Allogene Therapeutics, Inc. (ALLO)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 delivered disciplined execution and clear 2025 catalysts: ALPHA3 lymphodepletion selection/futility around mid-2025, ALLO-316 Phase 1b durability data mid-2025, and ALLO-329 autoimmune basket trial proof-of-concept by year-end 2025 .
• Financials: net loss of $59.9M and EPS of $0.28 loss; cash and investments ended at $373.1M; sequential cash burn accelerated consistent with R&D progress .
• 2025 guidance introduced: cash decrease of ~$170M and GAAP operating expenses of ~$250M (incl. ~$50M SBC); cash runway remains into 2H 2026—maintained from prior quarters .
• Strategic progress: 40 ALPHA3 sites activated; expanded Foresight MRD companion diagnostic partnership ex-U.S.; ALLO-316 holds RMAT designation and completed Phase 1b expansion cohort enrollment—setting up near-term data readouts .
• Street estimates (S&P Global) were unavailable; beat/miss assessment cannot be made. Values would be retrieved from S&P Global; unavailable this period.

What Went Well and What Went Wrong

What Went Well

• “We believe 2025 will be the year allogeneic CAR T broadly begins to demonstrate its potential to surpass autologous CAR T therapy” — pipeline positioned for three major clinical readouts (ALPHA3, ALLO-316, ALLO-329) .
• ALPHA3 momentum: ~40 sites activated; pivotal design with MRD-based selection aims to improve event-free survival in 1L LBCL; futility and lymphodepletion selection around mid-2025 .
• ALLO-316 progress: RMAT designation in RCC; Phase 1b expansion enrollment completed; prior Phase 1 showed 50% best ORR and 33% confirmed ORR in high CD70 TPS cohort with manageable safety .

What Went Wrong

• Continued operating losses with no product revenue: Q4 net loss $59.9M and EPS loss of $0.28; collaboration revenue at $0; ongoing cash burn trend .
• Impairment charges persisted across 2024 (non-cash): $15.7M for the year; Q3 also recorded $10.7M; highlights asset rationalization amid pipeline focus .
• Estimates context unavailable (S&P Global retrieval error), limiting beat/miss evaluation and potentially delaying investor consensus recalibration; management did not provide revenue or EPS guidance . Values would be retrieved from S&P Global; unavailable this period.

Financial Results

Notes:

• Stock-based compensation included: Q4 R&D $5.6M; Q4 G&A $7.3M; Q4 total SBC $12.9M; FY SBC $51.7M .
• No product revenue; collaboration revenue minimal.

Segment breakdown: Not applicable (no commercial product segments disclosed) .

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “We enter 2025 stronger than ever with a differentiated pipeline and a clear path to shaping the future of allogeneic CAR T” .
• “ALPHA3… is widely considered to be groundbreaking… momentum continues to build with 40 sites now activated” .
• “ALLO-329… powered by our proprietary Dagger technology… potential to reduce or even eliminate the need for lymphodepletion” .
• “ALLO-316 has the potential to redefine treatment for advanced renal cell carcinoma… Regenerative Medicine Advanced Therapy designation” .
• CFO: “We expect a cash burn of approximately $170 million [in 2025]… GAAP operating expenses approximately $250 million including ~$50 million SBC” .

Q&A Highlights

• Lymphodepletion selection: Management remains agnostic; both with/without ALLO-647 have advantages; formal EFS hypothesis test at interim with minimal alpha spend—possibility of statistical significance that could accelerate FDA interactions .
• MRD conversion/futility: Futility will assess totality of data, with MRD conversion expected to favor treatment arms vs observation; safety balance monitored .
• Autoimmune program differentiation: Biomarker-based PoC focused on CAR T expansion, B-cell depletion, autoantibody changes; dual targeting CD19/CD70 aims for broader indications and longer remission .
• Outpatient feasibility: Investigators decide case-by-case; many patients treated fully outpatient; remission status and low disease burden support safer outpatient management .
• Timeline confidence: Enrollment and data timing reiterated—ALPHA3 interim EFS 1H 2026; mid-2025 lymphodepletion selection/futility; mid-2025 ALLO-316 durability update .

Estimates Context

• Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable due to retrieval limits; therefore, we cannot assess beat/miss versus Wall Street this quarter. Values would be retrieved from S&P Global; unavailable this period.
• With no product revenue and collaboration revenue at $0, investor focus remains on operating trajectory (R&D/G&A trend) and cash runway/guidance rather than near-term P&L beats .

Key Takeaways for Investors

• Three near-term catalysts: mid-2025 ALPHA3 lymphodepletion selection/futility; mid-2025 ALLO-316 Phase 1b durability; YE 2025 ALLO-329 PoC—each can reshape narrative and valuation .
• Cash runway to 2H 2026 and 2025 cash burn guidance (~$170M) provide visibility to these milestones; GAAP opex ~$250M reflects planned execution pace .
• ALPHA3 design (MRD positivity; EFS endpoint) plus expanded CDx partnership positions cema-cel for a first-of-its-kind consolidation approach in 1L LBCL; interim EFS in 1H 2026 could be meaningful .
• RMAT for ALLO-316 underscores regulatory momentum in RCC; prior data showed promising ORR in high CD70 TPS with manageable safety—durability update is the next key inflection .
• Autoimmune strategy differentiated (CD19/CD70 dual CAR + Dagger tech); elimination or reduction of lymphodepletion could broaden applicability and reduce treatment burden .
• Operating discipline evident: sequential reduction in net loss and controlled G&A; continued non-cash items (SBC, impairment) require investor normalization when tracking burn .
• With Street estimates unavailable, trade the catalysts: monitor mid-2025 milestones and any signals on MRD conversion and outpatient feasibility—these can drive sentiment and multiple expansion .

Management’s reported financials and guidance are sourced from the Q4 2024 8-K/press release and the Q4 earnings call transcript .