Summit Therapeutics Inc. (SMMT) Earnings Call Transcript & Summary

So welcome to the session of Citi's Global Healthcare Conference. Yigal Nochomovitz, biotech analyst. I've been covering Summit for a number of years now and following them for longer. I think it started in -- when I first saw the ASCO data in June 2020. But anyway, I welcome, everyone. Thank you so much for joining.

Bob, do you want to start out and just sort of set the scene and tell us...

It's been a great journey to get here and, Yigal, you're at the top of the list of the way you dig in, your diversification and flexibility. This guy can do anything from play the piano to race cars to evaluate companies quite accurately. So Summit has been in existence for quite a while. I bought a 25% interest in the company when it was in the anti-infective business, antibiotics. And we did some work there. I like the evaluation that we did, but it was not an area where you got compensated correctly for the amount of breakthroughs that occurred. And we pivoted over to oncology. And then Maky and the team that had been working at Pharmacyclics joined in. So we're really a second-generation team. We spent 10, 15, some of us 20 years together. We've got -- and then we took a good hard look at what we wanted to do, but we had a couple of hundred million in cash ready to do something. That sounds like a small amount of money, but it's something to start with. And David joined us -- joined us, and we got him busy looking at opportunities and we came upon Akeso. Akeso cofounders were Americans. Michelle Shao had vested interest in a company called Celera, she worked at Celera, and that is where the IMBRUVICA really came from. So she knew that drug, and she knew us. And over spending 6 months together, we were really the only one standing up when she said, I need $0.5 billion and $5 billion, $4 billion partnerships. And within 24 hours, we raised the additional money, put it up. And 3 months later, we had a Phase III going. We've now got 4 Phase IIIs going, really to step into an opportunity, and I've been an investor since I was in my 20s to see a blueprint like KEYTRUDA has put forth. And behind that, another nominal product, OPDIVO, with a good reputation, but you're really dealing in $30 billion to $40 billion of revenue. And then to see a customer come in and go head-to-head with KEYTRUDA and score victories and wins and know the people and know their science and feel good and comfortable about it. We did the right thing at the right time by putting that partnership together. It's now validated and clear to everyone that if you want good drugs, go to China, and we were there first, [ ivonescimab ] in city of Shanghai introduced robotics to China. So we have a long-standing relationship and high appreciation for who the people are. So we've got a good team here. We really like the position that we're in. I believe you've got weight loss in Mounjaro, and you've got NSCLC and other solid tumors with pembro and you got ivo. And we just wanted to show people what ivo could do. But I don't know anyone that would have gotten off to the kind of start that we've gotten off to. And we've yet to see an iota of data that says, hey, you should slow down, you should be cautious. Pristine safety profile. In June, Akeso had dosed 50,000 patients. They're dosing at the rate of 1,000 a week. So you can imagine how many that they've got. Now no one else has that condition of proven safety. They went head-to-head with pembro and won. We stepped up into EGFR. And we misestimated the inertia that occurs when you bring a brand-new product from China to America and the transitioning from 2022 to 2023. And in the first 4 months, we enrolled all of 2 patients. Others, if you're a VC-backed, you have been fired. If you're a big pharma-backed, you have been lowered to the sandlot and discarded. We stayed right with it. And 16 months later, we actually had a p-value of 0.0323 and a great hazard ratio and demonstrated a great drug. But for the 12-month trial that we've been assigned and you don't go to the FDA and get assigned that kind of a trial and change it midstream. We had a p-value of 0.5 and change. And so we did not cut the line. But if you look at it very carefully, if you're patient, you're taking this drug if you have EGFR. There's anything that really compares to it in my opinion. So we've got a lot more than that going on, and I'll let the team and Yigal who knows us deeply express that. But I think we're in a primary position and we can talk if you might have questions on partnership and other transactions. I think we'll finish the year with close to $700 million in the bank. We have access to money. We were at ATM. We raised $0.5 billion in 48 hours 1.5 months ago. When we needed the $0.5 billion for Akeso, we raised that in 48 hours also. So in our view, there's no scarcity of money, there's a scarcity of confidence. People like what we're doing. We're doing good. And I think we've got an incredibly bright future.

Okay. Well, that was a great way to start the conversation. So that's a great point as far as the scarcity of confidence. And I think -- and if you could help us sort of identify the key data points this year. There have been a number of them that really everyone should look at and say, there should be a lot of confidence in this molecule and the data that you've generated at ESMO earlier in the year, updates from your partner, you pointed out Akeso a few times. So maybe Dave or Allen and Bob, Maky, talk us through what are the key gate points that show us that you're seeing the evidence that this drug is producing the kind of strong data that Bob and Maky had identified back in whenever it was summer, when you looked at it in December 2022, you did the transaction, right? So just what are the proof points that you're seeing this year? And then we'll talk about, of course, HARMONi-3 and everything else.

A couple of factors. I'll let David and Allen handle it, but evidence that it is, any evidence that it isn't and any evidence that anybody else is better or even in the same ballpark and we will have to cover all 3.

Yes, absolutely.

So are we not -- so thanks, Yigal, for the question. I think -- so if we look at where we started in -- coming into this year, into 2025, the announcement of the HARMONi-2 results have been published, right? So there was a strong PFS benefit between ivo versus pembro in the monotherapy setting. And as we came into 2025, basically the questions that people wanted to have answered were monotherapy showed improvement over PD-1. The overwhelming standard of care in non-small cell lung cancer in many solid tumors is in combination with chemotherapy. And so does that benefit hold when we look at chemotherapy combinations? Two, it was the data that has been produced in China is a single-region trial. When you get into a global study, does that data hold? And the third piece became strong data with respect to progression-free survival. And as we get into the gold standard of overall survival in many oncology trials, does a drug that contains a VEGF component like ivonescimab, does that lead from a PFS benefit into an OS benefit. And I think we pretty demonstratively and convincingly showed in 2025 that all 3 of those major points were very much proven and shown in favor of ivonescimab. So if we take PFS to OS, we saw the data that was generated in 2024, both in HARMONi-A as well as the HARMONi-2 study. We saw a statistically significant OS benefit in the HARMONi-A study, the single-region EGFR mutant trial. Bob spoke to with longer follow-up of patients in the global study, both very consistent data as well as a nominal p-value of 0.03, so showing the OS improvement there as well. When we look at the East versus West, again, same concept, we look at HARMONi-A to HARMONi, we now show in a global setting, very consistent results between the single-region study and the global study as well as within the individual cohorts of HARMONi, the consistency between the data that was shown in the Asian cohort versus that of the Western cohort. And the final piece, when we look at the data in combination with chemotherapy, we saw HARMONi-2 in a monotherapy setting looked very good in 2024. We saw the OS trend in the administrative cut for the CDE upon approval. So that was below the clinically meaningful threshold of 0.8, so 0.777 in at the ad hoc administrative look there. But also, we saw the HARMONi-6 data then readout in combination with chemotherapy, and that was strongly positive against the PD-1 plus chemo. So you take now 4 clinical trials have read out in the Phase III setting, 4 positive Phase III trials. So as we look at I think Bob was alluding to as well, the competitive landscape that exists, other PD-1 VEGFs, we've got 4 Phase III clinical trials that have read out positively. And it's the only PD-1 VEGF that's read out in a Phase III setting. Four for four is a pretty good start. And then when we look at each of the key questions coming into the year, in terms of how ivonescimab will perform East to West, PFS to OS, monotherapy to combination with chemo, all of those questions were pretty clearly answered in 2025. So as we look forward now with the opportunity to bring in the global setting in frontline non-small cell lung cancer, that's in combination with chemotherapy. So effectively, the KEYNOTE-407 in squamous and the KEYNOTE-189 settings in frontline non-small cell lung cancer. We have that data that we'll talk about in the short term from a catalyst perspective as well as expanding now with that confidence beyond non-small cell lung cancer. We've talked about the frontline colorectal trial that is open and enrolling. And then we also implied in the Q3 earnings call that we will be expanding our Phase III program beyond that. So in terms of setting that stage for the confidence and the meaningfulness, we're seeing all of that continue to come to fruition.

Okay. So you've answered a lot of very key questions, ones that we've explored in detail as you know. So when you think about what's coming up and obviously looking at HARMONi-6 partner, I assume we'll tell us about OS, which we don't know. You have a big readout, obviously, with HARMONi-3, which we can discuss in greater detail. But is it sort of augmenting the strength of those points you've already made and for example, with HARMONi-3, I mean you would kind of remake the point again on chemo combo, you remake the point on East versus West again. Allen, it looks like you want to...

Yes. Is this working? Okay. So yes, so maybe take a second here, and I want to take a victory lap for the team, right? We're approaching our third anniversary as an oncology company, right? And what has the team accomplished? So less than 3 years ago, there was Phase II data that looked very intriguing, right? But at the time, people looked at it and said, well, it's from China, there's no good biotech in China, right? Can you trust that stuff? And then -- so what's happened, HARMONi-A read out, randomized against placebo, second-line EGFR where PD-1s don't traditionally work, right? PFS endpoint, right? That's now been confirmed at SITC as hitting an OS endpoint in a very tough space, right? When I saw that data, I said, oh, wow, that's really tough. I get placebo. And then the next readout was HARMONi-2, right? I think it might, wow, that's going to be really tough because that against pembro. And there you go, you won against pembro. It was a definitive win on an interim PFS look. And what you're talking about this year is an interim OS look, right? This drug keeps exceeding expectations, right? What was really cool about looking at HARMONi-A and HARMONi-2 was that you -- not only was the efficacy phenomenal, the safety data was pristine, right? Then the natives, well, once you add chemo, you're going to wash out that frantically. HARMONi-6, we hit it out of the park, right, again, hindering on interim PFS, right? So what you're really going to see is confirmation of the OS. They want to see the OS, and that's what they are saying. Those voices have gone down because HARMONi-A, the first one, which is the toughest one, I think, has hit, right, and it's mature, right? There were selling [indiscernible] when you looked at 30% versus 50%, you see some deterioration. But you see a tail for them, right? That's what you wanted to see. So I think HARMONi-3, HARMONi-6 with chemotherapy in the same setting is going to sort of reiterate that. And then of course, HARMONi where you have Western data, and you see the same benefit there. So I think you're seeing all the naysayers go away, and I think those voices are going down. And this has all been accomplished in less than 3 years. So in the time when most studies can't even enroll in that period, we've already had 4 readouts, right? And they have 10 other Phase IIIs that have been publicly disclosed. So yes, I think there's a lot that's going to come out next year, but it's more confirmatory of what we think is a great molecule. And that's our victory over the last 3 years.

Would you agree though the HARMONi-3 sort of encapsulates everything into one place in terms of chemo combo, doing it in U.S. and Europe and front line. I know we can talk in more detail about the mechanics of the squamous and the non, we can get to that. But just at a high level, that sort of -- that is sort of the most definitive experiment or just adding to the overall trend set?

Yes, I was going to say like, we've already done the most definitive experiment 4 times, right? So they're placebo-controlled or PD-1 controlled, double-blind studies, right? I think the importance for HARMONi-3 is that it's going to be the linchpin of the franchise, right? So with that one study, you will capture 80% of the non-small cell advanced -- non-small cell market, right? And so that was the linchpin that pembro used to control the whole market, right, because that was probably the most important consideration. So with HARMONi-3 and HARMONi-7, you will pretty much dominate the advanced non-small cell lung cancer market 2 years ahead of everybody else, right? And I know that there's a lot of competition, Pfizer has jumped in, BMS has jumped in, BioNTech, right? Merck has even jumped in even after sort of entry data point, well, you have to think it's just Chinese. Well, they don't have OS yet, right? Then secretly, they were sort of jumping into the market themselves, right? So I think the 3 and 7 will be the linchpin for the rest of the franchises, right? And I think that's how you win the whole market, right? So if you go back, let's say, a decade to when Merck, BMS, Roche, were in sort of a foot race for PD-1, they were all going at it at the same time, right, because ipilimumab was approved about 3 years before. So they all knew that checkpoint inhibitors were going to be important, right? And if anything, Roche and BMS probably have a little bit of a head start, but Merck through a little bit of luck and a little bit of good science, won lung cancer and even indications where they were laid into, let's say, like kidney cancer, where BMS with nivo, ipi had a few year head start, they still not control 70% of the market. So I think if we stay focused in on HARMONi-3 and 7, we'll win.

So just for those less familiar since the last trial, just tell everyone what -- we know what it is, tell us everyone what HARMONi-7 is?

HARMONi-3 is sort of squamous, non-squamous, in combination with standard chemotherapy. That study is running against pembrolizumab, replacing classical KEYNOTE-407 and 189. HARMONi-7 is a repeat of HARMONi-2, with a slightly different population, the higher PD-1 population for Western audience, and that will replace KEYNOTE-024 and 042. So it's monotherapy. Monotherapy pembro versus monotherapy ivo. So again, sort of derisked by HARMONi-2, which is the Chinese data, but now a global population. But remember, 1/3 of those patients will probably come from Asia.

Okay. And then just kind of a little bit more mechanical questions on HARMONi-3 because originally, it was -- well, the original thesis [Technical Difficulty] I mentioned at the beginning, the ASCO data where you looked at the better OS and the squamous, remember that. And that set up the whole thesis for doing squamous first. Then you saw HARMONi-2 in May of '24 and we expanded. And now -- but now you kind of start to separate probably. So kind of just walk through the overall thought process there. And I mean, it makes sense why you did it in order to have Phase III data sooner. So just walk us through the thinking on that.

Yes, I think you actually did a really nice job of setting that up. And so yes, so from a Phase II perspective, we did the deal with Akeso in December, January. December '22, January '23, right, we immediately go into the EGFR mutant setting and then immediately set up the frontline chemo combination. And that, at that time, more mature data with respect to the squamous population. So immediately moved into the comparison trial against KEYNOTE-407 with HARMONi-3. So to your point, we see in May 2024 the results of the HARMONi-2 study, which showed benefit in both the squamous and non-squamous populations. And at that same time, the Phase II data in combination with chemo and the non-squamous is also very compelling. And so we make the amendment to include non-squamous patients single ICT, 1,080 patients. As we are now coming into 2025 and continuing through, we're rapidly enrolling the squamous population, which is, in some ways, a little bit more difficult to treat. You've got some different characteristics between squamous and non-squamous patients. And we're also, at the same time, rapidly enrolling the non-squamous patients, so a little bit of a broader market. And so when we take a look, 2 things in particular, become clear. One is there's a bit more regulatory scrutiny with respect to individual histology have sufficiently positive data for approvals. And then there's also looking at North American patients, in particular, becoming more of a focus. So as we look from a regulatory probability of success, we want to make sure that the histologies are fully powered for the 2 primary endpoints, PFS and OS, to ensure effectively no questions that come into play on, hey, did one perform a little better and drag the other one across the line, if you will? So full confidence in both, but instead of running a potential risk of having one just -- if you run a study, one may look better than the other by -- in some ways, chance, you want to make sure that you're fully powered both so that there's no question with respect to statistical significance. And then we can look at the North American patients in each of those and it's one kind of subpopulation as opposed to trying to do that across histologies as well. But the other piece that becomes very important as well is the accelerated time lines, right? And so with the opportunity to complete enrollment in the squamous cohort in the first half of 2026, that also lets that ITT now, a separated analysis read out in the second half of '26 and ultimately allow for potentially an earlier submission and approval in that setting based on the data, right? And so we're able to increase probability of technical and regulatory success and in particular, regulatory success and accelerate the time lines by which we can read out the squamous, which is a significant population in front line. We don't delay in that same point, the non-squamous population because we're able to enroll so rapidly in that population as well. So we're really either holding or accelerating time line in access to the market in frontline non-small cell lung cancer and improving probability of technical and regulatory success in the same way.

And then HARMONi-7 [Technical Difficulty] specific time line yet. Is that correct?

That's right. Not yet. We began enrollment earlier this year. Haven't laid out quite the time lines like HARMONi-3 just yet.

And then Bob started talking the work in EGFR and the improving OS results there. What is the latest from the filing perspective? What can you tell us about the discussion from the FDA around getting that from any of the agencies to get a label in that setting?

Sure. Yes. So I think we announced about a month ago that we -- so in May, we said that we intended to file, but the timing would be determined. And part of that, we said at the time, we wanted to continue to follow patients from the Western markets. We did that, and we announced that data in September. And then in October, we intended to submit the application in the fourth quarter of 2025. And so that still holds. We intend to submit the application in the fourth quarter of 2025. So no change in terms of guidance from that perspective. And so with respect to individual conversations, what we don't tend to get into is individual discussions with the agency, but those are intended to be collaborative conversations between the agency and the sponsor. So we won't necessarily give step-by-step updates there, but we'll provide further updates as appropriate as we go through the process.

Okay. And then the work to expand beyond lung cancer. So you mentioned colorectal and there are others too. How are you setting priorities there as far as where you want to go beyond lung cancer?

Yes, I'll start and then Allen can jump in. But I think -- so colorectal cancer is another one significant population of patients, right? It's also a place where PD-1 inhibitors in the non-MSI-high population, in particular, have not been effective, right? So this will be a trial that's designed ivo plus chemo compared to bevacizumab or Avastin plus chemo. So it's a significant opportunity. It's one that goes beyond the existing PD-1 markets. When we look beyond that in terms of where do we go, well, we've talked quite a bit about that, that there would be additional Phase III programs that go -- that are intended to be in the short term for initiation. And in reality, that will be judged off of a couple of points. One, there's a bit of Phase II data that's been generated by our partners at Akeso, some published, some not. There are 10 Phase III studies running in China with our partners that's either based on Phase II data or other supporting data that's been published. And then there's additional work that's been done in a combination with our collaboration with MD Anderson through Phase II data like the colorectal trial that we also opened Phase II sites in the U.S. and biological rationale, right? And so when we look across the landscape of the opportunity, in terms of prioritization, we're not going to necessarily give too much -- there are other competitors that are in play, and so we don't want to necessarily provide a direct road map in terms of where we're going, but we've been very clear that we intend to expand that Phase III program. And the confidence, I think going back to what we were talking about earlier, both the question that you asked, Bob laid out, I spoke a little bit too and Allen reiterated, the confidence that we have with respect to the data being generated by ivonescimab is not only narrow in terms of where we've gone, but it's quite broad in terms of what we're seeing across solid tumors, right? And so we see Phase II data. 4 Phase IIIs have now read out and have fully supported that Phase II data. I mean you take a look at even the frontline squamous, right? I think the medians for -- the median PFS for ivonescimab in China in Phase II was 11.1 months, and in China in Phase III, it was 11.1 months. So we're seeing consistent validation of that Phase II data as well. And so as we look across, we have a number of different opportunities that we can continue to expand and do so pretty quickly.

And Yigal, I want to add as well, for sure, we started our IC program about 2 years ago. So we are very well advanced in our IC program. And at a minimum, is around 60 of them and some of them up and running, and we are enrolling patients, which is totally different than some of the indication of Akeso's -- sorry, the expansion above other indication of Akeso. For sure, as the data is maturing and we are presenting, a lot of big pharma as well, they would like to combine with us because ivo will become the backbone of many, many indications, combinations with the ADC of the world or the combination of the KRAS of the world or other molecule. So that as well put us in the situation that is we have a lot of opportunity to expand with other big pharma.

Did you have a collaboration with Pfizer yet with the ADC portfolio or...

We started, but then at this moment of time, we decided to not continue with Pfizer as soon as they got their own molecule.

Okay. So I guess that's part of the larger question, which I always get is and you pointed out, big pharmas are interesting combinations. You've got lots of competitors, Bob listed all of them, I think. Everyone is asking me, and you're very successful raising capital very quickly. Is there a need for or do you want to have the imprimatur of a large pharma partnership to help you accelerate even further and infuse more capital so you can run the kind of KEYTRUDA-like scale of Phase III trials that can keep you in the lead with everyone competing?

Bob, do you want to answer or? You know what, at this moment of time, I can say that we are going with the speed of light, the team doing an outstanding job. We are really ahead of our competitors, I can say. Akeso is doing an outstanding job to provide us information and all of the latest data. When everybody thinks that we are a small company, but perhaps we are, but we are a big company in the small division. We -- what we did in the past 2 years, nobody could do it in such a short period of time with such a short team, smart team. So to answer your question, the speed that we have in the company right now is huge. So when and as is appropriate, we are going to partner. But we are not accelerating to just go for a partnership. We have enough cash. We have a great team. We have a great partner. And at the same time, at this moment of time, we are moving and when is appropriate, we will discuss the partnership.

Okay. So you feel comfortable about your position and your lead relative to the competitors and the pace of your continuing to generate data?

It's a critical time in the company when you want to make the decisions, and these decisions sometimes with all respect to the big pharma. They have their own way of strategy. We have our own way of strategy. We take more -- I'm not saying risk, but different way of doing ourselves and in a very fast space. So therefore, I believe in this regard, we are in a good position. Allen, Rob?

I think today, had we partnered with anyone, we would not be close to where we are today in terms of penetration to the market and access to patient bases. So now moving forward, as it becomes more clear that the pristine safety profile is there and the efficacy is, without question, there at that point in time, if big pharma decided to go all in, then it would have to be with us because there isn't another drug or another molecule at this point in time that is within 2 years of where we are. So then from our decision, how do we create wealth for our owners and maintain control. So my view of it as being a significant shareholder is I look at patients first. And if they can get to more patients more quickly, but we remain owners of the asset, even if it's embedded within a bigger pharma, then the right big pharma would be acceptable. There's no question about that. So it's just they would need to feel that, hey, look, this is pedal to the metal all in right now. I don't think they would have done the IST programs. I don't think they would have pivoted to outside of NSCLC. I don't think they would have gone forward with EGFR. There's a lot of things that be a little patient. And if it's a big money, we just spent $5 billion to get in and we need to spend another $3 billion or $4 billion to carry this out. They're going to go at a major pace. You're not dealing with the owners of the company. You're dealing with employees of the company, and they report to the Board members, and they elect, they decide really how the game is going to be played. So at Summit level, the Board all owns shares, the company owns shares, just take my share count out, we still have more shareholder ownership inside Summit than any of these other companies combined. They don't own 2%, 3%, 4%, 5% of the company. So we are, I believe, the best people at this time to be doing what we're doing. We've got significant money to carry out everything that is on our plate right now. We've got the ATM, and we always have access to money through people like yourself and others. People are attracted to winning situations. In all of pharma in the years I've been in it, close to 20 now, there have never been 3 more prominent molecules of magnitude. We have weight loss, you have the NSCLC pembro and you have ivo. And I don't see a fourth one that is sitting there. So this is -- if you want to make -- have a big impact and a pristine profile and a group that has moved molecules, our second-year commerciality at Pharmacyclics, we did $1 billion in revenue. We hadn't been in the business 5 years earlier. But we were good businesspeople. So that's the way I look at it. This is, to me, I haven't seen a riper apple sitting on a tree that is going to bear fruit than this ever. This is amazing.

Yes. And I can add to what Bob is saying is like, I can say that the development program hasn't been slowed because of number of people, right? So if you look at the indications like Dave and Maky pointed out, Akeso is a great partner. They're running 10 Phase IIIs and you can say, well, why aren't you running those Phase IIIs? I mean we were very clear like TNBC is a good example of that was obvious, right? Avastin is approved in Europe. Pembro is approved in triple-negative breast cancer. There was another company that went full in into TNBC. But we said early on that the landscape is important, like the study that they're running in China is where the puck was, right, because that's the control against chemotherapy. We now know ADCs are very important in TNBC. And so we were very strategic in waiting for the right data to understand the field, right? You don't want to jump into a study that's going to be out of date before it's done, right? Pancreatic cancer, another Phase III that Akeso is running. China is a different market. They see the signal. That's very unique, right, to understand the biology of why ivo works in pancreatic cancer, whereas other drugs like both VEGF and PD-1 were not that effective. But we didn't jump into that Phase III, right, because the control arm of chemotherapy. We knew that RAS inhibitors were going to be important and then the RevMed deal. So I think we are sort of being very strategic about our development program, and it's not just fast, like fast with colorectal cancer. We saw that 80% overall response rate, yes, we have to jump in there, right? Because that's where BMS and Pfizer have both jumped in. Interestingly, we still beat them, right? So I think we're not missing out by the size of what we have.

So -- and then just getting -- so with lung cancer, I mean, you've covered -- we've had this question before, but just -- so for the benefit of new listeners, you've covered all your bases in lung cancer in terms of -- I mean, you haven't looked at Stage 3, like extensive states, those are things you haven't looked at yet, right. Tell a bit more about that.

Yes. So from a metastatic perspective, and Allen alluded to this, right, between HARMONi-3, HARMONi-7, the non-driver mutations is largely covered in front line. EGFR mutant, the largest single driver mutation and then we'll continue to explore RAS mutant lung cancer through our collaboration with RevMed. That doesn't preclude where you get into the 1C to 3A, the resectable population. We've seen significant advancements from the PD-1s there. So that's -- we had data in 2024 that was released that was very promising in that particular setting. You talked about the unresectable in the Stage 3, right? So there's still additional opportunities even beyond the significant places that we've been in lung cancer at this point and in small cell as well.

And in fairness. It's not that we haven't looked at it. We look at it every day. We just haven't publicly disclosed our strategy there yet.

I remember at the event you had at ASCO, when Bob, you asked, when could ivo be on the market? I remember you asked that question. And that was a very good question. And then you remember that. And so if HARMONi-3 hits in squamous and like, let's just make up a time, October 2026, when -- and it goes fast and we had Marty Makary this morning talking about accelerating novel therapies and therapies that have transformative and benefit for human health, when could -- and I know you're going to have the EGFR approval. So that's -- but that's a much smaller market. So for the frontline market, the expectation should be what as far as getting onto the market in frontline, assuming you hit in HARMONi-3 in squamous.

You put that up pretty descriptively. In terms of -- absolutely, we have a readout in frontline squamous with PFS and an interim OS look in the second half of '26, right, as you mentioned. And so part of the component will depend on both the package there as well as the EGFR -- the HARMONi submission, right? Because with the HARMONi submission, if that continues to progress positively that is approved in sBLA for the frontline study. And if not, there's opportunities in the frontline setting as well to accelerate that time line. I think you've talked about this morning with Dr. Makary talking about accelerating novel therapies through. So there's certainly ample approaches we can take in terms of accelerating that process for the frontline.

2027.

Okay. I've got to tell my team to check the Excel model. All right. Well, I think we're wrapping up. So -- but thank you both, and thank you all so much. Great, great conversation. Appreciate it.

It's always a pleasure to be in your company. Appreciate your insights, your hard work. It's tremendous.

All right. We'll see you later for the dinner, I think, later tonight.