Ladies and gentlemen, thank you for standing by, and welcome to the First Quarter 2020 Xencor Conference Call. At this time, all participants' lines are in a listen only mode. After the speakers' presentation, there will be a question and answer session. I would now like to hand the conference over to your speaker today, Charles Lyle. Thank you, and please go ahead, sir.
Thank you, and good afternoon. Earlier this afternoon, we issued a press release which outlines the topics we plan to discuss today. The press release is available at www.zencor.com. Today on our call, Basil Dette, President and Chief Executive Officer, will provide updates regarding COVID-nineteen, our portfolio programs and licensing partnerships John Cush, Senior Vice President and Chief Financial Officer, will review the financial results from the Q1. Then we will open up the call for your questions, and Alan Yang, Senior Vice President and Chief Medical Officer, will join us for the Q and A.
Before we begin, I would like to remind you that during the course of this conference call, Xencor management may make forward looking statements, including statements regarding the company's future financial and operating results, future market conditions, the plans and objectives of management for future operations, the company's partnering efforts, capital requirements, future product offerings, research and development programs and the impacts of the COVID-nineteen pandemic on these topics. These forward looking statements are not historical facts,
but rather are based on
our current expectations and beliefs and are based on information currently available to us. The outcome of the events described in these forward looking statements are subject to known known risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these forward looking statements, including, but not limited to, those factors contained in the Risk Factors section of our most recently filed Annual Report on Form 10 ks and Quarterly Report on Form 10 Q. With that, let me pass the call over to
Bassil.
Basil, I believe we think you're on mute. Sorry, you know what? I believe I was on mute. I'm very sorry to all of you listening. That's a very COVID-nineteen kind of screw up.
So I'll start again. Good afternoon. Before we touch on the development portfolio update, I'm going to describe the effects of COVID-nineteen pandemic on our business. Now despite the numerous challenges, we're fortunate that our clinical trials and research work continue to progress with modest impact on trial enrollment to date and that we continue to enjoy a strong cash position. We're still enrolling patients into a number of clinical studies that are evaluating our bispecific antibodies in oncology.
And while clinical studies in oncology are still high priority for patients, their families and their physicians, the planned study initiations later this year for our 2 hematology programs, plimodimab, our CD20, CD3 program and vivacotamab, our CD123 by CD3 program. And the enrollment to our ongoing studies will likely be affected as many clinical sites have delayed starting new trials and others have postponed enrollment. The situation is very fluid and we'll continue to update as appropriate. Within the company, we've implemented a number of measures to protect the health and safety of our employees and our community. These include requiring all non laboratory employees to work remotely, a reduction of research lab staff density by implementing alternating shifts and by reorganizing our facility to further reduce staff density.
Now a core part of our business is to complement our internal pipeline development with partnering. And we received payments from the licensing of our XmAb technologies, the clinical advancement of XmAb candidates, as well as royalties from sales of approved products. We're monitoring for potential impacts of this partnership revenue. On the other hand, in April, our partners Alexion and Vir Biotechnology each announced plans to initiate clinical studies evaluating antibodies that incorporate our Xtend Fc technology to treat patients with COVID-nineteen. Lexion announced that they're initiating a Phase 3 trial with Ultomiris in treating patients with severe COVID-nineteen symptoms.
And Vir, under our expanded partnership to include antibodies targeting the SARS CoV-two virus, announced plans to initiate a Phase 2 study with such an antibody drug candidate. Now partnerships like these certainly highlight the plug and play nature of the suite of XmAb Fc domains we've created, which have small changes in their structure that we designed and allow us and our partners to engineer nearly any antibody to have improved activity, longer half life or bispecific structure. This flexibility and portability, they enable us to take multiple shots on goal simultaneously and generate proof of concept data to guide which programs we will independently advance or partner or terminate. We're focusing our R and D on the expansion and use of our XmAb bispecific platform to create drug candidates that find 2 or more different targets simultaneously. And we're currently running 6 Phase 1 clinical studies evaluating XmAb bispecific antibody.
Our plug and play approach to engineering enables the rapid design and simplified development of antibodies and other protein structures like cytokine. Bi specific antibodies and cytokines are a rapidly emerging area of therapeutic development, particularly in oncology. And in order to stay at the forefront of innovation in this space, we use our engineered heterodimeric Fc domain as a robust scaffold to rapidly develop new candidates that we group into 3 classes: T cell engagers, tumor microenvironment activators and cytokine. 1st and most advanced class of the T cell engagers, these are tumor targeted bispecific antibodies that contain both the tumor antigen binding domain and a cytotoxic T cell binding domain, specifically a CD3 binding domain. These T cell engagers, which we also call CD3 bispecifics, activate T cells at the site of the tumor in order to potently kill malignant cells.
Before we review these programs, please note that our first three CD3 bispecific programs, those targeting CD123, CD20 and somatostatin receptor 2 have recently received their non proprietary names, fivacotamab, plimodamab and tildutamab, respectively, and we will be referring to these with their new names. So, vivacotamab is XmAb14045, plimodamab is XmAb13676 and tigudamab is XmAb18087. Now, while we continue to dose patients in our Phase 1 studies of fibocotamab and pulmodamab in hematologic cancers, we're planning to initiate studies of these additional studies of these programs subject to possible impacts from the COVID-nineteen pandemic, as I mentioned earlier. We also continue to dose patients in the Phase 1 study of tidutumab and continue to expect that we will present initial data from this ongoing study in neuroendocrine tumors and gastrointestinal stromat tumors in the second half of this year. Further, we've expanded our CD3 class of bispecifics by developing our XmAb2 +1 bispecific format.
It uses the same heterogimeric XmAb Fc domain as in our other bispecific antibodies and cytokines, but has 2 identical tumor targeting domains and 1 CD3 targeting domain. The 2 tumor targeting binding domains can both can bind together when there is more target present, a property called avidity. This enables higher selectivity for tumor antigen expressing cells and greater flexibility in tuning the potency and hence efficacy and tolerability of the molecule. We'll be presenting preclinical data from 3 internally developed XmAb2 +1 bispecific antibodies targeting solid tumors at the 2nd session of the American Association of Cancer Research Virtual Annual Meeting in late June. The next group of bispecific antibodies are our tumor microenvironment activators.
Rather than directly bridging a cytotoxic T cell to a tumor cell, our TME activators, as we call them, seek to more effectively reactivate tumor reactive T cells than existing therapies. These antibodies simultaneously engage multiple T cell targets such as checkpoints or agonists. A key feature of our design is to choose individual binding affinities for each T cell target to give lower binding of T cells with only 1 of the 2 targets on its surface, but they have high binding when both targets are present. This zipping up when multiple handholds are present is the same ability properties in our 2 +1 CD3 bispecifics. Now our approach reduces the need for multiple antibodies typically using combination therapy and also allows for more selective targeting of T cells that have multiple checkpoint expression, which are typically found more in the tumor microenvironment than in the periphery.
Our 3 clinical stage TME activators target different checkpoint or co stim combinations and all demonstrate compelling in vitro in vivo data to support their clinical development. We're conducting Phase 1 studies evaluating these drug candidates in patients with advanced solid tumors. The study is evaluating XmAb22841, which targets CTLA-four and LAG-three and XmAb23104 which targets PD-one and ICOS are enrolling patients in the dose escalation portion of these studies. And we've recently opened expansion cohorts in the Phase 1 study of XmAb20717, which targets PD-one and CTLA-four. These cohorts are enrolling patients with advanced non small cell lung cancer, renal cell carcinoma, prostate cancer and other cancers without approved checkpoint therapies.
And the study continues to enroll patients in additional dose escalation cohorts separately. An expansion cohort for patients with the melanoma is fully enrolled. The American Society For Clinical Oncology accepted an abstract containing initial data from the dose escalation cohorts for publication in their virtual scientific program, which will appear online next Wednesday, May 13. We plan to update these data through a press release. Finally, we're developing a suite of cytokines, which are immune signaling proteins that are built on the XmAb bispecific Fc domain and incorporate our Xtend technology.
Using our Fc domain and tuning the potencies enables more druggable cytokines with potentially superior tolerability, slower receptor mediated clearance and longer half life. Our first cytokine program and the lead in our collaboration with Genentech is XmAb24306, which they are denoting as RG6323. It's an IL-fifteen, IL-fifteen receptor alpha complex fused with
our bispecific Fc domain. It targets the expansion and activation
of T cells XmAb24306 as a single agent and expansion study of XmAb24306 with a single agent in combination with atezolizumab, their anti PD L1 antibody. The study is enrolling patients with locally advanced or metastatic solid tumors. Recall that we can perform our own clinical studies with both our own pipeline assets and non Genentech agents within this collaboration subject to some conditions. We look forward to planning a number of these combination studies pending completion of the initial dose escalation study. We look forward to keeping you informed about all of our clinical programs as they progress.
Now I'll switch to reviewing some updates from our partnerships. While we have 10 ongoing partnerships for XmAb technology, which have resulted so far in 1 marketer product, one now under review for marketing approval, 7 clinical candidates and more in earlier stages of development, we're only going to update on 3 today before proceeding the financials. MorphoSys in 2010 licensed from a tafasitamab, which was previously known as MOR208 and before that XmAb5574. It's an anti CD19 antibody that we designed and initially developed incorporating our cytotoxic Fc domain for high ADCC function. In late February, the FDA accepted MorphoSys' BLA submission for treating patients with diffuse large B cell lymphoma, for which he received a $12,500,000 milestone payment.
Their submission was granted priority review and received a PDUFA goal date of August 30, 2020. We're eligible for additional milestones royalties on sales in the high single to low double digit rate percentage. We've also entered into research collaborations that include the creation of novel XmAb bispecific antibody to be advanced by partners. For example, AMG 509 is Amgen's steep 1xCD3 2 +1 bispecific antibody developed under our collaboration with them. Amgen is developing AMG 509 for patients with prostate cancer and Ewing sarcoma.
Preclinical data were presented during session 1 of the AACR Virtual Annual Meeting in April. Amgen is now recruiting patients in a Phase 1 study of AMG-five zero nine in patients with metastatic castration resistant prostate cancer. Now last program is in January we entered into a technology licensing with Gilead, who is accessing our extended half life and cytotoxic Fc technologies for developing and commercializing elapovimab, their 1st in class broadly neutralizing anti HIV antibody in Phase 1 clinical development, as well as up to 3 additional anti HIV antibodies. At this time, Gilead has exercised all three options for the additional antibodies, and in total, we received $13,500,000 under the agreement. Now our partnership with Gilead and the expansion of our partnership with Vir in COVID-nineteen both highlight our strategy to selectively license access to our XmAb technologies producing developing antibodies with improved properties and shows broad applicability in areas such as viral infectious disease.
And the plug and play nature of our XmAb technologies enable us enables our partners to advance their programs, gaining very little resources or effort from us. Now with that, I'm going to turn the call over to John Kish to review our Q1 2020 financials.
Thank you, Basil. Xencor continues to operate from a strong financial position, which enables us to support our portfolio of clinical stage and research stage bispecific antibody and cytokine drug programs. Cash, cash equivalents and marketable securities totaled $609,900,000 as of March 31, 2020, compared to $601,300,000 on December 31, 2019. The increase reflects upfront and milestone payments and royalties related to licensing agreements, net of spending on operations for the Q1. For the Q1 ended March 31, 2020, revenues were $32,400,000 compared to $111,900,000 for the same period in 2019.
These revenues include milestone revenue recognized from MorphoSys, royalty revenue recognized from Alexion and licensing revenue recognized from our Aimmune and Gilead collaborations compared to revenue from the same period in 2019, which were primarily revenue from our Genentech collaboration. Research and development expenditures for the Q1 in 2020 were $33,900,000 compared to $28,200,000 for the same period in 2019. The increase being primarily due to increased spending on our plan of tumumab and XNAb20717 programs, partially offset by reduced spending on our obexelimab program. General and administrative expenses for the Q1 of 2020 were $7,200,000 compared to $5,500,000 in the same period of 2019. The increase primarily being related to greater spending on personal costs and professional fees.
The net loss for the period ended March 31, 2020 was $8,100,000 dollars or $0.14 on a fully diluted per share basis for the Q1 compared to net income of $80,000,000 or $1.38 dollars on a fully diluted per share basis for the same period in 2019. The net loss for Q1 of 2020 compared to net income reported for the same period 2019 is primarily due to revenue recognized from the Chinnantec collaboration in 2019. Non cash share based compensation for the Q1 of 2020 was $6,500,000 compared to $5,900,000 for the same period in 2019. Total shares outstanding were 57,000,000 as of March 31, 2020, compared to 56,300,000 as of March 31, 2019. Based on current operating plans, we expect to have cash to fund research and development programs and operations into 2024 and to end 2020 with between $500,000,000 $550,000,000 in cash, cash equivalents and marketable securities.
With that, we'd now like to open up the call for your questions. Operator?
Thank you. And our first question comes from the
line of
SVB Leerink. Your line is now open.
Hi, guys. Thanks for taking my questions. First question, can you help set expectations for the Xpap-twenty seven-one 17 ASCO publication?
Sure. We to be able to report the escalation, the already completed dose escalation cohorts and we're really hoping to see the safety and tolerability of the M molecule, which is obviously very important for our product profile to differentiate from the rather toxic regimens that you get with PD-one CTLA-four blockade, for example, with the bibolimimab and nivolumab combinations. We're going to look for biomarkers to make sure they're moving in the right direction and we're going to look to see what efficacy we have from those cohorts. Of course, it's a very heterogeneous patient population, many different tumor types, some with approved checkpoint inhibitors that would make you expect many of the patients would be post PD-one therapy, some with different kinds of tumors. So that's the kind of data we'll present and we've really always thought that the way to get at efficacy is by doing expansion cohorts.
And that's something we've just gotten going very recently, because you can do larger numbers of patients with individual tumor types and really have a better shot at studying them.
Got it. Thanks for the color. And just a follow-up on that. Since you mentioned recently open expansion cohorts in this study, given the heterogeneous nature of a Phase I dose escalation study, can you talk about how you're teasing out signals of activity in the data you're generating and how you're thinking about which indications and settings to pursue further?
Yes. We're thinking about it based on what are the places that checkpoint inhibition can move the needle, right? So the dose expansion cohorts we have set up give you an indication there. They're a mixture of indications where there's known checkpoint therapy activity, where there's approved checkpoint inhibitors and where likely everybody is going to be receiving at least PD-one alone therapy prior to advancing to a clinical trial. Those would be our non small cell lung, our melanoma and our renal cell carcinoma expansion cohorts.
Those are cohorts where we hope we can study enough patients in each of those indications to establish whether we have meaningful activity in each of those indications post PD-one therapy. So looking at the PD-one relapsed and refractory population, tremendous opportunity, obviously very high bar. On the other couple of cohorts, to give you an indication of the other area we're looking where prostate cancer where there's only recently been significant and meaningful clinical activity from checkpoint inhibitors, but still a pretty heterogeneous multiline cancer that I think has a lot of opportunity that's relatively speaking compared to other areas in oncology more open as well as a basket of more unusual rare tumors that have just all sorts of different biologies that we want to explore. So with the basic science sort of if we can establish the basic science around our compound, we can study what's really going on in expansion cohorts.
Got it. Thank you. And just one last question. It sounds like the COVID-nineteen impact on your ongoing clinical studies is minimal so far. Can you expand on this?
I'm curious because we're hearing varied responses among even our oncology companies.
I'll let Alan Yang, our Chief Medical Officer, address that.
Yes. Thanks, Basil. Good question. So I can't comment on other companies, but at Xencor, what we've been hearing anecdotally is that a lot of sites are closing to new patient enrollment, not because they're being overwhelmed, but because they're preparing for a potential surge of COVID-nineteen patients. With that said, oncology is a large unmet need.
And so these would probably be the patients that need therapy the most. And so these would be the last patients that would be sort of denied access to care because of preparations for COVID. In addition, most of our studies since they're Phase 1 are in dose escalation. So you need very few patients for dose escalation. And so those slots, when they become available to patients, they get filled very quickly by our investigators.
And overall, the impact that Basil alluded to was on new patient studies. And so one can imagine, instead of oncology patients who need the therapy,
when you
have a study and you're setting up that study, it's about contracting, sort of getting the site up to speed, having them learn about the protocols. And this is mainly administrative and this can be deprioritized. So that's why we haven't seen much disruption.
Yes. I think it really comes down to the luck of the draw. Different sites have different what they've done. Before we go to the next question, I just wanted to comment. There have been on and off problems with the Q and A queuing system that we're going to continue through, but just bear with us if anything does pop up.
I'm ready for the next question.
Thank you. And our next question comes from the line of Arlinda Lee with Canaccord. Your line is now open.
Hi, guys. Thanks for taking my questions. On I was curious about the, I guess, milestone flow on MorphoSys' 208. The $12,500,000 milestone, can you talk about what that's for and what the $25,000,000 upcoming might be? And then also I was kind of curious, we've been talking a lot about your IO, IO bispecifics for a while and how that was a focus.
And now that you have this your next wave seems to be the 2 to 1. Can you kind of talk about shift in interest in focusing from the IO, IO to the 2 to 1? Thanks.
John, you want to take the milestone question?
Sure. Sure. Thanks, Carlainda. Yes, we had reported in our 10 ks that there were $37,500,000 of regulatory milestones related to the compound. We received $12,500,000 upon acceptance of the BLA by the FDA, which I guess occurred, I think, in January or February.
So that's a $12,500,000 The other $25,000,000 relates to additional regulatory approvals related to the compound.
Thank you.
Thank you.
And I'll take the IO, IO bispecific and 2 +1 CD3s. We go where the scientific hypotheses that we think are going to drive the best chance at having a differentiated drug that can help patients is. And with 3 IO, IO bispecifics in the clinic, that's testing 3 distinct hypotheses that were excited about. But there's a lot that can be done in particular to enable CD3 bispecifics to be more amenable for solid tumors, which often have a heterogeneous target density on healthy versus diseased tissue and things like that where a 2 plus 1 approach gives you a nice handhold. So it was just more of where does the science give us the best immediate opportunity and where have we already put a lot of bets down on multiple hypotheses.
But it's all going into expanding what we're doing into being more opportunity within solid tumors as opposed to, on our earlier work in the first two programs, Raheem.
Got it. Thanks. Could I also ask a question on the 23 sorry, 24,306 IL-fifteen compound in collaboration Genentech. You guys have talked about having a fairly aggressive program. I'm curious, since the trials already started to have started, I was curious about your whether that program might have any COVID impact and when we might be able to see first data from that?
Thank you.
We've been guiding that there is unlikely to be data from that program this year. That's in the hands of Genentech. They're executing on the trial and we have to reach agreement with them on when we do data releases. But I would not expect it this year given it is dose of the first patient in March. As for COVID-nineteen impacts, I know they're very committed to the trial.
They got a patient going right when COVID was starting to ramp up. And we that's what we know that they're still very committed and there's a lot of activity going on. And if and when we learn something meaningful about COVID impact, we'll absolutely report that in our next update.
Okay, great. Thank you very much.
Thank you. And our next question comes from the line of Peter with Barclays. Your line is now open.
Hi, guys. This is Walid on for Peter. Thanks for taking my questions. I apologize if I missed anything earlier. I had a bit of difficulty with the conference line.
But I just wanted to ask a question on XmAb18087. Wondering if you can give us clarity on whether or not that data is still on track for the second half? And maybe you can tell us how enrollment is going for the study and whether you're seeing any challenges for patients being able to get follow-up and just an update on that study?
So yes, we reaffirmed earlier on the call that XmAb18087, not called tedutumab, we expect to give a data update in the Phase 1 study second half of this year. We do continue to enroll. And Alan, do you want to touch on the question regarding follow-up visits and whatnot?
Yes. Just want to remind that neuroendocrine tumor and chiocerebral tumors are rare tumors. But despite that, we still are enrolling well. And in the patients that are on study, we haven't seen anybody miss key visits. And that goes across our studies.
And key visits would be dosing visits or tumor assessment visits. So I think we're doing pretty well.
Great, great. Thank you. That's helpful. And what can we expect to see in that data update, number of patients and maybe type of data? And then maybe you can help sort of set a bar for certain efficacy and safety benchmarks that you may want to meet to help consider your results positive?
So we're not guiding on the number of patients. It's we've been dose escalating to a number of cohorts, but so it is going to be in that range when you consider typically of 3 to 6 patients per cohort. Without getting into any specifics about the upcoming data, in general these neuroendocrine tumors are not they don't typically respond with a resist sort of response. I think you from the approved agents, they typically have around a 10% or 5% or 10% response rate. But what happens is you get a duration of the patient continuing on and being tolerant to the therapy, of course, and not getting worse, right.
So the approved agent recent approved agent, for example, which is a radionuclide peptide conjugate was approved on PFS and OS. So that might maybe set your expectation for what you would hope to see. On the safety front, it's a CD3 bispecific against the solid tumor where the antigen is expressed in various neuroendocrine tissues. So I think it's going to come tissue by tissue where those neuroendocrine cells are making sure that a patient can tolerate it. But these are advanced net patients with very few options.
So there's some latitude there if it's showing activity.
Got it. Thank you. Thanks for taking the questions.
Thank you. And our next question comes from the line of Gabriel Fong with Mizuho Securities. Your line is now open.
Hey, Basel. Thanks for taking the question. This is on Gabriel for Mara. And just the first question here, this is regarding the COVID-nineteen impact. Understandable that delays may be felt, but I was just wondering if you can quantify the magnitude of the delay.
Is it within like a quarter or maybe 2? And then the patient I mean, the trials that are ready going I mean, sorry, in the trials that you're expecting to start as of last quarter, have you already enrolled any patients? And I have a few more follow ups after that.
So we're going to average about 5 questions per analyst, I'm guessing. So to get to your first question, the studies that we had guided that we were going to initiate this year were in the second half, we would announce our plans for our pomodimab, our CD20, CD3 bispecific for the next set of trials. For that, we have no guidance we can offer on what kind of delays might emerge from COVID-nineteen. It seems reasonable to assume there will be, but it's far enough off and the COVID situation is so fluid, we don't know. We had planned by mid year to open the study for bivacotumab, our CD123, CD3 and a new study where we would give details at the time when it opens, that's how our agreement with Novartis works.
That is has I think felt some impacts because of the administrative points and some study sites just not wanting to take on new studies, while COVID was feared and it still is feared of course. I don't know if we can give a specific amount of time. We're hoping to be able to initiate that study sort of later in the part of mid year, certainly in the second half, we hope, but we don't have anything more specific than that. Now you had some other aspects to your question?
No, that's good. I'll come to the next question. It's pretty quick. It's just reading much on cash. Given your cash position right now, I was just wondering if it makes sense to even look externally for additional assets or technologies.
And that's it. Thank you.
We always are looking, and it's as a small company, you're a bit disadvantaged. And I think we're always looking for great new technology or molecules that can fit. I don't think we make it a primary corporate goal, but it's always a good idea. You should never feel like what you've got in your own shop is the end of the world. That said, we do have a very rich and a very busy, busy development team and a lot of research ongoing.
But it's something we have in mind for sure. Thanks, guys.
Thank you. And our next question comes from the line of Ed Tenthoff with Piper Jaffray. Your line is now open.
Great. Thanks so much. It's good to hear you guys' voices. I want to kind of follow-up on an earlier question on IL-fifteen. And I'm really trying to understand what are the optimal potential combinations here.
So really how does that mechanism play best either with check points or other targeted agents? So how are you guys at a very high level thinking about developing that candidate with Genentech? Thanks so much.
Hey, thanks, Ted. It's great to hear all you guys being safe and sound. So the initial work is with the checkpoint inhibitor, it's with the atezolizumab PD L1 molecule from Genentech. It's an approved agent. Doing pretty well, even though it's I think 3rd in the PD-one L1 space, it's doing pretty well when expanding.
We are hopeful that that can lead to a number of different exciting clinical trials that they can initiate once we're out of initial dose escalation. I think that there's certainly other checkpoint inhibitors and we have eyes for our own pipeline. If the molecule gets through this first trial nicely, then we would certainly imagine looking for how we can synergize with those checkpoint inhibitors. I do think that the natural killer cell opportunities are there. There is nothing we have specifically that we can guide to right now, though we and Genentech are talking avidly about them because it's both the T cells and the NK cells that IL-fifteen really drives.
I think that we're going to as we get through this Phase 1 and get tolerability data and understand our dose and hopefully see something exciting, we'll be able to pin that down more. But there's a lot of different opportunities. And so for starters, let's make sure we check the box on a checkpoint inhibitor for the Tezza that Genentech is very, very motivated to advance.
Yes, makes sense, Craig. And the whole NK cell fab makes a lot of sense too. Thanks so much for the update. Stay safe, guys.
Thanks, Ted.
Thank you. And our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is now open.
Hi, this is
Yi Yu
on for Craig. Thank you for taking my questions and congrats on the quarter. I have two questions. First, what are your disclosures then for the ongoing monotherapy trials of pomodumab and Can you remind us your priorities among the early stage programs?
Thank you.
So super hard to hear there were some definite connection issues there. I believe your first question was about are we guiding on any data readouts for plimodumab and vivacotumab for this year. We have not yet guided on those. We will we can give updates on when we might have data from those later in the year. We haven't guided on anything yet so far.
And I think it's prudent for us to make sure we understand the COVID impacts fully before we do. That said, I think, as Alan has said in some of the earlier comments, so far our trials have continued to enroll. They've done well. Some of it's the luck of the draw with our sites. But we don't know where the future is going to be.
So we're just going to stay very vigilant. But so far, the impacts have been somewhat relatively limited on our enrollment. Though our new study start in particular for bibacotamab, we know that that's impacted because that was something that was getting into the advanced stages of planning and prep. And that's we were hoping mid year it's going to slide from there, but we don't know exactly how much. And I couldn't hear anything beyond that.
Can you hear me now?
A little better.
Okay. My second question was, how do you think COVID-nineteen has shaped your development strategies? And can you remind us your priorities among the early stage program?
All right. So our priority is always to take all of our early stage programs until we can get some element of proof of concept data or not from them in a meaningful trial. And then from that point decide the strategy. So we've got to the point where we have active doses for bivacotumab and paltmetamab, and so we're initiating new studies with those, with the earlier ones. We're still in that initial data gathering phase.
So the priority is to manage the portfolio in a way that as we gather more data across that portfolio, we pick the winners and advance those. So that's how that is. I don't think COVID-nineteen has changed our priorities in any way regarding that. I think part of the reason for that is it's only been a couple of months. We don't know exactly where COVID-nineteen is going to impact our ability to do clinical trials of the industry or anything over the next few even years.
I will say that our strong cash position allows us to continue on in a fairly aggressive stance like we could try to do all of our clinical development for the time being and still play this strategy forward.
Great. Thank you very much.
Thank you. Thank you. And our last question comes from the line of Etzerodharu with Guggenheim Securities. Your line is now open.
Great. Thanks for taking the question here. Just one really for me. Obviously, we've gotten some activity data for PD-one CTLA-four bispecifics from a couple of different companies, including one that will come at ASCO. And I guess, for me, your question is, it's sort of it's early data sets.
But I mean, what are you going to what do we expect in terms of ultimate differentiation? I mean, one of the things that your excellular and your dose expansion studies is post PD-one patients. So I mean, it just is that one area where you kind of see your assets sort of being able to differentiate over some of these others that are sort of progressing through the clinic? Thanks.
Yes, I think our strategy is to look at both post PD-one patients in indications where PD-1s are established and look at other indications where there's a good biological hypothesis in particular for CTLA-four. We do hope that our design makes our molecule tolerable and easily combinable because of course there's always a desire to combine with whether it's chemo or targeted agents or what have you with these molecules and cancer combination therapy always ends up being something you look at. The differentiation, I think our molecule is designed to be truly as selective as possible for the double positive cells. And we'll see how that plays out both in terms of targeting and to get access to the tumor as well as in the the side of safety. But I think the data is far too early.
That's how we designed it to differentiate itself and we'll see how it all plays out over the next few quarters.
All right. Thank you.
Thank you.
And this does conclude today's question and answer session. I would now like to turn the conference call back to Basel Daghia for any closing remarks.
Well, I'd like to thank everybody very much for joining us today and also bearing through the multiple technical difficulties, including my being on mute for the first two minutes. Always more challenging when we are all remotely located like we are these days in COVID-nineteen. I look forward to catching up again and giving further updates on our progress throughout the year. And in the meantime, I hope everybody stays safe. Thank you.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.