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5/6/2022
Welcome to the Forma Therapeutics First Quarter 2022 Financial Results and Business Update Conference Call. All participants are currently in 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 1 on your touchtone phone. If anyone has difficulty hearing the conference, please press star 0 for operator assistance. As a reminder, this call is being recorded. Today, May 6, 2022. I would now like to turn the conference over to Mario Corso. Please go ahead.
Thank you, Gigi. 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 2022 financial results and business update. On this call, I'm joined by Frank Lee, our President and Chief Executive Officer, and 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 ongoing clinical trials, therapeutic potential, hypotheses of mechanisms of action and clinical benefits, and safety of our product candidates, planned regulatory submissions, our financial condition and capital requirements, our business operations, 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 titled Risk Factors in our annual report on Form 10-K for the year ended December 31st, 2021, and in our quarterly report on Form 10-Q for the quarter ended March 31st, 2022, that will be filed with the SEC today, and in subsequent reports, including our current reports on Form 8K. 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 our upcoming R&D Day with investors that was outlined in today's release. This meeting will take place virtually on May 26th from 8 to 10 a.m. Eastern Time. Further information 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. Good morning, everyone, and thank you for joining us today. The first quarter of this year marked strong progress in our ongoing clinical programs. We continued enrollment in our Phase 2-3 trial of atavlopivap in sickle cell disease, the Hibiscus Study, and are pleased to say we're on track for the first interim analysis in the latter part of this year. We're also on track with enrollment in the Phase 1 trial of FT7051 in metastatic castration-resistant prostate cancer. We expect to soon be able to identify a dose for further expansion. We're initiating two Etabo PVAP Phase II trials this year. The first is underway in transfusion-dependent and non-transfusion-dependent thalassemia, as well as sickle cell disease patients who are transfusion-dependent. Sickle cell disease patients who are transfusion-dependent represent approximately 20% of the overall sickle cell disease patient population and represent an area of substantial unmet need. The second trial will begin in the second half of this year in lower risk myelodysplastic syndrome, MDS. Low risk MDS represents another area of substantial unmet need. Chronic transfusions to treat the symptomatic anemia associated with MDS is common practice. Whether a patient is requiring blood transfusions to treat their hemolytic anemia as in the case of thalassemia or sickle cell disease, or to treat their anemia due to poor production, as in the case of MDS, iron overload remains a substantial and significant risk. We believe Etabopivac's unique mechanism of action may improve the symptomatic anemia in all these indications, reducing the need for transfusion therapy and reducing the risk for iron overload. As we look forward, we have some important upcoming events. On May 26th, we plan to host our first Research and Development Day. At this event, we will provide the first look into our research portfolio, including a compound which is currently in IND-enabling studies. In addition, we'll provide additional details on the non-sickle cell disease at TAVLA-PVEP programs and discuss the emerging science of red blood cell health. We'll also share a trial update on our FT7051 program. And towards the end of the year, we're on track to reach interim analysis one from the hibiscus study and also to show early data from the transfusion study. Being a trusted partner to the patient communities we serve is an important corporate goal for FORMA. Among other initiatives, we launched our FORMA Bridge program at the end of last year. The transition from pediatric to adult care can be very challenging. FORMA Bridge was designed to support this important transition, and I'm very pleased to report that there have been a high level of interest in the program, and we received a number of proposals from a mix of healthcare institutions, patient organizations, and community-based organizations. Grant awards are expected to be announced in the coming months. We've had a strong start to the year, and we're well-positioned to deliver on our goals. We are well-capitalized with over $441 million in cash. We have a differentiated and growing clinical stage pipeline, and we have a highly engaged group of employees who embody the idea of the science of giving a damn. In closing, I'd like to recognize the remarkable efforts of our investigators and patients for their support and contributions in advancing our purpose to transform the lives of patients living with rare hematologic disorders and cancers. I'll now turn over the call to Pat to provide a brief update on our development programs.
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