Forte Biosciences, Inc. (FBRX)·Q3 2025 Earnings Summary

Executive Summary

• Q3 2025 reflected rapid clinical execution but higher burn: net loss was $17.7M and diluted EPS was $(0.99), with cash and equivalents at $93.4M; R&D rose sharply to support Phase 2 CeD and Phase 1b vitiligo/alopecia trials .
• EPS beat Wall Street consensus by ~$0.08 (actual $(0.99) vs. consensus $(1.07)); revenue remained at development-stage levels (consensus $0.0) [Q3 2025]. Bold beat driven by disciplined G&A and higher other income despite increased R&D*.
• Management highlighted key catalysts: US IND opened and Phase 2 celiac enrollment expanded to US sites; Phase 1b vitiligo topline expected 1H26 and alopecia areata Phase 1b enrolling with 2026 readout .
• No Q3 earnings call transcript was available in our document catalog or public sources; investor communication primarily via press release and prior quarter disclosures .

What Went Well and What Went Wrong

What Went Well

• “We continue to make excellent progress with FB102” — US IND opened; Phase 2 CeD trial expanded to US sites; multiple 2026 readouts across CeD, vitiligo, alopecia areata .
• Clinical momentum continued post strong CeD Phase 1b readout presented by Prof. Jason Tye-Din; additional histologic and immunologic data further reinforced FB102 differentiation (e.g., IEL and TCR γδ modulation, NK cell decline) .
• Balance sheet remained robust with $93.4M in cash/equivalents at quarter-end, supporting multi-indication development .

What Went Wrong

• R&D expenses increased to $15.2M in Q3 (vs. $5.9M prior year), reflecting higher clinical/manufacturing costs and headcount; net loss increased to $17.7M, highlighting burn acceleration as trials scale .
• G&A rose to $3.2M vs. $2.8M prior year; non-cash stock comp contributed, albeit partially offset by lower professional/legal expenses .
• No new financial guidance provided (revenue/OpEx/tax), limiting near-term visibility; communication remained focused on clinical timelines rather than financial metrics .

Financial Results

Quarterly P&L and Liquidity (USD Millions unless noted)

Notes:

• Q2 cash uplift was driven by June/July equity offering net proceeds of ~$71.6M .
• Q3 cash decline aligns with increased R&D as Phase 2 and Phase 1b programs scale .

Q3 vs. Wall Street Consensus

Values with asterisk retrieved from S&P Global.

Operating Expense Components (Quarterly, USD Millions)

Segment breakdown and product revenues are not applicable; the company is in clinical development .

Clinical KPIs and Capitalization

Guidance Changes

Earnings Call Themes & Trends

No Q3 2025 earnings call transcript was available; themes reflect press releases and prior-quarter materials.

Management Commentary

• “We continue to make excellent progress with FB102. The US IND is now open and enrolment in the FB102 phase 2 celiac disease clinical trial has expanded to US sites with topline results expected in 2026… With 3 key clinical trial readouts for FB102, 2026 will be a very eventful year…” — Paul Wagner, PhD, CEO .
• “I am deeply appreciative of the Forte team’s incredible accomplishments in initiating 3 clinical trials for FB102 with data readouts shortly.” — Paul Wagner, PhD, CEO (Q2 release) .
• Additional CeD Phase 1b data: statistically significant benefits on composite histology (VCIEL), IEL density change, and symptom events; NK cell decline consistent with IL-15 pathway inhibition — Tampere Symposium highlights .

Q&A Highlights

• No Q3 2025 earnings call transcript identified; no Q&A highlights available. We searched recent documents and public sources and found no transcript or call details .

Estimates Context

• EPS: Actual $(0.99) vs. consensus $(1.07)* — beat by ~$0.08; supportive of near-term sentiment despite rising R&D burn. Actual EPS from company filings; consensus from S&P Global .
• Revenue: Consensus $0.0*; development-stage with no product revenue disclosed — in line*.
• Estimate coverage is thin (EPS estimates: 4; revenue estimates: 3), implying potential for volatility as clinical timelines progress*.
  Values with asterisk retrieved from S&P Global.

Key Takeaways for Investors

• Funding runway remains adequate for 2026 readouts across CeD Phase 2 and Phase 1b vitiligo/alopecia, with $93.4M cash at Q3 — watch quarterly burn vs. enrollment pace .
• Clinical differentiation in CeD (histology, IEL/TCR γδ/NK effects) strengthens the pipeline-in-a-product thesis for FB102 across autoimmune indications .
• EPS beat vs. consensus despite higher R&D signals disciplined operating execution; however, escalating trial costs will continue to pressure losses near term .
• Near-term catalysts: additional clinical enrollment updates, 2026 topline readouts, and continued conference presence (Guggenheim, TD Cowen, Evercore) to increase visibility .
• Absence of financial guidance shifts focus to clinical milestones; estimate adjustments likely tied to trial timelines and potential expansion of US enrollment .
• Risk factors include capital needs if timelines extend, and typical development uncertainties; management reiterates forward-looking caution .
• For trading, newsflow on US site activation/enrollment milestones and interim operational updates may drive sentiment ahead of 2026 readouts .

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