Welcome to a session of Citi's Global Healthcare Conference. I'm Yigal Nochomovitz, biotech analyst. We've been covering Summit for a number of years now, been following them for longer. I think it started when I first saw the ASCO data in June 2023, if I'm mistaken.
I was supposed to come in before that, too. Anyway, 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. You're at the top of the list of the way you dig in, your diversification, flexibility. This guy can do anything from playing the piano to race cars to evaluate companies quite accurately.
I forgot you asked that.
Yeah. Summit has been in existence for quite a while. I bought 25% interest in the company when it was in the anti-infective business, antibiotics, and we did some work there. I liked the evaluation that we did, but it was not an area where you got compensated correctly for the amount of breakthroughs that occurred. We pivoted over to oncology, and MaKy and the team that had been working at Pharmacyclics joined in. We are really a second-generation team. We spent 10, 15, some of us 20 years together. We took a good, hard look at what we wanted to do. We had a couple hundred million in cash ready to do something that sounds like a small amount of money, but it is something to start with. David joined us.
McGann's card.
Joined us, and we got him busy looking at opportunities. We came upon Akeso. Akeso, the co-founders, were Americans. Michelle Xia had a vested interest in a company called Celera Genomics. She worked at Celera Genomics, and that is where the Imbruvica really came from. She knew that drug, and she knew us. Over spending six months together, we were really the only ones standing up when she said, "I need $500,000,000 in a $5 billion-$4 billion partnership." Within 24 hours, we raised the additional money, put it up, and three months later, we had a phase III going. We have now got four phase III going. Really, to step into an opportunity—and I have been an investor since I was in my 20s—to see a blueprint like Keytruda has put forth.
Behind that, another nominal product that is Opdivo with a good reputation, but you're really dealing in $30-$40 billion of revenue. To see Akeso 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. We were there first. I have a key to the city of Shanghai, introduced robotics to China. I have a long-standing relationship and a high appreciation for who the people are. We've got a good team here. We really like the position that we're in.
I believe you've got weight loss and Mounjaro, and you've got NSCLC and other solid tumors with Pembro, and you've got Ivo. We just want to just show people what Ivo can do. I don't know anyone that would have gotten off to the kind of start that we've gotten off to. 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. 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 in the transition from 2022 - 2023. In the first four months, we enrolled all of two patients. Others, if you're a VC back, you would have been fired. If you're a big pharma back, you would have been lowered to the sandlot and discarded. We stayed right with it. 16- months later, we actually had a P-value of 0.0323 and a great hazard ratio and demonstrated a great drug. For the 12-month trial that we'd 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. We did not cut the line. If you look at it very carefully, you're a patient.
You're taking this drug if you have EGFR. There isn't anything that really compares to it, in my opinion. We've got a lot more than that going on. I'll let the team and Igal, who knows us deeply, express that. 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're at ATM. We raised $500 ,000,000 in 48 hours a month and a half ago. When we needed the $500 ,000,000 for Akeso, we raised that in 48 hours also. 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. I think we've got an incredibly bright future.
Okay. That was a great way to start the conversation. That's a great point as far as the scarcity of confidence. I think any of 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. Maybe Dave or Allen and Bob, Maky.
Talk us through what are the key data 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, when you looked at it in December 2022, you did the transaction. All right. Just what are the proof points that you're seeing this year? Then we'll talk about, of course, HARMONi-3 and everything else.
There's a couple of factors, David and Allen handled it, but evidence that it is, any evidence that it isn't, and any evidence that anybody else is better. Are even in the same ballpark. We'll go out to cover all three of these.
Yeah, absolutely.
Are we not?
Yeah. Okay.
Thanks, Igal, for the question. If we look at where we started coming into this year, into 2025, the announcement of the HARMONi-2 results had been published, right? There was a strong PFS benefit between Ivo versus Pembro in the monotherapy setting. 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 and many solid tumors is in combination with chemotherapy. Does that benefit hold when we look at chemotherapy combinations? Two, the data that has been produced in China is a single-region trial. When you get into a global study, does that data hold? The third piece became strong data with respect to progression-free survival.
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? I think we pretty demonstratively and convincingly showed in 2025 that all three of those major points were very much proven and shown in favor of ivonescimab. 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-reason 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, 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. The final piece, when we look at the data in combination with chemotherapy, we saw HARMONi-2 in a monotherapy setting look very good in 2024. We saw the OS trend in the administrative cut for the CDE upon approval. That was below the clinically meaningful threshold of 0.8, so 0.777 at the ad hoc administrative look there. We also saw the HARMONi-6 data then read out in combination with chemotherapy, and that was strongly positive against the PD-1 plus chemo.
You take now four clinical trials have read out in a phase III setting, four positive phase III trials. As we look at, I think Bob was alluding to as well, the competitive landscape that exists, other PD-1 VEGFs, we have four phase III clinical trials that have read out positively. It is the only PD-1 VEGF that has read out in a phase III setting, period. Four for four is a pretty good start. 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. As we look forward now with the opportunity to bring in the global setting and frontline non-small cell lung cancer, that is in combination with chemotherapy.
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. We also implied in the Q3 earnings call that we will be expanding our phase III program beyond that. In terms of setting that stage for the confidence and the meaningfulness, we're see+ing all of that continue to come to fruition.
Okay. You've answered a lot of very key questions, ones that we've explored in detail, as you know. When you think about what's coming up, and obviously looking at HARMONi-6, the partner at Akeso at some point, and soon will 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. Is it sort of augmenting the strength of those points you've already made? For example, with HARMONi-3, I mean, you would kind of remake the point again on chemo combo. You'd remake the point on East versus West again. Allen, you want to contribute?
Yeah. Sorry.
Is this working?
Oh, no.
Okay. So. Yeah. Maybe take a second here, and I want to take a victory lap for the team, right?
Okay.
We're approaching our third anniversary as an oncology company, right? And what has the team accomplished? Less than three years ago, there was phase II data that looked very intriguing, right? 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? What's happened? HARMONi-A readout randomized against placebo, second-line EGFR, where PD-1s don't traditionally work, right? PFS endpoints, right? That's now been confirmed at 50 as hitting an OS endpoint in a really tough space, right? When I saw that data, I said, "Oh, wow, that's really tough against placebo." The next readout was HARMONi-2, right? I'm thinking like, "Wow, that's going to be really tough because that's against Pembro." There you go. You won against Pembro.
It was a definitive win on an interim PFS look. What you're talking about this year is an interim OS look, right? This drug keeps exceeding expectations, right? What was really cool looking at HARMONi-A and HARMONi-2 was that not only was the efficacy phenomenal, the safety data was pristine, right? The naysayers, "Once you add chemo, you're going to wash out that effect." HARMONi-6 takes it out of the park, right? Again, hitting on interim PFS, right? What you're really going to see is confirmation of the OS. They want to see the OS. That's what they were saying. Those voices have gone down because HARMONi-A, the first one, which is the toughest one, I think, has hit, right? It's matured, right? There were some cases that, when you look at 30% versus 50%, you see some deterioration.
You see a tail forming, right? That's what you wanted to see. I think HARMONi-3, HARMONi-6 with chemotherapy in the squamous setting is going to sort of reiterate that. Of course, HARMONi, where you have Western data and you see the same benefit there. I think you're seeing all the naysayers go away, and I think those voices are going down. This has all been accomplished in less than three years, right? In a time when most studies can't even enroll in that period, we've already had four readouts, right? They have 10 other phase III that have been publicly disclosed. 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. That's our victory lap for the last three years.
Would you agree, though, that HARMONi-3 sort of encapsulates everything into one place in terms of chemo combo, doing it in the U.S. and Europe and frontline? I mean, I know we can talk in more detail about the mechanics of the squamous and the nons. We can get to that. Just at a high level, do you view that as sort of the most definitive experiment or just adding to the overall strength of the evidence?
You want to take that?
Yeah, go ahead.
I was going to say, we've already done the most definitive experiment four times, right? There are 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 lynchpin of the franchise, right? With that one study, you will capture 80% of the advanced non-small cell market, right? That was the lynchpin that Pembro used to control the whole market, right? That was probably the most important information. With HARMONi-3 and HARMONi-7, you will pretty much dominate the advanced non-small cell lung cancer market two years ahead of everybody else, right?
Yeah.
I know that there's a lot of competition. Pfizer's jumped in. BMS has jumped in too, high tech, right? Merck has even jumped in. Even after sort of every data point, we said, "Well, you have to think it's just Chinese too." They don't have OS yet, right? Secretly, they were sort of jumping into the market themselves, right? I think the three and seven will be the lynchpin for the rest of the franchises, right? I think that's how you win the whole market, right? If you go back, let's say, a decade to when Merck, BMS, Roche were in sort of a footrace for PD-1, they were all going at it at the same time, right? Ipilimumab was approved about three years before. They all knew that checkpoint inhibitors were going to be important, right?
If anything, Roche and BMS probably had 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. Even indications where they were late into, let's say, kidney cancer, where BMS with Nivo-IPI had a few-year head start, they still now control 70% of the market. I think if they focus in on HARMONi-3 and HARMONi-7, we'll win.
Just for those less familiar, since there aren't a lot of trials—
Yeah.
Sorry. Just tell everyone what HARMONi—we know what it is. Tell 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 chemo 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 chemo 024 and 042. It is monotherapy Pembro versus monotherapy Ivo. Again, sort of de-risked by HARMONi- 2, which is the Chinese data, but now a global population. Remember, a third of those patients will probably come from Asia.
Okay. Then just kind of a little bit more mechanical questions on HARMONi- 3, because originally it was—the original thesis from that I mentioned at the beginning, the after data where you looked at the better OS and the squamous, remember that? That set up the whole thesis for doing squamous first. Then you saw HARMONi- 2 in May of 2024, and you expanded. Now you kind of start a separate—
Which one?
Probably.
Saturday.
Kind of just walk through the overall thought process there. I mean, it makes sense why you did it in order to have phase III data sooner. Just walk us through the thinking on that.
Yeah. I think. You actually did a really nice job of setting that up. Yeah. From a phase II perspective, we do the deal with Akeso December, January, December 2022, January 2023, right? We immediately go into the EGFR mutant setting and then immediately set up the frontline chemo combination. At that time, more mature data with respect to the squamous population. Immediately move into the comparison trial against chemo 407 with HARMONi-3. 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. At that same time, the phase II data in combination with chemo and the non-squamous is also very compelling. 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. We're also at the same time rapidly enrolling the non-squamous patients, a little bit of a broader market. When we take a look, two things in particular become clear. One is there's a bit more regulatory scrutiny with respect to individual pathology have sufficiently positive data for approvals. There's also looking at North American patients in particular becoming more of a focus.
As we look at that from a regulatory probability of success, we want to make sure that the two histologies are fully powered for the two primary endpoints, PFS and OS, to ensure that there's 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. 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've fully powered both so that there's no question with respect to statistical significance. 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.
The other piece that becomes very important as well is the accelerated timelines, right? With the opportunity to complete enrollment in the squamous cohort in the first half of 2026, that also lets that ICT now, a separated analysis, read out in the second half of 2026 and ultimately allow for potentially an earlier submission and approval in that setting based on the data, right? We are able to increase probability of technical and regulatory success, and in particular, regulatory success, and accelerate the timelines by which we can read out the squamous, which is a significant population in frontline. We do not delay in that same point the non-squamous population because we are able to enroll so rapidly in that population as well.
We're really either holding or accelerating timeline in access to the market in frontline non-small cell lung cancer and improving probability of technical and regulatory success in the same way.
Okay. HARMONi- 7, you haven't set a specific timeline yet. Is that correct?
That's right. Not yet. We began enrollment earlier this year, haven't laid out quite the timelines like HARMONi-3 just yet.
When Bob started talking about the work in EGFR and the improving and now stacked big OS results there, what is the latest from the filing perspective? What can you tell us about discussions with the FDA around getting that into the ACC to get a label in that setting?
Sure. Yeah. I think we announced about a month ago that we—in May, we said that we intended to file, but the timing would be determined. 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. In October, we said we intended to submit the application in the fourth quarter of 2025. That still holds. We intend to submit the application in the fourth quarter of 2025. No change in terms of guidance from that perspective. With respect to individual conversations, what we do not tend to get into is individual discussions with the agency, but those are intended to be collaborative conversations between the agency and the sponsor.
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 the work to expand beyond lung cancer. 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?
Yeah. I'll start, and then Allen can jump in. I think 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? This will be a trial that's designed Ivo plus chemo compared to bevacizumab or Avastin plus chemo. 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 as well, we're talking quite a bit about the fact that there would be additional phase III programs that are intended to be in the short term for initiation. 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. There is additional work that's been done in a combination of our collaboration with MD Anderson through phase II data like the colorectal trial that we also open phase II sites in the U.S. and biological rationale, right? 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 we don't want to necessarily provide a direct roadmap in terms of where we're going. We've been very clear that we intend to expand that phase III program.
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 to, 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? We see phase II data. Four 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 median PFS for ivonescimab in China in phase II was 11.1 months, and in China in phase III, it was 11.1 months. We are seeing consistent validation of that phase II data as well.
As we look across, we have a number of different opportunities that we can continue to expand and do so pretty quickly.
Yigal, I want to add as well, for sure, we started our IC program about two years ago. We are very well advanced in our IC program. At minimum, it's 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 at Akeso. It's an expansion above other indication at Akeso. For sure, as the data maturing and we are presenting is 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 KRS of the world or other molecules. That as well put us in the situations that we have a lot of opportunity to expand with other big pharma.
Did you have a collaboration with Pfizer, yeah, with the ADC portfolio or no?
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. I guess that's part of the larger question, which I always get is, and you pointed out, big pharmas are interested in combinations. You've got lots of competitors. Bob listed all of them, I think. Everyone's 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? You know what? At this moment of time, I can say that we are going with the speed of light. The team is 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. Everybody thinks that we are a small company, but perhaps we are, but we are a big company in the small division. What we did in the past two- years, nobody could do it in such a short period of time with such a small team. To answer your question, the speed that we have in company right now is huge. When and as is appropriate, we are going to partner, but we are not accelerating to just go for the partnership. We have enough cash.
We have a great team. We have a great partner. At the same time, at this moment of time, we are moving. When it's 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. 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 our stuff and in a very fast pace. Therefore, I believe in this regard, we are in a good position. Allen, Bob?
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 basis. Now moving forward, as it becomes more clear that the pristine safety profile is there and the efficacy is without question, 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 two years of where we are. From our decision, how do we create wealth for our owners and maintain control?
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. 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 big money, we just spent $5 billion to get in, and we need to spend another $3 billion-$4 billion to carry this out.
They're going to go at a measured 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 decide really how the game is going to be played. At a 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. 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 the pharma in the years I've been in, close to 20 now, there have never been three more prominent molecules of magnitude. We have weight loss. You have the NSCLC, Pembro, and you have Ivo. I don't see a fourth one sitting there. If you want to have a big impact and a pristine profile and a group that has moved molecules, our second year commerciality at Pharmacyclics, we did a billion in revenue. We hadn't been in the business five years earlier, but we were good business people. That's the way I look at it. 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.
Yeah. I connect to what Bob is saying. It's like I can say that the development program hasn't been slowed because of number of people, right? If you look at the indications like Dave and the key point is 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. 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. We said early on that the landscape is important. The study that they're running in China is where the puck was, right? That's the control against chemotherapy. We now know ADCs are very important in TNBC.
We were very strategic in waiting for the right data to understand the field, right? You do not want to jump into a study that is going to be out of date before it is done, right? Pancreatic cancer, another phase III that Akeso is running. China is a different marker. They see the signal. That is 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. We did not jump into that phase III, right? Because the control arm was chemotherapy. We knew that RAS inhibitors were going to be important, and then the Revmed deal. I think we are sort of being very strategic about our development program. It is not just FAST. FAST was colorectal cancer. We saw that 80% overall response rate. Yeah, we have to jump in there, right?
Because that's where BMS and Pfizer have both jumped in. Interestingly, we still beat them, right? I think we're not missing out by the size of what we have.
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 three, like extensive stage. Those are things you haven't looked at yet, right?
Right.
Tell us more about that.
Yeah. From a metastatic perspective, and Allen alluded to this, right? Between HARMONi-3, HARMONi-7, the non-driver mutations largely covered in frontline. EGFR mutant, the largest single driver mutation, and then we'll continue to explore RAS mutant lung cancer through our collaboration with Revolution Medicines. That does not preclude where you get into the 1C to 3A, the resectable population. We have seen significant advancements from the PD-1s there. We had data in 2024 that was released that was very promising in that particular setting. You talked about the unresectable and the stage three, right? There are still additional opportunities even beyond the significant places that we have been in lung cancer at this point and in small cell as well. In fairness, it is not that we have not looked at it. We look at it every day. We just have not publicly disclosed our strategy there yet.
I remember at the event you had at ASCO, Bob, you asked, "When could Ivo be on the market?" I remember you asked that question. That was a very good question. You remember that. If HARMONi-3 hits in squamous in, let's just make up the time, October 2026, and it goes fast, and we had Marty Makary this morning talking about accelerating novel therapies and therapies that have transformative benefits for human health, when could, and I know you're going to have the EGFR approval, but that's a much smaller market. 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 set that up pretty descriptively in terms of the so absolutely, we have a readout in frontline squamous with PFS and an interim OS look in the second. After 26, right?
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 for an sBLA for the frontline. If not, there are opportunities in the frontline setting as well to accelerate that timeline. I think you talked about this morning with Dr. Makary talking about accelerating novel therapies through. There are certainly ample approaches we can take in terms of accelerating that process for the frontline. 2027.
Okay. I got to tell my team to check the Excel model. All right. I think we're wrapping up. Thank you both, and thank you all so much. Great conversation.
Yeah. I appreciate it. It's always a pleasure being in your company. Appreciate your insight, your hard work. It's tremendous.
All right. We'll see you later for the dinner, I think, later.