Bicara Therapeutics Inc at TD Cowen Healthcare Conference Transcript

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

Question: Tyler Van Buren - TD Cowen - Analyst : Wonderful. Thank you very much for that presentation, Claire. Split the time right down the middle. That was great. Ryan's going to be joining us too. Ryan Cohlhepp is the President and Chief Operating Officer at Bicara. So naturally starting in head and neck, you guys have kind of led the way in the front line in combination with pembro. You've got -- you put up a 9.8 month median PFS, that you referred to on the slides in HPV negative frontline patients. So can you just elaborate on your confidence in that number. And how it was calculated as opposed to just picking a middle point on the swim lane. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. MARCH 03, 2025 / 8:10PM, BCAX.OQ - Bicara Therapeutics Inc at TD Cowen Healthcare Conference

Question: Tyler Van Buren - TD Cowen - Analyst : Okay, and at ASCO you mentioned an important update that you guys are going to be having with the two year overall survival data. So can you help, I guess provide some context as to what the appropriate benchmarks are for survival and therefore, what would be impressive when we see that data?

Question: Tyler Van Buren - TD Cowen - Analyst : Okay, that's helpful. And the 12 month median overall survival, is that in all patients or HPV negative?

Question: Tyler Van Buren - TD Cowen - Analyst : And you would expect HPV negative patients to do worse.

Question: Tyler Van Buren - TD Cowen - Analyst : So I guess just to double click on that for four to five for the final median OS analysis, how did you factor all of that into the way that it's powered and designed?

Question: Tyler Van Buren - TD Cowen - Analyst : Perfect. That's helpful. And the Phase 2, 3, FORTIFI-HN01 trial early days I know but obviously enrollment is kicked off and dosing. So, maybe you could talk about early progress there if possible and what proportion of patients need to be tested for HPV status and that that's going to get in the way of your enrollment.

Question: Tyler Van Buren - TD Cowen - Analyst : I guess just to clarify, what percentage of patients have oropharyngeal head and neck, and how many of those are positive?

Question: Tyler Van Buren - TD Cowen - Analyst : Got it. Okay, the final dosing decision after that initial Phase 2 portion, can you talk, about how that's been optimized to ensure that it's not going to read, delay the readout and what you're going to use to make that decision?

Question: Tyler Van Buren - TD Cowen - Analyst : I guess, to make the decision, is it going to be response rate or durability response.

Question: Tyler Van Buren - TD Cowen - Analyst : And remind me the phase one expansion cohort at 750. Will that data come before you make that decision, or do you think we might hear about it at the same time?

Question: Tyler Van Buren - TD Cowen - Analyst : Yeah. That makes sense, right. Okay, wonderful. And then for the fortified trial, getting back, I guess to the potential for approval, the overall response rate that could be used for accelerated approval, potentially coming out in '27. What do you need to show on response rate to file for accelerated approval?

Question: Tyler Van Buren - TD Cowen - Analyst : How large do you believe the frontline head and neck cancer opportunities?

Question: Tyler Van Buren - TD Cowen - Analyst : Okay, and we talked about, the patients that might need to be tested in pivotal trial, but just as we think about the launch, is testing available in all of the practices outside of those academic sites? Is it readily available in the community? Yes.

Question: Tyler Van Buren - TD Cowen - Analyst : Okay. As you think about the pivotal trial or commercialization, does P16 status versus a true HPV positive patient, does that matter? Obviously some KOLs have discussed that in the context of some of the data that we've seen reported. Is that something that you --

Question: Tyler Van Buren - TD Cowen - Analyst : Okay, we've got a couple of minutes, so we'll move to some of the other indications, but, cutaneous AACR. What should the expectation be for this readout? What data will we get and what would be considered a success?

Question: Tyler Van Buren - TD Cowen - Analyst : And it's too early for PFS, it be more response rate based, okay.

Question: Tyler Van Buren - TD Cowen - Analyst : And moving forward, Phase 2, 3 potential pivotal plans, would it be as a monotherapy and combination or both?

Question: Tyler Van Buren - TD Cowen - Analyst : Okay. I know who the likely partner is there. All right, and then the anal canal, data that you guys showed that you covered from ASCO-GI, what's the pathway forward there? Obviously, standard care is horrible. These are super lateline patients. There appears to be an improvement. It's enticing to go into earlier line patients and see what that data shows. How are you thinking about moving that program forward or what are you weighing?

Question: Tyler Van Buren - TD Cowen - Analyst : What other fierra indications and development are you guys most excited by?

Question: Tyler Van Buren - TD Cowen - Analyst : Maybe just to wrap up, what do you believe is the most underappreciated aspect of the Bicara story by investors right now?