Good morning and thank you all for joining the GlycoMimetics call. At this time, all participants are in listen-only mode. Following management's remarks, we will hold a brief question-and-answer session and at that time the lines will be open for you. [Operator Instructions]. I would now like to turn the call over to Shari Annes of the Investor Relations Group at GlycoMimetics. Please go ahead.

Good morning. Today, we will highlight the key achievements of 2018, provide a summary of our financial results for the year-end, and comment on the milestones we anticipate in the next few months. The press releases we issued this morning on our year-ended Q4 financials and yesterday on our board transition are available in the News section of the company's website at www.glycomimetics.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. We will then open the call for Q&A. I'd 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 uproleselan, formerly known as GMI-1271; and for rivipansel, GlycoMimetics' product candidate licensed to our collaborator, Pfizer; and as well as 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 statements. 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 could affect the company. I'd now like to turn the call over to Rachel.

Thank you, Shari, and thank you all for joining our call. This morning, I'd like to cover three topics. First, the upcoming Phase III results for rivipansel in patients experiencing sickle cell crisis, next the major accomplishments of 2018, and finally, the milestones we expect to achieve in the coming months. I believe we're reporting accomplishments in 2019 all of which were made possible by the achievements of last year. As you may recall, Pfizer has said they intend to announce top-line results from the Phase III RESET trial of rivipansel at the end of the second quarter of this year. The anticipated timing of this readout has not changed. With less than four months until the Phase III readout our enthusiasm is high; the Phase III readout is an important milestone that very few drugs in development reach. Since our discovery of rivipansel, we focus chemistry, preclinical and clinical development resources to derisk and advance the program. Today, we believe we're on the crust of delivering a potential therapy for sickle cell crisis that could transform the way patients with this devastating disease are treated. This has been our goal for the program since its inception. While the pivotal data will tell the ultimate story, we do believe that the rivipansel study has a high probability of success, and if positive, that this novel on-demand agent could be utilized extensively in the major markets. We base this confidence on a number of factors. First, the data from our own Phase II trial which among other things demonstrated an 83% reduction in opioid use throughout the duration of hospitalization, a finding that gives us confidence that the drug is having its intended biological effect. Second, the fact that selectin inhibition has now been clinically validated as a therapeutic target based…

Thank you, Rachel. As of December 31, 2018, GlycoMimetics had cash and cash equivalents of $209.9 million compared to $123.9 million as of December 31, 2017. The company in the first quarter of the year successfully completed a follow-on public offering netting proceeds of $128.4 million. The company's research and development expenses increased to $12 million for the quarter ended December 31, 2018, as compared to $6.7 million for the fourth quarter of 2017. Research and development expenses increased by $16 million to $40 million for the year ended December 31, 2018, from $24.1 million in the year ended December 31, 2017. These increases were primarily the result of higher manufacturing costs to scale-up production of uproleselan clinical supplies for the Company's Phase III clinical trial and for clinical trials conducted by or in collaboration with third-parties. Personnel-related and stock-based compensation increased due to an increase in clinical headcount. The company's general and administrative expenses increased to $2.9 million for the quarter ended December 31, 2018, as compared to $2.8 million for the fourth quarter of 2017. General and administrative expenses for the year ended December 31, 2018, increased $11.4 million as compared to $9.8 million in the prior year. These increases were primarily due to an increase in legal and patent expenses as well as personnel-related costs and stock-based compensation expense. Patent expenses were higher due to an increase in the number of patent applications filed. Personnel-related and stock based compensation expenses increased due to additional headcount in 2018. In summary, GlycoMimetics is in 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.

Thank you, Brian. I hope you'll agree that we've been uniquely successful in progressing truly differentiated drug candidates from discovery well into late-stage development. Starting with rivipansel, pivotal results at the end of the second quarter of this year, we now anticipate what we hope will be a series of value creating milestones which I hope will reward patients and our shareholders for years to come. With that, I'd like to open the call for your questions. Operator?

Thank you. [Operator Instructions]. Our first question comes from the line of Jotin Marango of ROTH Capital. Your line is now open.

Good morning team and congratulations on all the progress.

Thanks, Jotin.

Good morning. Two questions first about upro, I know it's still early, still early in the process. But do you have any qualitative commentary or site feedback about the enrollment of patients such as granularity on screening or doc attitude and importantly whether or not this may be competing for patients with other trials in the same leukaemia style?

Let me make a comment and then I'll turn it over to Helen for some more detail. I will say we're getting enthusiastic responses from the sites. We have sites open now in the United States and Australia and we'll be shortly opening in Europe. So we're enrolling widely and well and the study has good momentum. But let me turn it to Helen for comments on more granularity around the reaction from some of the investigators.

So we have had, as we announced we had our first patient enrolled in November. We have sites coming online at a good pace in the U.S. and outside of U.S., as Rachel said, and multiple sites are excited about the trial. We've had good momentum with investigators and good, good momentum with start-up the site. So we're very pleased with that momentum so far and we've not had much feedback in terms of competing trials for patients. We think that this is a good space, in the relapsed refractory setting there is not very much available for patients or available to investigators and pairing uproleselan with the standard of care is a very attractive option in this clinical trial setting. So we're very optimistic with the feedback we had so far.

Thank you. And second the R&D pipeline. So thank you for the overview, Rachel. The data at ASH about the antithrombin effect is interesting and I remember the data from I think it was ASCO where you showed white cell mobilization, how are you thinking about prioritizing the early programs at this point because it seems like you can do a lot? And then a second, in some of the patients do share a common target with upro. How do you think about the possibility of just advancing new agents versus expanding the upro program? Is this overly clinical?

Yes. Well so I think that you raised a number of important points and actually highlight some of the great opportunities that we think we have going forward. 1687 is a compound that you reference which is a highly potent E-selectin antagonist. And as far as the follow-on pipeline is concerned that would be our next priority of among the compounds that are still preclinical. And I would say that that first of all, it offers a chance for us to take the indications in which we develop upro into a self-administered setting potentially, for example you know that some of the -- we were currently dosing uproleselan intravenously for patients who are hospitalized while they receive their chemotherapy. But you could envision over time wanted to be able to move an AML therapy into the outpatient setting and 1687 gives us the potential to do that because we believe it will be subcutaneously available. It also, as you indicate, gives us the potential to move into some other -- other indications. I would say our initial focus is going to be to look for other areas within the hematology oncology space that would allow us to build on the expertise and the relationships that we've built in that area. Also focusing as we have in the past on areas where we feel that the use of the drug could be potentially transformative and could also lead to streamlined development as well as potentially targeted commercial opportunities. So that's a reference to the 1687. We also have, as you indicated, you briefly have alluded to the fact that there were other molecules, there's also the Galectin program which is also preclinical. We introduced one of those molecules the E-selectin, Galectin combination molecule at ASH. That is a broad potential range of indications and there's some very exciting indications with the Galectin-3 antagonist alone. So we will be saying more about what we intend to do with those as we continue to develop the preclinical story. But I think at a high level, what I'd say is you'll see focused clinical programs that build on the expertise that we have but that continue to build out the pipeline based on what really is a unique, very differentiated specialized chemistry platform that we have here at the company.

Thank you very much and I look forward to the rivipansel data.

Okay, thanks. So are we.

Thank you. Our next question comes from line of Stephen Wiley of Stifel. Your line is now open.

Good morning. So maybe just a couple of sickle cell questions. Just curious as to how you see the potential approval of crizanlizumab perhaps impacting the addressable market opportunity. And I guess second to that, if a patient was taking that drug prophylactically and had a breakthrough, would there be hesitancy at all within the acute care setting to try to address a VOC with an asset that has somewhat similar mechanism of action?

Yes. So let me take the second question first. We actually think that there would not be hesitancy to use it and no reason not to use it. As you remember, may remember crizanlizumab targets P-selectin whereas rivipansel is a Pan-Selectin antagonist with specifically greater on activity against E-selectin and there's a lot of data in the literature that actually speaks to the dominance of E-selectin in the context of a vaso-occlusive crisis. So we think that as a breakthrough therapy or as a breakthrough crisis would occur in a patient on crizanlizumab that there would be every reason actually to give rivipansel to that patient in the acute care setting. As far as the addressable market is concerned, I do believe that with all the drugs that are in development now, there will be a number of different therapies potentially available for treatment of sickle cell disease which is good news for patients. But I think these are going to be complementary. You may note that the data from crizanlizumab is very similar to the data that was generated number of years ago with Hydroxyurea. And Hydroxyurea has been on the market for about 15 years, it had an excellent clinical trial output showing that it also significantly reduced the hospitalizations for crisis but had very little impact -- has had very little impact over the years on the actual hospitalizations for crisis. So I think fundamentally although treatment of the disease will improve, I don't think vaso-occlusive crisis is going away. And I'll remind you that rivipansel is the only drug in late- stage development for treatment of crisis. So we think that where there currently is a lot of competition right now in the prophylaxis setting, crizanlizumab, the global blood product, Hydroxyurea et cetera, there is no other late-stage development, no other drug in late-stage development currently for the treatment of crisis. So we think that rivipansel can really own that portion of the market.

Got it. And then maybe just a clarification question so the dual-functional antagonist. Did you see that goes into the clinic later this year?

No. The dual-function antagonist, which is preclinical I'm sorry; we had two dual-function antagonist. Let me clarify, there is 1359 which has already been in the clinic that's completed a Phase I trial and that's the drug that we intend to take into a solid tumor trial later this year. There is a second dual-function antagonist which targets E-selectin and the Galectin which is still at the preclinical stage. But 1359 is already in the clinic and we intend to continue with the clinical development of that program with the initiation of a solid tumor trial later this year.

Understood. And then just lastly, I know that there was some prior mention of potentially seeing some myeloma data this year. I guess is that still part of the plan and is the objective again really just to show changes in M protein? Thank you.

So we have de-prioritized the myeloma program largely because of the changes in the myeloma landscape particularly with the approval of Daratumumab and the way that that treatment landscape has continued to develop with more options for patients. So we actually have decided to discontinue enrollment in the myeloma trial. We'll continue to gather data on those patients and we'll see if there is anything that we want to report out about that. But we've decided that we feel there are greater opportunities for uproleselan in AML and potentially in other areas which we're continuing to explore. But we don't think that -- we think that given the changing treatment landscape in the myeloma field, we don't see as good an opportunity for uproleselan there as we think we could develop in other areas.

Thank you. Our next question comes from line of Peter Lawson of SunTrust Robinson. Your line is now open.

Thanks for taking my questions. Rachel, just following-up on the 1359 moving into solid tumors, which tumors are you thinking?

Yes. So we haven't announced specifically what we'll be doing in that trial. We do expect to state that later this year. What I can say though is that we've decided to move into a solid tumor setting in which the tumor has metastasized to the bone. And that's because the preclinical data that we've generated with that molecule demonstrates particular effect in that setting where we've shown that both CXCR4 and E-selectin are involved in both trafficking and maintenance of metastatic sites within the bone. So what we've designed is a study that's going to be looking at both PK and the cancer patients as well as some biomarkers that are going to allow us to begin to explore the potential use of 1359 in the setting of solid tumors metastasized to bone. So we'll be saying a bit more about that later in the year. But that's the general contours of what we expect to do with that trial.

Perfect, thank you. And then just as we think about follow-on molecules, for rivipansel is that completely in with the control of Pfizer to be thinking about follow-on molecules there and whether you need to move beyond IV into sub-cu and kind of what else we should be expecting on that? Thank you.

Yes, so the license with Pfizer is for rivipansel and for drugs which are very likely to pounce so essentially rivipansel and its family of molecules. We are not continuing work with other rivipansel like molecules here at GlycoMimetics. However Pfizer could take rivipansel into other indications if they would choose to do that. Here at GlycoMimetics, what we're doing is we are developing our own suite of molecules which are more focused and more potent than rivipansel, they're more -- they're newer molecules and have the benefit of what we learned through the early days of the discovery and development of rivipansel. But they are being taken forward in different indications from sickle cell here at GlycoMimetics. So we're not specifically working on follow-on to rivipansel here.

Perfect, thank you. And then just as we think about the number of trials that are enrolling upro, are there any that are enrolling better or worse than expected just anything you can do [indiscernible] of patients?

And I'll turn that over to Helen.

I think the question is about sites enrolling for uproleselan in Phase III and I think at this point our comment is simply that enrollment has started and enrollment is proceeding well demonstrating good early momentum and we have also the NCI program is underway. NCI has listed their trial for uproleselan also on clinical trials.gov. And so we're looking forward to seeing that trial and progress with that trial over the course of the coming time.

Thank you. [Operator Instructions]. Our next question comes from the line of Biren Amin of Jefferies. Your line is now open.

So Rachel, just a couple of questions on rivipansel Phase III design, as it relates to the Phase II data that you guys generated. So, on the Phase III, I think you're enrolling pediatric patients along with adults and given the pediatric patients were not enrolled in the Phase II. How do you think it would impact Phase III? And then also I think the adult patients in the Phase III are receiving fixed dose which is equivalent to lower weight base dose used in the Phase II. So a question on what led to the choice of that fixed dose in the adults in the Phase III and how you think that would impact it. And then lastly, I guess what are your thoughts on the site-to-site variability and how that would impact Phase III data?

So I think I'll turn those questions over to Helen. I wish you can answer this in bit more detail.

Yes, sure. So with regards to pediatric patients, you're correct. This Pfizer trial is enrolling patients down to Age 6. In our Phase II trial, we enrolled patients down to Age 12, the adolescent and adult population and Pfizer has included that adolescent and adult population and also I think quite appropriately extended the trial down to the younger group. As you know sickle cell disease faces quick to crisis occurs across the age ranges of pediatrics in adults. So that seems to be very appropriate for the trial and will allow for a dataset that informs the whole population. And so we think that's quite appropriate. In terms of the dosing, there is the fixed dose, the transition from weight based dosing in the Phase II to a fixed dose in the Phase III is a standard transition and the adult dose is based on the exposure levels demonstrated in the Phase II. Those exposure levels are looking at exposure on a population PK based analysis and so the fixed dose is simply selected to establish the exposure on a fixed dose level for the adult population. We have taken this approach also with uproleselan where in our Phase I/II we had weight based dosing in Phase III, we've been able to select a fixed dose built on population PK data. So that's a pretty standard approach. And I think we're quite comfortable with the way Pfizer's approached that. And then, your third question, I think was on the site-to-site variability. It is expected that there is variability at a patient level as well as at a site level in any clinical trial and that's the reason for expanding the number of sites and number of patients in a Phase III program. So that's fairly standard. Pfizer has a large trial with a good distribution of sites that represents the standard of care. They're also very similar to the nature of sites that were included in the Phase II and so we expect that the standard of care treatment as well as the outcomes that we'll be seeing should be representative certainly of what we saw in the Phase II as well. It's also a randomized trial which allows you to control for any potential sources of variability. The Pfizer trial is also sized substantially larger than our Phase II and as you'll remember there were some outcomes in our Phase II trial that either achieved statistical significance or trended towards significance even in that small trial. So we think that the Pfizer trial is well designed and well sized to address any variability that might be seen.

Okay. And then I just have one follow-up on upro. Given the Phase II data at ASH, it seems that suggest better outcomes in patients that have favorable and immediate risk compared to adverse risk. And this I think is the trend that you saw on both the refractory trial and the newly diagnosed trial. So my question is would you tend to more heavily recruit favorable and intermediate risk patients in the Phase III refractory study to have better odds?

I will let Helen take that one also.

Yes. Actually we were very pleased with the data that we saw in adverse outcomes in both the relapsed refractory group in our trial and in the newly diagnosed group. There were substantial levels of patients with adverse cytogenetics enrolled as well as high risk disease. And they did quite well especially compared to what you'd expect for those populations. Those populations have a poor remission rate and poor survival. We had patients in those groups -- in that average risk group achieve remission and have long survival outcomes with reduction in -- sorry with negativity in terms of measurable residual disease. And so we believe that that has demonstrated a deep durable remission even in patients with adverse risk at rates higher than we would expect from historical controls. We also know from the work that Pam Becker has done and that John Magnani has done that the adverse risk and those patients who are most likely to relapse early and have refractory disease have a higher proportion of E-selectin ligand expressed on those leukemic blasts illustrating that the cells that are most likely to be the cause of relapsed or the cause of resistant disease are in fact the cells that uproleselan is best designed to target. And so our data in the adverse population was very, very much in line with what we expected to see and hope to see in terms of targeting those patients with the highest risk and also the highest proportion of E-selectin ligand on their blasts and seeing negativity in terms of measurable residual disease and durable responses.

Thank you. And I'm showing no further questions at this time. I would now like to turn the call over to Ms. Rachel King for closing remarks.

Great. Thank you, Operator. And thank you everyone for your questions and for taking the time to join the call. In 2018, GlycoMimetics delivered achievements on all fronts in clinical development and preclinical research discovery and in finance. We've put into place a comprehensive Phase III clinical program for uproleselan that if successful could position this investigational drug as a foundational therapy across the spectrum of AML. This is an accomplishment that reflects the enthusiasm worldwide of clinicians who have seen our data and its impact to-date on patient outcomes as presented at top oncology congresses. In discovery, preclinical research, our specialized chemistry expertise produced new potential drug candidates to expand our pipeline opportunities into indications that go beyond sickle cell disease and hematologic cancers. Looking forward to 2019, with a strong financial position to pursue clinical and preclinical opportunities ahead. Importantly, we look to the rivipansel top-line readout expected late in the second quarter that could represent the first commercial success of our pipeline and the key financial resource going forward. Thank you very much.

Ladies and gentlemen thank you for participation in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.