Sign in

You're signed outSign in or to get full access.

BT

Bicara Therapeutics Inc. (BCAX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 EPS was -$0.39, below S&P Global consensus of -$0.2825; the miss was driven by higher R&D and G&A spend as the pivotal FORTIFI-HN01 trial ramped into dosing in February 2025 . EPS consensus values marked with * are from S&P Global.*
  • Total operating expenses rose to $26.64M in Q4 2024 vs $13.69M in Q4 2023 and $20.63M in Q3 2024, reflecting trial initiation and public-company costs .
  • Cash and cash equivalents ended Q4 2024 at $489.7M, with runway expected to fund operations into 1H 2029; management reiterated and maintained the multi‑year cash runway .
  • Clinical catalysts: dosing commenced in FORTIFI-HN01 (pivotal Ph 2/3, 1L R/M HNSCC) and updated Phase 1/1b data expected at ASCO 2025; multiple AACR abstracts and expansion cohorts underpin the broader development plan .

What Went Well and What Went Wrong

What Went Well

  • Initiated dosing in FORTIFI-HN01, a pivotal Ph 2/3 trial, advancing the lead asset ficerafusp alfa in 1L R/M HNSCC; CEO: “We continue to make strong progress in 2025, with patient dosing actively underway in FORTIFI-HN01” .
  • Strong liquidity: Q4 cash of $489.7M and reiterated runway into 1H 2029, providing capital to execute pivotal development and expansion cohorts .
  • Multiple upcoming data readouts (ASCO and AACR) strengthen visibility on efficacy and mechanistic biomarkers across HNSCC and other tumor types .

What Went Wrong

  • Operating expenses rose sharply: Q4 total opex $26.64M vs $20.63M in Q3 and $13.69M in Q4 2023, driving a wider net loss (Q4 net loss $20.96M vs $17.48M in Q3) .
  • EPS missed consensus (-$0.39 vs -$0.2825*), reflecting stepped-up R&D spend tied to trial initiation and public-company transition; no offset from revenue given pre-commercial status . EPS consensus values marked with * are from S&P Global.*
  • No earnings call transcript was available; investor information was disseminated via the 8-K press release and investor events, limiting Q&A clarity this quarter .

Financial Results

P&L and EPS vs prior periods and estimates

MetricQ4 2023Q3 2024Q4 2024
Revenues ($USD Millions)n/a n/a n/a
Total Operating Expenses ($USD Millions)$13.69 $20.63 $26.64
Loss from Operations ($USD Millions)$(13.69) $(20.63) $(26.64)
Interest Income ($USD Millions)$1.30 $3.15 $5.87
Net Loss ($USD Millions)$(12.44) $(17.48) $(20.96)
Diluted EPS ($USD)$(19.71) $(1.60) $(0.39)
Net Income Margin %n/a n/a n/a
Estimates vs Actual (Q4 2024)ConsensusActual
EPS ($USD)-0.2825*-0.39
Revenue ($USD Millions)0.0*n/a

Values marked with * are retrieved from S&P Global.

KPIs and Balance Sheet

KPIQ4 2023Q3 2024Q4 2024
Cash & Cash Equivalents ($USD Millions)$230.44 $520.76 $489.71
R&D Expense ($USD Millions)$7.83 $13.55 $19.07
R&D – Related Party ($USD Millions)$2.73 $2.31 $0.82
G&A Expense ($USD Millions)$3.13 $4.76 $6.75
Weighted Avg Shares (Basic & Diluted)0.63M 10.90M 54.42M
Cash Runway (Mgmt)n/a“into 1H 2029” “into 1H 2029”

Segment breakdown: Not applicable; Bicara reports as a clinical-stage company without commercial revenue .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearFund operations into 1H 2029 (Q3 2024) Fund operations into 1H 2029 (Q4 2024) Maintained
FORTIFI-HN01 Trial Status (ficerafusp alfa + pembro, 1L R/M HNSCC)Late Q4’24 / early Q1’25 initiationOn track to initiate late Q4 2024 or early Q1 2025 Dosing commenced (Feb 2025) Achieved/Updated
Phase 1/1b Updated Data (1L R/M HNSCC)1H 2025Updated data expected 1H 2025 Updated data to be presented at ASCO 2025 Maintained & specified timing
AACR/Additional Cohorts1H 2025cSCC monotherapy and SCAC combo data expected in 1H/Q1 2025 Multiple AACR abstracts; additional cohorts initiating (HPV-positive smokers; mCRC RAS/BRAF WT) Expanded detail

Earnings Call Themes & Trends

No earnings call transcript was found for Q4 2024; analysis reflects press release themes and investor materials .

TopicPrevious Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D ExecutionPrepared to initiate pivotal FORTIFI-HN01; strong Phase 1/1b signals (ORR/PFS) Dosing commenced in pivotal FORTIFI-HN01; ASCO update slated Positive progression
Regulatory/Trial DesignFDA-aligned pivotal Ph 2/3 design with potential accelerated approval based on interim ORR Seamless pivotal strategy reiterated; dose optimization and ORR→OS pathway maintained Stable confidence
Cash/Liquidity~$521M cash; runway into 1H 2029 post-IPO $489.7M cash; runway into 1H 2029 reiterated Stable (seasonal cash use)
Product Performance (HNSCC)Strong Ph 1/1b activity: HPV-negative CPS≥1 ORR 64%, mPFS 9.8 months Reinforced with upcoming ASCO data; AACR translational biomarker presentations Sustained momentum
Expansion Cohorts (cSCC/SCAC/mCRC)cSCC mono data expected 1H 2025; SCAC combo data Q1 2025; mCRC cohort planned Presented SCAC data at ASCO GI; AACR cSCC mono; mCRC cohort initiation planned Execution advancing
Tariffs/Macro/Supply Chain/AINot discussed Not discussed No change

Management Commentary

  • CEO: “2024 was a remarkable year for Bicara, marked by our successful transition to a public company… We continue to make strong progress in 2025, with patient dosing actively underway in FORTIFI-HN01…” .
  • Strategy emphasizes establishing ficerafusp alfa + pembrolizumab as a potential chemo-free 1L therapy in HPV-negative R/M HNSCC, with translational biomarker support and a pivotal design enabling potential accelerated approval at interim ORR and full approval at OS .

Q&A Highlights

No public earnings call/Q&A transcript available for Q4 2024; disclosures were provided via SEC 8-K press release and investor presentations .

Estimates Context

  • EPS: Q4 2024 actual -$0.39 vs consensus -$0.2825*; EPS missed consensus as operating expenses rose due to pivotal trial initiation and public-company costs . Values marked with * are retrieved from S&P Global.
  • Revenue: Consensus $0.0*; company did not report revenue given clinical-stage status . Values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term catalysts include ASCO 2025 updated Phase 1/1b data and multiple AACR abstracts; pivotal FORTIFI-HN01 dosing underway provides line of sight to interim ORR assessment and potential accelerated approval pathway .
  • Liquidity is robust (Q4 cash $489.7M) and runway into 1H 2029 reduces financing overhang; expect continued opex growth near term as pivotal enrollment progresses .
  • The quarter’s EPS miss reflects intentional investment in pivotal execution; without commercial revenue, EPS variability will track R&D and trial timing rather than top-line trends .
  • Trial design (dose optimization → ORR → OS) and translational biomarker data strengthen the mechanistic thesis for TGF‑β/EGFR dual targeting in HNSCC .
  • Watch for expansion cohorts (HPV-positive smokers, mCRC RAS/BRAF WT) to broaden optionality and validate tumor microenvironment remodeling beyond HNSCC .
  • Trading implications: data readouts and pivotal milestones likely to drive stock narrative and volatility; lack of revenue means headline EPS/opex surprises are less stock-moving than clinical efficacy/safety signals .
  • Maintain focus on interim ORR timing, enrollment cadence, and safety/tolerability profile to gauge probability of accelerated approval and medium-term value inflection .

Sources: Q4 2024 earnings 8-K press release and exhibits ; Q3 2024 earnings 8-K ; Corporate presentation 8-K (Jan 13, 2025) ; Company IR press release page and GlobeNewswire postings .

Estimates: S&P Global consensus via tool for Q4 2024. Values marked with * are retrieved from S&P Global.