Good day, and thank you for standing by. Welcome to the Bacara Therapeutics Second Quarter 2026 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you'll need to press star-11 on your telephone. You will then hear an automated message advising your hand is raised. To answer your question, please press star-11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today. Rachel Frank, please go ahead.

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 Investor section of our company website. Before we begin, please note that this call will include forward-looking statements under the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Please refer to our most recent SEC filings for important risk factors that could cause our actual performance and results to materially differ from those expressed or implied in these forward-looking statements. Any forward-looking statement made on this call represents our views only as of today, and we disclaim any obligation to update any forward-looking statements. Joining us on the call today are Claire Mazumdar, Chief Executive Officer, Ryan Colgey, President and Chief Operating Officer, and Ivan Hyatt, Chief Financial Officer. I'll now turn the call over to Claire.

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 Fortify HN01 study of Physerapis Alpha, or Physera, and frontline recurrent and metastatic HPV-negative head and neck squamous cell cancer. We also have strengthened our operational capabilities as we prepare the company for an exciting next chapter as we near a top-line interim analysis of our pivotal study and potential commercialization. Part of that momentum was our ASCO 2026 update where we presented three-year follow-up data showing that TGF beta inhibition leading to direct tumor penetration translates to unprecedented depth and duration of response. At three years, FICERA nearly doubled overall survival versus standard of care while maintaining a consistent safety profile, all driven by TTF 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 Fisera. Since founding Baikara, our goal has never been simply to build a successful development stage biotech company. It has been to build an enduring organization, one with the leadership, culture, and capabilities to create lasting value for patients and shareholders for many years to come. The leadership changes we are announcing today represent the next step in that evolution. Today, I am thrilled to announce that at the beginning of next year, Ryan will become President and Chief Executive Officer, while I transition to the role of Vice Chair of the Board and strategic advisor. When Ryan joined me in launching BICARA more than five years ago, we always discussed this moment as being the time at which I would hand him the torch and it's a reflection of our collective accomplishment that we're here today with a clear line of sight to a top-line interim analysis of our pivotal study that we believe may lead to an accelerated approval and subsequent launch. As we look toward that potential launch, Ryan's experience makes him exceptionally well-suited to lead the organization. As many of you know, he has over two decades of life science leadership from early stage R&D all the way through global commercial execution, including running Takeda's U.S. oncology portfolio and launching multiple approved drugs for solid and hematologic tumors. My own training is as a cancer biologist, and that background has shaped how I have led by Cara from the beginning, staying close the science and building the company around it but 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 by Cara board of directors have complete confidence that he is the right leader to guide us to our next chapter as we prepare for the potential commercialization of by Sarah and the next phase of growth at by Cara As I step into my new role as vice chair and strategic advisor, I look forward to continuing our partnership closely, supporting Ryan and this leadership team to our next phase. I'm also pleased to announce that Jen Larson will join Baikara 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 Baikara. As one of our early executives, he played a critical role in helping establish our finance organization, leading Vaikara 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 Jen to the leadership team. Jen brings extensive experience leading finance organizations at commercial stage biotech companies and has a strong track record of helping organizations navigate growth and commercialization. Her expertise will be an important addition as we head into this important stage ahead. I also want to highlight that we recently announced the appointments of Jeremy Bender and Christy Olinger to our board directors. Both new board members bring a strong track record of guiding biopharmaceutical companies through critical stages of growth, including pipeline development, corporate strategy, and commercialization. And their experience and guidance will strengthen our board as we look toward the future of BICARA. Personally, this transition is a meaningful moment for me. Looking back, I'm incredibly proud of what we've accomplished together, from advancing bold science to building an exceptional team and culture that I believe will continue to differentiate BICARA well into the future. 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.

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 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 lies ahead. As Clara mentioned, this transition is not about changing our direction. It's about building upon a foundation that has been intentionally created over many years and bringing my own background in oncology drug launches and pipeline expansions bear as I step up to succeed Claire. I had a clear vision for how we will build our commercial capabilities, which is precisely like Claire and the board tasked me with bringing on a chief commercial officer earlier this year, and Chris Sarki is exactly the right leader to help realize it. Today, BICAR 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 is defined by CARA 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 BICAR'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 have become one of BICAR'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 Bikara through this next chapter, including two additional leadership transitions that will become effective in January as well. Tanya Green, currently our Chief Development Officer, will succeed in 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 COOC 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 Schifferman as Chief Legal Officer. Effective at the end of the month, Greg brings deep biotech legal experience to BICARA, and he'll be a key partner to the team as we move through our pivotal milestones and toward a potential commercial launch of FICARA. As we approach what we believe will be a transformational period for BICARA, our mission remains unchanged to bring FICARA 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 First, as Claire mentioned previously, this past May at ASCO, we presented the most comprehensive and mature clinical data set assembled for FISERA in first-line recurrent or metastatic HPV-negative head and neck cancer. These data span approximately 90 patients across three-dose cohorts, with up to three years of follow-up in our 1,500-milligram weekly pivotal dose, the longest follow-up presented of any investigational agent in the HPV-negative head and neck cancer space. FICERA continues 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 one in three patients was alive at three years. Approximately doubling the survival rate observed in retrospective analyses with standard-of-care pembrolizumab in HPV-negative patients. Importantly, EGF-beta inhibition was observed to be the mechanistic foundation of this clinical benefit, driving tumor penetration, enabling immune cell infiltration, and translating depth of response into durable, long-term survival. A clinical profile no other EGFR-directed therapy in head and neck cancer has demonstrated. Second, the execution of Fortify 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 Fortify Flex, our alternative dosing study to support our loading and every three-week maintenance dose. The speed in which we designed and activated the study on the heels of strong clinical data from our exploratory every-two-week cohort presented earlier this year is a hallmark of the BICARA way, following science and executing with speed and precision to best serve the needs of patients. Our goal with Fortify Flex is to have the data in hand by the time of our central U.S. approval, supporting a compelling path for earlier adoption of this streamlined regimen. Finally, beyond our typical trial population, we continue to build out by Sarah's broad development strategy, both within head and neck cancer and beyond, where we have already established proof of concept and additional indications including cutaneous squamous cell carcinoma and anal canal cancer. Building on this foundation, there's a lot of momentum right now. I couldn't be more optimistic about the future, and I look forward to leading this outstanding organization into its next chapter. I'll now turn the call over to Ivan to discuss our financials.

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 Fortify H101 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, Fortify HNL1, 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 Fortify Flex, our alternative dosing study, which was recently initiated. Given the strength of a maturing phase 1B data for FISERA 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 Fortify HNL1 study in FISERA in frontline recurrent metastatic HPV-negative head and neck cancer through to a primary overall survival analysis, supporting a planned regulatory filing for FISERA, providing initial investment into medical and commercial infrastructure ahead of a potential U.S. approval and launch, clinical development costs for Fortify 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 VICARA'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 have gotten to know Jen, I am credibly 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?

Thank you. As a reminder, if you would like to ask a question, please press star 11 on your telephone. If you would like to remove yourself, please press star 1 again. game. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. First question will be coming from the line of Eric Smith of Cantor. Please go ahead.

Well, thanks for taking my question. Just let me start by saying congrats to Ryan and the team on their new appointments. And of course, Claire and Ivan 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 three readout? Thank you.

Thanks for your question, Eric. And, you know, when Ryan and I actually met six years ago to talk about BICARA, we always knew there would be a time when we would need to establish our commercial infrastructure and get ready for launch readiness in advance of top-line data. As we entered this year building on very strong momentum for Fortify HNO1, 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 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 as a strategic advisor 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.

And Claire, can I ask if you've got a full-time opportunity that you're thinking about or lined up?

But no, by car is my full-time opportunity from that perspective. I'm not taking on any additional operational roles.

Thank you very much.

Thank you. One moment for the next question. Tyler Van Byrne of TD Cal, when your line is open.

Hey, guys. Good morning. Claire and Ivan, I too want to thank you and congratulate you for all of your accomplishments. You both will be missed. And I'd also like to congratulate Ryan, Tanya, Jen, 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 Fortify FLEX study so that it's not disruptive to completing enrollment for the primary ongoing Fortify 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?

Hey, Tyler. Thank you for the question. I'll start and then pass it over to Tanya to speak a little bit more about Fortify Flux. As you can imagine, we have been very deliberate and thoughtful in terms of the footprint around Fortify Flux in order to make sure that it does nothing to, you know, impede the continued progress that we have on Fortify. But, you know, 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 pedosimprimab. It's not quite clear exactly what we'll see there, but obviously we will monitor that very closely. With that, Tanya, do you want to speak a little bit more to what we've done with 4.5 Sure.

This is Tanya Green, Chief Development Officer. Thanks for the question, Tyler. So, we are, you know, thoughtfully thinking about the potential overlap of sites. As it stands, there's only about a third of sites that will overlap with our Fortify 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 stagegating enrollment so that Fortify remains our top priority in terms of enrollment. One moment for the next question.

And our next question is coming from the line of Steve and Willie of CFO. Please go ahead.

Yeah, good morning. I would just like to echo my appreciation to Claire and I, 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 Fortify FLEX study, should we anticipate that any additional development steps in colorectal or additional tumor types to also leverage in doctrine and maintenance? And I just have a follow-up.

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 two open-label signal-seeking cohorts we're looking at. Both are third-line plus MSS colorectal cancer, KRAS and BRAS wild-type patients, one as a monotherapy with Fisera, the other in combination with Pembro. We anticipate having approximately 20 patients in each of these cohorts with short-term follow-up. So, 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 Fortify HN01 study. We have already demonstrated proof of concept in cutaneous squamous cell carcinoma and anal canal cancer, and do believe that there is a lot of biology and combination approaches in CRC as well that we have been exploring.

And that will be pursued with induction and maintenance?

Sorry, in colorectal cancer or?

Yeah, just colorectal and other tumor types.

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

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

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

All right. Thanks for taking the questions.

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

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, you know, given it's been about two, three months since ASCO, what has been the physician reaction to the TGF beta and core of 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, you know, now that we have two EGFR biospecifics moving into phase threes, is 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? Thank you.

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 three years' worth of follow-up. You know, 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, you know, building significant momentum in geographies where both M-evantimab and P-docimptimab were also enrolling patients. So we do think it was an important inflection point for us as well. from a momentum standpoint with Fortify HNO1. And 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 played 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 front-line setting of MSS patients.

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

Good morning. Congratulations from me as well on all of the new roles for everyone. I maybe just wanted to ask your thoughts about your competitors, update that they are still going to be presenting data from frontline 10 and next by the end of this year.

When they do, what should we be thinking about in terms of readout or read through rather for FISERA? Thanks.

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

Thank you.

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

Yeah, hi, guys. Thanks for taking the question, Claire and Ivan. It's been a pleasure to work with you guys, and congrats to the rest of the team. Maybe just a couple more on the competitive landscape with some more clarity on competitor timing and, you know, 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?

Thanks for your question, Judah. So, what I will say, you know, to your first question around both front-line 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 front-line setting, which is, you know, the largest majority of patients, and we anticipate, you know, 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 prepared mechanism of action of pedosymptomab 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. if you wanted to also use a different EGFR in the second-line setting. What I will also say is you are seeing additional ADCs outside of EGFRs testing their molecules in a post-EGFR setting, knowing that EGFRs will likely be the standard of care. 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 Fisera 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 M-eventimab is being studied in combination with chemotherapy. And today, investigators are really looking for a chemo-sparing regimen. Thank you for your question.

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

Oh, hey. Good morning. Thanks for taking our questions.

And congrats again on all the appointments.

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

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 GenMAD, depth of response will be an important indicator for what's to come in terms of durability and overall survival. We will, of course, as you may know, a six-month durability is an important aspect of the 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. To your question on FortifyFlex, by being able to start this study well and invincible, we had initially anticipated at the beginning of the year, we do anticipate having the data set in hand for the first event. Okay, great. Thank you so much.

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

Hey, good morning, guys. Thanks for taking the questions. Let me echo my congratulations as well to the entire team. Maybe two quick ones for us. One of our KOL calls mentioned left-sided CRC might benefit 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 FISERA? 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 Fortify Flex starts and, you know, 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?

Thank you for your question, Renny. 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, you know, that's where the approval is for EGFR monoclonal antibodies today and where both, I believe, J&J and Genmab are going with their phase 3s and 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 the 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 study. And with that, I'll pass it over to Ivan.

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 Fortify 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 Fortify study in the 27 timeframe and as we continue to ramp up commercial spend and the build around the FTEs. I think, Ryan, you're up.

Yeah, yeah, that was it. So probably it's for you, Ryan, regarding the Salesforce stuff.

Yeah, 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 to some of those metrics. Got it.

Thanks very much, guys.

Thank you. One moment for the next question. The next question is coming from the line of Zit Mukherjee. of US Bancorp BTIG. Please go ahead.

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

Thanks for your question, Jeet. So to that point on Fortify-Flex, the intent of the study is really to compare the two 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 posts the loading portion which is the same for both studies which is why the FDA was comfortable and in the sizing of the study and the data set that we plan to submit for it to include it in the label I apologize I missed the second part of your question so whether or not RAS combos in CRC yeah and so 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 CITSI 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, you know, 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.

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. I want to thank you all for joining today. And I can say I'm very energized by where Bikara 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. This concludes today's program and thank you for joining. You may now disconnect.