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Forte Biosciences, Inc. (FBRX)·Q1 2025 Earnings Summary

Executive Summary

  • Forte Biosciences reported a larger net loss in Q1 2025 as operating expenses ramped to support FB102 trials; Diluted EPS was $(1.37), missing S&P Global consensus of $(0.95). The increase was driven by ~$8.9M higher manufacturing and clinical costs for celiac and vitiligo trials .
  • Cash and equivalents strengthened to $45.9M at quarter-end, aided by prior-period investments; subsequent to the quarter, the company priced a $75M equity offering at $12 per share to further fund development .
  • Clinical execution advanced: first patient dosed in the FB102 vitiligo study; FB102 celiac Phase 1b topline was targeted for Q2 2025 and subsequently read out positively on June 23, with Phase 2 initiation and topline expected in 2026 .
  • Near-term stock catalysts are clinical data and financing runway clarity; positive celiac data and Phase 2 initiation extend the program’s visibility, while higher OpEx and dilution risk remain key watch items .

What Went Well and What Went Wrong

What Went Well

  • Clinical momentum: “We are looking forward to reading out the topline data from the FB102 celiac disease trial this quarter… we have now dosed the first patient in the FB102 vitiligo trial” — Paul Wagner, Ph.D., CEO .
  • Positive celiac Phase 1b data post-quarter: FB102 showed statistically significant benefits on VCIEL (p=0.0099), IEL density (p=0.0035), improved Vh:Cd ratio, and 42% symptom reduction vs placebo; no dropouts and generally mild TEAEs .
  • Liquidity improved: Q1 cash and equivalents were $45.9M; and the company subsequently priced a $75M offering, bolstering funding for FB102 clinical and preclinical work .

What Went Wrong

  • Higher operating expenses: Total OpEx rose to $16.1M from $7.8M YoY due to ~$8.9M higher manufacturing and clinical costs; this drove net loss to $15.7M and EPS to $(1.37) .
  • EPS missed consensus: Actual $(1.37) vs S&P Global consensus $(0.95) as spending accelerated ahead of data readouts, pressuring near-term P&L despite program advancement .
  • Continued pre-revenue status and dependency on external capital raise risk profile: the company reiterated the need to fund FB102 through clinical stages; subsequent financing mitigates but also dilutes .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Total Operating Expenses ($USD Millions)$8.629 $7.351*$16.124
Net Loss ($USD Millions)$8.392 $7.155*$15.656
Diluted EPS ($USD)$(4.54) $(1.17)*$(1.37)
Cash and Equivalents ($USD Millions)$16.363 $22.244 $45.856

Notes: *Values retrieved from S&P Global.

Q1 detail (operating lines):

  • R&D expense: $12.7M vs $4.4M YoY, primarily ~$8.9M higher manufacturing and clinical costs for the two trials (partly offset by ~$0.5M lower personnel) .
  • G&A expense: $3.4M vs $3.5M YoY, driven by ~$1.0M lower legal/professional costs offset by ~$0.9M higher personnel including ~$0.7M non-cash stock-based comp .
  • Shares and warrants outstanding at 3/31/2025: 6.6M common shares and 4.8M prefunded warrants; weighted average basic/diluted shares and prefunded warrants: 11,398,971 .

Q1 vs S&P Global consensus:

MetricConsensusActual
Diluted EPS ($USD)$(0.95)*$(1.37)
Revenue ($USD Millions)$0.00*— (pre-revenue)

Notes: *Values retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
FB102 celiac Phase 1b toplineQ2 2025“Topline expected in Q2 2025” (Q3 2024 update) “Reading out topline this quarter” (Q1 2025) Maintained
FB102 vitiligo trial statusQ1 2025Not previously guidedFirst patient dosed New
FB102 celiac Phase 2 initiation & topline2026Not previously guidedPhase 2 initiating; topline expected 2026 New
FB102 vitiligo toplineH1 2026Not previously guidedTopline expected H1 2026 New
Financial metrics (Revenue, margins, OpEx, OI&E, tax rate, dividends)2025No formal guidance disclosedNo formal guidance disclosed N/A

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was available in our document set.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Clinical milestones (FB102 – celiac)Dosing initiated; topline targeted Q2 2025 10-K reiterates Phase 1 HV completion; celiac patient trial ongoing; topline expected Q2 2025 Topline “this quarter”; positive Phase 1b data subsequently announced; Phase 2 initiating Accelerating
Clinical milestones (FB102 – vitiligo)Not highlightedFB102 indications include vitiligo; program potential described First patient dosed; topline expected H1 2026 Initiated
Safety/tolerabilityGood safety profile in Phase 1 HV; NK cell PD reductions Reinforced in 10-K Phase 1b celiac: no dropouts; TEAEs primarily grade 1; no ≥grade 3 SAEs in FB102 arm Positive
Manufacturing & OpExManufacturing costs eased in Q3 YoY Liquidity and funding plans covered in 10-K Manufacturing and trial costs drove ~$8.9M OpEx increase YoY Rising spend
Liquidity & financingCash $16.4M; reverse split noted Cash, ST investments ~$58.4M at 12/31/2024 Cash $45.9M at 3/31; $75M offering priced post-quarter Strengthened runway

Management Commentary

  • “FB102 continues to be well-tolerated and there have been no dropouts to date. Additionally, we have now dosed the first patient in the FB102 vitiligo trial. 2025 is shaping up to be a very eventful year which we believe will further validate the potential for FB102.” — Paul Wagner, Ph.D., CEO .
  • “FB102 demonstrated a statistically significant benefit on the composite histological VCIEL endpoint… and a 42% benefit in GI symptom events vs placebo… Phase 2 celiac disease study is initiating with a topline readout expected in 2026.” — Company release .
  • On spending mix: the increase in R&D “was primarily due to an increase of $8.9 million in manufacturing expenses to support our two clinical trials and clinical expenses for celiac disease and vitiligo indications” .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; no prepared remarks/Q&A session captured in our document set for this quarter.

Estimates Context

  • Q1 2025 EPS of $(1.37) missed S&P Global consensus of $(0.95), driven by higher manufacturing and clinical trial spend ahead of key data readouts .
  • Revenue remains non-material/pre-revenue; S&P Global consensus for Q1 2025 revenue was $0.00.
    Notes: Consensus values marked with * are retrieved from S&P Global.

Key Takeaways for Investors

  • Forte transitioned from Phase 1 to patient trials with FB102, delivering positive Phase 1b celiac data and initiating Phase 2; vitiligo program is now dosing with H1 2026 topline targeted — increasing clinical catalysts over the next 12–18 months .
  • OpEx surged YoY due to ~$8.9M manufacturing/clinical spend, producing an EPS miss; investors should anticipate continued elevated OpEx through Phase 2 setup and multi-indication progress .
  • Liquidity has improved: $45.9M cash at Q1 plus the $75M offering priced at $12 per share; runway for FB102 development is extended, albeit with dilution .
  • Safety/tolerability profile remains favorable (no dropouts; mild TEAEs); mechanistic signals (IEL density, VCIEL, Vh:Cd) strengthen FB102’s case in celiac and enhance optionality in vitiligo, alopecia areata, and T1D .
  • Near-term trading catalyst: clinical milestones (Phase 1b data confirmation and Phase 2 initiation progress) likely drive sentiment more than near-term P&L; monitor trial timelines and any regulatory interactions .
  • Watch items: execution risk in Phase 2 design/enrollment, manufacturing scale-up timelines, and ongoing need for capital vs dilution tradeoffs .
  • With no formal financial guidance, frame expectations around clinical progress; estimate revisions likely focus on OpEx trajectory and cash burn rather than revenue/EPS until later-stage clinical milestones are reached .