Forma Therapeutics Holdings, Inc.

Good morning. Welcome to the Formal Therapeutics 3rd 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 Q&A session. To ask a question at that time, please press the star key followed by 1 on your touch on telephone. If anyone has difficulty hearing the conference, please press star 0 for any operator assistance. As a reminder, this call is being recorded today, November 12, 2021. I would now like to turn the conference over to Mario Corso. Please go ahead, sir.

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 third quarter 2021 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 Chigog, 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, enrollment, success and data announcements of our current and ongoing clinical trials, therapeutic potential and clinical benefits and safety of our product candidates, planned regulatory submissions, our financial condition and capital requirements, our business operation, development plans, 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 performances. 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 quarterly report on Form 10-Q for the quarter ended September 30, 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. Before turning the call over to Frank, I'd like to mention two upcoming activities as outlined in today's release. We will be participating virtually in the Jefferies London conference next week, and we'll also be holding an investor briefing on December 13 to discuss clinical trial results being presented at the ASH annual meeting. Further information on these events will be made available on our website, formatherapeutics.com. With that, I will now turn the call over to Frank, our President and Chief Executive Officer.

Thank you, Mario. Good morning, everyone. FORMA continues to make good progress on our purpose to transform the lives of patients with rare hematologic disorders and cancers. Our portfolio includes potentially transformative molecules for patients with sickle cell disease and other hemolytic anemias, prostate cancer, and acute myeloid leukemia. Our clinical programs have important upcoming catalysts for growth and positions FORMA well for long-term success. Along with the progress in advancing our science, I'm pleased with the progress we're making in establishing FORMA as a trusted partner in the sickle cell community. In October, we collaborated with the Sickle Cell Disease Association of America to launch the Sickle Cell Clinical Trial Finder. It can be daunting and complex for sickle cell patients to learn more about clinical trials enrolling in a specific geographic area, and this resource allows users to easily find information about all the sickle cell clinical trials and about the clinical trials process itself. We're honored to be a part of this important effort that benefits the entire sickle cell community. Now I'd like to turn to the quarter, third quarter. First, let's have a PVAT, our once daily PKR activator with the potential to be a foundational therapy for sickle cell disease by not only addressing the anemia but improving red blood cell health via its multimodal mechanism of action. We've completed enrollment in our open-label extension of the Phase I sickle cell disease trial and plan to present the updated results along with the completed MAD data at ASH in December. We continue to open sites and enroll patients in our Phase II-III hibiscus study. And as a reminder, this study includes two co-primary endpoints, hemoglobin and VOCs, that support the traditional approval pathway. In addition, the study design also provides for the potential to pursue accelerated approval. And based on recent discussions with the FDA, we plan to provide additional information on hemoglobin as a surrogate endpoint by the time of accelerated approval submission, given the unique mechanism of action of atapivac. We've had productive discussions and plan to closely collaborate with the FDA moving forward in support of our overall development program, which is designed to ensure timely approval and to provide clinically meaningful and a differentiated data package. Based on the emerging data, we believe Atava PVET has the potential to be a pipeline and a product and have made progress in planning for a comprehensive development program, which includes the Hibiscus study, which includes patients, sickle cell patients age 12 and above, sickle cell pediatrics down to age six months, Sickle cell patients that are transfusion-dependent, thalassemia, both transfusion-dependent and non-transfusion-dependent. In addition, planning for additional studies is underway. Turning to our CBPP300 inhibitor, FT7051, we reached an important milestone in October with the triple-meeting presentation of the first inhuman results. from our ongoing phase one trial in metastatic castration-resistant prostate cancer. We're encouraged by the early data and the potential for FT7051 to target the novel pathway of CBP P300 inhibition. With respect to our third development compound, the IDH inhibitor elutisidinib for relapsed refractory AML, we plan to present new data from the azacitin combination cohort at ASH. These data further support the potential for ludicidinib to offer a differentiated profile, particularly given the impressive duration of response. We also continue to make good progress in preparation for a new drug application submission. Looking forward, I'm pleased to share some key events over the coming months. In December, at ASH, we plan to present four presentations on atavapivat and alucidinib. In addition, by year-end, we plan to start the Phase II study, which includes transfusion-dependent sickle cell patients and thalassemia patients, both transfusion-dependent and independent. Going into the first half of next year, we plan to start the sickle cell pediatric study and to host our first R&D day. Mid-2022, we plan to have additional data from our FT7051 Phase 1 Courage Study in prostate cancer. And late in 2022, we plan to have a TAVA-PVAT Hibiscus Study Interim Analysis 1. We're now guiding to the latter part of 2022. As we discussed before, the COVID-19 pandemic has created substantial challenges for both the clinical trial sites and for sickle cell patients, many of whom reside in areas disproportionately impacted by the pandemic. We're observing conditions improving over time and are working very closely with the clinical sites and the sickle cell community. With that, I'd like to acknowledge those who have helped navigate the ongoing challenges posed by the COVID-19 pandemic, including patients, investigators, healthcare workers, and our employees, as we pursue our purpose to transform the lives of patients living with rare hematologic disorders and cancers. I'll now turn over the call to Pat.