MacroGenics, Inc. (MGNX) Earnings Call Transcript & Summary

Good afternoon. We will begin the MacroGenics 2021 Second Quarter Corporate Progress and Financial Results conference call in just a moment. [Operator Instructions] At this point, I will turn the call over to Chris James, Vice President of Investor Relations and Corporate Communications of MacroGenics.

Thank you, operator. Good afternoon, and welcome to MacroGenics' conference call to discuss our second 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 announcement, 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, Chris. I'd like to welcome everyone participating via conference call and webcast today. For those who have not yet met Chris James, he recently joined MacroGenics as our VP of Investor Relations and Corporate communications. We are delighted to have him onboard. This afternoon, I will provide key highlights from our clinical programs. But before I do so, let me first turn the call to Jim Karrels, our Chief Financial Officer, who will review our financial results for the second quarter.

Thank you, Scott, and welcome, Chris. This afternoon, MacroGenics reported financial results for the quarter ended June 30, 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 $30.8 million for the quarter ended June 30, 2021, including $3.2 million net sales of MARGENZA which launched in mid-March, the $30.8 million compared to total revenue of $20.3 million for the quarter ended June 30, 2020. Revenue recognized during the quarter ended June 30, 2021, included $14.4 million from Zai Lab related to the recent June 2021 collaboration announcement and a $5 million milestone related to development progress of retifanlimab under our exclusive global collaboration and license agreement with Incyte. Our research and development expenses were $55.8 million for the quarter ended June 30, 2021, compared to $57.4 million for the quarter ended June 30, 2020. Selling, general and administrative expenses were $15.2 million for the quarter ended June 30, 2021, compared to $10.2 million for the quarter ended June 30, 2020. This increase was primarily due to MacroGenics 50% share of sales and marketing costs related to MARGENZA launch activities as per our agreement with EVERSANA. MacroGenics net loss was $39.9 million for the quarter ended June 30, 2021, compared to a net loss of $46.9 million for the quarter ended June 30, 2020. Our cash, cash equivalents and marketable securities balance as of June 30, 2021, was $297.3 million compared to $272.5 million as of December 31, 2020, our June 30, 2021 cash position did not include $55 million received from Zai Lab in July related to our broad strategic collaboration to develop and commercialize preclinical bispecific antibodies in oncology. This collaboration was announced on June 16, 2021, the $55 million consisted of a $25 million upfront payment and a $30 million equity investment as consideration for the execution of the collaboration agreement. Finally, in terms of our cash run rate, we anticipate that our cash, cash equivalents and marketable securities as of June 30, 2021, combined with funds subsequently received in addition to 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. We are excited by our continued progress towards our goal of providing multiple potentially life-changing therapeutics to patients with cancer. In March, we launched MARGENZA for the treatment of HER2-positive metastatic breast cancer. More recently at ASCO, we presented encouraging preliminary clinical data from a Phase 1 study of MGC018, our anti B7-H3 antibody drug conjugate. We plan to present updated clinical data from the MGC018 Phase 1 study as well as a Module A of the MAHOGANY study of margetuximab in gastric cancer at ESMO in September. With that backdrop, let me use this time to walk you through the updates on our portfolio of clinical molecules. When we first discussed MGC018, our investigational antibody drug conjugate designed to deliver a DNA alkylating duocarmycin cytotovic payload to cells that Express B7-H3. MacroGenics presented an update of clinical data from the ongoing Phase 1 study of MGC018 in patients with advanced solid tumors at ASCO in June of this year and held a conference call and webcast with external guest presenters to discuss the results. As of the May 3, 2021 data cutoff, the study demonstrated antitumor activity in all 3 melanoma patients from the 4 mg per kg dose escalation cohort who are enrolled subsequent to the 2020 ASCO poster presentation, including one with a confirmed partial response. As presented, preliminary results in the metastatic castration-resistant prostate cancer cohort expansion demonstrated 11 of 22 or 50% of the patients had a PSA reduction of 50% or greater. Antitumor activity was observed in 4 of 7 of these patients with measurable disease who have their first 9 week imaging results available, including one unconfirmed partial response. The adverse events continue to be manageable and include hematologic and skin toxicities as well as plural and pericardial fusions. Overall, we are encouraged by the data presented to-date. The poster presentation of this study is available under the Investors tab on our website. MGC018 trial cohorts are ongoing for metastatic castration-resistant prostate cancer, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and triple-negative breast cancer. Finally, we submitted a placeholder abstract to ESMO based on the same May 3, 2021, data cut presented at ASCO, and it was accepted for poster presentation. We anticipate that the data to be presented at ESMO will be based on a data cut closer to the actual meeting date in September. 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 with retifanlimab in patients who are PD-L1 positive. Although enrollment at this time is proceeding slowly, we are taking steps to accelerate recruitment and recently expanded efforts to enroll patients for this study in Europe. Next, let me discuss flotetuzumab, our investigational bispecific CD123 x CD3 DART molecule. We continue to enroll the single-arm registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure or early relapsed AML. We anticipate providing further updates on the clinical development of flotetuzumab in late 2021. We expect to submit the investigational new drug application for MGD024, our next-generation CD123 x CD3 DART molecule in the fourth quarter of this year. This molecule incorporates a CD3 component designed to minimize cytokine release syndrome, while maintaining antitumor cytolytic activity along with an FC domain to permit intermittent dosing through a longer half-life. Next up, let me walk you through our PD-1 based assets. tebotelimab is our investigational bispecific PD-1 x LAG-3 DART molecule. We are currently evaluating tebotelimab in patients in both monotherapy as well as in combination with other agents. Zai Lab, our partner in Greater China, is evaluating tebotelimab as monotherapy in patients with hepatocellular carcinoma and melanoma as well as in combination with niraparib in a variety of advanced or metastatic solid tumors. At ASCO, we're pleased to see Bristol-Myers Phase 3 relativity 047 data, which validated the combined targeting of both PD-1 and LAG-3. This is potentially good news for patients and provides further support for evaluating a bispecific molecule against these 2 targets. We expect to provide an update on plans for the next stage of development for tebotelimab in the coming months. Next, MGD019 is our investigational bispecific checkpoint DART molecule that targets PD-1 and CTLA-4. We are conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer, checkpoint naive non-small cell lung cancer, metastatic castration-resistant prostate cancer and melanoma. Let me next turn to retifanlimab, the investigational anti PD-1 antibody that we licensed to Incyte as INCMGA0012. Last Friday, after the close, Incyte announced that the FDA had issued a complete response letter or CRL regarding its BLA for retifanlimab for the treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal. Incyte's announcement indicated that the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlimab for the submitted indication and that Incyte is reviewing the CRL and will discuss next steps with the FDA. Beyond anal cancer, Incyte has stated, it is exploring development of retifanlimab as monotherapy and 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. Our second investigational ADC, 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 anticipate disclosing initial data in early 2022. Last but not least, I will provide an update on margetuximab. We are evaluating margetuximab in the Phase 2/3 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 cancer or gastroesophageal junction cancer. At the ESMO meeting in September, we expect to report initial safety and efficacy data relating to the approximately forting resist evaluable MAHOGANY Module A patients who are treated with a combination of retifanlimab and margetuximab. With regard to margetuximab in metastatic breast cancer, as a reminder, MARGENZA was launched in mid-March in coordination with our commercial partner, EVERSANA. 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 anti-HER2 regimens, at least one of which was for metastatic disease. We are pleased that MARGENZA is in the market and that patients are being treated and may benefit from the therapy. As reported, MARGENZA net sales were $3.2 million for the quarter after a few months on the market. As I mentioned in prior earnings calls, we have modest expectations from MARGENZA sales given competitive realities that have taken place in the HER2-positive breast cancer market, including multiple new approvals. We expect to provide MARGENZA's sales guidance after the therapy has been marketed for at least a year. Finally, as you may recall, the Phase 3 SOPHIA trial is still ongoing for overall survival. Based on the accrued overall survival events in the SOPHIA metastatic breast cancer Phase 3 study, we expect to complete and share top line results from the final analysis of overall survival data based on 385 OS events by the end of the third quarter of 2021. We look forward to continuing to build momentum and advance our pipeline of innovative products in 2021. We are now happy to open the call for questions. Operator?

[Operator Instructions] And we have a question from the line of Yigal Nochomovitz with Citi.

This is Carly on for Yigal. On MGC018, could you comment at all on if the anti-tumor activity observed in 4 out of 7 prostate cancer patients who had measurable disease is deepening over time? And relatedly, it's the one unconfirmed PR has since been confirmed. And then similarly, for the melanoma dose escalation patients, have you seen any evidence of antitumor activity deepening over time there?

This is Jim Karrels. I think Scott, we have a thunderstorm here, and I think Scott's line in the office dropped. So you're going to have to repeat that question in just a moment. So Caryl, would you -- Scott, did you hear the question, if not, maybe Carly would you mind repeating it.

Okay. Okay. Sure, I can repeat it. Yes. I was just asking about sort of an update to what you had shown at ASCO, if you've seen any evidence of anti-tumor activity deepening over time in the 4 out of 7 prostate cancer patients with measurable disease and weather that one unconfirmed PR has been confirmed? And if you had any similar comments on the melanoma dose escalation cohort in terms of deepening of tumor responses over time? That would be really helpful.

Yes. Thank you very much for the question. Obviously, we're very excited about providing updates at the upcoming ESMO meeting. And so we don't want to preview this ahead of that meeting. As we've said on the call today, we're going to try to provide a update of the data as late as possible and still meet the obligations of the poster session. My expectation is that we will have at least 3 months of additional data so that will include following the original 22 patients we discussed with regard to PSA 50 reduction and then additional patients in the study. In that regard, we have recently completed the full enrollment of the castration-resistant prostate cohort, which was consisted of 40 patients. In addition, we had completed enrollment of the 20 patients in the metastatic lung cancer cohort. So we're very happy with the strong interest of investigators and patients to participate in the study. We should be able to provide, obviously, updates of the data with regard to both PSA as well as the scans on original 4 or actually the original 13 patients that we had identified that had at least one scan at the time of ASCO further follow-ups on those patients plus additional patients that have come in over the last few months. While we will not have a full data set on all 40 patients, my expectation is that we should have approximately 30 or so patients included in that data set, of which we expect probably around half of those patients to be ones with measurable disease based on disease within the [ disro ] lymph nodes. With regard to the melanoma patients, as you recall, in the 4 mg per kg cohort, we had 3 patients with a significant reduction in tumor size. We noted on the call that one of those patients had a partial response, which was confirmed. I'm pleased to say that the patient continues as of last week, as I know of the last cut of data to continue on the study and continue to do well. So again, we're very encouraged by that. We should also note that we have enrolled some patients in the new identified melanoma cohort and hope to continue progress through the planned 20 patients over the course of this year and maybe into early next year.

Our next question is from Jonathan Chang with SVB Leerink.

First question, it looks like there will be data from a competing B7-H3 ADC program coming up at ESMO. How are you thinking about the competitive landscape for 018? And what are the key things that you'll be looking to learn from the competitor data set?

As you know, we are aware of competing data from Daiichi being presented at ESMO. Obviously, we're very encouraged by the fact that they at least anecdotally reported that they've seen responses in a couple of tumor types, which we have yet to enroll in our study. That's very encouraging that in terms of having an outside organization validate the target and the approach. Obviously, they're using a different antibody drug conjugate going forward. Overall, we feel that it's, again, always in the best interest of patients that have opportunities with different mechanisms of action and look forward to reviewing their data. But we're very encouraged, as I say, with the data we've seen to-date. And we intend to continue to expand our plans for this program.

Got it. And second question, what do you view as the appropriate efficacy benchmarks for 018 in non-small cell lung cancer?

In prostate, I assume. In lung and prostate or just lung, Jonathan?

Yes about lung.

For long. Okay. Well, the answer is it's too early to deem what's the appropriate response rate. I mean the only thing that I can comment on from equivalent mechanisms of action at ASCO, as I am aware, so there will be reported results in non-small cell lung cancer and late-stage patients with response rates approximately 25%. But clearly, we would like to see the best response there. And given that this will be a early cut of data, what we present, we will continue to follow these patients through the course of the year. So it's just too early to benchmark responses at this time.

Our next question is from Jonathan Miller with Evercore ISI.

First, I guess, the KOLs in your ASCO webinar talked about pleural effusion and hand and foot syndrome is potentially concerning for the 018 and prostate data, but it seems like you had a different take there. A little more follow-up, how are those signals evolving where those KOLs? At the time you also mentioned optionality on dosing and schedule, and I would love to check in on how those efforts at this point are evolving and how you balance the need to advance the molecule with the desire to fully explore the dosing space?

As we have noted consistently, we have found the side effect profile, which, as we stated today, including the skin toxicities, which include hand-foot syndrome and the pleural effusions as noted, to be manageable. We don't -- aren't deviating from that observation. Patients are continuing on studies, even in many of these patients who have experienced these side effects. As we have pointed out, we have included in the study design, the ability to hold doses or reduce doses going forward as some of these side effect profiles emerge. As we have taken our strategy forward, we felt it was more important to get a larger patient based experience at the 3 mgs per kg every 3 weeks and then make the alterations during the study to then do an evaluation when the 40 patients in the prostate study are completed, we will then be able to come up with a decision moving forward, what is the appropriate dose based on both the safety profile and the efficacy we observed. As we have noted before, some of the things under consideration would be to increase -- or decrease the frequency of giving a drug, we feel that most of the side effects are an area under the curve associated effect. And so the longer exposure to the drug, we think will be more beneficial to the patient. The other alternatives are load with reduced doses going forward and some other alterations. We have not come up with the conclusion, but all I can say is that based on enrollment between in paradigm right now, I think things are going as planned.

I guess, second question. The Incyte CRL obviously sits back that program, and I recognize that they're leading the development for retifanlimab, but does this impact your ability to use this molecule as a backbone for combos? Does it impact your -- does it delay any of your combo plans or your expectations for milestones associated with that advance and how relevant those are for your cash runway?

So with regard to the use of retifanlimab in any of our studies, this has no effect at all in either ongoing studies or other studies we might want to use this. Or in fact, any partnership that we develop in which we want to include retifanlimab as part of the opportunity to combine this with other parties molecule. So all that is the same. With regard to the cash runway, again, we risk-adjusted the opportunity for milestones from this payment. And as noted on today, there is no change in projected cash runway even with no anticipated milestones coming from an approval due to the CRL.

Our next question is from Tom Shrader with BTIG.

This is Kaveri on for Tom. My first question is for the Module A MAHOGANY study. Has the bar for go novo decision changed for the study after the data release from the Keynote 811 trial?

As many of you know, Merck announced and the FDA-approved on an accelerated basis in frontline gastric cancer, the use of Herceptin plus chemotherapy plus pembrolizumab in patients with newly diagnosed gastric gastroesophageal cancer. In that study, that was a controlled study, they saw a -- in the control population, approximately a 54% overall response rate in the treated population with pembrolizumab, it was 71%. As noted historically, as we've pointed out, the baseline data prior to this study was about a 47% overall response rate based on the previous approval of chemotherapy and Herceptin in this indication. So what we have always indicated, while not giving the specific number that we hope to exceed, it was greater than 50% based on conversations that we had with the FDA. I think the questions that we need to decide is if we do not achieve 71% or greater response, can this drug still be used in a chemo BRE setting in this population. Meaning somewhere between 50% and 71%. And that's something we don't have the data yet because the data will be analyzed in the coming month by -- with results from central review of the study. And if that does occur, we will certainly think about what the appropriate next steps are, and we will certainly seek advice from the FDA on what is the appropriate way to continue with the study to get it available for patients, but still yet to be determined.

Got it. And for the Module B of MAHOGANY study, you're evaluating combinations with both PD-1 and PD-1 LAG-3. Do you expect to screen patients for LAG-3 levels based on the emerging data?

So at this point, we are not that would obviously be a huge impediment in getting enrollment of a trial of that size [Technical Difficulty]. As you know, from the RELATIVITY-047 study, there was no difference in terms of responsiveness of patients based on LAG-3. And so we still do believe that based on our own results, particularly in solid tumor population, there is potentially a role for screening patients based on LAG-3. But at this point, we have not changed plans going forward with regard to screening, and we would then do this retrospectively and analyze based on clinical results as well as biomarker expression patterns.

Our next question is from Stephen Willey with Stifel.

Can you maybe just provide a little bit more granularity around when you completed enrollment into the prostate and lung expansion cohorts? And then, I guess, how should we be thinking about any potential disclosure coming out of a triple-negative cohort? This is for MGC018. And just whether or not there's an opportunity to maybe either sneak that into ESMO or maybe more likely into a San Antonio presentation?

Both -- as you recall, quite vividly, the guidance has always been to have both cohorts enrolled by midyear prostate and lung, and that was achieved and that was achieved quite recently. So while enrollment of prostate began late in last year, almost all the patients got enrolled since February on prostate and since March on lung. So as you can imagine, some of these patients came in quite recently, and therefore, would not have data. So again, to reiterate my guidance, what I said is as likely we should have for ESMO by the next data cut 30 or so patients in prostate to be able to describe in some -- with regard to PSA and some of the scans that will continue, obviously, as patients continue on treatment. And on lung, we're hoping to provide updates on about half of those patients. But by the end of the year, we certainly will have a lot more data on the full cohort of both those groups. With regard to triple-negative breast, we're continuing to enroll. As I've indicated, that will -- should complete in the second half of this year, but I can't give you specific commitments of time of update of that data.

Okay. That's helpful. And maybe you can just speak a little bit with respect to where you are with MGD019 dose escalation? And I guess, specifically, -- or not dose escalation with dose expansion. And I guess, specifically within the prostate cohort, I think if I remember correctly, you had seen -- if it was a PR or CR within dose escalation in prostate. And I'm just kind of wondering if that expansion data within prostate is going to serve as kind of the decision-making point for whether or not you pursue 018 combo with that asset rather than, say, something like retifanlimab.

Yes. Steve, thanks very much for both the suggestions and the questions. With regard to the dose expansion, if you recall, we initially started with colorectal and a stable colorectal and with lung, particularly lung that proceeded slowly because of our interest in enrolling patients who are naive to anti-PD-1 therapies. So that has picked up lately, mostly obviously in Europe from those patients. The new prostate and the new melanoma cohorts for 019 were only recently added. And while we have had some patients enrolled, they are very few at this point. With regard to future combinations of checkpoint, as I indicated on our call at ASCO, we are very encouraged with our preclinical data that combining checkpoint does increase the anti-tumor effect of 018. And so certainly, 019 would be one of those under consideration to combine. And as you pointed out, especially with the fact that we saw a CR in the original dose escalation study of a patient with late-stage prostate cancer. We're very encouraged as one of those -- as that is one of the leading candidates.

Okay. And maybe just one quick logistical question for Jim. Are the outgoing payments to EVERSANA, are those realized in real time, i.e., the quarter in which they happen? Or is there a look back or a true up payment that's made at some point towards the end of the year?

It's not the end of the year. It's on a quarterly basis.

Our next question is from Etzer Darout with Guggenheim securities.

Great. Just wanted to get a sense from you, Scott. If you have any updates on the number of evaluable patients, we may see for lung cancer with 018? And then a follow-up, I guess, to earlier question, just around sort of the benchmark question, think back to sort of the Trop 280C from Daiichi and the 21% to 25% response we saw in lung monotherapy, I guess, in sort of second-line plus setting. Is that kind of a fair benchmark, if you will, in terms of what we would consider as encouraging results? We know different mechanism, but just wanted to kind of get a sense -- of your sense, I guess, of the landscape given those data sets?

Yes, you may have missed my comments and some questions. Both these came up. What I said with regard to the lung, we've recently completed the enrollment of the 20 lung patients. Obviously, some of them came in more recently. We're going to do the data cut likely sometime in August. So given these scans are done every 9 weeks, I think while I can't give you the exact number of patients will report on the lung, I think it will be about 10 of the 20 Don't hold me to the specific number, but we'll obviously try to include as many as possible. With regard to the benchmark on the -- with regard to reported at ASCO on, so there will be 25%. I commented before, obviously, higher is better, but I noticed the same observation. So certainly, it would be nice to be in that 20% to 30% range and then potentially higher, but I have no sense right now exactly what it's going to be. And certainly, this will be just a cut off data, and we're going to be continuing to follow many of these patients through the rest of the year. So given that they presented the data of a completed study, we are going to be presenting data of ongoing study.

Our next question is from Boris Peaker with Cowen.

This is Cynthia on for Boris. Thinking through MGD024, how do you think about that development of that DART alongside retifanlimab? And then just thinking, I guess, preclinically, how do those 2 DART molecules stack up with regards to safety anti-tumor activity?

So thank you very much with regard to the questions on our CD123 x CD3 programs. With regard to 2024, obviously, we're going to enter into this as a dose escalation study. And we expect that IND to be filed in the fourth quarter. As noted, clearly, the initial patients that would be incorporated would be late-line patients who have progressed on other AML treatments initially, whether we expand this into other CD123 bearing indications, we have not determined that as of now, we'll focus initially on AML. Given that the way this drug is designed, both in terms of a dramatically reduced cytokine release profile based on preclinical studies as well as the Fc engineering, which allows us to give the drug intermittently and still achieve a Cmax binding to the tumor. We are looking forward to developing this in much earlier lines of therapy than flotetuzumab. We have data both with flotetuzumab and MGD024 that we can combine this with HMA inhibitors, venetoclax and other molecules. So I think this would be a very nice addition potentially based on the preclinical data to add to the Armamentaria treating AML and other diseases that express CD123. With regard to the safety in anti-tumor responses that we've seen in xenograft models, while the actual dose required for MGD024 is higher, we achieved the maximum killing effect and achieve equivalent amounts of tumor control in xenograft model systems. And with regard to monkey studies with regard to the elimination of circulating CD123 monocytes and other granular sites that would express CD123, they were equivalent in terms of their efficiency.

Our next question comes from Peter Lawson with Barclays.

I may have missed this, but for 018, where would we see the melanoma data, Scott?

Yes. So Peter, as you know, we -- that was one of the recent cohorts we added after we saw those 4 mg per kg responding patients. So it's very late added and a lot of those sites have just gone up recently. And we're very encouraged that we have had a number of patients enrolled. And I think this cohort will enroll quickly. But to be realistic about this, this is probably first half 2022 update. Obviously, we'll try to get that data out as early as possible. But we are, again, very encouraged to what we've seen to date.

Got you. And then just, I guess, holistically, Scott, just around B7-H3, the ADC. Are there particular indications where you think you would get single-agent activity, sufficient for pivotal trials?

Right now, there's nothing to preclude us from believing that, particularly in tumors, where we're seeing very effective responses in late line patients, especially ones that have no alternative therapy that single agents would not be possible. It's still too early to make that determination. We obviously want the updated date on prostate, we want the updated data on melanoma and the other cohorts. But at this point, our strategy is going to be in -- with different intent move as fast as possible with the monotherapy, particularly towards registration, if possible, if the data pans out in these Phase 1/2 studies, but don't stop looking at combinations, particularly with agents that we are developing ourselves to get even a better, higher response. We think in some of those cases, that may allow us to move further up quicker into earlier line therapies, especially in tumors that -- where, for instance, checkpoint molecules are ineffective or checkpoint molecules and chemo have not been approved. So we're analyzing this in terms of what's the fastest way to get a new classes of drugs of the type 2 market.

And just if I could sneak in another question, just around the PD-1 LAG-3 update for this year. What are we going to see data? Or is it going to be kind of a strategic update of directions you could go with that?

We have a little more data from the bearing studies. It doesn't change what we have expressed at previous meetings. We are in discussions with various organizations and with key opinion leaders on what would be the fastest and best venue to develop this molecule towards registration, ongoing discussions now is possible that we may provide data is more likely to focus in on what's the next steps with regard to particular tumor indications and how we intend to move this forward toward registration.

[Operator Instructions] We have a question from David Lebowitz with Morgan Stanley.

In the upcoming ESMO update, will we be able to see, I guess, a breakdown of safety and tolerability data in patients on original dosing versus those who've had dosing adjustments?

We have not obviously put this poster together yet and haven't even planned it out specifically, we want to get the cut of the data. But we do believe it's important to provide updates on the safety, how it's formatted with in that regard. We obviously want to get as much data out as possible. So right now, I can't tell you how we're going to put it out, but we certainly will add information regarding that.

And I'm not showing any further questions in the queue. I will pass it back to Scott for final remarks.

Yes. Thank you very much for participating today. Sorry for the interruption on the Q&A session due to the weather, but we look forward to a further update during the course of the year, and have a nice evening.

And with that, we conclude today's program. Thank you for your participation, and you may now disconnect.