Syndax Pharmaceuticals, Inc. 2026 Q2 Earnings Call

Great. Thank you, operator. Welcome, thank you all for joining us today for a review of Syndax's second quarter 2026 financial and operating results. I'm Sharon Klahre, 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 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, August 4th, 2026 only. A replay of this call will be available on the company's website, www.syndax.com, following its completion. With that, I'm pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax.

Thank you, Sharon. Good afternoon, everyone, thank you for joining us. Starting with Slide three. The Syndax team delivered another quarter of solid commercial results and progress across our growing pipeline of programs targeting areas of high unmet need and substantial commercial opportunity. The business fundamentals are strong. Sales of Revuforj and Niktimvo grew to a combined total of $115 million in the second quarter. Both medicines are now annualizing at well over $200 million each, and we have just started to unlock their multibillion-dollar potential. Revuforj continued to grow by double digits, with net revenue totaling $55 million in the second quarter, up 91% year-over-year and 12% quarter-over-quarter.

These results highlight our continued leadership in menin inhibition, robust demand in both NPM1 and KMT2A, and the positive impact of an increasing average treatment duration driven by multiple factors, including a growing number of patients on therapy for an extended period after receiving a stem cell transplant. As the number of patients on therapy post-transplant continues to stack, this reoccurring base will be an important driver of long-term compounding growth. Encouragingly, the average duration of treatment is also increasing among patients who are not proceeding to a transplant. As Steve will describe shortly, the positive impact of an extending average treatment duration, which was partially offset this quarter by fluctuation in the number of new patients initiating therapy, one of several drivers of our business. Today, we are even more confident in the forward trajectory and substantial commercial opportunity with Revuforj.

Our conviction is underpinned by the multiple drivers for continued growth, including a best-in-class profile valued by physicians, an increasing average duration of therapy, a broad and expanding prescriber base, and ample opportunity in NPM1, KMT2A, and other menin-dependent acute leukemias. We are well-positioned to extend our leadership in menin inhibition into the future and continue driving innovation for patients. Building on a long history of landmark firsts, we are positioned to be first to frontline AML, driven by strong global site initiation and patient enrollment in our pivotal trials. With future anticipated indications in frontline AML, we expect that Revuforj could reach in excess of $2 billion in peak annual net revenue in the U.S. alone. We have another data-rich period ahead for revumenib.

In the second half of the year, we will report additional practice-informing evidence from multiple trials at major medical meetings, expanding on the prominent presence we had at ASCO and EHA in June. We also expect to publish data in relapse refractory NUP98-rearranged acute leukemia in the fourth quarter. These results could inform clinical practice and guidelines in a patient population similarly sized to KMT2A. Patients with NUP98 urgently need new treatment options, including therapies that may reduce the risk of relapse after transplant, as is the case with KMT2A. Physician feedback indicates that NUP98 rearrangements are more common than once thought, occurring in perhaps 5% or more of AML cases, translating into potentially 1,000-2,000 pediatric and adult patients with NUP98 annually.

As the first and only company to report clinical data showing activity with a menin inhibitor in this subtype, we have a unique opportunity to pursue a guideline listing that could meaningfully expand the patient population treated with revumenib. Switching gears to Niktimvo and chronic GVHD. Niktimvo net revenue grew to $60 million in the second quarter, up 67% year-over-year. This performance reflects robust demand and Niktimvo's unique ability to address inflammation and fibrosis. Niktimvo is positioned for further growth with strong adoption in the fourth line and increasing uptake in the third line, driven by a broad base of prescribers who are enthusiastic about the results they've seen in their patients. We also have multiple expansion opportunities and important upcoming catalysts for axatilimab with phase II data in IPF and frontline chronic GVHD expected in the fourth quarter, poised to unlock new multi-billion-dollar opportunities.

Turning to our pipeline assets. At our R&D event last month, we unveiled two innovative assets we are advancing into the clinic, leveraging our world-class R&D capabilities and experience taking revumenib and axatilimab from IND to FDA approval in about five years. SNDX-4321 is a novel mutant-selective CNS penetrant allosteric EGFR inhibitor for non-small cell lung cancer that offers a new approach to addressing patient populations with high unmet medical needs, such as those with L858R mutations and CNS metastases. SNDX-62122 is a next-generation menin inhibitor we are developing for myelofibrosis, or MF, building on our extensive experience pioneering menin inhibition in hematology. It is the first molecule from our internally developed and wholly owned library of next-generation menin inhibitors, which we intend to advance into promising new areas.

We are entering into another exciting chapter for the company as we build Revuforj and Niktimvo into major commercial franchises and leverage our proven R&D engine to bring new treatment options to even more patients. We are fully funded to execute on our commercial and R&D priorities and continue to advance towards profitability with growing revenue from the first two medicines from our pipeline. I will now turn the call over to Steve to discuss our commercial results in more detail.

Steve? Thank you, Michael. Starting with Revuforj on slide four.

We delivered our sixth consecutive quarter of double-digit Revuforj net revenue and prescription growth and continue to track well above launch benchmarks set by other mutation-directed AML therapies. Net revenue totaled $55 million, up 12% from the prior quarter. Total prescriptions were approximately 1,500, up 15% from the prior quarter. These results reflect robust demand and an increasing average duration of therapy, one of several important drivers of our business. We have dominant share of the overall menin business today, having treated over 1,600 patients commercially since launch, including 250 new patients added in the second quarter.

We saw some fluctuation in new patient starts in Q2 relative to prior quarters, reflecting typical variation quarter to quarter in the number of available patients with a rare disease and market dynamics when physicians have more than one drug in class they can consider using, depending on the patient's mutational profile. To ensure we leave no appropriate patient behind, we have optimized our established customer footprint and targeting, expanded our ability to leverage lab data to engage physicians when they have a suitable patient in their care, and increased our promotional efforts and educational activities. We remain confident we will continue to lead this market with the strongest efficacy profile in an efficacy-driven market and multiple drivers supporting long-term growth. Our business in KMT2A and NPM1 is strong, and it is growing.

Revuforj is the standard of care for relapsed/refractory KMT2A translocated acute leukemia and remains the only targeted therapy for an aggressive cancer with no other effective treatment options. We continue to expand into our second indication, with NPM1 accounting for at least 40% of new patients in the second quarter and more than 30% of the $55 million in net revenue. All indicators suggest Revuforj will continue to be the menin inhibitor of choice for all menin-dependent acute leukemias. Physicians value having one efficacious and well-tolerated drug they can use across multiple acute leukemia subtypes in both adults as well as children. They appreciate that the efficacy they see with Revuforj in the real world is consistent with, or in fact, even better than the clinical trial results.