Bicara Therapeutics Inc. (BCAX)
NASDAQ:BCAX
Earnings Data
Report Date
May 19, 2026Before Open (Confirmed)
Period Ending
2026 (Q1)Consensus EPS Forecast
―Last Year’s EPS
-0.68Same Quarter Last Year
Strong Buy
Based on 10 Analysts Ratings
Earnings Call Summary
Earnings Call Sentiment|Positive
The call conveyed strong clinical and regulatory momentum: Breakthrough Therapy Designation, selection of a pivotal dose (1,500 mg weekly), robust Phase Ib durability and survival data (DOR ~21.7 months; OS ~21.3 months; DOR >3x vs pembro+chemotherapy), advancement into Phase III with an interim analysis mid-2027, and an oversubscribed financing that extends runway into H1 2029. Key risks discussed include rising operating expenses, reliance on interim analysis and regulatory alignment for accelerated approval, enrollment/execution risk for the pivotal and bridging studies, and clinical uncertainty in exploratory indications (e.g., colorectal cancer). On balance, the call emphasized de-risking milestones and readiness for next-phase development, while acknowledging operational and regulatory dependencies.Company Guidance
Regulatory Milestone – Breakthrough Therapy Designation
FICERA received FDA Breakthrough Therapy Designation in combination with pembrolizumab for first-line treatment of metastatic or unresectable HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, signaling regulatory recognition of differentiated clinical potential.
Robust Clinical Efficacy — Deep, Durable Responses
Phase Ib pooled experience (~90 patients across 3 cohorts) shows the 1,500 mg weekly cohort (most mature, ~2 years follow-up) with median duration of response (DOR) of 21.7 months and median overall survival (OS) of 21.3 months. DOR and OS materially outpace historical comparators (DOR ~21.7 months vs 6.7 months for pembrolizumab+chemotherapy, >3x longer), and OS is described as nearly tripling the median seen with pembrolizumab in HPV-negative patients.
Dose Selection and Advancement to Pivotal Phase III
Company selected 1,500 mg weekly as the optimal biologic dose and has transitioned into the Phase III portion of the pivotal FORTIFI-HN01 trial with a 2:1 randomization (1,500 mg weekly + pembro vs pembro monotherapy). An interim analysis is expected mid-2027.
Dosing Flexibility — Less-Frequent Regimen Planned
Higher but less frequent regimen (2,000 mg every 2 weeks) produced multiple deep responses (including a notable proportion with >80% tumor shrinkage and complete responses). Company plans a loading + every-3-week maintenance development path and expects to run a bridging study in parallel (estimated ~150–200 patients) to seek regulatory alignment and have data available at potential approval.
Translational and Mechanistic Differentiation
Translational data show consistent TGF-beta inhibition across doses (strongest with 1,500 mg weekly and the less-frequent 2,000 mg regimen), supporting the bifunctional EGFR + TGF-beta mechanism as a driver of tumor penetration, depth of response and durability — a claimed differentiator versus EGFR-only agents.
Commercial and Operational Momentum
Company is investing in prelaunch commercial/medical build (hiring Chief Commercial Officer announced), with 129 active Phase III sites globally and reported strong enrollment momentum across U.S., Europe, Asia Pacific and South America.
Strong Financing and Cash Runway
Entered 2026 with $414.8M in cash/cash equivalents/marketable securities and completed an oversubscribed public offering raising $161.8M net proceeds (~39% increase versus starting cash), and the company maintains cash runway guidance into the first half of 2029 to support pivotal activities, alternative dosing development, manufacturing and prelaunch investments.
BCAX Earnings History
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
BCAX Earnings-Related Price Changes
Report Date | Price 1 Day Before | Price 1 Day After | Percentage Change |
|---|---|---|---|
Mar 30, 2026 | $18.37 | $19.04 | +3.65% |
Nov 18, 2025 | $15.05 | $15.57 | +3.46% |
Aug 12, 2025 | $9.99 | $10.47 | +4.80% |
May 13, 2025 | $14.19 | $13.04 | -8.10% |
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Bicara Therapeutics Inc. (BCAX) report earnings?
Bicara Therapeutics Inc. (BCAX) is schdueled to report earning on May 19, 2026, Before Open (Confirmed).
What is Bicara Therapeutics Inc. (BCAX) earnings time?
Bicara Therapeutics Inc. (BCAX) earnings time is at May 19, 2026, Before Open (Confirmed).
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.
What companies are reporting earnings today?
You can see a list of the companies which are reporting today on TipRanks earnings calendar.
What is BCAX EPS forecast?
Currently, no data Available