Forma Therapeutics Holdings, Inc.

Welcome to the FORMA Therapeutics first quarter 2021 financial results and business update conference call. All participants are currently in a listen-only mode. Following management prepared remarks, we will hold a question and answer session. To ask a question at this time, please press the star followed by the one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator's assistance. As a reminder, this call is being recorded today, May 14, 2021. I would now like to turn the conference over to Mario Corso. Please go ahead.

Thank you, Operator. This is Mario Corso, Senior Director of Investor Relations at FORMA. Good morning to our listeners, and welcome to today's call to review first quarter 2021 financial results and business update. On this call, I'm joined by Frank Lee, our President and Chief Executive Officer, Pat Kelly, our Chief Medical Officer, Dave Cook, our Chief Scientific Officer, and Todd Shegog, 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 and assumptions regarding timing, success, and data announcements of our current ongoing clinical trials, therapeutics potential, and clinical benefits, and safety thereof, planned regulatory submissions, our financial condition, our business operations, development efforts, and the potential impact of COVID-19 on our business and clinical development, and relationships with third parties and collaborators, 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 ended December 31, 2020, and our quarterly report on Form 10-Q for the quarter ended March 31, 2021, that will be filed with the SEC today, and in subsequent reports, including our current reports on Form 8-K. 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 on today's call. I'm pleased to say we continue to make strong progress in the first quarter with our R&D pipeline, and I'll share some high-level thoughts with you before turning it over to Pat and Dave for more detailed remarks. I'd like to first acknowledge the time, effort, and contributions made by patients, investigators, healthcare workers, and our employees who are navigating the challenges posed by the COVID-19 pandemic and make it possible for us to pursue our purpose, and that is to transform the lives of patients living with rare hematologic disorders and cancers. I'm proud of our talented employees and how they live our guiding principles and values every day. in pursuit of our purpose, and I believe our patient-focused culture is a key strength which differentiates pharma. During the first quarter, we achieved important milestones for our two development programs, FT4202, our oral PKR activator being developed for sickle cell disease, and FT7051, our oral CBP P300 inhibitor for metastatic castrate-resistant prostate cancer. starting with FT4202, a potential foundational therapy with the potential to provide benefits in both hemoglobin and vaso-occlusive crisis in a once-daily pill. We disclosed that the Phase 2-3 hibiscus study began enrolling patients in the first quarter. In addition, we disclosed initial blinded results in the two-week from the second two-week cohort in our randomized multicenter placebo-controlled phase one trial, which successfully completed the MAD portion of the trial. The key takeaways were as follows. Number one, no dose-limiting toxicity or significant treatment-related adverse events have been identified. Number two, hematologic and or hemolytic responses indicated a consistent biologic effect and improvement in red blood cell health. And responses were typically best at the end of the 14-day treatment period, suggesting patients may benefit from longer duration of treatment beyond the 14 days. Importantly, completion of the MAD cohorts allowed us to continue moving forward with the next phase of this trial, the ongoing 400 milligram, 12-week open-label extension. And finally, results from the MAD cohorts together support the 200 milligram, and 400-milligram doses being evaluated in the ongoing Phase 2-3 trial to hibiscus study. The next steps of this program will be the presentation of the combined unblinded MAD cohorts, as well as initial open-label extension results to date at the European Hematology Association, or EHA, meeting taking place virtually June 9th through the 17th. Building on the ongoing sickle cell program and the thalassemia trial getting underway later this year, we see potential for FT4202 to benefit other patient populations with high medical needs, including hemolytic anemias and rare diseases. We're taking a review internally and expect to provide more specifics during the second half of the year. With respect to FT7051, our oral CBP-P300 inhibitor for metastatic castrate-resistant prostate cancer. We reported the first patient dosed in the ongoing phase one trial early in the first quarter and are pleased with the initial interest in the trial among both the centers and patients. We look forward to the initial results from this trial in the fourth quarter of this year, and in particular, the data for patients with ARV7 splice variants for which there are no currently available treatments. I'll now turn over the call to Pat to discuss FT4202 as well as elutisidinib in more detail. Pat?