Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndax second quarter 2024 earnings conference call. Today's call is being recorded. All participants have been placed in a listen-only mode. You will have an opportunity to ask questions after today's presentation. If you would like to ask a question, please press star five on your telephone keypad to be placed into the queue. You may also press star five again to remove yourself from the queue. At this time, I would like to turn the call over to Sharon Clary, head of investor relations at Syndax Pharmaceuticals.

Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndax's second 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 Goldanz, Chief Financial Officer. Also joining us on the call today for the question and answer session are Dr. Peter Oredemlik, 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 would 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 the statement 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 made represent our views as of today, August 1, 2024 only. A replay of this call will be available on the company's website, www.syndex.com, following its completion. With that, I'm pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndex.

Thank you, Sharon. Good afternoon, everyone, and thank you for joining us today. Starting with slide three, this is a very exciting year for Syndex as we stand on the cusp of becoming a commercial stage company with the anticipated upcoming FDA approvals of Revimentib and Axotilamab, two first-in-class treatments for diseases with high unmet medical needs. I'm pleased to report that we have achieved several clinical milestones in the second quarter that support our strategic priorities. In June, we presented updated positive Revimentib combination data from the BEAT-AML and Augment-102 trials at the European Hematology Association, or EHA, Congress. These data, which Neil will review shortly, continues to support revumens potential to enhance current standard of care agents. At EHA, we also presented additional positive data from the Agave 201 pivotal trial, evaluating axotilumab in patients with refractory chronic graft versus host disease, or GVHD. Reinforcing the previous organ response data that we had shared, This latest data set shows that responses were noted in all fibrosis-dominant organs that had clinical activity supported by clinician-reported and patient-reported changes in organ-specific symptoms, such as improvements in swallowing, shortness of breath, skin and joints, and sclerotic skin. Looking ahead, we are on track for a historic year with the anticipated FDA approval of Revimenib and Axotilmab coming soon. With axotilamab, our anti-CSF1 antibody for patients with chronic GVHD, we have a PDUFA action date of August 28, 2024, and anticipate launching in the fourth quarter of this year with our partner, Insight. With revimenib, our menin inhibitor being reviewed by the FDA for patients with relapse or refractory KMT2A-rearranged acute leukemias, we have a PDUFA action date of December 26, 2024. As we announced earlier this week, The FDA recently extended the PDUFA action date for Revimenib NDA from September 26 to December 26, 2024, a standard three-month extension to allow for additional time to conduct a full review of supplemental information we provided in response to their request. Importantly, we are confident that the information we have provided supports approval and continues to demonstrate the meaningful benefit Revimenib brings to patients. We look forward to continuing to closely engage with the FDA as they complete their review under the Real-Time Oncology Review Program, or RTOR, and we stand ready to launch Revumentib with strength as soon as we receive the anticipated approval. Later in the call, Steve will provide some additional color on our preparations for these two anticipated launches. We also have several other meaningful milestones approaching, such as the anticipated readout of pivotal top-line Revumentib data in relapsed or refractory NPM1 AML in the fourth quarter which could serve as the basis for a supplemental NDA filing in the first half of 2025. Additionally, we expect to make further progress advancing our clinical trials of Revimentib and Axotilamab that are underway or planned to initiate in the coming months. Positive results could support the future use of these agents in combination with standard of care medicines earlier in a patient's treatment and thereby expand their utility significantly. We are in a strong financial position with $455 million in cash as of June 30th that we expect will provide sufficient capital through 2026. Our current balance sheet not only supports our planned commercial launches and clinical trials, but also sets us up to expand beyond our first registration indications and to pursue early stage business development opportunities. I will now ask Neal to review some of our recent data presentations and pipeline. Neal?