MacroGenics (MGNX) Q4 2020 Earnings Call Transcript

MacroGenics (MGNX 5.32%)
Q4 2020 Earnings Call
Feb 25, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon. We will begin the MacroGenics 2020 fourth-quarter and full-year corporate progress and financial results conference call in just a moment. [Operator instructions] At this point, I will turn the call over to Jim Karrels, senior vice president and chief financial officer of MacroGenics.

Jim Karrels -- Senior Vice President and Chief Financial Officer

Thank you. Good afternoon and welcome to MacroGenics' conference call to discuss our fourth quarter and full-year 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 announcements which is available under the investors tab on our website at www.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 our 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. They 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 would like to turn the call over to Dr. Scott Koenig, president and chief executive officer of MacroGenics.

Scott Koenig -- President and Chief Executive Officer

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

Jim Karrels -- Senior Vice President and Chief Financial Officer

Thank you, Scott. This afternoon, MacroGenics reported financial results for the year ended December 31, 2020 which highlight our financial position as well as our recent progress. As described in our release this afternoon, MacroGenics total revenue, consisting primarily of revenue from collaborative agreements was $104.9 million for the year ended December 31, 2020, compared to $64.2 million the year ended December 31, 2019. Revenue recognized during the fourth quarter ended December 31, 2020 included $40 million in milestones from Incyte and a $20 million upfront payment from Janssen, the latter of which was not reflected in our cash on our December 31, 2020 balance sheet as it was received in early 2021.

Our research and development expenses were $193.2 million for the year ended December 31, 2020, compared to $195.3 million for the year ended December 31, 2019. General and administrative expenses were $42.7 million for the year ended December 31, 2020, compared to $46.1 million for the year ended December 31, 2019. This decrease was primarily due to a decrease in external costs including consulting fees. MacroGenics net loss was $129.7 million for the year ended December 31, 2020, compared to a net loss of $151.8 million for the year ended December 31, 2019.

Our cash, cash equivalents and marketable securities balance as of December 31, 2020 was $272.5 million compared to $215.8 million as of December 31, 2019. Again, the $20 million upfront from Janssen as well as the recently disclosed $10 million milestone from Incyte was not reflected in our cash balance at year-end. Finally, let me mention a few things about our cash runway. Earlier this year, Provention Bio announced the FDA's acceptance of their BLA for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals.

The PDUFA target action date is July 2 with an advisory committee meeting tentatively set in May. You'll recall that we had earlier developed and sold teplizumab to them in 2018. And if approved, MacroGenics is entitled to receive a $60 million milestone as well as royalties on sales. For cash budgeting purposes, we typically discount such milestones as we have no control over them.

With that background, there is no adjustment necessary to our previously disclosed cash guidance. And to remind listeners, we anticipate that our cash, cash equivalents and marketable securities as of December 31, 2020, 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. And now, I'll turn the call back to Scott.

Scott Koenig -- President and Chief Executive Officer

Thank you, Jim. 2020 was a big year for MacroGenics with the presentation of various data sets across our portfolio and most of the major oncology conferences including AACR, ASCO, ESMO, SITC, San Antonio and ASH as well as the approval of MARGENZA as an end year holiday gift. Still, we are equally, if not more, excited about our prospects in 2021. We are particularly excited about the multiple ongoing registrational or potentially registration-enabling studies including flotetuzumab in AML and margetuximab in gastric cancer, and this is in addition to two PDUFA target action date in July related to teplizumab and retifanlimab.

And finally, we know many of you eagerly await clinical data for multiple dose expansion or proof-of-concept studies including the next waves of data from MGC018, tebotelimab and MGD019. With that backdrop, let me use this time to walk you through updates on our portfolio of eight clinical molecules. First, let me provide an update on margetuximab. In December, the U.S.

FDA-approved MARGENZA in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti HER2 regimens, at least one of which was for metastatic disease. The anticipated March launch is being coordinated with our commercial partner, EVERSANA. They are a pioneer of next-generation commercial services to the global life sciences industry, and we intend to leverage their integrated commercial services to efficiently launch MARGENZA. We have been working closely with EVERSANA to fully align our commercialization strategies to distribute product, educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics cash runway to fund our broader portfolio.

As disclosed in November, under the terms of our agreement with EVERSANA, we maintained full ownership of margetuximab including all manufacturing, regulatory and development responsibilities for the product. EVERSANA has a co-exclusive right to conduct approved commercialization activities and will utilize their internal capabilities to support sales and marketing, market access, channel management services, data analytics, medical affairs and other patient access-related services. EVERSANA and MacroGenics will equally share in funding EVERSANA's commercialization expenses. MacroGenics will book margetuximab sales.

In exchange for co-funding these expenses, EVERSANA will earn future revenue share payments which will be capped at 125% of EVERSANA's cumulative service fees. The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions, affording us the ability to potentially partner margetuximab in the future. I'll briefly mention that we have modest expectations from MARGENZA sales given competitive realities that have taken place in the HER2-positive breast cancer market including multiple new approvals which is great for patients. Therefore, we will hold off providing sales guidance until MARGENZA is on the market and we have a better sense of uptake by oncologists.

Finally, with regard to margetuximab in breast cancer, based on the current accrual rate of overall survival events in the ongoing Phase 3 SOPHIA metastatic breast cancer study that supported the FDA approval, we now anticipate that the final OS analysis will take place in the second half of 2021. As a reminder, the final OS analysis occurs upon the accrual of the 385th OS event. Beyond breast cancer, we are evaluating margetuximab in the Phase 2/3 Mahogany study in patients with advanced gastric and gastroesophageal junction cancer. This trial consists of two modules designed to evaluate margetuximab as an investigational agent in combination with a checkpoint inhibitor with or without chemotherapy as a potential first-line treatment for patients with advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer.

We anticipate sharing initial safety and efficacy data in the first half of 2021 of the evaluable patients in Module A who were treated with a combination of retifanlimab, an investigational anti-PD-1 antibody, and margetuximab. We've submitted early data on a subset of the Module A cohort patients for presentation at a scientific conference in the first half of 2021. Enrollment in Module B which is evaluating margetuximab plus either of two of MacroGenics checkpoint inhibitor molecules in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors, irrespective of PD-L1 expression, is currently ongoing in coordination with our regional partner in Greater China, Zai Lab. Module B is expected to continue enrollment throughout 2021.

Next, let me discuss flotetuzumab, our investigational bispecific CD123 x CD3 DART molecule. At the annual ASH Conference in December, we had several flotetuzumab data presentations. Highlights of these presentations included achieving a complete remission rate including CR/CRh of 25% in the primary induction failure or early relapsed population based on a total of 44 AML patients in the ongoing study. Eight of the 14 responders received allogeneic hematopoietic stem cell transplantation as a consolidation therapy with durable remission with a median not reached as of November 10, 2020 data cutoff.

The most common treatment-related adverse event was mild to moderate grade 1 or 2 CRS events with only a single grade 3 event reported. We are very encouraged by the initial activity and safety data and continue to enroll the single-arm registrational clinical study to evaluate flotetuzumab in up to 200 AML patients with refractory AML. We anticipate providing further updates on the clinical development of flotetuzumab in the second half of this year and completing full enrollment of this study in 2022. I'll next discuss MGC018, our investigational antibody drug conjugate designed to deliver a DNA alkylating duocarmycin cytotoxic payload to cells that Express B7-H3.

Post ASCO 2020, we selected 3 milligrams per kilogram as the recommended dose for expansion. In November, we initiated the enrollment of patients with metastatic castration-resistant prostate cancer, triple-negative breast cancer, and non-small cell lung cancer in dose expansion portion of the Phase 1 clinical study. We are highly focused on execution of the MGC018 study and expect to provide an update on it midyear. Including results from patients who were dosed at the highest 4 mg per kg dose escalation level.

We have submitted a placeholder abstract to a midyear conference based on available data. Next, I would like to turn to tebotelimab, our investigational bispecific PD-1 x LAG-3 DART molecule, previously known as MGD013. We are evaluating tebotelimab in a Phase 1 dose expansion study as both monotherapy in several tumor types as well as a combination study with margetuximab. At the SITC meeting in November 2020, updated data was presented from our ongoing combination study of tebotelimab and margetuximab in patients with advanced HER2-positive neoplasms.

At ASH, in December 2020, data was presented from the ongoing tebotelimab Phase 1 dose expansion study in patients with relapsed refractory diffuse large B-cell lymphoma. In this study, 20 DLBCL patients were enrolled, half of whom were CAR-T cell therapy experienced. As of October 23, 2020, the cutoff date, there were 13 responsive valuable patients. A preliminary ORR of 53.8%, seven of 13 patients was observed including responses in five of seven CAR-T cell naive patients and then two of six CAR-T cell experienced patients, the latter of whom both had complete responses.

Tebotelimab was generally well tolerated among heavily pretreated relapse/refractory DLBCL patients with manageable infusion-related reactions and no evidence of tumor lysis syndrome. We expect to provide updates on both our monotherapy tebotelimab study and combination study with margetuximab in 2021 including future development plans. I should note that in November 2018, we licensed to Zai Lab the right to develop and commercialize tebotelimab in Mainland China, Hong Kong, Macau and Taiwan. Zai currently has multiple ongoing monotherapy and combination studies of tebotelimab.

Speaking of tebotelimab, I'd like to next tell you about a study combining this molecule with another of our investigational Fc-engineered antibodies. In the coming weeks, we expect to initiate a combination study of enoblituzumab which targets B7-H3 in a chemo-free regimen in frontline squamous cell carcinoma of the head and neck with either tebotelimab for patients who are PD-L1 negative or with retifanlimab in patients who are PD-L1 positive. Let me next discuss MGD019, our investigational bispecific checkpoint DART molecule that targets PD-1 and CTLA-4. Recall that at the ESMO Virtual Congress in September, data from our Phase 1 dose escalation study of MGD019 was reported via oral presentation.

We have expanded the study initially in patients with microsatellite stable colorectal cancer and checkpoint naive non-small cell lung cancer at the recommended Phase 2 dose of 6 mg per kg. We expect to provide a clinical update on this study in mid-2021. Let me next turn to retifanlimab, the investigational anti PD-1 antibody that we licensed to Incyte as INCMGA0012. As announced last month, the FDA has accepted for priority review Incyte's BLA for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, who have progressed on or who are intolerant of platinum-based chemotherapy.

According to Incyte statements, the PDUFA target action date for retifanlimab is July 25, 2021, with a likely FDA advisory committee meeting as part of the review process. In addition to anal cancer, Incyte has stated it's pursuing development of retifanlimab as monotherapy and potentially registration-enabling studies in patients with MSI high endometrial cancer, Merkel cell carcinoma and lung cancer. In addition, they are evaluating the molecule in combination with other assets in their immune oncology portfolio. I will remind listeners that under our collaboration agreement with Incyte, we have achieved $65 million in milestones to date including $40 million in the fourth quarter of 2020 and are eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones.

If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties tiered from 15% to 24% on future worldwide net sales of the molecule. And finally, our second investigational ADC, IMGC936 which targets ADAM9, is being advanced under co-development agreement with Immunogen. Under our 50-50 collaboration, ImmunoGen is leading clinical development and they have indicated they expect to complete dose escalation and move to expansion cohorts in the Phase 1 study, with initial data anticipated by the end of 2021 or early 2022. As I mentioned earlier, 2020 was a productive year.

And in 2021, we expect to continue to build momentum and advance our pipeline of innovative product candidates. We would now be happy to open the call for questions. Operator?

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Evan Seigerman with Credit Suisse. Your line is open.

Evan Seigerman -- Credit Suisse -- Analyst

Hey, guys. Thank you so much for taking the question. Congrats on all the progress last year, and I'm looking forward to this year. So on MARGENZA and gastric from Module A, what did you see in those patients that prompted you to submit the data to a meeting in this half of the year? And can you just remind us what you want to see from this trial overall and if the data for Module A would be potentially sufficient for some sort of accelerated approval?

Scott Koenig -- President and Chief Executive Officer

Thank you very much, Evan, for your nice comments. So we have achieved the enrollment of the first part of Module A which was 40 patients. Some of these patients have been enrolled quite recently. We have been able to follow up on at least two scans on a significant number of those patients.

And so we felt that it would be valuable to begin to report on the results. And so we put a placeholder abstract into ASCO. And if it's accepted, we will likely provide an update at a later cut of the data in the spring and be able to provide you the insights on the results of the study. As you recall, the basis for our interest in the frontline setting was set by the study we conducted in second-line setting of gastric cancer.

These are patients post HERCEPTIN and chemotherapy where they were treated with margetuximab and anti-PD-1, where we saw very nice objective responses in this population. And particularly what's notable is the overall survival benefit which was superior to patients, both in the second and first-line setting. Also, the safety data was dramatically better, both in cases of patients treated with therapies in first-line and second-line setting by historical data. With that, to give you a perspective, the frontline treatment of patients standard of care is HERCEPTIN and chemotherapy based on a study called TOGA.

In that study, the overall response rate was 47%. There was a 68% grade 3 adverse event observation in that study. So with that, we obviously, at a baseline, would like to see overall response rates greater than 47%. We have internal goals of, obviously set which we have not disclosed publicly.

But so far, we've been quite encouraged by the data that we've seen to date.

Evan Seigerman -- Credit Suisse -- Analyst

Great. Thank you.

Operator

Our next question comes from Jonathan Chang with SVB Leerink. Your line is open.

Unknown speaker

Hey, guys. This is David Ruche on for Jonathan. And congrats on all the progress last year. First question is just could you help set expectations for the updated MGC018 data in mid-2021 in terms of how many evaluable patients from the different expansion cohorts? And then with regard to the prostate cancer cohort, how many patients do you expect could be RECIST evaluable?

Scott Koenig -- President and Chief Executive Officer

David, thanks very much for those questions. As you know, we have advanced forward an expansion study of MGC019. We decided after the ASCO conference and based on additional analysis of pharmacokinetics of the drug and evaluation of safety that a 3 mg per kg dosing was the go-forward dose that we wanted to take in these expansion cohorts. We set a goal for enrolling 40 patients in prostate -- in castration-resistant prostate cancer, 20 patients with non-small cell lung cancer and 20 patients with triple-negative breast cancer.

We obviously had to submit amendments for the various protocols, and it took several months to achieve that. That was reached in October, and we enrolled the first patient in November in the prostate study. During Christmas, things slowed down. And now in the beginning of the year, we are now on a nice ramp of enrollment of patients.

So given that there's very short follow-up period, even in these initial patients, we don't expect large numbers of patients to be able to be updated midyear. But obviously, we would like to provide as much data as possible. Based on the enrollment that we're seeing at the current time, we do expect to meet our objectives by midyear of enrolling the 40 patients in prostate cancer, 20 in non-small cell lung and maybe the triple-negative breast as well, but more likely later this year. With regard to the data that we will provide, as noted by previous remarks, we will include patients that were in the dose escalation arm in the study at 4 mg per kg, and several of those patients are still on treatment, even at this time.

So again, we will provide an update as much with what we can in terms of data available at some cut date in the spring. And obviously, even later in the year, we will provide additional data as more scans come in and analysis of PSA, particularly in prostate patients. With regard to the RECIST evaluation of the prostate patients, this protocol will allow patients that have both bone-only disease as well as measurable disease in various organs. There is no set number.

And at this point, from the patients who have been enrolled, we clearly have patients that are coming in with measurable disease. But I won't be able to give you the specifics until the time occurs at the meeting.

Unknown speaker

Got it. Thanks. That's helpful. And then just for the prostate cancer patients, given that you have some patients from dose escalation and expansion, what kind of duration of PSA response do you think will be encouraging in this late-line patient population? And are there any other durability metrics that you might be looking to assess? Thank you.

Scott Koenig -- President and Chief Executive Officer

Yes. Thank you. And obviously, if you look at the historical data from other standard of care, the length of time which one sees a 50% reduction of PSA levels is relatively quite short. And maybe in the order of two to three months, maybe slightly longer in certain cases.

So clearly, we want to clear that bar. And we look for the length of this duration of responsiveness to be six months or hopefully even longer. One thing we have observed from the patients treated so far, to give you a little perspective, is that if the patients are able to continue on the drug, that the effects seem to last. Obviously, we can't predict what's going to happen in the future.

So the goal here is to identify the ideal not only dose of the drug, but the dosing interval of the drug and obviously select the populations that can have the most exposure to treatment with MGC018. And in those cases, we hope that that will then lead to prolonged responses. With regard to the other objective responses is obviously we are monitoring for other metastatic lesions. So we will look at radiographic evidence of PFS.

And then ultimately, our goal is obviously overall survival, given in these late line patients, survival is quite modest on the order of a little more than a year.

Operator

Our next question comes from Umer Raffat with Evercore. Your line is open.

Unknown speaker

Thank you. This is Bo for Umer and John. Hi, Scott. Could you remind us what is the biomarker panel that you're using for the LAG-3 PD-1 bispecific that includes LAG-3 and some other markets that you have talked about before? And could you give us some specific? And how are you measuring that panel? And how do you see that getting commercial adoption? Thanks.

Scott Koenig -- President and Chief Executive Officer

Thank you, Bo and a great question. The data that we presented last year was based on our own internal IHC data that we have developed with antibodies to LAG-3. We also analyze that data with respect to transcript levels in collaboration with NanoString, and with NanoString, we looked at a fairly large group of immune-associated markers. And as we noted previously, we had seen some very nice correlation with responsiveness in the monotherapy treated patients with some of the gamma interferon associated genes and other immune activation genes.

Going forward, we have not announced specifically which one or ones of these biomarkers will be employed for future studies. I would say, at the minimum, the data to date and an expanded analysis of additional patients in our study suggests a measurement of LAG-3 will be of value, particularly in solid tumor patients. But we will provide some update probably around midyear our next steps going forward with regard to either monotherapy treatment in solid tumors of DLBCL or combination studies that are ongoing with margetuximab in late-line HER-2 patients.

Unknown speaker

Thank you very much.

Operator

Our next question comes from Yigal Nochomovitz with Citi. Your line is open.

Unknown speaker

Hi. This is Carly on for Yigal. Thanks so much for taking the question. First, just to follow up on a prior question on the Mahogany Module A initial data this half.

Assuming you meet sort of that internal threshold that you were referring to on ORR, what would the next steps be? Would you plan to enroll additional patients? And if so, how many patients -- or would you need to go back to the FDA to discuss potential for accelerated approval?

Scott Koenig -- President and Chief Executive Officer

Thank you, Carly, for the question. So we have already had the discussion with the FDA with regard to the analysis of the data and what we would do next if we meet the criteria for Module A. This would be a continuation of the study as is, continued enrollment of patients, a really modest number, although we have not specifically defined what that is publicly. We'll also have initiated Module B with Zai Lab in Asia and have sites now up in Europe which we can recruit patients ourselves which is expected at the time we will finish our analysis of this first part of Module A.

It's important to note that within this Module B, there are opportunities to look at the contribution of components to support the study for the Module A. So all in total, I think that if we are successful to meet the criteria set, enrollment can go fairly quickly and should have a, hopefully, a good set of data that we could support submission to the FDA for accelerated approval.

Unknown speaker

OK. Great. That's really helpful. And are you able to comment on when we should expect initial data from Module B?

Scott Koenig -- President and Chief Executive Officer

Yeah. Right now, we're still in the early throes of enrollment there. As I said, Zai Lab is the main enroller right now. We will turn that on later this year again assuming we met our particular criteria.

But I can't give you projections right now in terms of the timing when that study would be complete.

Unknown speaker

OK, no problem. Understood. Thanks for taking the question.

Operator

Thank you. Our next question comes from Etzer Darout with Guggenheim. Your line is open.

Unknown speaker

Hi. This is Paul on for Etzer. Thanks for taking our question. For your tebotelimab study in DLBCL, you mentioned some clinical updates later this year.

Could that sort of be around this year's ASH meeting or are you aiming for something more near term? And also wondering if you could speak on any plans to explore combinations with tebo in the setting for DLBCL?

Scott Koenig -- President and Chief Executive Officer

So with regard to the update, we will provide an update probably outside the scientific conference, at least in terms of next plan and potentially some of the data update on DLBCL, probably before ASH, but not without a possibility that we'd also include a submission to ASH. I missed the second question was tebo and what?

Jim Karrels -- Senior Vice President and Chief Financial Officer

Combinations.

Unknown speaker

Any potential to explore combinations, yes.

Scott Koenig -- President and Chief Executive Officer

Yes. So as you may have heard earlier, we're very excited about the start of a study right literally in the next week or two, enoblituzumab plus tebotelimab in PD-L1 negative patients with head and neck cancer. This is a frontline study. Again, if you recall, as we presented early this year in our combination of tebo with MARG, the Fc engineering that we have incorporated in both those molecules has the ability to upregulate various checkpoints including PD-L1, LAG-3 and others.

And so again, our hope is that when we execute this in the head and neck study, we will take advantage of that activation property to then get a better therapeutic effect of combining tebo with enoblituzumab.

Unknown speaker

Got it. Thanks. That's helpful. And then just one more.

I was wondering if you could give a little bit more color on your MGD024 program and sort of how that differs from flotetuzumab and sort of what kind of dosing regimen you're aiming for with the longer half-life there? Thanks.

Scott Koenig -- President and Chief Executive Officer

Well, thank you. If you go back to some of our presentations at some of the scientific meetings, we're very excited about the prospects of the sort of next-generation redirected killing mechanism in our DART technology exploiting CD3-based mechanisms. We had spent a lot of time screening various mutations that could alter slightly the properties of CD3, so that the combined DART molecule targeted to a particular target would allow for maximum killing effects but mitigate the cytokine release associated with treatment. We have incorporated that paradigm in multiple molecules.

And the first one that will come in -- go into the clinic is MGD024 which has the exact same CD123 variable domain that's incorporated in flotetuzumab but the slightly altered CD3 that will allow for these hopefully improved properties. Of course, we've also added an Fc domain. And so the opportunity here is to extend the half-life of this molecule. So the drug will be given intermittently.

We should be able to achieve Cmax with this with relative safety. If all goes well, based on our preclinical data, we will start the study later this year. Right now, it is viewed as not a replacement for flotetuzumab, but essentially an add-on. We see the prospects are most beneficial in a sense of using this once the patient is on flotetuzumab and goes into a remission to use it as maintenance and consolidation therapy as well as expanding this into other indications including Myelodysplastic syndrome and other malignancies.

So we're very excited to be -- we expect to be the first of several different CD3 redirected next-generation molecules.

Operator

Thank you. Our next question comes from David Lebowitz with Morgan Stanley. Your line is open.

David Lebowitz -- Morgan Stanley -- Analyst

Thank you very much for taking my question. Could you characterize the opportunity for retifanlimab?

Scott Koenig -- President and Chief Executive Officer

So thank you, David. As you know, we're very excited about the activity that Incyte is pursuing for retifanlimab. I would say I look at this from a perspective, both as a very good anti-PD-1 molecule that is now being pursued as monotherapy in both niche and large tumor indications and many, many studies in combination. I believe there are over now 30 clinical studies ongoing using retifanlimab.

With regard to the near-term PDUFA date, the first indication is a niche opportunity, a small opportunity for which there is a great need, patients with anal cancer progress fairly rapidly. And many of these patients progress after platinum therapy or intolerant of that therapy. So we're hopeful that that will be the first molecule that will -- the molecule will be the first indication we'll get in the market. But as I noted earlier, there are multiple other registration-directed studies being conducted by them, so there is opportunity to expand the indications probably in a relatively short period of time.

For us, it's also a very important opportunity for revenue generation. As we've noted on the call today, literally in the last few months, we've gotten additional $50 million of milestone payments from Incyte. We expect more to come and certainly, if the drug is approved, a significant milestone, will be accompanying that as well.

David Lebowitz -- Morgan Stanley -- Analyst

So there will be an expected milestone with the first approval?

Scott Koenig -- President and Chief Executive Officer

There would be expected milestone with approval. The -- we are not -- we cannot -- we're not enabled to be able to tell you the magnitude of that. But given an approval of a first drug, that could be significant for us.

David Lebowitz -- Morgan Stanley -- Analyst

Would it be reasonable to expect that it will be larger than the milestone you just received?

Scott Koenig -- President and Chief Executive Officer

I'm not going to comment further on the specifics here, but it's considerable. I would also make note that there are future other milestones both for clinical and regulatory as well as commercial milestones that are quite sizable. And then royalty rates that started 15% and are tiered up.

David Lebowitz -- Morgan Stanley -- Analyst

OK. Thank you for taking my question.

Operator

Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.

Unknown speaker

Hi, everyone. This is Mitchell on for Peter. Thanks for taking our questions. For MGC018, how do you think about the positioning in prostate cancer given it's a broad landscape? And what could pivotal designs look like down the line?

Scott Koenig -- President and Chief Executive Officer

Thanks, Mitchell, for that question. As you know, we started out analyzing patients who are very late stage patients. As you noted in our dose escalation study, many of these patients have been in as many as six lines of therapy previously. Right now, our current pursuit is in the castration-resistant prostate indication in patients who have progressed on a chemotherapeutic agent and at least one AR agent.

So I think this is a nice first entry into the treatment of prostate cancer. Certainly, we could be moving up early in line as well. With regard to a registration study, if the results bear out in the current study, the current approved drug is cabazitaxel as a second chemotherapeutic agent. And so I could envision a head-to-head study of MGC018 with cabazitaxel as next steps for a registration study.

Obviously, we would have to talk to the regulatory agencies with regard to that. So let me leave it at that.

Unknown speaker

That's great. That's very helpful. And then on flotetuzumab, with the second half update, what kind of update can we expect? And what could the size and scope of the next data set look like?

Scott Koenig -- President and Chief Executive Officer

Well, thanks again for that question. As you know, we're in this single-arm registration study, for flotetuzumab in the primary induction failure, early relapse population. We're enrolling in that study currently. We have built in into the development of this study various looks at the data at various times of patient enrollment.

So right now, patients are enrolling, but I can't give you right now the projections of the numbers that we will achieve by the end of the year. What we are targeting is some analysis of at least a first or possibly second look at this data by the time of ASH. But right now, it's just too early to project that.

Unknown speaker

Thank you very much, Scott.

Operator

[Operator instructions] Our next question comes from Boris Peaker with Cowen. Your line is open.

Unknown speaker

Hi. This is Cynthia on for Boris. Congrats on all the progress in 2020 and thanks for taking our questions. A quick one for me for MGD019, should we expect data from both the colorectal and lung cancer cohorts in 2021? And has enrollment been pretty similar between both cohorts and what kind of data should we expect?

Scott Koenig -- President and Chief Executive Officer

Thanks so much for those questions. So we have -- are enrolling in the PD-1 CTLA-4 019 molecule, the colorectal is pretty close to enrollment of that cohort. We're just starting the enrollment on non-small cell lung cancer cohort because we wanted to go into checkpoint, anti-PD-1 naive patients. And as you know, given that's approved in the U.S., we had to go ex U.S.

to begin to recruit those patients. Those sites are up. We're beginning to enroll for that arm of the study. So I would say that it's most likely we would this year be able to provide an update for the colorectal study.

Also, it's likely we'll be able to talk about some additional cohorts that we will be adding to the study as well. With regard to the specific scientific forum, we haven't chosen one yet, but we'll be providing updates during the course of the year.

Unknown speaker

All right. Thank you for taking our questions.

Operator

And I'm currently showing no further questions at this time. I would like to turn the call back over to Dr. Scott Koenig for closing remarks.

Scott Koenig -- President and Chief Executive Officer

Thank you, operator and thank you all for participating in our call today. We look forward to update you on our various programs and the beginning of our launch of MARGENZA. Have a great day.

Operator

[Operator signoff]

Duration: 49 minutes

Call participants:

Jim Karrels -- Senior Vice President and Chief Financial Officer

Scott Koenig -- President and Chief Executive Officer

Evan Seigerman -- Credit Suisse -- Analyst

Unknown speaker

David Lebowitz -- Morgan Stanley -- Analyst

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