Awesome. Thank you everyone for joining us today for the 44th Annual TD Cowen Health Care Conference, everyone here and, you know, watching the recording online. We're really excited to turn it over to the Zymeworks management team. So with that, take it off.
It's great. Thank you very much. Pleasure to be here presenting Zymeworks for the first time at the TD Cowen Investor Conference, and thanks to those of you who stayed through day three to allow me to, to do that. Of course, those of you joining on the webcast, as you'll see on this slide here, I, I do expect and you expect me to make forward-looking statements about our business. So I, I refer you to our, our SEC filings, and other risk factors and information that you can, you can read at your leisure. With this slide, I'd like to try and explain to you why we are so excited at Zymeworks about 2024 and, and 2025 coming up the next two years.
We worked really hard over the last 2 years since I took over as Chair and CEO to put ourselves in exactly this position, which is to give ourselves the financial bandwidth, cash runway to really proceed with what we think is a really exciting portfolio of R&D agents, some like zanidatamab, which are right in front of a regulatory review process, and others which are moving into clinical studies and a longer-term R&D strategy. So I'd like to try during the course of the 30-minute timeframe explain to you so you can understand why we are so excited about our particular position in the oncology space with these agents. Obviously, as you can see on the left-hand part of the slide, zanidatamab is now going to be prosecuted this year in a regulatory review in the U.S.
And China for its initial indication in biliary tract cancer. And there's another phase 3 readout happening later this year in first line GEA patients in the HER2 targeted space, which we're obviously really excited about understanding how our phase 3 study can kind of confirm in a larger pivotal global study some of the exciting results we saw in phase 1 and 2 with this agent in this patient population. Beyond that, we're about 18 months ahead of creating a broad portfolio of both antibody-drug conjugates and trispecific antibodies in our 5 by 5 platform. So over the next 24 months, we'll have 5 new INDs filed to do 5 new studies in first-in-human in some really exciting agents.
For a company that hasn't filed an IND in 5 years, it's a really exciting timeframe for us to think about the productivity in our R&D group. And beyond that, that's not the end of it. We, we see a very productive scientific team doing high-quality science in next-generation antibody drug conjugates, next-generation TriTCEs, as well as going beyond that into other novel, diverse, innovative medicines. We're really excited about the long-term perspective for the company, even beyond the 5 by 5. And fortunately, we've put ourselves in a financial position to have the cash runway through our current cash position and additional milestones that we'll receive from zanidatamab's commercialization to be able to finance the high-quality science that we see inside our doors every day. I'd like to try and describe more of that to you during the course of the presentation.
This is the starting point for the slide. I drew this for our team the first day I started. We have chosen to work with our multifunctional therapeutics, our complex biologics on the most difficult to treat cancers that we can find today in the world. There are areas in oncology that have not been touched by innovation through other product modalities that have occurred in our sector, and these are areas of unmet need because we think additional innovative compounds like we're generating in next-gen ADCs, TriTCEs, which provide novel mechanisms that have not been tried before in patients, might provide the clinical responses to move the survival benefit needle for this group of patients. So our entire portfolio takes place within this sphere that we like to operate on.
And again, it's, it's the area that's most difficult, but we think if we can really make a breakthrough in these cancer indications, then that's where we want to spend our time and our innovation. Here, as I mentioned, we've got a great cash runway out to the second half of 2027. So we started the year with $455 million.
In addition to that, we obviously have additional monies which could become available to us. We can clearly support both the 5 by 5 program we have of taking 5 novel medicines into the clinic over the next 24 months, as well as a longer-term R&D strategy, which is going on in the background behind those. So let's start with the first part of our business, which is building next-generation ADCs. We developed auristatin payloads as our first two ADCs. One of which is in the clinic, which we own unencumbered.
The other is which is now under development with Exelixis as their tissue factor ADC. We completely pivoted on our thoughts around the ADC business a number of years ago to really focus on some other elements that we thought would really break through and see ADCs take their place in an earlier stage of patient population and more seen as combination agents than being used as monotherapy in late line. One of those big switches we made was to really focus on the novel payload in the camptothecin analog class focused on TOPO1 inhibitors. We still believe right now as a payload of choice that will deliver if you've done effective in ADC, better and more effective and durable responses in patients than other payloads that we or others have previously worked on.
So our three ADCs going in clinical studies this year and next year all contain a proprietary payload that we spent, a couple of years in a medicinal screening effort finding the perfect payload in that class that we think works well as an ADC rather than repurposing the existing drug. And we just published that a couple of weeks ago so that you can actually go and see the effort we took and the characteristics that we were looking for in that payload to make it effective in ADCs. And we put this payload on all three of our next ADCs against different targets. We also, having started life as a protein engineering company, believe that the antibody characteristics on an ADC are equally important to your linker conjugation and payload strategies.
So we always focus on best in class characteristics for an antibody attached to an ADC, which might be mono binding, might be biparatopic, might be bispecific as we've done. But we focus on internalization as an important characteristic and tumor penetration as a characteristic. So we think it's not all about payload linker strategy. The antibody plays a very important part in making an effective ADC and maybe as a protein engineering company where we started, we focus a little bit more on that than maybe some of our other competitors and peers. But we've pivoted on our ADC program in the last few years. I think scientifically we feel very comfortable with where we are and how we develop ADCs. A little bit more about the payload on this slide. In the camptothecin analog class, you really have 2 choices.
One is to pick an existing drug, and repurpose as an ADC. That's quick, but maybe not the best way to deliver that type of payload and ADC construct. So what we have done as others have done is do a medicinal screening effort, which we've detailed in a recent publication to then select what we think here is represented by 519 as the best camptothecin analog to deliver in an ADC format where you're trying to understand what that payload will do in an ADC, as opposed to what that payload might do as a naked chemotherapy agent or toxin. So we think that's an important part to our thesis of why we think we could be successful against some of these targets and be competitive and differentiated. And I suggest you read that publication and why we think that's a big part of our investment thesis.
We're not alone in this. It is how Daiichi constructed their DXd portfolio of ADCs, and there's others who've done this, but you need the time and capital and inclination to think that this is an important factor. And we believe that, and fortunately over the next 2 years, we'll be able to have clinical data to hopefully support that proposition in building these 3 ADCs. As you can see, the 3 ADCs going in the clinic with the 519 payload are shown here as they go in the clinic in 2024 and 2025. So ZW191, which is our folate receptor alpha ADC, ZW220, which is our NaPi2b, and ZW251. You can see when you start to look at our portfolio on this slide, and I'll follow up with the T-cell engagers.
We're very concentrated around a number of therapeutic categories in that sphere of where we work that I showed you earlier. One is in non-small cell lung cancer where we really like the idea of targeted therapy in that patient population. Gynecological cancers, both ovarian and endometrial, we also see and has been proved by Mirv that ADCs can play an important role in moving survival for that patient population. And GI, which is where we started with Zany and BTC and GEA, ZW251 takes us there in HCC, but we also have other ideas around colorectal cancer and pancreatic cancer. So, although we have a sphere that I showed you on the other slide, we're really concentrating our current efforts around those three therapeutic categories, and we have multiple opportunities to bring targeted therapy to those patient populations.
Our first one, which will be in the clinic this year, is ZW191. It is our belief that folate receptor alpha is a very important target, but the importance of folate receptor alpha is the breadth this biomarker has across patient populations and across expression levels. So we design a specific ADC, which we hope will have efficacy across multiple tumor types. And also at different expression levels of this biomarker in patients, which is different than where the current compound, which is leading, is approved, and different than maybe other folks are thinking about from a development standpoint. It's a really interesting biomarker. We developed a really interesting antibody here, which we think is very differentiated. We don't think any other antibody on a folate receptor ADC internalizes or penetrates tumors as well as this one, because we've compared all the ones we could get.
We can't find one. We think that's an important element for doing what I talked about, which is trying to find efficacy across tumor types and across expression levels. Selected a DAR 8 here, which we think is ideal for this particular target. Although some of other ADCs are different than this, really looking forward for showing how some of our preclinical evidence that we have now, that the construct we have with the antibody, the linker, which provides a good bystander killing effect, and this 519 proprietary payload can all work together holistically. To hopefully find a way to explore this particular biomarker broader than it's been explored by the approved compound or others in development. We're really excited to put this in clinical studies and prove our hypothesis. We're obviously not the only ones exploring this target. It's the case with every target.
There's no exclusivity anymore. There is some differentiation here. If you look on this chart here, we tried to simplify it where we can. There's a number of other competitive compounds in clinical studies, which are taking the approach of using a repurposed drug like Exelixis uses their payload. There are others like ourselves and AstraZeneca who have taken the approach of using a proprietary payload, which hopefully has a more modest potency and ideal drug characteristics to make it optimized in an ADC structure. And we'll probably see AstraZeneca data this year around their approach. And again, we're starting in clinical studies this year.
It'll be a little bit before you see our approach, but we're convinced that the modest potency, the great internalizing antibody, the design instability in the linker, and then proprietary nature of our payload, is how we can have a winning combination, across the breadth of potential patient populations of folate receptor, regardless of expression level and look for efficacy everywhere. Second behind that, another target, which is also again in ovarian cancer, non-small cell lung cancer, NaPi2b, which will be in the clinic, in 2025. Again, same payload, same great internalizing antibody, same linker, design instability concept. In this case, a DAR 4. We tend to make DAR 4 and DAR 8 versions of all our molecules. And then select either one before we go to IND based on certain characteristics.
In this case, we think a lighter touch ADC with a DAR 4 where we could potentially dose up to a higher protein dose to get efficacy is the way to go with this target. So it was target specific versus folate receptor alpha. As you've seen, there's been 2 unsuccessful programs in clinical studies in here, 1 from Roche and 1 from Mersana. 1 saw some issues around liability, 1 did not. We have not seen any of that in any of our preclinical data. We think the combination of what we constructed here as an ADC could be a very effective way to target NAPI 2B. There's also 5 new NAPI 2B compounds disclosed in the AACR abstracts yesterday in preclinical. So we're obviously not the only ones, but we think we have the right construct for this target.
It's another way for us, again, to look at the patient population in non-small cell lung cancer and ovarian, which are 2 important target populations for us to consider. We've got some really great data now showing, I think, how the combination of our antibody linker strategy and proprietary payload delivers a different mechanism than what we've seen before with either Roche and Mersana. And we're really excited to, to put this into clinical studies, and prove out some of this preclinical data as well.
Beyond that, there are some differences again that we tried to characterize on this slide here, but between the 2 prior failed programs and why we think we're very different, in many different ways and can be successful to maybe see this as a biomarker of interest in this patient population. Well, more to say about this as we get into clinical studies as well. Beyond that, really exciting and a little bit more novel than maybe things that have been pursued before is GPC3, which is a very important and interesting target in HCC. A number of product modalities have been utilized in development against this target, whether it's an antibody T-cell engagers or CAR T and now radioligands.
We think there has been difficulties in designing an effective ADC to be used in HCC for a variety of reasons, but we think, again, the combination of how we think about a strong internalizing antibody, the linker strategy, the proprietary payload, but also an antibody that's designed specifically to be used in standard of care in combination. So our thoughts around ADCs are how do we use these in combination of the earliest stage of a patient's treatment cycle? In this case, standard of care in this population is usually still A plus B, PD-1 plus VEGF. This particular ADC is designed to be used in combination with those agents to deliver combined efficacy with acceptable tolerability on a combination basis. That's how we designed it. It was behind the selection of DAR 4 for this compound versus DAR 8.
The characteristics of this payload, we think, make it ideal to be used as an agent in combination with A plus B or other standards of care that come along in a way that chemo regimens have not been able to be utilized in HCC. So really excited for this to be put in the clinic again in 2025. We're not alone here. But this is definitely a more novel application of an ADC than others have tried, a more narrow clinical application than you might see with folate receptor alpha and NaPi2b. But we think there's a chance here to make a tremendous benefit in the poor overall survival rates for even the earliest patients with HCC.
And so we think we have something that can be used in standard of care to really make a difference, and we're excited about putting this in the clinic next year and trying to understand if our preclinical hypothesis can be proven in clinical studies. And again, we've, we've disclosed and we'll continue to disclose preclinical data about why we feel this way, maybe why we selected a DAR 4 versus DAR 8. But all of our agents, with the way that we build them, seem to be able to get to a protein dose that we believe is in the effective range for an ADC and delivering a modest potent payload with a strong bystander killing effect because of the design instability in the linker.
Maybe the way to get at some of these targets like GPC3 where ADCs have not been able to be used before or even naked chemo agents or toxins. So here we still think it's a very important patient population, as I mentioned earlier, to really move the overall survival needle through innovation. And it's, it is a patient population that's failed to benefit from a lot of the innovation in our sector. And we're so hopeful that this ADC approach that we have will be able to really benefit these patients in a way that we've not been able to see before. And I've explained all of these elements already, so I'll skip through that. Beyond that, we're not just an ADC company. We started out as a protein engineering company, as I said.
So we have another concurrent arm of the company that focuses on multi-specific antibody therapeutics, which is our attempt to make a better bispecific, which in our words means trispecific. So how can I use three binding points to build multiple mechanisms into a T-cell engager to try and improve their potential benefit and improve their tolerability? That's the focus of what we do. Sometimes we combine these two elements like we'll do in the future and bispecific ADCs. But right now we have a whole strategy which builds on our experience with Zany, which really was, you know, still is the only bispecific antibody being considered in development in the HER2-targeted space. And we're hopeful if this comes to market, this year or next year, that we'll be able to see that benefit in patients. We've certainly seen it in our clinical data so far.
We have another phase 3 readout coming this year, but we think that nature of how we designed 2 different mechanisms into the same biologic structure gave us a very unique mechanism that maybe wasn't predicted. But now in the clinical data, you can see the mechanism in that clinical response that we've seen in multiple clinical studies. And so we're really excited to take that a little further and develop tri-specific antibodies, starting first with our 2+1 T-cell engager against mesothelin, which has a brand new novel CD3 antibody on it, which we hope with the low avidity will dial down some of the tolerability issues that have plagued bispecific antibodies for the last 15 years of my career in terms of the cytokine release syndrome and others, which seems to limit those.
So we can break through the efficacy ceiling on bispecific antibodies, and T-cell engagers. If we find a way to move tolerability into a better range for patients, and we think we can do that first with our 2 + 1 format. And then beyond that, we've come up with a number of different constructs of how to use that third binding point in a trispecific to advance against specific targets. We've published already on our ability to bring a CD28 co-stimulatory factor into a biologic structure to work with CD3. We use Claudin 18.2 to prove that point.
I think when you look at that data preclinically, you can see the benefit of controlling the balance of co-stimulation of CD28 in the same structure versus combining 2 different antibodies, 1 with CD28, 1 with CD3, or by throwing a CD28 antibody in with that CD3 bispecific T-cell engager. So we think we've got that right. And if we do, there's a whole host of other structures and ways that we can think about of using that 3rd binding point to our advantage to really improve, where T-cell engagers can be utilized. And so we're excited about the mesothelin 2+1 T-cell engager going to clinic this year. We haven't named our 5th candidate for the 5 by 5 program we have, but it's going to be a TriTCE.
So that 5 by 5 program will be the three ADCs we've announced, the 2+1 mesothelin-targeted agent here, and then the last one will be a true Tri T-cell engager, which we'll nominate sometime this year, to explain that target. Just going back to zanidatamab again, which is the first thing I talked about on the first slide about why we're so excited. And if you watched our presentation from our partner Jazz this week, you can see that their excitement now seems to exceed ours, about the potential for this agent. That's based on clinical data that we have in hand.
It's based on our expectations about a great phase 3 clinical study in 1st line GEA, which will read out this year, and we're hoping that's positive, as well as additional indications where I think Jazz would like to invest behind in breast cancer, but also some of the other indications in phase 1 where we saw activity, but we weren't able to proceed with a lack of capital. Unfortunately, our partners Jazz and BeiGene can do that and optimize the potential utility of zanidatamab, which Jazz publicly forecast last summer at being a $2+, $2 billion+ peak sales potential opportunity. We don't disagree with that at all. So we think zanidatamab will have an important place in HER2 targeted therapy as really the only bispecific approach being utilized.
We think it can be utilized across different tumor types. One of its big strengths is the ability to combine with other agents in standard of care. We had the same thought with zanidatamab as we have with our other ADCs and T-cell engagers. Combining with standard of care to do benefit for patients, we think is the way to develop novel drugs like zanidatamab. Tolerability profile allows it to be combined with immunotherapy, chemo agents, and other targeted therapies to do better for patients. And that's a clear strategy that we have in our entire portfolio. We're really excited to see what Jazz will do with zanidatamab in their hands.
Again, they've been, you know, really focused on the first regulatory review to happen this year, which is in second-line biliary tract cancer, and also prosecuting the completion of the phase 3 study, which will read out this year in first-line GEA, which is an even bigger patient population. Our phase 1 and 2 data we previously announced is very compelling. Very, very promising. Obviously, needs to be confirmed in a well-run, randomized clinical study, which we've done in BTC, are doing in GEA, but but we think you can clearly see the benefit of a unique and differentiated mechanism in this biparatopic or bispecific antibody, which has not been seen with other agents, whether they're ADCs or antibodies or a combination of of separate antibodies. So we think we're well positioned with zanidatamab.
We're really excited about the ability for Jazz and BeiGene, our 2 partners, to take on the development and commercialization of this agent. Based upon the financial terms, we do get a great financial benefit for this, which we'll reinvest into our product portfolio. Beyond that, I'll skip the biliary tract cancer information here for epidemiology. If you saw our results in late 2022, you've seen that even in monotherapy and in 2nd line BTC, we've really moved the needle for patients where there's no HER2 targeted therapy available now, and we seem to have something that can really benefit them. We've just initiated a confirmatory study, a requirement FDA, which will be in 1st line biliary tract cancer patients in combination with standard of care, which right now is GemCis plus a PD-1 in different parts of the world. Might be Durva, might be Pembro.
We think the ability to work in combination with GemCis and immunotherapy in a 1st line patient population could really get to some improved response numbers and durable responses and eventually survival benefit. That just was not imaginable in biliary tract cancer over the past number of 10 years. So zanidatamab really is, because of its unique and differentiated mechanism, providing some hope for those patients who have not been able to be helped by other HER2 targeted therapies that have been tried in development. And we're really excited about Jazz's continued prosecution in 1st line biliary tract cancer. GEA, obviously, a much larger patient population, 63,000 new patients per year in HER2 across Europe, U.S., and Japan.
Still, an underserved need, as adding trastuzumab to chemotherapy regimen made a difference a number of years ago, but really the ability to have a unique agent like zanidatamab being used in combination with chemo and sometimes a PD-1 really seems to build a much higher response rate from our clinical data so far. Fast responses, durable responses, consistent across the entire population. And we think in our phase 3, we hope that turns into a survival benefit when that data matures. And that's really what this patient population is underserved in. And so we're really excited about the potential for this agent and our phase 3 study will read out this year, and then we'll be able to see how to build on that, with Jazz and BeiGene, our partners. Beyond that, zanidatamab's not the end of our bispecific or multi-specific approaches.
As I mentioned, we've got our mesothelin CD3 multi-specific going to the clinic this year. Really excited about the design and the geometry we came up with for this. Mesothelin's always been an interesting target, but has not been really available for ADCs. We've seen some CAR-Ts. We think the approach we took with this 2 plus 1 product format might be the way to really use this biomarker in the way that I think it was intended when it was originally explored across a really broad set of patient populations. The geometry and the novel epitope for the CD3 antibody we're using now are really the key innovative parts of what we designed here.
Hopefully the clinical data, which we'll start to collect this year, will show that that innovation pays off in a mechanism which can provide a benefit to patients that's not been seen with other mesothelin targeted agents. And again, we published some preclinical data around this just to explain what those design considerations were, what those innovative elements are, and clearly we're doing something that's different than others have approached before, and so hopefully we'll have a different result. Beyond that, we'll focus on our TriTCE formats. As I mentioned, this will be the subject of some additional discussion at AACR.
The abstracts were released yesterday, so I encourage you to pay attention to the AACR posters that are coming up in April and hope to see a full explanation of what we're trying to accomplish with this idea of building in multiple mechanisms into a tri-specific antibody and why that's more beneficial than combinations of different mechanisms after that. There's obviously other people working on this in a different way, and we hope the way that we're approaching this is better and we'll accomplish what we try to accomplish with all these multiple mechanisms in a tri-specific structure. And hopefully that's the case. Over 2024 and 2025, we're really excited because I think up and down the portfolio as a company from Zany right through the longer term R&D strategy and agents we haven't even talked about today, we can see progress through 2024 and 2025.
So in the last 2 years, we made a lot of progress that really put the company in this position to be successful as an R&D entity. The next 2 years, if we're successful, could see a really exciting, growing, potentially very large biotech company in our sector. And we're really excited about the potential of our scientific expertise. The way we approach these product modalities and ADCs and T cell engagers, which we can broaden to really build the basis for a long term sustainable, R&D engine with the company and with the right financial and partnering and commercialization decisions in the future, we can really see ourselves being an important biotech company in the future. If we can be successful the next 2 years. The longer term strategy, we won't get into now. We'll have an R&D day in December of this year, or 4th quarter.
We'll talk a lot more about what's beyond the 5 by 5. So this is just a teaser until the end of the year. Finally, in summary, we're really on a mission, as you hopefully can see from that first slide with the sphere of where we work, to really try and change the landscape for those patient populations and indications where we have not seen innovation affect these long-term overall survival rates. That's what we want to do with our more complicated biologics, our multifunctional therapeutics. Building multiple mechanisms into one structure, we think might be the key to unlocking a therapeutic benefit we haven't seen before. We can do it beyond oncology. Right now, we're just focused on the pure oncology piece of that.
We've got 5 great new medicines moving into clinical studies now that we think could be the basis of changing the nature of treatment for those patient populations. Clinical data will sort that out. So we're excited to get these 5 new medicines in the clinic over the next 24 months and then see where our clinical data takes us. And again, we're very focused on combination therapies. 1st and 2nd line opportunities, the earliest time we can intervene in a patient's treatment life cycle, that's where we think ADCs and T cell engagers belong in combination. And they have to be very attractive markets from a, obviously from a financial perspective. And we would, unlike Zany, where we license out all global rights to BeiGene and Jazz, find a way to be a productive R&D company and keep some of those things for ourselves to commercialize.
That's in our plan in a more traditional U.S. ex-U.S. method. Hopefully, you can see the excitement that we have around the company. We have a lot in front of us in 2024 and 2025 that's really exciting, and we're looking to accomplish as much of that as we can as we laid out in a very, in a very excellent execution manner and hopefully in a way that that exceeds expectations, that even I've laid out here today. Thank you for your time and attention and look forward to any follow up you'd like to have. There's contact names here, for folks for future information. Thank you.