Bicara Therapeutics: Focus on long-term follow-up updates for ficera at ASCO; Reiterate Buy

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Bicara Therapeutics: Focus on long-term follow-up updates for ficera at ASCO; Reiterate Buy

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Bicara Therapeutics

Focus on long-term follow-up updates for

ficera at ASCO; Reiterate Buy

Reiterate Rating: BUY | PO: 35.00 USD | Price: 22.58 USD

Phase 3 interim analysis remains on track for mid-27 11 May 2026

BCAX highlighted significant progress in the development of ficerafusp alfa (ficera) in 1L Equity

r/m HPV-neg HNSCC and the upcoming long-term follow-up update at ASCO. They

reiterated the update will include 3-year follow-up from the 1500 mg QW cohort and 12-

Key Changes18-month follow-up from the 750 mg QW and 2000 mg Q2W cohorts. We think focus

will be on the 2000 mg Q2W cohort, which will provide initial insights into the depth and (US$) Previous Current

durability of response at a higher, less frequent dose as the company moves forward 2026E EPS -2.55 -3.64

with the Q3W maintenance dosing strategy. Management reiterated they expect the 2027E EPS -3.23 -4.10

phase 2/3 FORTIFI-HN01 pivotal trial evaluating ficera in combination with pembro to 2028E EPS -3.52 -4.43

be substantially enrolled by YE and they anticipate an interim analysis in mid-27, which

could support accelerated approval. We remain bullish on ficera’s differentiated depth Tazeen Ahmad Research Analyst

and durability of response as we await the upcoming update to provide further clinical BofAS

validation. BCAX is a top pick in 2026 with a Buy and $35 PO. +1 646 855 4236 tazeen.ahmad@bofa.com

Maintenance dosing study to initiate in 3Q DanielResearchGiraldoAnalyst

BCAX announced they have reached regulatory alignment on the design of a bridging BofAS

daniel.giraldoperez@bofa.com

trial to evaluate their loading (1500 mg QW) and maintenance (2250 mg Q3W) dosing

Jeremiah Lorentz