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5/13/2020
Good morning and welcome to Fulcrum Therapeutics' first quarter 2020 conference call. Currently, all participants are in listen-only mode. There will be a question and answer session at the end of this call. I would now like to turn the call over to Christy Ward, Director of Investor Relations and Corporate Communications at Fulcrum. Please proceed.
Thank you, Demetri. Good morning and welcome to the Fulcrum Therapeutics conference call to discuss our first quarter 2020 financial results and recent corporate highlights. Earlier today, we issued a press release outlining our recent progress. For those of you who don't have a copy, you can access it in the investor relations section of our website, www.ulcrumtx.com. Please be reminded that remarks made during this call may 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. 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. Please refer to our most recent filings with the Securities and Exchange Commission for discussion of certain risks and uncertainties associated with our business. With me on today's call are Robert Gould, President and Chief Executive Officer, Diego Cadavid, Senior Vice President of Clinical Development, Owen Wallace, Chief Scientific Officer, and Brian Stewart, Chief Operating Officer. Let me quickly run through this morning's agenda. Robert will begin the call with an overview of our recent progress, Diego will discuss our FSHD program, Owen will discuss our sickle cell program and research efforts, and Brian will cover our financials before opening the call for Q&A. With that, it's my pleasure to turn the call over to Robert. Robert?
Thank you, Christy. Good morning, everyone, and thank you for joining us today. I first want to thank the healthcare workers, investigators, and caregivers for their courage and compassion as they continue to support so many during the challenges of COVID-19. Our hearts go out to everyone who has been impacted. To all of our friends, colleagues, and the patient communities we serve, we hope you are keeping safe and healthy. Fulcrum's mission and purpose remain unchanged. As we work to discover and develop therapeutics to treat genetically defined diseases by addressing their root cause, I'm proud of how our employees have risen to the evolving challenges of the COVID-19 pandemic. I'd like to begin by highlighting some of our recent updates and accomplishments. Today, we announced an amendment to Redux IV, our Phase IIb trial with losmaphimod in patients with fascioscapulohumeral muscular dystrophy, or FSHD. Diego will go over the amendment in more detail. These changes will extend the patient treatment from the original trial design, and we believe will provide a more robust data set while addressing the challenges presented by COVID-19. Early in the quarter, we received orphan drug designation from the U.S. Food and Drug Administration for lesmaphimod in FSHD. I'm pleased to report that we have also received orphan designation from the European Commission for Los Matamad for the treatment of FSHD. Like in the U.S., orphan designation is granted by the European Commission to drugs that are intended for the treatment, prevention, or diagnosis of life-threatening or chronically debilitating rare diseases. We are extremely pleased to have received this designation, further supporting the advancement of Los Matamad's FSHD program. We recently presented dose-dependent target engagement data and Skeletal Muscle from our Phase 1 trial with Lasman and Hamad during a virtual clinical trial session of the Muscular Dystrophy Association meeting. We continue to make progress with FDX6058, an oral small molecule therapeutic designed to induce expression of fetal hemoglobin in select hemoglobinopathies. You'll hear about our sickle cell program from Owen later in the call. We also continue to make progress on our early research stage activities including building out FulcrumSeq, our proprietary product engine designed to identify drug targets, programs, and clinical development candidates in a broad range of genetically defined diseases. And we initiated research activities under our collaboration with Acceleron. I'd now like to turn the call over to Diego for an update on the FSHD program. Diego?
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