Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndex first quarter 2024 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.

Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndax's first quarter 2024 financial and operating results. I'm Sharon Clary, and with me this afternoon to provide an update on the company's progress and discuss financial results are Michael Metzger, Chief Executive Officer, Dr. Neil Gallagher, President and Head of R&D, Steve Kloster, Chief Commercial Officer, and Keith Goldant, Chief Financial Officer. Also joining us on the call today for the question and answer session are Dr. Peter O'Dentlick, Chief Scientific Officer, and Dr. Anjali Ganguly, Chief Business Officer. This call is accompanied by a slide deck that has been 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 the call that 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 factor 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 may represent our views as of today, May 8, 2024 only. A replay of this call will be available on the company's website, www.syndax.com, following its completion. With that, I am pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax.

Thank you, Sharon, and good morning, everyone, and thank you for joining us on the call today. I'd like to begin by welcoming Steve Kloster to the call. Steve joined us in March as Chief Commercial Officer. He brings over 30 years of commercial experience to Syndax, which includes establishing winning teams and leading successful product launches. Steve is building on the excellent framework that was in place prior to his arrival, and we are already benefiting from his keen insights as we prepare for commercialization. In the quarter, we made significant progress on executing against our corporate strategy. As you can see on slide three, we achieved several significant milestones this quarter, including securing priority review from the FDA for both the revument of NDA filing and the axotilumab BLA filing. We also completed enrollment, in the NPM-1 AML cohort of Augment 101 Pivotal Trial, bringing us one step closer to expanding the market opportunity for Revumenta. We look forward to reporting data from the initial trial in the fourth quarter of this year, which could serve as the basis for a supplemental NDA filing in the first half of 2025. These accomplishments set us up for an eventful 2024 that we expect will include two full U.S. regulatory approvals, NPM-1 pivotal data readout, additional combination data for Revimenib in KMT2A and NPM-1, initiation of a pivotal trial for Revimenib in frontline KMT2A and NPM-1 acute leukemia in combination with venetoclax, as well as the initiation of two combination trials for axotilamab in frontline chronic graft-versus-host disease. As we approach our expected approvals, we are working to ensure that we are fully prepared to successfully launch at any time during the third quarter with an ability to reach all patients in need as rapidly as possible. Steve will provide additional details on our launch preparations later in the call. Syndex has a differentiated profile as a SMITCAP biotech with two first and best-in-class drugs on the cusp of their potential first approvals. Notably, Revimenib has a potential second significant indication and near-term expansion opportunity in relapsed or refractory NPM1 that meaningfully extends the target patient population in acute leukemia. This is unique in a launch year as it quickly broadens the market opportunity for Revumentive in the relapsed or refractory setting to up to 6,500 patients. Multiple opportunities beyond the initial relapsed or refractory indication exist for both assets, and trials are ongoing that can drive significant long-term value for these franchises for years to come. We are well-funded with $522 million in cash as of March 31st that we expect will provide significant capital through 2026. Our current balance sheet not only supports our planned commercial launches and clinical trials, but also allows us to expand beyond our core registration indications and pursue select business development opportunities. I'll now ask Neil to provide an overview of the pipeline.