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Forte Biosciences, Inc. (FBRX)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 reflected continued clinical progress on FB102 with first celiac patients dosed; topline data expected in Q2 2025, and OpEx moderated sequentially after a Q2 legal/professional spend spike .
  • Net loss was $8.39M and diluted EPS was $(4.54), with cash and equivalents at $16.4M; share count reflects an August 1:25 reverse split (1.46M shares outstanding at quarter-end) .
  • G&A fell to $2.76M from $7.08M in Q2 (driven by lower legal/professional expenses), and R&D was $5.72M as the company advanced FB102 into a celiac patient study .
  • Post-quarter, Forte raised $53M via an oversubscribed private placement from leading healthcare investors, extending runway and enabling broader FB102 development across autoimmune indications—an important stock reaction catalyst and funding de-risking event .

What Went Well and What Went Wrong

What Went Well

  • Initiation of the celiac disease trial and clear clinical timing: “We have begun dosing patients in a celiac disease clinical trial… Topline data is expected to readout in the second quarter of 2025.” — Paul Wagner, Ph.D., CEO .
  • Mechanistic selectivity supported by non-human primate and in-vitro data: FB102 inhibited pathogenic NK/T cells while sparing Tregs (selectivity for intermediate vs. high-affinity IL-2 receptor) .
  • Sequential OpEx moderation: G&A expenses fell to $2.76M in Q3 from $7.08M in Q2 as legal/professional spend normalized, reducing quarterly burn .

What Went Wrong

  • Continued losses and limited balance sheet as of quarter-end: Net loss of $8.39M and stockholders’ equity down to $9.37M; cash declined to $16.36M pre-financing .
  • No revenue contribution; results driven entirely by R&D and G&A (typical of clinical-stage biotech), limiting financial levers beyond expense control .
  • Estimate benchmarking unavailable: S&P Global Wall Street consensus estimates for Q3 2024 were not available at the time of retrieval, limiting formal beat/miss framing relative to the Street.

Financial Results

Income Statement (Quarterly)

Metric ($USD Millions, except per-share and shares)Q1 2024Q2 2024Q3 2024
Research & Development$4.353 $5.590 $5.720
General & Administrative$3.451 $7.078 $2.759
Total Operating Expenses$7.804 $12.818 $8.629
Other Income, Net$0.384 $0.307 $0.237
Net Loss$(7.420) $(12.511) $(8.392)
Diluted EPS$(0.16) $(0.27) $(4.54)
Weighted Avg Shares (basic & diluted)46,082,861 46,131,151 1,847,644

Notes: Q3 EPS and share count reflect a 1:25 reverse split executed in August 2024 .

Balance Sheet KPIs

Metric ($USD Millions)Q1 2024Q2 2024Q3 2024
Cash & Cash Equivalents$30.444 $24.498 $16.363
Accounts Payable$1.685 $5.275 $5.159
Accrued Liabilities$1.647 $3.842 $3.421
Total Stockholders’ Equity$28.685 $16.961 $9.366
Shares Outstanding (end of period)36.395M 36.442M 1.460M

Q3 2024 vs Q3 2023 (YoY)

MetricQ3 2024Q3 2023
Research & Development ($M)$5.720 $6.369
General & Administrative ($M)$2.759 $3.847
Total Operating Expenses ($M)$8.629 $10.216
Other Income, Net ($M)$0.237 $0.261
Net Loss ($M)$(8.392) $(9.955)
Diluted EPS$(4.54) $(6.57)
Weighted Avg Shares1,847,644 1,514,509

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Celiac Disease Trial ToplineQ2 2025Initiation anticipated in 2H 2024; topline targeted by Q2 2025 Topline data expected Q2 2025; patients dosing underway Maintained timing
FB102 Program Advancement (additional indications)Next 12 monthsContinued preclinical/clinical evaluation Expect advancement into additional indications over next 12 months (post-quarter update) Raised ambition/scope
Revenue, Margins, OpEx, Tax Rate, Dividends2024-2025Not providedNot providedN/A

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript was available; themes derived from Q1–Q3 press releases.

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
R&D Execution (FB102 safety/PD)Phase 1 SAD/MAD completed; good safety; NK cell PD reductions observed Continued emphasis on mechanistic selectivity (in-vitro/NHP) and safety signal; advancing into patient trial Stable/positive
Celiac Disease Clinical TimingInitiation 3Q 2024; topline by Q2 2025 Patients dosed; topline expected Q2 2025 On track
Cash/Runway & Capital Markets~$30.4M (Q1); ~$24.5M (Q2) cash $16.4M cash at Q3; post-quarter $53M financing announced Strengthened post-quarter
Legal/Professional Spend (G&A)Elevated Q2 G&A ($7.08M), driven by legal/professional expenses G&A moderated to $2.76M; lower legal/professional Normalizing
Pipeline Indications (autoimmune breadth)GVHD, vitiligo, alopecia areata; “pipeline-in-a-product” concept Continued multi-indication strategy; plan to expand over next 12 months Expanding scope

Management Commentary

  • “We continue to make excellent progress with FB102 and have begun dosing patients in a celiac disease clinical trial… The topline data is expected to readout in the second quarter of 2025.” — Paul Wagner, Ph.D., CEO .
  • “Based on the biology of celiac disease and the mechanism of action of FB102, we are excited about the potential in celiac disease… We believe the data to date supports the significant potential for FB102 across a variety of autoimmune and autoimmune-related diseases.” — Paul Wagner, Ph.D., CEO .
  • “The SAD/MAD phase 1 healthy volunteer study has successfully completed and FB102 has demonstrated a good safety profile.” — Paul Wagner, Ph.D., CEO (Q2 release) .

Q&A Highlights

  • No Q3 2024 earnings call transcript or Q&A session was available in the document set; no additional Q&A-derived clarifications were observed.

Estimates Context

  • S&P Global Wall Street consensus for Q3 2024 EPS and Revenue was unavailable at the time of retrieval; as a result, formal beat/miss analysis vs. consensus cannot be provided for this quarter.
  • Implication: Near-term Street revisions are likely to focus on operating expense normalization, funding de-risking post-$53M placement, and clinical timing/catalysts rather than revenue/EPS modeling typical of commercial-stage companies .

Key Takeaways for Investors

  • Clinical catalyst clarity: celiac trial topline in Q2 2025 remains the principal value inflection; patient dosing underway supports on-track execution .
  • Capital de-risking: The oversubscribed $53M financing post-quarter extends runway and enables program expansion across autoimmune indications—a positive for sentiment and negotiation leverage in potential partnerships .
  • Expense normalization: G&A retrenched from an unusually high Q2, improving quarterly burn profile; monitor sustainability of lower legal/professional expenses .
  • EPS comparability: The August 1:25 reverse split alters per-share metrics (Q3 EPS $(4.54)); use total net loss and operating expense trends for like-for-like tracking .
  • Cash progression: Cash declined from $24.5M (Q2) to $16.4M (Q3) pre-financing; the subsequent $53M materially extends runway ahead of topline .
  • Pipeline breadth: Mechanistic data supports “pipeline-in-a-product” positioning for FB102; expect indication additions over the next 12 months, which could broaden the thesis beyond celiac .
  • Trading setup: With limited Street coverage and no revenues, stock reaction hinges on clinical milestones, financing signals, and expense discipline; near-term catalysts include the December 3 R&D Day and ongoing celiac study progress updates .