Bicara Therapeutics 2026 Q3 Earnings Call

Ma'am, please go ahead. Thank you, and good morning, everyone.

It is a pleasure to welcome you to Bicara Therapeutics Third Quarter 2026 Earnings Call. Earlier this morning, we issued a press release highlighting the results from the quarter and provided a business update. You can access the press release as well as the slides that we will be reviewing today by going to the Investor section of the 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 Ryan Cohlhepp, Interim Chief Executive Officer, Bill Schelman, Chief Medical Officer, Chris Sarchi, Chief Commercial Officer, and Jenn Larson, Chief Financial Officer. Tanya Green, Chief Development Officer, is also on the line and available for Q&A. I will now turn the call over to Ryan.

Thank you, Rachel, and good morning, everyone. Since stepping into the interim CEO role earlier this fall, I have spent a lot of time on the road with clinicians, investors, and the hardworking Bicarians that make our work possible. My conversations have reaffirmed my belief in the potential practice-changing benefit of ficerafusp alfa, known as FICERA, which continues to drive strong enrollment momentum in our ongoing pivotal FORTIFI-HN01 study of FICERA in combination with pembrolizumab for the treatment of frontline recurrent metastatic HPV-negative head and neck cancer. Our research and insights reinforce that the HCPs respond positively to the depth and durability of response that has become a hallmark of FICERA's clinical profile, the chemo-sparing nature of its regimen, and the potential for every three-week dosing regimen in the future.

Recurrent metastatic head and neck remains a disease of serious unmet need, particularly for patients with HPV-negative disease who continue to face limited treatment options, poor long-term outcomes, and a significant impact on quality of life. We are proud to be part of a field that is pushing what is possible for these patients, and we welcome progress from others working to change outcomes in this disease. Ultimately, what is good for patients is good for all of us. With that in mind, I want to acknowledge the top-line results recently announced by one of our peers in the space, which provided a very encouraging update for patients. Our conviction in FICERA's clinical profile in frontline recurrent metastatic HPV-negative head and neck cancer and our path forward, grounded in the role of TGF-β in our early clinical experience, is only strengthened by that news.

We still have much to learn about how those results may shape the treatment landscape for patients with HPV-negative disease, including how outcomes differ by HPV status and how mature the survival data are. What they do show is further validation for this new class of EGFR-targeted therapies in head and neck cancer, including FICERA, and they sharpen our focus as we evaluate our strategy to bring the greatest value to patients with HPV-negative disease. FICERA has Breakthrough Therapy designation specifically for the treatment of HPV-negative head and neck cancer based on a differentiated clinical data, which facilitates our ongoing interactions with the FDA.

Today, we remain focused on executing on enrollment, conducting an interim analysis that provides meaningful clarity to physicians, patients, and shareholders on FICERA's differentiated clinical profile, and filing a BLA that optimizes both our speed to a potential U.S. approval and our goal of a maximally competitive commercial profile. Today, we announced that FORTIFI-HN01 has achieved substantial enrollment to enable a top-line interim analysis, which we continue to expect in the middle of next year. With the aim of maximizing speed to market in a competitively differentiated way, we can confirm that we are planning for an interim overall survival analysis, something we've been evaluating for some time, and we'll share more on timing and scope as we believe is appropriate in the context of a fluid and competitive environment. Reaching substantial enrollment in FORTIFI-HN01 marks an important step forward for Bicara this quarter.

Alongside it, we advanced FORTIFI-FLEX to evaluate a more flexible dosing regimen, and we continued building the commercial and medical organization that will support a potential launch. Together, this progress positions us for our next phase of growth as we pursue our first approval in head and neck cancer, a large and growing market projected to reach more than $5 billion globally by 2030. Before I turn it over to Bill Schelman, I want to reinforce that our absolute priority at Bicara is clear: the successful development, approval, and commercialization of FICERA in frontline recurrent metastatic HPV-negative head and neck cancer. Beyond head and neck, there's also clear biologic rationale for FICERA in other solid tumors.

In our phase I-B expansion study in third-line MSS RAS/BRAF wild-type metastatic colorectal cancer, evaluating FICERA both as a monotherapy and in combination with pembrolizumab, we are seeing encouraging early safety and efficacy signals in this late-line population. What we are looking for is an efficacy signal paired with a safety profile that supports combination, since earlier lines are where we see the greatest potential for clinical benefit. We now plan to present these data at a relevant forum in January. As we near our top-line interim analysis and our first potential regulatory filing, we continue to evaluate how we can take an evidence-based approach to the next pillars of growth for Bicara beyond head and neck cancer, while being disciplined stewards of our financial resources. With that, I will turn it over to Bill.

Thanks, Ryan, and good morning, everyone. HPV-negative head and neck cancer is biologically distinct from HPV-positive disease. These tumors overexpress EGFR and are rich in TGF-β, which suppresses the immune response and drives resistance to therapy. FICERA was designed to inhibit both EGFR and TGF-β and to work synergistically with immunotherapy, overcoming barriers in the tumor microenvironment so that the drug and immune cells can penetrate the tumor. When I speak with treating physicians, what they tell me matters most for their patients is depth and durability of response, as they believe these yield the greatest long-term outcomes, like overall survival. By pursuing that clear mechanistic biologic fit, we believe FICERA has the potential to redefine the standard of care in first-line recurrent or metastatic HPV-negative head and neck cancer, which represents roughly 80%-90% of cases globally.

I want to take a few minutes to revisit the long-term phase I-B data we presented at ASCO this year, because while FORTIFI-HN01 remains blinded and ongoing, they are the clearest window we have into FICERA's clinical profile. As these data mature, we believe they continue to de-risk the pivotal study on the endpoints that matter most: response rate, complete response rate as a measure of depth, and most importantly, duration of response, progression-free survival, and overall survival. At the 1,500 milligram weekly pivotal dose, with a median follow-up of three years, FICERA plus pembrolizumab achieved a confirmed objective response rate of 54% and a complete response rate of 25%. As a clinician, what stands out to me is the depth of those responses. Specifically, 80% of responders had tumor shrinkage of 80% or more.

Responses came quickly, at a median of about six weeks, and they were durable, with a median duration of response of nearly 22 months. Median progression-free survival was 9.9 months, roughly three times what has been reported for pembrolizumab alone, and median overall survival was just over 21 months. Most importantly, about one in three patients was alive at three years. That is roughly double what real-world data would lead us to expect with pembrolizumab alone in HPV-negative patients. We continue to believe that these clinical results are driven by TGF-β and the role it plays in remodeling the tumor microenvironment to allow for greater depth of response.

When we pooled patients across all three dose cohorts in our phase I-B study, 750 milligrams weekly, 1,500 milligrams weekly, and 2,000 milligrams every two weeks, those with deep responses remained in response for a median of more than 2.5 years, and they went nearly three years without progression. We haven't yet reached median overall survival in that group. Our paired biopsies showed reduced TGF-β signaling in the tumor and greater CD8 T-cell infiltration. We believe that immune cell penetration potentiates immunotherapy, translating into more durable responses. With new data emerging in head and neck cancer, including recent results reported across both HPV-positive and HPV-negative patients, I think it's important to look at the context behind our data. In these patients, tumor characteristics matter as much as the efficacy numbers themselves. First, HPV status. Every patient in our phase I-B dataset was HPV-negative, and it's the only population we are enrolling in FORTIFI-HN01.