Bicara Therapeutics Inc at Morgan Stanley Global Healthcare Conference Transcript

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

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. We will get into all that, I promise. So just on the target, TGF-beta is a fairly well known target in oncology. Can you talk about historical efforts to target TGF-beta and how your molecule might be differentiated in that respect?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, that makes sense. So maybe with that in mind, kind of both arms of the bifunctional molecule, your lead indication is first line -- sorry, R/M head-and-neck cancer. So can you tell us about the unmet need that you're trying to address here and maybe even more specifically HIV-negative versus positive?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay. And maybe just to set the stage a little bit further, kind of some -- I think there have been some investigator-led efforts, cetuximab with pembro. Just can you talk about kind of what brought you to --

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, and then one question. I think we got around IPO time, but less now just the decision to pursue frontline and not go monotherapy and second line probably worth revisiting. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 08, 2025 / 8:05PM, BCAX.OQ - Bicara Therapeutics Inc at Morgan Stanley Global Healthcare Conference

Question: Judah Frommer - Morgan Stanley - Analyst : That makes sense. And you touched on it at the top, but you did have an important update at ASCO earlier this year, where you did give us some survival data. So can you recap that update for us and contextualize it with historical outcomes in the setting?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. And you've guided to an internal read out in 2027 for your Phase 2/3 FORTIFI-HN01 study. Is there anything you can share on progress on getting sites up and running and enrollment? Did the ASCO update have any impact on cadence, or too early to tell it?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. And just maybe taking a step back here. You're addressing Project Optimus requirements with the Phase 2/3. So can you remind us of why the trial was designed as it was, and also kind of process and timelines specifically for selecting pivotal dose and where we are there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 08, 2025 / 8:05PM, BCAX.OQ - Bicara Therapeutics Inc at Morgan Stanley Global Healthcare Conference

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, perfect. And like you said, you're going for an accelerated approval based on internal ORR. Can you comment on the regulatory path for FICERA beyond that? Have you had any recent interactions with FDA or read through from other programs that reinforce your confidence in the accelerated pathway?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. And like you said, the Phase 2/3 is only enrolling patients that are HPV-negative. Can you tell us about the reasoning for that decision, which you did touch on mechanistically? But maybe adding on to that, how does that affect commercial opportunity for -- I think there's probably some misconceptions about how large the addressable market is if you do in the end exclude HPV-positive.

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, so maybe a more direct question on that topic that that we do get from time to time. I guess from the clinician's perspective, is there incremental testing that they would be doing beyond what they're doing currently in the commercial setting for ficerafusp alfa?

Question: Judah Frommer - Morgan Stanley - Analyst : Got it. And another question we got is can you just remind us on frequency of dose? And is there potential for that to change over time?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay. And in terms of that timing aligning with potential accelerated approval, how are you thinking about that?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, that makes sense. Great. You're also studying FICERA in other head-and-neck populations. Can you tell us about some of those cohorts and when we can expect updates on those? I think you have an HPV-positive cohort, if I remember correctly.

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, excellent. And maybe moving into some of the other solid tumor indications outside of head-and-neck. You've got SCAC, CSCC. You'll also be initiating, a third line-plus.

Question: Judah Frommer - Morgan Stanley - Analyst : Okay. So for all of those indications, you think we'll have some --?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. And then maybe just kind of moving back to commercial potential here, right? Maybe it's worth reminding folks kind of how many centers you have your head-and-neck trials in, how are those centers thinking about enrolling your trial versus competing trials and kind of maybe level of comfort with FICERA in a commercial landscape where there's more than one.

Question: Judah Frommer - Morgan Stanley - Analyst : Okay. And in terms of thinking about the addressable market in the US versus other countries, there seem to be some nuances and kind of addressable population outside of the US. So are there particular geography that you're thinking about as kind of more toward the top of your list versus the bottom?

Question: Judah Frommer - Morgan Stanley - Analyst : Yes.

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, that makes sense. And maybe just to kind of wrap up the company-specific conversation. Can you remind us of cash runway, what catalyst will that fund the company through? And maybe also just remind us from IPO have -- how's that changed in any way?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. Before I move on to the next set of questions, any questions in the room? We do have some mics if anybody is interested. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 08, 2025 / 8:05PM, BCAX.OQ - Bicara Therapeutics Inc at Morgan Stanley Global Healthcare Conference Okay, don't be shy to raise your hand if they come up. So I'm going to move on to a second set of questions that we're asking all biotech companies at the conference. I think there are varying degrees of relevance depending on who we're asking them to. So biotech does seem to be more exposed to external and macro factors of weight. So we are asking each management team the following three questions. The first is related to China's rise in biotech innovation. So how are you thinking about your competitive position here? Will this influence R&D internally or business development strategy? And maybe to kind of sum up that question, does Chinese biotech keep you up at night?

Question: Judah Frommer - Morgan Stanley - Analyst : Yeah. Maybe just kind of on that topic. Can you remind us of IP position for --?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, great. Kind of the next theme is AI. So how are you currently leveraging AI or thinking about AI's future to potentially disrupt your or the broader biotech business models or anything you'd point to and kind of development or clinical activities for FICERA or beyond that?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, that makes sense. And the third is I think kind of most relevant to most of the companies that we've spoken to. What's been the most impactful to your business on the regulatory side of things? So kind of on the list, we have changes in FDA, pricing debates, tariffs, anything else you you'd highlight. I guess maybe you could take FDA specifically and then if there's anything else that you highlight. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. SEPTEMBER 08, 2025 / 8:05PM, BCAX.OQ - Bicara Therapeutics Inc at Morgan Stanley Global Healthcare Conference

Question: Judah Frommer - Morgan Stanley - Analyst : Makes sense. And it's early for FICERA, but I guess as you think about pricing and the potential commercial launch, how has that thought process changed over the last months?

Question: Judah Frommer - Morgan Stanley - Analyst : Okay, makes sense. All right. If there are no questions in the room, I think we'll call it end.