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Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 8:30 a.m. ET Chief Executive Officer - Claire Mazumdar President and Chief Operating Officer - Ryan Cohlhepp Chief Financial Officer - Ivan Hyep Chief Development Officer - Tanya Green Need a quote from a Motley Fool analyst? Email [email protected] Operator: Good day, and thank you for standing by. Welcome to the Bicara Therapeutics Second Quarter 2026 Earnings Conference Call. [Operator Instructions] 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: Thank you, and good morning, everyone. It's 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'll be reviewing today by going to the Investors 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. Any forward-looking statements 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'll now turn the call over to Claire. Claire Mazumdar Clemon: 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 3-year follow-up data showing that TGF-beta inhibition leading to direct tumor penetration translates to unprecedented depth and duration of response. At 3 years, Ficera nearly doubled overall survival versus standard of care while maintaining a consistent safety profile, all driven by TGF-beta inhibition. 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 Adviser. When Ryan joined me in launching Bicara more than 5 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 towards that potential launch, Ryan's experience makes him exceptionally well suited to lead the organization. As many of you know, he has over 2 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. My own training is as a cancer biologist, and that background has shaped how I have led Bicara from the beginning, staying close to the science and building the company around it. The 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 Adviser, 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. 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. Jenn 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 towards 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. 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: 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 that what lies ahead. As Claire mentioned, this transition is not about changing our direction. It's about building upon a foundation that's been intentionally created over many years and bringing my own background in oncology drug launches and pipeline expansions there as I step up to succeed Claire. I had a clear vision for how we will build our commercial capabilities, which is precisely why Claire and the Board [ asked ] 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. At the same time, we'll 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. And just as important, we'll continue investing in the people and culture that 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'm also excited about the strength and depth of the leadership team that will help guide Bicara through this next chapter, including 2 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. 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 of Bicara. Likewise, Jenna has made immediate strategic impact 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 will be a key partner to the team as we move through our pivotal milestones and for a potential commercial launch of Ficera. As we approach what we believe will be a transformational period for Bicara, our mission remains unchanged, 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 3 dose cohorts with up to 3 years of follow-up in our 1,500-milligram 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. At our pivotal study dose of 1,500 milligrams weekly, an estimated 1 in 3 patients was alive at 3 years, approximately doubling the survival rate observed in retrospective analyses with standard of care pembrolizumab in HPV-negative patients. Importantly, EGF-beta inhibition was observed to be the mechanistic foundation of this clinical benefit, driving tumor penetration, enabling immune cell infiltration and translating in 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, and 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. Third, we are excited to announce we have initiated FORTIFI-FLEX, our alternative dosing study to support our loading and every 3-week maintenance dose. The speed in which we designed and activated the study on the heels of strong clinical data from our exploratory every 2-week cohort presented earlier this year is a hallmark of the Bicara way, following the 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. Building on this foundation, there is 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: 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. 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 the maturing Phase Ib 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, cash equivalents and marketable securities, which provides cash runway into the first half of 2029. 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. I am proud of what we have built together. As I've 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'll now turn the call back over to the operator for questions. Operator? Operator: [Operator Instructions] First question will be coming from the line of Eric Schmidt of Cantor. Eric Schmidt: Just let me start by saying congrats to Ryan and the team on the new appointments. And of course, Claire and Ivan we will miss you going forward. And 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? Claire Mazumdar Clemon: Thanks for your question, Eric. And when Ryan and I actually met 6 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. And so we saw this as an intentional succession planning from a position of strength that allowed us to set the groundwork for what's to come. I'm very excited about the momentum we have, and I look forward to supporting him as a Strategic Adviser and Vice Chair. I'm not planning to disappear in any way. This is just to elevate a team of experienced executives, who have significant commercial experience. Eric Schmidt: And Claire, can I ask if you've got a full-time opportunity that you're thinking about or lined up? Claire Mazumdar Clemon: No, Bicara is my full-time opportunity from that perspective. I'm not taking on any additional operational roles. Operator: One moment for the next question. Tyler Van Buren of TD Cowen. Tyler Van Buren: Claire and Ivan, I too want to thank you and congratulate you for all of your accomplishments. You both will be missed. And I'd 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'll manage enrollment of the FORTIFI-FLEX study so that it's not disruptive to completing enrollment for the primary ongoing FORTIFI trial? And 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'll be paying close attention to? Ryan Cohlhepp: Tyler, thank you for the question. I'll start and then pass it over to Tanya to speak a little bit about 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, but I'll let Tanya speak to that a bit more. As far as ESMO, again, what we've 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 petosemtamab, it's not quite clear exactly what we'll see there. But obviously, we will monitor that very closely. With that, Tanya, you want to speak a little bit more to what we've done with FORTIFI-FLEX. Tanya Green: Sure. This is Tanya Green, Chief Development Officer. Thanks for the question, Tyler. So we are thoughtfully thinking about the potential overlap of sites. As it stands, there's only about 1/3 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. And our next question is coming from the line of Stephen Willey of Stifel. Stephen Willey: I would just like to echo my appreciation to Claire and Ivan and congrats to everyone on the new appointments. Maybe just a couple of questions. So 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. And 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? And I just have a follow-up. Claire Mazumdar Clemon: Thank you for your question, Steve. So to speak to the third-line CRC studies that we are pursuing, as you may remember, we have 2 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 pembro. We anticipate having approximately 20 patients in each of these cohorts with short-term follow-up. So 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. We have all 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: And that will be pursued with induction and maintenance. Claire Mazumdar Clemon: Sorry, in colorectal cancer or. Stephen Willey: Yes, just colorectal and other tumor types. Claire Mazumdar Clemon: 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 [indiscernible]. Stephen Willey: And then just curious how do you think a potential approval of Ami in second-line patients might impact the post-progression treatment dynamics of FORTIFI. And can you just remind us what percentage of sites that you've enrolled and activated with FORTIFI are based in the U.S. Claire Mazumdar Clemon: I believe about 20% of our sites are in the U.S. today in terms of our frontline FORTIFI-HN01 study. And to your question around the potential accelerated approval of amivantamab in second line, we don't anticipate seeing significant changes to our enrollment study given we do plan to be substantially enrolled in the -- for the interim analysis by end of year and remain on track to do so. Operator: One moment for the next question, please. Next question is coming from the line of Bradley Canino of Guggenheim. Bradley Canino: Well, it's definitely rare you get to congratulate so many people at once. So it's great to see the continuity for the company as well. Two check-in questions for me. First, in head and neck. I'm wondering, given it's been about 2, 3 months since ASCO, what has been the physician reaction to the TGF-beta and core the biology work presented there? And have you noticed that impact enrollment in a positive way at all? And then second, maybe following up on Steve's question, just more of a pointed question, colorectal. Now that we have 2 EGFR bispecifics moving into Phase IIIs, why are you not following that? And how are you thinking about that balance against the opportunities you've called out in skin and rectal cancer? Claire Mazumdar Clemon: Thank you for your questions, Brad. So to your first question, I do believe that ASCO was a very good -- we did get very good feedback from investigators at ASCO based off the data set 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 3 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 petosemtamab were also enrolling patients. So we do think it was an important inflection point for us as well from a momentum standpoint with FORTIFI-HN01. 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-beta. And that took us initially into the third-line setting, where we believe that TGF-beta expression play a significant role in EGFR resistance and beyond. We have already demonstrated that TGF-beta 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: One moment for the next question. The next question is from the line of Tazeen Ahmad of Bank of America. Tazeen Ahmad: Congratulations from me as well on all of the new roles for everyone. I maybe just wanted to ask your thoughts about your competitors' 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? Claire Mazumdar Clemon: Thanks for your question, Tazeen. So 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 time lines are now slated for Q4 of this year for LiGeR-HN1 to read out. Our anticipation is that, that top line readout, we will likely get overall response rate 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, and it will very much depend on how that data is broken out by HPV status and the like. Operator: One moment for the next question. Next question is coming from the line of Judah Frommer of Morgan Stanley, Judah Frommer: 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 and potentially Peto 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? And where can you differentiate on safety versus the other EGFR bispecifics? Claire Mazumdar Clemon: Thanks for your question, Judah. So 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. And 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 proposed mechanism of action of petosemtamab does speak to the degradation of the EGFR receptor. And so 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, when you -- if you wanted to offer you a different EGFR in the second-line setting. What I will also say is you are seeing additional ADCs with outside of EGFRs testing their molecules in an EGFR post-EGFR setting, knowing that EGFRs will likely be the standard of care. So I think there is a very clear recognition around EGFRs moving into the frontline setting. And 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 pembro, 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. Operator: One moment for the next question. Next question is coming from the line of Kelsey Goodwin of Piper Sandler. Kelsey Goodwin: 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 in potential areas of differentiation before we get that longer-term follow-up? And 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? Claire Mazumdar Clemon: Thanks for your question, Kelsey. So to speak to your first question, a large part of the data set 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 6-month durability is an important aspect of the data set that will be used to support a potential accelerated approval as well. And so I really do believe it will be the totality of the data beyond just response rates that will be important in distinguishing these 2 data sets. 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 data set in hand for the first approval. Operator: One moment for the next question. Our next question is coming from the line of Reni Benjamin of Citizens. Reni Benjamin: Let me echo my congratulations as well to the entire team. Maybe 2 quick ones for us. One of our KOL calls mentioned left-sided CRC might benefit more than certain combination -- with certain combinations versus, let's say, right-sided CRC, which kind of leads us to ask like as you think about the underlying factors and potential stratifications you might be looking at, like what are you kind of focusing on to ensure that you're getting a true kind of go-forward signal for Ficera? And 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? How much of a burn increase should we be thinking about? And any preliminary sales force metrics you might be able to talk about? Claire Mazumdar Clemon: Thank you for your question, Reni. So I'll start with the question on colorectal cancer and then pass it over to Ivan to answer your question around burn. So to your point, there is a history of EGFR usage in left-sided colorectal cancer, which is why that's where the approval is for EGFR monoclonal antibodies today. And there are both, I believe, J&J and Genmab are going with their Phase IIIs 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-beta plays a role in angiogenesis and wanted to determine whether there was an opportunity to have a similar impact with our EGFR TGF-beta bifunctional. We do anticipate that given the small signal-seeking size of a 20-plus 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. And with that, I'll pass it over to Ivan. Ivan Hyep: And 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, what we'll end up seeing is consistency as we eventually sunset some of the spend on the FORTIFI study in the '27 time frame and as we continue to ramp up commercial spend and the build around the FTEs. Reni Benjamin: Yes, yes, that was it. So probably it's for you, Ryan, regarding the sales force metrics. Ryan Cohlhepp: Yes, absolutely. I think at this point, we're not prepared to start speaking to that. And certainly, as we get closer to commercialization, we'll be prepared to guide some of those metrics. Operator: One moment for the next question. Next question is coming from the line of Jeet Mukherjee of U.S. Bancorp BTIG. Jeet Mukherjee: Congratulations to you, Ryan, and best wishes to you, Claire and Ivan, on your next step. So 2 quick questions from us. I believe you had previously said FORTIFI-FLEX will not be a non-inferiority study. So could you just specify again what supports approval of this regimen? And 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? Claire Mazumdar Clemon: Thanks for your question, Jeet, So to that point on FORTIFI-FLEX, the intent of the study is really to compare the 2 regimens between our weekly dosing of 1,500 milligrams weekly to our loading and maintenance dose. And so what we're 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, which is why the FDA was comfortable in the sizing of the study and the data set that we plan to submit for -- to include it in the label. I apologize, I missed the second part of your question. Whether or not we [indiscernible]. RAS combos CRC. Yes. So we have been thinking quite a bit about it. As you may be aware, we've presented quite a bit of data at AACR and SITC around our work in combination with RAS inhibitors that shows that the TGF-beta arm of our molecule is able to address many of the resistance mechanisms to those RAS inhibitors and so 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. And with that, thank you for your question. Operator: Thank you. And 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 Clemon: I want to thank you all for joining today. And I can say I'm 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 program, and thank you for joining. You may now disconnect. Before you buy stock in Bicara Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Bicara Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Bicara Therapeutics (BCAX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

President & Chief Operating Officer Ryan Cohlhepp, Pharm.D. appointed President & Chief Executive Officer effective January 2027 Claire Mazumdar, Ph.D., MBA to transition to Vice Chair of the Board of Directors and serve as Strategic Advisor On track for substantial enrollment of pivotal FORTIFI-HN01 study by year-end, enabling topline results from interim analysis in mid-2027; initiated FORTIFI-FLEX alternate dosing study Company to host conference call and webcast today, Tuesday, August 11, 2026 at 8:30 am ET BOSTON, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced financial results for the second quarter ended June 30, 2026 and provided a business update, including strategic leadership transitions marking the company’s next era of execution and growth. Ryan Cohlhepp, Pharm.D., Bicara’s President and Chief Operating Officer (COO) will succeed Claire Mazumdar, Ph.D., MBA as Chief Executive Officer (CEO) effective January 1, 2027. As part of this planned evolution in leadership, Dr. Mazumdar will serve as Vice Chair of the Board of Directors and Strategic Advisor, with the goal of ensuring a seamless transition as Bicara enters its next era of execution and growth. Dr. Mazumdar will leverage her deep institutional knowledge to provide management guidance and support future growth, while empowering the next phase of strategic and operational leadership at Dr. Cohlhepp’s direction as the company prepares for the potential commercialization of ficerafusp alfa in first-line (1L) recurrent or metastatic (R/M) human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), with topline data from an interim analysis of the FORTIFI-HN01 pivotal trial expected in mid-2027. Tanya Green, Chief Development Officer, will succeed Dr. Cohlhepp as COO, effective January 1, 2027. Since joining Bicara in October 2025, Ms. Green has demonstrated enterprise-wide responsibility for driving operational strategy, execution, and organizational performance across key development and operational functions including global clinical operations, technical operations, regulatory affairs, quality, and program management. Jenn Larson, CPA, has been appointed Chief Financial Officer and will succeed Ivan Hyep, MBA, effective August 12, 2026. Ms. Larson is a tenured financial operator who brings decades of experience in roles of increasing strategic and operational responsibility at publicly traded, revenue-generating, commercial-stage biotechnology organizations. Jenna Cohen will be promoted from Chief Corporate Affairs Officer to Chief Business Officer, effective January 1, 2027. Ms. Cohen has demonstrated an increasing scope of strategic and executional impact since joining Bicara in October 2025, and in her new role will retain oversight of corporate affairs, corporate development, and strategy. Greg Shiferman, J.D., has been appointed Chief Legal Officer effective August 31, 2026. Mr. Shiferman is an accomplished life sciences professional who has served in executive positions across legal and program leadership. Mr. Shiferman brings deep experience providing strategic counsel across corporate development, commercialization, and governance. He will lead all aspects of our legal and compliance functions through key corporate milestones, including the potential commercial launch of ficerafusp alfa. "This transition marks a natural evolution for Bicara as we maintain strong enrollment momentum that enables a clear line of sight to a topline interim analysis which we believe will lead to an accelerated approval and subsequent launch of ficerafusp alfa in head and neck cancer. I am incredibly proud of what our team has accomplished so far—transforming bold science into meaningful impact for patients while establishing a strong foundation for future growth. Having worked closely with Ryan since Bicara’s earliest days, I have seen firsthand his ability to translate strategy into disciplined execution, and we have been true partners in shaping the Bicara of today. I have complete confidence that he is the right leader to guide our next chapter,” said Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics. “In addition, I want to thank Ivan for serving as an early executive at Bicara, for leading us through private and public offerings during his tenure, and for establishing the early infrastructure for the Finance organization. In my new role, I look forward to continuing to help shape the future of Bicara—both on the Board and supporting the leadership team as they build on this momentum and continue creating lasting value for patients, employees, and shareholders.” "On behalf of the Board, I want to thank Claire for her extraordinary vision, leadership, and commitment to building a company defined by scientific excellence, a deeply rooted culture, and an unwavering focus on patients. Throughout her tenure, Claire has led with a long-term perspective, and this leadership transition reflects her thoughtful stewardship and commitment to Bicara’s continued success,” said Mike Powell, Chairman of the Board of Bicara Therapeutics. “The Board has great confidence in Ryan to lead Bicara into its next era of execution and growth. This transition also reflects the investments we have made to prepare for our next chapter—including strengthening our executive team with experienced commercial leaders, elevating outstanding internal talent, and expanding the Board with directors who bring deep operational and commercialization expertise. Together, these steps have created a management team equipped to execute on the significant opportunities ahead, position the company for its next stage of growth, and broaden Bicara’s impact for patients.” "It is an incredible privilege to lead Bicara at such an important moment in its journey. Since the early days of Bicara, I have had the opportunity to help shape our strategy, help build the organizational capabilities and leadership team at the appropriate time in the company’s evolution, and work alongside an extraordinary group of colleagues to bring the tremendous promise of ficerafusp alfa to many people around the world through our clinical trials,” said Ryan Cohlhepp, President and COO. “I am deeply grateful to Claire for her partnership and unwavering commitment to the ongoing success of this organization, and to the Board for its confidence in me. As we look ahead, my focus will be on building on the exceptional foundation we have created together—establishing our commercial footprint, advancing a pipeline with discipline and purpose, and continuing to invest in the people and culture that make Bicara unique.” Leadership biographies may be accessed on the Bicara website. Second Quarter 2026 Highlights and Recent Progress Ficerafusp Alfa in 1L R/M HPV-Negative HNSCC Initiated FORTIFI-FLEX, a randomized, open-label, clinical study that will evaluate ficerafusp alfa in combination with pembrolizumab, administered as a 12-week loading dose of 1500mg weekly (QW) followed by maintenance dosing of 2250mg every three weeks (Q3W). The company expects to have results from this study by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC. Presented extended follow-up data out to three years from the Phase 1/1b study of ficerafusp alfa in combination with pembrolizumab in 1L R/M HPV-negative HNSCC at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data demonstrated deep, durable responses representing substantial improvements over standard of care treatment, observed to be driven by TGF-β inhibition, allowing for direct tumor penetration. Specifically, three-year follow-up from the 1500mg QW dose cohort showed an estimated OS rate of 31%, approximately doubling the survival rate observed in retrospective analysis with standard of care pembrolizumab in HPV-negative patients. Key Anticipated Upcoming Milestones HNSCC Continued to enroll Phase 3 of the FORTIFI-HN01 pivotal trial in 1L R/M HPV-negative HNSCC and expect to be substantially enrolled by the end of the year to enable topline results from an interim analysis in mid-2027. Other Solid Tumors, Including mCRC Present data from Phase 1b expansion cohort evaluating ficerafusp alfa both as monotherapy and in combination with pembrolizumab in patients with 3L+ mCRC (RAS/BRAF wild type MSS) in the second half of 2026. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, Bicara had cash, cash equivalents and marketable securities of $497.3 million, compared to $414.8 million in cash, cash equivalents and marketable securities as of December 31, 2025. Based on its current operating and development plans, the company expects that its existing cash, cash equivalents and marketable securities will fund operations into the first half of 2029. Research and Development Expenses: Research and development expenses were $45.8 million for the second quarter of 2026 as compared to $24.8 million for the second quarter of 2025. The increase was primarily due to costs associated with the ongoing FORTIFI-HN01 pivotal trial, as well as the company’s ongoing Phase 1/1b dose expansion cohorts, and an increase in personnel costs. General and Administrative Expenses: General and administrative expenses were $14.2 million for the second quarter of 2026 as compared to $7.2 million for the second quarter of 2025. The increase was primarily due to additional personnel costs and professional fees associated with expanding the organization as we advance in a pivotal study and prepare for potential commercialization. Net Loss: Net loss totaled $55.4 million for the second quarter of 2026 compared to $27.4 million for the second quarter of 2025. Upcoming Investor Conference Bicara Therapeutics will participate in one upcoming investor conference: 2026 Cantor Global Healthcare Conference on Wednesday, September 9, 2026 at 9:10 a.m. ET. A live webcast of the fireside chat will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. A replay of the webcast will be archived and available for 30 days following the event. Conference Call Information Bicara will host a live conference call and webcast at 8:30 a.m. ET today to discuss second quarter 2026 financial results and business updates, including strategic leadership transitions. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of Bicara’s website under Events and Presentations. An archived replay will also be available for 30 days following the event. About Bicara Therapeutics Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara’s lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment (TME). Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-β inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all contain identifying words. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding Bicara’s strategy, business plans and focus; the clinical development of ficerafusp alfa, including anticipated substantial enrollment of the FORTIFI-HN01 pivotal trial by the end of 2026 and interim analysis readout in mid-2027, the alternate dose study to evaluate a loading and Q3W maintenance regimen with anticipated results by the time of a potential U.S. accelerated approval in 1L R/M HPV-negative HNSCC, and the expansion cohorts of Bicara’s Phase 1/1b trial of ficerafusp alfa and the timing of future data releases; the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability; Bicara’s ability to scale and prepare for potential commercialization of ficerafusp alfa; the potential for U.S. regulatory approval and launch of ficerafusp alfa; Bicara’s expected operating expenses and capital expenditure requirements, including its cash runway into the first half of 2029; and anticipated contributions by members of Bicara’s Board and management team. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks relating to Bicara’s research and development activities; Bicara’s ability to execute on its business plans and strategy, including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to the clinical development of ficerafusp alfa; the company’s dependence on third parties; risks related to the company’s financial condition and need for additional funds in order to commercialize ficerafusp alfa, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Bicara’s intellectual property protections; and risks related to the competitive landscape for ficerafusp alfa; as well as other risks described in “Risk Factors,” in Bicara’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Bicara’s subsequent filings with the U.S. Securities and Exchange Commission (SEC). In addition, any forward-looking statements represent Bicara’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Bicara intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the company’s Investor Relations website, in addition to following the company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Contacts InvestorsRachel Frank [email protected] MediaDan [email protected]

Interested in Bicara Therapeutics Inc.? Here are five stocks we like better. FICERA’s pivotal FORTIFI-HN01 trial remains on track for substantial enrollment by the end of 2026, with an interim analysis planned for mid-2027. Bicara highlighted three-year data suggesting roughly one-third of patients were alive at the 1,500-milligram weekly dose, while noting the results are based on a small cohort. Bicara is preparing for a leadership transition in January 2027, when President and COO Ryan Cohlhepp will become CEO and current CEO Claire Mazumdar will move to vice chair and strategic advisor. The company is also adding new executives across operations, business development, finance and legal functions. The company began the FORTIFI-FLEX study to evaluate a loading dose followed by every-three-week maintenance dosing and plans additional colorectal cancer cohorts. Bicara ended Q2 with approximately $497 million in cash and marketable securities, which it expects to fund operations into the first half of 2029 despite rising trial and commercialization expenses. Bicara Therapeutics (NASDAQ:BCAX) used its second-quarter 2026 earnings call to outline leadership changes, progress in its pivotal head and neck cancer program and plans to expand development of ficerafusp alfa, or FICERA, while reaffirming its cash runway into the first half of 2029. The company is advancing FICERA in the Phase III FORTIFI-HN01 trial for first-line recurrent or metastatic HPV-negative head and neck squamous cell cancer. Management said it remains on track for substantial enrollment by the end of 2026, positioning the company for a planned interim analysis in mid-2027 and a potential accelerated-approval path. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Chief Executive Officer Claire Mazumdar will transition at the beginning of 2027 to vice chair of the board and strategic advisor. Ryan Cohlhepp, currently president and chief operating officer, will become president and CEO. Mazumdar said the succession plan had been discussed since the company’s founding and comes as Bicara prepares for potential commercialization. She said Cohlhepp’s experience includes oncology drug launches, management of Takeda’s U.S. oncology portfolio and commercial leadership across solid and hematologic tumors. → 3 Dividend Champion Utilities for a Market That Can't Sit Still “This transition is not about changing our direction,” Cohlhepp said. “It’s about building upon a foundation that has been intentionally created over many years.” Other planned leadership changes include: Tanya Green, currently chief development officer, will become chief operating officer in January. Jenna Cohen, currently chief corporate affairs officer, will become chief business officer in January. Greg Shiferman will join the company as chief legal officer at the end of August. Jenn Larson will succeed Chief Financial Officer Ivan Hyep effective the day after the earnings call. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Hyep, an early executive at Bicara, helped lead more than $800 million in capital raises and guided the company’s transition to the public markets, Mazumdar said. The company also recently added Jeremy Bender and Christy Oliger to its board. Bicara said more than 200 sites are active in FORTIFI-HN01 and that investigator engagement has remained strong. The trial is a major priority as the company seeks to complete substantial enrollment this year. At the American Society of Clinical Oncology meeting in May, Bicara presented three-year follow-up data from approximately 90 patients across three dose cohorts in first-line recurrent or metastatic HPV-negative head and neck cancer. At the company’s pivotal 1,500-milligram weekly dose, management said an estimated one in three patients was alive at three years, which it said was approximately double the survival rate seen in retrospective analyses of standard-of-care pembrolizumab in HPV-negative patients. Mazumdar said the ASCO data demonstrated “unprecedented depth and duration of response,” while Cohlhepp said the results reinforced FICERA’s potential to become a best-in-class treatment in the setting. Management also highlighted what it described as a consistent safety profile over the follow-up period. During the question-and-answer session, Mazumdar said the company has received positive feedback from investigators following the ASCO presentation, including on response durability and tolerability. She said the company expects depth of response, six-month durability and the totality of the data to be important considerations at the planned interim analysis, rather than response rates alone. Bicara has initiated FORTIFI-FLEX, an alternative-dosing study intended to support a loading-dose and every-three-week maintenance regimen for FICERA. The company said it designed and activated the study after presenting exploratory every-two-week cohort data earlier in 2026. Management said the goal is to have FORTIFI-FLEX data available by the time of a potential U.S. approval, potentially supporting a streamlined regimen at launch. Mazumdar said the study will compare the alternative regimen with the 1,500-milligram weekly regimen, focusing on comparability in durability of response after the loading phase. Green said Bicara is seeking to limit interference with enrollment in FORTIFI-HN01. About one-third of FORTIFI-FLEX sites will overlap with the pivotal trial, with enrollment staged across Europe, Latin America, Asia-Pacific and the U.S. to keep FORTIFI-HN01 as the priority. Beyond the pivotal head and neck cancer program, Bicara is pursuing signal-seeking cohorts in third-line or later microsatellite-stable colorectal cancer. The company expects to report data by year-end from two open-label cohorts of about 20 patients each: one evaluating FICERA as monotherapy and one evaluating it with pembrolizumab. Mazumdar said the company expects the early colorectal update to provide short-term safety and efficacy information. Management is also considering biomarker and patient-selection questions, including potential differences between left-sided and right-sided colorectal cancer, and said it has explored combinations with RAS inhibitors. Bicara said it has previously established proof of concept for FICERA in cutaneous squamous cell carcinoma and anal canal cancer, and it continues to evaluate opportunities in locally advanced head and neck cancer and other tumor types. For the second quarter, Hyep said total operating expenses increased from the prior-year period due to clinical operations, development and manufacturing costs related to FORTIFI-HN01, as well as higher personnel costs and stock-based compensation. The company expects operating expenses to rise sequentially through the rest of 2026 as it invests in the pivotal trial, FORTIFI-FLEX, technical operations, medical affairs and commercial launch preparation. Bicara ended the quarter with approximately $497 million in cash equivalents and marketable securities. Hyep said the company expects that capital to fund operations into the first half of 2029, including the pivotal program through a primary overall-survival analysis, a planned regulatory filing, initial commercial and medical infrastructure, alternative-dosing development and manufacturing activities. Bicara Therapeutics 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Bicara Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is executing a planned leadership transition, elevating Ryan Cohlhepp to CEO to leverage his commercial oncology experience as the company nears potential launch. The company's strategic focus remains on the pivotal Phase III FORTIFI-HN01 study for HPV-negative head and neck cancer, which is on track for substantial enrollment by year-end. Three-year follow-up data presented at ASCO 2026 demonstrated that TGF-beta inhibition nearly doubled overall survival versus standard of care pembrolizumab in the pivotal dose cohort. Management attributes clinical success to the mechanistic foundation of TGF-beta inhibition, which drives deeper tumor penetration and immune cell infiltration compared to standard EGFR-directed therapies. Operational expansion is underway with over 200 active clinical sites and the initiation of the FORTIFI-FLEX study to optimize dosing regimens for future market adoption. The company maintains a disciplined capital allocation strategy, ending the quarter with $497 million in cash to fund operations into the first half of 2029. Management expects to reach substantial enrollment in the FORTIFI-HN01 study by the end of 2026, enabling a top-line interim analysis in mid-2027. The FORTIFI-FLEX study is designed to provide data on a streamlined loading and maintenance dosing regimen by the time of potential U.S. approval to support earlier clinical adoption. Operating expenses are projected to increase for the remainder of the year, driven by clinical operations, manufacturing costs, and initial investments in commercial infrastructure. The company anticipates disclosing early safety and efficacy data from two signal-seeking Phase Ib cohorts in third-line colorectal cancer by year-end 2026. Strategic expansion plans include exploring Ficera's potential in locally advanced head and neck cancer and combination therapies with RAS inhibitors. The leadership transition effective January 2027 includes new appointments for CEO, COO, and CBO, following the appointment of a new CFO effective in 2026. to shift the organizational focus from R&D to commercial execution. Management highlighted the competitive landscape at ESMO, specifically monitoring data from J&J and Genmab, but believes Ficera's durability profile remains a key differentiator. Cash runway into 2029 is contingent on successful execution of the pivotal study and assumes no significant delays in regulatory filing or manufacturing timelines. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. CEO Claire Mazumdar stated the transition was planned years ago to ensure commercial leadership was in place well ahead of top-line data and potential launch. The move is intended to elevate a team with specific experience in launching oncology drugs and building global commercial organizations. Management is stage-gating enrollment to ensure the new FORTIFI-FLEX study does not impede the primary Phase III trial. Only approximately one-third of clinical sites will overlap, with the company utilizing different regions across Europe, Latin America, and Asia Pacific to balance recruitment. Management believes Ficera differentiates through its chemo-sparing regimen and superior tolerability compared to competitors combining EGFR bispecifics with chemotherapy. The company emphasized that investigators are looking for depth of response as a leading indicator for long-term durability and overall survival. Bicara is pursuing a 'first-in-class' approach in CRC by targeting TGF-beta resistance mechanisms rather than following competitors into standard frontline MSS populations. Preclinical data suggests the TGF-beta arm of Ficera can address resistance to RAS inhibitors, supporting future combination strategies.

BOSTON, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that it will report second quarter 2026 financial results and business updates before the market opens on Tuesday, August 11, 2026. Bicara will host a conference call to discuss the financial results and business updates at 8:30 a.m. ET the same day. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and a unique PIN that will allow them to access the call. To access the live webcast, please visit the “Events & Presentations” section within the Investors page on the Bicara website. A replay of the webcast will be available for 30 days following the event. About Bicara Therapeutics Bicara is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara has built a platform designed to facilitate the development of bifunctional therapies that precisely target the tumor and deliver a tumor-modulating payload to the tumor site. This approach was deployed in the development of Bicara’s lead program ficerafusp alfa, formerly BCA101, a bifunctional epidermal growth factor receptor (EGFR) directed monoclonal antibody bound to a human transforming growth factor beta (TGF-β) ligand trap. By combining these two clinically validated targets, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment (TME). Ficerafusp alfa directs the TGF-β inhibitor into the immediate TME through the binding of EGFR on tumor cells, which Bicara believes will lead to deep and durable responses and an increase in overall survival, while reducing the potential adverse effects previously associated with systemic TGF-β inhibition. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit www.bicara.com or follow us on LinkedIn and X. Contacts InvestorsRachel [email protected] MediaTim [email protected]

Image source: The Motley Fool. Monday, May 11, 2026 at 8:30 a.m. ET Chief Executive Officer — Claire Mazumdar Clemon Chief Operating Officer — Ryan Cohlhepp Chief Financial Officer — Ivan Hyep Chief Development Officer — Tanya Green Need a quote from a Motley Fool analyst? Email [email protected] Claire Mazumdar Clemon: Good morning, and welcome to Bicara Therapeutics Inaugural Quarterly Earnings Call. I'm Claire Mazumdar, Chief Executive Officer. Today marks an important milestone for our company as we begin this tradition of regular communication with investors, analysts and stakeholders to provide transparent updates on our business progress and strategic direction via the quarterly earnings call process. We're implementing these quarterly calls as part of our commitment to maintain an open dialogue with the Street and ensuring you have consistent visibility into our execution against key milestones and strategic objectives. Before I jump into our Q4 2025 highlights and recent progress, let me provide a brief background for those who are newer to our story. Bicara Therapeutics is a clinical stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston with a clear focus on advancing our lead asset, ficerafusp alfa or FICERA, a potentially first-in-class bifunctional EGFR-directed antibody combined with the TGF-beta ligand trap. Our innovative approach combines tumor targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator designed to deliver superior efficacy, improved safety and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-beta-driven resistance mechanisms. ultimately designed to drive the deep durable responses that may translate into better outcomes and survival for patients. Over the past several months, there have been significant shifts in how the competitive landscape in frontline recurrent and metastatic head and neck cancer is evolving. Our recent clinical data and regulatory progress clearly position FICERA as a potential best and first-in-class asset with a differentiated clinical profile on both long-term outcomes and tolerability. Looking back at the progress we've made since October 2025, I'm energized by the exceptional momentum we've built across our pipeline and operations. Over the past several months, we've achieved multiple critical inflection points that fundamentally strengthen our position as we advance FICERA toward a pivotal study interim analysis in the middle of next year. First, FICERA received breakthrough therapy designation, or BTD, in combination with pembrolizumab for the first-line treatment of patients with metastatic or with unresectable HPV-negative recurrent head and neck squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative head and neck cancer as a distinct clinical indication within head and neck cancer, one with particularly poor outcomes, limited therapeutic options and that represents the vast majority of patients. Second, we presented 2 additional Phase Ib clinical data sets across clinically active doses of FICERA that demonstrated consistent overall response rates, further validating FICERA's unique dual mechanism targeting both EGFR and TGF-beta and derisking the OR endpoint in our pivotal study interim analysis. Third, building on this robust data set, we selected 1,500 milligrams as our optimal biological dose and have successfully moved into the Phase III portion of our pivotal FORTIFI-HN01 study, for which we expect an interim analysis in the middle of next year. This represents a major strategic advancement that brings us significantly closer to our goal of delivering a potential best and first-in-class treatment option for patients living with HPV-negative head and neck cancer. Fourth, we recently announced plans to develop FICERA with a loading and every 3-week maintenance dose, a strategic commercial decision based upon updated clinical, translational and pharmacokinetic data that we believe will enable additional optionality for patients and providers choosing treatment with FICERA. Lastly, to support this accelerated trajectory and pull forward investments in our early commercial and medical build, we successfully completed an oversubscribed public offering, strengthening our balance sheet and providing the capital foundation necessary to execute this next chapter of our business with confidence. With that, I'll turn it to Ryan to provide a bit more detail on our recent clinical updates and business progress. Ryan Cohlhepp: Thank you, Claire, and good morning, everyone. We've now reported clinical experience in approximately 90 patients across 3 Phase Ib cohorts evaluating FICERA in combination with pembrolizumab in frontline recurrent metastatic HPV-negative head and neck squamous cell carcinoma. Our 1,500-milligram every week data is the most mature with 2 years of follow-up and demonstrates deep durable responses that lead to median duration of response and median overall survival of 21.7 and 21.3 months, respectively, nearly tripling the median overall survival observed with the standard of care of pembrolizumab in HPV-negative patients. Late last year and just last month, we presented 2 additional cohorts. In December of 2025 at ESMO Asia, we presented data from our 750-milligram every week cohort, which helped to ultimately inform 1,500 milligrams every week as the optimal biologic dose for our ongoing pivotal Phase III FORTIFI-HN01 trial. And just last month, at the Multidisciplinary Head and Neck Cancer Symposium, we presented data from a higher but less frequent dose of FICERA in combination with pembrolizumab, 2,000 milligrams every 2 weeks, from which we announced our plan to develop a less frequent loading and maintenance dosing option. Our aim is to gain alignment with the FDA on this approach and initiate that study in parallel to the pivotal study to allow to have data from that regimen in hand upon potential U.S. approval. Clinically, tumor shrinkage is seen at all doses that trends deeper with higher exposure. The 1,500-milligram cohort showed deeper median depth of response versus 750 milligrams, and the exploratory 2,000-milligram every 2-week cohort produced consistently high proportions of deep responders with greater than 80% shrinkage and complete response rates. Our translational data shows consistent TGF-beta inhibition across all FICERA doses, confirming the mechanism that drives tumor penetration and immune activation. Importantly, inhibition is strongest with the 1,500-milligram weekly dose and less frequent 2,000-milligram regimen. We believe this TGF-beta-driven depth of response is the defining hallmark of FICERA and a clear differentiator versus EGFR-directed therapies, which do not target TGF-beta. This mechanism is especially meaningful in HPV-negative disease, a setting with poor outcomes and limited innovation where deeper, more durable responses are urgently needed for patients. We remain confident that this biology will continue to translate into clinically differentiated long-term outcomes for these patients. Importantly, FICERA's deep responses are paired with sustained durability without any trade-off. The median duration of response approaches 22 months, more than 3x longer than the 6.7 months median duration of response reported with pembrolizumab plus chemotherapy. Our 2,000-milligram every 2-week cohort similarly delivered multiple deep responses persisting beyond 20 months, underscoring the consistency of benefit across dosing schedules. Crucially for patients, providers and payers, FICERA maintains this level of durability even with less frequent dosing. This positions FICERA favorably in a market moving toward treatment regimens that reduce clinic burden, improve quality of life and support long-term adherence. We believe this performance reflects FICERA's tumor-penetrating mechanism, enabling depth and durability that translate into meaningful long-term outcomes while supporting a more flexible patient-centric dosing paradigm. We're often asked whether deep depth of response translates to long-term outcomes. As we first showed at ASCO last year, there is a clear distinction in duration of response, progression-free survival and overall survival among HPV-negative head and neck cancer patients who have had deep responses versus those that do not. This data is what drives our belief that deep responses that are the hallmark of FICERA's clinical profile drive outsized durability and long-term benefit. Importantly, other investigational agents also need to demonstrate the deep and durable responses to meaningfully improve long-term clinical outcomes. As our recent financing highlights, we have strong conviction in FICERA's clinical data and its differentiated profile compared to other investigational agents in the head and neck space. And we are continuing to bolster our commercial and medical investment in preparation for a potential U.S. launch, including hiring of the Chief Commercial Officer this year. Head and neck cancer is a significant and fast-growing global market, projected to reach more than $5 billion in global sales in the 2030s. HPV-negative patients represent the heavy majority of patients in the frontline recurrent metastatic setting and HPV status is known by the time the disease recurs or metastasizes, which means the HPV testing will not be a barrier to care. There are roughly 50,000 annually incident patients across major markets, including approximately 18,000 in the U.S. where we plan our initial launch. With FICERA, we have the potential to significantly expand an already significant HPV-negative head and neck cancer market. FICERA's clinical data show us that we further expand that market in 2 ways: first, by growing the number of patients who are responding to therapy as seen with the fact that FICERA provides a 2 to 3x greater overall response rate; and second, by growing the duration of response as seen by FICERA's two to threefold improvement over standard of care median duration of response. We are pioneering a new treatment paradigm for HPV-negative head and neck cancer with a tailored therapy engineered to overcome the unique biology of this disease and achieve deep, durable and clinically significant benefit while sparing the use of chemotherapy to further improve quality of life for patients. With this knowledge in hand, we are eager to further invest in our prelaunch activities across commercial and medical, including additional evidence generation strategies that may further expand the market opportunity beyond that being studied in our pivotal trial. Recent competitive updates have only strengthened our conviction that FICERA may have the best chemo-sparing regimen that actually addresses both the EGFR and TGF-beta inhibition underlying biology of HPV-negative head and neck cancer to improve long-term outcomes for patients. We are preparing to launch in an environment where based upon evolving regulatory and clinical development commentary across our competitor set, we have the opportunity to set the tone for what the therapeutic bar looks like for significantly improving unmet medical need in this space. As we head into the second quarter, we look forward to providing long-term follow-up data from across our Phase Ib studies of FICERA in combination with pembrolizumab in frontline recurrent metastatic HPV-negative head and neck cancer. The Phase Ib 1,500-milligram every week data presented at ASCO 2025 were mature with a median duration of response of 21.7 months and a median overall survival of 21.3 months. In this update, we are looking for a better understanding of that IO tail at extended duration of follow-up as well as the additional maturity on key endpoints from the 750 milligram every week and the 2,000-milligram every 2-week data sets. No other investigational agent targeting EGFR in the head and neck cancer space have shown durability of outcomes out this far, a key differentiating factor for FICERA that resonates deeply with clinicians. With that, I'll turn it to Ivan to review the financials. Ivan Hyep: Thanks, Ryan. Earlier this morning, we reported detailed fourth quarter and full year 2025 financial results in our press release, and I'll summarize a few highlights here. Our total operating expenses for 2025 increased compared to the fourth quarter and full year 2024, driven by clinical operations and development expenses, including increased manufacturing and process development costs associated with our ongoing pivotal FORTIFI-HN01 study. We also saw an increase in personnel-related costs, including stock-based compensation as we grew our workforce throughout the year, primarily in support of clinical operations and development functions. We anticipate an increase in operating expenses for 2026, driven by increased investment in clinical operations, particularly for the pivotal FORTIFI-HN01 study, the interim analysis for which is expected in mid-'27 as well as an increase in SG&A and headcount expenditures as we invest in early commercial and medical infrastructure to support the potential launch of FICERA. We entered 2026 with $414.8 million in cash, cash equivalents and marketable securities. In the first quarter, we raised an additional $161.8 million in net proceeds via an oversubscribed public offering, which further strengthens our balance sheet, and we maintain cash runway guidance into the first half of 2029. This additional capital will allow us to support a planned regulatory filing for FICERA, further invest and build in our medical and commercial infrastructure ahead of a potential U.S. approval and launch. Further accelerate the development of FICERA in head and neck cancer, including a less frequent dosing schedule, fund manufacturing costs for FICERA for ongoing and anticipated drug development efforts, fund early signal finding activities to support further indication expansion for FICERA and fund other general corporate purposes. Our existing cash as of year-end and this additional recent cash infusion puts us in a position to be able to drive smart growth for FICERA as we enter a period of disciplined but increased investment to drive future clinical and commercial success. With that, I'll now turn the call back over to the operator for questions. Operator? Operator: [Operator Instructions] Our first question comes from Tyler Van Buren with TD Cowen. Tyler Van Buren: Can you provide more color on the patient demand and willingness to participate in pivotal FORTIFI study that you're seeing in both the U.S. and in ex U.S. sites? And as a follow-up or kind of related question, do you have a sense of how many patients you might need to enroll in a separate study of the less frequent dosing regimen to achieve registration? Claire Mazumdar Clemon: Thank you for your question, Tyler. So there are two questions. One was around momentum around patient enrollment in the FORTIFI-HN01 study. And then the other was approximately how many patients do we plan to enroll in the parallel bridging study for the loading and maintenance dose? I'll answer the first one -- the second one first and speak to the fact that we are looking for regulatory alignment, and we'll provide far more clarity to the study in more detail once we have that regulatory alignment. But the approximate size is anywhere between 150 to 200 patients is our current estimate. The first question was around enrollment of the FORTIFI study. What I can say is that we continue to build significant momentum in that study as we have both received breakthrough designation as well as moving from the Phase II to the Phase III portion and going now to the 2:1 randomization of 1,500 milligrams weekly, randomized 2:1 to pembro monotherapy. We've seen great momentum also ex U.S., in particular, in European sites, Asian Pacific sites as well as South America with a significant momentum in areas where we know that there's a high prevalence of smoking. I will pass it over to Tanya to give additional details to the FORTIFI-HN01 momentum. Tanya Green: This is Tanya Green, Chief Development Officer. So yes, as Claire said, we're -- we have really strong momentum for the Phase III study in terms of enrollment. As is publicly available, we have 129 active sites right now. And this team remains highly focused in executing the study to achieve substantial enrollment by the end of this year, which will keep us on track to have our interim analysis by mid-2027. Operator: Our next question comes from Eric Schmidt with Cantor Fitzgerald. Eric Schmidt: Congrats on all the recent progress. Questions on the colorectal cancer update that we might see in the second half of the year. Could you just give us a sense for the scope of that update in terms of patients dosing? And in particular, what type of benchmarks you think you'd hope to be able to provide in order to demonstrate proof of concept? Ryan Cohlhepp: Eric, thank you for the question. In terms of our CRC update, as we've indicated, we look to have data in the second half of this year on those cohorts. In terms of the total number of patients that we plan to present, I think that's still somewhat variable based upon enrollment. But consistent with our previous updates, we're always looking for data sets probably no less than 20 patients per cohort. I think that certainly, even as recent, we've seen the treatment landscape evolve, and we're mindful of that with recent data that's been out. I'd say what we're -- the two cohorts that we are currently exploring and seeking signals in are third line. As you know, that's a highly challenging population. And again, we've got both a cohort in monotherapy as well as one in combination with pembrolizumab at the 1,500-milligram weekly dose. So again, I think we continue to look at that data for signal-seeking purposes and determine whether there's a path forward in CRC, particularly as we look to see about the opportunity to move into earlier lines of therapy in colorectal cancer using those signals to determine whether there's something there to invest further. Operator: Our next question comes from Stephen Willey with Stifel. Stephen Willey: I guess with the understanding that you're going to be providing the kind of pooled expansion cohort data at ASCO in a few months. Just curious if the patients in the 750 mg once-weekly cohort were given the opportunity to up-titrate to the 1,500 mg dose, just given the, I guess, the relative deficiency in depth of response. Claire Mazumdar Clemon: Great question, Steve. So what we'll be presenting at ASCO is likely an update from 3 separate cohorts. The 3-year follow-up -- median follow-up for the 1,500-milligram dose weekly. The 750-milligram weekly dose was about a 30-patient cohort with at least 18 months of follow-up and same for the 2,000-milligram every 2-week cohort, an additional 30 patients with about 18 months of follow-up. So in that particular cohort, to your question, the 750, we did not increase the dose afterwards. These were patients that were maintained at the 750-milligram dose throughout their course of treatment. And we will be providing an update to PFS and duration of response from those cohorts that will continue to speak to the depth and durability profile that we see across our cohorts. If your question regarding the pivotal study in FORTIFI-HN01, I do believe that we were able to cross over the patients enrolled at this lower dose. And so they were -- if they remained on treatment, they did cross over to the 1,500-milligram dose in the pivotal study. Thank you for your question. Stephen Willey: And then maybe just a quick follow-up. I know there's been kind of some background discussion about having interest in the pre-metastatic setting, whether it's neoadjuvant and adjuvant. And just wondering kind of where you are on that now? And does the pursuit of this new loading maintenance strategy and the need to generate maybe a couple of hundred patients worth of data change perhaps the plans to pursue [indiscernible] in the pre-metastatic... Claire Mazumdar Clemon: No. I think to that question, we do believe that the locally advanced setting of head and neck has always been a large opportunity. And given the signal we've seen in the recurrent and metastatic setting, there is a strong biology to move into earlier lines of head and neck cancer. And we do believe it is also becoming a more competitive landscape as well. So we have begun initial signal-seeking studies in those areas and hope to provide updates as we move forward in more detail. But we do think it is a very important opportunity that could potentially triple the market opportunity compared to recurrent and metastatic setting. Ryan Cohlhepp: Yes. Steve, I'd say that, in fact, our evolution of the dosing paradigm, I think, further supports and reinforces our ability to go into those earlier lines in head and neck cancer. And from an overall operational execution perspective, part of the key driver of our last financing was to be able to fund that alternative dosing schedule as well as continued investment in earlier areas of head and neck cancer. Operator: Our next question comes from Judah Frommer with Morgan Stanley. Judah Frommer: Maybe just can you help us with an update on how many centers you're in with FORTIFI-HN01, what overlaps are with petosemtamab trials and kind of what that does from a potential market share capture perspective for you, the likelihood based on investigator response for investigators at your centers to stick with FICERA in the case of an approval? And then just secondarily, maybe just help us with that cash runway guidance being maintained despite the raise, what was not contemplated in the previous guide that is in there now that will eat up some of the cash that was raised to maintain that guidance? Claire Mazumdar Clemon: Sounds great. And so I'll pass over the first part of the question to Tanya Green, Chief Development Officer, to speak to the sites and the study and then to Ivan Hyep, our CFO for cash -- guidance. Tanya Green: Yes. Thanks for the question. So in terms of sites, we have 129 sites that are open globally. And in terms of the competitive overlap with the other studies, we do believe that there are some sites that overlap, but we have seen great momentum at all of our sites in terms of patients. So we don't see that being a consideration. Ivan Hyep: And Judah, thanks for the question. In terms of use of proceeds for this recent financing, we are heavily focused on the alternative dosing, prelaunch activities and investment in both commercial and regulatory. And so for us, we didn't feel that we needed to change guidance there as it allows us to kind of build up instead of just extending runway. Operator: Our next question comes from Kelsey Goodwin with PSC. Kelsey Goodwin: Maybe again just on FORTIFI and the enrollment. How should we think about the ultimate split of enrollment across geographies? And is this similar to other trials in the setting? And then second, in terms of the bridging trial design, I guess, do you have a sense of when you might be able to provide more color for the Street? Ryan Cohlhepp: Great, Kelsey, thank you for the question. In terms of geographical distribution on the trial, I'd say what we anticipated is it will be very similar to some of the recent trials, KEYNOTE-048 in particular, I think what we had anticipated and continue to see in our own enrollment is very consistent with some of those historical trials. In terms of the alternative dosing, again, as Claire mentioned, we intend to get regulatory input on that trial and do expect to be able to provide greater clarity later this year. Operator: Our next question comes from Reni Benjamin of Citizens. Reni Benjamin: Congrats on the progress. Just sticking with FORTIFI, can you maybe just help quantify a little bit as to what you mean by substantial enrollment? And as we think about the number of patients required for the ORR interim versus kind of the final OS, can you give us a sense as to how that might look? And then just kind of related, since this would be used for accelerated approval, can you give us some thoughts on how you're thinking about more of a global filing as well for FICERA? Claire Mazumdar Clemon: Great question. So to your question around substantial enrollment, that is really predicated on what the FDA is looking for at the time in terms of a seamless Phase II/III design. What the FDA wants to ensure is that we are close to fully enrolled in the total confirmatory study, so as not to introduce bias at the time of granting an accelerated approval. So substantial is a key objective for very meaningful enrollment to ensure we're not introducing additional bias into the confirmatory study. To that question, we do believe that in the United States, with the FDA, we are on a path to potential accelerated approval predicated on a response rate endpoint from an interim analysis that will also look at durability of response as well as qualitative overall survival. The study will continue for full confirmatory approval on an overall survival endpoint. Today, we believe that ex U.S., a full overall survival endpoint is needed to predicate a global approval. Operator: Our next question comes from Jeet Mukherjee with BTIG. Jeet Mukherjee: Great. Two for me. Could you speak to the rationale and reasons for confidence on the loading and once every 3-week maintenance strategy when it was a 2,000 mg once every 2-week regimen that showed a notable response and depth of response? And the second question was just related to the colorectal cancer update. Could you confirm if the patient enrollment criteria allows for liver mets? Ryan Cohlhepp: Thanks for the question. So on the alternative dosing, we have gotten comfortable with our proposed strategy there. Looking at the compilation of all of our data sets. I think this is where really having the 750-milligram weekly, the 1,500 weekly and then the 2,000 every 2 weeks has given us the ability to do extensive exposure response modeling across those data sets. I think a couple of key notes in terms of the data. One of the things that we know when we look at the patients in our Ib data is that 1,500-milligram weekly dose, we're getting very rapid responses at 1.4 months that we're getting responses. The vast majority of patients will have achieved the response within 12 weeks. And at that same time, most of them will have hit their maximal depth of response by the 12-week time. And so that gives us the confidence in why we want to initiate with a weekly dosing phase and then be able to transition to extend that interval out to every 3 weeks. Again, what we'll look to do is to match the pharmacokinetic profile from both an exposure as well as a C trough perspective to the 750-milligram weekly, which, again, we know, as you saw in that data set that we presented last year, you see really good response rates. You see really good activity even at the 750. I think one of the things to remember here, if you recall our data, that depth of response, we're seeing more than 80% of our patients get an 80% or greater reduction in their tumor. So you think they're at that 12-week mark, you've got significantly less tumor in the patients at the 12-week mark, which gives us confidence in our ability to extend out that interval, maintain a very durable response and give the patients the ability to have a more convenient administration schedule. For your CRC question, the inclusion criteria does allow for liver metastases. And in fact, the anal canal data that we have presented previously really shows our ability and FICERA's ability to resolve liver metastases in that population. So it is something that we think could be a unique differentiating perspective of our molecule, and so we did allow liver mets. Operator: Our next question comes from Eva Fortea with Wells Fargo. Eva Fortea-Verdejo: A quick one from us. We've seen now in the 3 different dose cohorts with FICERA plus pembro, a similar response rate or even higher in some cohorts with CPS 1-19 compared to CPS 20 or higher. And so is there anything about the biology that could explain this? And if this holds in the Phase III, could you comment on the potential implications from a commercial standpoint? Claire Mazumdar Clemon: Great question, Eva. So to your question, it is known that, in particular, in HPV-negative head and neck cancer, there are both higher levels of EGFR and TGF-beta that makes these tumors typically more immunosuppressive or treatment-resistant than their HPV-positive counterparts. In particular, in fact, HPV-negative tumors tend to have a slight skewing for CPS low or the CPS 1 to 19. And in fact, it's in this patient population that pembro has worse response rates across the board. And so seeing very strong response rates in the CPS 1 to 19 really speaks to the underlying biology of being able to target both EGFR and TGF-beta, which is why we believe we're able to target these very immunosuppressive tumors. In fact, we do think that it's always going to be a differentiating aspect for our molecule compared to other EGFR inhibitors that are currently being tested that have not seen the outsized impact in the CPS flow. And in fact, we do believe that especially given we are going after a chemo-sparing regimen, being able to go after these 1 to 19 will allow us to have a dominant share in what accounts for approximately 50% of the total head and neck market, but slightly skewed even higher in the HPV negative. In fact, to your question, you may remember that we also have a cohort open in the CPS 0 cohort that we plan to disclose at a later time point that also speaks to this underlying biology. Operator: Our next question comes from Richard Law with Goldman Sachs. Unknown Analyst: This is [indiscernible] on for Rich. Just one from us. How are you thinking about when to unblind the study for the interim analysis for accelerated approval? Will it be based on an overall survival rate? Claire Mazumdar Clemon: To your question, this is a fully double-blinded study. We will not be unblinding the study as it needs to continue for overall survival. At the time of our prespecified statistical analysis based off of the number of patients for overall response rates, durability and qualitative overall survival, the IDMC will look at that data. But as management, we will not be unblinded to the data. Thank you for your question. Operator: And I'm not showing any further questions at this time. I'd like to turn the call back over to Claire. Claire Mazumdar Clemon: Thanks, everyone, for joining us for our first quarterly earnings call and for your support of Bicara Therapeutics. There's never been a better time to be following our story, and we look forward to speaking with you all again soon. Thank you, and have a good day. Operator: Well, ladies and gentlemen, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is prioritizing the development of ficerafusp alfa (ficera) for HPV-negative head and neck cancer, a segment where they believe the biological rationale and unmet need align for a best-in-class profile. The company attributes its potential first-in-class status to a combination of internal enrollment momentum and a competitor's decision to significantly upsize their pivotal trial, which has narrowed the perceived timing gap. Strategic leadership transitions, including the appointment of a new Chief Medical Officer and Chief Commercial Officer, are designed to pivot the organization from clinical-stage to commercial-readiness. The 'immunotherapy tail' observed in clinical data is attributed to ficera's dual mechanism, specifically the TGF-beta inhibition which drives tumor penetration and durable responses beyond standard EGFR-directed therapies. Management emphasizes that their development approach specifically targets HPV-negative patients, who represent the vast majority of the frontline recurrent/metastatic market and typically face poorer outcomes. Financial positioning was strengthened by an oversubscribed $161.8 million public offering, extending the cash runway into 2029 to support pivotal trial completion and commercial infrastructure. The pivotal FORTIFI-HN01 trial remains on track for an interim analysis in mid-2027, which will evaluate overall response rates (ORR) with 6 months of durability to support a potential accelerated approval. A new randomized study will initiate in Q3 2026 to evaluate an alternative dosing regimen (12-week loading followed by every 3-week maintenance) to improve patient quality of life and clinic burden. Management expects to present 3-year follow-up data at ASCO 2026, which they believe will further validate the long-term survival benefit driven by TGF-beta inhibition compared to historical benchmarks. Expansion strategies include evaluating ficera in locally advanced head and neck cancer and other solid tumors like colorectal cancer, though management maintains a 'high bar' for further investment in challenging indications. The company anticipates continued increases in operating expenses throughout 2026 as it scales manufacturing and builds out medical affairs and commercial operations. The transition of the former CMO to an advisory role was framed as a planned evolution to bring in commercial-stage leadership as the company matures. Management noted that while they are exploring colorectal cancer (CRC), the landscape is evolving rapidly and patients are often very sick, necessitating a measured approach to resource allocation. The alternative dosing study is being run in parallel with the pivotal trial to ensure a streamlined regimen is available potentially at the time of initial approval, mitigating adoption barriers. Competitive dynamics in the HPV-positive space are being monitored, but management remains focused on the HPV-negative population where they see the clearest path to market leadership. Management noted that real-world data for pembrolizumab in HPV-negative subsets typically shows a 15% to 20% 3-year overall survival rate. Ficera's upcoming ASCO data will aim to demonstrate a superior 'tail' on the survival curve due to the durability of response driven by TGF-beta inhibition. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The 1,500 mg weekly dose is critical for achieving rapid, deep tumor reductions (80% or greater) in the first 12 weeks. The 2,250 mg every 3-week maintenance phase is designed to maintain exposure levels comparable to the 750 mg dose while significantly reducing clinic burden for patients. Management observed that a peer (InhibRx/LiGeR-1) increased enrollment from 500 to 700 patients, likely to balance HPV-positive and negative cohorts. This change, combined with Bicara's steady execution, supports management's belief that ficera could be first-to-market in the HPV-negative setting. The study uses Progression-Free Survival (PFS) as the primary endpoint to ensure durability is maintained when switching to the every 3-week regimen. The FDA agreed to this design as a descriptive comparability study rather than a formal, larger non-inferiority trial. Management dismissed immediate competitive concerns from OX40 assets, noting those trials often focus on CPS high (≥20) patients and have later pivotal timelines (2029). Ficera's data shows strong activity in the CPS 1-19 'low' population, which represents roughly 50% of the market.

This article first appeared on GuruFocus. Operating Expenses: Increased due to clinical operations and development expenses for the Fortify HNO1 study, including manufacturing and development costs. Personnel Costs: Rise in personnel-related costs, including stock-based compensation, due to workforce growth in clinical operations and development. Cash and Equivalents: Ended the quarter with $539.8 million, bolstered by a $161.8 million net proceeds from an oversubscribed public offering in February. Cash Runway: Expected to extend into the first half of 2029. Warning! GuruFocus has detected 3 Warning Signs with BCAX. Is BCAX fairly valued? Test your thesis with our free DCF calculator. Release Date: May 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Bicara Therapeutics Inc (NASDAQ:BCAX) made significant progress with their lead asset, Physaris Alpha (Fisera), which is positioned as a potentially best and first-in-class treatment for HPV-negative head and neck cancer. The company is on track to achieve substantial enrollment in their Fortify HN01 trial by the end of the year, with an interim analysis expected in mid-2027 for potential accelerated approval. Bicara has strengthened its leadership team with key hires, including a new Chief Commercial Officer, to prepare for the commercial launch of Fisera. The company completed an oversubscribed public offering, bolstering its cash position to $539.8 million, providing a runway into the first half of 2029. Recent peer-reviewed publications and presentations at major conferences like ASCO validate Fisera's differentiated mechanism and clinical benefits, enhancing its scientific credibility. Operating expenses increased significantly compared to the previous year, driven by clinical operations and development costs, which may impact short-term profitability. The transition from a clinical-stage to a commercial-stage organization involves substantial investment in infrastructure and personnel, which could strain resources. There is competitive pressure in the market, with peers advancing their own trials, potentially affecting Bicara's timeline and market positioning. The company's strategy relies heavily on the success of Fisera, which is still in clinical trials, posing a risk if the trials do not meet expectations. The alternative dosing regimen study for Fisera adds complexity and uncertainty to the development process, with potential implications for regulatory approval and market adoption. Q: Can you provide benchmarks for three-year outcomes data at ASCO for HPV-negative head and neck cancer, and will there be correlations between PD and response rates? A: The ASCO 2026 datasets will include long-term follow-up for three expansion cohorts in frontline recurrent metastatic HPV-negative head and neck cancer, with the 1,500-milligram cohort having three years of median follow-up. We aim to highlight the immunotherapy tail driven by TGF-beta durability. Historically, pembrolizumab in all comers shows a 20-25% three-year overall survival, while it's about 15-20% in the HPV-negative subset. The data will emphasize TGF-beta inhibition's role in driving depth and durability of response, leading to superior survival benefits. Q: How much follow-up should we expect with the 750 mg and 2,000 mg dose cohorts at ASCO? Also, could the alternate dosing regimen improve durability? A: The 750 mg weekly and 2,000 mg every two-week cohorts have approximately 12 to 18 months of median follow-up, and longer-term data will be shared at ASCO. Regarding the alternate dosing regimen, starting with 1,500 mg weekly and transitioning to 2,250 mg every three weeks, we believe this approach maintains durability after achieving significant tumor reductions, offering a potentially more durable and tolerable profile. Q: Can you explain the use of PFS as a primary endpoint in the dose optimization trial, given there's no control arm? A: The trial is not designed as a non-inferiority study. The FDA was comfortable with PFS as the endpoint to ensure consistent durability between the two arms, focusing on depth and durability of response with the induction into maintenance dosing. Q: How does the competitor's increased enrollment in their frontline trial affect Fortify's trial size and timing? A: The competitor's trial increased enrollment to 700 patients, likely due to an imbalance in HPV-positive versus HPV-negative patients. This highlights Fisera's potential to be best and first-in-class. We continue to execute strongly on the Fortify HN01 study, and we believe in our potential first-in-class status. Q: What are the expected timelines for OS analysis in your Phase 3 study? A: We anticipate the interim analysis for potential accelerated approval in mid-2027, focusing on overall response rates with six months of durability and qualitative overall survival. Given our focus on HPV-negative patients, we expect event rates and OS endpoints to occur more rapidly than our peers. Q: How do investigators view the 12-week weekly regimen followed by once every three weeks compared to a pure once every two-week regimen? A: Investigators prioritize rapid and deep responses, which the weekly regimen provides. The transition to every three weeks after 12 weeks is seen as a balance between achieving rapid efficacy and offering a more convenient maintenance regimen. Q: How important is the alternative dosing regimen from a commercial and competitive perspective? A: Efficacy remains the key differentiation factor. The 12-week weekly regimen maximizes efficacy, and transitioning to a three-week maintenance phase optimizes the profile for convenience and tolerability, enhancing commercial competitiveness. Q: When will management become unblinded to the interim Phase 3 results, and how will the BLA filing process work? A: The study is blinded, with an interim analysis for potential accelerated approval in mid-2027. The data lock will be done, and the BLA will be submitted by the BICARA team, following standard procedures. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. May 11, 2026, at 8:30 a.m. ET Chief Executive Officer — Claire Mazumdar Clemon Chief Medical Officer — Bill Schelman Chief Commercial Officer — Chris Sarchi Chief Financial Officer — Ivan Hyep Executive Vice President, Clinical Development (transitioned to CMO) — Bill Schelman Senior Executive Adviser (prior CMO) — Dave Raben Chief Operating Officer — Ryan Cohlhepp Need a quote from a Motley Fool analyst? Email [email protected] Claire Mazumdar Clemon: Good morning, and thank you for joining us today. The first quarter of 2026 set a strong foundation for the year ahead. We made measurable progress on the strategy we outlined earlier this year with continued momentum behind our lead asset, ficerafusp alfa or ficera, which we believe is a potentially best and first-in-class bifunctional EGFR-directed antibody combined with the TGF-beta ligand trap for the treatment of HPV-negative first-line head and neck cancer. Our priorities remain focused on executing a strategic development plan for ficera, preparing for commercial success by laying the foundation to capture a large and growing global market in head and neck cancer and expanding ficera's potential beyond our lead indication, while maintaining financial discipline. To deliver on those priorities, we are building the team to match our ambitions as we transition from a clinical stage to a commercial stage organization. With that in mind, I want to share a few updates this morning. After several years as our Chief Medical Officer, Dave Raben has transitioned to a Senior Executive Adviser role and Bill Schelman, previously Executive Vice President of Clinical Development, has stepped into the CMO role. Dave has been instrumental in shaping Bicara into the company it is today, guiding ficera into pivotal Phase III development and building the foundation of our clinical and medical organization. We are deeply grateful for his contributions and look forward to his continued partnership in his advisory capacity. Bill is well positioned to build on that foundation. He joined us last fall as an experienced development and commercial stage leader and has quickly made an impact across our development programs. And as we build toward commercial launch, we are thrilled to have brought on a proven leader to guide that work. Chris Sarchi joined last week as our Chief Commercial Officer, bringing extensive oncology, commercialization and leadership experience. Chris will continue building out the team with additional hires across market access and commercial operations in the months ahead. In addition, we made a number of key updates in the first quarter. First, our continued execution has us on track to achieve substantial enrollment in FORTIFI-HN01 by the end of the year, positioning us for an interim analysis in mid-2027 for potential accelerated approval. With that progress, our belief in ficera's potential to be both best and first-in-class in frontline recurrent and metastatic HPV-negative head and neck cancer has only strengthened. That conviction is grounded in ficera's differentiated mechanism, the depth and durability of response we have observed and our development approach. Recent developments in the competitive landscape are reinforcing this view. While the market has at times viewed peer time lines as ahead of ours, that picture is changing, driven by our own continued progress as well as the significant upsizing of a peers pivotal trial. Together, these dynamics support our potential path to first-in-class. They also validate the strategic choice we made to develop ficera specifically for HPV-negative patients, where the science, the unmet need and the commercial opportunity align. Second, and Bill will speak to this in more detail, based on discussions with the FDA, we plan to initiate a study that will evaluate ficera in combination with pembrolizumab as a loading and every 3-week maintenance dosing regimen. This is an advancement that we believe has the potential to expand optionality for patients and providers and enhances the long-term commercial profile of ficera. Third, just last Friday, a peer-reviewed manuscript was published in the Journal of Clinical Oncology, detailing results from our Phase Ib expansion cohort, evaluating 1,500 milligrams of ficera weekly in combination with pembrolizumab in frontline recurrent metastatic head and neck cancer, data most recently presented at ASCO 2025. This publication is an important milestone that validates and adds to the growing body of scientific evidence supporting ficera's differentiated mechanism of action and clinical benefit. It also provides the broader oncology community with a peer-reviewed view of the data underpinning our pivotal program. And lastly, with the completion of an oversubscribed public offering in February, built on an already strong cash position, we are well positioned to invest in the opportunities ahead of us. As we look ahead to the next quarter and the remainder of the year, we're excited to share meaningful long-term follow-up data at ASCO in a few weeks. The data will further characterize ficera's safety profile, along with the depth and durability of response driven by TGF-beta inhibition. These data span all 3 clinical doses tested in expansion cohorts, including the dose we're advancing in our pivotal trial. We are also continuing to enroll multiple Phase Ib expansion cohorts to identify early proof-of-concept signals and inform ficera's development strategy, both within head and neck cancer and across solid tumors. With that, I'll turn it to Bill to walk through our recent clinical updates and what to expect from us at ASCO this year. Bill Schelman: Thanks, Claire, and good morning, everyone. We have taken a deliberate and thoughtful approach to evaluating ficera in patient populations with high unmet need and with the strongest biological rationale. This has included development in head and neck cancer as well as other solid tumors, including metastatic colorectal cancer, cutaneous squamous cell carcinoma and anal cancer. In that context, our recent disclosures have focused on clinical data from approximately 90 patients across 3 cohorts from our Phase Ib study evaluating ficera in combination with pembrolizumab in frontline recurrent or metastatic HPV-negative head and neck cancer. This patient population has particularly poor outcomes with limited treatment options and represents the vast majority of patients in this setting. The 1,500-milligram weekly plus pembrolizumab cohort, which is the dose we are currently evaluating in the Phase III portion of the FORTIFI-HN01 pivotal trial was presented at ASCO last year and represents our most mature data set. With 2 years of follow-up, deep and durable responses were observed with a median duration of response of 21.7 months and a median overall survival of 21.3 months, more than doubling the overall survival observed with the standard of care of pembrolizumab in HPV-negative patients. The 750-milligram weekly plus pembrolizumab cohort supported the evaluation of the optimal biological dose of ficera in the Phase II portion of our ongoing FORTIFI trial and helped to inform selection of the 1,500-milligram weekly as the OBD that is currently being evaluated in the Phase III portion of the study. The data from these cohorts also reinforces our confidence in the interim analysis of overall response rate as the foundation for pursuing accelerated approval. The cohort evaluating 2,000 milligrams every other week plus pembrolizumab demonstrated that even at a less frequent dose, we see rapid and deep responses that are the hallmark of the ficera clinical profile. The data from this cohort also helped inform our alternative dosing regimen study. Across all 3 Phase Ib cohorts, the depth and durability of response observed underscore the central role of TGF-beta inhibition in ficera's mechanism. By enabling tumor penetration, TGF-beta inhibition drives the kind of deep and durable responses that translate to long-term survival benefit. Taken together, the data presented to date affirm that ficera has the potential to be a well-tolerated chemotherapy-free treatment option across the spectrum of disease burden, including in patients with large bulky tumors and low CPS scores, where rapid and deep responses are particularly critical. As we look towards ASCO 2026, we will be presenting updated data across all 3 of these cohorts from the Phase Ib study. We will provide 3-year follow-up data from the 1,500-milligram cohort, which will allow us to characterize the long-term efficacy from this dose compared to the standard of care. We will also share long-term endpoints from the 750-milligram weekly and the 2,000-milligram every other week data sets. These data will provide the most comprehensive look at ficera in frontline recurrent and metastatic HPV-negative head and neck cancer to date, including durability of outcomes not seen with other investigational agents targeting EGFR in this setting, a key differentiator and the signal of ficera's best-in-class potential. Additionally, the strength and consistency of these results across cohorts further derisk our pivotal FORTIFI-HN01 trial. Another key aspect of our ASCO update is that we'll further characterize the role of TGF-beta in head and neck cancer. TGF-beta inhibition is the defining feature of ficera and what sets it apart from other EGFR-directed therapies. Our translational data has shown consistent TGF-beta inhibition across all ficera doses, confirming the mechanism behind tumor penetration and immune activation with the strongest inhibition at the 1,500-milligram weekly dose and the 2,000-milligram every other week dose. We'll also look to show how tumor penetration driven by TGF-beta inhibition translates into depth and durability of response that leads to long-term outcomes for patients. Alongside the clinical story, we'll continue to build at ASCO, we're also focused on optimizing how ficera is delivered to patients. As previously mentioned, based on discussions with the FDA, we plan to initiate an alternative dosing study in the third quarter of this year. This study will enroll approximately 150 to 200 patients and will evaluate the efficacy of ficera on a 12-week loading phase followed by an every 3-week maintenance phase regimen. All patients will receive 1,500 milligrams weekly of ficera plus pembrolizumab for 12 weeks and will then be randomized to either continue 1,500 milligrams weekly of ficera plus pembrolizumab or transition to 2,250 milligrams every 3 weeks plus pembrolizumab. The primary endpoint will evaluate progression-free survival. In designing an alternative dosing regimen, our priority is to preserve ficera's potential best-in-class profile while creating practical options for patients and providers. Since we expect to seek accelerated approval for ficera with the 1,500-milligram weekly dose from the FORTIFI-HN01 study, running this randomized study in parallel will allow us to potentially have results from this study in time for a potential approval, creating a compelling path for early adoption of the streamline regimen. Additionally, this addresses an important need for patients, providers and payers, specifically by providing treatment options that will reduce clinic burden, improve quality of life and support long-term adherence. And critically, this dosing strategy is shaping how we are thinking about life cycle management and ficera's opportunity beyond frontline recurrent or metastatic head and neck cancer. With that, I'll turn it over to Ryan to discuss the potential market opportunity and what's ahead for the rest of the year. Ryan Cohlhepp: Thank you, Bill. Turning to the broader opportunity, we have strong conviction in the differentiated profile ficera has shown across our clinical program compared to other investigational agents in head and neck and the development strategy we built around that profile designed to deliver against the full opportunity ahead. Head and neck cancer is a significant and fast-growing global market projected to reach more than $5 billion in global sales into the 2030s. HPV-negative patients represent a large majority of patients in the frontline recurrent metastatic setting and HPV status is known at the time of diagnosis, which means that HPV testing is not a barrier to care. Across major markets, there are roughly 50,000 annually incident patients, including approximately 18,000 in the U.S. where we plan to launch initially. The unmet need in this population for a therapy that drives deep, durable and clinically significant benefit while sparing chemotherapy and improving quality of life is what makes the rigor of our clinical data and the discipline of our development strategy matter. It is also why we continue to invest in the medical and commercial infrastructure required to deliver ficera to patients. This includes the commercial leadership team we have been building with Chris now leading our commercial efforts, including the prelaunch evidence generation and field readiness work required for a successful oncology launch, and we look forward to having him on the road with us at ASCO and beyond. While the frontline recurrent metastatic setting is our initial focus, the opportunity for ficera in head and neck cancer is much larger. Given our conviction in ficera's potential to be both first and best-in-class, we see clear space to own and lead a broader segment of the head and neck cancer landscape. The locally advanced setting, in particular, represents another large market with clear biologic rationale for ficera and a meaningful opportunity for expansion. As we think about that opportunity, we have initiated 2 investigator-initiated sponsored studies in the locally advanced setting and continue to enroll additional cohorts that will inform our expansion strategy. including a cohort of patients in frontline recurrent metastatic HPV-negative head and neck cancer with CPS less than or equal to 1 as well as a cohort of patients with frontline recurrent metastatic HPV-positive head and neck cancer with heavy history of smoking. Beyond head and neck, we believe there is a strong biologic rationale to expand ficera's pipeline and the potential into solid tumor types with significant unmet need. We have already shown proof of concept in indications such as cutaneous squamous cell carcinoma and anal canal cancer, reinforcing our conviction in ficera's broad applicability across TGF-beta-driven tumors. Building on that foundation, we are currently enrolling patients in a Phase Ib expansion cohort evaluating ficera, both as a monotherapy and in combination with pembrolizumab in patients with third-line plus metastatic colorectal cancer. TGF-beta is implicated in metastatic disease and resistance to current treatments, providing a biologic rationale for evaluating ficera in this setting. This is also a challenging setting. Patients are very sick, often progressing rapidly through prior lines of therapy. And with the treatment landscape in CRC continuing to evolve, we are taking a measured approach with a high bar for what would warrant further investment. As the data mature across these cohorts, we will continue to make thoughtful decisions about where ficera can deliver the most differentiated value and how we allocate our resources accordingly. With that, I'll turn it to Ivan to review the financials. Ivan Hyep: Thanks, Ryan. Earlier this morning, we reported detailed first quarter 2026 financial results in our press release, and I'll summarize a few highlights here. Our total operating expenses for the first quarter of 2026 increased compared to our first 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. Consistent with the first quarter, we anticipate continued increases in operating expenses for 2026, reflecting increased investment in our clinical operations, particularly for the pivotal FORTIFI-HN01 study, with the interim analysis expected in mid-2027 and parallel study as well as an increase in SG&A, as we invest in early commercial and medical infrastructure to support the potential launch of ficera. We ended the first quarter of 2026 with $539.8 million in cash, cash equivalents and marketable securities, bolstered by an oversubscribed public offering in February that generated $161.8 million net proceeds and meaningfully strengthened our balance sheet, which provides cash runway into the first half of 2029 and allows us to invest thoughtfully in areas we believe will deliver future clinical and commercial success. With that, I'll now turn the call back over to the operator for questions. Operator? Operator: [Operator Instructions] And our first question comes from Eric Schmidt of Cantor. Eric Schmidt: Maybe one in terms of what to expect at ASCO in a couple of weeks' time. Can you provide us with any benchmarks for 3-year outcomes data, landmark data in HPV-negative head and neck? And then you mentioned looking at the role of TGF-beta as well. Does that mean that we're going to see some correlations between PD and response rates? Claire Mazumdar Clemon: Thank you for your question, Eric. So the question was relating to a preview of the ASCO 2026 data sets. So as we highlighted during the call, there are 2 separate abstracts that were accepted at behalf of ASCO. One is focused on long-term follow-up in terms of the 3 expansion cohorts in frontline recurrent and metastatic HPV-negative head and neck with the most mature data set being the 1,500-milligram one you were alluding to, which will have 3 years' worth of median follow-up. In that one, we really hope to speak to the so-called immunotherapy [ tail ] driven by the TGF-beta durability. And so in there, if you look at prior precedents, pembrolizumab in all-comers delivers about a 20% to 25% 3-year overall survival, while it's believed to be about 15% to 20% in the HPV-negative subsets of real-world data sets. The other abstract is focused on looking at depth and durability of response from the TGF-beta inhibition, and we'll continue to speak to what we believe is ficera's defining hallmark that TGF-beta inhibition is driving this depth and response that's ultimately leading to far superior durability than other investigational agents and leading to outsized overall survival benefit. Operator: And our next question comes from Tyler Van Buren of TD Cowen. Tyler Van Buren: Congrats on the progress. Just wanted to ask a quick follow-up before my question, if you don't mind. A follow-up on Eric's question related to the ASCO data. I guess it's clear that we'll have 3 years of follow-up with the 1,500 mg dose. But since investors are asking, it would be helpful if you could just clarify how much follow-up we should expect with the 2,000 and 750 dose cohorts. We can obviously guess, but just clarity there would be helpful. And then I guess my main question is related to the alternate dosing regimen of the 1,500 mg induction with the 2,250 mg maintenance. Do you think it's possible that, that regimen could have improved durability than either 1,500 or 2,250 alone based upon exposure and the data that you've produced to date? Claire Mazumdar Clemon: Thanks for your questions, Tyler. So I'll answer the first question first, which is a question around the other 2 cohorts being presented at ASCO, which are the 750-milligram weekly cohort as well as the 2,000-milligram every 2-week cohort. Both of those have approximately 12 to 18 months worth of median follow-up. And so we do plan to share longer-term follow-up data sets for both of those at ASCO in a few weeks. And to help answer your question around durability of response in the maintenance setting, I'll pass that question over to Ryan. Ryan Cohlhepp: Thanks, Tyler, for the question. In terms of the regimen, again, the overall approach that we are taking there, as you mentioned, is we're initiating with the 1,500 milligrams weekly and then transitioning to a maintenance phase of 2,250. A couple of, I think, key tenets of that approach. One, as you recognize in the data that we presented thus far, we see deep rapid responses, which are enabled by the 1,500-milligram dose. And really being able to get a depth of response, more than 80% of our patients are getting depth of response of 80% or greater, which we really believe is contributing to that durability. One of the things that the 2,250 every 3 weeks enables is an exposure profile that allows us to, I think, maintain that durability after we received -- or achieved very meaningful reductions in tumor reductions and keeping patients on from a tolerability perspective, I think being able to bring people into clinic every 3 weeks rather than every week while maintaining exposures that maintain that durable response. We absolutely believe that this regimen potentially enables both a more durable as well as a better -- a more tolerable profile. Operator: And our next question comes from Stephen Willey of Stifel. Stephen Willey: Maybe just some color around the use of PFS as a primary endpoint in the dose optimization trial, just given that this is obviously an event-driven endpoint, there's no control arm. And then is there a formal non-inferiority margin that you need to hit? I guess just any color you can provide around kind of this formal notion of comparability would be helpful. Claire Mazumdar Clemon: Thanks for your question, Steve. So I'll actually answer the second part of your question first around non-inferiority. This is actually not designed as a noninferiority study. We got positive feedback from the FDA based off of our discussions based off of the sizing of the study, which we alluded to being approximately 150, 200 patients, it does not -- it would have required far more patients as a non-inferiority study. The other focus, again, going back to Tyler's question, the other focus of looking at this dosing regimen is really, again, to ensure that we're maintaining the efficacy profile focused on depth and durability of response with the induction into maintenance dosing. And so the focus of the PFS endpoint was really to look at that ensuring the durability is consistent between the 2 arms. And the FDA was comfortable with PFS being that endpoint for that reason. Operator: And our next question comes from Kelsey Goodwin of Piper Sandler. Kelsey Goodwin: I think you alluded to it in the prepared remarks, but for your competitors' frontline trial where they increased target enrollment by about 200 patients, I just first wanted to confirm, is there any read-through to FORTIFI in its trial size? And then secondly, how do you think about the gap in timing now between ficera and [ Pido ]. Claire Mazumdar Clemon: Thank you for question, Kelsey. So just to highlight, we were alluding to the LiGeR-1 study, and you may have not seen on clinicaltrials.gov that the page is updated to reflect enrollment of 700 patients, up from the original 500 in an all-comers study. I think that's consistent with feedback we've been hearing from investigators that they were planning to add additional HPV-negative patients. From what we have heard today that there was potentially an imbalance in terms of HPV-positive versus HPV-negative patients in that particular study given that -- there are no other HPV-positive studies in Phase III. We haven't seen any read-through other than the fact that it continues to highlight what we've always highlighted that ficera has the potential to be both best and first-in-class. We've seen very strong execution of the FORTIFI-HN01 study, and those dynamics continue to speak to what we believe is a significant narrowing of the perception around ficera and FORTIFI being second to market. In fact, we continue to believe in our potential first in class. Operator: And our next question comes from Brad Canino of Guggenheim. Bradley Canino: It's nice to be on the call. At ASCO, maybe just to drill into one of the doses, the lower 750 mg, which wasn't selected for the Phase III. So how do you look at that as really being able to support the TGF-beta hypothesis given the exposure and coverage that it provides? And will that view only be in a subset of patients such as the responders? And then just a quick second, given we're talking about the competitor trial and the upsize, where do you sit with expected timing of OS analysis for your Phase III study today? Claire Mazumdar Clemon: Thanks, Brad, for your question, and welcome to the team. So to the first question around the 750-milligram dose, so that was, as you highlighted, a dose that we did not take forward in the pivotal Phase III study. However, we do see a significant TGF-beta inhibition. And we know that from an EGFR receptor occupancy, we are fully saturating the EGFR locus. So we've always thought of it as still superior than EGFR monoclonal antibody while showing slightly less TGF-beta inhibition. What you will continue to see at ASCO is that even in this patient population, the hypothesis that TGF-beta inhibition is driving improved depth and durability will continue to speak to another strong data set that will reinforce the notion now in a total of 90 patients that we have strong depth and durability data that will speak to that overall survival benefit. And your second question was related -- I apologize, timing of OS analysis. As we continue to guide to the interim analysis for potential accelerated approval is slated for mid-2027, which is a look at overall response rates with 6 months of durability and likely a look at qualitative overall survival at that time. We do anticipate being focused on HPV-negative patients only that our event rates will happen more rapidly than those of our peers and that the OS endpoint will come again more rapidly than anticipated. Operator: And our next question comes from Judah Frommer of Morgan Stanley. Judah Frommer: Maybe just broadening out the competitor conversation a bit. We saw some data from an OX40 targeting asset this morning, but I believe in CPS greater than 20. So maybe can you just remind us of kind of the breakdown of the epidemiology by CPS score and kind of what the advantages of a broader targeting asset in ficera could be? And again, what time lines could look like versus this asset? Claire Mazumdar Clemon: Thanks for your question, Judah. I do believe you're referring to an InhibRx presentation that actually I believe is happening at the same time as our call. So while we haven't had a chance to significantly look at the data set, I can speak at a high level to those results. So as you alluded to, the data set from, I believe, a randomized Phase II is focused on CPS greater than or equal to 20. So these are considered the CPS high patients who typically do respond to pembro monotherapy. What we do know is that ficera is being and the FORTIFI study is being looked at in the CPS greater than or equal to 1 as well, we have shown some strong results from our late-line patients in CPS 0 and are currently looking at an open-label CPS 0 cohort. In the CPS 1 to 19 category, we see stronger response rates across all 3 of our cohorts between 50% to 70%, really speaking to the TGF-beta inhibition going after the more so-called immunosuppressive patients for the CPS low. From an epidemiological standpoint, it's believed to be about 50-50 CPS 1 to 19 versus CPS 20 to greater and 15% of the frontline market being the CPS 0. I think your other question was around just the competitive threat. What we believe we are hearing is that they are slating to start enrollment in the pivotal study later this year with full enrollment scheduled to be 2029. So significantly later than our interim analysis for potential accelerated approval coming mid-2027. So we do not see this as a competitive threat in terms of timing. Operator: And our next question comes from Reni Benjamin of Citizens. Reni Benjamin: Congrats on the progress. As my question is mainly focused around the Phase Ib expansion cohorts and the early proof-of-concept signals. Can you just maybe provide more color on each of those expansion cohorts, kind of why we're going after CPS less than 1 and those patients with heavy smoking. And then same thing with the CRC, what is that high bar that you're hoping to achieve when those results come out in the second half? Ryan Cohlhepp: Thank you for the question. So I'll start with the other cohorts. You mentioned CPS less than 1 and also the heavy smokers. So I think what we saw in dose escalation is we actually saw some pretty significant responses in those patients who had CPS 0. In fact, one patient in particular had a complete response there. As you go back to kind of the fundamental biology of our molecule of EGFR and TGF-beta, there's a lot of biological support for the synergy associated with those 2 mechanisms being given together and also in combination with a PD-1. And so that was a biology that we wanted to probe and again, exploring a population. As Claire had alluded to in the last response, in terms of an epidemiological perspective, about 15% of patients are CPS less than 1. So it's a meaningful population. And again, a biology that's supported by our molecule. In the heavy smokers, I think it goes back to our view when we looked at our dose escalation data retrospectively, there was a responder population with an HPV positive. All of those patients who responded were heavy smokers. In that case, we saw people who had a history of smoking of 20 pack a year or greater who responded. And again, of our 3 responders there, 2 out of the 3 of them were complete responses. So our view is that there's likely a component of smoking that's driving the biology there, even more so than the HPV positive infection. And again, an area that we wanted to probe as we think about those expansion opportunities within the head and neck population. CRC, I think, honestly, it's an evolving target. We continue to look at the landscape. We've seen data sets out from other agents of recent. And I think the other thing not only is relative to the competitive landscape, but also our own internal. We had mentioned activity in cutaneous anal canal. There's good opportunities for this molecule in the locally advanced setting of head and neck. So as we evaluate the various opportunities, there are, I think, are ample opportunities to develop ficera across a range of different tumors and more broadly in head and neck cancer. And that really is the bar is, where we think we're going to have the most meaningful impact, and that's where we're going to end up investing our capital. Reni Benjamin: And can I just follow up with when we might see some of the data for -- we know when the CRC data is coming out, but maybe from these other cohorts, when might we see those data? Ryan Cohlhepp: Again, we've not provided specific guidance on that. And again, we'll provide greater clarity in terms of timing for that in future updates. Operator: And our next question comes from Jeet Mukherjee of BTIG. Jeet Mukherjee: Just looking ahead to your loading and maintenance regimen, just as you talk to your investigators, how do they think about a 12-week weekly regimen followed by once every 3 weeks versus just a pure once every 2-week regimen from [ Pido ] there? Is there any preference that they have generally between one or the other? Obviously, safety and efficacy being the primary point there. But just was curious if there's any preference there between the 2 regimens. And then just coming back to ASCO, are we looking to have updated data be a part of the abstract? Or will they be reserved for the conference presentation? Ryan Cohlhepp: So I'll take your first question there. As we have talked with investigators and the broader community, I think there's a real focus on that initial therapy and the rapidity and the depth of that initial therapy. I think even if you look at the historical treatment paradigm, we continue to see a fair amount of chemotherapy used, and that is largely being driven by the desire to have very rapid responses. And so in terms of that trade-off of being able to go to every 2 weeks at the outset versus being able to get rapid deep responses, the preference continues to be that rapid deep response, which the weekly regimen gives. Again, I think as you think about the overall administration schedule transitioning to every 3 weeks at the 12-week mark, I think the view there is a willingness to get faster, better efficacy quick and then be able to go to a more convenient maintenance regimen over time. Claire Mazumdar Clemon: And to your second question, Jeet, which I believe was about whether the abstracts -- whether the data presentation will have more mature data than the abstracts, that is correct. There will be more data provided during our presentation than what was provided in the abstracts. Thank you for your question. Operator: And our next question comes from Boris Peaker of Jones Trading. Boris Peaker: Just a follow-up on a prior question when we're talking about every 2-week dosing, every 3-week maintenance dosing. In addition to potentially satisfying FDA's Project Optimus requirements, how important do you see this dosing from the commercial perspective and kind of competitive perspective? Claire Mazumdar Clemon: I'll answer your first question around Project Optimus and then pass it over to Ryan. So just to highlight for us, we have satisfied Project Optimus by choosing the 1,500-milligram dose weekly as opposed to the 750-milligram dose weekly within the FORTIFI-HN01 study. So this is a separate parallel clinical study that is looking at moving this new alternative dosing regimen into a potential ultimate label. To your second question around the commercial uptake, I'll pass it over to Ryan. Ryan Cohlhepp: Yes. In terms of -- from a differentiation perspective, efficacy remains the key parameter for differentiation, consistent, I think, with most oncology molecules. Again, that's why we continue to initiate with 12 weeks of weekly therapy to maximize efficacy, deep durable, rapid responses. And again, we think that, that will be the key that's going to drive differentiation and the initial share uptake between ourselves and competitor molecules. Being able to then also maximize and optimize for schedule once you get out to that 12-week maintenance phase, we believe that we have -- we'll be creating a regimen that has the ability to not only compete but to differentiate and be best-in-class from an efficacy, tolerability and from a convenience perspective, really being able to fully optimize the profile across all 3 dimensions. Operator: And our next question comes from Joe Catanzaro of Mizuho. Joseph Catanzaro: I actually had one as well on this maintenance trial that you've sort of, I think, touched on. But wondering if you could speak to the quantitative difference in exposure at steady state, if any, between 1,500 weekly and 2,250 every 3 weeks. It sounds like you need those longer-term efficacy metrics, but wondering if the argument can be made on sort of equivalent PK and safety between those 2 regimens. Ryan Cohlhepp: Yes. I mean, again, from an overall exposure perspective, what we are looking to accomplish there, the 2,250, essentially, we're looking for exposures that are comparable to what you've seen at 750. And again, why we look across the various data sets to really get, I think, the regimen that we have gotten to, we're looking at the strength of the data across all of our various cohorts. So again, I mean, I think the key here is starting the 1,500 milligrams, getting that rapid deep response and then being able to maintain the exposure levels to maintain the durability of response. Operator: Our next question comes from Richard Law of Goldman Sachs. Jin Law: So based on that accelerated approval time line, I believe you mentioned in the past that only a small clinical team will be unblinded to review the interim Phase III results and management will still be blinded. So when will management team become unblinded? And when should we expect to see the data as well? And also, does it mean that the unblinded clinical team will file the BLA without management seeing what's in there initially when filed? Claire Mazumdar Clemon: Richard, I think you're -- just to understand your question, the study is a blinded study. We have an interim for potential accelerated approval in mid-2027 that will be based on response rates with 6 months' worth of follow-up as well as qualitative overall survival. Like any company, there will be -- the data cut will be done, the data lock will be done and then our team within Bicara will submit the BLA. There are no oddities to that process. Jin Law: So there's no separate unblinding with a different team and then we're -- I thought that was the case before, if not. Claire Mazumdar Clemon: No, there is an IDMC like in many cases that will allow us to submit and then we will move to the Bicara team. Operator: I'm showing no further questions at this time. I'd like to turn it back to Claire Mazumdar for closing remarks. Claire Mazumdar Clemon: Thank you for joining us today and for your continued support of Bicara. We're focused on the work ahead for the program and most importantly, for the patients we're working to serve. And we look forward to seeing many of you at ASCO in a couple of weeks. Operator: This concludes today's conference call. Thank you for participating, and you may now disconnect. Before you buy stock in Bicara Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Bicara Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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Interested in Bicara Therapeutics Inc.? Here are five stocks we like better. Bicara said its pivotal FORTIFY-HN01 trial for ficerafusp alfa remains on track, with substantial enrollment expected by the end of 2026 and an interim analysis targeted for mid-2027 to support a possible accelerated approval filing. The company plans to present more mature Phase 1b data at ASCO 2026, including three-year follow-up for its lead dosing cohort, while highlighting durable responses and survival outcomes that it says support its TGF-beta inhibition strategy. Bicara also outlined a new alternative dosing study expected to start in Q3 2026, and said its strengthened balance sheet leaves it with a cash runway into the first half of 2029 after February offering proceeds. Bicara Therapeutics (NASDAQ:BCAX) said it made progress during the first quarter of 2026 on the development and commercialization strategy for its lead drug candidate, ficerafusp alfa, or FICERA, while reporting a strengthened cash position following a February public offering. On the company’s first-quarter earnings call, Chief Executive Officer Claire Mazumdar said Bicara remains focused on advancing FICERA, which she described as a potentially “best and first-in-class” bifunctional EGFR-directed antibody combined with a TGF-beta ligand trap for the treatment of HPV-negative first-line head and neck cancer. → Beyond NVIDIA: Picks-and-Shovels AI Plays with Strong Momentum Mazumdar said the company is working to execute its development plan for FICERA, prepare for commercial launch and explore the drug’s potential beyond the lead indication while maintaining financial discipline. Bicara said enrollment in its pivotal FORTIFY-HN01 trial remains on track to reach “substantial enrollment” by the end of 2026. The company expects an interim analysis in mid-2027 to support a potential accelerated approval filing. → 3 Ways to Target the Resources Powering AI and Data Centers The FORTIFY-HN01 study is evaluating FICERA in combination with pembrolizumab in frontline recurrent or metastatic HPV-negative head and neck cancer. Chief Medical Officer Bill Schelman said the company’s most mature Phase 1b data set, evaluating 1,500 milligrams of FICERA weekly plus pembrolizumab, showed deep and durable responses with two years of follow-up. Schelman said that cohort demonstrated a median duration of response of 21.7 months and median overall survival of 21.3 months, which he said was more than double the overall survival observed with standard-of-care pembrolizumab in HPV-negative patients. → Quantum Earnings Season Is Ramping Up—What to Watch From 2 Major Players The company also evaluated 750 milligrams weekly and 2,000 milligrams every other week in combination with pembrolizumab. Schelman said data across the three Phase 1b cohorts support the role of TGF-beta inhibition in FICERA’s mechanism and reinforce the company’s confidence in overall response rate as the basis for a potential accelerated approval strategy. Bicara expects to present updated data at ASCO 2026 from all three Phase 1b expansion cohorts in frontline recurrent or metastatic HPV-negative head and neck cancer. Schelman said the presentation will include three-year follow-up from the 1,500 milligram weekly cohort, as well as longer-term endpoints from the 750 milligram weekly and 2,000 milligram every-other-week cohorts. During the question-and-answer session, company executives said the 750 milligram and 2,000 milligram cohorts will have approximately 12 to 18 months of median follow-up. Mazumdar also said the ASCO presentation will include more mature data than the abstracts. In response to a question about benchmarks for three-year survival in HPV-negative head and neck cancer, Mazumdar said pembrolizumab in all-comers has delivered about 20% to 25% three-year overall survival, while real-world data suggest roughly 15% to 20% in the HPV-negative subset. She said Bicara aims to discuss what it views as an “immunotherapy tail” driven by TGF-beta-related durability. Bicara also outlined plans to begin an alternative dosing study in the third quarter of 2026, following discussions with the U.S. Food and Drug Administration. The randomized study is expected to enroll approximately 150 to 200 patients. All patients in the study will receive 1,500 milligrams weekly of FICERA plus pembrolizumab for 12 weeks. They will then be randomized to either continue the weekly FICERA regimen with pembrolizumab or transition to 2,250 milligrams of FICERA every three weeks plus pembrolizumab. The primary endpoint will be progression-free survival. Schelman said the study is designed to preserve FICERA’s potential efficacy profile while creating more practical treatment options for patients and providers. He said the company still expects to seek accelerated approval based on the 1,500 milligram weekly dose in FORTIFY-HN01, while running the alternative dosing study in parallel. In the Q&A, Mazumdar said the alternative dosing study is not designed as a non-inferiority trial. She said the FDA was comfortable with progression-free survival as the endpoint because the study is intended to assess whether durability is maintained between the two dosing approaches. President and Chief Operating Officer Ryan Cohlhepp said the company believes the 12-week weekly induction period can support rapid and deep responses, followed by a maintenance phase that may reduce clinic burden and improve convenience. Bicara said it is expanding its leadership team as it moves toward potential commercialization. Mazumdar said former Chief Medical Officer David Raben has moved into a senior executive adviser role, while Schelman has stepped into the CMO position. The company also recently hired Alex Kharazi as chief commercial officer. Cohlhepp said head and neck cancer represents a significant global market projected to exceed $5 billion in global sales in the 2030s. He said HPV-negative patients represent a large majority of frontline recurrent metastatic cases, with roughly 50,000 annual incident patients across major markets, including approximately 18,000 in the U.S., where Bicara plans to launch first. Beyond frontline recurrent metastatic HPV-negative head and neck cancer, Bicara is evaluating FICERA in other settings and tumor types. Cohlhepp said the company has initiated two investigator-sponsored studies in locally advanced head and neck cancer and is enrolling additional cohorts, including patients with frontline recurrent metastatic HPV-negative disease with CPS less than or equal to 1 and patients with HPV-positive disease with a heavy smoking history. The company is also enrolling a Phase 1b expansion cohort evaluating FICERA as monotherapy and in combination with pembrolizumab in third-line or later metastatic colorectal cancer. Cohlhepp said Bicara is taking a measured approach in colorectal cancer and will apply a high bar before making further investment decisions. Chief Financial Officer Ivan Hyep said first-quarter operating expenses increased from the prior-year period, driven by clinical operations and development expenses related to FORTIFY-HN01, including manufacturing and development costs. Personnel-related expenses, including stock-based compensation, also rose as the company expanded its workforce. Hyep said Bicara expects operating expenses to continue increasing in 2026 as it invests in clinical operations, the pivotal FORTIFY-HN01 trial, the parallel dosing study and early commercial and medical infrastructure. The company ended the first quarter with $539.8 million in cash, cash equivalents and marketable securities. Hyep said Bicara’s February public offering generated $161.8 million in net proceeds and provides a cash runway into the first half of 2029. Bicara Therapeutics 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Bicara Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.