Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndax Third Quarter 2023 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 Syndax Pharmaceuticals.

Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndax's Third Quarter 2023 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, and Keith Goldan, Chief Financial Officer. Also joining us on the call today for the question and answer session are Dr. Peter Ordenwek, 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 this 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 made represent our views as of today, November 2, 2023 only. A replay of this call will be available on the company's website, www.syndex.com, following its completion. With that, I am pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndex.

Thank you, Sharon, and thank you to everyone joining us on the webcast. This continues to be an exciting year for Syndax, and I look forward to sharing a number of updates with you on the significant progress we've made. Throughout the third quarter, we delivered on key pipeline milestones that are highlighted on slide three, including reporting positive top-line Agave 201 pivotal data of axotilumab for the treatment of chronic graft-versus-host disease. We also reported positive top-line pivotal Augment 101 data for Revumentive in adult and pediatric patients with relapsed refractory KMT2A rearranged acute leukemia. Together, these results put us on a clear path to becoming a commercial stage biopharmaceutical company in 2024 with two potentially first and best-in-class products. We are also happy to provide data today from additional relapse or refractory MPM-1 patients that were enrolled in the final stages of the Phase I portion of the Augment 101 trial. Neil will walk us through the data a little later in this call, but in summary, we are encouraged by the 36% CRCRH rate and deep responses that we are seeing in the MPM-1 population. Responses elicited by Revumentib in the NPM1 population are durable, with some patients in remission beyond 22 months, further supporting the rationale that Revumentib can provide a meaningful benefit to NPM1 patients and emphasizing its blockbuster commercial potential across both KMT2A and NPM1 acute leukemia. We continue our positive momentum heading into the end of 2023, with a primary focus on completing two potential regulatory filings by year-end and launching both drugs in 2024. This will put Syndex in a very unique position to create value as a SMIDCAP biotech company. We will have a significant presence at the American Society of Hematology ASH annual meeting, including at our planned investor event, and expect to provide several data updates on both these programs at that time. I am pleased to share that as of a few days ago, we initiated the NDA submission of Revumenev for KMT2A acute leukemia under the FDA's Real-Time Oncology Review Program, or RTOR. We view RTOR as a significant benefit for the Revumenev program. It complements our BTD and fast-track status for KMT2A and provides a more efficient review process to ensure that Revumenev is available to patients as early as possible. Under RTOR, the sponsor has consistent engagement with the FDA throughout the submission process. Drugs that are accepted for review into this program need to meet specific eligibility criteria, the most important of which is the likelihood of demonstrating substantial improvement over available therapy. In accordance with FDA guidance, For AML and in line with the approvals of other AML agents in the relapsed refractory setting, we anticipate Revimenib would be granted full approval based on the results of Augment 101. With our partner Insight, we also remain on track to complete the BLA filing for axotilamab by year end. As you saw from our press release earlier today, Data from both the Agave 201 and Augment 101 pivotal trials, including post-transplant maintenance data, along with revumetive combination data from the SAVE trial, will be presented at the ASH meeting in December. Beyond the Congress presentations, we will also have the opportunity to share additional data from ongoing revumetive combination trials at our ASH investor event, which will further reinforce revumetive's compelling clinical profile and meaningfully add to its value proposition. We are well-funded with $379 million in cash as of September 30th. Our current balance sheet not only supports our planned commercial launches and the trials that we have outlined, but also allows us to expand beyond our core registration indications and pursue select business development opportunities. Now let's dive into Revimenib, our highly-selective menin inhibitor. I'll ask Neil to provide a recap of the results from the Augment 101 pivotal trial, speak to the ASH abstracts, and review the data from the MPM-1 patients in the Phase 1 portion of the Augment 101 trial.