Macrogenics Inc Q2 FY2020 Earnings Call

Good afternoon. We will start the MacroGenics 2020 Second quarter Corporate Progress and Financial Results Conference Call shortly. I will now hand the call over to Anna Krassowska, Vice President of Investor Relations and Corporate Communications at MacroGenics.

Thank you. Good afternoon, and welcome to the MacroGenics conference call to discuss our second quarter 2020 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 listen to this conference call via webcast on our website where it is 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, Anna. 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 over to Jim Karrels, Senior Vice President and Chief Financial Officer, who will review our financial results for the quarter.

Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended June 30, 2020, which highlight our financial position as well as our recent progress. As described in our release, MacroGenics total revenue consisting primarily of revenue from collaborative agreements was $20.3 million for the quarter ended June 30, 2020, compared to $10.6 million for the quarter ended June 30, 2019. This increase was primarily due to the recognition of a $12 million payment from Boehringer Ingelheim under a 2010 license and collaboration agreement. Our research and development expenses were $57.4 million for the quarter ended June 30, 2020, compared to $51.4 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs. General and administrative expenses were $10.2 million for the quarter ended June 30, 2020, compared to $12.1 million for the quarter ended June 30, 2019. This decrease is primarily due to a decrease in consulting costs with a smaller decrease in travel-related costs due to COVID-19. MacroGenics net loss was $46.9 million for the quarter ended June 30, 2020, compared to a net loss of $31.8 million for the quarter ended June 30, 2019. Our cash, cash equivalents and marketable securities as of June 30, 2020, were $232.8 million compared to $215.8 million as of December 31, 2019. During the quarter ended June 30, 2020, we received $96.5 million in net proceeds from the sale of approximately 4 million shares of our common stock pursuant to an at the market or ATM offering. Subsequent to June 30, 2020, we received an additional $21.3 million in net proceeds from the sale of approximately 726,000 shares pursuant to the ATM as well as the earlier mentioned $12 million from Boehringer Ingelheim. I'll point out that as of June 30, 2020, the $12 million from BI was reflected on our balance sheet as a receivable. Finally, we anticipate that our cash, cash equivalents and marketable securities as of June 30, 2020, plus the additional proceeds just described, which we subsequently received, combined with anticipated and potential collaboration payments should enable us to fund our operations into 2023, assuming the company's programs and collaborations advance as currently contemplated. This represents an extension of our previously reported cash runway guidance. I'll now turn the call back to Scott.

Thank you, Jim. We are excited about the momentum we have built to date in 2020 as well as the events we are anticipating during the remainder of the year and into 2021. I would like to begin by introducing Stephen Eck. As we announced, Stephen joined us at the beginning of July as our Senior Vice President of Clinical Development and Chief Medical Officer. Stephen is a hematologist oncologist by training with broad leadership experience in the development and commercialization of oncology therapeutics, and we are excited to have him on the team. Assets that he has managed include enzalutamide, erlotinib, and gilteritinib. Stephen is with us on the call today and will join us for the Q&A portion. Welcome, Stephen.

Thank you, Scott. I'm delighted to have joined MacroGenics at such an exciting time in its history.

Thank you, Stephen. I will start with flotetuzumab, an investigational bispecific CD123 x CD3 DART molecule and our most recent product candidate to date in a registration study. Informed by discussions with the FDA, this trial will be a single-arm study in up to 200 AML patients whose disease is either refractory to induction treatment, which we refer to as primary induction failure or as relapsed early within 6 months after an initial response. The study will be conducted as an expansion of the ongoing Phase I/II study. The primary endpoint is the response rate comprised of complete remission and complete remissions with partial hematological recovery or CRH. We plan to submit updated study data for presentation at a scientific conference in the fourth quarter of 2020. In June, research led by Dr. Sergio Rutella at the John van Geest Cancer Research Center in the U.K., was published in Science Translational Medicine and describes an immunological signature related to interferon-gamma gene expression in the tumor microenvironment. In patients with primary refractory or early relapsed AML, this gene signature appears to be predictive of resistance to chemotherapy, yet associated with a response to flotetuzumab treatment. These data provide a molecular basis to understand why AML patients who are refractory to chemotherapy may be responsive to immunotherapy with flotetuzumab. Moving on to MGC018, our investigational antibody-drug conjugate designed to deliver a DNA alkylating, duocarmycin cytotoxic payload to cells that express B7-H3. Initial dose escalation data for the ongoing Phase I study was very well received at the ASCO Virtual Annual Meeting. Of particular interest was the early evidence of clinical activity observed in patients with metastatic castration-resistant prostate cancer or MCRPC. Reductions in PSA levels of 50% or more were observed in 5 of 7 patients, including 1 with substantial regression of bone disease. The safety profile of MGC018, which includes hematologic and skin toxicities as expected, has been manageable. The patients with prostate cancer reported at ASCO were enrolled at 2 mg/kg or 3 mg/kg dose cohorts. Since ASCO, we have completed the planned dose escalation up to 4 mg/kg and selected 3mg/kg as the recommended dose for expansion based on pharmacokinetic analysis. In the third quarter, we expect to begin dose expansion in patients with metastatic CRPC with a target enrollment of up to 40 patients. Next, I would like to turn to initial data related to MGD013, our investigational bispecific PD-1 x LAG-3 DART molecule, also presented at ASCO. In the ongoing Phase I dose expansion study, the data presented showed antitumor activity of MGD013 as monotherapy across several tumor types evaluated. Initial translational studies have indicated that response to MGD013 monotherapy was associated with LAG-3 expression and a gamma-interferon gene signature in tumor samples taken at baseline, a finding that we are investigating further. We have previously observed that LAG-3 expression on immune effector cells is enhanced by margetuximab, our investigational Fc-engineered monoclonal antibody targeting HER2. Therefore, we included an expansion cohort of patients with advanced HER2-positive tumors treated with a combination of MGD013 and margetuximab. Of the 14 evaluable patients treated with this combination, we observed confirmed and non-confirmed objective responses in 6 or 43% of patients. In contrast to the monotherapy finding presented at ASCO, in the combination cohort, the majority of responders with baseline tumors that were evaluated were either negative for or expressed low levels of LAG-3 or PD-L1. Given this strong but early efficacy signal and acceptable safety profile, we are prioritizing the combination of MGD013 and margetuximab for further development. We are enrolling 3 subgroups of patients with HER2-positive tumors, one with gastric or gastroesophageal junction cancer, one with breast cancer, and finally, a basket of all other HER2-positive cancer types. We are initially targeting 30 patients in each group. We believe that combining Fc-engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments. With regard to margetuximab, the BLA for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer, the PDUFA target action date is December 18, 2020. As previously announced, during the mid-cycle communication with the U.S. FDA, they notified us they no longer plan to hold an ODAC meeting to discuss the BLA. Beyond breast cancer, the Phase II/III MAHOGANY study is evaluating margetuximab and checkpoint blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer. Module A, the single-arm part of the MAHOGANY study of margetuximab and retifanlimab, an investigational anti-PD-1 antibody, is enrolling, and we expect to submit initial data for presentation at a scientific conference in the first quarter of 2021. Module B, the randomized component of MAHOGANY, is currently planned to start in the fourth quarter of 2020. Let me next discuss MGD019, our investigational bispecific PD-1 x CTLA-4 DART molecule. We are excited to have data from the Phase I dose escalation study of MGD019 selected for an oral presentation at the ESMO Virtual Congress in September. The study is ongoing in a diverse population with advanced cancers. We have not restricted the study to tumor types that are known to respond to checkpoint inhibitors. Dose cohorts ranged from 0.03 to 10 mg/kg. Additional patients have been enrolled more recently at 3 mg/kg, 6 mg/kg, and 10 mg/kg, dose levels at which we have observed initial clinical activity. The data continues to mature with some patients early in their treatment course. By the time of the data cutoff date for the presentation at ESMO, we anticipate up to a total of 30 patients will be evaluable for response, having had at least 1 on-treatment scan. Note that this number includes patients enrolled and treated at all doses with approximately 18 enrolled at 3 mg/kg and above. Let me next turn to retifanlimab, previously known as MGA012, the investigational anti-PD-1 antibody that we licensed to Incyte. At ESMO, data are scheduled to be presented from Incyte's ongoing POD1UM-201 study of retifanlimab monotherapy in patients with Merkel cell carcinoma. Those data are in addition to the data expected in the second half of the year from POD1UM-202 Incyte's potentially registration-enabled study in patients with anal cancer, which is fully enrolled. Furthermore, we expect Incyte to initiate 2 Phase III studies in 2020, POD1UM-304 in patients with metastatic non-small cell lung cancer and POD1UM-303 in patients with anal cancer, both in combination with chemotherapy. In all, there are currently 6 registration-directed clinical studies ongoing or planned in 2020 by either MacroGenics or Incyte across a broad range of tumor types. Last but not least, we are pleased that our second antibody-drug conjugate is expected to enter clinical testing this year. We recently received FDA clearance of the Investigational New Drug, or IND, application for IMGC936, an ADC targeting ADAM9 that is being advanced under a co-development agreement with ImmunoGen. Under this 50-50 collaboration, ImmunoGen will be leading clinical development, and they expect to initiate a Phase I dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020. For background, ADAM9, a disintegrin and metalloproteinase domain containing protein 9 is a cell surface antigen that is overexpressed in various solid tumor types and has been shown to correlate with poor prognosis in several cancers. This regulation of ADAM9 has been implicated in tumor progression and metastasis as well as pathological neovascularization. Anti-ADAM9 antibodies are efficiently internalized and degraded by ADAM9-expressing tumors, making it an attractive ADC target for delivering a cytotoxic payload. IMGC936 is comprised of a humanized antibody engineered by MacroGenics, conjugated in a site-specific manner to a DM21, a next-generation linker/payload designed by ImmunoGen. This molecule combines a maytansinoid microtubule-disrupting payload with a peptide linker that is designed to convey greater stability and bystander activity than other DM platforms. The drug-antibody ratio, or DAR, is 2. As you can see, we continue to build momentum and advance our pipeline of innovative product candidates. We would now be happy to open the call for questions.

Our first question comes from Debjit Chattopadhyay with H.C. Wainwright.

Could you talk to the ability to get to higher doses with MGD019? Is it an engineered lower affinity for CTLA-4? Or do you need engagement of both PD-1 x CTLA-4 on the T-cells, which allows you to kind of circumvent the GI toxicity?

The molecule was designed very specifically to get maximum engagement of PD-1. As you remember, this was a tetravalent bispecific molecule. And so the affinity is a slight increase on PD-1 to get initial engagement with that, and because there are 2 binding sites for CTLA-4, you get an advantage for then binding the CTLA-4 site. So in essence, we are maximizing recognition of cells that express both receptors. You also see, obviously, binding to cells that express PD-1 alone and occasionally ones that have only CTLA-4, but it was really designed as a way to enhance engagement of these co-expressing cell types. Could we go higher than 10 mg/kg? It certainly could. But we found, as we will discuss at the ESMO presentation, that we're in a very optimal range. We're seeing clinical responsiveness across multiple doses. What we have previously reported are seeing responses between 3 and 10 mg/kg. And secondly, we saw activation markers associated with these therapeutic responses. So we see no need to expand the treatment above 10 mg/kg.

Great. Just one follow-up, then. Since you're collecting the biomarker data, are you seeing any differential evolution in either the CD-8 or CD-4 effector T-cell compartment compared to monotherapy PD-1 x CTLA-4?

In the patients?

Yes, in the responders, for example, versus, say, the non-responders?

I can't really address that with regard to the subpopulations at this time, but it's a question we could look at in subsequent analysis.

Great. And just one last follow-up from me. Have all the six responses for the MGD013 plus margetuximab been confirmed since it has been more than a few weeks since ASCO?

The unconfirmed responses have now been confirmed, and we've had additional patients that have been enrolled in the trial as we've just described. We expect that we will provide an update on this combination trial at a scientific conference later this year.

Our next question comes from the line of Etzer Darout with Guggenheim Securities.

This is Paul on for Etzer. I wanted to ask about MAHOGANY. I understand, I know we're expecting data for Module A of the trial next year. I was wondering, have you measured LAG-3 expression in the Module A patients as a potential kind of hint for what the patient makeup in Module B might look like? And if so, what have you observed? Also wondering about whether LAG-3 expression might inform your plans for potentially accelerating in the margetuximab plus L1-2 combo in the study?

Thanks for that question. I'm not aware of actually looking at those patients at this point. So I can't comment on LAG-3 in Module A. Clearly, we will continue to look and follow the biomarkers in Module B as we go forward. And certainly, as we get more data from the MGD013 monotherapy study alone, in terms of determining which biomarkers are best predictive for responsiveness, and that could be expanded beyond LAG-3 x PD-L1 and other activation markers. So it's still too early to comment on that.

Okay, great. And then just one more follow-up on flotetuzumab. Just a little bit on the timing. Could you give us an update about whether or not the trial with PD-1, the ex-U.S. Phase I/II study that was paused due to COVID has started up again?

So what we have decided to do, given that we've had the go-ahead to start this registration study with monotherapy and given the broadness of our portfolio, we decided not to start up the combination study until a later time. We're still very interested because we do see an enhanced signal in preclinical studies. And as you know, we treated a few patients initially, but because of the COVID-19 situation, it was difficult to enroll patients. But that's more likely to start up sometime next year.

Our next question comes from the line of Jonathan Miller with Evercore ISI.

I guess a couple here. First, the cancellation of the ad com for margetuximab, is that a sign of the FDA's thinking on the approvability of that drug? Do you perceive that as a direct read-through to the likelihood of success there? And secondly, do we have any color on when that registrational cohort for flotetuzumab, when that 200-patient cohort could get started? And if so, when you might expect data from them?

Thanks, Jonathan, for the question. So with regard to the ad com, it's very difficult to interpret what the thinking is from the FDA. I would say that given this was at mid-cycle review many months before the ad com, we perceive this as a very favorable response, but I can't speak for the FDA in that context. And similarly, the questions that we had gotten at that time and subsequently suggest that they're continuing to show interest in evaluating this and considering it for approval. But again, it's in the hands of the FDA. I can't comment on that. Regarding the registration study for flotetuzumab. As I had previously reported, we had made modifications on the Phase I/II program. And so we have not stopped enrollment in that trial, including the patients with specific pretreatment regimens that we've aligned with the FDA. And so that is, in fact, ongoing right now. Our expectation right now is that we will have some update on data for patients that we have treated from the previous ASH meeting last December. Hopefully, if our abstract is accepted at the ASH meeting this year. So we'll be able to provide interim updates on some additional data of patients being treated, and then our hope is to complete the enrollment not later than the end of next year, assuming that the enrollment goes as planned.

Great. I guess one of the things that I wanted to ask about is when you discussed your cash runway now being extended into '23, you mentioned that this relies on the payment of certain future milestones. And I guess you probably won't tell us which milestones exactly or assuming you're going to hit it. But can you tell us how much milestone-based money is assumed in that new runway guidance?

So...

Thank you for your question, Jonathan. Unfortunately, we can't provide a specific answer, but I want to remind you and others that under our agreement with Incyte, we have the potential to receive up to $405 million in clinical and regulatory milestones, as well as $330 million in commercial milestones. Additionally, regarding teplizumab, which we sold to Provention Bio, we can earn a $60 million milestone upon the approval of that asset, as the BLA is currently being submitted on a rolling basis, and we expect a PDUFA date in the middle of next year. We evaluate all these milestones as appropriately as possible, which informs our budgeting, and we tend to approach this with caution. I'll leave it at that.

Our next question comes from the line of Jonathan Chang with SVB Leerink.

First question on MGC018. Can you elaborate on your decision to move forward with the 3 mg/kg dose?

Yes, pleasure, Jonathan. As I had commented on the last call, we were seeing responses at the 2 mg/kg and the 3 mg/kg range with, as I've noted, acceptable toxicity profiles. We had performed pharmacokinetic analysis since our last call. And we found that, in fact, what I had predicted is that we would see suitable PK between 2 and 3 mg/kg would be acceptable to move things forward. So we selected the 3 mg/kg dose. And that protocol is being amended right now. We expect to have patients starting to enroll later in this quarter.

Got it. When could we expect the next data update on the MGC018 program?

So we were thinking about what's the most appropriate form for this going forward because we'd like some additional data from some of these new patients that would be enrolled. So given that the data cut on the Phase I study was very recent, in May, we believe that it's most likely that we would present data very early in 2021 at an appropriate scientific meeting with the acceptance of an abstract.

Got it. And just one last question to follow-up on a previous question. Earlier in the year, you spoke about prioritizing your pipeline. Can you talk about your current thoughts on that as it relates to your cash position and runway?

I'm sorry, prioritization of what?

The pipeline.

The pipeline looks promising based on today's announcements. We're continuing to support margetuximab for the BLA and progressing with the flotetuzumab registration study, as well as studies on MGD013, particularly expanding that area. We're also advancing the new program with ADAM9 in collaboration with ImmunoGen. Additionally, we expect to share more data from 2019 next year regarding current patients. This aligns with our expansion plans for MGC018. Overall, everything fits well with our future strategies, and the additional funding is providing us with more runway. We anticipate having a strong pipeline to report new data in the next 6 to 9 months as we include these new patients.

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

Scott, on the flotetuzumab registrational trial. Can you remind us if you're going to be enrolling both transplant-eligible and ineligible patients? And I guess, as you assess for durability of response, are you going to be able to allow for any censoring of patients who subsequently are bridged to transplant?

Yes. So we are going to allow both eligible and ineligible patients. In fact, our hope is even patients who are initially ineligible may become eligible through the course of therapy. We've actually observed that in some of the patients in the earlier Phase I study. So this is very much the hope that if we can get a significant number of these patients to transplant, our experience to date is that they've lived much longer lives, and there's always the possibility of cure. So this is obviously a very big objective for this study.

Okay. And just on MGC018, is there anything that you can say about the experience you had with patients at the 4 mg/kg dose level? And maybe the number of patients that you enrolled into that? And just any observations you might be able to share?

I will probably state that this is still ongoing. There are very few patients in the 3+3 design. So really, there is nothing more that I can attribute to what we've observed in the other parts of the study, and we'll provide the details at our next update on patients, but there is nothing particularly notable there that allows for any conclusions.

Okay. And then just finally, maybe for Jim, another cash guidance question. Can you maybe speak to what extent that guidance runway contemplates any kind of margetuximab commercialization activities?

Thanks for that question, Steve. So baked into our budget, we have minimal spend on commercialization. As Scott has indicated in the past, our intent here is to partner the opportunity. So we have a bare minimum of commercial spend to sort of deliver that asset to a place where a partner could be helpful in bringing it over the finish line in terms of commercialization.

Our next question comes from the line of Yigal Nochomovitz with Citi.

This is Samantha on for Yigal. First question is on MAHOGANY Module A, the data now expected in the first quarter. I'm just wondering if you could help set expectations there regarding the number of patients we should expect and the degree of durability? And whether or not these patients will be sufficient for you to look for accelerated approval?

Thanks so much, Samantha. So as I guided previously, we're targeting to have 40 patients enrolled by the end of the year. And again, a significant portion of those patients, even if we hit the 40, would not be evaluable because they would come later in the year. So a lot of this will be timing of when those patients come in. I'm pleased that, despite the COVID-19 situation, we've been able to enroll additional patients in the U.S. Now we have 11 sites opened in Korea. We're hoping that there will be a greater influx of patients coming into the trial from those Korean sites to get to the 40 by the end of the year. If we hit that target and have it sufficiently early enough in 2020, then it's likely we would be able to report this out early in 2021 and make some decisions about how to further accelerate this trial to get it enrolled. But we'll provide updates during the course of the year on how that's going.

Got it. And then just on the MGD013 and margetuximab combo, you're rolling in gastric cancer patients there. And ensure the overlap perhaps a bit with MAHOGANY and Module B, even though that is a chemo arm as well. Just what's your rationale for having both of those combinations? And how do you see them fitting into the landscape?

Excellent question. Again, the fact that very late-stage patients, even in the Phase I study in combination, were responding was very exciting for the patients and for us. We would like to understand how robust that signal is by adding additional late-stage gastric patients in that combination study for the MGD013 trial. Clearly, in the MAHOGANY B, we're looking at newly diagnosed patients, so it's a completely different population. As we get those combination studies, the late-line therapy, if that data is compelling, it gives us more impetus to accelerate the MAHOGANY B study. Remember, though, the difference is that in MAHOGANY B, we're adding chemotherapy to that arm. So there will be differences irrespective of that and getting to understand the effects of adding chemotherapy to those immune-based therapies.

Got it. And when you started enrolling in MAHOGANY B, is that going to be primarily Zai Lab? Or will you start enrolling in U.S. sites as well in the fourth quarter?

So Zai will take the lead. They will start enrolling first, and then we will follow with enrollment. The expectation is that they will enroll this year, and we will start enrolling in Module B next year.

Our next question comes from the line of Peter Lawson with Barclays.

On MGC018, what's the benchmark you think you need for prostate? What do you want to see in the next read?

Well, that's a good question, Peter. Obviously, looking at historical response rates in late-stage prostate cancers, they've been below 50% for most trials. Obviously, in the Lutetium trial, recently, they had a response rate of about 66%, but that's already a labeled drug. Our goal is, clearly, if we could achieve responses comparable to what we've seen in the Phase I study, that would be ideal. Right now, we haven't given specifics regarding the range that would ultimately determine how we would take this further. I think that by enrolling up to 40 patients, as we've just recently described, we should get a good idea of how effective this drug is.

And what would you like to see around duration of treatment?

Excellent question as well. Remember that historical data suggests a progression-free survival rate of currently approved drugs at around 2 to 3 months with a survival in this late-stage population of around a year, depending on the study, perhaps a little less or a little more. If we exceed those parameters, plus have a persistence of reduction of PSA of greater than 50% early on and lasting, I think we'll be in pretty good shape with regard to the drug.

And then just finally, around CD123 flotetuzumab, just what should we expect to see by Q4 as regards to data?

So the plan is to present at ASH. We've submitted a number of different abstracts. Obviously, they have to undergo a review. But the expectation is to present the double-digit number of patients since the last ASH meeting. So there'll be a nice sized population to evaluate since our last formal presentation.

Our next question comes from the line of David Lebowitz with Morgan Stanley.

Given the response you've seen thus far with MGD013 in combination with margetuximab, are there any other combinations that you are thinking about trying with the PD-1 x LAG-3?

Thanks, David, for that question. Clearly, we are very excited about the prospects of using an Fc-engineered molecule like margetuximab, which we know induces both innate and specific immunity. What we have seen to date is that it up-regulates many of the activation markers, including LAG-3 x PD-L1 and other checkpoints. So given that the Fc-engineered ublituximab molecule has the same Fc modulation as margetuximab and also induces the same up-regulation of these markers in some of our in vitro studies, we expect to design combination studies with MGD013 within ublituximab, and we will be updating later this year on the specific design and the start of those studies, which is likely to occur in 2021.

Our next question comes from the line of David Nierengarten with Wedbush.

I see you have the list of analysts with some challenging names. I have a quick question regarding margetuximab in study 013. Have you reported on CD16 mutations or polymorphisms in the patients already treated? Additionally, are you planning to stratify or screen those patients in the expansion cohorts, particularly in breast cancer, as you move forward?

David, excellent question. We have not planned to either select prospectively patients based on the allelic variations. But we will obviously analyze these retrospectively. It is very possible that with the combination therapy here, with immune activation, differences between the VF allele may go away. This is another question that is very interesting to us, and so we don't want to exclude patients with different allelic types.

Our next question comes from the line of Boris Peaker with Cowen & Company.

This is Cynthia on for Boris. A few on the ImmunoGen IMGC-936 molecule. Can you please put in context what particular tumor types express ADAM9 at a high level? And perhaps what other programs are out there that may be targeting ADAM9?

Thank you very much for that question. I'm glad we got at least 1 question because we're very excited about the prospects of this molecule.

You are welcome.

We don't know of any other program that historically has been directed or is in progress to target ADAM9. So it's clearly a target that we are exploiting. This is an antigen that is highly overexpressed on many different solid tumor types, so included are non-small cell lung cancer, pancreatic cancer, gastric cancer, triple-negative breast cancer, prostate cancer, and others. We think that, presuming that we achieved a good safety profile and evidence of efficacy, that presents a very good opportunity to address lots of different cancer types.

This concludes today's question-and-answer session. I would now like to turn the call back to Scott Koenig for closing remarks.

Thank you very much for joining our call today. We look forward to updating you in the near future about our programs. Have a good afternoon.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.