Sign in

You're signed outSign in or to get full access.

FT

FATE THERAPEUTICS INC (FATE)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 revenue was $3.1M, down sequentially on milestone timing; GAAP operating expenses rose to $55.5M and net loss was $47.7M ($0.40 per share). Cash and investments were $330.5M, with runway projected through YE26 .
  • Programs advanced: FT819 in SLE added a second, no-conditioning arm; FT522 autoimmunity IND was allowed by FDA; FT825/ONO-8250 showed favorable safety and on-tumor selectivity in early data .
  • Sequential comparison: revenue declined vs Q2 ($6.8M) due to absence of the $5M collaboration milestone recognized in Q2; operating expenses rose, resulting in a wider net loss vs Q2 ($38.4M) .
  • Near-term catalysts: initial FT819 autoimmunity data at ACR/ASH, initial FT522 BCL data at ACR, and continued FT825 dose escalation including combination mAb therapy; leadership transition announced for Jan 1, 2025 may also influence sentiment .

What Went Well and What Went Wrong

What Went Well

  • FT522 autoimmunity basket IND allowed by FDA; Phase 1 designed to treat without conditioning across B cell-mediated diseases, highlighting potential platform differentiation .
  • FT825/ONO-8250 early Phase 1 monotherapy data showed favorable safety with no CRS/ICANS/GvHD, CAR T expansion at Day 8, and activated phenotype; preclinical data demonstrated cancer-selective HER2 targeting via H2CasMab-2 .
  • Management emphasized progress and upcoming data: “We continue to make great strides… assessing FT819 with fludarabine-free conditioning as well as… maintenance therapy without conditioning chemotherapy” .

What Went Wrong

  • Collaboration revenue fell sequentially (Q3 $3.1M vs Q2 $6.8M) as Q2 benefitted from a $5M milestone; Q3 lacked similar events, underscoring revenue volatility tied to collaborations .
  • GAAP operating expenses increased to $55.5M (R&D $34.7M; G&A $20.8M), widening the quarterly net loss to $47.7M against Q2’s $38.4M; stock-based comp was $11.8M in Q3 .
  • Street consensus comparison unavailable via S&P Global this quarter due to access limits, limiting external benchmarking of revenue/EPS and potentially increasing uncertainty around investor expectations (S&P Global data unavailable) [GetEstimates error].

Financial Results

MetricQ1 2024Q2 2024Q3 2024
Revenue ($USD Millions)$1.925 $6.772 $3.074
GAAP Operating Expenses ($USD Millions)$52.993 $51.855 $55.451
Net Loss ($USD Millions)$(48.004) $(38.427) $(47.678)
EPS (basic/diluted) ($USD)$(0.47) $(0.33) $(0.40)
Cash & Investments ($USD Millions)$391.1 $352.0 $330.5

YoY comparison (Q3 2024 vs Q3 2023):

MetricQ3 2023Q3 2024
Revenue ($USD Millions)$1.944 $3.074
GAAP Operating Expenses ($USD Millions)$53.223 $55.451
Net Loss ($USD Millions)$(45.170) $(47.678)
EPS (basic/diluted) ($USD)$(0.46) $(0.40)

KPIs:

KPIQ1 2024Q2 2024Q3 2024
R&D Expense ($USD Millions)$32.138 $34.604 $34.650
G&A Expense ($USD Millions)$20.855 $17.251 $20.801
Common Shares Outstanding (Millions)113.8 113.8 113.9
Pre-funded Warrants Outstanding (Millions)3.9 3.9 3.9
Preferred Shares Outstanding (Millions; 5:1 conversion)2.8 2.8 2.8

Note: Company does not report gross margin/operating margin metrics; margins not applicable.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating runway (cash)Through YE26Projected runway through YE26 (Q2) Projected runway through YE26 (Q3) Maintained
FT522 autoimmunity IND status2H 2024IND to be submitted in 3Q24 IND allowed by FDA; Phase 1 basket to treat without conditioning Raised (regulatory progress)
FT819 SLE clinical designOngoingSingle-agent cyclophosphamide added as alternative conditioning in Q2 Second arm added: maintenance therapy without conditioning; enrollment open Expanded clinical protocol
Financial guidance (rev/EPS/margins)N/ANot providedNot provided N/A

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript was available in the document set; themes tracked across quarterly communications (press releases):

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3)Trend
Autoimmunity focus (FT819)First SLE patient treated (Q1) and added cyclophosphamide regimen (Q2) Three SLE patients treated with fludarabine-free conditioning; new arm with no conditioning added Expanding clinical scope
Conditioning-free paradigm (FT522 ADR NK)Conditioning-free arm opened; IND planned (Q1/Q2) IND allowed; basket design without conditioning across diseases Regulatory progress achieved
Solid tumor program (FT825/ONO-8250)First patients treated; combo mAb dosing planned (Q1/Q2) Favorable safety; CAR T expansion; cancer-selective HER2 domain highlighted; combo mAb enrollment initiated Clinical momentum building
Collaboration revenue dynamicsQ1 $1.9M; Q2 $6.8M with $5M milestone Q3 $3.1M; milestone absent Volatile (milestone-driven)
Cash runway$391.1M (Q1); projected YE26 (Q2) $330.5M; runway through YE26 Maintained, lower cash balance

Management Commentary

  • Strategic focus: “We continue to make great strides in our pursuit of therapeutic differentiation for patients with B cell-mediated autoimmune diseases” .
  • FT522: “We are very pleased with the Phase 1 study design allowed by the FDA… assess multiple doses… without conditioning chemotherapy across a basket of B cell-mediated autoimmune diseases” .
  • FT825/ONO-8250: “Initial low-dose cohort… demonstrated a favorable safety profile… CAR T-cell expansion… activated state… no evidence of exhaustion” .
  • Leadership update post-quarter: “Bob Valamehr, Ph.D. MBA, To Become President and CEO January 1, 2025… Scott Wolchko to retire…” with comment that first FT819 LN patient achieved drug-free clinical remission per R&D leadership .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available; thus, there are no accessible Q&A clarifications to report for the period. Management commentary above is sourced from press releases .

Estimates Context

  • Wall Street consensus via S&P Global could not be retrieved for Q3 2024 due to access limitations (Daily Request Limit exceeded). As a result, comparisons versus Street estimates are unavailable for this recap; caution is warranted when inferring beats/misses without external benchmarks (S&P Global data unavailable) [GetEstimates error].
  • Given collaboration revenue variability (Q2 benefitted from a $5M milestone), Street models likely embed milestone timing; Q3’s $3.1M suggests a lighter collaboration revenue quarter absent milestones .

Key Takeaways for Investors

  • Revenue volatility tied to collaboration milestones persists; Q3’s $3.1M was below Q2 due to absence of a $5M Ono milestone, while operating expenses increased, widening losses .
  • Autoimmunity pipeline depth increased: FT819 added a no-conditioning maintenance arm and has initial SLE patient data presentations scheduled (ACR/ASH), offering near-term clinical readouts .
  • FT522 reached a key regulatory milestone with FDA IND allowance for a conditioning-free basket study—an important differentiator for off-the-shelf cell therapies and a catalyst as enrollment begins .
  • Solid tumor program (FT825/ONO-8250) continues to de-risk safety with on-tumor selectivity; combination mAb dosing opens multi-antigen strategies, expanding potential efficacy paths .
  • Cash runway is projected through YE26, supporting multi-program execution; however, cash declined to $330.5M as spend increased, making disciplined opex management a focus .
  • Leadership transition effective Jan 1, 2025 introduces a potential narrative shift; continuity is supported by internal R&D leadership stepping into CEO role, with initial FT819 remission anecdote underscoring strategic confidence .
  • Near-term trading catalysts include ACR/ASH data and potential early FT522 BCL updates; absent Street estimates, price reaction may hinge on clinical signals and platform differentiation rather than financial metrics .