Immunome Inc to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat Transcript

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

Question: Andrew Berens - Leerink Partners LLC - Analyst : Thanks, and congrats on the results, Clay and Max. They're definitely worth waiting for. Just a couple for me. Do you think that the numerical difference that you saw in the trial in the ovarian dysfunction rates versus OGSIVEO, is that meaningful? And why would there be such a difference in the rates? I think previously, you discouraged us from expecting a difference because it's thought to be a non-targeted effect of the GSIs of the class. And then a commercial question about launching the drug on your own. Can you give us some idea of the infrastructure you need? And will we be likely to see another [BDF] deal for a late-stage asset to complement the desmoid efforts?

Question: Andrew Berens - Leerink Partners LLC - Analyst : Okay. Thank you. Can I sneak one in for the doctor? Is that okay, Clay?

Question: Andrew Berens - Leerink Partners LLC - Analyst : Okay. Well, thanks, and congrats again.

Question: Tyler Van Buren - Cowen and Company LLC - Analyst : Congratulations on the tremendous results across the board. I believe you said the KM curve separated at the first tumor assessment, so can you elaborate on the time to response and how meaningful that is for patients? And as a follow-up, based upon the data, it seems obvious that most, if not all, new patients would choose to go on varegacestat. But since Dr. Gounder had to step away, can you just talk about what you've heard from the KOLs in terms of switches? Could they see a significant number of current OGSIVEO or nirogacestat patients switching to varegacestat, given this profile?

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : Well, thanks for taking our questions, and truly congrats on the data. Maybe just first on pill burden. Roee, I believe that you talked about the plan to reduce the pill burden for varegacestat. Can you give us some color on where you're on that front and when can we start to think about the reduced pill burden formulation that will be on the market? And then I have a quick follow-up. Thank you.

Question: Brian Cheng - JPMorgan Chase & Co - Analyst : Okay. And then just on your preparation towards the NDA filing, what's the gating factor here now that you have your clinical package in place? Can you talk about specifically the manufacturing preparations and also the toxicology work behind the scenes.

Question: Salveen Richter - Goldman Sachs Group Inc - Analyst : Congratulations on the data. I was just wondering if you could comment on the strategy here to encourage more patients to be actively managed and if you could compare your data or give us any color on discontinuations due to AEs and dose reductions, where I believe [GVO] had about a 20% discontinuation rate on that front and 42% dose reduction. Thank you.

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : Congrats from me as well on this outstanding trial result. The efficacy obviously speaks for itself, but maybe just going back to some of the tolerability, some of those side effects look meaningfully lower, numerically lower than what was seen in DeFi, especially some of the GI adverse events and rash. And we know that OGSIVEO is discontinued fairly frequently or dose reduced. And I was just curious how you think about duration of therapy in clinical practice in that context. What is a good assumption there? And then the other question I had, in your prepared remarks, you did note that there are additional trials planned. And I was just wondering what are some of the other areas that you're considering for clinical studies with varegacestat. Thanks so much.

Question: Michael Schmidt - Guggenheim Securities LLC - Analyst : All right. Thank you.

Question: Cory Kasimov - Evercore Inc - Analyst : Add my congrats on these great results. So I wanted to follow up on the duration question you mentioned in the slide, this idea of pausing therapy on what's a potential chronic treatment journey for desmoid patients. When this does happen, how long do you expect drug holidays to be after 1.5 to 2 years of treatment? Is this an evolving consensus view among doctors to pause? Or is it really just patient-dependent and you kind of go as you play as you go?

Question: Cory Kasimov - Evercore Inc - Analyst : Great. And then just to follow up on that, Clay, do you see most of your adverse events, like the ones you do have, are they usually early onset and they get better tolerated with time? Or are they throughout the treatment? LSEG STREETEVENTS | www.lseg.com | Contact Us consent of LSEG. 'LSEG' and the LSEG logo are registered trademarks of LSEG and its affiliated companies. DECEMBER 15, 2025 / 1:30PM, IMNM.OQ - Immunome Inc to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat

Question: Cory Kasimov - Evercore Inc - Analyst : Perfect. Thanks again. Super helpful.

Question: Biren Amin - Piper Sandler Companies - Analyst : Thanks for taking my questions, and congrats on the Phase 3 data. Given the data, how should we think about the price of varegacestat compared to nirogacestat? And then the second question, I know you talked about disclosing worse pain intensity data at a medical conference next year, but I was wondering if you saw trends on pain reduction to tumor volume reduction? Thank you.

Question: David Nierengarten - Wedbush Securities Inc - Analyst : I was curious how many patients had been previously treated with either niro or other agents, and if there were differences in response rates in tumor shrinkage in patients depending on the prior treatment. Thanks.

Question: David Nierengarten - Wedbush Securities Inc - Analyst : Thank you.

Question: Karina Rebayeva - Truist Securities - Analyst : Congrats on the stellar data. Can you guys comment on what percentage of patients with ovarian dysfunction discontinued treatment and on how many patients the condition resolved? And the second question is, given that this study involved patients who were 12 years and older compared to nirogacestat, 18 years and older, what percentage of patients could potentially be added from this younger age group? Thank you.