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Macrogenics Inc (NASDAQ:MGNX)
Q3 2019 Earnings Call
Nov 6, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon. We will begin the MacroGenics 2019 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. [Operator Instructions]

At this point, I will turn the call over to Anna Krassowska, Vice President, Investor Relations and Corporate Communications of MacroGenics.

Anna Krassowska -- Vice President, Investor Relations and Corporate Communications

Thank you. Good afternoon and welcome to MacroGenics' conference call to discuss our third quarter 2019 financial and operational results. For anyone who has not had a chance to review our results, we issued a press release this afternoon outlining today's announcement, which is available under the Investors tab on our website and 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 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 -- President, Chief Executive Officer and Director

Thank you Anna. I'd like to welcome everyone participating via conference call and webcast today. Thank you for joining us. This afternoon I will focus my prepared remarks on our more advanced programs and the near term milestones expected during the remainder of the year. 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.

James Karrels -- Senior Vice President, Chief Financial Officer and Secretary

Thank you, Scott. This afternoon MacroGenics reported financial results for the quarter ended September 30, 2019, which highlight our financial position as well as the progress we have made over the quarter. As described in our release, MacroGenics had research and development expenses of $44.9 million for the quarter ended September 30, 2019, compared to $46.2 million for the quarter ended September 30, 2018.

This decrease was due to decreased development and manufacturing costs for MGA012 and flotetuzumab, partially offset by increased clinical trial costs related to our MGD013 study. We had general and administrative expenses of $11.8 million for the quarter ended September 30, 2019, compared to $9.6 million for the quarter ended September 30 2018.

This increase was primarily due to consulting expenses and other professional service fees. We recorded total revenue, consisting primarily of revenue from collaborative agreements of $18.7 million for the quarter ended September 30, 2019, compared to $20.8 million for the quarter ended September 30, 2018. The decrease was primarily due to decreased revenue recognized under our collaboration and license agreement with Incyte. This decrease was partially offset by an increase in revenue recognized from the deferred upfront payments under both our collaboration and license agreements with Zai Lab and Servier, as well as revenue related to manufacturing services performed under our clinical supply agreements with Zai Lab.

We had a net loss of $44.6 million for the quarter ended September 30, 2019 compared to a net loss of $34 million for the quarter ended September 30, 2018. Note that for the quarter ended September 30, 2019, this net loss reflected other expenses of $6.7 million, which included $7.6 million in unrealized losses recognized on corporate equity securities held. And finally, our cash, cash equivalents and marketable securities as of September 30, 2019 were $254.4 million compared to $232.9 million as of December 31, 2018.

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

Scott Koenig -- President, Chief Executive Officer and Director

Thank you, Jim. Let's begin with Margetuximab, our investigational Fc optimized anti-HER2 anybody being evaluated in SOPHIA, our Phase 3 trial in HER2-positive metastatic breast cancer designed to compare margetuximab plus chemotherapy against trastuzumab plus chemotherapy. We have previously reported that progression-free survival in the margetuximab arm was prolonged compared to the trastuzumab arm, meeting the study's first sequential primary endpoint.

In October, we reported data from the second pre-specified interim analysis of overall survival conducted after 270 events have been reached. The data showed a trend in OS in favor of margetuximab. In the Intent to treat population, the median OS of patients treated with margetuximab and chemotherapy was 21.6 months, compared to 19.8 months for patients who receive trastuzumab and chemotherapy, a prolonging survival of 1.8 months. The hazard ratio was 0.89 and the p value was 0.33.

Margetuximab optimized Fc region binds with increased affinity to CD16A, including the 158F low-affinity allele carried by approximately 85% of the human population, In the pre-specified exploratory analysis of this major sub-population of genetically defined patients in SOPHIA carrying the 158F allele, median OS was 23.7 months in the margetuximab arm compared to 19.4 months in the trastuzumab arm, a prolongation of 4.3 months. The hazard ratio was 0.79 and the p-value was 0.09. We look forward to presenting further details of the second interim analysis at the San Antonio Breast Cancer Symposium on December 11. The final OS analysis is planned after 385 events have accrued and is projected to be completed in 2020. We believe that patients with HER2-positive metastatic breast cancer inactive to new therapies. Margetuximab, if approved by regulators will address an important unmet need and could become a valuable treatment option for patients living with this devastating disease.

Therefore, we expect to submit a BLA to the FDA before the end of the year. We also seek to address unmet needs of HER2-positive cancers beyond breast cancer. At the ESMO Congress in September, we presented updated data from our ongoing Phase 2 study evaluating margetuximab in combination with pembrolizumab in second line patients with HER2-positive metastatic gastric cancer. This study testing a chemotherapy free regimens for patients who had received prior first-line standard of care therapy with chemotherapy in trastuzumab.

As a reference a response rate of 47% with a median overall survival of 13.1 months was reported from the first line chemotherapy and trastuzumab in the ToGA study. In our Phase 2 study in second line Gastric cancer patients, who are HER2 IHC3 positive, we reported a median overall survival of 16.8 months. Furthermore, in the HER2 IHC3 plus and PDL1 double-positive patients, we observed, the median overall survival of 20.5 months and a response rate of approximately 50%.

Notably, the safety profile of margetuximab and pembrolizumab observed in our study was similar to that of pembrolizumab monotherapy. Based on those promising second-line data, we have advanced a chemo free regimen of margetuximab and MGA012, our anti-PD-1 mAb into a Phase 2-3 registration study called MAHOGANY, in first-line patients with gastric cancer who are HER2 IHC3 plus and PDL-1 double positive. The first patient was dosed in October. This chemotherapy free part of the study, which we refer to as module A is designed as a single-arm study to support a potential accelerated approval of this regimen in the US based on the primary efficacy endpoint of objective response rate. We believe there may be a significant opportunity to change the treatnebt paradigm for some patients living with metastatic HER2-positive gastric cancer.

The second component of the MAHOGANY study, which we refer to as Module B, is designed as a randomized controlled trial to evaluate the combination of margetuximab, with chemotherapy plus either MGA012 or MGD013, our PD-1 x LAG-3 DART molecule compared to trastuzumab and chemotherapy in a broader population of patients with HER2-positive gastric cancer. The study designed to evaluate overall survival as the primary endpoint. We expect to initiate Module B in the first half of 2020 and plan to coordinate the global efforts with our partner in Greater China, Zai Lab.

Turning briefly to enoblituzumab, the most advanced in our portfolio of molecules targeting B7H3, enoblituzumab is an investigational mAb into which we have incorporated the same Fc mutations as margetuximab. We are planning a randomized Phase 2-3 study enoblituzuma plus MGA012 with or without chemotherapy in patients with first-line metastatic head and neck cancer. We expect to initiate the study shortly and plan to coordinate the global efforts with our partner in Greater China, I-Mab Biopharma.

The next program. I will discuss is flotetuzumab, our investigational bispecific DART molecule that recognizes both CD123 and CD3. As we announced this morning, there will be five presentations on flotetuzumab at the ASH annual meeting in December. These include to our presentations of updated data from the Phase 1 monotherapy study in patients with relapsed or refractory acute myeloid leukemia or AML. The study enrolled a total of 50 patients at the recommended Phase 2 dose, including 30 patients enrolled with refractory AML, that will be the focus of the ASH presentation.

These patients represents an extremely challenging population to treat. Where based on our data, we believe there may be an opportunity to address an unmet need. The second presentation will describe data suggesting in the mean signature associated with patients who are likely to respond to flotetuzumab, supporting the mechanism being exported by this molecule. We have initiated discussions with the FDA to define a potential registration path for this molecule and anticipate providing further guidance early next year. We have also initiated a combination study of pertuzumab and MGA012 in relapsed or refractory AML patient at potential being to both broaden and lengthen the duration of response of AML patients on flotetuzumab. The combination is supported by a strong scientific rationale, based on data that we have previously reported.

Turning to our PD-1 programs, the first and most advanced is MGA012, which as you know is exclusively licensed to Incyte Corporation globally, although we retained the rights to develop our pipeline molecules in combination with MGA012. Incyte is initially pursuing development of MGA012 monotherapy through three potentially registration directed clinical trials.

One in MSI-high endometrial cancer and one in Merkel cell carcinoma with initial data anticipated in 2020 and the study in anal cancer with initial data expected in 2021. And then there is about Incyte and MacroGenics are each studying MGA012 in multiple combination trials. In total, the expanding development program for MGA012 includes approximately a dozen clinical studies. As you may have seen from the abstracts we released yesterday, Incyte has several post the presentation at the SITC Annual Meeting taking place this week.

As a reminder, under the terms of our agreement with Incyte, MacroGenics is eligible to receive up to $405 million of potential, development and regulatory milestones and up to $330 million in potential commercial milestone. If MGA012 was approved and commercialized, MacroGenics would be eligible to receive royalties tiered from 15% to 24% on future sales of MGA012 by Incyte. Our second checkpoint molecule is MGD013, a first-in-class investigational DART molecule that is designed to provide co-blockade of two immune checkpoint molecules expressed on T-cells, PD-1 and LAG-3.

We have now enrolled out approximately a 150 patients in the Phase 1 dose expansion study in nine tumor types. We have observed some early signals of clinical activity with MGD013 monotherapy across several tumor types, which is very encouraging. The majority of patients, however have not been far long enough to be evaluated for an assessment of response. We plan to submit data from this study for presentation at a scientific conference in the first half of 2020.

In summary, our most advanced programs are positioned to initiate or complete registration directed studies over the next year. As we head to the close of 2019, we look forward to presenting detailed results from the second interim analysis of OS and SOPHIA at San Antonio Breast and submitting the BLA to support registration of margetuximab as well as presenting flotetuzumab data at ASH.

We will now be happy to address any questions that callers may have. Operator?

Questions and Answers:

Operator

Thank you. [Operator Instructions] And our first question is from Jonathan Chang with SVB Leerink. Your line is open.

Jonathan Chang -- SVB Leerink -- Analyst

Hi guys, thanks for taking my questions. First question, any color on the business development front for margetuximab?

Scott Koenig -- President, Chief Executive Officer and Director

Jonathan, thanks very much for the question. We continue our discussions with potential partners in that and are extending discussions with others at this time. But at this point. I have no further updates to report.

Jonathan Chang -- SVB Leerink -- Analyst

Got it, thanks. And how should we be thinking about, I guess the different allele populations in the SOPHIA study? Is the plan still to file for approval in the overall population or would you file for approval and just the epithelial subgroup at this point?

Scott Koenig -- President, Chief Executive Officer and Director

Jonathan, thanks for that question. As you know, we [Technical Issue] statistically significant improvement in PFS ini the margetuximab arm of the intent to treat population with a positive trend in OS in both interim analysis for margetuximab and we think that the results are particularly profound in the CD16A, 158 allele population. So as a result, given the magnitude of the effect that we're seeing is primarily in that population that will certainly be included in the filing of the BLA and we assume will be reviewed in the context of the total package that we submit.

Jonathan Chang -- SVB Leerink -- Analyst

Got it. And just one last one from me. For flotetuzumab, how do you think about benchmarks for the overall study, as well as just in the primary refractory population?

Scott Koenig -- President, Chief Executive Officer and Director

So, am -- as you saw from today's abstract, we're very excited about the results and we will be sharing obviously the definitive data at the upcoming ASH meeting. As you noted in the abstract the additional patients that were included in this Phase 1 study. We were seeing in the -- at the targeted dose that we are intending to move forward. In the refractory population, we were seeing over 30% CR response rate, which again was consistent with a 29% response rate that we reported out at ASH last year. As also noted in the abstract, if you look at patients with refractory disease, after they have sold the first chemotherapy, and then they're treated with a subsequent chemotherapy. Literature suggests the best response in the low teens and then subsequent salvage responses are almost close to zero.

So given that we're seeing responses, particularly in this population with a mean number of treatments where three -- over three, we think that, we are in great shape to advancing this toward the registration study. With regard to the specifics, some what the ultimate response and we want to obtain, obviously greater is better, but clearly if we are achieving responses, greater than 20% or more, I think we will be in a nice range. But this is obviously a discussion that we will have with the FDA to discuss how to move forward in a registration study.

Jonathan Chang -- SVB Leerink -- Analyst

Got it. Thanks for taking my questions.

Operator

Thank you. And our next question is from David Lebowitz with Morgan Stanley. Please go ahead.

David Lebowitz -- Morgan Stanley -- Analyst

Thank you very much for taking my question. I had a question on the SOPHIA trial data. Given that the subset was an exploratory endpoint, albeit it's pre-specified, is it something that can actually have be included in the labeling as a separate group or specifically approved for that group or is it something they would have to be studied separately with a primary endpoint for it to be included to be labeled for that population specifically?

Scott Koenig -- President, Chief Executive Officer and Director

David, thank you very much for that question. And you have pointed out quite correctly that we had predefined [Indecipherable] population, which represents 85% of all patients and where we're seeing the predominant response and as you again pointed out correctly, it was exploratory which means we within a lot any alpha to this endpoint. We will include obviously the totality of data here, make a case to the FDA while such information should be evaluated, but ultimately it will come down to the FDA view, on whether this is approvable. I'm sure that they will seek additional guidance from outside clinicians and is probably will be done [Indecipherable] deck if this is a point that they want to get further defined. But again, we will make a strong case, why -- why we will be filing on an intent to treat population. We think that they should consider the data given even in the recent overall survival the interim data, which is not complete, we're seeing in that population, an overall survival benefit of 4.3 months in the March versus trastuzumab population.

David Lebowitz -- Morgan Stanley -- Analyst

Thanks for taking my question.

Operator

Thank you. And our next question is from Yigal Nochomovitz with Citi. Your line is open.

Masa Sekulic -- Citi -- Analyst

Hi, this is Masa on for Yigal. Thanks very much for taking the questions. On an -- excuse me -- enoblituzumab, in the Phase 2 portion of the study, I'm curious, at the go or no-go futility analysis. What are the threshold that will help you -- that you need to meet in order to move forward for both the enoblituzumab plus MGA012 and also in the chemo combo group?

Scott Koenig -- President, Chief Executive Officer and Director

Thank you very much for that question. As you know, we are very excited about the prospects of enoblituzumab given the data that we presented at last years SITC meeting, where we were seeing in combination with an anti-PD-1 molecule enoblituzumab response rates in the mid '30s in that population. Now, as you know in this Phase 2 design, we are comparing enoblituzumab and our anti-PD-1 MGA012 as one arm, a combination of enoblituzumab MGA012 plus chemo as a second arm and ultimately comparing this to the control arm, which currently the standard of frontline therapy is pembrolizumab and chemo, which as you probably know at a response rate in the mid '30s.

So without giving precision about an exact number, we would obviously like-for-one of those experimental arms of both those experimental arms to approach that range of responsiveness. Before we proceed to the Phase 3 arm, we'll be looking at primary endpoint of OS.

Masa Sekulic -- Citi -- Analyst

Thanks for that. And if the -- arm that does not include chemo happens to be in that range, is there potential for moving that forward as well or a similar accelerated approval pathway that you have for margetuximab in gastric cancer?

Scott Koenig -- President, Chief Executive Officer and Director

Well, that will be very exciting if we do achieve that range and again given that we did see that range of responsiveness in the later-line therapies, albeit it was small numbers of patients, that clearly would give us reason to approach the FDA to discuss alternative ways of getting such a drug approved.

Masa Sekulic -- Citi -- Analyst

Thanks. One more from me on flotetuzumab, is there -- do you see potential registrational path forward for also the relapse AML and now is there any data to suggest that the combination with MGA012 could improve response rates in the relapsed population.

Scott Koenig -- President, Chief Executive Officer and Director

Terrific questions. So with regard to define in the population that we plan to move forward, toward a registration study. As I stated, we will primarily look at the refractory population given, where we've seen the greatest response rate. However, both -- on some of the biomarker data that we have shown to date and will be updated at the ASH meeting subsequently. There is a segment of relapse patients, who relapse very quickly, even though they have an initial response to chemotherapy, and this may be a population that we will be able to evaluate as well and hope to see a salutary effect of flotetuzumab.

Getting back to your second question on in terms of combination of 012, our anti-PD-1 with flotetuzumab, I think, again this is purely speculative, but given a very strong pre-clinical signals that combining this with anti-PD-1 to flotetuzumab in various AML models and in vitro analysis leads to much more effective killing of AML targets. And actually given some data that you may be aware of when [Indecipherable] studies more recently, which obviously is a completely different population combining with anti-PD-1 also enhancing responses in populations they are exploring. The idea that there is up regulation of checkpoints, both on the AML blasts as well as PD-1 on the T-cells that are being activated here, I think we are very excited to hopefully see an improved response, responsiveness in the populations, treated with AML. Now, the way we're looking at this going forward is that, this could be used upfront, but quite often. What we have seen in our studies is that the longer the patients have been able to remain on flotetuzumab therapy, the better these patients tend to respond. And so again, if the opportunity by combining these two together leads to prolongation of flotetuzumab treatment and better outcomes, that would be obviously in the interest of the patients. So, we look forward to having some data hopefully next year as we have already begun the dosing of patients with this combination a very recently.

Masa Sekulic -- Citi -- Analyst

Thanks very much for taking the question.

Operator

Thank you. And our next question is from Jonathan Miller with Evercore. Please go ahead.

Jonathan Miller -- Evercore -- Analyst

Hi guys, thanks for taking the question. I think, I heard you maybe imply that the FDA would have some more complicated things to say about that and what we had sub-population for the margetuximab trials. Do you think there is a possibility for an Adcom [phonetic] to get that on label or a potential bottleneck there? And then on the flip side, even if the ITT population is approved, what do you think the commercial bottleneck is or the adoption in the ITT population? I know you plan on having a test available in your conversations with docs, how much importance have they put on that sub-population?

Scott Koenig -- President, Chief Executive Officer and Director

Thanks, Jon for the questions. Let me go back over the -- from the beginning. The FDA has not said anything to us about specifics about an Adcom. I was speculating that -- given that the study was designed as an intent to treat population, but given that the major response appears to be in the F allele population, I was speculating that they would likely hold that Adcom to address these questions. But at this point it's, there's to [Indecipherable] after we submit the data in the BLA and for them to review. But if I had to guess, I would assume that would occur.

With regard to the commercial side of the population, clearly, we would like to have the -- if approved by the FDA, the discussion at labeling to include information regarding the F allele population, if it is not there, we certainly will be publishing the data in scientifically reviewed journals. And so it is obviously out there and available to physicians now, but obviously the more details will be provided subsequently.

With regard to the opportunity commercially, it's just too early to assess at this point. Our commercial teams are looking at the landscape, which as you know is continually changing. Right now we are working with two potential vendors to develop a laboratory developed test because we think it would be important for both the oncologists and patients to have that test available if the drug is approved. So that the populations that would most benefit from margetuximab could be selected and be included. So, was there anything else, did I miss anything?

Jonathan Miller -- Evercore -- Analyst

No, I think that was, that was perfect. I guess moving on from margetuximab, I had one or two about the other pipeline. It seems like the PD-1 and LAG-3 bispecific timing is getting pushed out a little bit, is there a reason for that you have any color for why we expect that now in 2020 as opposed to the second half of this year? And then secondly, do you have any more details on the flotetuzumab plus PD-1 combo trial, which I know it is not on -- not on control?

Scott Koenig -- President, Chief Executive Officer and Director

I'm sorry, from the flotetuzumab and PD-1, did you say?

Jonathan Miller -- Evercore -- Analyst

Yes, detail on that trial, which is not on clintrials.

Scott Koenig -- President, Chief Executive Officer and Director

Yes, OK. So let me answer the first question, which is our PD-1 LAG-3 bispecific DART molecule. As we noted today in my earlier remarks, we have actually now up to over 150 patients being treated with the PD-1 x LAG-3 DART molecule in up to -- in over nine tumor types. And what, we made a decision because a significant proportion of those patients had not either have been received their first scan or had only received one scan, we didn't think the data was mature enough to give a fair evaluation of the results. What I have said previously, we are very excited about the prospects of this molecule, given that we're seeing responses across multiple different tumor types. But we felt it would be valuable to [Phonetic] to have a few more months of maturation of the data to be able to provide this in a very balanced manner. So as was noted, we expect to submit to one of the major scientific conferences in the first half of the year for presentation. With regard to the flotetuzumab and PD-1, the reason why you don't see it on clintrials -- clintrials.gov. We started the study, but the study is being conducted outside the US currently in, I believe three countries at this point.

Jonathan Miller -- Evercore -- Analyst

Thanks very much. I think we're all very excited to see that PD-1 LAG-3 data.

Scott Koenig -- President, Chief Executive Officer and Director

Great. Terrific. Thanks, John.

Operator

Thank you. And our next question is from Debjit Chattopadhyay with HC Wainwright, please go ahead.

Debjit Chattopadhyay -- HC Wainwright -- Analyst

Hey, good afternoon guys. First a clarification (Technical Issue) in terms of the activity you're seeing primarily in the refractory patients, how does this, why is this different from, say, some of the other CD123 ADCs for example?

Scott Koenig -- President, Chief Executive Officer and Director

Great question Debjit and it really gets to the core observations. We have recently made with regard to a biomarker work. And again that will be updated in an oral presentation at ASH. As was pointed out at the last ASH Meeting that seems to be a segregation of patients that respond to chemotherapies and patients that respond to immune-based therapies based on immune-based markers.

So clearly for the population that are responding to flotetuzumab, we're seeing a very significant gamma interferon associated signature with other immune parameters. It turns out that patients who respond to chemotherapy fall in the other group, which are essentially immune depleted and so it's not 100%, there is a clear segmentation of the responsiveness in this population.

And so, given that current drugs, which include as you described ADCs, is are essentially directed chemotherapy -- therapeutics they fall in the other group that do not have likely to have the immune signature. And therefore, quite distinctly, I think flotetuzumab provide a mechanism of action that other therapies that are being explored right now cannot address.

Debjit Chattopadhyay -- HC Wainwright -- Analyst

Got it. Thank you. And then moving on to -- more of a 40,000 foot question, given where the stock is and the streets reaction to the SOPHIA data, how do you prioritize the prospect of potentially running three or four registration directed studies, over the next year and your balance sheet constraints?

Scott Koenig -- President, Chief Executive Officer and Director

That's an excellent question Debjit. Obviously the company is spending considerable amount of time currently, both to prioritize the programs that we think will have the greatest chance of success and continue to have a prolonged runway with the current cash position. So with regard to the prioritization -- what I can -- first state is that given the signal that we've seen obviously with margetuximab not only in breast cancer patients, but in the gastric cancer patients, we believe that advancing the frontline study in metastatic gastric cancer should be a priority. And given, particularly as we've described this trial as a two-module study, we're going to put a strong emphasis to get objective data next year on the sub-population of the PDL-1 positive, IHC-3 plus positive population, so that we can make a decision whether the signal is strong enough to proceed forward for expansion given that the opportunity that is afforded us for that study is a potential accelerated approval, if we meet the results both from an efficacy and safety perspective. So that will be given certainly a priority.

As you've heard today, we're very excited about flotetuzumab and we'll have more to speak early next year and how do we move forward for it's registration studies there. And again, given that we can hone in on a specific population. We think that -- that could be executed in a very cost effective and a -- I would say, fairly rapid manner, relatively speaking compared to some of the more other larger potential trials. Again we still have further conversations with the FDA to get an understanding of how the best way to move forward on flotetuzumab.

With respect to the other programs, obviously we are about to initiate a study in the head, neck population with enoblituzumab. And here again, then that we have partnerships with that molecule with I-Mab. There is an opportunity that they will help to participate in the enrollment there, which obviously will help to mitigate some of the costs and back to the gastric study, our partnership with Zai Labs, we have a very close relationship with them discussing ways on how to accelerate development of that molecule in the gastric population.

And again, their ability to contribute patients and obviously offset some of our expenses there will be a very valuable. I should also note that in the past year, we've done two partnerships that are brought non-dilutive capital and have a very strong history of bringing in non-dilutive capital of luxurious portfolio and I would not be surprised if opportunities will afford us in the coming year.

Last but not least, is the fact is that as noted in our call today, we have some very significant milestone payments that may occur if Incyte is successful in the registration directed studies that they're undertaking now and the guidance that they have provided is that data from these studies will come in the course of the next year to two years.

And so again that fits quite nicely with the timing and some of the capital requirements for keeping on these programs moving forward. So hopefully that gives some insight on what we're thinking. We certainly will provide more precision over the course of the next few months as we continue to evaluate our entire portfolio in depth.

Debjit Chattopadhyay -- HC Wainwright -- Analyst

Great and just one last follow-up. So independent of what happens on the regulatory front for SOPHIA, if you were to have another do over with margetuximab in breast cancer, would you consider doing combination with an estrogen receptor inhibition -- plus CDK4/6 inhibition? Thank you so much.

Scott Koenig -- President, Chief Executive Officer and Director

So that's a nice speculation, I haven't thought about specifically on hormone receptors CD4K combinations. Clearly the opportunity, given the signal a margetuximab irrespective of how the regulators opine on approval. We think this drug is quite effective and given the enhanced signal we've seen with in gastric cancer with anti-PD-1, with -- and the design as you know with the anti-PD-1 and Anti-PD-1 LAG-3, we think the opportunity is quite right to look at combinations margetuximab with these checkpoint in breast cancer particularly late line and potentially early line as well. And so, irrespective of how the outcome that comes out on the regulatory front, we think that there is -- there is certainly merit to proceed forward in that manner. And certainly given the recent successes reported on TKIs particularly [Indecipherable] study that was reported out and will be updated at San Antonio in late-line patients. Again we think mechanistically these work orthogonally [Phonetic] and could enhance the responsiveness of patients both in late and early line treatments. But I think your points are well taken that, this could be a broader discussion to include families of estrogen blockade as well as on the CDK4/6 molecules.

Debjit Chattopadhyay -- HC Wainwright -- Analyst

Thank you.

Operator

Thank you. Our next question is from Stephen Willey with Stifel. Your line is open.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

Yeah, good afternoon. Thanks for taking the questions. I guess just a couple on margetuximab first. So with respect to the upcoming San Antonio presentation. Just curious, if we're going to see either a, the impact if any on of post-study therapy? And then also whether or not you're going to be breaking out overall survival as a function of allele status, specifically in those patients that are homozygous for the V allele?

Scott Koenig -- President, Chief Executive Officer and Director

Thanks very much for the question. I have not seen a final package of slides, I know, obviously we have a very large data set that we would like to present there by the investigators, so I can't comment what ultimately will get in front of the presentations. But there is clear interest in giving a in-depth analysis of the various sub-populations that although exploratory, can potentially benefit by this treatment and looking at differences among those populations for some insight here. So we are very happy to share that with you, but I can't give you the specifics on what's going to be included in the final presentation at this point.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

All right. That's fair. And we -- you're planning on filing here before the end of the year, is there a scenario by which you guys supplement the BLA filing with final OS data, if that final event,I guess has triggered before some kind of regulatory decision is reached? If the hazard ratios continue to trend in the right direction here and is it your expectation that would potentially constitute a major amendment that could delay a regulatory decision?

Scott Koenig -- President, Chief Executive Officer and Director

That's an excellent question, Steve, given where we see the rate of OS accumulation to get to the 385 events and not knowing what the timing will be for it yet, until -- for regulatory review, whether there will be a ODAC meeting and the timing. I certainly put it on the table that if the -- there is results for final OS, which obviously continues to not only trend favorably, but particularly if you look at the p-values and the hazard ratios for the F allele population, although it would be a nominal statistic if that obviously crosses over into significance there, it would be obviously important to share that information. So ultimately I can't -- I don't have the vision right now to know exactly when all those events will occur, but that's certainly is something for us to consider.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

Okay. And then maybe just a clarification question on flotetuzumab. So it sounds like you're still enrolling primary refractory patients. Are you using biomarker selection criteria to enrich the patient population from here on forward and I guess what are the logistics of trying to secure biomarker data in this patient population. Specifically, just given that, a lot of these...

Scott Koenig -- President, Chief Executive Officer and Director

A great question.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

Primary refractory patients are kind of in the midst of an acute medical emergency?

Scott Koenig -- President, Chief Executive Officer and Director

Yeah, now, that's a great question. So let me be quite clear on this, which is, yes, we are continuing to enroll patients (Technical Issue) mostly for refractory patients, but are also treating some relapse patients as well. As we pointed out before, not only treating as monotherapy, but we're also obviously just started the combination study with the anti-PD-1. However, it is not our intent to specifically use a biomarker to select these patients. We are pursuing today better define populations that may mechanistically respond. But in the current plans for design of future studies, it will be based on clinical criteria, specifically on failures of previous treatments or lack of response in this two treatments. But again, as I pointed out earlier we will have some follow-up discussions with the FDA shortly to get a little more, to get clear definition on how to move forward.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

I think you may have mentioned in your prepared comments as to when you may be in a position to communicate that to investors, but could you just repeat that. If you don't mind?

Scott Koenig -- President, Chief Executive Officer and Director

Yeah, it will be in the first part of next year. We are in a very good position to be able to do that.

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

Okay. Thanks for taking my questions.

Scott Koenig -- President, Chief Executive Officer and Director

Thank you.

Operator

Thank you. Our next question is from Michael Schmidt with Guggenheim Securities. Your line is open.

Charles Zhu -- Guggenheim Securities -- Analyst

Hey guys, this is Charles Zhu on for Michael Schmidt. Thanks for taking the questions. First one is a bit of a follow-up from previous ones on flotetuzumab, but could you provide any color around why it, for whatever reason seems to work better in primary refractory or early release as opposed to late relapse patients. And whether or not the ASH presentations will provide any insight on this front.

Scott Koenig -- President, Chief Executive Officer and Director

Charles, you might have missed it, in one of the responses to one of the questions earlier, is that in a very thorough analysis that was presented initially last year and which will be updated in an oral presentation this year, there has been a valuation of looking at patients who respond to chemotherapy based on a NanoString 770 marker profile, which is focused primarily on immune responsiveness.

And it seems to be a segregation that in what our so-called immune depleted signatures, the patients who will respond to chemotherapy, tend to fall in that bucket, whereas those in theory who will respond to immune-based therapies fall in sort of the immune enriched population markers, which particularly include up regulation of gamma interferon associated genes. We then did an analysis of the patients with refractory disease and who were treated with flotetuzumab and in fact the majority of those patients fell in that immune enriched gamma interferon signature bucket. And so clearly mechanistically, there is some reason that in a environment that has a lot of inflammation, for some reason chemotherapy isn't working very well. And I can give you the specifics, why, but that's certainly an avenue of further exploration.

Charles Zhu -- Guggenheim Securities -- Analyst

Got it, OK. Thanks, and could you also just remind me, again, given the mechanism of action of the PD-1 LAG-3 bispecific, would you expect activity in the post-PD-1 setting for those 150 patients and how do you evaluate the PD-1 pre-treated versus naive patients for this particular age? Thank you.

Scott Koenig -- President, Chief Executive Officer and Director

Thanks for that question. And as you may recall, Charles. What we have observed in our pre-clinical studies when we assessed separate in vitro analysis of T-cell activity restoration, in a bispecific DART molecule configuration, that configuration was much more effective, it is activating T-cells as compared to anti-PD-1 or anti-LAG-3 antibody is alone. To assess your question clinically, we are including patients that are both PD-1 experienced and that has progressed on therapy. And I should note that for one example for instance when we spoke at the time of ASCO with regard to the design of our MAHOGANY study, we presented a patient with gastric cancer, who had been our multiple lines of therapy, which included refractoriness to [Indecipherable] and yet this patient was able to respond with complete resolution of his target lesions for I think over a year. And so what we believe. And based on very strong data that has come pre-clinically, combinations of PD-1 and LAG-3 blockade seem to induce a immune response that is superior to individual treatment alone. And there is synergy there in terms of either expanding populations that are in the activation phase or restoring cells that have an exhaustion profile.

So again, we will be examining the populations of patients that are both anti-PD-1 naive, looking at historical responsiveness to those patients with those particular tumors to PD-1 therapies and obviously looking for improved responses in the anti-PD-1 naive and then as well as looking to the PD-1 experienced patients to look for responsiveness.

Charles Zhu -- Guggenheim Securities -- Analyst

Understood. Okay. Last question from me and I don't know if you kept up with just one, but there was something that happened a couple of days ago. There was another company had a like Phase 3 trial hit PFS, had OS in the secondary endpoint yet and they ended up pushing out to an NDA or a BLA. And I guess like does this -- has this events, I guess changed your view on the FDA's level or willingness these days to accept a BLA or NDA filing based only on in PFS endpoint with OS pending? Yes, that's the question.

Scott Koenig -- President, Chief Executive Officer and Director

So, I'm not aware of the specific case you're signing. But as you probably are quite well aware, there are a very large list of oncology drugs that have been approved based on PFS data, that ultimately do not meet OS criteria now as data, statistically. As long as there are trends in terms of favorable responses for the experimental drug. Given the magnitude of effect, we are seeing here particularly in this F allele population, we think that it is prudent to all the BLA at this point, ultimately it will be the decision by the FDA whether to accept the filing and review it, but we are optimistic that they will accept it and review it, and we'll see very shortly.

Charles Zhu -- Guggenheim Securities -- Analyst

Got it, thanks for taking the question.

Operator

Thank you. And we have a question from the line of Boris Peaker with Cowen. Your line is open. Boris. Your line is open. Mr.Peaker, please check your mute button. Okay. Doctor, can I move to the next question.

Scott Koenig -- President, Chief Executive Officer and Director

Yes.

Operator

Okay. And we have a question from Christopher Marai with Nomura Instinet. Please go ahead.

Jackson Harvey -- Nomura Instinet -- Analyst

Hi, Scott. This is Jackson Harvey on for Christopher. Thanks for taking the questions. I was just curious if you could provide some more color around the durability of response that you've seen with flotetuzumab in the monotherapy trial? And with regards to the PD-1 combos study with flotetuzumab, what do you think, based on the pre-clinical data should be the primary expectation for enhancement? Do you think we should be looking for longer duration of response, higher overall response rates or maybe an expansion of the AML populations that respond? Thank you.

Scott Koenig -- President, Chief Executive Officer and Director

Thank you very much for the question, Jackson. Regard to the durability of response, I'm going to leave that to our ASH presentation that's coming up in a few weeks. What we had noted before, as I recall from last year's presentation, the responding population was a little over three months. My expectation is that it is now longer in the responsive population, but I'll let the data speak for itself when it comes out in a few weeks. With regard to the combination with anti-PD-1, I think you've hit all the high points. I think we have the opportunity here for greater duration of response, increased responsiveness and expansion of the population. In one way, what I'm hoping is that this -- and as we study this is is that, particularly in the subsequent cycles of therapy or during periods of consolidation that we will be able to dramatically improve the length in which these patients respond, but obviously, we'll have to wait for the data.

Jackson Harvey -- Nomura Instinet -- Analyst

Great, thank you so much.

Operator

And this concludes today's question and answer session. I would like to turn the call back to Dr. Koenig for his closing remarks.

Scott Koenig -- President, Chief Executive Officer and Director

Thank you, operator. I just like to thank everyone again for joining us this afternoon and to let you all know that we look forward to continuing to advance our programs in the coming months and providing updates on our progress. Have a good day.

Operator

[Operator Closing Remarks].

Duration: 61 minutes

Call participants:

Anna Krassowska -- Vice President, Investor Relations and Corporate Communications

Scott Koenig -- President, Chief Executive Officer and Director

James Karrels -- Senior Vice President, Chief Financial Officer and Secretary

Jonathan Chang -- SVB Leerink -- Analyst

David Lebowitz -- Morgan Stanley -- Analyst

Masa Sekulic -- Citi -- Analyst

Jonathan Miller -- Evercore -- Analyst

Debjit Chattopadhyay -- HC Wainwright -- Analyst

Stephen Willey -- Stifel, Nicolaus & Company -- Analyst

Charles Zhu -- Guggenheim Securities -- Analyst

Jackson Harvey -- Nomura Instinet -- Analyst

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