Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndax fourth quarter 2025 earnings conference call. Today's call is being recorded. If you would like to ask a question following the company's prepared remarks, please press star five during the call. 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 fourth quarter and full year 2025 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, Steve Kloster, Chief Commercial Officer, Dr. Nick Botwood, Head of R&D and Chief Medical Officer, and Keith Goldan, Chief Financial 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 factors section in the company's most recent Form 10-K, as well as other reports filed with the SEC. Any forward-looking statements may represent our views as of today, February 2026 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 afternoon, everyone, and thank you for joining us. Starting with slide three. I'm pleased to share our fourth quarter and full year financial results following a transformational year that positions Syndex for continued growth in 2026 and beyond. In 2025, we demonstrated the exceptional strength of our commercial and R&D capabilities, successfully launching two first and best-in-class medicines and achieving our third FDA approval within the span of approximately one year. 2025 was a remarkable year for Syndex, and we have only just started to unlock the potential of our first two medicines. Let's dive into our commercial results for Revuforge. In the first full year of sales, we generated robust top-line results, delivering $125 million in Revuforge net revenue in 2025 and further solidifying our leadership in Mennon Innovation. Notably, we ended the fourth quarter with 38% growth in Reviforge net revenue and 35% growth in prescription quarter-over-quarter, showing strong demand and momentum heading into 2026. Two main factors drove this impressive increase in demand. First, continued growth in our KMT2A business as the number of patients on therapy post-transplant begins to meaningfully stack. Second, growing uptake and relapse refractory NPM1 mutated AML following the FDA's approval of our expanded label at the end of October. Our launch into NPM One is off to an excellent start, building on the solid foundation we established through our launch in KMT2A, including a robust prescriber base that has extensive experience and comfort using ReviForge. We are confident we will win in NPM One with a best-in-class product profile, including the broadest label and unmatched efficacy data, together with strong customer relationships and excellent market access. Turning to Nictimbo and chronic graft-versus-host disease, or GVHD. Fourth quarter results were strong, with a 22% increase in Nictimbo net revenue quarter over quarter. This continued growth reflects a steady stream of new patient starts and a high percentage of patients staying on therapy. Nictimbo net revenue for 2025 reached $152 million in the first 11 months of launch, tracking ahead of the one-year benchmark set by Sanofi's Resuroc, which reached $500 million in annual U.S. net sales within the first four years of launch in the same indication. Nictimbo's outperformance highlights its unique ability to address both fibrosis and inflammation. As we expected, Nictimbo contributed significantly to our bottom line in 2025. Our 50% share of the Nictimbo product contribution totaled $42 million in collaboration revenue to Syndax in 2025. As Nictimbo sales continue to ramp, while much of the expense base stayed largely fixed, we expect to retain an even larger proportion of Nictimbo revenue over time. Altogether, Syndex revenue reached $172 million in 2025. Achieving this result in our first year as a commercial company underscores the significant unmet needs we are addressing and our ability to execute at the highest level. We remain confident in the continued success of both launches supported by multiple growth drivers that Steve will discuss shortly. Importantly, we remain well-funded to continue investing in our strategic priorities to fuel the next phase of growth. This includes advancing our lifecycle and frontline programs to expand our patient impact and unlock more than $10 billion in total addressable market opportunity. On the clinical development front, we made significant progress advancing our pipeline in 2025 and recent months. In addition to achieving a second FDA approval for Reviforge, we were also the first company to initiate enrollment in a pivotal frontline trial of a Menden inhibitor, positioning Syndax to be the first to frontline. We also delivered the first real-world evidence for a Menden inhibitor, among many other achievements that advanced our scientific leadership and the body of evidence supporting our medicines. More recently, we completed enrollment in MaxPyre, a robust phase 2 trial of axotilamab in idiopathic pulmonary fibrosis, or IPF, a disease with high unmet need which affects a large patient population. This trial has the potential to demonstrate axotilamab's utility in IPF and provide further rationale for its mechanism in a number of diseases with similar manifestations. We've made remarkable strides advancing our mission and building Syndex into a leading oncology company. With two successful commercial launches, gaining momentum, important upcoming data readouts, and multiple exciting opportunities for label expansions, we are positioned to make a major impact on patient care and deliver long-term and sustained growth. With that, I will turn the call over to Steve to discuss our commercial progress in more detail. Steve?