Bicara Therapeutics Stock Price, News & Analysis

Bicara Therapeutics (NASDAQ: BCAX) presented promising Phase 1/1b trial results for ficerafusp alfa combined with pembrolizumab in first-line recurrent/metastatic HPV-negative head and neck cancer at ASCO 2025. The trial demonstrated impressive efficacy with a median duration of response of 21.7 months and 80% of responders achieving deep responses (≥80% tumor shrinkage). Key results include a 54% confirmed objective response rate, 21% complete response rate, median overall survival of 21.3 months, and a 2-year overall survival rate of 46%. The drug, a first-in-class bifunctional antibody targeting EGFR and TGF-β, showed a manageable safety profile. These results support the advancement of FORTIFI-HN01, the company's pivotal Phase 2/3 trial in first-line recurrent/metastatic setting.

Bicara Therapeutics (NASDAQ: BCAX) has announced updated interim data from their Phase 1/1b trial of ficerafusp alfa in combination with pembrolizumab for first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The data will be presented at the 2025 ASCO Annual Meeting. Key results from the HPV-negative population (n=28) include:

• 64% objective response rate, with 21% achieving complete response
• Median progression-free survival of 9.8 months
• 12-month overall survival rate of 61%
• Median overall survival exceeding 20 months (not yet reached)

Ficerafusp alfa, a first-in-class bifunctional antibody, targets EGFR and TGF-β to enhance tumor penetration. The safety profile remains consistent with previous findings, and biomarker data shows encouraging TGF-β inhibition. The company will host a conference call on June 1, 2025, to discuss the complete dataset.

Bicara Therapeutics (NASDAQ: BCAX) reported its Q1 2025 financial results and provided updates on its clinical programs. The company's lead drug candidate, ficerafusp alfa, a first-in-class dual-action bifunctional EGFR/TGF-β antibody, continues to advance in clinical trials. The company is currently conducting FORTIFI-HN01, a pivotal Phase 2/3 trial for first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Updated data from the ongoing Phase 1/1b trial will be presented at the 2025 ASCO Annual Meeting. The company reported $462.1 million in cash and cash equivalents as of March 31, 2025, expected to fund operations into first half of 2029. Q1 2025 saw a net loss of $36.8 million, with R&D expenses of $34.3 million and G&A expenses of $7.5 million.

Bicara Therapeutics presented multiple datasets for their lead drug ficerafusp alfa at the AACR Annual Meeting 2025. The drug is a first-in-class bifunctional antibody targeting EGFR and TGF-β across various solid tumors.

Key highlights:

• In head and neck cancer trials, the drug showed effectiveness in blocking TGF-β signaling and preventing drug resistance
• For skin cancer patients, the drug achieved a 30.4% overall response rate and 82.6% clinical benefit rate in previously treated patients
• Median progression-free survival reached 7.0 months in skin cancer patients
• Common side effects included skin-related issues and fatigue

The company also presented promising preclinical data showing ficerafusp alfa's potential to overcome resistance to KRAS-G12C inhibitors in lung cancer treatment. These results support the drug's broad therapeutic potential across multiple solid tumor types, particularly in combination with other cancer therapies.

Bicara Therapeutics (Nasdaq: BCAX) announced it will present updated data from its ongoing Phase 1/1b clinical trial of ficerafusp alfa at the 2025 ASCO Annual Meeting. The presentation will focus on the drug's application in first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Ficerafusp alfa is a first-in-class bifunctional antibody targeting both EGFR and TGF-β, being evaluated across multiple solid tumor types. The data, to be presented on June 1, 2025, will showcase updated survival and durability results specifically for HPV-negative R/M HNSCC patients, who typically face worse prognosis and poorer outcomes compared to HPV-positive cases.

Bicara Therapeutics (NASDAQ: BCAX) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company commenced dosing in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa for first-line recurrent/metastatic head and neck squamous cell carcinoma.

Financial highlights include a strong cash position of $489.7 million as of December 31, 2024, expected to fund operations into first half of 2029. The company reported Q4 R&D expenses of $19.9 million and G&A expenses of $6.8 million, with a net loss of $21.0 million. Full-year 2024 results showed R&D expenses of $63.6 million, G&A expenses of $18.8 million, and a net loss of $68.0 million.

The company will present updated data from its ongoing Phase 1/1b trial at the 2025 ASCO Annual Meeting and has multiple expansion cohorts planned across various cancer types, including colorectal cancer and HPV-positive patients.

Bicara Therapeutics (Nasdaq: BCAX) has announced three abstract presentations featuring their lead product ficerafusp alfa at the upcoming AACR Annual Meeting 2025 in Chicago (April 25-30, 2025).

The presentations will showcase:

• Dose expansion results of ficerafusp alfa monotherapy in advanced cutaneous squamous cell carcinoma (cSCC) patients
• Data on dual blockade of EGFR and TGF-β with ficerafusp alfa in combination with Pembrolizumab for HNSCC treatment
• Preclinical findings on how ficerafusp alfa reverses resistance to sotorasib in KRAS-G12C-mutated lung tumors

Ficerafusp alfa is a first-in-class bifunctional antibody targeting both EGFR and TGF-β, currently being evaluated across multiple solid tumor types.

Bicara Therapeutics (Nasdaq: BCAX), a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, has announced its participation in the TD Cowen 45th Annual Health Care Conference. Claire Mazumdar, PhD, MBA, Chief Executive Officer, will deliver a presentation on Monday, March 3, 2025, at 3:10 p.m. ET.

The presentation will be accessible via live webcast through the Events and Presentations section, with a replay available for viewing after the event.

Bicara Therapeutics (Nasdaq: BCAX) has initiated patient enrollment in FORTIFI-HN01, a pivotal Phase 2/3 trial evaluating ficerafusp alfa in combination with pembrolizumab for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

The global, randomized, double-blinded trial aims to enroll approximately 650 patients with R/M HNSCC, excluding HPV-positive oropharyngeal cases. Patients must have a PD-L1 CPS ≥1 and no prior systemic therapy in the R/M setting. The study's primary endpoints include overall response rate and overall survival.

Ficerafusp alfa is a first-in-class bifunctional antibody targeting EGFR and TGF-β. The trial's design was supported by encouraging interim Phase 1/1b data showing durable and meaningful anti-tumor activity when combined with pembrolizumab.