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4/30/2026
Good day, everyone, and welcome to the Syndax first quarter 2026 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 spell five during the call. At this time, I would like to turn the call over to Sharon Cleary, head of investor relations at Syndax Pharmaceuticals.
Thank you, Operator. Welcome, and thank you all for joining us today for a review of Syndox's first quarter 2026 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 factor section in the company's most recent quarterly report on Form 10Q, as well as other reports filed with the SEC. Any forward-looking statements made represent our views as of today, April 30, 2026 only. A replay of this call will be available on the company's website, www.syndax.com, following its completion. And with that, I'm 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. In the first quarter, we continue to make strong progress advancing our commercial objectives and pipeline programs designed to unlock the full potential of our first two medicines. On the commercial front, we delivered over $100 million in combined sales of Revuforge and Nictimbo, underscoring robust demand for both medicines and advancing the company towards profitability. RevenueForge net revenue totaled $49 million in the first quarter, highlighting our leadership position in men in innovation and strong adoption across both indications. Revuforge net revenue grew by double digits quarter over quarter, primarily driven by new NPM1 patients. Adoption in NPM1 has been strong and growing steadily since Revuforge was added to the NCCN guidelines for relapse refractory NPM1 mutated AML in September of 2025, followed by the FDA approval of our expanded label in October of 2025. We are the leaders in the relapse refractory space in both NPM1 and KMT2A and well-positioned to drive further growth and unmatched efficacy data and expanding prescriber base, excellent payer coverage, and multiple evolving treatment dynamics that should ultimately extend the average duration of therapy, including a growing number of KMT2A patients proceeding to transplant after receiving Reviforge. Notably, recent analysis indicates that Reviforge is enabling nearly half of KMT2A patients to receive a potentially curative stem cell transplant, a significant increase from our prior estimates of 33%. This growing transplant rate gives patients the best chance for durable remissions, ultimately driving longer treatment durations as an increasing number of patients return to therapy post-transplant. This step change compared to the 25% transplant rate we observed in our clinical trial aligns with what we have expected as Reviforge is used earlier in the treatment paradigm and often in combination with other therapies in the real world. The pool of patients on Revuforge post-transplant is expanding each quarter, although that growth continues to be obscured by the large number going to transplant. While the robust transplant rate seen with Revuforge has a short-term impact on the business, it is first and foremost a very positive outcome for patients and will translate into durable and sustainable growth as an increasing number of patients return to therapy. This is an important and unique growth driver of our KMT2A business. Turning to Nictimbo and chronic graft-versus-host disease, or GVHD. Nictimbo delivered $55 million in net revenue in the first quarter. This result reflects consistent new patient starts, partially offset by natural attrition among the large cohort of predominantly later line patients who started Nictimbo during the first quarter of launch last year. Notably, the same dynamic was also seen during the same period of the launch of Resiroc, as well as other rare disease therapies. Looking ahead, we expect strong growth with multiple drivers supporting the business, including a broad prescriber base and increasing uptake in the third line, which should extend the average duration of therapy. Turning to our pipeline, we've made excellent progress advancing the programs that will fuel the next phase of growth for the company, including our pivotal frontline trials of Revimentib. We are well positioned to be the first to get a Mennon inhibitor approved in frontline AML with strong global site activation, and patient enrollment underway in our pivotal trials. We will continue to expand the body of evidence supporting our medicines with multiple important data readouts anticipated in the second quarter and throughout the year. Similar to past years, we will have a major presence at ASCO, EHA, and ASH with new data for multiple studies of Reviforge across the acute leukemia treatment continuum, including new maintenance data, which will be highlighted in an oral session at ASCO. These upcoming datasets will continue to advance our leadership in men and inhibition and highlight ReviForge's best-in-class profile across multiple acute leukemia subtypes and settings. We are also nearing two potentially transformative Nictimbo readouts in the fourth quarter, including phase two data in idiopathic pulmonary fibrosis, or IPF, and in newly diagnosed chronic GVHD patients treated with Nictimbo plus Jacify. Data from these trials could further unlock Nictimbo's multibillion-dollar potential in chronic GVHD, IPF, and beyond. From a position of strength, we are delivering long-term and sustainable growth and advancing innovative treatments that can significantly improve the lives of patients. We have a world-class R&D and commercial organization with a proven track record of delivering breakthrough medicines to patients. We have two products poised for future label expansion, important upcoming data readouts, and the expertise necessary to continue delivering innovative medicines. We are well-funded to invest in the successful commercialization and further development of RevenueForge and Nictimbo and on our way to reaching profitability with growing revenue and a stable expense outlook. I'll now turn the call over to Steve to discuss our commercial results in more detail.
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