Summit Therapeutics Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : 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?

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : 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?

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : 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,

Question: Yigal Nochomovitz - Citigroup Inc. - Analyst : 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?

Question: Bradley Canino - Stifel, Nicolaus & Company, Incorporated - Analyst : 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?

Question: Bradley Canino - Stifel, Nicolaus & Company, Incorporated - Analyst : 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

Question: Bradley Canino - Stifel, Nicolaus & Company, Incorporated - Analyst : 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?

Question: Kelly Shi - Jefferies - Analyst : 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?

Question: Kelly Shi - Jefferies - Analyst : 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?

Question: Kelly Shi - Jefferies - Analyst : 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.

Question: Sadia Rahman - Wells Fargo - Analyst : 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?

Question: Sadia Rahman - Wells Fargo - Analyst : 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?

Question: Sadia Rahman - Wells Fargo - Analyst : 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? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 24, 2025 / 2:00PM, SMMT.OQ - Q4 2024 Summit Therapeutics Inc Earnings Call

Question: Mitchell Kapoor - H.C. Wainwright & Co - Analyst : 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?

Question: Mitchell Kapoor - H.C. Wainwright & Co - Analyst : 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?

Question: Mitchell Kapoor - H.C. Wainwright & Co - Analyst : 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?

Question: Mitchell Kapoor - H.C. Wainwright & Co - Analyst : Congrats again on this collaboration.

Question: Asthika Goonewardene - Truist Securities, Inc. - Analyst : 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?

Question: Asthika Goonewardene - Truist Securities, Inc. - Analyst : 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.

Question: Asthika Goonewardene - Truist Securities, Inc. - Analyst : 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?

Question: Reni Benjamin - Citizens JMP Securities - Analyst : 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? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 24, 2025 / 2:00PM, SMMT.OQ - Q4 2024 Summit Therapeutics Inc Earnings Call 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.

Question: Reni Benjamin - Citizens JMP Securities - Analyst : 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.

Question: Reni Benjamin - Citizens JMP Securities - Analyst : 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