GlycoMimetics Inc (GLYC) 2020 Q1 法說會逐字稿

Good morning, and thank you for joining the GlycoMimetics Corporate Update Conference Call. (Operator Instructions) I would now like to turn the call over to Ms. Shari Annes of Investor Relations Group of GlycoMimetics. Please go ahead.

Good morning. Today, we will review our accomplishments and financial results for the first quarter of 2020. 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 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, Senior VP and Chief Financial Officer; and Dr. Helen Thackray, our Senior VP of Development and Chief Medical Officer.

We'll start today's call with comments from Rachel and Helen. And after that, Brian will provide an overview of the company's financial position. We will then open the call for Q&A.

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 company's product candidates, uproleselan, GMI-1359 and rivipansel, as well as our other pipeline programs and the potential impact of the ongoing global COVID-19 pandemic on the company's clinical programs, operations as well as 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 or on the GlycoMimetics' website. I'd now like to turn the call over to Rachel.

Thank you, Shari, and thank you all for joining our call. Before beginning, on behalf of the entire team, I'd like to say we hope that you and your families remain healthy, while the world adjusts to the challenges of the COVID-19 pandemic.

Today, on this call, we're all working from our homes, as has been our practice now for well over a month in compliance with CDC and Maryland state guidelines. We're diligently coordinating our activities to maintain ongoing business operations. We do look forward to going back to on-site operations as soon as we can, but not if doing so compromises the health and safety of our employees, collaborators or their families.

In addition to providing an overview of the quarter, we're opting to use this call to address the questions that you may have about our current programs and future activities. In so doing, I've asked Helen and Brian to provide updates on our clinical activities and financial resource utilization.

In our year-end call, we commented on several of the first quarter's highlights: continued enrollment in our Phase III registrational trial in relapsed/refractory AML; progress in our collaborative multicenter registration trial with the NCI in newly diagnosed elderly AML patients who are fit for intensive chemotherapy; execution of a license agreement with Apollomics for uproleselan and GMI-1687 in Greater China; start-up of the GMI-1359 trial in advanced breast cancer at the Duke Cancer center; and the return to GlycoMimetics' from Pfizer of development and commercial rights to rivipansel, our investigational drug candidate for the treatment of vaso-occlusive crisis, or VOC, in sickle cell disease. We'll comment on each of these achievements in a moment.

For quite a long time now, our operational focus has been on uproleselan, the most advanced investigational drug candidate in our pipeline. I've ask Helen to begin with comments on our clinical development activities for uproleselan, including both our company-sponsored Phase III trial and the NCI trial. Her comments will then also touch briefly on GMI-1359. Once she shares this, Brian will comment on our financial planning efforts and then provide the financial results for the quarter. After they've finished, I'll make a few concluding remarks, and then we'll open to Q&A. Helen, please go ahead.

Good morning, and thank you, Rachel. In February, in our year-end call, we noted enthusiasm for the Phase III registration trial, evaluating uproleselan in relapsed/refractory acute myeloid leukemia, or AML, was high among clinicians. This was due to the novelty of this approach and the potential benefits of uproleselan observed in clinical data we presented in several prestigious medical meetings. As you know, our clinical trials of uproleselan have illustrated the drug's potential to improve chemotherapy outcomes and in addition to ameliorate some of the serious adverse effects of intensive cytotoxic chemotherapy.

Furthermore, we have elucidated the role we believe E-selectin plays in the pathology of AML in the tenacity of tumor cells in the bone marrow microenvironment and their survival. New data on this mechanism was just published in Nature Communications this week. Hence, there is a very strong scientific case for the potential role of uproleselan in breaking chemoresistance of AML to improve patient survival. In the first quarter of 2020, we continued to see our global Phase III trial gain momentum with new sites opening and the brisk enrollment pace. However, enrollment slowed in April, not surprisingly because of the pandemic as well as recommendations, both here and abroad, to shelter in place and to conserve hospital resources for treatment of patients with COVID-19.

However, we are seeing the hospitals continue to screen and enroll patients, both in regions with lesser impact of the pandemic and in regions with some of the highest density of infections. At this point, it's difficult to predict how quickly the affected regions and sites will return to usual clinical trial operations. For those regions and sites experiencing an impact on enrollment, our study team is well positioned to support quickly returning again to full trial activities once that becomes possible. We do observe, however, that some regions and sites have seen limited impact on screening and enrollment during this time, indicating that the global nature of our trial may somewhat protect against broad effects of the pandemic.

There are several additional aspects of our clinical program that may further mitigate the risks to the trial during this global crisis. First, patients will be admitted to the hospital for their leukemia even in this pandemic. The AML patients we are treating are seriously ill and require hospitalization for intensive chemotherapy. This is not an elective hospitalization that can be avoided even in a global crisis, nor are we asking them to undergo monitoring other than that required for their care, whether on trial or not.

The second important point here is that the key clinical endpoints we are evaluating are gathered as part of the standard of care in AML. They will be captured in the medical record through routine documentation. This gives us confidence that we are capturing critical data for patients on the study during this period.

Third, we are able to use alternative means of communication to achieve routine trial milestones and interactions. We have gone to virtual site initiations and remote monitoring to ensure continuity of operations and the robust collection of clinical data, while these restrictions are in place.

These aspects of the trial will help ensure we can maintain the integrity of the trial through this global crisis. And when regions begin to pass the peak of new infections and relax restrictions on hospital clinical trial staff, we believe, our efforts will lead to a more rapid return to steady enrollment.

We are not attempting to project when the COVID-19 pandemic might resolve. As a result, we feel it is premature to assess the extent of any potential impact on timing of the completion of enrollment of our Phase III registration trial.

What I can say today is that we are in close contact with all of our investigator sites across the globe. We have seen continued enrollment and new site activation during the month of April, and we are monitoring the situation closely.

With respect to the NCI trial in newly diagnosed, older AML patients who are fit for intensive chemotherapy, where both major medical centers and community hospitals are participating, we believe the pandemic's impact on enrollment will likely vary across the sites. At this time, we do not have NCI's assessment upon which to provide a clearer picture.

Moving now to GMI-1359. We initiated a Phase Ib proof-of-concept trial at the Duke Cancer Center in January. This trial is evaluating pharmacodynamic or PD markers, such as hematopoietic stem cell mobilization, mobilization of circulating tumor cells into the periphery and other biomarkers of biologic activity following both single ascending and multiple doses within the same patient. Our goal is to use these data to define a recommended dose for Phase II, while also establishing the safety and pharmacokinetic profile of GMI-1359 in patients with advanced disease.

At present, this is being conducted on an outpatient basis with an elective treatment, and enrollment is on hold due to the pandemic, but we do hope to resume enrolling patients soon.

I look forward to answering your questions during the Q&A. Rachel?

Thank you, Helen. And now I would like to turn to Brian to both review the quarter's financial results and to provide his perspective on our financial situation. Brian?

Thank you, Rachel. Strategically, biotech CFOs contribute to their organization's long-term planning efforts by identifying a range of possible future scenarios handicapping their likelihood and preparing accordingly to ensure that resources are available to deliver on our goals.

Given our company-wide focus and the critically important goal of delivering top line Phase III data that demonstrates the full value of uproleselan in AML, I want to reiterate that our R&D portfolio has always been prioritized and focused, our cash has always been prudently managed and our fixed burn rate is low to allow us to weather potential delays in the normal course of business and R&D. I'd like to elaborate on several of these points in greater detail.

First, we've always managed our company with fiscal conservatism, and we will continue to do so. We have just under 60 full-time employees and our fixed burn is low, given we are managing 2 programs in the clinic, one of which is a registrational trial, and we are collaborating on 2 additional pivotal trials in AML.

Secondly, our portfolio has already prioritized for success with a focus on the pivotal program for uproleselan, where needed and to advance our programs, we have relied on collaborations, such as the one with the NCI to maximize the potential commercial value of uproleselan in a cost-efficient way.

In other cases, we have backed away from commitments that no longer made sense from a financial perspectives, as was the case with HOVON collaboration late last year. Because of its long-standing fiscally responsible financial approach, we importantly sit here today with 2 years of cash in the bank. Thus, our focus is a late-stage product portfolio, backed by a robust R&D engine.

We have and will continue to manage our cash prudently. With that, I'd like to summarize results for the quarter ended March 31, 2020.

As of March 31, 2020, GlycoMimetics had cash and cash equivalents of $154.8 million as compared to $158.2 million as of December 31, 2019. In January 2020, GlycoMimetics received upfront cash payments of $9 million from Apollomics, pursuant to the exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Greater China.

Beginning with R&D expenses. The company's research and development expenses increased to $12.7 million for the quarter ended March 31, 2020, as compared to $11.8 million for the quarter -- first quarter of 2019. Clinical development expenses increased by $2.4 million based on higher clinical costs related to the company's ongoing Phase III clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase III clinical trial being conducted by the NCI. In addition, personnel-related and stock-based compensation expenses increased by $540,000 due to annual performance adjustments processed in the quarter ended March 31, 2020. These increases were offset in part by a $2.1 million decrease in manufacturing and formulation due to lower raw material expenses in the first quarter ended March 31, 2020, as compared to the first quarter ended March 31, 2019.

Turning now to G&A expenses. The company's general and administrative expenses increased to $4.4 million for the quarter ended March 31, 2020, as compared to $3.4 million for the first quarter of 2019. Personnel-related expenses increased by $684,000 due to additional general and administrative headcount and annual salary adjustments awarded in the first quarter of 2020.

The patent, legal fees, consulting and other professional expenses, including Director and Officer's insurance premiums, increased by $373,000 for the quarter ended March 31, 2020, as compared to March 31, 2019.

In summary, assuming our programs are not impacted to the long-term by the COVID-19 pandemic, GlycoMimetics remains well positioned to carry out its planned initiatives and to advance applications for its unique technology platform into 2022.

I'll now turn the call back over to Rachel.

Thank you, Brian. Before I turn to rivipansel, I'd like to hire one more accomplishment with uproleselan this quarter. In January, we announced our collaboration and license agreement with Apollomics, a Chinese company committed to the discovery and development of oncology combination therapies and their goal to conduct a registration program with uproleselan in AML in Greater China. Since executing the deal, Apollomics has made significant progress defining their own development strategy and engaging with KOLs in their territory. Their near-term priorities are the regulatory interactions required for program startup. We're excited by the speed at which they're operating, and as they proceed with executing on their development strategy, will provide some top line guidance on timing of their activities in Greater China.

Moving now to rivipansel. We shared with you in our year-end call, Pfizer's decision to return to GlycoMimetics its rights to rivipansel, our investigational drug for vaso-occlusive crisis or VOC in sickle cell disease. The transfer of these rights and licenses and the IND for clinical development program, together with the entire dataset for the Phase III RESET trial back to GlycoMimetics, is now essentially complete. We're now reviewing the data, and we look forward to completing our analysis of the program. We're committed to a full assessment of what, if any, next steps to take. Our focus will be determining if there is a potential path forward for this asset in sickle cell disease. We and many KOLs in the sickle cell community continue to believe that the role of the selectins in VOC has been clinically validated. As such, with the asset back in our hands, we intend to evaluate and share the efficacy, safety, PK and biomarker data from the Phase III RESET trial.

Furthermore, we can now evaluate opportunities in sickle cell disease for our more potent and more selective E-selectin inhibitor, which has been shown in animal studies to be bioavailable through subcutaneous dosing.

I'd like to close by reiterating our confidence in our clinical pipeline and, of course, in our specialized glycomimetic chemistry platform. Our chemistry insights have fueled several innovations that we believe will improve the standard of care in AML and potentially in other diseases as well. Notwithstanding the challenges we all face in working remotely, I can share with you the dedication of our team and their commitment to making it through the new normal of a pandemic and forward to improve outcomes for patients where there are also serious unmet medical needs.

Operator, please open the call for questions.

(Operator Instructions) Your first question comes from the line of Ed White with H.C. Wainwright.

So just to start with -- you just mentioned rivipansel. How long do you think it's going to be, Rach, before we see what the full dataset was? And then also, because a sickle cell disease trial would be rather large, is this something that you would bring forward on your own? Or do you think once you go over the data, you would start to look for a partner if you think it can move forward?

Yes. So thanks for the questions. As far as when we see the data, it's hard to predict specifically when that would be because we're in the process of reviewing the data and looking at the overall program. I would say, within the coming months, we would be able to say something about that data. And as far as what we would do next, again, that would follow from the review of the data as well as from our assessment and potentially discussions with regulatory authorities around what a follow-on trial might look like if that is where -- if that does seem to be the appropriate next step.

So at the moment, it's premature to say anything specifically about what those next steps might potentially be. But in the coming months, we'll be reviewing the data more fully, hopefully getting more of that data out. And in the context of that assessing what, if any, next steps we will be taking with that program. And as part of that, we would also be assessing whether those are steps that we would take alone or with a partner. So I would say that whole process of evaluating the data and the opportunity is going to be undertaken now in earnest once the data -- now that the asset has been returned to us.

And then I understand it's tough to comment on any of the time line for upro, and it seems that 1359 is completely stopped now. But just on 1687, I'm curious as to -- since this is preclinical data, when you think you can reach the clinic or, at least, have the IND filed and be ready to go with that product?

Yes. So that is a product that we're excited about and the preclinical data has been very compelling in a number of indications. We think it's an interesting potential follow-on to uproleselan. We have not given forecast as to IND readiness for that asset.

So at this point, I'm not prepared to say when we would take that into the clinic other than to say, we're looking at opportunities with 1687, and we do believe it represents a potentially important follow-on asset to uproleselan.

Okay. And then maybe a question for Brian. Just with the COVID-19 and working from home and everything, I'm curious as to impact on SG&A and R&D, if you're going to see any impact, had there been any layoffs or expense cuts that will be material to R&D or SG&A expenses going forward?

No, thanks. As we've discussed in the past, we have just under 60 employees. So we've been very capital-efficient over the years with a very low fixed burn rate. So we did evaluate the impact of that. We -- some reduction in travel expenses and some other overhead expenses with working from home, but no anticipation of any layoffs at this time. And as we get through this, again -- once we get through this, we'll be able to give an updated cash guidance.

Okay. And when you say you have cash through 2 years, is that a firm through 1Q into Q2 2022?

I'd say 2 years right now into Q2 of '22. And again, as we get through this, we start to see the pick back up of the Phase III trial, we'll be able to give a better cash guidance on that.

Ok. I hope everybody remains healthy.

Thank you, you, too, Ed.

Your next question comes from the line of Boris Peaker with Cowen.

I'd like to focus on upro. I'm just curious, how frequently do patients need to show up to the hospital in the trial? How long do they have to spend there during each visit? And how does that compare to their alternative options?

So I'm going to turn that question over to Helen. So Helen, could you take that?

Yes. The uproleselan trial is in the setting of intensive induction chemotherapy. And so the patients are being admitted to the hospital for usually multiple weeks and perhaps longer than a month for their treatment of the relapsed or refractory acute leukemia. And so that need for hospitalization for intensive chemotherapy is present for the underlying condition, the leukemia. And it is in the context of their existing admission to the hospital that we are then enrolling them on the trial. There are follow-up visits once they have recovered from the initial reduction in leukemia. When they have recovered their counts or proceeding to treatment at home, they will come into the clinic for their usual scheduled visits for their medical care through the follow-up period, and it is during those scheduled visits that subsequent evaluations take place.

I would emphasize that the great majority of data that is relevant to this trial to assessing the safety and efficacy for uproleselan in the treatment of patients with AML is taken -- is being collected during that hospital stay, which is part of their routine care and during the follow-up visits, which are again part of routine care. So there is access to patients for the data that's needed for assessment of the drug and while they're in the setting of either the hospital stay or follow-up visits and those potentially could include virtual visits.

And I just wanted to understand how does that compare to their alternative options? Like how much extra burden? Or is there any extra hospital stay burden being on the trial versus not being on a trial?

So they -- this trial is designed quite specifically to be assessing during those routine medical interactions. And so there's -- there are -- there's no additional hospital stay that would be trial-specific. It's just during the routine treatment. So for example, the hospital stay is driven by their medical care, not by their study participation and their visits to the clinic or follow-ups afterwards are driven by their medical care rather than the trial itself. Does that answer the question?

Yes.

Your next question comes from the line of Stephen Willey with Stifel.

I was just -- maybe if you guys, I guess, specifically, how I might be able to comment just to the rate of patient screen failures that you might be seeing as you enroll the trial, and I guess, just whether or not if there's any variables that are proving to be not necessarily problematic, but I guess, occurring more frequently on the screen failure side. And just whether or not that rate of screen failure is just trending towards your internal assumptions.

Stephen, could you just repeat that last few words, trending towards...

Towards your internal assumptions -- that US model...

Assumptions. Okay. Okay. Yes. So thank you for the question. We are seeing risk assessment of patient, brisk presentation of patients for screening for the trial. There are some patients who are screened and do not meet the eligibility criteria, as you would expect. We are seeing a great number of patients, I would say, a good proportion of patients who are approached and screened for the trial are, in fact, eligible and are, in fact, enrolled on the trial. And so our screen fail rate is well within what we would have expected it to be. The reasons for not meeting eligibility criteria are also fairly typical and well within the range of what we expected. And I would say that we're seeing a proportion of patients who were then enrolled on the trial to be very closely aligned with what we would have expected. So there's nothing unusual or different in what we're seeing on the trial. And I find that actually quite reassuring. We're seeing investigators who are very knowledgeable of the disease, but also knowledgeable about the protocol, and they are appropriately offering this trial to their patients and enrolling patients who fit the criteria that we need.

Okay. That's helpful. And I guess I was just looking at some of the participating sites, the most updated version on trials.gov. I guess it looks like MD Anderson is no longer participating. And I guess I would have perhaps just thought that they would have been a large pool of potentially accessible patients. So can you maybe just kind of speak to their exclusion there? And maybe if that's just a conflict that they have with perhaps another sponsor on the AML side?

So I actually will have to check on that because as far as I'm aware, MD Anderson has been participating in the trial and has been an enthusiastic center in terms of our discussion around the use of the drug in this disease.

Okay. And then just on the preclinical publication that came out, I know that we've seen a lot of data around E-selectin inhibition and its utility in AML and its ability to break chemoresistance. I guess I haven't had a chance to go through the manuscript in detail, but can you maybe just highlight what you think is kind of the most important points there? And maybe what's incremental relative to some of the other presentations that we've seen on the preclinical side?

Yes. This is with regards to the Nature Communications' manuscript just published?

Yes, correct.

Yes. We're very excited about that manuscript, and this is definitive preclinical elucidation of the mechanism. It's assessing the specifics of how the drug is -- how AML cells are interacting through E-selectin to achieve chemoresistance essentially and be protected from chemotherapy. The specifics in this manuscript are further describing how that is achieved and the use of uproleselan to block that on a mechanistic basis. So we're very excited with the strength of the data here, which is illustrating the mechanistic reasons for what we're seeing in the clinic.

Yes. And I would add that -- one of the, I think, important observations there was the fact that the greater amount of E-selectin ligand on the blast leads to even increased chemoresistance. So again, further tying the ligand to the chemoresistance.

Okay. And actually, I just looked at a different view of the clinictrials.gov, and it actually does look like the most current version shows MD Anderson recruiting -- I was looking at the historical changes on kind of a side-by-side basis. And I think the way that they had portrayed it suggested that maybe MD Anderson had dropped. So forgive me...

So thank you for clarifying that.

Yes. Clearly surprised.

I want to cause any unfortunate...

No -- the MD Anderson has been an important -- no, they're, of course, a thought leader in the field. They have been important collaborators for us and important -- they've been very helpful in thinking through not only this trial and how the drug in -- the rivipansel is best used in this relapsed/refractory population, but also in thinking through where else, the drug may be important to assess in AML. And in fact, they've been an important collaborative partner with us throughout. So I was surprised by your comments, and I appreciate your clarifying.

Yes. No, of course. I'm going practice my web-browsing skills. I appreciate it. I appreciate the color.

Our next question comes from the line of Zegbeh Jallah with Roth Capital Partners.

First one, I think, for Helen. Have any additional patients been enrolled in the 1359 study since January?

So we have advised on initiation of enrollment for the 1359 study being run at the Duke Cancer Center, and that was the early guidance this year, that the first patient has been -- had been enrolled. We are not commenting on individual patient enrollments. And so our guidance today was simply that with this trial being run in the outpatient setting and the elective participation setting that at the moment is currently on hold briefly for the pandemic.

Okay. And then can you comment at all on the screening process with this? And then is this something that you could potentially expand to another clinical site as well? Or no?

So thank you for the question. That's an interesting question. I will say we have had interest both from investigators and researchers in the field, but investigators who are seeing patients with breast cancer and metastatic breast cancer. We've also had interest from patients. And we signed the molecule one that is exciting and has -- we -- greatly interested in the potential for treating this population. The study is running at the Duke Cancer Center and the investigators there have been important collaborators preclinically as well as clinically with this molecule, as we learn more about the pharmacokinetics and pharmacodynamics and early first-in-human experience in patients, we -- I think we'll be considering how best to advance this drug to either other sites or other trials?

Okay. And then I did see the publication for upro in AML. I thought that data looked really good and showing the potential for upro to prevent chemoresistance in AML. So just had 2 questions. I think one of which was, do you expect that this could also be the case for other hematologic malignancies? And then the second question is, there was some data from Aptus that showed that E-selectin inhibition, I think, with your molecule, could actually prevent BTK resistance. So I wanted to know what your plans were to pursue more preclinical development looking at BTK inhibition as well?

So I'll take a first cut at that. The -- as far as the potential application to other hematologic malignancies, I think that is a very interesting question. And we have in the past presented preclinical data, which you may be familiar with, and if not, it's on our website, where we have looked at and, in fact, demonstrated the potential of using E-selectin inhibition as a strategy and in other hematologic malignancies. So I think that is something that is worth exploring. We have explored preclinically and that is certainly on our radar screen.

As far as the second question on BTK resistance. I actually -- I don't know the answer to that. I'm not sure if Helen does. And if we can't answer that on the call, we're happy to follow-up with you more directly with our Chief Scientific Officer. But Helen, do you have a comment on that second question?

Only that we think that, that is a very interesting area. We have had some initial discussions about where that may be useful to us further explore the utility of the drug in diseases where that's more of an issue. And I think we have no immediate plans for -- no immediate conceived plans, but it's certainly an area of interest and we'll continue to discuss.

Yes. And that would refer -- I think you're referring to data that was presented at ASH out of MD Anderson, in the laboratory of Michael Andreeff, I believe, we've presented that data at ASH this year. So yes, I think there's preclinical data that's supportive.

Awesome. I think it's great in terms of looking for how -- in addition to 1687 being used for life cycle management for upro, but applicability for other indications that upro may be useful for as well.

Yes. 1687 isn't a molecule, but it is, as you know, in our preclinical models, is bioavailable subcutaneously. So it does offer the potential as a follow-on compound that could potentially be used in an outpatient setting. So we do think it does offer longer-term for potential good life cycle management opportunities within the E-selectin ligand or E-selectin dosing space say.

(Operator Instructions) Your next question comes from the line of Biren Amin with Jefferies.

Just on Upro, I think Brian commented earlier on the cash runway extending out to Q2 or mid-2022 type time frame. And if you look at your prior guidance on completion of enrollment in the second half of 2021, given the COVID situation and slowing of enrollment, in the Phase III, do you still expect that you would be able to meet timelines in terms of Phase III data before the cash runway runs out.

So the -- in terms of the guidance that we've given, we've not yet changed our guidance on completion of enrollment. We want to wait and see. We've had the one month of effect so far of COVID. So we think it's too early to assess the specific impact on completion of enrollment. I will say we do feel that 2 years is a long time. It's a long cash runway to have in the bank, and we're certainly glad that we have the financing in the bank for that period of time.

As Brian said, we're continuing to manage the cash very carefully. And we think we may have opportunities potentially to add to the balance sheet as we did with the Apollomics deal. So we're going to continue to manage with the objective of both completing enrollment and getting to top line data with the cash that we have.

Okay. And then is there a possibility to add additional sites? So for example, with the Apollomics deal, Greater China is available. Have you discussed with them the potential to extend the Phase III protocol into China possibly?

So we're currently contemplating that as a separate study, and we're not contemplating adding those sites to the sites as part of the main Phase III study. That's the current plan.

And at this time, there are no further questions. I would like to turn the call back over to Ms. Rachel King.

Great. Thank you. Thank you, operator, and thank you, everyone, for your questions and for taking the time to listen to our call, and we hope you all stay well.

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.