Terns Pharmaceuticals Inc Initial Interim Results from Phase 1 CARDINAL Trial of TERN-701 for CML Call Transcript

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

Question: Silvan Tuerkcan - JMP Securities - Analyst : Congratulations on this great data set. Maybe a big picture question here, and I think you summarized it really nicely on slide 28, where you already checked several boxes. For -- as we look at the data that you have to date, what will be your potential improved efficacy over the competition here for your update next year, would that be only against asciminib? And how would you make the call to go into front line versus second line? And then I have a follow-up.

Question: Silvan Tuerkcan - JMP Securities - Analyst : Great. And then obviously, an important to point out on the efficacy data here, you're not at your top dose yet. Given the PK/PD data that you collected to date, what can we expect from the 500-milligram dose?

Question: Etzer Darout - BMO Capital Markets Equity Research - Analyst : Congrats on the data today. Just a first question, given the safety results to date, are you able to potentially amend the protocol to move beyond 500 milligrams doses if you wanted to do so? And then I have a follow-up.

Question: Etzer Darout - BMO Capital Markets Equity Research - Analyst : Right. Great. And the benefit of post-asciminib was a bit of a surprise to us. And I guess the front line -- potential frontline would be straightforward. But I guess, does this maybe change your thinking around potential second line setting to potentially include patients with prior asciminib? I know you talked a little bit about before whether or not this is a population that you could potentially exclude in the second line, but given the efficacy, could you sort of see a broader approach where you include patients post-asciminib?

Question: Ritu Baral - TD Cowen - Analyst : Congratulations on this. I wanted to dig in a little further on sort of the differential activity and tolerability in your asciminib treated patients. Looking at slide 12 and that swimmer plot, looking at that first patient and the efficacy evaluable patent, the one that discontinued. And going back to your comment on increased or better potency or efficacy. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 03, 2024 / 1:00PM, TERN.OQ - Terns Pharmaceuticals Inc Initial Interim Results from Phase 1 CARDINAL Trial of TERN-701 for CML Call Can you go over what either in the binding or the kinetics in the preclinical data support this now clinical signal that some patients are responding better to 720 than Scemblix. And then -- well, I'll let you answer that and then I have follow-ups around those two specifics.

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then that first question -- I'm sorry, that first patient in the swimmer plot. I believe that was also the patient featured in slide 16. And you mentioned there were some lipid abnormalities on asciminib. Were those lipid abnormalities maintained? Were they improved after the switch to 701. Can you comment on that?

Question: Ritu Baral - TD Cowen - Analyst : Okay. So -- but can you say whether that lipid profile has improved on 701? Or is that something we'll find later?

Question: Ritu Baral - TD Cowen - Analyst : Got it. And then final question, that last patient, the one who discontinued, -- was there any -- was there anything unique about that patient versus the others that did show responses? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 03, 2024 / 1:00PM, TERN.OQ - Terns Pharmaceuticals Inc Initial Interim Results from Phase 1 CARDINAL Trial of TERN-701 for CML Call

Question: Ritu Baral - TD Cowen - Analyst : Got it. That's helpful. And I'm sorry, I have 1 more question, because apparently today, I have all the questions. In your next data update, will that include -- will we get anything ahead of that, including which doses you're moving for dose expansion and at least the next data update will that include the dose expansion data along with continuing data and backfill patients?

Question: Eliana Merle - UBS Investment Bank - Analyst : Congratulations on the data. Can you elaborate a little bit on what the different potential scenarios for your Phase III strategy could look like? You mentioned the potential for our frontline study. Can you just talk a little bit about what the different potential designs could see and maybe what you're looking for in your data to inform this?

Question: Eliana Merle - UBS Investment Bank - Analyst : Great. And just can you -- I know you got a lot of questions on the dose selection, but just maybe just have you -- like your latest thinking on what the 2 dose levels that you would select for the expansion? And any more color you'll plan to decide on this just in terms of -- I know you said you'll start the dose expansion in the first half of next year, but just adding more color on when you would expect to start dosing there.

Question: Graig Suvannavejh - Mizuho Securities USA - Analyst : Congratulations on the data. I've got two questions, if I could. First, I'm interested in the patients that you've shared data on and by the fact that think 40% of the patients that you're sharing data on had prior treatment with asciminib. So I was wondering if you have any evolving thoughts around what asciminib is showing like in the real world and how that might inform of what you are seeing as the opportunity for 701, clearly, you're seeing a potential in the first and second line plus, but assuming that, I think, has gotten off to a great start, but clearly, it's perhaps not the cure all. So just interested in your thoughts there. And then secondly, maybe bigger picture, maybe this is for Amy. Amy, you've got 2 really exciting opportunities in 601 for obesity and 701 for CML. So with this in mind, how are you thinking about like capital allocation across your R&D pipeline efforts and strategically, has there been any evolution in your thinking around the assets since you've come on board as CEO.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Congrats on these impressive results, and thanks for providing the update today. Could you talk about how soon you could start a pivotal trial for 701 and then some of the gating factors and time line for getting started?

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Super helpful. Congrats again on the results.

Question: Corinne Jenkins - Goldman Sachs Group, Inc. - Analyst : I guess maybe a couple from us. In terms of the next data update, I guess, what information are you looking to gain from the data that you'll produce as well as sort of the real-world utilization transcripts asciminib that will help you make a decision around the pivotal trial strategy here? And then in terms of the asciminib tolerability, I guess, of those patients who had some intolerance, when did the challenges started to emerge? And what was -- I guess, how does that compare to kind of like less than 3 months on therapy?

Question: Eric Joseph - JPMorgan Chase & Co - Analyst : Just a question about the data and then one forward-looking question related in regards to a potential pivotal study. Of the 6 patients that entered the trial here that were in MR at baseline, can you just comment a little bit on what their rationale for switching to 701 was? Just trying to get a sense of whether it was primarily on tolerability or if you saw signs of actually a rise in the transcript level prior to entering the study.

Question: Eric Joseph - JPMorgan Chase & Co - Analyst : Okay. Great. And then maybe just picking up on the prior question. Is -- can you just clarify what the eligible patient population would be by their baseline transcript level in a potential pivotal trial? And maybe just how well represented they are in the data here today? And then maybe talk to that, do you expect cumulative MMR potentially to be leverageable as a registrational endpoint?

Question: Eric Joseph - JPMorgan Chase & Co - Analyst : That's great. What's your -- do you have any ability to enrich for patients with higher transcript levels in your expansion cohorts, 1% or greater?

Question: Antonio Arce - H.C. Wainwright & Co - Analyst : Congrats on the early data here. I have two. First, I just wanted to focus again on those 40% of 6 out of 15 patients with immediately prior asciminib treatment. Obviously, the one patient on slide 16 with a categorical change was quite positive. I'm wondering about the other 5, how would you characterize the responses in those and if there were any other categorical improvements in those patients? And then I have a follow-up.

Question: Antonio Arce - H.C. Wainwright & Co - Analyst : Great. And then just thinking about ahead once you potentially reach the market and obviously, as 1 of 2 allosteric inhibitors, wondering if you might consider more just for commercial evidence and perspective, a head-to-head study with asciminib, perhaps as a separate study that may not be part of any registrational package.