Epizyme, Inc.
Q3 2017 Earnings Call Transcript

Published: 2 Nov 2017

[Operator:]

Good afternoon. And welcome to Epizyme's Third Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only-mode. There will be a question-and-answer session after the prepared remarks. Please be advised that this call is being recorded at Epizyme's request. I would now like to turn the call over to Monique Allaire with THRUST Investor Relations. You may begin.

[Monique Allaire:]

[Technical Difficulty] We issued a press release detailing Epizyme's third quarter results and outlining recent company updates. The press release is available on the Investor Center of our website at epizyme.com. Joining me on the call are Rob Bazemore, Chief Executive Officer; and Dr. Peter Ho, Chief Medical Officer; and Suzan Graf, Chief Business Officer. During this call, we will use forward-looking statements related to Epizyme’s current expectations and plans, which are subject to risks and uncertainties. Actual results may differ materially due to various important factors, including factors, including those described in the Risk Factor section of Epizyme’s Form 10-Q filed in November. These statements represent our views as of this call and should not be relied upon as representing our views as of any date in the future. We undertake no obligation to publicly update any forward-looking statements. Let me now turn the call over to Rob.

[Rob Bazemore:]

Thank you, Monique and good afternoon everyone, thank you for joining us. This month nearly today marked Epizyme's 10th anniversary as a company. Over the last decade, we have pioneered the discovery and development of epigenetic medicines, culminating into a transformational 2017 for the organization. With each milestone achieved we move closer to realizing the vision on which we were built, bringing important epigenetic medicines to patients in need. Throughout the year, we have executed a number of important initiatives that put us in a very strong position to deliver on our promise of providing new treatments to patients and physicians, and value to our shareholders. tazemetostat our late stage product candidate has significant potential given the breadth of the program as a monotherapy and combination agent, in early and late lines of treatments for both hematological malignancies and solid tumors. We have a line of side to our first NDA submission for tazemetostat, for the treatment of epithelioid sarcoma targeted for 2018. We are on track to begin regulatory engagement around our NHL program later this quarter, with the potential for our lymphoma NDA submission in 2019. Enrollment in the EZH2 mutation cohorts of our NHL program has accelerated as expected following efforts like establishing our collaboration with U.S. Oncology. We made encouraging advancements across our solid tumors programs in pediatric and the adult patients with INI1-negative tumors and patients with mesothelioma. We’ve begun our activities necessary to support the anticipated launch of tazemetostat in multiple indications. We have identify the next development program in our pipeline, which targets G9a, and we are financially strong after the recent $160 million follow-on financing, which extended our run way through many key milestones and supports our operations into at least the third quarter of 2019. With a progress made we are well on our way to achieving our 2020 vision. We have a number of updates to share on today’s call. Let me begin by discussing our programs in follicular lymphoma and diffuse large B-cell lymphoma. Our NHL program has continued to advance well since our ICML data presentation, we are very encouraged by the activity and the durability observed in the June data update particularly among FL patients with EZH2 mutations, as well as tazemetostat favorable safety, which was consistent with the experience across the entire clinical program. We are also pleased to see that the overall prevalence of patients with EZH2 mutations in our ongoing Phase II study align with the literature with approximately 20% of enrolled FL and germinal center DLBCL patients having an EZH2 mutations. As we look ahead, our focus is on completing enrollment of the EZH2 mutations cohorts, which may represent the fastest path to markets for tazemetostat in NHL. Since our last update, we’ve made more progress in study recruitment and are happy to report that our collaboration with U.S. Oncology has already contributed to new patients enrolling in our study. Collaboration such as this one are important to helping us fully enroll two open cohorts more quickly. Since, they increase the number of site screening for patients with an EZH2 mutations. While we are providing specific guidance on enrollment numbers, we are encourage by the increased screening that we have seen as a result of the initiative that we’ve put in place, with August and September being our highest screening months to-date. We have also seen an increase in both awareness and enthusiasm among the physician community since our ICML data presentation, and we expect this momentum to continue. We plan to present a full update from our Phase II NHL study in 2018, before then there are number of meaningful events anticipated this year. ASH will be an important meeting for the company. We will present new data from our 62 gene panel and plan to hold multiple engagements with our investigators and NHL thought leaders to further discuss the tazemetostat program. Leveraging tazemetostat fast track designation, we intent to have multiple interactions with U.S. FDA to fully define the path to registration for tazemetostat in NHL. The first interaction with the FDA to formally initiative discussions on the registration strategy has been schedule for later this quarter. To best position ourselves for success we plan to use this interaction to review key overarching aspects of the program. This includes tazemetostat’s novel mechanisms of action, putting the data from our current trail into context and discussing the potential role for tazemetostat particularly in FL where we’ve generated the most compelling data. We believe FL could represent the fastest path to market in NHL. We anticipate being able to provide an update from our initial interactions early next year. As the data from this program evolve and mature throughout 2018, and we continue engaging with the FDA we’ll refine our NHL filing strategy, and update as appropriate. In addition to our monotherapy program, we’re advancing multiple combination studies in DLBCL. Our studies are both in Alcomer and EZH2 wild-type patients, and in both the frontline and replaced, refractory settings. These studies are designed to investigate tazemetostat safety as a combination agent, with both targeted and chemotherapeutic agents, and to evaluate combination anti-tumor activity across a range of treatment settings. Our goal is to establish proof-of-concept for tazemetostat in various combination regiments, with initial data in 2018. We also anticipate beginning a combination study in follicular lymphoma next year. We’re evaluating a study design that was support both our overall approach to the FL market and our registration strategy. So, we plan to discuss the study’s design with the FDA before initiating. We continue to believe that tazemetostat holds tremendous potential in treating patients with both FL and DLBCL, and are highly encouraged by the progress made to bring the program to where it is today. Let me ask Peter, to review some update from our solid tumor program. Peter?

[Peter Ho:]

Thanks, Rob. Let’s begin with the progress in our INI1-negative adult and pediatric programs. As a reminder, our adult study is assessing tazemetostat in multiple solid tumors driven by loss of INI1. In July, we completed enrollment of the 60 patient cohort for epithelioid sarcoma that we believe will support our NDA submission and potential registration in this cancer. In addition, we recently opened a separate cohort in our Phase II study to enroll up to an additional 40 ES patient, who’ll undergo paired pre and post treatment tumor biopsies. Although not intended for registration purposes, the translational data that this cohort will generate will be important in exploring the effect of tazemetostat treatment on immune responsiveness in ES, as well as other tumors. In other cohorts of the studies, based on assessment by our independent data monitoring committee, we’re pleased to share that our rhabdoid tumor and other INI1-negative tumor cohorts have surpassed their futility assessments with objective responses observed in both populations. Based on these findings, we will complete enrollment in these cohorts with a plan of representing updated data from this study in 2018. While we’ve seen activity in the cohort of patients with renal medullary carcinoma, we’ve not seen sufficient activity to warn moving forward as a monotherapy for this aggressive disease. In the cohort of other INI1-negative tumors, we’ve enrolled a number of patients with chordoma, a rare sarcoma that involves the bone and soft tissue around the spine. Based on the early encouraging activity, we’ve seen in these patients, including confirmed objective responses, we recently added a new cohort to evaluate tazemetostat in patients with INI1-negative chordoma, in order to more fully assess tazemetostat potential in this sarcoma. This new cohort will enroll up to 30 patients. We’ll continue to follow these cohorts closely and look forward to seeing how the data progress. In addition to our adult INI1-negative study, we’re very pleased with the progress made in our pediatric study. In August, we announced that we had completed the dose escalation portion of the study, and are now advancing through dose expansion. Just recently, during an oral presentation at the Molecular Targets Meeting, our lead study investigator, Dr. Susan Chi, presented the first data from our Phase I dose escalation trial in children. Thus far, we observed objective responses in pediatric patients with epithelioid sarcoma, chordoma and atypical teratoid rhabdoid tumor or ATRT at doses above 520 milligram per meter square twice daily. These results are consistent with our adult solid tumor experience and give us confidence in tazemetostat’s potential in children with these devastating cancers. Additionally, adult and pediatric epithelioid sarcoma data originally presented at ASCO in June and the Molecular Targets Meeting in October have been selected for a plenary presentation at the Connective Tissue Oncology Society or CTOS annual meeting on November 9th. CTOS have selected epithelioid sarcoma as the sarcoma of the year, given the significant unmet need in this tumor type. We are honored that these data were selected for oral presentations at both meetings, giving us the opportunity to share these promising findings. To finish out the solid tumor program, we have also advanced our mesothelioma study. Mesothelioma is a difficult to treat cancer and the life expectancy for patients is very poor. We have found that both patients and investigators are eager for new treatment options as evidenced by the rapid enrollment in our study, which was completed months ahead of our projected timelines. We announced last quarter that we fully enrolled the study with 74 patients and we are pleased to report that the study has achieved its primary endpoint, having exceeded a 30% disease control rate at 12 weeks and many patients remain on study. In order to assess the durability of the clinical activity, we will continue to follow these patients and are planning for our first data presentation in 2018. In September the FDA granted tazemetostat orphan drug designation for mesothelioma. We are encouraged by the agencies recognition of the potential for tazemetostat to become a new treatment in this highly aggressive disease. And we look forward to seeing how the study progresses. Let me now pass the call back over to Rob.

[Rob Bazemore:]

Thanks, Peter. As we’ve talked about one of our corporate goals has been to introduce three new programs into the clinic by 2020, and we have made significant progress to bring forward the next development candidate in our pipeline. The proprietary platform has led to breakthroughs in epigenetic drug discovery and development. While our original discovery efforts focused on the development of histone methyltransferases or HMTs for oncology. The science has led us to the application of HMT and other serious diseases. I am excited to share the next program that will follow tazemetostat into the clinic, a novel program against the target, known as G9a. Based on our scientific research and third-party published literature, we know that G9a is an important target for a range of diseases. This includes various cancers and blood disorders like sickle cell disease, which is a group of inherited disorders that cause abnormalities in the shape of red blood cells in the body. These abnormalities caused blockages in blood flow, extreme chronic and episodic pain, anemia and other dangerous complications, including vaso-occlusive crisis and stroke. Sickle cell disease is the most commonly inherited blood disorder. Current treatments have limited efficacy or associated with challenging toxicities demonstrating an urgent need for new treatments that modify the underlying disease rather than just treating the symptoms. In sickle cell disease, increasing the level of feel hemoglobin has been shown to have disease modifying effects and the research in the field has shown a clear link between the inhibition of G9a and a reactivation of the fetal hemoglobin. We initiated a program to find high quality G9a inhibitors, utilizing our HMT platform for the treatment of sickle cell disease and will present data on this during an oral presentation at ASH. Our results confirm a direct link between G9a inhibition and the reactivation of fetal hemoglobin, which when combined with the totality of our preclinical data lead us to believe that inhibition of G9a is a potentially relevant clinical approach. We look forward to sharing more details at ASH. In addition to the progress made across our pipeline, our business is in a very strong position. Let me ask Susan to provide a brief review of our financial strength. Susan?

[Susan Graf:]

Thanks, Rob. The details of our results can be found in the press release we issued this morning. So let me highlight just a few points. As you have heard 2017 has been a very productive year for Epizyme. As we look ahead we have the financial strength to continue to advance our pipeline and achieve the many important clinical and regulatory milestones in our future that will create value for the company. Importantly we have continued to operate with financial discipline focused on executing against our strategic priorities. This is reflected by our research and development spend of $28.7 million and G&A expense of $9.3 million for the third quarter of 2017. We do expect to R&D expense to grow modestly heading into 2018. Particularly as we initiate additional covenant effect trials, prepare for our first NDA submission and initiate the GLP Toxicology and associated preclinical work to move our G9a program towards the clinic. We ended the third quarter in a very strong capital position with $307.2 million in cash, cash equivalent and marketable security. This includes a $151.3 million in net proceeds from our follow-on financing completed in September. The capital raised in this oversubscribed offering, along with our existing cash extends our operating runway into at least the third quarter of 2019. Notably, this runway does not take into account any additional milestones or other potential non-dilutive sources of cash. As we think about the funding of Epizyme's future, particularly as it relates to maintaining a strong balance sheet and creating value for our shareholders. We are taking a disciplined approach to our investments, focused on the critical items to scaling up the company to insure successful launch. We will continue to invest widely in the advancement of tazemetostat and take a structured investment approach to our earlier pipeline efforts to support delivering three new candidates into the clinic by 2020 as part of our long-term plan the first of which Rob just described. I'll now have the call back to Rob, to close this out.

[Rob Bazemore:]

Thanks, Susan. 2017 has been a year of tremendous progress and 2018 is set to be a significant year for Epizyme as we begin our transition towards a commercial stage company and prepare for the potential launched of our first product. It's with our company’s transformation in mind that Peter Ho has made the decision to leave Epizyme at the end of the year given that his passion has always been early stage R&D. Importantly, Peter will continue to lead our clinical strategy and support our regulatory efforts throughout the remainder of the year as we identify his successor. Since joining Epizyme in 2014, Peter has been instrumental in building the strong clinical organization and bringing the tazemetostat program to where it is today. We are incredibly grateful for all of Peter’s efforts, without which we would not be approaching our first NDA submission next year. On behalf of the entire organization, I would like to thank Peter for all that he has done for Epizyme. This transition provides us the opportunity to add new strength to the team with a seasoned clinical executive with extensive late-stage drug development experience and a track record of driving new treatments to approval. We're highly confident in our ability to attract a senior leader who can help guide the company through the next phase of our evaluation. Expanding the clinical development strategy for tazemetostat and preparing for its commercial launch. The search for this candidate is already underway and we are in the process of securing an Interim Chief Medical Officer to serve in a consulting capacity through the transition. I remain completely confident in our R&D organization’s ability to continue executing all of our objective. The clinical development team is exceptionally strong and executing as planned on the many ongoing trails for tazemetostat. We have a strong executive leadership team in place with a deep regulatory and commercial expertise and a track record of bringing new treatments to market. We stand well positioned to achieve our vision through 2020, including launching tazemetostat in NHL and solid tumors, advancing three new epigenetic development candidates into the clinic and maintaining the capital to support these efforts. We believe we have the potential to change the way many severe diseases are treated and an opportunity to improve patents’ lives. Thank you for joining us today. We’d now like to open the call for questions.

[Operator:]

Thank you. [Operator Instructions] And our first question is from the line of Geoff Porges with Leerink. Your line is open.

[Geoff Porges:]

Thanks very much for taking the question and thanks for all the help you've given us over the years Peter. Congratulations I hope things are going well. In terms of questions on lymphoma program, quite a few an important driver. So could you clarify what combination there you expect to have in 2018? And then what particular lymphoma subset you're expecting to be filing in 2019 given that you've committed to a timeline there. And perhaps a follow-up question on mesothelioma, you'll have 74 patients worth of data, what is the regulatory strategy or opportunity there and a potential for filing? Thanks.

[Rob Bazemore:]

Thank you for the question, Geoff. I'll ask Peter to answer your first question around the combination data that we plan to have next year. And I'll address the regulatory approach including the meeting that we have scheduled with the FDA later in the fourth quarter.

[Peter Ho:]

Yes, sure. Thank you for your kind words Geoff; it really has been my pleasure to work on tazemetostat, which I think is a wonderful drug in something that will bring a lot of benefit to patients as we move forward. The combination trials that we have ongoing in DLBCL are the ones that we expect to hear from in terms of results in 2018. So just to review the first one that we've started is the R-CHOP combination study. And this is in the elderly high risk DLBCL patients where the regimen of R-CHOP plus tazemetostat is being used as frontline therapy. Now this is a phase 1b/2 study so definitely two parts to this and we have been in the dose escalation portion of the trial where tazemetostat is being dose escalated in combination with full dose R-CHOP. And we are progressing through that very well and are anticipate being able to share data from that first phase of the study before it moves on into the formal Phase II portion. Beyond that we have the combination of tazemetostat with steroid prednisolone that is an added cohort to our Phase II monotherapy study, where also the accrual for DLBCL patients, has been progressing very nicely and we should have results to share as well next year. The third study that is ongoing in DLBCL is the combination with atezolizumab. And that is a study that is being operationalized by our collaborators at Genentech. And because that is a study that Genentech is operationalizing a little more difficult to make firm commitments in terms of the data presentation. But again, we know that the accrual to that study is going along very well. And so those are the three existing studies in DLBCL that we're looking for data.

[Geoff Porges:]

Perfect, that's very helpful. And then mesothelioma?

[Peter Ho:]

Okay, so yes very quickly on mesothelioma, absolutely we've been very excited by how quickly that study has accrued. And as you mentioned 74 patient sets in two parts of the study. The -- it is monotherapy tazemetostat monotherapy in patients being treated in the second line setting. So as you know we've completed accrual in the summer time. And we are following the data as it matures and we do look to be representing those data in 2018 as well. Now we started this as an exploratory study, we didn't have any mesothelioma clinical experience from our Phase 1 study unlike the case for many of the other tumors. And so we'll be looking at this study to give us direction as to how best to move forward whether as a single agent or monotherapy, what type of trial, what type of patients as well. But we certainly share the enthusiasm that we saw from our investigators in terms of having a potentially targeted therapeutic for patients with mesothelioma.

[Geoff Porges:]

Great, thanks very much.

[Rob Bazemore:]

And then in terms of the NHL regulatory strategy, Geoff, first of all we are excited to begin to define the path registration in patients with non-Hodgkin lymphoma. We thought it was important on this call to update since our guidance has been that we would schedule the first interaction in the fourth quarter, so that interaction is now scheduled. This is a large program as you know including both follicular lymphoma and diffuse large B-cell lymphoma. And the study is still ongoing, we’re still evaluating the evolution of responses in the cohorts that are full, and we continue to enroll the EZH2 mutant cohorts. But we’re excited to begin to define the path, in this first interaction we’ll focus exclusively on patients with follicular lymphoma since this is where we’re most encouraged by the data that we’ve seen and presented so far. We believe that follicular lymphoma potentially represents the fastest path to market for tazemetostat and lymphoma. So this first interaction will focus exclusively on follicular lymphoma.

[Geoff Porges:]

Great, thanks. Just a follow-up, could you just clarify when we will get to see the expanded data for particularly the EZH2 population as you add to the enrollment?

[Rob Bazemore:]

Yes, for sure Jeff, our intent is to be able to present this data in 2018. We’ve not defined which medical meeting obviously that would be -- the priority would be to be able to present it at a medical meeting. But we want to continue to be able to enroll those EZH2 mutant cohorts. And it’s also important that we follow the data to be able to understand better the durability of benefits. As you recall, when we presented the data this summer, many of these patients were still very early in therapy. And we’d like to have both of those two things, when we present a full data update. So, that will be in 2018.

[Geoff Porges:]

Okay, thanks very much.

[Operator:]

Thank you. And our next question is from the line of Carmen Augustine with Jefferies. Your line is open.

[Carmen Augustine:]

Hi there, thanks for taking the question. So, a follow-up on the update on regulatory strategy follicular lymphoma, first just wanted to confirm that the early 2018 update will only be FL? And if so, when you expect to go back to the FDA to talk about DLBCL? Second, as you could comment on, what kind of forum you expect to present the update in, and what level of detail we might be able to see then? Thanks.

[Rob Bazemore:]

Thanks for the question Carmen. So, yes, I think the first update that we plan to provide on the regulatory interactions early in 2018 will be on follicular lymphoma, since that will be the focus of the first interaction that we’re having. In terms of the timing of reengaging with the FDA on diffuse large B-cell lymphoma, as you know, this is a cohort, the patients who have easy EZH2 mutations, we’re continuing to enroll. Unlike in the follicular lymphoma patient population, with the EZH2 mutation, where we saw very clear and compelling benefit of 92% overall response. We feel like that number will continue to evolve in the patients who have DLBCL, with EZH2 mutations. We’d like to engage when we have a better sense of what the real estimate or response rate in DLBCL is. Our goal here with the strategy is to make sure that we ensure ourselves the highest likelihood of success of being able to bring tazemetostat to market for patients with both FL and DLBCL as quickly as we can.

[Operator:]

Does that answer your question, Carmen?

[Carmen Augustine:]

Yes, it does. Thanks.

[Operator:]

Thank you. And our next question is from the line of Matthew Eckler with RBC Capital Markets. Your line is open.

[Matthew Eckler:]

Great, thanks guys for taking the question. So, sticking with the FDA meeting theme here, are you able at all to provide any update around how many patients worth of data you may have by the time you meet with FDA? And then separately, I guess particularly for follicular lymphoma what are your assumptions around the number of patients needed to file?

[Rob Bazemore:]

Yeah, Matt, thank you for the question. We generally don’t provide specific details on ongoing regulatory interactions. I really wouldn’t want to speculate on what the FDA may set as the bar, how many patients they would require for registration, considering that we’ve not had the initial meeting with them yet.

[Matthew Eckler:]

Okay, got it. Understood. And then maybe turning to your current cash guidance, maybe if you could just flush out a little bit more what assumptions go into that? And specifically does this include any assumptions around the need to run an additional NHL study?

[Susan Graf:]

Hi Matt, it’s Susan. In terms of the current runway into at least 3Q of ‘19, some key assumptions in terms of clinical studies that go into that. It does include a confirmatory study for epithelioid sarcoma on the assumption that we have an accelerated approval path for that NDA. It includes a new follicular lymphoma combo study, which we’ve already guided we’ll initiate in 2018. And it includes our initiation of our non-small cell lungs cancer, combination with atezolizumab also in collaboration with Genentech, which will start enrolling patients by the end of this year. It also includes other new activities, which we’ll have on going with [technical difficulty].

[Operator:]

Ladies and gentlemen please standby.

[Susan Graf:]

Carmen can you hear us? I understand that folks on the line can hear us, can you hear us.

[Operator:]

And presenters you may continue.

[Susan Graf:]

Brilliant, thank you Carmen, welcome back. So who is in queue please?

[Operator:]

Matthew Eckler, you may restart with your question.

[Susan Graf:]

Thank you. Did you hear the answer, we are not sure.

[Matthew Eckler:]

I saw -- I heard very little of the first part.

[Susan Graf:]

Okay, start again. When we did the recent financing and updated the guidance to at least 3Q of ‘19 the new studies that we communicated would be included with a confirmatory study for our epithelioid sarcoma program on the assumption that we have an accelerated approval path in that indication. It also included the new follicular lymphoma combo study, which we have guided we’ll initiate in 2018, as well as the non-small cell lung cancer study, which we’re also conducting in collaboration with Genentech and will be a tazemetostat plus atezolizumab combo expected to start enrolling patients by the end of this year. Those were the only new studies included in the run way guidance.

[Matthew Eckler:]

Okay, got it. Understood, thank you.

[Operator:]

Thank you. And our next question is from the line of Mike King with JMP Securities. Your line is open.

[Mike King:]

Good afternoon guys, thanks for taking the question and got to speak to Peter as well, Peter it was great to see you in Philadelphia this past weekend. Maybe we could talk about epithelioid sarcoma, Peter I know we talked about the results that you presented. But I am just wondering if you guys based on your some of the PKPD work that you are doing, how many more dose groups you think you might need to go through before you get the kind of brain penetrants that you’re looking for? And do you feel like you have got enough of therapeutic window that you won’t get an MT, some other MTD while you are searching for better brain penetration.

[Peter Ho:]

Thanks very much Mike and also great to see you at the Molecular Targets Meeting. So the question related to our pediatric Phase 1 trial, which of course is not limited solely to epithelioid sarcoma it’s a group of INI1 negative tumors. And in children unlike that for adults it is the case that a much higher proportion of INI1 negative tumors are primary brain tumors the -- a typical territory rhabdoid tumors ATRT. And so it is for that reason as you mentioned that we are targeting a higher systemic exposure to get greater CNS penetrants. Now we have gone through several dose levels and we're now in the dose expansion phase. So we do not anticipate having to dose escalate further, we selected 1,200 milligram per meter square as our pediatric recommendation phase 2 dose. That does provide a much higher exposure in children than -- systemic exposure in children than in adults. And we certainly hope that that will result in greater CNS penetrants. To be fair we don't know that that is going to be the case, but we hope to learn that from this expansion cohort where we will have a much larger group than the -- and of 6 patients we had in the escalation cohorts to really evaluate well whether indeed we are having effect on tumors that are behind the blood brain barrier.

[Mike King:]

Okay, thanks for the additional color on that. And I just wanted to ask also from a regulatory strategy standpoint. At what point might you consider filing for pediatric rare disorder application for taze in this indication? And do you think that's a realistic avenue to go down?

[Peter Ho:]

That's a great point Mike. And with our regulatory colleagues here, we have been looking into that as possibility for us. So, stay tuned, we’re still exploring that that certainly is something that we are looking at and thinking hard about.

[Mike King:]

Okay. And if I could just shift to the gene panels Rob you had mentioned in your formal remarks. I know that the ASH abstracts are out today I don’t what you can comment about regarding some of the more interesting or provocative gene signatures or markers that might be indicative of response and outcome.

[Rob Bazemore:]

Right Mike. I think first of all that dataset will be updated further before the actual presentation at ASH. But the intent is to be able to present an update on that 62 gene panel there is a data we showed this summer with more patients included. When we showed the panel outcome this summer at ICML we had about 92 patients that we had done the complete analysis. And we intent to have more patients involved in this analysis. So stay tuned, we'll do a final data analysis on that before the presentation in December.

[Mike King:]

Okay, fair enough. And then just finally on the pipeline, you mentioned your G9a program. So wanted to ask just kind from a commitment of corporate resources point of view sickle cell has attracted a tremendous amount of approaches of late between gene therapy and things like what global blood is doing, et cetera. I'm just wondering from a standpoint of commitment of corporate resources whether that is something that will generate a positive IRR? And also at one point in the past, you had mentioned CARM1 I thought has a potential target that has at your radar. And just wondering if that is still a program that you anticipate moving forward? Thank you.

[Rob Bazemore:]

So to answer that maybe I'll ask Peter to comment on the disease and why we feel this is an important opportunity for a molecule like our G9a inhibitor and then Suzan can comment from the standpoint of the resources they were committing to this program at this point.

[Peter Ho:]

Sure, thanks Rob. So Mike as you know we've been mining very hard the HMT space. And one of the efficiencies from having the extensive discovery group having worked on this for years is the ability to take learnings from one HMT in terms of the discovery platform and applying it to other HMT targets. And that's how we came about to looking at G9a and G9a not only in cancer as we do for all of the targets, but in this case sickle cell. So we're really leveraging the science that has been published by others, where G9a was very recently linked to the reactivation of fetal hemoglobin expression, which obviously would be a great thing for patients with sickle cell disease, which is really quite underserved. I mean we've known for a long time that sickle cell right is a monogenic disease. And now we're able to apply an epigenetic approach to that which is really striking for being a very, very different approach than traditional small molecules and even the gene therapy approaches that are being taken now.

[Susan Graf:]

And in terms of the resource that we are investing around this, as you know Mike we have our commitment via our vision 2020 to deliver three new candidates into development as part of our long-term plan. We are taking a disciplined investment approach to what those candidates are and of course as we progress this and the program does become more costly, we will continue to evaluate the impact of the program.

[Mike King:]

Alright, just thank you for those additional details. Peter I assume the G9a program would be an oral program?

[Peter Ho:]

Well, certainly it was Mike we had both oral and IV agents in tazemetostat and pinometostat respectively and we certainly think that having an oral dosing of an HMT inhibitor is the best way to deliver the molecule and to have a pharmacodynamic effect we haven’t spoken to the details of the precise candidate that is to be declared and we will be speaking more to that at ASH, but certainly that’s our philosophy.

[Mike King:]

Okay, great. Thanks again for taking my question guys.

[Operator:]

Thank you. And our next question is from the line of Peter Lawson with SunTrust Robinson. Your line is open.

[Unidentified Analyst:]

Hi this Max moving in for Peter Lawson. I was wondering if you can just clarify in the adult Phase 2 INI1-negative tumor study, it cleared the futility hurdles is the futility hurdle the same as in the other stage where is the response from the first 2 out of the 10 patients?

[Peter Ho:]

So, we haven’t gone into details with respect to the futility hurdle for each of the cohorts here, but suffice to say, I mean, these INI1-negative diseases in adults are really not well served at all by existing therapies and it can range to be very, very aggressive diseases. So, we set the bar accordingly and to just to again to make sure that we’re not seeing insufficient activity in the first stage such that it wouldn’t want enrolling to the second stage. But now that we’ve cleared that for the rhabdoid tumor and other INI1-negative cohorts those two, we will be looking to complete the enrollment and obviously read out the full study.

[Unidentified Analyst:]

And can you give us any color on when we might see that I know it’s going to be updated in 2018, but do you have any guidance about which medical conference or first half or second half?

[Peter Ho:]

Yes, I think it’s a little early for us now since we are working to complete the enrollment, but we certainly will put it out at the appropriate meeting and meeting time.

[Unidentified Analyst:]

Thank you.

[Operator:]

Thank you. And our next question is from line of Robyn Karnauskas with Citigroup. Your line is open.

[Unidentified Analyst:]

Hi this is Greg Harrison [ph] on for Robyn. Thank you for taking my question. Just kind of a big picture question wondering what are the changes we can expect as you guys continue this transition to become more of a commercial company, is there could be any further restructuring or just what we should expect around that change? Thanks.

[Rob Bazemore:]

So, I wouldn’t expect any other significant changes of the executive level, as companies evolve through different stages so do their leadership teams. And based on what the company needs, the planned transitions that we have had this year have been good and they have provided an opportunity for our leaders to step-up and take on expanded roles and they have been good for those individuals and I think for the company. If you look at how we are performing on the research side our intent was to be able to bring three new molecules into the clinic the G9a program is the delivery of the first of those. And then we’ll talk a lot more about that program at ASH. Moving to financing organization under Susan made a tremendous amount of sense in terms of how we think about financing the company going forward using both partnering as well as capital markets. And Susan has done a tremendous job including the most recent financing that we executed just back in September. And then this transition as Peter explained it gives us an opportunity to bring in a seasoned clinical executive who has a tremendous amount of late stage clinical experience, as well as a track record of brining products through the approval process and commercialization. So, I would say that the changes that we anticipate next year going to be adding depth to certain functions that are part of the commercialization of an asset like tazemetostat in the medical affair organization, the marketing organization, manufacturing as we scale up for commercial supply. Those are the kinds of changes that we would anticipate next year.

[Unidentified Analyst:]

Great, thank you.

[Operator:]

Thank you. And our next question is from the line of Geoff Porges with Leerink. Your line is open.

[Geoff Porges:]

Thanks for taking the follow-up question. I just want to talk a little bit -- we see obviously little bit more about chordoma what is the incidence as far as you can tell? And then what might be the development path based on the signal that you are seeing out of the mix patient study? Thanks.

[Peter Ho:]

Yes, Geoff this is Peter. So just to clarify, there are a broader range of chordomas and we're focused on the once that are INI1-negative and they tend to be this group of chordomas that are termed deep differentiated or poorly differentiated to chordomas, which is not the majority of all chordoma patients. So, we've seen some very interesting activity in the pediatric study and as well we're following that up in the adult study now. So really we look at it as a similar path as epithelioid sarcoma, which is of course a rare sarcoma. And so in terms of getting additional clinical data in this group of patients who generally do well with existing therapies and are like epithelioid sarcoma identified by a molecular defect in terms of their sensitivity to EZH2 acquisition. It’s early days and I don't want to overstate things, but certainly one can see that there may be a similar path to an eventual registration in this very focused population that again shares the commonality of INI1 laws.

[Geoff Porges:]

Okay. Thanks, Peter.

[Operator:]

Thank you. Ladies and gentlemen this concludes our Q&A section for today. I would like to turn the call back to Rob Bazemore for his final remark.

[Rob Bazemore:]

Thank you. 2017 has been a transformational year for Epizyme where we’ve delivered on the number of significant milestones. 2018 will again be a pivotal year for the year with numerous important data readout, new trails begging and submission of our first NDA. Thank you again for joining us today, and we look forward to talking more in the days and weeks ahead.

[Operator:]

And ladies and gentlemen, thank you for participating in today’s conference. This concludes the call, and you may all disconnect. Have a wonderful day.