Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndax fourth quarter and full year 2024 earnings conference call. Today's call is being recorded. If you'd like to ask a question following the company's prepared remarks, please press star five during the call. 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 Synax's fourth quarter and full year in 2024 financial and operating results. I'm Sharon Clary, and with me this morning 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 for the call today for the question and answer session are Dr. Peter Ordentlich, Chief Scientific Officer, and Dr. Anjali 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 report titled, Form 10-K, as well as other reports filed with the SEC. Any forward-looking statements made represent our views as of today, March 3, 2025 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. Good morning, everyone, and thank you for joining us on the call today. Starting with slide three, we made exceptional progress in 2024 with the FDA approval of two first-in-class medicines that address major unmet needs, a truly remarkable achievement which puts Syndax in a unique category as a biopharmaceutical company. Today marks another major milestone in the company's evolution as we report our first quarter with product revenue. As a reminder, on November 15, 2024, the FDA approved RevuForge, our first-in-class menin inhibitor for relapsed refractory acute leukemia patients with a KMT2A translocation. Just five days later, we had product in the channel with immediate ordering, a very fast timeline that highlights the caliber of the team that we have built to support our transition into a leading commercial oncology company. We are off to a strong start with the U.S. launch of Reviforge and are very encouraged by the early patient demand, breadth of prescribing, and coverage from payers. For the fourth quarter of 2024, we reported $7.7 million in Revuforge net revenue from the initial five weeks of the launch. These early results reflect the high unmet need and demand that Revuforge addresses and the strong execution of our organization to deliver the product. We were very excited about the opportunity we have with Revuforge, especially given the clinical data supporting the significant opportunity for future label expansions. We recently reported the first positive pivotal data set in relapse or refractory mutant NPM1 AML, and have continued to report data that shows strong evidence of synergistic activity in combination with standard of care therapies across newly diagnosed and relapsed or refractory patients with KMT2A rearrangements, the MPM1 mutations, or NIP98 rearrangements. We are preparing to file a supplemental new drug application, or SNDA, next quarter that could expand the indicated population for Reviforge into mutant MPM1 AML around the end of the year. In parallel, we are also aggressively advancing our clinical development strategy in the frontline setting to support label expansions and inclusion in the NCCN guidelines. We are very confident that we are well positioned to lead in the frontline setting, building off our leadership in the space as the first and only company with approved Mennon inhibitor. Shifting gears to our second product, Nictinvo. We are thrilled to have launched Nictinvo in chronic graft-versus-host disease, or CGVHD, in late January in partnership with Insight, the leader in graft-versus-host disease. Nictinvo is the first and only FDA-approved treatment for chronic GVHD that targets CSF1R to reduce the drivers of inflammation and fibrosis. Like Revuforge, Nictimbo has significant potential for expansion. To unlock those opportunities, we at Insight are advancing multiple trials. Two trials are underway that are evaluating Nictimbo in combination with standard of care therapies in newly diagnosed chronic GVHD patients, including a phase two trial with Jacopi and a phase three trial with steroids. Enrollment is also ongoing for MaxPyre, our phase 2 trial in idiopathic pulmonary fibrosis, or IPF, with top-line data expected in 2026. Turning to our financial position. In November, we further strengthened our balance sheet through a deal with Royalty Pharma, the premier company and the largest buyer of biopharmaceutical royalties. We received $350 million upfront in exchange for a capped royalty on US net sales of Nictimbo, a deal that highlights Nictimbo's multi-billion dollar potential. We are in a strong financial position with a balance sheet that is expected to fund our operations through profitability. I will now turn the call over to Steve to discuss our commercial progress in more detail. Steve?