Q1 2026 Syndax Pharmaceuticals Inc Earnings Call

April 30, 2026

Operator 2: Good day, everyone, welcome to the Syndax Q1 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 star five during the call. At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.

Operator: Good day, everyone, welcome to the Syndax Q1 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 star five during the call. At this time, I would like to turn the call over to Sharon Klahre, Head of Investor Relations at Syndax Pharmaceuticals.

Speaker #3: At this time, I would like to turn the call over to Sharon Clary, Head of Investor Relations at Syndax Pharmaceuticals. Great. Thank you, operator.

Sharon Klahre: Great. Thank you, operator. Welcome, and thank you all for joining us today for a review of Syndax's Q1 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; Steven Closter, Chief Commercial Officer; Dr. Nicholas 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 2. 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.

Speaker #3: Welcome, and thank you all for joining us today for a review of Syndax's first 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; Steven Closter, Chief Commercial Officer; Dr. Nicholas Botwood, Head of R&D and Chief Medical Officer; and Keith Goldan, Chief Financial Officer.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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 10-Q.

Sharon Klahre: 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, 30 April 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.

Speaker #3: 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.

Speaker #3: And with that, I'm pleased to turn the call over to Michael Metzger, Chief Executive Officer of Syndax.

Speaker #2: 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.

Michael Metzger: Thank you, Sharon. Good afternoon, everyone, thank you for joining us. Starting with slide 3. In Q1, we continued to make strong progress advancing our commercial objectives and pipeline programs designed to unlock the full potential of our first 2 medicines. On the commercial front, we delivered over $100 million in combined sales of Revuforj and Niktimvo, underscoring robust demand for both medicines advancing the company towards profitability. Revuforj net revenue totaled $49 million in Q1, highlighting our leadership position in menin inhibition strong adoption across both indications. Revuforj net revenue grew by double digits quarter-over-quarter, primarily driven by new NPM1 patients.

Speaker #2: On the commercial front, we delivered over $100 million in combined sales of RevuForge and Nictimvo, underscoring robust demand for both medicines and advancing the company towards profitability.

Speaker #2: RevuForge net revenue totaled $49 million in the first quarter, highlighting our leadership position in men and inhibition and strong adoption across both indications. RevuForge net revenue grew by double digit, double digits, quarter over quarter, primarily driven by new MPM1 patients.

Speaker #2: Adoption in MPM1 has been strong, and growing steadily since RevuForge was added to the NCCN guidelines for relapse refractory MPM1 mutated AML in September of 2025, followed by the FDA approval of our expanded label in October of 2025.

Michael Metzger: Adoption in NPM1 has been strong and growing steadily since Revuforj was added to the NCCN guidelines for relapsed refractory NPM1 mutated AML in September 2025, followed by the FDA approval of our expanded label in October 2025. We are the leaders in the relapsed 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 Revuforj. Notably, recent analysis indicates that Revuforj is enabling nearly half of KMT2A patients to receive a potentially curative stem cell transplant, a significant increase from our prior estimates of 33%.

Speaker #2: We are the leaders in the relapse refractory space in both MPM1 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 RevuForge.

Speaker #2: Notably, recent analysis indicates that RevuForge is enabling nearly half of KMT2A patients to receive a potentially curative stem cell transplant, a significant increase from our prior estimates of 33%.

Speaker #2: This growing transplant rate gives patients the best chance for durable remissions ultimately driving longer-term treatment durations as an increasing number of patients return to therapy post-transplant.

Michael Metzger: 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 Revuforj is used earlier in the treatment paradigm and often in combination with other therapies in the real world. The pool of patients on Revuforj 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 Revuforj 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.

Speaker #2: This step change compared to the 25% transplant rate we observed in our clinical trial aligns with what we have expected as RevuForge is used earlier in the treatment paradigm and often in combination with other therapies in the real world.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: This is an important and unique growth driver of our KMT2A business. Turning to Nictimvo and chronic graft versus host disease, or GVHD. Nictimvo delivered 55 million in net revenue in the first quarter.

Michael Metzger: This is an important and unique growth driver of our KMT2A business. Turning to Niktimvo and chronic graft versus host disease, or GVHD. Niktimvo delivered $55 million in net revenue in the Q1. This result reflects consistent new patient starts, partially offset by natural attrition among the large cohort of predominantly later-line patients who started Niktimvo during the Q1 of launch last year. Notably, the same dynamic was also seen during the same period of the launch of Rezurock, 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.

Speaker #2: This result reflects consistent new patient starts, partially offset by natural attrition among the large cohort of predominantly later line patients who started Nictimvo during the first quarter of launch last year.

Speaker #2: Notably, the same dynamic was also seen during the same period of the launch of Reseroc 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.

Speaker #2: 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 Revumenib, we are well positioned to be the first to get a men and inhibitor approved in frontline AML with strong global site activation and patient enrollment underway in our pivotal trials.

Michael Metzger: 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 revumenib. We are well-positioned to be the first to get a menin 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 Q2 and throughout the year. Similar to past years, we will have a major presence at ASCO, EHA, and ASH with new data from multiple studies of Revuforj 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 menin inhibition and highlight Revuforj's best-in-class profile across multiple acute leukemia subtypes and settings.

Speaker #2: 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.

Speaker #2: Similar to past years, we will have a major presence at ASCO, EHA, and ASH with new data from multiple studies of RevuForge across the acute leukemia treatment continuum, including new maintenance data, which will be highlighted in an oral session at ASCO.

Speaker #2: These upcoming data sets will continue to advance our leadership in men and inhibition and highlight RevuForge's best-in-class profile across multiple acute leukemia subtypes, and settings.

Speaker #2: We are also nearing two potentially transformative Nictimvo readouts in the fourth quarter, including Phase 2 data in idiopathic pulmonary fibrosis, or IPF, and in newly diagnosed chronic GVHD patients treated with Nictimvo plus Jakafi.

Michael Metzger: We are also nearing 2 potentially transformative Niktimvo readouts in Q4, including Phase 2 data in idiopathic pulmonary fibrosis, or IPF, and in newly diagnosed chronic GVHD patients treated with Niktimvo plus Jakafi. Data from these trials could further unlock Niktimvo's multi-billion 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 2 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 successful commercialization and further development of Revuforj and Niktimvo, on our way to reaching profitability with growing revenue and a stable expense outlook.

Speaker #2: Data from these trials could further unlock Nictimvo'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.

Speaker #2: 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.

Speaker #2: We are well funded to invest in the successful commercialization and further development of RevuForge and Nictimvo, and on our way to reaching profitability with growing revenue and a stable expense outlook.

Speaker #2: I'll now turn the call over to Steve to discuss our commercial results in more detail. Steve.

Michael Metzger: I'll now turn the call over to Steve to discuss our commercial results in more detail. Steve?

Speaker #3: Thank you, Michael. Starting with the RevuForge on slide four. RevuForge is now a little over a year into launch, and by any measure, it has been an exceptional commercial success with net revenue now annualizing at nearly $200 million.

Steven Closter: Thank you, Michael. Starting with Revuforj on slide 4. Revuforj is now a little over a year into launch. By any measure, it has been an exceptional commercial success, with net revenue now annualizing at nearly $200 million. We continue to track well above launch benchmarks set by other AML therapies and expect to continue to outpace other drugs and redefine success in this space. Two factors underpin our conviction, our ability to target a substantially larger population than other mutation-directed AML therapies and multiple treatment patterns that are expected to extend the average treatment duration. In Q1, we delivered approximately $49 million in Revuforj net revenue and double-digit quarter-over-quarter growth across all key metrics, including net revenue, total prescriptions, and new patient starts. Two drivers of our business, new patient starts and patients returning to therapy post-transplant. Both are building nicely.

Steve Closter: Thank you, Michael. Starting with Revuforj on slide 4. Revuforj is now a little over a year into launch. By any measure, it has been an exceptional commercial success, with net revenue now annualizing at nearly $200 million. We continue to track well above launch benchmarks set by other AML therapies and expect to continue to outpace other drugs and redefine success in this space. Two factors underpin our conviction, our ability to target a substantially larger population than other mutation-directed AML therapies and multiple treatment patterns that are expected to extend the average treatment duration. In Q1, we delivered approximately $49 million in Revuforj net revenue and double-digit quarter-over-quarter growth across all key metrics, including net revenue, total prescriptions, and new patient starts. Two drivers of our business, new patient starts and patients returning to therapy post-transplant. Both are building nicely.

Speaker #3: We continue to track well above launch benchmarks set by other AML therapies, and expect to continue to outpace other drugs and redefine success in this space.

Speaker #3: Two factors underpin our conviction: our ability to target a substantially larger population and other mutation-directed AML therapies and multiple treatment patterns that are expected to extend the average treatment duration.

Speaker #3: In the first quarter, we delivered approximately 49 million in RevuForge net revenue, and double-digit quarter-over-quarter growth across all key metrics, including net revenue, total prescriptions, and new patient starts.

Speaker #3: Two drivers of our business: new patient starts and patients returning to therapy post-transplant, and both are building nicely. We added about 330 new patients in the first quarter, up approximately 10% compared to last quarter, with the growth driven by new MPM1 patients.

Steven Closter: We added about 330 new patients in Q1, up approximately 10% compared to last quarter, with the growth driven by new NPM1 patients. New patient starts have increased even more significantly compared to the 200 to 250 patients we were adding per quarter prior to the expansion of the Revuforj label to include patients 1 year and older with relapsed refractory NPM1-mutated AML. We've continued to gain momentum and reach new highs, demonstrating the durability of Revuforj's strong market position, even with the launch of a second menin inhibitor approved for adult NPM1 patients. Early indicators suggest at least 40% of new starts in Q1 were NPM1 patients, up significantly from 10% of new patients prior to the NCCN guideline update in September 2025.

Steve Closter: We added about 330 new patients in Q1, up approximately 10% compared to last quarter, with the growth driven by new NPM1 patients. New patient starts have increased even more significantly compared to the 200 to 250 patients we were adding per quarter prior to the expansion of the Revuforj label to include patients 1 year and older with relapsed refractory NPM1-mutated AML. We've continued to gain momentum and reach new highs, demonstrating the durability of Revuforj's strong market position, even with the launch of a second menin inhibitor approved for adult NPM1 patients. Early indicators suggest at least 40% of new starts in Q1 were NPM1 patients, up significantly from 10% of new patients prior to the NCCN guideline update in September 2025.

Speaker #3: New patient starts have increased even more significantly compared to the 200 to 250 patients we were adding per quarter prior to the expansion of the RevuForge label, to include patients one year and older with relapse refractory MPM1 mutated AML.

Speaker #3: We've continued to gain momentum and reach new highs demonstrating the durability of RevuForge's strong market position, even with the launch of a second men and inhibitor approved for adult MPM1 patients.

Speaker #3: Early indicators suggest at least 40% of new starts in the first quarter were MPM1 patients, up significantly from 10% of new patients prior to the NCCN guideline update in September 2025.

Speaker #3: Between the MPM1 patients who started in the first quarter and those continuing on therapy from prior months, we estimate MPM1 accounted for at least 30% of the 49 million in net revenue.

Steven Closter: Between the NPM1 patients who started in Q1 and those continuing on therapy from prior months, we estimate NPM1 accounted for at least 30% of the $49 million in net revenue. We're positioned to be the market leader in NPM1 with the strongest clinical profile. In recent market research, HCPs who treat our target population ranked efficacy as the most important factor in their treatment decision, followed by safety and tolerability, availability of long-term efficacy data, personal experience with the drug, and inclusion in clinical guidelines. Notably, more HCPs strongly favored Revuforj over the other approved menin inhibitor on the top five most important factors, as well as nearly all other factors, including ease of access, drug-to-drug interactions, peer or KOL endorsement, ease of administration, and flexible dosing, to name a few. Turning to slide 5.

Steve Closter: Between the NPM1 patients who started in Q1 and those continuing on therapy from prior months, we estimate NPM1 accounted for at least 30% of the $49 million in net revenue. We're positioned to be the market leader in NPM1 with the strongest clinical profile. In recent market research, HCPs who treat our target population ranked efficacy as the most important factor in their treatment decision, followed by safety and tolerability, availability of long-term efficacy data, personal experience with the drug, and inclusion in clinical guidelines. Notably, more HCPs strongly favored Revuforj over the other approved menin inhibitor on the top five most important factors, as well as nearly all other factors, including ease of access, drug-to-drug interactions, peer or KOL endorsement, ease of administration, and flexible dosing, to name a few. Turning to slide 5.

Speaker #3: We're positioned to be the market leader in MPM1 with the strongest clinical profile. In recent market research, HCPs who treat our target population ranked efficacy as the most important factor in their treatment decision, followed by safety and tolerability, availability of long-term efficacy data, personal experience with the drug, and inclusion in clinical guidelines.

Speaker #3: Notably, more HCPs strongly favored RevuForge over the other approved men and inhibitor on the top five most important factors, as well as nearly all other factors, including ease of access, drug-to-drug interactions, peer or KOL endorsement, ease of administration, and flexible dosing, to name a few.

Speaker #3: Turning to slide five, we have a strong foundation to support the continued expansion of our KMT2A and MPM1 business, including a world-class team with excellent customer relationships and favorable listings in the NCCN guidelines—the most influential guidelines for clinicians, as well as payers.

Steven Closter: We have a strong foundation to support the continued expansion of our KMT2A and NPM1 business, including a world-class team with excellent customer relationships and favorable listings in the NCCN guidelines, the most influential guidelines for clinicians as well as payers. Our already robust prescriber base has continued to expand following our approval in NPM1, including our activation of Tier 1 and Tier 2 accounts, the highest volume centers in the US who treat two-thirds of our target population. Over 85% of these accounts have now ordered, up from 70% prior to the label expansion. The total number of accounts that have ordered has also increased quarter over quarter and is now well over 500 accounts, reflecting growing adoption in centers of all sizes, including community practices.

Steve Closter: We have a strong foundation to support the continued expansion of our KMT2A and NPM1 business, including a world-class team with excellent customer relationships and favorable listings in the NCCN guidelines, the most influential guidelines for clinicians as well as payers. Our already robust prescriber base has continued to expand following our approval in NPM1, including our activation of Tier 1 and Tier 2 accounts, the highest volume centers in the US who treat two-thirds of our target population. Over 85% of these accounts have now ordered, up from 70% prior to the label expansion. The total number of accounts that have ordered has also increased quarter over quarter and is now well over 500 accounts, reflecting growing adoption in centers of all sizes, including community practices.

Speaker #3: Our already robust prescriber base has continued to expand following our approval in MPM1, including our activation of Tier 1 and Tier 2 accounts. The highest volume centers in the U.S., who treat two-thirds of our target population.

Speaker #3: Over 85% of these accounts have now ordered, up from 70% prior to the label expansion. The total number of accounts that have ordered has also increased quarter over quarter and is now well over 500 accounts, reflecting growing adoption in centers of all sizes, including community practices.

Speaker #3: Our growing prescriber base reflects physicians' enthusiasm to use RevuForge for their MPM1 patients and physicians of us to drive further penetration in both indications.

Steven Closter: Our growing prescriber base reflects physicians' enthusiasm to use Revuforj for their NPM1 patients and positions us to drive further penetration in both indications. We also have nearly perfect payer coverage, and physicians can access the menin inhibitor they prefer without any meaningful barriers. Revuforj's formulary coverage stands at 97% of all covered lives, including all commercially covered lives, Medicare, and Medicaid, a coverage position that leads the class. We have engaged and educated payers extensively, they recognize the value of Revuforj and its status as the only menin inhibitor approved for multiple acute leukemia subtypes. While the class leader in NPM1 will be determined by HCP preference, not price or recommendations from payers, I will note that payers understand the two menin inhibitors are priced at parity, with Revuforj actually costing less for the large percentage of patients on CYP3A4 inhibitors.

Steve Closter: Our growing prescriber base reflects physicians' enthusiasm to use Revuforj for their NPM1 patients and positions us to drive further penetration in both indications. We also have nearly perfect payer coverage, and physicians can access the menin inhibitor they prefer without any meaningful barriers. Revuforj's formulary coverage stands at 97% of all covered lives, including all commercially covered lives, Medicare, and Medicaid, a coverage position that leads the class. We have engaged and educated payers extensively, they recognize the value of Revuforj and its status as the only menin inhibitor approved for multiple acute leukemia subtypes. While the class leader in NPM1 will be determined by HCP preference, not price or recommendations from payers, I will note that payers understand the two menin inhibitors are priced at parity, with Revuforj actually costing less for the large percentage of patients on CYP3A4 inhibitors.

Speaker #3: We also have nearly perfect payer coverage and physicians can access the men and inhibitor they prefer without any meaningful barriers. RevuForge's formulary coverage stands at 97% of all covered lives, including all commercially covered lives, Medicare, and Medicaid.

Speaker #3: A coverage position that leads the class. We have engaged and educated payers extensively and they recognize the value of RevuForge and its status as the only men and inhibitor approved for multiple acute leukemia subtypes.

Speaker #3: While the class leader in MPM1 will be determined by HCP preference, not price or recommendations from payers, I will note that payers understand the two men and inhibitors are priced at parity with RevuForge actually costing less for the large percentage of patients on CYP3A4 inhibitors.

Speaker #3: This was made clear in a recently updated IPD analytics monograph, which no longer suggests use of one men and inhibitor over another, based on price alone.

Steven Closter: This was made clear in a recently updated IPD Analytics monograph, which no longer suggests use of one menin inhibitor over another based on price alone, clearing up a point that had led to temporary confusion among a small handful of plans representing less than 1% of all covered lives. Turning to slide 6 and the multiple factors that will drive further Revuforj growth. The first is our continued expansion into relapsed refractory NPM1-mutated AML. Of the 4,500 patient annual incident population, we estimate that less than 10% of patients have received a menin inhibitor, highlighting the substantial opportunity for further growth.

Steve Closter: This was made clear in a recently updated IPD Analytics monograph, which no longer suggests use of one menin inhibitor over another based on price alone, clearing up a point that had led to temporary confusion among a small handful of plans representing less than 1% of all covered lives. Turning to slide 6 and the multiple factors that will drive further Revuforj growth. The first is our continued expansion into relapsed refractory NPM1-mutated AML. Of the 4,500 patient annual incident population, we estimate that less than 10% of patients have received a menin inhibitor, highlighting the substantial opportunity for further growth.

Speaker #3: Clearing up a point that had led to temporary confusion among a small handful of plans representing less than 1% of all covered lives. Turning to slide six and the multiple factors that will drive further RevuForge growth.

Speaker #3: The first is our continued expansion into relapse refractory MPM1 mutated AML. Of the 4,500 patient annual incident population, we estimate that less than 10% of patients have received a men and inhibitor, highlighting the substantial opportunity for further growth.

Speaker #3: Compared to KMT2A, where we saw a steep uptake curve due to the lack of other approved therapies, we expect our MPM1 business will build over time, because there are other options that physicians may consider for this population, depending on their co-mutations, for example.

Steven Closter: Compared to KMT2A, where we saw a steep uptake curve due to the lack of other approved therapies, we expect our NPM1 business will build over time because there are other options that physicians may consider for this population, depending on their co-mutations, for example. With two to two and a half times as many NPM1 patients as KMT2A patients, we expect NPM1 will become a major component of our business over time. With strong physician support and unmatched efficacy data in a disease where efficacy is the most important attribute to physicians, we expect to have dominant market share in NPM1 and KMT2A. The second factor is the growing number of KMT2A patients who are proceeding to transplant after receiving Revuforj and then returning to therapy post-transplant.

Steve Closter: Compared to KMT2A, where we saw a steep uptake curve due to the lack of other approved therapies, we expect our NPM1 business will build over time because there are other options that physicians may consider for this population, depending on their co-mutations, for example. With two to two and a half times as many NPM1 patients as KMT2A patients, we expect NPM1 will become a major component of our business over time. With strong physician support and unmatched efficacy data in a disease where efficacy is the most important attribute to physicians, we expect to have dominant market share in NPM1 and KMT2A. The second factor is the growing number of KMT2A patients who are proceeding to transplant after receiving Revuforj and then returning to therapy post-transplant.

Speaker #3: With two to two and a half times as many MPM1 patients as KMT2A patients, we expect MPM1 will become a major component of our business over time.

Speaker #3: With strong physician support and unmatched efficacy data in a disease where efficacy is the most important attribute to physicians, we expect to have dominant market share in MPM1 and KMT2A.

Speaker #3: The second factor is the growing number of KMT2A patients who are proceeding to transplant after receiving RevuForge and then returning to therapy post-transplant. As Michael noted, the transplant rate has been building over time, with recent analysis indicating that nearly half of KMT2A patients are proceeding to transplant after receiving RevuForge.

Steven Closter: As Michael noted, the transplant rate has been building over time, with recent analysis indicating that nearly half of KMT2A patients are proceeding to transplant after receiving Revuforj. Around 45% have restarted after pausing treatment for 1 to 2 quarters, a percentage we expect will grow over time. While the pool of patients in Revuforj post-transplant is expanding, that growth continues to be obscured by the large number going to transplant each quarter. Importantly, we expect to observe a meaningful step up in post-transplant use after leading institutions report on their experience using revumenib as maintenance in Q2.

Steve Closter: As Michael noted, the transplant rate has been building over time, with recent analysis indicating that nearly half of KMT2A patients are proceeding to transplant after receiving Revuforj. Around 45% have restarted after pausing treatment for 1 to 2 quarters, a percentage we expect will grow over time. While the pool of patients in Revuforj post-transplant is expanding, that growth continues to be obscured by the large number going to transplant each quarter. Importantly, we expect to observe a meaningful step up in post-transplant use after leading institutions report on their experience using revumenib as maintenance in Q2.

Speaker #3: Around 45% have restarted after pausing treatment for one to two quarters, a percentage we expect will grow over time. While the pool of patients in RevuForge post-transplant is expanding, that growth continues to be obscured by the large number going to transplant each quarter.

Speaker #3: Importantly, we expect to observe a meaningful step up in post-transplant use after leading institutions report on their experience using Revumenum as maintenance in the second quarter.

Speaker #3: Long-term, we expect up to 70% to 80% of transplanted patients will ultimately be put back on therapy for one to two years, based on our clinical trial experience, and feedback directly from physicians.

Steven Closter: Long term, we expect up to 70% to 80% of transplanted patients will ultimately be put back on therapy for 1 to 2 years based on our clinical trial experience and feedback directly from physicians. The third factor is use of Revuforj in early lines of treatment and in combination with other therapies. Claims data show about 70% of use in the 2nd and 3rd line, even as we've added more NPM1 patients to our mix. This is encouraging because when patients are treated earlier, you expect to see higher response rates, longer durations of response, and more patients proceeding to transplant, as we now see playing out. Claims data also show about 40% combination use. While Revuforj is approved and promoted as a monotherapy, the significant combination use highlights physicians' comfort with the Revuforj profile, and that could extend treatment durations.

Steve Closter: Long term, we expect up to 70% to 80% of transplanted patients will ultimately be put back on therapy for 1 to 2 years based on our clinical trial experience and feedback directly from physicians. The third factor is use of Revuforj in early lines of treatment and in combination with other therapies. Claims data show about 70% of use in the 2nd and 3rd line, even as we've added more NPM1 patients to our mix. This is encouraging because when patients are treated earlier, you expect to see higher response rates, longer durations of response, and more patients proceeding to transplant, as we now see playing out. Claims data also show about 40% combination use. While Revuforj is approved and promoted as a monotherapy, the significant combination use highlights physicians' comfort with the Revuforj profile, and that could extend treatment durations.

Speaker #3: The third factor is use of RevuForge in early lines of treatment and in combination with other therapies. Claims data show about 70% of use in the second and third line, even as we've added more MPM1 patients to our mix.

Speaker #3: This is encouraging because when patients are treated earlier, you expect to see higher response rates, longer durations of response, and more patients proceeding to transplant as we now see playing out.

Speaker #3: Claims data also show about 40% combination use, while RevuForge is approved and promoted as a monotherapy, the significant combination use highlights physicians' comfort with the RevuForge profile and that could extend treatment durations.

Speaker #3: All these evolving treatment patterns will drive an increase in the average treatment duration, especially with the growing number of KMT2A patients proceeding to transplant and then returning to therapy.

Steven Closter: All these evolving treatment patterns will drive an increase in the average treatment duration, especially the growing number of KMT2A patients proceeding to transplant and then returning to therapy. This group of patients is already approaching 9 months of therapy on average, with this duration expected to meaningfully increase over time. We are confident in our ability to continue building a sustainable business with our first two indications for Revuforj, which together represent a $2 billion plus market opportunity, as shown in slide 7. Turning to Niktimvo on slide 8. Building on an excellent launch year, Niktimvo delivered $55 million in net revenue in the Q1 of 2026 and is now annualizing at over $200 million.

Steve Closter: All these evolving treatment patterns will drive an increase in the average treatment duration, especially the growing number of KMT2A patients proceeding to transplant and then returning to therapy. This group of patients is already approaching 9 months of therapy on average, with this duration expected to meaningfully increase over time. We are confident in our ability to continue building a sustainable business with our first two indications for Revuforj, which together represent a $2 billion plus market opportunity, as shown in slide 7. Turning to Niktimvo on slide 8. Building on an excellent launch year, Niktimvo delivered $55 million in net revenue in the Q1 of 2026 and is now annualizing at over $200 million.

Speaker #3: This group of patients is already approaching nine months of therapy on average, with this duration expected to meaningfully increase over time. We are confident in our ability to continue building a sustainable business with our first two indications for RevuForge, which together represent a $2 billion-plus market opportunity as shown on slide seven.

Speaker #3: Turning to NICTINVO on slide eight. Building on an excellent launch year, NICTINVO delivered 55 million in net revenue in the first quarter of 2026 and is now annualizing at over $200 million.

Speaker #3: In the first quarter, about 5,000 infusions were administered and approximately 300 new patients started even with severe weather impacting patient access to infusion drugs in the first quarter.

Steven Closter: In Q1, about 5,000 infusions were administered and approximately 300 new patients started, even with severe weather impacting patient access to infusion drugs in Q1. Performance this quarter reflects strong and consistent new patient starts and solid persistency, partially offset by natural attrition among the large cohort of predominantly later-line patients who started Niktimvo during Q1 of launch last year. This dynamic was also seen at a similar point in the Rezurock launch, a drug which reached $500 million in annual US net sales within the 4 years of launch in the same indication. All indicators of demand suggest we will resume growth next quarter as we continue to steadily add new, less advanced patients. Turning to slide 9. The fundamentals of our Niktimvo business remain strong with multiple drivers for continued growth.

Steve Closter: In Q1, about 5,000 infusions were administered and approximately 300 new patients started, even with severe weather impacting patient access to infusion drugs in Q1. Performance this quarter reflects strong and consistent new patient starts and solid persistency, partially offset by natural attrition among the large cohort of predominantly later-line patients who started Niktimvo during Q1 of launch last year. This dynamic was also seen at a similar point in the Rezurock launch, a drug which reached $500 million in annual US net sales within the 4 years of launch in the same indication. All indicators of demand suggest we will resume growth next quarter as we continue to steadily add new, less advanced patients. Turning to slide 9. The fundamentals of our Niktimvo business remain strong with multiple drivers for continued growth.

Speaker #3: Performance this quarter reflects strong and consistent new patient starts and solid persistency partially offset by natural attrition among the large cohort of predominantly later-line patients who started NICTINVO during the first quarter of last year.

Speaker #3: This dynamic was also seen at a similar point in the Reseroc launch, a drug which reached 500 million in annual US net sales within the first four years of launch in the same indication.

Speaker #3: All indicators of demand suggest we will resume growth next quarter as we continue to steadily add new, less advanced patients. Turning to slide nine.

Speaker #3: The fundamentals of our NICTINVO business remain strong, with multiple drivers for continued growth. The first is continued adoption in the fourth line and growing usage in the third line.

Steven Closter: The first is continued adoption in the fourth line and growing usage in the third line. Within one year of launch, Niktimvo has captured 32% the third line plus market with the majority of use in the fourth line and increasing uptake in the third line as providers gain experience. As the patient mix shifts more towards third line patients with less advanced disease, we expect this will extend the average treatment duration. Second, this is a chronic disease with the potential for patients to stay on therapy for long periods. Of the patients who started Niktimvo at launch in Q1 of last year, 60% to 70% remained on therapy in Q1 of this year, highlighting the potential for extended durations of therapy, especially as our patient mix shifts more towards third line patients.

Steve Closter: The first is continued adoption in the fourth line and growing usage in the third line. Within one year of launch, Niktimvo has captured 32% the third line plus market with the majority of use in the fourth line and increasing uptake in the third line as providers gain experience. As the patient mix shifts more towards third line patients with less advanced disease, we expect this will extend the average treatment duration. Second, this is a chronic disease with the potential for patients to stay on therapy for long periods. Of the patients who started Niktimvo at launch in Q1 of last year, 60% to 70% remained on therapy in Q1 of this year, highlighting the potential for extended durations of therapy, especially as our patient mix shifts more towards third line patients.

Speaker #3: Within one year of launch, NICTINVO has captured 32% of the third-line-plus market, with the majority of use in the fourth line and an increasing uptake in the third line as providers gain experience.

Speaker #3: As the patient mix shifts more towards third-line patients with less advanced disease, we expect this will extend the average treatment duration. Second, this is a chronic disease with the potential for patients to stay on therapy for long periods.

Speaker #3: The patients who started NICTINVO at launch in the first quarter of last year 60% to 70% remained on therapy in the first quarter of this year, highlighting the potential for extended durations of therapy, especially as our patient mix shifts more towards third-line patients.

Speaker #3: Our clinical trial experience shows the duration of therapy can be measured in years, for a meaningful proportion of patients. Third, NICTINVO has a broad and productive prescriber base and strong commercial synergies for both Syntax and Insight.

Steven Closter: Our clinical trial experience shows the duration of therapy can be measured in years for a meaningful proportion of patients. Third, Niktimvo has a broad and productive prescriber base and strong commercial synergies for both Syndax and Incyte. Virtually every bone marrow transplant center in the US has prescribed Niktimvo, and all have become repeat customers. Physicians' feedback is very positive. They continue to report strong activity in multiple organs, with particularly notable results observed in patients with lung and skin fibrosis, some of the most challenging to treat manifestations of the disease. All these drivers put us in a strong position to expand our impact third line plus chronic GVHD, the $2 billion US market opportunity, as we can see on slide 10. In summary, our quarterly results underscore the strong demand for Revuforj and Niktimvo and the substantial commercial opportunities we have with both products.

Steve Closter: Our clinical trial experience shows the duration of therapy can be measured in years for a meaningful proportion of patients. Third, Niktimvo has a broad and productive prescriber base and strong commercial synergies for both Syndax and Incyte. Virtually every bone marrow transplant center in the US has prescribed Niktimvo, and all have become repeat customers. Physicians' feedback is very positive. They continue to report strong activity in multiple organs, with particularly notable results observed in patients with lung and skin fibrosis, some of the most challenging to treat manifestations of the disease. All these drivers put us in a strong position to expand our impact third line plus chronic GVHD, the $2 billion US market opportunity, as we can see on slide 10. In summary, our quarterly results underscore the strong demand for Revuforj and Niktimvo and the substantial commercial opportunities we have with both products.

Speaker #3: Virtually every bone marrow transplant center in the U.S. has prescribed NICTINVO, and all have become repeat customers. Physician feedback is very positive. They continue to report strong activity in multiple organs, with particularly notable results observed in patients with lung, skin, and fibrosis—some of the most challenging to treat manifestations of the disease.

Speaker #3: All these drivers put us in a strong position to expand our impact third-line-plus chronic GVHD to $2 billion US market opportunity as we can see on slide 10.

Speaker #3: In summary, our quarterly results underscore the strong demand for RevuForge and NICTINVO, and this substantial commercial opportunities we have with both products. We have the right medicines, the right team, and the right strategies to continue delivering for patients and driving strong and sustainable growth.

Steven Closter: We have the right medicines, the right team, and the right strategies to continue delivering for patients and driving strong and sustainable growth. With that, I'll hand the call to Nick to discuss our development programs.

Steve Closter: We have the right medicines, the right team, and the right strategies to continue delivering for patients and driving strong and sustainable growth. With that, I'll hand the call to Nick to discuss our development programs.

Speaker #3: With that, I'll hand the call to Nick to discuss our development programs. Thank you, Steve. Starting with Revumenum on slide 11, we've made significant progress advancing our pivotal frontline trials and our integrated evidence generation plan designed to establish Revumenum as the main inhibitor of choice across the acute leukemia treatment continuum.

Nicholas Botwood: Thank you, Steve. Starting with revumenib on slide 11, we've made significant progress advancing our pivotal frontline trials and our integrated evidence generation plan designed to establish revumenib as the menin inhibitor of choice across the acute leukemia treatment continuum. I'd like to highlight a few key points. First, we're focused on advancing enrollment in our pivotal frontline trials, which have the potential to support additional FDA approvals and the registration of revumenib outside the US. We are well-positioned to be the first to deliver pivotal frontline data for a menin inhibitor. Global site activations and patient enrollment are well underway in these trials, which were informed by a robust body of clinical evidence, allowing optimization of endpoint assumptions and other aspects of the study design.

Nick Botwood: Thank you, Steve. Starting with revumenib on slide 11, we've made significant progress advancing our pivotal frontline trials and our integrated evidence generation plan designed to establish revumenib as the menin inhibitor of choice across the acute leukemia treatment continuum. I'd like to highlight a few key points. First, we're focused on advancing enrollment in our pivotal frontline trials, which have the potential to support additional FDA approvals and the registration of revumenib outside the US. We are well-positioned to be the first to deliver pivotal frontline data for a menin inhibitor. Global site activations and patient enrollment are well underway in these trials, which were informed by a robust body of clinical evidence, allowing optimization of endpoint assumptions and other aspects of the study design.

Speaker #3: I'd like to highlight a few key points. First, we're focused on advancing enrollment in our pivotal frontline trials, which have the potential to support additional FDA approvals and the registration of Revumenum outside the US.

Speaker #3: We are well positioned to be the first to deliver pivotal frontline data for a main inhibitor. Global site activations and patient enrollment are well underway in these trials, which were informed by a robust body of clinical evidence allowing optimization of endpoint assumptions and other aspects of the study design.

Speaker #3: We've also been able to leverage the strong relationships we've built with leading investigators and patient advocacy groups around the world through our work pioneering this new class of therapy.

Nicholas Botwood: We've also been able to leverage the strong relationships we've built with leading investigators and patient advocacy groups around the world through our work pioneering this new class of therapy. To support these collaborations and rapid enrollment, we have a team of highly qualified and well-connected MSLs located in key geographies, including Asia, fully focused on revumenib. As a reminder, EVOLVE-2 is the Phase 3 trial of revumenib plus venetoclax and azacitidine in newly diagnosed unfit NPM1 or KMT2A AML patients. This trial, conducted in partnership with the highly regarded HOVON network, was the first pivotal frontline trial of a menin inhibitor to begin enrolling patients. EVOLVE has dual primary endpoints of complete remission and overall survival, both in the NPM1 population to support the potential for accelerated and full approval respectively.

Nick Botwood: We've also been able to leverage the strong relationships we've built with leading investigators and patient advocacy groups around the world through our work pioneering this new class of therapy. To support these collaborations and rapid enrollment, we have a team of highly qualified and well-connected MSLs located in key geographies, including Asia, fully focused on revumenib. As a reminder, EVOLVE-2 is the Phase 3 trial of revumenib plus venetoclax and azacitidine in newly diagnosed unfit NPM1 or KMT2A AML patients. This trial, conducted in partnership with the highly regarded HOVON network, was the first pivotal frontline trial of a menin inhibitor to begin enrolling patients. EVOLVE has dual primary endpoints of complete remission and overall survival, both in the NPM1 population to support the potential for accelerated and full approval respectively.

Speaker #3: To support these collaborations and rapid enrollment, we have a team of highly qualified and well-connected MSLs located in key geographies, including Asia, fully focused on Revumenum.

Speaker #3: As a reminder, evolve2 is the phase three trial of Revumenum plus Vanadoclax and Azacitidine in newly diagnosed unfit MPM1 or KMT2A AML patients. This trial, conducted in partnership with the highly regarded HOVON network, was the first pivotal frontline trial of a main inhibitor to begin enrolling patients.

Speaker #3: Evolve has dual primary endpoints of complete remission and overall survival, both in the MPM1 population to support the potential for accelerated and full approval, respectively.

Speaker #3: Reveal is the phase three trial of Revumenum plus intensive chemotherapy in newly diagnosed fit MPM1 patients, including adults and children 12 years of age and older.

Nicholas Botwood: REVEAL is the phase 3 trial of revumenib plus intensive chemotherapy in newly diagnosed fit NPM1 patients, including adults and children 12 years of age and older. REVEAL also has dual primary endpoints of MRD negative CR and event-free survival to support the potential for accelerated and full approval respectively. In the fit KMT2A population, we are pursuing a novel and differentiated approach. In addition to generating further data in combination with intensive chemotherapy in partnership with the National Cancer Institute, we are progressing the RAVEN trial with leading clinical researchers. RAVEN is a phase 2 trial of revumenib plus venetoclax and azacitidine in newly diagnosed KMT2A patients who would be considered fit for intensive chemotherapy.

Nick Botwood: REVEAL is the phase 3 trial of revumenib plus intensive chemotherapy in newly diagnosed fit NPM1 patients, including adults and children 12 years of age and older. REVEAL also has dual primary endpoints of MRD negative CR and event-free survival to support the potential for accelerated and full approval respectively. In the fit KMT2A population, we are pursuing a novel and differentiated approach. In addition to generating further data in combination with intensive chemotherapy in partnership with the National Cancer Institute, we are progressing the RAVEN trial with leading clinical researchers. RAVEN is a phase 2 trial of revumenib plus venetoclax and azacitidine in newly diagnosed KMT2A patients who would be considered fit for intensive chemotherapy.

Speaker #3: Reveal also has dual primary endpoints of MRD negative CR and event-free survival to support the potential for accelerated and full approval, respectively. In the fit, KMT2A population, we are pursuing a novel and differentiated approach.

Speaker #3: In addition to generating further data in combination with intensive chemotherapy in partnership with the National Cancer Institute, we are progressing the Raven trial with leading clinical researchers.

Speaker #3: Raven is a phase two trial of Revumenum plus Venaza in newly diagnosed KMT2A patients who would be considered fit for intensive chemotherapy. The design of Raven is supported by the strong activity observed with Revumenum plus then HMA in KMT2A patients and growing physician interest in moving from 7 plus 3 intensive chemotherapy backbones to more tolerable then HMA backbones.

Nicholas Botwood: The design of RAVEN is supported by the strong activity observed with revumenib plus ven-HMA in KMT2A patients and growing physician interest in moving from 7+3 intensive chemotherapy backbones to more tolerable ven-HMA backbones. The second point I would like to highlight is that we will continue to advance our scientific leadership in menin inhibition with a major presence at key medical meetings, including at least 15 revumenib abstracts accepted for presentation at ASCO or EHA. The volume and breadth of the data we will present underscore physicians' interest and commitment to revumenib, with its differentiated profile and strong activity across multiple genetic subtypes. I'd like to highlight now some of the key datasets we expect to report in Q2 2026. First, we expect new real-world evidence with revumenib.

Nick Botwood: The design of RAVEN is supported by the strong activity observed with revumenib plus ven-HMA in KMT2A patients and growing physician interest in moving from 7+3 intensive chemotherapy backbones to more tolerable ven-HMA backbones. The second point I would like to highlight is that we will continue to advance our scientific leadership in menin inhibition with a major presence at key medical meetings, including at least 15 revumenib abstracts accepted for presentation at ASCO or EHA. The volume and breadth of the data we will present underscore physicians' interest and commitment to revumenib, with its differentiated profile and strong activity across multiple genetic subtypes. I'd like to highlight now some of the key datasets we expect to report in Q2 2026. First, we expect new real-world evidence with revumenib.

Speaker #3: The second point I would like to highlight is that we will continue to advance our scientific leadership in main inhibition with a major presence at key medical meetings, including at least 15 Revumenum abstracts accepted for presentation at ASCO or IHA.

Speaker #3: The volume and breadth of the data we will present underscore physicians' interest and commitment to Revumenum, with its differentiated profile and strong activity across multiple genetic subtypes.

Speaker #3: I'd like to highlight now some of the key data sets we expect to report in the second quarter of 2026. First, we expect new real-world evidence with Revumenum.

Speaker #3: This data set will build on the first real-world evidence that another group, Moffitt Cancer Center, presented for Revumenum and the Therapeutic Class at ASH last year.

Nicholas Botwood: This dataset will build on the first real-world evidence that another group, Moffitt Cancer Center, presented for revumenib and the therapeutic class at ASH last year. Moffitt reported a 77% overall response rate and 75% MRD negativity rate among relapsed refractory NPM1, KMT2A, and NUP98 acute leukemia patients who primarily received revumenib as part of combination therapy. In addition to showing compelling clinical activity, revumenib was well-tolerated as a monotherapy and in combination with standard of care therapies. We also expect new post-transplant maintenance data, including a dataset accepted for oral presentation at ASCO. These will be important datasets given physicians' growing interest in using revumenib post-transplant. The upcoming data will build on retrospective data presented by MD Anderson at ASH last year from 10 pediatric KMT2A or NUP98 rearranged patients. They reported that revumenib was well-tolerated in the post-transplant setting with encouraging early efficacy.

Nick Botwood: This dataset will build on the first real-world evidence that another group, Moffitt Cancer Center, presented for revumenib and the therapeutic class at ASH last year. Moffitt reported a 77% overall response rate and 75% MRD negativity rate among relapsed refractory NPM1, KMT2A, and NUP98 acute leukemia patients who primarily received revumenib as part of combination therapy. In addition to showing compelling clinical activity, revumenib was well-tolerated as a monotherapy and in combination with standard of care therapies. We also expect new post-transplant maintenance data, including a dataset accepted for oral presentation at ASCO. These will be important datasets given physicians' growing interest in using revumenib post-transplant. The upcoming data will build on retrospective data presented by MD Anderson at ASH last year from 10 pediatric KMT2A or NUP98 rearranged patients. They reported that revumenib was well-tolerated in the post-transplant setting with encouraging early efficacy.

Speaker #3: Moffitt reported a 77% overall response rate and 75% MRD negativity rate among relaxed refractory MPM1, KMT2A, and NEUP98 acute leukemia patients. Who primarily received Revumenum as part of combination therapy.

Speaker #3: In addition to showing compelling clinical activity, Revumenum was well tolerated as a monotherapy and in combination with standard of care therapies. We also expect new post-plant maintenance data including a data set accepted for oral presentation at ASCO.

Speaker #3: These will be important data sets, given physicians' growing interest in using Revumenum post-transplant. The upcoming data will build on retrospective data presented by MD Anderson at ASH last year, from 10 pediatric KMT2A- or NUP98-rearranged patients.

Speaker #3: They reported that Revumenum was well tolerated in the post-transplant setting with encouraging early efficacy. Notably, all patients were alive and 90% were relapse-free at a median follow-up of 19 months.

Nicholas Botwood: Notably, all patients were alive and 90% were relapse-free at a median follow-up of 19 months. Additionally, we expect updated data from our phase 1 trial of revumenib plus intensive chemotherapy in newly diagnosed NPM1, KMT2A or NUP98 AML. You will first see an abstract with a data cutoff that is similar to the preliminary 7+3 data we presented at ASH last year, showing high rates of response and MRD negativity along with a favorable safety profile. Data with longer follow-up will be presented at the meeting. We also anticipate updated data from the relapsed refractory cohort in the SAVE trial of revumenib plus venetoclax and decitabine instead of uridine in NPM1, KMT2A or NUP98 acute leukemias. This update will build on the compelling data previously reported from SAVE, which shows overall response and MRD negativity rates above 80% in heavily pre-treated patients.

Nick Botwood: Notably, all patients were alive and 90% were relapse-free at a median follow-up of 19 months. Additionally, we expect updated data from our phase 1 trial of revumenib plus intensive chemotherapy in newly diagnosed NPM1, KMT2A or NUP98 AML. You will first see an abstract with a data cutoff that is similar to the preliminary 7+3 data we presented at ASH last year, showing high rates of response and MRD negativity along with a favorable safety profile. Data with longer follow-up will be presented at the meeting. We also anticipate updated data from the relapsed refractory cohort in the SAVE trial of revumenib plus venetoclax and decitabine instead of uridine in NPM1, KMT2A or NUP98 acute leukemias. This update will build on the compelling data previously reported from SAVE, which shows overall response and MRD negativity rates above 80% in heavily pre-treated patients.

Speaker #3: Additionally, we expect updated data from our phase one trial of Revumenum plus intensive chemotherapy in newly diagnosed MPM1, KMT2A, or NEUP98 AML. You will first see an abstract with a data cutoff that is similar to the preliminary seven or eight data we presented at ASH last year, showing high rates of response and MRD negativity along with a favorable safety profile.

Speaker #3: Data with longer follow-up will be presented at the meeting. We also anticipate updated data from the relaxed refractory cohort in the SAVE trial of Revumenum plus Vanadoclax and Acitidine instead of Zuridine in MPM1, KMT2A, or NEUP98 acute leukemias.

Speaker #3: This update will build on the compelling data previously reported from SAVE, which shows overall response and MRD negativity rates above 80% in heavily pre-treated patients.

Speaker #3: And finally, we expect additional relapse refractory NEUP98 rearranged data from our Augment 101 trial and expanded access program. NEUP98 rearrangements, which are found in up to 5% of AML cases, are associated with a poor prognosis and high unmet need with no approved targeted therapies.

Nicholas Botwood: Finally, we expect additional relapsed refractory NUP98 rearranged data from our AUGMENT-101 trial and expanded access program. NUP98 rearrangements, which are found in up to 5% of AML cases, are associated with a poor prognosis and high unmet need with no approved targeted therapies. Last year at EHA, we presented the first and only data to our knowledge showing compelling activity with a menin inhibitor in NUP98 patients. This data was met with strong enthusiasm by clinicians, we are already seeing academic centers treating relapsed refractory NUP98 patients with revumenib, underscoring the benefit of having one menin inhibitor with activity across multiple subtypes. NUP98 is one of several subtypes associated with acute leukemias associated with upregulation of HOX genes that may be sensitive to revumenib. Altogether, more than 50% of AML patients may have a genetic alteration which is susceptible to revumenib.

Nick Botwood: Finally, we expect additional relapsed refractory NUP98 rearranged data from our AUGMENT-101 trial and expanded access program. NUP98 rearrangements, which are found in up to 5% of AML cases, are associated with a poor prognosis and high unmet need with no approved targeted therapies. Last year at EHA, we presented the first and only data to our knowledge showing compelling activity with a menin inhibitor in NUP98 patients. This data was met with strong enthusiasm by clinicians, we are already seeing academic centers treating relapsed refractory NUP98 patients with revumenib, underscoring the benefit of having one menin inhibitor with activity across multiple subtypes. NUP98 is one of several subtypes associated with acute leukemias associated with upregulation of HOX genes that may be sensitive to revumenib. Altogether, more than 50% of AML patients may have a genetic alteration which is susceptible to revumenib.

Speaker #3: Last year, at IHA, we presented the first and only data to our knowledge showing compelling activity with a main inhibitor in NEUP98 patients. This data was met with strong enthusiasm by clinicians, and we are already seeing academic centers treating relaxed refractory NEUP98 patients with Revumenum underscoring the benefit of having one main inhibitor with activity across multiple subtypes.

Speaker #3: NEUP98 is one of several subtypes associated with acute leukemias associated with upregulation of HOX genes, that may be sensitive to Revumenum. Altogether, more than 50% of AML patients may have a genetic alteration, which is susceptible to Revumenum.

Speaker #3: The body of evidence supporting Revumenum will continue to grow throughout 2026, with additional data expected in the second half of the year, including an update from the BEAT AML trial of Revumenum plus Venaza in newly diagnosed MPM1 or KMT2A AML. We also expect an update from a phase one trial of Revumenum plus gilteritinib in relapsed refractory patients with a FLT3 mutation.

Nicholas Botwood: The body of evidence supporting revumenib will continue to grow throughout 2026, with additional data expected in the H2 of the year, including an update from the BEAT AML trial of revumenib plus venaza in newly diagnosed NPM1 or KMT2A AML. We also expect an update from a Phase 1 trial of revumenib plus gilteritinib in relapsed refractory patients with a FLT3 mutation and an alteration associated with HOX overexpression. Early data presented at ASH last year showed the combination appeared tolerable with early signs of efficacy supporting continued evaluation. For the subset of relapsed refractory NPM1 patients with FLT3 co-mutations, a menin plus FLT3 inhibitor combo is one of several potential options that physicians may consider depending on patient-specific facts. I'd now like to turn to axatilimab development on slide 12. This will be an important year with 2 upcoming data readouts.

Nick Botwood: The body of evidence supporting revumenib will continue to grow throughout 2026, with additional data expected in the H2 of the year, including an update from the BEAT AML trial of revumenib plus venaza in newly diagnosed NPM1 or KMT2A AML. We also expect an update from a Phase 1 trial of revumenib plus gilteritinib in relapsed refractory patients with a FLT3 mutation and an alteration associated with HOX overexpression. Early data presented at ASH last year showed the combination appeared tolerable with early signs of efficacy supporting continued evaluation. For the subset of relapsed refractory NPM1 patients with FLT3 co-mutations, a menin plus FLT3 inhibitor combo is one of several potential options that physicians may consider depending on patient-specific facts. I'd now like to turn to axatilimab development on slide 12. This will be an important year with 2 upcoming data readouts.

Speaker #3: And an alteration associated with HOX overexpression. Early data presented at ASH last year showed the combination appeared tolerable with early signs of efficacy supporting continued evaluation.

Speaker #3: For the subset of relaxed refractory MPM1 patients with FLIT3 co-mutations, a main plus FLIT3 inhibitor combo is one of several potential options that physicians may consider depending on patient-specific factors.

Speaker #3: I'd now like to turn to axitillumab development on slide 12. This will be an important year with two upcoming data readouts. We are now expecting top-line data from the Phase 2 trial of axitillumab plus ruxolitinib in the fourth quarter, a timeline which pulled in due to faster-than-anticipated accrual.

Nicholas Botwood: We are now expecting top-line data from the phase 2 trial of axatilimab plus ruxolitinib in Q4, a timeline which pulled in due to faster than anticipated accrual. Data from this trial could inform the potential for axatilimab in earlier lines of chronic GVHD and potentially pave the way to a steroid-sparing approach. We also expect top-line data from our phase 2 MAXPIRE IPF trial in Q4. Earlier this year, we completed enrollment and actually exceeded our original enrollment target of 135 patients due to the number of patients put into screening as we neared the end of enrollment. This speaks to investigator enthusiasm for axatilimab and the desire for new treatment options in IPF. Given the high interest in this program, I will highlight the evidence supporting the scientific rationale for CSF1R inhibition and outline the trial design.

Nick Botwood: We are now expecting top-line data from the phase 2 trial of axatilimab plus ruxolitinib in Q4, a timeline which pulled in due to faster than anticipated accrual. Data from this trial could inform the potential for axatilimab in earlier lines of chronic GVHD and potentially pave the way to a steroid-sparing approach. We also expect top-line data from our phase 2 MAXPIRE IPF trial in Q4. Earlier this year, we completed enrollment and actually exceeded our original enrollment target of 135 patients due to the number of patients put into screening as we neared the end of enrollment. This speaks to investigator enthusiasm for axatilimab and the desire for new treatment options in IPF. Given the high interest in this program, I will highlight the evidence supporting the scientific rationale for CSF1R inhibition and outline the trial design.

Speaker #3: Data from this trial could inform the potential for axitillumab in early lines of chronic GVHD and potentially pave the way to a steroid-sparing approach.

Speaker #3: We also expect top-line data from our Phase 2 MAXPIRE IPF trial in the fourth quarter. Earlier this year, we completed enrollment and actually exceeded our original enrollment target of 135 patients due to the number of patients put into screening as we neared the end of enrollment.

Speaker #3: This speaks to investigator enthusiasm for axitillumab and the desire for new treatment options in IPF. Given the high interest in this program, I will highlight the evidence supporting the scientific rationale for CSF1R inhibition and outline the trial design.

Speaker #3: Moving to slide 30, significant evidence points to CSF1-dependent monocyte-drived alveolar macrophages as a promising new target in IPF. These cells are believed to play a key role in driving lung fibrosis.

Nicholas Botwood: Moving to slide 13. Significant evidence points to CSF1-dependent monocyte-derived alveolar macrophages as a promising new target in IPF. These cells are believed to play a key role in driving lung fibrosis. Multiple studies implicate the CSF1R pathway in IPF and provide strong mechanistic rationale for our program. For instance, high CSF1R levels are observed in IPF patients versus healthy controls, and higher levels of CSF1R and monocytes predict shorter survival among IPF patients. Turning to slide 14. Axatilimab is an IgG4 monoclonal antibody which is optimized for diseases with an inflammatory and fibrotic component. It binds to the CSF-1 receptor on the surface of monocytes and macrophages, preventing their activation by CSF1 and IL-34. This reduces the levels of circulating pro-fibrotic and pro-inflammatory monocytes and monocyte-derived macrophages and inhibits the activity of these pathogenic macrophages in tissues.

Nick Botwood: Moving to slide 13. Significant evidence points to CSF1-dependent monocyte-derived alveolar macrophages as a promising new target in IPF. These cells are believed to play a key role in driving lung fibrosis. Multiple studies implicate the CSF1R pathway in IPF and provide strong mechanistic rationale for our program. For instance, high CSF1R levels are observed in IPF patients versus healthy controls, and higher levels of CSF1R and monocytes predict shorter survival among IPF patients. Turning to slide 14. Axatilimab is an IgG4 monoclonal antibody which is optimized for diseases with an inflammatory and fibrotic component. It binds to the CSF-1 receptor on the surface of monocytes and macrophages, preventing their activation by CSF1 and IL-34. This reduces the levels of circulating pro-fibrotic and pro-inflammatory monocytes and monocyte-derived macrophages and inhibits the activity of these pathogenic macrophages in tissues.

Speaker #3: Multiple studies implicate the CSF1R pathway in IPF and provide strong mechanistic rationale for our program. For instance, high CSF1R levels observed in IPF patients versus healthy controls and higher levels of CSF1R and monocytes predict shorter survival among IPF patients.

Speaker #3: Turning to slide 14, axitillumab is an IgG4 monoclonal antibody which is optimized for diseases with an inflammatory and fibrotic component. It binds to the CSF1 receptor on the surface of monocytes and macrophages, preventing their activation by CSF1 and IL-34.

Speaker #3: This reduces the levels of circulating pro-fibrotic and pro-inflammatory monocytes and monocyte-derived macrophages, and inhibits the activity of these pathogenic macrophages in tissues. Based on these observations, axatilimab has the potential to make a more pronounced impact on the fibrotic process by targeting pathways that sit upstream of the pathways engaged by currently available IPF therapies.

Nicholas Botwood: Based on these observations, axatilimab has the potential to make a more pronounced impact on the fibrotic process by targeting pathways that sit upstream of the pathways engaged by currently available IPF therapies. The IPF program is supported by the remarkable activity observed with axatilimab in chronic graft-versus-host disease. Responses were observed across all organ studies, including organs with fibrotic manifestations of the disease, such as the lung and skin. Among patients with lung involvement who received axatilimab at the dose we are studying in MAXFIRE, nearly 50% achieved a lung response, and over 90% reported improvements in shortness of breath at rest. These data, together with the strong mechanistic rationale, are driving strong physician support for axatilimab's potential in IPF. Slide 15 shows the design of MAXFIRE, a Phase 2 randomized double-blind placebo-controlled trial of axatilimab in approximately 135 IPF patients.

Nick Botwood: Based on these observations, axatilimab has the potential to make a more pronounced impact on the fibrotic process by targeting pathways that sit upstream of the pathways engaged by currently available IPF therapies. The IPF program is supported by the remarkable activity observed with axatilimab in chronic graft-versus-host disease. Responses were observed across all organ studies, including organs with fibrotic manifestations of the disease, such as the lung and skin. Among patients with lung involvement who received axatilimab at the dose we are studying in MAXFIRE, nearly 50% achieved a lung response, and over 90% reported improvements in shortness of breath at rest. These data, together with the strong mechanistic rationale, are driving strong physician support for axatilimab's potential in IPF. Slide 15 shows the design of MAXFIRE, a Phase 2 randomized double-blind placebo-controlled trial of axatilimab in approximately 135 IPF patients.

Speaker #3: The IPF program is supported by the remarkable activity observed with axitillumab in chronic graft versus host disease. Responses were observed across all organ studies, including organs with fibrotic manifestations of the disease, such as the lung and skin.

Speaker #3: Among patients with lung involvement who received axitillumab at the dose we are studying in MAXPIRE, nearly 50% achieved a lung response and over 90% reported improvements in shortness of breath at rest.

Speaker #3: These data together with the strong mechanistic rationale are driving strong physician support for axitillumab's potential in IPF. Slide 15 shows the design of MAXPIRE, a phase two randomized double-blind placebo-controlled trial of axitillumab in approximately 135 IPF patients.

Speaker #3: This is a well-designed trial that has the potential to provide robust proof-of-concept data for axitillumab in IPF to inform a registrational program. The inclusion criteria are similar to other recent IPF trials.

Nicholas Botwood: This is a well-designed trial that has the potential to provide robust proof-of-concept data for axatilimab in IPF to inform a registrational program. The inclusion criteria is similar to other recent IPF trials. Background anti-fibrotic therapy is allowed but not required, and the primary endpoint is the annualized rate of decline in forced vital capacity or FVC measured at 26 weeks. In summary, we have a data-rich period ahead and are laser-focused on executing our pivotal programs. We are just starting to demonstrate our ability to translate promising science into novel medicines for patients with hard-to-treat diseases. With that, I will hand the call to Keith to discuss our financials.

Nick Botwood: This is a well-designed trial that has the potential to provide robust proof-of-concept data for axatilimab in IPF to inform a registrational program. The inclusion criteria is similar to other recent IPF trials. Background anti-fibrotic therapy is allowed but not required, and the primary endpoint is the annualized rate of decline in forced vital capacity or FVC measured at 26 weeks. In summary, we have a data-rich period ahead and are laser-focused on executing our pivotal programs. We are just starting to demonstrate our ability to translate promising science into novel medicines for patients with hard-to-treat diseases. With that, I will hand the call to Keith to discuss our financials.

Speaker #3: Background anti-fibrotic therapy is allowed but not required, and the primary endpoint is the annualized rate of decline in forced vital capacity, or FVC, measured at 26 weeks.

Speaker #3: In summary, we have a data-rich period ahead, and I'll laser-focus on executing our pivotal programs we are just starting to demonstrate our ability to translate promising science into novel medicines for patients with hard-to-treat diseases.

Speaker #3: With that, I will hand the call to Keith to discuss our financials. Thank you, Nick. Earlier this afternoon, we reported detailed first-quarter 2026 financial results on our Form 10Q.

Keith Goldan: Thank you, Nick. Earlier this afternoon, we reported detailed Q1 2026 financial results on our Form 10-Q, and I'll now highlight a few key points on slide 16. Total revenue for Q1 was $64.9 million, up 224% over the same period last year. Demand for Revuforj remains strong, with $48.9 million in net revenue, up 144% from the same period last year. We achieved these results even with typical Q1 dynamics, including severe winter storms, which had a transient impact on both products in February, and a growing number of KMT2A patients temporarily pausing Revuforj to proceed to transplant. Inventory levels remain within the 2 to 3-week range we have previously guided.

Speaker #3: And I'll now highlight a few key points on slide 16. Total revenue for the first quarter was $64.9 million, up $224% over the same period last year.

Speaker #3: Demand for revenue Forge remained strong, with $48.9 million in net revenue, up 144% from the same period last year. We achieved these results even with typical first-quarter dynamics, including severe winter storms, which had a transient impact on both products in February.

Speaker #3: And a growing number of KMT2A patients temporarily pausing revenue forge to proceed to transplant. Inventory levels remain within the two to three-week range. We have previously guided.

Speaker #3: We expect continued growth over the coming quarters, as adoption in MPM1 increases, and the average duration of therapy extends as revenue forge is used earlier in the treatment journey and the number of patients on therapy post-transplant continues to build.

Keith Goldan: We expect continued growth over the coming quarters as adoption in NPM1 increases and the average duration of therapy extends as Revuforj is used earlier in the treatment journey and the number of patients on therapy post-transplant continues to build. Now I want to turn to Niktimvo, which continues to be an important cash flow contributor to Syndax with our 50% share of the net commercial profit totaling $15.9 million in collaboration revenue in Q1. The collaboration revenue that we reported was 29% of the Niktimvo product revenue reported by Incyte within the range of 25% to 30% that we've been guiding to.

Speaker #3: Now I want to turn to Noctimvo, which continues to be an important cash flow contributor to Syndax, with our 50% share of the net commercial profit totaling $15.9 million in collaboration revenue in the first quarter.

Speaker #3: The collaboration revenue that we reported was $29% of the Noctimvo product revenue reported by Insight within the range of $25 to 30% that we've been guiding to.

Speaker #3: Our collaboration revenue for the first quarter is a significant step up from the 0.2 million in collaboration loss we reported from the first two months of sales of Noctimvo in the first quarter of 2025.

Keith Goldan: Our collaboration revenue for Q1 is a significant step-up from the $0.2 million in collaboration loss we reported from the first 2 months of sales of Niktimvo in Q1 2025. We continue to expect our Niktimvo margin contribution, defined as a collaboration revenue recorded by the company as a percentage of Niktimvo net sales, to be in the 25% to 30% range in the near term and increase longer term as sales grow while much of the expense base stays largely fixed. We anticipate continued growth throughout the year as Niktimvo is increasingly used in the 3rd line and duration of therapy extends. With regard to expenses, guidance remains at total R&D plus SG&A expenses in 2026 of approximately $400 million, excluding the impact of $50 million in estimated non-cash stock compensation expense.

Speaker #3: We continue to expect our Noctimvo margin contribution defined as the collaboration revenue recorded by the company as a percentage of Noctimvo net sales to be in the 25 to 30% range in the near term, and increase longer term as sales grow while much of the expense base stays largely fixed.

Speaker #3: We anticipate continued growth throughout the year as Noctimvo is increasingly used in the third line and duration of therapy extends. With regard to expenses, guidance remains at total R&D plus SGNA expenses in 2026 of approximately $400 million excluding the impact of $50 million in estimated non-cash stock compensation expense.

Speaker #3: We are well-funded to continue investing in our commercial and development priorities, with $352.1 million in cash, cash equivalents, and marketable securities as of March 31st 2026.

Keith Goldan: We are well-funded to continue investing in our commercial and development priorities with $352.1 million in cash equivalents, and marketable securities as of 31 March 2026. With this robust balance sheet, growing revenue from two medicines, and stable expenses, we are on our way to reaching profitability. With that, I will hand the call to Michael for closing remarks.

Speaker #3: With this robust balance sheet, growing revenue from two medicines, and stable expenses, we are on our way to reaching profitability. With that, I will hand the call to Michael for closing remarks.

Speaker #1: Thank you, Keith. Looking ahead, we are focused on driving revenue growth and delivering on the milestones shown on slide 17, which will fuel further innovation and support value creation.

Michael Metzger: Thank you, Keith. Looking ahead, we are focused on driving revenue growth and delivering on the milestones shown on slide 17, which will fuel further innovation and support value creation. We are in a strong position with multiple near and long-term growth drivers supporting both of our medicines. Revuforj is poised for further growth as we expand into NPM1 and continue to penetrate the KMT2A market, a segment where Revuforj is the only approved therapy. A growing number of KMT2A patients are proceeding to transplant, outpacing our near-term expectations and returning to therapy post-transplant, which will extend the average treatment duration and drive durable and sustainable growth.

Speaker #1: We are in a strong position with multiple near and long-term growth drivers supporting both of our medicines. Revenue forge is poised for further growth as we expand into MPM1 and continue to penetrate the KMT2A market, a segment where revenue forge is the only approved therapy.

Speaker #1: A growing number of KMT2A patients are proceeding to transplant, outpacing our near-term expectations, and returning to therapy post-transplant, which will extend the average treatment duration and drive durable and sustainable growth.

Speaker #1: With the broadest label and best efficacy profile of the men in class, we have the unique opportunity to cement revenue forge as the menin inhibitor of choice in relapse refractory disease and ultimately be the first to front line, unlocking a $5 billion plus market opportunity.

Michael Metzger: With the broadest label and best efficacy profile of the menin class, we have the unique opportunity to cement Revuforj as the menin inhibitor of choice in relapsed refractory disease and ultimately be the first to front line, unlocking a $5 billion plus market opportunity. Niktimvo continues to be a meaningful contributor to our bottom line. We have ample opportunity for further growth in our first indication as our patient mix evolves and important rate readouts later this year in frontline chronic GVHD and IPF that could open transformational multi-billion dollar markets in the near term. I'll close by thanking everyone who has made it possible for us to deliver breakthroughs for patients, especially the individuals and clinicians who have chosen to participate in our clinical trials, as well as our dedicated Syndax team and the long-term investors.

Speaker #1: Noctimvo continues to be a meaningful contributor to our bottom line. We have ample opportunity for further growth in our first indication as our patient mix evolves and important readouts later this year and front line chronic GVHD and IPF that could open transformational multi-billion dollar markets in the near term.

Speaker #1: I'll close by thanking everyone who has made it possible for us to deliver breakthroughs for patients, especially the individuals and clinicians who have chosen to participate in our clinical trials, as well as our dedicated Syndax team and the long-term investors.

Speaker #1: With that, I would like to open the call for questions. Operator?

Michael Metzger: With that, I would like to open the call for questions. Operator?

Speaker #4: At this time, I would like to remind everyone that in order to ask a question, press star and then the number five on your telephone keypad.

Operator 2: At this time, I would like to remind everyone that in order to ask a question, press star and then the number 5 on your telephone keypad. If you would like to withdraw your question, press star and the number 5 once again. We'll pause just a moment to compile the Q&A roster. Okay. The first question is from Anupam Rama from JPMorgan. The line is open.

Operator: At this time, I would like to remind everyone that in order to ask a question, press star and then the number 5 on your telephone keypad. If you would like to withdraw your question, press star and the number 5 once again. We'll pause just a moment to compile the Q&A roster. Okay. The first question is from Anupam Rama from JPMorgan. The line is open.

Speaker #4: If you would like to withdraw your question, press star and the number five once again. We'll pause just for a moment to compile the Q&A roster.

Speaker #4: Okay, the first question is from Anupan Rama from JPMorgan. The line is open.

Speaker #5: Hey guys, thanks so much for taking the question. Just a quick one on revenue forge. I know that later this quarter you're going to have data from that multi-central real-world study that you're going to that you highlighted in your opening comments.

Anupam Rama: Hey, guys. Thanks so much for taking the question. Just a quick one on Revuforj. I know that later this quarter you're gonna have data from that multicenter real-world study that you highlighted in your opening comments. What should we be looking for in that presentation beyond what we learned in that Moffitt study that you highlighted? Looking for data points that might help us understand how physicians are using the product and how we should think about extrapolating to the revenue trajectory of the product moving forward. Will this real-world study include both the KMT2A and NPM1 experience?

Speaker #5: What should we be looking for in that presentation beyond what we learned in that Moffett study that you highlighted? Looking for data points that might help us understand how physicians are using the product and how we should think about extrapolating to the revenue trajectory of the product moving forward.

Speaker #5: And will this real-world study include both the KMT2A and MPM1 experience?

Speaker #1: Anupam, thanks for the question. Very important new data coming, so we're excited about that, and I'll pass it to Nick to give you a little bit more detail.

Michael Metzger: Anupam, thanks for the question. Very important new data coming, so we're excited about that. I'll pass it to Nick to give you a little bit more detail.

Speaker #6: Yeah, thank you. I'm not going to throw out the data specifically, but I'll give you a flavor of the things to look for, as you'd anticipate in these types of data sets.

Nicholas Botwood: Yeah, thank you. I'm not going to talk about the data specifically, but I'll give you a flavor of the things to look for as you would anticipate in these types of data set. I mean, one is we're expecting, you know, broad coverage across the genetic subtypes, including NUP98. As previously seen, what we're seeing in the real world is extensive use in combinations of therapy. That's clearly not part of our current indication, but given the data we've generated, we know that physicians like to use it in combination in early lines of therapy. I think the other things I would say to look out for is, you know, the number of patients that are progressing to transplant because of those catalysts and factors for that, the number of patients that are able to get to transplant.

Nick Botwood: Yeah, thank you. I'm not going to talk about the data specifically, but I'll give you a flavor of the things to look for as you would anticipate in these types of data set. I mean, one is we're expecting, you know, broad coverage across the genetic subtypes, including NUP98. As previously seen, what we're seeing in the real world is extensive use in combinations of therapy. That's clearly not part of our current indication, but given the data we've generated, we know that physicians like to use it in combination in early lines of therapy. I think the other things I would say to look out for is, you know, the number of patients that are progressing to transplant because of those catalysts and factors for that, the number of patients that are able to get to transplant.

Speaker #6: I mean, one is we're expecting broad coverage across the genetic subtypes. Including Newton98, as previously seen, what we're seeing in the real world is extensive use in combinations of therapy.

Speaker #6: That's clearly not part of our current indication, but given the data we've generated, we know that physicians like to use it in combination in early lines of therapy.

Speaker #6: I think the other things I would say to look out for is the number of patients that are progressing to transplant because of those catalysts and factors for that, the number of patients that are able to get to transplant.

Speaker #6: I think that'll be an important data point to look for. And then, of course, the ability to get patients onto maintenance. Now, that's not, again, something we're promoting on, but it's an important part of patient care.

Nicholas Botwood: I think that'll be an important data point to look for. Then, of course, the ability to get patients onto maintenance. Now that's not, again, something we're promoting on, but it's an important part of patient care. Physicians who wanted to do it, we want to provide data, we are observing it in the real world. Those are the things I'd be looking out for as we generate more real-world evidence.

Nick Botwood: I think that'll be an important data point to look for. Then, of course, the ability to get patients onto maintenance. Now that's not, again, something we're promoting on, but it's an important part of patient care. Physicians who wanted to do it, we want to provide data, we are observing it in the real world. Those are the things I'd be looking out for as we generate more real-world evidence.

Speaker #6: Physicians are wanting to do it. We want to provide data. And we are observing it in the real world. So those are the things I'd be looking out for as we generate more real-world evidence.

Speaker #4: Thanks so much for taking our question.

Anupam Rama: Thanks so much for taking our question.

Speaker #1: Thanks, Anupam.

Michael Metzger: Thanks, Anupam.

Speaker #4: The next question is from Karine Jenkins from Goldman Sachs. Your line is open.

Operator 2: The next question is from Corinne Jenkins from Goldman Sachs. Your line is open.

Operator: The next question is from Corinne Jenkins from Goldman Sachs. Your line is open.

Speaker #7: Sorry, I was muted. Good afternoon, guys. Maybe quickly from us, is there a way that you can kind of help us quantify the headwinds to revenue or patients you're facing in a given quarter if 50% of the KMT2A population is going to transplant, recognizing that that normalizes once you reach a steady state of KMT2A penetration?

Corinne Jenkins: Sorry, I was muted. Good afternoon, guys. Maybe quickly from us, is there a way that you can kind of help us quantify the headwind to revenue or patients you're facing in a given quarter if 50% of the KMT2A population is going to transplant, recognizing that that normalizes once you reach a steady state of KMT2A penetration? Maybe on that note as well, I think you'd commented at the end of Q4, you were at about 50% penetration in the KMT2A market. Is there an update on that front as well? Thanks.

Speaker #7: And maybe on that note as well, I think you've commented at the end of 4Q you were at about 50% penetration in the KMT2A market.

Speaker #7: Is there an update on that plan as well? Thanks.

Speaker #1: Yeah, thanks, Karine, for the question. So I'm going to hand it over to Steve. Maybe I'll handle the second part of the question first, which is sort of the state of the KMT2A market, which is certainly growing.

Michael Metzger: Yeah. Thanks, Corinne, for the question. I'm gonna hand it over to Steve. Maybe I'll handle the second part of the question first, which is sort of the state of the KMT2A market, which is certainly growing. We had gotten to, roughly, you know, approaching 50% penetrated on an incidence population of about 2,000 patients last year, and we continue to see that progressing. Certainly the impact on maintenance is a big growth driver for that business. We do think we'll get, you know, nicely north of 50% this year, but I do believe that the maintenance piece is such a, you know, considerable part of what grows in the future as more patients are now going to transplant.

Speaker #1: We had gotten to roughly approaching 50% penetrated on an incidence population of about 2,000 patients last year, and we continue to see that progressing.

Speaker #1: Certainly, the impact on maintenance is a big growth driver for that business. We do think we'll get nicely north of 50% this year, but I do believe that the maintenance piece is such a considerable part of what grows in the future as more patients are now going to transplant with about 50% of patients going to transplant.

Michael Metzger: We have about 50% of patients going to transplant and right around that number coming back. I think that's likely to grow considerably in the coming year or so, and that's driven by what we hear from physicians and all the data that will be coming out. Nick mentioned some should help that with that growth rate. That's, that's KMT2A, very healthy piece of our business. May, I'll turn it over to Steve for the other.

Speaker #1: And right around that number coming back. But I think that's likely to grow considerably in the coming year or so. And that's driven by what we hear from physicians and all the data that will be coming out.

Speaker #1: Nick mentioned some should help that with that growth rate. But that's KMT2A, very healthy piece of our business, but maybe I'll turn it over to Steve for the other.

Speaker #8: Yeah, I think it was the same question around KMT2A. I think the first part of the question was just headwinds, and maybe that's around bringing patients back and that post-transplant setting.

Steven Closter: I think it was the same question around KMT2A. I think the first part of the question was just headwinds, maybe that's around bringing patients back in that, in that post-transplant setting. I think what we've looked and some of the numbers we've updated this quarter using claims data, we look back and we realize there's a greater percentage going to transplant and this increasing number coming back post-transplant.

Steve Closter: I think it was the same question around KMT2A. I think the first part of the question was just headwinds, maybe that's around bringing patients back in that, in that post-transplant setting. I think what we've looked and some of the numbers we've updated this quarter using claims data, we look back and we realize there's a greater percentage going to transplant and this increasing number coming back post-transplant.

Speaker #8: I think what we've looked and some of the numbers we've updated this quarter using claims data, and we look back and we realize there's a greater percentage going to transplant, and it's increasing number coming back post-transplant.

Speaker #8: The way to think about it is average is probably three to four months to get patients back, but the longer we're on market, we realize there's patients that may be six months or more off treatment from that transplant to when they get back on.

Michael Metzger: The way to think about it is average is probably 3 to 4 months to get patients back. The longer run market, we realize there's patients that may be 6 months or more off treatment from that transplant to when they get back on. The timing is gonna be important. We've seen that grow as an important piece of our business. It's a little slower to build than it would be just bringing new patients in, which is, you know, driving the business right now on the NPM1 side. You know, in terms of that, 'cause it all lands on duration of treatment, which is something we've seen extend. In particular, I think we have this in our notes.

Steve Closter: The way to think about it is average is probably 3 to 4 months to get patients back. The longer run market, we realize there's patients that may be 6 months or more off treatment from that transplant to when they get back on. The timing is gonna be important. We've seen that grow as an important piece of our business. It's a little slower to build than it would be just bringing new patients in, which is, you know, driving the business right now on the NPM1 side. You know, in terms of that, 'cause it all lands on duration of treatment, which is something we've seen extend. In particular, I think we have this in our notes.

Speaker #8: So the timing is going to be important. We've seen that grow as an important piece of our business. It's a little slower to build than it would be just bringing new patients in, which is driving the business right now in the MPM1 side.

Speaker #8: So in terms of that, because it all lands on duration of treatment, which is something we've seen extend, in particular, I think we have this in our notes.

Speaker #8: The patients that do come back, particularly those that start in the first seven months of launch, they're already at nine months and longer in terms of duration of treatment.

Michael Metzger: The patients that do come back, particularly those that start in the first 7 months of launch, they're already at 9 months and longer in terms of duration of treatment. That, that will extend and there'll be more folks in that group over time, which is why we expect the duration of treatment to grow considerably over 2026.

Steve Closter: The patients that do come back, particularly those that start in the first 7 months of launch, they're already at 9 months and longer in terms of duration of treatment. That, that will extend and there'll be more folks in that group over time, which is why we expect the duration of treatment to grow considerably over 2026.

Speaker #8: And that will extend, and there'll be more folks in that group over time, which is why we expect the duration of treatment to grow considerably over 2026.

Speaker #7: Thanks.

Steven Closter: Thanks.

Corinne Jenkins: Thanks.

Speaker #1: Thanks, Karine.

Michael Metzger: Thanks, Corinne.

Speaker #4: The next question is from Phil Netto from T-Day Cowen. Phil, your line is open.

Operator 2: The next question is from Phil Nadeau from TD Cowen. Phil, your line is open.

Operator: The next question is from Phil Nadeau from TD Cowen. Phil, your line is open.

Speaker #9: Good afternoon. Thanks for taking our questions. Two from us. One commercial and one on the pipeline. In terms of the NPM1 penetration, what do you think is gating for increasing that penetration?

Phil Nadeau: Good afternoon, thanks for taking our questions. Two from us, one commercial and one on the pipeline. In terms of the NPM1 penetration, what do you think is gating for increasing that penetration? Is this simply time on market or are there datasets that could be important, such as the FLT3 combo data that's expected later this year? That's first. Then second on the pipeline, the data you present from lung involvement in GVHD is very impressive. What is the time course of the responses in GVHD? Is 26 week duration likely to be sufficient in IPF? Thanks.

Speaker #9: Is it simply time on market, or are there data sets that could be important such as the FLIP3 combo data that's expected later this year?

Speaker #9: That's first. And then second, on the pipeline, the data you present from lung involvement and CGVHD is very impressive. What is the time course of the responses in GVHD?

Speaker #9: Is 26-week duration likely to be sufficient in IPF? Thanks.

Speaker #1: Great. Thanks, Phil, for the question. So the first question related to sort of what's gating relative to the growth of NPM1. Maybe I'll turn it over to Steve to make a comment there and maybe to Nick for the pipeline question.

Michael Metzger: Great. Thanks, Phil, for the question. The first question related to, sort of what's gating relative to the growth of NPM1. Maybe I'll turn it over to Steve to make a comment there and maybe to Nick for the pipeline question. Yeah, NPM1, it's, you know, clearly we're at the front end of that population, Phil, there's a lot more patients to grab. I think when you think about our own business, there's been step-ups in the business, and it really began for us in that Q3 timeframe, right? In the end of September, we got NCCN guidelines obviously the full indication for Q4. We've seen big step-ups in our own business, roughly in the 250 range in Q3 of new patients. A big step up in Q4, another step up in Q1.

Speaker #8: Yeah, NPM1, it's clearly we're at the front end of that population, Phil. So there's a lot more patients to grab. I think when you think about our own business, there's been step-ups in the business, and it really began for us in that Q3 timeframe at the end of September.

Speaker #8: We got NCCN guidelines, and then obviously the full indication for the fourth quarter. So we've seen big step-ups in our own business, roughly in the 250 range in Q3, new patients, a big step-up in Q4, another step-up in Q1.

Speaker #8: Our average is we're looking at 330 new patients in the quarter. So that'll build. It's a different market. KMT2A was obviously our launch. Lots of patients came in.

Michael Metzger: Our average is, you know, we're looking at 330 new patients in the quarter. That'll build. It's a different market. You know, KMT2A was obviously our launch. Lots of patients came in. Rev is already the standard of care. Patients had no other options. We know for NPM1 they do. There's FLT3 co-mutation, it's a little bit more complex. The patient tends to be older. We're not gonna see as much likely transplant and then restarts in that population. We're gonna give it time, and the time to peak will just be a little bit longer in the NPM1 population relative to KMT2A. Yeah, I'll just add that the profile that we're showing for NPM1 is best in class. I think we feel very confident.

Speaker #8: There's rev is ready to standard of care. Patients had no other options. We know for NPM1, they do. There's FLIP3 combination, so it's a little bit more complex.

Speaker #8: The patient tends to be older. We're not going to see as much likely transplant and then restarts in that population. So we're going to give it time, and the time to peak will just be a little bit longer in the NPM1 population relative to KMT2A.

Speaker #1: And I'll just add that the profile that we're showing for NPM1 is best in class. I think we feel very confident physicians tell us that time and again that we have as Steve said in his remarks, broad advantages across the profile.

Michael Metzger: Physicians tell us that time and again that we have, you know, as Steve said in his remarks, broad, you know, broad advantages across the profile. We feel very confident that we'll continue to build that market, build that business of that dominant share over time. Now the next question was related to IPF, and I'll turn it over to Nick to answer that.

Speaker #1: So we feel very confident that we'll continue to build that market, build that business in that dominant share over time. And now the next question was related to IPF, and I'll turn it over to Nick to answer that.

Speaker #10: Yeah, thank you, Phil. Happy to take that question. So first thing I say, this is a very robust and statistically rigorous proof of concept study in IPF, and we're very confident in the 26-week endpoint.

Nicholas Botwood: Thank you, Phil. Happy to take that question. First thing I'd say, this is a very robust and statistically rigorous proof of concept study in IPF, and we're very confident in the 26-week endpoint. There have actually been some other previous POCs that have even looked at 12 weeks. We think 26 weeks is a very good compromise in terms of it being too short, but enough time to be able to detect a difference. We actually annualize that. We'll report annualized rates of FVC decline using, you know, standard FDA-approved models for modeling that out to 52 weeks. This will be a very rigorous proof of concept to inform a Phase 3 program. If you look at previous Phase 3 studies, if you actually look at the graphs for separation, you see very clear separation by week 26.

Nick Botwood: Thank you, Phil. Happy to take that question. First thing I'd say, this is a very robust and statistically rigorous proof of concept study in IPF, and we're very confident in the 26-week endpoint. There have actually been some other previous POCs that have even looked at 12 weeks. We think 26 weeks is a very good compromise in terms of it being too short, but enough time to be able to detect a difference. We actually annualize that. We'll report annualized rates of FVC decline using, you know, standard FDA-approved models for modeling that out to 52 weeks. This will be a very rigorous proof of concept to inform a Phase 3 program. If you look at previous Phase 3 studies, if you actually look at the graphs for separation, you see very clear separation by week 26.

Speaker #10: There have actually been some other previous POCs that have even looked at 12 weeks. We think 26 weeks is a very good compromise, in terms of it being not too short, but enough time to be able to detect a difference.

Speaker #10: We actually annualize that. We'll report annualized rates of FCC decline. Using a standard FDA-approved models for modeling that out to 52 weeks. So this will be a very rigorous proof of concept to inform a phase three program.

Speaker #10: And if you look at previous Phase 3 studies, if you actually look at the graphs for separation, you see very clear separation by week 26.

Speaker #10: So we're confident that 26 weeks will be sufficient to detect a difference and inform a phase three.

Nicholas Botwood: We're confident that 26 weeks will be sufficient to detect a difference and inform a phase 3.

Nick Botwood: We're confident that 26 weeks will be sufficient to detect a difference and inform a phase 3.

Speaker #9: Perfect. Thank you.

Phil Nadeau: Perfect. Thank you.

Speaker #1: Thanks, Phil.

Michael Metzger: Thanks, Phil.

Speaker #4: The next question is for Brad Canino from Guggenheim. Brad, your line is open.

Operator 2: The next question is for Bradley Canino from Guggenheim. Brad, your line is open.

Operator: The next question is for Bradley Canino from Guggenheim. Brad, your line is open.

Speaker #11: Hey, just following on the previous question of the transplant maintenance dynamic continuing to be more of a temporary headwind for now. My question is really simply, when will this start to flip to a tailwind?

Bradley Canino: Hey, just following on the previous question on the transplant maintenance dynamic continuing to be more of a temporary headwind for now. My question is really simply when will this start to flip to a tailwind? It sounds like there's two levers now. You're pointing to flat quarterly patient starts, so you're refilling the population. How much higher than a 50% transplant rate can even be possible in this population? Are you topped out there and now you can grow that maintenance restart? Are you confident in that 6-ish month now wait to the restart for maintenance? Could that even extend too to be, you know, patients starting 7, 8, 9 months later and push out the time to that start of the tailwind as well?

Brad Canino: Hey, just following on the previous question on the transplant maintenance dynamic continuing to be more of a temporary headwind for now. My question is really simply when will this start to flip to a tailwind? It sounds like there's two levers now. You're pointing to flat quarterly patient starts, so you're refilling the population. How much higher than a 50% transplant rate can even be possible in this population? Are you topped out there and now you can grow that maintenance restart? Are you confident in that 6-ish month now wait to the restart for maintenance? Could that even extend too to be, you know, patients starting 7, 8, 9 months later and push out the time to that start of the tailwind as well?

Speaker #11: It sounds like there's two levers now. And you're pointing to flat quarterly patient starts. So you're refilling the population. But how much higher than a 50% transplant rate can even be possible in this population?

Speaker #11: Are you topped out there? And now you can grow that maintenance restart? And then are you confident in that six-ish month now weight to the restart for maintenance?

Speaker #11: Or could that even extend to be patients starting seven, eight, nine months later and push out the time to that start of the tailwind as well?

Bradley Canino: Separately, it looks like you lost about 14 points of year-over-year growth due to gross to net. Is there a chance that reverses back later this year? Can it get worse, or should we think about that being a neutral effect for the rest of the year? Thank you.

Speaker #11: Separately, it looks like you lost about 14 points of year-over-year growth due to gross-to-net? Is there a chance that reverses back later this year?

Brad Canino: Separately, it looks like you lost about 14 points of year-over-year growth due to gross to net. Is there a chance that reverses back later this year? Can it get worse, or should we think about that being a neutral effect for the rest of the year? Thank you.

Speaker #11: Can it get worse? Or should we think about that being a neutral effect for the rest of the year? Thank you.

Speaker #1: Great, Brad. Thanks for the questions. So I think your you're right about the maintenance dynamic as today is a bit of a headwind. I mean, obviously, a great opportunity for patients, many more going to transplant.

Michael Metzger: Great, Brad. Thanks for the questions. I think you're right about the maintenance dynamic is a bit of a headwind. I mean, obviously a great opportunity for patients, many more going to transplant. It's far exceeded our expectations. You've probably heard us talk about the fact that maintenance could, or rather transplant could get as high as 50%, and that's essentially where we're at. I think that happened a little bit faster than we expected, but that's probably where it'll be. I don't expect it to be much higher than 50%. I do think that has sort of topped out. We will ultimately see, but that's point number one.

Speaker #1: It's far exceeded our expectations. You've probably heard us talk about the fact that maintenance could, or rather, transplant could get as high as 50%.

Speaker #1: And that's essentially where we're at. So I think that happened a little bit faster than we expected. But that's probably where it'll be. I don't expect it to be much higher than 50%.

Speaker #1: So, I do think that has sort of topped out. We will ultimately see, but that's point number one. Point number two is the effect on restarting and how long we're going to need to wait until that really becomes a big factor.

Michael Metzger: Point number two is the effect on restarting and how long we're gonna need to wait until that really becomes a big factor. We have talked to many physicians. Obviously, the work that we've done seems to indicate that we'll get to 70% to 80% of patients restarting maintenance, and we've seen that accelerate as every quarter has gone by. I think that's a, that's an important milestone or important bogey for us. Whether that takes another quarter, 2 quarters, a year, we'll see. We ultimately think that's where we'll be at steady state. That'll be an important driver of growth as we go forward here, and that's the dynamic we see playing out.

Speaker #1: We have talked to many physicians. Obviously, the work that we've done seems to indicate that we'll get to 70 to 80 percent of patients restarting maintenance.

Speaker #1: And we've seen that accelerate as every quarter has gone by. So I think that's an important milestone, an important bogey for us, whether that takes another quarter, two quarters, a year.

Speaker #1: We'll see. We ultimately think that's where we'll be at steady state. So that'll be an important driver of growth as we go forward here.

Speaker #1: And that's the dynamic we see playing out. We do see patients as Steve mentioned that over a six-month period of time, as you wait to come back and in graftment for maintenance, it's a little bit longer than we expected.

Michael Metzger: We do see patients, as Steve mentioned, that over a 6-month period of time, as you wait to come back at engraftment for maintenance, it's a little bit longer than we expected. We are picking up patients now in the claims that it's not 3, 4 months of engraftment and restart. It's more like 5, 6 months, maybe even longer. That, again, that is a, you know, a piece of this. I don't think that's the vast majority of patients. I think that's some of the patients. Again, we do expect in future quarters to start to see some of the compounding effect as we sort of peaked at our 50% transplant rate, and then we'll have more patients coming back. That's the dynamic to look forward to. Maybe, Keith, do you wanna talk about gross-to-net?

Speaker #1: We are picking up patients now in the claims that it's not three, four months of in graftment and restart. It's more like five, six months, maybe even longer.

Speaker #1: So that, again, that is a piece of this. I don't think that's the vast majority of patients. I think that's some of the patients.

Speaker #1: So again, we do expect in future quarters to start to see some of the compounding effect as we sort of peaked at our 50% transplant rate and then we'll have more patients coming back.

Speaker #1: So that's the dynamic to look forward to. Maybe Keith, do you want to talk about gross-to-net?

Speaker #12: Yeah, Brad, with respect to gross-to-net, I would just say, not sure exactly of your math, but I would say that we've consistently guided since we launched that we expect gross-to-net to settle in the 20% to 25% range.

Keith Goldan: Brad, with respect to the gross-to-net, I would just say, not sure exactly of your math, but I would say that, you know, we've consistently guided since we launched that we expect gross-to-nets to settle in the 20% to 25% range. We're still squarely within that range and you know, I'm not changing our guidance at this time. We did see, you know, what I would call typical Q1 seasonality impacts on the gross-to-net just due to the high deductible... mostly due to the high deductible commercial resets and the Part D donut hole. The, you know, the impact was still landed us within the guided range.

Speaker #12: We're still squarely within that range. And I'm not changing our guidance at this time. We did see what I would one Q, seasonality impacts on the gross-to-net, just due to the high deductible.

Speaker #12: Mostly due to the high deductible commercial resets, and the Part D don't hold. But the impact still landed us within the guided range.

Speaker #4: Thank you. The next question is from Stephen Wiley from Stifel. Stephen, your line is open.

Operator 2: Thank you. The next question is from Stephen Willey from Stifel. Stephen, your line is open.

Operator: Thank you. The next question is from Stephen Willey from Stifel. Stephen, your line is open.

Speaker #13: Hey, good afternoon. This is Josh on for Steve. Thanks for taking our question. Do you think that the data from the phase two acts eructs combo trial would be sufficient to potentially support a compendium listing for frontline GBHD?

[Analyst] (Stifel): Hey, good afternoon. This is Josh on for Steve. Thanks for taking our question. Do you think that the data from the phase 2 Axa Rux combo trial would be sufficient to potentially support a compendia listing for frontline GVHD? How do you think data from this trial will serve to inform or de-risk, if at all, the phase 3 trial looking at Axa in combo with steroids in the frontline setting?

Speaker #13: And then how do you think data from this trial will serve to inform or de-risk, if at all, the phase three trial looking at AXA and combo with steroids in the frontline setting?

Speaker #1: Thanks, Josh. Good question. So let me turn it over to Nick to handle both of those. I think.

Michael Metzger: Thanks, Josh. Good question. Let me turn it over to Nick to handle both of those, I think.

Speaker #14: Yeah. I think it's a very it's a well-designed study and a very interesting hypothesis that you might be able to avoid steroids in the frontline setting.

Nicholas Botwood: Yeah. I think it's a very well-designed study and a very interesting hypothesis that you might be able to avoid steroids in the frontline setting. This is a potential steroid setting approach. It's 120 patients, about 40 patients per arm, and is basically, I mean, it's a noncomparative randomized study, but really the benchmark for this is about a 40% response rate using standard NIH criteria at around 6 months. If you see a meaningful improvement on that, let's say 60%, which is kind of aligned to where the study would be, I think that could not only inform clinical practice, but potentially also compendia listing just because of the morbidity associated with long-term dexamethasone.

Nick Botwood: Yeah. I think it's a very well-designed study and a very interesting hypothesis that you might be able to avoid steroids in the frontline setting. This is a potential steroid setting approach. It's 120 patients, about 40 patients per arm, and is basically, I mean, it's a noncomparative randomized study, but really the benchmark for this is about a 40% response rate using standard NIH criteria at around 6 months. If you see a meaningful improvement on that, let's say 60%, which is kind of aligned to where the study would be, I think that could not only inform clinical practice, but potentially also compendia listing just because of the morbidity associated with long-term dexamethasone.

Speaker #14: So this is a potential steroid-setting approach. It's 120 patients, about 40 patients per arm, and it's basically—I mean, it's a non-comparative randomized study, but really the benchmark for this is about a 40% response rate using standard NIH criteria at around six months.

Speaker #14: So if you see a meaningful improvement on that, let's say 60%, which is kind of aligned to where the study would be, I think that could not only inform clinical practice, but potentially also compendium listing just because of the morbidity associated with long-term dexamethasone.

Nicholas Botwood: We will also look at a number of other clinically meaningful endpoints in that study, like the time to actually have to reintroduce steroids. If you can really delay that, again, I think clinically that's significant. Duration of response and time to events or other endpoints. I think when we look at the totality of those, it'll be very informative both to practice and compendia and could inform future registrational studies. The dexamethasone combination phase 3 study that you mentioned is a different hypothesis. This is where axatilimab can actually add to dexamethasone. It's a slightly different hypothesis. That could offer an alternative standard of care. They have quite complementary mechanisms of actions. That is a pivotal phase 3 study.

Speaker #14: We will also look at a number of other clinically meaningful endpoints in that study, like the time to actually have to reintroduce steroids. And if you can really delay that again, I think clinically that's significant.

Nick Botwood: We will also look at a number of other clinically meaningful endpoints in that study, like the time to actually have to reintroduce steroids. If you can really delay that, again, I think clinically that's significant. Duration of response and time to events or other endpoints. I think when we look at the totality of those, it'll be very informative both to practice and compendia and could inform future registrational studies. The dexamethasone combination phase 3 study that you mentioned is a different hypothesis. This is where axatilimab can actually add to dexamethasone. It's a slightly different hypothesis. That could offer an alternative standard of care. They have quite complementary mechanisms of actions. That is a pivotal phase 3 study.

Speaker #14: The duration of response and time to events or other endpoints. And I think when we look at the fatality of those, it'll be very informative both to practice and compendia.

Speaker #14: And could inform future registrational studies. The dexamethasone combination phase three study that you mentioned is a different hypothesis. This is where the acetylimab can actually add to dexamethasone.

Speaker #14: So it's a slightly different hypothesis. And that could offer an alternative standard of care. They have quite complementary mechanisms of actions. And that is a pivotal phase three study.

Speaker #4: Thank you. The next question is from Faizal Kershid from Jefferies. Faizal, your line is open.

Operator 2: Thank you. The next question is from Faisal Khurshid from Jefferies. Faisal, your line is open.

Operator: Thank you. The next question is from Faisal Khurshid from Jefferies. Faisal, your line is open.

Speaker #15: Hello. This is Anand Shan for Faisal. I just wanted to follow up on the progress in the first line AML phase three trials. Where do you see yourself relative to the competition there and maybe a little bit more on Evolve2 and how you see that stacking up in the end?

[Analyst] (Jefferies): Hello, this is Enan John for Faisal. Just wanted to follow up on the progress in the first line AML phase 3 trials. Where do you see yourself relative to the competition there? Maybe a little bit more on EVOLVE-2 and how you see that stacking up in the end. Thank you.

Enan Chan: Hello, this is Enan John for Faisal. Just wanted to follow up on the progress in the first line AML phase 3 trials. Where do you see yourself relative to the competition there? Maybe a little bit more on EVOLVE-2 and how you see that stacking up in the end. Thank you.

Speaker #15: Thank you.

Speaker #1: Thanks, Anand. Yeah. So let me first comment, and then I'll let Nick make other comments. The progress on the trials, we're doing quite well.

Michael Metzger: Thanks, Unidentified. Yeah, let me first comment, and then I'll let Nick make other comments. The progress on the trials, we're doing quite well. I think as Nick remarked, or in his written remarks, you know, this is a period of standing up our trial, standing up sites, enrolling patients. Everything is on track and going quite well. We feel we are, you know, going to be first at frontline. We feel confident in everything that we're doing to execute against our timelines. Everything's on track. I'll turn to Nick, maybe more about EVOLVE.

Speaker #1: I think as Nick remarked or in his written remarks, we have this is a period of standing up our trial, standing up sites, enrolling patients.

Speaker #1: Everything is on track and going quite well. So we feel we are going to be first of front line. We feel confident in everything that we're doing to execute against our timelines.

Speaker #1: And so everything's on track. And I'll turn to Nick, maybe born about Evolve.

Speaker #15: Yeah. No, thanks. And this is I mean, simply, this is one of the highest focuses for my teams. It's a very high priority. We're spending a lot of time on this.

Nicholas Botwood: Yeah. No, thanks. I mean, simply this is one of the highest focuses for my teams. It's a very high priority, and we're spending a lot of time on this, and we have two different approaches. EVOLVE-2, again, this was the first study to start enrolling, so it's been enrolling now for nearly a year. We're working with HOVON, which is giving us a fantastic network of sites across US, and we are also now entering sites in the US, making a lot of progress with site activations and indeed patient enrollment. In fact, some of the metrics around patients per site per month are actually in somewhat in excess of what we modeled, and that's quite exciting because I think it speaks to the physicians' enthusiasm and the support of the HOVON group to enroll this study.

Nick Botwood: Yeah. No, thanks. I mean, simply this is one of the highest focuses for my teams. It's a very high priority, and we're spending a lot of time on this, and we have two different approaches. EVOLVE-2, again, this was the first study to start enrolling, so it's been enrolling now for nearly a year. We're working with HOVON, which is giving us a fantastic network of sites across US, and we are also now entering sites in the US, making a lot of progress with site activations and indeed patient enrollment. In fact, some of the metrics around patients per site per month are actually in somewhat in excess of what we modeled, and that's quite exciting because I think it speaks to the physicians' enthusiasm and the support of the HOVON group to enroll this study.

Speaker #15: And we have two different approaches. Evolve2—again, this was the first study started enrolling. So it's been enrolling now for nearly a year. We're working with Hovon, which is giving us a fantastic network of sites across the US.

Speaker #15: And we are also now entering sites in the US. Making a lot of progress with site activations and indeed patient enrollment. In fact, some of the metrics around patients per site per month are actually in somewhat in excess of what we modeled.

Speaker #15: And that's quite exciting because I think it speaks to the physician's enthusiasm and the support of the Hovon group to enroll this study. So because we've generated such a body of evidence with Vene that we actually feel very confident in the design and some of the statistical assumptions of that study.

Nicholas Botwood: Because we've generated such a body of evidence with venetoclax, we actually feel very confident in the design and some of the statistical assumptions of that study. It's moving along very nicely, and our expectation is to be first with the readout for that trial. Likewise, REVEAL, we've made a lot of progress. As you know, we recently confirmed the dose at 162.70 in combination with intensive chemotherapy, which is great. We're working with a leading CRO internationally. We're busy setting up sites in Asia and activating sites. Again, we're running very much to track. We're feeling very confident about that study as well, and more on that to come. no, the teams are feeling confident, and we're in a good place.

Nick Botwood: Because we've generated such a body of evidence with venetoclax, we actually feel very confident in the design and some of the statistical assumptions of that study. It's moving along very nicely, and our expectation is to be first with the readout for that trial. Likewise, REVEAL, we've made a lot of progress. As you know, we recently confirmed the dose at 162.70 in combination with intensive chemotherapy, which is great. We're working with a leading CRO internationally. We're busy setting up sites in Asia and activating sites. Again, we're running very much to track. We're feeling very confident about that study as well, and more on that to come. no, the teams are feeling confident, and we're in a good place.

Speaker #15: And it's moving along very nicely. And our expectation is to be first with the readout for that trial. Likewise, Reveal, we've made a lot of progress, as you know.

Speaker #15: We recently confirmed the dose at 162/70 in combination with the 10% chemotherapy, which is great. We're working with a leading CRO internationally. We're busy setting up sites in Asia.

Speaker #15: And activating sites. And again, we're running very much to track, so we're feeling very confident about that study as well. And more on that to come.

Speaker #15: But no, the teams are feeling confident. And we're in a good place.

Speaker #16: Thank you so much, guys. Appreciate the caller.

[Analyst] (Jefferies): Thank you so much, guys. Appreciate the call.

Enan Chan: Thank you so much, guys. Appreciate the call.

Speaker #1: Thank you. Thanks, Anand.

Michael Metzger: Thank you.

Keith Goldan: Thanks, Enan John.

Speaker #4: The next question is from Mayank Mantami from B Riley. Mayank, your line is open.

Operator 2: The next question is from Mayank Mamtani from B. Riley. Mayank, your line is open.

Operator: The next question is from Mayank Mamtani from B. Riley. Mayank, your line is open.

Speaker #17: Yes. Good afternoon. Thanks for taking our question and congrats on the progress going on for you guys. Just any chance you are able to share the absolute number of patients launched to date that have returned post-transplant?

Mayank Mamtani: Yes, good afternoon. Thanks for taking our questions and congrats on the lots going on for you guys. Just any chance you are able to share, you know, the absolute number of patients launched today that have returned post-transplant? On the 300 new patients added intra-quarter, you know, if you can give any color on the mix NPM1 and KMT2A versus what we saw in the prior quarter and, if anything on the NPM1 you can share on duration and co-mutation use, you know, relative to what you had maybe initially expected last quarter, that would be great to hear. I will follow up.

Speaker #17: And on the 300 new patients added intra-quarter, if you can give any color on the mix—NPM1 and KMT2A—versus what we saw in the prior quarter, and if there's anything on the NPM1 you can share on duration and co-mutation use relative to what you had maybe initially expected.

Speaker #17: Last quarter, that would be great to hear. And then I have a follow-up.

Speaker #1: Yeah. Mayank, thank you for the question. So on the absolute number of patients, I think maybe I'll ask Steve to make a comment if we have that data.

Michael Metzger: Yeah, Mayank, thank you for the question. On the absolute number of patients, I think, maybe I'll ask Steve to make a comment if we have if we have that data.

Speaker #15: We can estimate. We don't have exact numbers that I would share right now. We know we've treated 1,400 patients roughly from launch date through now.

Steven Closter: We can estimate it. We don't have exact numbers.

Steve Closter: We can estimate it. We don't have exact numbers.

Michael Metzger: Yeah

Steven Closter: That I would share right now. We know we've treated 1,400 patients roughly from launch date through now.

Steve Closter: That I would share right now. We know we've treated 1,400 patients roughly from launch date through now.

Michael Metzger: Yeah.

Steven Closter: Break it down by KMT2A and NPM1 patients. It's probably at least a few hundred at this point more.

Speaker #15: Break it down by KMT2A and NPM1 patients. So it's probably at least a few hundred at this point, more. So we can come back with a.

Steve Closter: Break it down by KMT2A and NPM1 patients. It's probably at least a few hundred at this point more.

Michael Metzger: Yeah. Yeah. I mean.

Steven Closter: We can come back, so we can come back.

Steve Closter: We can come back, so we can come back.

Speaker #1: Yeah. I mean, look, I think that part of what the challenge of breaking down KMT2A versus NPM1 is it doesn't work like that in claims.

Michael Metzger: I mean, look, I think that Part of what the challenge of breaking down KMT2A versus NPM1 is it doesn't work like that in claims, so you have to make some certain estimates. You know, that's a little bit trickier. Your question about co-mutations was, you know, what percent of patients have co-mutations, I think that was my interpretation of your question. I think, you know, broadly speaking, NPM1, you know, a high degree, 85% of patients have co-mutations. You know, about half of those have FLT3 mutations. We're running trials to look at combinations and things like that in terms of the FLT3 population. Other patients have IDH inhibitor, IDH mutations as well.

Speaker #1: So you have to make some certain estimates. So that's a little bit trickier. Your question about co-mutations was what percent of patients have co-mutations.

Speaker #1: I think that was my interpretation of your question. I think broadly speaking, NPM1, a high degree, 85% of patients have co-mutations. About half of those have FLIP3 mutations.

Speaker #1: So we're running trials to look at combinations and things like that in terms of the FLIP3 population. Other patients have IDH inhibitor IDH mutations as well.

Speaker #1: So it breaks down at a multifaceted population of patients that you have to deal with with combinations or with, in some cases, we use venetoclax and azitidine to combine our drug with in order to handle all of that.

Michael Metzger: It breaks down as a, you know, multifaceted population of patients that you have to deal with combinations or. In some cases, we use venetoclax and azacitidine to combine our drug with in order to handle all of that. I think that's, you know, that's the extent of, you know, the co-mutation question. We'll leave it there for now.

Speaker #1: So, I think that's the extent of the co-mutation question. So we'll leave it there for now.

Mayank Mamtani: Thank you, Michael. Duration in NPM1, could you comment on that?

Speaker #17: Duration? Thank you, Michael. Duration and NPM1, could you comment on that?

Mayank Mamtani: Thank you, Michael. Duration in NPM1, could you comment on that?

Speaker #1: Yeah. Yeah. Thanks. So duration, I mean, we had talked about duration of NPM1. Over time, being in the roughly seven to nine-month range I think it's early days to look at and have a duration calculation specifically for NPM1.

Michael Metzger: Duration, I mean, we had talked about duration of NPM1, you know, over time being in the roughly 7 to 9-month range. You know, I think it's early days to look at, you know, and have a duration calculation specifically for NPM1. We had talked a little bit more about the KMT2A population and how that's kind of coming together with the impact of more patients going to transplant and returning for maintenance. As Steve mentioned in his remarks, patients who have actually received a transplant and have gone on to maintenance are on average out to 9 months and counting. That's a very positive forward indicator of where that business is going. I can think that, you know, NPM1 is certainly tracking with patients staying on drug for multiple months.

Speaker #1: We had talked a little bit more about the KMT2A population and how that's kind of coming together with the impact of more patients going to transplant and returning for maintenance.

Speaker #1: And as Steve mentioned in his remarks, patients who have actually received a transplant and have gone on to maintenance are on average out to nine months and counting.

Speaker #1: So that's a very positive forward indicator of where that business is going. And I can think that NPM1 is certainly tracking with patients staying on drug for multiple months, some will get transplant, most will not.

Michael Metzger: Some will get transplant, most will not. That'll be an impact, you know, a factor in how duration ultimately plays out. We expect patients to do quite well and, you know, be on drug for months.

Speaker #1: And so that'll be an impact a factor in how duration ultimately plays up. But we expect patients to do quite well. And be on drug for months.

Speaker #17: Got it. And on the ad surplus drug study, the phase two, timeline got pushed up. Is the phase three steroid study that Nick, you just mentioned, is that also tracking ahead of plan?

Mayank Mamtani: Got it. On the axatilimab plus drug study, the phase 2, you know, timeline got pushed up. Is the phase 3 steroid study that, you know, Nick, you just mentioned, is that also tracking ahead of plan? I believe you've said early 2028 readout. If you can clarify that. Thanks for taking our questions.

Speaker #17: I believe you've said early 2028 readout. If you can clarify that. Thanks for taking our questions.

Speaker #1: Yeah. I know. That timeline's the same. Nothing's moved out. They're independent of one another, as Nick mentioned in the trials or different trials, and they have different everything's different about them.

Michael Metzger: Yeah, no, that timeline's the same. Nothing's moved out. They're independent of one another. You know, Nick mentioned in the trials are different trials and they have everything's different about them. No, I wouldn't assume that timeline has changed.

Speaker #1: So no, I wouldn't assume that timeline has changed.

Speaker #17: Gotcha. Thank you.

Mayank Mamtani: Gotcha. Thank you.

Speaker #1: Thank you.

Michael Metzger: Thank you.

Speaker #4: The next question is from Itza Darut from Barclays. Itza, your line is open.

Operator 2: The next question is from Etzer Darout from Barclays. Etzer, your line is open.

Operator: The next question is from Etzer Darout from Barclays. Etzer, your line is open.

Speaker #1: Great. Thanks for taking the question. Maybe if you could just provide any color commentary or even guide post on 2026 revenue guidance. And then any color as well or commentary on commercial dynamics with just different NMP1 call points with Ziftomedib on the market.

Etzer Darout: Great. Thanks for taking our question. Maybe if you could just provide any color, commentary, or even guideposts on 2026 revenue guidance. Any color as well or commentary on commercial dynamics with just different NPM1 call points, with zevotamab on the market. Anything you can provide there would be great as well. Thank you.

Speaker #1: Anything you can provide there would be great as well. Thank you.

Speaker #15: Sure. Thanks for the question. So first, maybe I'll turn to Keith on how we're approaching revenue guidance, which is going to be easy to answer.

Michael Metzger: Sure. Thanks for the question. First, maybe I'll turn to Keith on how we're approaching revenue guidance, which is gonna be easy to answer.

Steven Closter: Easy to answer. Sorry, Etzer, we don't provide revenue guidance. You know, we're early in the launch of NPM1. There's competition out there, so probably wouldn't be responsible for us to go out and give guidance at this point.

Keith Goldan: Easy to answer. Sorry, Etzer, we don't provide revenue guidance. You know, we're early in the launch of NPM1. There's competition out there, so probably wouldn't be responsible for us to go out and give guidance at this point.

Speaker #15: Sorry, we don't provide revenue guidance. We're early in the launch of NPM1. There's competition out there, so it probably wouldn't be responsible for us to go out and give guidance at this point.

Speaker #1: Right. And then anything on the commercial dynamics between us and our competitor, I think that was a Genesis question there. Steve?

Michael Metzger: Right. Then any on the commercial dynamics between us and our competitor, I think that was the genesis of the question there. Steve?

Speaker #15: Yeah, I mean, dynamics we can share. Competition's always good for us to be at our best. But I think, importantly, MENINs are exciting. Lots of physicians are interested.

Steven Closter: Yeah, I mean, dynamics we can share. Competition's always good for us to be at our best. I think importantly, menins are exciting. You know, lots of physicians are interested. Awareness is there. It's an obvious path in KMT2A. We've done very well and met and probably exceeded physician and patient expectations. The NPM1 patient's different. I think you can see by the nature of these calls, there's co-mutations. It'll build differently over time. We think it's a good thing that there's another menin player in the market, raising awareness, finding a place for menins. We've shared, Michael's shared thoughts on just our profile, how physicians think about it. We've got a better profile in NPM1, anything that's done on behalf of the class will have benefit to us as the market leader in NPM1 and in KMT2A.

Steve Closter: Yeah, I mean, dynamics we can share. Competition's always good for us to be at our best. I think importantly, menins are exciting. You know, lots of physicians are interested. Awareness is there. It's an obvious path in KMT2A. We've done very well and met and probably exceeded physician and patient expectations. The NPM1 patient's different. I think you can see by the nature of these calls, there's co-mutations. It'll build differently over time. We think it's a good thing that there's another menin player in the market, raising awareness, finding a place for menins. We've shared, Michael's shared thoughts on just our profile, how physicians think about it. We've got a better profile in NPM1, anything that's done on behalf of the class will have benefit to us as the market leader in NPM1 and in KMT2A.

Speaker #15: Awareness is there. It's an obvious path in KMT2A. We've done very well. And probably exceeded physician-to-patient expectations. The NPM1 patient's different. I think you can see by the nature of these calls, there's co-mutations.

Speaker #15: It'll build differently over time. So we think it's a good thing that there's another Mennon player. In the market, raising awareness, finding a place for Mennons.

Speaker #15: We've shared, and Michael's shared thoughts on just our profile, how physicians think about it. We've got a better profile in NPM1. So anything that's done on behalf of the class, we'll have benefit to us as the market leader.

Speaker #15: In NPM1 and in KMT2A. So we'll see how it we'll see how it rolls over the coming months, but we think it's a good thing.

Steven Closter: We'll see how it rolls over the coming months, but we think it's a good thing, and we think ultimately we'll benefit from it.

Steve Closter: We'll see how it rolls over the coming months, but we think it's a good thing, and we think ultimately we'll benefit from it.

Speaker #15: And we think ultimately, we'll benefit from it.

Speaker #1: Yeah. And then I'd just say that NPM1 is a very considerable piece of our business as it's growing. We feel very good about our competitive position.

Michael Metzger: Yeah, I would just say that, you know, NPM1 is a very considerable piece of our business, and it's growing. We feel very good about our competitive position. Steve's organization, you know, essentially, you know, built us into the market leader, and we expect to continue to build that piece of the business, competition or no competition.

Speaker #1: Steve's organization is essentially built us into the market leader, and we expect to continue to build that piece of the business competition or no competition.

Etzer Darout: Okay. Thank you.

Speaker #1: Thank you. Thank you.

Michael Metzger: Thank you.

Speaker #4: The next question is from David Dye from UBS. David, your line is open.

Operator 2: The next question is from David Dai from UBS. David, your line is open.

Operator: The next question is from David Dai from UBS. David, your line is open.

Speaker #7: All right. Thanks for taking my questions. Just on the NCTIMBL in IPF, what levels of investigator or payer interest have you seen today in NCTIMBL's antifibrotic potential?

David Dai: Great. Thanks for taking my questions. Just on the Niktimvo IPF, what levels of investigator or payer interest are you seeing today in Niktimvo's anti-fibrotic potential? How might a positive IPF data change the commercial opportunity long term?

Speaker #7: And how might positive IPF data change the commercial opportunity long term?

Speaker #1: Thanks for your questions, David. So two questions related to NCTIMBL. One, excuse me, payer interest around IPF. I think that was the first question Steve that you have comment on that.

Michael Metzger: Thanks for your questions, David. Two questions related to Niktimvo. One, payer interest around IPF. I think that was the first question. Steve, do you have a comment on that?

Speaker #15: Really don't. I mean, this is handled. There's interest. There's clearly unmet need. The drugs that are there don't work incredibly well. So you're going to see payer interest serving that population.

Steven Closter: I really don't, Penny. This is Hamilton. We know there's interest. There's clearly unmet need. The drugs that are there don't work incredibly well, you're gonna see payer interest serving that population. Work is generally done by Incyte.

Steve Closter: I really don't, Penny. This is Hamilton. We know there's interest. There's clearly unmet need. The drugs that are there don't work incredibly well, you're gonna see payer interest serving that population. Work is generally done by Incyte.

Speaker #15: Work is generally done by insight. Handle that piece.

Speaker #1: I mean, what a. Yeah. But I would just add is that I mean, this remains an area of high unmet need. It's poorly served by currently approved therapies.

Michael Metzger: I mean.

Steven Closter: handle that piece.

Steve Closter: handle that piece.

Michael Metzger: Yeah.

Nicholas Botwood: What I would just add is that, I mean, this remains an area of high unmet need. It's poorly served by currently approved therapies. I mean, there are three, maybe four therapies approved. None of them are very satisfactory. The survival and prognosis of these patients is very poor, and no drug to date has really impacted the natural history of the disease. There really is like a great need for a drug that could potentially impact the natural history of the disease. You know, that's the hope with axatilimab, that it might be able to do that.

Nick Botwood: What I would just add is that, I mean, this remains an area of high unmet need. It's poorly served by currently approved therapies. I mean, there are three, maybe four therapies approved. None of them are very satisfactory. The survival and prognosis of these patients is very poor, and no drug to date has really impacted the natural history of the disease. There really is like a great need for a drug that could potentially impact the natural history of the disease. You know, that's the hope with axatilimab, that it might be able to do that.

Speaker #1: I mean, there are three, maybe four therapies approved. None of them are very satisfactory. The survival and prognosis of these patients is very poor.

Speaker #1: And no drug to date has really impacted the natural history of the disease. So there really is a great need for a drug that could potentially impact the natural history of the disease and that's the hope with acetilmab that it might be able to do that.

Speaker #1: From an investigator and physician perspective, the support we've had from investigators and their desire to contribute in a potential phase three is very high, which I think speaks to their interest in a novel and differentiated approach to the treatment of IPF.

Nicholas Botwood: You know, from an investigator and physician perspective, the support we've had from investigators and their desire to contribute in a potential phase 3 is very high, which I think speaks to their interest in a novel and differentiated approach to the treatment of IPF. We're feeling very good about that.

Nick Botwood: You know, from an investigator and physician perspective, the support we've had from investigators and their desire to contribute in a potential phase 3 is very high, which I think speaks to their interest in a novel and differentiated approach to the treatment of IPF. We're feeling very good about that.

Speaker #1: So we're feeling very good about that. And as you know, the market opportunity here is quite large. We're talking about 150,000 patients or thereabouts in the U.S.

Michael Metzger: As you know, the market opportunity here is quite large. We're talking about 150,000 patients or thereabouts in the US. This is a new mechanism for this disease. If we're able to show in this trial meaningful impact on the epic endpoints and safety as well, we'll, I think, have a very interesting and compelling proposition in IPF to serve patients. It could be a, you know, sort of a, I'd call it a game-changer relative to market size. I mean, GVHD is considerable, as we've laid out. We think we have a very compelling proposition in GVHD alone. Once you add in IPF, it's a, you know, obviously a completely different size of opportunity in the US for us to get involved. Excited about that.

Speaker #1: And this would be a new mechanism for this disease. If we're able to show in this trial meaningful impact on the efficacy endpoints and safety as well, we'll, I think, have a very interesting and compelling proposition in IPF to serve patients.

Speaker #1: So, it could be sort of a—I call it a game changer—relative to market size. I mean, GVHD is considerable, as we've laid out.

Speaker #1: We think we have a very compelling proposition in GVHD alone. Once you add in IPF, it's a obviously a completely different size of opportunity in the US for us to get involved.

Speaker #1: So excited about that.

Speaker #7: All right. Thank you so much.

David Dai: Thank you so much.

Speaker #1: Thank you, David.

Michael Metzger: Thank you, David.

Speaker #4: The next question is from Yugal Nachomovits from City. Yugal, your line is open.

Operator 2: The next question is from Yigal Nochomovitz from Citi. Yigal, your line is open.

Operator: The next question is from Yigal Nochomovitz from Citi. Yigal, your line is open.

Speaker #16: Hi. Great. Thank you for taking the questions. On RAVEN, I had a question. If that study—the phase two—looks good, would you then consider a phase three, given that the regulatory pathway is a little less well worked out relative to what you would be doing with REVEAL-ND?

Yigal Nochomovitz: Oh, hi. Great. Thank you for taking the questions. On RAVEN, I had a question. If that study, that Phase 2 looks good, would you then consider a Phase 3 given the regulatory pathway is a little less well worked out relative to what you're doing with REVEAL ND? That's my first question. I was also interested, you know, you mentioned that you're getting to 50% to transplant up from the 33%, you're still restarting about 70% to 80% on revumenib. I'm just wondering if, you know, why that number was staying the same. If you're increasing the number going to transplant, I thought perhaps maybe you'd get even more restarting, but that's not the right logic.

Speaker #16: That's my first question. And then I was also interested you mentioned that you're guiding to 50% to transplant up from the 33%. But then you're still restarting about 70 to 80 percent under every four.

Speaker #16: I'm just wondering if why that number was staying the same if you're increasing the number of going to transplant. I thought perhaps maybe you'd get even more restarting, but maybe that's not the right logic.

Speaker #16: So, just curious how you think about that part too. Thank you.

Yigal Nochomovitz: Just curious to how you think about that part too. Thank you.

Speaker #1: Yeah. Thanks, Yugal. Let me just clarify on the second question. So we had said that we're getting to about 50% patients transplanted. That was correct.

Michael Metzger: Thank you, Yigal. Let me just clarify on the second question. We had said that we're getting to about 50% patients transplanted. That was correct. What we expect as the target is 70%, 80% of patients to come back. Not everybody will come back for maintenance, but the vast majority we expect to get to that point. Right now, we're not there yet, right? We're at kind of approaching half of the patients coming back for maintenance. That number will grow. It'll grow based on our confidence from the data that we've put together, some of which will be presented in the coming weeks at some of the medical conferences. We've heard from physicians, this is what they expect. Expect to put patients back on maintenance. They feel very strongly about that.

Speaker #1: What we expect as the target is 70 to 80 percent of patients to come back. Not everybody will come back for maintenance, but the vast majority, we expect to get to that point.

Speaker #1: Right now, we're not there yet, right? So we're at kind of approaching half of the patients coming back for maintenance. That number will grow.

Speaker #1: It'll grow based on our confidence from the data that we've put together. Some of which will be presented in the coming weeks at some of the medical conferences.

Speaker #1: We've heard from physicians this is what they expect. Expect to put patients back on maintenance. They feel very strongly about that. So this is what we expect will happen, and we feel very confident in that over time.

Michael Metzger: This is what we expect will happen, and we feel very confident in that over time, but we're not quite there yet. That's the dynamic we're experiencing. It's great for patients. Many more going to transplant. The funnel, the actual funnel of patients who are available for maintenance is expanding, that's all very positive driver of business going forward. The second question related to RAVEN, and I'll turn it to Nick.

Speaker #1: But we're not quite there yet. So that's the dynamic we're experiencing. It's great for patients. Many more going to transplant. The funnel, the actual funnel of patients who are available for maintenance is expanding.

Speaker #1: And so that's all very positive driver of business going forward. So the second question related to Raven, and I'll turn it to the next question.

Speaker #17: Yeah, I'm happy to take that question. And we're excited about this hypothesis because this is a bit of innovation in an area where patients could potentially get an alternative and a better-tolerated approach.

Nicholas Botwood: Yeah. Happy to take that question. We're excited about this hypothesis because this is a bit of innovation in an area where, you know, patients could potentially get an alternative and a better-tolerated approach, you know. These patients would normally get intensive chemotherapy in order to try to get them to transplant. The hypothesis here is by giving them venet and revumenib, you can get these, you know, fit KMT2A patients, many of them quite young, to transplant without all of the morbidities. Now, in terms of its intent, clearly that's a high, you know, an area of high unmet need. We haven't talked about the specifics of the study design yet.

Nick Botwood: Yeah. Happy to take that question. We're excited about this hypothesis because this is a bit of innovation in an area where, you know, patients could potentially get an alternative and a better-tolerated approach, you know. These patients would normally get intensive chemotherapy in order to try to get them to transplant. The hypothesis here is by giving them venet and revumenib, you can get these, you know, fit KMT2A patients, many of them quite young, to transplant without all of the morbidities. Now, in terms of its intent, clearly that's a high, you know, an area of high unmet need. We haven't talked about the specifics of the study design yet.

Speaker #17: And these patients would normally get intensive chemotherapy in order to try to get them to transplant. And the hypothesis here is by giving them venator and Revumenib, you can get these fit KMT2A patients, many of them quite young, to transplant without all of the morbidities.

Speaker #17: Now, in terms of its intent, clearly, that's a high area of high unmet need. We haven't talked about the specifics of the study design yet.

Speaker #17: But clearly, a compelling result—that you get high rates of transplant and good outcomes with a much more better tolerated regimen—would certainly be informing clinical practice, potentially guidelines.

Nicholas Botwood: Clearly a compelling result that you get high rates of transplant and good outcomes with a much more, a much better tolerated regimen would certainly be, you know, informing a clinical practice, potentially guidelines. We would even be thinking about, you know, how would that support a registrational approach given the totality of the data we're gonna be generating in the frontline setting. More on that to come, but we think it's a very differentiated and innovative approach to this patient population.

Nick Botwood: Clearly a compelling result that you get high rates of transplant and good outcomes with a much more, a much better tolerated regimen would certainly be, you know, informing a clinical practice, potentially guidelines. We would even be thinking about, you know, how would that support a registrational approach given the totality of the data we're gonna be generating in the frontline setting. More on that to come, but we think it's a very differentiated and innovative approach to this patient population.

Speaker #17: And we would even be thinking about how would that support a registrational approach given the totality of the data we're going to be generating in the frontline setting.

Speaker #17: So more on that to come. But we think it's a very differentiated and innovative approach to this patient population.

Speaker #7: Thanks.

Yigal Nochomovitz: Thanks.

Speaker #1: Thanks, Yugal.

Michael Metzger: Thanks, Yigal.

Speaker #4: The next question is from Jason Zemensky of Bank of America. Jason, your line is open.

Operator 2: The next question is from Jason Zemansky of Bank of America. Jason, your line is open.

Operator: The next question is from Jason Zemansky of Bank of America. Jason, your line is open.

Speaker #18: Good afternoon. Congrats on the progress, and thanks for taking our questions. Two, if we may. Wanted to return to the subject of RevuForge access.

Jason Zemansky: Good afternoon. Congrats on the progress, and thanks for taking our questions. Two, if we may. Wanted to return to the subject of Revuforj's access. There was some discussion last year in the community that some plans were requiring step edits through one menin inhibitor. You mentioned there was some confusion over the relative cost of Revuforj. Was curious as to whether or not this was related, and can you speak to whether or not you're seeing any step edits throughout the universe? I guess secondarily, you mentioned that about 45% of KMT2A patients were resuming therapy post-transplant. I think last quarter you cited a range of 40% to 45% of patients. Just curious what kind of gets you through that barrier of, I guess, 45%?

Speaker #18: There was some discussion last year in the community that some plans were requiring step edits through one menin inhibitor. You mentioned there was some confusion over the relative cost of RevuForge. I was curious as to whether or not this was related.

Speaker #18: And can you speak to whether or not you're seeing any step edits throughout the universe? And I guess, secondarily, you mentioned that about 45% of KMT2A patients were resuming therapy post-transplant.

Speaker #18: I think last quarter, you cited a range of 40% to 45% of patients. Just curious, what kind of gets you through that barrier of, I guess, 45%?

Speaker #18: Is this a case of sort of fast adopters and very cautious adopters? And really, what's it take to get more of those docs on board?

Jason Zemansky: Is this a case of sort of fast adopters and very cautious adopters? You know, really, what's it take to get more of those docs on board? Thanks.

Speaker #18: Thanks.

Speaker #1: Thanks, Jason. Good question. So let me start with your question about access, which I'll turn to Steve, and he can address.

Michael Metzger: Thanks, Jason. Good question. Let me start with your question about access, which I'll turn to Steve, and he can address.

Speaker #19: Yeah. So, as you know, the access is great—97% across both indications. Not only is that a high number, but it was achieved very quickly. So, plans have been reimbursing RevuForge since the launch.

Steven Closter: Yeah. As you know, the access is great, you know, 97% across both indications. Not only a high number, but it did it very quickly. Plans have been reimbursing Revuforj since the launch. Your point about step edits, and I did mention this in my comments, there's literally three plans that have step edits in place, and it's really restricted just to the 270 milligram dose. It's not a lot of patients. It's less than 1% of the overall. Some of that came about on a monograph, which I also referenced in my prepared comments.

Steve Closter: Yeah. As you know, the access is great, you know, 97% across both indications. Not only a high number, but it did it very quickly. Plans have been reimbursing Revuforj since the launch. Your point about step edits, and I did mention this in my comments, there's literally three plans that have step edits in place, and it's really restricted just to the 270 milligram dose. It's not a lot of patients. It's less than 1% of the overall. Some of that came about on a monograph, which I also referenced in my prepared comments.

Speaker #19: So your point about step edits—and I did mention this in my comments—there are literally three plans that have step edits in place.

Speaker #19: And it's really restricted just to the 270 milligram dose. It's not a lot of patients. It's less than 1% of the overall. And some of that came about on a monograph, which I also referenced in my prepared comments.

Speaker #19: A monograph that came out later part of 20205. And just had some incorrect information. And it made some assumptions just based on dosing. That if you were to exclusively prescribe the 270 dose, you would have a higher WACC than the other menin competitor.

Steven Closter: A monograph that came out, later part of 2025 and just had some incorrect information and made some assumptions just based on dosing, that if you were to exclusively prescribe the 270 dose, you would have a higher WAC than the other menin inhibitor. We know that that is not the case. In fact, most patients, 75% to 80% of them are not on that dose. The WAC ends up being lower, about 15% to 20% lower than our competitor at the 1 dose that they have. Since the monograph has been adjusted, they've corrected the fact base, they've removed the guidance on a step through our competitor at that dose, and the recommendation is no longer there. Plus they updated it for other reasons, clinical, non-clinical. The information is there.

Steve Closter: A monograph that came out, later part of 2025 and just had some incorrect information and made some assumptions just based on dosing, that if you were to exclusively prescribe the 270 dose, you would have a higher WAC than the other menin inhibitor. We know that that is not the case. In fact, most patients, 75% to 80% of them are not on that dose. The WAC ends up being lower, about 15% to 20% lower than our competitor at the 1 dose that they have. Since the monograph has been adjusted, they've corrected the fact base, they've removed the guidance on a step through our competitor at that dose, and the recommendation is no longer there. Plus they updated it for other reasons, clinical, non-clinical. The information is there.

Speaker #19: We know that that is not the case. In fact, most patients—75 to 80 percent of them—are not on that dose. So the WACC ends up being lower, about 15 to 20 percent lower than our competitor at the one dose that they have.

Speaker #19: So since the monograph has been adjusted, they've corrected the fact base. They've removed the guidance on a step through our competitor at that dose.

Speaker #19: And the recommendation is no longer there. Plus, they updated it for other reasons—clinical, non-clinical. So the information is there. So the step that is in place is practically ineffective.

Steven Closter: The step that is in place is practically ineffective, and physicians get to choose what they want to. There's, according to our information, there's not one patient that has had to walk through a step for Revuforj to date, and we don't expect that to continue moving forward.

Steve Closter: The step that is in place is practically ineffective, and physicians get to choose what they want to. There's, according to our information, there's not one patient that has had to walk through a step for Revuforj to date, and we don't expect that to continue moving forward.

Speaker #19: And physicians get to choose what they want to. So there's according to our information, there's not one patient that has had to walk through a step for RevuForge to date.

Speaker #19: And we don't expect that to continue moving forward.

Speaker #1: Great, thanks, Steven. And I guess the second question relates to maintenance. How do you increase maintenance beyond the 45%? I'll just remind you that we've actually increased the use of maintenance throughout last year.

Michael Metzger: Great. Thanks, Steve. I guess the second question relates to maintenance and how do you increase maintenance beyond the 45%? I'll just remind you that we've actually increased the use of maintenance throughout last year. You saw it kind of go from about, you know, a third of patients all the way up to 45%. It is steadily increasing. We do, as I said earlier, that, you know, data and real-world evidence will ultimately drive it, and we have a robust strategy in place to deliver to get to this steady state, 70% to 80%, you know, point, which will happen at some point in the future. We can't predict exactly when. I was a little off on my 50% prediction.

Speaker #1: So you saw it kind of go from about a third of patients all the way up to 45%. It is steadily increasing. But we do, as I said earlier, that data and real-world evidence will ultimately drive it.

Speaker #1: And we have a robust strategy in place to deliver to get to this steady state, 70 to 80 percent. Point, which will happen at some point in the future.

Speaker #1: We can't predict exactly when. I was a little off on my 50% prediction. I thought that would happen later, and it happened more quickly.

Michael Metzger: I thought that would happen later, and it happened more quickly. We are very, you know, bullish on the fact that we will get there. All the data that we have coming out, and we're very focused on this, should help physicians think through how best to dose patients and at what interval. You know, they're just. Some are very cautious about patients coming back from transplant, as you can expect. Their engraftment period varies by patient, and physicians want to make sure that count recovery is well underway and that they're managing patients really effectively. We help them with that, where there's lots of data that's coming out and ultimately, getting to that 70% to 80% should be quite achievable. Thank you.

Speaker #1: So we are very bullish on the fact that we will get there. And all the data that we have coming out, and we're very focused on this, should help physicians think through how best to dose patients.

Speaker #1: And at what interval. And they're just some are very cautious about patients coming back from transplant, as you can expect. They're in graftment period.

Speaker #1: Varies by patient. And physicians want to make sure that count recovery is well underway and that they're managing patients really effectively. So we help them with that.

Speaker #1: There's lots of data that's coming out, and ultimately, getting to that 70 to 80 percent should be quite achievable. So, thank you.

Speaker #7: Great. Thanks for the call.

Jason Zemansky: Great. Thanks for the color.

Speaker #1: Thank you.

Michael Metzger: Thank you.

Speaker #4: Once again, if you have a question, you may press star 5 on your telephone keypad. The next question is from Salim Said from Mizoho.

Operator 2: The next question is from Salim Syed for Mizuho. Salim, your line is open.

Operator: The next question is from Salim Syed for Mizuho. Salim, your line is open.

Speaker #4: Salim, your line is open.

Speaker #7: Hey, great. Congrats on the quarter, guys. In progress. I guess two from us. One on just Maxphire. And then just the other one on the RevuForge chart you provided on slide 4.

Salim Syed: Hey, great. Congrats on the quarter, guys, and progress. I guess 2 from us. 1 on just MAXFIRE, and then just the other 1 on the Revuforj chart you provided on slide 4. On MAXFIRE, Nick, could you maybe remind us, I understand it's a robust study, but could you remind us what your power to show at the 26-week time point? I presume the powering was done on the 26-week and not the 52-week that you plan to model to. What the variability or standard deviation you're assuming on the primary endpoint? That's question 1. Question 2, just on Revuforj.

Speaker #7: On Maxphire, Nick, could you maybe remind us—since it's a robust study—but could you remind us what your power is to show at the 26-week time point?

Speaker #7: I presume the powering was done on the 26th week, and not the 52-week that you plan to model to. And then, what’s the variability or standard deviation you’re assuming?

Speaker #7: On the primary endpoint. That's question one. And then question two, just on RevuForge. I guess one of the dynamics here, it looks like from this chart, which I thought was super helpful here, it looks like on KMT2A, you guys actually maxed out sort of at this 200 new patients per quarter pretty quick.

Salim Syed: I guess, like, one of the dynamics here, it looks like from this chart, which I thought was super helpful here, it looks like on KMT2A, you guys actually, like, maxed out sort of at this 200 new patients per quarter pretty quick. Are you anticipating the same sort of dynamic on NPM1 to max out with, you know, new patients per quarter within, I guess, like, maybe 3 quarters here or so, 4 quarters? What would be the underlying dynamic why you would max out so quickly? Thank you.

Speaker #7: Are you anticipating the same sort of dynamic on NPM12 to max out with new patients per quarter within, I guess, maybe three quarters here or so, four quarters?

Speaker #7: And what would be the underlying dynamic why you would max out so quickly? Thank you.

Speaker #1: You want to answer the Nick?

Michael Metzger: You want to answer the, Nick?

Speaker #2: Yes, clearly. Thank you for the question on Maxphire. It's a good question. And what I would say is, and I don't want to go into specifics, but the statistical assumptions, but I would say it's a very well-powered study.

Nicholas Botwood: Yes, Salim. Thank you for the question on MAXFIRE. It's a good question. What I would say is I don't want to go into specifics of the statistical assumptions, but I would say it's a very well-powered study. We plan to recruit 135 patients. We actually slightly over-enrolled because of the physician support, so we over-enrolled by about 10 patients. It's a 2-to-1 randomized study with an FVC primary endpoint. It is well-powered, and we'll look at an annualized rate, and we'll use the standard statistical modeling to report out the annualized rate. You know, rather than what is powerful, what I would suggest to you is, you know, what we would want to see, because we're actually looking for a fairly significant difference, you know, in order to inform a Phase 3 design.

Nick Botwood: Yes, Salim. Thank you for the question on MAXFIRE. It's a good question. What I would say is I don't want to go into specifics of the statistical assumptions, but I would say it's a very well-powered study. We plan to recruit 135 patients. We actually slightly over-enrolled because of the physician support, so we over-enrolled by about 10 patients. It's a 2-to-1 randomized study with an FVC primary endpoint. It is well-powered, and we'll look at an annualized rate, and we'll use the standard statistical modeling to report out the annualized rate. You know, rather than what is powerful, what I would suggest to you is, you know, what we would want to see, because we're actually looking for a fairly significant difference, you know, in order to inform a Phase 3 design.

Speaker #2: So we plan to recruit 135 patients. We're actually slightly over-enrolled because of the physician support. So we're over-enrolled by about 10 patients. It's a 2 to 1 randomized study with an FVC primer endpoint.

Speaker #2: And it is well-powered. And we'll look at an annualized rate. And we'll use standard statistical modeling to report out the annualized rate. Rather than what it's powered for, what I would suggest you is what we would want to see.

Speaker #2: Because we're actually looking for a fairly significant difference in order to inform a Phase 3 design. We're not looking for small, incremental differences. So, in terms of the rate of decline, somewhere in the region of a 40% improvement in terms of the reduction in the rate of decline would be really meaningful.

Nicholas Botwood: We're not looking for small incremental differences. You know, in terms of the rate of decline, somewhere in the region of a 40% improvement in terms of the reduction in the rate of decline would be really meaningful. That's the kind of, you know, based on historical controls, the sort of figures looking at the totality of the data we'd wanna be looking at to inform a Phase 3. The study is well powered to be able to show that type of difference. We'll let it read out and look forward to reporting those data in the Q4.

Nick Botwood: We're not looking for small incremental differences. You know, in terms of the rate of decline, somewhere in the region of a 40% improvement in terms of the reduction in the rate of decline would be really meaningful. That's the kind of, you know, based on historical controls, the sort of figures looking at the totality of the data we'd wanna be looking at to inform a Phase 3. The study is well powered to be able to show that type of difference. We'll let it read out and look forward to reporting those data in the Q4.

Speaker #2: And that's the kind of based on historical controls, the sort of figures looking at the totality of the data, we'd want to be looking at to inform a phase 3.

Speaker #2: And the study is well-powered to be able to show that type of difference. So we'll let it read out and look forward to reporting those data in the fourth quarter.

Speaker #1: And Salim, I think your second question about dynamics on RevuForge. I'll just simply say that when you think about KMT2 and NPM1, we have not maxed out.

Michael Metzger: Salim, I think your second question about dynamics on Revuforj. You know, I'll just simply say that when you think about KMT2A and NPM1, we have not maxed out. I think KMT2A is continuing to grow. As I mentioned earlier, is in this population of about 2,000 patients. It's a rare disease. You need to find the patients, and I think we are, you know, getting as many as are available. We're the only menin in that space. We have the best profile, and physicians are recognizing that the drug works very well for these patients. We expect to continue to build that market share well beyond what we're at. You know, every quarter is gonna be a little bit different, but I feel very confident about that.

Speaker #1: I think KMT2A is continuing to grow. As I mentioned earlier, the incidence population is about 2,000 patients. So, it's a rare disease. You need to find the patients.

Speaker #1: And I think we're getting as many as are available. We're the only men in that space. We have the best profile. And physicians are recognizing that the drug works very well for these patients.

Speaker #1: So we expect to continue to build that market share. Well beyond what we're at. And every quarter is going to be a little bit different.

Speaker #1: But I feel very confident about that. And then NPM1, same thing. There's no it's a much bigger market, as you know. It's about 2 to 2 and a half times the size of KMT2A.

Michael Metzger: NPM1, same thing. You know, it's a much bigger market. As you know, it's about 2 to 2.5 times the size of KMT2A, and the opportunity there is large. We expect to, you know, cover the whole universe and get as many patients as possible. This should continue to grow. In NPM1, it's all about new patients. In KMT2A, it's about adding incremental patients quarter over quarter, new patient starts. I would say the increase in maintenance, in transplanted, as we talked about in maintenance, is going to be a big driver of growth for that segment as well.

Speaker #1: And the opportunity there is large. So we expect to cover the whole universe and get as many patients as possible. This should continue to grow.

Speaker #1: In NPM1, it's all about new patients. And then in KMT2A, it's about adding incremental patients quarter over quarter, new patient starts. But I would say the increase in maintenance is in transplanted, as we talked about, in maintenance is going to be a big driver of growth for that segment as well.

Salim Syed: I guess my question is more at the rate that they're coming in. It looks like that's what's maxed out, not the number of total patients, but the rate that they're coming into, it seems pretty consistent here, 200-

Speaker #7: I guess my question is more about the rate that they're coming in. It looks like that's what's maxed out, not the total number.

Speaker #7: Patients. But the rate that they're coming into it seems pretty consistent here—200.

Speaker #1: Well, we've talked about—yeah, we've talked about consistent rate of new adds, right? So we're not—it's, I wouldn't say we've—we haven't penned it.

Michael Metzger: Well, we've talked about a consistent rate of new adds, right? I wouldn't say we've, you know, we haven't penetrated. We'll continue to penetrate and build. It will be a steady new rate of patients coming for KMT2A. NPM1 should be, you know, slightly different, larger market, and new patient starts will be more, certainly in the early stages of launch, be, you know, more dramatic. I think the, you know, the businesses and the way the business actually accrue revenue are slightly different as we talked about.

Speaker #1: We'll continue to penetrate and build. It will be a steady new rate of patients coming for KMT2A. NPM1 should be slightly different, larger market.

Speaker #1: And new patient starts will be, certainly in the early stages of launch, more dramatic. But I think the businesses, and the way the business actually accrues revenue, are slightly different, as we talked about.

Speaker #7: Sure. Okay. Got it. Super help. Thanks so much, guys.

Salim Syed: Sure. Okay. Got it. Super helpful. Thanks so much, guys.

Speaker #1: Thank you.

Michael Metzger: Thank you.

Speaker #4: Our final question today is from the line of Andre Maldonado from HC Wainwright. Andre, the line is yours.

Operator 2: Our final question today is from the line of Andres Maldonado from H.C. Wainwright. Andres, the line is yours.

Operator: Our final question today is from the line of Andres Maldonado from H.C. Wainwright. Andres, the line is yours.

Speaker #8: Hi, guys. Thanks for taking my questions and congrats on the progress. Just two quick ones for me. First, quick follow-up on Axitalimab and IPS.

Andrés Maldonado: Hi, guys. Thanks for taking my questions, and congrats on the progress. Just two quick ones from me. First, a quick follow-up on axatilimab and IPF. I guess, you know, can you provide a little bit more color on how we should be thinking about the phase 2 readout as primarily an all-comer VFC study, or is there a biological subgroup, you know, such that, you know, patients with maybe more monocyte/maybe macrophage-driven inflammation where you expect to break out just based upon the fact that, you know, the CSF1R mechanism, you know, is stronger there? Then maybe a underlying question for, you know, Revuforj.

Andres Maldonado: Hi, guys. Thanks for taking my questions, and congrats on the progress. Just two quick ones from me. First, a quick follow-up on axatilimab and IPF. I guess, you know, can you provide a little bit more color on how we should be thinking about the phase 2 readout as primarily an all-comer VFC study, or is there a biological subgroup, you know, such that, you know, patients with maybe more monocyte/maybe macrophage-driven inflammation where you expect to break out just based upon the fact that, you know, the CSF1R mechanism, you know, is stronger there? Then maybe a underlying question for, you know, Revuforj.

Speaker #8: I guess could you provide a little bit more color on how we should be thinking about the phase 2 readout as primarily an all-comer VFC study?

Speaker #8: Or is there a biological subgroup, such that patients with maybe more monocyte/maybe macrophage-driven inflammation where you expect to break out just based upon the fact that the CSFR1 mechanism is stronger there?

Speaker #8: And then maybe an underlying question for RevuForge. I guess as we look at the NUP98 kind of opportunity, I guess what would you need to see clinically to treat this as distinct expansion opportunity rather than just a scientifically interesting, but commercially smaller subset?

Andrés Maldonado: I guess, you know, as we look at, you know, the NUP98 kind of opportunity, I guess what would you need to see clinically to treat this as distinct, you know, expansion opportunity rather than just a scientifically interesting but commercially smaller subset? Thank you very much.

Andres Maldonado: I guess, you know, as we look at, you know, the NUP98 kind of opportunity, I guess what would you need to see clinically to treat this as distinct, you know, expansion opportunity rather than just a scientifically interesting but commercially smaller subset? Thank you very much.

Speaker #8: Thank you very much.

Speaker #1: Yeah, Andre, thank you very much for the question. So I'm going to let Nick get into the IPF questions.

Michael Metzger: Andres, thank you very much for the questions. I'm gonna let Nicholas get into the IPF questions.

Speaker #2: Yeah, it's a very interesting and relevant question. Of course, we'll analyze the intent-to-treat population. Our expectation is that we'll see a benefit across all comers.

Nicholas Botwood: It's a very interesting and, you know, relevant question. Of course, we'll analyze the intent to treat population. Our expectation is that we'll see a benefit, you know, across all comers. These patients are treated on a background of antifibrotics. We have stratified for by the type of antifibrotic they're on, whether it's nintedanib, pirfenidone, or, you know, or no antifibrotic. We will look at that, and we'll look at those subgroups. Given that we know that patients that have high levels of monocytes and high levels of CSF1R, we are expecting that and that that is correlated with a poor prognosis in IPF. We are expecting that the benefit would be seen across the intent to treat population.

Nick Botwood: It's a very interesting and, you know, relevant question. Of course, we'll analyze the intent to treat population. Our expectation is that we'll see a benefit, you know, across all comers. These patients are treated on a background of antifibrotics. We have stratified for by the type of antifibrotic they're on, whether it's nintedanib, pirfenidone, or, you know, or no antifibrotic. We will look at that, and we'll look at those subgroups. Given that we know that patients that have high levels of monocytes and high levels of CSF1R, we are expecting that and that that is correlated with a poor prognosis in IPF. We are expecting that the benefit would be seen across the intent to treat population.

Speaker #2: These patients are treated on a background of anti-fibrotic. So we have stratified for the type of anti-fibrotic they're on and whether it's in tandem, and they've had nifedipine or no anti-fibrotic.

Speaker #2: So we will look at that. And we'll look at those subgroups. But given that we know that patients that have high levels of monocytes and high levels of CSF1R, we are expecting that this population and that that is correlated with a poor prognosis in IPF.

Speaker #2: We are expecting that there would be the benefit seen across the intent-to-treat population. So that would be our expectation. And what we would be planning to do with a Phase 3.

Nicholas Botwood: That would be our expectation and what we'd be planning to do with the phase 3. Certainly we will look at subgroups accepting in a smallish phase 2, it's difficult to tease out differences in subgroups. I'm happy to talk a little bit about NUP98.

Nick Botwood: That would be our expectation and what we'd be planning to do with the phase 3. Certainly we will look at subgroups accepting in a smallish phase 2, it's difficult to tease out differences in subgroups. I'm happy to talk a little bit about NUP98.

Speaker #2: But certainly, we will look at subgroups, accepting in a smallish Phase 2. It's difficult to tease out differences in subgroups. And I'm happy to talk a little bit about NUP98 as well, just to start.

Michael Metzger: Sure, please.

Nicholas Botwood: As well just to start. Just from a clinical perspective, we have, as you already know, presented data on a small subset of NUP98, where we showed that three out of five patients had a form of morphological remission, which was very encouraging. We are planning to present additional data this year. I mean, biologically, it makes complete sense for these patients with NUP98R that they should benefit from Revuforj. You know, we've seen that across the spectrum. You know, we plan to publish further data this year. Certainly, considerations for submitting for the consideration of NCCN guidelines would be something we would be thinking about. You know, that's, that's the plan based on the data we've seen for this subset.

Nick Botwood: As well just to start. Just from a clinical perspective, we have, as you already know, presented data on a small subset of NUP98, where we showed that three out of five patients had a form of morphological remission, which was very encouraging. We are planning to present additional data this year. I mean, biologically, it makes complete sense for these patients with NUP98R that they should benefit from Revuforj. You know, we've seen that across the spectrum. You know, we plan to publish further data this year. Certainly, considerations for submitting for the consideration of NCCN guidelines would be something we would be thinking about. You know, that's, that's the plan based on the data we've seen for this subset.

Speaker #2: Just from a clinical perspective, we have, as you already know, presented data on a small subset of NUP98, where we showed that 3 out of 5 patients had a form of morphological remission, which was very encouraging.

Speaker #2: We are planning to present additional data this year. I mean, biologically, it makes complete sense for these patients with NUP98R that they should benefit from RevuForge.

Speaker #2: We've seen that across the spectrum. And as we plan to publish further data this year, certainly, considerations for submitting for the consideration of NCCN guidelines would be something we would be thinking about.

Speaker #2: So that's the plan based on the data we've seen for this subset. And we probably estimate of the baseline of AML. So it's not an insignificant subset.

Nicholas Botwood: We probably estimate it to be somewhere around 5% of the baseline for, of AML, so it's not an insignificant subset and clearly an area of higher unmet need because these patients tend not to do very well.

Nick Botwood: We probably estimate it to be somewhere around 5% of the baseline for, of AML, so it's not an insignificant subset and clearly an area of higher unmet need because these patients tend not to do very well.

Speaker #2: And clearly, an area of higher met need because these patients tend not to do very well.

Speaker #1: Yeah, I think that as seems to be somewhat an underdiagnosed area. We hear this from physicians regularly now, that RevuForge could be a good option for them.

Michael Metzger: I think that's, you know, as Nick said, 5%, it seems to be a somewhat underdiagnosed area. We hear this from Healthcare Professionals regularly now that Revuforj could be a good option for them. We've been following the HOXA/MEIS gene signature, which has, you know, kind of yielded NPM1, and now NUP98, and there may be other subsets. The ability to expand even beyond, call it 50% of AML is potentially possible. You know, we feel like we're, you know, on the cutting edge to make this part of, hopefully part of the portfolio. We'll follow up on that, thanks for the question.

Speaker #1: We've been following the HOXME signature gene signature, which has kind of yielded NPM1 and now NUP98. And there may be other subsets. So the ability to expand even beyond, call it 50% of AML, is potentially possible.

Speaker #1: And we feel like we're on the cutting edge to make this part of hopefully part of the portfolio. So we'll follow up on that.

Speaker #1: But thanks for the question.

Speaker #4: This concludes our question and answer session. I will now turn the floor over to Mr. Michael Metzger for any additional comments or closing remarks.

Operator 2: This concludes our question and answer session. I will now turn the floor over to Mr. Michael Metzger for any additional comments or closing remarks.

Operator: This concludes our question and answer session. I will now turn the floor over to Mr. Michael Metzger for any additional comments or closing remarks.

Speaker #1: Thank you, operator. Thank you, all. We appreciate everyone tuning in today to discuss our recent progress and the exciting milestones ahead. We look forward to seeing many of you at the upcoming ASCO and EHA medical conferences and, of course, several investor conferences in the second quarter as well.

Michael Metzger: Thank you, operator. Thank you all. We appreciate everyone tuning in today to discuss our recent progress and the exciting milestones ahead. We look forward to seeing many of you at the upcoming ASCO and EHA medical conferences and, of course, several investor conferences in Q2 as well. With that, have a great evening, everyone.

Q1 2026 Syndax Pharmaceuticals Inc Earnings Call

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