Bicara Therapeutics Inc. · NASDAQ:BCAX
Bicara Therapeutics — Q4 2025 Earnings Presentation
36 slides from Bicara Therapeutics's earnings presentation, Mar 30, 2026
Slide 1: Fighting cancer with precision and power
Fighting cancer with precision and power. March 2026 Corporate Deck © 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 statements regarding our strategy, business plans a
Slide 3: A clinical-stage biotechnology company developing targeted tumor modulators
A clinical-stage biotechnology company developing targeted tumor modulators Advancing ficerafusp alfa (FICERA), the first and only EGFR-directed antibody bound to a TGF-β ligand trap, with blockbuster potential in 1L R/M HPV- Developing bifunctional antibodies that negative HNSCC combine tumor-targe
Slide 4: FICERA – EGFR-directed antibody combined with a TGF-β ligand trap
FICERA – EGFR-directed antibody combined with a TGF-β ligand trap designed to drive tumor penetration Inadequate tumor penetration has challenged the 1 Targeting EGFR treatment of many 1. Direct anti-tumor effect solid tumor cancers, including HPV- 2. Drives tumor targeting negative R/M HNSCC 2 Tra
Slide 5: Following the science to establish a clinical foothold in HPV-negative HNSCC
Following the science to establish a clinical foothold in HPV-negative HNSCC HNSCC is a fibrotic, immunosuppressive solid tumor HPV-negative is a distinct and compelling clinical subset of HNSCC Increased EGFR expression Elevated levels of TGF-β1 in serum High rate of therapeutic resistance Bedi, At
Slide 6: Recent accomplishments position FICERA as potentially the next great advance
Recent accomplishments position FICERA as potentially the next great advance in the treatment of HPV-negative HNSCC Presented proven Awarded Breakthrough Pivotal study initiated; clinical data Therapy Designation optimal dose selected Only investigational EGFR- First and only designation to Thoughtf
Slide 7: 2026 plan to drive growth and value inflection
2026 plan to drive growth and value inflection Executing a strategic Expanding FICERA’s development plan for FICERA Preparing for commercial potential while maintaining in 1L HPV-negative R/M HNSCC success financial discipline Accelerating enrollment to enable Laying the foundation to achieve Follow
Slide 8: Executing a Strategic Development Plan for FICERA in 1L R/M HPV-Negative HNSCC
Executing a Strategic Development Plan for FICERA in 1L R/M HPV-Negative HNSCC 8
Slide 9: Significant unmet need for better treatment options in HPV-negative HNSCC
Significant unmet need for better treatment options that improve outcomes in HPV-negative HNSCC patients Current standard of care HPV-negative HNSCC… Pembro + Represents the heavy majority (80 – 90%) Pembro of HNSCC in the R/M setting chemo ORR ~19% ~36% Characterized by high tumor burden and mDOR ~
Slide 10: FICERA 1500 mg QW drives deep responses in HPV-negative patients
FICERA 1500 mg QW drives deep responses in HPV-negative patients ORR with FICERA 1500 mg QW + Pembrolizumab in HPV-negative, CPS≥1 1L R/M HNSCC (Ph. 1b) 320 PD * CPS 1-19 • Confirmed ORR: 54% (15/28) PD – Disease Control Rate: 89% (25/28) 60 SD • Deep Responses: 80% (12/15) of Best change from basel
Slide 11: FICERA's tumor penetration was designed to drive durability
FICERA’s tumor penetration was designed to drive durability Median Duration of Response: Pembro Combinations in 1L R/M HNSCC Pembro + chemotherapy 6.7 months Non-Tumor Penetrant (Chemo / EGFR) 10.1 Responses Pembro + lenvatinib months HPV-All ~11.0 Pembro + petosemtamab months* Tumor Penetrant 13.1
Slide 12: Depth and durability observed with FICERA translates to OS benefit
Depth and durability observed with FICERA translates to OS benefit Overall Survival with FICERA 1500 mg QW + Pembrolizumab in HPV-negative, CPS≥1 1L R/M HNSCC 100 n=28 Median OS 21.3 months 80 2-year OS Rate 46%* 60 Median Follow-up 25.2 months OS, % 40 HPV-negative mOS of 7 – 9 months in SOC 20 Cen
Slide 13: Impact of depth of response to durability and outcomes
Impact of depth of response to durability and outcomes Analysis of FICERA + Pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC (Ph. 1b) Evaluating whether deep responses (≥80% shrinkage) impact outcomes Duration of Response Progression Free Survival Overall Survival No tumor shrinkage Tumor shrinkage <80%
Slide 14: FICERA's clinical profile shows promise for improved outcomes compared to SOC
FICERA’s clinical profile shows promise for improved outcomes compared to SOC Current standard of care ~3X increase Pembro + FICERA (1500mg QW)* Pembro in ORR chemo + pembro4 vs. pembro alone ORR ~19% ~36% ~54%* >3X increase mDOR ~23.4 months ~6.7 months 21.7 months* in mDOR Median OS vs. pembro + c
Slide 15: FICERA 1500 mg QW is generally well-tolerated with no treatment-related deaths
FICERA 1500 mg QW is generally well-tolerated with no treatment-related deaths Most common (>20%) adverse events related to FICERA – summary by preferred term and maximum grade: All 1L R/M HNSCC subjects received 1500mg QW and FICERA 1500 mg QW + pembro in 1L pembrolizumab (n=42) R/M HNSCC safety pr
Slide 16: FICERA case highlight: rapid lesion shrinkage and deep response in aggressive HNSCC
FICERA case highlight: rapid lesion shrinkage and deep response in aggressive HNSCC 66-year-old male with recurrent oral cavity cancer Tumor assessment Baseline: One target lesion of 49 mm Prior Therapy: 6-week scan: 55% Disease characteristics shrinkage in target lesion • Oct 2021: Partial glossect
Slide 17: Phase 1b data evaluating higher, less frequent dose support alternate dosing regimen
Phase 1b data evaluating higher, less frequent (2000mg FICERA Q2W) dose support development of alternate dosing regimen FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC • Confirmed ORR: 48% (13/27) * ▪ Disease Control Rate: 85% (23/27) 100 PD * CPS 1-19 PD • Deep Responses: 77% (10/1
Slide 18: FICERA continues to exhibit a generally well-tolerated safety profile
Safety Data FICERA continues to exhibit a generally well-tolerated safety profile FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC Most frequently reported (≥20%) TEAEs related 1 to FICERA Safety set (N=30) Preferred term, n (%) Any grade Grade 3 Grade 4 Grade 5 Any TEAE 29 (97%) 16
Slide 19: Preliminary efficacy data demonstrated enhanced durability
Efficacy Preliminary efficacy data demonstrated enhanced durability Data FICERA 2000mg Q2W + pembrolizumab in HPV-neg, CPS≥1 1L R/M HNSCC confirmed responders Data snapshot: December 16, 2025. Investigator-assessed best overall response per RECIST 1.1. 19 *Deep response refers to ≥ 80% tumor shrinka
Slide 20: 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, dose selected for less frequent regimen pivotal study 2000mg Q2W‡ 1500mg QW† 750mg QW* Metric EE set (N=27) EE set (N=28) EE set (N=30) • Consistent safety, efficacy, depth
Slide 21: 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 22: Key principles guiding less frequent dose exploration for FICERA
Key principles guiding less frequent dose exploration for FICERA Mechanistic Patient Differentiation Meaningful Clinical Data Optionality Maintain FICERA’s hallmark TGF-β inhibition at a less Enhance convenience and Rapid and deep responses patient flexibility by offering frequent dose while being t
Slide 23: Totality of data support development of a loading and Q3W maintenance regimen
Totality of data support development of a loading and Q3W maintenance regimen for FICERA TGF-β neutralization (plasma) at 2000mg Q2W FICERA plus pembrolizumab Mechanistic Differentiation * Rapid tumor penetration and shrinkage with TGF-β targeting creates a natural opportunity to extend the dosing i
Slide 24: Totality of Phase 1b data across all doses supports clinical differentiation
Totality of Phase 1b data across all doses of FICERA supports mechanism-driven clinical differentiation Observed consistent, generally well-tolerated safety profile and rapid, deep responses in Phase 1b cohorts from 1500mg QW (ongoing Phase 3 pivotal study dose) and 2000mg Q2W FICERA (exploratory co
Slide 25: Pivotal FORTIFI-HN01 trial design enabled accelerated dose selection
Pivotal FORTIFI-HN01 trial design has enabled accelerated dose selection and efficient Phase 3 initiation FORTIFI: seamless registration-enabling Phase 2/3 study Phase 1b Phase 2 Phase 3 Open-label safety and Blinded safety, efficacy, and Blinded safety and efficacy dose selection dose selection FIC
Slide 26: Preparing for Commercial Success
Preparing for Commercial Success 26
Slide 27: 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 28: 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 29: Expanding FICERA's Potential While Maintaining Financial Discipline
Expanding FICERA’s Potential While Maintaining Financial Discipline 29
Slide 30: Known EGFR, TGF-β biological fingerprint provides rationale for expansion across solid tumors
Known EGFR, TGF-β biological fingerprint provides strong rationale for FICERA expansion potential across solid tumors Frequent EGFR TGF-β signaling Strong unmet need in solid tumors that could overexpression is pro-tumorigenic benefit from enhanced tumor penetration Ex-US market expansion represents
Slide 31: TGF-β is heavily implicated in CRC metastasis and resistance to treatment
TGF-β is heavily implicated in CRC metastasis and resistance to treatment Key Drivers of Metastatic CRC TGF-β is highly expressed in CRC and drives metastasis via: • EMT: Tumor cells undergo the epithelial-mesenchymal Angiogenesis transition (EMT) process and then spread to distant sites • Angiogene
Slide 32: FICERA positioned to address multiple pathways in mCRC
FICERA positioned to address multiple pathways in mCRC Currently, two main targeted approaches to treating RAS/BRAFwt mCRC (MSS): Anti-EGFR FICERA Anti-Angiogenic / Anti-VEGF Simultaneously targeting Approved Agents: both anti-EGFR and anti- Approved Agents: • Cetuximab angiogenic pathways via • Bev
Slide 33: Expansion to 3L+ MSS RASwt metastatic colorectal cancer (mCRC)
Expansion to 3L+ MSS RASwt metastatic colorectal cancer (mCRC) Initial Ph. 1/2 Proof of Concept Study Unresectable mCRC: • 2-3 previous lines FICERA – Anti-EGFR is not the last N ~20 line of treatment – Received prior biologics Randomized i.e. anti-VEGF 1:1 FICERA + pembro • Confirmed RAS/BRAF wt an
Slide 34: Anticipated key milestones in 2026 to drive growth and value inflection
Anticipated key milestones in 2026 to drive growth and value inflection 2026 Milestones Timing Determine OBD for Phase 2/3 FORTIFI-HN01 study of ficerafusp alfa in 1L R/M HPV-negative HNSCC Present data from an exploratory Phase 1b expansion cohort evaluating 2000 mg of ficerafusp alfa every other w
Slide 35: Maximizing the franchise value of FICERA
Maximizing the franchise value of FICERA Indication Phase 1b Phase 2 Phase 3 Commercial 1L R/M HPV-Negative Head and Neck Squamous Cell Carcinoma 1500mg QW plus pembrolizumab to support Pivotal study dose selected OBD selection 750mg QW plus pembrolizumab to support OBD selection 2000mg Q2W plus pem
Slide 36: Thank You
BICARA THERAPEUTICS” Thank You