Bicara Therapeutics Inc. · NASDAQ:BCAX

Bicara Therapeutics — Investor Presentation (November 2024)

22 slides from Bicara Therapeutics's investor presentation, Nov 12, 2024

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 product development activi
Slide 3: Bicara Therapeutics Investment Highlights
Copyright © 2024 Bicara Therapeutics Bicara Therapeutics Investment Highlights Advancing ficerafusp alfa – a bifunctional EGFR-directed antibody x TGF-β ligand trap 1 5 4 3 2 Ficerafusp alfa + pembrolizumab offers a potential new chemo-free 1L therapy for HPV-negative R/M HNSCC that may meaningfully
Slide 4: Bicara is led by a seasoned and energetic management team
Bicara Therapeutics is led by a seasoned and energetic management team Copyright © 2024 Bicara Therapeutics Claire Mazumdar, Ph.D., MBA Chief Executive Officer Ivan Hyep, MBA Chief Financial Officer Ryan Cohlhepp, Pharm.D. President & Chief Operating Officer David Raben, M.D. Chief Medical Officer J
Slide 5: Ficerafusp alfa's bifunctional design targets EGFR and TGF-β directly in the TME
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa’s bifunctional design targets EGFR and TGF-b directly in the TME to drive a differentiated clinical profile MOA Action 1 Targeting EGFR Direct anti-tumor effect Inhibits EGFR signaling, killing cells Maintains ADCC functionality to EGFR+ cells Dri
Slide 6: Clinical biomarkers demonstrated tumor target engagement in Ph. 1/1b
Ficerafusp alfa clinical biomarkers demonstrated tumor target engagement in Ph. 1/1b and predicted MOA Copyright © 2024 Bicara Therapeutics MOA First definitive demonstration of pSMAD2 knockdown in patient tumors by a TGF-b inhibitor Ficerafusp alfa dose (mg QW) Statistically significant inhibition
Slide 7: Ficerafusp alfa dose expansion strategy driven by strong biologic rationale
EGFR Overexpression Role of TGF-β Copyright © 2024 Bicara Therapeutics Ficerafusp alfa dose expansion strategy driven by strong biologic rationale for the dual inhibition of both EGFR and TGF-β 2L+ CSCC n = 12 + 25* ficerafusp alfa monotherapy R/M 1L HNSCC n = 13+ 26* 2L+ SCAC ficerafusp alfa + pemb
Slide 8: HNSCC is a common cancer with significant unmet need
Copyright © 2024 Bicara Therapeutics Sources: Cancer.net, Cleveland Clinic (2022); SEER 2012-2018 data; Cerner (2022); Bedi et al. Mol Cancer Ther. 2012; Acta Otorhinolaryngol Ital. 2020, KeyNote-048 ph.3 trial; ASCO (2022); DRG HNSCC (2019) HNSCC is a common cancer with significant unmet need for i
Slide 9: HNSCC patient journey and treatment landscape
Copyright © 2024 Bicara Therapeutics Symptoms Testing and Staging MDT & Treatment Patient presents to primary care/ENT with symptoms: Pain, swallowing difficulty, mucosal bleeding, asthenia, weight loss 1 2 3 Diagnosis of cancer Work-up may include: Laryngoscopy, biopsy, imaging (CT scan, MRI) HPV/p
Slide 10: Ficerafusp alfa + pembrolizumab studied in R/M HNSCC expansion cohort
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa + pembrolizumab studied in a R/M HNSCC expansion cohort based on mechanistic synergies with anti-PD-1 and IST precedent Design Open-label, single-arm Phase 2 in 1L R/M HNSCC (n=33) Cetux + pembro Efficacy Data: ORR = 48% CR = 3% mPFS = 6.5 months
Slide 11: Ficerafusp alfa + pembrolizumab demonstrates preliminary activity in 1L R/M HNSCC
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa + pembrolizumab demonstrates compelling preliminary activity and depth of response in 1L R/M HNSCC regardless of HPV status Note: Out of 42 patients, 3 patients were non-efficacy evaluable. Best overall response (investigator-assessed according to
Slide 12: 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-β1 in
Slide 13: Improved activity and depth of response in HPV-negative CPS≥1 1L R/M HNSCC
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa + pembrolizumab demonstrates significantly improved activity and depth of response in HPV-negative CPS≥1 1L R/M HNSCC In HPV-negative patients: 64% (18/28) ORR observed, CPS≥1 patients Historical1 pembro mono expected to be ~19% ORR 15/18 confirme
Slide 14: HPV-negative 1L HNSCC suggests improved median PFS over pembro monotherapy
Copyright © 2024 Bicara Therapeutics HPV-negative 1L HNSCC suggests improved median PFS over pembro monotherapy supportive of TGF-b hypothesis Median PFS of 9.8 months in HPV-negative subgroup 57% (16/28) of pts with PFS>6 months Median duration of response (DOR) not yet reached Median overall survi
Slide 15: Ficerafusp alfa has been generally well-tolerated with no treatment-related deaths
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa has been generally well-tolerated with no treatment-related deaths HNSCC Most common (>10%) related adverse events – summary by preferred term and maximum grade ficerafusp alfa + pembro 1L HNSCC safety profile: EGFR-related AEs: 76% had dermatitis
Slide 16: Ph.1b expansion supports a pivotal trial with path to accelerated approval
Copyright © 2024 Bicara Therapeutics Ficerafusp alfa 1L HNSCC Ph.1b expansion supports a pivotal trial with path to accelerated approval Alignment with FDA on registrational trial design Feedback supports potential accelerated approval pathway 64% ORR in HPV-negative, CPS≥1 R/M HNSCC in combination
Slide 17: FORTIFI-HN01 Phase 2/3 trial design allows for efficient path-to-market
Copyright © 2024 Bicara Therapeutics FORTIFI-HN01 Phase 2/3 trial design allows for efficient path-to-market R/M HNSCC 1L Setting CPS ≥ 1 excl. HPV-positive OPSCC R ficerafusp alfa 1500mg QW + Pembrolizumab 200mg Q3W ficerafusp alfa 750mg QW + Pembrolizumab 200mg Q3W Pembrolizumab 200mg Q3W ficerafu
Slide 18: Advancing to earlier stages of HNSCC represents a significant opportunity
Copyright © 2024 Bicara Therapeutics Relapse 1L R/M HNSCC CPS = 0 CPS≥1 Platinum-based + cetuximab Study Platinum + 5FU + Pembro2 Study Pembrolizumab mono 50% Relapse within 2 years after treatment for LA HNSCC1 LA HNSCC Metastatic at diagnosis expansion opportunities Advancing to earlier stages of
Slide 19: Potential expansion to areas of EGFR / TGF-β involvement
Potential expansion to areas of EGFR / TGF-β involvement: Cutaneous squamous cell carcinoma (cSCC) – preliminary 42% ORR (5/12) in 2L+ PD-1-refractory with ficerafusp alfa monotherapy Colorectal cancer (CRC) – cetuximab precedent Squamous cancer of the anal canal (SCAC) Copyright © 2024 Bicara Thera
Slide 20: Future clinical studies evaluating ficerafusp alfa in HNSCC and other SCCs
CRC Cutaneous SCC (cSCC) 1L R/M HNSCC CPS = 0 Neoadjuvant / locally advanced HNSCC Copyright © 2024 Bicara Therapeutics Future clinical studies evaluating ficerafusp alfa in HNSCC and other SCCs and solid tumors Beyond HNSCC Opportunity: CPS = 0 is roughly 20% of R/M HNSCC Significant unmet with onl
Slide 21: Clinical, regulatory and financial summary
Clinical Showed strong clinical activity of ficerafusp alfa in combination with pembro in HPV-negative 1L R/M HNSCC (64% ORR, 18% CRR, 9.8mos PFS) Demonstrated activity of ficerafusp alfa in other squamous cell carcinomas and solid tumors Copyright © 2024 Bicara Therapeutics Bicara Therapeutics hope

Bicara Therapeutics — Investor Presentation (November 2024) on 6ix

Bicara Therapeutics — Investor Presentation (November 2024)

Slide 1: Fighting cancer with precision and power

Slide 2: Forward-Looking Statements

Slide 3: Bicara Therapeutics Investment Highlights

Slide 4: Bicara is led by a seasoned and energetic management team

Slide 5: Ficerafusp alfa's bifunctional design targets EGFR and TGF-β directly in the TME

Slide 6: Clinical biomarkers demonstrated tumor target engagement in Ph. 1/1b

Slide 7: Ficerafusp alfa dose expansion strategy driven by strong biologic rationale

Slide 8: HNSCC is a common cancer with significant unmet need

Slide 9: HNSCC patient journey and treatment landscape

Slide 10: Ficerafusp alfa + pembrolizumab studied in R/M HNSCC expansion cohort

Slide 11: Ficerafusp alfa + pembrolizumab demonstrates preliminary activity in 1L R/M HNSCC

Slide 12: HPV-negative disease demonstrates distinct biological and mutational features

Slide 13: Improved activity and depth of response in HPV-negative CPS≥1 1L R/M HNSCC

Slide 14: HPV-negative 1L HNSCC suggests improved median PFS over pembro monotherapy

Slide 15: Ficerafusp alfa has been generally well-tolerated with no treatment-related deaths

Slide 16: Ph.1b expansion supports a pivotal trial with path to accelerated approval

Slide 17: FORTIFI-HN01 Phase 2/3 trial design allows for efficient path-to-market

Slide 18: Advancing to earlier stages of HNSCC represents a significant opportunity

Slide 19: Potential expansion to areas of EGFR / TGF-β involvement

Slide 20: Future clinical studies evaluating ficerafusp alfa in HNSCC and other SCCs

Slide 21: Clinical, regulatory and financial summary

Slide 22: Fighting cancer with precision and power