Bicara Therapeutics Inc. (BCAX) Earnings Call Transcript

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.

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.

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.

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.

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 Instructions] First question will be coming from the line of Eric Schmidt of Cantor.

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?

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.

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

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

One moment for the next question. Tyler Van Buren of TD Cowen.

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?

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.

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.

One moment for the next question. And our next question is coming from the line of Stephen Willey of Stifel.

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.

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.

And that will be pursued with induction and maintenance.

Sorry, in colorectal cancer or.

Yes, just colorectal and other tumor types.

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].

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.

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.

One moment for the next question, please. Next question is coming from the line of Bradley Canino of Guggenheim.