Forma Therapeutics Holdings, Inc.

Welcome to the Form of Therapeutics year-end 2021 financial results and business update conference call. All participants are currently in listen-only mode. Following management's prepared remarks, we'll hold a Q&A session. To ask a question at that time, please press the star key followed by one on your touchstone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, March 1st, 2022. I would now like to turn the conference over to Mario Corso. Please go ahead.

Thank you, Michelle. This is Mario Corso, Senior Director of Investor Relations at FORMA. Good morning to our listeners and welcome to today's call to discuss year-end 2021 financial results and a 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 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 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 business. reports on Form 10-K for the year ended December 31st, 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 law. Before turning the call over to Frank, I'd like to mention two upcoming activities as outlined in today's press release. We'll be participating virtually in the Oppenheimer Healthcare Conference, March 15 to 16, and we'll be holding our first R&D pipeline review in May 2022. Further information on these events will be made available on our website, www.formatherapeutics.com. With that, I will now turn the call over to Frank, our President and Chief Executive Officer. Thank you, Mario.

morning everyone it's my pleasure to review forma's significant accomplishments in 2021 and outline our plans for 2022 as well as the longer term vision for the company as you know former's purpose is to transform the lives of patients living with rare hematologic diseases and cancers in support of our mission 2021 was a year to generate early-stage clinical trial results on our two active clinical development programs, EtablaPVAP for people living with sickle cell disease and FT7051 for men living with metastatic castration-resistant prostate cancer. These clinical data formed the building blocks for expanded development in 2022 and beyond. In the latter part of 2021, we completed the Phase I trial of our once-daily PKR activator, Etabopivac. This molecule has the potential to be a foundational therapy for sickle cell disease via its multimodal mechanisms of action. Results were presented from the open-label extension of the trial at the ASH annual meeting in December, and we believe this was the most rigorous and comprehensive Phase I program conducted in people living with sickle cell disease, not only assessing the typical measures of hemoglobin and hemolysis, but also analyzing numerous biomarkers of red blood cell health. Pat will review the impressive results here shortly. While we completed the Phase 1 trial and continued to enroll the Phase 2-3 hibiscus study, we also furthered our commitments to improving access to care, with the recent announcement of our Form-a-Bridge program to aid in pediatric to adult transition, as well as the addition of a renowned leader in sickle cell disease, Dr. Ed Fiasunco, in the newly created role of Chief Patient Officer. Unlike similar orphan diseases such as hemophilia and cystic fibrosis, sickle cell disease remains underfunded, under-resourced, and under-appreciated. As a result, sickle cell patients must endure barriers to quality of care like no other disease. We believe every sickle cell patient deserves high-quality care, and we're working closely with the community to make this happen. Being a trusted partner to the communities we serve is important for rare orphan diseases, but it's particularly the case with sickle cell disease. Another important 2021 milestone was achieved with our CBP P300 inhibitor FT7051. With the presentation in October at the triple meeting of the first in human results from our ongoing phase one trial in metastatic castration resistant prostate cancer. We're encouraged by the safety profile and the early data suggesting that CBP P300 inhibition may provide a novel approach for patients who have failed standard of care. Dave will detail the results shortly. Now looking ahead, 2022 is a year of advancing the clinical development of Etabla PVAT and expanding FORMA's pipeline to position the company for longer-term success. We continue to enroll the Global Phase 2-3 Hibiscus Study and expect the interim analysis 1 dose selection decision towards the end of this year. We're also broadening our ETAVA PBAT development in sickle cell disease to include the transfusion-dependent and pediatric populations. We are also progressing in new areas such as thalassemia and low-risk myelodysplastic syndrome, or MDS, while also evaluating other disease areas in order to bring all that we have learned about PKR mechanism and red blood cell health to additional areas with substantial unmet patient need. We expect to provide updated data for FT7051 in metastatic castration-resistant prostate cancer later in the year, including its safety, tolerability, profile, and activity. This data will enable us to discuss the clinical development approach for FT7051 and positioning in the current treatment landscape. Finally, this year, with respect to our third development compound, the IDH1 inhibitor, the ludicidinib, for relapsed refractory AML, we're progressing a new drug application as we continue a partnering strategy for this molecule. I'm proud of all that we accomplished at FORMA last year and enthused about our plans for this year and beyond. We're building a company that is positioned for success with multiple clinical stage assets and development. research capabilities to sustain our strategy, and with substantial capital to achieve our near-term and long-term objectives. As we discussed before, the COVID-19 pandemic has created substantial ongoing challenges for both the clinical trial sites and for patients. We're observing conditions improving over time and are working very closely with the clinical sites as well as 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 Kelly to discuss recent Etabla PVAT and the ludicide NIV results in more detail. Pat.