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Forte Biosciences, Inc. (FBRX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was operationally solid: Forte initiated FB102 Phase 2 in celiac disease, reported positive Phase 1b CeD data (significant histology and symptom benefits), and strengthened liquidity via a $69.9M June equity raise plus $1.7M overallotment in July .
  • EPS of $(0.96) beat S&P Global consensus of $(1.11) by $0.15; revenue remains pre-revenue (no revenue line reported) . EPS consensus source: S&P Global*.
  • R&D spend stepped down sequentially as Phase 1b costs rolled off (Q2 R&D $8.5M vs Q1 $12.5M), while G&A continued to decline YoY on lower legal/professional fees .
  • Stock reaction catalysts: Phase 2 CeD underway (topline 2026), Phase 1b vitiligo topline 1H26, and Phase 1b alopecia areata initiation 2H25 with 2026 readout; clinical momentum and funding de-risking are near-term narrative drivers .

What Went Well and What Went Wrong

  • What Went Well

    • Positive celiac Phase 1b: FB102 showed significant benefit on the composite VCIEL (mean change: placebo −1.849 vs FB102 +0.079; p=0.0099) and IEL density (placebo +13.3 vs FB102 −1.5; p=0.0035); 42% reduction in gluten challenge symptoms (4.0 vs 6.9 events/subject) .
    • Execution and pipeline: “We have begun dosing subjects in the FB102 phase 2 celiac disease clinical trial and look forward to reporting topline results … in 2026 … Enrolment in the FB102 phase 1b vitiligo clinical study is ongoing … initiating a phase 1b trial in alopecia areata” .
    • Balance sheet fortification: $69.9M net proceeds in June and $1.7M net from overallotment in July; cash and cash equivalents ended the quarter at $106.1M .

  • What Went Wrong

    • Still loss-making and pre-revenue: Net loss $(11.2)M in Q2; no revenue line reported in the condensed statements .
    • Villus height:crypt depth (VH:CD) ratio trend favored FB102 but was not statistically significant in Phase 1b; longer gluten challenge in Phase 2 is intended to drive clearer separation .
    • R&D likely to increase as development advances: “R&D expenses may increase as we continue to advance FB102 through phase 2 … and commence a phase 1b clinical trial for alopecia areata” .

Financial Results

Summary P&L and Liquidity

MetricQ2 2024Q1 2025Q2 2025
Total Operating Expenses ($USD Millions)$12.8 $16.1 $11.6
Net Loss ($USD Millions)$(12.5) $(15.7) $(11.2)
Diluted EPS ($)$(6.78) $(1.37) $(0.96)
Cash & Cash Equivalents ($USD Millions)$22.2 $45.9 $106.1

Notes: Company reports no revenue line in the condensed statements and remains pre-revenue .

Operating Expense Detail

MetricQ2 2024Q1 2025Q2 2025
Research & Development ($USD Millions)$5.6 $12.5 $8.5
General & Administrative ($USD Millions)$7.1 $3.4 $3.0

Drivers: R&D increase YoY driven by clinical/manufacturing for FB102 (CeD, vitiligo); G&A decreased YoY on lower legal/professional fees .

EPS vs S&P Global Consensus

MetricQ1 2025Q2 2025
EPS Actual ($)$(1.37) $(0.96)
EPS Consensus Mean ($)$(0.95)*$(1.11)*
Surprise ($)$(0.42) miss*+$0.15 beat*
# of EPS Estimates3*4*

Revenue consensus was $0.0 and actual remained pre-revenue (no revenue line) . Consensus source: S&P Global*.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FB102 CeD Phase 1b toplineQ2 2025“Topline data this quarter” (Q1 update) Reported positive topline June 23, 2025 Achieved
FB102 CeD Phase 2 topline2026Not previously dated as topline (Phase 2)“Phase 2 … topline results in 2026” New/Initiated
FB102 Vitiligo Phase 1b topline1H26“Topline … 1H26” (Q1) “Topline … 1H26” confirmed Maintained
FB102 Alopecia Areata Phase 1b2H25 start; 2026 toplineNot specified prior“Initiating a phase 1b trial … data … in 2026” New
US IND (CeD)Late 2025 / Early 2026Not specified prior“US IND expected late 2025/early 2026” New
OpEx/Financial Guidancen/aNone providedNone providedn/a

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q1 2025)Current Period (Q2 2025)Trend
R&D execution (FB102)Q3’24: Patient dosing initiated in CeD; safety in HV; moving to patient trial . Q1’25: “Topline CeD this quarter; first vitiligo patient dosed” .Positive Phase 1b CeD histology & symptoms; Phase 2 CeD initiated; vitiligo enrolling; AA Phase 1b to initiate 2H25 .Accelerating
Regulatory/INDNot highlighted in prior press releasesUS IND for CeD expected late 2025/early 2026 .Firming plans
Clinical endpointsPrior: assessing histology and activity in CeD .VCIEL and IEL significant; VH:CD trend; Phase 2 to use longer gluten challenge and composite endpoints .Clearer framework
Financing/liquidityQ3’24 cash $16.4M .$69.9M net raise (June) + $1.7M OA (July); cash $106.1M .De-risked near term
Safety/tolerabilityHV safe; proceeding to patients .Phase 1b: mostly mild AEs; one Grade 3 in placebo (gluten-challenge related) .Consistent

Management Commentary

  • “We have begun dosing subjects in the FB102 phase 2 celiac disease clinical trial and look forward to reporting topline results from that study in 2026 … Enrolment in the FB102 phase 1b vitiligo clinical study is ongoing … initiating a phase 1b trial in alopecia areata” — Paul Wagner, CEO .
  • On Phase 1b CeD efficacy: “VCIEL … placebo −1.849 vs FB102 +0.079 (p=0.0099) … IELs … placebo +13.3 vs FB102 −1.5 (p=0.0035) … 42% symptom benefit” .
  • On Phase 2 design and endpoints: longer gluten challenge (8g/day then 3g/day), induction then maintenance dosing, composite histology/symptom assessment .
  • On mechanism and differentiation: blocking both IL‑2 and IL‑15 may drive stronger symptom protection versus IL‑15 blockade alone, per Prof. Tye-Din .

Q&A Highlights

  • Clinical meaningfulness and endpoints: Management expects longer gluten challenge in Phase 2 to yield stronger VH:CD and symptom differentiation; composite endpoints to include histology and validated symptom tools .
  • Phase 2 design rationale: Induction to potentially deplete antigen-specific tissue-resident memory T cells, then maintenance; immediate high gluten challenge to accentuate symptom separation .
  • Comparative perspective: Prof. Tye-Din emphasized combined IL‑2/IL‑15 blockade as a differentiator versus IL‑15 alone, with symptom protection not typically seen in single-pathway data .
  • U.S. expansion: US IND for CeD targeted late 2025/early 2026 .

Estimates Context

  • EPS beat: Q2 2025 EPS $(0.96) vs S&P Global consensus $(1.11); +$0.15 surprise; 4 estimates. Q1 2025 missed: $(1.37) vs $(0.95); $(0.42) surprise; 3 estimates. Revenue consensus $0 in both periods (pre-revenue) . Consensus source: S&P Global*.
MetricQ1 2025Q2 2025
EPS Actual ($)$(1.37) $(0.96)
EPS Consensus Mean ($)$(0.95)*$(1.11)*
# EPS Estimates3*4*
Revenue Consensus Mean ($)$0.0*$0.0*

Where estimates may adjust: The EPS beat alongside lower sequential R&D and strong liquidity may modestly lift near-term EPS trajectories and reduce financing overhang risk assumptions; revenue remains unchanged given pre-revenue status .

Key Takeaways for Investors

  • FB102’s Phase 1b CeD data offer compelling histologic (VCIEL, IEL) and symptom signals with a favorable safety profile, supporting Phase 2 risk-reward .
  • Clinical momentum across three indications (CeD Phase 2 underway; vitiligo Phase 1b enrolling; AA Phase 1b to initiate 2H25) sets up multiple 2026 readouts as key stock catalysts .
  • Q2 EPS beat vs consensus, declining sequential R&D, and cash of $106.1M post-raise reduce nearer-term balance sheet risk and support trial execution .
  • Phase 2 CeD design (longer gluten challenge; composite endpoints) is structured to translate Phase 1b trends (notably VH:CD) into more robust statistical differentiation, an important gating item for later-stage development/partner interest .
  • Differentiated MOA (dual IL‑2/IL‑15 blockade) may confer broader efficacy (including symptom protection) relative to single-pathway approaches, per KOL perspective; watch for additional immunologic subtype data (e.g., TCR γδ, NK, Treg) presented at conferences .
  • Near-term trading: sentiment likely tracks enrollment updates and IND timing; medium-term thesis hinges on Phase 2 CeD topline magnitude and symptom outcomes in 2026 .
  • Risk checks: pre-revenue status, R&D expected to rise as programs scale, and dependence on successful clinical readouts remain core risks .

Footnotes:

  • Values retrieved from S&P Global.

Sources:

  • Q2 2025 press release and financials ; Q2 2025 8‑K with exhibits .
  • Q1 2025 press release and 8‑K .
  • June 23, 2025 study update call transcripts for management commentary and Q&A .
  • Additional CeD data presentation PR (Sept 15, 2025) .