Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndex Third Quarter 2022 Earnings Conference Call. Today's call is being recorded. At this time, I'd like to turn the call over to Sharon Clary, Head of Investor Relations at Syndex Pharmaceuticals. Please go ahead.

Great. Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndex's Third Quarter 2022 Financial and Operating Results. I'm Sharon Clary, and with me today to provide an update on the company's progress and to discuss financial results are Michael Metzger, Chief Executive Officer, Dr. Briggs Morrison, President and Head of R&B, and Keith Goldan, Chief Financial Officer. Also joining us on the call today for the question and answer session is Dr. Peter Redland, Chief Scientific Officer, and Dr. Angelique Angoulid, Chief Business Officer. The call of the company is by a slide that is posted on the investor page of the company's website. You can now turn to our forward-looking statements on slide two. Before we begin, I'd like to remind you that any statements made during this call are not historical, are considered to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these statements. as a result of various important factors, including those discussed in the risk factors section in the company's most recent quarterly report on Form 10-Q, as well as other reports filed with the SEC. Any forward-looking statements represents our views as of today, November 3rd, 2022 only. A replay of this call will be available on the company's website, www.synbest.com, following this call. With that, I'm pleased to turn the call over to Michael Metzger, Chief Executive Officer of CINDAC.

Thank you, Sharon, and thank you to those joining us on the webcast. We made significant progress during the third quarter, and I look forward to sharing the updates with you today. I expect this momentum to continue as we advance towards two pivotal data readouts and potential registration filing in 2023 for our two lead drug candidates. both of which are first and potentially best in class treatments. I want to repeat that for emphasis. We are, we anticipate having both an NDA and VLA filing in 2023, an almost unprecedented accomplishment for a Smithcap biotechnology company, which speaks to our focus and our determination to realize a future in which people with cancer live longer and better than ever before. We have a strong balance sheet that supports our clinical efforts, and enables us to aggressively advance our programs through key near-term milestones. We are also fortunate to have Insight as a strong partner to help us successfully advance one of our lead molecules, exothelamab. Everyone at Syndax is incredibly excited about the opportunities and important milestones ahead. Turning to slide three, we provide a high-level summary of our current corporate priorities. We have designed a broad development plan for both revumative and exothelamab, that is focused on realizing their full potential, given their compelling clinical profiles. Starting with Revumetiv, our highly selected menin inhibitor, our pivotal Phase II Augment 101 trial evaluating Revumetiv in patients with relapsed refractory MPM1 mutant or MLLR acute leukemia is ongoing. We expect to report top-line data from at least one of the cohorts for the Phase 2 portion in the third quarter of 2023, and we continue to expect to file an NDA by the end of 2023. This morning, we published a press release highlighting positive updates from the Phase 1 portion of the Augment 101 trial that will be presented during two oral presentations at the American Society of Hematology, or ASH, annual meeting this December. Beyond the Augment 101 trial, testing the effect of monotherapy and relapsed refractory disease, RevuMed is the focus of several ongoing and planned trials that present important expansion opportunities in acute leukemias. In addition to acute leukemias, we are on track to initiate our first solid tumor proof-of-concept trial in colorectal cancer in the fourth quarter of this year. Moving back to tilumab, our antibody against CSF1R. Enrollment is now complete in our pivotal Phase II Agave 201 trial evaluating axotilamab in patients with chronic graft-versus-host disease, and we expect to report data in the trial in mid-2023. We are working in collaboration with our partner, Insight, to maximize the value of the axotilamab program, and this includes an expected DLA filing by the end of 2023, as well as initiating a trial testing the combination of axotilamab and ruxolitinib in frontline chronic graft-versus-host disease. Looking beyond CGVHD, we expect to begin a Phase II trial of axotilamab in idiopathic pulmonary fibrosis, or IPF, in the fourth quarter of this year. We also continue to assess potential business development opportunities to complement our existing pipeline. While our bar is quite high for in-licensing drug candidates given the strength of our pipeline, we continue to evaluate potential opportunities to in-license earlier stage targeted oncology compounds that we believe could become high-value differentiated assets. Let's now turn to slide four, and I'll provide further details on the recommendative program. First, our pivotal phase two Augment 101 trial It is designed as three single-arm Phase II trials that enroll independently and can each provide the basis for a co-regulatory filing in the U.S. The Augment 101-2A trial is enrolling patients with relapsed refractory MLLR-ALL, 2B is enrolling patients with relapsed refractory MLLR-AML, and 2C is enrolling patients with relapsed refractory NPM1-AML. Each trial is designed to enroll approximately 64 patients, adult patients, and up to 10 pediatric patients aged one month or older. As site staffing issues industry-wide have impacted startup timelines in certain geographies, we have updated our guidance for when our first cohort in this trial will be fully enrolled and expect enrollment to extend into the first quarter of 2023. Interest in the trial remains incredibly high with strong enrollments. Investigators are finding it as challenging as we are to deal with the unfortunate resourcing issues at some of their institutions, and we are working collaboratively to resolve it. We now expect to present top-line data in the third quarter of 2023 for at least one of the three cohorts in the augment one-on-one trial, and importantly, we continue to anticipate filing an NDA by the end of 2023. We have agreement with FDA that for each cohort or trial, The primary endpoint will be the percentage of patients achieving CR-CRH, with secondary endpoints including durability of CR-CRH response, transfusion independence, overall survival, and safety. We also have agreement with FDA on the statistical design of each trial. Importantly, the trial design allows patients to be treated again with Revumetiv after bone marrow transplant, a design feature that provides data on the potential role of Revumetiv in the post-transplant maintenance settings. I'll now hand the call to Briggs to provide an update on the ASH abstract, which published earlier today. Briggs?