Bicara Therapeutics Inc. · NASDAQ:BCAX
Bicara Therapeutics — Q1 2026 Earnings Presentation
12 slides from Bicara Therapeutics's earnings presentation, May 11, 2026
Slide 1: Q1 2026 Earnings Call
Q1 2026 Earnings Call May 11, 2026 © 2024 – 2026 Bicara Therapeutics
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements other than historical factual information are forward-looking statements, including without limitation express or implied statements regarding our strateg
Slide 3: Agenda & today's presenters
Agenda & today’s presenters 1 Introduction Claire Mazumdar, Ph.D., MBA Chief Executive Officer 2 Clinical Progress Bill Schelman, MD, Ph.D. Chief Medical Officer 2 Business Updates Ryan Cohlhepp, Pharm.D. President & Chief Operating Officer 3 Financial Results Ivan Hyep, MBA Chief Financial Officer
Slide 4: Q1 2026 highlights and recent progress
Q1 2026 highlights and recent progress Continued strong execution in FORTIFI-HN01 pivotal trial of FICERA; expect to be 1 substantially enrolled by the end of the year to enable interim analysis in mid-2027 Based on recent discussions with the FDA, expect to initiate an alternate dose study 2 in Q3
Slide 5: FICERA Phase 1b clinical experience in 1L R/M HPV-negative HNSCC
FICERA Phase 1b clinical experience in 1L R/M HPV-negative HNSCC Phase 1b data from Phase 1b data from exploratory higher dose selected for dose, less frequent pivotal study regimen 2000mg Q2W‡ 1500mg QW† 750mg QW* Pembrolizumab# • Consistent safety, Metric EE set (N=27) EE set (N=28) EE set (N=30)
Slide 6: FICERA's TGF-β inhibition and tumor penetration are associated with deeper responses
FICERA’s TGF-β inhibition and tumor penetration are associated with deeper responses Depth of Response At 24-Weeks 73% 64% 27% Median Depth of Response % Of Responders Observed trends of higher TGF-β inhibition within the Achieving Deep (≥80%) TME at higher doses, including pivotal study dose Respon
Slide 7: FICERA's alternate dosing regimen study to expand optionality and convenience
FICERA’s alternate dosing regimen study to expand optionality and convenience for patients and providers 1L R/M HPV-negative HNSCC Loading phase Maintenance phase 12 weeks FICERA 1500mg QW + 200mg pembro Q3W Primary endpoint: FICERA 1500mg QW Progression free survival + 200mg pembro Q3W R (n=150-200
Slide 8: FICERA has the potential to achieve blockbuster status in HNSCC
FICERA has the potential to achieve blockbuster status in HNSCC FICERA, an EGFR-directed antibody x TGF-B ligand trap designed to drive tumor penetration $5B+ Evidence-based development and commercialization strategy focused on greatest unmet need, HPV-negative disease projected global market for HN
Slide 9: FICERA has the potential to significantly expand the HPV-negative HNSCC market
FICERA has the potential to significantly expand the HPV-negative HNSCC market Significant Untapped Potential for Market Expansion Pioneer Treatment Paradigm Shift Continue to build market understanding of HPV-negative HNSCC as a distinct clinical disease Drive Better Patient Outcomes 2-3X responses
Slide 10: Broader opportunity for FICERA in head and neck cancer
Broader opportunity for FICERA in head and neck cancer Registration-enabling Multiple expansion opportunities representing Phase 3 ongoing ~50,000 patients in HNSCC (U.S. incidence) ~26,000 ~4,000 Locally Advanced CPS < 1 1L R/M HPV-negative HNSCC 1L R/M HPV-negative HNSCC HPV-negative Earlier-line
Slide 11: Strong financial position to support strategic investment
Strong financial position to support strategic investment (in thousands) Three Months Ended Three Months Ended Statement of Operations (Unaudited) 3/31/26 3/31/25 Total operating expenses Research & development1 $ 47,500 $ 34,333 General & administrative2 $ 12,742 $ 7,455 Other income $ 4,083 $ 5,01
Slide 12: Thank You
BICARA THERAPEUTICS” Thank You