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8/13/2021
Welcome to the Formal Therapeutics Second Quarter 2021 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, August 13th, 2021. 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 second 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 Shigog, our Chief Financial Officer. Before we begin, I'd like to caution listeners that comments made and financial information provided during the conference call include certain statements that are estimates, beliefs, forward-looking, and or subject to various risks and uncertainties. Any statements made during this call that are not statements of historical or Recurrent 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 and ongoing clinical trials, therapeutic potential and clinical benefit and safety of our product candidates, planned regulatory submissions, our financial condition and our business operations, development efforts, 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 quarterly report on Form 10-Q for the quarter ended June 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 those required by applicable law. I will now turn the call over to Frank. our President and Chief Executive Officer.
Thank you, Mario. And good morning, everyone, and thank you for joining us on today's call. The second quarter marked FORMA's one-year anniversary as a public company, and I'm extremely proud of all that we've accomplished while at the same time recognizing that we have much work left to do on our mission to improve the lives of patients living with rare hematologic diseases and cancers. Before turning the call over to Pat and Dave for more detailed review of our pipeline, I'd like to provide some high-level thoughts on our second-quarter achievements. First, our lead development program, the once-daily PKR activator, now called ETAPA-PVAP, formerly FT4202. We believe that the new Phase I results in sickle cell disease presented at the EHI meeting in June provide growing evidence that etabopevat has a highly differentiated profile and the multimodal mechanism of action may be able to modify the course of this complex and multifactorial disease. More specifically, initial etabopevat results show sustained hemoglobin increase in nearly all patients and improvement in red blood cell health and lifespan as measured by metabolic and systemic markers. Altogether, These data support the potential of Atabipivac to improve important clinical outcomes, such as vaso-occlusive crisis or VOCs. And our goal is to have Atabipivac approved as a first sickle cell treatment that can improve both hemoglobin and VOCs. As we advance our ongoing pivotal Phase II-III sickle cell trial, the Hibiscus Study, we We're also partnering closely with the sickle cell community to improve patient access and care. And I'm very proud to say that we've assembled a talented group of people who are all in to make a difference in the lives of patients living with sickle cell disease. Looking forward, we plan to start the phase two thalassemia trial later this year and a sickle cell pediatric trial in the first half of next year. Furthermore, we're evaluating a tab of PVAP for study in other populations where improving red blood cell health and lifespan could benefit patients. Turning to our prostate cancer program, we began enrolling at phase one trial earlier this year of the oral CBP P300 inhibitor, FT7051, in men with metastatic castration-resistant prostate cancer. This is a population of men whose cancer has either progressed while on current standard of care antiandrogen treatment and or for whom chemotherapy has not been successful. So the unmet need is significant. CBP-P300 is a novel pathway, and we're very interested in the potential to address a broad range of AR-driven cancers, and in particular, patients with ARV7 splice variant, for which there are no approved therapies. Dave will shortly provide an update on our FT7051 development program. With respect to our third development compound, the IDH1 inhibitor, olivacidinib, or relapsed refractory AML, the registrational results presented at EHA and ASCO show that we believe it's a very competitive profile in terms of response rate, duration of response, and survivability. And based on these results, we're preparing a new drug application for regulatory submission. In addition, I'm very pleased to welcome John Bishop, our new chief technology officer to the executive team. John will lead chemistry, manufacturing, control, CMC-related functions, and quality, encompassing FORMA's early pipeline through commercial. John's background includes extensive experience in CMC development, in oncology and hematology, and we're very excited to have them on board. Before turning the call over to Pat for a more in-depth review of Atavapivac and Alucidinib, I'd like to once again this quarter recognize the contributions made by patients, investigators, healthcare workers, and our employees as they navigate the challenges posed by the COVID-19 pandemic. and help us pursue our purpose to transform the lives of patients living with rare hematologic diseases and cancers. I'll now turn over the call to Pat.
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