Syndax Pharmaceuticals, Inc.

Good day, everyone, and welcome to the Syndex second 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 Clarie, head of investor relations at Syndex Pharmaceuticals.

Thank you, Operator. Welcome, and thank you all for joining us today for a review of CINDAS' second quarter 2025 financial and operating results. I'm Sharon Clary, and with me today 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, Keith Goldan, Chief Financial Officer. Also joining us on the call today for question and answer session are Dr. Peter Ardentlich, Chief Scientific Officer, and Dr. Angela 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 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 the 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 10-Q, as well as other reports filed with the SEC. Any forward-looking statements may represent our views as of today, August 4th, 2025 only. A replay of this call will be available on the company's website, www.syndax.com, following its completion. And with that, I am pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax.

Thank you, Sharon, and good afternoon, and thank you all for joining us today. Starting with slide three. First half of 2025 has been a transformational period for Syndax marked by excellent commercial and pipeline execution. We are well positioned for rapid growth in the second half of 2025 and beyond with its two first and best-in-class therapies with a combined market opportunity exceeding $10 billion. RevuForge and Nick Timbo sales are growing with nearly $100 million in combined net product sales in the first half of the year, significantly exceeding expectations. Notably, RevenueForge net revenue increased 43%, quarter over quarter, to $28.6 million, even with approximately a third of patients pausing treatment to receive a stem cell transplant. Importantly, we are on the road to profitability, with growing contributions from RevenueForge and Nictimbo, a strong balance sheet, and an operating expense base that will remain stable for the next few years while fully funding our strategic priorities. Looking to the future, our leadership in the men in space positions us to be first to the front line and meaningfully expand the RevuForge franchise. We have a similarly compelling opportunity to bring Nictimbo into earlier lines of therapy and additional patient populations. Turning to slide four, let's dive into more detail on RevuForge, the first and only FDA-approved treatment for relapse or refractory acute leukemia with a KMT2A translocation. The continued growth reflects strong uptake, the high medical need, and physicians' enthusiasm for RevuForge. It is clear following the recent presentations at ASCO and EHA that RevuMedib has a best-in-class profile with compelling activity across multiple genetic subtypes, including efficacy data in relapsed refractory mutant NPM1 AML that surpass any other results seen in the field. The breadth and strength of our clinical data will be the key to our success in acute leukemia, a market that is efficacy-driven given the severity of the disease. As we look ahead, the outlook is very promising, with multiple drivers that will further solidify our leading position and ensure sustained growth for many years to come. I will briefly highlight those drivers, and the team will provide additional details. First, patient identification and uptake has been strong. Since launch, we have already treated over 500 patients with Reviforge with approximately 90% of usage in KMT2A patients. In just seven months, we have already reached a quarter of the 2,000 patients diagnosed with relapsed refractory KMT2A acute leukemia each year. Based on the robust activity we have seen in this population and physician excitement around the drug, we expect the total number of patients treated with Revuforge to grow materially in future quarters, particularly as it is the only approved therapy for these patients. Second, Revuforge is increasingly being used in earlier lines of therapy. Emerging claims data show that the use in KMT2A as of this quarter is already being concentrated in the second line. This trend is especially important in oncology because as patients are treated earlier, they generally have a higher response rate, a longer duration of response, and a higher chance of proceeding to a potentially curative stem cell transplant. Thus, as Revuforge is used earlier, we expect to see an increase in the average time on drug for all patients. We also expect to see a high rate of patients proceeding to transplant, a higher rate of patients treating to proceeding to transplant than was observed in our pivotal trial, which on average enrolled a later line patient population. In fact, early indicators suggest that we are already seeing a meaningfully higher transplant rate in the commercial setting. Third, as the group of patients receiving Revuforge post-transplant increases, it should substantially increase the overall duration of therapy. Notably, prescribing physicians tell us they plan to restart patients on Revuforge post-transplant for one to two years. Given the high risk of recurrence, both patients and physicians tell us they are eager to restart the therapy that induced remission, especially when the drug has an excellent tolerability profile. These three drivers position Reviforge to transform care for KMT2A patients from an acute treatment paradigm with survival measured in a few months to a more chronic disease with the potential to extend survival from months to years. Importantly, relapsed refractory KMT2A acute leukemia is just the first opportunity for Revuforge. In the near term, we anticipate both the inclusion of Revuforge in the clinical treatment guidelines and the approval of our supplemental new drug application, or SNDA, in relapsed refractory mutant NPM1 AML. The anticipated approval of our SNDA, which was recently granted priority review and assigned a PDUFA action date of October 25, 2025, would expand our addressable population to over 6,000 patients across both genetic subtypes and increase the relapse refractory market opportunity for Revuforge in the U.S. to $2 billion. Importantly, Revuforge is positioned to become the first and only menin inhibitor with a label that expands to mutant NPM1 and KMT2A translocated patients, both adults and children. Based on resounding KOL feedback, the expected breadth of our label will be a major competitive advantage. Looking to the future, we will further extend our leadership into the frontline setting, a U.S. market opportunity exceeding $5 billion. Enrollment is already ongoing in our frontline trial for patients unfit to receive intensive chemotherapy, and startup activities are well underway to initiate our trials in patients able to receive intensive chemotherapy. With RevuForge's best-in-class profile and a multi-year start into the market versus potential MeToo competitors, we will maintain our dominant position in this multibillion-dollar market opportunity. Shifting gears to slide 5 to Nictimbo, our first-in-class therapy for chronic graft-versus-host disease, or GVHD. I am pleased to highlight a very successful first full quarter for sales with our partner Insight reporting $36.2 million in net revenue. This is up significantly from $13.6 million in the first two months of the launch in Q1. The $50 million in net revenue generated in the first five months of the launch underscores the substantial opportunity in chronic GVHD. Importantly, Nictimbo is already profitable to Syndex, with our 50% share of the Nictimbo product contribution amounting to $9.4 million for the second quarter. As sales continue to ramp, the cash flow contributions to Syndex from Nictimbo will only grow in significance. With initial Nictimbo sales tracking with the early benchmark set by Resiroc, another product approved in the third-line chronic GVHD setting, now annualizing at more than $500 million in the U.S. within three years of its launch. We are confident that Nictimbo will be a critical component of our success for many years to come. Finally, before I hand the call over to the team, I would like to highlight that we also strengthened our leadership team this quarter with the addition of Dr. Nick Botwood as head of R&D and chief medical officer. Nick is a medical oncologist by training with over 25 years of experience leading the development and global commercialization of novel oncology medicines, including blockbuster drugs such as Updivo and Urovoi during his time at BMS. I would also like to thank Bill Meary for his seven years of service on our board and congratulate him on his new role as CEO of Insight, our partner for Nictimbo. Bill has been an invaluable member of our board as we developed and launched both rugs, and we look forward to working closely with him and the Insight team as we continue to unlock Nictimbo's value. And with that, I will turn the call over to Steve to discuss our commercial progress in more detail. Steve, please.