Bicara Therapeutics Inc. · NASDAQ:BCAX
Bicara Therapeutics — Investor Presentation (January 2025)
26 slides from Bicara Therapeutics's investor presentation, Jan 13, 2025
Slide 1: Fighting cancer with precision and power
Exhibit 99.1 Fighting cancer with precision and power. Corporate Presentation | January 2025 © 2024 - 2025 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 product development activi
Slide 3: Bicara Therapeutics Investment Highlights
Bicara Therapeutics Investment Highlights Advancing ficerafusp alfa (FICERA) – a bifunctional EGFR-directed antibody x TGF-β ligand trap FICERA + pembro offers a potential new chemo-free 1L therapy for HPV-negative 1 R/M HNSCC that may meaningfully improve upon current standard of care FORTIFI-HN01
Slide 4: Bicara Therapeutics is led by a seasoned and driven management team
Bicara Therapeutics is led by a seasoned and driven management team Ryan Cohlhepp, Pharm.D. Claire Mazumdar, Ph.D., MBA Ivan Hyep, MBA President & Chief Operating Chief Financial Officer Chief Executive Officer Officer David Raben, M.D. Lara Meisner, J.D. Rachel Salazar, D.H.Sc. Chief Medical Office
Slide 5: Maximizing the value of FICERA across HNSCC & other solid tumors
Maximizing the value of FICERA across HNSCC & other solid tumors Indication Phase 1/1b Phase 2/3 Status 1L R/M Head and Neck Squamous Cell Carcinoma Pivotal Ph. 2/3: FORTIFI-HN01 – 1500mg QW (+ pembro) Trial initiated December 2024 Ph. 1b Expansion Cohort – 1500mg QW (+ pembro) Updated data expected
Slide 6: FICERA's bifunctional design targets EGFR and TGF-β directly in the TME
FICERA’s bifunctional design targets EGFR and TGF-β directly in the MOA TME to drive a differentiated clinical profile Action 2 Improve tolerability Trapping TGF-β 1. Improves immune response Improve anti-tumor (anti-PD-1 Synergies) activity • Relieves immune suppression • Blocks cancer associated f
Slide 7: FICERA clinical biomarkers demonstrated tumor target engagement and predicted MOA
FICERA clinical biomarkers demonstrated tumor target engagement in MOA Ph. 1/1b and predicted MOA Statistically significant inhibition of tumor TGF-β observed at FICERA doses >750mg via pSMAD2 levels FICERA dose (mg QW) First definitive demonstration of pSMAD2 knockdown in patient tumors by a TGF-β
Slide 8: FICERA dose expansion strategy driven by strong biologic rationale
Dose FICERA dose expansion strategy driven by strong biologic rationale for Expansion the dual inhibition of both EGFR and TGF-β Dose Expansion FICERA monotherapy EGFR 2L+ CSCC Overexpression n = 12 + 25* FICERA – 1500mg QW Based on preliminary efficacy and safety & tolerability data, 1500mg QW FICE
Slide 9: HNSCC is a common cancer with significant unmet need
Market HNSCC is a common cancer with significant unmet need for improved Opportunity treatment options that extend survival Overview of head & neck cancers ~67,000 • Head and neck cancer accounts for ~4% of all cases of HNSCC each year in the U.S. cancers in the U.S. • Squamous cell carcinomas repre
Slide 10: The patient journey in HNSCC
Market The patient journey in HNSCC Opportunity Symptoms 1 Relapse 4 LA HNSCC Patient presents to primary care/ENT with symptoms: 50% Relapse within 2 years Pain, swallowing difficulty, mucosal 1 after treatment for LA HNSCC bleeding, asthenia, weight loss Testing and Staging 2 Work-up may include:
Slide 11: HNSCC patients suffer significant symptomology and represent a major unmet need
Market HNSCC patients suffer significant symptomology and represent a major Opportunity unmet need Patients experience acute and chronic toxicities after surgery and/or chemo-radiation Acute side effects Chronic side effects • Painful sores in the mouth or throat (oral • Trismus – difficulty opening
Slide 12: FICERA + pembro R/M HNSCC expansion cohort based on mechanistic synergies
FICERA + pembro R/M HNSCC expansion cohort based on mechanistic 1L HNSCC synergies with anti-PD-1 and IST precedent Two ISTs exploring anti-PD-1 + cetuximab help inform FICERA registration path 1 Study KEYNOTE-048 Sacco, et al 2021 Chung, et al 2022 Action 2 Published Trapping TGF-β Pembro Cetux + p
Slide 13: FICERA + pembro demonstrates compelling activity and depth of response in 1L R/M HNSCC
FICERA + pembro demonstrates compelling activity and depth of 1L HNSCC response in 1L R/M HNSCC regardless of HPV status FICERA + pembro expansion in R/M HNSCC • Population § 1L R/M HNSCC § Oral cavity, oropharynx, hypopharynx & larynx § HPV testing required for oropharyngeal cancer § CPS≥1 • 54% (2
Slide 14: HPV-negative R/M HNSCC: overexpression of EGFR and TGF-β
Market HPV-negative R/M HNSCC: a challenging tumor type associated with Opportunity overexpression of EGFR and TGF-β HPV-negative disease demonstrates Overexpression of EGFR and TGF-β in HNSCC distinct biological and mutational features correlated with a poor prognosis • HPV-negative disease is etio
Slide 15: FICERA + pembro improved activity and depth of response in HPV-negative CPS≥1
FICERA + pembro demonstrates significantly improved activity and 1L HNSCC depth of response in HPV-negative CPS≥1 1L R/M HNSCC In HPV-negative patients: • 64% (18/28) ORR observed, CPS≥1 patients 1 § Historical pembro mono expected to be ~19% ORR § 15/18 confirmed responses • High response rates in
Slide 16: HPV-negative 1L HNSCC suggests improved median PFS over pembro monotherapy
HPV-negative 1L HNSCC suggests improved median PFS over pembro 1L HNSCC monotherapy supportive of TGF-β 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 survival (OS) not yet rea
Slide 17: FICERA has been generally well-tolerated with no treatment-related deaths
1L HNSCC FICERA has been generally well-tolerated with no treatment-related deaths Most common (>10%) related adverse events – summary by preferred term and maximum grade All 1L R/M HNSCC subjects received 1500mg QW and Pembrolizumab (n=42) All Grade Grade FICERA + pembro in 1L R/M HNSCC Preferred t
Slide 18: FICERA Ph.1b expansion supports a pivotal trial with path to accelerated approval
FICERA 1L HNSCC Ph.1b expansion supports a pivotal trial with path to 1L HNSCC accelerated approval FICERA has demonstrated a strong clinical profile • 64% ORR in HPV-negative, CPS≥1 R/M HNSCC in combination with pembro vs. ~19% 1 historical pembro monotherapy • 18% complete response rate vs. ~3-5%
Slide 19: FORTIFI-HN01 Phase 2/3 trial design allows for efficient path-to-market
FORTIFI- FORTIFI-HN01 Phase 2/3 trial design allows for efficient path-to-market HN01 Potential Potential Accelerated Approval Full Approval Interim Analysis Endpoint: Endpoint: Dose Selection ORR (primary) OS (primary) FICERA 1500mg QW + Pembro 200mg Q3W FICERA optimal dose R/M HNSCC + FICERA 750mg
Slide 20: Seamless design in FORTIFI-HN01 expedites timelines to potential approval
FORTIFI- Seamless design in FORTIFI-HN01 expedites timelines to potential HN01 approval Ph. 2/3 FORTIFI-HN01 is designed such that patients enrolled in dose selection at the optimal dose will contribute to the final efficacy analyses, while those at the non-optimal dose will not Enrollment not stopp
Slide 21: Proposed OBD data package will include data from both Ph1b and Ph2/3
Dose Proposed OBD data package will include data from both Ph1b and Ph2/3 Selection studies Based on FDA feedback, team will request a Type D meeting to seek agreement on the dose to carry forward 1 N = 30 FICERA dose 1500mg >2 years follow up Ph. 1/1b selection: QW Extended (n=39) Dose Expansion sa
Slide 22: Advancing to earlier stages of HNSCC represents a significant opportunity
LA HNSCC Advancing to earlier stages of HNSCC represents a Opportunity significant opportunity for FICERA expansion opportunity Relapse LA HNSCC 50% Relapse within 2 years 1 after treatment for LA HNSCC >60K cases / year in U.S. 1L R/M HNSCC Metastatic at diagnosis Recurrent / Metastatic CPS = 0 CPS
Slide 23: Most HNSCC patients are diagnosed with locally advanced HNSCC
LA HNSCC Most HNSCC patients are diagnosed with locally advanced (LA) HNSCC Opportunity Strong rationale to explore FICERA in LA-HNSCC Standard-of-care HNSCC disease stage 2,3 Stage 2,3 treatment 1 at diagnosis 60% 30% Locally Treatment goals for 30% Radiotherapy or surgery Early stage advanced pati
Slide 24: Plan to expand FICERA to additional tumor types
Beyond Plan to expand FICERA to additional tumor types where there is strong HNSCC biologic rationale and / or early signals of activity Other Solid Tumors / Squamous Cell Carcinomas FICERA monotherapy: 42% ORR across n=12 patients in 2L+ post-PD-1 Potential expansion to areas of EGFR / TGF-β involv
Slide 25: Expansion to 3L+ MSS RASwt metastatic colorectal cancer
CRC Expansion to 3L+ MSS RASwt metastatic colorectal cancer (mCRC) Initial Ph. 1/2 Proof of Concept Study Expansion to mCRC Unresectable mCRC • EGFR an established target in mCRC FICERA • 2-3 previous lines N = ~20 in Stage 1 • Ability to target TGF-β driven resistance to • Anti-EGFR is not the last
Slide 26: Bicara Therapeutics is poised to establish FICERA + pembro as a new potential therapy
Bicara Therapeutics is poised to establish FICERA + pembro as a new At a Glance potential therapy for 1L HPV-negative R/M HNSCC Focus Key Achievements Showed strong clinical activity of FICERA in combination with pembro in HPV-negative 1L ü R/M HNSCC (64% ORR, 18% CRR, 9.8mos PFS) Clinical Demonstra
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