CARGO Therapeutics, Inc. (CRGX)·Q3 2024 Earnings Summary

Executive Summary

• Clinical execution advanced: 57 patients have been dosed in FIRCE-1 (potentially pivotal Phase 2) with the IDMC completing its safety/futility assessment and recommending continuation; interim analysis remains on track for 1H25 .
• Cash runway intact through 2026 with $404.8M in cash, cash equivalents and marketable securities at 9/30/24; management reiterated funding sufficiency through 2026 .
• Q3 financials in line with a clinical-stage profile: R&D $35.9M, G&A $11.2M, net loss $(41.9)M or $(0.88) per share; YoY opex increases reflect manufacturing scale-up, trial activity, headcount, and facilities costs .
• Pipeline momentum: CRG-023 preclinical data to be presented at ASH 2024; IND submission anticipated in Q1’25 with first patient in 2025, reinforcing a 2025 pipeline catalyst path alongside FIRCE-1 interim in 1H25 .
• Street estimates: S&P Global consensus for Q3 2024 was unavailable via our data access; therefore, we cannot provide comparisons to EPS/revenue estimates (see Estimates Context).

What Went Well and What Went Wrong

What Went Well

• Continued operational progress in FIRCE-1: “We are pleased to report another quarter of strong execution… With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025.” – Gina Chapman, CEO .
• Positive oversight outcome: The IDMC completed its safety/futility assessment and recommended study continuation without modification .
• Pipeline advancement and near-term catalysts: Successful pre-IND meeting for CRG-023; IND in Q1’25 and first patient in 2025; preclinical data to be presented at ASH 2024 .

What Went Wrong

• Operating expense intensity: R&D rose $13.7M YoY in Q3 driven by manufacturing/technical ops, clinical costs for FIRCE-1, headcount, and facilities; G&A rose $4.7M YoY on higher headcount/stock comp and facilities/software costs .
• Net loss widened YoY to $(41.9)M in Q3 (from $(35.5)M), as spending accelerated with program execution .
• Controls: Material weaknesses in internal control over financial reporting remain unremediated as of Q3 (insufficient personnel, risk assessment, segregation of duties, monitoring/communication) .

Financial Results

Operating results (GAAP)

Liquidity

KPIs and operational disclosures

Notes:

• Company reported no product revenue; operations reflect clinical-stage investment focus .
• No non-GAAP measures were provided; press release and 10-Q present GAAP results (operating expenses, net loss, EPS) .

Guidance Changes

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript was available in our document set; themes below reflect press releases and the 10-Q.

Management Commentary

• “We are pleased to report another quarter of strong execution… With 57 patients dosed and continued, strong manufacturing success, we remain on track to report our interim analysis in the first half of 2025.” – Gina Chapman, President & CEO .
• “We also anticipate a clear path forward to advancing CRG-023… following our successful pre-IND meeting with the FDA… share more at the upcoming ASH meeting.” – Gina Chapman .
• COO appointment: “Anup Radhakrishnan… appointed as Chief Operating Officer and CFO… instrumental in transforming CARGO… leading our successful IPO… positioned CARGO for future growth.” – Gina Chapman .

Q&A Highlights

• No earnings call transcript was available; no Q&A highlights could be extracted from primary documents.

Estimates Context

• S&P Global (Capital IQ) consensus estimates for Q3 2024 EPS and revenue were unavailable via our data access (missing mapping for CRGX), so we cannot provide a comparison to Street expectations at this time.
• Given CRGX is a clinical-stage company with no reported product revenue, formal Street EPS/revenue estimate frameworks may be limited in coverage for near-term quarters .

Key Takeaways for Investors

• Near-term binary catalysts: (1) ASH 2024 preclinical data for CRG-023, (2) FIRCE-1 interim analysis in 1H25, and (3) CRG-023 IND filing in Q1’25 with first patient in 2025; these events are likely to drive stock reactions as clinical risk/reward crystallizes .
• Execution de-risks manufacturing/supply: >95% success rate cited in Q2 and “strong manufacturing success” reiterated in Q3 underpin confidence in CMC readiness for pivotal-stage execution .
• Liquidity sufficient into/through 2026: $404.8M cash/securities supports continued clinical and CMC investment without near-term financing needs, reducing dilution risk ahead of key data readouts .
• Expense trajectory reflects investment phase: YoY increases in R&D/G&A stem from manufacturing scale-up, clinical costs, headcount, and facilities; investors should expect elevated burn as programs advance .
• Controls remain a watch item: Material weaknesses in internal controls are unremediated; successful remediation would reduce governance risk as the company scales .
• Strategy signal: Expanded role for CFO to COO/CFO suggests continued focus on operational scale-up and execution across clinical, CMC, and corporate functions .
• Estimate dynamics: With Street estimates unavailable and no product revenue, share performance will be primarily driven by clinical/regulatory milestones and balance sheet durability rather than quarterly “beats/misses” .

Appendix: Source Documents

• Q3 2024 Press Release (8-K Item 2.02, Ex. 99.1): patients dosed, IDMC outcome, CRG-023 timelines, cash, Q3 financial highlights .
• Q3 2024 10-Q: full financial statements, MD&A (expense drivers, liquidity), controls, risks .
• Q2 2024 Press Release (8-K): pipeline, manufacturing success rate, $110M PIPE, cash .
• Q1 2024 Press Release (8-K): early FIRCE-1 status, IDMC continuation, cash .

Segment note: Company reports operating expenses and does not disclose revenue segments (clinical-stage, no product revenue) .