Q4 2023 Kymera Therapeutics Inc Earnings Call

Participants

Justine Koenigsberg; VP, IR; Kymera Therapeutics Inc

Nello Mainolfi; President, Chief Executive Officer, Co-Founder, Director; Kymera Therapeutics Inc

Jared Gollob; Chief Medical Officer; Kymera Therapeutics Inc

Bruce Jacobs; CFO; Kymera Therapeutics Inc

Vikram Purohit; Analyst; Morgan Stanley

Adam Vogel; Analyst; Wells Fargo

Marc Frahm; Analyst; TD Cowen

Brad Canino; Analyst; Stifel, Nicolaus & Company, Incorporated

Kalpit R. Patel; Analyst; B. Riley Securities, Inc.

Presentation

Operator

Good morning and welcome to the Kymera Therapeutics Fourth Quarter 2023 results call. (Operator Instructions) Please not this event is being recorded. I now turn the call over to Justine Koenigsberg.
Thank you.

Justine Koenigsberg

Good morning and welcome to Kymera's investor update. Joining me this morning are Nello Mainolfi, Founder, President and CEO; Jared Gollob, our Chief Medical Officer; and Bruce Jacobs, Chief Financial Officer. Following our prepared remarks, we will open the call to questions. We ask that you limit your questions to one and a relevant follow-up to allow enough time to address everyone's questions.
Before we begin, today's discussion will include forward-looking statements about our future expectations, plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected. A description of these risks can be found in our most recent 10 K filed with the SEC. Any forward-looking statements speak only as of today's date, and we assume no obligation to update any forward-looking statements made on today's call.
With that, I will now turn the call over to Nello. Thank you, Justine.

Nello Mainolfi

And as always, we appreciate everyone joining us for our Q3 call today. This is particularly exciting call for us in that we're reporting from our new corporate headquarters in Watertown, Massachusetts, just down the road from our previous office. Our new building provides added space for our growing team, enabling us to maintain a strong on-site presence as we enhance and scale critical capabilities for our R&D organization, especially in areas like C. and C. as well as other development functions. We look forward to the opportunity to welcome those of you who would like to visit us at our offices in the future, as many of you know, were on-site five days a week during our prepared remarks will cover three main topics today. First, I'll provide an update on our strategy to build the best in industry oral immunology pipeline. Next, Jeff will provide an update on our clinical and newly disclosed immunology programs as well as our two clinical oncology programs.
And before we open the call for questions, Bruce will review our financial results at our immunology R&D Day in early January, you heard us discuss our strategy for building a best-in-industry oral immunology pipeline of first-in-class, highly valuable programs. We believe we're uniquely positioned to change existing treatment paradigms for immune-mediated diseases with our innovative and differentiated oral degrader medicines, as we reported this morning, with $745 million in cash and a runway into the first half of 27 were well-capitalized to continue to support these very ambitious goals.
I thought I'd start with a few comments reflecting on what has ledKymera to our current strategic positioning with an innovative immunology pipeline of oral degraders with biologic like activity potential. As those of you that have been following us for a long time know, we have been driven by our unique type target selection strategy we're focused on first or best-in-class opportunities and in particular and drive or fully for our targets for which protein degradation is either the best or the only solution. We've also dedicated capacities that have been that have strong clinical and genetic validation where there is a clear path for early clinical differentiation. And of course, our focuses on those indications that represent large clinical and commercial opportunities that create significant value for patients and shareholders. As you all know, we pioneered the first protein degrader program in immunology with our ARX-04 program, which in addition to that three were the initial targets at Cana when it was founded in 2016. And it was the early clinical results with the Eric Ford program with KT. four seven for the deep and well-tolerated degradation. The early signs of clinical efficacy, which has this Inspire too increase our focus in immunology. Additionally, we believe the activity and see that the translation of activity, the Block four indicators for seven for Phase one trial services. And this is an important read through and informs the probability of success of our new sub-6 and stick to oral immunology program once that's one aspect of the current landscape in immunology, that is particularly notable and creates a significant opportunity forKymera's. The dominance in the market of injectable biologic. These antibody-based therapies have transformed and revolutionized the treatment of immune inflammatory diseases with what, in many cases have been great clinical outcomes for patients at the same time, monoclonal antibodies, as you know, are injected, they can be costly to manufacture and can be inconvenient for patients.
To put this in context, in a recent industry survey, 75% of patients taking biologics said they would switch to orals with an equivalent profile. We believe this creates a significant opportunity for effective and well-tolerated oral medicines and in particular for protein degraders In fact, while traditional small molecules offer convenience benefits, they frequently cannot match the power from pharmacology of biologics. They don't have the ability to block these pathways at the same level we believe in and have shown with preclinical and early clinical data. Their protein degraders have the potential to provide a unique solution with biologics like specificity and activity.
But with the flexibility of oral small molecules.
Importantly, because of this profile, we believe that they can potentially reach much broader patient populations, creating significant opportunities for the modality broadly and for Kymera specifically so as you think about our immunology pipeline, if we can build a portfolio of molecules that provide comparable pathway inhibition to biologics as we believe we can. But one with the convenience of oral dosing, we believe the potential is enormous. We have a lot happening across our pipeline, including plenty of activities in our early pipeline that we haven't yet disclosed were really at the cutting edge of protein degradation and using this technology to address fundamental clinical commercial needs and opportunities. I believe our unique approach has resulted in one of the most robust high-value pipeline in the industry. I'm very proud of the continued execution and innovation by our team to support our future growth. I will now pass it to Jared to walk you through the more detailed a our clinical and preclinical pipeline. Jared?

Jared Gollob

Thanks, Nello. Starting with our direct for program in the fourth quarter, our partner Sanofi initiated to Katy for seven four Phase two trials, one in Hyderabad, 90 Sepetiba and one in atopic dermatitis. Enrollment in both trials is ongoing with top-line data expected to be reported in the first half of 2025. Importantly, with the start of these trials and the dosing of the first HS. in 80 patients that we disclosed late last year, we collectively earned $55 million in development milestones from Sanofi, which we have already received. We and Sanofi are enthusiastic about the potential for this program. In addition to the two initial indications, we continue to discuss and explore additional potential indications, and we will plan to share more details as we are able in the future.
Moving now to our two recently announced preclinical immunology programs, KT. six two one. Our once daily oral S6 or greater is slated to enter the clinic later this year for makes this program, particularly exciting, is that the IL-4 IL-13 pathway has been exceptionally well-validated CT. 61 targets that six, which is an essential transcription factor to the IL-4 IL-13 signaling pathway and the central driver of type two inflammation in allergic diseases by degrading that six, we believe we can selectively block this pathway fully. And importantly, this pathway only potentially clinical being upstream biologics, such as dupilumab.
At our R&D Day, we shared what we believe is a very compelling set of preclinical data that supports a high level of enthusiasm and confidence we have in this program specifically in our preclinical studies, we have demonstrated full inhibition of the IL-4 IL-13 pathway in all relevant human cell context, what type of mode potency superior to dupilumab and exquisite selectivity. We also demonstrated very high levels of activity in multiple well-established preclinical models that gives us confidence in the potential of KT. 61 to deliver biologic like activity as we advance this program into clinical trials later this year. If we are able to replicate our strong preclinical data in the clinical setting, which is something we have accomplished with our clinical-stage programs, we believe 86 to one would be poised to be a best-in-class therapeutic option for multiple indications representing a multi-billion dollar opportunity. We are currently in the midst of I&D enabling studies and expect to advance KT. six to one into Phase one testing in the second half of 2024 with data from that study in 2025. We also recently unveiled KT. two nine for our potential first-in-class oral tick two degrader. We believe KT. two nine four also has a potential biologics like profiles, creating an opportunity to treat a range of autoimmune and inflammatory diseases. We believe degradation of Take-Two has the potential to overcome the challenges of small molecule two inhibitors, which have limitations due to lack of selectivity, limited target engagement and or lack of potent activity against type one interferon. Importantly, we believe to degradation could allow us to recapitulate the human loss-of-function biology of near full pathway inhibition of type one interferon, IL-12 and IL-23, while also Sperry iOS 10 representing a best in class to two agents. Our plan is to move this program into first-in-human studies in 2025 across our immunology portfolio. We intend to present preclinical data from the SAD 62 programs at multiple scientific and medical meetings this year, starting with the American Academy of Dermatology annual meeting next month. We also expect multiple clinical data readouts from these programs next year.
To summarize, in the first half of 2025, we plan to share top line data from the KT. four seven for Phase two trials as well as data from the KT. six to one Phase one study, which as mentioned is planned to start later in 2024.
Switching gears to our oncology portfolio, we expect additional proof-of-concept data readouts for both KT. three three three and KT. two five three this year. Both programs have demonstrated initial encouraging antitumor activity in liquid and solid tumors and are progressing through dose escalation in line with our expectations for KT. three three three or Stat three to greater. We shared data at ASH in December, demonstrating early signs of anti-tumor activity at doses that were generally well tolerated and associated with substantial statutory knockdown in blood and tumor. Our preclinical to clinical translation showed strong objective responses in both CTCL and in Hodgkin's lymphoma as well as induction of an interferon gamma response in tumor and blood. That preclinically was shown to enhance the response of solid tumors to anti-PD-1 drugs. We believe this supports KD. three three three's potential to address both hematological malignancies as a single agent and solid tumors as a potential novel combination therapy with anti-PD-1 or other targeted therapies. Our intent is to complete dose escalation in the Phase 1a study in 2024, at which point we will share the trial results and disclose our plans for the next phase of development for the program.
And lastly, KT. two five three, our MDM to greater. This is another really exciting program Arm A. of the Phase Ia in solid tumors and lymphomas is ongoing. And in November, we reported clinical data demonstrating evidence of target engagement and P53 pathway activation as well as initial antitumor activity and a lack of the traditional hematological toxicity seen with small molecule inhibitors. We also announced that we commenced enrollment in Arm B for patients with high-grade myeloid malignancies, including AML for both arms of the study. Enrollment is progressing in line with our expectation, Bankwest and three, we expect to complete dose escalation in 2024 at which point we will disclose our plans for the next phase of development for the program as part of our development plans later this year, we also expect to present comprehensive preclinical and clinical translational data across liquid and solid tumors that will inform our patient selection strategy for KT to five three in ongoing and future clinical studies.
I'll now turn the presentation over to Bruce for a review of the Q4 financials. Bruce.

Bruce Jacobs

Thanks, Yaron. I'll quickly review the fourth-quarter financial results, and you can certainly reference the tables in the back of the press release today. As Nello mentioned, with the advancement of force and four into the Phase two trials in HS. and AD., we earned $55 million in milestones from Sanofi. We received $40 million of that in the fourth quarter. The other $15 million, which was recorded as receivable at year end. That payment was received in the in the early part of 2024. These milestones were added to the total consideration received under the Sanofi collaboration with the partial portion recognized as revenue in the fourth quarter and the remaining in deferred revenue. At the end of the quarter, our deferred revenue balance total on the balance sheet was approximately $54.7 million. That reflects partnership revenue that we expect to receive over the next several years, excluding the receipt of any potential future milestones.
And then quickly with respect to operating expenses, R&D for the quarter totaled $53 million. Of that, about $5.3 million was non-cash stock-based compensation. The adjusted cash R&D spend of $47.7 million, excluding stock-based comp, was up 13% from the comparable quarter a year ago.
On the G&A side, our spending for the quarter was $14.2 million, of which $5.6 million was non-cash stock-based comp. And that adjusted G&A spend of $8.6 million, again, excluding stock-based comp, is a 5% increase year over year. And then finishing up with our cash balances, as stated earlier, at the end of 2023 was $436 million, including the $300 million of net proceeds from our equity offering last month and the $15 million that I referenced from Sanofi that was received early this year. That brought our unaudited cash and equivalent balance as of January 9, to approximately $745 million that is expected to provide a runway into the first half of 2027, and it will enable us to deliver the next stage of growth and data readouts, including, as Gerard mentioned, the KT. four seven for Phase two data oncology proof of concept results this year and in several critical and clinical inflection points for our statics and take two programs. So that's what we had for you today in terms of our prepared remarks, and now we'd be happy to answer any questions.

Question and Answer Session

Operator

(Operator Instructions) Vikram Purohit, Morgan Stanley.

Vikram Purohit

So hi, good morning. Thanks for taking our questions on. We had two both on immunology first. So you alluded to in your prepared remarks, potential pipeline expansion for four seven four to the extent possible. I was wondering if you could speak a bit about what's going to feed into that decision and how the datasets we get in the first half of next year for HS. and AD. might be related to how you think about with Sanofi, where to go next with this molecule.
And then a similar question for six to one and 2.4. What will you be assessing from the initial clinical data we're going to be getting next year to help prioritize indications for subsequent development and I&I indications? Thank you.

Nello Mainolfi

Hi, Vikram. Maybe I'll start. So if we're fortunate and four, we anticipate more challenging because this, as you know, this is a collaboration with Sanofi. So we're not in the liberty to disclose that and several things around decision making and timing. But what as we said in the past, the reason why we built this program several years ago, actually, we said today that I referenced that we were the first programs in 2016 17. So the idea around direct for degradation is the opportunity to generate and develop a broad anti-inflammatory drug with a good tolerability profile. So in our in our goal has always been the possibility of high probability to move beyond skin indications. And we've disclosed some of the other potential indications that one could go after really could be respiratory could be rheumatology. It could be GI. So I think it's a and I think when we're ready with our partner, Sanofi to disclose the path forward would be happy to do so. Obviously, I personally I don't believe that a skin indication will inform necessarily the probability of success of this drug in other type of diseases, but obviously confirming the the safety and activity in longer term Phase two studies will bolster confidence to then move into other indications. Maybe that's high level. How I would characterize it today for a for aesthetics and take two. And I think it's early for us to comment on decision-making beyond early early clinical studies. I mean, these are you know we could spend hours talking about your question, maybe just high-level, what's that six that we've been saying now for a few months for which is a two month few months but it's actually two months now is that the value proposition is the oral degrader that can match in biologics like activity of upstream monoclonal antibodies such as dupilumab. We've shown with our preclinical data that we can match that type of phenotype, you know, some would argue were more potent than 18, some contacts that maybe we don't have to go there. So we have a pretty exciting blueprint of development plans in front of us. I think we as we've done with all the other programs for us, it's imperative that we go into humans and demonstrate this beautiful translation that we've seen with other programs of target knockdown, predictable safety, predictable PK/PD. And then we have this, I think, very elegant biomarker strategy that we'll be talking about later in the year that I think will allow us to validate the ability to match on the type of pathway, the vision that upstream biologics to end 42 briefly again is a well-characterized mechanism. We know what other tick two inhibitors are missing, which I would say several things. Some are still activities in all our target engagement that and some our ability to block and all the other scaffolding functions into what good looks like for us is a loss of function like phenotype, and we know what that looks like based on human genetics. And that's what we want to confirm in Phase one. And then once we're there, I know Joe and his team will be happy. I'm sure to share more details about the development plan.

Operator

Michael Schmidt Guggenheim.

This is Paul on for Michael. Thanks for taking our questions, minor on KT. three, three three on the first one is on your bar for pursuing a development in solid tumors. And I believe that actually that had about a third of the patients with stable disease. So would higher rates and stable disease and biomarker data be sufficient to advance the program into combinations? Or would you really need to see some objective responses to sort of commit to the evaluation in solid tumors? And then second is just how does your thinking now on for statutory and autoimmune put into your current pipeline that are waiting for data to evolve further before making for the committed? Thanks.

Nello Mainolfi

So maybe, Jared, you want to take the first one and then I'll make comments in the second one

Jared Gollob

Sure. I think regarding your question on the bar for solid tumors, as you noted, and we have had some patients who have had prolonged stable disease and that, of course, is of interest to us. And we continue as we enroll patients onto the study, continue to dose escalate and look for opportunities for bringing on solid tumor patients that can give us a better idea as to what our activity will be as a monotherapy in solid tumors. I think all along, we've been guiding that we expect that ultimately, if we move this into solid tumors, it would be a combination approach and especially a PD-1 combination is something we're very interested in based on our promising preclinical data and based on what we've shown with our biomarkers that we can induce this interferon gamma response in tumor and blood, which and we can actually facilitate responses. They have a PD-1. We're also looking at additional targeted agent combinations preclinically. So I think what we'll have for moving forward with solid tumors will be a combination of what we continue to learn preclinically with combination studies and whether we do see continued signals of some sort of activity as a monotherapy, either stable disease or even preferably new major responses at with regard to major responses, we are seeing those in hematologic malignancies, including Hodgkin's lymphoma and cutaneous T-cell lymphoma. And that continues to be of interest to us, and we'll continue to bring on patients onto the ongoing Phase Ia study to further explore activity there as well.

Nello Mainolfi

Yes. Thanks, Jared. That's great. And then done the surgery. And I maybe I just want to go back to our strategy, which is something that we've talked about at the R&D day, we believe we exist to bring together the power of the technology and unmet needs that are both clinical commercial. And I would say also the opportunity to do with this technology, things that it cannot be done with other technologies. So I guess another type of unmet need, the technological One & Only I think when we marry those three together, we're going to go all in. And as you've seen with direct for which that seeks to, I think we have a very, very easy to articulate value proposition. I hope you guys also feel that way. And these are complete degradation of target that lead to exceptional anti-inflammatory profiles that are well-tolerated, at least in our hands so far until we start three, it's obviously a program that we know I would argue better than anybody at this point. We've been working on this target for several years and the reason why you haven't seen us disclosing more details on Saturday night because we feel that at this point, we don't have all the information in hand to being able to say that we'll see the profile of the type of programs that we've articulated so far when we do when it does and will be we'll be able to do so. We'll disclose more.

Operator

Elli Merle, UBS.

Yes, this is [Jonathan] on for Elli. Thanks so much for taking your question. And hi, this is Jonathan on for leaving so much for taking your question. What's the latest thinking on whether you would take both at dot three and the M2 into Phase two? Or is the thinking that you'll prioritize one over the other given your focus on immunology and what would your threshold for success be for each program and thinking go and no-go decision?

Nello Mainolfi

Thank you. I think I felt like there were to be moved. But anyway, I think we got the question. I'm sure there were similar questions. So So great question. So maybe I would start with saying that it has everything that we've done at Kymera new for the past almost eight years, all our decisions are going to be data driven. So and as you know, for example, decisions that we made for programs that were discontinued, for example, for one three, even though the molecule was behaving well and was well-tolerated was driven by a plethora of data. Obviously, the clinical commercial landscape and continue to do a larger sample set is the analysis that we did. So we'll apply the same rigor to all programs in our pipeline whether these are in immunology and oncology, as we've said, in order for us to invest in the, let's say, these two oncology programs, we need to be able to see in front of us opportunities to impact broad patient populations. So I think our goal criteria for both programs will be driven by opportunities. There are both in heme and solid tumors generally at this level. And I think we'll we should probably wait for when we disclose more data later in the year on what exactly the strategy will be, what I will say that for Stat three, we've shown something that has not been shown before, which is this is an active target and we have an active drug. We've shown a small data set in December at ASH will show more later in the year. And in MDM2, we also have an active drug which showed really few patients. Data in November will show much more later in the year. So I think only one we're able together to look at the totality of the data. It will be much clearer what the decision-making process is going to look like.

Operator

Thank you. The next question is from the line of Geoff Meacham from Bank of America. Please go ahead.

Hi, good morning. This is [Susan] on for Jeff, thanks for taking our question. Can you walk us through what the strategy is for indication selection for the immunology program, the subsection B, the sorry, the Tek-Tools and BMIL. four? And just commenting specifically on maybe competitive landscape or maybe what kind of data you're when you look at prior to initiating first-in-human studies?

Nello Mainolfi

Okay. So I'm going to take these really high level just because I want to be consistent with our message, which has been that as we get into the clinic in our healthy volunteer studies at least 4% fixed and 42. I think at that point we will feel more comfortable talking about laser development for several reasons. One, we don't have to talk about it now and to visit this, this will be the landscape. As you say, it is competitive and I don't believe at this point is necessary to disclose information that are not needed so just so better with a high level. What I want to say is a high-level for statics. I don't believe that there are a well-tolerated oral drug in indications in which to belimumab has been approved. It was well-tolerated, stronger activity. So we have a huge potential in a variety of indications. I don't have to name them because they're all well established from ADRs and hopefully soon COPD, chronic sinusitis in other COEO., there is actually white space in that area for oral drugs with a good safety profile. And so while, obviously, all of those indications are going to get more and more competitive given large investments that the biopharma is putting into immunology, we're actually in a really unique position right now going forward. And once we disclose our development plans, you'll see and how how much we would be able we believe to be really competitive in terms of timing of both of our trials as well as the design of our trials.
With regards We stick to it. It's obviously a different landscape, but I would say that there was there are several Tier two small molecule inhibitors. We've seen also recently data from another 23 peptide from Protagonist slash J & J. There is still room to match 23 type one interferon biologics, especially in a single oral molecule that is well tolerated and active. And so I think that is the gap that we're going to see with our programs. So just patient on the design, but they will come, you know, as we get into the Phase one study.

Operator

Question comes from Thomas Smith from Leerink.

This is [Will] on for Thomas. Thanks for taking our questions. A couple on the Zen and advanced trials. If you could give us a sense of how enrollment is progressing thus far and any color on what the patient enthusiasm willingness to enroll has looked like and when enrollment is complete for those trials, are you planning to share that information or just wait until the data release and then I have a follow-up.

Jared Gollob

Thanks for the question. Andy, as you know, that Sanofi is running both of those Phase two trials.
And if you look on clintrials.gov. You can see the publicly stated time lines for estimated primary completion for both of those studies, which is in the first half of next year and to our knowledge you know, both studies are still on track to meet those time lines, and that's pretty much all we can really say right now with regard to how those are staying on track. Our understanding is that there is significant enthusiasm out there of the various states we're being engaged with. These are both sort of global studies. And so I think that's been very encouraging in terms of what we've heard from Sanofi in terms of site engagement. And so I think again, in the works, we're still expecting that both of those studies would read out on the top of the stated time lines in terms of. Yes, the sharing of data, I think that will be something that, you know, Sanofi and Kymera will need to sort of work out in terms of exactly how that will look and next year in the first half of next year when those readouts are expected to occur.

Okay. That's helpful. And then on the follow-up as well.

Operator

Next question comes from Kelly Shi from Jefferies.

Yes, hi, good morning. This is Ian for Kelly. Thanks very much for taking the questions and are able to share the status of the dose escalation in step three and also the MDM. two program and also on are able to have you disclosed, have you reached the targeted 90% degradation that you so could be required for in clinical efficacy and also for I&I indications. Is there a specific threshold like the 90% in oncology indication that you think you will have to achieve? And based on your experience with oncology indications, how confident are you that then preclinical degradation data will translate into human data?
Thank you.

Nello Mainolfi

It was I think three questions and I lost track of them. But so let's start with the oncology program. So we generally do not provide updates in this quarterly call on how recruitment is going. We provide updates when we disclose data, obviously, and we tried to target medical meetings. So you should just look out for meetings later in the year where a full update on each of those two programs will be provided. And we love to share our plans. But because, as you know, there is extra commission and then we need to hear from the conferences. We're not able to now confidently say exactly where, but just know that there is a plan in place and we believe this will be both presenting the high impact medical meetings within 2024. If you look at what we've disclosed so far, obviously, we have reached for Stat three, the targeted degradation and really here we continue dose escalation because we're getting through we're targeting to reach an MTD, which, as we've seen preclinically seems to be above our targeted degradation. And that's really a testament to the design of the molecule, the design of the study that the translation has happened in a very predictable and positive manner for MDM to its earlier. I think it's hard for us to comment based on three, four patients' worth of data that we shared in November. So just stay tuned for our next update where you'd be clearer where we are with regard to target engagement?
You know, I think if you look at all our programs, if you look at our R&D data or actually on our corporate deck today, you will see that each one of our programs, whether in oncology or immunology, we have reached targeted liberalization in the clinic with a good safety profile with ARX-04. We reached complete degradation in blood as we've said, three, we've reached more than 90%, around 90% or more depending on patients in both the bladder tumors with even for one three, we reached our targeted degradation. So we know really well how to design our molecule and translate that those profile in the clinic. So we expect that for sub-6 and stick to that should happen just the same way like that is one thing that we're not concerned about here at Kymera.
And with regards to what is the profile in immunology, the profile in immunology is what you've seen in our preclinical data, you've seen very few degree, for example, that six anywhere between 80% and 90%, you can match dupilumab activity in those preclinical, for example, asthma models or even 80 models. So it doesn't look like you need complete target removal. But we will as we've done in the past as target complete, that's that six degradation and I know that we can obviously do a dose exploration in the clinic similarly with Pictou. So so once once we generate data, we can talk more about what is our late-stage design, but the Phase one design will look a lot like the DRM04 program for immunology.

Operator

Thank you. The next question comes from Adam Vogel with Wells Fargo.

Adam Vogel

Go ahead, and thank you for taking my call today. I'm on for Derek. So maybe just a few quick questions from us on oncology pipeline on new markets. Further, what data you expect to share from KT. two Phase three will be reading out data from both arms A. and B. And then perhaps on given your deepening focus and efforts in I&I, will you be looking to partner either at three to three or two by doing that? Thank you.

Nello Mainolfi

All right, Jared, maybe you take the first one. I just want to take the second first. So on, you know, I think we need to think about for us, our decision to invest in programs is driven by a philosophy of the opportunities and the return on investment and the patient impact. It turns out that based on our analysis, if you look at our current immunology pipeline, we believe that these are all extremely valuable program at the outset. I think for our oncology pipeline, we believe that is the program translate into a way that we hope based on preclinical data. Those could be also really valuable programs MDM to if we can unlock it, that biology day is going to be another really large program for us that three, if we're able to also unlock the of the solid tumor opportunity, I think there will be the case, too. So I think that partnering discussion comes with the conversation around what type of expertise we want to build in terms of late-stage clinical and commercial, given that we're still an early company, I think at some point, hopefully we won't be asked anymore. You know, you can only do one versus the other because we're trying to build a large commercial stage company. And as you've seen all, the successful ones can navigate multiple disease areas. But we also are not naive. And so we understand that at this stage in terms of late-stage capabilities, it probably makes much more sense to invest in one area. And we've said very clearly that we're committed heavily in immunology. And so I think with oncology, the question is what are the key value driver thatKymera wants to drive this program through? And then if we feel that these programs are best positioned in a collaboration for maximum value creation. We can do that, but we also reversed the reserve the right to being able to advance this program or one of these programs on our own, if we believe that the value proposition fits the philosophy of the Company right now. Jared, maybe you can comment on the type of data and to further ensure.

Jared Gollob

So our plan for this year is to complete dose escalation across both studies to three three three eight two five three new Phase Ia trials and to establish an MTD and then to present those data at a medical meeting later in the year. That would include, of course, update on enrollment, the types of patients that we're including in four to five three, as you mentioned, yes, we're enrolling in both the solid tumor and lymphoma Arm A., as well as in the high-grade myeloid malignancy, AML RMB. So to show what types of patients that we enroll, what's the safety profile look like? And what is PD. and what kind of clinical efficacy are we seeing to start to give us insights into where we want to go in terms of the next stage of development for both of these programs. And as I mentioned earlier in the presentation upfront for two five three. We've also been doing a lot of work on preclinical work and clinical work to really understand your patient selection, both for the remainder of Phase 1a, but also for the next steps in development. And so I think we're also looking for an opportunity potentially at a medical meeting to present those data sometime this year as well.
To give further insights into how we think about patient selection for either liquid and solid tumors we have to fight for it.

Operator

Next question comes from Marc Frahm from TD Cowen.

Marc Frahm

Thanks for taking my questions, but maybe I'm no direct for when we get the data next year and Sanofi will make their own decision of going forward or not. But you guys will also have Sanofi chooses to move forward. You guys will have an opt-in decision, say how are you kind of approaching that the opt-in? What do you want to see that you would commitKymera's resources from early on and how important is kind of the Phase one data from stat six and two and seeing carry exposure? Do you want to make that decision prior efforts?

Nello Mainolfi

It's a great question. It probably requires a very nuanced answer. So I'm trying to do my best in the short time we have. So first, as I just said earlier, we are extremely bullish on Eric for our value proposition. It's only grown with more data. This has the potential to be one of the largest drug in inflammatory diseases. We have early positive data, but I think we are all here recognizing that we just don't know how active this drug is until we run a well-powered randomized study, which is what we're doing with Sanofi actually within two of them on the value proposition for this drug, in our view is, as I said earlier, it's the inactive oral drug with a good safety profile in indications that, to be honest, go well beyond HS. and 80, I think these are these are obviously treating exciting, early indications, but by no means our view is that this is where the drug should go only, I think gives the drug to fill that profile and we believe the Company's position to to support the growth of the Company, the way we see it today for us would be a no-brainer to obtain when the time is right. Again, if the drug fulfill that profile and the reasons are very not only the value that can be created downstream. But the way that our collaboration is built, we've done all sorts of analyses and all the analysis that we've done financially, even though it might be a bit more expensive early on in the opt-in phase while we do in co-development, the value creation at the back end is so vast that the decision will be so easy.
Yes. If we have successful programs with Phase one, which we believe will be sufficient to, I mean, I suppose that our cost of capital will be different that we can continue to sustain the growth of this company to support the pipeline. So hopefully that answered the question, but that's that's how we're viewing it at this point.

Operator

Brad Canino, Stifel.

Brad Canino

Can you morning this is Brad and perhaps an expansion of the prior questions. Really for MDM to and the data this year would be great to get just more of a scope of the disclosure that you expect to present in terms of patient's disease types. And would you flag any key data elements to watch. And just maybe to be clear on the decision making process at this disclosure, will you be in a position to outline the broader development thesis? Thank you.

Nello Mainolfi

So maybe just high-level, and then I'll ask Jared to comment on some more specifics, if it's if we're willing to do so. But I think there is the totality of our of our data of our disclosure plans, which hopefully was clear enough from from our press release and from comments from Jerry's earlier.
So what is the totality of the data? The totality of the data is large. We hope that hopefully because the complete dataset from the dose escalation in both solid lymphomas and leukemias, married with the the patient stratification work that we're doing that should enable us to build a development program, extremely differentiated from others in this space. I think if those things come together and we believe we should be able for those things to come together in 2024. And if all of those are suggesting that we both have activity and also we have see, let's call it a smart way to develop this drug. I think that decision of continuing investment will be a no-brainer, obviously, then depending on the nuances there, the decisions could be different. But I think that high-level the expectation. I think this year what I hear, obviously, a lot of excitement around the immunology programs and we share those, but those would be 2025 datasets. Many datasets impactful dataset. But I also want to make sure we're also paying attention to 24 data releases around these programs because we believe there is an opportunity here to change how we think about this target and what about patients that are we can say.

Jared Gollob

I mean, I think maybe just to briefly elaborate, you know, I mean, obviously for this program we do plan on providing a pretty comprehensive update later in the year. As I mentioned earlier, our hope is to peek through dose escalation in both arms. You know, the solid tumor and lymphoma arm and the heme malignancy arm to really provide a comprehensive update on safety, PD and efficacy. Keeping in mind again, that one of the important premises here is that this is going to be very differentiated from the from MDM to small molecule inhibitors. We want to show that we have a therapeutic index and is superior to MDM to small molecule inhibitors that takes into account both superior safety as well as potentially superior efficacy. And so I think our aim is to be able to show that dataset that will hopefully establish, you know that we are well differentiated from MDM to small molecule inhibitors and show what the real potential is for this drug in both solid tumors and in liquid tumors and to marry that to our presentation, potentially with a separate presentation on our patient selection strategy, which is also going to be a very important part of what we do moving forward after Phase one.

Operator

Kalpit R. Patel, B. Riley Securities.

Kalpit R. Patel

Hey, good morning and thanks for taking the question. One for the for the stacked six and two program, and you've shown data from their proteome study to confirm the selectivity and maybe rule out the off-target effects. Can you share how many proteins were identified in those studies and what the coverage rate was in those proteome studies?
Thank you.

Nello Mainolfi

So we run so we're not going to share anymore data today on that program, and we're going to be, to be honest, quite sensitive about what else we're going to share just based on. We want to maintain our competitive advantage here. But that doesn't mean I'm not going to answer your question. So we have high proteome coverage in these studies. We usually can detect north of 11,000 proteins in every proteomic study. And what we do at Kymera we actually look across several cell types. So what we've shown, I believe where PBCI., because we believe are one of the more relevant for the diseases we're going after. But in order for us to actually cover the whole proteome, which as you know, it's in the 20,000 proteins roughly of resizing. You can get a round number here so we actually go across many cell types so that we actually cover 100% of the proteome. And the picture that you've seen in our slides is consistent. We only really leverage that six.
And I would say we always really bind to statutory, and that's true also for the Tipton program and for the for growth and for the whole company.

Operator

Andy Chen with Wolfe Research

Hi, This is [Emma] on for Andy. Thanks for taking our question. I guess just focusing on tech, too, curious where you see weaknesses inhibitors on the market and just how much headroom there is for improvement with a potential degrader entrant like KPT. nine points in them. Thank you.

Nello Mainolfi

So I mean, as we said before, there are several layers of differentiation a. So there is first to that small molecule inhibitors. These are other steric inhibitors that are actually block also this kinase function and some of the scaffold function, but not the full scaffolding function. And so the actual phenotype of small molecule, even allosteric inhibitor is closer to kinase inhibitor than to the loss of function profile.
We have a slide in our deck that shows you with the pluses and shows where is the kinase that versus loss of function versus wild type and only a degrader Mary's matches sorry, the loss of function profile, which basically means we Block 23 as well, type one interferon in spare I have time. So the comparator is approved. The drug that is approved right now, which is in our steric inhibitor that actually is not as selective. It actually impacts also Jack one. And so also impacts IL-10, which is a big detriment for GI indications.
It's also not very selective.So they have to play around with the doses in order to hit the target, had a reasonable target engagement and other molecules in the clinic as more I would say, maybe a higher selectivity profile, but they're not able to block what was the scaffolding function and match the loss of function profile. And we believe that by blocking the pathway fully we should be able again, as we've shown with that six, we've shown with Eric for once you you have to find the mode of full pathway blockade, you should be able to match the upstream biologics to the 23 biologics, the type one interferon biologics in a single oral molecule. So what does that what is that going to translate in the clinic. We don't have a number, right? So if you look at biologics in psoriasis, they reach, you know, close to 90%, a tidy 75, for example, small molecules don't get there. They get into the 60s 70s, maybe we are pushing into the mid 70s. So maybe that is a gap that we can feel. But I think that the actual extent of of gap that we're going to be filling with our degrader. We have a goal of biologics, but we actually don't know it might be even superior or may be RBCs and slightly inferior. I think that is a clinical experiment that we have to run. So all we're saying here is that biologically, we have a differentiated profile and we have confidence that that will clinically result in a meaningfully differentiated drug.

Operator

Thank you. This concludes our question and I would like to turn the conference back over to Justine Koenigsberg for any closing remarks.

Justine Koenigsberg

Thank you. And on behalf of the Kymera team, we'd like to thank everyone for joining us this morning and look forward to keeping you updated on our progress in the meantime, please don't hesitate to reach out if there are any additional questions following today's. Thank you.

Operator

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disocnnect.