FDA Designation and Trials - Bicara Therapeutics received FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab for first-line treatment of HPV-negative R/M HNSCC[2] - The pivotal Phase 2/3 FORTIFI-HN01 trial is ongoing, focusing on ficerafusp alfa in first-line HPV-negative R/M HNSCC[3] - Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly is expected to be presented at ESMO Asia 2025[9] - The company aims to present additional data for ficerafusp alfa across various dose cohorts to inform future studies[2] Financial Performance - As of September 30, 2025, Bicara had approximately $408 million in cash, cash equivalents, and investments, down from $489.7 million as of December 31, 2024[9] - Research and development expenses for Q3 2025 were $33.0 million, compared to $15.9 million in Q3 2024, reflecting increased costs associated with clinical trials[9] - General and administrative expenses for Q3 2025 were $7.7 million, up from $4.8 million in Q3 2024, primarily due to additional personnel costs[10] - Net loss for Q3 2025 totaled $36.3 million, compared to a net loss of $17.5 million in Q3 2024[10] - The company expects its existing cash resources to fund operations into the first half of 2029[9] Management Changes - Bicara expanded its management team with new appointments, including Chief Corporate Affairs Officer and Chief Development Officer[5]
Bicara Therapeutics Inc.(BCAX) - 2025 Q3 - Quarterly Results