Q1 EPS: Ficera Could Be Best- And First-In-Class With Favorable Q3W Maintenance

Research evidence excerpt

Q1 EPS: Ficera Could Be Best- And First-In-Class With Favorable Q3W Maintenance

Biotechnology

Bicara Therapeutics

TD SECURITIES (USA) LLC EARNINGS UPDATE

May 11, 2026

Price: $22.58 (05/8/2026) Q1 EPS: Ficera Could Be Best- And First-In-

Price Target: NA Class With Favorable Q3W Maintenance

BUY (1)

ESG SCORE: 59/100

Tyler Van Buren THE TD COWEN INSIGHT

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The Phase III FORTIFI-HN01 trial is expected to be substantially enrolled by YE, with topline

tyler.vanburen@tdsecurities.com

data mid-2027 that is derisked given the 50-55% ORR across 85 patients. We expect updated

Nicholas Lorusso Phase Ib data at ASCO to support that TGF-β inhibition drives improved durability, and should

646 562 1390 derisk the 1,500mg QW induction and 2,250mg Q3W maintenance approach. Initial CRC data

nick.lorusso@tdsecurities.com

in H2 could expand ficera's reach.

Sam Rollenhagen

212 468 7785 1,500mg Selected As Go-Forward Dose For Phase III FORTIFI-HN01 Trial, Given Increased

samuel.rollenhagen@tdsecurities.com TGF-β Inhibition That Likely Correlates With Durability

Greg W. Torres, Ph.D. Bicara announced the go-forward dose of 1,500mg for the Phase II/III (FORTIFI-HN01) in HPV-

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1L HNSCC patients (note here). At ASCO 2025 (discussed here), the 1,500mg ficera + pembro

gregory.wiessner@tdsecurities.com

cohort led to a 54% cORR, 64% unconfirmed ORR, 21% CRR (n=6/28), and 80% of confirmed

Key Data responders had a >80% tumor reduction.

Symbol NASDAQ: BCAX

Bicara presented Phase Ib 750mg ficera data at ESMO Asia 2025 (note here) and 2,000mg

Beta: (0.56)

Q2W data at MHNCS 2026 (note here), which suggested that the higher doses (1500mg and

52-Week Range: $24.01-$8.71

2000mg) led to greater TGF-β inhibition through greater depth of response. This should lead to

Market Cap: $1.5B