Bicara Therapeutics Inc.

Good day and thank you for standing by. Welcome to the Bicara Therapeutics first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rachel Frank, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, and good morning, everyone. It's a pleasure to welcome you to Bicara Therapeutics' first quarter 2026 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter in recent business progress. 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 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, Bill Shellman, Chief Medical Officer, Ryan Kohlhepp, President and Chief Operating Officer, and Ivan Hayev, Chief Financial Officer. I'll now turn the call over to Claire. 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, Phytherafisp-alpha, or Phycera, which we believe is 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. Our priorities remain focused on executing a strategic development plan for Fisera, preparing for commercial success by laying the foundation to capture a large and growing global market in head and neck cancer, and expanding Fisera'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 Rabin has transitioned to a senior executive advisor role, and Bill Shellman, previously executive vice president of clinical development, has stepped into the CMO role. Dave has been instrumental in shaping Vicara into the company it is today, guiding Pfizer into pivotal phase three 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 Sarkey 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 Fortify 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 Pfizer'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 Pfizer'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 timelines as ahead of ours, that picture is changing, driven by our own continued progress, as well as the significant upsizing of a peer's pivotal trial. Together, these dynamics support our potential path to first in class. They also validate the strategic choice we made to develop PHYSERA 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 Fisera in combination with Pembrolizumab as a loading and every three-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 Fisera. Third, just last Friday, a peer-reviewed manuscript was published in the Journal of Clinical Oncology, detailing results from our Phase 1B expansion cohort, evaluating 1,500 milligrams of Fisera weekly in combination with Pembrolizumab in frontline recurrent and 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 Fisera's differentiated mechanism of action and clinical benefits. 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 Pfizer's safety profile along with the depth and durability of response driven by TGF beta inhibition. These data span all three clinical doses tested in expansion cohorts, including the dose we're advancing in our pivotal trial. We are also continuing to enroll multiple phase 1B expansion cohorts to identify early proof of concept signals and inform Pfizer'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.