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8/4/2026
Good day, everyone, and welcome to the Syndex second quarter 2026 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 would like to turn the call over to Sharon Klahre, head of investor relations at Syndex Pharmaceuticals.
Great, thank you, Operator. Welcome, and thank you all for joining us today for a review of CINDEX'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 Closter, 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. 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. The Syntax 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 Revuforge and Nictimbo 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 multi-billion dollar potential. Revuforge continue 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 men and 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 recurring 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 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 Revuforge. 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, Thank you for joining us today. With future anticipated indications in frontline AML, we expect that Revuforge 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 Revumenta. 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 to 2,000 pediatric and adult patients with NUP98 annually. As the first and only company to report clinical data showing activity with a Mennon inhibitor in this subtype, we have a unique opportunity to pursue a guideline listing that could meaningfully expand the patient population treated with RevuMennon. Switching gears to Nictimbo and chronic GVHD. Nictimbo net revenue grew to $60 million in the second quarter, up 67% year over year. This performance reflects robust demand and Nictimbo's unique ability to address inflammation and fibrosis. Nick Timbo 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 axotilamab with phase two 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 Revimedib and Axotilimab from IND to FDA approval in about five years. SNDX 4321 is a novel mutant-selective CNS-penetrant allosteric EGFR inhibitor for non-smell 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. SNGX62122 is a next-generation MEN inhibitor we are developing for myelofibrosis, or MF, building on our extensive experience pioneering MEN inhibition in hematology. It is the first molecule from our internally developed and wholly owned library of next-generation MEN inhibitors, which we intend to advance into promising new areas. We are entering into another exciting chapter for the company as we build Revuforge and Nictimbo 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?
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