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FT

FATE THERAPEUTICS INC (FATE)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 revenue was $1.9M, down sequentially vs Q3 2024 ($3.1M) and far below Q2’s $6.8M; net loss widened to $52.2M driven by a $14.7M one-time non-cash impairment in equipment and ROU assets .
  • Cash, cash equivalents, and investments totaled $306.7M with management reiterating operating runway through YE26; prior quarter cash was $330.5M .
  • Clinical momentum: FT819 CAR T in SLE entered Phase 1 dose expansion with fludarabine-free conditioning; first SLE patient reached drug-free DORIS clinical remission at 6 months; FDA Type D meeting enabled expansion into other autoimmune diseases and multi-dose/re-treatment paradigms .
  • No formal financial guidance (revenue, EPS, OpEx) was provided; estimates data from S&P Global were unavailable at run time, so beat/miss vs consensus cannot be determined. Key stock reaction catalysts: fludarabine-free conditioning progress, add-on maintenance arm without conditioning, and confirmed YE26 runway .

What Went Well and What Went Wrong

What Went Well

  • FT819 SLE program advanced: initiated Phase 1 dose expansion at 360M cells (flu-free conditioning) and escalated to 900M cells; first patient achieved DORIS clinical remission at 6 months and remains off immunosuppressives .
  • Regulatory progress: Completed FDA Type D meeting permitting additional autoimmune indications (AAV, IIM, SSc), multi-dose cycles, re-treatment on progression, and broader eligibility (ages 12–17) .
  • Pipeline breadth: FT825/ONO-8250 in advanced solid tumors showed favorable initial safety and Day-8 CAR expansion; FT522 (ADR CAR NK) displayed persistence and B-cell depletion without conditioning, supporting an allogeneic, outpatient-like paradigm .

What Went Wrong

  • Sequential revenue decline to $1.9M with heavier operating loss; OpEx rose to $63.6M due to $14.7M non-cash impairment and $9.1M stock-based compensation .
  • Net loss increased to $52.2M vs $47.7M in Q3; EPS loss widened to $(0.44) vs $(0.40) in Q3 .
  • Continued dependency on collaboration revenue (Ono-related preclinical/clinical activities) without product revenues; estimates comparison unavailable at run-time, limiting external benchmarking of financial execution .

Financial Results

Income Statement and Cash Metrics

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$6.772 $3.074 $1.860
Total Operating Expenses ($USD Millions)$51.855 $55.451 $63.608
Loss from Operations ($USD Millions)$(45.083) $(52.377) $(61.748)
Net Loss ($USD Millions)$(38.427) $(47.678) $(52.153)
EPS (Basic & Diluted, $)$(0.33) $(0.40) $(0.44)
Cash, Cash Equivalents & Investments ($USD Millions)$352.0 $330.5 $306.7

Notes: Q4 OpEx includes $14.7M non-cash impairment and $9.1M stock-based comp .

Prior-Year Comparison (Select Q4 YoY)

MetricQ4 2023Q4 2024
Revenue ($USD Millions)$13.631 $1.860
Total Operating Expenses ($USD Millions)$49.751 $63.608
Net Loss ($USD Millions)$(44.122) $(52.153)
EPS (Basic & Diluted, $)$(0.45) $(0.44)

KPIs

KPIQ2 2024Q3 2024Q4 2024
Common Shares Outstanding (Millions)113.8 113.9 113.9
Pre-funded Warrants (Millions)3.9 3.9 3.9
Preferred Shares (Millions; 5 common per preferred)2.8 2.8 2.8

Segment breakdown: Revenue primarily from Ono collaboration activities (preclinical/clinical support), including a milestone in Q2 and ongoing work in Q3–Q4 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating runway (Cash coverage)Through YE26YE26 runway reiterated in Q2 and Q3 YE26 runway reiterated in Q4 with $306.7M cash/investments Maintained
Financial guidance (Revenue, EPS, OpEx)2024 / Q4None providedNone providedN/A
Clinical plans – FT819 (SLE)2024–2025Enrollment ongoing; new Regimen B add-on without conditioning opened in Q3 Dose expansion initiated; escalation to 900M; FDA enabled additional diseases, multi-dose, re-treatment Raised program scope
Clinical plans – FT522 (Autoimmunity)2024–2025IND allowed; basket study design without conditioning Evaluating timelines; design permits up to four weekly doses as add-on to induction/maintenance Maintained/clarified
Clinical plans – FT825/ONO-8250 (Solid tumors)2024–2025Monotherapy dose escalation; combo with EGFR mAb to start Advancing into higher-dose cohorts; first combo patient treated Progressed

Earnings Call Themes & Trends

Note: No Q4 earnings call transcript was found; we use the Q4 press release and a March 11, 2025 Barclays fireside chat transcript as proxies .

TopicQ2 2024 (Q-2)Q3 2024 (Q-1)Q4 2024 (Current)Trend
FT819 in SLEEnrollment ongoing; single-agent cyclophosphamide conditioning added Initial data slated for ACR/ASH; Regimen B (add-on to maintenance) opened Dose expansion at 360M; escalation to 900M; first patient in Regimen B treated without conditioning; 6-month DORIS remission highlighted Accelerating with broader regimens
FT522 (ADR CAR NK)First patient without conditioning in BCL; IND for autoimmunity planned IND allowed; basket study to treat without conditioning Protocol allows multi-dose, add-on to rituximab regimens; persistence without conditioning shown Building translational validation
FT825/ONO-8250 (HER2)Monotherapy initiated; plan for combo dosing Initial safety and CAR expansion at SITC; ongoing dose escalation First combo patient treated; advancing dose cohorts Progressing dose and combo
Regulatory/FDAExpanding FT819 conditioning options Regimen B added; IND allowed for FT522 basket Type D meeting enables additional autoimmune indications, multi-dose, re-treatment, expanded age eligibility Regulatory tailwinds
Supply chain/tariffs/macroNot discussedNot discussedInventory-based “off-the-shelf” resilience; reagent redundancy; U.S. manufacturing; cautious on long-term FDA resource disruptions (Barclays Q&A) Risk-aware but near-term resilient
R&D executionPlatform and ADR advances SITC/ACR/ASH data planned ASH/ACR data delivered; Sword & Shield tech highlighted Continued science-led differentiation

Management Commentary

  • “We begin 2025 with resolve and focus to advance our lead clinical programs in autoimmunity and oncology… We look forward to providing clinical and regulatory updates as we advance our FT819… and sharing clinical data from these two high-priority programs throughout the year.” — Bob Valamehr, President & CEO .
  • “The first lupus nephritis patient treated with a single dose of FT819 and fludarabine-free conditioning has achieved drug-free clinical remission and continues free of all immunosuppressive therapy.” — Bob Valamehr (leadership transition PR) .
  • Physician perspective: “If we continue to see similar results… off-the-shelf CAR T-cell therapy could be a complete game-changer for our sickest lupus patients.” — Dr. Jennifer Medlin, PI (ACR case study) .
  • Cost and outpatient ambition: “The product is a lot cheaper… $3,000 a dose… we’re engaging with the FDA… to reduce those 72 hours into… outpatient.” — Bob Valamehr (Barclays Q&A) .

Q&A Highlights

  • Macro/supply chain: Management emphasized “off-the-shelf” inventory and dual-sourcing of ~80 reagents, U.S.-based manufacturing; near-term resilience with caution on long-term tariff/FDA resource risks .
  • Trial design/endpoints: Two arms (light conditioning vs add-on to maintenance without conditioning), dose levels at 360M and 900M; aiming for high-bar endpoints (e.g., DORIS remission) pending FDA alignment on pivotal strategy .
  • Safety/tolerability: Favorable profile; minimal CRS (some Grade 1–2), seeking outpatient feasibility based on safety record .
  • Economics and paradigm: Off-the-shelf, uniform product from master cell banks; management asserts much lower per-dose cost vs autologous CAR-T and potential multi-dose cycles akin to biologics .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 and Q3 2024 was unavailable at run-time due to access limits; therefore, quantitative comparisons to consensus for revenue and EPS cannot be presented. We will update beat/miss analysis once S&P Global data can be retrieved.
  • Company did not provide formal financial guidance for revenue, EPS, or OpEx, limiting forward benchmarking .

Key Takeaways for Investors

  • Clinical momentum with FT819 in SLE (flu-free conditioning, add-on without conditioning) and early remission signal de-risk the autoimmune strategy and may broaden addressable populations via FDA-enabled multi-dose/re-treatment designs .
  • Cash runway through YE26, even after Q4 non-cash impairment, supports clinical execution across FT819, FT522, and FT825 without near-term financing pressure; watch quarterly burn and non-cash items .
  • Sequential revenue decline and widened loss highlight continued reliance on collaboration revenue; near-term stock drivers are clinical/regulatory updates rather than P&L beats .
  • FT522’s conditioning-free persistence and B-cell depletion offer an outpatient-friendly profile that could complement/augment mAb regimens in autoimmune niches, a potentially differentiated value proposition .
  • Solid tumor program FT825/ONO-8250 shows early safety/expansion and is advancing into combination therapy; while secondary to autoimmunity, positive signals can add optionality .
  • Operational resilience: inventory-based manufacturing and reagent redundancy mitigate near-term supply risks; monitor macro/tariff developments and FDA bandwidth as possible execution overhangs .
  • Near-term catalysts: FT819 dose-expansion data flow, EULAR/other medical meeting updates, further FDA interactions on pivotal strategy, FT522 basket IND progress, and FT825 combo cohort read-throughs .

References: Q4 2024 8-K and press release ; Q3 2024 8-K ; Q2 2024 8-K ; FT819 ASH/ACR data ; FT522 ACR data ; Leadership transition PR ; Barclays fireside chat transcript .