Summit Therapeutics Inc Q1 2025 Earnings Call Transcript

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

Question: Unidentified Participant 1 - Goldman Sachs - Analyst : Hey team, this is Mark on for Salvin. Thank you so much for taking our question and congrats on the quarter. Couple questions on the upcoming Harmony EGFR data set. So I think everyone's going to be focused on sort of the subgroup data to confirm if because those prior data generated in China translates to Western regions. So what do you believe the bar for success here is in this context? Like how closely does the data have to mirror Harmony A to support the translatability, and also. In the context of (Rybervan's) approval on (Mariposa 2), what profile are you hoping to see from Harmony, to and sort of what level of benefit do you believe would convince Docs to use (ivonescimab and second line E year far)? Thanks.

Question: Unidentified Participant 1 - Goldman Sachs - Analyst : That makes sense. Thank you.

Question: Egan Chomaditz - Citigroup - Analyst : Hi, everyone. Thank you very much for taking the questions and congrats on the very positive recent developments. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, SMMT.OQ - Q1 2025 Summit Therapeutics Inc Earnings Call My question also on harmony, could you just be more specific in terms of what will we see with respect to the geographic data, meaning China versus ex-China patients? Are we going to be getting separate hazard ratios on PFS and OS for each of these geographies? Would it be something in the form of a forest plot? Or would it just be some kind of a more qualitative statement around potential comparability? That's my first question. Thank you.

Question: Egan Chomaditz - Citigroup - Analyst : Okay, thanks. And then two more on harmony with respect to timing you consistently said mid 2025. Is it fair to assume that we would see harmony before we see Harmony two and Harmony six, which you've alluded to would be at the fall medical meetings, and then also with Harmony, what is your view on whether you need OS to beat (ig) for a competitive filing in the United States? Thanks.

Question: Egan Chomaditz - Citigroup - Analyst : Oh, I was just curious about the relative importance of hitting on OS in harmony to have a competitive BOA filing.

Question: Egan Chomaditz - Citigroup - Analyst : And maybe if I could just squeeze one in, maybe for you, Allen, maybe Jack, obviously the Pfizer partnership for the ABCs is great, however, that one is missing some of the more perhaps relevant targets in non-small cell lung cancers such as a (rope 2 or HER2 HR3). So how are you thinking about that aspect of a longer term strategy in lung cancer to combine potentially down the road with those types of ADCs?

Question: Egan Chomaditz - Citigroup - Analyst : Okay, thank you so much.

Question: Corey Casamogh - Evercore - Analyst : Hey, good afternoon guys, thanks for taking the questions. I'll stick the two of them, I guess. First one is for Harmony two, you obviously showed pretty profound PFS benefits across all cuts of the data and histologies, everything else. Would you expect that to broadly hold for overall survival as well? And then I'll have a follow up.

Question: Corey Casamogh - Evercore - Analyst : Okay, understood. And then a question we get a lot I want to ask you is, do you expect safety trends in the global population, whether it's the Harmony study or some of your following ones to match what's been seen in the data sets coming out of China? What would be the rationale as to why it could be different?

Question: Corey Casamogh - Evercore - Analyst : yeah, on the safety front.

Question: Corey Casamogh - Evercore - Analyst : Okay, yeah, we found the safety language in the Akeso press release on Harmony 6 to be very reassuring, but that answer is very helpful. I appreciate it guys. Thank you.

Question: Kelly Shi - Jeffries - Analyst : Congrats on the progress and my first question is for Harmony 3, the chemo combo trial in frontline, do you set enrollment target for squamous and the non-squamous, versus non-squamous patients? Is it expected to be split equally across two subtypes and also have a follow up?

Question: Kelly Shi - Jeffries - Analyst : Great. And also for Harmony 7, the global trial running by summit in the PDL1 positive patient, what kind of media overall survival benefit in terms of like how many months of improvement over PD1 would be considered transformative and replace PD one standard of care. In this front line, settings.

Question: Kelly Shi - Jeffries - Analyst : Thanks very much.

Question: Unidentified Participant 2 - True Securities - Analyst : Hi, this is Karina for Asuka. Thanks for taking the question. Congrats on the progress. First one is when do you guys expect the Chinese and MPA label to be publicly available by PA for Harmony too, and, have you seen what the OS curves look like? And since it's now approved in China, can you tell if they show consistent or widening separation over time?

Question: Unidentified Participant 2 - True Securities - Analyst : Yeah, if you've seen the OS curves, what they look like and since it's already in China, can you tell like whether they're consistent or they're writing over time?

Question: Unidentified Participant 2 - True Securities - Analyst : And also one more on Harmony 3, have you guys had discussions with FDA about leveraging, Project Runner for approval? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, SMMT.OQ - Q1 2025 Summit Therapeutics Inc Earnings Call

Question: Unidentified Participant 2 - True Securities - Analyst : (Repeating the I have bad service), project front runner and accelerated conditional filing.

Question: Unidentified Participant 2 - True Securities - Analyst : Alright, thank you.

Question: Mohit Bansal - Wells Fargo - Analyst : Great, thank you very much for taking my question and congrats on all the progress. I have two questions. I'll ask one by one. So regarding Harmony 2, is it fair to assume that the majority of the OS events would have happened only among the low PD1 patients given that (OS forkura) tends to be significantly longer for PD1 high patients and by extension (of ivonescimab).

Question: Mohit Bansal - Wells Fargo - Analyst : Got it. Okay, so let me ask you other one. Thank you. I appreciate that. So look, I mean, in the lung cancer, especially non-sponsor lung cancer, you're going after, an indication thatamro is pretty strong. Are there other indications where the delta for VAI PD1 combination could be much more pronounced versus a PD one inhibitor, where you know VAI could add a lot more value than than just lung cancer, and then where are you in terms of pursuing those indications outside of lung cancer? Thank you.

Question: Mohit Bansal - Wells Fargo - Analyst : Helpful. Thank you.

Question: Mitchell Kapoor - HG Wainwright - Analyst : Hey team, congrats on the recent progress and thank you for taking the questions. I wanted to ask, so the NMPA granted the first line of approval and PL1 positive non-small cell lung cancer patients in China based on Harmony II, but wanted to understand what it's going to take to get approval in the PDL1 low patients. Why didn't they grant this approval? Did they indicate anything like they need to see more data, or is that indicative of anything they're seeing in the Harmony II trial so far? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, SMMT.OQ - Q1 2025 Summit Therapeutics Inc Earnings Call

Question: Mitchell Kapoor - HG Wainwright - Analyst : Yeah thank you sorry so what I meant to to ask is the PDL1 negative, patients, is there, something that needs to be shown there that would be able to, gain approval in that population.

Question: Mitchell Kapoor - HG Wainwright - Analyst : Yeah, thank you.

Question: Mitchell Kapoor - HG Wainwright - Analyst : Perfect thank you I appreciate that. And then last one for me just on the next update for Harmony two, are you able to just, appreciate the nominal alpha, but are you able to say if we'll be able to see P value, reported along with that nominal alpha level? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, SMMT.OQ - Q1 2025 Summit Therapeutics Inc Earnings Call

Question: Mitchell Kapoor - HG Wainwright - Analyst : Sorry, yeah, so then basically the next overall survival, update, obviously you're 30%, the 39% data maturity, but at the next update, would we be able to see the p value in addition to that nominal alpha level, trying to search for statistical significance.

Question: Mitchell Kapoor - HG Wainwright - Analyst : Got it. Thank you very much.

Question: Eric Schmidt - Cancer Fitzgerald - Analyst : Well, thank you for taking my questions. One on harmony and one on, harmony two. First on Harmony, when we see the data in mid 2025 on overall survival, will that OS result be a mature one, and what is required, via your conversations with the FDA around the US approval, either in terms of what you need to see with OS or PFS. In the Western population.

Question: Eric Schmidt - Cancer Fitzgerald - Analyst : And they owe its maturity.

Question: Eric Schmidt - Cancer Fitzgerald - Analyst : Great, thank you for that. Second question on the harmony two HR that you've given 0.7777 of the pre-in term analysis, let's call it. I guess the number one question I get is whether with time that hazard ratio is likely to mature. In a favorable or unfavorable direction, do you have a view on that?

Question: Eric Schmidt - Cancer Fitzgerald - Analyst : Very helpful. Thank you both.

Question: Wren Benjamin - Citizens - Analyst : Hey, good afternoon. Thanks for taking the questions. I guess one, in the Harmony study, is the (PFSNOS) going to be evaluated as a co-primary endpoint, or as Maky mentioned with Harmony three and seven dual endpoints, and can you remind us why, you would favor, let's say one over REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MAY 01, 2025 / 8:30PM, SMMT.OQ - Q1 2025 Summit Therapeutics Inc Earnings Call the other and and a more broader question, just given recent geopolitical tensions, can you Kind of give us your thoughts on how you're thinking about potential impact of tariffs, how you're thinking about manufacturing, and any IP and and API, based scenarios.

Question: Wren Benjamin - Citizens - Analyst : And just as a follow up, I mean the the manufacturing, from the CDMOs, will that product find its way into the Harmony 3 and Harmony 7 trials so that, upon potential approval, this is going to be quite kind of seamless in terms of the, utilizing the material or or will there need to be a bridging study? How do we think about that?

Question: Wren Benjamin - Citizens - Analyst : Great, thanks for taking the questions. Sure, thanks friend.