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

All right, everyone. Thank you for joining us. Our fireside chat with the Summit Therapeutics. It's a great pleasure to welcome Manmeet Soni, Chief Financial Officer; and Dave Gancarz, Chief business and Strategy Officer. And before I start, I just want to do a quick -- kind of just check -- for anybody who wants to ask a question here, please feel free to scan the QR code and we can ask a question on your phone, then they will transfer over to my iPad here, and then I'll ask a question. So feel free to ask away any questions that you might have. All right. With that out of the way, Manmeet, Dave, really pleasure to have you. Welcome to the UBS Healthcare Conference.

Thank you. Appreciate you having us.

Thanks, David. Thanks for having us.

Excellent. So maybe just to start from a high-level perspective. Of course, Summit is a very topical name everybody cares about now. But could you just provide a kind of high-level overview of Summit your lead molecule, ivonescimab and the overall strategy for the company.

Yes. Yes. So thank you for the question. I think the -- overall, our lead molecule is ivinezumab, but it's a PD-1 VEGF bispecific antibody. This is our lead and primary focus of Summit Therapeutics. So from a background perspective, Bob Duggan and Maky Zanganeh our co-Chief Executive Officers, as well as the rest of our management team, Manmeet and I are here, [indiscernible], when we look at the opportunity of what someone is looking to do, it is focused primarily on bringing the mechanism of a PD-1, the mechanism of an anti-VEGF together into a single molecule and creating a novel mechanism through it. So we target both PD-1 and VEGF, but the molecule itself was specifically engineered to really exceed what both previously established targets do into a new mechanism that's primarily driven by a couple of factors. One, ivonescimab being a tetravalent bispecific antibody has a shorter half-life. And so what that does is really emphasize the safety of the compound. So when we look at some historical considerations for anti-VEGF therapy that have had higher risks of bleeding proteinuria and hypertension that have ultimately been results of accumulating toxicity that maybe have reduced some of the opportunities for overall survival. Ivanesmab was designed to, with a shorter half-life, reduce that risk. And then finally, cooperative binding is a key component of this. So in the presence of VEGF ligands, the affinity or the binding of ivonesemab to PD-1 is about -- is tenfold stronger than in and of itself, a traditional PD-1, if you will, without the presence of the VEGF and the VEGF finding. So what that allows for is really the hypothesis being that, that is most effective in the tumor microenvironment where both PD-1 and VEGF exist. And so that really attracts the molecule to be on target at the tumor to help ultimately slow disease and ultimately kill the tumor cells and then the ultimate goal being to increase survival for patients. And if we move earlier and outside the metastatic phase, increased cure rates would be the intent.

Got it. That's really helpful here. Great. We can move on to some of the key trials. You do have multiple trials, including HARMONi, HARMONi-6, HARMONi-2 and others, right? So let me start maybe talking about the Harmony I and then the most recent update from [indiscernible], which is HARMONi-H trial where you guys provided some updated data in overall survival that should have a ratio of 0.74, which is static. It's 0.019, right? So maybe help us contextualize that data here, Dave, what does it mean for you? And also at the same time, how do you think this data kind of translates into HARMONi-I, which was recently presented at WCLC?

Yes. So there are 4 Phase IIIs that have read out with respect to ivonescimab. So the first trial -- and all 4 of those were positive readouts. So 4 Phase IIIs that have read out 4 positive Phase IIIs. When we look at the opportunity in HARMONi-A, that was the first trial that was initiated from a Phase III perspective, right? So that ultimately, on Friday, you mentioned, resulted in a statistically significant OS benefit. So contextualizing that, if we think about -- and this was part of what we spoke about at the beginning, what was ivenesimab designed to do. It was really to increase the potential of duration and quality of life of patients. In doing so, the half-life of ivanesemab is intended to make a more safe molecule as opposed to the individual compounds. And so what we hear historically, the notion is that if you -- anti-VEGF when you accumulate duration of therapy, you ultimately accumulate toxicity and that prevents survival. This really was intended -- this shows that that's not the case for ivonescimab. This was the first Phase III study. It was a statistically significant OS benefit, though. And so this is a place where PD-1s have failed historically. PD-1 plus VEGF has not shown an overall survival benefit. And so this really puts on the -- or puts to rest the notion that a PD-1 VEGF bispecific will not show an overall survival benefit full stop. In addition, you asked about the translation to HARMONi, the global study. And so what we saw there as well was the data that we presented at the World Conference on Lung Cancer, World Lung in September, we showed a longer-term follow-up of overall survival as well for the global patient population, right? So HARMONi-A is specific to China, HARMONi global population. And that had a nominal p-value of 0.03. And so again -- and which would have been below the statistical cutoff for survival in that study. So what we show is the mechanism is very much bringing an additional enhanced benefit to those patients. And we think the benefit risk profile is reflected in both of these studies now. It also shows the consistency of the data. When we overlay the curves from HARMONi-A and HARMONi extraordinarily consistent in terms of the overlap. We showed at World Lung as well the consistency of those curves from a PFS perspective as well when we added in additional patients from the West. So I think in total, I think that kind of covers the translatability and the opportunity.

If you go back like 18 months, 2 years, there were a lot of open cushions, right, which all investors had -- and all of them have been mostly answered, right? The first one was, guys, can Chinese data replicate into Western. We have shown that, right, through HARMONi, right? Will BFS translate into OS. We have shown that also, right? And the OS will be consistent, right, like on maturity is not Detroit. And we have shown that through HARMONi-A, right, which it used to be 0.80 and after further follow-up, it's now 0.74. So all those questions which were there have been answered, right? Best in versus Eastern, BFS to OS and OS to further mature OS.

Yes. Do you attribute that difference in terms of OS, where we saw a benefit and start static statistically significant OS in the HARMONi-A trial whereas the HARMONi-I, although the nominal p-value is less than 0.05, do you first analysis that the primary analysis was not, right? The attributes to the statistical plan powering? Or how do we think about this? Timing of enrollment, right? The Western patient was data was not mature enough. Once we did the mature data for Weston, it was significant. It can't be called fat significant because now we have used that, done that, but it's a statistic issue. But the drug is working as it was engineered, right, as you were saying, the drug demonstrated but you'll have to wait for the appropriate follow-up of the patients, right? You can't have 8, 9 months material data to show an OS benefit. And once we reach 13, 14 months of follow-up, that was converted into showing a significant.

I think there was an understatement on the expectations when we started this trial in terms of what it takes to bring a trial directly into Phase III in the U.S. and Europe where it hadn't been previously exposed. So if you think about the factors here, right, we took a -- we had -- obviously, we did the deal in end of 2022, beginning of 2023. I had a lot of confidence in the opportunity, and that's why we started immediately. But for physicians, they had not been previously working with the drug. So this was we're effectively asking trust the data that we had been generated. Now today, over 40,000 patients have been administered ivonescimab, either 3,000 or so in a clinical trial setting. And when you include those in the commercial setting in China, over 40,000. But at the time, we had several hundred patients, but all from China. And so we're asking physicians to trust the data from China. There were, as we talked about concerns with respect to VEGF tolerability. Is this something that leads to bleeding risk? Are there additional risks for patients. And we were able to demonstrate through putting a few analyses together and then ultimately further data readouts that the risk was much lower. When you look at the specific factors for EGFR-mutated lung cancer, brain metastases is a common location of metastasis. TKI is effective in slowing down progression of brain mets. There was -- we didn't have data that has been published at that time with respect to control of brain mets. We've now -- you see the published curves, PFS and OS with those patients with brain metastases entering the trial. And we see that, that has been something that ivenesumab has shown an improved hazard ratio for those patients with existing baseline brain metastases. And finally, we're still working through a lot of sites. We're still working through some of the ramifications of COVID in early 2023 in terms of fully gearing up their staff back and whatnot. That led to as Manmeet talked about that 4-month delay or so. When we did that ad hoc analysis at the -- it were lung -- at 4 months later on follow-up, and then you saw the p-value that was attributed to that study. The nominal p-value.

I think another thing to add and might be in different words is when you generally are doing a Phase III, you had some experience in the United States, right? Because we had got this drug from China. There was 0 experience, right, with the drug. We had to open up the sites. The company was just starting up, right, to open up the site, get the operational delays in getting the CTAs up and sites up, it takes time, right? So that was the few months delay, right? And now it's like now we have announced that we are enrolling so fast on [indiscernible] how many. It's different now after 18 months, 2 years.

It's ironic when you look back, I think people talk a lot about the PD-1 VEGF class. We talk about the other big pharma who are very interested. Only a short period of time ago, all of that was a bit different in terms of the climate, the experience and the perceived opportunity at the time.

Yes. That's really helpful. And then regarding the HARMONi and BLA submission, which I think called many investors back surprise here, and then you're saying that you're actually planning to submit in 4Q. So I was curious around the decision to do that. Have you met with the FDA? Have you got buy-in from them regarding the submission how confident are you that overall package of the FDA will lead to an approval.

Yes. So we don't -- we have a ton of respect for the agency. And we've -- across -- we have announced or started 4 Phase III clinical trials that obviously comes with a lot of meetings with the agency across a bunch of divisions as well. What we don't do is get into meeting-by-meeting discussions in terms of what we have. But what we made the conclusion on was really the benefit risk profile that we saw with ivinezimab, considering what's the historical precedent, what's been approved historically. There are no regimens within statistically significant OS benefit that have been approved in the U.S. in this setting. We look at the tolerability of the ivonescimab plus chemo in the setting and we see a very manageable safety profile. So that risk-benefit profile in consultation with many folks in many different areas, physicians and so on and so forth, this became the path forward that we wanted to pick.

Got it. And then for the BLA submission, do you expect the FDA to have a later data cut of the OS for the submission?

Similar to what I said. I think we don't -- we're not going to presuppose what the agency will do. We ultimately -- we have an extreme amount of respect for the agency as well as the process to go through that, whether it's the pre-BLA, the BLA process and whatnot. So we'll have multiple engagements throughout, but we're not going to give kind of step by step through that, but we'll certainly work with the agency.

But to answer your question in different words, right, if they will ask, right, yes, we want to and provide them, right? We generally have to do that and follow their advice and their questions.

Yes. That's fair. Great. Let's switch gears and talk about HARMONi-6 data here. So HARMONi-6 is the China trial for ivonescimab plus chemo versus tislelizumab plus chemo in frontline non-squamous lung cancer...

Squamous...

I'm sorry, yes, squamous -- my apologies, squamous non-small cell lung cancer. So just help us understand concentrate the meaningful efficacy there. And what does it mean for, let's say, readthrough ability to the global HARMONi-3 trial there.

Yes. I think you know that [indiscernible] right, there's a pretty comparable to pembro, right? It's in China. And that trial, like if you're comparing with PD-1 showing 0.60 hazard ratio, 40% improvement in PFS is huge. And that gives us confidence and read out on HARMONi-3, which we said, right, we will be completing enrollment for that in first half that it's looking pretty stronger in our view.

I think the other -- so continuing on that thought, right? I think we saw HARMONi-A reads out, and it's against placebo and albeit in an indication that PD-1s have been ineffective. And it was, okay, well, you need to go in to PD-1. And then HARMONi-2 reads out in PD-1 versus ivo head-to-head and that being pembrolizumab, beat it head-to-head. Then -- well, but when you add chemo that rising tides raise all ships. And so that will dilute the effect decisive statistically significant and clinically meaningful PFS benefit over PD-1 plus chemo. Frontline -- now this is the frontline undisputed standard of care in terms of both squamous and non-squamous patients, right? Squamous, this is very much comparable in terms of the results of pembro, tisle, so on and so forth, cemiplimab, they've all shown reasonably consistent results here in terms of the PD-1 category. So now then you take the next step with respect to the safety profile, right? Anti-VEGF, again, accumulating toxicities and in particular, in squamous patients, where it's effectively contraindicated because of the very high risk of hemorrhagic events, grade 3 to 5 leading risks, so on and so forth. We not only show a victory in terms of the trial from an efficacy perspective, but also the safety was incredibly important here. This is a randomized Phase III study against PD-1 plus chemo in squamous lung cancer patients. And so these are patients who are not necessarily highly preselected either in terms of risk criteria, so central lesions, capitated lesions, surrounding major blood vessels, right? So this isn't a cherry picked profile as well. And what we saw was a very manageable safety profile, oftentimes between the 2 Ivo plus chemo or tisle plus chemo, it was difficult to tell which was which. And so that's also extraordinarily reassuring in terms of going back a couple of years and people are saying, "Hey, VEGF, there's a risk, how do we mitigate some of those safety risks. This is a great example of the tolerability and the manageability of Ivo.

And how should we think about the PFS benefit will translate to OS benefit there going forward? Dave, you mentioned about the short half-life, improved tolerability there. just help us understand then the other flip side of the argument is there may not be contribution to the PD-1 arm. I'm just curious in terms of your thoughts around the PFS to OS translation ultimately.

Yes. I think the HARMONi-A study for 1 showed directly that PFS benefit leads to an overall -- a statistically significant overall survival benefit. So I think now that argument becomes a little bit tougher with [indiscernible] benefit. I think the other piece becomes what's the rationale why it won't right? Because in some ways, I want to turn that question around. We say, "Hey, why do we think it will. But if we look at the -- what are the concerns? Again, VEGF, toxicity accumulates shorter duration of treatment, ultimately, those toxicities can lead to earlier death. We didn't see either of those. We saw a duration of response that was longer. We saw higher overall response, and we saw an increased PFS benefit. We also saw an increase in a PFS curve that continue to separate further, right. And with that, you ultimately -- you see the first trial run lead to a statistically significant benefit. We talked about HARMONi, the global study. And with the -- what we believed would be the follow-up time for when that analysis would take place, nominal p-value under the threshold. We're seeing HARMONi-2 in an early ad hoc data cut that was requested from the Chinese health authorities, already showing an OS hazard ratio under 0.8, but generally accepted clinically meaningful threshold. And now we're seeing very positive, albeit early results in terms of the HARMONi-6 study without the toxicity and with and with a growing benefit across all of the major early end points here, if you will. And so it becomes, in some ways, difficult to believe that, that is not something that translates into OS instead of the other way around in terms of why not.

Got it. And then in terms of the other debt, which is thinking about the China to floorage inflation, a lot of skeptics around how likely will a China trial translate in terms of global trials. So I'm curious in your thoughts around any updated data or anything you've seen so far that would give us some confidence around the translation from China trial to global trials. How many was that, right? How many was from how many or how many are replicated. If you see in North America, the OS was exactly similar, right? PFS was exactly right. So that's how -- if you look at those graphs right there totally so much overlapping over there to translate. And now you'll have to wait for the next 1 is HARMONi-3, which will read out next year to do that right?

Yes. So in addition to what Manmeet said, if you look at median overall survival, 17 months versus 14 months in the West, 16.8 months versus 14 months in the East right? I mean, effectively, incredibly consistent median overall survival. You look at -- so let's look at, for example, on this one, it's the same follow-up time. Right. And so in HARMONi-A at ASCO 2024, at about 50% data maturity, 52% of events that took place, hazard ratio of 0.80. That included those who didn't receive a third-gen TKI. We've seen about a $0.02 difference when you exclude those patients, right? So if you pull those patients out of HARMONi-A, it's about 0.82 at that point in time. Pretty much exact same follow-up in the long-term Western follow-up that we presented a world long 0.84. So you're talking 0.82, 0.84, that same about 50% of events time period, incredibly consistent. The PFS curves as Manmeet talked about as soon as you add in more longer-term follow-up on those western patients, the curve doesn't move same with OS. You can overlay the HARMONi and the HARMONi-A curves. If there were a difference in terms of the way patients reacted, you would see fundamentally different shapes. 38% of patients from the HARMONi trial are from the West, 38% of patients acting differently will absolutely change the curve.

Got it. Okay. Great. And then in terms of the next steps for HARMONi-6, could you maybe just share some of the thoughts around what should we expect next data on OS data or PFS data?

Yes. I think importantly, that trial is sponsored by and conducted by [indiscernible]. So that is mainly for them. I think the -- there's been some -- the publication in terms of the land it had a little bit more indication with respect to statistics. So that looks like something that comes at some point next year, but that's really for the team at [indiscernible] to give specifics in terms of that guidance.

Great. And then moving on to your global trial HARMONi-3. So you recently amended the protocol to increase sample size for both the squamous and non-squamous non-small cell lung cancer where each cohort now is powered separately. Could you provide some color in terms of what you saw in terms of enrollment rates, physician feedback and end of the clinical data that made you decide to amend the protocol there?

Enrollment has been going pretty fast. That's why we guided in October only that we will be able to finish squamous enrollment by first half of 20 and non-squamous, which is now 1,000 patients, it's double the size, right? Because squamous patients is 1/3 of the frontline and nonsquamous is 2/3 of the population. So that's why they are powered separately to see that 600 versus 1,000 patients. But non-squamous is also -- we started only this year, and we are saying we'll be finishing the enrollment right in the second half of 2026. So enrollment is going pretty fast. That gives us the confidence. And that's why the readout for squamous could happen in the second half of '26 for squamous and nonsquamous readout would be in 2027.

Any kind of physician feedback you'd be hearing so far on the enrollment on the receptor.

Yes, we had a lot of calls with all our sites. We have now so many sites up and activated, all positive feedback. They were all surprised with the outcome of the data and ivonescimab has always right work. So we are not seeing anything all positive feedback from physicians. Their enrollment is going pretty fast. So I think...

Yes, I think the only thing I would add to that is I agree with everything that Manmeet said, I would also add a decrease in regulatory risk here. So it increases the probability of regulatory success here by splitting it out the 2 individual cohorts, right? You never want 1 to look a little bit better than the other, then you asked the question, did 1 drag, the other 1 across the line. We started squamous a little bit earlier. And so I think part of this becomes -- let's have clean IT for squamous and nonsquamous power them both individually. In that way, when we look at the analysis, they are very clean. You can look at the we've had a lot of topics of conversation in terms of -- and this is -- this being a more general comment, but the FDA really wanted to make sure that U.S. patients reflect the overall global patients results that we see in the trial, we've seen that across a couple of ADCOM meetings or ODAC, the FDA has held in the past year. And so this what's out the populations between the squamous and the non-squamous and that will make everything a bit cleaner in terms of review and not have any implied questions that can come. So these are very important settings for ivanesamab and for Summit as a whole. And so this becomes important to be as clean as possible.

So just to clarify, so by separating them out, you're actually able to derisking the regulatory side of things, right? You're able to separately submit BLA submission. We respect of other success of [indiscernible] trials.

That's exactly right. And so think of it as 2 clinical trials within 1 protocol, if you will.

And it accelerates the opportunity for squamous to come faster, almost a year faster because otherwise, you have to wait until end of '27, if you do combined analysis.

Anything to share on the powering assumptions for the trials there.

I don't think so we have discussed any public assumption.

Other than to say that they're both squamous and non-squamous are adequately powered for both PFS and primary endpoints.

Yes. It's interesting. You also mentioned that you're able to get PFS data for squamous and at the same time, you're able to get in terms of the OS. So could you help us understand what's next steps from here? Are you able to file for approve if you are to show data in the second half, 26-year to approve or are you to submit data right away? Submitted for approval right away.

Assuming positive data, right, that would be the intent to submit it for the BLA.

Yes, it's a total package question exactly as Manmeet said, it's -- we have to review the data and if that data supports, then that would be the decision to make at that time.

But our confidence increased, right, because of the HARMONi-6, right? HARMONi-6 squamous PD-1 plus chemo, right? That tells you that guys. The drug is working in squamous patients and our mechanism of action which was engineered denier, right, for that half-life and the cooperative mining, it's working exactly how it was planned and engineered.

Got it. Great. And then moving to HARMONi-2, the China trial for [indiscernible] monotherapy versus pembro, we've seen the PFS data. We also saw the interim OS 39% maturity. Anything you can guide on in terms of when should we expect the OS data for the final analysis?

So again, that's in Akeso sponsored study. So at that point, I'll let the team at Akeso updates with respect to that guidance. But obviously -- and it was really an administrative ad hoc look at that OS look when the CDE was looking to approve and the NMPA ultimately approve that indication, but we'll leave it for the team at Akeso in terms of updated guidance there.

Great. Okay. And then you moved recently into a CRC, which it's great to see that. And the indication expansion. Maybe you can just tell us a little more about the clinical trial design, any powering assumptions and potential time lines for enrollment and readout.

So we're just getting ready to start at this point. So I appreciate the readout in the next steps question there. But look, we're very excited. And I think -- so we gave a little bit of detail in our press release and 10-Q, but currently structured at 600 patients with a PFS primary endpoint. I think the place where I would focus that really, though, is if you take a step back, right, because I think you're -- I'm anticipating your question, but with this, how do you how you think about where this goes and how you're going beyond lung cancer, right? So if I step back a little bit, this becomes -- and just look at ivonescimab, right, there's 14 Phase III clinical trials right now. being conducted globally now including the CRC and then 10 being conducted by our partners at Akeso in China. 4 of them have read out, 4 of them are positive studies. So great backbone. But what that 10 implies is really that there's multiple additional places we can go. So CRC is 1 of the places where Akeso was also running a Phase III study. But then you get into head and neck, you get into pancreatic cancer, you get into triple-negative breast cancer, additional spaces within lung cancer, so on biliary tract cancer, so on and so forth. And so there is a multitude of different places where this drug can go. Another piece that might have been slightly overlooked with respect to HARMONi-6 is the consistency by which ivonescimab performed in that trial compared to the Phase II trial, so that AK112201 study, 11.1 months of median PFS 11.1 months of median PFS in the Phase III study. So you typically have that drop off from Phase II to Phase III and whatnot. And look, that's not something that I expect will have in every single time by any stretch. But when I mentioned at the beginning, 3,000 patients have been administered ivonescimab in a clinical trial setting. Obviously, a lot of that data has not yet been published. But what it shows us is the consistency of the impact of ivonescimab, the different settings in which ivonescimab can be impactful in all of the places that ivonescimab has the opportunity to go in addition to where even those 14 Phase III clinical trial starts. So we have an opportunity. And we mentioned this during the earnings call, we have the opportunity to expand into a multitude of places, and we plan to do so in the shorter term as well here. This is not done with CRC and then we're going to take a break, and we're going to prepare to continue to expand that plan because this is what the drug deserves.

Yes. I mean this thing on which I know we're 3 minutes left. I do want to ask some questions around the competitive landscape as you can imagine as an is picking up is getting really fierce with Pfizer jumping on and beyond Tacos has a competitive PD-L1 VEGF program as well, and they're all going after different indications, right? And there potentially adding different combination strategies with ADCs and others. So curious your thoughts around how are you -- how are you viewing the compete landscape and how you're staying ahead of the curve in terms of developing ivonescimab?

Yes, it's a great question. So I think we need to continue to expand the places that we look, and that's what I was just speaking to in terms of all of the trials that are being run in lung cancer, the opportunity to go into colorectal cancer and now expanding -- continuing further within the solid tumor space. In addition, combinations are and will continue to be important with respect to treating solid tumors. I think we have a competitive advantage in the sense of -- and we're evidencing this with our collaboration with Rev Med. So we're taking ivonescimab and combining it with multiple RAN inhibitors from Rev Med. And that -- those patients will begin to receive that combination in early 2026, right? But that's not the only time we'll do that. I think we've been very clear, we'll continue to expand the number of clinical trial collaborations that we have by following the data. There's no chemotherapy backbone that's the standard of care across all solid tumors. And we don't believe that there'll be a single ADC platform with a single payload that will be the standard of care across solid tumors. We've seen many places where Platform A has worked in 1 type of tumor, but not necessarily another and then platform B is worked there, but not in the third place, right? And so solid tumors biologically are very different. I appreciate that we put solid tumors around all of them, but they're biologically extraordinarily difficult. We see PD-1 work in some and not all, right? And so what we can do is really follow the data and continue to expand the number of different novel combinations that we do with ivonesumab, and that positions us extraordinarily favorably in terms of where we can go quickest without being encumbered by our own pipeline, if you will, in terms of looking to find synergies within our own portfolio. And obviously, there are other companies who see where the puck is going. We see this now read out with HARMONi-6 that gives a lot of confidence in terms of HARMONi-3. And so as we look at non-small cell lung cancer going forward, could ivonescimab be part of that standard of care backbone. Well, now other companies are -- can reach out and say, "Hey, is we're looking to get into that space as well, this might make sense for combinations.

And you know the right checkpoint anime market is expected by 2030 to be over $90 billion, right? So that is -- there will be competition, and you should expect that. And lung cancer is there, right, non-small cell and cancer, colorectal, they are big markets, right, to play. And I think we are not saying it's the -- we are taking the 100% market share also, right? So it's -- it's good to have competition, and it's good for patients, right?

Absolutely. Yes. Great. All right. Great. One last question. Just over the next 12 to 18 months, what should be -- what is scale we should watch for.

HARMONi-3, is a big one, right? Squamous, you'll get the readout, right? The first global trial, which people have been waiting. Again, all the questions, which we have answered is how many will be again answered through HARMONi-3, and BLA filing, right, for EGFR. So those all will come in 12 months and 18 months, you get HARMONi-3 non-squamous. And then further updates on colorectal and few expansion opportunities in the pipeline.

We're not stopping anytime soon.

That's great.

[indiscernible]

Yes, don't stop. Just keep going.

We have to love it. We have an obligation. We have taken responsibility to bring this medicine to patients who are in need.

Excellent. Okay. Great. I think with that, we can wrap it up here. Manmeet, Dave thank you for joining us here.

Thank you for having us.

Appreciate it.

Thank you, everyone.