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GlycoMimetics (NASDAQ:GLYC)
Q2 2018 Earnings Conference Call
Aug. 10, 2018 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, and thank you all for joining the GlycoMimetics call. [Operator instructions] I would now like to turn the call over to Shari Annes of the investor relations group at GlycoMimetics. Please go ahead.

Shari Annes -- Investor Relations

Good morning. Our goals today are to highlight the key achievements of the second quarter, outline the upcoming milestones we anticipate, and to brief you on key financial results. The press release we issued yesterday afternoon is available in the news section of the company's website at www.glycomimetcs.com. This call is also being recorded.

A dial-in phone replay will be available for 24 hours after the close of the call. The webcast replay will also be available in the Investor Relations section of the company's website for 30 days. Joining me on the call today from GlycoMimetics are Rachel King, chief executive officer; Brian Hahn, chief financial officer; and Dr. Helen Thackray, senior VP of development and chief medical officer.

We will start today's call with comments from Rachel; and after that, Brian will provide an overview of the company's financial position. When we open the call for Q&A, Helen will be available to provide clinical perspective in response to your questions. I would like to remind you that today's call will include forward-looking statements based on current expectations. Forward-looking statements contained on this call include, but are not limited to, statements about the development plan for GMI-1271, which we are now referring to as uproleselan, or upro, and for rivipansel, like GlycoMimetics product candidate licensed to our collaborator Pfizer and our other pipeline programs.

Such statements represent management's judgment and intention as of today and involve assumptions, risks, and uncertainties. GlycoMimetics undertakes no obligation to update or revise any forward-looking statement. Please refer to GlycoMimetics filings with the SEC, which are available from the SEC or on the GlycoMimetics website for information concerning the risk factors that would affect the company. I'd now like to turn the call over to Rachel.

Rachel?

Rachel King -- Chief Executive Officer

Thank you, Shari, and thank you all for joining our call this morning. During the second quarter of this year, we continued to advance our development plans for uproleselan or GMI-1271 in AML by announcing an agreement with the National Cancer Institute to support a pivotal Phase 3 trial to evaluate upro in older patients with newly diagnosed AML who are fit for intensive chemotherapy. This trial, along with our own pivotal Phase 3 trial and the HOVON consortium trial, positions us to explore the use of our candidate across the spectrum of AML. With two of the world's leading consortia as our partners, we believe that we're executing on a unique strategy to produce meaningful data.

This data could potentially expand labeling and use of the product beyond what the company-sponsored Phase 3 trial alone could achieve. More specifically, we announced at the end of May, the signing of a Cooperative Research and Development Agreement or CRADA with the NCI, part of the NIH. Under the terms of the CRADA, GlycoMimetics will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized controlled clinical trial testing the addition of upro to a standard cytarabine/daunorubicin or seven plus three regimen in older adults with previously untreated AML who are suitable for intensive chemotherapy. This Phase 3 trial will be led by Dr.Geoffrey Uy, Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia at the Washington University School of Medicine in St.

Louis. This primary endpoint will be overall survival with a planned interim analysis based on event-free survival after the first 250 patients have been enrolled in the study. The NCI support at this clinical development program in AML reflects a high level of interest from the U.S. leading clinical investigators and thought leaders in leukemia research.

Based on our Phase 2 data, we and our consortia partners believe upro has a profile that could allow it to become the foundation of treatment across the continuum of care in AML. This is an important collaboration for us as we seek to fulfill the potential of this novel therapeutic. Under the terms of the CRADA, the NCI may also fund additional research including clinical trials involving pediatric patients with AML, as well as preclinical experiments and clinical trials evaluating alternative chemotherapy regimens. GlycoMimetics will supply upro, as well as provide financial support to augment data analysis and monitoring for the Phase 3 program.

As you recall, and I won't spend time on details we laid out for you during last quarter's call, we're also working with the HOVON consortium in Europe to conduct a randomized controlled clinical trial evaluating upro in newly diagnosed patients who are unfit for chemotherapy. Across our GMI, NCI and HOVON-sponsored clinical programs, we expect to have over 850 patients treated in Phase 2 and 3 studies, evaluating upro, which we believe will result in a comprehensive data set for this product. As you know, uproleselan has received Breakthrough Therapy Designation in relapsed/refractory AML from the FDA. If the results from each of these studies are positive, we expect that the totality of the data could support a broad use across the continuum of care in AML.

I'm pleased to report our own Phase 3 trial and both of the consortia-sponsored trials are actively working to initiate patient enrollment. For our own trial in relapsed/refractory AML, we anticipate study initiation during the current quarter. We plan to have the majority of our study sites in the U.S., but also to have meaningful participation from leading centers in other strategic countries as well. I'd now like to turn to rivipansel in our sickle cell program.

Pfizer, our collaborator, said earlier this year that they anticipated top-line data from the ongoing Phase 3 clinical trial by the end of 2018. They recently notified us that their timeline has shifted slightly. They now expect this trial to complete enrollment in early 2019, with a top-line data readout in the second quarter. Pfizer's confident about its projection, in that enrollment is already approximately 75% complete.

As they indicated in their own earnings release, the projected completion date is calculated based on historical enrollment over the last 12 months. I'd like to highlight a number of key aspects of the rivipansel program that we believe position it well as we anticipate the top-line readout. First, we believe that the selectins have now been established as important targets in sickle cell disease based on data from two randomized controlled trials in sickle cell patients. Our own rivipansel Phase 2 trial, of course, showed important improvements in treated patients and the data were chosen for Best of ASH when it was prevented.

The other was the trial conducted to test a drug being studied by Novartis for prevention of vaso-occlusive crisis in sickle cell disease. Both of these studies showed improvements in clinical endpoints, which we believe is key support for the relevance of this target in this disease. Second, data from our Phase 2 study showed meaningful improvements, not just in biomarkers but in clinical endpoints across all endpoints studied and in all subgroups analyzed. The consistency of that data set also contributes to our confidence.

Third, the ongoing Phase 3 trial was designed based on data from the Phase 2, which is being even more rigorously collected in the Phase 3 with use of a simple checklist that's evaluated at regular time points during hospitalization. This is also being done under a special protocol assessment agreed to with the FDA, so we have clear guidance as to what should be an approvable result from the trial. Finally, with a study that's four times larger than the Phase 2, we believe that the trial is well powered to show a difference between drug and placebo. For all these reasons, we believe the program is well-positioned for potential clinical and commercial success as we anticipate the top-line readout now projected by Pfizer for the second quarter of 2019.

If this Phase 3 trial is positive and if the drug is approved, rivipansel would be the only on-demand therapy that selectively disrupts an ongoing vaso-occlusive crisis to decrease time in the hospital. While other drugs are being developed as prophylactic therapies in the sickle cell arena, rivipansel has the potential to be the only on-demand drug on the market that could reduce time in the hospital and reduce use of opioids during a pain crisis. As a reminder, in our blinded randomized controlled Phase 2 trial, we observed a statically significant 83% reduction in narcotic use in patients receiving rivipansel compared to patients receiving the control. This observation is particularly important in the context of the opioid crisis our nation is currently facing.

In addition to evaluating this endpoint in the Phase 3 trial, our main goal of the therapy will be to abort the crisis and to get patients out of the hospital faster. Thus we believe rivipansel has the potential to demonstrate meaningful clinical and pharmaeconomic benefits with clear value to patients, physicians, and payers. Simply put, we will not be relying only on biomarker improvements with rivipansel to support our commercial proposition. As we think about the market potential for rivipansel, we'd like to call your attention to Pfizer's recent corporate statement, describing rivipansel as a potential blockbuster.

They estimate possible peak sales greater than $1 billion based on major addressable markets. Under our agreement with Pfizer, GlycoMimetics is entitled to double-digit royalties on rivipansel product sales. GlycoMimetics is also entitled to receive potential future development, regulatory, and commercial milestone payments of up to $285 million in aggregate, with the next milestone payment due to us on acceptance of an NDA for rivipansel. After that, we're entitled to a further milestone payment upon the first commercial sale in the U.S.

We're also eligible for similar regulatory and commercial milestone payments based on progress in the European Union. While we're not able to disclose details at this point, these are meaningful financial milestone payments, which, together with potential royalties from sales of the drug, would add substantially to our cash balance and further extend our cash runway. We continue to execute across our portfolio and plan to nominate a second solid tumor trial population -- excuse me, plan to nominate a solid tumor trial population for GMI-1359, our dual E-selectin CXCR4 inhibitor program, which we anticipate announcing later this year. In preclinical models, we've observed both single-agent activity, as well as synergistic antitumor activity when GMI-1359 is combined with metatoxic drugs and with checkpoint inhibitors.

GMI-1359 has also been observed to have effects on modulating the tumor micro environment, including shifting the inter tumor T-cell population. Thus we're particularly excited about the potential of this drug candidate to be combined with both chemotherapy and checkpoint inhibitors. In addition, at the earlier stage, we continue to make progress at our other programs that leverage our unique chemistry expertise toward identification of additional differentiated treatments of unmet needs. In particular, these include our galectin programs targeted at fibrosis and oncology and our work in discovery of potential glyco-immune checkpoint inhibitors targeting enhancement of NK cell functions in cancer.

As CEO, I'm proud of the progress we've made and very much look forward to the value-creating opportunities we hope to deliver as we announce rivipansel top-line data and continued progress with upro and other programs in our pipeline. I do believe we have uniquely been successful in progressing truly differentiated drug candidates from discovery well into late-stage development, an achievement which I hope will primarily reward patients but also shareholders and employees. Let me now turn the call over to Brian, who will review our financials with you. Brian?

Brian Hahn -- Chief Financial Officer

Thank you, Rachel. As of June 30, 2018, GlycoMimetics had cash and cash equivalents of $229.4 million, compared to $123.9 million as of December 31, 2017. The company successfully completed a follow-on public offering of 8,050,000 shares, netting proceeds of $128.4 million during the first quarter. The company's research and development expenses increased to $9.3 million for the quarter ended June 30, 2018, as compared to $5.7 million for the prior-year quarter.

The increase was primarily due to higher manufacturing cost for upro clinical supplies as the company prepares for a planned Phase 3 trial and to meet our supply obligations for clinical trials of upro conducted by or in collaboration with third parties. This increase was offset in part by a decrease in clinical trial expenses as patient enrollment for our Phase 1/2 clinical trial of upro was completed in May of 2017. General and administrative expenses increased to $2.8 million for the quarter ended June 30, 2018, as compared to $2.5 million for the prior-year quarter. The increase is primarily due to higher patent and other legal expenses.

In summary, GlycoMimetics is in an excellent financial position to carry out its planned initiatives and to advance applications for its unique technology platform. I'll now turn the call back over to Rachel.

Rachel King -- Chief Executive Officer

Thank you, Brian. With that, I'd like to open the call for your questions. Operator? 

Questions and Answers:

Operator

[Operator instructions] Our first question comes from the line of Yatin Suneja from SunTrust. You may begin.

Yatin Suneja -- SunTrust Robinson Humphrey -- Analyst

Just maybe starting with rivipansel enrollment, could you maybe give a little bit more color? Just trying to understand if it was a one-time delay in enrollment or is there something structural when you're trying to enroll patients in the acute setting that is a little bit difficult. Just really trying to understand how close you are and the confidence around the new guidance?

Rachel King -- Chief Executive Officer

Sure. Well, it is challenging to enroll patients in the acute setting and sickle cell crisis. They can present at any hour of the day and night. It may be that they present when clinical trial staff is not available.

So there are a number of aspects of the acute setting that are simply more challenging than the chronic setting where you can schedule patients to come for treatment at a particular time. So that's, I think, in part just the nature of enrolling in this type of study. As far as the confidence, I think what's important at this point is two points that Pfizer specifically made in their own release. One was that they're reporting, as they reported to us, that the study is already 75% complete in terms of its enrollment, and, in addition, that the current forecast is based on their specific experience with accrual over the past 12 months.

So I would say that it's -- they've expressed a high degree of confidence to us in their ability to complete enrollment, and it's now based on their recent experience with the trial. So I think that suggests that this is a confident prediction of the likelihood getting top-line data in the second quarter.

Yatin Suneja -- SunTrust Robinson Humphrey -- Analyst

Got it. Very helpful. And then on 1271, could you tell us when we should anticipate myeloma data? And what should we be looking at? Is it the N protein level or should we be focusing on the response rate?

Rachel King -- Chief Executive Officer

Yes. The myeloma study is currently enrolling in Europe, and we do still predict that we'll have data in 2019 for that study. That study is specifically looking at M protein as a biomarker, and we are going to be looking at changes to the trajectory of M protein. So it's a very specific proof-of-concept study that we're going to be evaluating.

Not clinical response in the sense that you are typically seeing in myeloma studies, but looking for whether we can change the trajectory of M protein as an indicator of whether we're having an impact of improving responses to the underlying chemotherapy through the addition of 1271 to that background chemotherapy regimen. So that's what we'll be looking for in that trial.

Yatin Suneja -- SunTrust Robinson Humphrey -- Analyst

Got it. And then question on the -- just a broader question on the AML side. I mean, if you look at the landscape, there's a lot going on. I think our check suggests more than 170 studies are ongoing.

So from enrollment perspective, having these consortia, NCI, HOVON, attached to the trial, is it beneficial in enhancing the recruitment for some of these AML centers? And could you also talk about what you are doing to ensure that the consortia-funded trial are of registration quality and will be accepted by the global regulators?

Rachel King -- Chief Executive Officer

Yes. I think that the fact that these consortia, both in the U.S. and Europe, have effectively voted with their feet by supporting these clinical trials is a very strong indication of the interest of KOLs around the world in the uproleselan program, so I think that bodes well for accrual, given the strong support from these important networks of KOLs. I also think that with respect to the changing landscape, which is true in AML, I think that really supports our decision which we made earlier this year to go after what is the most important endpoint in our registration trial, which is the gold standard, which is overall survival.

So as we get that data from that trial, I think that that study design is going to deliver on the endpoint that everybody's going to care most about. And I think it's going to position us as strongly as possible for launch with the data from that endpoint assuming that that's successful. As far as registration is concerned, we are, as I indicated, we are supplementing the work that's being done with these other consortia by funding additional data monitoring, in order to ensure that the data collected from these trials is data that we would be able to use with regulatory agencies. That's actually interesting, it's similar to what Novartis did with the very same consortia, the NCI Alliance when they did their midostaurin trials and they used that data for regulatory approval.

And so we also are planning to supplement the studies with our own support for additional monitoring to ensure that the registration -- that the data is registration quality.

Yatin Suneja -- SunTrust Robinson Humphrey -- Analyst

Got it. And just final question and then I'll get back in the queue. So for the NCI trial, I think the interim is based on 250 EFS [Inaudible]. Could you potentially file based on that? And what is the full size of that trial?

Rachel King -- Chief Executive Officer

Yes. So it's hard to say, of course, if we could file on that endpoint until we see what the data looks like. It is true that there have been studies that have filed on EFS as an endpoint in that setting. But I think it would be premature to speculate about filing on that out of this particular trial, and as for the full size of the trial, that has not yet been disclosed by the NCI.

We expect that it will be soon, and then we'll be able to give the full picture of the trial. But yes, there is a plan to have an interim analysis for EFS after 250 patients.

Operator

And our next question comes from the line of Ritu Baral from Cowen. You may begin.

Ritu Baral -- Cowen & Company -- Analyst

Good morning, everyone. Thanks for taking the question. One on upro and then one on rivipansel. On the new NCI trial, are there going to be any protocol managing or specifying transference readiness or any protocol around when patients will be eligible? Or is it still completely clinician-directed? And then I've got a follow-up on rivipansel.

Rachel King -- Chief Executive Officer

I'm sorry. I'm not sure I understood that question, but I think Helen was nodding so...

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Yes. [Inaudible] So I think the most important thing to understand is that the drug can be used in the context of standard of care. And the NCI has indicated that their comfort essentially with using the drug in the context of standard of care. So that trial is adding the drug to seven plus three for patients with newly diagnosed AML.

And any standard decisions around transplants in the context of those patients we would expect to be made by the provider rather than something that's mandated in the protocol.

Ritu Baral -- Cowen & Company -- Analyst

Got it. And how are you seeing those, I guess, those clinician standards or judgment calls progressing and I guess developing in all the trials, especially in your relapsed/refractory trial?

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Yes...

Ritu Baral -- Cowen & Company -- Analyst

From what we've understood, clinicians are getting more aggressive, and I'm just wondering how that can potentially shift the data that eventually comes out.

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Yes. I think what you're maybe commenting on is in the field especially in older patients, there is a general move to try to get more patients into intensive therapy and then more patients onto transplant where a transplant is seen as a chance of a long-term cure. And I think the addition of uproleselan to chemotherapy may improve the ability of patients to tolerate chemotherapy, and so could potentially allow patients to get to intensive chemotherapy and potentially to get to transplant where they might not otherwise be able to if they just had a standard chemotherapy approach.

So I think the current field is pushing toward increasing the age at which transplant might be relevant and I think the addition of uproleselan in the context of both the newly diagnosed patient population in the NCI trial and the relapsed/refractory population in our sponsored trial could improve the ability of patient -- in each individual patient to get to transplant if they are in uproleselan. So we'll be looking for that outcome as we look at the data from the trial. We do have -- in our Phase 3 trial, in the relapsed/refractory population, we have the expectation that data for survival would not be censored for transplant, which allows you to capture the benefit of transplant in that overall survival endpoint and I think that's going to be important way to look at the data for the other trials as well.

Ritu Baral -- Cowen & Company -- Analyst

So that will -- so the NCI study won't censor for transference in overall survival either?

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

I think that is in the process of being finalized. I don't think we can comment on that.

Ritu Baral -- Cowen & Company -- Analyst

Got it. And then rivipansel, can you talk a little bit about how you see rivipansel potentially and you and Pfizer fitting into the landscape, not just for other prophylactic therapies but specifically against Novartis' crizanlizumab, which has a very, very similar mechanism but that's being developed for [Inaudible] but may see some episodic use as well? Can you compare and contrast the data and the mechanisms there?

Rachel King -- Chief Executive Officer

Yes, so, let me first take the mechanism and then I can speak to some of the -- how we see it from the market issues. Mechanistically, the Novartis drug is a P-selectin antibody as compared to ours, which is pan-selectin antagonist. So our drug hits E-, P-, and L-selectin, whereas their drug hits only P-selectin. And as you indicated that was studied in the context of prevention of crisis whereas ours is being studied in the context of treatment of crisis.

So I think the real market dynamic as far as prevention is concerned would be between that drug and other drugs that are being developed for prevention of crisis. So those drugs would be competing for patient share based on how patients proceed, both efficacy and any issues around compliance, etc. So our drug is being used in the inpatient setting for the treatment of crisis as an on-demand drug. And I think it is important to note that in the sickle cell market, in general, that we do have experience with the drug that is actually quite effective at prevention of crisis and that's Hydroxyurea, which has been on the market for about 15 years and has had very little impact on the occurrence of crisis.

And I think that's because very high levels of compliance are required in order to see the benefit of that drug, and I expect that would be likely also for many drugs that are being developed in the prevention setting. So I think that the market for treatment is going to continue to be an important opportunity. And I think we may have an opportunity, potentially, if the drug is successful in the inpatient setting also to move it to, let's call it a subacute setting, where it could potentially be used outpatient in the clinic or potentially in the emergency room. So I think there are potentials for our market also to expand.

Ritu Baral -- Cowen & Company -- Analyst

If you were to take that approach, Rachel and Helen, and move it into subacute understanding -- with the understanding that patients experience many more subacute attacks than attacks that they go into the hospital for, would there be any additional safety analysis do you think required? Because these patients would likely be exposed to a multiple of the drug than they would in just a hospital setting?

Rachel King -- Chief Executive Officer

Yes. I think It's a -- I don't want to speculate on that at this point. I think -- and I specifically don't want to speculate on Pfizer's specific plans. But I do think that there is a possibility of studying the drug in that setting going forward.

Helen, do you want to comment further?

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

I would just add that the Pfizer program does include an open-label extension trial. Their Phase 3 trial, which is the primary trial for the FDA, is looking at the time to resolution of crisis. They have an open-label extension trial where they are allowing patients who have been on the trial to be treated again on subsequent hospitalization. So that gives you data already within the registration program on repeat exposure to rivipansel for subsequent crises.

That data, I think, is potentially supportive of additional uses in the outpatient setting, perhaps in the subacute setting.

Operator

And our next question comes from the line of Jotin Marango from Roth Capital. You may begin.

Jotin Marango -- Roth Capital Partners -- Analyst

Good morning, team, and congrats on building a pretty wide leukemia program. So a few of the questions that I had were answered. But I have one or two more about 1271, and I apologize for using 1271, I'm still practicing using the other name.

Rachel King -- Chief Executive Officer

That's why we call it upro for short.

Jotin Marango -- Roth Capital Partners -- Analyst

Good. So I'll follow a little bit in the direction that Yatin was going on the question of design and endpoint. So on the NCI-sponsored study, there is this very interesting EFS interim read. Now was there -- I understand this is NCI-letter sponsored study, but was there any FDA consideration or feedback that went into that choice of interim? The rest of us, just as you I'm sure, are very interested in the FDA's evolving view on endpoint on this disease.

And so I'm trying to understand the possibility or the probability here of filing that study on that interim if for one reason or another that ends up being the first data that you have in hand?

Rachel King -- Chief Executive Officer

Yes. Well, so again, I don't want to speculate now on filing on that data but I will say that the FDA has been consulted in the design of the program.

Jotin Marango -- Roth Capital Partners -- Analyst

OK. Got it. And is the -- this point is the design of the HOVON study set and locked? Could you remind us what the endpoints are on that one?

Rachel King -- Chief Executive Officer

Yes, Helen, do you want to speak to the side of the HOVON study?

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Yes. So the HOVON study is a randomized controlled trial. And it's a Phase 2 trial that will enroll 140 patients, and it's enrolling patients, adults, with AML who are not fit for traditional cytotoxic chemotherapy but are able to receive the Cytarabine treatment for their AML, And they will be randomized to receive the Cytarabine with or without uproleselan. We have not had extended discussions publicly about the endpoints for that trial, but we believe that the endpoints that HOVON is intending to study are very consistent with those that we are assessing with the other trials in the program.

Operator

And our next question comes from the line of Stephen Willey from Stifel. You may begin.

Stephen Willey -- Stifel Financial Corp -- Analyst

Good morning. Thanks for taking the questions. Just curious with respect to the relapsed/refractory trial, the pivotal -- how many months of enrollment in that trial will you want to have under your belt before you're comfortable providing guidance to the Street? And then kind of as a follow-up, will you also be in a position to be able to communicate any kind of progress or enrollment guidance from the ongoing collaborative studies?

Rachel King -- Chief Executive Officer

So we provided the guidance that we expect to have top-line data by the end of 2020 -- of 2020. And as we get more enrollment, if that changes, then we'll provide an update. I think that's the best way to answer your first question. And as to enrollment targets with the other studies, once they start and once they begin to get some enrollment history, then we will be giving ongoing updates as to when we expect top-line data.

I don't know that we'll be giving specific accrual updates, x number of patients, I wouldn't expect that, but we would like to be able to give general targets for when we would expect to have data from those studies. We're not doing that currently because we want to let those studies start and once they start and once we see them getting some experience with enrollment, then we'll give that specific guidance.

Stephen Willey -- Stifel Financial Corp -- Analyst

Understood. And then I guess just kind of a bigger-picture AML question, it looks like venetoclax is going to be kind of a focal point of treatment in a variety of different settings. I know with hypomethylating agents now and I think there's a push to maybe even try to move that into low-dose chemo settings or lower-dose chemo settings in fit patients. So just kind of wondering if you've internally considered trying to evaluate upro in combination with BCL2 inhibition at all and whether or not you think that those two mechanisms for whatever reason may be synergistic?

Rachel King -- Chief Executive Officer

Yes. So I don't want to comment on any specific plans that we haven't already announced or addressed. But what I will say is, what I think you're seeing us doing at GlycoMimetics here is combining this drug with multiple different chemotherapy regimens in multiple different settings to expand the use. So at AML, we're combining with seven plus three, we've combined with Mech, we're going to be combining with FAI, we're combining with hypomethylating agents.

So what you're seeing in our revolving program in AML is combining with multiple different chemotherapy regimens. I would add to that what we're doing in multiple myeloma, which combines with both bortezomib and Kyprolis. So what you're seeing, I think, is a program that we are developing across the hematologic malignancies with 1271 is an effort to combine it with multiple chemotherapy regimens in multiple settings in order to develop broad experience with the drug. So that's what we're doing and as we develop any other plans then we'll continue to announce those.

But I think you can see philosophically what we're trying to do with the drug in terms of our strategic approach to spreading it across multiple settings with multiple different regimens.

Stephen Willey -- Stifel Financial Corp -- Analyst

OK. And then just lastly, any thoughts around just when we might hear about the initiation of a 1359 trial?

Rachel King -- Chief Executive Officer

Yes. So as a reminder, that trial would -- we are in a Phase 1 trial now with healthy volunteers and we have said that by the end of this year, we'll be saying more about what are we going to be doing in terms of the first patient population. And we are on track to provide that by the end of the year.

Stephen Willey -- Stifel Financial Corp -- Analyst

So presumably you'll be going with the dose expansion cohorts within selected tumor types?

Rachel King -- Chief Executive Officer

Again, without saying specifically what we're doing, we're going to be looking at a patient population, one or more patient populations with 1359 and we'll be describing those by the end of this year.

Operator

[Operator instructions] And our next question will come from the line of Biren Amin from Jefferies. You may begin.

Biren Amin -- Jefferies -- Analyst

Just on the NCI trial, Rachel, can you share the stats assumptions around the EFS endpoint? What are you hoping to show on the primary endpoint that would achieve a statistically significant outcome?

Rachel King -- Chief Executive Officer

Actually, I would say that's not been publicly disclosed, so I'm not in a position to share that at this point.

Biren Amin -- Jefferies -- Analyst

Got it. And then when you say older patients, what's the age cutoff? Because I think when we look at some of the trials with seven plus three in newly diagnosed AML patients, some trials have cut off at 50 years and older, others are at 60. Are you able to describe how you define older in that patient -- in that trial.

Rachel King -- Chief Executive Officer

Yes, I'm going to turn that to Helen for study design.

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Yes. A commonly used age differentiation for older in AML is 60 years. That's what we used in our Phase 2 trial in that older population and it's that same group that the NCI will be studying in their trials.

Biren Amin -- Jefferies -- Analyst

Got it. And Helen, should we assume that the active arm is going to show similar to what you saw in the Phase 2? I think in the Phase 2, you reported EFS of around 11 months median.

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

So the NCI trial is designed to include a population that is extremely consistent with that population we had in our Phase 2, and I would expect the baseline data to look quite similar.

Operator

And I'm showing no further questions at this time. I'd like to turn the call back to Ms. Rachel King, CEO, for closing remarks.

Rachel King -- Chief Executive Officer

Thank you, Operator. And thank you, everyone, for your questions and for taking the time to listen the call. So we believe the company is now well-positioned to deliver key clinical data readouts, in particular, with major news in the second quarter of 2019 with top-line data from the ongoing Phase 3 trial of rivipansel in sickle cell disease. And followed starting in 2020 with ongoing data readouts from our own, wholly owned uproleselan program.

We're excited to have a platform which continues to provide potentially game-changing therapeutic opportunities and are pleased to have a strong balance sheet that we believe can finance the planned initiatives that we've discussed today, and we look forward to continuing to update you on our progress. Thanks very much.

Operator

[Operator signoff]

Duration: 38 minutes

Call Participants:

Shari Annes -- Investor Relations

Rachel King -- Chief Executive Officer

Brian Hahn -- Chief Financial Officer

Yatin Suneja -- SunTrust Robinson Humphrey -- Analyst

Rachel King -- Chief Executive Officer

Ritu Baral -- Cowen & Company -- Analyst

Helen Thackray -- Senior Vice President of Development and Chief Medical Officer

Jotin Marango -- Roth Capital Partners -- Analyst

Stephen Willey -- Stifel Financial Corp -- Analyst

Biren Amin -- Jefferies -- Analyst

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