Crescent Biopharma, Inc. (CBIO) Q4 2020 Earnings Report, Transcript and Summary

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

Thank you. Good morning. Today, we will review our accomplishments and financial results for both the 3- and 12-month periods ended December 31, 2020. We'll also update you on recent - the press release we issued this morning is available on the company's website at www.glycomimetics.com under the Investors tab. This call is 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 on 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; and Brian Hahn, Senior VP and Chief Financial Officer. We'll start today's call with comments from Rachel. Brian will follow Rachel to provide an overview of the company's financial position. And we'll then open the call for Q&A. Our Co-Founder and Chief Scientific Officer, Dr. John Magnani, and our newly promoted Senior VP and Chief Medical Officer, Dr. Eric Feldman will join us in the Q&A to address your questions. 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 company's product candidates, uproleselan, rivipansel, GMI-1687, and GMI-1359, and our other pipeline programs, along with operations and cash burn. 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. For information concerning the Risk Factors that could affect the company, please refer to GlycoMimetics filings with the SEC, which are available from the SEC, are on the GlycoMimetics website. I'd now like to turn the call over to Rachel.

Thank you, Shari. Throughout 2020, GlycoMimetics' primary operational focus was on advancing uproleselan registration program in AML. Despite the challenges of COVID uproleselan continues to garner significant attention and interest from leading clinicians, academic centers, collaborative networks and regulatory agencies working with us here in the U.S. and abroad. GlycoMimetics' pivotal Phase 3 trial in relapsed/refractory AML continued to enroll patients in U.S., Australia and in Europe at a steady and predictable pace in the second half of 2020. While the pandemic slowed enrollment during March and April of 2002, site activation continued to extend the global reach of the trial and by year-end the company's interim target for enrollment had been achieved. With momentum from the second half of 2020 carrying into 2021, we can confirm that we anticipate completion of enrollment of all 380 patients in the second half of this year. This demonstrates the high level of enthusiasm and scientific interest of investigators and it is a very significant accomplishment in the context of a global pandemic. In addition, we've had productive interactions with the FDA under our breakthrough therapy designation. These are the kinds of conversations that a company would have in the normal course of moving towards a specific regulatory filing plan. To complement our regulatory activities, we completed certain other critical development work, such as release of the NDA batches, initiation of the commercial batch manufacturing and completion of human ADME work. That is studies that evaluate the absorption, distribution, metabolism and excretion of a drug in development. These are all measures of steady progress toward filing a New Drug Application or NDA should our read out be positive. In parallel, the NCI-sponsored Phase 2/3 registration trial that's evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy continues to accrue at a steady pace. Based on the NCI's enrollment projection, we anticipate the trial will complete enrollment of the initial 262 patients necessary for the interim Phase 2 event-free survival or EFS analysis before yearend. Assuming the EFS trigger would occur within 6 months of enrollment completion, we would then expect to see the readout from this analysis to occur sometime in the first half of 2022. Together, the GlycoMimetics and NCI sponsored programs will constitute a large dataset of patients treated with uproleselan and intensive chemotherapy. The data for our Phase 3 trial and the NCI Phase 2 EFS analysis are likely to read out around the same timeframe. If both are positive, we would anticipate filing for approval for treatment of patients in both settings. Further underscoring the global interest in uproleselan is our collaboration with Apollomics announced last year. In January of this year, uproleselan was designated as a breakthrough therapy in China for treatment of AML, complementing a prior designation by the FDA. In addition, Apollomics announced the filing of an IND to begin clinical development of uproleselan in China. Our plan is to announce when the first patient is treated in Greater China, which is anticipated late this year. Beyond the NCI's prestigious consortium and our partnership with Apollomics, we're also receiving significant interest from clinicians at key centers of excellence, who would like to pair uproleselan with other AML therapies. In a few minutes, I'll describe some preclinical work that validates this, in particular, the research that combine uproleselan, venetoclax and a hypomethylating agent or HMA. Working in collaboration with clinical investigators consortia, partners and regulatory agencies around the globe, we have 1 goal in mind, namely to establish Upro as a foundational therapy across the entire spectrum of AML. Whereas most other AML therapies in development are focusing on narrow patient populations as defined by certain genetic markers, Uproleselan targets the bone-marrow microenvironment by inhibiting those prosurvival pathways that render cancer cells protected from the effects of chemotherapy. This is a novel approach that would be broadly applicable across the spectrum and range of therapies used for relapsed/refractory or newly diagnosed patients fit for chemotherapy. We soon hope to treat those not fit for a rigorous chemo regimen as well. Scientific rationale for targeting E-selectin and the role it plays within the bone-marrow microenvironment as a driver for AML resistance has always been robust. I'd still like to spend a few moments highlighting some of the new data our research teams generated that were presented in with oral and poster presentations at multiple scientific and medical meetings this past year. Of note, throughout 2020 preclinical data on uproleselan's mechanism of action were published in numerous scientific publications, including Nature Communications in April and an independent review paper in the journal Cancers in January of this year, 2021. These papers detailed the various mechanisms by which uproleselan dampens AML blast regeneration and strongly synergizes with chemotherapy. Importantly, they support the role and importance of targeting the tumor microenvironment, the key novel approach in cancer, where GlycoMimetics has a leadership position. Uproleselan was also featured at several major medical meetings, including the June 2020 AACR Meeting. There investigators presented preclinical data supporting the potential use of uproleselan in the treatment of AML as well as in the setting of stem-cell transplantation. Additionally, new information demonstrated the ability of transcriptome profiling to identify additional tumor types, most likely to benefit from targeted E-selectin antagonism, a key mechanism of both uproleselan and GMI-1359. And finally in September, at the meeting of the Society of Hematologic Oncology, and again at the annual ASH meeting, investigators from the MD Anderson Cancer Center Department of Leukemia, presented preclinical data and an oral presentation, showing how antagonizing E-selectin with uproleselan overcomes microenvironment-mediated resistance to venetoclax/HMA therapy. Just to elaborate on the model. This experiment was conducted using a cell line from a patient who had acquired resistance to venetoclax/HMA. In this setting, the addition of uproleselan not only prolonged survival of these mice, but also promoted normal HSC pro-survival signaling. The data were striking, and we were pleased that it was selected as an oral presentation at ASH. It's here in this last setting that we look forward to initiating an investigator-sponsored trial in the near future. As you know, uptake on venetoclax/HMA in the frontline, unfit AML setting has been strong. And while 60% to 70% of patients achieve a response, the responses are incomplete and approximately half the patients reducing durability and leading to relapse. Thus, they remained a significant unmet need. We're hearing from investigators eager to evaluate the triple combination to explore the potential of the uproleselan and overcoming some of the limitations related to the depth and durability of response with Ven/HMA alone. Turning now to sickle cell disease, I'd like to comment the 2020 gave us an opportunity to further explore opportunities for treating this disease, which we had previously been precluded from doing under our agreement with Pfizer. By April, Pfizer had completed its transfer to us of all rights and licenses originally granted in our 2011 agreement as well as the rivipansel IND and the datasets from both the Phase 3 research study and the Open Label Extension study. We committed to a detailed assessment of the full clinical data set for rivipansel and presentation of the full results at a scientific congress. Our analyses were presented at several key sickle cell meetings, the last of which was a December ASH meeting. The data highlighted the importance of early intervention, and validated E-selectin as a critical target for treating vaso-occlusive crisis or VOC for adults as well as pediatric patients. In parallel, we were invited to make oral presentations on GMI-1687 that those key meetings as well. I remind you that GMI-1687 is a significantly more potent E-selectin antagonist than rivipansel, and we've shown in animal models that it is fully bioavailable following subcutaneous dosing. Specifically in each of these congresses, we highlighted data demonstrating the compound's ability to prevent sickle red blood cells adherence to inflamed vasculature, inhibit vessel occlusion and restore normal blood flow within 90 minutes of administration. It is not a surprise given the strength of this preclinical data each of the abstracts was selected for oral presentation. The data supports development of GMI-1687 as the best-in-class E-selectin antagonist for self-administration at the time of VOC onset, potentially reducing the need for opioids, acute care visits and inpatient hospitalization. I'd like to highlight that the GMI-1687 program leverages all the clinical safety, efficacy and biomarker information gained with rivipansel, it can potentially be self-administered outside the hospital setting at the earliest stage of VOC onset, which we now know is critical for clinical benefit. This is particularly important, since the care of individuals with sickle cell disease has continued to shift to the outpatient setting, a trend which has accelerated during the pandemic. Based on input from the FDA with respect to rivipansel as well as KOLs from sickle cell disease, we will now focus development in this setting on GMI-1687. We are moving forward to complete the required IND-enabling activities with treatment of acute VOC is the potential lead indication. We believe that GMI-1687 may be ideally suited for this indication to ensure that patients can receive treatment early in their VOC crisis. Since it potentially can be self-administered, GMI-1687 also commands a much greater value proposition than rivipansel. Therefore, we have decided to discontinue development of rivipansel. We will keep you updated as to progress with the GMI-1687 program as we get closer to filing the IND, which we anticipate will occur in 2022. The last clinical program, I'd like to touch on is the ongoing Phase 1b study of GMI-1359, or dual-function E-selectin and CXCR4 antagonists, being conducted by Duke University Medical Center in patients with advanced breast cancer with bone metastases. This proof-of-concept study is evaluating pharmacodynamic or PD markers, such as CD34 mobilization. Mobilization of circulating cancer cells into the periphery down-regulation of soluble E-selectin and other biomarkers of biological activity, following both single ascending and multiple doses within the same patient. Our goal has been to use these PD markers to study dose response to inform our next trial, while also establishing the safety profile on PK of GMI-1359 in patients with advanced disease. While study enrollment has been impacted by COVID-19, I'm pleased to report that we have observed clear biologic - clear evidence of biologic activity in the first patients treated in this trial. We intend to present the interim findings from this trial at an upcoming scientific conference. Lastly, I'd like to highlight our specialized GlycoMimetics chemistry platform that continues to generate novel drug candidates. As you may be aware, our chemists have been focusing their efforts on galectin-3, a carbohydrate-binding protein whose expression has been shown to play a central role in fibrosis and cancer. Over the past year, our chemists have rationally designed several highly potent galectin-3 antagonists that have shown activity in preclinical models of fibrotic disease, including NASH, IPF, retinal degeneration and thrombosis, as well as the pancreatic cancer model where our galectin-3 inhibitor was combined with an anti-PD-L1 agent. In fibrosis models administration of our galectin-3 antagonists resulted in robust, statistically significant reductions in fibrosis, when given as a single agent. In the pancreatic cancer model, the addition of galectin-3 optimized anti-PD-L1 therapeutic activity through shifts in fibrotic response and cellular infiltration leading to a robust anti-tumor response. We plan to share more details regarding these galectin-3 inhibitors, and upcoming scientific conferences, while we consider strategic options for this novel class of compound. I hope you'll agree that the challenges of the pandemic notwithstanding, our team has been incredibly productive. While most of us worked almost exclusively out of our homes, we succeeded in continuing to advance both development and discovery. We have a diversified portfolio while remaining a lean organization is only about 55 full time individuals and an executive team that's been working together for many years. In 2020, we were pleased to add veteran regulatory leader Dr. Myra Rosario Herrle to the management team as Vice President, Regulatory Affairs. Myra came to us from AbbVie, a leader in AML and the developer of venetoclax. And this just last month, we promoted Dr. Eric Feldman, who will join our Q&A today to Senior Vice President and Chief Medical Officer. Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders. Eric has spent the last 2 years at the company running our Phase 3 registration trial, and he has dedicated his career to patients with hematologic malignancies. He is especially well positioned to lead our uproleselan program as it advances through registration trials. As you know, Dr. Helen Thackray, our outgoing CMO and Senior Vice President of Clinical Development, has accepted another position giving her an expanded role. We wish her well in that endeavor. Her contributions to us have been substantial, and this has been a pleasure working with her as a valued colleague. Importantly, our cash position provides runway through key milestones in the uproleselan program. I've asked Brian now to comment in greater detail on our financial results. Brian?

Thank you, Rachel. As of December 31, 2020, GlycoMimetics had cash and cash equivalents of $137 million as compared to $158.2 million as of December 31, 2019. During the year ended December 31, 2020, the company recognized revenue of $10.2 million, all of which was the result of payments received under our agreements with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China. There was no revenue recognized during the year ended December 31, 2019. The company's research and development has increased to $11.7 million for the quarter ended December 31, 2020 as compared to $11.5 million for the fourth quarter of 2019 due to higher clinical development expenses. Clinical expenses were higher as a result of increased number of sites and enrollment of the company's ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML. Research and development expenses for the year ended December 31, 2020 decreased $44.9 million as compared to $47 million in the prior year. The decrease in expenses was due to lower raw material purchases in the year ended December 31, 2020 offset by higher clinical development expenses due to the company's ongoing global Phase 3 clinical trial of uproleselan. Now, turning to the G&A expenses, the company's general and administrative expenses increased to $4 million for the quarter ended December 31, 2020 as compared to $3.9 million for the fourth quarter of 2019. General and administrative expenses for the year ended December 31, 2020 increased to $16.7 million as compared to $14.4 million in the prior year. These increases were due to a significant increase in the cost of directors and officers liability insurance in 2020, as compared to 2019. In addition, personnel-related and stock-based compensation expenses increased due to additional headcount, annual salary adjustments and retention bonuses. Other expenses decreased as compared to the prior year due to lower travel, meals and conference registration expenses as a result of travel restrictions due to the COVID-19 pandemic. I'd now like to turn the call back to Rachel.

Thank you, Brian. We have a busy year and an important milestone ahead as we look toward completion of enrollment of our AML trial. We're confident that we'll soon be able to share news of newly initiating trials with independent investigators, as well as continue to share scientific data that broadens the scope and potential impact of our unique GlycoMimetics platform. Operator, would you now please open the lines for our Q&A session?

[Operator Instructions] First question comes from Zegbeh Jallah with ROTH Capital Partners.

Good morning, guys. Thanks for the update and congrats, Eric, on the promotion, really exciting. It sounds like Upro, it's now kind of taking center stage with the plans to not move forward with rivipansel, which is okay in our opinion. But I think I just kind of wanted to just get some additional clarity on how you kind of came to that decision about Upro. And then, also just kind of what can we expect next from 1687?

Sure. And thanks, Zeg. It's nice to hear your voice. Yeah. So you're right. Upro is in fact at center stage, as it has been operationally for some time with the focus that we've had on advancing the registration study at the company as well as the support we've been providing to the NCI. As far as the decision around rivipansel, there are a number of factors that went into it. One was the fact that as we look at the landscape for treatment of patients with sickle cell disease, we see the treatments moving to the outpatient setting. We see that becoming increasingly important. As we announced in December, we realized that additional data would be required to take rivipansel forward. And we also realize that 1687 is really optimally, potentially useful in the outpatient setting, given that it can be administered subcutaneously, it is significantly more potent than rivipansel, therefore can be administered at a much lower dose. And the fact that it could potentially be given as a self-administered drug really would enable us to take advantage of the ability to treat patients earlier, and therefore, actually to treat potentially more patients, because we're not waiting for patients to be - to present and then be admitted to the hospital. So there are a number of factors that made us feel that 1687 really is ideally positioned for use in the outpatient setting in vaso-occlusive crisis. And we felt that that's therefore the best opportunity for the company as we look at potentially applying our technology in VOC. So we're quite excited about moving 1687 to the clinic. We're going to be working toward filing an IND as I indicated in 2022. And as we get closer to that, we'll provide you further updates. But we're very excited about the opportunity that 1687 represents for the company.

Thanks, Rachel. And then, just on 1359, it's really nice that you guys saw some clear evidence of biologic activities. So I was just wondering, what's the next step as well with that program. Would it be another investigator-sponsored study? Or would you initiate something else on your own?

So we're in the process of defining next steps. As I indicated, we do intend to share that data at an upcoming scientific meeting. And based on what we're learning in that trial, and looking at the quite a wide range of potential opportunities for uses of 1359, we're in the process of defining where specifically we would go next with that trial - with that compound.

Thank you. And then the last one is just on Upro. I'm excited to see some of the combinations, because the science is supportive of that. But just kind of want to know, have you picked a potential partner for the investigator-sponsored study, what needs to happen before we can start to see some of that?

Yeah, so we've been really gratified by the high level of interest from a number of investigators around potential other uses of uproleselan. And so, we've been working with a number of investigators toward advancing these investigator-sponsored trials. We will not - we don't intend to announce details until the trials actually begin, because with ISTs, they're not fully under the control of the company. But we're very excited about the level of interest that we're getting, particularly as I indicated around the combination of uproleselan with venetoclax/HMA. And so, we do expect that in the coming months, we'll be able to say more about the details around that trial or trials.

Thanks for the update.

Thanks, Zeg.

Next question comes from Stephen Wiley with Stifel.

Yeah. Good morning. Thanks for taking my questions.

Good morning. Sure, good morning, Steve.

How is it going? So on the NCI trial, is the event-free survival analysis that's going to be, I guess, triggered presumably some point maybe later this year, is that both of utility and an interim look? And then, can you just remind us with respect to the co-primary endpoints within this trial? I know it is event-free survival and overall survival. Are those true co-primary endpoints or is there some kind of hierarchical analysis that dictates the analysis of those? And I'm just trying to think about this in the context of your commentary regarding being able to perhaps simultaneously file for both indications at the same time.

Sure, sure. So this is a question, I think I'll turn to Eric to answer the details of. So, Eric, could you answer on that?

Yeah, sure, thanks, Rachel. So with regard to your first question, the trial is basically - it has run in 2 sequences. First, there's an event-free survival, which is the randomized Phase 2. And then, following that, if that is considered positive enough, it moves on to a Phase 3, with an overall survival endpoint. So they're not necessarily co-primary endpoints, they're just 2 different analysis done at different times, to trigger the Phase 2 EFS or trigger the Phase 3 overall survival.

Understood. So, I guess, how does that then extrapolate to? I think what was Rachel's comment with respect to getting that data potentially around the same time with filing both?

So let me make a comment and let's see if Eric wants to add anything. So we do expect that the EFS analysis will be completed around the same time. EFS analysis on the so-called Phase 2 portion of that study would be completed around the same time, as we get our data from our company-sponsored Phase 3 trial. And if that data is sufficiently positive, we could potentially file on that data. So there are several possible outcomes at that point. One is that we could file on that data. Another is that it's positive, but the study would also continue toward its Phase 3 survival endpoint, or of course, could be negative, we're obviously hoping that's not the outcome, but there are a number of possible outcomes at that point. We do anticipate, though, that the event free survival analysis on that first group of patients would be performed at around the same time as the survival analysis on our - as overall survival analysis in our study.

Okay. And, I guess, it's safe to presume that would Breakthrough, you've presumably had some of these conversations with FDA?

I'm sorry, what did you say?

And, I guess, it's safe to presume that with Breakthrough, you've had some of these conversations with FDA?

Under the Breakthrough Therapy designations, we've had multiple conversations, ongoing engagements with the FDA with respect to our program, yes.

Okay. And then just lastly for me, so on 1687, I guess, what is your preclinical pharmacology tell you about the half-life of this product? And whether or not you can formulate this into kind of a single-shot subcu? And then just from a clinical development perspective, given that the mechanism appears to be de-risked in the context of acute VOC just based upon some of the retrospective rivipansel data? How quickly do you think you can move through some of the kind of initial proof-of-concept work in the clinic?

Yeah. So those are some of the details we're not yet in a position to answer. With respect to the pharmacology, we have put 1687 into multiple animal models where we've dosed in a different - a variety of different times and settings, and indications. So we're building up what we think is a strong overall preclinical dataset showing excellent activity and showing the essentially full bioavailability by the subcu dosing route. So we're very confident that it gives us a potentially excellent positioning within the context of sickle cell disease. As to whether it's a single-shot or as to whether people give themselves, let's say, multiple shots during the context of the crisis itself. We think that, again, based on the animal data that we've generated so far, that there would be that a single dose, again, in the animal models did abrogate the sickle cell crisis. Whether one might need to follow with another dose some period of hours later to continue to maintain the effect, we'll have to study that when we get into the clinic. But again, the preclinical data so far is very strong, and strongly supportive of moving into sickle cell VOC or potentially other indications as well. We think it could be - this compound could be used potentially even more broadly. I think your point about de-risking is important, because we do feel that the clinical data that was generated with rivipansel has established that E-selectin is an important biological target in VOC and also established that dosing early in the clinical - in the context of VOC is going to be important. So we think that both of those are going to be very helpful to us as we move forward to define the program with 1687, details of which we will be sharing in the future, I'm not in a position to share those today.

Okay. That's very helpful. And yeah, my question was just whether or not you could formulate a single dose of 1687 into a single subcu administration. But I appreciate the feedback, and congrats on progress.

Great. Thanks, Steve.

Next question comes from Boris Peaker with Cowen.

Good morning. This is Cynthia on for Boris, and congrats on the progress in 2020. For your Phase 3 trial, what kind of benchmark should we be keeping in mind for the readout? And how should we be thinking about the market opportunity in this setting versus the NCI-sponsored trial?

So I didn't hear your question clearly, when I heard about the market opportunity, what was the first part of it? I'm sorry.

Oh, just what kind of efficacy - [yeah, I will come] [ph], just what kind of efficacy benchmark should we be keeping in mind for the readout in the first half of 2022?

Okay. So I'll turn this to Eric, let me just answer generally that, again, we're looking at overall survival for the one study and initially EFS for the other study. But, I think, Eric, perhaps you could speak more broadly to how we see the potential of uproleselan in AML?

Yeah, thanks, Rachel. Yeah, to answer your question, the readout is an overall survival readout and our study is powered to show significant benefit for relapsed/refractory patients over standard of care chemotherapy. And the frontline AML study from the NCI line, of course, is the EFS initially, and then the overall survival after that. Relapsed AML is still a huge problem and even though there are a number of new drugs that have been developed, there still is a huge unmet medical need, most patients end up relapsing and dying. And the only really important treatment is to get those patients to an allogeneic transplant and the data that we showed in our Phase 1/2 demonstrated that a high percentage of our patients who got - who responded, ended up going to transplant. And I think that's going to be at a critical important endpoint that we will be looking for in addition to overall survival is the ability to undergo transplant. In the frontline setting, I think, again, there are advances, obviously, venetoclax is an important advance. But when we look at the data, we know that a lot of the responses are incomplete, and patients end up relapsing. And also, in particular, patients with secondary AMLs, and those with poor risk biologic features may not do as well when you add venetoclax. Uproleselan may have an advantage in some of those subsets. So we'll be looking very carefully if that data when it comes out.

Great. Thank you.

[Operator Instructions] Next question comes from Biren Amin with Jefferies.

Yeah. Hi, guys. Thanks for taking my question.

Hi, Biren.

How are you, Rachel?

Good.

So on, I guess, GMI-1687, can you - I think, at ASH, you presented some data on the TALENs model in sickle cell with the 1687. Can you tell us how 1687 compares to rivipansel and that model or in another preclinical models in terms of potency?

Yeah. So in terms of potency, it's many, many times more potent, 500 or so more times - times more potent than rivipansel with respect to the target of E-selectin. Therefore, we're able to dose at much lower doses then we're able to dose with rivipansel and that's why we've been able to dose subcutaneously in those models. So it's the increase in potency that leads to the potential for subcu availability. And the molecule is also very soluble, so that's also been helpful in looking at the subcutaneous dosing so far in the animal models. There's not been direct head-to-head comparison in the same models of rivipansel with 1687. But we believe these models are certainly comparable in terms of looking at the ability to affect - to at least as well as preclinical models can to predict the impact on VOC in humans.

Got it. Okay. And then on Upro and the NCI study, how many events would that study need in order to conduct the EFS analysis, the Phase 2 portion that's expected at the end of the year?

I don't believe that the NCI has disclosed that publicly. And we don't want to get ahead of their public disclosure. So I don't know that I can comment on that. Eric, do you know if that's been disclosed publicly?

I'm not aware of that either, Rachel.

Yeah, so sorry, Biren. We can't get ahead of the NCI's disclosure. But they have set a certain number of events, as you'd expect us, as one would, so it's driven by both enrollment and by events.

Got it. And so, NCI is, I guess, keeping you guys updated in terms of the number of events that are growing on a quarterly basis or regular basis.

Yeah, we…

Sorry, go ahead.

I was going to say, we do have regular updates and communications with the NCI group, yes.

Okay. And then, I guess, maybe a last question on that study. You mentioned that you potentially could approach FDA with the EFS data. What type of a scenario or improvement would you need to see or benefit in the EFS analysis that would allow you to approach FDA and potentially file that data?

So, again, I don't believe that the NCI has disclosed the specific details around that analysis. And therefore, I don't think that we can. But I think suffice it to say that if they meet their pre-specified criteria for the evaluation of EFS at that point, then we would be able to take that forward.

Okay. Because I thought there was a poster a few years ago that outlined hazard ratio 0.64 for that analysis. So if they meet that, is that something where you could approach FDA with?

So I'm not - so thank you for reminding me, Biren. I'm not - I don't remember what the public disclosure was on that. But if the - so they have to meet their - they have to meet their criteria. And I believe there is some [outer spend] [ph] that needs to be accounted for in that analysis as well.

Okay, great. Thanks.

And at this time, I will turn the call over to Ms. Rachel King.

Okay. Well, thank you very much for joining our call. We appreciate your interest and your questions.

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