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Xencor Inc (XNCR -3.51%)
Q3Â 2020 Earnings Call
Nov 5, 2020, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen, and thank you for standing by and welcome to the Third Quarter 2020 Xencor Conference Call. [Operator Instructions]
I would now like to hand the conference over to your speaker today. Charles Liles, head of investor relations. Thank you and please go ahead, sir.
Charles Liles -- Head of Investor Relations
Thank you and good afternoon. Earlier today we issued a press release which outlines the topics we plan to discuss today. The press release is available at www.xencor.com. Today on our call, as well, dat yet president and chief executive officer will provide updates regarding COVID-19 impacts as well as partnerships, Allen Yang, Chief chief medical officer will review updates throughout our clinical portfolio. In john Cush, chief financial officer will review financial results, and then we'll open up the call for your questions.
Before we begin, I would like to remind you that during the course of this conference call, Zen core management may make forward looking statements including statements regarding the company's future financial and operating results, future market conditions, plans and objectives of management for future operations, the company's partnering efforts, capital requirements, future product offerings, Reacher's research and development programs, and the impacts of the covid 19 pandemic on these topics. These forward looking statements are not historical facts, but rather are based on our current expectations and beliefs. And they're based on information currently available to us.
The outcome of the events described in these forward looking statements are subject to known and unknown 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 K, and quarterly report on form 10 Q.
With that, let me pass the call over to Bassil.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thanks, Charles. And good afternoon everyone. So of course approach to creating antibody and cytokine therapeutics is centered around our ex Mab protein engineering platform. By making small changes to an antibody structure specifically in its FC domain, we can improve its natural functions and performance and create new mechanisms of action. The plug and play nature of our suite of x Mab FC veins allows us to engineer nearly any antibody to have improved activity, longer half life or bust civic structure. This flexibility and portability enable us to take multiple take multiple simultaneous shots on goal in the clinic.
And a proof of concept data we generate will guide which programs we independently advance which we will partner in which we will terminate. We're focusing our R&D on the expansion and use of our x men by specific platforms create antibodies that bind two or more different targets simultaneously, and also to engineer cytokines with structures optimized for particular therapeutic use. We're currently running six phase one clinical studies evaluating such x men by specific antibodies. And we continue to explore novel mechanism of action for oncology treatments with our eczema by a specific platform.
And we're presenting three preclinical programs at the Society for immunotherapy of cancer meeting or city meeting next week are B seven H three by cd 28 by specific is a pre clinical program that targets a T cell co stimulatory signal via cd 28 to the pan tumor target B seven H three. This creates an opportunity to enhance treatment in a wide range of tumor types. The T cell targeted therapies like checkpoint inhibitors in CD three engagers. We're also presenting our PD one targeted TGF beta receptor blocker for T cell activation in our potency engineered aisle 12 program, both of which are engineered to enhance tolerability and duration of action while providing highly active immune stimulation in tumors.
So before we move on to our clinical portfolio Today, I'd like to provide an update on the impact of code the covid 19 pandemic on our operations, the pandemic did not significantly disrupt patient enrollment in our six ongoing clinical studies during the third quarter. manufacturers that provide our drug supply, however, notified us that they're currently experiencing critical shortages of material used in their manufacturing processes. We have sufficient supplies of drug material to continue conducting our ongoing studies without interruption. However, we expect a small delay in the development timelines for the pre clinical x map 30819 program, or mp3 by CD three by specific for renal cell carcinoma.
Timelines for advancing additional early stage programs into the clinic and for ongoing clinical programs could be affected if the supplier interruption goes longer than we currently estimate. The autoimmune aisle to FC program X up to 7564, however, is not affected by And the initiation of a phase one study is on track for early 2021 will continue to update you on manufacturing impacts from COVID. If it wasn't a merge within the company, we're maintaining requirement for non laboratory employees to work remotely. But we're also continuing our on site measures to protect the health and safety of our employees in our community.
With that Allen Yang, our chief medical officer will review updates to the clinical portfolio now.
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Thanks, Bassil. Yesterday, the American Society of hematology published an abstract containing updated data from our Phase One study by boat by Dakota map in patients with relapsed and refractory acute myeloid leukemia, which we will present in December by the code of app is a cd 123 by CD three T cell engager. One in a class of tumor targeted by specific class of bodies that contain both a tumor antigen binding domain, in this case cd 123 and aside to toxic T cell binding domain, such as CD three, CD three biospecifics fix activate T cells at the side of the tumor in order to potentially kill malignant cells. Data emerging from the study suggests that the patients with AML having low baseline disease burden and specific T cell signatures may be more likely to respond to treatment with five acota map the primary toxicity cytokine release syndrome is generally mild to moderate and severity when observed and is manageable.
We continue to optimize the dosing regimen in this study, along with our partner of Novartis, we are exploring opportunities to develop by the Kota map and patients with lower baseline leukemic disease burden, for whom and intermittently dose cd 123 targeting antibody could be a needed therapeutic option. Next, a phase one study of provoke promote a map our CD 20 cd three by specific antibody continues to enroll patients with non Hodgkins lymphoma in chronic lymphocytic leukemia with planned expansion codes that are in 2021. In addition, operational preparations are under way for phase two monotherapy trial in diffuse large B cell lymphoma and for a fee for a phase two combination therapies study as well.
Our third clinical stage CD three five specific antibody is tied to map which targets somatostatin receptor to last month we presented initial dose escalation data from the ongoing Phase One study in patients with neuroendocrine tumors for nets. I did a map was generally well tolerated at the recommended dose identified for the expansion portion of the study at 0.3 micrograms per kilogram priming dose and a subsequent 1.0 microgram per kilogram repeat dose. peripheral blood biomarkers indicated I do have induced acute and sustained T cell activation, those dependent increases and proliferation and activation markers of city positive T cells CDA positive T cells were observed which is consistent with phytomass mechanism of action.
In 14 patients where we described clinical activity, the best overall response was stable disease and the median duration of treatment was approximately seven months. We believe completion of enrollment, and longer follow up are required to evaluate progression free survival and the clinical utility of doing that for patients with neuroendocrine tumors. early next year, we plan to initiate an additional clinical study in patients with Merkel cell carcinoma and small cell lung cancer, which are somatic statten to receptor expressing tumor types known to be responsive to immunotherapy. In addition to these CD three biospecifics, we have developed another suite of by specific antibodies, where the binding affinities are tuned for selective engagement of T cells. And we call these our tumor microenvironment activators. Selecting for dual checkpoint expression, for example, distinguishes these from combination therapy, and most checkpoint inhibitors.
T cells that have multiple checkpoint expression are typically found more in the tumor microenvironment than in the periphery. Our design of this class seeks to more effectively reactivate these tumor reactive T cells than existing therapies and is meant to potentially drive improved efficacy and tolerability compared to the dosing of separate anti ctla four and anti PD one antibodies in combination. In mid October after abstracts from the city Annual Meeting were temporarily available to the public. We issued an 8k with an abstract containing data from our ongoing Phase One study evaluating xmap 20 717 the dual PD one or ctla four checkpoint inhibiting by specific antibody in patients with advanced solid tumors. The 16 meeting is next week so we won't review the abstract in its entirety. Now.
In summary, Vo x Pep 20 717 continued to be well tolerated and heavily pretreated patients and we are encouraged by the anti tumor activity observed in patients with various types of advanced solid tumors at the 10 milligram per kilogram dose level. The study is currently enrolling patients with renal cell carcinoma two expansion card and continues to roll patients with additional dose escalation code starting at 15 milligrams per kilogram, as we did not reach the maximum tolerated dose, expansion cohorts with melanoma, advanced non small cell lung cancer, prostate cancer and other cancers without approved checkpoint therapies are fully enrolled.
The first studies evaluating two other clinical stage tumor microenvironment activators, x map 22 841 and x map 23 104 continued to enroll and those patients with advanced solid tumors Finally, we're developing a suite of cytokines, which are immune signaling proteins we have engineered with the x map by specific FC domains. We also tuned the potency of these cytokines to improve their properties and make them more drug like, for example, by slowing their receptor media clearance and extending their circulating HalfLife. Our first cytokine program and lead in our collaboration with Genentech to the aisle 15 fuse to its alpha receptor and R by specific FC domain, which is x map 24 306 or rG 6323.
It targets the expansion and activation of T cells and natural killer cells does not bias toward regulatory T cells like its cousin, the cytokine aisle to genetec is currently enrolling patients in a phase one study evaluating xpad 24 306 initially is a monotherapy. And then in combination with the Tesla lizza map, their anti PDL one antibody, we are planning to explore a number of our own combination studies after safety and dose in the ongoing phase one has been established. Our second cytokine candidate x map 27 564 is an aisle to FC fusion protein that we are planning to develop for patients with autoimmune diseases. It is engineered to selectively activate regulatory T cells.
And similar to the aisle 15 program, we reduce its potency and incorporate or extend technology in order for it to have more drug like properties. As basil mentioned, we are tracked to start dosing healthy volunteers in early 2021. We look forward to keep you informed about all our clinical programs as they progress as well.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thanks, Alan. So now on to partnerships. a core part of our business is to complement our internal development portfolio with partnering. These partnerships generate payments from the licensing of XML technologies, the clinical events would have excellent candidates, as well as royalties from sales approved products to remove COVID-19 impacts to partner in revenue during the third quarter.
But we will continue to monitor potential impacts of course. Now our many partnerships really highlight the plug and play nature of the suite of x men that see domains that we've created. With small changes to the FC structure that we've engineered we can for nearly any antibody, improve its activity HalfLife or rapidly create stable multivalued structures. We have 12 ongoing partnerships for x map technology which have resulted in two marketing products. Alexia is ultomiris for rare blood disorders. And now we're posesses mondovi or Kapha city map as a first second line treatment for patients with an aggressive form of lymphoma, diffuse large B cell lymphoma.
Unlike ultomiris, where we just licensee extend se technology to alexian. We create a tablet city map which Morphosis licensed from us in 2010. Then also initiated its clinical development running the phase one study. It's a cd 19 antibody engineered with our x NAB cytotoxic FCT. Or first this has guided the decision on tapis tested Matt's European marketing authorization application should be in the second half of 2021. The plug and play nature of our zmapp Technologies enables partners to advance their programs with very few resources from us, and we selectively license access to our extra technologies. We recently entered into an agreement with Emirates Corporation providing them a non exclusive license to extend FC technology. As is typical for these types of agreements.
Omarosa is responsible for all development and commercialization activities for all candidates. We received the upfront payment of $5 million and are eligible to receive milestone payments in royalties. Finally, I just wanted to touch on progress. Our partners are making an advancing antibody therapies that incorporate extend FC domains for the treatment of patients with COVID-19 alexian in fear alexian is conducting a randomized controlled phase three study of ultomiris in hospitalized patients with advanced COVID. Vir has non exclusive access to our extend FC technology to extend the half lives of Vir 7831 and 07832 both not Atlanta buys and they're investigating potential treatments for covid 19.
Vir has commenced a phase three clinical study for VR 73, one for the early treatment of COVID-19 patients who are at high risk of hospitalization and they plan to initiate a clinical study of VR 73 to in your future. A partnership is zero additionally demonstrates the broad applicability of extend across viral infectious disease as their other antibody programs, Vir 3434 and hepatitis B virus infection and virulence For an influenza a are both advancing through early stage clinical development.
Now hand call over to John Kuch, our CFO who review the third quarter and first nine month financial results, John.
John J. Kuch -- Senior Vice President and Chief Financial Officer
Thanks Bassil. During the third quarter cent course portfolio partnerships, collaborations and licensing arrangements continue to generate strong cash flow, which help offset the growing investment in our pipeline of clinical and early stage drug candidates. This afternoon's press release report cash cash equivalents and marketable securities totaling 582.9 million as of September 30 2020, compared to 601.3 million at December 31 2019. The decrease reflect cash used to fund operating activities in the first nine months of 2020 offset by total proceeds of 89.1 million received in upfront payments, milestone payments and royalties from licensing agreements.
So revenue for third quarter ended September 30 2020, was 35.4 million compared to 21.8 million for the same period in 2019. revenues in the third quarter included milestone revenue from Morphosis related to approval module B. Licensing revenue from our ameris and royalty revenue from Alexia compared to revenues from the same period of 2019, which were primarily reflects milestone revenue from the election, Amgen and Novartis collaborations, pull revenue for nine months ended September 30 2020 was 80.8 million, compared to 153.2 million for the same period in 2019. Revenues from nine month period in 2020 include royalty revenue from election milestone revenue for more posters and licensing revenue from gilliat, aimmune and ameris compared to licensing and collaboration, revenue from genetec and astell. us and muscle revenue from Lexan, AMS and Novartis collaborations in 2019.
Research and Development expenditures for third quarter ended September 30 2020 were 44.5 million compared to 29.8 million for the same period in 2019. Total R&D expenses from nine months ended September 30 2020 121.9 million compared to 91.3 million for the same periods 0.19. additional spending on R&D for third quarter and first nine months of 2020 over months for the same period in 2019 is primarily due to increased spending on our clinical programs, including promote promoter Mab, x snip 20 717 in our aisle to FC cytokine Development Program x map 20 756. For general administrative expenses for third quarter ended September 3 2020, where 7.6 million compared to 6.3 million the same period 2019.
So g and x. Total GMA expenses from nine months ended September 30 2020, or 22.1 million compared to 17.5 million for the same period in 2019. Vishal spending on GMA for third quarter the first nine months 2020 over mods for the same periods in 2019 is primarily to increase compensation costs related to additional general administrative staffing and spending on intellectual property, including patents and licensing costs. Non cash stock based compensation expense for the nine months ended September 30th 2020 was 23.1 million compared to 24.7 million for the same period in 2019.
Net loss for third quarter ended September 30 2020 was 12.6 million or 22 cents on a fully diluted per share basis comparison net loss of 10.2 million or 18 cents on a fully diluted per share basis for the same period in 2019. The higher net loss for for third quarter 2020 compared to the same period in 2019 is primarily due to increased RV spending over increased revenue earned during the period. For the nine months ended September 30 2020. net loss was 55.6 million or 97 cents on a fully diluted diluted per share basis, compared to net income of 53.8 million or 92 cents on a fully diluted per share basis for the sector in 2019.
The net loss report for nine months ended September 30 20 20%. net income report for the same period 2019 is primarily due to higher collaboration licensing revenue report in 2019 compared to 2020 and increased spending on R&D programs in 2020 over 2019 a month. The total shares outstanding were 57.4 million is September 30 2020 compared to 56.7 million is September 30 2019. based on current operating plans projected spending expected proceeds from our partnerships and collaborations. We expect to have cash to fund research and development programs and operations in the 2024 at the end 2020 with between 525 and 575 million in cash, cash equivalents and marketable securities.
With that we'd now like to open up the call for your questions. Operator?
Questions and Answers:
Operator
[Operator Instructions] And our first question comes from Ted Tenthoff of Piper Sandler. Please proceed.
Ted Tenthoff -- Piper Sandler -- Analyst
Hey, thanks so much, guys. In a nice update, I wanted to ask with respect to 1404. Five, we'll see 1234 AOL definitely was intrigued to see the crude safety and some responses there. Maybe a little bit more detail in terms of what the next steps might be to potentially use that in combination with other agents. Thanks.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thanks, Ted. I'll just state at the outset. Of course, we have some restrictions because of our ongoing partnership with Novartis around 1445. About how much we can say. Alan, do you want to comment on the population?
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Yeah, I have to be cautious here. But you know, it was kind of an interesting scientific observation that we found more activity in patients with a lower burdens of disease. And there are specific populations in people with myeloid malignancies that will have lower burdens of disease, that I'm sorry, I can't say more at this time. But, you know, I think it's fairly obvious where you could go with this. Yeah. And regarding combination agents, I think, you know, we did observe also a correlation of response to people who expressed certain T cell markers. So we would potentially explore, explore that as well. But you know, the next step is, as the artisans and core advance along the timeline to getting that the next set of groups of patients enrolled, we're able to disclose things more fully.
Ted Tenthoff -- Piper Sandler -- Analyst
Thank you so much for the update.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thanks.
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Thanks.
Operator
Thank you. Our next question comes from Peter Lawson of Barclays. Please proceed
Mitchell -- Barclays -- Analyst
Hi, everyone, this is Mitchell [Phonetic] on for Peter, and thank you for taking our questions. For five acota mad I can appreciate how you can't say so much about positioning, but can you talk about maybe the bar for for AML in this population? And how you see that? And then maybe your view on peer Cb 123, CD three data in the space?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, without committing too much on on pure data. I think that, you know, the populations that are that are possible with this. with aging, if we focus on low leukemic burden. It there's a there's a variety of different bars, depending on the specific sub population. So it's hard to give you an answer to that. But we do have good ideas about what the bar is, without also disclosing unfortunately, things we can't disclose.
Mitchell -- Barclays -- Analyst
Okay, and then I think you've mentioned potential other indications that the asset to go into, do you have any ideas of where you might be able to take it beyond the low burden? No.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
I would say it's low burden, myeloid diseases in general, that they're pretty broad expresses of cd 123 things from this month from my lineage and there's a variety of my board malignancies. Be beyond in addition to ml.
Mitchell -- Barclays -- Analyst
Great, thanks.
Operator
Thank you. Our next question comes from Gregory renza of RBC capital markets. Please proceed.
Gregory Renza -- RBC Capital Markets -- Analyst
Hi, guys, this is being long for Greg. I also have a question on Lakota mad. I was just wondering, in light of the recent publication on another CD, three cd 123, by specific that demonstrated association between 233 mutations and completely Swansea ammo, just wondering what your thoughts are on the retail there. And have you explored or plan to explore the potential in subpopulations of AML patients with specific mutation? Thank you.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, I don't think specifically patients are or how we, how we orient this molecule c 123, a pan marker and various modeling malignancies. And so we think of it from a sort of a broader use perspective, focusing now on where we see Lower, lower disease burden. You know, so I don't I don't think there's too much read through through there. Does that answer your question?
Gregory Renza -- RBC Capital Markets -- Analyst
Yeah, they did. Thanks. And I have another one if I may. I'm just wondering What's your level of confidence in the tolerability of 20 717? based on the data so far? And how do you think the design of the molecule contribute to is differentiation from other PD one ctla? Four by specific or combination therapy?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, I'll comment on the design. And then Alan, maybe you should jump in and talk about tolerability observations. So the design of the molecule was so that to take advantage of its by specific structure, it allowed us to design a molecule that requires cooperative binding force in order to have strong binding, cooperative binding to both PD one and ctla four. So there's only one PD one binding domain, only one ctla four binding domain, they have fairly modest affinity. So if there's only one target and the other on the cell, they're not going to stick to well, which means they don't have a terribly high affinity to cells that have low expression of one or the other of the markers, you have to have both. If you have both markers, you get nice avid binding, you have like both arms able to grab on and you know, pull yourself onto the cell.
So that was so we would focus on the volatiles activity, if you were pressing these checkpoints on specific subpopulations that are typically more over represented in tumor microenvironment. That's the double positive checkpoint itself. So that's the distinction of the design and the hope there was to activate the cells that matter for better tolerability and and efficacy profile. So that's the essence of the design. And I think that's distinct from certainly from a combination therapy of two different antibodies. But it's also distinct from most of the PD one ctla, four by specific antibodies that are in early clinical development alongside 20 717. Now maybe you want to touch on the the tolerability and the sort of nature of of ease that we see.
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Yeah, we're very pleased with the tolerability profile to date. You know, as basil alluded to the design, it's hard to sort of demonstrate differences in, in safety in a clinical study, especially a phase one clinical study from sort of predecessor molecules. But with that said, There seems to be a suggestion that the profiles slightly different, we're seeing a lot of rash, we don't tend to see kaleidos, you know, at the, the way the study was designed to 10 milligrams, or milligrams per kilogram was our sort of top dose and we didn't hit an MTD, so we're continuing to dose escalate now 15 milligrams per kilogram, to see if we can dose higher.
And you know, the idea is if you have better tolerability you could possibly dose higher and then get more efficacy. But you know, we still have to sort of see what the maximum tolerated dose is. In addition to you know, in the abstract, there was a great five and a great four event and I can add some color to that, you know, the patient with the great five pancreatitis did have pancreatic involvement and metastasis. And the one with a great for Myo carditis had a non small cell lung cancer that involved the myocardium. So, you know, that is sort of something that's in the abstract, but I think this helps to understand the profile. We're actually very pleased with the data so far.
Gregory Renza -- RBC Capital Markets -- Analyst
Thank you very much. Thank you.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thank you.
Operator
Our next question comes from Jonathan Chang, of SVB Leerink. Please proceed.
Jonathan Chang -- SVB Leerink -- Analyst
Hi, thanks for taking my questions. First question, can you provide any more color on the learned Apollo math monotherapy in combination studies and dlbcl.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
At this time, all the Cabal we're really able to say is that they're phase two studies that were you know, both in in relapsed refractory dlbcl. They'll be looking at specific groups of patients or defined populations within there, but more details will be forthcoming. I think that the strategy that has always been that the broad use of a cd 20, cd 30, again, depends on the strategy you have for how you combine it with other agents, because there's so many agents of different ways that work in non Hodgkin lymphoma. You know that what we've seen for the last 20 years with the success of detoxing chemo, combining them in the right way gives you the best outcomes. And I think we're gonna have a whole new generation of these combination regimens to choose from going forward. But a monotherapy in in this setting could give you rapid acquisition of data and a much faster to market strategy sort of try to have both prongs going. Well, they said we'll have more details forthcoming as the final operational plans and nuances lock into place.
Jonathan Chang -- SVB Leerink -- Analyst
Got it. Thank you. And just second question. From Colombo map, when can we see updated data from that program?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
We will be sending updated data next year and we'll give specifics on the exact timing of that as we get a little closer to the day disclosures.
Jonathan Chang -- SVB Leerink -- Analyst
Got it? Thank you very much.
Operator
Thank you. Our next question comes from Tom Shrader of BTIG. Please proceed.
Carrie -- BTIG -- Analyst
Hi. Thank you. Our next question comes from Tom Shrader of BTIG. Please proceed. Hi, this is Carrie [Phonetic]on for Tom, thanks for taking our questions. For autoimmune disorders, I believe two different approaches are being evaluated in the clinic. One is to suppress auto CDA or effector T cells and the other like yours, which is to stimulate or activate T. Right. Can you tell us what are the advantages? And what type of autoimmune disorders makes sense for your approach?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, I think that it is a bit it, it's sort of suggesting too much to think that anybody really understands the specific cellular etiology and drivers of any particular autoimmune disease I recall, not too many years ago. And this was considered a T cell driven disease and Ray was considered a B cell antibody driven disease. And yet, of course, you see highly effective ms treatments from B cell targeting therapies like like a previous and you see highly effective therapies when you look at T cell blocking therapies in RA, like a redsea. So I think some simple descriptions of what drives the disease makes it hard to decide a priori, what a particular agent or particular mechanism of action, which specific disease types that might benefit. So, you know, I think I think that that means that we have to look at the factors like population unmet need, the preclinical models, that that will help us pick the indications for our automated aisle to program. But I'm not a believer that there's detailed enough mechanistic understandings of most the vast majority of autoimmune diseases to really dial yourself in like that.
Carrie -- BTIG -- Analyst
Sure, right. Yeah, that makes sense. And just the last one for me, oh, with all the engineering going around the aisle to molecules to avoid cd 25 binding, which seems to prevent t reg activation and vascular leak syndrome, at least preclinically. How is the aisle 15 approach different from these novel attenuated aisle two molecules.
John J. Kuch -- Senior Vice President and Chief Financial Officer
So l 15. And this is for our oncology program, our x men 24 306. Currently in phase one studies, with Genentech, a partner, aisle 15, doesn't bind the cd 25, or aisle two alpha receptor, it just doesn't, right. So I think that, that that's a critical feature that you might be able to tune away. I'll talk receptor binding or a four eliminated by regulating in the right spot if the team starts out of that as baseline. And so that's, that's, that's, we believe, are just an inherent benefit and a risk reducer. The other factor is the potency reduction we do is dependent on or rather was was was selected to have really the minimal amount of potency, you could have and still activate the cells. And so I can't comment on the exact degree of how people attenuated the potency of their molecules. But we think having a single defined composition of matter that has a specifically well known potency is an advantage over say, mixtures of different potencies or kinetically, variable potencies, based on some chemical reaction around the molecule, and having it attached to our FC domains, with our extend technology on it to sort of smooth out those bumps. I think is is also a benefit. And we'll see how that all plays out in the in the humans in our 24306 program.
Carrie -- BTIG -- Analyst
That's helpful. Thank you.
Operator
Thank you. Our next question comes from Etzer Darout of Guggenheim securities, please proceed.
Etzer Darout -- Guggenheim Securities -- Analyst
Great. Thanks for taking questions and congrats on the updates here in the progress just a couple of minutes. So first, just went back to, you know, clinical trials. gov to remind myself of the other two checkpoints, a TMA by specifics and just sort of given you know, sort of been dealing with COVID for the better part of the year, just wondering about the progress of these programs and in phase one and what we could expect to see clinical data from from those two assets.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Right, we we like to guide on when we're gonna have clinical data when when we're pretty close to getting those disclosures going on. Note those two programs started about a year after our 20717 program, which we just had our first data disclosures over the last few months. So so they're about a year less mature, having been in the clinic now for something like 15 or 16 months each. You know I can't I can't say without until we get closer have more definitive information to tell you when we would update those programs. But they are both actively enrolling they have not had either of them any meaningful impacts from COVID. You know, dose escalation, and they both they both have dose escalation and expansion cohorts baked into them that, that we should be able to talk to people about in due course, and hopefully not that long, but we can't give any specific guidance right now.
Etzer Darout -- Guggenheim Securities -- Analyst
Yeah, no, that's helpful. That's helpful. Thank you. And second question, just wonder, you know, I guess to the extent that you can speak to discern any major differences and patient characteristics that you can speak to, and the upcoming bit Kodama data, relative to sort of the previously recorded data backpack and fat as 2018.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
I guess within the bounds of the abstract, I don't know, Alan, if there's much we can say about the different. I'm assuming you're asking about demographics that sir.
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Yeah. Yeah. You got another, there hasn't been any significant change to the inclusion exclusion criteria. So, you know, in terms of population shifts of the total patients enrolled, there's probably not going to be changes.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah. So it wouldn't, it wouldn't reflect our our insights around the kinds of kinds of patients in the lower disease burden that were better likelihood of response, that would not reflect that.
Etzer Darout -- Guggenheim Securities -- Analyst
Great, awesome. Well, I can always follow up as well after the presentation, but but thank you.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thank you.
Operator
Thank you. Our next question comes from Gabriel Fung of Mizuho Securities, please proceed.
Gabriel Fung -- Mizuho Securities -- Analyst
Hi, sir. This is Gabriel on from Mara Goldstein. This question here on the 15 243 is just a candidate. How are you thinking about planning? On expansion, the study, I had to get how you think about the planning of expansion studies move forward with more of combinations with portfolio products, more leaning more toward established external candidates? And does the agreement with intake have any restrictions on which targets either party can explore?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
So I'll take that one. So in terms of timing, of course, you have to establish safety, and dose, you know, schedule with the agent before we can kick off other other combinations, we would look at not just our own internal candidates, but also third party molecules. And some of which have been predefined in the contract that we're planning on doing combination studies with some of which we can just, you know, proposing initiate there are some restrictions around Of course, creating problematic safety signals and things like that those are sort of, you know, par for the course for combination studies. But also, we cannot, and we would not want to have the same exact mechanisms of action compete with each other within the sort of overall study approaches, right. So it'll be fairly broad. And we know genetec has a pretty broad view, beyond just in the phase one during that initial combination with the Tesla lism AB, which is something that's been disclosed.
Gabriel Fung -- Mizuho Securities -- Analyst
Right. Good. And also, just one extra quick question on the on your comment about on by Makoto, earlier, when you discuss the ABC my rash thing? kaleidos. Could you provide more color as to your discussions with the physicians in the trial as how meaningful The difference is? And if maybe a physician would prefer a rash over kaleidos events with the drug?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, Alan, you want to you want to take that without obviously speaking for all the doctors and oncologists in America?
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Yeah. So, you know, again, just to clarify, it wasn't for Vivek Kota Mab, it was for XPath 20 717, or PD one ctla. Four. And, you know, I think it's still early in the development to say that, you know, we're gonna sort of distinguish it based on its safety profile, but I think it does suggest differences in the design of the molecule, it's doing the things that we're hoping it's doing. So at this stage, I'm optimistic. But I'm not going to go and say that people are going to use or prescribe differently based on the profile that's always been challenging in oncology. Because when you talk to oncologist, it's always about efficacy.
Gabriel Fung -- Mizuho Securities -- Analyst
Thank you very much.
Operator
Thank you. Our next question comes from Arlinda Lee of Canaccord, please proceed.
Arlinda Lee -- Canaccord -- Analyst
Thanks for taking my question. Um, I had questions about your dis escalations for 1404 five and by the Kota man. I'm so neither of these you've reached an MTV and I'm wondering if you're still in exploring what you're looking for. To decide and to go forward goes. And then on 1404. Five is do you think that going into a lower burden, myeloid malignancy would have the same dose? And I'm curious on the better efficacy that you're seeing, are you also seeing lower CRS? Thank you.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
So there's a several layers of questions there. Maybe to start with the first. And I, you, so you're talking about one programmer by the code, right?
Arlinda Lee -- Canaccord -- Analyst
And the 2717?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Well, mainly the bytecode amount, but also 2017, you haven't.
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Okay, so now I can multiply all that by two, hold on a sec. Just make a note. So um, I think that the places we're still nailing down details around dosing regimen, proportional 45, around exactly the schedule of priming doses to give. So that's that that piece, that's always the last bits of details. And, you know, it's fair to say that the restrictions around dose changing and escalation within a patient that we had put on us by the FDA coming off the clinical hold, just definitely make that make that a little slower of a process. For that, that's fair to say that that made it definitely more difficult.
Arlinda Lee -- Canaccord -- Analyst
So you then ask the question about lower burden disease having necessarily the same or a different dose, Alan might want to take that I guess, you would expect more flexibility around the tolerability, the agent with lower disease burden, though?
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
Yeah, it's a great question Arlinda. In you know, it's really around, not so much the dose. But, you know, remember, we're giving ours intermittent dosing, so you know, every other day or weekly, and, you know, it's the schedule and how quickly you can escalate, because we know that you can get fairly high doses that can be tolerated, but they have to be sort of primed, and you have to sort of move up to that dose.
Arlinda Lee -- Canaccord -- Analyst
And so it's really a balancing act of how quickly do you want the dose to go up? and How high do you need it to go up to get the efficacy that you want to see?
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
And, you know, I think there's a little bit of work that still needs to be done there. Clearly, if you have lower burdens of disease, you may need a different dose or schedule. But I don't think we have that completely figured out yet. And then lower CRS with lower burden disease. I don't know that we have enough data to even comment on that, though. Nothing jumps out.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Yeah, we are watching that. I will say from the history of bi specific that has been sort of demonstrated, you know, clearly with blend seido, the higher leukemic burden has more CRS, etc. So it's something that we would expect to see. And we will keep an eye out for that.
J ohn R. Desjarlais, Ph.D. -- Senior Vice President, Research and Chief Scientific Officer
Yeah, now for 717. Because we saw activity at 10 days per gig, we did expand there and it's it's a tolerable dose and we're exploring higher but we're not letting exploring higher doses hold us back from from really pushing forward with 10 Beats Per King and then maybe maybe adjusting later, if higher is really well. Really well tolerated and suggest it might give us an incremental bit of activity. But we are confident that 10 Beats Per kicks in after dose.
Arlinda Lee -- Canaccord -- Analyst
Okay, great. Thank you.
Operator
Thank you. Our next question comes from Zhiqiang Shu Berg, please proceed.
Zhiqiang Shu -- Berenberg -- Analyst
Thank you very much. Congrats on the progress. few questions here. prepared remarks you mentioned about the strategy for companies to use to decide which program to move forward with program to terminate, I guess at the current state of the art assets, which ones would you would you say that you, you would definitely move forward?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Well, they're all moving forward right now to get that key proof of concept data that gives you that ability to make the decision and that's essentially was for a program stand, I think are polonium and 20717 programs are, are at that point with a proof of concept data is emerging as we observe it doesn't all happen at once. In these open label oncology trials, data emerges and rolls out and gives you the directions to take. So we're in the midst of that decision process for how to advance plasma and 20 717. And we're actually optimistic about both I think we feel pretty confident that both are going to continue advancing for the others will wait data and you will have the thumbs up thumbs down on those data emerges.
Zhiqiang Shu -- Berenberg -- Analyst
Okay, great. And then for iOS 12 and iOS 15 on the sand both of them policy based on, I guess, pretty clinical or translational data? Do you see the difference in terms of which indications for a fighter program?
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
You know, not really, I think that they're both. They both have a broad activity at improving T cell function and number. I don't think there's anywhere near the granularity of data, you would you would want to look at indication based on their specific mechanisms.
Zhiqiang Shu -- Berenberg -- Analyst
Okay, understood. And finally put IO to program for Huntington's disease to understand that you mentioned eventually, probably this will be partnered out, as, you know, as the company's first oncology. When do you think it will be a good time for the company to start looking? Do you want to get the phase one data ready? Or? Or are you looking for parties outside but right now?
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
You know, I would, I would actually park the idea that we're definitely going to partner the aisle to program I think it really comes down to the in the indication strategy, that that we select that we're right now pulling all the pieces together on that we would implement immediately after we come out of our healthy volunteers dose escalation, which we hope happens very quickly. Because that's the beauty of healthy volunteer studies in these autoimmune indications just to get your mechanism of action, you're permitted to damage your PK nail down. That that indications Daddy's going to drive, whether we want to keep the asset for the long haul, or partner it I think that we have to be realistic that sometimes not a new disease partner is what needs to do. But I don't want to make that a predicate. That's what we're definitely going to do that program. We'll be able to give more car on on that as our, our as we can start hopefully disclosing our strategy.
Zhiqiang Shu -- Berenberg -- Analyst
Guy. Thank you very much.
Operator
Thank you. I would now like to turn the call back to Bassil Dahiyat, for closing remarks.
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Thank you very much, operator. And thank you, everybody, for joining us today. Take care of yourselves. Have a great evening. We look forward to updating you again over the coming weeks. [Operator Closing Remarks]
Duration: 47 minutes
Call participants:
Charles Liles -- Head of Investor Relations
Bassil I. Dahiyat, Ph.D. -- President and Chief Executive Officer, Director
Allen Yang, M.D., Ph.D. -- Senior Vice President and Chief Medical Officer
John J. Kuch -- Senior Vice President and Chief Financial Officer
J ohn R. Desjarlais, Ph.D. -- Senior Vice President, Research and Chief Scientific Officer
Ted Tenthoff -- Piper Sandler -- Analyst
Mitchell -- Barclays -- Analyst
Gregory Renza -- RBC Capital Markets -- Analyst
Jonathan Chang -- SVB Leerink -- Analyst
Carrie -- BTIG -- Analyst
Etzer Darout -- Guggenheim Securities -- Analyst
Gabriel Fung -- Mizuho Securities -- Analyst
Arlinda Lee -- Canaccord -- Analyst
Zhiqiang Shu -- Berenberg -- Analyst
