Bicara Therapeutics Inc. reports clinical and corporate developments as a clinical-stage biopharmaceutical company developing bifunctional therapies for solid tumors. Its lead program, ficerafusp alfa, is a bifunctional antibody combining an EGFR-directed monoclonal antibody with a domain that binds human TGF-beta, with company updates focused on first-line recurrent or metastatic HPV-negative HNSCC and the FORTIFI-HN01 pivotal trial.
Recurring news also includes quarterly financial results, business updates, public equity financing, common stock and pre-funded warrant offerings, Nasdaq inducement grants, and executive appointments tied to clinical development, medical affairs and commercial readiness.
Bicara Therapeutics (Nasdaq: BCAX) said company leadership will attend multiple investor conferences in early March 2026, with live fireside chats and webcasts scheduled. Ryan Cohlhepp, Pharm.D., President and COO, will present at TD Cowen (Mar 2) and Barclays (Mar 10) and attend Jefferies Biotech on the Beach (Mar 10-11).
Live webcasts and archived replays will be available via the company’s Investor Relations Events and Presentations page.
Bicara Therapeutics (Nasdaq: BCAX) presented Phase 1b data showing 2000mg ficerafusp alfa Q2W plus pembrolizumab produced a 48% confirmed ORR, 26% CR rate and 77% of responders with ≥80% tumor shrinkage (n=27; data snapshot Dec 16, 2025).
Results show sustained TGF-β inhibition and support development of a loading plus every‑three‑week maintenance regimen; a conference call is scheduled for Feb 20, 2026 at 8:30 a.m. ET.
Bicara Therapeutics (Nasdaq: BCAX) announced on February 5, 2026 that it granted inducement awards under its 2026 Inducement Plan to two new employees.
The company granted non-qualified stock options to purchase 158,900 shares at an exercise price of $16.76 per share (closing price on February 2, 2026). Awards vest 25% after one year then quarterly over three years and were approved by the compensation committee under Nasdaq Listing Rule 5635(c)(4).
Bicara Therapeutics (NASDAQ: BCAX) selected 1500 mg weekly ficerafusp alfa (with pembrolizumab) as the optimal Phase 3 dose for the FORTIFI-HN01 pivotal trial in 1L HPV-negative R/M HNSCC.
The company expects substantial enrollment by end-2026 to enable an interim analysis in mid-2027 supporting a potential accelerated filing. Bicara also plans multiple expansion-cohort readouts in 2026, including Phase 1b data on 2000 mg every-other-week dosing in Q1 2026 and mCRC cohort results in H2 2026. Management will present at the J.P. Morgan Healthcare Conference on Jan 12, 2026.
Bicara Therapeutics (Nasdaq: BCAX) announced that Claire Mazumdar, PhD, MBA, Chief Executive Officer, will present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12, 2026 at 11:15 a.m. PT.
A live webcast will be accessible via the company’s Investor Relations website under Events and Presentations, and a replay will be archived and available after the event.
Bicara Therapeutics (Nasdaq: BCAX) presented preliminary Phase 1b expansion data for ficerafusp alfa 750mg QW plus pembrolizumab in 1L HPV-negative R/M HNSCC on Dec 6, 2025.
Key metrics: 57% confirmed overall response rate, 10% complete responses, and 29% of responders with ≥80% tumor shrinkage at preliminary follow-up. Biomarker comparisons show 1500mg yields greater intratumoral TGF-β inhibition, higher immune activation, and deeper responses (median depth 82% vs 63%). Company expects to declare the pivotal FORTIFI-HN01 optimal dose in Q1 2026.
Bicara Therapeutics (NASDAQ: BCAX) reported preliminary Phase 1b expansion cohort data evaluating 750 mg weekly ficerafusp alfa plus pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (1L HPV-negative R/M HNSCC).
Key readouts (July 9, 2025 cutoff) in the efficacy-evaluable population (n=30): 57% objective response rate (17/30; 15 PR, 2 CR) and 83% disease control rate (25/30). Complete, prolonged neutralization of TGF-β1 was observed and safety was consistent with the known profile. Data inform dose selection for the pivotal FORTIFI-HN01 trial and supported the company’s FDA Breakthrough Therapy Designation. Results will be presented at ESMO Asia 2025 with a company webcast and conference call on Dec 6, 2025 at 9:00 a.m. ET.
Bicara Therapeutics (NASDAQ: BCAX) reported Q3 2025 results and a business update on Nov 10, 2025. The FDA granted Breakthrough Therapy Designation for ficerafusp alfa plus pembrolizumab in 1L HPV-negative R/M HNSCC. The company continues to enroll the pivotal Phase 2/3 FORTIFI-HN01 trial and plans multiple Phase 1b data presentations, including a 750mg cohort at ESMO Asia 2025. Financials: $407.6M cash, cash equivalents and investments as of Sept 30, 2025; cash expected to fund operations into H1 2029. Q3 operating spend included R&D $33.0M and G&A $7.7M; net loss $36.3M.
Bicara Therapeutics (Nasdaq: BCAX) announced the U.S. FDA granted Breakthrough Therapy Designation to ficerafusp alfa plus pembrolizumab for first-line treatment of metastatic or unresectable, recurrent HPV-negative HNSCC with PD-L1 CPS ≥1 (excluding HPV-positive oropharyngeal SCC) on Oct 13, 2025.
BTD was supported by Phase 1/1b cohorts presented at ASCO 2025 showing a median duration of response 21.7 months and median overall survival 21.3 months with a favorable safety profile. The designation enables increased FDA interaction, senior leadership involvement, and eligibility for rolling and priority review and supports the ongoing pivotal FORTIFI-HN01 trial.
Bicara Therapeutics (Nasdaq: BCAX), a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, has announced its participation in three major upcoming healthcare investor conferences in September 2025.
The company will present at the Cantor Global Healthcare Conference (September 3, 10:55 a.m. ET), the Wells Fargo Healthcare Conference (September 3, 2:15 p.m. ET), and the Morgan Stanley Global Healthcare Conference (September 8, 4:05 p.m. ET). All fireside chat presentations will be available via webcast through Bicara's Investor Relations website.