Q3 2024 Syndax Pharmaceuticals Inc Earnings Call
Good day everyone and welcome to the Syndax Third Corps 2024 Irings Copper Skull. Today's call is being recorded. All participants have been placed in a listen only mode. You'll have an opportunity to ask questions after today's presentation.
If you'd like to ask a question, please press star 5 on your telephone keypad to place in the queue. And I also press star 5 again to remove yourself from the queue. At this time, I'd like to turn over the call to Sharon Clary, head of Investor Relations at Syndex Pharmaceuticals.
Sharon Clary: Great, thank you, operator. Welcome and thank you all for joining us today as we review sinnexis 3rd quarter, 2020-4th financial and operating results.
Sharon Clary: and with me this afternoon to provide an update on the company's progress and discuss financial results.
Chief Executive Officer, Dr. Neil Gallagher, President and Head of R&D, Steve Closter, Chief Commercial Officer, and Keith Goldan, Chief Financial Officer.
Also joining us on the call today for the question and answer session, our doctor Peter Ardethlick, Chief Scientific Officer, and Dr. Angelangangolick, Chief Strategy Officer.
This calls and accompanied by a slide that is imploded on the investor page of the company's website.
You can now turn to our Ford-looking statement on slide 2. Before we begin, I'd like to remind you that any statements may during the call that are not a historical are considered to be Ford-looking statements within the meaning of the private securities litigation or format of 1995.
Actual Results May differ materially from those indicated by these statements as a result of various important factors, including those discussed in the risk factor section in the company's most recent quarterly report on Form 10Q.
As well as other reports filed with the SEC. Any four of looking statements may represent our views as of today, November 5th, 2024 only.
Speaker Change: A replay of this call will be available on the company's website, www.synax.com, following its completion. With that, I am pleased to turn the call over to Michael Metzger, Chief Executive Officer.
Michael Metzger: Thank you.
Michael Metzger: Thank you, Sharon. Good afternoon, everyone, and thank you for joining us today.
Michael Metzger: We made remarkable progress in the third quarter. We delivered on multiple important milestones that demonstrate our ability to bring novel medicines to patients, and in doing so, we marked our transition from a development organization to an integrated commercial stage company with an extremely bright future.
Michael Metzger: with the announcement of yesterday's $350 million royalty agreement for Nictimvo with Royalty Pharma.
Michael Metzger: We have strengthened our balance sheet significantly, and now have the capital to fund Syndax through profitability, ensuring strong launches for Revumative and Nick Timbo, and solidifying our commitment to their continued development and expansion of the pipeline overall.
Michael Metzger: Importantly, this deal further highlights how vastly underappreciated the value of Nictimbo is in the market and why it remains a critical element of our long-term strategy.
Michael Metzger: Let me now dig into some third quarter milestones.
Michael Metzger: In August, we received FDA approval for Nictimbo, the first and only CSF1R antibody approved for the treatment of chronic graft-versus-host disease, or GVHD, after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms.
Michael Metzger: Shortly after we received FDA approval, the positive pivotal Agave 201 trial results were published in the New England Journal of Medicine and Nictimbo was added to the latest NCCN guidelines.
Michael Metzger: Two achievements that highlight the significance of this data set and the important role of Nick Timbo in the treatment armamentarium.
Michael Metzger: With Insight's deep understanding of the GBHD market and long-standing relationships with key stakeholders, we are thrilled to partner with them to bring this much-needed new option to patients.
Michael Metzger: Later in the call, Steve will provide more color on our plans for the commercial launch.
Michael Metzger: We believe the approval of NICTIMBO represents the initial opportunity to make a major impact for patients by targeting the CSF1R pathway.
Michael Metzger: Together with Insight, we are advancing a robust clinical development program investigating the potential for Nictimbo in frontline chronic GVHD in combination with standard-of-care therapies and in other diseases marked by fibrosis and inflammation, such as idiopathic pulmonary fibrosis, or IPF.
Michael Metzger: In addition to making tremendous progress with Nictimvo, we've also continued to make excellent progress advancing RevuMenin, our selective menin inhibitor that we anticipate will receive FDA approval this quarter in relapsed or refractory KMT2A rearranged acute leukemia.
Michael Metzger: With a PDUFA date of December 26, 2024 and compelling clinical data across the treatment continuum, we believe Revimenev is poised to become first-in-class and practice-changing therapy for KMT2A and MPM1 acute leukemia.
Michael Metzger: In addition to the anticipated approval of REVUMENUM, we are also looking forward to the top-line readout from the pivotal cohort of patients with mutant MPM1 AML, our Augment 101 trial this quarter.
Michael Metzger: In the recent months, we've executed on multiple initiatives that we believe lay the foundation for a strong, revolutionary launch and successful long-term franchise growth across both KMT2A, Rearranged, End Mutant, and PM1 acute leukemias.
Michael Metzger: In September, we published the pivotal data from the AUGMENT 101 trial supporting the use of Revumenib in relapsed or refractory KMT2A rearranged acute leukemia in the Journal of Clinical Oncology.
Michael Metzger: This publication is raising awareness of Revumentum's compelling profile and potential utility once approved and will be instrumental in gaining rapid acceptance into the NCCN guidelines.
Michael Metzger: As you saw from our press release earlier today, we have multiple presentations at ASH that highlight the clinical data supporting our two assets, including additional reprimanded data in KMT2A Acute Rearranged Acute Leukemia from the phase two portion of our Augment 101 trial.
Michael Metzger: and new combination data for the investigator-sponsored SAVE trial.
Michael Metzger: These data, which are consistent with our previously reported data, continue to show remarkable responses that are deep and durable in heavily pre-treated patients.
Michael Metzger: Furthermore, in both monotherapy and combination, Revumentum continues to demonstrate a tolerability profile that allows patients to benefit significantly from continued therapy.
Michael Metzger: Beyond the conference presentations, we will also have the opportunity to discuss the latest data supporting our pipeline at ASH and our event on Monday, December 9th.
Speaker Change: And with that, I'm going to turn the call over to Neil to review the latest data in the ASH Abstracts and review our RevuMetab Clinical Development Program.
Neil: Thanks, Michael. It's a pleasure to be with you all today to discuss the latest data emerging from a robust clinical development program investigating RevuManib across the treatment continuum in both adults and pediatric patients with KM22A rearrangement or mutant MPM1 acute leukemias.
Neil: Through a thoughtful combination of syndex-sponsored and investigator-sponsored trials, we're rapidly generating data supporting the use of Revumenib, both as monotherapy and in combination with standards of care, both in the frontline or relapsed refractory settings.
Neil: On the next few slides, I'll review the recently released ASH abstracts that contain the latest data from a number of ongoing trials and briefly review the Revumenib clinical development program. Turn to slide four.
Michael Metzger: At ASH we will be presenting an updated analysis that includes additional patients enrolled in the Pivotal Phase II portion of the Augment 101 trial of reviumative inpatients with relapsed or refractory KM22A rearranged acute leukemia.
Michael Metzger: These new data are highly consistent with what was previously reported.
Michael Metzger: with the previously reported data rather, that form the basis of our NDA application.
Michael Metzger: with a February 2024 data cutoff, the updated safety population comprised of 116 patients, 22 more than in the original analysis. And the efficacy population has expanded to a total of 97, 40 more than in the original analysis.
Michael Metzger: The median age was 35, and 24% of the population was under the age of 18. The median number of prior therapies was 2, with 44% of the population having received 3 or more prior treatments. 63% had prior exposure to Advoneticlax, and 51% underwent prior stem cell transplant.
Michael Metzger: The efficacy results.
Michael Metzger: from this expanded analysis are highly consistent with what was previously reported from the interim analysis, with an overall response rate of 64%, a CR-CRH rate of 23%, and a composite complete remission rate of 42%. 21 of the 62 responders, or 34%, went on to receive allogeneic stem cell transplant, and 9 patients resumed revumenib as maintenance therapy following transplant.
Michael Metzger: The median duration of CR-CRH was 6.4 months at the time of the data cutoff. Among patients who are valuable, 61% of CR-CRH and 58% of patients with CRC achieved MRD negativity.
Michael Metzger: Achieving MRD negativity or the absence of detectable leukemic cells is an important clinical milestone as it may correlate with improved long-term outcomes. The consistently high rates of MRD negative status achieved with RevuMab are indicative of its best-in-class potential.
Michael Metzger: Revumenib continues to be generally well-tolerated with only 5% of patients discontinuing treatment due to a treatment-related adverse event. The frequency and severity of AEs were consistent with previous reports.
Michael Metzger: Moving to slide five.
Michael Metzger: The updated analysis also includes an assessment of the durability of response among the 13 patients who achieved CR-CRH in the previously reported interim analysis that was presented at ASH in 2023. At the time of that analysis, the median duration was 6.4 months. In this updated analysis with 7 additional months of follow-up, the updated median duration has extended to 13 months.
Michael Metzger: At the time of the most recent data cut-off, five of the 13 patients remained in follow-up without relapse.
Michael Metzger: Moving to slide six.
Michael Metzger: SAVE is an investigator-sponsored Phase 1b trial conducted by Dr. Issa at the MD Anderson Cancer Center.
Michael Metzger: The trial is evaluating an all-oral combination of revumaneb, venetic clacks, and all-decidedine in children and adults with relaxed or refractory AML or mixed lineage of cute bikinis. [inaudible]
Michael Metzger: As you may recall, at last year's ASH meeting, Dr. Issa presented promising data from the first nine patients enrolled in the trial. This new abstract includes data from 26 patients with a median age of 35. 42% of the patients had KMT2A rearrangements, 38% had mutant NPM1, and 20% had MUP98 rearrangements.
Michael Metzger: Patients had received a median of three prior lines of therapy including 65% who received prior venetoclax and 42% who had prior stem cell transplants.
Michael Metzger: The combination was well-tolerated, with a safety profile similar to what is expected for phonetoclax and hypermethylated agents alone. As you can see on the right-hand side of the slide, the oral-oral combination showed promising results. It is of note that two-thirds of these patients failed prior therapy with phonetoclax.
Michael Metzger: The overall response rate was 88% with a CR rate of 46% and a CRH rate of 12%. Among the MRD-evaluable patients with CR-CRH, 13 of 14 patients, or 93%, were MRD-negative.
Michael Metzger: Twelve patients, or 46%, proceeded to stem cell transplant, with three patients resuming that regimen the following transplant.
Michael Metzger: With a median follow-up of 6.4 months, the six-month relapse-free survival was 59%, and overall survival was 74%. The median duration of CR-CRH was not reached. As of the data cutoff, two patients have completed maintenance post-stem cell transplant and remain in remission.
Michael Metzger: These data, which further support the combinability of Revumena with venetoclax and hypermethylating agents are encouraging. We look forward to sharing further data from this trial and due course, including from a frontline cohort that is now enrolling.
Michael Metzger: Turning to slide seven, the two trials that I just reviewed are important parts of our comprehensive clinical development program evaluating review metabolic cost of treatment continuum.
Michael Metzger: In addition to the trials just described, there will be an oral presentation at ASH on preliminary results from INTERCEPT, an investigator-sponsored platform trial led by the Australasian Leukemia and Lymphoma Group.
Michael Metzger: This trial is evaluating novel therapies, including Revumenib, to target measurable residual disease or early relapse in patients with AML. Patients are enrolled in remission and their MRD status is monitored. Patients who become MRD positive or experience early relapse are then allocated to treatment.
Michael Metzger: As of the data cutoff, 9 patients with MRD relapse, including 8 with mutant NPM1 and 1 with KM22A rearranged AML, were enrolled in the safety cohort and received Revumenib.
Michael Metzger: Three patients had prior venetoclax exposure and six had prior intensive chemotherapy.
Michael Metzger: The preliminary data from mutant MPM1 patients treated with verivium antiviral promising was five of eight patients achieving a reduction in measurable residual disease, including three who achieved MRD negativity within six cycles. We look forward to seeing further data from this trial.
Michael Metzger: BEAT AML is another ongoing investigator-sponsored trial that is being conducted by the Leukemia and Lymphoma Society.
Michael Metzger: This trial is evaluating a combination of revumenib with zanetoclaxonazacitin in front-line patients with NPM1 or KM22AR AML. Data from the trial were recently presented at the European Hematology Association meeting in June. The CRC rate was 96%.
Michael Metzger: We are looking forward to the next anticipated update in the fourth quarter of 2024. Data from this trial have informed the design of the Pivotal Frontline Phase 3 that we expect to initiate by the end of this year.
Michael Metzger: Moving to slide 8, you can see a high-level overview of this phase 3 trial design. The design of the pivotal frontline trial of Revumatib in combination with Venetoclax and Azacitidin, or Venasa, newly diagnosed adults with mutant MPM1 or KM228 AML who are considered ineligible for intensive chemotherapy.
Michael Metzger: This will be a randomized, double-blind, placebo-controlled trial conducted in partnership with the HOVON Network.
Michael Metzger: We're delighted to partner with HOVENT. The group has conducted many robust phase 3 trials in AML over the last several decades.
Michael Metzger: Syndax and Hovhann have a shared commitment to improving outcomes for patients with AML and therefore the partnership is a robust one and as I mentioned we're very pleased to be partnering with the group.
Michael Metzger: The trial will enroll approximately 400 patients, randomized one-to-one, to receive placebo plus venasa or revimena plus venasa.
Michael Metzger: The primary endpoint is overall survival in patients with mutant MPM1 AML. Secondary endpoints include event-free survival, rate of CR-CRH, and rates of response without MRD.
Michael Metzger: We expect the first site to be open for enrollment by year-end.
Michael Metzger: Turning to slide 9.
Michael Metzger: Ahead of our top-line readout from the Phase II cohorts of patients with relapsed refractory mutant MP1 AML from Augment 101, I wanted to briefly review the unmet need of these patients.
Michael Metzger: Mutations in eukaryotoxin-1 gene are the most common genetic alterations in AML occurring in approximately 30% of adults with the disease.
Michael Metzger: While NPM1 mutations can be associated with favorable outcomes in certain frontline populations, the outcomes for patients who have relapsed or were refractory to therapy remain poor, with expected median overall survival of approximately six months or less after three or more lines of therapy.
Michael Metzger: As compared to patients with other genetic alterations such as KM22A rearrangements, patients with MPM1AML tend to be older and less fit to, for instance, receive intensive chemotherapy and proceed to transplant.
Michael Metzger: In the Phase 1 trial of Revumenib in patients with relapsed refractory mutant MPM1-AML, a robust response rate was observed. Overall, the efficacy and safety profile in those patients was highly consistent with what has been observed in KM22AR patients.
Michael Metzger: Based on historical approvals of other AML therapies, we believe that a CR-CRA trade of 20-30% with a median duration of response in the 4-6 month range would represent a clinically meaningful improvement over the current standard of care and therefore potentially support regulatory approvals.
Michael Metzger: We look forward to reporting top-line data from the ongoing NPM1 cohort in Augment 101 later this quarter.
Speaker Change: So, with that, I'm going to hand it over to Steve, who can tell us about progress on the commercial front. Steve? Yeah. Thank you, Neil. Starting with slide 10, we are thrilled that Nictemvo is now FDA approved.
Speaker Change: and include in the latest NCCN guidelines as a recommended treatment for chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms.
Speaker Change: We anticipate that this new medicine will be available to patients no later than early in the first quarter of 2025
Michael Metzger: Addressing the needs of patients who have progressed after at least two prior lines of therapy is an attractive commercial opportunity.
Michael Metzger: For example, in the three years since the launch of Belumocidil or Reziroc, another drug indicated for the same line of treatment as Nictinvo, net sales continue to grow in the high double digits and suggests that the drug is now annualizing at over 500 million dollars in US sales alone.
Michael Metzger: with a new mechanism and clinical data showing that Nictinvo can provide both rapid and durable responses in heavily pre-treated patients including results in difficult-to-treat organs
Michael Metzger: We believe that we will be able to capture a significant portion of the $1.5-2 billion estimated total addressable market for third-line or later chronic GVHD treatment in the U.S.
Michael Metzger: This will be a targeted launch as there are roughly 200 important transplant centers in the U.S.
Speaker Change: The Syndax team will provide 30% of the sales effort for Natembo and our partner, Insight, will provide 70%, leveraging their existing field force that is already deeply engaged with the chronic GVHD community through their work with Jackify.
Speaker Change: The key transplant centers that we will be targeting fall squarely within the larger group of accounts that are also important for Revumetib, creating opportunities for commercial synergy.
Speaker Change: In addition to preparing for the launch of Nictemvo, we and Insight are also continuing to advance clinical trials evaluating Nictemvo in earlier lines of chronic GVHD treatment and other diseases.
Michael Metzger: INSIGHT is now enrolling patients in a Phase II trial of Nictimvo in combination with Jackify in patients with newly diagnosed chronic GVHD, and we continue to enroll patients in a Phase II trial on top of standard of care in IPF with top-line data expected from that trial in 2026.
Michael Metzger: Turning to slide 11.
Speaker Change: Revumentum has the opportunity to transform the treatment paradigm for certain genetically defined acute leukemia patients who currently have no targeted options.
Speaker Change: There are several important factors that differentiate our program and position Syndax to establish a successful men in franchise. First, we're set up to secure first mover advantage.
Speaker Change: We have built a highly experienced commercial organization that is already engaging with key stakeholders and is ready to launch review meta as soon as we receive the anticipated FDA approval before the end of the year and relapse or refractory can T2A rearranged acute leukemia.
Speaker Change: We believe that physicians' familiarity with Revumetib will expand quickly because patients with these alterations have an urgent need for new treatment options as no drugs are currently approved for this population or under investigation of late-stage trials.
Speaker Change: With today's standard of care therapies, the median overall survival for patients who have received more than two prior lines of treatment is less than two and a half months, a truly devastating prognosis for patients.
Michael Metzger: Given this is a high-risk population, centers are already routinely testing for KNT2A rearrangements.
Michael Metzger: Further, with compelling data across both KNT2A and MPM1 alterations, as well as adults and pediatrics, we expect to have a broad future label that drives a strong competitive advantage.
Michael Metzger: Last, but not least, we have a near-term opportunity for a unique launch trajectory, with pivotal top-line data in relapser refractory mutant NPM1AML.
Michael Metzger: expected in the same quarter as our anticipated FDA approval in CAMP T2a.
Michael Metzger: Positive data would enable us to file a supplemental NDA in the first half of 2025, and if approved, we'd be positioned to launch into a second indication, leveraging an already established commercial effort.
Speaker Change: Thank you. Thank you. Thank you.
Speaker Change: We estimate that the two distinct market segments in acute leukemias, KNT2A and MPM1, equal a combined accessible population of 5,000 to 6,500 patients.
Michael Metzger: in the relapse of refractory setting and an addressable market opportunity that approaches $2 billion in the U.S.
Michael Metzger: In summary, I'm very excited about positively impacting the lives of patients and the commercial opportunities we have with Nictimbo and Revumatum. I'm confident that we are well prepared to successfully launch both of these drugs.
Speaker Change: With that, I'll pass the call to Keith to talk about our financials. Thanks, Steve.
Keith Goldan: Turning to slide 12, we expect that the $399.6 million in cash equivalents and short and long-term investments on our balance sheet as of September 30th
Keith Goldan: plus the $350 million in cash received from the Royalty Funding Agreement to Frederick Timbo will provide sufficient cash for Syndex to reach profitability.
Keith Goldan: Under the terms of the Royalty Funding Agreement, Sinex received $350 million in exchange for a 13.8% royalty on U.S. net sales of the McTimbo.
Keith Goldan: Royalty payments to Royalty Pharma are capped, which preserves the upside longer-term for opportunities.
Keith Goldan: including treatment of frontline chronic GVHD and IPS.
Keith Goldan: Our financial strength allows us to fund the commercialization of Nictimbo, as well as the anticipated launch of Revumentib, while also appropriately investing in our pipeline to fuel continued growth and value creation.
Keith Goldan: Turning to the income statement, operating expenses in the third quarter were $102.1 million and included $71 million of research and development expense and $31.1 million of selling general and administrative expense.
Keith Goldan: For the full year of 2024, the company is narrowing its guidance and now expects research and development expenses
Keith Goldan: to be 245 to 250 million dollars.
Keith Goldan: and total expenses to be $365 to $370 million.
Keith Goldan: Note that the guidance range for operating expense for the full year 2024 includes an estimated $41 million of non-cash stock compensation expense, which is down from a previously estimated $43 million.
Keith Goldan: and that research and development expense guidance includes any milestones earned or expected to be earned by our partners for potential approvals.
Speaker Change: With that, let me now turn the call back over to Michael.
Michael Metzger: Thank you, Keith. As you heard today, we have built remarkable momentum heading into another exciting period filled with several near-term value-generating milestones that can be seen on slide 13.
Michael Metzger: Building on the FDA approval of our first novel medicine in August, we are confident that Revimena will also be approved this year and launched soon thereafter.
Keith Goldan: We believe this first anticipated approval on relapsed or refractory KMT2A rearranged acute leukemia will be just the first of several potential approved indications for revumentib, and we are extremely focused on leveraging our first mover advantage to build long-term franchise value.
Speaker Change: This quarter we will be presenting the first Pivotal NPM-1 dataset, which gives us the opportunity to further solidify our position in the emerging Mennon space. So stay tuned.
Keith Goldan: Finally, I want to take a moment to thank our dedicated SYNDAX team, collaborators, and most importantly, the patients, families, investigators, and trial sites who have participated in our clinical trials and made it possible for us to advance our mission.
Keith Goldan: I'd also like to thank our committed long-term investors who continue to share in our mission and support our work building Syndax into a leading oncology company. And with that, I'd like to open the call for questions. Thank you, operator.
Speaker Change: At this time, I'd like to remind everyone, in order to ask a question, please press star and the number 5 on your telephone keypad. If you'd like to withdraw your question, press star and the number 5 once again. We'll pause for just a moment to compile the Q&A roster.
Speaker Change: The first question will come from Anupam Rama with J.P. Morgan. Your line is now open.
Speaker Change: Hi, guys. This is Priyanka on FrontoPOM. Just a quick question from us. Post the potential approval of KMT-2A and pending positive NPM-1 data for RevMenib, can you remind us of the process to get into guidelines and potential timeline considerations we should be thinking about?
Speaker Change: Sure, thanks for your question Priyamka. So the timing to get the
Speaker Change: the guidelines or get into the guidelines first you have to obviously have an approved
Speaker Change: drug and then you have to have
Speaker Change: data that you can publish. So you publish the data and move quickly to do so. And that's our plan. And then ultimately, we'll submit for guidelines.
Speaker Change: They meet the NCCN guidelines.
Speaker Change: panels meet probably twice a year, but they do it
Speaker Change: and on an ad hoc basis as well. So there's the opportunity for important approvals, as we would expect these to be, to be engaged and brought into the guidelines pretty expeditiously, and we did.
Speaker Change: actually experienced that with axotilumab.
Keith Goldan: contemporaneous you know publication of that that data in the New England Journal as I mentioned in my remarks and then we were into within two to three weeks we were into the guidelines so that is that is all you know very very much the the plan to move as quickly as possible to move into guidelines
Speaker Change: Thank you so much for answering my question.
Speaker Change: Thank you.
Speaker Change: The next question will come from the line of Brad Camino with Stiefel. Your line is now open.
Brad Camino: Thank you. Lots to talk about, and I look forward to asking more at ASH, but two topics for me for now. For Augment 101, in the updated data, you noted 9 of 21 or 43 percent of transplanted patients restarted regumenter maintenance. Is that a maintenance percentage rate you expect in the commercial setting, or could it be higher? And also, what have you seen so far on durations?
Keith Goldan: And then congratulations on the Hovahn collaboration for frontline AML. I think you do point to beat AML updates in 4Q24. Help us understand what you're looking for in those data to finalize and initiate that pivotal trial. Thank you.
Speaker Change: Yeah, thank you Brad. So maybe I'll take the first question and then I'll pass it over on the BDAML trial to Neil.
Speaker Change: So, in terms of the Augment 101 trial, we did note that there were certain patients that went back on maintenance.
Speaker Change: And, you know, that is a trial-driven result. Patients were allowed, physicians were allowed to put their patients back on.
Speaker Change: therapy post-engraftment and many many physicians elected to do so. We do expect that that phenomenon will continue to advance once the drug is approved and we'll have the opportunity to
Speaker Change: have many more patients treated and of course that would lead to potentially the opportunity to have patients not only go to transplant but get back on therapy and stay on therapy for an extended period of time. So I think we'll continue to build the data in the real world but we are encouraged by what we've seen thus far in Augment 101 in that regard.
Speaker Change: And then BDAML, I think I'll turn it over to Neal in terms of what we expect on an update. Sure. Thanks, Brad. So what I think everyone should expect is more patients, right? Specifically more patients treated at dose level 1, so the combination of 113 mg of Revumenib.
Speaker Change: with venetoclaxonasis cited and some more patients also compared to what was previously reported.
Speaker Change: One thing, just a point of clarification, that is not rate limiting for us, we're currently actually applying for a health authority approval to initiate the study and that's why we remain on track to potentially initiate the phase.
Speaker Change: three study by the end of the year. So those things are actually moving in parallel.
Speaker Change: Thank you.
Speaker Change: Thank you, Brad.
Speaker Change: The next question is from the line of Pierre Lawson with Barclays. Your line is now open.
Pierre Lawson: Okay, thank you so much. Just for the sale of some of the Royalty Shrine from Nick Timbo, does that accelerate any programs under development?
Speaker Change: So,
Speaker Change: Proforma lands us at somewhere around $800 million. So I think we have a very strong.
Speaker Change: balance sheet at which to execute on. I think we're set up.
Speaker Change: extremely well for all the trial initiations that we have planned for frontline trials, pivotal trials.
Speaker Change: several additional trials. We haven't named yet, but that will be in support of the utilization of our drug in other settings.
Speaker Change: So, I think it's, you know, definitely helps us aggressively move forward with plans for revumentib and for axotilumab, nictimbo.
Speaker Change: So it really advances the portfolio overall and gives us the opportunity to expand the portfolio with other molecules as well. So it's a very, very happy, very healthy balance sheet. Performa, I think I said, approaching 800, it's about 750 actually.
Speaker Change: just to correct myself.
Speaker Change: Thank you, Brett. Thank you, Peter.
Speaker Change: and then the timing of the NPM1 data and you know is that before or after a publication how we should be thinking about that and kind of if it
Speaker Change: It's direct to NCCN guidelines, so you're kind of thinking supplemental.
Speaker Change: Right, so I think the
Speaker Change: order events here. You get approval on your molecule. We'll have
Speaker Change: obviously pivotal data within that same timeframe on the on NPM-1.
Speaker Change: You need to publish that data for NPM-1. The KMT-2A data is already published so we could get into guidelines for KMT-2A upon approval, but for NPM-1, you publish that data and then you submit it to guidelines. It moves independently of approval, so you could use, you know, and the plan would be to move as quickly as we can.
Speaker Change: to get it into guidelines, and that would most likely precede approval on NPM1.
Speaker Change: Thank you.
Speaker Change: Okay, perfect. Thank you so much. Thank you.
Speaker Change: The next question is from the line of Chris Shibutani with Goldman Sachs. Your line is now open.
Speaker Change: and many more. Thank you. Thank you.
Chris Shibutani: Great, thank you very much. I think many of us are beginning to turn to 2025 and I realize that with important data readouts coming out that's a factor, but can you give us any sense early in terms of how we should be thinking about the trajectory of an initial commercialization of NIC to Invo?
Speaker Change: and what we can think about how the results from the NPM1 data may impact the level of spending that you have, particularly from the SGNA-START aspect. Thank you.
Speaker Change: Great, thanks so much, Chris. So maybe I'll turn it over to Steve to talk a little bit about the, as you say, the early launch trajectory and that question related to 2025.
Steve Closter: Yeah, so a good question. Chris, I think, you know, in terms of trajectory, I think, you know, is the market ready and is there unmet need? I think the answer is a yes. You know, we've seen a real growing market, very encouraging. If you looked at the latest sales for Resiroc, which I mentioned in my comments, it's in Trugnitz.
Speaker Change: annualizing well over 500 million dollars a year in its third year of promotion. Any of the market research we've done suggests that patients are
Speaker Change: So I'm happy with treatment, but many are dissatisfied, so we know there's a need.
Speaker Change: The second piece I'd say is just preparedness. So we've had a little extra time to get prepared. We're lucky that we're partnered with Insight. They've essentially built this market. They're in market now and calling on all the.
Speaker Change: important customers. I mentioned it's over a little under 200 transplant centers in the country. We know that 35 of them generate half of the patient volume. They're already there profiling. So it's a small targeted group. They're already there. We'll obviously add some effort and everything is in place.
Speaker Change: to pull this product through at launch. There is, we'll say, a small bolus of patients that are always looking for something new. We may see those come into the market immediately after that. And we think we've got a great molecule that's got some real compelling attributes.
Speaker Change: that we think we know will resonate with clinicians and we're ready, you know, once we were able to press go to pull through.
Speaker Change: Subs by www.zeoranger.co.uk
Speaker Change: Right, and so maybe you want to make a comment on Revumentum as well.
Speaker Change: Yes, and on Revumatum, I think we're in the same place in terms of the...
Speaker Change: the trajectory. We've had the gift of time, you know, we've had a little bit of delay, and I think what that's enabled us to do from a preparedness standpoint is be ready. The market's ready. We've been able to
Speaker Change: focus on man inhibition as a mechanism of disease, the awareness is
Speaker Change: is high. We've got a very talented team that's been put in place. They started calling the customers back in the June time frame. We've got about 2,000 accounts that we call on for Abiumetab.
Speaker Change: There's about 200 that cover two-thirds of the patient opportunity. We prioritize them. So we've taken a very talented, experienced sales team. It's got over 20 years in the space. Many of them have launched products, average is about six.
Speaker Change: They came in with pre-existing relationships, so we know a lot about our accounts and how they think about AML and ALL, where the role that K2AR will place.
Speaker Change: testing is very high. We're understanding how to pull things through and then on the payer side we've been calling in customers for
Speaker Change: well over a year. So the goal is to get on to formulary as close to approval as we can. It generally takes about nine to twelve months.
Speaker Change: with all the activity we have placed against payers. We think we can truncate that to the six to nine month frame. We've also got a really great group of specialty pharmacies and distributors in place that are the best at what they do, so they'll be able to pull through prescriptions really at launch, getting through the medical exception process.
Speaker Change: So, I think for that drug, there's not much of a bullet. Patients aren't too sick. I think I mentioned the prognosis for patients.
Speaker Change: with Relapse Refractive Acanthic to AR is about two and a half months and customers are incredibly eager for this drug to get approved.
Speaker Change: And we think, you know, once the drug is available, we'll get some immediate utilization.
Keith Goldan: And then, Chris, this is Keith. With respect to your question on SG&A spending, you know, as Steve just pointed out, we are fully built from a commercial perspective. So, you know, I think if you look back at our 3Q spending of just over $31 million,
Speaker Change: for us, G&A combined, you know, that will grow as A&P advertising and promotion costs, you know, increase when we do get approval and do launch these drugs.
Speaker Change: but I don't think, I think you can expect that not to be, you know, it'll be incremental growth, not a sharp curve up because like Steve said, this is the field force, market access.
Speaker Change: Medical Affairs, etc. is fully built out.
Speaker Change: That's helpful context. Thank you.
Speaker Change: Thank you, Chris.
Speaker Change: The next question is from the line of Kelly Shee. With Jeffries, your line is now open.
Kelly Shee: Congrats on the great progress in the quarter and for the upcoming also very eventful Q4. Firstly curious your view
Kelly Shee: on the clinical bar for CR, CRH rate for the Pivotal NPM-1 data. And also, how do we think about the correlation with OS benefit?
Speaker Change: and what is the OS benefit expectation relative to KMT2A subgroup. Thank you.
Speaker Change: Great. Well, thank you, Kelly. I appreciate your kind comments. So, in terms of the clinical bar for MPM1, I think we've been very consistent in our approach here. I think the
Speaker Change: The data for KMT2A and MPM1 so far across all different trials, monotherapy combination has looked very consistent and we are you know
Speaker Change: based on precedent you can look at 20 to 30 percent CRCRH rate as
Speaker Change: and many others. Thank you. Thank you.
Speaker Change: as you know the approvable bar as low as you know probably 20 percent could be approvable but you know I think it's in terms of
Speaker Change: what we would expect. We've shown data in that range for NPM1 even higher. Our phase one data was at 36 percent, so we feel very confident that the results will fall in that range and be very, very positive.
Speaker Change: So, you know, I think this is a, you know, there's an approval question and then there's, you know, ultimately what.
Speaker Change: where the data falls. And I think we feel very confident that we're gonna have a result that is not only consistent with what we've seen before, but hits the mark for physicians. Obviously, the higher, the better. Then in terms of your second question on OS benefit, maybe I'll ask Anjali to make a comment.
Anjali: Yeah, sure. So, Kelly, I think in the historic data analyses that have been published, we've seen with KMT2A, you know, with
Anjali: increasing lines of therapy you have shorter and shorter survival expectations getting down to between two and three months
Anjali: by the time you're you're treating a third line patient. It's similar for NPM1, but maybe the decrease isn't as steep. You know, they start off as a more favorable prognosis, but over time they will also, when they relapse, get down to
Anjali: shorter survival benefit, and I think in third line, it's something like four to five months benefit expectation.
Speaker Change: and many more. Thank you. Thank you. Thank you. Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you, Kelly.
Speaker Change: The next question is from the line of Phil Nadeau with TD Cowan. Your line is now open.
Phil Nadeau: Good afternoon. Thanks for taking our questions. Two questions from us. So first, the updated KMT-2A Augment 101 data that we saw in the abstracts today.
Speaker Change: Is that the most recent analysis that the FDA has? Is that what was submitted to the FDA and is that what the FDA is reviewing?
Speaker Change: That's first. And then, second, we noticed on your slides describing the pivotal trial in combination with Venase in the front line, there was no revumentib dose listed. Have you determined with CFT's input what that dose is likely to be? Thanks.
Speaker Change: Thank you. So, in terms of the KMT2A update, look, I think we've
Speaker Change: We tend to not comment specifically around the FDA review and what, as I said before, we described the fact that the agency had asked
Speaker Change: for additional information related to the clinical trial and they had asked for it sort of late in the cycle review which
Speaker Change: which led to the PDUFA delay of three months where now it sits at December 26th.
Speaker Change: We have not, I'm not going to, you know, confirm or deny that this is the information that they were specifically looking for. All I can say is this information is
Speaker Change: highly consistent and supportive of approval. We had made the comment that the information that was submitted was also.
Speaker Change: highly supportive of approval. And so it gives us.
Speaker Change: and I'm sure others, a lot of confidence. I mean, you're taking the data set from 57 patients and basically doubling it and getting ultimately the same results. I'll note that in the 57 patients.
Speaker Change: that were followed for additional seven months. You had an extension of the 13 months on the duration, the median duration of response. So some encouraging signs, of course.
Speaker Change: but this is very robust data that I know investors and others were interested in seeing and so we are keen to to provide an update there but you know the agency has access to all of our information and so you know
Speaker Change: again, not confirming or denying, but feeling quite confident that the information here is very supportive. And then in terms of the pivotal trial, maybe I'll turn it over to Neil. We can make a comment on it. Yeah, go ahead. Yeah, sure.
Neil Gallagher: So Phil, thanks for the question. As I mentioned a little earlier, the health authority approvals are currently in process. In fact, several of the submissions have been made, or submissions have been made in several countries, and we're initiating the study on 160 milligrams.
Speaker Change: That's very helpful. Thank you.
Phil Nadeau: You're welcome. Thank you.
Speaker Change: The next question is from Michael Schmidt with Guggenheim. Your line is now open.
Michael Schmidt: Hey guys, thanks for taking our questions. Two from us, just on the KMT2A data, on the 13-month duration of response that you've disclosed today in the ASH-ASTRAC in Auckland 101.
Neil Gallagher: Would you expect a similar duration in NP1-treated patients once you have longer follow-up from that cohort?
Neil Gallagher: And then...
Neil Gallagher: You know, as we think about the menin inhibitor competitive landscape, there's been greater focus recently on differences in drug product characteristics.
Neil Gallagher: As investors are looking to project how combinable the different agents are, particularly on PK or drug explosion metabolism. And as we continue to look at the emerging combo data at ASH, are there any learnings you can highlight where you feel confident about potential advantages for repumatib over others in the field? Thanks so much.
Speaker Change: Okay, so thank you Michael, appreciate it. So in terms of duration of response, you know, we did note, I did note the 13 months.
Neil Gallagher: extension on the follow up there. I think, you know, I think the that is, you know, I think an interesting result, important result, I think the follow up has the capacity to sometimes extend duration, especially when the upper bound hasn't been reached.
Neil Gallagher: and you are taking a certain cut in time. So can't really comment too much on the NPM1 data and what that's going to look like at this stage. Obviously we don't know the data. So I think
Neil Gallagher: We'll have to see just what what that looks like at the time, but
Neil Gallagher: Yeah, certainly encouraging around the KMT2A and
Neil Gallagher: Patients who got transplant, I'll say, tends to help extend time on therapy and ultimately could impact the duration. So there may be some differences there between KMT2A, the number of patients.
Neil Gallagher: who have KMT2A and go to transplant versus patients who have MPM1. So, you know, we'll see what that looks like. I can't really speculate at this point.
Neil Gallagher: And then your second question about some of the combination data and the differences between the molecules and obviously the ash abstracts came out today.
Neil Gallagher: You know, it's...
Neil Gallagher: Perhaps we can draw some conclusions. I think it's a little bit early. You'll have to see some of the follow-up at ASH, right, in terms of the overall presentations.
Neil Gallagher: I think what we can say about our own data, specifically the saved data, is that it's
Neil Gallagher: highly encouraging of what we're seeing. These are essentially fourth-line patients.
Neil Gallagher: who have had lots of stem cell transplant and prior venetoclax.
Neil Gallagher: and to see, you know, extremely high rate of overall response, but even in CRC, CRCRH.
Neil Gallagher: 58%.
Neil Gallagher: We're seeing, you know, very good tolerability, very good duration. So far, patients are being followed for more than six months and staying on drug, the vast majority. So this is a highly well, you know, very well tolerated efficacious regimen. Now in 26 patients, whereas you saw.
Neil Gallagher: the last data cut or the last update or first update, I should say, was at ASH last year. So, highly encouraging. Again, very heavily pretreated patients.
Neil Gallagher: We hope to have an update at our investor event on the BEAT AML trial at ASH. And that will be an extended data set, as Neil pointed out earlier. But we've seen excellent safety, tolerability, and efficacy adding to the doublet in the frontline patients as well.
Neil Gallagher: So, you know, I think our profile is really, really showing itself to be, you know, distinguished among what others are seeing in their trials. Again, we're furthest advanced, both in relapse refractory as well as in frontline setting, specifically around the VenAZA combos.
Speaker Change: Thanks, really appreciate it.
Michael Schmidt: Thank you, Michael.
Speaker Change: and many more. Thank you. Thank you.
Speaker Change: The next question comes from Jagal Nojomovic with Citi. Your line is now open.
Speaker Change: Hi guys, this is Asher Khan for EGAL. Thanks for taking my questions and congrats on all the the updates here I just wanted to ask a follow-up on the on the maintenance setting questions asked earlier for ReadyManEd
Neil Gallagher: I guess, you know, for the Augment 101 KMT2A cohort, it was 9 out of 21 patients that got maintenance therapy, but 3 out of 12 in SAVE.
Neil Gallagher: in terms of whether or not they could use readymanib in a maintenance setting. And I'm also just curious, to what degree are you aware of how physicians are sort of deciding when to use readymanib in a maintenance setting and what sort of decision matrices there are in place today? Thanks.
Speaker Change: Yeah, thanks you all. I think this is a work in progress. As I said before, I think maintenance is a very interesting concept. We're talking about relapsed refractory patients who have had a lot of prior treatment.
Neil Gallagher: stem cell transplants, often more than one, venetoclax as well. So there's some fragility to their treatment. And so I think the physicians are thinking about this.
Neil Gallagher: and it's sort of on a case-by-case basis. There's nothing in the protocol, in these two protocols, that prevent them from getting maintenance. It's just up to the physician as to whether they initiate maintenance and how long they keep them on maintenance. So, as I said earlier, I think it's...
Neil Gallagher: Over time, this will play out, and physicians, as they gain experience, they'll learn how best to administer it, how long they'll keep patients on. And as you've seen, it's very encouraging to see sometimes up to half the patients are more getting maintenance, and it will differ from these early trials. But ultimately, we're in very good shape.
Speaker Change: Yeah, just one thing to add is that just to remind everyone that we've seen, you know, patients staying on for a very extended period of time. So we've seen patients staying on for
Neil Gallagher: you know, three years or more.
Speaker Change: So we know, and physicians know that as well, I'm not going to reiterate what Michael said, it is a, you know, it's a complex paradigm that, or a complex thinking that goes into the decision to transplant the patient. But physicians are aware that the drug is well tolerated as a monotherapy in the post-transplant maintenance setting for prolonged periods of time.
Neil Gallagher: And, you know, we've heard many of them speak publicly about their willingness to actually use this as a treatment paradigm, recognizing the tolerability of the drug in that setting.
Speaker Change: Got it, and I forgot to ask one more.
Speaker Change: One more. Yeah, sorry. One more quick clarifying question. On the front line recommended post-Beneza study, it looks like the primary endpoint is overall survival in just the NPM1 population. But it looks like you're enrolling both NPM1 and KMT2A. So I'm wondering why just the focus on NPM1. Is that related to more population dynamics or something else? Thanks.
Speaker Change: Yeah, I'll take that one. So, thanks for the question. So, yes, that is correct. The study, I think I mentioned as well in the script, the study is actually powered by the NTM1 population.
Speaker Change: You know, I think I also mentioned in the script, this population, so think about the population that
Speaker Change: that will go into the study. These are older patients who are not suitable for intensive chemotherapy.
Neil Gallagher: and therefore the predominant mutation in that population is actually NPM1.
Neil Gallagher: If you look for instance, we expect the median age of that population to be somewhere around 65 or older.
Neil Gallagher: maybe around 65, right? So if you look at the median age in our KMT population for instance from Augment 101, the median age is 35.
Neil Gallagher: in the updated analysis that we just talked about, the abstract of which was published today. So KM22A is more prevalent in the younger population, NPM1 is more prevalent overall and more prevalent than KM22A in the older population.
Neil Gallagher: that came to 2A is quite rare in the older population, include some of those patients as well. That's why it's designed the way it is. Does that make sense? Yep, makes a lot of sense. Thanks very much and congrats again.
Neil Gallagher: Thanks a lot. Thanks, Jake.
Speaker Change: The next question is from Jason Zmanski with Bank of America. Your line is now open.
Jason Zmanski: Thank you. Good evening. Congrats on the quarter and thanks for taking our question, as well as the additional color on Ash. Maybe two quick ones from me. For NPM1,
Jason Zmanski: One efficiency range or efficacy range, you know, certainly you mentioned for physicians higher the better But is that 20% floor you mentioned necessary for approval? Does that still apply or is that higher? Thanks
Neil Gallagher: and many more. Thank you. Thank you.
Speaker Change: Yeah, Jason, thanks for the question. So first of all,
Neil Gallagher: for NPM1 in terms of breakthrough therapy designation. Yeah, we had
Neil Gallagher: In the phase one, we had 14 patients that were at the RP2D, which I think we have been very clear, it basically falls short of what's required.
Neil Gallagher: for submission for Breakthrough.
Neil Gallagher: We didn't have the applicable data for that designation, so we had not applied at the time.
Neil Gallagher: decide, obviously, once the data is available, that it's a good idea to apply for breakthrough at that point. If it helps us in our submission, then we could always apply for it. It's very important to have, for your first indication, which we, of course, had, which led to Artur and other things that advantaged us with KMQA, having breakthrough for your second indication is less impactful. So, again, just to be clear, we didn't apply for it. It didn't, we didn't have the, you know, the data from the phase one at the right dose.
Neil Gallagher: in order to substantiate that you need at least 20 patients' worth of data. So that that's how that came that came about. So no, we did not apply for it. And then your second question...
Jason Zmanski: I know you're focused on the 20% hurdle for MPM1. I think, as I said before, the precedent here, again, these therapies and AML, 20% or higher, CRC or HRA, duration of response in the four to six-month range, those are general parameters that we see other drugs get approved by, and that's just historical precedent.
Jason Zmanski: From our standpoint, having a CR-CRH rate north of 20% would be a good result because it would likely result in a statistically significant trial.
Neil Gallagher: and that would be seen as approvable and impactful for patients. I think the, when I said the higher the better, it would be, you know, obviously nice to see a point estimate that's higher than that, but not necessarily, you know, mandatory. So, I think we're feeling quite good. We've seen data in phase one, as I pointed out, highest in category, 36%, the RP2D. So, we have no reason to believe that we're going to fall short. We feel very confident and we've talked about the fact that.
Neil Gallagher: There's differences between KMT2A and MPM1 in terms of transplant rate and how that impacts, potentially impacts the CRCRH rate, which, you know, could be favorable in this regard relative to what we've seen for KMT2A. So we feel very good, and we'll see the data soon, so thank you.
Speaker Change: Great, thanks.
Speaker Change: The next question is from George Farmer with Scotiabank. Your line is now open.
Speaker Change: and many more. Thank you. Thank you.
George Farmer: Hi, good afternoon. Thanks for taking my questions.
George Farmer: Really appreciate your decision to disclose the additional KM2TA2A data. Question on this 6.4 month duration that you showed in 97 patients with the February cutoff. Are you going to be showing anything more mature than that and is it possible that we could see something closer to the 13 months that you reported from the first 57 patients?
Speaker Change: Yeah, thanks, George.
Speaker Change: I wouldn't anticipate we're going to update the data set again. I think we have...
Speaker Change: and approval coming, and we have NPM1 data to focus on. It obviously takes a lot of work to continue to interrogate a data set, and I think
Neil Gallagher: We're very keen to kind of get this drug approved and obviously real world we'll get a chance to see what it how it performs
Neil Gallagher: relative to all of these measures, whether it's, you know, patients staying on drug, maintenance, what have you. And so I think
Neil Gallagher: The 6.4 seems very consistent, obviously. The 13-month extension on the 57 was an encouraging result. I think, as I mentioned before, kind of lets us believe, or potentially believe that there's a...
Neil Gallagher: a longer duration possible with follow-up and, you know, it was a point in time. So, I just, you know, at this point, we're not having, we don't have any plans to update the data set beyond what we've already provided.
Speaker Change: Okay, and then the HOVAN trial, when do you anticipate that concluding and to be reporting on data? Maybe I missed that in your primary comments.
Neil Gallagher: and many more. Thank you. Thank you.
Speaker Change: Yeah, I think we haven't given any specific timeline to, you know, to, you know, conclude that. I think there's some general parameters of trials that are similar, like VIALA-A, that was, you know, roughly a four-year trial or something in that range. And this is an OS-driven endpoint, so it'll take time to to read out. But at the end of the day, that's, you know, we haven't provided a specific timeline to, you know, to, to, you know, complete the trial just yet. We need to get it started. We'll get it started at the end of the year, and then we'll give, you know, more guidance as we go.
Speaker Change: Okay and then one more if you don't mind. With the Royalty Pharma deal, were they looking at the potential of Nick Timbo in IPF by any chance when they were contemplating the terms?
Speaker Change: Yeah, so we're very excited about Royalty Pharma's, you know, partnership with us and how they really looked at the opportunity for the drug over many years, not just in GVHD, but potentially beyond that.
Speaker Change: I'll note that there is a cap on the transaction, in other words, we're paying them back.
Neil Gallagher: supports and the drug forecast will support that. And then some, we believe that they looked at all of the indications and the potential indications both in GBHD, relapsed refractory frontline, as well as the extensions, IPF included.
Speaker Change: to arrive at a
Speaker Change: forecast that supported the deal on their end. And it aligned very closely with what we believe, right, and really quite a robust forecast, which is different, of course, than what
Speaker Change: the market has believed up to this point. So we feel that the partnership is well aligned and the value that we were able to attain in this deal for Syndax is...
Speaker Change: quite helpful in support of long-term of our objectives.
Speaker Change: Okay, good. Thanks very much.
Speaker Change: Thank you.
Speaker Change: The next question is from Kalpit Patel with B Riley Securities. Your line is now open.
Kalpit Patel: Yeah, hey, good afternoon, and thanks for taking the question. Just one more follow-up on that overall survival endpoint in the frontline triplet trial. I guess I understand the rationale for just including NPM1 patients in that analysis, but is there a minimum efficacy threshold that you need for the KMP2AR patients to make sure that they will be included on the label, or do you just need to hit the primary endpoint for NPM1 patients?
Speaker Change: Yeah, thanks for the question. So, as I mentioned, the study is designed to test the hypothesis in NPM1 patients.
Neil Gallagher: So the statistical power is designed around that number. The approximate number of patients that have been disclosed publicly includes a certain amount of KN228 patients.
Neil Gallagher: We will be looking for consistency of effect in the KM228 patients, but the study is not designed to test a statistical hypothesis in those patients.
Neil Gallagher: and many more. Thank you. Thank you.
Neil Gallagher: comment on what may what may happen from a regulatory perspective down the road but the primary the primary objective or the primary reasons for conducting the study is to have the drug approved in combination with an ASA for NPM1 patients
Speaker Change: Okay, got it. And then at ASH, I guess what sort of additional analysis should we expect for the...
Neil Gallagher: KMP2AR patients from the Pivotal cohort, if any, anything at all.
Neil Gallagher: I think a lot of investors have been wondering what the efficacy analysis is like for patients based on the number of priors and the types of priors and just looking at a baseline demographic. Thank you.
Speaker Change: Yeah, go ahead Neil, why don't you? Yeah, look, we...
Speaker Change: We've been pretty busy. We're focused on getting the abstract in as it stands. You can expect to see additional analyses, additional data presented at ASH, but we haven't been specific about exactly what those details are. But you can expect to see more detail around it at the ASH presentation.
Speaker Change: Sorry, I can't be more specific. Okay.
Speaker Change: You got it. Thank you very much. Thanks, Scott. Thank you.
Speaker Change: The next question comes from Justin Veland with BTIG. Your line is now open.
Justin Veland: Thanks for taking our question and congrats on the progress. So on the revimentib filing, I understand that patients are regularly tested for KMT2A status, but do you expect you'll need a companion diagnostic for approval?
Speaker Change: and many more. Thank you. Thank you.
Speaker Change: Yeah, thanks, Justin, for the for the question.
Speaker Change: No, I don't. I think, look, we haven't really gotten into...
Neil Gallagher: discussion about what will be necessary for regulatory approval, but there is precedent for companion diagnostic post-approval. So I think at this point, we feel very confident that we'll be able to get the drug approved, and that there may be a requirement down the line for a companion diagnostic, but there is, for KN-T2A, there are some existing diagnostics available that make testing available and robust. So at this stage.
Neil Gallagher: A little bit more to say post-approval, but I think at this point we have all the confidence that we're on track to To get the drug approved and we'll follow up to that
Speaker Change: Great. Thanks for taking our question.
Speaker Change: Thank you.
Speaker Change: This concludes our question and answer session. I'll now turn the floor over to Mr. Michael Metzger for any additional comments or closing remarks.
Michael Metzger: Thank you, Operator, and thank you all. We appreciate you tuning in today to discuss our recent progress and the transformative milestones that we have ahead. We look forward to seeing many of you at the upcoming Guggenheim, UBS, Stiefel, and Jeffries conferences in November, as well as our ASH event in December. And with that, have a great evening.