We are a clinical-stage biopharmaceutical company targeting head and neck squamous cell cancer with our leading drug candidate, ficerafusp alfa, a bifunctional antibody to target solid tumors. (Incorporated in Delaware)

We are evaluating ficerafusp alfa in an ongoing Phase 1/1b clinical trial in the U.S. to treat patients with head and neck squamous cell cancer. We plan to start a Phase 2/3 trial late in the fourth quarter of 2024 or early in the first quarter of 2025 to evaluate ficerafusp alfa in combination with pembrolizumab as a first-line therapy in recurrent/metastatic head and neck squamous cell cancer, excluding patients associated with HPV infection or HPV-positive patients, with oropharyngeal squamous cell cancer.

We also believe ficerafusp alfa has the potential to provide meaningful clinical benefit in other solid tumors where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-b, such as colorectal cancer and other squamous cell carcinomas which typically overexpress EGFR and TGF-b pathways. We have demonstrated preliminary activity of ficerafusp alfa in combination with pembrolizumab or as a monotherapy across several squamous cell carcinomas, including cutaneous squamous cell carcinoma, or CSCC. Within our Phase 1/1b dose expansion cohorts conducted in the U.S. and Canada, we have observed to date a preliminary 42% (5/12) ORR with ficerafusp alfa monotherapy in relapsed and/or refractory CSCC patients.

Note: Net loss and revenue are for the 12 months that ended June 30, 2024. 

(Note: Bicara Thereapeutics upsized its IPO at pricing to 17.5 million shares – up from 14.71 million shares – and priced the IPO at $18.00 – the top of its $16.00-to-$18.00 price range – to raise $315 million on Thursday night, Sept. 12, 2024.)

(Note: Bicara Therapeutics filed an S-1/A on Sept. 11, 2024, and increased the number of shares in its IPO – to 14.71 million shares (14,705,882 shares) – up from 11.77 million shares – and kept the price range at $16.00 to $18.00 – to raise $250.0 million. Background: Bicara Therapeutics filed an S-1/A on Sept. 6, 2024, and disclosed terms for its IPO: The company is offering 11.77 million shares (11,765,000 shares) at a price range of $16.00 to $18.00 to raise $200.01 million ($200,005,000) – if priced at the $17.00 mid-point of its range. Background – S-1 Filing: Bicara Therapeutics filed its S-1 for its IPO on Aug. 22, 2024, without disclosing the terms for the IPO; estimated IPO proceeds are up to $200 million. Background: Bicara Therapeutics submitted its confidential IPO documents to the SEC on June 10, 2024.)