MacroGenics (MGNX) Q4 2021 Earnings Call Transcript

MacroGenics (MGNX -2.86%)
Q4 2021 Earnings Call
Feb 24, 2022, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon. We'll begin the MacroGenics 2021 fourth quarter corporate progress and financial results conference call in just a moment. [Operator instructions] At this point, I will turn the call over to Chris James, vice president of investor relations and corporate communications of MacroGenics.

Chris James -- Vice President of Investor Relations and Corporate Communications

Thank you, operator. Good afternoon, and welcome to MacroGenics' conference call to discuss our fourth quarter and full year 2021 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the investors tab on our website at macrogenics.com. You may also listen to this conference call via our webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.

I'd like to alert listeners that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change, except to the extent required by applicable law.

And now I'd like to turn the call over to Dr. Scott Koenig, president and chief executive officer of MacroGenics.

Scott Koenig -- President and Chief Executive Officer

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

Jim Karrels -- Chief Financial Officer

Thank you, Scott. This afternoon, MacroGenics reported financial results for the year ended December 31, 2021, which highlight our financial position, as well as our recent progress. As described in our press release this afternoon, MacroGenics total revenue, consisting primarily of revenue from collaborative agreements with $77.4 million for the year ended December 31, 2021, compared to total revenue of $104.9 million for the year ended December 31, 2020. Revenue for the year ended December 31, 2021, included $12.3 million net sales of Margenza, which was launched in March.

Our research and development expenses were $214.6 million for the year ended December 30, 2021, compared to $193.2 million for the year ended December 31, 2020. The increase was primarily related to increased clinical trial and development costs related to MGC018 as well as other preclinical molecules and increased clinical expenses related to enoblituzumab and lorigerlimab. These increases were partially offset by decreased development and manufacturing costs related to retifanlimab for Incyte, and decreased clinical costs and BLA support for margetuximab compared to the prior year. Selling, general and administrative expenses were $63 million for the year ended December 31, 2021, compared to $42.7 million for the year ended December 31, 2020.

This increase was primarily related to the Margenza launch, as well as labor-related costs and legal expenses. Our net loss was $202.1 million for the year ended December 31, 2021, compared to a net loss of $129.7 million for the year ended December 31, 2020. Our cash, cash equivalents and marketable securities balance as of December 31, 2021, was $243.6 million compared to $272.5 million as of December 31, 2020. Finally, in terms of our cash runway, we anticipate that our cash, cash equivalents and marketable securities as of December 31, 2021, in addition to anticipated and potential collaboration payments, should enable us to fund operations through 2023.

Our guidance does not reflect expenditures related to the potential late-stage development of MGC018 in prostate cancer or further expansion of studies currently ongoing. And now I'll turn the call back to Scott.

Scott Koenig -- President and Chief Executive Officer

Thank you, Jim. I'm encouraged by the progress made during the fourth quarter and our development plans for our B7-H3 directed programs in 2022. Since our presentation at the European Society of Medical Oncology or ESMO meeting in September, in which we showed promising data for our lead molecule, MGC018, we have prioritized the advancement of MGC018 and enoblituzumab, our two programs targeting B7-H3, and are taking additional steps to operationalize all aspects of these programs. This included planning for the advancement toward a registration-directed study of MGC018 in metastatic prostate cancer later this year.

Outside of these product candidates, we are moving closer to dosing the first patient with MGD024, our next-generation CD123 by CD3 DART molecule for patients with CD123-positive hematologic malignancies and working with investigators on the next steps in the development of tebotelimab, our PD-1 x LAG-3 bispecific DART molecule. Beyond these programs, we have significant ongoing preclinical activities to fuel our pipeline of investigational product candidates for the potential treatment of cancer. With that backdrop, let me use this time to walk you through updates on our portfolio of investigational clinical molecules, starting with our molecules targeting B7-H3, a member of the B7 family of molecules involved in immune regulation. We are developing two molecules that target B7-H3 through complementary mechanisms of action that take advantage of this antigen's broad expression across multiple solid tumor types.

MGC018 is our investigational antibody drug conjugate designed to deliver a DNA alkylating duocarmycin cytotoxic payload to tumors expressing B7-H3. Recall in September, we presented an encouraging update of clinical data from our ongoing study of MGC018 in patients with advanced solid tumors at ESMO. We are currently developing plans for a registration-directed study of MGC018 in metastatic castration-resistant prostate cancer and plan to meet with the FDA later this quarter to discuss these plans. Based on our analysis of Phase I/II study data to date, we intend to modify the dose and administration of MGC018, potentially including a slightly reduced dose and increasing the interval between doses, which we believe will help to achieve the maximum therapeutic effect while aiming to reduce potential side effects.

In parallel, we are advancing various operational aspects of the program. In addition to these next steps for MGC018, our Phase I/II dose expansion study is fully enrolled for patients with metastatic castration-resistant prostate cancer, non-small cell lung cancer, melanoma and triple-negative breast cancer, while enrollment continues in patients with squamous cell carcinoma of the head and neck. We expect to provide an update from this study during the second half of the year as the data further matures. Beyond the ongoing monotherapy study, I am pleased to share that we plan to initiate a combination study of MGC018 and lorigerlimab, formerly known as MGD019, in the coming weeks.

The scientific rationale for undertaking this trial is supported by our preclinical data, which suggests that antitumor activity with MGC018 may be significantly enhanced by combination with an anti-PD-1 agent without meaningful overlapping toxicities. As further support for this combo study, we have seen some interesting initial data from our lorigerlimab dose escalation study. Of relevance to the imminent combination study with MGC018, I'll share an exciting anecdote on one of the prostate cancer patients from our dose escalation study of lorigerlimab. A patient with metastatic castration-resistant prostate cancer had been on six prior lines of systemic therapy, including chemotherapy, abiraterone, enzalutamide and cabazitaxel.

While patients with metastatic castration-resistant prostate cancer have not been particularly responsive to checkpoint inhibition, this individual achieved a confirmed CR with complete resolution of his disease and normal PSA after treatment with lorigerlimab. He began treatment with lorigerlimab in December 2019 for 24 weeks than every six weeks thereafter for a total of just over one year as per protocol. He received his last dose of lorigerlimab in January 2021, and based on a recent update from the investigator, remains in CR with a normal PSA. Medscape has created a profile of this patient within a video they produced regarding bispecific checkpoint molecules.

Stories like this tell why we as a company and the industry develop drugs. Although only a single patient experience, this patient's story underscores part of our rationale for wanting to study the combination of lorigerlimab and MGC018 in various solid tumors, including prostate cancer. As I mentioned earlier, we expect to initiate a combination study of MGC018 and lorigerlimab in patients with solid tumors, including renal cell carcinoma, pancreatic cancer, ovarian cancer, hepatocellular carcinoma, metastatic castration-resistant prostate cancer, and melanoma in the coming weeks. Another of our investigational molecules exploiting the overexpression of B7-H3 in solid tumors is enoblituzumab, an Fc-engineered antibody created using our Fc-optimization platform.

In March 2021, we initiated a combination study of enoblituzumab in a chemotherapy-free regimen in frontline squamous cell carcinoma of the head and neck with either tebotelimab for patients who are PD-L1 negative, or with retifanlimab in patients who are PD-L1 positive. We expect to complete enrollment of the PD-L1 positive patient cohort during the first half of this year and provide an update on this cohort during the second half of the year. I-Mab, our partner in Greater China, announced in December that the Center for Drug Evaluation of China's National Medical Products Administration approved its IND submission for the initiation of a Phase II trial in China for enoblituzumab in combination with pembrolizumab in patients with solid tumors, including non-small cell lung cancer, urothelial carcinoma and other selected cancers. I'll next walk you through our PD-1-based bispecific molecules designed to provide further differentiation from existing PD-1-based options and to enable a broad set of combination options across our portfolio.

Lorigerlimab is an investigational bispecific tetravalent DART molecule designed to enable simultaneous and/or independent blockade of PD-1 and CTLA-4. We are currently evaluating lorigerlimab in a Phase I/II dose expansion study in patients with microsatellite stable colorectal cancer, metastatic castration-resistant prostate cancer, melanoma and checkpoint naive non-small cell lung cancer at a dose of 6 mg per kg and expect to provide an update on the study this year. Tebotelimab is our investigational bispecific PD-1 x LAG-3 DART molecule. Tebotelimab was evaluated in a Phase I/II dose expansion study in several tumor types and is currently being studied in combination with enoblituzumab in squamous cell carcinoma of the head and neck.

We are formulating plans for potential future development of tebotelimab and expect to provide an update in the second half of 2022. MacroGenics' partner in Greater China, Zai Lab, recently informed the company that it has decided to discontinue development of tebotelimab for indications it was enrolling in its territory and is evaluating future development plans in other indications. Next up, let me discuss our efforts to advance treatment of patients with CD123-positive hematologic malignancies. We have prioritized the development of MGD024, our next-generation bispecific CD123 x CD3 DART molecule, which will replace our flotetuzumab development program.

MGD024 incorporates the CD3 component designed to minimize cytokine release syndrome while maintaining anti-tumor cytolytic activity and permitting intermittent dosing through a longer half-life. At the ASH meeting in December, we presented encouraging preclinical data demonstrating the enhancement of antitumor activity with MGD024 in combination with cytarabine and venetoclax, two standard of care agents used to treat patients with AML. We announced in November the submission of the IND application for MGD024, and we expect to begin to enroll patients with relapsed or refractory hematologic malignancies in a Phase I dose escalation study pending IND clearance by the FDA. In a single study evaluating flotetuzumab, our first-generation continuous infusion CD123 x CD3 DART molecule in AML patients who are refractory to induction therapy, the interim efficacy analysis threshold was met with manageable safety.

Nonetheless, we recently made the decision to discontinue the flotetuzumab to prioritize MGD024, which we believe may have a superior profile. Next, I will provide an update of our product candidates being developed by our collaboration partners for which we retain certain economic rights. Our second investigational ADC, IMGC0936 which targets ADAM9, a cell surface protein overexpressed in several solid tumor types, is being advanced under a co-development agreement with ImmunoGen. Under our 50-50 collaboration, ImmunoGen is leading clinical development, and they have indicated that they anticipate disclosing initial data from a Phase I study in multiple solid tumor types in 2022.

Teplizumab is an anti-CD3 monoclonal antibody that was acquired from us by Prevention Bio in 2018. Prevention is developing teplizumab for the treatment of type 1 diabetes. In July 2021, the FDA issued a complete response letter for teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals. Earlier this week, Prevention announced that they had resubmitted the BLA for teplizumab for the same indication.

The BLA resubmission followed Prevention's Type B meeting with the FDA earlier this year. Last, I will provide an update on margetuximab. As a reminder, Margenza was launched in the U.S. in March 2021 in coordination with our commercial partner, EVERSANA.

Margenza is approved in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. We continue to believe patients may benefit from Margenza as another marketed metastatic breast cancer therapy option. As reported, net sales were $12.3 million for Margenza in 2021. Given the competitive realities that have taken place in the HER2-positive breast cancer market, including multiple new approvals, we continue to have modest expectations for Margenza sales.

In terms of our margetuximab partner in Greater China, Zai Lab recently informed us that they have decided to discontinue enrollment of Module B of the MAHOGANY study based on their review of both the clinical data and the changing treatment landscape. Recall, in November 2021, we announced our decision to discontinue enrollment of Module A of the MAHOGANY study. With regard to Zai's effort in breast cancer, they announced last month that the China NMPA had accepted the NDA for margetuximab in combination with chemotherapy for certain patients with breast cancer. Finally, we look forward to continuing to build momentum and advancing our pipeline of innovative product candidates and sharing our progress with you throughout 2022.

We would now be happy to open the call for questions. Operator?

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Jonathan Chang with SVB Leerink. Your line is open.

Unknown speaker -- SVB Leerink -- Analyst

Hi guys. This is Scott Frusheid on for Jonathan. Just wanted to follow up on what you mentioned on MGC018 and the dosing strategy. Is there any color you can provide there? Like are these lower doses or schedules already being evaluated or something that needs to be done? And also, how does this factor into the regulatory strategy?

Scott Koenig -- President and Chief Executive Officer

Thanks very much for the question. After we discussed the results of our data at ESMO and continued to follow the patients, both in prostate cancer, as well as the other indications, we did an evaluation of the response rate side effect profile and various pharmacokinetics, both looking at the area under the curve, as well as Cmax associated with both responses, as well as side effect profiles. From that we derived an evaluation of what modifications we could do with the dosing to maximize the therapeutic response and to minimize the side effect profile. In particular, we were interested in the hand-foot syndrome, where while we saw most of those patients had grade 1/2 side effects, we wanted to further mitigate that side effect given the bothersome nature of that effect.

We've incorporated that in a plan going forward and have included that in a briefing document to the FDA. We will be discussing that plan going forward at that meeting. And after we have feedback, we will provide further insights on how the modification of dose, both initial dose and increasing the time between doses, might be implemented.

Unknown speaker -- SVB Leerink -- Analyst

Got it. Thank you so much, that's super helpful. And then if I can just squeeze in one on the combination strategy with lorigerlimab, I guess what do you see as the benefits of that approach versus pursuing a combo with something like a retifanlimab or an approved checkpoint inhibitor?

Scott Koenig -- President and Chief Executive Officer

First of all, thank you very much for that question. And as we did our analysis of combining MGC018, the ADC with anti-PD-1s including retifanlimab, or alternatively with a combination of our bispecific checkpoint molecules, we saw additional benefit in this particular case of adding the anti-PD-1 and the CTLA-4 blockade. I should refresh your memory that Bristol-Myers had conducted a study of looking at combinations of Ipi/Nivo in the setting of metastatic prostate cancer. And although they did not meet their objective endpoints for that study, there was some evidence that the combination of blockade of those two molecules could provide some benefit to patients with metastatic prostate cancer.

Given that, and as you know, we are currently doing a monotherapy study, expansion study with lorigerlimab currently right now. As we discussed in this particular call, while very anecdotal, a single patient, as you recall in our dose escalation study, we highlighted one of the patients who achieved a CR and today provided follow-up on that patient, where more than a year after stopping therapy is still in CR with a normal PSA. So we think that mechanistically, there may be additional benefits beyond just the anti-PD-1 blocker to incorporate something that blocks a CTLA-4 axis as well.

Unknown speaker -- SVB Leerink -- Analyst

Got it. Thank you so much.

Scott Koenig -- President and Chief Executive Officer

Operator, can we have the next question, please.

Operator

Our next question comes from Kaveri Pohlman with BTIG. Your line is open.

Kaveri Pohlman -- BTIG -- Analyst

Good afternoon. Thanks for taking my question. For enoblituzumab, does lawful CD16 expression play any role in its efficacy? And any thoughts on combining this with cytokines like IL-15 or maybe NK cell therapies?

Scott Koenig -- President and Chief Executive Officer

Thank you very much for that question, Kaveri. So clearly, enoblituzumab was designed to enhance binding to CD16 with a reduced binding to CD32B like we have characterized for Margenza in our approved product. We have observed that the Fc modification we've incorporated in enoblituzumab by engaging CD16 on various immune cells drives over expression of gamma-interferon associated genes. And this results as a consequence in upregulation of various cytokines beyond gamma-interferon, but also upregulation of various checkpoint molecules.

With regard to the use of cytokines in addition, that certainly could be explored. And in addition, there has been interest of combining enoblituzumab with various NK cells, both in vivo and ex vivo in other settings, and we are having certain discussions with other parties regarding that possibility. So thank you very much for the question, Kaveri.

Kaveri Pohlman -- BTIG -- Analyst

That's helpful, thank you. And for tebotelimab, just curious to know your plans for DLBCL. And generally, I just wanted to get your thoughts on role of PD-1 for this tumor type because there aren't a lot of checkpoint inhibitors in this space.

Scott Koenig -- President and Chief Executive Officer

Yes. Thanks again for that question. And as you know quite well, we had very encouraging early data in very late-stage patients with DLBCL, including those who had received various cell therapies. And as a result, we are exploring the possibility of developing this in a DLBCL line of therapy as well as in solid tumors.

As noted today, we should be able to provide updates on the next steps for new trials in potentially the hematologic and solid tumor indications in the second half of this year. With regard to the PD-1, you are absolutely correct, they have not, the blockers have not been particularly effective in the DLBCL treatment. I think this is an opportunity by blockading multiple pathways that are involved in exhaustion of cells, one might get an additional beneficial effect in various lymphomas. And so that's some of the rationale of why we're looking at this not only in DLBCL, but combinations of such in solid tumors as well.

Kaveri Pohlman -- BTIG -- Analyst

Appreciate it.

Operator

Our next question comes from Etzer Darout with BMO Capital Markets. Your line is open.

Etzer Darout -- BMO Capital Markets -- Analyst

Great. Thanks for taking the question The first one for me on the PD-1 CTLA-4 study with MGC018. Just wondered if you had an opportunity to look at that combination preclinically from a tolerability standpoint. And given sort of I think the efficacy argument is clear, just wanted to know if you had the chance to kind of look at that from a tolerability standpoint.

And then the second question, unrelated, but any meaningful impact of the flotetuzumab discontinuation on R&D spend in 2022? Thank you.

Scott Koenig -- President and Chief Executive Officer

Etzer, thank you so much for the questions. And certainly, as we considered the opportunities of combining a checkpoint with MGC018, one of the things paramount in our view was in addition to driving better efficacy was understanding the potential for a safety signal beyond that what we have seen to date. From what we are observing, both in terms of our clinical experiences with PD-1 CTLA-4 lorigerlimab as monotherapy as well as the monotherapy we're giving for MGC018, we see very modest opportunities for the additive or worsening of side effect profiles based on side effects seen to date. However, one never can predict that one might appear in a clinical trial.

In the way we are designing this trial, and we'll get more into this very shortly once the trial gets started, we have fixed the dose of lorigerlimab at the current 6 mg per kg but starting at a lower dose of the MGC018 and then we'll dose escalate in a 3 + 3 design for that study to mitigate any unexpected side effect profiles for the drug. But again, right now, we're hoping that that goes smoothly and we expect that study to get started in the next few weeks. With regard to flotetuzumab, we do think that we will get some advantage in terms of reduction of R&D spend. I can't comment on the specifics right now.

We're obviously just giving, providing that information to investigators. Patients are still on the study right now and we'll continue some spend in the near term, but we do expect some savings as a result of discontinuing that trial.

Etzer Darout -- BMO Capital Markets -- Analyst

Great. Thank you and thank you for the update today.

Operator

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

Yigal Nochomovitz -- Citi -- Analyst

Hi. This is Asha Babaric on for Yigal. Thanks for taking my questions. Can you comment on what drove the decision to discontinue flotetuzumab? Was there something in the interim analysis that may have contributed? Or was it just the emerging profile for MGD024?

Scott Koenig -- President and Chief Executive Officer

Thank you very much for the question. And as we pointed out, we believe, as you've stated, the superior profile of MGD024 with regard to flotetuzumab for the long-term treatment of patients with hematologic malignancies. Certain comments I've been following is that, number one, the flotetuzumab molecule as you know has given us continuous infusion, requires initial hospitalization of patients during the first two weeks before they can go to an outpatient setting. With the design of an Fc incorporated molecule plus with the next-generation version of the CD3 component in this molecule, we believe that this drug can be given more easily, intermittently, on an outpatient basis technically.

But as important, we expect to have a significant reduction in cytokine release syndrome as a result of treatment. On top of that, as you know, when we started out the study a couple of years ago, the treatment regimens for AML were established with some new molecules, but that landscape is constantly changing. And since we are now conducting a single-arm study, we think that there may be additional risk given the changing landscape with the final readout here, which will require obviously significant more investment in this current study. But on top of that, if we want to file for European approval, that will certainly require a controlled study.

So all in all, given the superior profile of this molecule, plus as we pointed out in the announcement today, based on data that we have shown at the recent ASH meeting that combinations of MGD024 plus some standard of care can expand the use of this in early lines of therapy for AML potentially, plus expanding beyond to other CD123 tumors, we think that our decision was the right one now given these various aspects, as I described to you.

Yigal Nochomovitz -- Citi -- Analyst

OK. Thank you. If I could sneak in one more. Could you provide any color as to why Zai Lab chose to discontinue development with tebotelimab? Curious if you can share any additional details.

Scott Koenig -- President and Chief Executive Officer

I can't at this point in that regard, but let me emphasize they're not discontinuing it. They're discontinuing on the current indications that they were testing, so they're not enrolling any patients in that. They are considering additional indications and may, in the future, as we decide to advance this into additional studies, to participate in such studies. It's still up to them.

But as of now, it's just that they will not be enrolling any additional patients in the current indications that they've pursued to date.

Yigal Nochomovitz -- Citi -- Analyst

OK. Thank you very much.

Operator

Our next question comes from Charles Zhu with Guggenheim. Your line is open.

Charles Zhu -- Guggenheim Partners -- Analyst

Hi, everybody. Thanks for taking the question. I may have missed this one earlier, but it sounds like your melanoma TNBC and NSLC cohorts are fully enrolled for MGC018. How are you evaluating go/no-go decisions for these indications as data mature? And what are some of the potential benchmarks on which you would be able to make those decisions? And also, how should we think about timelines toward those kinds of points?

Scott Koenig -- President and Chief Executive Officer

Charles, thanks very much for the question. As you recall, and as I've stated on previous calls, these cohorts beyond the prostate are much smaller. We've enrolled, for the ones that have completely enrolled, between 16 to 20 patients in those cohorts and we're continuing to follow these patients. As I have stated before, given the size of these cohorts, it's still too early to make a decision going forward on which ones we will prioritize for additional say Phase II or registrational-directed studies.

What we expect to do is obviously look at what the standard of care is in these late-line patients and come to both an assessment of the responsiveness. But in addition, as I pointed out for the plans for prostate cancer, we want to also have additional experience with the slightly modified dose with additional patients for the specific cohorts we want to further test. And so given all this together, we'd like to see the data mature a little more. That will allow us to then make some decisions on which one of these cohorts we want to prioritize.

And then we will be able to provide some guidance in the second half of this year with regard to that and also after we get the feedback from the FDA. So that's sort of the plans at this moment.

Charles Zhu -- Guggenheim Partners -- Analyst

Got it. Makes sense. And thanks for that color. If I may just squeeze in one more on MGC018.

I also kind of want to gauge perhaps your reactions to Daiichi's DS-7300 data coming out of the ASCO GU and how or if at all that weighs in on your thinking for MGC018, especially when it comes to positioning. Thanks.

Scott Koenig -- President and Chief Executive Officer

Well, thank you, Charles, again. Again, as you know, we feel that we have the right profile to move forward with MGC018 in late-stage prostate cancer. It is also nice to see that an organization like Daiichi with expertise in ADCs are interested in pursuing that in this indication. As you know, the toxins that are incorporated in their molecule 7300 as well as ours target DNA, but are working by different mechanisms.

I would say that I'm very encouraged by the data in the following sense is that the data we've reported in terms of RECIST criteria at ESMO, we're quite comparable to what they reported at the recent ASCO GU meeting. The PSA50 reductions that we have reported seem to be better than what the data that they've reported to date. And so overall, I would say we're seeing both companies' very encouraging data in the treatment of prostate cancer, which provides further validation for target B7-H3 with this type of mechanism. I would say we are also in a potentially better position now that we're going to start this combination study with our checkpoint molecules without knowledge that Daiichi has a similar plan in place.

So I think all in all, I think we will try to advance this as quickly as possible for the benefit of patients.

Charles Zhu -- Guggenheim Partners -- Analyst

Sounds great. thanks for taking the questions.

Operator

Our next question comes from Jon Miller with Evercore. Your line is open.

Jon Miller -- Evercore ISI -- Analyst

Hi guys, thanks for taking the questions. I'd like to start with maybe the ADAM9, which I know is being led by ImmunoGen. But maybe could you give us some color on what we ought to expect from the data release this year in terms of just tumor types, patient numbers, that sort of thing? And maybe your level of conviction on that program relative to your other internal early stage candidates.

Scott Koenig -- President and Chief Executive Officer

Thanks, Jon. Good to hear from you. With regard to ADAM9, correct, ImmunoGen is running those clinical trials. They are still in dose finding, doing some additional expansions.

That continues. They have not selected a dose for expansion into other tumor types as of yet. We expect that should occur in the near term. Consistent with the guidance that they have provided us, they do expect to have that dose and be able to announce late this year plans for expansion into specific tumor types.

The specific types have not been detailed publicly, so I'll leave it to them and wait until then. With regard to where this fits into our portfolio, again, we're very encouraged by the preclinical data. Until we see the specific dose that's selected and further expansion, it's just too early to comment on that in terms of the prospect overall. As you know, except for MGDO24, we have a lot more data on many of our other programs and have obviously much more encouraged about the prospects for other things in our portfolio going forward at this time.

Jon Miller -- Evercore ISI -- Analyst

OK. And then maybe just to follow up on some of the B7-H3 questions that have been asked, I guess given that we know that the dose is going to come down from 3 mgs a kg already, how should we expect to interpret the expansion cohort data when that does come out?

Scott Koenig -- President and Chief Executive Officer

In that regard, I will emphasize that the doses are more of a tweaking of a dose as planned right now with regard to slight reductions and the time interval. But remember, as I said, the way we evaluated this was actually taking real data from patients, understanding what dose modifications occurred in these patients to achieve the responsiveness or side effect profile. In fact, we do have the overall total dose that these patients received to make this decision. But surely, we would obviously want additional confidence by the prospective use of this drug.

But right now, I think this is as good as we can do to move forward in the study.

Jon Miller -- Evercore ISI -- Analyst

Thanks very much, Scott.

Scott Koenig -- President and Chief Executive Officer

Thanks, Jon.

Operator

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

Steve Willey -- Stifel Financial Corp. -- Analyst

Yeah. Thanks for taking the question. Maybe just to clarify then, are you prospectively treating patients at this revised lower less frequent dose of MGC018? Or have you just I guess layered this dosing regimen into existing patients that still remain untreated?

Scott Koenig -- President and Chief Executive Officer

Thanks, Steve. We have not started any additional expansions with this proposed modified dose. This will be part of our discussion with the FDA coming up this quarter. And then what our plan would be is to incorporate that alteration in the design of the registration-directed study if everything else follows through from our FDA discussion.

And then also, as I said earlier, incorporate that dosing regimen in additional expansion cohorts for indications that we want to pursue beyond prostate cancer.

Steve Willey -- Stifel Financial Corp. -- Analyst

OK. So, I guess you don't feel the need then to do any bridging work and you'd be comfortable going right into a registrational design in the absence of clinical experience at this dose?

Scott Koenig -- President and Chief Executive Officer

Well, rather than comment on that, let's wait until we have the FDA guidance and feedback. And then we will come back to you with regard to what we will do next for the various aspects of the prostate, as well as the other indications. We'd like to have that regulatory insight before we get more definitive about the specific design of that prostate study.

Steve Willey -- Stifel Financial Corp. -- Analyst

OK. And then maybe just a question I guess for you and/or Jim, but just on the cash runway guidance, I know that 018 is kind of excluded from that in terms of the pursuit of a later-stage study. Is that just a function of needing that regulatory clarity? Or is there still some uncertainty with respect to whether or not the tumor type is going to be prostate and/or how big and what that trial is going to look like?

Scott Koenig -- President and Chief Executive Officer

Jim, did you want to take that?

Jim Karrels -- Chief Financial Officer

No. I mean the intention is -- thanks for the question. We do plan to move ahead. Obviously, we're waiting to have the dialogue with FDA this quarter.

We've not completely priced out what the trial might look like. We'd like to have a better sense of that before we know what the nut is that we need to find to make this happen. However, we do have adequate cash to launch the study. We just want to be in a position where we can fully fund the entire study.

Obviously, BD, we've had a very active BD history at the company, bringing in north of $700 million since our IPO in 2013. We intend to continue to advance various BD dialogue with various parties moving forward. And obviously, where stock is trading today, the whole market is off, it's an option that we don't like to look at, but one that we would if we had to.

Steve Willey -- Stifel Financial Corp. -- Analyst

Understood. That's very helpful. Thanks for taking the question.

Jim Karrels -- Chief Financial Officer

Sure.

Operator

Our next question comes from Silvan Tuerkcan with JMP Securities. Your line is open.

Silvan Tuerkcan -- JMP Securities -- Analyst

Hello, good afternoon. Thanks for taking the question. Congrats on all of the progress. My question is, and I might have missed this, is the goal of the MGC018 dosing regimen modification to reduce the side effects? And if so, which ones specifically are you trying to ameliorate? Or is it to keep the dose in the patient over the course of treatment as high as possible? Thank you.

Scott Koenig -- President and Chief Executive Officer

Silvan, I think -- thanks for the question, and I would say that we're trying to probably accomplish both in that we'd like to mitigate some side effects. As I pointed out today, the one we feel that was most problematic based on feedback from the patients was the hand-foot syndrome and like to decrease the incidence severity of that. We feel that things like the hematologic side effects that we were observing such as the neutropenia were easily handled by holding dose and supplementary growth factors like GCSF. And again, also increasing the time interval between dosing should also provide some value there.

Ultimately, as you point out on the second comment, is that by the reduction and reducing side effects, we think that we can hopefully treat patients for a longer period of time and offer obviously a greater benefit to those patients as a result. So that's the objective going forward.

Silvan Tuerkcan -- JMP Securities -- Analyst

Great. Thank you. And so at the upcoming update, will we get an idea of what the average dose was per patient rather than I guess the label dose that you're administering?

Scott Koenig -- President and Chief Executive Officer

Yeah. I think at a future discussion, we will be able to provide some guidance in terms of the fully administered dose to the patients which we think would be most valuable for getting the best effects. But again, we will wait until after we have a discussion with the regulators.

Silvan Tuerkcan -- JMP Securities -- Analyst

Great. Thank you so much for taking my question.

Operator

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

Peter Lawson -- Barclays -- Analyst

Hey. Thanks for taking the question. Just on the FDA meeting in Q1, just -- will you communicate that to us, the outcome around the dosing? And then will the combination with your PD-L1 CTLA-4, will that start on the basis of that discussion with the FDA? Or will that start sooner? Just kind of help us through the timing and communication in 1Q.

Scott Koenig -- President and Chief Executive Officer

Yes. So, with regard to the meeting, as you know, we're approaching March. The quarter ends at the end of March, so we will have the FDA meeting sometime within the next 4 weeks. The outcome of that meeting has no effect on the start of the combination study.

Actually, patients are in screening right now and it is likely that we will have first patient dosed potentially even before that meeting. So that will start. With regard to communication about that, obviously we'll have to see what the written comments come back. I think more or less, the likelihood is we'll be able to communicate this sometime in the second quarter.

Peter Lawson -- Barclays -- Analyst

Great. Thank you. And the data for B7-H3 in the second half, is that going to be with the new dosing? That's the idea versus existing patients?

Scott Koenig -- President and Chief Executive Officer

No. I think, Peter, the point was is we wanted the data to continue to mature on the patients that are on the 3 mg per kg q3 regimen and obviously with the modifications that occur. So whatever update we provide them, irrespective of that, for the particular indications we can plan to continue, we would then apply new dosing and that wouldn't start until the second half of the year.

Peter Lawson -- Barclays -- Analyst

Great. Thank you. Thank you so much.

Operator

[Operator instructions] Our next question comes from David Dai with SMBC. Your line is open.

David Dai -- SMBC Nikko Securities -- Analyst

Hey. Thanks for taking my questions. Several questions on MGC018. Regarding the dose expansion data in prostate cancer in the second half of this year, could you just set the data expectation? And what would be the clinical benchmark we should be expecting? And then also on MGC018 in prostate cancer, could you also share with us some of your thoughts on biomarker strategies to further identify responders in prostate cancer?

Scott Koenig -- President and Chief Executive Officer

So with -- Thanks, David. So with regard to dose expansion, as you know, these are very late-line castration-resistant prostate patients. The patient line of therapy for the expansion cohorts were third and fourth-line therapy. As you know, historically these patients had, based on progression, usually had several months until they progressed.

It obviously varied depending on which study they had been previously looked at. We are clearly looking at those markers for advancing beyond what the historical data has. And we have reviewed our data with experts in the field and feel that we have a profile, even with the limited 40 patients, that could provide significant benefits to these patients going forward. Of course, as I pointed out earlier, we are looking to even further enhance the effect here by dosing modifications.

So that will be certainly part of the analysis. And clearly, we will continue to look at different populations of patients. To date, we have not specifically identified any gene markers per se that would predict a more favorable outcome of one patient versus another based on MGC018. But we will continue to look at that analysis and also continue to look at patients who have various types of disease.

Those that have visceral disease that are limited to various organs or lymph nodes versus those with bony disease. So again, at this point, while we've treated approximately 50 patients with this dose, it's still a limited number of patients. The other thing we are keeping an eye on is B7-H3 expression. And to date, that doesn't seem to portend the predictions for those patients who respond or not.

We saw patients in general had very high levels by H-scores of B7-H3, but we did see the occasional patients with low H-scores that also had evidence of activity. At this point, at least for prostate cancer, that does not seem to be the predictable marker going forward.

David Dai -- SMBC Nikko Securities -- Analyst

Got it. Very helpful. Thank you.

Operator

There are no further questions. I'd like to turn the call back over to Dr. Scott Koenig for any closing remarks.

Scott Koenig -- President and Chief Executive Officer

I want to thank everybody for participating in the call today. Obviously, we have a lot of exciting data that will be coming up during the course of the year and look forward to sharing with you at a future conference. Thank you.

Operator

[Operator signoff]

Duration: 55 minutes

Call participants:

Chris James -- Vice President of Investor Relations and Corporate Communications

Scott Koenig -- President and Chief Executive Officer

Jim Karrels -- Chief Financial Officer

Unknown speaker -- SVB Leerink -- Analyst

Kaveri Pohlman -- BTIG -- Analyst

Etzer Darout -- BMO Capital Markets -- Analyst

Yigal Nochomovitz -- Citi -- Analyst

Charles Zhu -- Guggenheim Partners -- Analyst

Jon Miller -- Evercore ISI -- Analyst

Steve Willey -- Stifel Financial Corp. -- Analyst

Silvan Tuerkcan -- JMP Securities -- Analyst

Peter Lawson -- Barclays -- Analyst

David Dai -- SMBC Nikko Securities -- Analyst

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