Epizyme's (EPZM) CEO Rob Bazemore on Q2 2016 Results - Earnings Call Transcript

| About: Epizyme (EPZM)

Epizyme (NASDAQ:EPZM)

Q2 2016 Earnings Conference Call

August 08, 2016 08:30 AM ET

Executives

Julie DiCarlo - SVP of IR

Rob Bazemore - CEO

Peter Ho - CMO

Andy Singer - CFO

Analysts

Phil Nadeau - Cowen and Company

Mike King - JMP Securities

Peter Lawson - SunTrust

Rich Goss - Leerink Partners

Simos Simeonidis - RBC Capital Markets

Operator

Good morning, and welcome to Epizyme’s Second Quarter 2016 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 Julie DiCarlo, Senior Vice President of Investor Relations. You may begin.

Julie DiCarlo

Thank you. Good morning everyone and thank you for joining us on Epizyme’s second quarter 2016 results conference call. Earlier this morning, we issued a press release outlining our financial results, which is available in the investor center of our website at www.epizmyme.com. Joining me on the call are Rob Bazemore, Chief Executive Officer; Dr. Peter Ho, Chief Medical Officer; and Andy Singer, Chief Financial Officer. Additional members of the Executive Team will be joining us for the Q&A portion of the call. During today’s call, we’ll be making forward-looking statements related to the Company’s future expectations, plans and prospects. These statements are subject to risks and uncertainties. Our actual results may differ materially as a result of various important factors, including those described in the risk factor section of our Form 10-Q filed earlier this morning. These statements represent our views as of today 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.

I will now turn the call over to Rob.

Rob Bazemore

Thanks you Julie and thank you all for joining us this morning. Before we begin, I want to welcome Julie DiCarlo to Epizyme as our new Senior Vice President of Corporate Communication and Investor Relations. Julie brings tremendous experience leading global strategic communications initiative including [indiscernible] through its acquisition by Merck. Her contributions will be invaluable to further enhancing our communications and our connections with the investment committee. The first half of 2016 was an exciting and productive time for Epizyme with progress made on all aspects of our multi-year vision. Our focus through 2020 is an on completing the trials necessary to launch tazemetostat globally; expanding the clinical utility of tazemetostat into new tumor types and treatment settings as both a monotherapy and in combinations; advancing our wholly owned discovery pipeline to discover three new programs into the clinic; and building upon our leadership position in the field of epigenetic drug development.

For today's call, we'll focus on the ongoing and planned development of tazemetostat in patients with non-Hodgkin lymphoma or NHL and patients with genetically defined solid tumors. I will also talk about our revised thinking on the next critical updates from our phase 2 studies and Andy will comment on the extension of our operating runway, which we announced this morning. Our global program with tazemetostat is well underway. Tazemetostat is a first-in-class inhibitor of EZH2, a protein implicated in a broad range of cancers. We're excited to develop this novel therapy as a twice-daily, oral product candidate, having already established clinical proof of concept in both hematological malignancies and solid tumors. This is our first public call since announcing the early data from our registration supporting Phase 2 study of tazemetostat in NHL. And we are very pleased with the early data that we reported at the ASH Meeting on Lymphoma Biology in June, which were in line with our expectations.

Let me now turn the call over to Peter to give more color on the early NHL data as well as update on our solid tumor program. Peter?

Peter Ho

Thanks, Rob. As a reminder, the phase 2 trial is a global study designed to evaluate the safety and efficacy of tazemetostat in five different subtypes of NHL, and to determine potential paths toward registration in each subtitle. As of the date of cutoff date in late May, approximately 30% of the total 270 patients have been enrolled. These relapse to refractory patients were heavily pretreated and many have had four, five or even more prior therapies. There is tremendous need for these patients, who have a poor prognosis, a low rate of survival and no meaningfully effective treatment options today. The data highlight three important features of this potential therapy. First, tazemetostat continues to demonstrate a favorable safety profile, now in a much broader set of patients from study sites in multiple countries. A majority of adverse events were mild and resulted in very low rates of dose reductions and/or discontinuations. The safety profile for tazemetostat and it's convenient oral dosing are important product attributes for the long-term treatment of patients.

Second, tazemetostat treatments demonstrated clinical activity in all five subtypes of diffused large B cell lymphoma and follicular lymphoma. Across the various arms of the study reported, between 50% and 86% of patients were refractory, meaning they never responded to their last treatment. Among the 47 efficacy valuable patients we reported on, both objective responses, including complete and partial responses and ongoing disease stabilization were observed. All of the patients who achieved a complete response and the majority of patients who achieved a partial response or stable disease as best response were still on tazemetostat treatment as of the date of cut off. Third, we're continuing to see a pattern of tumor reduction over time, some patients demonstrate an objective response by the first scan and others have responses that deepen with continued treatment.

In June, we reported on a follicular lymphoma patient from our phase 1 study whose tumor improved to a complete response after nearly two years on therapy. This appears to be a unique characteristic of tazemetostat, such that with patients stay on treatment, they can experience continued benefit and even improvement over time. As the phase 2 study progresses, we anticipate seeing an increase in and deepening of tazemetostat responses along with longer durations of response for many patients who remain on therapy. Enrollment in the phase 2 study is proceeding according to our internal projections. We are pleased to report that we have recently opened enrollment in the US and are initiating additional sites globally.

In addition to the progress in NHL, our ongoing program in adult and pediatric patients with certain genetically defined solid tumors is also advancing well. Our phase 2 study in adult patients with the INI1-negative tumors or synovial sarcoma is enrolling on track at sites across six countries, with more sites coming. We are further enhancing our efforts to recruit patients in the study using rare disease patient identification and recruitment strategies. We were honored to be invited to speak at FDA's pediatric subcommittee of the Oncology Drugs Advisory Committee, which met in June to review novel targeted agents for the treatment of pediatric cancers. Committee members were supportive of our ongoing pediatric clinical program and the safety profile of tazemetostat. We are well into the dose escalation portion of our Phase 1 study and look forward to moving into the dose expansion part of this trial. We believe this is a promising, first-in-class agent and look forward to presenting mature data as the studies progress.

Now let me turn the call back to Rob.

Rob Bazemore

Thank you, Peter. Looking ahead to the remainder of 2016, our focus is on execution of these registration supporting trials of tazemetostat to further define its clinical benefit. As Peter described, tazemetostat has a unique product profile in both NHL and solid tumors with a novel mechanism of action that can result in responses that develop and deepen with extended treatment. Given what we know about tazemetostat's mechanism, we believe that it is important, when presenting data on these trials, to enroll enough patients and allow enough time to see the true effect of tazemetostat, including objective responses, durability of responses and the differences between the patient cohorts. Presenting data too early may, in fact, under represent the true clinical benefit.

We now plan to present data from our phase 2 studies in both NHL and solid tumors in the first half of 2017. This decision has no implication on our development timelines for tazemetostat and we believe that this is in the best interests of physicians and the patients who are participating in the study as well as our shareholders. In mid-2017, we intend to meet with regulatory authorities, beginning with the FDA, depending on the data. The goal of these interactions is to review our phase 2 data from all cohorts in the solid tumor study and discuss registration strategies. We also intend to meet with the agency to review the phase 2 NHL data in 2017. We expect these discussions will inform the next steps towards registration of tazemetostat.

In parallel to these efforts, the team is executing our strategy to expand the clinical program for tazemetostat, leveraging its full pipeline within a product potential in new indications and in combinations. Our global clinical trial evaluating tazemetostat in the next cancer indication, mesothelioma, is now open for enrollment. We expect patient dosing in the US to begin imminently. Nearly half of all patients diagnosed with mesothelioma have tumors that are characterized by BAP 1 loss of function. This Epizyme sponsored trial represents a new area for tazemetostat development in a well-defined patient population for which there is clear, unmet need. There is strong external excitement about tazemetostat from industry as well as the scientific and medical communities.

We’re delighted to be collaborating with Genentech, a member of the Roche group, to investigate tazemetostat in combination with Tecentriq, the first and only approved PD-L1 immunotherapy in patients with relapse to refractory DLBCL. The trial will be managed by Genentech and is scheduled to begin in the second half of the year. Preclinical data show that EZH2 inhibition may have a priming effect on the immune system and improve the activity of checkpoint inhibitors. This collaboration with a global hematology and oncology leader is an example of our strategy to use partnering to broaden and to accelerate the development of tazemetostat, while conserving our resources.

We are also working towards initiation of a second combination study that will evaluate tazemetostat in the frontline setting with R-CHOP and DLBCL. This study extends our reach with tazemetostat into the first-line setting, an important component to evaluating the full therapeutic potential for this agent. We’re collaborating with the Lymphoma Study association who will sponsor this trial in newly diagnosed, high-risk elderly patients, which is expected to start in the second half of this year. As you've heard, it's been a very productive first half of 2016 and we have a number of new study starts planned for the second half that are designed to expand the clinical utility and the value of tazemetostat.

Let me ask Andy to provide an update on our financial position and on our investment strategy. Andy?

Andy Singer

Thanks, Rob. Epizyme is in a strong financial position, with $289 million in cash, cash equivalents and marketable securities as of June 30 with no debt. And as we announced this morning, we expect our runway to extend into at least the second quarter of 2018. R&D expense for the second quarter of 2016 was $21.5 million as compared to $20.6 million for the second quarter of 2015. We have significantly redirected our R&D expenditures to match the business goals laid out in our 2020 vision. We have expanded both the NHL and genetically-defined solid tumor studies of tazemetostat and modestly increased our investment in discovery activities. For the rest of 2016, we plan to broaden the clinical development of tazemetostat with the initiation of the mesothelioma and combination trials and as a result, our R&D expenses will increase.

G&A expense for the second quarter of 2016 was $7.4 million as compared to $6 million in the second quarter of last year, as we made important additions to the senior management team to further position us to achieve our 2020 goals. Our core component to our long term strategy for value-creation is maintaining financial discipline. We will carefully manage the anticipated growth in our costs. In particular, through the next data disclosures and the regulatory interactions that will guide future spending. Clinical development is a significant portion of our investment and we are prioritizing the new indications in combinations for tazemetostat that we believe have the maximum potential to deliver benefit for patients. We have also prioritized the new target discovery and drug discovery activities that we believe have the greatest potential to deliver high-quality development candidates and INDs over the coming years.

As a result of these efforts, we are updating our financial guidance. Based on our revised operating projections, we believe that our capital will be sufficient to fund the Company's operations into at least the second quarter of 2018. The goal of this extended runway is to allow us to maintain our financial strength well past key milestones through mid-2017. We have many additional options available to further improve our financial strength. We have a platform that is now largely unpartnered. We own tazemetostat globally outside of Japan. And we have the ability to gate future spending, as appropriate, to meet our long term goals. In summary, we have a solid cash position today, and we're well positioned to execute on our corporate strategy.

Now let me pass the call back over to Rob.

Rob Bazemore

Thank you, Andy. As we approach my one-year anniversary with Epizyme, it's a great time to reflect on our achievements in that period and where we're heading. I believe that Epizyme has an approach to epigenetic drug discovery and development that is unmatched in the industry. In the last five years, we've discovered three novel epigenetic therapies, two of which are in the clinic now being developed by Epizyme and one that will be entering the clinic later this year by one of our partners. Our pioneering work in epigenetic drug development is led by the advancement of tazemetostat in a number of cancer indications and treatment settings.

Our unique scientific capabilities have enabled us to expand our platform into new epigenetic target classes that are likely to be highly important in oncology. Our discovery research is yielding exciting new targets for which we are developing novel, small molecule programs with a goal of creating a sustainable pipeline of clinical candidates. We have established a foundation of strategic collaborations that allow us to accelerate our portfolio, while helping manage our resources and extend our financial runway. And finally, our exceptional team remains wholly dedicated to bringing epigenetic therapies to the many patients who can benefit from them.

With that, we'll open up the calls to your questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Phil Nadeau from Cowen and Company. Your line is open.

Phil Nadeau

I guess first, on the upcoming clinical updates. It seems from your prepared remarks and the language in press release that you haven't plan on presenting anything at ASH. I'm just curious, first, whether that interpretation is correct? And then second, what's the reasoning for that? Why not give some update towards the end of the year?

Rob Bazemore

Phil, yes. That's correct and thank you for the question. Our intent is not to present an update on data at ASH. We plan to present in the first half of the year. As I've said in the remarks, I think given what we know about the mechanism of tazemetostat now, it's important that we make sure that we're able to enroll enough patients, allow enough time to see the impact of tazemetostat and that includes three important parameters, they include objective responses, which is obviously, one of the things that we've talked about at ASH Lymphoma. But also durability of those responses and be able to really describe the differences between the patient cohorts. And we think that presenting data too early may actually under represent the true clinical benefit and not allow us to achieve those goals. So we want to present the next update when we're able to describe those things in more detail.

Phil Nadeau

Then second, on the potential to register in NHL, specifically, based on the phase 2 trial, just curious whether your thinking has changed? Or if you learned anything from the announcement that Celgene's REMARC trial failed?

Rob Bazemore

Our assumption - so this - the announcement of when we plan to present data in no way changes our assumptions around the clinical development of the molecule. It also doesn't change our intentions with regards to regulatory strategy. As I said, we intend to approach the FDA next year with our NHL data and this doesn't change that at all. Would you like to comment further? Okay.

Operator

Thank you. Our next question comes from the line of Mike King from JMP Securities. Your line is open.

Mike King

Good morning, guys. Thanks for taking the questions as well. Maybe just to follow-up where Phil left off. I guess, Rob, the characteristics of tazemetostat have long been known in terms of time to response, durability of response. So I'm just wondering, I just find timing a little curious. Was this something that was decided at the board level? I guess just I'm a little bit puzzled by the decision.

Rob Bazemore

Well, so Mike, we have talked about this very broadly. And in fact, if you remember at ASH Lymphoma, we indicated that if possible, we may not present the next update at ASH because of the way that we see the responses evolve. Keep in mind, when we present the data at the ASH Lymphoma meeting, we have done a major financing in the early part of the year and we felt that it was important to show an early look at the data and how the study was progressing and in fact that was progressing exactly as we had planned. We thought that was beneficial, both to the scientific community as well as the medical community and to our investors.

We are very pleased by what we saw, and we certainly looked at the data, it was in line with what we expected at the time and I believe that we indicated that at ASH Lymphoma. Yet it would still raise some questions because it wasn't in line with our Phase 1 experience. And that's the trial where our patients have been on drug now for two years. So given what we know about the mechanism and we learn more about it, as we do these studies, we believe it's important to enroll enough patients and allow enough time to see the true effect or we present the next tranche of data.

Mike King

Okay. Fair enough. And just I guess in absence of that then, can you give us any - even qualitatively, I know you say your trials are enrolling. You're pleased with the trial enrollment but if you can just give us some approximation of how much more advanced the enrollment is in the [indiscernible] studies.

Rob Bazemore

Yes. We're not providing any specific updates, I can only tell you that we're continuing to enroll patients as we expected. We are enrolling patients with EZH2 mutations at the rate that we would expect as a part of the whole. We're very pleased by the enrollment and we're pleased by the data that we've seen so far on the study and will continue to provide updates as they're meaningful, we'll continue to provide those.

Mike King

Okay. And then one quick question for Andy. And I just - guess I wasn't paying close enough attention, but just the extension of the cash runway just if you could repeat how you guys accomplished that. Thank you.

Andy Singer

Sure. So the extension of the runway is now that we have cash until, at least the second quarter of 2018. And this was really a process of focusing our investments in the areas, both in clinical and research that have the maximum potential to allow us to deliver against our 2020 goals. So this is a process that's been going on now for about five months since we rolled out the 2020 vision. It involves focusing our expenditures and also creative deal making if you think back on the [indiscernible], Genentech deal, these are creative partnerships that allow us to leverage our cash and further extend our runway and really do more with less.

Mike King

Okay. All right. Thanks guys.

Rob Bazemore

Mike, just one other point I guess to your question. I just wanted to reiterate and that is what is our focus in the second half of the year, given that we're not presenting data at ASH. The second half, for us, is really about execution. We've been very transparent with you about the things that we intend to do, both in the fourth quarter of last year as well as we rolled out our 5-year vision for the company and we're executing on all those things that we laid out that's important to the company. The second half is all about executing. It's about enrolling these two large Phase 2 studies so that we can get the data as quickly as we can.

We're adding three new tazemetostat studies in the second half alone. We have mesothelioma study, which is now open for enrollment. We're adding the two new combination studies. All three of these are going to have substantial value implications for tazemetostat. We're preparing our strategy to be ready to talk to the FDA about our tazemetostat data once we see this Phase 2 data. So there's an awful lot going on this year. It's really about executing on the plans that we've communicated very clearly and are putting in place.

Mike King

Yes. Sorry, to ask another question but just based on that comment, the one update you didn't provide was regarding other small molecule epigenetic modifiers. And just wondering if you're still planning on delivering those along the same timelines as you had guided the 2020 vision? And whether the spending continues at the same level as it has?

Andy Singer

Yes. Thank you. So the majority of the investment that we make continues to be in tazemetostat. Obviously, that's in the short term, the most important value driver but we do continue to invest in the pipeline. We think we have the potential to build incredible value beyond tazemetostat, but we have to invest to be able to do that. Nothing has changed with regards to the timelines. We're continuing to look at a number of different targets, HMTs as well as other chromatin modifying proteins. We're making great progress against those. And we look forward to providing an update on our platform and our discovery pipeline as we approach 2017.

Rob Bazemore

Yes, Mike. I'd just like to add one point which is to reiterate that our adjustment in spending in runway is completely consistent with achieving our objectives under the 2020 vision that we rolled out back in March.

Mike King

Okay. Thanks for explicitly stating that. Appreciated.

Operator

We'll be taking our next question from the line of Peter Lawson from SunTrust. Your line is open.

Peter Lawson

Thanks for taking my question. Just, I may have missed this, but on the follicular lymphoma, has that passed the utility hurdle and when would we see a readout of that?

Rob Bazemore

So I'll direct that question to Peter.

Peter Ho

Yes. Hi, Peter. Peter Ho here. So, as you know, we have reported on response in all of the five arms for this study and there are a number of patients still in the follicular lymphoma wild type arm who are still on treatment and we're following them actively. For this cohort, we've not yet reached the point where utility has been assessed. But either way, whatever the result is, we do plan to disclose the result of that assessment when we have sufficient data to take to the independent data monitoring committee.

Peter Lawson

Got you. Thank you. And then selecting the data, when can we potentially see that? Doesn't seem if it’s this year or either.

Peter Ho

Well, we haven't guided as to the timing of that, but certainly, it's our intent to assess that data as quickly as possible and to report that out for the purposes of completing the trial.

Peter Lawson

Got you. And then the pushback in the trial readouts, is that associated with any longer-than-expected or anticipated time to get a response rate in an NHL patient? Has that changed in anyway?

Peter Ho

No, not at all, Peter. What we're seeing in the Phase 2 study, as we reported out at ASH is very consistent with what we've seen in Phase 1. Obviously, the Phase 2 study, it was much larger in terms of each cohort. And it really is the desire to bring forth a larger and more complete data set when we do present the data.

Peter Lawson

Got you. And should we be thinking about like AACR as a venue for the next set of data?

Peter Ho

Well we haven't decided as yet as to what forum the data will be presented but we are planning for data updates in mid-2017 and we look forward to letting you know more details about that as we get closer.

Peter Lawson

Okay. Thank you so much.

Operator

Our next question comes from the line of Seamus Fernandez from Leerink Partners. Your line is open.

Rich Goss

Hi. This is Rich Goss calling in for Seamus. Thanks for taking my question. Just regarding your upcoming atezolizumab combo trial, just wondering if you can provide some more color on why you decided on collaborating with Roche in particular? Do you believe there's a biological reason why tazemetostat might combine better with PD-L1 versus the PD-1 or do this mostly come down to economics or specific deal terms? Thanks.

Rob Bazemore

Yes. So this is Rob. I'll start with the answer and then Peter may want to add to it. I think we had an opportunity to look at a number of different partners. We weren't focused, in this case, as much on the specific molecule. We didn't think that in terms of demonstrating proof of concept, there would be large differences between the molecules. We’re actually focused more on the right partnership. And we were looking for a partner who was a, willing to share the cost of the study, not just provide study drug. We were looking for a partner, obviously, who would be willing to execute the study because we have a number of trials, not only our large Phase 2 trials that are already ongoing.

We're starting in mesothelioma study and we wanted a partner who would be willing to execute the trial with us. The other that was important was a partner who was willing to put in place a robust biomarker, just part of the study set, and we can actually look at the underlying mechanism of what was happening between the two agents. So that if we see clinical efficacy, we can actually understand what's driving that. That might inform future studies. It might even inform future directions in terms of where the competition could be useful. And we found that Roche, Genentech was the appropriate partner to do this with. Peter, I don't know if you want to add to that.

Peter Ho

Yes, Rich, I mean, just to reiterate, as you know for our own studies, the NHL study and the genetically-defined solid tumor study, biomarkers and translational research is a very important component to that, and we put a lot of effort behind that. We talked about the 62-gene panel that we're using to try to look for biomarkers for a response or resistance in the patients of the NHL study. And we have similar type efforts ongoing in our solid tumor study. So likewise, in this area that we're moving into, the combination with immune oncology agent, very exciting for us. It was important for us to work with a partner who is very aggressive and in looking at the translational research that goes along with that. And I can just say at the team level, our biomarker team has been interacting very, very well with that of Roche's already and so we're really excited to move forward in that area.

Rich Goss

Okay, great. Thank you.

Operator

Thank you. Our next question comes from the line of Simos Simeonidis from RBC Capital Markets. Your line is open.

Simos Simeonidis

Hi, guys. Thank you for taking the questions. In your press release and your prepared remarks, you spoke about the two different instances of meeting with FDA. In one case, you said meet with the FDA in mid-17 to discuss NHL and solid tumors. And then you talked about meeting with the FDA in 2017 to discuss NHL. Can you help us understand these two different cases?

Rob Bazemore

Yes, Simos, this is Rob. I’ll start and then Peter may want to add as well. But the reason that we look at them separately is we anticipate the firs interaction will be around the genetically defined solid tumors. The reason they are also separate is that they actually are discussed with two different review divisions of FDA. So they’re actually two separate meetings. So the plan is that we would present the data first on our genetically-defined solid tumors, Phase 2 program, starting with the FDA and then we would meet with the European regulatory authorities after that. And then we would also schedule meetings on the Non-Hodgkin Lymphoma Phase 2 data as well. But they are different review divisions of FDA. So they have to actually be scheduled separately.

Simos Simeonidis

I see. Okay. Great. That's very helpful. And then in terms of the Roche trial, the partnership trials with Roche, can you tell us the approximate size of each trial? And roughly, when we might be seeing the first top line data?

Peter Ho

Hi, Simos, this is Peter. This combination study that we're doing with atezolizumab will be conducted by Roche and as we get closer to the start of that study, we’ll provide more details, but right now, it's a little too early to describe those details.

Simos Simeonidis

Okay. So last question, in terms of the size of the potential opportunity for mesothelioma, I know you said roughly half the patients have a BAP1 loss of function, in terms of commercial opportunity, how should we think about that?

Rob Bazemore

So globally, if you look at all of mesothelioma, it's about 12,000 patients. And so the BAP1 loss of function patient population is about half of that, globally. And this is a patient population for which, from a commercial point of view, there is a significant unmet need here. There is first line therapy for these patients, but beyond that, there really isn't available for treating them and so this will be an important opportunity, not only commercially but just in terms of meeting a substantial unmet patient need if tazemetostat were to succeed in the study.

Simos Simeonidis

Okay. And finally, I know you're not going to show clinical data for another nine months or so. But in terms of what you can tell us of your understanding at this point of how the drug works between EZH2 wild-type and EZH2 mutant patients. I know that's something you're going to have to talk to FDA about what is your progress that you've done there? What do you know today that you didn't know 6 or 12 months ago?

Rob Bazemore

Well, I'll start. The latest data that we presented was that, that we presented at ASH Lymphoma, where we were excited to see that we are seeing activity across all five arms of the study. Based on what we know now about the mechanism, the work that Bob Copeland and his team have done in research as well as Peter in the clinical development team, we come to understand that there's a role of EZH2 in all of these subsets and we're seeing that clinically. One of the reasons that we want to wait, Simos, for the next data presentation is that we actually want to be able to describe the differences between the treatment arms and answer that question and that's part of the reason that we feel that presenting data before that will be premature because we want to be able to answer exactly that question.

Peter, I don't know if you want to add to that.

Peter Ho

Sure. So as Rob mentioned, it really is about gathering a larger patient end essentially in each of the cohorts to see what those differences are in between the cohorts. And then along with that, one of the things that we had presented earlier at the ASH 2015 from the Phase 1 trial is some preliminary biomarker work, again looking at potential indicators of treatment response, sensitivity or resistance. And with the 62-gene panel work that I mentioned previously that's ongoing, and this is an internally-developed panel of genes that we're using to test all of the patients who come on study, we are looking for that to help us to understand much better the biologic underpinnings behind why we’re seeing the sensitivity beyond the EZH2 mutation. As you know, we have seen activity in Phase 1 and early on, we reported in the phase 2, in the non-GCB cohort as well, and we think that this work will be very important for us with more mature data of course, to helping to understand those biologic underpinnings.

Simos Simeonidis

Great. Thank you very much.

Operator

Thank you. Ladies and gentlemen, this now concludes today's Q&A session. I'd like to turn the call back over to Rob Bazemore, CEO, for closing remarks.

Rob Bazemore

Okay. Thank you. And as you've heard, we've made great progress so far in 2016 and I think we're entering the second half of the year with really strong momentum. We look forward to keeping you updated on the continued execution of our multiyear vision. Thank you all. Have a great day.

Operator

Ladies and gentlemen, thank you, again, for your participation in today's conference. This now concludes the program. And you may all disconnect at this time. Everyone, have a great day.

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