MGNX - NASDAQ
MacroGenics, Inc.
MGNX·NASDAQ
$4.34
+7.3%HealthcareBiotechnology
MacroGenics, Inc., a biopharmaceutical company, develops and commercializes antibody-based therapeutics to treat cancer in the United States. Its approved product is MARGENZA (margetuximab-cmkb), a human epidermal growth factor receptor 2 (HER2) receptor antagonist indicated, 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. The company's pipeline of immuno-oncology product candidates includes MGC018, an antibody drug conjugate (ADC), which targets solid tumors expressing B7-H3; Enoblituzumab, a monoclonal antibody that targets B7-H3; and MGD024, an investigational bispecific CD123 × CD3 DART molecule to minimize cytokine-release syndrome for patients with hematologic malignancies. It also develops Lorigerlimab, a monoclonal antibody that targets the immune checkpoints PD-1 and cytotoxic T-lymphocyte-associated protein 4; Tebotelimab, an investigational tetravalent DART molecule for PD-1 and lymphocyte-activation gene 3; Retifanlimab, an investigational monoclonal antibody targeting metastatic squamous cell carcinoma of the anal canal and metastatic non-small cell lung cancer; and IMGC936, an ADC that targets ADAM9, a cell surface protein over-expressed in various solid tumor types. Further, the company develops MGD014 and MGD020, a DART molecule to target the envelope protein of human immunodeficiency virus infected cells and CD3 on T cells; Teplizumab for the treatment of type 1 diabetes; and PRV-3279, a CD32B × CD79B DART molecule for the treatment of autoimmune indications. It has collaborations with Incyte Corporation; Zai Lab Limited; I-Mab Biopharma; and Janssen Biotech, Inc. The company was incorporated in 2000 and is headquartered in Rockville, Maryland.
At a Glance
Live SnapshotMarket Cap$276.18M
EPS-1.1800
P/E Ratio-3.68
Earnings Date08/11/2026
Earnings Call Transcript
MGNX • 2023 • Q1
Operator
Good afternoon. We will begin the MacroGenics 2023 First Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a listen only mode at the moment, and we will conduct the question-and-answer session at the conclusion of the call. At this point, I will turn the call over to Jim Karrels, Vice President, Chief Financial Officer of MacroGenics. Please go ahead.
Jim Karrels
Thank you, operator. Good afternoon. And welcome to MacroGenics conference call to discuss our first quarter 2023 financial and operational results. For anyone who's not had the chance to review these results, we issued a press release this afternoon outlining today's announcement, which is available under the Investors tab on our Web site at macrogenics.com. You may also listen to this conference call via webcast on our Web site, 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 the turn call over to Dr. Scott Koenig, President and CEO of MacroGenics.
Scott Koenig
Thank you, Jim. I'd like to welcome everyone participating via conference call on webcast today. This afternoon, I will provide key updates on our clinical programs. But before I do so, let me first turn the call back to Jim, who will review our financial results.
Jim Karrels
Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended March 31, 2023, which highlight our financial position. As described in a release this afternoon, MacroGenics's total revenue consisting primarily of revenue from collaborative agreements was $24.5 million for the quarter ended March 31, 2023 compared to total revenue of $11.1 million for the quarter ended March 31, 2022. Revenue for the quarter ended March 31, 2023 included recognition of the $15 million milestone received from Insight for the US FDA approval of
Scott Koenig
Thank you, Jim. The US FDA recently approved Insight’s
Operator
[Operator Instructions] Our first question comes from the line of Jonathan Chang with SVB Securities.
Jonathan Chang
First question on cash position. How are you guys thinking about your cash position now following the non-dilutive deals you've completed over the past nine months? At this point, do you feel you have enough to execute on your plans until the next value inflection point, and are you still actively seeking opportunities to continue bolstering your balance sheet?
Scott Koenig
So we're very pleased, obviously, with our cash position. And as stated on the call, this will take us through 2025 and early into early 2026. And yes, this has all the opportunities to execute on the plan that we have outlined and the programs that we discussed today and potentially looking at additional opportunities, especially in prostate cancer and beyond in solid tumors. Of course, as you know, we have been always very active in business development activities and have continuous ongoing discussions, both in terms of our preclinical and clinical pipelines and we anticipate in the future that further revenues could be accrued via successful execution of those business deals.
Jonathan Chang
And second question should we expecting clinical data from the vobra duo plus lorigerlimab combo study this year and if so, could you help set expectations ahead of that update?
Scott Koenig
So, as I had mentioned on earlier calls, we've been moving forward with identifying the proper dosing for individual components in that combination and obviously open up the study to six different tumor indications to participate in the study. We have not yet settled on the specific dose to move forward in expansion studies and would anticipate once that is achieved, we would move forward in one or two expansion studies of particular indications, which I expect would probably include prostate in one and possibly another. At this point, given where we are at this year, it is less likely that we will have data by the end of this year and more likely in the first part of 2024.
Operator
Our next question comes on the line of Charles
Unidentified Analyst
This is Edward on for Charles
Scott Koenig
So if you look the historical data of this docetaxel control arm in patients who have progressed on ARAT agents, rPFS has been consistent across the board with KEYNOTE-921 preside Phase 3b and TRIDENT-3 of 8.3 months, and median overall survival of 19 and 18.9 respectively in 921 and TRIDENT-3. So obviously, we would like to exceed those, certainly, meet them but certainly exceed them with the current study and obviously, longer is better in this case.
Unidentified Analyst
And then maybe just as a follow up. So what are your -- how are you seeing the sort of the competitive landscape shaping up in the chemo naive setting again with -- so PSMA 4, we know it hit that thing. So just kind of how you're thinking about it there and how you see the combo fitting in?
Scott Koenig
Well, I mean, clearly, the historical data on checkpoints in -- first of all, in prostate in general or prostate, certainly, in that line of setting, has been dismal. If you look at all the studies that had been conducted with pembrolizumab, including KEYLYNK-010, KEYNOTE-921, 991 and 641, they all did not meet the expected outcomes, even though those are in different lines of therapy and different combinations. And as you know, from the recent data on CheckMate 650 with a combination of nivolumab and ipilimumab, the responses at nivolumab 3 Ipi 1 were not good with 9.3% overall response rate in the PSA-50 of 13.8%. So we think that we have an unusual molecule now as a bispecific to introduce a checkpoint molecule on top of standard therapy that could really change the course of this disease.
Operator
Our next question comes from the line of with Yigal Nochomovitz with Citi.
Ash Mubarak
This is Ash Mubarak on for Yigal. Maybe just asking another one on lorigerlimab. I think in the past you've alluded to the idea of lowering lorigerlimab dose as a way to better manage AEs, but still have full target engagement. And I guess within that context, how are you thinking about dosing for the docetaxel cohort, combo cohort you're planning on starting up very shortly, are there any specific comments you can make on lorigerlimab dose in that combo?
Scott Koenig
And as you've noted, we have a very robust data set from our dose escalation and expansion studies where in our dose escalation we went up to 10 mgs/kg without dose limiting toxicity. Designed the study on expansion at 6 mgs/kg on a Q3 weekly basis in over -- in 127 patients, which we presented recently at the ASCO-GU Meeting. As we have pointed out previously, we get full occupancy of PD-1 receptor at 1 mg/kg or higher and have historically shown in a dose escalation study of lorligerlimab, objective response is a 3 mgs/kg and also at 6 mgs/kg. And we were seeing biomarker data of expansion, both CD4s and CD8s at 1 mg/kg or higher, as well as the induction of ICOS in CD4 positive cells in similar ranges. So we have a very wide window of opportunity to adjust treatment doses based on either combinations of drugs that may add on additional toxicities. So back to your initial question, we are starting at 6 mgs/kg on a Q3 weekly basis. We have the opportunity to make adjustments and we're also looking at potential future studies where we would study more than the 6 mgs/kg dose in prostate cancer or potentially other tumors as well to get the best safety and efficacy profile for the drugs.
Ash Mubarak
And if I could ask one more on vobra duo. I guess, we're still waiting for the TAMARACK data before ultimately you make any ultimate decisions. But do you have any updated thoughts on how you're thinking about vobra duo as a monotherapy within prostate cancer? I think, maybe once we have clarity on the treatment paradigm maybe within the coming years, have you -- is there a possibility you would reconsider a pivotal trial with just the monotherapy?
Scott Koenig
Absolutely. I mean, I think the current plan right now was just taking the realization of the time to enrollment where we made the amendments to the protocol of TAMARACK to remove the control group. The idea of this study right now is to execute as quickly as possible, so we were able to decide both on the safety and the activity what is the appropriate dose either the 2 mgs/kg Q4 or the 2.7 mgs/kg Q4. At that point, we would go into -- our plan would be, if we achieve the goals that we set for that study, to go into a single arm study moving forward in Phase 3. And clearly, obviously, we're exploring the opportunity of combining it with other active agents given as was discussed earlier, the combination with lorigerlimab but we're also looking at other combinations potentially in the future.
Operator
Our next question comes on the line of Kaveri Pohlman with BTIG.
Kaveri Pohlman
Thanks for the updates and congrats on the approval of
Scott Koenig
And obviously this is designed as a controlled study, 2:1. But given that this is only a 150 patients, we do not expect that this study alone would be sufficient to meet the regulatory requirements for an approval and would then base the successful study to expand that into a full Phase 3 study. Obviously, great overarching data trumps all. But right now, we’d only intend that this study would serve as a trial for approval.
Kaveri Pohlman
And my second question is also on lorigerlimab. So based on KEYNOTE-199 and CheckMate 650 trial results, it seems like PD-1, CTLA-4 combination is more active than PD-1 alone. Any thoughts on going into MSI high cRPC prostate cancer as monotherapy, is it commercially attractive? And similarly, does the combination of PARP inhibitors make sense, because CheckMate 650 trial showed better efficacy in HRD positive patients?
Scott Koenig
So answering your question, obviously, responding -- and I agree with you based on the 199 study and the 650 study, and the data that we have shown at ASCO-GU in terms of a 26% objective response rate and over 90% PSA50, and all responding patients had actually greater than PSA90 responses, that we're in a very good position with this molecule to move it forward. With regard to MSI-high, we have not set up a trial that's something we could consider. We certainly are looking at additional combinations. And given that the treatment regimens for prostate cancer are revolving with the use of PARP inhibitors even in early line therapy without DNA repair defects, we would consider additional combination studies of the future, but have nothing right now that would incorporate this in our current studies.
Kaveri Pohlman
And maybe a last one on the ADC, since we’re waiting for the updated data. But do you plan to show any mature data from the Phase 1 trial? I believe from the last readout in 2021, the sample size will be since -- for the patients who remained on treatment.
Scott Koenig
As we have noted on previous calls, we've had objective response rates in all the tumor types that we looked at and had historically considered actually studying additional patients after prostate cancer in melanoma, because at that time we did not have the cash runway to justify moving forward with that, we stopped that planned study. What I have said in previous calls is that we will provide data at times when we start or plan to initiate studies in additional indications and not until then.
Kaveri Pohlman
Got it, that’s helpful. Thanks for taking my questions.
Scott Koenig
I would also like -- let me just also add a comment from the earlier call that when I was discussing the treatment in the lorigerlimab study that I was talking about a single agent not a single arm study. So just to make sure that people were not confused by my statement.
Operator
Our next question comes on the line of Stephen Willey with Stifel.
Stephen Willey
So I know you've done a couple of licensing deals here just to gain access to some novel linker-payload technology. And I guess just wondering how that preclinical work is progressing, whether you're specifically focused on [Topo 1] derivatives, which is I guess kind of seemingly where the entire landscape is tilting right now, and whether the added balance sheet strength now allows you to accelerate some of those development efforts going forward?
Scott Koenig
As you know, we've been very high on the opportunities that have been afforded us by these additional licensing deals with Synaffix, originally having access to three linker toxin combinations for specific targets that we expanded for four additional targets, so [seven in all]. The preclinical development is going exceptionally well. As we've pointed out on an earlier call, we intend to file an IND in the fourth quarter this year with the first of these new agents. And at this point, it's all forward on the next one. And you know, again, without getting precision here, we're trying to target for late ‘24 for the second one as we are building additional molecules going forward. You should be assured that many of these molecules will include a topoisomerase linker toxin the opportunity.
Operator
[Operator Instructions] Our next question comes from the line of Shay Simin with Barclays.
Shay Simin
This is Shay on for Peter Lawson. Maybe first, just quickly on the vobra duo and lorigerlimab combo. It sounds like you're still finding the right go forward dose here, maybe that is not till 2024. But could you give a little more color on what's built into there, is that the room to go dose escalate higher or is this more about finding the right balance from a safety perspective?
Scott Koenig
As noted before, we want to have both combinations that give the safety and activity that we think that can be achieved in both an additive or a potential synergistic way. And so we could envision that these could be both. In terms of, let's say, lorigerlimab, which we start at 6 mgs/kg, we didn't expect to go higher on lorigerlimab. So the opportunity was to keep that or going lower and the same story with vobra. As you know, we are exploring 2 and 2.7 in the current study. And given the potential here for synergy here on activity, there is also an opportunity that you may be able to even lower the doses from the historical use of this drug at 3 mgs/kg. And as you know, we started initially at 1 mg/kg in the first cohort going forward. So where we end up at this point we don't know and until we have that precision, we won't go forward into the expansion studies.
Shay Simin
And just a last quick question, considering the removal of the control arm for vobra duo and prostate. I guess, how are you thinking now about your registrational strategy moving forward?
Scott Koenig
As you know, this is a changing landscape where we sit right now with [indiscernible] coming on board recently, we want to see how far that use of that drug is. And in various lines of therapy, we want to see other combinations. It was brought up earlier on this call about the use of PARP inhibitors. So we are right now going to look at the landscape when we've completed and selected the doses for vobra going forward and we'll see what the appropriate control. One could envision a specific control or one of several that investigators get to choose from. But we're right not ready yet to make that decision.
Operator
Thank you. I would like to turn the conference back over to Jim Karrels for any further or closing remarks.
Scott Koenig
Thank you, operator. This is Scott Koenig. I want to thank everybody who participated in this call today. We appreciate and look forward to updating you on our future studies on the next call.
Transcript from May 9, 2023
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