of 2018. The year-over-year increase in research and development expenses was driven primarily by $2.5 million of cost incurred during the third quarter of 2019 associated with the achievement of a milestone due under the right of reference and license agreement with GlaxoSmithKline upon the initiation of our Phase 2 studies, as well as increased costs related to the advancement of losmapimod for the treatment of FSHD and increased personnel-related costs due to additional headcount to support the growth of Fulcrum’s research and development organization. General and administrative expenses for the third quarter of 2019 were $3.5 million. This represents an increase of $1.4 million, compared to the third quarter of 2018, driven by increased personnel-related costs due to increased headcount to support the growth of our organization, as well as well as increased consulting and professional fees. I will now turn the call back over to Robert.

Thank you, Bryan. Partnership with the patient community is essential to progressing our development efforts. And I would like to extend sincere gratitude to all who have contributed, including patients who have enrolled and those currently participating in Fulcrum’s clinical trials. Thank you also to our consultants who have participated in our progress to date. Finally, I’d like to thank all of the employees of Fulcrum to remain committed to executing on our goal of advancing therapeutics focused on improving the lives of patients with genetically defined diseases. We look forward to keeping you up to date on our progress. With that, I’ll now turn the call over to the operator for questions. Operator?

[Operator Instructions] Our first question comes from Dae Gon Ha with SVB Leerink.

Great, good morning. Thanks for taking our question. This is Dae Gon dialing in for Joe. So one question on losmapimod and one question on the hemoglobinopathy program if I may. So on losmapimod, I guess you’ve got a Natural History ReSOLVE study going on. So I guess how is that enrollment going? And just trying to gauge the sense of timing here as you’re going with two Phase 2 programs concurrently, so maybe if you can talk about enrollments across all three of these programs? And in terms of the end points, I guess, natural history will provide some meaningful insights there. So can we expect natural history data to come somewhat before Phase 2 to provide some context or what parameters or what numbers would you be looking forward to in the Phase 2 double-blind ReDUX4 study? And then on the hemoglobinopathy program, I guess if you can maybe talk to us a little bit about that 30% you saw in the human erythroid progenitor cells, can you remind us what the baseline you would normally expect a fetal hemoglobin in these cell types and what’s the translatability into hemoglobinopathy patients, particularly sickle cell and beta cell? Thanks.

Yes, thank you for the questions. So we’re pleased with the way enrollment is going. Just to remind you, the Natural History ReSOLVE study is a study that’s sponsored by the NIH and is being run at a number of clinical centers throughout the U.S. through a clinical trial network that had previously been set up. That enrollment is proceeding nicely. The projected number of patients is 220. And as of the end of this year or currently we are well on track to complete enrollment in that by the end of the year. The other Phase 2 studies that we’re going, the simultaneous Phase 2 studies, the open label-study is being run at a single site in Europe. And again, we’re pleased with how enrollment on that is going, as well as the ReDUX4 trial. In both those cases, we’re still on track with our projected enrollment and on track to release the top-line data from ReDUX4 in the third quarter of next year. The second question that you had was in that regard was related to interim look and end points around the ReSOLVE study. Those studies are – the ReSOLVE study is continuing to enroll patients and we’ll be projected to present those natural history studies in the course of interim analysis during the course of the next year. I’ll let Owen speak to the hemoglobin program.

Yes, thank you, Robert. The 30% number that you referenced was from our previously described study where we looked at the elevation of fetal hemoglobin in our CD34+ derived cells. And we saw a robust effect as you noted with our lead compound, FTX-6058. The baseline in these cells is somewhat variable depending on the donor. In this particular study, we saw around the 10% fetal hemoglobin baseline level. And this was elevated to approximately 30% as you noted. The translation to sickle cell patients and beta-thal patients is still a little bit uncertain. There are very few compounds that have gone into clinical development that have elevated fetal hemoglobin. So the translation back to preclinical studies is not very robust. What we could say is that we have benchmarked our compound and our mechanism with hydroxyurea, which is known to have a minimal effect in humans. We’ve also demonstrated a minimal effect in our cell lines and FTX-6058 has a considerably greater effect in our cell lines.

Great. Thanks for taking the question and congrats.

Thank you.

The next question comes from Matthew Harrison with Morgan Stanley.

Yes, do you have any updated thoughts on your regulatory plan in terms of engaging regulators ahead of the Phase 2 pivotal study with updates from the open label-study?

So the regulatory strategy for losmapimod is going to take advantage of the ongoing ReDUX4, the ongoing OL study, the natural history studies, as well as the open-label extension study, all of that data will be part of the package that we present for discussions with the U.S. and the EU regulatory authority. So I’d remind you that we have had several discussions already with the regulatory agencies, particularly the FDA, including a pre-IND meeting and then of course the discussion as we filed our IND and proceeded into the Phase 2 programs that we’ve described for you previously. We’ll be having additional conversations with the regulatory agencies as we move into 2020, including type B meetings that will be requested in the first half of next year. Also remind you that we have now hired Pam Strode as our Head of Regulatory Affairs. Pam brings a great deal of experience and interactions with the regulatory agencies around orphan diseases and approval in those areas. So as we move into 2020, we’ll be looking forward to continuing that dialogue with the FDA, particularly using the data coming out of all the studies that we’ll be generating.

Thank you. I’m not showing any further questions at this time. I’d like to turn the call back over to Robert.

Thank you, operator, and thank you all for joining Fulcrum’s first earnings call today and for your continued support. We look forward to updating you again in the near future. Thank you.

Ladies and gentlemen that does conclude today’s presentation. You may now disconnect and have a wonderful day.