MacroGenics, Inc. (MGNX) CEO Scott Koenig on Q2 2018 Results - Earnings Call Transcript

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About: MacroGenics, Inc. (MGNX)
by: SA Transcripts

MacroGenics, Inc. (NASDAQ:MGNX) Q2 2018 Earnings Conference Call August 7, 2018 4:30 PM ET

Executives

Jim Karrels - SVP and CFO

Scott Koenig - President and CEO

Analysts

Peter Lawson - SunTrust Robinson Humphrey

Umer Raffat - Evercore

Jackson Harvey - Nomura/Instinet

Yigal Nochomovitz - Citigroup

Boris Peaker - Cowen

Debjit Chattopadhyay - H.C. Wainwright

Stephen Willey - Stifel

Operator

Good afternoon. We will begin the MacroGenics 2018 Second Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a listen-only mode at the moment, and we will conduct a question-and-answer session at the conclusion of the call.

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

Jim Karrels

Thank you, operator. Good afternoon, and welcome to MacroGenics' conference call to discuss our second quarter 2018 financial operational results. For anyone who has not had the chance to review our results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at www.macrogenics.com. You can also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two 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, MacroGenics' President and Chief Executive Officer.

Scott Koenig

Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. Thank you for joining us. During the second quarter of 2018, we made significant progress on several fronts and I'm happy to provide an update that is focused on our most advanced product candidate and our financial position. But before I do so, let me first turn the call back to Jim who will review our financial results for the quarter and year.

Jim Karrels

Thank you, Scott. This afternoon, we reported results for the second quarter, which highlight our strong financial position. As described in our release, MacroGenics had research and development expenses of 52 million for the quarter ended June 30, 2018 compared to 34.5 million for the quarter ended June 30, 2017. This increase was primarily due to the continued enrolment in our two margetuximab clinical studies mainly the SOPHIA Phase 3 trial for metastatic breast cancer and the combination study with an anti-PD-1 in gastric cancer as well as the flotetuzumab monotherapy clinical trial in AML. We also increased headcount to support our expanded manufacturing and development activities.

We had general and administrative expenses of $11.1 million for the quarter ended June 30, 2018 compared to 8.4 million for the quarter ended June 30, 2017. This increase was primarily due to costs incurred related to the implementation of our new enterprise resource planning or ERP system as well increased pattern expenses. We recorded total revenue, consisting primarily of revenue from collaborative agreements of 18.8 million for the three months ended June 30, 2018.

This included $9.9 million related to manufacturing services and clinical supply of MGA012, also known as INCMGA0012 to Incyte Corporation as well as $6.1 million related to two transactions entered into with Provention Bio in which we received warrants to purchase a total of 2.4 million shares of their common stock. Revenue of 18.8 million for the three months ended June 30, 2018 compared to 1.7 million for the three months ended June 30, 2017.

Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year. For the quarter ended June 30, 2018, we had a net loss of $43.2 million compared to a net loss of 40.7 million for the three months ended June 30, 2017. Our cash, cash equivalents and marketable securities balance as of June 30, 2018 was $300.9 million, which compare to 305.1 million as of December 31, 2017.

And I'll point out that a significant portion of our accounts receivable balance of $17.8 million at June 30, 2018 relates to an amount owed to us from Incyte for the previously mentioned MGA012 activities. Based on our current operating plan, we believe that our cash, cash equivalents and marketable securities combined with collaboration payments we anticipate receiving should enable us to fund our operations in to mid-2020, assuming our programs and collaborations advance as currently contemplated.

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

Scott Koenig

Thank you, Jim. As I mentioned in the opening, MacroGenics continues to make progress across multiple fronts. I will focus my comments this afternoon on our leading program, which represents the most significant near-term value creation opportunities. Let me begin with margetuximab, our novel immune optimized anti-HER2 antibody, which has an Fc domain engineered to enhance engagement and activation of the inate immune system.

Our pivotal SOPHIA study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory HER2-positive metastatic breast cancer patients. We expect to complete enrollment of the Phase 3 trial in the next few months and based on the rate of PFS events, which have accrued to date for this study, we expect to be in a position to announce top line results in the first quarter of 2019.

In June, at the ASCO Annual Meeting, we presented interim clinical data from our ongoing Phase 2 study of margetuximab plus the anti-PD-1 agent, Pembrolizumab, in patients with gastric and gastroesophageal junction cancer. The data we presented demonstrated that this chemotherapy-free combination may enhance anti-tumor activity in patients with advanced gastric cancer. You may recall that earlier this year, we announced the expansion of the margetuximab gastric study by enrolling 25 additional gastric cancer patients. We expect to complete enrolment in the next few months and we anticipate presenting results from the trial in the first quarter of 2019.

In summary, we are encouraged by our progress with margetuximab and we look forward to announcing additional results in the first quarter of 2019.

Our next program is Flotetuzumab, our DART molecule that recognizes both CD123 and CD3, which is being developed as monotherapy for the treatment of acute myeloid leukemia or AML. We have completed enrolment in the dose expansion cohort and we plan to present updated clinical data and announce next steps in the development of Flotetuzumab later this year. Our partner, Servier, has development and commercialization rights for Flotetuzumab outside of North America, Japan, Korea and India.

You will recall that MGA012 is a PD1-directed immune-oncology molecule that we licensed at Incyte in late 2017. Under the terms of our agreement, Incyte has exclusive worldwide rights for the development and commercialization of MGA012 while MacroGenics retains the right to develop our pipeline assays in combination with this anti-PD1 antibody.

In June, Incyte announced their intention to pursue monotherapy development of MGA012 in three indications. The cohort of patients with microsatellite instability-high endometrial cancer will be further expanded. And in addition, they are planning to open Phase 2 studies in merkel cell carcinoma and anal cancer later this year. Data from these studies is anticipated in the 2020-2021 timeframe according to their disclosures.

In addition, Incyte will likely provide an update on the ongoing monotherapy MGA012 study that MacroGenics had initiated at a scientific meeting later this year. We have additional programs in development and I will provide brief updates on them.

MGD013 is a first-in-class DART molecule that provides co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MGD013 is currently being evaluated in a Phase 1 study and we expect to establish the dose and schedule for MGD013 administration as well as initiate dose expansion cohorts by the end of the year.

Another DART molecule focused on the co-blockade of two immune checkpoint molecules, is MGD019, which is designed to target both PD-1 and CTLA-4 on T cells. We anticipate submitting the IND application for MGD019 also by year end 2018.

Let me shift to our B7-H3 franchise, another opportunity for value creation in 2018 and beyond. Our most advanced candidate, Enoblituzumab is an FC-optimized monoclonal antibody that targets B7-H3. We have completed the enrolment in our ongoing study of the Enoblituzumab in combination with an anti-PD1 mAb and expect to present clinical data and provide guidance on further development of Enoblituzumab in the fourth quarter of 2018.

The second clinical candidate in our B7-H3 franchise is Orlotamab, previously known as MGD009, a DART molecule targeting B7-H3 and CD3. Orlotamab is being evaluated in a Phase 1 study across multiple solid tumor types. We recently established the dose and schedule for Orlotamab administration and initiated monotherapy dose expansion cohorts in six different tumor types. In addition, we started a combination study of MGA012 in the first quarter that is currently accruing patients.

The third candidate in our B7-H3 franchise is MGC018, an anti-B7-H3 antibody drug conjugate that has shown potent anti-tumor activity in preclinical models. We have submitted an IND for MGC018 and in the coming months anticipating initiating a Phase 1 study both as monotherapy and in combination with MGA012 in patients with solid tumors.

I'll quickly mention that we continued to progress two additional DART molecules in Phase 1 clinical development. The first MGD007 is a DART molecule that recognizes gpA33 and CD3. We recently commenced a combination study of MGD007 with MGA012 in patients with colorectal cancer. In addition, we expect to commence the phase 1 study of MGD014, a DART molecule being developed to kill HIV infected cells during the third quarter of 2018 under a contract with NIAID at the NIH.

Finally, I'll provide a brief corporate update. MacroGenics has completed the build out of a GMT suite in our headquarters building in Rockville, Maryland to support larger scale clinical and commercial manufacturing and we recently completed a successful engineering run. We have initiated GMT production run in this facility in the third quarter of 2018. This is a major milestone in our development and supports our goal of becoming a fully integrated biopharma company.

So as you can see, this has been another busy and productive quarter for MacroGenics. We continue to be excited by the progress we've made and look forward to continuing our efforts to advance our program and to develop innovative new therapies for the treatment of cancer.

And now, we would be glad to address any questions that callers may have. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] The first question comes from Peter Lawson with SunTrust Robinson Humphrey.

Peter Lawson

On the Margetuximab in breast cancer, what would you view as success in that 1Q 19 top line data?

Scott Koenig

Thank you very much Peter. Obviously, as you recall, the read out for this study is a sequential primary endpoints of PFS and OS. The study was designed based on historical controls for testing in a population of HER2 experienced individuals. And the expectation on baseline, we use - was the trace of control arm for which [indiscernible] was approved. These patients had a PFS of approximately 3.3 months. What we have set as our base is approximately four months on the control for PFS and we're looking at optimistically as much as two or more months improvement in the experimental arm. As you know, we set out the PFS with a hazard ratio of 0.67 and this is powered in 90%. If successful, we would then go on and follow the patients for the overall survival and the overall survival was powered at 80%.

Peter Lawson

And then just on the H7 or sorry the B7-H3 franchise, what's the strategy there? How do you think that kind of differentiates and plays out the three different approaches you have? Do you think you're getting to the position where you just move one forwards or do you think there is enough differentiation there and at what point, do you think you have a either a single molecule to move forward?

Scott Koenig

Thanks for that questions. As you know, we've put a lot of effort into exploring the B7-H3 target, given that this target is highly over expressed, more solid tumors with very well expression on normal tissues. Preclinical studies have shown that mechanistically we get explored and that's the enhanced antibody, a bispecific which engages the CD3 on T cells to kill tumor targets as well as antibody conjugate with an ADC. As you also know, the preclinical models don't necessarily predict that efficacy and as well as safety in human studies.

We've had a very long experience now with Enoblituzumab, as we point to that on the call earlier, we'll be updating our results of Enoblituzumab in combination with Pembrolizumab, the anti-PD1 later this year, where we look at four different tumor types and we plan at that time to also give you guidance in terms of next steps for further clinical development of that molecule.

Second is, as you heard today, we have selected those for MGD009 or Orlotamab as monotherapy and we have just begun to expand into six different tumor types that we expect for next year to have approximately 100 patients dosed with Orlotamab as monotherapy and earlier this year, we began the combination study with our own MGA012 anti-PD1. Again, mechanistically, this makes a lot of sense and it's supported by preclinical data that combines with our anti-PD1 will enhance the effects of the monotherapy effects of MGD009.

Today, as you heard, we announced a filing of the IND for MGC018 and we found that this molecule was extremely potent at eliminating tumors and preclinical model systems even with single dosing. And so we think that there is an opportunity to all three molecules to succeed potentially either a lower or combination with checkpoint inhibitors, but we will have more data by next year to be able to give better guidance on which of these molecules we will advance further to registration studies.

Operator

Thank you. The next question comes from Umer Raffat with Evercore.

Umer Raffat

I wanted to focus on the CD123 for a minute if I may. And I guess our question was really aimed at understanding the efficacy data we've seen, as it relates to CR rates. And specifically, should we or should we not be including CRis when we think about the overall efficacy profile of the CD123. And I ask because we've read varying takes from FDA on whether or not CRis should be included or not and I was partially dependent on whether the durability response is different between CRs and CRis. So just looking to get your sort of color on that broader question on how we should think about this drug? Is it a 20% CR rate, CR/CRi, or was it close to low-teens and I had a follow up?

Scott Koenig

So thank you very much for that question. As you know, we presented our initial data on the first 14 patients at ESMO last year and had follow-up data on another 8 patients at ASH last year. As I announced on the call, we've completed enrolment of the many patients in the 25 expansion cohort, relapsed refractory patients and continue to follow those patients and we'll update this at a scientific meeting later this year.

With regard to your specific question regarding the importance of CRi, as you know, these relapsed refractory patients, many of these patients have undergone very extensive chemotherapy treatments that in a large part reduced the bone marrow reserves of stem cells. And so even under the best circumstances, if the blood cells and leukemic stem cells can be controlled, it may be insufficient precursor stem cells of the normal variety, so it's quite to expand to completely reach normal levels.

So a patient, for instance, for example, with a CRi that achieves 50,000 platelet recovery which is not a normal value, but will reduce the opportunity for a bleed would be considered a success here. With regard to have the FDA look at this, obviously, we cannot predict that on a case by case basis. But as you know, some products have been approved based on CRHs as well as CR and of course durability will enter into this.

So again, we will be looking at these parameters as we go forward and as we hope to update you, we will not only discuss the opportunity for Flotetuzumab as monotherapy later this year with updated data, but we will also some guidance on how we move to the next step, both as monotherapy and as we have noted previously, we expect to initiate very soon a combination study of Flotetuzumab with MGA012, our anti-PD1 molecule based on very compelling data that we showed last year at ASH, where we showed that after a single course of - single cycle of Flotetuzumab, we see an up regulation of PDL1 on AML blood, which gives a lot of rationale, where combination of the two molecules may result in a better outcome. So this is how we kind of view the scene at this point.

Umer Raffat

That's really helpful Scott. And perhaps can you offer some color on what type of durability of responses are you seeing overall. And how that differentiate between our CR patient, a true CR patient versus a CRi patient?

Scott Koenig

So as we posted on at the ASH last year, we were seeing responses that were durable as long as six months and some of these patients continued further in their durability to their initial response. A lot of this is also dictated by how long the patient maintains the drug as maintenance therapy and that can also dictate how long the durability will be sustained. We will update this kind of data at the scientific meeting later this year.

Operator

Thank you. The next question comes from Christopher Marai with Nomura/Instinet.

Jackson Harvey

This is Jackson Harvey on for Christopher Marai. I have another question on Flotetuzumab. I'm just curious if you're still doing the continuous infusion or if you're working on a next gen technology and if you could elaborate a little bit on your registrational path, if you believe it will be for the continuous infusion? Thank you.

Scott Koenig

Thank you very much, Jackson to your question. With regard to Flotetuzumab, as you recall, we had worked on identifying a dosing regimen that will maximize the therapeutic benefits and minimize the profile and we arrived at a dosing strategy where we start with the leading dose of 30 nanograms per kg, we increased it up to 100 nanograms per kg and then end up as 500 nanograms per kg to the remaining three weeks of infusion.

And that's one after four weeks of patients are evaluated and then if they continue on additional dosing as a result of favorable laboratory evaluation, it would then be put on a dosing regimen of 4 days on 3 days off and maintain that schedule for 102 or as much as three additional cycles, depending on the patient. That is the strategy we are anticipating moving forward with monotherapy. We are exploring other dosing regimens in combination with MGA012 as we described and we'll be updating that dosing regimen later this year.

With regard to a next generation molecule, as we have pointed out, we have had great success in creating long-acting [indiscernible] DART molecule and a CD123 with an SC domain that enhances the half-life of this molecule is no different here. We are chosen based on the CD123 expression pattern on both cells as well as normal tissue to be cautious and start with a short acting molecule. We do have a long acting molecule in the wings, we're continuing the preclinical development of that molecule.

I should note that we have earlier this year presented some data with some alternative CD3 molecules that may be incorporated with such a long acting CD123 molecule. The advantage of such a molecule is that we've observed in both small and large small studies, a dramatic reduction in cytokine without any effect on the reduction of - or the elimination of CD123 cells. So we're very encouraged that our next generation molecule may be able to be used, for example, in a maintenance type therapy along with MGD006 or for other indications where patients may be getting drug for longer periods of time.

Operator

Thank you. The next question comes from Yigal Nochomovitz with Citigroup.

Yigal Nochomovitz

Maybe I missed this, but I didn't hear any updates on the Enoblituzumab new adjuvant prostate cancer study. Is that still underway? Do you have a comment there? And then I thought there was also a combo study with ipilimumab?

Scott Koenig

So with regard to the passage study, we did not have an update today about that. This is an IST study that is being conducted at John Hopkins. As you recall, earlier in the year, the study was expanded from the initial eight patients to enroll another eight patients. As I understand it, they are getting close to completing enrolment of that study, but have not finished it out. And my expectation is that sometime within the next six months to a year, they should be providing an update at a scientific meeting with regard to those results.

With regard to the Enoblituzumab and ipilimumab, as you recall on an earlier earnings call, we had noted that we had stopped enrolment very early in that combination study. Not so much for issues about effects of the Enoblituzumab and ipilimumab, but we've heard from the competitive standpoint, given that we did not have a CTLA4 molecule that we were developing ourselves that from a commercial standpoint, this was not best for the company at this time. So that study that we enrolled a small number of patients continues its close of additional enrolment, but I do believe there is at least one patient on that continues to get the drug in combination.

Jim Karrels

Just a quick clarification on the new adjuvant prostate study, that's actually expanded from 16 patients to 32.

Yigal Nochomovitz

And then regarding the ADC molecule, MGC018, I just wanted to get a sense as to the level of understanding you have of the, at least, pre-clinically obviously, the safety of the linker and the warhead. As you know, there have been some reports of unfortunate patient deaths with the Daiichi ADC as well as the Mersana ADC. I know those were HER2 directed ADCs, but nonetheless, I just like to understand the work you've done to be comfortable with the safety of that molecule. And I assume maybe nonhuman primates heading into the human studies.

Jim Karrels

Yes. Thank you very much Yigal for that question. We are very excited about the prospects of MGC018. As you know, the linker/toxin technology we in-licensed from Synthon with their linker payload. As you recall or may recall, Synthon has actually started a Phase 3 study with the exact same linker path technology for a HER2 directed molecule. They had an update at the June meeting at ASCO. From my understanding, from the data that they have presented publicly or from what we know, there is no toxicity with regard to grade five or deaths as seen with some of the other molecules that you've reported.

Obviously, some toxicities associated with the drug, which is specific, but not as quite nicely, our preclinical studies were conducted both in mice and in primates, it's in monkeys. I believe, we have a very good dose and did not have achieved the dose limiting toxicity in the ranges that we intend to introduce for human studies. So we obviously have to see as we start with the study, if the primate studies and the mice studies predict what is seen in humans.

Yigal Nochomovitz

Okay. And then just 09, are you providing any more details on the dosing schedule at this point?

Scott Koenig

I'm actually happy to do that. We're limiting that. We're on a Q2 weekly dosing regimen right now. There is a leading dose as we have done for other drugs where we have loads out and then move to a higher dose and that's being conducted right now.

Operator

Thank you. The next question comes from Boris Peaker with Cowen.

Boris Peaker

So my first question is in the SOPHIA trial, since you have a sequential analysis of PFS and OS, I'm just curious what happens if one endpoint hits statistical significance and another one does not, how does that work out?

Scott Koenig

Well, technically, we need to have PFS, have a statistically significant difference for us to proceed for an OS readout. Clearly if we don't hit PFS, we will still follow those patients for the OS, if the OS is quite remarkable in terms of its relative patient, it still provides opportunities to present that data to the FDA, but we'll have to see what the data readout looks like.

Boris Peaker

And I'm just curious for Flotetuzumab, how many patients of data will we get at, I'm assuming this is going to be ASH at the end of the year and what do you consider to be a good data?

Scott Koenig

So I'll let you make the decision on what's good data. What my - our plan was to present the full dataset that we conducted at the targeted dose which was at least 25 or more patients.

Operator

Thank you. The next question comes from Debjit Chattopadhyay with H.C. Wainwright.

Debjit Chattopadhyay

So in flotetuzumab, it has been in development for a long time and obviously the checkpoint inhibition landscape has evolved considerably over that same period. So given that we get some data from you guys over the next few months, how should we interpret that data, given the evolution in front line and even second line treatment and what do you plan to take forward.

And then just a follow up, with MGD009, you're starting that program up. Is that a read into something in the combo study with Enoblituzumab plus Keytruda?

Scott Koenig

So the answer to the second is quick as I pointed out earlier, these are totally independent programs and one that Eli Lilly and the other were looking to develop these independently as molecules and looking at the opportunity combining these with different molecules. There could be including other molecules, targeting B7-H3. So that's the answer with regard to 009.

With regard to the Enoblituzumab and the combination with anti-PD1, as you recall, we are looking in combination with pembrolizumab because at that time, we didn't have MGA012 ready to go into the clinic in combination. And so we wanted to get a dataset in four different tumor types, which include head and neck, lung, bladder and melanoma.

Within the both head and neck and lung cohorts, we are looking at both PD1 - PDL1 experience and as well as unexperienced individuals. So as you hear, we have a fairly large dataset with regard to different populations and what we plan to obviously present are the data that we think that potentially could have the best therapeutic benefit going forward. Clearly, we will also outline the next steps in the development of this molecule for a particular indication, based on internal set of response rate and this has been garnered both from our experience with Enoblituzumab as monotherapy and then of course, what the experience has been with other checkpoint molecules and other current therapies for each one of these indications, both our front line as well as later line therapies. So stay tuned, we will be able to provide an update later this year on that.

Debjit Chattopadhyay

And just a follow-up on MGD018, the antibody drug conjugate that Enoblituzumab, could you just remind us what the drug to antibody ratio is for the construct?

Scott Koenig

It's 2.7, the toxins on each antibody molecule.

Operator

[Operator Instructions] The next question comes from Jonathan Chang with Leerink Partners.

Unidentified Analyst

This is David Rusch [ph] dialing in for Jonathan. I know we've touched on MGD009 a bit on this discussion, but I was wondering if you could provide any context on which indications you plan on exploring. And what you might be looking at for that there?

Scott Koenig

We've actually outlined that. So with regard to the monotherapy studies, we're looking at testing this in non-small cell lung cancer, bladder cancer, head and neck, mesothelioma, melanoma, and prostate, approximately 16 patients each for the monotherapy cohort. So the combination study with our anti-PD1, NGAL12, we're looking at approximately 20 patients when we get to the expansion. We are still in dose escalation right now towards essentially an all comers study, but once we get to expansion, we're looking there at non-small cell lung, renal cell cancer, sarcoma, mesothelioma, prostate and the high tumors. Obviously, we have the opportunity to change that as we get closer, depending on what we see in the earlier part of the study.

Unidentified Analyst

Just a quick - one more question. With Incyte presenting the monotherapy data on MGA012 later this year, do you have any insight on which indications they plan to present in and have they given you any insight on what to expect regarding endpoints and data.

Scott Koenig

So, as you know, we had initiated expansion studies in over 100 patients before we transferred the molecule over, the R&D over to Incyte and we have - we know the data are now, but we are not at liberty to describe the data but stay tuned. I can say that given that we are expanding our proven combination, they are expanding their efforts, both as monotherapy and the two additional new indications that were described, as they pointed out, the MSI patients were part of the original expansion cohorts and they intend to look for a registration pathway for that indication as well. So and they're intending to expand into combination studies going forward for many of their molecules. So I would say stay tuned for the results.

Operator

And the next question comes from Stephen Willey with Stifel.

Stephen Willey

I joined a little bit late, so my apologies if this has been asked. But just kind of curious with respect to the gastric cancer study, the Phase 2 data that we're going to be getting at ASCO GI presumably in the first quarter of next year. Should we assume that if that data continues to look consistent with the response and the progression that we've seen today that that is essentially the trigger for a go forward decision?

And then I guess maybe just along the same lines if you can talk a little bit about where you are in terms of the decision of perhaps swapping out what has been a temporal arm with MGA012 and perhaps what the timing consequences of that might be in terms of just a program reset?

Scott Koenig

As you know, the plan was to enroll 25 additional patients with the - in gastric study with HER2 expression. We're getting close to full enrolment in that study as I pointed out earlier on the call in the next couple of months. We obviously want to see that data mature and as you point out, early next year is a good place to present that data. My sense is that, if that data looks good, would be in our sites to plan out a registration pathway for this molecule in the HER2 positive gastric cancer. Obviously, things to consider is whether this should be proceeded along second line therapy as is being conducted right now. Should we consider front line therapy and also as you point out, using pembrolizumab or swapping out MGA012 or something else. We haven't come to a final decision about that. I can tell you this is part of internal discussion, but we will be very clear by the time we present the data, what the pathway will be.

Operator

We have a follow-up question from Debjit Chattopadhyay with H.C. Wainwright.

Debjit Chattopadhyay

But for the gastric cancer study, is the enrolment primarily in Asia currently, because the preliminary efficacy data had, the data was obviously much better in the Asian patients versus Caucasian?

Scott Koenig

So thank you for the question, Debjit. So as you know that in gastric cancer and gastroesophageal cancer, there is a higher proportion of gastroesophageal cancer patients in the US and a higher proportion of gastric cancer patients in Asia, both in terms of numbers and the overall percentages that gastric cancer represents. We are enrolling both in the US and Europe. I would say that there is a higher proportion right now still being enrolled in Asia for the gastric cancer patients, but there clearly are patients coming from USX.

Debjit Chattopadhyay

And then just one quick follow-up on MGD007, the gpA33, that program was put in the backbone as of the last conference call. But did I hear you correctly that you're bringing that forward again in combination with your in-house PDL1?

Scott Koenig

So what we, just a clarification is that our goal for monotherapy was to establish an acceptable safety profile and dose of the drug as monotherapy, but we did not believe that as monotherapy, the signal was sufficient to go on to further development of this as monotherapy. And so [indiscernible] and so that's what we initiated and patients are really in that study. So we are continuing to follow a few of the patients that still are on the original monotherapy study, but ultimately if we continue to develop the combination going forward, if the results are successful, later on, it will be in combination with the anti-PD1.

Debjit Chattopadhyay

And this is a pan-CRC study, just based on the gpA33 expression and not MSI or MSS patients, right?

Scott Koenig

Correct.

Operator

Thank you. This concludes the question-and-answer session. I'll now turn the call back to Dr. Koenig for closing remarks.

Scott Koenig

I'd like to thank everyone again for joining us and let you know you know that we look forward to continuing to advance our programs in the coming months and provide updates on our progress. Have a good day.

Operator

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