Bicara Therapeutics Inc.

Good day and thank you for standing by. Welcome to the Bicara Therapeutics fourth quarter and full year 2025 earnings call. At this time, all participants are on 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised, today's conference is being recorded. I would like to hand the conference over to your speaker today, Rachel Frank. Please go ahead.

Thank you and good morning, everyone. It's a pleasure to welcome you to Bicara Therapeutics' fourth quarter and full year 2025 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter and 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 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, Brian Kolheap, President and Chief Operating Officer, and Ivan Hyatt, Chief Financial Officer. I'll now turn the call over to Claire.

Good morning and welcome to Baikara 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, Phycerophosp-alpha, or Phycera, 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 improve safety and enhance durability directly at the tumor site. BiSERA 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 and frontline recurrent and metastatic head and neck cancer is evolving. Our recent clinical data and regulatory progress clearly position Phycera as the 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 FISERA toward a pivotal study interim analysis in the middle of next year. First, Vysera 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 two additional Phase Ib clinical data sets across clinically active doses of Fisera that demonstrated consistent overall response rates, further validating Fisera's unique dual mechanism targeting both EGFR and TGF-beta, and de-risking the OR endpoint in our pivotal study interim analysis. Third, building on this robust data set, we selected 1500 milligrams as our optimal biological dose and have successfully moved into the phase three portion of our pivotal Fortify 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 Phycera with a loading and every three 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 Phycera. 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.