Bicara Therapeutics

What Bicara Therapeutics does

Bicara Therapeutics is a clinical-stage biopharmaceutical company developing ficerafusp alfa (BCA101), a first-in-class bifunctional antibody designed to simultaneously target the EGFR receptor on tumor cells and modulate TGF-β signaling in the tumor microenvironment. Its lead clinical focus is first-line treatment of HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in combination with Merck's pembrolizumab, supported by FDA Breakthrough Therapy Designation granted in October 2024 and the pivotal Phase 3 FORTIFI-HN01 trial. The company plans to broaden the asset into additional solid tumor indications including metastatic colorectal cancer.

Bicara has no approved products and generates no commercial revenue today; its economic model is anchored on future pharmaceutical sales of ficerafusp alfa upon regulatory approval in the United States, supplemented by potential licensing and royalty income in additional indications or territories. Capital is being deployed to build a US specialty-pharmacy and field-sales distribution channel targeting oncologists and head/neck specialists at major cancer centers, with commercial infrastructure work accelerated by a February 2026 follow-on public offering and the May 2026 appointment of a Chief Commercial Officer with nine prior oncology launches.

Founded in 2018 as a Biocon spinout, Bicara has raised approximately $807.5 million across a Series B, Series C, a $362 million September 2024 Nasdaq IPO, and follow-on offerings in 2026, ending Q1 2026 with $539.8 million in cash to fund operations into 2029. The company is headquartered in Boston, Massachusetts, employs 51-100 people, and reports FY 2025 and Q1 2026 net losses of $137.95 million and $56.2 million respectively, consistent with late-stage clinical development and pre-launch investment.

Name

Bicara Therapeutics

Legal name

Bicara Therapeutics, Inc.

Website

https://bicara.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

101–250 employees

Short description

Bicara Therapeutics is a clinical-stage biopharmaceutical company developing ficerafusp alfa, a first-in-class bifunctional EGFR/TGF-β antibody, for HPV-negative head and neck squamous cell carcinoma in combination with pembrolizumab, with broader solid tumor expansion plans.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Bispecific & Multispecific Antibodies (HLAAAAAF)

akta.pro secondary industries

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Immunology & Inflammation Pharmaceuticals (HLAIAAAD)

Keywords

• Bifunctional antibody therapy
• Oncology drug development
• Head and neck cancer treatment
• Tumor microenvironment modulators
• EGFR TGF-beta antibody

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Marketing or Sales, Personnel

Revenue model

1. Pharmaceutical drug sales: As a clinical-stage biopharmaceutical company with no current revenue, Bicara Therapeutics plans to generate revenue through commercial sales of its drug candidates, primarily ficerafusp alfa upon FDA approval. The company is building commercial infrastructure to support potential launch.
2. Drug licensing and partnerships: Future potential revenue from licensing agreements for ficerafusp alfa in additional indications or territories.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class bifunctional antibody therapies that combine tumor-targeting antibodies with tumor microenvironment modulators. Its lead product candidate, ficerafusp alfa (BCA101), is a dual-action EGFR/TGF-β antibody being developed for solid tumor cancers, with primary focus on HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab. The candidate is in late-stage clinical development (pivotal Phase 3 FORTIFI-HN01) and has received FDA Breakthrough Therapy Designation.

Product overview

Bicara Therapeutics is a clinical-stage biotechnology company developing a single lead product: ficerafusp alfa (BCA101), a first-in-class bifunctional EGFR/TGF-β antibody. The company is focused on developing this novel biologic therapy for the treatment of solid tumors, with primary emphasis on head and neck squamous cell carcinoma (HNSCC). The product is currently in late-stage clinical trials (Phase 2/3 FORTIFI-HN01 pivotal trial) and has received FDA Breakthrough Therapy Designation for first-line HPV-negative recurrent/metastatic HNSCC in combination with pembrolizumab.

Differentiator

Problem solved

Functional benefit

Products and services

• Ficerafusp alfa (BCA101)

Quantifiable outcome

• 31% overall survival at 3 years with 1500mg weekly dose of ficerafusp alfa plus pembrolizumab
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Two partnerships are on record, tiered core.

• BioconcoreStrategic or Co-development Partner · 1 September 2024Biocon incubated Bicara Therapeutics and is its founding partner. Claire Mazumdar, CEO of Bicara, is the niece of Biocon founder Kiran Mazumdar-Shaw. Bicara is positioned as Biocon's succession vehicle and innovation arm for novel biologics development.
• Merck (Pembrolizumab partnership)coreStrategic or Co-development PartnerFicerafusp alfa is being developed in combination with pembrolizumab (Keytruda) from Merck. Bicara has received FDA Breakthrough Therapy Designation for this combination therapy in first-line HPV-negative recurrent/metastatic HNSCC.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• MacroGenics: Clinical-stage biotech developing bispecific antibodies for oncology, including DART platform molecules targeting solid and hematologic tumors. Directly comparable to Bicara's bifunctional antibody approach and oncology-focused pipeline.
• Genmab: Pioneer in bispecific antibody technology (Duobody platform) with approved oncology assets including Rybrevant and Tecvayli. Closely comparable business model as a bispecific-antibody-focused oncology company.
• Merus: Clinical-stage oncology biotech developing bispecific antibodies (Biclonics and Triclonics platforms), including petosemtamab in HNSCC. Direct competitor in both bispecific antibody technology and HNSCC indication.
• Akeso: China-based biotech with a leading bispecific antibody pipeline including ivonescimab (PD-1/VEGF), a novel dual-mechanism oncology biologic. Directly comparable as a clinical-stage bispecific antibody developer.
• Coherus BioSciences: Commercial-stage biopharmaceutical company with U.S. rights to toripalimab (Loqtorzi), an approved PD-1 inhibitor for nasopharyngeal carcinoma and under review for additional HNSCC indications. Direct competitor in the HNSCC immuno-oncology space.

Broad incumbents

• Regeneron Pharmaceuticals: Established oncology and immunology company with approved bispecific antibodies including Linvoseltamab and REGN-COV. Broader portfolio, but overlapping bispecific antibody platform technology and immuno-oncology focus.
• AstraZeneca: Large incumbent with extensive oncology portfolio including EGFR/HER2 inhibitors and immuno-oncology assets relevant to HNSCC. Overlaps with Bicara through EGFR targeting and checkpoint combination strategies, though operates at vastly greater scale across many therapeutic areas.
• Merck & Co. Developer of pembrolizumab (Keytruda), Bicara's combination partner and the dominant 1L HNSCC standard of care. Strategic partner but also a competitive threat given the breadth of Merck's oncology pipeline.

Emerging players

• Arcus Biosciences: Clinical-stage immuno-oncology biotech developing adenosine receptor and checkpoint inhibitors in combinations, including for HNSCC. Comparable as a smaller-cap oncology biotech pursuing combination immunotherapy strategies.
• IDEAYA Biosciences: Clinical-stage precision medicine oncology biotech developing targeted therapies including MAT2A and DNA damage response inhibitors. Comparable as a similarly-sized clinical-stage oncology company with a focused pipeline and public-market profile.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/bicaratx
• LinkedInlinkedin.com/company/bicara-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds4 records

Investors20 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Bicara Therapeutics