Bicara Therapeutics Inc. Common Stock Q4 FY2025 earnings call

Bicara Therapeutics is a clinical stage biotech company pioneering bifunctional antibodies. Claire Mazumdar, CEO, provided background on the company. They've achieved multiple critical inflection points: Vysera received breakthrough therapy designation, presented Phase Ib clinical data, selected optimal biological dose for pivotal study, announced plans for dosing regimen, and completed an oversubscribed public offering. Ryan Kolheap detailed clinical updates, including data from Phase 1b cohorts, TGF-beta inhibition, and durability of responses. Ivan Hyatt summarized financials, noting increased operating expenses, cash position, and plans for 2026 investments.

Anticipate increase in operating expenses in 2026 driven by clinical operations, SG&A, and hedge fund expenditures. Entered 2026 with $414.8 million in cash, raised additional $161.8 million in first quarter, maintaining cash runway guidance into first half of 2029. Capital will be used for regulatory filing, medical and commercial infrastructure, Fisera development, manufacturing costs, signal finding activities, and general corporate purposes.

Q: Provide more color on patient demand and willingness to participate in pivotal study and enrollment in separate study of less frequent dosing regimen.

A: Approximate size of separate study is 150 - 200 patients. Fortify HN01 study has strong momentum with 129 active sites and progress in US and ex-US sites.

Q: Scope of colorectal cancer update.

A: Data expected in second half of year, with no less than 20 patients per cohort, exploring third line cohorts in monotherapy and combination with pembrolizumab.

Q: Whether patients in 750-mig once-weekly cohort were given opportunity to up titrate.

A: Patients in 750 milligram weekly cohort were maintained at that dose, update to be provided on PFS and duration of response.

Q: Update on centers in Fortify HN01, overlap with other trials, and cash runway.

A: 129 sites globally, no significant overlap with other trials, cash raised used for alternative dosing, pre-launch activities, etc., maintaining cash runway guidance.

Q: Ultimate split of enrollment across geographies and bridging trial design.

A: Geographical distribution similar to recent trials, greater clarity on alternative dosing trial expected later this year.

Q: Quantify substantial enrollment and thoughts on global filing.

A: Substantial enrollment based on FDA requirements for accelerated approval, potential accelerated approval predicated on response rate endpoint, full overall survival endpoint needed for global approval.

Q: Rationale for loading and once every three-week maintenance strategy and colorectal cancer enrollment criteria.

A: Confidence from exposure response modeling and rapid responses, enrollment criteria allows for liver mets.

Q: Biology explanation for response rate differences and commercial implications.

A: HPV-negative tumors have higher EGFR and TGF-beta, Pyschera targets both, potential dominant share in relevant market.

Q: When to unblind study for interim analysis.

A: Study is fully double-blinded, IDMC will look at data at pre-specified statistical analysis, management will not be unblinded