Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndex Third Quarter 2024 Earnings Conference Call. Today's call is being recorded. All participants have been placed in a listen-only mode. You'll have an opportunity to ask questions after today's presentation. If you'd like to ask a question, please press star 5 on your telephone keypad to be placed in the queue. You may also press star 5 again to remove yourself from the queue. At this time, I'd like to turn over the call to Sharon Clary, Head of Investor Relations at Syndex Pharmaceuticals.

Great. Thank you, Operator. Welcome. And thank you all for joining us today as we review Syndex's third 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 Goldan, Chief Financial Officer. Also joining us on the call today for the question and answer session are Dr. Peter Ardentlich, Chief Scientific Officer, and Dr. Angela Ganguly, Chief Strategy 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 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 may represent our views as of today, November 5, 2024 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.

Thank you, Sharon. Good afternoon, everyone, and thank you for joining us today. We made remarkable progress in the third quarter. We delivered on multiple important milestones that demonstrate our ability to bring novel medicines to patients, and in doing so, we marked our transition from a development organization to an integrated commercial stage company with an extremely bright future. With the announcement of yesterday's $350 million royalty agreement for Nictimbo with Royalty Pharma, we have strengthened our balance sheet significantly and now have the capital to fund Syndax through profitability, ensuring strong launches for RevuMentive and Nictimbo, and solidifying our commitment to their continued development and expansion of the pipeline overall. Importantly, this deal further highlights how vastly underappreciated the value of Nictimbo is in the market and why it remains a critical element of our long-term strategy. Let me now dig into some third quarter milestones. In August, we received FDA approval for Nictimbo, the first and only CSF1R antibody approved for the treatment of chronic graft-versus-host disease, or GVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms. Shortly after we received FDA approval, the positive pivotal Agave 201 trial results were published in the New England Journal of Medicine, and Nictinvo was added to the latest NCCN guidelines, two achievements that highlight the significance of this dataset and the important role of Nictinvo in the treatment armamentarium. With Insight's deep understanding of the GBHD market and longstanding relationships with key stakeholders, we are thrilled to partner with them to bring this much-needed new option to patients. Later in the call, Steve will provide more color on our plans for the commercial launch. We believe the approval of Nictimbo represents the initial opportunity to make a major impact for patients by targeting the CSF1R pathway. Together with Insight, we are advancing a robust clinical development program, investigating the potential for Nictimbo in frontline chronic GVHD in combination with standard of care therapies and in other diseases marked by fibrosis and inflammation, such as idiopathic pulmonary fibrosis or IPF. In addition to making tremendous progress with Nictimbo, we've also continued to make excellent progress advancing Revimenib, our selective menin inhibitor that we anticipate will receive FDA approval this quarter in relapse or refractory KMT2A rearranged acute leukemia. With a PDUFA date of December 26, 2024, and compelling clinical data across the treatment continuum, we believe Revimenib is poised to become first-in-class and practice-changing therapy for KMT2A and MPM1 acute leukemia. In addition to the anticipated approval of Revimenib, we are also looking forward to the top-line readout from the pivotal cohort of patients with mutant MPM1 AML, our Augment 101 trial this quarter. In the recent months, we've executed on multiple initiatives that we believe lay the foundation for a strong Revumentib launch and successful long-term franchise growth across both KMT2A-rearranged and mutant NPM1 acute leukemias. In September, we published the pivotal data from the Augment 101 trial supporting the use of Revumentib in relapsed or refractory KMT2A-rearranged acute leukemia in the Journal of Clinical Oncology. This publication is raising awareness of Revumentum's compelling profile and potential utility once approved and will be instrumental in gaining rapid acceptance into the NCCN guidelines. As you saw from our press release earlier today, we have multiple presentations at ASH that highlight the clinical data supporting our two assets, including additional revument of data in KMT2A acute, rearranged acute leukemia from the phase two portion of our Augment 101 trial and new combination data from the investigator-sponsored SAVE trial. These data, which are consistent with our previously reported data, continue to show remarkable responses that are deep and durable in heavily pretreated patients. Furthermore, in both monotherapy and combination, Revimenib continues to demonstrate a tolerability profile that allows patients to benefit significantly from continued therapy. Beyond the conference presentations, we will also have the opportunity to discuss the latest data supporting our pipeline at ASH and our event on Monday, December 9th. And with that, I'm going to turn the call over to Neil to review the latest data in the ASH abstracts and review our RevuMedib clinical development program.