Syndax Prescribed drugs, Inc. (SNDX) Q2 2024 Earnings Name Transcript

Syndax Prescribed drugs, Inc. (NASDAQ:SNDX) Q2 2024 Earnings Convention Name August 1, 2024 4:30 PM ET

Firm Members

Sharon Klahre – Head, IR
Michael Metzger – CEO
Steve Closter – Chief Business Officer
Keith Goldan – CFO
Neil Gallagher – President, Head of Analysis and Growth

Convention Name Members

Malcolm Kuno – JPMorgan
Kevin Sterling – Goldman Sachs
Ernie Rodriguez – TD Cowen
Brad Canino – Stifel
Michael Schmidt – Guggenheim
Ashiq Mubarack – Citi
Kalpit Patel – B. Riley
Justin Zelin – BTIG
Cameron Bozdog – Financial institution of America

Operator

Good day, everybody, and welcome to the Syndax Second Quarter 2024 Earnings Convention Name. At this time’s name is being recorded. [Operator Instructions]

Right now, I want to flip the decision over to Sharon Klahre, Head of Investor Relations at Syndax Prescribed drugs.

Sharon Klahre

Thanks, operator. Welcome, and thanks all for becoming a member of us at the moment for a overview of Syndax’s second quarter 2024 monetary and working outcomes. I am Sharon Klahre, and with me this afternoon to offer an replace on the corporate’s progress and talk about monetary outcomes are Michael Metzger, Chief Government Officer; Dr. Neil Gallagher, President and Head of R&D; Steve Closter, Chief Business Officer; and Keith Goldan, Chief Monetary Officer. Additionally becoming a member of us on the decision at the moment for the question-and-answer session are Dr. Peter Ordentlich, Chief Scientific Officer; and Dr. Anjali Ganguli, Chief Enterprise Officer.

This name is accompanied by a slide deck that has been posted on the Investor web page of the corporate’s web site. Now you can flip to our forward-looking statements on Slide 2. Earlier than we start, I want to remind you that any statements made through the name that aren’t historic are thought-about to be forward-looking statements inside the which means of the Non-public Securities Litigation Reform Act of 1995.

Precise outcomes could differ materially from these indicated by these statements because of varied necessary elements, together with these mentioned within the threat elements part within the firm’s most up-to-date quarterly studies on Kind 10-Q in addition to different studies filed with the SEC. Any forward-looking statements made symbolize our views as of at the moment, August 1st, 2024, solely. A replay of this name will likely be obtainable on the corporate’s web site, www.syndax.com, following its completion.

With that, I am happy to show the decision over to Michael Metzger, Chief Government Officer of Syndax.

Michael Metzger

Thanks, Sharon. Good afternoon, everybody, and thanks for becoming a member of us at the moment.

Beginning with Slide 3. This can be a very thrilling yr for Syndax. We stand on the cusp of changing into a business stage firm with the anticipated upcoming FDA approvals of Revumenib and Axatilimab, new first-in-class therapies for ailments with excessive unmet medical wants.

I am happy to report that we’ve achieved a number of medical milestones within the second quarter that assist our strategic priorities. In June, we offered up to date optimistic Revumenib mixture knowledge from the BEAT AML and AUGMENT-102 trials on the European Hematology Affiliation, or EHA Congress. These knowledge, which Neil will overview shortly, proceed to assist Revumenib’s potential to boost present commonplace of care brokers.

At EHA, we additionally offered extra optimistic knowledge from the AGAVE-201 pivotal trial evaluating Axatilimab in sufferers with refractory continual graft versus host illness or GVHD. Reinforcing the earlier organ response knowledge that we had shared, this newest knowledge set reveals that responses had been famous in all fibrosis-dominant organs that had medical exercise supported by clinician reported and affected person reported modifications in organ particular signs resembling enhancements in swallowing, shortness of breath, pores and skin and joints, and sclerotic pores and skin.

Trying forward, we’re on monitor for a historic yr with the anticipated FDA approval of Revumenib and Axatilimab coming quickly with Axatilimab, our anti CSF-1 antibody for sufferers with continual GVHD, we’ve a PDUFA motion date of August twenty eighth 2024 and anticipate launching within the fourth quarter of this yr with our accomplice Incyte.

With Revumenib, our menin inhibitor being reviewed by the FDA for sufferers with relapse or refractory KMT2A-rearranged acute leukemias, we’ve a PDUFA motion date of December 26, 2024. As we introduced earlier this week, the FDA not too long ago prolonged PDUFA motion date for Revumenib NDA from September 26 to December 26, 2024, an ordinary three month extension to permit for added time to conduct a full overview of supplemental data we offered in response to their requests.

Importantly, we’re assured that the knowledge we’ve offered helps approval and continues to show the significant profit Revumenib brings to sufferers. We look ahead to persevering with to intently interact with the FDA as they full the overview beneath the real-time Oncology Evaluation Program, or RTOR, and we stand able to launch Revumenib with power as quickly as we obtain the anticipated approval.

Later within the name, Steve will present some extra coloration on our preparations for these two anticipated launches. We even have a number of different significant milestones approaching, such because the anticipated readout of pivotal prime line Revumenib knowledge in relapsed or refractory and NPM1 AML within the fourth quarter, which might function the premise for a supplemental NDA submitting within the first half of 2025. Moreover, we count on to make additional progress advancing our medical trials of Revumenib and Axatilimab which might be underway or plan to provoke within the coming months.

Constructive outcomes might assist the long run use of those brokers together with standard-of-care medicines earlier in a affected person’s therapy and thereby broaden their utility considerably. We’re in a powerful monetary place with $455 million in money as of June thirtieth that we count on will present ample capital by means of 2026. Our present stability sheet not solely helps our deliberate business launches and medical trials, but additionally units us as much as broaden past our first registration indications and to pursue early stage enterprise improvement alternatives.

I’ll now ask Neil to overview a few of our latest knowledge shows and pipeline. Neil?

Neil Gallagher

Thanks Michael.

Turning to Slide 4, in Revumenib, we’ve a strong medical improvement technique underway that may assist the usage of Revumenib in KMT2A-rearranged and mutant NPM1 acute leukemias throughout the therapy paradigm. The event plan extends past the preliminary relapsed or refractory indications with trials of Revumenib together with requirements of care that probably assist use of the frontline relapse, refractory and post-transplant upkeep settings.

On the following two slides, I’ll briefly overview the information not too long ago offered at EHA from the 2 mixture trials that you just see listed BEAT AML and AUGMENT-102. On Slide 5, at EHA in June, we and our collaborators on the Leukemia Lymphoma Society offered up to date knowledge from the BEAT AML trial of revumenib together with venetoclax, azacitidine or Ven/Aza in sufferers newly recognized with mutant NPM1 or KMT2A-rearranged AML.

This up to date knowledge set with a lower off of the first of Could 2024, contains 24 efficacy of worthwhile sufferers, 96% of sufferers had a composite full response for CRc and 92% had no residual illness and had been due to this fact MRD-negative.

As in all the mix trials performed thus far, two doses of revumenib are being investigated, 113 milligrams and 163 milligrams administered each 12 hours. The dose limiting toxicity or DLT window for every was cleared final yr on this trial, and each cohorts are at present being expanded to be able to determine the dose for Section 3 improvement.

The mixture is effectively tolerated and the protection profile reported at EHA is in line with what has been beforehand reported. Of observe, the charges of opposed occasions related to the mix of Revumenib with Ven/Aza noticed within the research are in line with knowledge for Ven/Aza from historic controls. For instance, the addition of Revumenib to the doublet doesn’t seem to exacerbate the modest related to Ven/Aza alone.

Moreover, the BEAT AML investigators concluded that the information means that adjusting the dose of venetoclax whereas sustaining the dose of Revumenib often is the most reasonable technique for future improvement. As we beforehand communicated, we intend to provoke a pivotal trial with this triplet mixture in newly recognized sufferers by yr finish.

Turning to Slide 6, at EHA, we additionally offered up to date knowledge from the AUGMENT-102 trial of Revumenib together with fludarabine/cytarabine or FLA in a predominantly pediatric inhabitants with relapsed refractory mutant NPM1, NUP98-rearranged or KMT2A-rearranged AML.

As of the date of cutoff of fifteenth of January 2024, 27 sufferers obtained FLA plus Revumenib at 113 milligrams or 163 milligrams. Sufferers included within the trial had been closely pretreated, with a median of three prior strains of remedy 67% had prior FLA containing regimens 52% of sufferers achieved composite full remission or CRc. The MRD detrimental charge amongst CRc sufferers was 71%. Moreover, seven sufferers, or 50% of responders, proceeded to transplant as soon as that they had entered remission.

As with the Ven/Aza triplet we simply mentioned, Revumenib doesn’t seem to change the tolerability profile of the usual of care routine. These two up to date knowledge units offered at EHA present additional assist for combining Revumenib with totally different requirements of care within the newly recognized in addition to relapsed or refractory settings.

Turning to Slide 7, in March, we accomplished enrollment within the pivotal cohort of the AUGMENT-101 trial with the enrollment of 64 adults and as much as 20 pediatric relapsed refractory NPM1 mutant AML sufferers. We’re on monitor — our acute leukemia sufferers. We’re on monitor to report knowledge within the fourth quarter.

On this slide, you’ll be able to see the outcomes from 14 mutant NPM1 sufferers within the Section 1 portion of AUGMENT-101, which confirmed that fifty% of sufferers achieved a response and 36% achieved a whole remission or CR, with partial hematological restoration.

Notably, all sufferers with a CRh had been MRD detrimental, in line with the KMT2A inhabitants Revumenib additionally enabled sufferers in remission to proceed to transplant with sturdy responses, regardless of most of the sufferers having failed prior venetoclax remedy and stem cell transplant. These knowledge additionally point out that Revumenib is effectively tolerated in sufferers with mutant NPM1 with an total security profile that’s in line with what has been beforehand reported within the KMT2A-rearranged inhabitants.

Earlier than I hand over to Steve, I might like to offer a fast overview on Slide 8, of the preparations we have made on the medical facet of the group to assist the upcoming anticipated launches. We have constructed a extremely skilled Medical Affairs workforce that’s driving deep scientific engagement and strong proof technology.

As you’ve got seen from our participation in ASH and EHA, in addition to varied papers and prime tier journals resembling Nature. We now have an formidable convention and publication plan underway to extend consciousness of the compelling knowledge from our two brokers. We additionally proceed to organize for future NCCN pointers submissions for Revumenib that we anticipate will embody the prescribing data in addition to peer reviewed publications and congress shows.

Of observe, as soon as the top-line knowledge in mutant NPM1 AML can be found, we plan to publish as quickly because it’s possible to assist potential guideline inclusion following the approval of Revumenib in KMT2A. Moreover, we’ve a workforce of seasoned medical science liaisons within the area. They’ve made large progress driving scientific change with physicians at main facilities of excellence throughout the nation. We have additionally constructed a well being economics and actual world proof workforce centered on supporting the worth of our portfolio, and we proceed to extend engagement with affected person advocacy teams.

With that, I will now flip over to Steve to speak about our business launch plans and the market alternatives. Steve?

Steve Closter

Thanks Neil, and due to everybody, for becoming a member of us at the moment. Actually respect it.

It is actually a pleasure to be with you to speak in regards to the intensive preparations we’re making to place Syndax because the main business stage group serving sufferers and healthcare suppliers. We’re effectively ready to execute on the thrilling alternatives in entrance of us.

Turning to Revumenib preparations on Slide 8, our objective merely is a powerful launch and we’re able to hit the bottom working with Revumenib as quickly as we obtain the anticipated approval from FDA. We have employed and educated a gross sales workforce with intensive expertise and pre-existing relationships within the hematology oncology area and a demonstrated monitor document of success. This workforce is within the area proper now profiling accounts and understanding the affected person therapy journey so we will meet the wants of the totally different stakeholders concerned of their care.

This strong pre-launch preparation will allow us to quickly start assembly affected person wants upon the anticipated approval. Our buyer going through workforce has a median of twenty-two years of expertise, primarily in hematology, oncology and a median of six product launches every. With an environment friendly area drive footprint within the vary of 30 to 50 people. We imagine that we will successfully attain the related educational and neighborhood primarily based facilities and meet the wants of physicians and sufferers.

We plan to name in roughly 2,000 facilities, with roughly 200 of these accounts representing greater than two-thirds of the chance enabling a concentrated effort. With our plan, we imagine we should always attain facilities the place 98% or extra of potential relapse refractory KMT2Ar sufferers obtain therapy.

Now one other necessary factor we have performed in preparation for the launch is develop superior knowledge mining capabilities to appropriately determine sufferers in want. As a result of these are excessive threat sufferers that require fast identification of the therapy choices, we have developed capabilities that may assist us provoke very focused doctor engagement primarily based on the place our instruments point out there are applicable sufferers.

Now, with respect to market entry, we constructed an achieved workforce, with intensive expertise working with payers and different commerce companions to facilitate entry to new merchandise. Along with the Medical Affairs workforce, our payers area workforce continues their pre-approval data change work with payers, and we’re on monitor to succeed in plans overlaying greater than 90% of all coated lives, each business and Half D, previous to the anticipated approval.

Payers inform us that they acknowledge the unmet wants and respect the worth that Revumenib offers. We imagine plans will make their formulary choices inside 6 months to 12 months of approval, and we’ll work with them to expedite the overview when doable.

Importantly, given the pressing affected person want, we count on that plans will present sufferers entry to the product at launch by means of the medical exception course of. The assist suppliers and sufferers we have partnered with main best-in-class specialty pharmacies who’re effectively acknowledged for his or her capability to assist suppliers and sufferers navigate entry to new oncology medicines.

By means of a community of specialty pharmacies and specialty distributors. We’re ready to have product and channel in a short time, proper after we obtain approval. We’re additionally able to launch a devoted affected person assist program that may present a stage of assist on par with what you see from main oncology corporations.

Flip to Slide 9 and the market alternative. KMT2Ar and NPM1 acute leukemias symbolize as much as 40% of all AML sufferers. There aren’t any FDA accepted focused therapies for this inhabitants. We imagine relapse or refractory KMT2Ar acute leukemia alone represents a complete addressable market alternative of roughly $750 million within the U.S. The annual incidence of KMT2Ar acute leukemia is about 2,600 sufferers, with the vast majority of these sufferers about 2,000 experiencing relapsed or refractory illness.

We estimate a median period of remedy throughout the handled inhabitants of roughly 9 months, and we imagine the medical knowledge helps pricing competitively to different focused therapies in AML, resembling FLT3 or IDH inhibitors. Physicians we have spoken with point out an eagerness to prescribe Revumenib early throughout an eligible affected person’s therapy journey, to deliver extra sufferers to transplant, after which prolong responses by persevering with with Revumenib monotherapy following transplant engraftment.

We count on that our first mover benefit and the early expertise physicians will achieve treating sufferers with Revumenib will likely be vitally necessary to the long run success of our manufacturers. Our vital market share is more likely to prolong meaningfully past kMT2Ar, particularly as we would be the first to ship significant, pivotal knowledge and different indications resembling NPM1 AML.

We estimate that the 2 distinct market segments in acute leukemias, KMT2Ar and NPM1 equal a mixed accessible inhabitants of 5,000 to 6500 sufferers within the relapse or refractory setting and an addressable market alternative that approaches $2 billion within the U.S.

Through the varied conferences that I’ve had the prospect to take part in with clinicians, from advisory boards to area visits and extra, I’ve seen large pleasure and assist for Revumenib, making a momentum that I look ahead to constructing on by means of our dedication to delivering an best possible in school expertise for healthcare suppliers and sufferers.

Transferring to Axatilimab on Slide 10. The anticipated commercialization of Axatilimab will likely be led by the Incyte workforce and can profit from the deep expertise and longstanding relationships that they’ve established by means of their work constructing the GVHD market with Jakafi.

We’ll present 30% of the gross sales effort, leveraging our personal area drive that we anticipate will carry two merchandise with extremely overlapping name factors, pave the best way for a profitable launch Incyte is constant to drive engagement with payers and lift consciousness of the distinct pathway that Axatilimab targets and the compelling outcomes noticed within the AGAVE-201 trial, which we not too long ago detailed on the 2023 ASH Congress.

Turning to Slide 11, we estimate there are roughly 17,000 sufferers on therapy for continual GVHD at anyone time, the vast majority of whom are refractory and cycle by means of therapies for higher symptom management as their illness progresses. We imagine there are roughly 6500 sufferers progressing to later strains of therapy after two earlier strains of therapy, which might be our goal inhabitants for our first indication and represents a pretty preliminary alternative.

As an example, within the three years because the launch of Rezurock, one other drug with a 3rd line indication, internet gross sales proceed to develop they usually’re annualizing at practically $500 million. We estimate that the entire addressable marketplace for third line therapy within the U.S. is between $1.5 billion to $2 billion, which assumes that sufferers will stay on remedy for over 12 months and assuming Axatilimab is priced at a premium to accepted brokers for continual GVHD primarily based on its product profile and Half D reimbursement. Past the third line setting, we plan to review Axatilimab in earlier line settings for continual GVHD and different ailments the place we imagine its anti-fibrotic and anti inflammatory mechanism is related, resembling IPF, which represents a big alternative.

I will now flip the decision over to Keith to overview our monetary outcomes.

Keith Goldan

Thanks, Steve.

Turning to Slide 12, as Michael talked about earlier, the $455 million in money equivalents and quick and long run investments on our stability sheet as of June thirtieth is predicted to offer runway by means of 2026. Our monetary power permits us to fund the anticipated commercialization of two medicine and appropriately make investments to proceed to understand the worth of our pipeline.

Turning to the earnings assertion, working bills within the second quarter was $77.7 million and included $48.7 million of analysis and improvement expense and $29.1 million of promoting, normal and administrative expense. I might like to offer monetary steerage for the third quarter and full yr 2024.

For the third quarter, the corporate expects analysis and improvement expense to be $70 million to $75 million and complete working bills to be $105 million to $110 million. For the total yr of 2024, there isn’t a change to the prevailing steerage and the corporate expects analysis and improvement bills to be $240 million to $260 million and complete working bills to be between $355 million to $375 million. Please observe that the steerage vary for working bills for the total yr contains an estimated $43 million of non-cash inventory compensation expense and that analysis and improvement expense steerage contains any milestones owed to our companions on potential drug approvals.

Forward of the upcoming launch of Axatilimab, I need to briefly overview how we are going to acknowledge income for that accomplice and product. Slide 13 offers an illustrative instance of accounting for gross sales of Axatilimab and isn’t meant to offer any margin or some other steerage.

We are going to document 50% of the business revenue outlined as internet product income minus the price of gross sales and business bills. Through the interval the place there’s internet business revenue for Axatilimab, as within the prime instance of the slide, our 50% share of the online revenue will likely be acknowledged beneath P&L as collaboration income.

Through the interval the place there’s a internet business loss for Axatilimab, as within the instance on the underside of the slide, our 50% share of the online business loss could be included in working bills designated as a separate line merchandise referred to as share of collaboration loss. The milestone income from varied world business and regulatory milestones that we obtain from Incyte, will likely be recorded as milestone income on our earnings assertion.

As a reminder, analysis and improvement bills beneath our partnership, together with regulatory and CMC bills, shared 55/45 within the U.S., and our 45% share is included within the earnings assertion as a part of our R&D expense. Outdoors of america, Incyte is liable for 100% of the event and regulatory bills and we’re entitled to obtain milestones plus a double-digit royalty on ex- U.S. gross sales.

With that, let me flip the decision again over to Michael.

Michael Metzger

Thanks, Keith.

As you heard throughout our name, we’ve made large progress over the previous few months and are well-prepared for the transformational interval forward of us with the anticipated FDA approval and launch of our first two medicines. With the momentum we’ve constructed and our strong medical improvement technique designed to discover the total potential of Revumenib and Axatilimab, we’re excited in regards to the path forward and the chance we’ve to make a significant affect for sufferers.

On Slide 14, you’ll be able to see a recap of our upcoming anticipated milestones that we imagine we are going to proceed to gas our momentum and drive worth. As all the time, I need to specific my gratitude to the Syndax workforce and our companions for his or her laborious work and dedication to our mission.

Most significantly, I need to thank all the sufferers, households, trial websites and investigators who’ve participated in our trials and encourage us with their tenacity and dedication to discovering new methods to enhance the lives of sufferers with most cancers. I might additionally prefer to thank our dedicated long run traders who proceed to share in our imaginative and prescient and assist our work constructing Syndax.

With that, I want to open the decision for questions. Operator.

Query-and-Reply Session

Operator

[Operator Instructions] Our first query comes from Anupam Rama from JPMorgan. Your line is open, be at liberty to unmute.

Malcolm Kuno

Hello, thanks for taking the query. That is truly Malcolm Kuno on for Anupam. Are you able to remind us of the scale and scope of the sphere drive? After which what kind of medical schooling efforts will you will have ongoing forward of Axatilimab, Revumenib approval?

Michael Metzger

Thanks for the query, Malcolm. Let me flip it over to Steve to deal with it.

Steve Closter

Sure, thanks, Malcolm, for the query. When it comes to dimension, I believe my feedback within the opening was roughly 30 to 50. Sorry for the big selection. We’ve not given a precise quantity, however it’s ample to cowl the viewers. We have overlapping area groups. I imply, it is a complicated therapy journey for sufferers. They have therapy facilities which have physicians and nursing workers and lab and pathology and formulary. So we have got totally different buyer going through groups to cowl that, will cowl, I believe I might mentioned, 98% of the chance. So it is in place. The sector workforce is activating.

I believe your different query was round schooling and what are we doing. I might say, for the sphere proper now, as a company, we’re actually making an attempt to do two issues. One in all them is profiling accounts. I discussed the complicated therapy journey. We need to perceive for any given establishment that we name on how they do enterprise, how they see sufferers, how they’re handled, there is a ton for us to study from understanding how they take a look at for KMT2Ar. How these sufferers get highlighted for clinicians, how they prefer to ship drug, the function of nursing workers.

So of the two,000 accounts that I discussed, we have already been to greater than half of them. I additionally, I believe I discussed that we name in about 200 which might be the precedence accounts we have been to, in all probability at this level, 85% of them, and in a few of them we have made a number of calls. In order that’s one factor we’re doing and that is profiling accounts. And the objective is to. on the time of launch, know all the things that we have to know to be able to get sufferers on drug and deal with it.

Second piece is the schooling piece. There’s a little little bit of a carry right here for Menin inhibition from a mechanism of illness standpoint. So that’s one thing else that our area groups are delivering. We have additionally obtained a non-personal effort, actually, to lift consciousness, clearly not speaking in regards to the drug, no less than from a business standpoint, however are elevating consciousness of the mechanism. We’re the one one which’s going to be out. The attention stage ought to be excessive by the point we get to launch, so between profiling, elevating consciousness, we’ll be in nice form as soon as the drug will get accepted to tug it by means of.

Malcolm Kuno

Nice, thanks.

Steve Closter

Thanks, Malcolm.

Operator

Our subsequent query comes from Chris Shibutani from Goldman Sachs. Your line is now open.

Kevin Sterling

Hello, that is Kevin Sterling for Chris. Thanks for taking my query. Simply wished to speak in regards to the mixture research for Revumenib within the second half, you mentioned you’d have knowledge updates. Might you simply spotlight in bookend what these will likely be? I imagine there’s going to be an replace from the save trial. After which additionally for the BEAT AML trial. Are you able to discuss the place you might be with respect to establishing a really useful part 2 dose there? After which what the rate-limiting steps are to begin that pivotal trial by the tip of the yr? After which probably what number of doses you possibly can deliver ahead into that trial? Thanks.

Michael Metzger

Proper. So, Kevin, thanks. Perhaps I will tackle that. So, for the BEAT AML trial — the BEAT AML I will begin there’s, as , we’re in search of our really useful Section 2 dose. We have made large progress at EHA. We had offered the information on each of these doses. We now have — within the technique of filling out no less than these 2 doses, simply filling out the anticipated variety of sufferers. And we will be making a alternative at some point between the 2 doses, which is the really useful Section 2 dose. And we’ll be working by means of that over the following weeks.

So we’re in superb form, finally, to begin a trial, we imagine, by the tip of this yr. Pivotal trial. And so keep tuned for added updates on that as we get by means of the yr. Within the save trial, this once more, that is Dr. Gus East’s trial at MD Anderson. That is in relapse, refractory sufferers, mixture of Ven and COVI plus Revumenib.

We offered knowledge offered final yr at EHA — sorry at ASH. So the investigators advised us that there will likely be some up to date presentation within the latter half of this yr, however in fact, we’re not at liberty to say precisely the place that’s presently. However we do count on it to be extra sufferers, extra comply with up. And as , it was thrilling knowledge, so we’re eagerly anticipating that as effectively.

Kevin Sterling

Nice. Thanks.

Michael Metzger

Thanks, Kevin.

Operator

The subsequent query is from the road of Phil Nadeau from TD Cowen. Your line is now open.

Ernie Rodriguez

Hello, Tim. That is Ernie Rodriguez for Phil. Thanks for taking our questions. I’ve two fast ones. The primary one is, given the overlap within the goal therapy facilities between Revu and Axa and all of the prep work, business prep work that you have been doing, do you see any profit to the now form of like delay or longer time between the 2 launches? Are you able to see maybe that perhaps any profit or any learnings that you should use to later speed up the launch in KMT2A relative to what your inside estimates had been? After which the second query is for the intercept trial of Revumenib in monotherapy within the upkeep setting. I imagine that trial has been ongoing for some time. I used to be questioning if there’s any updates there, when might we see knowledge from that trial? Thanks.

Michael Metzger

Nice. Sure. Thanks for the questions. First, I will ask Neil to deal with the trial query that you just requested, after which Steve will tackle your business query.

Neil Gallagher

Thanks. I believe you are asking in regards to the intercept trial. So that you’re proper. The intercept trial has been ongoing for a while. The trial is progressing effectively. As you might be additionally not conscious, it’s a third social gathering trial, and due to this fact, we do not management disclosure of knowledge. However our understanding is that recruitment goes comparatively effectively, and we count on that the investigators will current knowledge at a medical assembly sooner or later. However we do not have a precise timing on that. With that, I will go over to Steve in your first query, truly.

Steve Closter

Sure. So, simply to reiterate, the primary query was actually, there a profit in an additional time, notably the overlap of the 2 compounds? So I believe simply talking, and actually talking from expertise, there’s by no means been a launch wherever somebody, when it comes to the prelaunch interval, do they want that they had much less time or extra time upfront of an approval? I believe the reply is all the time, they want that they had extra time. So we clearly have extra time in Revumenib than we might have in any other case anticipated.

The exercise that I described earlier than will allow us all of the profiling and the mechanism of illness and illness state consciousness work we’re doing will put to good use over nonetheless lengthy it takes us to get, , to approval. And the 2000 accounts that I discussed, there is a good likelihood we will likely be in any respect of them, if not most of them, then we’ll be there a number of occasions. So I believe that will likely be — we’ll have the ability to leverage all that point.

And I believe the purpose made there’s large overlap with the Axatilimab alternative. I do not assume I shared the variety of therapy facilities for continual GVHD, however we primarily coated all of them by overlaying all the Revumenib alternatives. And what I imply by that, 2000 facilities, each educational and neighborhood, that we’re overlaying for AML and Revumenib. There’s beneath 200 that you just cowl for transplant to assist Axatilimab.

So we’re already in these, primarily. So we’re profiling these accounts as effectively. There’s a number of connectivity between HemoG and transplanters, and there is truly some benefits with rev, notably as sufferers hopefully transfer to our transplant and probably go on continued therapy.

So we have all the time seen this strategically, each medicine are extremely aligned to what we’re making an attempt to do as a company. The decision level, it is the identical name level, so we will actually accomplish each. And we’ll, like I mentioned, make use and leverage the time we’ve from now till both product involves market.

Ernie Rodriguez

Thanks. Obtained it. That is useful.

Steve Closter

Thanks.

Operator

Our subsequent query comes from the road of Peter Lawson from Barclays. Your line is now open.

Unidentified Analyst

Hello, good afternoon. That is Alex on for Peter from Barclays. Thanks for taking our questions. Only a fast clarification for me on the BEAT AML research. Can we see extra knowledge from this research later this yr? After which a separate query is, might we see preliminary Section 1 knowledge out of your 7 plus 3 mixture in 2024?

Michael Metzger

Hello, Alex, thanks for the query. So, for BEAT AML, I believe we had clearly talked about that this isn’t our trial. We’re collaborating intently with the sponsor, however the final replace was performed at EHA. In order that was a fairly complete replace. We do not have data but when that is going to be up to date. It is doable it might come within the second half of this yr at one of many medical conferences, however we do not have excellent data there, so keep tuned on that.

After which for the 7 plus 3 part one which we have initiated. We’ve not given steerage but as to once we — we will be placing collectively the preliminary knowledge for that, so keep tuned. I would not count on that we might have it in 2024. That is more likely to are available in 2025.

Unidentified Analyst

Okay, nice. And simply, if I’ll, a fast follow-up. Do you must enroll form of opposed threat sufferers right here initially, or what kinds of sufferers are being enrolled within the part 1? Thanks.

Michael Metzger

Sure, I do not assume we have truly talked in regards to the precise kind of sufferers that we’re enrolling. That is proper. I believe they’re simply newly recognized sufferers with 7 plus 3 together.

Unidentified Analyst

Sure. Thanks.

Operator

Thanks. Our subsequent query comes from the road of Brad Canino from Stifel. Your line is now open.

Brad Canino

Thanks. That is Brad. I believe it could be good to clear up a number of the sequence across the Revumenib overview. I believe a number of us presumed that with RTOR and the shut FDA collaboration that that gives, plus your rampant business and vocal about it, that you just had actually good visibility about what you wanted to get this throughout the road both at or effectively earlier than the PDUFA. So are you able to assist us perceive a little bit of what occurred right here?

Michael Metzger

Sure. Thanks, Brad. And I believe we had been capable of meet up with lots of you earlier within the week when the information got here out. Look, I believe this was unlucky within the sense that we had been in receipt of some RFIs and that is an ongoing course of beneath RTOR that is been happening since final yr the place we submitted our NDA. After which since then we have been receiving request for data from the company. The 2, I might say two newest RFIs had been, resulted in fairly a bit of knowledge going again to the company.

As soon as they obtained that data, they tell us as of final Friday, late final Friday that that may require them to really spend extra time on the complement data they usually had been going to increase the clock beneath a significant modification. That is a 3 month delay.

In order that was, and also you’re proper, we had been truly fairly collaborative over many months with the company and have been working very intently with them. The knowledge that we offered we imagine might have been reviewed inside the time of the PDUFA. And so for us, we had been fairly assured that that was the method that we had been following. We had been slightly bit stunned that the company would prolong the clock, however they did. That is as much as them. That is their determination.

So look, that is data that, as I beforehand mentioned, that is data that we didn’t have within the NDA. It was not requested of us on the time of the submission of the NDA. It was new data, new medical data that they wished to overview. And so we offered that. This was one thing that we had been ready for, however they did not ask for it, after which we offered it after they did ask for it. The one unlucky a part of that is, that they requested for it, however we discovered about it form of late within the overview cycle. We had gone by means of our mid cycle and our late cycle overview and it was with out occasions.

So we had been feeling fairly assured in all the things that we’ve not solely been by means of with the company, however what we submitted and heard again. So these are the sequence of occasions and we really feel very assured that this drug will get accepted on the December timeline as they’ve prolonged the date. So we’re in — I believe, an excellent place to launch the drug earlier than the tip of the yr.

Brad Canino

Sure. And perhaps simply to comply with on that, as a result of I believe many people are actually a scenario the place there is a potential for heightened asymmetry of knowledge. You have obtained the FDA probably knowledge that we’ve not been capable of vet, I assume, what assurance are you able to give that the general profile that we all know publicly from Revumenib is constant and that prior knowledge lower stays dependable? Thanks.

Michael Metzger

Sure, thanks, Brad. Look, I believe the knowledge, and we do not get into the specifics of anyone RFI and what’s being requested of us in an ongoing overview. However what I can say on the late cycle overview we did discovered that there is going to be no AdCom for the product, they usually assured us no REMS program for that may be required as effectively. This isn’t manufacturing data that they’ve appeared for. It is a medical bundle that’s in our minds, utterly constant and supportive of approval. This isn’t data that modifications the profile of the danger profit in any respect.

And so we really feel truly it is much more strong of a bundle than as beforehand labored on. It was mainly what the company had requested for they usually requested for supplemental data. So we really feel prefer it does not change something in any respect having to do with the profile or the danger profit. And for that motive, that is why we’re so assured that the drug is not going to solely get accepted, however it’ll get accepted on the timeline as proposed. So I believe that is as detailed as I might get for you Brad.

Operator

The subsequent query comes from the road of Michael Schmidt from Guggenheim. Please go forward.

Michael Schmidt

Hello guys, thanks for taking my query. Perhaps only a fast follow-up. So provided that the Revumenib NDA clearly continues to be beneath RTOR overview, and with the prolonged PDUFA date until finish of September now giving ample time for the FDA. Simply questioning what your view is on the potential for an approval to return forward of that prolonged PDUFA date. Is that also on the desk, any opinion? After which I had an unrelated comply with up.

Michael Metzger

Sure, Michael, thanks for the query. It isn’t unprecedented for even with the extensions, we have seen a few our RTOR merchandise, Rezurock being one which obtained accepted beneath RTOR, obtained prolonged, truly obtained accepted about six weeks sooner than their prolonged timeframe or their prolonged PDUFA. So we have seen RTOR merchandise get prolonged and get accepted. Many merchandise beneath precedence overview, similar factor.

More often than not they go the gap, which means that they are accepted on or round their prolonged PDUFA date. It’s extremely laborious to know if that may or is not going to be the case for us. We do count on it to be on or earlier than, in fact, however we will not — it is very laborious to guage whether or not that is very faraway from the prolonged date itself. So our expectation is that it’s going to come on or across the date that they’ve specified.

Michael Schmidt

Tremendous useful, thanks. After which unrelated comply with up. Simply form of fascinated about the upcoming registration knowledge in NPM1 sufferers later this yr, maybe relative to KMT2Ar, how ought to we take into consideration the transplant dynamics within the NPM1 subset? And associated to that, what’s a very good modeling assumption for durational remedy for that market subset relative to KMT2Ar, thanks a lot.

Michael Metzger

Sure, thanks for the query. Look, I believe NPM1 our view has been all alongside that the NPM1 knowledge that we have seen within the Section 1 trial seems to be similar to what we have seen with KMT2A is consistency throughout all of the measures between the information units. That additionally contains what we have seen in transplant. And though the sufferers within the NPM1 cohort are usually slightly older, maybe significantly so, I imply, versus KMT2A, we have additionally seen a very good proportion of these sufferers get transplanted.

So whereas the best way that sufferers are handled by physicians, there could also be extra of an urgency to take sufferers to transplant who’ve KMT2A versus NPM1, it does not preclude a doctor from considering in the identical manner that in the event that they’re wholesome sufficient they usually’ve cleared their tumor to get them to a transplant. So, once more, that dynamic has seen — we have seen that with NPM1 in addition to we’ve with KMT2A.

So our view is that the modeling assumptions, and, in fact, that is your individual mannequin, however we might mannequin them very equally when it comes to share of sufferers who go on to transplant after which probably even return on drug post-transplant, although that occurs to be a barely older affected person inhabitants. So I believe that is to the very best of our data, primarily based on data that we have seen from the Section 1 and now in our pivotal trial for KMT2A.

Michael Schmidt

Nice. Thanks.

Michael Metzger

Thanks, Michael.

Operator

Our subsequent query comes from the road of Kelly Shi from Jefferies. Your line is now open.

Unidentified Analyst

Hello, that is Claire on Kelly. Thanks for taking our query. So, now that you’ll probably have pivotal knowledge learn out in NPM1 that had approval in KMT2A surprise, how would that probably change your dialogue with the NCCN committee for the rule of thumb inclusion and perhaps, one step ahead additionally, what would be the dialog with payers going to be like upon this replace as effectively? Thanks.

Michael Metzger

Sure, Claire, thanks for the query. Look, I believe the cadence of occasions right here in our minds appears to be that we are going to have NPM1data now on our pivotal trial forward of our KMT2A approval, they will be in shut proximity to 1 one other, however it’s not the opposite manner round. So having NPM1 knowledge first, our precedence will likely be to get that knowledge revealed as rapidly as we will. And as soon as the drug is accepted in KMT2A, we will proceed with potential guideline inclusion for NPM1.

So that is the form of cadence right here. And there will be some urgency to maneuver to be able to have an effect on the truth that we’ve a drug available on the market. After which one other indication in NPM1, which is shifting by means of — rapidly by means of an sNDA course of on the similar time, however may very well be included in pointers forward of approval. So there will likely be fairly a little bit of exercise associated to not solely getting the drug accepted, but additionally shifting pointers by means of publications and conversations with thought leaders who work on an adhoc foundation, if you’ll, to get new medicine included in pointers.

Perhaps I will flip it over to Steve to speak in regards to the different questions.

Steve Closter

I believe half two is what’s the affect on payers of NPM1, in my opening feedback, I talked about our exercise with payers, which has been intensive. We’ll have talked to payers that cowl 90% of managed care lives in each business and Half D. I believe payers, they acknowledge the unmet want in KMT2Ar they usually acknowledge it in NPM1. They like what they’ve seen with Revumenib. And given the value level within the area of roughly $27,000 to $32,000 a month, we imagine we’ll be at a slight premium to these brokers.

It is an apparent connection between NCCN pointers and payers. Payers prefer to see what’s within the public area. They need to see knowledge revealed, they need to see the rules clearly. The entree level is KMT2Ar. That is the place we’ll set value. I believe payers need to service sufferers. They will produce some hurdles and obstacles up entrance, and boundaries which they all the time cope with merchandise like this.

We have unbelievable specialty pharmacy companions and distributors, and a affected person portal, when wanted, to usher sufferers by means of the early days of a launch when merchandise are usually not but on formulary. So we perceive the medical exception course of in addition to our most popular pharmacy companions, in addition to treaters and establishments. So we predict both manner we’ll have the ability to set the precise value and we’ll have the ability to get sufferers on drug with some problem. However we’ll get there and we’re ready to do it.

Unidentified Analyst

Thanks. That was very useful.

Michael Metzger

Thanks, Claire.

Operator

Subsequent query comes from Yigal Nochomovitz from Citi. Your line is now open.

Ashiq Mubarack

Hello, guys, that is Ashiq Mubarack on for Yigal. Thanks for taking my questions. I simply wished to ask one on Axatilimab. Seems like all the things is on monitor with the PDUFA, which is arising fairly quickly. I simply wished to know in case you might share any coloration on perhaps the place issues are within the form of BLA course of. Have you ever reached label negotiations? Was there something of worth with the — perhaps a mid-cycle overview? Something to form of verify that BLA is on monitor could be very useful. Thanks.

Michael Metzger

Sure, Ashiq. Thanks for the query. So we do not touch upon particular — any particular a part of our negotiations or discussions with the company through the course of. It’s beneath precedence overview. As you bear in mind, it was — we mentioned alongside, it is going effectively. We do count on the drug to be accepted on across the PDUFA date, which is the tip of August. Nothing that we have encountered within the overview course of modifications that perspective. I will not remark particularly round whether or not we’re or we aren’t in label discussions, however we’re feeling very assured that the drug will likely be accepted and will likely be accepted on its timeline.

Ashiq Mubarack

Okay. Perhaps one follow-up on that then. Ought to we form of count on the business launch to happen perhaps instantly after a possible approval of Axatilimab? Or is there a motive to form of assume there is likely to be slightly little bit of a lag, perhaps ready for revumenib, so there’s some synergy with that business launch as effectively? Thanks.

Michael Metzger

Proper. So, no, thanks for the follow-up, Ashiq. We mentioned that the launch is predicted within the fourth quarter, in order that’s our steerage. We’re working with our accomplice to prepare to try this, and we’ll launch the drug when it is prepared.

Ashiq Mubarack

Obtained it. Thanks very a lot.

Michael Metzger

Thanks.

Operator

Our subsequent query comes from the road of Kalpit Patel from B. Riley. Your line is now open.

Kalpit Patel

Sure. Hello, good afternoon and thanks for taking the query. Perhaps one for Revumenib. Is there something that you have discovered from the KMT2Ar regulatory submitting right here that may very well be helpful for the NPM1 submitting, and assist streamline that? I do know the timeline says first half ’25 as a substitute of perhaps first quarter ’25. Is there a motive for that? After which I’ve a follow-up.

Michael Metzger

Sure. Thanks, Kal. Let me flip it over to Neil to perhaps take a crack at that.

Neil Gallagher

Sure, thanks for the query. So the easy reply to your query is sure. So, I believe that we have discovered quite a bit in regards to the course of, and naturally, it is necessary to attract the excellence between the NDA and the sNDA. So within the NDA, we do — a number of the heavy lifting is completed and any subsequent utility — supplementary utility is rather more simple. So, we’re clearly excited and looking out ahead to getting the NPM1 knowledge through the fourth quarter. And you may ensure that we will likely be submitting or submitting these knowledge as expeditiously as doable.

There was part of your query I missed. Did I tackle your entire questions, or is there one thing I missed?

Kalpit Patel

Sure. It is simply — it says first half ’25 as a substitute of first quarter ’25 for submitting for the NPM1 cohort.

Neil Gallagher

Sure. We’ve not been that particular with our steerage but, however you’ll be able to ensure that we will likely be working fairly laborious at it. I will — with that, I will go you again to Michael.

Michael Metzger

Kal, your second query?

Kalpit Patel

Sure. So — after which the second query is form of associated right here. Was there the brand new data that was requested by the FDA? I assume, was any a part of the NPM1 cohort knowledge set that was despatched to the FDA for this replace?

Michael Metzger

No, Kal, I — Kalpit, I’d truly simply deal with the KMT2A submission. That is what we’re working with the FDA on now. NPM1 knowledge hasn’t even been — we’re not even by means of the trial. It hasn’t — all of it hasn’t been performed but. So when that trial is on the market or when the information is on the market, we’ll publish it, and that’ll be within the fourth quarter. So you must — the knowledge that we’re centered on with the company pertains to KMT2A.

Kalpit Patel

Okay. Thanks for taking the query.

Operator

Thanks. Our subsequent query comes from the road of Justin Zelin from BTIG. Your line is now open.

Justin Zelin

Thanks for taking our query. Michael, I might prefer to make clear relating to your confidence on the Revumenib approval by the tip of the yr. Ought to we proceed to count on a standard approval right here, or might there be a situation within the overview cycle the place Revumenib may very well be accepted beneath an accelerated approval foundation?

Michael Metzger

Justin, thanks for the query. I do not assume you must assume for a second that that is going to be accepted in some other manner aside from full approval. All the precedent medicine which have gotten accepted in AML as monotherapy-targeted therapies have been within the — by means of the very same course of.

And in order that’s by no means been mentioned with the company that we might. There isn’t a accelerated approval pathway, and that is not the pathway we’re pursuing right here. So I’d not assume that that may change in any respect. After which we’ve excessive confidence that that is only a delay of three months. It does not change the method in any respect when it comes to what we’re submitting for, what we’re more likely to have at approval.

Justin Zelin

Nice. Thanks for clarifying and taking our query.

Michael Metzger

Thanks, Justin.

Operator

The subsequent query comes from the road of Jason Zemansky from Financial institution of America. Your line is open.

Cameron Bozdog

Hello, good afternoon. That is Cameron Bozdog on for Jason. Congrats on the progress, and thanks a lot for taking our query. So, looking forward to the potential near-term launch of Axatilimab, are you able to perhaps remark in your inside market analyses and what you’ve got been listening to from prescribers? I imply, do you count on uptake, no less than initially, to be largely pushed by educational prescribers centered at transplant facilities versus neighborhood docs, particularly when you concentrate on the path to administration? Thanks.

Michael Metzger

Nice. Thanks for the query. I will flip it over to Steve to deal with it.

Steve Closter

Sure. Thanks for the query, Cam. I might begin off saying it is a fairly small viewers, and there is a number of excessive science and specialists within the area of transplantation. So it is — from the therapy heart standpoint, I believe I’ll have offered the numbers earlier. 10% of the facilities, it is beneath 200. So it’s all pushed by that, I believe within the a part of who the drivers educational versus neighborhood, it is the most important facilities are going to drive all this for essentially the most half. Definitely, at launch, there will be some consciousness outdoors of that, and even inside the 200 heart, there’s in all probability 35 that see half the sufferers within the nation. So it’s as — I would not say it is the smallest doctor viewers to name in, however it’s one of many smallest.

And it is a tight neighborhood. I believe to — chatting with market alternative, there’s a number of enterprise right here. There’s a number of unmet want and dissatisfaction. The present therapy GVHD inhabitants, they need extra. They want extra brokers. It is a actually insidious illness. So it will be, I might say, early uptake, and a gaggle of sufferers in all probability which might be ready for one thing like this. It isn’t an enormous quantity, however there’s some variety of sufferers ready. So there will be some type of bolus, however the market’s prepared and will likely be prepared shortly, too. And I believe it will be effectively obtained by physicians and sufferers.

Operator

And our last query comes from the road of George Farmer from Scotiabank. Your line is open.

Unidentified Analyst

Hello, that is Chloe on for George. Are you able to hear me okay?

Michael Metzger

I hear you, Chloe. Thanks.

Unidentified Analyst

Sure. So two from us. So, primarily based in your preliminary knowledge bundle for Revumenib. So that you mentioned that FDA did its factor and ODAC was mandatory. You continue to imagine now to be the case. So how assured are you that the extra data is submitted that prompted the proof extension is not going to be topic of an ODAC overview within the subsequent six months?

And the second query is, Michael, you talked about BD in your ready remarks, so simply curious what kinds of BD offers you had in thoughts and examples of areas of curiosity or kinds of belongings. Your eyes in the meanwhile, each as a purchaser or perhaps a goal, and in case you might perhaps put it in context to provide the Incyte relationship for us and inform us form of the way you see that evolving over time.

Michael Metzger

Chloe, thanks for the query. So, first, when it comes to ODAC, I believe excessive diploma of confidence that an ODAC is not going to be required. The company, on a couple of event, has advised us this. The info that we submitted, as I referenced earlier, is just in our minds and really clearly supportive of approval and solely augments the bundle that we have submitted. So there’s actually — there’s — in our minds and primarily based on what we have heard from the company, there’s — does not appear to be any threat of an ODAC and that we all know of. So I really feel fairly assured about that.

After which when it comes to BD, which is an fascinating query, primarily pertains to how can we develop the pipeline and proceed doing what we do effectively at Syndax, partly, which is in-licensing of — or buying new molecules so as to add to the pipeline. And we have mentioned previously, and we proceed to work on including or backfilling the pipeline as early-stage molecules within the focused remedy area in oncology — centered on oncology.

We do not converse particularly about which mechanisms we’re going after or the standing of any of those discussions and what — once we conclude our offers, we often deliver — we do deliver them ahead and discuss them publicly, however at this stage, we’re very actively wanting and really feel fairly good about potential. However at this level, it is laborious to invest on enterprise improvement transactions till they’re performed and closed.

So — however no matter we do will likely be of — it appears of an earlier selection. So we’re not seeking to tackle late-stage initiatives, earlier initiatives, or the kind of the — kind and complexion of what we really feel like we will accommodate presently with all the opposite fascinating issues we’ve happening in our pipeline for Axatilimab and for Revumenib. So it is a balanced technique and one which we’re actively engaged in.

Unidentified Analyst

Okay. Thanks. With respect to the partnership with Incyte, we’ve not seen — any ideas on the way you see that evolving sooner or later?

Michael Metzger

Our partnership with Incyte is an effective one. We conceived it again in 2021 once we introduced that they have been good companions to us. And as Steve outlined, and we have talked about, we’re eager to launch that, get that product accepted and launched, and definitely broaden the utilization of Axatilimab in a wide range of indications earlier within the therapy course for GVHD. We’re pursuing IPF. In order that’s — these are — this can be a world partnership with Incyte. And so it is gone fairly effectively. And we proceed to imagine that it’s going to broaden and proceed in perpetuity in the best way we envisioned it to begin. We’re very pleased with that.

Unidentified Analyst

Obtained it. Thanks.

Michael Metzger

Thanks, Chloe.

Operator

This concludes the question-and-answer session. I will now flip the ground over to Mr. Michael Metzger for any extra feedback or closing remarks.

Michael Metzger

Sure. Thanks, all. We respect you all tuning in at the moment to debate the progress we’ve made and the thrilling milestones forward for the Firm. We look ahead to seeing you at our deliberate investor occasions, together with the upcoming BTIG Convention in August. And with that, want you a very good day. Thanks a lot.