Q2 2025 Syndax Pharmaceuticals Inc Earnings Call

Good day, everyone, and welcome to the Syndax second quarter 2025 earnings conference call.

Today's call is being recorded. If you would like to ask a question following the company's prepared remarks, please press *5 during the call.

Over to Sharon Klahre, head of investor relations at Syndax Pharmaceuticals.

Great. Thank you, operator. Welcome, and thank you all for joining us today for a review of Syndax's second quarter 2025 financial and operating results. I'm Sharon Klahre, and with me today to provide an update on the company's progress and discuss financial results is Michael Metzger, Chief Executive Officer.

Steve. Closter

Chief commercial officer Dr. Nick botwood head of R&D and chief medical officer Keith golden Chief Financial Officer.

Also joining us on the call today. For question and answer session our Dr. Peter or dentl chief scientific officer, and Dr. Angela guling. Chief strategy officer.

This call is accompanied by a slide deck that has been posted on the invest.

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 or concerned to be forward-looking statements within the meeting of the private Securities. Litigation Reform, Act of 1995, after a result may be for materially from those indicated by the statements as a result of various important factors including those discussed in the risk factor section, in the company's most recent quarterly report on form 10q as well as other reports filed with the SEC.

And if we're looking statements, may represent our views as of today, August, 4th.

2025 only.

A replay of this call will be available on the company's website.

Thank you, Sharon and good afternoon and thank you all for joining us today.

Starting with slide 3.

First half of 2025 has been a transformational period for syndax marked by excellent commercial and pipeline execution. We are well, positioned for rapid growth in the second half of 2025 and Beyond with its first 2. First, if its 2 first and best-in-class therapies with a combined Market opportunity exceeding, 10 billion dollars Revenue Forge and Nick Timbo sales are growing with nearly 100 million dollars in combined. Net product sales in the first half of the Year significantly. Exceeding expectations, notably Revy Forge net revenue, increased 43% quarter over quarter to 2 8. 6 6.

Importantly, we are on the road to profitability with growing contributions from Revy Forge. And Nick Timbo, a strong balance sheet and an operating expense base that will remain stable for the next few years while fully funding our strategic priorities.

Looking to the future, our leadership and amendments position us to be first to the front line and meaningfully expand the Revy Forge franchise. We have a similarly compelling opportunity to bring Nick Timbo into earlier lines of therapy and additional patient populations.

Turning to slide 4, let's dive into more detail, on rev Forge the first and only FDA approved treatment for relapse or refractory acute leukemia with a kmt2a. Translocation

The continued growth, reflects strong, uptake, the high on medical need and Physicians enthusiasm for revvy Forge. It is clear, following the recent presentations at ASCO and eiha, that rev has a best-in-class profile with compelling activity across, multiple genetic subtypes, including efficacy data and relapse, refractory mutant npm1 AML that surpass. Any other results seen in the field.

The breadth and strength of our clinical data will be the key to our success in acute leukemia, a market that is efficacy-driven given the severity of the disease.

As we look ahead, the Outlook is very promising with multiple drivers. That will further solidify our leading position and ensure sustained growth for many years to come.

I will briefly highlight those drivers and the team will provide additional details.

First patient. Identification and update has been strong since launch. We have already treated over 500 patients with Revy Forge, with approximately 90% of usage in KMT2A patients.

In just 7 months, we have already reached a quarter of the 2,000 patients, diagnosed with relapse refractory kmt2a acute. Leukemia each year.

Based on the robust activity, we have seen in this population and physician excitement around the drug, we expect the total number of patients treated with Revy Forge to grow materially in future quarters particularly as as it is the only approved therapy for these patients.

is already being concentrated in the second line.

This trend is especially important in oncology because as patients are treated earlier, they generally have a higher response rate, a longer duration of response and a higher chance of proceeding to a potentially Curative stem cell transplant.

Thus as revi Forge is used earlier. We expect to see an increase in the average time on drug for all patients.

We also expect to see a high rate of patients proceeding to transplant, a higher rate of patients, treating to proceeding to transplant and was observed in our pivotal trial, which on average enrolled a later line patient population.

In fact, early indicators suggests that we are already seeing a meaningfully higher transplant rate in the commercial setting.

Third is the group of patients, receiving revvy Forge, post-transplant increases. It should substantially increase. The overall duration of therapy.

Notably prescribing Physicians. Tell us they plan to restart patients on revvy Forge post-transplant for 1 to 2 years.

Given the high risk of recurrence, both patients and physicians are eager to start the therapy that induces remission when the drug has an excellent tolerability profile.

These 3 drivers position revi Forge to transform care for kmt2a patients, from an acute treatment Paradigm with survival measured in a few months to a more chronic disease with the potential to extend survival from months to years.

Importantly, relapse-refractory KMT2A acute leukemia is just the first opportunity for Revivi Forge in the near term. We anticipate both the inclusion of Revivi Forge in the clinical treatment guidelines and the approval of our supplemental new drug application (sNDA) in relapsed refractory mutant NPM1 AML.

The anticipated approval of our snda which was recently granted priority review and a signed a Paducah action date of October 25th, 2025 would expand. Our addressable population to over 6,00 patients across both genetic subtypes and increase the relapse refractory Market opportunity for revvy Forge in the US to 2 billion dollars.

importantly, rev Forge is positioned to become the first and only men and inhibitor with a label that expands

To mutant npm1 and kmt2a translocated, patients, both adults and children.

Based on resounding kol feedback, the expected breadth of our label will be a major competitive advantage.

Looking to the future. We will further extend our leadership into the Frontline setting, a US market opportunity, exceeding 5 billion, enrollment is already ongoing in our Frontline trial, for patients on fit to receive intensive chemotherapy and startup activities are well underway to initiate our trials in patients able to receive intensive chemotherapy

With revi for its best-in-class profile and a multi-year start into the market versus potential Meto competitors. We will maintain our dominant position in this multi-billion dollar market opportunity.

Shifting gears to slide 5 to to Nick Timbo. Our first in class therapy for chronic graph versus host disease or GB.

I am pleased to highlight a very successful full court first full quarter for sales with our partner Insight, reporting $36.2 million in net revenue.

This is up significantly from 13.6 million in the first 2 months of the launch in q1.

the 50 million in net revenue generated in the first 5 months of the launch underscores, the substantial opportunity in chronic gbh

Importantly, Nick Timbo is already profitable to sendex with our 50% share of the Nick Timbo product contribution, amounting to 9.4 million for the second quarter.

As sales continue to ramp, the cash flow contributions to Syndax from Nick and Timbo will only grow in significance, with initial Nick and Timbo sales tracking with the early benchmark set by Reser, another product approved in the third line chronic GVHD setting. Reser is now annualizing at more than $500 million in the U.S., with 3 years within its launch. We are confident that Timbo will be a critical component of our success for many years to come.

Finally, before I hand the call over to the team, I would like to highlight that we also strengthen our leadership team. This quarter with the addition of Dr. Nick botwood as head of R&D and chief medical officer.

Nick is a medical oncologist by training, with over 25 years of experience, leading the development and Global, commercialization of Novel oncology medicines, including Blockbuster drugs, such as updo and Uruguay during his time at BMS.

I would also like to thank Bill Murray for his 7 years of service on our board and congratulate him on his new role, as CEO of insight our partner for Timbo.

Him and the inside team as we continue to unlock Nick timbo's value.

And with that, I will turn the call over to Steve to discuss our commercial progress in more details. Steve

Thank you, Michael. Let's Dive Right into our commercial updates on rev view, Forge and Nick tovo starting with Revy forge on slide 6.

As Michael said, the launch is going very well with net revenue for the second quarter increasing 43% quarter over quarter to nearly $29 million, and $56 million generated over the first seven months of the launch. These impressive results are driven by multiple factors including the high unmet patient need, a robust stream of new patient starts over the quarter, expanding breadth and depth of prescribing, excellent formulary coverage, and a product and revenue forge that is delivering for patients.

Physicians are observing excellent activity in clinical. Practice, revvy Forge is rapidly becoming a standard of care in our indicated population.

Over 1,300 prescriptions for Revvi Forge have been written for more than 500 patients since launch. Through the end of June, just midway through the year, we have already penetrated 25% of the annual 2,000 patient incidents and are on track to penetrate 50% by year's end.

Next, I’m excited to share some of the emerging data and customer feedback that provide important insights into the population of patients being treated with Revy Forge and bolster our confidence. The momentum we have seen since launch will continue well into the second half of the year and beyond.

Forge is increasingly being used to treat patients earlier in their treatment journey. Early claims data show that 70% of revenue for juice has been concentrated in the second and third-line settings, with approximately 50% of use coming from that second line, which we can also call first relapse patients alone.

second, we estimate that 1/3 of kmt2a patients treated with revv Forge have proceeded to transplant based on our analysis of medium to large academic institutions using rev Forge commercially

In contrast, 1 out of 4, kmt to a patient's proceeded to transplant after treatment with revvy Forge and augment 101, which enrolled a significant percentage of later line and heavily pretreated patients.

It's important to understand that patients who ultimately proceed to transplant are typically treated with Revy Forge for 2 to 4 months to ensure complete disease remission before pausing Revy Forge for approximately 3 months to ensure engraftment of the transplant.

Notably, physicians tell us they expect to put most, if not all, of their patients back on Reboo Forge post-transplant for 1 to 2 years.

In fact, in our clinical trial experience in compassionate use program, we have already seen transplant patients, who have been on Revenue Forge for 1 to 2 years. And we're still on drug at the time of the day to cut off.

Encouragingly in the commercial setting, we have started to see the first cohort of patients restart Revenue Forge based on a sampling of our accounts. We estimate that at least a third of transplant patients have already restarted Revenue. Forge with that percentage expected to grow over time. As more patients, clear the engraving periods.

As Revy Forge continues to move earlier in the treatment paradigm, we expect this will translate to a significant increase in the average duration of therapy over time.

Specifically, we expect the average treatment duration to build to 4 to 6 months in the first year of launch.

According to our assessment of patients who started Revenue Forge shortly after launch. The average time on therapy is already with well, within the projected 4, to 6 month range. And we expect this duration, to expand to an average of 6 to 12 months as treatment patterns mature in the second year of launch.

I now like to briefly review, some other metrics that underscore underscore the strong position we're in, for continued growth, in kmt2a, and our anticipated launch into relapse, refractory mutant npm1 AML.

First, we have a broad and growing prescriber base from launch. Through the end of June, we've penetrated 65% of our higher priority Tier 1 and Tier 2 accounts, up from 44% of accounts at the end of last quarter, and we're continuing to grow into Q3.

These Tier 1 is tier 2 accounts are the centers of excellence. And the medium to large academic institutions, which represent 2/3 of the patient opportunity.

Adoption is also increasing across all of their tiers too, including in the community setting.

Among all accounts that have ordered, the vast majority have ordered multiple times.

Second, we have established that excellent market access formula coverage is now complete, with more than 97% of all lives covered, including commercial Medicare and Medicaid patients. Nearly all prescriptions are reimbursed, with very few patients requiring our patient assistance program.

Is less than 4 days significantly faster than typical industry benchmarks.

The best-in-class customer service. We are delivering will be a key factor for our long-term competitive, immunity and brand loyalty.

Notably Revy Forge. Performance is outperforming yearly launch Benchmark set by other targeted AML therapies on key metrics, including revenue, and prescriptions patients treated activation accounts, as well as formulary coverage further. All indicators, give us confidence that Revy Forge is delivering for patients. Now, we are well, positioned to develop this medicine into an industry-leading franchise with the market opportunity, exceeding, 5 billion, the relapse refractory, and Frontline setting is outlined on slide 7.

Now turning to key Nick simple metrics on slide 8.

Since the beginning of the launch over, 4,000 in the fusions have been administered to an estimated 700 patients representing a approximately 10% of the third line plus chronic gvhd total Market.

Of all the patients that had started in NMO, approximately 80% to 90% remain on therapy today. More than 80% of all bone marrow transplant centers in the U.S. are using Nick Timbo, reflecting solid execution and the strong commercial synergies that Nick Timbo has with both companies' product portfolios.

Importantly, Timbo is poised for further growth, given the high unmet need in the chronic GVHD space and the positive experiences physicians and patients are having with the drug.

Physicians are reporting rapid and durable improvements across organ systems. Including some of the most difficult to treat organs like the lungs and skin.

These observations align with the results we demonstrated in our pivotal trial, highlighting timbo's unique ability to address both fibrosis and inflammation—hallmarks of the condition.

As shown on slide, 9 and Teemo has a multi-billion dollar market opportunity. Our current indication allows us to Target. The 6,500 chronic gvhd patients in the US who require 3 or more lines of therapy. This represents a 2 billion dollar total addressable Market, assuming an average treatment duration of 12 months, which could be conservative. Given the chronic nature of the disease and the tolerability of Nintendo.

Notably in our clinical trial experience. We have seen some patients. Stay on therapy for more than 3 years.

To summarize we are very pleased with the progress. We've made with both revi Forge and Nick Timbo, early indicators for both launches driver confidence and continued growth and expansion. With both products. With that, I'll hand the call over to Nick.

It's a pleasure to be on the call today and to have the opportunity to build upon the exceptional work that Syndax has done pioneering two new therapeutic approaches.

Starting on slide 10 with Review 4, is your review, Mintean, an asset which has the potential to become the menin inhibitor of choice across the breadth of menin-driven acute leukemias.

In the second quarter, we advanced our leadership position with a strong presence at EIHA and ASCO.

Including 2 important Publications.

Aiha we and our collaborators presented. The latest data for mment 101, and the beat AML trial. I'd like to highlight 2 key. Takeaways from these first the augment 101 day to demonstrate the breadth of Revenue of activity across relapsed refractory mutant mpm. 1 came to TA and new 98 are acute leukemias notably in the pivotal mpm. 1 population, nearly half of the patients achieved an overall response and in a subgroup in analysis. A median overall, survival of 23 months was a m was observed among these responders.

These data along with the rate of clch and duration of CR CR are results that really stand out in this population.

The compelling results are particularly relevant, as efficacy is paramount in patients with acute leukemia, given the severity of the disease and the need for improved outcomes.

Data from the pivotal npm1 population were recently published in Blood and important Milestone. That makes these Landmark results available to the clinical community

turning out to new 98r.

Phase 1 data from the augment. 101 trial show, an overall response rate of 60% among 5, patients, with relapsed or refractory new 98, our AML

Which is an aggressive, difficult-to-treat form of acute leukemia.

While it's on the f is small. Physicians are encouraged by these data and further trials are underway that will evaluate Roi manob in new 98 hour as well as other acute leukemias associated with Hawks upregulation.

The compelling and consistent results observed with Revenue manip across these genetic subtypes highlight the potential for Revy manner to transform the standard of care for potentially 50% or more of all patients with AML.

Moving now to the second key takeaway.

Updated representative EHA and simultaneously published in the Journal of Clinical Oncology are encouraging. As a reminder, this is a Phase 1B trial evaluating Revenue in combination with an article in AA citadine in newly diagnosed older patients with mutant NPM1 or KMT2A rearranged AML.

The data support the combined ability of reim man, with Venza in the Frontline setting and the potential for the triplet to provide High rates of complete, remission and mrd negativity.

Two treatment goals associated with improved clinical outcomes.

The overall response rate was 88%.

And the complete remission rate was 67% in the 43 patient, intense Street population.

Importantly, MRD negativity was 100% by centralized flow cytometry testing.

Both for Crescent and Mr. Negativity, we compare very favorably to the historical rates reported in the V, a trial of NASA.

Looking ahead, we have revenue, many publications, and presentations planned. At major upcoming medical congresses, including the anticipated presentation of the first real-world evidence before the end of the year.

Given the strong clinical interests in real-world evidence, we are thrilled to be working with leading cancer centers and physicians to present outcomes for this new therapeutic class.

Turning now to slide 11 and our further work developing Review Forge and Ximbo into industry-leading franchises. I want to highlight three key points.

First, we are laser focused on extending our leadership position in men and inhibition into the Frontline setting.

Enrollment is well underway in the pivotal evolved to trial of Revenue in combination with Vasa in newly diagnosed patients with mutant, mp1 or kmt2a rearranged AML Who are ineligible or unfair to receive intensive chemotherapy.

Evolved to is a Phase 3 randomized, double-blind, placebo-controlled trial.

This trial will have dual primary endpoints of complete remission and overall survival to support potential accelerated approval and full approval, respectively.

While the trial is open to both NPM1 and KMT to rate patients for enrollment, the primary efficacy analysis will be based on the MPM1 population. This is the population that is more commonly ineligible for intensive chemotherapy due to advanced age or other comorbidities, unlike the KMT2A population, which tends to be younger and fit enough for intensive chemotherapy.

We are conducting this trial in partnership with the HOVON Group, a leading clinical trial organization known for executing clinical trials that deliver practice-changing data in hematology.

Second.

In the newly diagnosed fed population studies, the start of activities is well underway for two randomized, receiver-controlled trials of studies of Revy. Mano in combination with intensive chemotherapy, followed by maintenance. We have named these the Reveal trials.

1 trial is designed for patients with an npm1 mutation and 1 for patients with km2. T t to a rearrangements.

We expect to initiate in the fourth quarter of 2025.

In the MPM, one population, the study will have dual primary endpoints of MRD-negative crescent and event-free survival. These are important clinical endpoints in this population and could have the potential to support accelerated approval and full approval, respectively.

We expect that high awareness of Revenue, Forge and positive experience in the clinic will drive rapid enrollment across our Frontline programs.

In support of our trials in the fit population. We are also looking forward to reporting Phase 1, data in newly diagnosed patients treated with reboo humanoid and intensive chemotherapy in the fourth quarter of the Year. Lastly I want to highlight the work on the way to develop Nick Timbo or act for additional patient. Populations in partnership with Insight. Several important trials are well underway, including a phase 2 trial, studying axilla.

in combination with Rook selatan nib and a phase 3, Placebo controls registration, director trial investigating access in combination with steroids,

Beyond chronic graph versus host disease. We have an ongoing Phase 2, Placebo controlled trial called Max py.

Which is studying AAT in idiopathic pulmonary fibrosis or IPF.

Enrollment is proceeding very well, and we are on track to complete enrollment in the fourth quarter of this year, with topline data anticipated in the second half of 2026.

We are optimistic about the potential for IPF and beyond, given the strong mechanistic rationale and preclinical evidence, along with the remarkable lung response observed in the AGAVE 201 trial.

With that, I will hand the call over to Keith to discuss our financials.

Second quarter, 2025 financial results, and I'll touch on a few of these key points on slide 12.

For the second quarter, 2025, we reported Revenue Forge, net, revenue of 28.6 million.

Quarter over quarter. Sales growth was driven by demand as inventory levels, remained stable to the first quarter at 2 to 3 weeks.

We expect quarterly growth to meaningfully accelerate over the next year, with the potential approval in npm1, as well as the benefit of a longer duration of treatment in kmt2a are acute. Leukemia,

Also, in the second quarter, Insight reported Nick Timbo net revenue of $36.2 million.

With inventory accounting for less than 5% of sales.

Sendex reported 9.4 million in Nick Tempo, collaboration Revenue after deducting, the cost of sales and Commercial expenses.

Importantly, the Timbo is already a positive cash flow contributor to Syndax in just its first full quarter of sales.

We expect the Nikto margin contribution, defined as collaboration revenue recorded by Syndax as a percentage of Nikto net sales.

To be in the 20 to 30% range in the near term. And we anticipate this in will improve longer term, as sales grow and the partnership, leverages a largely fixed expense base.

We expect continued sales growth, giving gbh remains a chronic disease where there is a high response rate tenant Timbo and the average patient will likely likely remain on therapy for years.

R&D. Expense was 62.2 million in 2q with the increased versus the comparable prior year. Driven by costs related to ongoing trials and increased activities to support commercialization.

Sgna expense was 43.8 million with the increase versus the comparable prior year, driven by cost related to the US commercial launch of Revenue Forge.

With regard to expenses, you can find our guidance for the third quarter of 2025 and full year and the press release issued today, notably, we announced today we expect our operating expenses to remain stable over the next few years.

Turn a new balance sheet, we continue to maintain a strong financial position with 518 million in cash, equivalents and short and long-term Investments as of June 30th.

As I've said in the past and I reiterate today, we expect index will reach profitability with current funds on hand.

In fact, my confidence is higher today. Given both drugs are outperforming. Our original forecasts,

We are confident we can execute commercially and also deliver on our integrated clinical development plans for both drugs while keeping operating expenses at today's levels.

Our combined cache, with increasing Revenue, Forge, and Nick Timbo cash flow contributions, alongside an fixed expense base will drive our path to profitability.

Turn the call back over to Michael.

Thank you, Keith.

Before we move to Q&A, I want to take a moment on slide 13 to reiterate how well positioned index is as a company Revenue, Forge, and Nick Timbo are outperforming expectations as strong physician enthusiasm drives robust adoption. We have a very sizable cash balance that will allow us to control our destiny and Achieve sustained profitability with what we know are 2. Dominant products in multi-billion dollar markets.

A few key points to recap on revvy Forge. Revvy Forge is the only FDA approved therapy for kmt2a patients. And we have already identified and treated over 500 patients since launched, with 90% of those being on label.

Physicians are treating earlier relapse refractory patients, which pertains to more favorable outcomes.

Wherever Forge is getting patients for transplant, we are seeing an even higher rate than what was observed in our clinical trials.

Physicians are eager to put their patients back on Revy Forge post-transplant, and we have begun to see evidence of this. This is happening.

Further all key indicators of demand remains strong in July which gives us confidence in the continued momentum of this launch. Ultimately in the future kmt2a patients and Revy Forge. And with the aid of transplant will likely remain on drug for a year or more with the best hope of of improved survival.

In the near term, we are poised to expand into relapse-refractory mutant NPM1 AML, pending the FDA's anticipated approval of our SNDA.

Additionally, we are extending our leadership position to the front line with enrollment already under well underway in our first pivotal Frontline trial. It is important to keep in mind that acute leukemia is an efficacy driven market and it is clear that revvy Forge is a highly effective therapy with a favorable safety and tolerability profile.

Finally, I will also note that we've retained worldwide rights to revvy forge and patent protection continues through at least the late 2030s.

Collaboration with our partners at Insight. The leaders in gvhd the nick Timbo. Launch is off to an exceptional, start. It is well, positioned for growth in a 2 billion dollar market for third line. Chronic for third line, chronic qvhd treatments with patent protection. Extending to the late 2030s

Nick Timbo provides a novel option in a market that needs new mechanisms of action patients initiating therapy. May continue drug for years. We incite continue to advance development programs. Designed to bring this drug into earlier lines of chronic, gvhd therapy and other diseases, starting with IPS.

Nick Timbo's financial contribution to Syndax is already profitable in its first full quarter. This will grow materially as sales ramp and operating margins continue to expand.

Synex has never been a stronger position than we are today and I look forward to sharing additional progress with you in the months ahead.

As always, I want to close by thanking everyone who has supported us on this journey, including, most importantly, the patients and families who have placed their trust in us, as well as our dedicated Syndax employees and long-term investors. With that, I would like to open the call for questions, operator.

To remind everyone in order to ask.

Question press star 5, then the press star. Then the number 5 on your telephone keypad. If you would like to withdraw your question, press star and the number 5 once again, will pause a moment to compile the Q&A roster.

Our first question will come from Anu from Rama with JP Morgan. Your line is open.

Hey guys, thanks so much for taking the question. Um, just wanted to ask a question about this past the profitability. Keith I know you mentioned operating, expenses, staying stable over the next couple years, but what are you in? Assuming, in terms of the Top Line in terms of treatment settings, for Revy, Forge, and Nick Timbo, can you get to profitability on sort of the refractory settings alone? Uh, is there some sort of assumptions on for Frontline expansion? Baked in to getting to profitability? How do, how should we be thinking about that?

On a bob. Thanks for the question. Um,

Uh, you know, we have been pretty consistent since November that we expect to get the profitability with the existing resources, uh, that we have today. And, you know, I I would say, the only thing that's changed since then is that we have 2 launches that are both outperforming our expectations. So the, the new disclosure that we provided today, you know, stable operating expenses for the foreseeable future.

Uh say the next 2 to 3 years, we're we're doing that because we want to give the buy side and South Side, we want to give the street the appropriate data for them to model our business better. Um so you guys can get to the same answer that we're getting to, we're not giving Revenue guidance per se on a pump, but I will say that uh, given the timelines to get to approval in the Frontline setting. You can definitely assume that we are getting a profitability on the relapse refractory indications alone.

um, and and I think, you know, I just want to add

the, the guidance that we are giving stable operating expenses is not to be taken, as we are taking our foot, off the gas pedal, because we're not, um, you know, the, the modeling that we've done allow us to fully invest in the continuing successful launches of 2 products, executing commercially, but additionally, executing our integrated clinical development plan, as Nick talked about, um, both for, um, both for Revy Forge and Nick Timbo. So, you know, I, I think we're in a pretty unique position to control our own destiny. We have 2 launches that are both outperforming and stable, stable expense base and

You know, the team has worked, extremely hard to put ourselves in this position to specifically reward our shareholders for their investment. So thanks for the question.

Thanks so much for taking the question.

Our next question will come from kurin Johnson with Goldman Sachs, your line is open.

Hi. This is Kevin Strang on for Karen. Um, good afternoon.

Had a quick question on. Uh, the patients moving on to transplant. Um after how many cycles is that typically occurring. And for patients that are going back on drug. You said that I was about a third of patients. So far, what are your expectations for the ultimate proportion of patients that will move on to maintenance therapy. Um and is this something you'll report quarterly, thanks.

Kevin, thanks for your questions. Um, so...

Within the first few Cycles.

that generally is, um,

Is preceded by, you know, a transplant thereafter and that that transplant can happen uh, very quickly, it can happen within, you know, a couple of weeks that's usually for ct2a patients, a goal to get them to transplant as quickly as possible. So a few Cycles uh certainly 2 to 3, uh getting into remission, moving to transplant. Uh, that's how that's how it generally works. We do. We do see in our trial, about a third. So, in our, in our, um, commercial experience, rather about a third of patients getting to transplant, we expect that number to accelerate. And the reason for that is we are treating patients earlier, and earlier in the treatment Paradigm. Uh, Physicians had had told us they would put patients on uh, rebbe Forge and sort of second line, or first relapse, we see a vast majority of our patients being treated. Now in second and third line, which is a great outcome for them, generally means patients, do stay on drug longer, do better, uh, and have a better chance of going to transplant. So, we do think that, that 1/3 number could could go up from here and we expect it to, uh, and all

Ultimately, um, we will continue to track this over time. It's early days in the launch. Uh, and and we do expect uh to, you know, report on that metric. Uh, you know, at some point going forward.

And then, in terms of Maintenance, I think your your last question. Uh, patients are are coming back on maintenance. We know that, uh, we'd reported that based on the earliest patients. That earliest cohort of patients that we've seen about a third of patients, have already come back again, early days of launch. That's a very good indicator. And, uh, Physicians have told us repeatedly that they expect to put the vast majority of their patients back on on maintenance and that could range, uh, you know, anywhere, you know, 8, 70, 80, 90% of the patients, assuming that there are eligible for for maintenance. And so that's a, I think a goal for us and we'll see that play out over time.

Our next question will come from Kelly Shei with Jeff. Your line is open.

Uh, thank you for taking my questions. So, after the second full quarter of launch, could you comment on the latest observation of treatment duration for rev foraging in real-world practice? And, uh, also, how do you expect the treatment duration to evolve over time, especially now when you have a small earlier second line of patients on the treatment? Thank you.

Hey Kelly, thank you for the question. So first question uh, duration in the real world. What's what are we seeing? I'm going to hand that to Steve to, to answer that. Yeah, thanks Kelly for the question. And, you know, we'd always predicted this first year, would be roughly in the 4 to 6 month range for average duration, Based on data that we've been able to see, we're very confident, that's the case. We take a look at the earliest cohort of patients, and they're certainly within that range that will improve over time. Appreciate the mention of the earlier line patients, which were also in our prepared remarks and that's a, that's a real phenomenon. And this happened very, very quickly, you know, the first patients at launch were were not these patients, they were likely more third, fourth line patients, but have moved earlier, uh, very very quickly and, and that pertains well, uh, on terms of treatment duration. So, better chance of of success of getting, to a transplant, uh, and and more likely as Michael just described on the previous question that the concept of returning to drugs. So that will build over the course of this year. Uh, we would expect in 2026 that that average, you know, treatment duration, will be, uh, 6 to 12 months and

And could you know, skew towards the latter end of that as the as the launch matures and we're able to move patients earlier and Physicians gain more experience.

Thanks very much. Uh, just 1 more question if I may. So on the cost side, how could we expect a change quarter over quarter for the rest of the year? Thanks?

Thanks, Kay. I'm gonna ask you the cost side, the cost, just adding change over a quarter to quarter. Yeah, yeah. Um, Kelly, thanks for the question. So we gave guidance today, uh, that we expect we we changed the way we gave guidance actually we, we used to give guidance uh with respect to Opex inclusive of non-cash stock comp, but we heard from investors that there were more focused on our cash consumption. So today, we changed the way, we gave guidance to focus on, um, our operating expenses, less non-cash calm. We said that for the third quarter, we expected that to be 95 to 100 million and reiterated our full year, uh, guidance that we expect that to be now, 370 to 390. Um, we implicitly gave fourth quarter guidance, uh, because we have 3 quarters of, uh, 2 quarters of expenses gave third quarter guidance. So um, the fourth quarter guidance, that uh, is implicit through the math is almost exactly. Even with our third quarter guidance for uh, research and development Plus

let's not catch.com.

Thank you, Kelly. Thanks Kelly.

Our next question comes from Philadelphia with TD Cowen. Your line is open.

Good afternoon. Congrats on the 26th of launches a couple questions from us. First on the kmt2a launch for Revy Forge.

You suggested. I think that 25% of um patients with kmt2a for a year. Have initiated therapy in the second quarter which suggests um, in the instant population that the penetration is is probably quite high can. Can you give us a sense of

Where you think the penetration is in the incident kmt2a population. Uh, here today in in Q2 of of 2025 and kind of where could that go at Peak? I guess we're trying to understand it. How much growth could be left over the next couple quarters before the label expansion and then second on the npm1 lab label expansion. Uh, any update on inclusion of npm1 and the nccn guidelines.

Yeah, Phil thanks for the questions. Um, the first question related to kmt2a and penetration in 25, I think it we're going to clarify that I'm going to ask Steve to clarify that a little bit. Yeah. Hey, Phil. Thanks for the question and, um, yeah, I mean, so so we've created over 500 patients, uh, since launch, uh, we often, you know, measure ourselves versus that overall, available Market of 2000, k&t to a relapse refractory ML and Al LL patients. So since since launch we estimated we've covered about 25% of that population. I think 1 thing to think about, it's 2,000 patients over the course of the year. Not at any 1 point in time. There's going to be some

Variability. As those patients were identified and diagnosed. We feel great about finding patients. Rev is, is very early. It's become the standard of care. Uh, Physicians. Are you know? Diagnostic testing is is prevalent so they're finding patience. Uh, and the the over the course of the quarter, the number of new patients coming in has been strong and robust. So, we expect that to continue for the rest of this year. We'd expect to finish the year roughly at 50% of the identified population. We think that would be a great launch doing a lot of good for patients but also really filling the funnel uh for every Forge in our in our initial indication.

And then, in terms of your second question, Phil uh, about label expansion, npm1, you had asked about the guidelines comment is, you know, we've submitted to the guidelines, uh, we published in blood, the data is available very helpful to, uh, our medical team to help educate in advance of launch guidelines. Uh, you know, we don't have perfect information about when the guidelines will be updated. Could be any day. Uh, we do expect it before we get, um, we get approval and npm1 and that will help aid our launch, uh, even more by having guidelines. I think that's, uh, important pay for payers as well as Physicians. So looking forward to that, uh, but everything is all set up and ready for launch. We're just, uh, we're eager to uh, continue to make progress.

Great could I just follow up on the first 1? So if there's 2,000 patients in a year it's reasonable to assume a thousand patients in 6 months. It's been 6 months since launch

500 patients, have started therapy.

So it's 50%, you're suggesting 50% of the identified population by the end of the year, obviously more and more patients will go on over time. But but this is a very sick population, so some are going to fall off. So, are you kind of at Peak penetration now and, and therefore, Revenue growth over in the kmt2a population? Specifically Revenue growth over the next 6 to 12 months will be basically dependent on patients living longer and uh, the duration of therapy increasing

No fillers. There's there's a lot of upside. So what we're seeing is over the first year, there's 2,000 eligible patients. We're going to get to a thousand of them over the year, right? Through the end of 25, we can go higher than that. So there is definitely some upside, I'd say we're not at Peak penetration right now. There are more patients that will ultimately need big diagnosed. We have a, a great deal of momentum executing at a at a very high level, but there's a lot of upside still on kt2 are. And then the, you know, the next driver of growth on top of that is going to be npm1, right? Which Padua date in in late October, and that'll be the next leg of the stool and that's obviously a much much larger patient population. But if that's how I would think about growth on the new patient side. Yeah, yeah. I would just add Phil. Yeah. Obviously other part of this is duration, as you brought up the duration of therapy is going to be a key driver for kmt2a. As you treat patients earlier, more patients are going to translate we're seeing that evidence in our in our commercial experience and you're going to be able to put

More patients are back on therapy. We're seeing that early evidence as well. So we expect those to be major drivers year-over-year, as you've added new patients. New patient starts, plus the compounding effect of duration of therapy for these patients who come back and stay on Main. I think there's quite a bit of growth left to do.

That's very helpful. Thank you.

Thank you. Phil.

Our next question comes from Peter, Lawson with Barclays, your line is now open.

Thank you so much. Congratulations on the quarter. Just

um, FDA approval, kind of

what can you tell us around any remaining open items or feedback you got from the FDA and kind of just anything that kind of helps add around the the confidence around the the FDA approval and then kind of the second question would just be around the maintenance setting and kind of what percentage of patients do you think you can eventually get on in the maintenance setting? Thank you.

Yeah, Phil. Thank sorry. Peter thank you for the questions. Um first on, on FDA approval. Um I'm going to turn it over to Nick. Are we learning anything new? Yeah. Thank, you know, the the um, the submissions progressing very well. We have up, we do for today. We've been working very closely with the FDA. It's a, it's a team, we know. Well, now and things are progressing very well, you know, according to plans. So, uh, we're looking forward to the boffer as

As guided on October 25th. Yeah. And and is it with regard to your second question maintenance? What percentage do we think we can put back on? Look, I think the we had heard from Physicians, we continue to hear from Physicians, you know, the vast majority. If not all of their patients, they'd like to put back on maintenance, we know that not every patient will be eligible for maintenance. Uh, but with Physicians treating patients earlier and the majority of the, the treatment, being concentrated, in second line, uh, even at this early stage of launch, and that's a very good sign that Physicians will drive hard to, uh, take more patients to transplant, which give us more opportunity to put them back on once they clear their transplant and grab. So, uh,

Can't give you exact percentage but it should be a very high percentage of k&t 2A patients.

Gotcha, thank you. Maybe I can Circle back on the the first question just around the FDA. I know there's always level on on certainty and it seems to be a python level of uncertainty. Have you seen any any changes in in that dialogue? Any moving targets.

yeah, Peter know, I mean, I think that's clearly that's not what's what's there's nothing to uh indicate that it's anything other than

really very good progress. We have priority review, we're under our tour. Uh, we're having, you know, consistent quality dialogue with the agency. Uh, the feedback has been very good, we have a Pua date, um, that's coming close and uh, we're prepared for launch. So I think everything was on the regulatory front is really hitting on all cylinders. No indication that is any, it's anything other than that?

Perfect, thank you so much.

Thanks Peter.

Our next question will come from Michael Schmidt. With Guggenheim, your line is now open.

Hey guys. This is Paul. I'm from Michael. Thanks for checking out a question. I have two on the front line, combo opportunities. Um, so first on the recent E-I updates from BML. It seems pretty clear that everybody is enhancing the CR and MRD compared to an ASO loan. But I would love to get your thoughts on the degree of OS improvement you're seeing and whether or not you plan to provide another survival update from the study with additional follow-up. And then secondly, um, just looking ahead to the intensive chemo combo, um, can you sort of...

Talk about how we should think about TCR and mrd benchmarks for that combo and sort of what to expect for the update later this year. Thank you.

Paul, thank you so much for the questions. I'm going to turn it over to Nick to, uh, Talk touch on the BML piece of this first. Yeah, thank you for that. And, uh, you know, firstly, very encouraged by the beat AML study. I mean, this is an important study. We were able to confirm a dose to take into phase 3 and show that the dose was tolerable. And also, as you say report out some early efficacy measures and I think the efficacy measures that are probably most in this most important in this setting are the complete response rate and mrd negativity because remember this is a relatively small 43 patient phase 1B study.

So interpretation that context is quite difficult and the CRA and mrd negativity were very high. There were 67% and 100% emodi negativity.

Which, as I said in the earlier comments are, are really, um, a step change above what you expect from, historical controls. Now, when you look at the overall survival, you have to remember that. The median follow-up is quite short. Currently, the median, follow-up was only around 7 months and it's over 20 months in viala. So certainly we expect as those data and mature. Uh, you'll see some changes in the median OS. There's a lot of steps in the capital M currently, which suggests the median is quite unstable and it's therefore very difficult to estimate. Having said that it's already very comparable or somewhat similar to Via which you must also recall is is a very heterogeneous group of um, subtypes of AML with a variety of different genetic mutations, and when you actually Benchmark it, grants against npm1, you probably find the medium.

Of onset and mrd negative Crescent. Both plasma and bone marrow are important. End points in this setting, uh, they've been shown to predict for improved outcomes around uh event free survival and Os.

Um, and believe that they could serve as uh, surrogates to support accelerated approval. Um, those are obviously discussions, we have had with the agency, um, and have refined those, they are built in to the protocols as dual primary end points, which means that they are independently powered. So you can have either, uh, the surrogate CRM point or the time to event endpoint whether that be Os or EF to give a positive study and um, we remain quite confident that that both of those should should read out favorably, um, as previously indicated, we will be updating data for our combination with intensive chemotherapy for fit patients, specifically, the 7 plus 3 regimen um from our own sponsor study, the 7008 study um, and also will likely hear from the study we're doing in collaboration with the NCI uh, which is also a combination of intensive chemotherapy um, in in the latter part of this year and those data should both confirm the dose tolerability and also early signs of efficacy to support our phase 3s with intensive chemotherapy.

So overall, we feel very confident about the programs and and we really have very good momentum going into the latter part of this year.

Thank you, Paul.

Our next question comes from Eagle novitz with City, your line is open.

Hey Michael and team. Thank you. Um, on the uh the 1/3 of the patients that have restarted um after the transplant and then the 2/3 that don't can you just clarify. So of those 2/3, are they not expected to restart? Or is it simply that they're not ready to restart? And and the expectation is that most of them, in fact will restart

Thanks.

You got good, thanks for the questions. Um it's the latter, right? So clearly we said early days, 1/3 have restarted already which is very encouraging to us which does leave 2/3 of those those patients who could restart and we expect a very high proportion of patients to restart out of that cohort as well. So it's it's an ongoing evolving landscape of of patients, coming back from transplant and going on to maintenance. So we we have an excluded that 2/3. We actually we're waiting for those to come back.

Okay, and then just can you clarify on the mechanics? Um do they need to get a reimbursement approval again when they come back after the transplant? Or is it seamless? And they just start for every Forge again without a second. A second. Um need to to request the reimbursement.

Yeah. Steve you want to address that? Yeah. Our expectation is all that it's it's pretty seamless. I mean there's typically in in the this industry, I mean it's 6 months renewals which are pretty standard that may be the case here, but typically if you're within that window they'll restore without any challenges from payers and even when there's a restart or a reinitiate of a prescription, we have not heard of any.

Any challenges with doing that? Payers covered at the formulary coverage is over. 97% of claims are being reimbursed on a regular basis, so we're not expecting any challenges with restarting at all.

Okay. And and lastly I'm just curious. If you could speak in a little more detail about this uh first wave of the real world evidence uh that you're going to have at the end of the year, can you can you just expand on that a little please?

Or maybe Nick can take that. Yeah, I'd be happy to. So, we're obviously working with leading centers across the U.S. and leading thought leaders. And we're at the point now, with the drug being used in clinic from commercial supply, that we're getting some interesting series of data from.

Uh, Physicians experiencing in the real world. So we're collaborating closely with them to collect those data and and look forward to presenting those real world experiences from those centers. Um, you know, in the latter part of this year and I think we're uniquely well placed to be able to do that uh with this new therapeutic classes. We, you know, we're now available commercial in the clinic and can actually report Real World experience versus just clinical trial experience. So I think those data and how the drug is getting used in the real world will be, will be very um insightful and and we're looking forward to those reporting out later in the year.

Thanks.

Thank you, call our next question.

Our next question will come from Justin Zelen with BTIG. Your line is open.

Congrats on the strong quarter. Uh, so looking ahead to the October 25th to do for day for npm1 label expansion. Uh, could you walk us through how you're preparing? Uh, the commercial Organization for launch Readiness and do you, do you, do you anticipate um, a meaningful incremental uptake in the population, right? Out of the gate? Or would it be more, uh, gradual?

Obviously with another indication which would be different from someone who's entering the market. So here's how I would think about, you know, this launch. I mean part of the the success or the, the preparation is doing a great job right now, right. So Physicians, uh, we're leveraging that market experience in kt2 are uh patients understand how to dose the drug, they they appreciate the dosing options that they have. How do they initiate treatments? How to manage any AES that? Uh, that might occur in treatment initiation getting through them? What do they expect from an efficacy and and how to bring the drug in, right? How do they as in a treatment center prefer to bring the drug in? So that's 1 piece. I think the the other piece is we're in the same audience, right? Right now. So when we think about treatment centers that treat K2, are they are the same ones that treat npm1. So, we're already there, we've got a, a best-in-class customer facing team, they have excellent relationships. Uh, they understand the space, they understand how these treatment centers treat, so they've already got a leg up at once. The indication is granted on the snda.

And the last piece is just a great drug, right? We believe we've got a best-in-class profile, uh, with npm1 data. Uh, any physician would tell you most important across any of these types of Agents is does the drug work, um, and does it work better than anything else that's out there? Um, we believe we've got a winner in Revenue Forge. The FC data really screams Physicians. Tell us that I think it's Michael May appoint that on his comments. The fact that we've got

Multiple indications for 1 Man. Inhibitor. That is a big deal. That is not. That is not something that's uh that's minor.

And that holds for Shredder, is it also holds for payers, right payers when looking at a second indication, like, they are with revi Forge. It's in, it's an easy, add and that will that will get us ahead. So those are the, those are the things I think about, in terms of uptake. Absolutely. We're, we're expecting a bump, right? We know that right now the, uh, the usage outside of K2. R is small. We maintain its about 10%, we'll call it spontaneous or off label use. Um, the biggest bank for npm1 is going to be at the indication uh, granting right. When Promotional and commercially, we can stand behind the drug. We think it'll make a big splash. Uh, Physicians are are ready for it. So we'll expect a decent driver at that time, later this year.

Yeah, I'll just add that any npm 1. You know, you take your patient population for about 2,000 patients to 6,000 patients. That's a big difference. And so we we expect it to be a really important driver. Not only starting in the end of the year, but going into next year and Beyond, it's a, you know, it's important to be first. It's important to have the best profile uh, we have both so we're in good shape.

Great. Thanks for taking the questions.

Thanks Justin.

Our next question will come from Selen said with Miss Duo, your line is open.

Great. Hey guys, congrats on the quarter. Um, Mike, Keith, maybe, um, just a couple from US1 on Nick Timbo. So I apologize, this is going to be another math question. But when I look at the 2026 consensus, currently, I think is around $240 million or so on the end user sales number and just kind of looking at some of the numbers that have been released between yourselves and Insight.

There were 45 million of sales, I think or, or so, X inventory, that's our number. I think 4,500 infusions. I think they, they mentioned that on their call. I know you guys are saying over 4,000 but they said 4500. Um, so it looks like I bought 10,000 net price per infusion. Assuming, you know, the trial duration of 10.3 months, you start to get to this price of, you know, 225,

Thousand dollars. So for the 22 infusions that would take place. So assuming you're, you know, they they talked about having a thousand patients at the end of this year, perhaps, so you start to get to these numbers of 225,000. And again, that's using the, the 10.3, not the 12 months duration, no, additional inventory impact. No additional penetration, no growth. Is it just me or is that number just incredibly light, the 26th, Nick Timbo and the user sales number, just based on that math is there something I'm missing?

Thanks for the question. So we're we're tracking with your. We're trying to track with your math here but keep bunch of comments. Yeah. Trying to track you the math. I mean I think you going back to some of the comments that Muhammad and Bill made on the uh call that Insight had last week. I think they were asked a question about Peak sales and there was a response that included, a an estimate of you know, looking at

Necessarily Frontline indications by then. But um you know we definitely think this can be several hundred million dollar product uh in the next few years.

Okay. Yeah, I mean they did talk about the Thousand sort of at the end of the year from the current 700 or so

Um, that's sort of the basis for the math, but I understand your point. And just quickly, I guess on your slides, it looks like you updated your EP data for...

For the NPM, from 3,000 to 40,500, just to 4,500. Is there something you guys did on the EPI to make you more confident around the upper end of that?

Range.

The 1 that is $5 billion.

Yeah, so yeah, thanks for the question. I I look the only thing that, um, you know, a lot of things give us confidence. I think what we, we think about the evidence. I mean, we're we're treating patients now. Really much more in the second line. So you're going to capture the upper end of uh, of that number, if you continue to treat in that capacity. So that's our physicians, tell us, they want to treat, they want to treat earlier. And so that gives us, you know, confidence to kind of capture the upper end of that. That range.

Um, just making a comment. I want to go back to you for a second to your Nick Timbo question. You mentioned a duration of 10 months. I would just point you to the fact that this is a drug that physicians intend to keep patients on potentially for years. I mean, this is a very applicable drug, and so we believe that there's potentially a lot of upside in the duration of therapy. And so, I would be thinking about.

Your assumptions there. And, uh, we'll track with that obviously, over time. But I think that's a, you know, 1 thing that's about to me in your in your math, that you might want to take a look at, oh yeah. It was meant to be conservative. Yeah, yeah.

No, I'm just again, I think it's, as a conservative estimate, I understand where you're coming from. But I think we are encouraged by duration here and what this category, and what specifically this drug and mechanisms can bear. So I would just pay attention, especially 5 months in the launch. Insight made comments that 80 to 90% of patients that started on therapy are still on therapy. Very good point.

Fair enough. Thanks so much guys. Appreciate it.

Thank thanks, Lynn. Thanks Lynn.

Our next question will come from David die with UBS. Your line is open.

Oh great. Thanks for taking my questions and those from class on the quarter. A couple of questions for me. I want to discuss the tonnage million. I wrote for revenue. Could you talk about the percentage of revenue that is inventory and also how much of that is coming from new patient starts versus refills?

Thanks David. Um,

Yeah, so David May, um, comments that I made said that, you know, that only well, I'm sorry, let me back up the demand and the quarter was driven by, uh, patient growth to Patient demand, um, inventory, state level 2 to 3 weeks.

Um, we expect that to be the case going forward. You know, it's pretty typical of a drug that's distributed using specialty pharmacy and specialist distributors to have 2 to 3 weeks of inventory. So we don't expect that to grow.

Got it. Okay. And then just another question on the, uh, patients on, uh, uh, the stem cell transplant. And right now you have about 33% a quarter of it, uh, or 1 third, I'm just curious, you know, do you expect this to increase given that you have 50% of patients currently treated in a second line? So how should we think about this? You know, going forward in terms of to increase in samsar transplantation?

Yeah, David, thanks for the question. Um, we try to get at this a little earlier. Look, I think the transplant rate is at about a third. Remember, in AUGMENT-101, we were at about a quarter of patients going to transplant. Now we're at about a third. We're treating patients.

A lot earlier, uh, instead of, you know, third and fourth line, more more second and third line, 70% of, our of our prescriptions are in that second and third line.

Transplant rate could go 50% higher. We we we we don't know. Um, but we are expecting it to materially change over time and get get better. And what gives us confidence is that we know if we treat patients earlier, they tend to get to a higher level of response, higher rate of response and are more eligible or will be eligible for a transplant. So I think that's what's giving us confidence. Uh, we don't have the upper bound of that but we do expect it to grow.

Over time.

Great. Thank you for taking my questions.

Thank you, David.

Our next question will come from Jason zamansky with Bank of America. Your line is open.

Good afternoon. Congrats on the quarter. And thank you so much for taking our questions, uh, a couple from us. If we met based on your your earlier comments. But first being of the 2000 or so, of last refractory kmt2a patient. Can you, uh, give us any color on your assumptions regarding the, the overall Peak penetration here?

All opportunity in relapse refractory, at least as far as your cash runway goes. Um, any color on, uh, your insights or assumptions as far as the competitive split in the NPM1 population look like? Thanks.

Thanks Jason. Thanks for the question. So first question related to uh Peak penetration RS. If it's on Peak penetration for for the 2000 kmt2a patients.

Steve, do you want to take a shot at that? Yeah, I think we can. As we said, we've already covered 25% of the population; we'll get to 50% of that. Um, there's some upside to that we haven't guided to a number on peak. Um, but I think, you know, we'll be at a level that is close to the upper end of the models that some of you may have. But we think there's some, you know, beyond that. Uh, treating earlier, I think it's Michael [Metzger] said, brings more people in. And just remember, Jason and everyone that in K2, there's no one in the near term coming to market. So it is really a wide space, and Rev is already the standard of care after just 7 months on the market, and physicians are using it that way.

Yeah, Jason. I was just, I would say there's penetration into a market never happens within 1. Year, always takes an oncology more than that. And I think we expect as Steve said within the fact, a thousand patients, uh, this year. So we have more work to do next year and the year Beyond. So that's I think just in terms of new patient starts in terms of really building this market, I'll say it again. Duration of therapy is going to be key, right? Physicians, treating early.

Earlier. We know that that's going to give us the best outcomes. Uh, patients are going back on therapy, post-transplant. That will ultimately compound. The, the, uh, the revenue as it goes forward. Patients staying on drug for long periods of time. So I think those are the real drivers, those 2 2 things. It's very actually pretty simple. Um, but that's it's not just about how many patients you can penetrate on kmt2a. It's how long they stay on drug as well.

And then, uh, overall opportunity you had mentioned that the second question being, what do you, what's your estimate for, um, competitive split and NPM1? Look, I think we were first to market. Uh, we, we know we have the best profile. Uh, I think the data speaks for itself. We're feeling very confident about that. Uh, we would expect to have a significant, uh, percentage of that market and dominate NPM1 as well as KMT2A. So we feel very, you know, positive about the fact that we're entering the market first and, um, you know, that's, uh, you know, essentially how we see it. So we're not, we can't guide exactly to what the, uh, the split would be, but we would expect to have a big share.

Fair enough. Appreciate the color. Thanks guys.

Our next question will come from George farmer with Scotia Bank. Your line is open.

Hi. This is Chloe on for George. Thank you for squeezing us in.

Um can you talk a little bit about the um monitoring that's happening in the real world right now for potential cardiac AES um how they're being managed and to the extent that you're privy to this information? What percent of these cardiac AES, like the QT, prolongation is due to read human. It was opposed to any concoct medications and how many of those have resulted in in this continuations in the real world?

Um, then number 2, um if you could give, uh some color on how to model the royalty Pharma interest expense.

In the P&L moving forward. That would be super helpful.

and the last one on Nick Timbo, um, in IPS

Uh, could you?

Please speak to the unmet need, how big that opportunity is, and how you're thinking about positioning in a market that's currently dominated by generics.

Yeah, Corey, thanks for your questions. Um, so I counted three. So let's start with the first one. Uh, Nick will take that house monitoring being done for a while. Yeah, thank you, uh, for the question. So, firstly, we've shown in our, you know, extensive time control experience now that, um, you know, management of QT has done very simply. It does clear guidelines in the label. Now, uh, for QTs in the first month, we know that almost all patients that have any sign of prolongation happen early, uh, and are monitored and managed appropriately. That's very consistent with our real-world experience. As I said, we'll be reporting on some of that later this year. We, of course, have very extensive safety surveillance systems in place, but we're really not hearing any evidence of concerns with standard guidelines and management of those patients. So, um, you know, things are progressing very well, and physicians are very happy with the profile and not flagging any concerns.

Great and Keith. You want to talk about the royalty, please? Yeah. Chloe um.

The the Nick Timbo. So you know, we've already achieved profitability First full quarter sales, we mentioned that uh, 36 million in net revenue, we reported 9 million in collaboration Revenue. So we're already in, in a, in a range of 25 to 30%, um, from a gross contribution perspective and like I said, am I prepared marks? We only expect that to grow with respect to the royalty. It's really easy. It's it's simply 13.8% of the net revenue that is reported by Insight. So in second quarter, that represents 5 million in royalties, paid on 9.4 million in collaboration Revenue.

We're using the effective interest rate method, so the cash paid to Royalty Pharma won't exactly match what we report on the P&L.

And then, lastly, I think you asked about IPF. Um, so IPF is a very important indication for us. We have a Phase 2 trial ongoing and expect to fully enroll that trial this year, with data next year. Uh, that's a big market opportunity, as you pointed out. There are some entrenched competitors, and we have a different mechanism of action brought by this drug, which we think is very impactful. There are about 150,000 patients in the U.S. and 280,000 worldwide, so it's a big market. Patients are still in absolute need of new therapy, and we believe we can bring that with Nick Timbo, potentially, with this mechanism. So we'll have those trial results, and we think we'll be able to differentiate over time, especially if those results are positive. So, more to come on that.

It's, we think, a very big opportunity for us to exploit as a secondary education.

Great, thank you very much.

Thank you. Thanks B.

Our last question comes from Mayank Matami with B. Riley Securities. Your line is open.

Uh, yes, good afternoon Dean. Thanks for taking your questions and congrats on the progress. Uh, could you just, uh, clarify and sorry? If I missed that if there's any real world evidence, your planning to generate, uh, as you strengthen the case for uh, rebuild force, uh use as maintenance therapy post transplant, and and and what's your expectation for duration of therapy there. Uh say relative to the 4, to 6 months you're seeing in pre-transplant and I have a quick follow-up.

Yeah, thank you. Thanks so much for your question. I'm going to let Nick address the real world part. Yeah, we'll be presenting some, um, relatively preliminary data from the serious Ruby monitoring towards. Um, the latter part of this year. Second office here. We're looking forward to presenting that will obviously include, uh, you know, patients demography, uh, how they do on therapy. And importantly, also, the proportion of patients that go on to transplant in the real world from these series. And and also those patients that then start on um, you know, on on revvy Forge after the transplant. So I think those will be important data. Obviously as time goes by and our commercial experience increases will be able to add to those data. But I think it'll be interesting preliminary data and we'll look forward to reporting those out and I think they'll uh, they'll shed some light on some important questions.

And I I'll just make a comment. I think you just asked about what our assumptions are on post-transplant maintenance. What percentage of patients are likely to go um, you know, onto onto transplant and then of course on what time frame. And I think we commented earlier about high percentage of patients going to transplant. I think that's obviously very clear to us now. Uh and exciting. And then in terms of staying on therapy positions, have repeatedly told us a year to 2 years, is what I said. In my prepared remarks, a year to 2 years is pretty consistent. Uh, could be longer some Physicians, say that they will keep them on indefinitely without a real compelling reason to take them off and, and obviously, these patients are at high risk of relapse. You want to keep them in remission as long as possible. That's the key goal. So, uh, you know, I I think an assumption, you can make, uh, on average for for for maintenance that Physicians are thinking about year a year to 2 year uh time frame.

Uh, they are helpful, thank you. And then on Nick Timbo, can you just remind us what development milestones to look out for as you think about that therapy moving into earlier lines of GVHD? I believe on the labels it's third line, fourth line, but the update is in earlier lines. I was curious if there are any additional clinical data milestones we should be on the lookout for. Thanks for taking your questions.

ITF.

Thank you.

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.

Thank you, all. We appreciate you tuning in today to discuss our recent progress and the exciting milestones ahead. We look forward to seeing many of you at several investor conferences and events in Q3. With that, have a great evening.

The call is now concluded, thank you for joining. You may now disconnect