CARGO Therapeutics (CRGX) Q3 2024 earnings summary

Executive summary

• Clinical-stage biotech focused on next-gen cell therapies for cancer, with lead program firi-cel in Phase 2 for large B-cell lymphoma post-CD19 CAR T failure; 57 patients dosed in pivotal FIRCE-1 study, interim analysis expected 1H25.

• Completed successful pre-IND meeting with FDA for CRG-023; IND submission planned for Q1 2025 and Phase 1 initiation in 2025.

• Net loss of $41.9M for Q3 2024 and $122.1M for the nine months ended September 30, 2024; accumulated deficit of $267.2M.

• Cash and marketable securities of $404.8M as of September 30, 2024, expected to fund operations through 2026.

• Appointment of Anup Radhakrishnan as COO in addition to CFO role, effective November 2024.

Financial highlights

• Q3 2024 research and development expenses were $35.9M; G&A expenses were $11.2M.

• Net loss per share for Q3 2024 was $(0.88); weighted-average shares outstanding: 47.7M.

• Cash, cash equivalents, and marketable securities totaled $404.8M as of September 30, 2024.

• Operating expenses for Q3 2024 were $47.1M, up from $28.7M in Q3 2023.

• Non-cash stock-based compensation was $4.9M for Q3 2024.

Outlook and guidance

• Interim analysis for FIRCE-1 Phase 2 study of firi-cel on track for first half of 2025.

• IND submission for CRG-023 in Non-Hodgkin's lymphoma anticipated in Q1 2025; first patient dosing planned for 2025.

• Cash position expected to fund operations through 2026.

• Anticipates continued significant net operating losses as clinical and preclinical development, pipeline expansion, and hiring continue.

• No revenue expected until regulatory approval and commercialization of product candidates.