IGM Biosciences Inc (IGMS) Q4 2019 Earnings Call Transcript

IGM Biosciences Inc (IGMS -3.89%)
Q4 2019 Earnings Call
Mar 26, 2020, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, everyone, and welcome to the IGM Biosciences fourth-quarter and full-year 2019 financial results. Today's call is being recorded. At this time, I would now like to turn the call over to Misbah Tahir, chief financial officer of IGM.

Misbah Tahir -- Chief Financial Officer

Thank you, operator. Welcome, and thank you to those of you joining us today to discuss IGM's fourth-quarter and full-year 2019 financial results. With me this afternoon to discuss the financial results and to provide a general corporate update, are Fred Schwarzer, chief executive officer; Bruce Keyt, chief scientific officer; and Dan Chen, chief medical officer. Before we begin, please note that we will be making forward-looking statements on this call including statements about IGM's plans, expectations and forecasts and about future events.

Actual results may differ materially as a result of various risks and uncertainties including those discussed in the company's most recent annual report on Form 10-K, as well as its other filings with the SEC. Any forward-looking statements represent IGM's views as of today, March 26, 2020 only, and the company disclaims any obligation to update these statements, except as required by law. Following this call, a replay will be available on the company's website www.igmbio.com. With that, I will now turn the call over to Fred.

Fred Schwarzer -- Chief Executive Officer

Thank you, Misbah. Good afternoon, everyone, and thank you for joining us on this call to discuss our fourth-quarter and full-year 2019 financial results. Obviously, the COVID-19 pandemic is at the forefront of everyone's thoughts and concerns at this time. We're very pleased and relieved to advise you that to date, none of our IGM employees have reported that they have been infected.

However, to reduce the risk that any such infection would spread among the IGM team, we have adopted a general work-from-home policy, pending further clarity. While none of us can accurately assess the medium and long-term impacts of the COVID-19 pandemic. As of now, we are hopeful that the impact on our current time lines will be modest. Of course, if the current level of restrictions and limitations were to be expanded or continued for several months, we expect that we might start to see a greater impact on our time line.

Fortunately, as Misbah will discuss, we are in a strong position from a cash reserve perspective. We have adequate cash to last us into 2022. And if the financial situation appears concerning later this year, we can take steps to extend that cash runway. Notwithstanding the overhang of COVID-19, we remain excited about the potential of our pipeline and we're eager to see the clinical results of the dose-escalation portion of Phase 1 clinical trial of IGM-2323, our CD20 x CD3 T-cell engaging antibody toward the end of this year.

We continue to hope that IGM-2323 will prove to be a best-in-class antibody for the treatment of resistant and refractory non-Hodgkin's lymphoma. Dan will shortly provide an update as to the current status of that clinical trial. We're also excited by the prospects for IGM-8444, our IgM DR5 agonist antibody, which we believe may have application in the treatment of a broad range of cancer types. As Bruce will discuss shortly, we currently remain on track to file an IND for IGM-8444 this year and our preclinical toxicity profile and therapeutic index appear to be very encouraging.

Finally, as Bruce will describe, we are excited about the prospects for IGM-7354, our targeted IL-15 immune cell-stimulating antibody. We expect to file an IND for this product candidate next year. So while these exciting product pipeline events are now coming at a relatively rapid pace for IGM, this progress has been made possible by a decade of dedicated, creative and inventive effort focused on the engineering and enhancement and manufacturing of IgM antibodies. As a reminder, IgM antibodies are one of the five classes of natural antibodies, and you all have lots of IgM antibodies in your body.

But IgM antibodies are the only antibody class with 10 binding units as compared with only two binding units for IgG antibodies. Nonetheless, all of the currently marketed antibody drugs are IgG based. We believe that the 10 binding units inherent in IgM antibodies enable them to bind more strongly to the cell surface targets relative to IgG antibodies. Also, our IGM team has developed a unique bispecific antibody format, which we believe may have certain safety and efficacy advantages in the treatment of cancer, when compared to IgG antibodies.

At this point, it's my pleasure to turn the call over to Dan, who will describe IGM-2323 and the current state of our clinical trial.

Dan Chen -- Chief Medical Officer

Thank you, Fred. So we're very happy to be in the clinic with our first high affinity, high avidity engineered IgM T-cell engager. And that, of course, is an IGM-2323. IGM-2323 is a CD20 x CD3 bispecific IgM antibody, designed for the treatment of patients with CD20 positive cancer, including non-Hodgkin's lymphoma.

CD20 is a protein commonly expressed on the surface of non-Hodgkin's lymphoma cells, as well as chronic lymphocytic leukemia cells and even multiple myeloma cells, albeit at low levels. CD3 is a protein expressed on the surface of T cells. In our preclinical studies, IGM-2323 strongly bound to CD20 positive cancer cells and demonstrated two distinct mechanisms to potently eliminate those cancer cells. These are T-cell dependent cytotoxicity and complement-dependent cytotoxicity.

This cell killing was even possible for cancer cells expressing very low levels of CD20. We also observed that the potent elimination of cancer cells by T cells with IGM-2323 occurred with very low levels of cytokine release, relative to comparable IgG-based CD20 x CD3 antibodies. In nonhuman primate studies with CD20 x CD3 IgM, we again observed very low levels of detectable cytokine release. And importantly, no observable safety findings despite the elimination of all detectable CD20 expressing cells in circulation and in tissue compartments.

So last October, we announced the initiation of our first-in-human Phase 1 clinical trial of IGM-2323 in relapsed and refractory B cell lymphoma patients. This trial is a multicenter, open-label trial intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell non-Hodgkin's lymphoma. IGM-2323 is being administered at a planned fixed-dose as part of a dose-escalation protocol. Our initial six clinical trial sites are now open, and they include City of Hope, Sarah Cannon, MD Anderson, Fred Hutch, HonorHealth and Dana-Farber.

We also hope to open additional U.S. and ex U.S. centers later this year in preparation for our Phase 1 expansion. We've been able to readily dose escalate IGM-2323 per our clinical trial protocol.

And we are currently recruiting to our 30-milligram fixed-dose, which happens to be the fourth dose cohort in Phase 1. Escalation has gone well to date and with no obvious signs of cytokine release syndrome. This is consistent with what we've observed with our CD20 x CD3 IgM in our nonhuman primate studies. We look forward to gaining further characterization of the clinical performance of IGM-2323 during dose escalation, as the data from the Phase 1 study is collected, analyzed and verified.

While we have not yet experienced a significant slowdown in our Phase 1 enrollment due to COVID-19, we do recognize that this is possible. That said, our goal is to begin dosing at the 100-milligram dose by the summer and complete dose escalation by the end of the year. We continue to target the presentation of initial safety and efficacy data from this clinical trial at a future meeting, such as the ASH 2020 Conference. At this point, I will turn the call over to Bruce, who will discuss IGM-8444 and IGM-7354.

Bruce Keyt -- Chief Scientific Officer

Thank you, Dan. IGM-8444 is an IgM antibody targeting Death Receptor No. 5 which is expressed on a broad range of solid tumors, as well as on leukemias and lymphomas. When DR5 receptors are bound on the surface of a cell, they act to send a commit suicide or apoptotic signal to the cell.

This intracellular apoptotic signaling requires efficient cross-linking of at least three DR5 receptors on any given cell at that location. Now IgM with its 10 binding sites, is an especially appropriate format for an antibody to induce productive cross-linking of DR5 receptors on cancer cells. In preclinical studies, our DR5 IgM antibodies demonstrated significantly enhanced apoptotic signaling compared to an IgG antibody with the same binding domains. That resulted in greater than 1,000-fold increased potency in killing cancer cells, and this has been seen with multiple cancer types.

In addition to the encouraging signs of preclinical efficacy, our current preclinical data for IGM-8444 indicates that we have a very strong safety profile and an excellent therapeutic index of safety versus efficacy. So we are currently expecting to file an IND with the U.S. FDA for IGM-8444 this year. Initially for the treatment of patients with solid tumors.

Now I would also like to introduce IGM-7354 and our targeted immune-stimulating IL-15 antibody, which we hope will have broad oncology applications. This product candidate demonstrates another use of our novel J chain based bispecific technology. In this case, the immune-stimulating IL-15 is attached to the J chain of an anti-PD-L1 specific IgM antibody, which serves to display the immune-stimulating IL-15 on the surface of PD-L1 positive cells, such as cancer cells. In our preclinical studies, this targeted IL-15 creates strong proliferation of CD8 type T cells, also called killer T cells and natural killer cells or NK cells.

Both of these cells play important roles in the treatment of cancer. We are currently expecting to file an IND on this molecule 7354 with the U.S. FDA in 2021. Now finally, we continue to make excellent progress with our manufacturing efforts.

We have now completed our fourth GMP manufacturing run of IGM-2323 with yields improving on each run. In addition, we've manufactured enough IGM-2323 to meet our currently contemplated clinical trial needs for at least the next 12 months. We also continue to make progress with yield and process improvements on our pipeline programs as part of the overall evolution and growth of our IgM antibody expression and manufacturing capabilities. To that end, we are in the process of preparing to build out a GMP manufacturing facility at our site here in Mountain View, California.

We expect the buildout to begin once restrictions related to COVID-19 are lifted. Now I'll turn the call over to Misbah to review the financial results from this quarter and for the full-year 2019.

Misbah Tahir -- Chief Financial Officer

Thank you, Bruce. In addition to the brief financial overview I'll provide on the call today, you can read additional detail on our fourth-quarter and year-end financial results in our press release issued to this call and in our 10-K, which was filed with the SEC. 2019 was a very strong fundraising year for IGM. We raised gross proceeds of $201 million in our initial public offering in September, and gross proceeds of $102 million in our Series C private placement in June and July.

As a result, we are fortunate to be in a strong financial position with cash and investments totaling $236.6 million as of December 31, 2019. In the fourth quarter, our research and development expenses were $12.8 million. For the full-year 2019, R&D expenses were $35.3 million. General and administrative expenses for the fourth quarter of 2019 were $3.2 million and $9.2 million for the full-year 2019.

Our net loss for the fourth quarter of 2019 was $14.8 million or a loss of $0.49 per share. For the full-year 2019, our net loss was $43.1 million or a loss of $4.80 per share. Turning now to the financial guidance for 2020, we will continue to invest in our R&D programs. By the end of this year, our goal is to generate initial data from our ongoing trial of IGM-2323 and to file an IND for IGM-8444.

Also, as Bruce noted, we will look to start the buildout of our Mountain View GMP manufacturing facility. As a result, we expect our full-year 2020 non-GAAP operating expenses to be between $75 million and $85 million. This excludes estimated noncash stock-based compensation expense of approximately $8 million based on the recent trading range of our stock, including noncash stock-based compensation expense, our 2020 GAAP operating expenses are expected to be between $83 million and $93 million. We also expect to end 2020 with a balance of over $140 million in cash and investments providing IGM with an expected cash runway into 2022.

With that, I'll now turn the call back over to Fred.

Fred Schwarzer -- Chief Executive Officer

Thank you, Misbah. I'd like to take a moment just briefly to thank the IGM team for their excellent work. I believe that they have established IGM as the global leaders in the research and development of engineered IgM antibodies. The first-in-human application of our engineered IgM antibody technology IGM-2323 is now a smooth dose-escalating in our Phase 1 clinical trial.

Our DR5 antibody IGM-8444 is expected to follow into the clinic this year and our targeted IL-15 immune-stimulating antibody, IGM-7354 is expected to move into the clinic next year. We believe that we're well-positioned to begin to realize the potential of IgM antibodies and to possibly change the course of therapeutic antibody development. We greatly appreciate your interest in IGM, and we look forward to keeping you all informed as to our progress toward this mission. With that, operator, I'd like to open the call for questions.

Questions & Answers:

Operator

[Operator instructions] Our first question comes from Stephen Willey with Stifel. You may proceed with your question.

Stephen Willey -- Stifel Financial Corp. -- Analyst

Thanks for taking the questions and congratulations on the progress. Maybe just a point of clarification. So are you going to commit to a year-end dose-escalation presentation, kind of regardless of just whether or not some of the timing gets potentially delayed here in terms of your ability to ramp up additional cohorts?

Fred Schwarzer -- Chief Executive Officer

Steve, this is Fred. I would say that our current expectation is that we will update the market by the end of the year as to where we stand on what we've learned so far in this clinical trial. I suppose we're in very uncertain times and that could change, but that very much is our intention.

Stephen Willey -- Stifel Financial Corp. -- Analyst

OK. And maybe a question for either Dan or Bruce, it sounds like you're in the 30 mg fixed-dose cohort now. Can you maybe just talk about what that dose from a molar equivalency perspective in nonhuman primates buys you in terms of B cell depletion?

Fred Schwarzer -- Chief Executive Officer

Sure. Why don't I turn that question over to Bruce since it's a preclinical question?

Bruce Keyt -- Chief Scientific Officer

Right. So at that point, Steve, at the 30 mg per kg equivalent in the monkey model, we had seen depletion of peripheral B cells in the normal peripheral B cells circulating in the monkey on the order of 50% or more of those peripheral B cells had been depleted at that site. And of course, that functions in a sense as a biomarker, the circulating B cells. And the next question or the next clinical question will be, how well that occurs on tumors, of course.

Stephen Willey -- Stifel Financial Corp. -- Analyst

OK. And then just lastly, you talked about some of the other programs and the timing associated with those with respect to IND filings. I know you guys have also talked about wanting to go after other tumor antigens on the bispecific front, I think CD123, CD38. Can you maybe just talk a little bit about what the cadence of those next-gen programs is? And I guess, what is happening to 2323 dictates the pace at which those things progress through various IND-enabling studies?

Fred Schwarzer -- Chief Executive Officer

Sure. This is Fred. I'll turn that question over to Bruce in a second, but I guess I would say that at this point, nothing that we've seen in 2323 would indicate that we wouldn't want to push forward with 123 and 38 as quickly as possible. So we are pushing those preclinical programs as fast as we can, subject to current limitations, of course.

So Bruce, do you want to talk about this?

Bruce Keyt -- Chief Scientific Officer

Yes. Fred, thank you. I agree that we are moving as fast as we can on both of those programs. They're slated for an IND in likely the year after the immune-stimulating program or possibly that same year.

But right now, the data looks very good in vitro and in vivo, and we're encouraged with the platform. So we're moving full steam ahead on both of those programs.

Fred Schwarzer -- Chief Executive Officer

Bruce, you might mention that we're seeing the same type of cytokine release data on preclinically on 123 and 38 that we saw on 20.

Bruce Keyt -- Chief Scientific Officer

Absolutely, Fred. Yes. As we're well aware and we've described in great detail with the CD20 program, 2323, we get very strong efficacy without cytokine release in our preclinical studies both in vitro and in vivo. And both with CD123 program, as well as the anti-CD38 program, we see the same responses.

We're seeing strong profound potent tumor cell killing without the attenuate cytokine release. So we're seeing really a confirmation of this safety advantage of the platform.

Stephen Willey -- Stifel Financial Corp. -- Analyst

Thanks for taking the questions.

Operator

Our next question comes from Biren Amin with Jefferies. You may proceed with your question.

Biren Amin -- Jefferies -- Analyst

Hi, guys. Thanks for taking my questions and I hope you guys are staying safe. So maybe I just want to start with the 2323 program. Can you talk about your expectations of data later this year? I know, clearly, it's a fluid situation.

But if everything goes according to plan, and if you don't observe any dose-limiting tox, do you think we could see the 1,000-milligram dose being presented at ASH? Or is it more likely the 100 and the 300-milligram doses that we're going to see at ASH? Thanks.

Fred Schwarzer -- Chief Executive Officer

Thanks, Biren, for that question. I'll take it at a top line and just say, we still hope that we're going to be through 1,000 milligrams by the time of ASH. But at this point, I'll turn it over to Dan and he can go into more detail.

Dan Chen -- Chief Medical Officer

Yes. Thanks, Biren, for that question. So we are targeting having dosed IGM-2323 at the 1,000-milligram dose level by the time of ASH 2020. Now, of course, a lot can happen between now and then.

In terms of our continued enrollment onto the study at the pace that we would like it to go. But what we continue to see is, we believe, right now, our ability is there to get through the 1,000-milligram cohort. Whether we're able to do that enough ahead of ASH 2020 will ultimately determine whether any data presented at a meeting like ASH 2020 includes the 1,000-milligram cohort. You can imagine safety from 1,000 milligrams generally could come in very quickly, whereas efficacy requires follow-up.

So you imagine that we would have depending on when that cohort gets enrolled, we'll determine what potentially is there for that potential presentation.

Biren Amin -- Jefferies -- Analyst

OK. And then maybe a question for Bruce. In your prepared remarks mentioned about the manufacturing yield for 2323 in terms of the fourth manufacturing run. Can you just talk a little bit about the yield relative to the earlier runs on 2323 and also the yield compared to IgG on this fourth run? And I think you mentioned that you have sufficient doses for the next 12 months, are your assumptions based on dose level at the 1,000 milligrams, or is it based on lower dose levels? And I guess, what duration of dosing are you assuming in your assumption of 12 months?

Bruce Keyt -- Chief Scientific Officer

Thank you, Biren. So let me go back to your first question. We've done four runs, and we've steadily improved, and I don't see that we're going to stop doing that. Our yields get better and better.

Roughly, we've doubled the yield since our first run. And that puts us in very good range of other bispecific IgGs, those types of programs don't typically have the yields of a standard IgG. So we'll be very much in the range. And as we indicated, we'll be improving all along.

Now the second half of the question on the clinical supply and inventory. And we did take a high-level look at this where we intended to be able to treat at 1,000 milligrams and at least for 10 to 12 doses. Dan, you could comment on the duration, but I think we will be able to handle dosing in this escalation and even in the expansion trials with the currently available inventory.

Dan Chen -- Chief Medical Officer

Yes. And thanks, Bruce. I think that as we think about dosing schedule and duration of therapy for IGM-2323, I think we have to realize we don't know what that ultimate dosing schedule and duration of therapy will be. And in fact, we built this program to enable the clinical data coming in from the trial to help us make those determinations.

So not just dose, but actual schedule that we take forward, as well as how long we treat with. As a base case, the protocol was written to assume that we would initially target dosing of up to about six months. But we also built-in provisions to both back off on the frequency of that dosing and potentially also further adjust the duration of therapy. So a lot will have to depend on the data itself.

But I think that I very much support what Bruce said, which is, I think we have a clinical supply right now that is well-positioned to get us through this Phase 1.

Biren Amin -- Jefferies -- Analyst

Great. Thanks for taking my questions.

Operator

Your next question comes from Ted Tenthoff with Piper Sandler. You may proceed with your question.

Ted Tenthoff -- Piper Sandler -- Analyst

I'm thankful to hear that everybody is doing well, and it's good to hear all of your voices on the call today. I'm going to go kind of to some of the earlier stage stuff, and I'm really excited about the 7354 in terms of IL-15. Bruce and Dan, maybe you guys can characterize that a little bit because you've certainly seen some other approaches here. So how does that IgM format really work to address these immune stimulators?

Dan Chen -- Chief Medical Officer

Maybe I'll ask Bruce to start and then we can go to Dan if there's further follow up.

Bruce Keyt -- Chief Scientific Officer

Right. Thank you, Dan. Sorry, Ted. Thank you for the question.

And we're very excited about the IL-15 immune-stimulating IgM. And of course, first and foremost, it's targeting immune cells. We have a specific targeting of IL-15 to PD-L1 positive cells and we've demonstrated, as on all of our programs, we're able to target lower expressing cells with the IgM compared to the corresponding IgG, so that gets us to even low expressing PD-L1 positive tumor cells. The next important thing is, of course, we're displaying IL-15 to incoming NK cells and CD8 T cells.

And we get not only the high avidity of binding to PD-L1, but we get a strong, durable context-dependent presentation of the IL-15. So this is a different type of bispecific immune cell engaging mechanism, where we have a durable, stable platform to display IL-15 on the surface of the tumor cell. And what we've seen in our preclinical studies. So this is a robust enhancer of local IL-15 activity.

Fred Schwarzer -- Chief Executive Officer

Dan, do you want to offer some additional thoughts about the application of that?

Dan Chen -- Chief Medical Officer

Sure. So as you can imagine, we're very enthusiastic about our IL-15 by PD-L1 program. We think that IL-15 does offer some really interesting characteristics in terms of being an immune modulator. Obviously, in the clinic, IL-15 as a cytokine tends to be much safer in dosing than, for example, the very closely related IL-2 as a therapeutic.

IL-15 also tends to really push a more of a memory phenotype in the T cells that respond to it. And so we think these two characteristics together make it a really excellent therapeutic for us to have in our pipeline for development. And finally, I'm a strong believer, as Bruce had mentioned, that the stability of the IgM platform, both for binding to a target cell so that it's not coming on and off and also the ability to present in context, so recall that IL-15 in an immune response is often presented to a T cell. It's presented by generally things like myeloid cells, life dendritic cells.

And so you can imagine when that IL-15 signal is presented to that T cell, not only is the T cell seeing the IL-15, but they're seeing other molecules possibly present on the surface of those cells, and that's what we mean by context. And so I think the IgM platform really allows us to use that.

Ted Tenthoff -- Piper Sandler -- Analyst

Yes. I really like that program. One other quick question, if I may. Just in terms of scale and in terms of the ability of the new facilities that you're planning, how large do you think will that facility be? What will your scale be when that's up and fully running?

Fred Schwarzer -- Chief Executive Officer

I'll ask Bruce to answer that question.

Bruce Keyt -- Chief Scientific Officer

Right. Thanks, Ted. We are looking forward to our, as we call it, the building two of our manufacturing site. We have put in plans to have two trains of production ending at 1,000 liters.

So initially, we'll build out the first train for 1,000-liter bioreactor. And then coming on later, we'll bring in the second bioreactor at 1,000 liters.

Ted Tenthoff -- Piper Sandler -- Analyst

Good luck, guys. Thanks so much.

Fred Schwarzer -- Chief Executive Officer

Thank you.

Operator

[Operator instructions] Our next question comes from Michael Schmidt with Guggenheim. You may proceed with your question.

Michael Schmidt -- Guggenheim Partners LLC -- Analyst

Hey, guys. Thanks for taking my questions, and I appreciate the comments on the coronavirus outbreak. Maybe just a couple of follow-ups on IGM-2323. Maybe Dan or Bruce, could you remind us at what dose level you would expect clinical activity based on your animal data?

Fred Schwarzer -- Chief Executive Officer

I'll turn that question over to Dan to start. Dan, you want to take that?

Dan Chen -- Chief Medical Officer

Thank you, Michael. So recall that for IGM-2323, we used the cynomolgus monkey model to really map out all of our expectations around this program and molecule. And by using that data, we set a MABEL dose, which is a minimally active biologic effect level. That's the first dose that we started, the 500-microgram fixed-dose.

And then we went all the way up to the planned dose of 1,000 milligrams fixed-dose. So throughout that entire range, we observed biologic effect. It just was obviously increasing with dose. So when we set that MABEL dose at 500 micrograms, that had an essentially reproducible 20% decrease observable in the cyno for CD20 expressing B cells.

And so we've observed across those preclinical studies activity throughout the entire dose range. And that is, we believe, relatively simple biology to then try to translate into humans.

Michael Schmidt -- Guggenheim Partners LLC -- Analyst

Got it. And as you sort of go through dose escalation with 2323. What are your thoughts around the potential for initiating those expansion cohorts below a hypothetical MTB should you not see toxicity by year-end that is limiting?

Bruce Keyt -- Chief Scientific Officer

Yes. So in the Phase 1 protocol for IGM-2323, we actually built in the ability to expand at any of the dose levels. Clearly, dose escalation is mostly set at three plus three. But we think it may be important to also further define all of the parameters at any of the given dose levels.

So we have the ability to do that at any point in time once a given cohort is cleared.

Michael Schmidt -- Guggenheim Partners LLC -- Analyst

OK. Understood. And then a question on the DR5 program, with the sort of study initiation planned here in the IND filing. Can you maybe help us understand what types of patients you will be enrolling in the Phase I study? Will this be all-comers or will this cohort be enriched for patients that might be potentially responsive to DR5 agonists?

Fred Schwarzer -- Chief Executive Officer

Dan, do you want to talk about our strategy here for DR5 clinical development?

Dan Chen -- Chief Medical Officer

Absolutely. So as you can imagine, we're very excited about our IGM-8444 program, our multivalent DR5 agonist. It's something that on the clinical side, we've been preparing for quite some time, engaging with investigators and preparing to initiate the Phase 1 study. So that initial Phase 1 study for 8444 would be in all-comer solid tumors.

We think that the biology for DR5 agonism is very broad. It extends from solid tumors into hematologic malignancies. And we don't think it's limited to any one particular subset of human cancers. So the Phase 1 dose-escalation would essentially be an all-comer solid tumor.

We would add on hematologic malignancies after completing dose escalation. And we would not initially be selected because we want to understand those early efficacy and safety signals in a very broad range of patients. Once we've completed dose escalation, we can certainly target expansions in more discrete indications. But at this point in time, based not only on our preclinical data and our understanding biology but also from the history of other DR5 agonists in the clinic, we think that these types of molecules have the potential to generate single-agent and combination efficacy in a very, very broad range of cancer types.

Michael Schmidt -- Guggenheim Partners LLC -- Analyst

OK. Very good. Well, thanks everybody for the information and congrats on the progress.

Fred Schwarzer -- Chief Executive Officer

Thank you.

Operator

Thank you. And I'm not showing any questions at this time. I would now like to turn the call over to Fred Schwarzer for any further remarks.

Fred Schwarzer -- Chief Executive Officer

Well, thank you all for your support and interest in IGM, and thank you for joining us on today's call, and we look forward to keeping you updated as to our progress.

Operator

[Operator signoff]

Duration: 53 minutes

Call participants:

Misbah Tahir -- Chief Financial Officer

Fred Schwarzer -- Chief Executive Officer

Dan Chen -- Chief Medical Officer

Bruce Keyt -- Chief Scientific Officer

Stephen Willey -- Stifel Financial Corp. -- Analyst

Biren Amin -- Jefferies -- Analyst

Ted Tenthoff -- Piper Sandler -- Analyst

Michael Schmidt -- Guggenheim Partners LLC -- Analyst

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