Bicara Therapeutics Inc. · NASDAQ:BCAX

Bicara Therapeutics — Investor Presentation (August 2026)

37 slides from Bicara Therapeutics's investor presentation, August 2026

  1. Slide 1: Fighting cancer with precision and power

    Fighting cancer with precision and power. August 2026 Corporate Deck Copyright © 2026 Bicara Therapeutics

  2. 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

  3. 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

  4. Slide 4: FICERA – EGFR-directed antibody combined with a TGF-β ligand trap designed to drive tumor penetration

    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 tumors including HPV-negative R/M 2. Drives tumor targeting HNSCC 2 Trapping TGF

  5. 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

  6. Slide 6: Building momentum toward a potential breakthrough in HPV-negative HNSCC

    Building momentum toward a potential breakthrough in HPV-negative HNSCC Differentiated overall survival representing a ~2x increase vs. standard of care1 and 1 generally well-tolerated safety out to three years at pivotal study dose TGF-β inhibition translates to unprecedented depth of response, dri

  7. Slide 7: 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 7

  8. Slide 8: Significant unmet need for better treatment options in HPV-negative HNSCC patients

    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 vast majority (80 – 90%) of Pembro1 HNSCC in the R/M setting chemo1 ORR ~19% ~36% Characterized by high tumor burden and Media

  9. Slide 9: Baseline characteristics were balanced across cohorts

    Baseline characteristics were balanced across cohorts and evaluated in patients across the spectrum of disease burden 750mg QW (N=31) 1500mg QW (N=30) 2000mg Q2W (N=30) Age, median (min-max) 64 (28-78) 63 (31-84) 63 (32-94) Sex, n (%) Male 20 (65) 19 (63) 20 (67) Female 11 (35) 11 (37) 10 (33) Prima

  10. Slide 10: FICERA continued to exhibit a generally well-tolerated safety profile

    FICERA continued to exhibit a generally well-tolerated safety profile Most frequently reported (≥20%) TEAEs related to ficerafusp alfa 750mg QW (N=31) 1500mg QW (N=30) 2000mg Q2W (N=30) Preferred term Any Grade* Grade 3 Any Grade† Grade 3 Any Grade* Grade 3 Any TRAE 31 (100) 11 (35) 28 (93) 15 (50)

  11. Slide 11: 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)

  12. Slide 12: TGF-β inhibition drives rapid, deep responses and dose-dependent CR rates

    TGF-β inhibition drives rapid, deep responses and dose-dependent CR rates across cohorts 750mg QW 1500mg QW 2000mg Q2W 100 320 100 Confirmed ORR (95% CI) 57% (37%-74%) CPS Confirmed ORR (95% CI) 54% (34%-72%) CPS Confirmed ORR (95% CI) 48% (29%-68%) CPS 80 DCR 80% ≥20 80 DCR 89% ≥20 80 DCR 85% ≥20 C

  13. Slide 13: 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 + chemotherapy1 ~6.7 months Non-Tumor Penetrant (Chemo / EGFR) 10.1 Pembro + lenvatinib2 Responses months HPV-All ~11.0 Pembro + petosemtamab3 months Tumor Penetrant 13

  14. Slide 14: FICERA demonstrated clinically meaningful DOR across dose cohorts

    FICERA demonstrated clinically meaningful DOR across dose cohorts 750mg QW 1500mg QW 2000mg Q2W 100 100 100 Censored Censored Censored 80 80 80 Ongoing response, % 60 60 60 40 40 40 Total, Events, Censored, Median DOR, Total, Events, Censored, Median DOR (95% Total, Events, Censored, Median DOR, 20

  15. Slide 15: FICERA demonstrated clinically meaningful PFS across dose cohorts

    FICERA demonstrated clinically meaningful PFS across dose cohorts 750mg QW 1500mg QW 2000mg Q2W 100 100 100 Total, Events, Censored, Median PFS Total, Events, Censored, Median PFS Total, Events, Censored, Median PFS n n n (95% CI), months n n n (95% CI), months n n n (95% CI), months 80 30 19 11 6.9

  16. Slide 16: FICERA demonstrated clinically meaningful OS across dose cohorts

    FICERA demonstrated clinically meaningful OS across dose cohorts 750mg QW 1500mg QW 2000mg Q2W 100 100 100 Total, Events, Censored, Median OS, Total, Events, Censored, Median OS Total, Events, Censored, Median OS, n n n months n n n (95% CI), months n n n months 80 30 15 15 Not mature 80 28 20 8 21.

  17. Slide 17: FICERA demonstrated rapid, deep responses across disease burden

    FICERA demonstrated rapid, deep responses across disease burden, supporting a chemo-free therapeutic approach Confirmed ORR by CPS score, tumor burden and 750mg QW 1500mg QW 2000mg Q2W disease site (n=30) (n=28) (n=27) CPS 1-19: 1-19 73 (8/11) 54 (7/13) 57 (8/14) FICERA delivered 54-73% CPS, % (n/N)

  18. Slide 18: DOR: deep responders maintained DOR for a median 31.6 months

    DOR: deep responders with ≥ 80% tumor shrinkage maintained DOR for a median 31.6 months across pooled cohort analysis Depth of response Events, n Censored, n Median DOR (95% CI), months 100 Deep response (n=30) 11 19 31.6 (21.6-NE) PR <80% (n=15) 8 7 8.2 (4.0-NE) HR, 0.31 80 (95% CI, 0.11-0.84) Ongo

  19. Slide 19: PFS and OS: Deep responders showed durable benefit across pooled cohort analysis

    PFS and OS: Deep responders showed durable and clinically meaningful benefit across pooled cohort analysis Median PFS Median OS Depth of response (95% CI), months Depth of response (95% CI), months Deep response (n=30) 36.9 (22.7-NE) Not reached (26.3- Deep response (n=30) 100 PR <80% (n=15) 10.9 (5

  20. Slide 20: 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 TGF-β Inhibition Tumor Penetration Depth of Response At 24-Weeks pSMAD2 CD8+ T Cell Tumor Infiltration 73% 750 mg QW 1500 mg QW 2000 mg Q2W 64% 27% Median Depth of Response % Of Responders Achieving Deep (≥80%) Resp

  21. Slide 21: 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

  22. Slide 22: FICERA's clinical profile aligns with what oncologists say matters most

    FICERA's clinical profile aligns with what oncologists say matters most at the point of treatment selection More impact on treatment decisions Overall survival (mOS), Hazard Ratio (HR) Progression Free Survival (mPFS) In addition to OS and PFS, CR rates, DOR, and depth of KEY DIFFERENTIATORS Complet

  23. Slide 23: 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

  24. Slide 24: 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 int

  25. Slide 25: Totality of Phase 1b data supports mechanism-driven 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

  26. Slide 26: Pivotal FORTIFI-HN01 trial design has 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 2 Phase 3 Blinded safety, efficacy, and Blinded safety and efficacy dose selection FICERA 1500mg QW + 200mg pembro Q3W Primary endpo

  27. Slide 27: 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

  28. Slide 28: Preparing for Commercial Success

    Preparing for Commercial Success 28

  29. Slide 29: FICERA has the potential to significantly expand the HPV-negative HNSCC market

    FICERA has the potential to significantly expand the HPV-negative HNSCC market Pioneer Treatment Paradigm Shift Continue to build market understanding of HPV-negative HNSCC as a distinct $5B+ clinical disease Drive Better Patient Outcomes 2-3X responses projected global market 2-3X duration of respo

  30. Slide 30: Expanding FICERA's Potential While Maintaining Financial Discipline

    Expanding FICERA’s Potential While Maintaining Financial Discipline 30

  31. Slide 31: 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

  32. Slide 32: 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

  33. Slide 33: 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

  34. Slide 34: 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 N

  35. Slide 35: Anticipated key milestones in 2026 to drive growth and value inflection

    Anticipated key milestones in 2026 to drive growth and value inflection Expect to present data from Presented data from Phase Presented long-term Phase 1b cohort evaluating FICERA 1b cohort evaluating follow-up data from Phase both as monotherapy and 2000 mg of FICERA Q2W + 1b study of FICERA + + pe

  36. Slide 36: Maximizing the franchise value of FICERA

    Maximizing the franchise value of FICERA Indication Phase 1b Phase 2 Phase 3 Commercial 1L R/M Head and Neck Squamous Cell Carcinoma FORTIFI-HN01 pivotal study of 1500mg QW plus pembrolizumab in HPV- Interim analysis expected mid-2027 and negative CPS>1 potential U.S. launch in 2028 Long-term follow

  37. Slide 37: Thank You

    BICARA THERAPEUTICS” Thank You

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