Forma Therapeutics Holdings, Inc.

Welcome to the former therapeutics fourth quarter and year end 2020 financial results and business update conference call. All participants are currently in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press the star key followed by the one on your touchstone telephone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, March 30th, 2021. I would now like to turn the conference over to Mario Corso. Please go ahead.

Thank you, Josh. This is Mario Corso, Senior Director of Investor Relations at Forma. Good morning to our listeners and welcome to today's call to review fourth quarter and year-end 2020 financial results and business update. On this call, I'm joined by Frank Lee, our President and Chief Executive Officer, Patrick Kelly, our Chief Medical Officer, Dave Cook, our Chief Scientific Officer, and Todd Shigog, our Chief Financial Officer. Before we begin, I'd like to caution listeners that comments made and financial information provided during this conference call include certain statements that are estimates, beliefs, forward-looking, and are subject to various risks and uncertainties. Any statements made during this call that are not statements of historical or current facts are intended to be forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We want to emphasize that such forward-looking statements reflect our current expectations, assumptions, and currently available data regarding, among other things, our business operation, development efforts, regulatory strategy, and relationships with third parties and are neither predictions nor guarantees of future events or performance. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with our business, including those under the heading entitled Risk Factors in our annual report on Form 10-K for the year ending December 31, 2020, being filed today, and in subsequent reports, including our quarterly reports on Form 10-Q and our current reports on Form 8K. In addition, today we will make a number of comments about our expectations for the COVID-19 pandemic on our business. We provide these comments to give investors insights into what we're observing. However, given the dynamic nature of the pandemic, there is a high degree of uncertainty around any forward-looking statements made. The company disclaims any obligation to update or revise any forward-looking statements except as required by applicable law. I will now turn the call over to Frank, our President and Chief Executive Officer.

Thank you, Mario. Good morning, everyone, and thank you for joining us. I'm excited to host FORMA's first quarterly call and to provide an update on the strong progress we've made over the course of 2020, as well as our plans for 2021. Before I get started, I'd like to express my deep gratitude to our patients, investigators, healthcare workers and employees. Throughout the pandemic, so many have made tremendous sacrifices and demonstrated remarkable resilience to advance our science and to advance our mission to transform the lives of patients living with rare hematologic disorders and cancers. Today, we'll provide updates on three development stage programs. Following my opening remarks, our Chief Medical Officer, Pat Kelly, will provide an update on FT4202, a PKR agonist being studied in sickle cell disease, and elutacidinib, an IDH1 inhibitor being studied in acute myeloid leukemia and glioma. Afterward, our chief scientific officer, Dave Cook, will provide an update on FT7051, a CBP P300 inhibitor being studied in metastatic castration-resistant prostate cancer. Following a brief financial review from our Chief Financial Officer, Todd Chagag, we'll be happy to answer any of your questions. In 2020, we made strong progress in three important areas. Number one, advancing our pipeline. Number two, building our organizational capabilities. And number three, funding our future activities. With regard to advancing our pipeline, we reported at Ad Ash in December. initial phase one results for lead compound, FT4202, in people living with sickle cell disease. These data exceeded our hopes for the emerging profile of this potential foundational therapy. In October, we reported positive results from our pivotal trial for ludicidinib in patients with relapsed refractory AML with an IDH1 mutation. Notably, these results included compelling survival benefit in such a heavily pretreated patient population. Lastly, we progressed FT7051 into the clinic with a phase one trial in late-line patients with metastatic castration-resistant prostate cancer. This trial will broadly enroll late-line patients, including those with ARV7 splice variant identified by genetic mutation analysis. In January of this year, we reported first patient dose in this trial. With regard to building our organizational capabilities, we've strengthened our board of directors with three new appointments and also attracted top quality talent into the organization and collectively established a culture centered on three guiding principles. Patients are our purpose, people are why we succeed, and science drives us. I'm proud of our culture and believe it will differentiate FORMA over the long term. With regard to our funding of future activities, we completed our successful initial public offering in June and a subsequent follow-on equity offering in December. This extends our current cash runway through the third quarter of 2024. When I joined FORMA two years ago, we sharply focused our vision on being a leader in rare hematologic disorders and cancers. And it's been very gratifying to see the vision take shape. We now stand with three potentially transformative molecules in development, with a talented organization, as well as a well-capitalized company. I'd like to now turn to 2021. I'm pleased to say 2021 is off to a strong start for FORMA. We reported today in a separate press release the latest clinical data from our randomized multicenter placebo-controlled trial, Phase I trial, of FT4202 in people living with sickle cell disease. These initial top-line blinded results from the 600-milligram multiple ascending dose cohort are being reported as planned in the first quarter of this year, despite the challenges associated with the COVID pandemic. We're pleased with the initial 600-milligram results. and plan to report the full unblinded analysis at an upcoming scientific meeting this summer. I'd like to touch on some key points. Number one, while treatment assignment remains blinded, the initial results of the 600-milligram MAT2 cohort support the 200-milligram and 400-milligram doses being evaluated in our ongoing Phase 2-3 trial, the Hibiscus study. Number two, Doubling the dose to 600 mg once a day for 14 days was well-tolerated in patients with sickle cell disease with no dose-limiting toxicity or treatment-related adverse events identified. Number three, hematology and chemistry parameters in the 600 mg dose cohort were comparable to that observed with the 300 mg dose previously. Of note, hematologic and hemolytic responses were typically best at the end of the 14-day treatment, suggesting patients may benefit from longer duration of treatment beyond 14 days. Importantly, these data with the 600-milligram dose cohort have allowed us to continue moving forward with the next phase of this Phase I trial, the ongoing 400-milligram 12-week open-label extension. I'll now turn over the call to Pat to discuss our FT4202 results in more detail. as well as review elutisidinib for relapsed refractory AML and glioma.