Bicara Therapeutics Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, and good morning, everyone.

It is a pleasure to welcome you to Bicara Therapeutics second quarter 2026 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter and provided a business update, including strategic leadership transitions, marking the company's next era of growth and execution. You can access the press release as well as the slides that we will be reviewing today by going to the investor section of our company website. Before we begin, please note that this call will include forward-looking statements under the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Please refer to our most recent SEC filings for important risk factors that could cause our actual performance and results to materially differ from those expressed or implied in these forward-looking statements.

Any forward-looking statement made on this call represents our views only as of today, and we disclaim any obligation to update any forward-looking statements. Joining us on the call today are Claire Mazumdar, Chief Executive Officer, Ryan Cohlhepp, President and Chief Operating Officer, and Ivan Hyep, Chief Financial Officer. I will now turn the call over to Claire.

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

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

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

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.

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

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 by what lies ahead. As Claire mentioned, this transition is not about changing our direction. It's about building upon a foundation that has been intentionally created over many years and bringing my own background in oncology drug launches and pipeline expansions bear as I step up to succeed Claire.

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

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