Bicara Therapeutics Inc. Common Stock (BCAX) Q3 2026 Earnings Call Transcript

Operator: Good day, and thank you for standing by. Welcome to the Bicara Therapeutics Third Quarter 26 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. You will then hear an automated message advising your hand is raised. To withdraw your question, please press *11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Rachel Frank, Vice President of Investor Relations. Ma'am, please go ahead.

Rachel Frank: Thank you, and good morning, everyone. A pleasure to welcome you to Bicara Therapeutics Third Quarter 26 Earnings Call. Earlier this morning, we issued a press release highlighting the results from the quarter and provided a business update. You can access the press release as well as the slides that we will be reviewing today by going to the Investors section of the company website. Before we begin, please note that this call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 2000. Please refer to our most recent SEC filings for important risk factors that could cause our actual performance and results to materially differ from those expressed or implied in these forward-looking statements. Any forward looking statement made on this call represents our views only as of today, and we disclaim any obligation to update any forward-looking statements. Joining us on the call today are Ryan Cohlhepp, Interim Chief Executive Officer Bill Schelman, chief medical officer Boris Peaker, chief commercial officer, and Jennifer Larson, chief financial officer. Tanya Green, Chief Development Officer, is also on the line and available for Q&A. I will now turn the call over to Ryan.

Ryan Cohlhepp: Thank you, Rachel, and good morning, everyone. Since stepping into the interim CEO role earlier this fall, I have spent a lot of time on the road with clinicians, investors, and the hardworking Bicarans that make our work possible. My conversations have reaffirmed my belief in the potential practice-changing benefit of high Visericose Alpha known as Ficera, which continues to drive strong enrollment momentum in our ongoing pivotal FORTIFY-HN-O1 study of FICERA in combination with pembrolizumab for the treatment of frontline recurrent metastatic HPV negative head and neck cancer. Our research and insights reinforce that the health care providers respond positively to the depth and durability of response that has become a hallmark of PICERRA's clinical profile. The chemosparing nature of its regimen, the potential for every 3-week dosing regimen in the future. Recurrent metastatic head and neck remains a disease of serious unmet need. Particularly for patients with HPV negative disease who continue to face limited treatment options or long term outcomes and a significant impact on quality of life. We are proud to be part of the field that is pushing what is possible for these patients. And we welcome progress from others working to change outcomes in this disease. Ultimately, what is good for patients is good for all of us. With that in mind, want to acknowledge the top line results recently announced by 1 of our peers in the space, which provided a very encouraging update for patients. Our conviction in FICERA's clinical profile in frontline recurrent metastatic HPV negative head and neck cancer and our path forward grounded in the role of TGF beta in our early clinical experience is only strengthened by that news. We still have much to learn about how those results may shape the treatment landscape for patients with HPV negative disease. Including how outcomes differ by HPV status, and how mature the survival data are. What they do show is further validation this new class of EGFR targeted therapies in head and neck cancer. Including Ficera, and they sharpen our focus as we evaluate our strategy to bring the greatest value to patients with HPV negative disease. Ficera has breakthrough therapy designation, specifically for the treatment of HPV negative head and neck cancer based on a differentiated clinical data, which facilitates our ongoing interactions with the FDA. Today, we remain focused on executing on enrollment, conducting an interim analysis that provides meaningful clarity to physicians, patients, and shareholders on VICERA's differentiated clinical profile, and filing a BLA that optimizes both our speed to a potential US approval and our goal of a maximally competitive commercial profile. Today, we announced that FORTIFY-HN-O1 has achieved enrollment to enable a top line interim analysis, which we continue to expect in the middle of next year. And with the aim of maximizing speed to market in a competitively differentiated way, we can confirm that we are planning for an interim overall survival analysis. Something we have been evaluating for some time and will share more on timing and scope as we believe is appropriate in the context of a fluid, competitive environment. Reaching substantial enrollment in FORTIFY-HN-O1 marks an important step forward for Bicara this quarter. Alongside it, we advanced Fortify Flex to evaluate a more flexible dosing regimen and we continued building the commercial and medical organization that will support a potential launch. Together, this progress positions us for our next phase of growth as we pursue our first approval in head and neck cancer. A large and growing market projected to reach more than $5 billion globally by 2030. Before I turn it over to Bill, I want to reinforce that our absolute priority at Bicara is clear. The successful development, approval, and commercialization of Ficera in frontline recurrent metastatic HPV negative head and neck cancer. Beyond head and neck, there is also clear biologic rationale for Ficera and other solid tumors. In our phase 1b expansion study, in third line MSS RAS BRAF wild type metastatic colorectal cancer, evaluating Ficera both as a monotherapy and in combination with pembrolizumab, seeing encouraging early safety and efficacy signals in this late line population. What we are looking for is an efficacy signal paired with a safety profile that supports combinations since earlier lines are where we see the greatest potential for clinical benefit. We now plan to present these data at a relevant form in January. As we near our top line interim analysis, our first potential regulatory filing, and we continue to evaluate how we can take an evidence based approach to the next pillars of growth for FICERA beyond head and neck cancer while being disciplined stewards of our financial resources. With that, I will turn it over to Bill.

Analyst: Thanks, Ryan, and good morning, everyone. HPV negative head and neck cancer is biologically distinct from HPV positive disease. These tumors overexpress EGFR and are rich in TGF beta, which suppresses the immune response and drives resistance to therapy. Vysera was designed to inhibit both EGFR and TGF beta, and to work synergistically with immunotherapy. Overcoming barriers in the tumor microenvironment so that the drugs and immune cells can penetrate the tumor. When I speak with treating physicians, what they tell me matters most for their patients is depth and durability of response. As they believe these yield the greatest long term outcomes like overall survival. By pursuing that clear mechanistic biologic fit, we believe Vysera has the potential to redefine the standard of care in first line, recurrent, or metastatic HPV negative head and neck cancer, which represents roughly 80% to 90% of cases globally. I want to take a few minutes to revisit the long term Phase 1b data we presented at ASCO this year Because while FORTIFY-HN-O1 remains blinded and ongoing, they are the clearest window we have into PICERRA's clinical profile. As these data mature, we believe they continue to derisk the pivotal study on the endpoints that matter most. Response rate, complete response rate as a measure of depth, most importantly, duration of response, progression free survival, and overall survival. At the 1500 milligram weekly pivotal dose, with a median follow-up of 3 years, Ficera plus pembrolizumab achieved a confirmed objective response rate of 54%, and a complete response rate of 25 percent. As a clinician, what stands out to me is the depth of those responses. Specifically, percent of responders had tumor shrinkage of 80% or more. Responses came quickly, at a median of about 6 weeks. And they were durable with a median duration of response of nearly 22 months. Median progression free survival was 9.9 months. Roughly 3x what has been reported for pembrolizumab alone. Median overall survival was just over 21 months. Most importantly, about 1 in 3 patients was alive at 3 years. that is roughly double what real world data would lead us to expect with pembrolizumab alone in HPV negative patients. We continue to believe that these clinical results are driven by TGF beta and the role of plays in remodeling the tumor microenvironment to allow for greater depth of response. When we pool patients across all 3 dose cohorts in our phase 1 b study, 750 milligrams weekly, 1500 milligrams weekly, and 2,000 milligrams every 2 weeks. Those with deep responses remained in response, for a median of more than 2.5 years. And they went nearly 3 years without progression. We have not yet reached median overall survival in the group. Our paired biopsy showed reduced TGF beta signaling in the tumor. And greater CD8 T cell infiltration. We believe that immune cell penetration potentiates immunotherapy translating into more durable responses. With new data emerging in head and neck cancer, With cancer including recent results reported across both HPV positive and HPV negative patients, I think it is important to look at the context behind our data. In these patients, tumor characteristics matter as much as the efficacy numbers themselves. First, HPV status. Every patient in our phase 1b dataset was HPV negative. And it is the only population we are enrolling in FORTIFY-HN-O1. These patients have the poorest prognosis in head and neck cancer. So every number you have heard from me today comes from the hardest to treat patients. it is also why results broken out by HPV status are essential to interpreting any dataset in this disease. Second, site of disease. Most patients that are pivotal dose have local regional disease. Either alone or with distant. Local-regional recurrence is typically harder to treat. Because previously irradiated tissue can limit how well a drug reaches the tumor. Third, PD L1 expression. Half of our patients in the phase 1 b study had a CPS below 20. Checkpoint inhibitors have historically been least effective, yet responses with Ficera plus pembrolizumab were essentially the same regardless of CPS and fourth, tumor burden. Nearly half of patients had large bulky tumors, where rapid and deep responses matter most. In these patients, clinicians have historically added chemotherapy. Ficera has shown rapid responses in tumor debulking. And offers the potential for a chemotherapy sparing regimen in this setting. Taken together, our data come from a more symptomatic, harder to treat population, often with worse outcomes and a significant impact on quality of life. With up to 3 years of follow-up, that makes the depth and durability we have observed and their potential to translate into overall survival all the more notable. We remain confident in VICERRA's potential to deliver meaningful outcomes for patients living with HPV negative head and neck cancer. And to change clinical practice. Ultimately, we believe the phase 3 data will define how this treatment landscape evolves. And we look forward to sharing our pivotal results. With that, I will turn it over to Boris to talk about the commercial opportunity. Thanks, Bill. As Ryan mentioned earlier, head and neck squamous cell carcinoma is a large and growing market. Each year, roughly 50,000 patients across The US, EU 5, and Japan newly diagnosed with HPV negative disease, about 18,000 of them here in The US. And today's options for these patients offer limited response rates and limited durability. VYSARA was specifically designed for this population has the potential to grow the market by increasing both response rates and duration of therapy. As Bill described, what sets Vysera apart is how deeply and how durably patients responded, not just how many responded. Depth and durability are exactly what this market lacks today, and FORTIFY-HN-O1 is designed to confirm this benefit. Our market research over the past year suggests a meaningful shift in how physicians view Ficera. Oncologists increasingly see HPV negative disease as a distinct population that warrants a targeted approach. Complete responses historically in the single digits with standard of care regimens, are now cited alongside durability as key drivers of treatment choice. And we believe our mechanism is increasingly understood as a reason for the depth and durability we have seen to date. We are also optimizing FICERA's dosing for flexibility and convenience. Fortify Flex is evaluating a less frequent dosing option which physicians have asked for with the potential to further enhance VICERA's profile. Behind all of this, our commercial leadership team with more than 50 collective new-product launches is now in place. And our go to market strategy disease education, payer and access strategy, and data and analytics infrastructure are all underway. As the landscape evolves, we recognize that being first to market can bring certain advantages. As we have seen in many oncology launches and based on discussions we have had with HCPs, the first entrant does not necessarily translate to sustained market leadership. Over time, physicians choose the therapy the most compelling clinical profile and the strongest label for their patients. that is why our focus is twofold. Moving with speed, aiming to deliver a differentiated BLA submission that we believe can support the strongest label. Beyond the regulatory considerations, our aim is for Ficera to enter the market with a competitive profile that gives physicians patients, and payers a clear reason to choose it. With a label that reflects its depth and durability of response and ultimately survival in HPV negative patients. But let me close with what this means for patients. First line head and neck cancer is a market that is large enough to sustain many entrants. We intend to successfully compete in this market but let me provide an important new option and a new sense of hope for these patients and their providers. With that said, I will now turn the call over to Jennifer to discuss our financials.

Jennifer Larson: Thanks, Boris. Earlier this morning, we reported detailed third quarter 26 financial results in our press release. I will summarize a few highlights here. Research and development expenses were $56.5 million for the third quarter of 26, as compared to $33 million for the third quarter of 25. The increase was primarily due to costs associated with the ongoing FORTIFY-HN-O1 pivotal trial, FORTIFY FLEX trial, as well as the company's ongoing phase 1b dose expansion cohorts and an increase in personnel costs. General and administrative expenses were $19.2 million for the third quarter of 26. As compared to $7.7 million for the third quarter of 25. The increase was primarily due to additional personnel costs and professional fees associated with expanding the organization as the company advances its pivotal trial and prepares for potential commercialization. We anticipate that our overall operating expenses through year-end remain consistent with our most recent quarterly results as we continue with the development of Ficera and continue to prepare for a potential US launch. We ended the third quarter of 26 with approximately $442 million in cash equivalents, and marketable securities which provides cash runway into the first half of 29. As a reminder, that runway includes advancing the pivotal FORTIFY-HN-O1 study of FICERA in frontline recurrent metastatic head and neck cancer through to a final overall survival analysis. Supporting a planned regulatory filing for Ficera, providing initial investment into medical and commercial infrastructure ahead of a potential U. S. Approval and launch, clinical development costs for Fortify Flex, funding manufacturing costs for FICERA for existing drug development efforts, and other general corporate purposes. With that, I will now turn the call back over to the operator for questions. Operator?

Operator: Thank you. As a reminder, to ask a question, please press *11 on your telephone and wait for your name to be announced. We ask that you please limit yourselves to 1 question. Our first question will come from the line of Tyler Van Buren with TD Cowen. Your line is open. Please go ahead.

Tyler Van Buren: Hey, guys. Thanks for the update, and good morning. I know you discussed it to some extent, but maybe you can just elaborate on why HPV status is so central to PICERRA's strategy in the context of recent developments. And given the open questions around recent data in the space, why do HPV subgroups and survival maturity matter, and what should investors be looking for at the full data presentation?

Ryan Cohlhepp: Thanks, Tyler, for the question. So this has been a key area. In terms of our approach and what we believe is a differentiated approach to our clinical development plan. If you look at the historical data with EGFR monoclonal antibodies, I think you consistently see a real clear distinction between the activity seen with an eGFR monoclonal and the positive versus negative, you know, based upon the biology and what is driving that. In our own data, you know, we saw similar results which is why we chose to you know, develop the drug in HPV negative only in our pivotal trial. I think, of recent, we also saw data from the origami cohort, and then that particular cohort, what they demonstrated with amate was about a 29 percent response rate from an HPV you know, positive perspective. So I think again, that data also was continued, reinforcement of you know, the historical data we have seen. As we think about the subsets from a survival perspective, I think that it also plays forward 1 of the things that is known is the HPV positive patients historically have lived longer than HPV negative. The overall you know, I think, overall you know, ability to. For those patients to live longer is just greater. So I think there is a clear distinction both from a response rate as well as a survival outcome that can meaningfully influence the outcome by subset of both response rate and overall survival. So understanding that, understanding especially when you are looking at different points in the Kaplan Meier's survival curve, understanding the influence of different subsets is important and an area that investors should continue to focus on as they evaluate the datasets. Thank you.

Operator: And 1 moment for our next question. Our next question is going to be from the line of Eric Schmidt with Cantor. Your line is open. Please go ahead.

Eric Schmidt: Thanks for taking my question, and congrats on the progress on I was curious about the comment that you can now confirm an interim overall survival analysis in that frontline study. Could that analysis happen as early as mid 27, and, what are your plans for sort of statistical utilization around analysis? Thank you.

Ryan Cohlhepp: Yeah. Thanks for that question, Eric. So we definitely are at a point where, you know, we can confirm that we will incorporate OS analysis, at a-- at an interim. We have not yet guided to when that will be. Certainly, we will continue to provide greater clarity as we, I think, finalize that. I think 1 of the things-- I think all along in the conduct of this trial, our plans were to closely evaluate emerging survival data both for our own program as well as the class and the overall space as a whole and taking that relevant information, that is accruing over time to incorporate it into our own planning. And so again, we are not at a point now where, you know, we are providing more clarity on that top line guidance middle of next year, but certainly we will as we, you know, continue to work towards, you know, that point and refining guidance. Thank you. Thank you.

Operator: And our next question is going to come from the line of Tazeen Ahmad with Bank of America. Your line is open. Please go ahead.

Tazeen Ahmad: I am sorry if I missed this in your prepared remarks. But Ryan, if you need to upsize the study in order to be able to include OS as part of that interim next year. And then given that investors have assumed that there is now, I guess, basically a bogey that you need to be close to. Can you just share what your thoughts are about what OS benefit is going to be needed to be seen in order to be competitive just based on maybe any initial discussions you have had with physicians and also how important the hazard ratio becomes at that point as well. Thanks.

Ryan Cohlhepp: Again, thank you for the question, Tazeen. So we actually did not speak to overall trial size. What I can say is we are confident in the size as currently. Again, the overall size of our trial is around 650 patients in an HPV negative only population. So by comparison, again, the other studies that are recently read out, I think are now 700 in a mixed population. You know, early on in the design of our trial, we did so with that size. Know, reflecting that it was a negative only population and was going to be adequately sized not only for a final analysis, but also to give us optionality as we think about incorporating an interim analysis. So I would say that, you know, we thought about that prospectively, and are not in a position where we are going to need to upsize. Terms of what is gonna be competitive, you know, I think, you know, to some degree, you know, again, that will be influenced you know, based upon historical standard of care, to 3- to 4-month improvement over that standard of care would have been seen as meaningful. We were targeting for an overall effect that, you know, exceeded that, based upon what we had seen in our early phase 1 experience. I do think that it is an evolving view in terms of what that level of competitiveness is gonna need to be. And I think in the absence of further information, I think it is hard to speculate. But again, if you look at our phase 1 experience, you know, we have a high degree of confidence in our ability to meaningfully, show survival well ahead of what would clinically meaningful in a you know, today's standard of care. Thank you.

Operator: And 1 moment for our next question. Our next question will come from the line of Stephen Willey with Stifel. Your line is open. Please go ahead.

Stephen Willey: Yes, good morning. Thanks for taking the questions and apologies if I missed this earlier. But I am sure that you are projecting the number of death events that you hope to have accrued at the time of the response rate interim. So just curious what that projection suggests about the statistical power that you might have at that point to similarly detect an OS benefit at the interim? And then also, maybe I think there is, just curious as to if your expectations kind of what a disclosure framework might look like when you announce the interim data Have those expectations at all kind of changed in light of how Genmab chose to disclose their top line data. Thanks.

Ryan Cohlhepp: Yeah. So your first question, yeah, I will start with, and then I will ask Bill to add to it as well. You know, again, you know, I think 1 of the things, as you know, the key difference in our trial versus the LIGR trials is it is a blinded trial. So in terms of the data that we have with our own trial, which will be used to, I think, answer your key question. You know, I think that is a key difference, but we will ask Bill to also speak to what we are able to see and as we think about at our interim, the power we will have there.

Bill Schelman: Yeah. Thanks, Ryan. So, at the interim, we are in anticipating reporting the response characteristics. As we have discussed, depth and durability are definitely underpin the prediction to overall survival. And so with the design we have, we definitely are looking to show not only the response characteristics, but the depth and durability and then how they translate into overall survival. With the current study design we have, we have already contemplated those factors, and then are looking to the number of events that will support an overall survival benefit.

Ryan Cohlhepp: And then to your second question, again, we certainly, you know, saw the approach, you know, taken with the most recent dataset. I think we will continue. The 1 thing I think both ourselves and, in that particular company can agree on is that it is an increasingly competitive space and want to make sure that we put ourselves in a position and our data in a position to. You know, both from a regulatory perspective and an overall competitive perspective to be best positioned. That being said, we also, have a philosophy here that there are many stakeholders. Including the investor community. So, you know, finding that right balance of transparency at our data disclosure, while also making sure that we maintain, the right posture from a competitive perspective will be what guides the way we do that disclosure.

Stephen Willey: Alright. Thanks for taking the questions.

Operator: Thank you. And our next question is going to come from the line of Kelsey Goodwin with Piper Sandler.

Kelsey Goodwin: Hi, good morning. Thanks for taking our question. Maybe shifting a bit to CRC. In terms of the third line dataset, coming in January, maybe first, what kind of led to getting pushed into 2027.? And then in terms of how we should think about that dataset given its late line, and the plan is to kind of move forward into earlier lines, how should we think about how to translate that third line data? How to think about the path to frontline? And how far behind J and J and Genmab you might be, how you might be able to catch up. Just trying to kind of wrap our heads around that. Thanks so much.

Ryan Cohlhepp: Yeah, absolutely. So in terms of timing, you know, again, historically, we have always presented at medical congresses. And prefer to be able to do that. And not just any conference. We wanna be able to put it in a venue that is relevant for the audience. And that really guided our view in terms of where the data should sit, and we will look to be able to provide more clarity in terms of when in January we will be presenting that data. In terms of the read through, again, I think the most relevant data sets you know, with the data that we have coming out, you know, again, as a reminder, it is a third-line plus dataset, both in monotherapy and then a cohort in combination with pembro is, I think some of the more recent data sets what we have seen from petosemtamab in that same population is around a 10% response rate. We saw insight, with their PGF beta PD 1 showing about a 15% in that population. So I would say those are the relevant benchmarks. Based on most recent data. Yeah, I think that being said, at most recent ESMO, we saw what that can translate to as you move into earlier lines in the first second line, which is much stronger and also very consistent with the way EGFR monoclonals have operated and behaved. So I would say the read through from a third-line into frontline I think, a lot of ways, even in terms of wealth of data that exists with EGFR monoclonal antibodies would suggest that these are going to be highly active compounds, Bicera included, as you move into earlier line. So 1 of the things that is also, was an important piece for us in the third line setting is understanding whether there was a concern consistent tolerability profile in CRC to what we had seen in head and neck cancer. So I would say some degree of activity consistent with what has been seen historically as well as a consistent safety profile are important read throughs as we present that data in January. Thank you.

Operator: And 1 moment for our next question. Our next question will come from the line of David Lebowitz with BMO Capital Markets. Your line is open. Please go ahead.

Dale: Hi. This is Dae on for David. Thanks for taking our questions. So a quick 1 from us regarding. So we see that has recently been approved for head and neck and late line. Just kind of curious about your thoughts over if patients in the FORTIFY trial who progressed can receive aniventumab, And how should we think about the impact on the shape of the OS curve for both the interim and also for the full analysis? Thank you.

Ryan Cohlhepp: Yeah. So in terms of the most recent approval, again, if you look at the. what is approved within that label, it is patients who have progressed on PD-1 plus chemotherapy. As a reminder of the design of our trial, the active arm is VICERRA plus pembrolizumab, and the control arm is pembro monotherapy. So strictly within the label that has recently been approved, neither 1 of those arms, is within the label of Ami. That being said, we know in The US that there can be off label use. We would not yet seen that trend. RYBREVANT has been available. In many cases, you know, you would have seen that off label use even in the absence of an approval, which we have not yet seen. I think the other important element, again, is the fact that we have a blinded trial So not only are those patients not within label for Ami, it is also not clear to physicians because of the blinded nature of the trial and their ability to. Whether they are EGFR-naive or not. So we think there is very limited exposure, based upon that approval. And again, a lot of our enrollment sits outside of The US. Where again, that approval does not exist. In terms of, I think, your question on survival curve, you know, we will ask Bill to speak to that.

Bill Schelman: Yeah. Thanks, Ryan. So Ryan commented, the study is a blinded study. And so with that, the clinicians will not have a sense of whether or not they received EGFR, prior EGFR therapies or not. This is again something that we have been thinking about and planning for, and ensuring that post discontinuation therapies are contemplated. And we also have some statistical analyses to look at this and to understand the potential impact of post discontinuation therapies further. And I think in terms of the relevance and as you think about the shape of the OS curve, I think the data that we presented out at 3 years where you saw twice as many patients are alive at the 3 year mark on VICERRA plus pembro versus standard of care. We believe that, you know, that is likely to represent the tail end of the curve, even in the FORTIFY trial. Thank you.

Operator: And 1 moment for our next question. Our next question will be from the line of Jeet Mukherjee. With Morgan Stanley. Your line is open. Please go ahead.

Sean: Good morning, Ryan and team. Thank you for taking my question and hope everyone is well. A couple of questions just on the commercial positioning and how has petosemtamab changed your launch assumptions, if at all? And if it is approved in 2027 and establishes a few years of prescribing experience before Viscera gets approved. You know, where do you think Viscera can realistically, you know, win first? You know? Is it h r. Negative specialists, deeper responders, patients avoiding chemo? You know, that type of thing. And what evidence do you believe would justify, premium pricing for Ficera You know, would Superior CR and durability be sufficient, or do you think payers will require demonstrated OS differentiation? Thank you.

Ryan Cohlhepp: Great. So I will start and then ask Boris to, to speak to your various questions. I mean, I think 1 thing that I would like to point out is timing. You know, again, I think the. A key view that we continue to hold is that, you know, that timing, sits at less than a year between ourselves and petosemtamab, which we know based on historical analogs, is a key driver of ultimate peak share uptake, when you have got a competitive space with multiple agents. So I think that is 1 area that is really important to clarify. You know, we have not shifted our view in terms of where we sit relative to the approval of edasimtamab. And, Boris, if you would like to speak to the broader competitive dynamic and how we think about the uptake of ourselves versus Peto. Yeah. Thanks for the question, Sean. So as Ryan said, we view Peto as an important competitor. And we also think that the recent Phase II results are further validation of the significant unmet need and the opportunity that exists in first line metastatic head and neck cancer. And so, you know, as this market evolves, being first to market we recognize, can bring certain advantages. But as we have also seen many times, first mover does not necessarily translate into sustained market leadership And so, you know, our goal, as you have heard, is to move with speed. And a differentiated BLA, to establish a competitive profile that gives physicians, patients, and payers a reason to choose Ficera. In regards to your question around pricing, we are going to be pricing relative to the value that we believe Ficera will bring to the market. But we are excited about the opportunity. The only thing I would add, you know, as we think about the launch dynamic is, I think, you know, prior to last week, I think we had gone in with an assumption that both drugs were going to have an initial accelerated approval label, on a basis of response rate. Where the, you know, longer term endpoints like overall survival would not be not part of that initial label. I think what our view has shifted is it is more likely that both initial labels will have a component of overall survival. Again, we have not yet had regulatory interactions. We do not know frankly, whether. You know, even though, you know, we had a clear hazard ratio coming from the petosemtamab trial, ultimately, whether that data will be mature enough and representative enough to be incorporated into the label, their initial label. So there is still a lot to be answered there from a regulatory perspective. You know, with an assumption that both agents, you know, get out with an OS label. I do think, you know, we continue to believe that the depth and durability will drive differentiated overall survival for our program. And the data that we saw last week, does not do anything to reduce our confidence and our agents' ability to meaningfully differentiate based upon depth and durability that we have demonstrated. And we will probably now be in a position with our, you know, early stage of the launch where you are actually able to compete on the endpoint we think will have a ability to meaningfully differentiate on. Wonderful. Thank you both.

Operator: Thank you. And 1 moment for our next question. Our next question will come from the line of Jeet Mukherjee with US BTIG. Your line is open. Please go ahead.

Blake: Hey. This is Blake Ahn for Jeet. Thank you for taking our question. Quick 1 on the FLEX trial. Can you just give any update on enrollment progress there? And does the FDA commentary from last quarter still stand that you are okay with a 150 to 200 patients in the trial. Thank you.

Ryan Cohlhepp: Yeah. So, you consistent with what we have communicated on enrollment progress with Fortify. You know, we do not speak to specifics on that. What we have guided to is that we anticipate having that data prior to our first approval. That remains unchanged. And the overall design of the trial also has remained unchanged. Thank you.

Operator: 1 moment for our next question. Our next question comes from the line of Reni Benjamin with Citizens Bank. Your line is open. Please go ahead.

Reni Benjamin: I guess, Ryan, I would like to maybe expand a little bit more on your regulatory strategy. You commented a little bit to a prior question, but if Peto and pembro get approved before Ficera, how are you thinking in terms of best and worst case scenarios full approval versus accelerated approval? And how do you address those different scenarios? Thanks.

Ryan Cohlhepp: Yeah. Again, we do not speak to specifics in terms of our regulatory strategy. But, you know, what we did say today is that we plan to incorporate an interim analysis for overall survival You know, I do think that, you know, in the absence of specific regulatory interactions or guidance, you know, we have always recognized that overall survival is a key endpoint and ultimately the endpoint that the FDA is looking for a final analysis. So, yeah, I do not want to speculate or to, I think, say much more than that other than the fact that you know, we will continue to engage with the FDA and other regulatory bodies. We have got the pathway to do that. On a real time basis with breakthrough designation. And, you know, I think that will be a nature of the discussion. You know, what I had said earlier is you know, while we saw a top-line hazard ratio number last week, You know, we do not yet have clarity even in terms of their regulatory path. So I think there is still a lot of unknowns and we will, you know, continue to update our own plan, and guide to that. Based upon, you know, when there is, you know, relevant changes and interactions that we had with regulators and new information that we gather over time.

Reni Benjamin: And just. When do you think you will have those interactions with the regulators? Will it be after you have data or do you plan on having that beforehand?

Ryan Cohlhepp: Again, you know, we do not speak to specifics in terms of our regulatory strategy. But, you know, throughout any clinical trial and BLA process, there are different natural time points to engage with the FDA and other regulators And again, I will not speak to the specifics of that, but we have ongoing dialogue with the FDA as we move through this process.

Reni Benjamin: Right for taking the questions.

Operator: Thank you. And I would now like to hand the conference back over to Ryan Cohlhepp for closing remarks.

Ryan Cohlhepp: Thank you very much, to everyone for joining today. As is very clear,, this is an incredibly important moment for our field and for Bicara. We remain focused on execution and speed and on bringing FICERA to patients with HPV negative head and neck cancer. We look forward to updating you as we progress through the end of this year and into 2027. Thank you everyone.

Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect. Everyone have a great day.