Bicara Therapeutics Inc. · NASDAQ:BCAX
Bicara Therapeutics — ESMO Asia 2025
22 slides from Bicara Therapeutics's conference presentation, Dec 8, 2025
Slide 1: ESMO Asia 2025 Clinical Update
ESMO Asia 2025 Clinical Update December 6, 2025 FICERA: enabling tumor penetration to drive deep and durable responses in HPV-neg HNSCC
Slide 2: Forward-looking statements
Forward-looking statements 2 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 clinical development of
Slide 3: Agenda & today's presenters
Agenda & today’s presenters 3 Claire Mazumdar, Ph.D., MBA Chief Executive Officer Ryan Cohlhepp, Pharm.D. President & Chief Operating Officer Tanya Green, MS Chief Development Officer ESMO Asia 2025 Clinical Update2 Preliminary safety & efficacy data for 750mg QW FICERA + pembro Looking Ahead 3 Cont
Slide 4: Ficerafusp Alfa (FICERA) in 1L R/M HPV-Negative HNSCC
Ficerafusp Alfa (FICERA) in 1L R/M HPV-Negative HNSCC First and only EGFR x TGF-β bifunctional antibody 4 Granted Breakthrough Therapy Designation¥ ¥ U.S. FDA Breakthrough Therapy Designation or ficerafusp alfa in combination with pembrolizumab for the first-line (1L) treatment of patients with meta
Slide 5: FICERA – first and only bifunctional EGFR-directed antibody x TGF-β ligand trap
5 FICERA – the first and only bifunctional EGFR-directed antibody x TGF-β ligand trap designed to drive tumor penetration Inadequate tumor penetration has challenged the treatment of many solid tumor cancers, including HPV-Neg R/M HNSCC FICERA was specifically designed to enable tumor penetration a
Slide 6: 1L HPV-negative R/M HNSCC is a sizable and growing market
6 1L HPV-negative R/M HNSCC is a sizable and growing market • Head and neck cancer accounts for ~4% of all cancers in the U.S. • Squamous cell carcinomas represent ~90% of H&N • Oropharyngeal lesions are typically tested for HPV HPV-positive caused by HPV infection HPV-negative typically caused
Slide 7: HPV-negative disease demonstrates distinct biological and mutational features
HPV-negative disease demonstrates distinct biological and mutational features correlated with a poor prognosis • HPV-negative disease is etiologically distinct from HPV-positive disease and associated with: Increased EGFR expression compared to HPV- positive HNSCC patients Elevated levels of TGF
Slide 8: Significant unmet need for better treatment options that improve outcomes
Significant unmet need for better treatment options that improve outcomes Pembrolizumab Pembrolizumab + chemotherapy Pembrolizumab + FICERA (1500mg QW)* ORR ~19% ~36% ~54%* mDOR ~23.4 months ~6.7 months 21.7 months* Median OS HPV-all ~12.3 months ~13.6 months NA HPV-negative ~9 months ~7 months 21.3
Slide 9: 750mg FICERA case highlight: rapid lesion shrinkage and deep response
9 750mg FICERA case highlight: rapid lesion shrinkage and deep response in aggressive HNSCC Disease characteristics • Oral Cavity • LR only • CPS 20 Multiple Comorbidities ECOG 1 Performance Status Baseline Two Weeks Eight Weeks Tumor assessment Baseline: One target lesion of 49 mm 6-week scan: 55%
Slide 10: Ongoing FORTIFI-HN01 trial design allows for efficient path-to-market
10 Ongoing FORTIFI-HN01 trial design allows for efficient path-to-market R/M HNSCC 1L Setting CPS ≥ 1 excl. HPV-positive OPSCC R FICERA 1500mg QW + Pembro 200mg Q3W FICERA 750mg QW + Pembro 200mg Q3W Pembro 200mg Q3W FICERA optimal dose + Pembro 200mg Q3W Dose Selection Endpoint: ORR (primary) Endpo
Slide 11: Phase 1b dose-expansion cohorts informing dose selection
11 Ph. 1b Overview FICERA Phase 1b dose-expansion cohorts informing dose selection HPV-Neg, CPS≥1 1L R/M HNSCC (Ph. 1b) Ph.1b Dose Expansion Cohorts Informing Dose Selection Presented here FICERA 1500mg QW + Pembrolizumab (n=30) FICERA 750mg QW + Pembrolizumab (n=31) FICERA 750mg QW + Pembrolizumab
Slide 12: Preliminary safety & efficacy data for 750mg QW FICERA + pembro
ESMO Asia 2025 Clinical Update Preliminary safety & efficacy data for 750mg QW FICERA + pembro 12
Slide 13: Baseline Characteristics
13 Baseline Characteristics Data snapshot: July 9th, 2025. . Characteristic Safety set (N=31) Age Median (range) 64 (28-78) Sex – n (%) Male/Female 20/11 (65%/35%) Primary disease site – n (%) Oropharynx 5 (16%) Oral cavity 19 (61%) Hypopharynx 5 (16%) Larynx 2 (6%) CPS – n (%) 1-19 12 (39%) ≥20 19
Slide 14: Safety
14 Safety Data snapshot: July 9th, 2025. *TRAEs includes TEAEs possibly, probably, or definitely related to ficerafusp alfa; also includes TEAEs with missing drug relationships. †n=1 each for TEAEs leading to dose reduction and discontinuation. AE = adverse event; TEAE = treatment-emergent adverse e
Slide 15: Efficacy
15 Efficacy Data snapshot: July 9th, 2025. Investigator-assessed best overall response per RECIST 1.1.* Includes one unconfirmed CR at the time of data snapshot. HPV-negative efficacy-evaluable population (n=30). 1 patient was not evaluable for efficacy due to early death unrelated to treatment. 1 p
Slide 16: Ph. 1b Summary
16 Ph. 1b Summary Data snapshot: July 9th, 2025. *Breakthrough Therapy Designation (BTD) granted for the first line treatment of patients with metastatic or with unresectable, recurrent (R/M) HNSCC whose tumors express PD-L1 with CPS ≥1, excluding HPV-positive oropharyngeal squamous cell carcinoma (
Slide 17: Looking Ahead: Contextualizing 750mg QW dose in FORTIFI-HN01 Trial
Looking Ahead Contextualizing 750mg QW dose in FORTIFI-HN01 Trial 17
Slide 18: Efficacy By Dose
18 Efficacy By Dose 1. Data snapshot: July 9th, 2025. 2. Presented at ASCO 2025. 3. Data from KEYNOTE-048 represents CPS≥1, HPV-all population. HPV-negative efficacy-evaluable population. Investigator-assessed best overall response per RECIST 1.1. Deep response refers ≥ 80% tumor shrinkage from base
Slide 19: Biomarkers By Dose
19 Biomarkers By Dose Bicara Therapeutics data on file. Plots show mean with SEM. **p ≤ 0.01 pSMAD2 Analysis: N=5 samples at 750mg, N=7 samples at 1500mg. Immune-activation cytokine analysis: N=24 samples for 750mg (except N=25 for CXCL10), N=27 for 1500mg. Higher doses of FICERA demonstrate increas
Slide 20: Dose Comparison
20 Dose Comparison Bicara Therapeutics data on file. TME = tumor microenvironment. Median depth of response represents the median of the best percent change from baseline amongst the confirmed responders at 24-weeks follow-up. Increased TGF-β inhibition in the tumor drives deeper responses FICERA 75
Slide 21: 750mg data further derisk pivotal FORTIFI-HN01 study
21 750 mg data further derisk pivotal FORTIFI-HN01 study 1 4 3 2 Consistently high ORR across multiple dose levels increases confidence in the ORR interim analysis Consistent safety and early efficacy profiles observed across the 750mg and 1500mg FICERA dose regimens, and generally well-tolerated Do
Slide 22: Thank You
BICARA THERAPEUTICS” Thank You