Bicara Therapeutics Q2 2026 Earnings Report

Bicara Therapeutics EPS Results

• Actual EPS: -$0.82
• Consensus EPS: -$0.82
• Beat/Miss: Missed by -$0.00
• One Year Ago EPS: N/A

Bicara Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Bicara Therapeutics Announcement Details

• Quarter: Q2 2026
• Date: 8/11/2026
• Time: Before Market Opens
• Conference Call Date: Tuesday, August 11, 2026
• Conference Call Time: 8:30AM ET

Bicara Therapeutics (NASDAQ:BCAX) is a clinical-stage biopharmaceutical company dedicated to developing novel neurohormone-based therapies for psychiatric and neurological disorders. The company’s research focuses on harnessing endogenous signaling pathways in the brain, with the goal of offering new treatment options for conditions that remain inadequately addressed by existing medications. Bicara applies proprietary peptide engineering and intranasal delivery platforms to optimize central nervous system uptake and therapeutic effect.

The company’s lead candidates include PST-001, an intranasal vasopressin-1A receptor antagonist in development for postpartum depression, and PST-002, an oxytocin receptor modulator being investigated for social anxiety and autism spectrum disorder. Both programs are supported by preclinical validation and early-stage clinical data demonstrating target engagement and potential improvements in mood and social functioning. Bicara’s pipeline leverages translational biomarkers to guide dose selection and patient stratification in ongoing studies.

Founded in 2020 and headquartered in Cambridge, Massachusetts, Bicara Therapeutics completed its initial public offering on the Nasdaq in 2021. The company’s management team brings together experienced leaders from neuroscience, endocrinology and pharmaceutical development. Bicara also collaborates with academic centers and contract research organizations to accelerate its clinical programs and expand the understanding of neurohormone mechanisms in human disease.

Looking ahead, Bicara plans to advance its lead candidates through proof-of-concept studies while exploring additional neurohormone targets for depression, anxiety and other central nervous system indications. By combining peptide chemistry with intranasal formulations, the company aims to address significant unmet needs in mental health and to establish a new class of therapeutics with improved efficacy and tolerability profiles.

Bicara Therapeutics Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Management highlighted three-year follow-up data for FICERA in HPV-negative head and neck cancer, saying approximately one in three patients remained alive at three years—nearly double retrospective standard-of-care estimates—while maintaining a consistent safety profile.
• Positive Sentiment: The pivotal FORTIFI-HN01 study remains on track for substantial enrollment by year-end, with more than 200 sites active and a planned interim analysis in mid-2027 that could support a potential accelerated approval.
• Positive Sentiment: Bicara initiated the FORTIFI-FLEX study to evaluate loading and every-three-week maintenance dosing, aiming to have data available by a potential U.S. approval and support inclusion of a more convenient regimen in the product label.
• Neutral Sentiment: The company reported approximately $497 million in cash and marketable securities at quarter-end, providing projected runway into the first half of 2029, while warning that operating expenses will rise as pivotal-trial, manufacturing, medical-affairs, and commercial-launch investments increase.
• Neutral Sentiment: Leadership transitions will take effect as Ryan Cohlhepp becomes CEO and Claire Mazumdar moves to vice chair and strategic advisor; Bicara also announced new finance, operations, business, and legal leadership intended to support potential commercialization.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to the Bicara Therapeutics second quarter 2026 earnings conference call. At this time, all participants are in listen only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, Rachel Frank. Please go ahead.

[Rachel Frank, VP of Investor Relations and Corporate Communications at Bicara Therapeutics]

Thank you, and good morning, everyone. It is a pleasure to welcome you to Bicara Therapeutics second quarter 2026 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter and provided a business update, including strategic leadership transitions, marking the company's next era of growth and execution. You can access the press release as well as the slides that we will be reviewing today by going to the investor section of our 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.

[Rachel Frank, VP of Investor Relations and Corporate Communications at Bicara Therapeutics]

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 Claire Mazumdar, Chief Executive Officer, Ryan Cohlhepp, President and Chief Operating Officer, and Ivan Hyep, Chief Financial Officer. I will now turn the call over to Claire.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Before we get into today's announcements, I want to begin by acknowledging what has been another important quarter for Bicara. Across the organization, our team has continued to execute with focus and discipline as we advance the pivotal phase III FORTIFI-HN01 study of FICERAfusp alfa, or FICERA, in frontline recurrent and metastatic HPV-negative head and neck squamous cell cancer. We also have strengthened our operational capabilities as we prepare the company for an exciting next chapter as we near a top-line interim analysis of our pivotal study and potential commercialization. Part of that momentum was our ASCO 2026 update, where we presented three-year follow-up data showing that TGF-β inhibition leading to direct tumor penetration translates to unprecedented depth and duration of response. At three years, FICERA nearly doubled overall survival versus standard of care while maintaining a consistent safety profile, all driven by TGF-β inhibition.

[Claire Mazumdar, CEO at Bicara Therapeutics]

I'm incredibly proud of everything our employees have accomplished and grateful for their continued commitment to our mission. Today's leadership announcements reflect that same philosophy of thoughtful planning that has governed our approach to the development of FICERA. Since founding Bicara, our goal has never been simply to build a successful development stage biotech company. It has been to build an enduring organization, one with the leadership, culture, and capabilities to create lasting value for patients and shareholders for many years to come. The leadership changes we are announcing today represent the next step in that evolution. Today, I am thrilled to announce that at the beginning of next year, Ryan will become President and Chief Executive Officer while I transition to the role of Vice Chair of the Board and Strategic Advisor.

[Claire Mazumdar, CEO at Bicara Therapeutics]

When Ryan joined me in launching Bicara more than five years ago, we always discussed this moment as being the time at which I would hand him the torch, and it's a reflection of our collective accomplishment that we're here today with a clear line of sight to a top-line interim analysis of our pivotal study that we believe may lead to an accelerated approval and subsequent launch. As we look toward that potential launch, Ryan's experience makes him exceptionally well-suited to lead the organization. As many of you know, he has over two decades of life science leadership from early-stage R&D all the way through global commercial execution, including running Takeda's U.S. oncology portfolio and launching multiple approved drugs for solid and hematologic tumors.

[Claire Mazumdar, CEO at Bicara Therapeutics]

My own training is as a cancer biologist, and that background has shaped how I've led Bicara from the beginning, staying close to the science and building the company around it. Commercialization calls for something different, real hands-on experience launching drugs and building commercial organizations, and that is precisely Ryan's experience. Both I and the entire Bicara Board of Directors have complete confidence that he is the right leader to guide us through our next chapter as we prepare for the potential commercialization of FICERA and the next phase of growth at Bicara. As I step into my new role as Vice Chair and Strategic Advisor, I look forward to continuing our partnership closely, supporting Ryan and this leadership team through our next phase. I'm also pleased to announce that Jenn Larson will join Bicara as our Chief Financial Officer, succeeding Ivan effective tomorrow.

[Claire Mazumdar, CEO at Bicara Therapeutics]

You'll hear from Ivan in a few minutes on our financials for the quarter, but first, I'd like to thank him for everything he has contributed to Bicara. As one of our early executives, he played a critical role in helping establish our finance organization, leading Bicara through more than $800 million in capital raises, stewarding our transition to the public markets, and building the financial foundation that has positioned us for where we are today. We are sincerely grateful for his leadership. At the same time, we're excited to welcome Jenn to the leadership team.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Jen brings extensive experience leading finance organizations at commercial-stage biotech companies and has a strong track record of helping organizations navigate growth and commercialization. Her expertise will be an important addition as we head into this important stage ahead. I also want to highlight that we recently announced the appointments of Jeremy Bender and Christy Oliger to our board of directors. Both new board members bring a strong track record of guiding biopharmaceutical companies through critical stages of growth, including pipeline development, corporate strategy, and commercialization, and their experience and guidance will strengthen our board as we look toward the future of Bicara. Personally, this transition is a meaningful moment for me. Looking back, I'm incredibly proud of what we've accomplished together, from advancing bold science to building an exceptional team and culture that I believe will continue to differentiate Bicara well into the future.

[Claire Mazumdar, CEO at Bicara Therapeutics]

While my role at Bicara is evolving, my commitment to its success is unwavering. I look forward to continuing to support Ryan, our leadership team, and our board as Bicara enters this exciting next phase. With that, let me turn the call over to Ryan for a few remarks.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Thank you, Claire. I first want to acknowledge your extraordinary leadership and partnership. Since Bicara's founding, you've established not only a compelling scientific vision, but also a culture centered on excellence, collaboration, and an unwavering commitment to patients. It has been a privilege to work alongside you, and I'm grateful for your continued partnership as you transition into your new role. I'm honored by the confidence the board has placed in me and energized by what lies ahead. As Claire mentioned, this transition is not about changing our direction. It's about building upon a foundation that has been intentionally created over many years and bringing my own background in oncology drug launches and pipeline expansions bear as I step up to succeed Claire.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

I've had a clear vision for how we will build our commercial capabilities, which is precisely why Claire and the board tasked me with bringing on a Chief Commercial Officer earlier this year, and Chris Sarchi is exactly the right leader to help realize it. Today, Bicara is in a very different position than when we started. We have a promising late-stage development program, a highly capable organization, and a leadership team with the experience necessary to support the next phase of the company's evolution. Our focus now is on executing against the opportunity with the same discipline and long-term perspective that has defined Bicara from the beginning. Looking ahead, our priorities are clear. We will continue preparing the organization for the potential commercialization of FICERA while maintaining excellence in execution across every function.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

At the same time, we will continue to advance FICERA's development program thoughtfully and strategically, ensuring that we allocate capital and resources in ways that maximize long-term value creation. Just as important, we will continue investing in the people and culture that have become one of Bicara's greatest strengths. Because building an enduring biotech company requires more than outstanding science. It also takes exceptional people working together with clarity, accountability, and shared purpose. I am also excited about the strength and depth of the leadership team that will help guide Bicara through this next chapter, including two additional leadership transitions that will become effective in January as well. Tanya Green, currently our Chief Development Officer, will succeed me as Chief Operating Officer, and Jenna Cohen, currently our Chief Corporate Affairs Officer, will be promoted to Chief Business Officer.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

When Tanya joined us last year, it was immediately clear that she was suited to take on the COO seat when the time came. Her appointment to the role reflects the strength of operational and executional excellence that has become an immediate hallmark of her leadership at Bicara. Likewise, Jenna has made immediate strategic impacts since joining Bicara. Her expanded role positions us well as we continue to strengthen our corporate strategy, corporate development, and long-term growth initiatives. Finally, we are pleased to welcome Greg Shiferman as Chief Legal Officer, effective at the end of the month. Greg brings deep biotech legal experience to Bicara, and he will be a key partner to the team as we move through our pivotal milestones and toward a potential commercial launch of FICERA. As we approach what we believe will be a transformational period for Bicara, our mission remains unchanged.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Bring FICERA to patients who need it most urgently, starting with people living with HPV-negative head and neck cancer, continue advancing innovative science, execute with discipline, and create long-term value for all of our stakeholders, starting with the patients we serve. With that in mind, I want to highlight some of the important recent progress that we have made. First, as Claire mentioned previously, this past May at ASCO, we presented the most comprehensive and mature clinical data set assembled for FICERA in first-line recurrent or metastatic HPV-negative head and neck cancer. These data span approximately 90 patients across three dose cohorts, with up to three years of follow-up in our 1,500 mg weekly pivotal dose, the longest follow-up presented of any investigational agent in the HPV-negative head and neck cancer space. FICERA continued to deliver deep, durable responses, reinforcing its best-in-class potential in this setting.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

At our pivotal study dose of 1,500 mg weekly, an estimated one in three patients was alive at three years, approximately doubling the survival rate observed in retrospective analyses with standard of care pembrolizumab in HPV-negative patients. Importantly, TGF‑β inhibition was observed to be the mechanistic foundation of this clinical benefit, driving tumor penetration, enabling immune cell infiltration, and translating depth of response into durable long-term survival. A clinical profile no other EGFR-directed therapy in head and neck cancer has demonstrated. Second, the execution of FORTIFI-HN01 remains a top priority. We are on track for substantial enrollment by year end, keeping us positioned for an interim analysis in mid-2027 and a potential path to accelerated approval. We continue to see strong momentum across the study, with over 200 sites now active and sustained engagement from our investigator base more broadly.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Third, we are excited to announce we have initiated FORTIFI-FLEX, our alternative dosing study to support our loading and every-three-week maintenance dose. The speed in which we designed and activated this study on the heels of strong clinical data from our exploratory every-two-week cohort presented earlier this year is a hallmark of the Bicara way. Following science and executing with speed and precision to best serve the needs of patients. Our goal with FORTIFI-FLEX is to have the data in hand by the time of our potential U.S. approval, supporting a compelling path for earlier adoption of this streamlined regimen. Finally, beyond our pivotal trial population, we continue to build out FICERA's broad development strategy, both within head and neck cancer and beyond, where we have already established proof of concept in additional indications, including cutaneous squamous cell carcinoma and anal canal cancer.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Building on this foundation, there's a lot of momentum right now. I couldn't be more optimistic about the future, and I look forward to leading this outstanding organization into its next chapter. I'll now turn the call over to Ivan to discuss our financials.

[Ivan Hyep, CFO at Bicara Therapeutics]

Thanks, Ryan. Earlier this morning, we reported detailed second quarter 2026 financial results in our press release, and I'll summarize a few highlights here. Our total operating expenses for the second quarter of 2026 increased compared to the second quarter of 2025, driven by clinical operations and development expenses associated with our ongoing pivotal FORTIFI-HN01 study, including increased manufacturing and development costs. We also saw an increase in personnel-related costs, including stock-based compensation, as we have grown our workforce primarily in support of clinical operations and development functions. We expect quarter-over-quarter operating expenses to increase for the remainder of the year, driven by continued investment in clinical operations, technical operations, and workforce growth in support of those functions.

[Ivan Hyep, CFO at Bicara Therapeutics]

We anticipate increased spend within clinical operations to support our pivotal study, FORTIFI-HN01, particularly as we expect to be substantially enrolled by the end of this year to enable a top-line interim analysis in the middle of 2027, as well as new investment in FORTIFI-FLEX, our alternative dosing study, which was recently initiated. Given the strength of maturing phase I-B data for FICERA in head and neck cancer, and consistent with today's leadership announcements that positions us well for our next phase of growth and execution, we also anticipate increased investment in key functions to enable launch readiness, including medical affairs and our commercial organization to position us for launch success upon potential U.S. regulatory approval. We ended the second quarter of 2026 with approximately $497 million in cash equivalents and marketable securities, which provides cash runway into the first half of 2029.

[Ivan Hyep, CFO at Bicara Therapeutics]

That runway is expected to take us through several important milestones, including advancing the pivotal FORTIFI-HN01 study in FICERA in frontline recurrent metastatic HPV-negative head and neck cancer through to a primary 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 FORTIFI-FLEX, and funding manufacturing costs for FICERA for existing drug development efforts. Before we begin our Q&A section, I want to close by saying that it has been an incredible privilege to help build Bicara's finance organization from the ground up and to be a part of this team as we have grown from a private company to where we stand today. It has been an honor to work alongside Claire and Ryan for all these years.

[Ivan Hyep, CFO at Bicara Therapeutics]

I am proud of what we have built together. As I have gotten to know Jenn, I am incredibly confident that she is the right person with the right commercial experience set to lead the finance organization from here. Thank you. With that, I will now turn the call back over to the operator for questions. Operator?

[Operator]

Thank you. As a reminder, if you would like to ask a question, please press star one on your telephone. If you would like to remove yourself, please press star one again. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. First question will be coming from the line of Eric Schmidt of Cantor. Please go ahead.

[Eric Schmidt, Analyst at Cantor]

Well, thanks for taking my question. Just let me start by saying congrats to Ryan and the team on their new appointments. Of course, Claire and Ivan, we will miss you going forward. Maybe a question on the transition for you, Claire, when you did discuss years ago with Ryan that this was the right moment for the transition. Why is this the right moment for the transition? Why say in advance of data as opposed to following the phase III readout? Thank you.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thanks for your question, Eric. When Ryan and I actually met six years ago to talk about Bicara, we always knew there would be a time when we would need to establish our commercial infrastructure and get ready for launch readiness in advance of top-line data. As we entered this year building on very strong momentum for FORTIFI-HN01, I started to really see the light at that end of the tunnel and knew that we needed to elevate a new executive team to build that foundation. We saw this as an intentional succession planning from a position of strength that allowed us to set the groundwork for what is to come. I am very excited about the momentum we have, and I look forward to supporting as a strategic advisor and vice chair. I am not planning to disappear in any way.

[Claire Mazumdar, CEO at Bicara Therapeutics]

This is just to elevate a team of experienced executives who have significant commercial experience.

[Eric Schmidt, Analyst at Cantor]

Claire, can I ask if you have got a full-time opportunity that you are thinking about or lined up?

[Claire Mazumdar, CEO at Bicara Therapeutics]

No, Bicara is my full-time opportunity from that perspective. I am not taking on any additional operational roles.

[Eric Schmidt, Analyst at Cantor]

Thank you very much.

[Operator]

Thank you. One moment for the next question. Tyler Van Buren of TD Cowen, your line is open.

[Tyler Van Buren, Analyst at TD Cowen]

Hey, guys. Good morning. Claire and Ivan, I too want to thank you and congratulate you for all of your accomplishments. You both will be missed. I would also like to congratulate Ryan, Tanya, Jenn, Jenna, and Greg on their promotions. Look forward to continuing to work together. Maybe you guys could discuss how you will manage enrollment of the FORTIFI-FLEX study so that it is not disruptive to completing enrollment for the primary ongoing FORTIFI trial. Then the second question would just be, as you continue to evaluate the competitive head and neck cancer landscape, are there any presentations at ESMO that you believe are important to note and that you will be paying close attention to?

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Hey, Tyler. Thank you for the question. I will start and then pass it over to Tanya to speak a little bit more about FORTIFI-FLEX. As you can imagine, we have been very deliberate and thoughtful in terms of the footprint around FORTIFI-FLEX in order to make sure that it does nothing to impede the continued progress that we have on FORTIFI. I will let Tanya speak to that a bit more. As far as ESMO, again, what we have seen thus far, we are aware of abstracts that are going to be out there from J&J with ami, and it also appears as if there will be some additional data on pidocetimab. It is not quite clear exactly what we will see there. Obviously, we will monitor that very closely. With that, Tanya, do you want to speak a little bit more to what we have done with FORTIFI-FLEX?

[Tanya Green, Chief Development Officer at Bicara Therapeutics]

Sure. Hi, this is Tanya Green, Chief Development Officer. Thanks for the question, Tyler. We are thoughtfully thinking about the potential overlap of sites. As it stands, there's only about a third of sites that will overlap with our FORTIFI-HN01 study, and we'll be looking at different regions across Europe, Latin America, Asia-Pacific, and the U.S., and ensure that we're stage-gating enrollment so that FORTIFI remains our top priority in terms of enrollment.

[Operator]

One moment for the next question. Our next question is coming from the line of Stephen Willey of Stifel. Please go ahead.

[Stephen Willey, Analyst at Stifel]

Yeah, good morning. Would just like to echo my appreciation to Claire and Ivan, and congrats to everyone on the new appointments. Maybe just a couple questions. I guess as we get closer to a year-end colorectal disclosure, just curious if you have a better sense of the number of patients and duration of follow-up we should expect to see. I guess now that you have initiated the FORTIFI-FLEX study, should we anticipate that any additional development steps in colorectal or additional tumor types to also leverage induction and maintenance? I just have a follow-up.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thank you for your question, Steve. To speak to the third-line CRC studies that we are pursuing, as you may remember, we have two open label signal-seeking cohorts we're looking at. Both are third-line plus MSS colorectal cancer, KRAS and BRAF wild type patients, one as a monotherapy with FICERA, the other in combination with pembrolizumab. We anticipate having approximately 20 patients in each of these cohorts with short-term follow-up. It will be really a look at early safety and efficacy from those cohorts at the time of the disclosure. To your second question around other types of focus, you will see us really develop a strategy around other indications outside of our FORTIFI-HN01 study.

[Claire Mazumdar, CEO at Bicara Therapeutics]

We have already demonstrated proof of concept in cutaneous squamous cell carcinoma and anal canal cancer and do believe that there is a lot of biology and combination approaches in CRC as well that we have been exploring.

[Stephen Willey, Analyst at Stifel]

That will be pursued with induction and maintenance?

[Claire Mazumdar, CEO at Bicara Therapeutics]

Sorry, in colorectal cancer or-

[Stephen Willey, Analyst at Stifel]

Yeah, just colorectal and other tumor types.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Correct. We've been looking both at late line tumors as well as earlier in the case of head and neck in the locally advanced setting as well, as where we have a-

[Stephen Willey, Analyst at Stifel]

Okay. Understand.

[Claire Mazumdar, CEO at Bicara Therapeutics]

investigating. Yep.

[Stephen Willey, Analyst at Stifel]

Okay. Just curious, how do you think a potential approval of ami in second-line patients might impact post-progression treatment dynamics of FORTIFI? Can you just remind us what percentage of sites that you've enrolled and activated in FORTIFI are based in the U.S.? Thank you.

[Claire Mazumdar, CEO at Bicara Therapeutics]

I believe about 20% of our sites are in the U.S. today in terms of our frontline FORTIFI-HN01 study. To your question around the potential accelerated approval of amivantamab in second line, we do not anticipate seeing significant changes to our enrollment study given we do plan to be substantially enrolled for the interim analysis by end of year and remain on track to do so.

[Stephen Willey, Analyst at Stifel]

All right. Thanks for taking the questions.

[Operator]

Thank you. One moment for the next question, please. Next question is coming from the line of Bradley Canino of Guggenheim. Please go ahead.

[Bradley Canino, Analyst at Guggenheim]

Well, it is definitely rare you get to congratulate so many people at once, so it is great to see the continuity for the company as well. Two check-in questions from me. First, in head and neck, I am wondering, given it has been about two, three months since ASCO, what has been the physician reaction to the TGF-β and cordial biology work presented there? Have you noticed that impact enrollment in a positive way at all? Second, maybe following up on Steve's question, just more of a pointed question, colorectal. Now that we have two EGFR bispecifics moving into phase III's, why are you not following that and how are you thinking about that balance against the opportunities you have called out in skin and in rectal cancer? Thank you.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thank you for your question, Brad. To your first question, I do believe that ASCO was very good. We did get very good feedback from investigators at ASCO based off the dataset we shared, the maturity of our data when it came to depth and durability of response, but also the tolerability profile that has now been seen with three years' worth of follow-up. I think as we see the development strategies of our competitors, the feedback has continued to be extremely positive for Bicara and has led to building significant momentum in geographies where both amivantamab and pidocetimab were also enrolling patients. We do think it was an important inflection point for us as well from a momentum standpoint with FORTIFI-HN01.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Now, I think to your questions around colorectal cancer, while both Genmab and J&J have very different resources than Bicara, our intention has really been to follow the science and go where we believe that not only there is a hypothesis for EGFR, but as well for TGF-β. That took us initially into the third line setting where we believe that TGF-β expression played a significant role in EGFR resistance and beyond. We have already demonstrated that TGF-β hypothesis in both cutaneous and anal canal cancer and believe that there is a strong rationale in the locally advanced setting of head and neck. That's not to say that there isn't a strategy in colorectal cancer, but we do believe that there are combination approaches that will make us a first-in-class approach rather than following our competitors into the frontline setting of MSS patients.

[Operator]

Thank you. One moment for the next question. The next question's coming to the line of Tazeen Ahmad of Bank of America. Please go ahead.

[Tazeen Ahmad, Analyst at Bank of America]

Hi. Good morning. Congratulations from me as well on all of the new roles for everyone. I maybe just wanted to ask your thoughts about your competitor's update that they are still going to be presenting data from frontline head and neck by the end of this year. When they do, what should we be thinking about in terms of readout or read-through, rather, for FICERA? Thanks.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thanks for your question, Tazeen. What we do know just from the update from Genmab's earnings last week is that they do plan. The only new information we have is the timelines are now slated for Q4 of this year for FORTIFI-HN01 to read out. Our anticipation is at that top line readout, we will likely get overall response rates data and not much more than that. I think in many ways, the read-through is really around speaking to the potential profile of EGFRs changing the treatment landscape, as a standard of care in the frontline setting. It will very much depend on how that data is broken out by HPV status and the like. Thank you.

[Operator]

Thank you. One moment for the next question. Next question is coming from the line of Judah Frommer of Morgan Stanley. Please go ahead.

[Judah Frommer, Analyst at Morgan Stanley]

Yeah. Hi, guys. Thanks for taking the question. Claire and Ivan, it's been a pleasure to work with you guys, and congrats to the rest of the team. Maybe just a couple more on the competitive landscape with some more clarity on competitor timing. Potentially pido and ami being there in second line ahead of EGFR bispecifics in first. What's kind of latest feedback from docs on utilizing an EGFR-directed therapy in first line, if they are approved in second line, and how those dynamics could play out? Where can you differentiate on safety versus the other EGFR bispecifics? Thanks.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thanks for your question, Judah. What I will say to your first question around both frontline and second-line usage of EGFR, what we're hearing from investigators is in general, there is a hope and want that EGFRs will be used in the frontline setting, which is the largest majority of patients. We anticipate that to really become the de facto standard of care. The question then becomes a little bit around sequencing of potential EGFR bispecifics. What we do know is the purported mechanism of action of pidocetimab does speak to the degradation of the EGFR receptor. You're starting to hear investigators think through what makes the most sense in terms of sequencing and what to use in the frontline setting, if you wanted to also use a different EGFR in the second-line setting.

[Claire Mazumdar, CEO at Bicara Therapeutics]

What I will also say is you are seeing additional ADCs outside of EGFRs, testing their molecules in a post-EGFR setting, knowing that EGFRs will likely be the standard of care. I think there is a very clear recognition around EGFRs, moving into the frontline setting. Our belief is that the EGFR naive second-line setting will be a diminishing patient population. To your question around tolerability, we continue to hear excellent feedback on the tolerability of FICERA in combination with pembrolizumab, as we've expanded in a pivotal study, which does seem to differentiate from the other combinations that are being studied in the frontline setting. What we do know, of course, is that amivantamab is being studied in combination with chemotherapy, and today investigators are really looking for a chemo-sparing regimen. Thank you for your question.

[Operator]

Thank you. One moment for the next question. Next question is coming from the line of Kelsey Goodwin of Piper Sandler. Please go ahead.

[Kelsey Goodwin, Analyst at Piper Sandler]

Oh, hey, good morning. Thanks for taking our questions, and congrats again on all the appointments. For my first question, building on, I think, a prior question. Just given FICERA's unique profile is very much durability focused, as we head into this initial wave of the ORR interim updates for you and for your competitor, how are you thinking about these first looks and potential areas of differentiation before we get that longer-term follow-up? Then second, just quickly on FORTIFI-FLEX. I think you had mentioned you aim to have data in hand at the time of approval. When might that be included in the eventual label? Thanks so much.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thanks for your question, Kelsey. To speak to your first question, a large part of the dataset we put out at ASCO this year was around connecting our depth of response to ultimately durability and overall survival benefit. We do believe that at the time of the interim analysis for both ourselves and Genmab, depth of response will be an important indicator for what's to come in terms of durability and overall survival. We will, of course, as you may know, a six-month durability is an important aspect of the dataset that will be used to support a potential accelerated approval as well. I really do believe it will be the totality of the data beyond just response rates that will be important in distinguishing these two datasets.

[Claire Mazumdar, CEO at Bicara Therapeutics]

To your question on FORTIFI-FLEX, by being able to start this study well in advance of what we had initially anticipated at the beginning of the year, we do anticipate having the dataset in hand for the first approval.

[Kelsey Goodwin, Analyst at Piper Sandler]

Got it. Okay, great. Thank you so much.

[Operator]

Thank you. One moment for the next question. Our next question is coming from the line of Reni Benjamin of Citizens. Please go ahead.

[Reni Benjamin, Analyst at Citizens]

Hey, good morning, guys. Thanks for taking the questions. Let me echo my congratulations as well to the entire team. Maybe two quick ones for us. One of our KOL calls mentioned left-sided CRC might benefit more with certain combinations versus, let's say, right-sided CRC, which kind of leads us to ask, as you think about the underlying factors and potential stratifications you might be looking at, what are you focusing on to ensure that you're getting a true go-forward signal for FICERA? As a second question, I'd be remiss not to ask Ivan something. Ivan, during your prepared remarks, you mentioned the burn rate increase, that we should be factoring as FORTIFI-FLEX starts and some of these other programs move forward. Can you talk a little bit about how we should be thinking about the burn?

[Reni Benjamin, Analyst at Citizens]

How much of a burn increase should we be thinking about? Any preliminary sales force metrics you might be able to talk about. Thanks.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thank you for your question, Reni. I will start with the question on colorectal cancer and then pass it over to Ivan to answer your question around burn. To your point, there is a history of EGFR usage in left-sided colorectal cancer, which is why that is where the approval is for EGFR monoclonal antibodies today. And where both, I believe, J&J and Genmab are going with their phase III in left-sided CRC. Part of our attempt from a signal-seeking perspective to also look at right-sided colorectal cancer was given the role that VEGF inhibitors, including bevacizumab, play from an anti-angiogenic standpoint in the right-sided CRC. We know that TGF-β plays a role in angiogenesis and wanted to determine whether there was an opportunity to have a similar impact with our EGFR TGF-β bifunctional.

[Claire Mazumdar, CEO at Bicara Therapeutics]

We do anticipate that given the small signal seeking size of the 20+ patient study, we will need to tease out left-sided, right-sided and other potential biomarkers to help determine what is the right patient population. But that was the intent of our signal-seeking cohorts. With that, I will pass it over to Ivan.

[Ivan Hyep, CFO at Bicara Therapeutics]

With your question on burn, we anticipate a fairly consistent burn rate quarter-over-quarter as we continue to get deeper into this pivotal study. With these FORTIFI-FLEX as well, as we continue with enrollment, we will end up seeing is consistency as we eventually sunset some of the spend on the FORTIFI study in the 2027 timeframe, and as we continue to ramp up commercial spend and the build around the FTEs.

[Ivan Hyep, CFO at Bicara Therapeutics]

I think, Ryan, you are up.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Go ahead.

[Reni Benjamin, Analyst at Citizens]

Yeah, that was it. So probably it is for you, Ryan, regarding the sales force metrics.

[Ryan Cohlhepp, President and COO at Bicara Therapeutics]

Yeah, absolutely. I think at this point, we are not prepared to start speaking to that. Certainly, as we get closer to commercialization, we will be prepared to guide to some of those metrics.

[Reni Benjamin, Analyst at Citizens]

Got it. Thanks very much, guys.

[Operator]

Thank you. One moment for the next question. Next question is coming from the line of Jeet Mukherjee of BTIG. Please go ahead.

[Jeet Mukherjee, Analyst at BTIG]

Great. Good morning, and thanks for taking the question and congratulations to you, Ryan, and best wishes to you, Claire and Ivan, on your next step. Two quick questions from us. I believe you had previously said FORTIFI-FLEX will not be a non-inferiority study. Could you just specify again, what supports approval of this regimen? The second question was just related to colorectal cancer. Are you thinking potentially about combining FICERA with mutant selective KRAS or pan-RAS inhibitor combinations? Thanks.

[Claire Mazumdar, CEO at Bicara Therapeutics]

Thanks for your question, Jeet. To that point on the FORTIFI-FLEX, the intent of the study is really to compare the two regimens between our weekly dosing of 1,500 mg weekly to our loading and maintenance dose. What we are looking for is a comparability around durability of response and ensuring that we can maintain the same durability of response post the loading portion, which is the same for both studies. This is why the FDA was comfortable in the sizing of the study, and the dataset that we plan to submit to include it in the label. I apologize, I missed the second part of your question. About whether or not we are thinking Oh, RAS combos in CRC. Yeah.

[Jeet Mukherjee, Analyst at BTIG]

Right.

[Claire Mazumdar, CEO at Bicara Therapeutics]

We have been thinking quite a bit about it. As you may be aware, we have presented quite a bit of data at AACR and SITC around our work in combination with RAS inhibitors that shows that the TGF-β arm of our molecule is able to address many of the resistance mechanisms to those RAS inhibitors, and ensure improved durability of effect. Part of our strategy is to determine what is the best area to go into and to ensure that we can also combine with RAS inhibitors, and ensure that there is no synergistic toxicities. With that, thank you for your question.

[Operator]

Thank you. This does conclude today's Q&A session. I would like to turn the call over to Claire for closing remarks. Please go ahead.

[Claire Mazumdar, CEO at Bicara Therapeutics]

I want to thank you all for joining today, and I can say I am very energized by where Bicara stands and confident in the team that is going to lead us forward. We look forward to updating you on our progress very soon. Thank you all.

[Operator]

This concludes today's programming. Thank you for joining. You may now disconnect.

Participants

Executives

• Rachel Frank, VP of Investor Relations and Corporate Communications
• Claire Mazumdar, CEO
• Ryan Cohlhepp, President and COO
• Ivan Hyep, CFO
• Tanya Green, Chief Development Officer

Analysts

• Eric Schmidt, Analyst at Cantor
• Tyler Van Buren, Analyst at TD Cowen
• Stephen Willey, Analyst at Stifel
• Bradley Canino, Analyst at Guggenheim
• Tazeen Ahmad, Analyst at Bank of America
• Judah Frommer, Analyst at Morgan Stanley
• Kelsey Goodwin, Analyst at Piper Sandler
• Reni Benjamin, Analyst at Citizens
• Jeet Mukherjee, Analyst at BTIG