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Mahkam Zanganeh

Thank you, Bob, and good morning, everyone. As Bob said, I remain incredibly enthusiastic about the future of Summit and the possibilities of what can be accomplished with our lead candidate, Ivonescimab.
Before providing some additional detail and reviewing the current pipeline, I would like to touch on the clinical work that has been conducted with Ivonescimab and some of the interest and recognition received last year.
Since first entering the clinic with our partner, Akeso back in 2019, more than 2,300 patients have been treated in clinical trials with Ivonescimab. In 2024, alone, Ivonescimab was featured in 14 publications across seven tumor types and selected for five oral presentations at major medical conferences. Currently, between our partners at Akeso and our team at Summit, four Phase III trials have been completed enrollment, two of which are waiting top line data readout including the Summit sponsored HARMONi trial.
Five Phase III trials are currently ongoing, two of these are Summit sponsored drugs in first-line non-small cell lung cancer and three are Akeso sponsored trial studying Ivonescimab in head and neck, biliary tract, triple-negative breast cancers.
Akeso has also announced its intention to start a clinical study in pancreatic cancer later this year. A significant amount of additional data is being generated in additional indications, including colorectal cancer, ovarian cancer, gastric cancer and hepatocellular carcinoma, in addition to more data to support the lung cancer program.
Turning specifically to the Summit sponsored pipeline, as Bob mentioned last quarter, HARMONi completed enrollment in the fourth quarter with top line data expected in mid-2025. This data is expected to contain data for both primary endpoints, progression-free survival and overall survival. HARMONi-3 was amended by significantly expanding the addressable patient population to include all frontline metastatic, non-small cell lung cancer patients without driver mutations by including patients with non-squamous tumors in addition to squamous tumors.
Squamous tumors represent approximately 25% to 30% of non-small cell lung cancer in the United States with non-squamous tumors representing a large proportion of the rest. A reminder, this trial includes patients with tumors that are PD-L1 negative, PD-L1 low expressing and PD-L1 high expressing.
We announced our intention to initiate HARMONi-7 in early 2025, for which we have begun to activate clinical trial site in the United States. Later this year, we expect to announce additional details around expanding our clinical development plan around Ivonescimab, specifically beyond lung cancer.
After receiving interest for more than 75 investigator-sponsored trials in the most recent open window, we have approved over 30 ISTs today, which will either enhance our sponsored clinical development activities or can show signals in settings where Akeso has not yet had the opportunity to explore.
In 2024, we started our collaboration with MD Anderson, which now has studied that are activated and open for enrollment in Houston. We have committed $15 million to the collaboration to quickly discover additional opportunities for Ivonescimab, including several tumor things outside of its current development plan as well as the possibility of either buying biomarkers through additional research activities.
Finally, as we announced this morning, our clinical trial collaboration with Pfizer will look at Ivonescimab in combination with several Pfizer vedotin-based ADCs in multiple tumor types. As we seek to accelerate the development of Ivonescimab across non-small set lung cancer and other solid tumor setting, this collaboration will allow us to quickly advance beyond our promising late-stage development plan to evaluate Ivonescimab in combination with some of the most innovative ADCs provider.
Clinical trials as part of this collaboration are expected to start mid-2025. Pfizer will be responsible for the operations and costs associated with these trials, we will provide Ivonescimab and join the overseas study.
As a reminder for those new to the Summit story, Ivonescimab has significant lead in the clinical development of this global class of compound. Ivonescimab brings two highly validated targets together into one novel bispecific antibody that targets both PD-1 and VEGF.
Next, I would like to review upcoming catalysts for this year and beyond. As we touch on a moment ago, we are expecting HARMONi top line data in mid-2025 which we expect will include both primary endpoints of progression-free survival and overall survival. This will be the first global Phase III clinical trial readout for Ivonescimab which provides a potential path to applying for marketing authorization in our territories, including potentially, the United States.
Secondly, we intend to expand our sponsored clinical development plan to go beyond non-small cell lung cancer in 2025 and 2026 in addition to continuing engagement with a rapidly increasing number of investigators seeking to conduct investigator-sponsored trial at various institutions across a large number of different tumor types. And you will see continual activating of additional ISTs in a variety of solid tumor settings.
This is in addition to Akeso continuing its execution of its Phase III studies, including completing the enrollment of HARMONi-6 in frontline squamous non-small set lung cancer with Ivonescimab combined with chemo as well as continuing the enrollment of its Phase III biliary tract cancer, triple-negative breast cancer and head and neck cancer study.
Over the course of this year, we will continue to seek clinical trial data readouts from Akeso in variety of tumor times. And finally, we expect to see more Phase III initiations from Akeso in non-small cell lung cancer and beyond, likely in indications in which Phase II data has been generated, which we touched on earlier. We are excited for the catalyst switch path ahead of us for convention and belief in the potential for Ivonescimab to improve patient lives for the better, remains strong and consistent.
Now I would like to take a moment to review study design for our two ongoing global Phase III trials, HARMONi-3 and HARMONi-7. Here, we have the study design for HARMONi-3, HARMONi-3 is a randomized, double-blind, global Phase III clinical trial, evaluating Ivonescimab in combination with chemotherapy against pembro in combination with chemotherapy as first line treatment for patients with metastatic non-small cell lung cancer.
This trial includes patients with squamous and non-squamous histologies with no activating genomic alterations regardless of PD-L1 expression, including high, low and negative PD-L1 expressing tumors. Dual primary endpoint for HARMONi-3 include progression-free survival and overall survival, and results will be stratified by squamous and non-squamous histology.
Next, we have the study design for HARMONi-7. HARMONi-7 is randomized double-blind global Phase III clinical trial, evaluating Ivonescimab monotherapy against pembro monotherapy as first-line treatment for the metastatic non-small cell lung cancer patients with tumors with high PD-L1 expression.
Dual primary endpoints for HARMONi-7 include progression-free survival, overall survival and results will be stratified by squamous and non-squamous histologies. As a reminder, our HARMONi-7 study shares similarity with Akeso sponsored HARMONi-2 Phase III trials which reported data last year, but specifically targeted the PD-L1 high expressing tumors consistent with the standard of care for monotherapy immunotherapy in the US and Europe.
Turning to the market opportunity for Ivonescimab, the value proposition here is clear. Ivonescimab has the potential to be a platform blockbuster drug and is well positioned to make a significant impact across the treatment landscape of non-small cell lung cancer and beyond. Specifically in non-small cell lung cancer, there are a combined six announced or ongoing Phase III studies conducted by either Akeso or Summit.
Non-small cell lung cancer alone has an addressable market that could ultimately approach $20 billion for checkpoint inhibitors according to the third quarter research from the likes of TD Cowen and others, but this is just a start.
There are more than 50 indications where PD-1, PD-L1 or VEGF therapies have been approved. Ivonescimab will continue to be rapidly tested and developed beyond non-small cell lung cancer. Across all checkpoint inhibitors indications, the addressable market approached $90 billion globally in the next couple of years, according to IQVIA Research.
However, this still excludes the full impact that Ivonescimab could have, where it has shown promising data in multiple tumor types, where checkpoint inhibitors have not been effective, including microsatellite stable colorectal cancer, PD-L1 low triple-negative breast cancer and EGFR mutant non-small cell lung cancer after targeted therapy.
We are excited to continue to progress our development in non-small set lung cancer into '25. Additionally, data shared in 2024 showed that Ivonescimab has a market potential much larger than non-small set lung cancer and our current ongoing global Phase III clinical studies that we are sponsoring at Summit.
There are multiple Phase II trials that have been conducted, providing encouraging data to continue to explore Ivonescimab and the opportunity to become a standard of care across several solid tumor settings, which we intend to continue to explore with a goal to improve the lives of as many patients as possible facing high unmet medical needs.
I would also like to take the opportunity to thank most importantly, the patients in our clinical studies as well as our investigators, hospitals, including our collaborators at MD Anderson and our partner in China, Dr. Michel Shaw and the entire Akeso team, as we continue to pave the way for rapid development of Ivonescimab globally.
And of course, the Summit team. As Bob and I look back on all of the many achievements over just the past two years, Team Summit has done a tremendous job across every department in making our goals a reality and appropriately condensing time when and where possible. We continue to look at opportunities to accelerate our timeline in bringing additional therapeutic options to patients with high unmet cancer needs.
It is an honor and privilege to work with each member of Team Summit, and I would like to express my heartfelt thanks to everyone of our team members.
With that update, I will now ask Manmeet provide details on our financial position and operations update.

Manmeet Soni

Thank you, Maky, and good morning, everyone. This morning, we issued our earnings release for the fourth quarter and year ended 2024. Today, in addition to providing you with an update on our cash position and operating expenses, I will also be providing an update on our progress on clinical trial enrollment on HARMONi-3, HARMONi-7, an update on tech transfer for manufacturing in our licensed territories.
On the financial front, let me start with the cash position. We ended the year 2024 with a strong cash position of approximately $412 million. Let me remind you that we have paid off our debt in entirety and now we are debt free. With a strong cash position and zero debt, we are well positioned to continue to execute on our clinical trials.
Turning to operating expenses, I will be providing details to both GAAP and non-GAAP numbers. You can refer to our press release issued this morning for a reconciliation of GAAP to non-GAAP financial measures. Just to remind you, non-GAAP expenses exclude stock-based compensation expense. Our GAAP R&D expense during the full year 2024 were $150.8 million compared to $59.4 million for the previous year.
And non-GAAP R&D expenses were $134.8 million during the full year 2024 compared to $55 million for the previous year. The increase in the R&D expenses reflect the expansion of our clinical trials related to Ivonescimab.
Our acquired in-process R&D expenses during the year 2024 were $15 million compared to $520.9 million for the previous year. To remind, acquired in-process R&D expenses for the year 2023 which were $520.9 million were related to the upfront payments made to Akeso for the licensing agreement. And $50 million expense in the year 2024 is related to the amendment of the licensing agreement with Akeso to include Latin America, Middle East and Africa regions into our license territory.
Our GAAP G&A expenses during the full year 2024 were $60.5 million compared to $30.3 million for the previous year. And non-GAAP G&A expenses were $25.5 million during the full year 2024 compared to $20.6 million for the prior year.
Our GAAP G&A expenses primarily increased due to an increase in the stock-based compensation charges related to achievement of certain conditions on performance milestones, which vested during 2024. Overall, our non-GAAP expenses during the full year 2024 were $175.3 million compared to $596.5 million previous year.
The decrease in non-GAAP operating expenses was primarily related to the decrease in acquired and in-process R&D expenses, as mentioned earlier, which were offset by the increase in R&D expenses due to the expansion of clinical studies and development costs related to Ivonescimab.
To remind that last quarter, we announced that we plan to expand HARMONi-3 study to include non-squamous patients in addition to the squamous patients. I'm very pleased that our Summit Team was able to activate non-squamous arm in a record time, and we recently started enrolling patients for non-squamous in the United States.
We expect to start activating sites to enroll non-squamous patients in other regions during the second quarter of 2025. We continue to enroll squamous patients in all the territories. Additionally, during last quarter, we had given guidance that we will initiate our newly announced pembro trial HARMONi-7 in frontline non-small cell lung cancer or PD-1 high patients in early 2025.
A head of our schedule, Team Summit has already begun to activate sites in the United States. We expect to initiate activating sites in the other regions during this quarter of 2025.
Turning to tech transfer for manufacturing, we continue to make progress in transferring relevant know-how to third parties to establish additional supply sources in our licensed territory. And with that, I will hand it back over to Dave. Dave?

Dave Gancarz

Thank you, Bob, Maky and Manmeet. We will now see if there are any questions that we can help -- that our team can help answer. Kate, if you could please open up the line for questions.

Question and Answer Session

Operator

(Operator Instructions).
Yigal Nochomovitz, Citigroup.

Yigal Nochomovitz

Obviously, we're getting a lot of inbounds on HARMONi-2 and Akeso has provided some comments on the timing of the OS. If you could help us understand what you believe to be the timing for the HARMONi-2 OS. And given the fact that it may be approved in China as early as the third quarter of this year for the second indication for frontline, what is the potential or is there any expectation that we could see glimpse of some early OS data in that China label?

Dave Gancarz

Thanks, Yigal. This is Dave. So I appreciate the question, and I know there's a bit of commentary with respect to HARMONi-2. As our partners at Akeso have mentioned, they expect to reach the number of events required for their interim analysis by the end of year 2025. We ultimately don't have more information on that front other than continuing partnership with Akeso. But at this point, there's been nothing new on that front with respect to any additional information. But appreciate the question.

Yigal Nochomovitz

Okay. No worries. And then on the second-line EGFR, the HARMONi trial, I think Maky mentioned, you will have the OS data in the top line readout. What is your understanding as to whether you need that to be only a trend or actually hit on set that significant in order to be in a good position for approval in the US?

Allen Yang

Yes, Yigal. This is Allen Yang. Thanks for the question. So I think there's two things. I think we, of course, would want to hit OS and be statistically significant. However, if you look at the precedent of previous approvals in this space, they have not required OS for PFS has been adequate.

Yigal Nochomovitz

Okay. And then I know Manmeet just mentioned that you're starting to add the patients for non-squamous in the second quarter for HARMONi-3. Is there any possibility you could provide even a rough guideline as to the timing for the top line readout for HARMONi-3. And if you can't do that, anything you can say around HARMONi-6, given that's possibly helpful in terms of the read-through to HARMONi-3.

Manmeet Soni

Yigal, this is Manmeet. You heard it correct, right? We have just initiated our sites in US, and we have started enrolling for US the non-squamous arm. It's too early to give clarity on the completion of the enrollment until we complete all the sites and other territories, which is obviously in Europe and other regions, which we plan to initiate. We would be able to provide once all those sites are activated, and we have a quarter or two of the run rate, then we will have clarity in our time lines over there.
Related to HARMONi-6, you're also correct, right, that trial has been completed enrollment, which was fully in China in the squamous arm and what I believe as for the guidance from Akeso, that should read out sometime in the middle to end of this year. We don't have visibility into any more details further than that.

Yigal Nochomovitz

And then last quick one, I would be remiss if I didn't ask you about the news in on the Pfizer collab. Anything you could say there in terms of additional details, which of the vedotin ADCs, what tumor types? How big would these early studies be? And things of that nature?

Dave Gancarz

Yes. Thanks, Yigal, this is Dave. I really appreciate the interest there. I think -- so what we've said this morning, multiple ADCs from Pfizer, we plan to go into multiple solid tumor settings and expanding that beyond just non-small cell lung cancer, obviously. We haven't given specifics in terms of which ones just yet, but they are likely to be Phase Ib2 level trail at this point. We need -- these are the first combinations that we'll do with Ivonescimab in these specific ADCs. So normal course operations there. But we'll give additional details as we get close up.
But we are very excited to get moving here. And I think as we've mentioned before, this is one of the strategic advantages that we feel we have in terms of the opportunity to combine Ivonescimab with a number of different products from a number of different organizations, pharmas and biotechs. And so this is one of the first steps in terms of moving forward from that perspective, but we will be giving additional details as we continue to get closer to the beginnings of these trials, which are expected in the middle of this year, so short term from that perspective.

Operator

Brad Canino, Stifel.

Bradley Canino

In the Pfizer ADC collaboration, do you think about this more from the perspective of providing further therapeutic enhancement beyond the KEYNOTE-189 benchmark or more from the perspective of bringing Ivonescimab outside of lung with a better probability of success?

Allen Yang

Brad, thanks for the question. Both, but probably the latter more. So clearly, ADCs are going to be important across solid tumor oncology. I think the data in lung cancer is interesting but the data outside of lung cancer has been stronger. And I think the fact that multiple ADCs is involved in this is important.

Bradley Canino

And maybe just a quick follow-up on that. In lung specifically, as I look at the Pfizer pipeline of ADCs. Can I check your confidence level in integrin beta-6 for an ADC target over TROP-2 where obviously, competitors have frontline Phase III reading out this year?

Dave Gancarz

Yes. So I appreciate the question, Brad. And I think we'll be in a better position to give a little bit more details as we get closer to launching the Phase Ib2 clinical trials. But at this point, we're not really getting into the specifics just yet in terms of the design as we want to allow for this trial to get up in the activation portion and then ultimately get up and running.

Allen Yang

Brad, for what it's worth, it's an important question. We wish we can answer it, but we can't do it yet.

Bradley Canino

Maybe last for me. With the HARMONi EGFR data coming midyear, how do you plan to show the data to investors to demonstrate that there's comparable efficacy and safety and its effect in Western patients relative to Akesa's China patients?

Dave Gancarz

Thanks, Brad. Yes, I mean, I think that is going to be a key component. I think we and especially Allen, have been talking about this for over the course of the past year or so. One of the key components we'll be showing, the comparability of the data, to your point, both efficacy and safety in the eastern and western population.
So while we haven't explicably described the ways in which we will show this. We'll obviously have presentations at major medical conferences. And this, the granularity will be there so that, that data can be interpreted.

Operator

Kelly Shi, Jefferies.

Kelly Shi

Congrats on the progress. Maybe a couple of questions, how many trials, global trial design. So regarding the following assumptions on both PFS and OS, should we assume it is designed based on the total of 420 patients, but not a subgroup of ex-China patients?

Allen Yang

Yes. Kelly, this is Allen Yang. Yes, it is a primary analysis of the total study population. Of course, as Brad alluded to, that there will be looks at the regional differences. We've had discussions on this from a regulatory standpoint about how the data analyzed and presented. But then, of course, during the analysis and during the review process, they could always ask for additional studies as well.

Kelly Shi

Okay. And you guided a midyear for the data disclosure. I just want to confirm, this is referring to like June, July or actually could be like the entire Q2, Q3 time frame?

Dave Gancarz

Yes, I appreciate the question, Kelly. I think we're probably a little bit broader on that and more in the Q2, Q3 timeline. But obviously, as we get closer to that, we'll be letting people know.

Kelly Shi

Okay. Terrific. And one more on Pfizer collaboration. So regarding EV in bladder cancer, just curious, is there like a possibility to add some combo arm to the ongoing or the initiating Phase III trials running by Pfizer? Or should we expect more like early phase trials.

Allen Yang

Yes. I don't think we've disclosed anything. We're exploring every opportunity to move as quickly as possible. We haven't said anything about EV specifically, but we believe that EV is important in bladder cancer. And yes, more to come.

Dave Gancarz

Yes. We're excited to give you a little bit more details in the upcoming couple of months.

Operator

Mohit Bansal, Wells Fargo.

Sadia Rahman

This is Sadia Rahman on for Mohit. Congrats on all the progress over the year. So I wanted to ask on the Pfizer collaboration. Curious how you're thinking about the overlapping toxicities with VEGF and inhibition and vedotin-based ADCs, and how this could differ from combinations with ADCs using topoisomerase summary payloads?

Dave Gancarz

Yes, I appreciate the question there. I think part of -- if I take a step back, one of the things that we've expressed more broadly, is that we want to be able to take Ivonescimab and combine it with the best available treatments on a tumor-by-tumor level, right? And so part of what we will be doing is doing safety run-ins with any combination in which we combine with Ivonescimab, and that will be the same here.
So I don't think we're in a position to commentate specifically on each of the different types of ADCs, whether it be MMAE base, whether it be topoisomerase base. We've seen data historically, whether it be in combination with immunotherapy like pembrolizumab in some of these ADCs whether it would be, again, MMAE-based or topoisomerase base.
But at this point, we're excited about the profile that's been shown to date for Ivonescimab. We're very aware of the profile to date for many of the progressing ADCs. And I think that's where we're going to take the opportunity to do rational step-by-step combinations, and then we'll take that to the next step as we see the data.

Allen Yang

Yes. And I would just add there's emerging data in combination with pembrolizumab that these types of ADC combinations are feasible, and we have good safety data comparing Ivonescimab to pembrolizumab. So we don't expect any additions or surprises in the combinations.

Sadia Rahman

Got it. And then on the upcoming readout this year in EGFR mutant lung cancer, I think you said the majority of those patients are coming from the China HARMONi study, and the majority of those patients received the first or second-gen TKI before getting a third-gen TKI.
Would all of the patients recruited into the HARMONi study receive only a third-gen TKI in that first-line setting? And can you talk about how -- about any differences in those populations that we could expect in terms of time from diagnosis or survival after that third-gen TKI, and whether that could result in any differences in efficacy when looking at the next line of treatment?

Allen Yang

Yes, Sadia, just to be clear, the majority of patients in HARMONi A did receive a third-generation TKI as part of the standard of care, and those patients will be included. Whether they received a first or second generation before receiving a third generation, they would still be eligible. And in terms of differences and responses in those that got first or second versus third generation and where they got them, that's outlined in The Lancet publication by Zhang, et all., and we didn't expect any differences.

Sadia Rahman

Okay. And then maybe one more on the HARMONi-2 trial and your global trial. So the to separation on the PFS curve in HARMONi-2 happened very early on. Can you talk about what you would expect for the global study since it adds on chemo combination? Just trying to understand how much the curves could shift and how that could affect timing of when you hit on PFS relative to when HARMONi-2 hit on PFS?

Dave Gancarz

Yes. I think we've put out a decent amount of data with respect to AK112-201, which was the Phase II, which looked at Ivonescimab plus chemotherapy in multiple settings, including both squamous and non-squamous in the frontline setting. That's probably the earliest or best rather in terms of an early thought process with respect to what we would see from data with Ivonescimab plus chemo, and comparing that against the historical benchmarks that you would see from trial such as KEYNOTE-189, KEYNOTE-407, et cetera.
So I think that's probably -- those are probably the landmarks that I would look at from an early read in terms of what's publicly available. And then obviously, as we get continuing data, including HARMONi-6 from our partners at Akeso in the squamous front-line setting, those will be additional inputs that we'll provide more color.

Operator

Mitchell Kapoor, H.C. Wainwright.

Mitchell Kapoor

Congrats on this deal. Just can we just talk about kind of when you were searching for a BD transaction like this, can you just talk about what you were looking for before you came to this arrangement with Pfizer. And now that this deal is on the table, do you foresee additional BD opportunities or does this kind of preclude those for a while?
And could you just talk about if you expect future business development to be in the pursuit of combination similarly like this? And importantly, if there are any particular BD opportunities that you're not considering?

Dave Gancarz

Yes. Thanks for the question, Mitchell. I think if I, again, take a step back here. I think one of the things that we have talked about is the strategic advantage for Summit and Ivonescimab is that we don't have that pipeline internally that we're kind of almost committed to combining with and will almost force through combinations as much as possible to try to keep internal synergies.
And so in general, our approach will to look out and say, what are the best therapies, what are the standards of care across each of the different solid tumor settings and to the extent that Ivonescimab plus one of those whether antibodies or small molecules make sense, then that will be an opportunity where Ivonescimab can combine there.
So I would say, as a whole, we don't believe there's a single ADC platform that individually is the only way to move forward, but we do believe that multiple companies have multiple different types of ADCs, whether it be topoisomerase base, whether it be MMAE base, whether it's switching up the antibodies in different settings. Obviously, there's a number of, for example, TROP-2 ADCs with different antibodies. So what we can do is really exploit different combinations of Ivonescimab plus X, Y or Z, ADC, antibody small molecule.
So we're not really giving guidance in terms of what we plan to do X additional collaborations like this or whatnot. But in general, we certainly feel well position for is that we will take Ivonescimab and look to combine it with the best possible alternative, if you will, out there from a standard of care perspective to bring the most potential value to Ivonescimab and ultimately help patients in any way that we can there.

Allen Yang

Yes, Mitch, and this is Allen Yang. I would just say we just want to pursue the best science to help patients, right? And so I think there was a lot of interest in combining with pembro in terms of combination therapies with different immunotherapies and different other agents. And based on the HARMONi-2 data, as we had suspected that now companies are interested in sort of pairing with Ivonescimab, and that's where the puck is going.

Mitchell Kapoor

Okay. Great. And just to clarify the last point, are there anything, any particular BD opportunities that you're not open to at this juncture?

Dave Gancarz

No, I wouldn't say that there's specific things we're not open to. I think it's more about what is possible with Ivonescimab.

Allen Yang

Yes. And I would just add, if there was some clear safety issue or something like that, but we have not seen that signal yet. So we're pretty excited that we have a lot of opportunity.

Manmeet Soni

Sorry, Mitch. This is Manmeet. And I would just clarify, I guess, to answer your question very specifically, this transaction with Pfizer doesn't preclude us to do any other regional or any partnerships or any other activities?

Mitchell Kapoor

Very helpful. And the last one for me, just on the first-line trials. Can you talk about a little bit more about the HARMONi-3 enrollment? I know you briefly touched on that, but does HARMONi-7 site activation compete for patients for the PD-L1 high enrollment for HARMONi-3 at all?

Manmeet Soni

Yes, Mitch, this is Manmeet, again. Yes. Obviously, there is a segment of patients, right, PD-1 high patients, which will be covered in our HARMONi-3 also, right? So there is some sort of that, but as you know, we have much ahead in our schedule on HARMONi-3 activations and there will be not a full overlap of the sites, right, as compared to HARMONi-7.
So we have just taken HARMONi-7 initiation in the last few weeks, and HARMONi-3 is already enrolling, right, our patients. So there will be -- obviously, there is an overlap, but we don't expect there is a competition because of the new sites which we are planning to add in HARMONi-7.

Mitchell Kapoor

Congrats again on this collaboration.

Operator

Asthika Goonewardene, Truits Securities.

Asthika Goonewardene

Congrats on the progress as well. I wanted to dig into HARMONi-3 a little bit, please. Will the primary statistical analysis for that study, are you doing the primary analysis on the combined non-squamous plus squamous population? Or will you do it more in a step-wise manner kind of looking at the squamous and non-squamous subgroups individually first and then look at the overall population?
I ask it because I believe the BioNTech study is structured more like the latter. I'm curious to know if you take a different approach if so, why you prefer your method?

Allen Yang

This Allen. Yes, so it is -- our plan is to do a primary analysis of the combined population, and we believe that, that was the best way to bring this product to patients as fast as possible from an operational perspective. Of course, there is always data and ongoing data coming out, the HARMONi-6 will be informative as well, but our current plan is to do a combined analysis.

Asthika Goonewardene

Got it. Thanks, Allen. Have you discussed with the FDA anyway to accelerate a filing with HARMONi-3. I'm wondering if you're seeing a strong PFS signal, is there -- have you talked to the FDA about maybe doing an accelerated filing based on that.

Allen Yang

Of course, we want to bring this to patients as fast as possible and we've had several discussions with them on this study, but I can't disclose our discussions at this time.

Asthika Goonewardene

Got it. Okay. And then on the Pfizer collaboration, do you feel Ivonescimab would be -- could better leverage the immunogenic cell death versus PD-1? Or is the rationale behind this deal, mainly about layering on the classical anti-angiogenic pressure in addition to PD-1 with the ADC?

Allen Yang

Yes, Asthika, great question. We could talk a lot about that. But with that said, part of it is empiric. We know that both of these drugs are -- a lot of these drugs are active in different tumor types and then you clearly want to add those efficacies. Whether there will be some synergistic effect through to the immune system for the profile? Would it be different from pembro's sort of additive or synergistic effect, we think all of those are actually possible, and we're looking forward to these combinations, but yes, it's very interesting.

Operator

Ren Benjamin, Citizens JMP.

Reni Benjamin

Congratulations on all the progress. With HARMONi-3 and 7 kind of off to the races, can we talk a little bit about the next solid tumor indications you plan to invest in? And you've got some -- we had some ongoing study data reported last year. Can you talk a little bit about when we might see some updated results from those studies?
And I guess just as a sticking with this theme, I guess, broadly, do you kind of strategically follow Akeso based on their data, their solid tumor data and kind of do global studies based on what they reported? Or do you kind of broaden exposure and go after indications that maybe they're not addressing.

Dave Gancarz

Sure, Ren. Thanks very much for the question. In reality, everything that you mentioned resonates, right? And so if you think about the last part of your question, which is do you follow Akeso or do you look to branch out, as Maky talked about, part of our MD Anderson collaboration looks to accomplish parts of that as well as our IST program.
If you look at some of the Phase II data generated by our partners at Akeso, which were released over the course of last year, whether it be BTC, colorectal cancer, head and neck cancer, and triple-negative breast cancer. There are some promising efficacy in that Phase II data.
There are also additional indications that have been explored in Phase II data hasn't yet been fully disclosed from that perspective, which gives us opportunities. And then obviously, we can run additional signal seeking or Phase II studies as well, whether on our own or through things like the collaboration the clinical trial collaboration with Pfizer here, which we'll look to do that as well.
So as a whole, we've -- as Maky mentioned in her comments earlier, we're very keen to in addition to the significant work being done in non-small cell lung cancer look beyond lung cancer as well, and that's part of our '25-'26 development plan.

Allen Yang

No, Ren. I was just going to add. So we haven't disclosed it, we're in the midst of multiple regulatory discussions around that. I would just say that we have been thinking about this for a long time, so we did this exercise even before the HARMONi-2 data read out shortly after the deal was done, looking at all the prior checkpoint inhibitor approvals, looking at all the angiogenic -- anti-angiogenic approvals.
Looking at we think the population size would be, what the comparator arm would be, and then you layer on top of that the Phase II data coming out from Akeso that all goes into the calculus of how we make those decisions and hopefully, we'll be able to disclose some exciting opportunities soon.

Reni Benjamin

Outside of the opportunities, could we expect updated results from any of those studies or do you feel like they're largely concluded and it really, it's about the Phase III studies that are up and running.

Manmeet Soni

Yes. Ren, this is Manmeet. You will continue to hear more updates as we progress on those all the studies which we had given some initial top line data earlier in the last year. But I would also mention that, right, colorectal cancer, right, where we are pretty excited. And we have just recently partnered with Akeso also on the Phase II study, which we have begin to activate over here on our side, and that would be the first one, which is -- which you would hear more details in next coming quarters.

Reni Benjamin

Excellent. Okay. And just one last one for us. I think ct.gov said that there are three active sites for HARMONi-7. Can you talk a little bit about how many sites globally you expect to have on board by, call it, by the end of 2025 and for both HARMONi-3 and HARMONi-7.

Manmeet Soni

Ren, this is Manmeet, again. I think we don't give the specific number, but on the sites which we activate because we go into multiple regions, right, this is a global multi-regional study, but I would expect by end of 2025, almost -- most of the sites are like 100% -- near to 100% of the site should be activated.

Operator

I will now turn the call back to Dave Gancarz for closing remarks.

Dave Gancarz

Thanks very much, and I'd like to hand it over to Bob Duggan just for a couple of remarks before we close.

Robert Duggan

Yes. I just want to weigh in on the question business development. Business development has a couple of arms. One is develop optimized ivo and make it the best product monotherapy, combination therapy that the world has -- can get from us and our partner, Akeso. And we're daily looking at that and evaluating that, there's plenty of room to go, as you see with the trials that we're entering into.
The second aspect of business development is what's the timing of gaining markets, additional market space, additional market opportunity and then how much share can you get? And how do you go about doing that? And that's also a major part of business development. So we're very active on two footprints: Pfizer is footprint one, how do we optimize the product.
Other activities, we're constantly working on those here also. I just want to make clear that Pfizer is not the beginning and end of business development at Summit. Not that it isn't for most of you, but even for some of you.
So back over to Dave.

Dave Gancarz

Really appreciate it, Bob. Thanks very much. And I want to thank everyone for attending today's earnings call. An archived version of the webcast will be available later on our website, www.smmttx.com. Thank you very much for your participation, and we hope you enjoy the rest of your day. Thank you.

Mahkam Zanganeh

Bye-bye.