Bicara Therapeutics Q3 2026 Earnings Call Transcript

Bicara Therapeutics (NASDAQ:BCAX) reported third-quarter financial results on Monday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Bicara Therapeutics reported a significant increase in R&D expenses to $56.5 million, reflecting ongoing trials and personnel costs, with cash reserves of $442.3 million expected to last into 2029.

The company is progressing with its pivotal FORTIFY HN01 study of Ficera in HPV-negative head and neck cancer, with substantial enrollment achieved and interim analysis expected mid-next year.

Ficera, with Breakthrough Therapy designation, shows promising results in phase 1b trials with high response rates and patient survival, positioning it for a competitive launch in a projected $5 billion market by 2030.

Strategic initiatives include advancing the FORTIFY FLEX trial for dosing flexibility and preparing for potential US launch, with a focus on demonstrating superior clinical efficacy and securing a strong market position.

Management emphasizes the importance of Ficera’s depth and durability of response for market differentiation, aiming for both speed and a comprehensive BLA submission to support a robust label.

Full Transcript

OPERATOR

Good day and thank you for standing by. Welcome to the Bicara Therapeutics third quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. To ask a question during this session, you’ll need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 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 (Vice President of Investor Relations)

Thank you and good morning everyone. It’s a pleasure to welcome you to Bicara Therapeutics’ third quarter 2026 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’ll 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 1995. 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 Sheldman, Chief Medical Officer, Chris Sarkey, 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’ll now turn the call over to Ryan.

Ryan Cohlhepp (President and CEO)

Thank you, Rachel, and good morning everyone. Since stepping into the interim CEO role earlier this fall, I’ve spent a lot of time on the road with clinicians, investors, and the hard-working Bicarans that make our work possible. My conversations have reaffirmed my belief in the potential practice-changing benefit of Ficera, which continues to drive strong enrollment momentum in our ongoing pivotal FORTIFY HN01 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 healthcare providers respond positively to the depth and durability of response that has become the hallmark of Ficera’s clinical profile, the chemo-sparing nature of its regimen, and the potential for every-three-week dosing 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, poor 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, I want to acknowledge the top-line results recently announced by one 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 and 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 for 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 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 Ficera’s differentiated clinical profile, and filing a BLA that optimizes both our speed to a potential U.S. approval and our goal of a maximally competitive commercial profile.

Today we announced that FORTIFY HN01 has achieved substantial 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’ve been evaluating for some time, and we’ll share more on timing and scope as we believe is appropriate in the context of a fluid and competitive environment.

Reaching substantial enrollment in FORTIFY HN01 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’s also clear biologic rationale for Ficera in 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, we’re seeing encouraging early safety and efficacy signals in this late-line population.

What we’re looking for is an efficacy signal paired with a safety profile that supports combination. Since earlier lines are where we see the greatest potential for clinical benefit, we now plan to present these data at a relevant forum in January. As we near a top-line interim analysis and our first potential regulatory filing, 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’ll turn it over to Bill.

Bill Sheldman (Chief Medical Officer)

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. Vicera was designed to inhibit both EGFR and TGF-beta and to work synergistically with immunotherapy, overcoming barriers in the tumor microenvironment so that the drug 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 Fisera 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 HN01 remains blinded and ongoing, they are the clearest window we have into Ficera’s clinical profile. As these data mature, we believe they continue to de-risk the pivotal study on the endpoints that matter most: response rate, complete response rate as a measure of depth, and most importantly, duration of response, progression-free survival, and overall survival at the 1,500 milligram weekly pivotal dose.

With a median follow-up of three years, Visero plus pembrolizumab achieved a confirmed objective response rate of 54% and a complete response rate of 25%. As a clinician, what stands out to me is the depth of those responses. Specifically, 80% of responders had tumor shrinkage of 80% or more. Responses came quickly, at a median of about six weeks, and they were durable with a median duration of response of nearly 22 months. Median progression-free survival was 9.9 months, roughly three times what has been reported for pembrolizumab alone, and median overall survival was just over 21 months.

Most importantly, about one in three patients was alive at three years. That’s 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 it plays in remodeling the tumor microenvironment to allow for greater depth of response. When we pool patients across all three dose cohorts in our phase 1b study — 750 mg weekly, 1,500 mg weekly, and 2,000 mg every two weeks — those with deep responses remained in response for a median of more than two and a half years, and they went nearly three years without progression.

We haven’t yet reached median overall survival in the group. Our paired biopsies 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, including recent results reported across both HPV-positive and HPV-negative patients, I think it’s important to look at the context behind our data. In these patients, tumor characteristics mattered as much as the efficacy numbers themselves. First, HPV status: every patient in our phase 1b dataset was HPV negative, and it’s the only population we are enrolling in Fortify HN01. These patients have the poorest prognosis in head and neck cancer, so every number you’ve heard from me today comes from the hardest to treat patients.

It’s also why results broken out by HPV status are essential to interpreting any dataset in this disease. Second, site of disease: most patients at our pivotal dose have locoregional disease, either alone or with distant metastases. Locoregional 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 1b study had a CPS below 20, where checkpoint inhibitors have historically been least effective.

Yet responses with Visera 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. Viithera has shown rapid responses and 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 three 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 Visera’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’ll turn it over to Chris to talk about the commercial opportunity.

Chris Sarkey (Chief Commercial Officer)

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, EU5, and Japan are 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. Vicera was specifically designed for this population and has the potential to grow the market by increasing both response rates and duration of therapy.

As Bill described, what sets Vicera apart is how deeply and how durably patients responded, not just how many responded. The depth and durability are exactly what this market lacks today, and Fortify HN01 is designed to confirm this benefit. Our market research over the past year suggests a meaningful shift in how physicians view vysara. 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’ve seen to date.

We’re also optimizing Fysera’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 Fisera’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’ve seen in many oncology launches and based on discussions we’ve had with HCPs, the first entrant doesn’t necessarily translate to sustained market leadership over time. Physicians choose the therapy with the most compelling clinical profile and the strongest label for their patients. That’s why our focus is twofold: moving with speed and aiming to deliver a differentiated BLA submission that we believe can support the strongest label.

Beyond the regulatory considerations, our aim is for Fisera 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’s large enough to sustain many entrants. We intend to successfully compete in this market, only to provide an important new option and a new sense of hope for these patients and their providers. With that said, I’ll now turn the call over to Jen to discuss our financials.

Jennifer Larson (Chief Financial Officer)

Thanks, Chris. Earlier this morning we reported detailed third-quarter 2026 financial results in our press release, and I’ll summarize a few highlights here. Research and development expenses were $56.5 million for the third quarter of 2026 as compared to $33 million for the third quarter of 2025. The increase was primarily due to costs associated with the ongoing Fortify HN01 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 2026 as compared to $7.7 million for the third quarter of 2025. 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 will remain consistent with our most recent quarterly results as we continue with the development of Fisera and continue to prepare for a potential US launch. We ended the third quarter of 2026 with approximately $442.3 million in cash, cash equivalents, and marketable securities, which provides cash runway into the first half of 2029. As a reminder, that runway includes advancing the pivotal Fortify HN01 study of Fisera in frontline recurrent metastatic head and neck cancer through to a final overall survival analysis; supporting a planned regulatory filing for Fisera; providing initial investment into medical and commercial infrastructure ahead of a potential US approval and launch; clinical development costs for Fortify Flex; funding manufacturing costs for Fisera for existing drug development efforts; and other general corporate purposes. With that, I’ll now turn the call back over to the operator for questions.

OPERATOR

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please limit yourselves to one question. One moment while we compile our Q&A roster. Our first question will come from the line of Tyler Vembern with TD Cowan. Your line is open. Please go ahead.

Tyler Vembern (Analyst at TD Cowen)

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 Physera’s strategy in the context of recent developments, you know, 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 (President and CEO)

Thanks, Tyler, for the question. So definitely 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, you consistently see a real clear distinction between the activity seen with an EGFR monoclonal and the positive versus negative based upon the biology and what is driving that? In our own data we saw similar results, which is why we chose to develop the drug in HPV negative only in our pivotal trial.

I think of recent we also saw data from the Origami cohort, and in that particular cohort what they demonstrated with AMI was about a 29% response rate from an HPV positive perspective. So I think again that data also was continued reinforcement of the historical data that we’ve seen. As we think about the subsets from a survival perspective, I think that it also plays forward. One of the things that is known is the HPV positive patients historically have lived longer than HPV negative. The overall, I think overall ability 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 outcomes by subset of both response rate and overall survival.

So understanding that understanding, especially when you’re looking at different points in the Kaplan-Meier survival curve, understanding the influence of different subsets is important and an area that investors should continue to focus on as they evaluate the data sets.

OPERATOR

Thank you. And one moment for our next question. Our next question is going to be from the line of Eric Schmidt with Cantor Fitzgerald. Your line is open. Please go ahead.

Eric Schmidt (Analyst at Cantor Fitzgerald)

Thanks for taking my question and congrats on the progress on execution of FORTIFY. 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-2027? And what are your plans for sort of statistical utilization around that analysis? Thank you.

Ryan Cohlhepp (President and CEO)

Yeah, thanks for the question, Eric. So we definitely are at a point where we can confirm that we will incorporate OS analysis at an interim. We’ve not yet guided to when that will be and certainly we’ll continue to greater clarity as we finalize that. I think one 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, and so again, we’re not at a point now where we’re providing more clarity on that top line guidance middle of next year, but certainly will as we continue to work towards that point and refining guidance.

OPERATOR

Thank you. Thank you. And our next question is going to come from the line of Tazeen Ahmed with Bank of America. Your line is open. Please go ahead.

Tazeen Ahmed (Analyst at Bank of America)

Hi, good morning. Thanks for taking my questions. I’m sorry if I missed this in your prepared remarks. But Ryan, do you know 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 with maybe any initial discussions you’ve had with physicians and also how important the hazard ratio becomes at that point as well?

Thanks again.

Ryan Cohlhepp (President and CEO)

Thank you for the question. So we actually did not speak to overall trial size. What I can say is we’re confident in size as currently, again, the overall size of our trial is around 650 patients and an HPV negative only population. So by comparison, again, the other studies that have recently read out I think are now 700 in a mixed population. Early on in the design of our trial we did so with that size, 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 interim analysis.

So I would say that we thought about that prospectively and are not in a position where we are going to need to upsize. In terms of what’s going to be competitive, I think to some degree, again that will be influenced based upon historical standard of care. Three to four month improvement over that standard of care would have been seen as meaningful. We were targeting for an overall effect that exceeded that based upon what we had seen in our early phase one experience.

I do think that it’s an evolving view in terms of what that level of competitiveness is going to need to be and I think in the absence of further information, I think it’s hard to speculate. But again, if you look at our phase one experience, we have a high degree of confidence in our ability to meaningfully show survival well ahead of what is clinically meaningful in today’s standard of care.

OPERATOR

Thank you. And one 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 (Analyst at Stifel)

Yeah, good morning. Thanks for taking the questions and apologies if I missed this earlier, but I’m sure that you’re projecting the number of death events that you hope to have accrued at 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’s just curious as to if your expectations around 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 (President and CEO)

Yeah, so, you know, your first question I’ll start with, and then I’ll ask Bill to add to it as well. You know, again, you know, I think one of the things, as you know, the key difference in our trial versus the Liger trial is that it’s a blind trial. So in terms of the data that we have with our own trial, which will be used to, you know, I think, answer your key question, I think that’s a key difference. But we’ll ask Bill to also speak to what we are able to see and as we think about at our interim, the power we’ll have there.

Bill Sheldman (Chief Medical Officer)

Yeah, thanks, Ryan. So at the interim, we are anticipating reporting the response characteristics. As we’ve discussed, depth and durability 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 already contemplated those factors and then are looking to the number of events that will support an overall survival benefit.

And then to your second question again, we certainly saw the approach taken with the most recent data set. I think we’ll continue. The one thing that I think both ourselves and that particular company can agree on is that it’s an increasingly competitive space and want to make sure that we put ourselves in a position and our data in a position, both from a regulatory perspective and an overall competitive perspective, to be best positioned. That being said, we also have a philosophy here.

There are many stakeholders, including the investor community. So 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 (Analyst at Stifel)

All right, 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. Your line is open. Please go ahead.

Kelsey Goodwin (Analyst at Piper Sandler)

Hi, good morning. Thanks for taking our questions. Maybe shifting a bit to CRC in terms of the third-line data set 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 data set, given its late line and, you know, 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&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 (President and CEO)

Yeah, absolutely. So in terms of timing, again, historically, we have always presented at medical congresses and prefer to be able to do that. And not just any conference. We want to 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 look to be able to provide more clarity in terms of when in January that we’ll be presenting that data. In terms of the read-through, again, I think the most relevant data sets with the data that we have coming out, again as a reminder, it’s a third-line plus data set both in monotherapy and then a cohort in combination with pembro, is I think some of the more recent data sets. What we’ve seen from patritumab in that same population is around a 10% response rate. We saw Incyte with their TGF-beta/PD-1 showing about a 15% in that population. I would say those are the relevant benchmarks based on the 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 and second line, which is much stronger and also very consistent with the way EGFR monoclonals have operated and behaved. So I’d say the read-through from a third line into front line, I think in a lot of ways even in terms of the wealth of data that exists with EGFR monoclonal antibodies, would suggest that these are going to be highly active compounds, by Sarah included, as you move into that earlier. So one of the things that also was an important piece for us in the third-line setting is understanding whether there was a 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.

OPERATOR

Thank you. And one moment for our next question. Our next question will come from the line of David Leibowitz with BMO Capital Markets. Your line is open. Please go ahead.

Theo Onvo (Analyst at BMO Capital Markets)

Hi, this is Theo Onvo. David, thanks for taking our question. So a quick one from us regarding, so we see the meventamab has recently been approved for head and neck and later line. Just kind of curious about your thoughts over if patients in the FORTIFY who progressed can receive meventamab, and how should we think about the impact on a shape of the OS curve after both interim and also for the full analysis? Thank you.

Ryan Cohlhepp (President and CEO)

Yeah, so in terms of the most recent approval, again if you look at what’s approved within that label, it’s for patients who have progressed on PD-1 plus chemotherapy. As a reminder of the design of our trial, the active arm is Pysera plus Pembro and the control arm is Pembro monotherapy. So strictly within the label that has recently been approved, neither one 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’ve not yet seen that trend. Ribrovant has been available, so in many cases you would have seen that off-label use even in the absence of an approval, which we’ve 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’s also not clear to physicians, because of the blinded nature of the trial, whether they’re EGFR naïve or not.

So I think we think there is very limited exposure based upon that approval. And again there’s a lot of our enrollment that sits outside of the US where again that accrual doesn’t exist. In terms of, I think your question on survival curve, we’ll ask Bill to speak to that.

Bill Sheldman (Chief Medical Officer)

Yeah, thanks, Ryan. So as Ryan commented, the study is a blinded study and so with that the clinicians won’t have a sense of whether or not they received prior EGFR therapies or not. This is again something that we’ve 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, I think in terms of the relevance as you think about the shape of the OS curve, I think the data that we presented out at three years where you saw twice as many patients alive at the three-year mark on Fysera plus Pembro versus standard of care, we believe that that is likely to represent the tail end of the curve, even in the FORTIFY trial.

OPERATOR

Thank you, and one moment for our next question. Our next question will be from the line of Shawn Lehman with Morgan Stanley. Your line is open. Please go ahead.

Shawn Lehman (Analyst at Morgan Stanley)

Good morning, Ryan and team. Thank you for taking my question and hope everyone’s well. A couple of questions just on the commercial positioning: how has pedasentimab changed your launch assumptions, if at all? And if it is approved in 2027 and establishes a few years of prescribing experience before Vicera gets approved, where do you think Vicara can realistically win first? Is it HPV-negative specialists, TB responders, patients avoiding chemo, you know, that type of thing?

And what evidence do you believe would justify premium pricing for Physera? Would superior CR and durability be sufficient? Or do you think payers will require demonstrated OS differentiation? Thank you.

Ryan Cohlhepp (President and CEO)

So I’ll start and then ask Chris to speak to your various questions. I mean, I think one thing that I’d like to point out is timing. Again, I think a key view that we continue to hold is that that timing sits at less than a year between ourselves and pedosymptomab, which we know, based on historical analogs, is a key driver of ultimate peak share uptake when you’ve got a competitive space with multiple agents. So I think that’s one area that is really important to clarify.

We have not shifted our view in terms of where we sit relative to the approval of Pitocinab. And Chris, if you’d like to speak to the broader competitive dynamic and how we think about the uptake of ourselves versus peto.

Chris Sarkey (Chief Commercial Officer)

Yeah, thanks for the question, Shawn. So, as Ryan said, we view PETO as an important competitor, and we also think that the recent phase 2 results are further validation of the significant unmet need and the opportunity that exists in first-line metastatic head and neck cancer. And so as this market evolves, being first to market we recognize can bring certain advantages, but as we’ve also seen many times, first mover doesn’t necessarily translate into sustained market leadership.

And so our goal, as you’ve heard, is moving with speed and a differentiated BLA to establish a competitive profile that gives physicians, patients, and payers a reason to choose Visera. In regards to your question around pricing, we’re going to be pricing relative to the value that we believe Fysera will bring to the market, but we’re excited about the opportunity.

Ryan Cohlhepp (President and CEO)

The other thing that I would add as we think about the launch dynamic is I think prior to last week 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 longer-term endpoints like overall survival wouldn’t be part of that initial label. I think our view has shifted: it’s more likely that both initial labels will have a component of overall survival. Again, we haven’t yet had regulatory interactions.

We don’t know, frankly, whether even though we had a clear hazard ratio coming from the pedo symptomab trial, ultimately whether that data will be mature enough and representative enough to be incorporated into their initial label. So there’s still a lot to be answered there from a regulatory perspective. With an assumption that both agents get out with an OS label, I do think 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 doesn’t do anything to reduce our confidence in our agent’s ability to meaningfully differentiate based upon the depth and durability that we’ve demonstrated. And we’ll probably now be at a position with our early stage of the launch where you’re actually able to compete on the endpoint we think we’ll have ability to meaningfully differentiate on.

Shawn Lehman (Analyst at Morgan Stanley)

Wonderful. Thank you both.

OPERATOR

Thank you. And one moment for our next question. Our next question will come from the line of Jeet Mercury with UBS. Your line is open. Please go ahead.

Blake

Hey, this is Blake on for Jeet. Thank you for taking our question. Quick one 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’re okay with 150 to 200 patients in the trial? Thank you.

Ryan Cohlhepp (President and CEO)

Yeah. So, consistent with what we’ve communicated on enrollment progress with FORTIFY, we don’t 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.

OPERATOR

Thank you. One moment for our next question. Our next question comes from the line of Rennie Benjamin with Citizens Bank. Your line is open. Please go ahead.

Rennie Benjamin (Analyst at Citizens Bank)

Great, thanks for taking the questions. I guess, Ryan, I’d 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 Fisera, 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 (President and CEO)

Yeah, again, you know, we don’t speak to specifics in terms of regulatory strategy. But, you know, what we did say today is that we plan to incorporate an interim analysis for overall survival. I do think that in the absence of specific regulatory interactions or guidance, we have always recognized that overall survival is a key endpoint and ultimately the endpoint the FDA is looking for for a final analysis. So I don’t want to speculate or to, I think, say much more than that other than the fact that we will continue to engage with the FDA and other regulatory bodies.

We’ve got the pathway to do that on a real-time basis with breakthrough designation, and I think that will be the nature of the discussion. What I had said earlier is while we saw a top hazard ratio number last week, we don’t yet have clarity even in terms of their regulatory path. And so I think there’s still a lot of unknowns. And we will continue to update our own plan and guide to that based upon when there’s relevant changes and interactions that we’ve had with regulators and information and new information that we gather over time.

Rennie Benjamin (Analyst at Citizens Bank)

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 (President and CEO)

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

Rennie Benjamin (Analyst at Citizens Bank)

Great. Thanks 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 (President and CEO)

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 Therapeutics. We remain focused on execution and speed on bringing Pfizera 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.

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