MacroGenics Inc (MGNX) 2021 Q1 法說會逐字稿

Good afternoon. We will begin the MacroGenics 2021 First Quarter Corporate Progress and Financial Results Conference Call in just a moment. (Operator Instructions)

At this point, I will turn the call over to Jim Karrels, Senior Vice President, Chief Financial Officer of MacroGenics.

Thank you, operator. Good afternoon, and welcome to MacroGenics conference call to discuss our first quarter 2021 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately 2 hours after the call is completed.

I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC.

In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except to the extent required by applicable law.

And now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics.

Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key highlights from our clinical programs. But before I do so, let me first turn the call back to Jim, who will review our financial results for the first quarter.

Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended March 31, 2021, which highlight our financial position as well as our recent progress. As described in our release this afternoon, MacroGenics total revenue, consisting primarily of revenue from collaborative agreements, was $16.9 million for the quarter ended March 31, 2021, including $0.9 million net sales of MARGENZA, which launched in mid-March, compared to total revenue of $13.7 million for the quarter ended March 31, 2020.

Revenue recognized during the quarter ended March 31, 2021, included a $10 million milestone related to development progress of retifanlimab outside the U.S. under our exclusive global collaboration and license agreement with Incyte. Our research and development expenses were $53.1 million for the quarter ended March 31, 2021, compared to $48.9 million for the quarter ended March 31, 2020. This increase was primarily due to higher expenses related to flotetuzumab, MGC018, MGD019 and preclinical projects, partially offset by a decrease in development and manufacturing costs from retifanlimab.

Our selling, general and administrative expenses were $15 million for the quarter ended March 31, 2021, compared to $10.2 million for the quarter ended March 31, 2020. This increase was primarily due to MacroGenics' 50% share of sales and marketing costs related to MARGENZA prelaunch and launch activities as per our agreement with EVERSANA. Our net loss was $51.3 million for the quarter ended March 31, 2021, compared to a net loss of $44.7 million for the quarter ended March 31, 2020.

Our cash, cash equivalents and marketable securities balance as of March 31, 2021, was $343.2 million compared to $272.5 million as of December 31, 2020. During the quarter ended March 31, 2021, we sold 3.62 million shares through our at-the-market, or ATM, facility at an average price per share of $27.60, raising net proceeds of $98.2 million. As is fully depleted, our previously filed $100 million ATM facility, today, we refreshed the ATM by filing a $200 million prospectus supplement to our shelf registration statement.

Finally, in terms of our cash runway, I will remind listeners that there are 2 PDUFA target action dates scheduled for July of this year relating to BLAs for both retifanlimab and teplizumab. For cash budgeting purposes, we continue to discuss both milestones as we have no control over them. Even with this discounting, we anticipate that our cash, cash equivalents and marketable securities as of March 31, 2021, combined with anticipated and potential collaboration payments, should enable us to fund our operations through 2023, assuming the company's programs and collaborations advance as currently contemplated.

And now I'll turn the call back to Scott.

Thank you, Jim. With the recent launch and commercialization of MARGENZA, we are delivering on our vision to provide potentially life-changing therapeutics to patients with cancer. We are well positioned to advance this mission as the growing body of data emerges from our deep pipeline of clinical and preclinical product candidates.

We are particularly excited about the multiple ongoing registrational or potentially registration enabling studies, including flotetuzumab in AML and margetuximab in gastric cancer. These are in addition to 2 PDUFA outcomes related to teplizumab and retifanlimab in July. And finally, we know many of you are eagerly awaiting clinical data for multiple dose expansion or proof-of-concept studies, including from MGC018, tebotelimab and MGD019. With that backdrop, let me use this time to walk you through updates on our portfolio of 8 clinical molecules.

First, let me provide an update on margetuximab. As Jim and I both mentioned, MARGENZA was launched in mid-March in coordination with our commercial partner, EVERSANA. As a reminder, MARGENZA is approved in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received 2 or more prior anti HER2 regimens, at least one of which was for metastatic disease.

MARGENZA was recently included in NCCN Guidelines. As I mentioned on our last quarterly call, we have modest expectations for MARGENZA sales given competitive realities that have taken place in the HER2-positive breast cancer market, including multiple new approvals, which is great for patients. Owing to these recent changes in the market and abbreviated sales history, we don't expect to provide MARGENZA sales guidance until later this year when we have a better sense of uptake by oncologists.

Finally, with regard to margetuximab in metastatic breast cancer, as you may recall, the Phase III SOPHIA trial is still ongoing for overall survival. Based on the current accrual rate of OS events in the ongoing Phase III SOPHIA metastatic breast cancer study that supported approval by the FDA, we now anticipate completing the final analysis of OS data based on accrual of the 385th OS event by the end of the third quarter.

Beyond breast cancer, we are evaluating margetuximab in the Phase II/III MAHOGANY study in patients with advanced gastric and gastroesophageal junction cancer. This trial consists of 2 modules designed to evaluate margetuximab as an investigational agent in combination with a checkpoint inhibitor with or without chemotherapy as a potential first-line treatment for patients with advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer.

As previously indicated, we submitted a placeholder abstract of margetuximab in gastric cancer in mid-February for our first half medical meeting. The submitted abstract included initial safety and efficacy data relating to 24 RECIST evaluable MAHOGANY Module A patients who are treated with a combination of retifanlimab, an investigational anti PD-1 antibody, and margetuximab. The abstract was accepted by ASCO. However, in consultation with the study's lead investigator, whose preference is to present updated results when most of the 40 enrolled patients will have been evaluated radiographically by central review, we and the lead investigator withdrew the ASCO abstract, and we will submit an updated one to ESMO.

Module B, which is evaluating margetuximab plus either of 2 of MacroGenics checkpoint inhibitor molecules in combination of chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors, irrespective of PD-L1 expression, is currently ongoing enrollment in coordination with our regional partner in Greater China, Zai Lab. Module B is expected to continue enrollment through 2021.

Next, let me discuss flotetuzumab, our investigational bispecific CD123 x CD3 DART molecule. We continue to enroll the single-arm registrational clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure or early relapse AML. We anticipate providing further updates on the clinical development of flotetuzumab in late 2021 and completing full enrollment of the study in 2022.

I'll next discuss MGC018, our investigational antibody drug conjugate designed to deliver a DNA alkylating duocarmycin cytotoxic payload to cells that express B7-H3. As you saw in ASCO's release of abstract titles yesterday, we plan to provide an update on MGC018 Phase I clinical data at the upcoming conference via poster presentation. When the ASCO abstract comes out in mid-May, you will see that as of January 21, 2021, data cutoff, ahead of the February 17 submission deadline, we had enrolled a 4 mg per kg cohort, which included 3 melanoma patients.

Based on preliminary data from these patients, we added a melanoma expansion cohort to the Phase I study. In addition, although we did not enroll any squamous cell carcinoma of the head and neck patients in dose escalation, based on preclinical PDX mouse model data presented at AACR and other available data, we also added a squamous cell carcinoma of head and neck dose expansion cohort with both melanoma and squamous cell carcinoma of the head and neck patients to be dosed at 3 mg per kg.

We expect to fully enroll the 40 metastatic castration-resistant prostate cancer patients as well as the 20 non-small cell lung cancer patients by midyear and the 20 triple-negative breast cancer patients later this year. With regard to the metastatic castration-resistant prostate cancer expansion cohort, as of today, we have enrolled more than 20 patients. All but 2 of them remain on therapy, and we are encouraged by the PSA data we've seen to date.

Again, with appropriate caveats here, this is early preliminary data. We have too few scans from any of the cohort expansion patients at this time to draw any conclusions. We look forward to presenting the MGC018 data at ASCO. Another of our investigational molecules exploiting the overexpression of B7-H3 in solid tumors is enoblituzumab, an Fc engineered antibody created using our Fc Optimization platform. In March, we initiated a combination study of enoblituzumab in a chemotherapy-free regimen in frontline squamous cell carcinoma of the head and neck with either tebotelimab for patients who are PD-L1 negative or retifanlimab in patients who are PD-L1 positive.

Next up, tebotelimab is our investigational bispecific PD-1 x LAG-3 DART molecule. We are evaluating tebotelimab in a Phase I dose expansion study as both monotherapy in several tumor types as well as in combination study with margetuximab. We expect to provide updates on the next stage of development for tebotelimab later this year. Our partner, Zai Lab, has the right to develop and commercialize tebotelimab in Mainland China, Hong Kong, Macau and Taiwan and currently has multiple ongoing monotherapy and combination studies of tebotelimab.

Let me next discuss MGD019, our investigational bispecific checkpoint DART molecule, that targets PD-1 and CTLA-4. Our Phase I dose expansion study is initially evaluating patients with microsatellite stable colorectal cancer and checkpoint naïve non-small cell lung cancer at the recommended Phase II dose of 6 mg per kg. We are in the process of adding expansion cohorts with metastatic castration-resistant prostate cancer patients and with melanoma patients.

Let me next turn to retifanlimab, the investigational anti-PD-1 antibody that we licensed to Incyte is INCMGA0012. The FDA accepted for priority review Incyte's BLA for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy. According to Incyte's statements, the PDUFA target action date for retifanlimab is July 25, 2021. In addition to anal cancer, Incyte has stated it is pursuing development of retifanlimab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer, Merkel cell carcinoma and lung cancer. In addition, they are evaluating the molecule in combination with other assets in their immuno-oncology portfolio.

And finally, our second investigational ADC, IMGC0936 (sic) [IMGC936], which targets ADAM9, is being advanced under a co-development agreement with ImmunoGen. Under our 50-50 collaboration, ImmunoGen is leading clinical development, and they have indicated they expect to complete dose escalation and move to expansion cohorts in the Phase I study with initial data anticipated by early 2022. We look forward to continuing to build momentum and advance our pipeline of innovative product candidates in 2021.

We would be happy now to open the call for questions. Operator?

(Operator Instructions) Our first question will come from the line of Jonathan Chang from SVB Leerink.

First question. Can you provide your latest thoughts and help set expectations as it pertains to the upcoming MGC018 update at ASCO? You provided some color on the prostate expansion cohort. Maybe a follow-up on that. Should we expect to see any lung cancer expansion cohort data at ASCO?

Jonathan, thanks very much for your question. At this point, we're not expecting update on the lung cohort given the very early nature of that study. As I have indicated previously, patients did not start enrolling in that study until after the beginning of this year. We haven't actually looked at the full data set available. We are devising the poster very shortly. But as of now, I don't expect the lung cancer patients to be included in the update.

Got it. And one clarifying question. I think I heard this, but I just want to double check. Are both the MGC018 expansion courts in head and neck cancer and melanoma evaluating the same 3 mg per kg dose level in regimen as the other ongoing expansion cohorts?

That's correct. The new expansion cohorts in head and neck and melanoma are at 3 mg per kg, Q3 weekly.

Got it. And just one final question for me. What are your latest thoughts on potential 018 updates beyond ASCO this year?

So we intend to provide updates at future scientific meetings this year. We are considering a submission to ESMO. Obviously, the data has not come up yet, but that is in the planning stage.

Our next question will come from the line of Peter Lawson from Barclays.

Just the -- as we think about the ASCO data for B7-H3, I guess, 2 parts, really. Kind of how much prostate data should we expect to see? And would we see any other indications for triple-negative breast cancer or any of the other earlier data?

Thanks, Peter. So with regard to the quantity, as I said, we're doing a cutoff this past week in terms of the data update. I haven't seen the actual data as yet as we devise the poster. My expectation is you'll have in the new expansion cohort of prostate patients there will be a double-digit number of patients included. As I said on the call today, we have treated over 20 patients. So given that we are looking at PSA results on a Q3 weekly basis and looking at scans on every 9-week basis, it is possible that we'll have significant number of patients having at least some initial PSA evaluations in that prostate cohort.

With regard to the triple-negative breast, as I indicated, that is enrolling slower than the prostate and lung cancer patients and don't expect to complete enrollment of the 20 patients in that cohort till the second half of this year. So we will not include that at the ASCO meeting. However, as we have indicated today, we have data from the 4 mg per kg Q3 week dosing in the dose expansion, which, as I noted today on the call, will include 3 melanoma patients. We had historically said we had 2 prostate patients and there will be another patient with another indication included in the study.

And the reason to add head and neck -- was that influenced by Daiichi's trial or just the PDX model?

As our -- as we commented today, the latter with regard to the PDX model was obviously very reassuring. But even before we had the PDX model data, as you recall, 2.5 years ago, we presented very compelling data of enoblituzumab combined with pembro in late-line head and neck patients with 33% overall response rate with a lot of durability of those responses. As you know, frontline head and neck cancer treatment is pembrolizumab plus chemotherapy. So the ability now of potentially treating a frontline population with 2 different checkpoints based on PD-L1 status, plus enoblituzumab was very encouraging to us. And we thought that it was very natural then to add an MGD018 in late-line patients as well.

Got you. Just a final question. Would we get durability data in the abstract or we have to wait for the presentation?

With regard to the abstract, again, as discussed today, the cutoff date was January. The abstract was due on February 17. So very little data, but for the comments on the 4 mg per kg cohort group is included in that abstract. Having said that, as I have noted on earlier calls in the past month, I know there's at least one of the 4 mg per kg patients that's still on therapy. So again, you'll have to wait for the actual data to hear the update.

Our next question will come from the line of Jonathan Miller from Evercore ISI.

Yes. I think let's start with maybe one more about the ASCO data. Are we expecting to see any color at all on those other cohorts in non prostate cohorts midyear? Or should we have to wait till ESMO to see anything on the activity side from those cohorts? Secondly, you said you -- I thought I heard that you said the PSA response -- is you're happy with PSA responses in the mCRPC cohort. Is that -- did I hear you correctly? Is it fair to say that those rates are holding in? And then maybe switching gears a little bit. Let me hear these questions first before I inundate you .

Yes. Thanks, Jon. So with regard to the other cohorts and the timing, all I can project right now is obviously what we're going to do at ASCO. We typically like to present these data at scientific meetings and time it appropriately. So my sense is that it's most likely represented at one or more scientific meetings in the second half of the year. With regard to the PSA and the expansion cohorts, I'll just keep it general that the biological activity is trending favorably in the data that I looked at literally a week ago. And I won't say more than that. Obviously, we'll have some additional numbers come in this week. But from what I've seen so far, I'm very pleased of what I'm seeing with regard to bioactivity, the safety profile we've described historically and with the new patients and then additional data that we're getting from the 4 mg per kg expansion cohort.

I guess now we can switch gears maybe. I noticed the new CD123 x CD3 moving forward there. Should we -- how should we think about that in the context of potentially registrational cohort for flotetuzumab and your plans for updates on that data set?

Totally independent. The enrollment of the registration study of flotetuzumab in the primary induction failure, early relapse patient is continuing. We anticipate providing updates by the end of the year on that study. As I've highlighted before, we're very excited about the prospects of advancing our platform technologies. So with regard to this CD123 x CD3, this contains a slightly altered CD3 molecule that should really dramatically reduce cytokine release but preserve the antitumor effects we have seen with flotetuzumab plus the ability of having intermittent dosing of those patients based on incorporation of an Fc domain. So we're very excited as this is one of several molecules in our preclinical portfolio that's emerging on this -- advancing our platform technology.

Makes sense. And just one last one. On the new expansion cohorts for MGD019, what's giving you confidence in prostate? I think melanoma makes sense for these sorts of targets. So prostate is a little bit different. Can you talk a little bit about what's driving you into that indication?

So there are a couple of things that's driving. Obviously, with our strong interest in prostate cancer, we're looking at opportunities to advance multiple molecules in that indication. As you probably remember, one of the patients that had an objective response, in fact, a complete response in our dose escalation study was a patient with castration-resistant prostate cancer, which again, was quite remarkable. And that patient is still in remission. And I think that's coming on close to 2 years now. I know it's at least 1.5 years. So we're very pleased about that. Also, as you know, studies that were conducted with it in vivo in prostate cancer showed the responses that were quite favorable, although they did not meet the objectives of the study for approval.

The idea here of being able to use a safer and potentially safer and a very active molecule like MGD019 gives us a lot of enthusiasm. And finally, as you know, one of our missions in our company is the combinability of our molecules. And so as we develop these molecules individually in a particular indication, we look for the opportunity to combine them in a mechanism -- in mechanisms that are orthogonal to each other to get to an even better response. Our preclinical data, for instance, combining MGC018 and checkpoint molecules has been shown to be quite favorable. And so do not be surprised and future studies may be designed to ask those questions in indications that we are pursuing as monotherapy.

Our next question will come from the line of Stephen Willey from Stifel.

And I'm going to ask you a couple 018 questions, if you don't mind. But I guess, there seems to be a lot of emphasis around this notion of whether or not we're going to see, I guess, some RECIST evaluable prostate cancer patients at ASCO, even though this is, I believe, the minority of most refractory prostate cancer patients. Is there anything that you can say just with respect to, I guess, the double-digit patients that may be included in the presentation? Of what proportion of those do you think we may actually be able to see some RECIST data in?

Thanks, Steve. So with regard to the expansion cohort, with regard to RECIST evaluable patients, I haven't looked over the latest list of patients with regard to whether they had measurable disease. What I've noted on previous looks, they seem to be following the normal composition of patients that have bone only disease, which are a little bit more than 50%, and then patients that have either lymph node or visceral disease that is measurable, which is a little less than 50%.

So I'm assuming that we have a pretty normal distribution. I think that the issue becomes is whether we have any evaluable scans at the time because, as I said, most of these patients came in, in 2021, and we're only getting scans every 9 week. So if we don't have anything that's evaluable by ASCO, we certainly will have it evaluable in the second half of this year. So it's not that we're holding back anything. We just -- the patients have to have time to be evaluated.

Got it. That's very helpful. And I know in the literature, right, there's the suggestion that the correlation between a PSA50 response and a RECIST response is pretty high. But do you think that correlation differs on a target by target basis in terms of just modality of therapy? Or do you think that that's just a correlation that broadly holds across the treatment landscape?

I think the full answer is not in yet. I think that the recent data suggests a pretty good correlation. As you know, many of the agents that are approved for treatment are part of the AR inhibitor family. And so I suspect that the effects on PSA and then multiple prediction there may be different than, say, an ADC molecule with cytotoxic effects. I think we'll just need some more time to evaluate this. I think that it is -- in the case here, where you're using an ADC, the only thing that I can truly ascribe to the reduction of PSA is actually a reduction in tumor. That's the only mechanism that I can see here either by direct cytotox effects or possibly by secondary immunological mechanisms. So we'll have to see whether that correlation holds.

I should also note that for patients that -- particularly late-stage patients that have continually rising PSAs, the ability to shut that off that doubling time is also -- should be also seen as quite favorable because, ultimately, we're not curing late stage patients. We're looking at both improving the morbidity and mortality of these patients and prolonging their lives. So I think, again, we're going to need more time to ultimately come out with the conclusions here. But as I said, I was very -- we were very excited last year by the initial data. We continue to see the current data in a positive light.

That's helpful. And just lastly, Scott, you mentioned the possibility of combining 018 with a PD-1 inhibitor. I know that the protocol for the MGC018 trial calls for, I guess, with or without retifanlimab. Have you started dose escalation with retifanlimab? And I guess, does the -- does some of the PD-1 plus chemo data that we've seen in the refractory data -- in the refractory setting kind of accelerate that -- those development time lines, especially now as you've settled on a recommended Phase 2 dose?

Excellent question, Steve. So when we were starting the dose escalation, we expect it to quickly go over and flip to the combo study with retifanlimab. However, we were obviously pleasantly surprised with the robustness of data we saw with the PSA reduction. And so rather than continue on with that part of the protocol. As you know, we didn't even finish out the dose escalation. We went to the expansion. Now that we have so much more data with both tebotelimab, the PD-1 x LAG-3, and with MGD019, PD-1 x CTLA-4, in addition to retifanlimab, we have a lot of different opportunities now and don't necessarily have to resort to just using retifanlimab. And so we're right now in discussions of next steps in designing those combination studies. And so I wouldn't necessarily assume that it's going to be retifanlimab.

Our next question will come from the line of Yigal Nochomovitz from Citigroup.

Could you just clarify why you're combining enoblituzumab with tebotelimab in the PD-L1 negative head and neck patients given that tebotelimab targets PD-1?

Yes. So Yigal, this goes back to the observations we made and described last year at ASCO with regard to our Fc engineering and the combination with tebotelimab. As you recall, we presented a very exciting data of margetuximab with tebotelimab in patients that were HER2-positive in late-line patients who the majority or many of these had very low checkpoint ligand expression. So very low PD-L1, very low LAG-3. In fact, many of the patients were PD-L1 zero. At the same time, we were conducting the preclinical studies with that combination. We were also conducting enoblituzumab in combination studies with tebotelimab and demonstrated, as we have discussed before, the ability to drive up innate and specific immunity as a result of treating with the Fc engineered enoblituzumab.

And by up-regulating both LAG-3 and PD-L1, we see that as an opportunity of now getting a much more dramatic therapeutic effect when added to tebotelimab. So again, this is a Phase I study in the enoblituzumab in PD-L1 negative, but our assumption is the same Fc engineering that's in marge where we showed positive clinical results would translate the same way for the PD-L1 negative patients when given this Fc engineering plus tebotelimab. And as you know, the historical data from Merck with pembro or from Bristol with nivo in head and neck with PD-L1 negative was very poor. So any way to increase the expression here we think will have salutary effects.

Okay. Got it. And then could you just comment on the rationale for expanding the Phase I MGC018 study into melanoma? I'm just wondering if you also had mouse PDX data for melanoma, as you did for head and neck.

Okay. So without revealing specific data, as you noted on our call today, we had at the 4 mg per kg, 3 patients with melanoma. That's all I'll say about those patients and wait until the ASCO presentation. But I also should put this in the context of our historical experience in melanoma. With enoblituzumab as a single agent, we had objective responses or tumor reduction in late-stage melanoma patients.

And the same thing was also observed in patients who were treated with our bispecific MGD009, which was a CD3 x B7-H3. So we have many avenues at this point that suggests melanoma would be a good population to continue to evaluate. And of course, we also have done immunohistochemistry studies with tissue specimens for melanoma patients showing high expression of B7-H3.

Our next question will come from the line of Brad Canino from Crédit Suisse.

Great. I'll just ask one and not about data expectations. But I do have a question on the product market fit for the gastric cancer Module A that you're going to be reporting at ESMO because I understand the rationale of a chemo-free regimen to reduce toxicity. But these patients present with pretty debilitating symptoms from the tumor, are likely struggling to eat. And I would think they would want a fast response, which is what the chemo would provide. So how important is the chemo-free regimen? Is this just a niche opportunity relative to your chemo triple that you'll have later? Or do you think there's really a demand here?

That's an excellent question, Brad. Nice to meet you via phone. So again, if you recall, we had conducted studies in second-line of margetuximab and pembrolizumab and actually saw -- and these are patients who have progressed on HERCEPTIN and chemotherapy and saw in the HER2 3 plus positive PD-L1 positive population actually a very quick response in certainly a large number of those patients. And the additional value of that is that our overall survival of that population was dramatically better than the approved second line therapy, ramucirumab plus paclitaxel and was even -- and much better than first-line therapy when you compare to across different studies.

And so that was the rationale. Also, the fact is, is that when you look at the patients in the frontline setting, their HER2 expression tends to be higher and their PD-L1 expression tends to be higher. So again, we are expecting or had expected and hoped to be able to present the data later this year at the scientific conference, addressing the question you had in terms of the rapidity of response and the durability of that response.

Our next question will come from the line of Boris Peaker from Cowen. And our next question will come from the line of Etzer Darout from Guggenheim Securities.

Great. The first one, I guess, is another sort of clarifying question from the introductory remarks. Just wanted to confirm that all but 2 patients in the sort of the prostate expansion army made on therapy? And then also on the pace of enrollment in melanoma and head and neck? And then I have a second question.

So as the data that I had seen as of a couple of days ago that was -- that is correct. So I can't tell you it changed today. But as of a couple of days ago, that statement is correct. With regard to the speed in which we will enroll the head and neck and melanoma patient in this cohort, this is just opening up. The expectation is that we would enroll a significant number in the second half of this year. But again, we'll provide updates over the course of the year, how that's going.

Great. And then one question on MGD024. I guess, based on the preclinical evaluation you've done so far, how are you thinking about sort of maybe frequency of administration as it kind of relates to sort of flotetuzumab in terms once every week, once every 2 weeks? Any thoughts around what that interval could be based on what you're seeing?

Good question. So obviously, we'll have to see what happens in patients, but I think a Q2 weekly dosing regimen is certainly possible and may reduce the Q1 or increase to Q3. We'll just have to see.

(Operator Instructions) Our next question will come from the line of David Lebowitz from Morgan Stanley.

On the gastrointestinal trial Module A, what is it -- I guess, how many patients were originally expected to be presented at ASCO versus the 40 that will be presented later this year? And what, I guess, does -- is the driving factor behind the -- I guess, the leading physician wanting to postpone presenting the data at this point? What factors are, I guess, pushing, wanting to just hold off until the complete data set is ready?

Yes. Thanks, David. It was -- very simple is that, as you know, our decision to move forward is based on central review of 40 patients. And we only had about 20 -- a little over 20 patients that had investigator review. So it was really in between presentation. And so since there was no compelling decision and we're waiting until the full 40 patients get evaluated radiographically, we didn't see any harm on allowing the investigator to present this at -- hopefully, at ESMO. Given that it was only a partial study, this was going to be a poster session and with a much more fuller data set. There is obviously a potential for an oral presentation with this type of study.

Have any of the patients in that original abstract undergone the, I guess, radiographic assessment to this point?

So they have -- all the patients -- 20-some-odd patients have investigator evaluations. There's been some additional patients. But there's no full central review data set available at this point.

Okay. And I'm not showing any further questions in the queue. I'd like to turn the call back over to the speakers for any closing remarks.

Thank you, operator, and thank you for your participation in the meeting today. We look forward to updating you on our programs in the not-too-distant future. Have a wonderful afternoon.

This concludes today's conference call. Thank you for participating. You may now disconnect.