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Allogene Therapeutics, Inc. (ALLO)·Q2 2025 Earnings Summary

Executive Summary

  • EPS beat: Q2 2025 diluted EPS was -$0.23 vs S&P Global consensus of -$0.268, a ~$0.04–$0.05 beat; lower R&D and G&A drove the improvement while interest income provided a tailwind . Values retrieved from S&P Global.*
  • Guidance reset earlier in the year was reaffirmed: 2025 GAAP OpEx ~$230M including ~$45M SBC and cash burn ~-$150M, extending runway into 2H 2027 .
  • Strategic inflection: ALPHA3 now a two‑arm randomized trial using standard FC lymphodepletion (FCA arm closed after an ALLO‑647–related Grade 5 event), with futility analysis on MRD conversion remaining on track for 1H 2026 .
  • Pipeline momentum: RESOLUTION (ALLO‑329) initiated with first proof‑of‑concept and biomarker read planned for 1H 2026; ALLO‑316 Phase 1b results presented at ASCO and remained aligned with FDA on pivotal trial design, supporting partnering discussions .

What Went Well and What Went Wrong

What Went Well

  • ALPHA3 streamlined to standard FC lymphodepletion, improving operational simplicity and potential community-center adoption; “Early observations indicate an encouraging minimal residual disease (MRD) conversion rate and a favorable safety profile” .
  • Autoimmune expansion advancing: RESOLUTION basket trial initiated with first update planned 1H 2026, incorporating a no‑lymphodepletion arm to broaden applicability .
  • Solid tumor progress: ALLO‑316 Phase 1b data showed confirmed ORR of 31% in CD70 TPS ≥50% patients, with durable responses and robust CAR T kinetics under standard FC lymphodepletion, underpinning the Dagger platform .

What Went Wrong

  • Safety setback: FCA (FC+ALLO‑647) arm in ALPHA3 was closed after a Grade 5 event attributed to ALLO‑647‑related immunosuppression leading to disseminated adenovirus and hepatic failure; Allogene removed ALLO‑647 from open trials/pipeline .
  • Timelines extended: ALPHA3 lymphodepletion selection and futility shifted earlier in the year to 1H 2026 driven by site readiness and screening cadence; RESOLUTION proof‑of‑concept moved to 1H 2026 to include biomarker plus clinical data .
  • Ongoing losses consistent with clinical stage: Net loss was $50.9M (vs $66.4M in Q2 2024), reflecting continued investment ahead of pivotal milestones .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
Collaboration Revenue ($USD)$0.00 $0.00 N/A (not disclosed in Q2 press release)
R&D Expense ($USD Millions)$50.355 $50.200 $40.156
G&A Expense ($USD Millions)$16.087 $14.991 $14.281
Impairment of Long‑Lived Assets ($USD Millions)$4.989 —$2.382
Total Operating Expenses ($USD Millions)$71.431 $65.191 $56.819
Net Loss ($USD Millions)$66.358 $59.733 $50.943
Diluted EPS ($USD)-$0.35 -$0.28 -$0.23
Interest & Other Income, net ($USD Millions)$5.073 $5.458 $5.876
Cash, Cash Equivalents & Investments ($USD Millions)$444.628 $335.549 $302.630

Estimates vs Actuals (S&P Global consensus):

MetricQ2 2024Q1 2025Q2 2025
EPS Actual ($USD)-$0.35 -$0.28 -$0.23
EPS Consensus Mean ($USD)-$0.34945*-$0.295*-$0.26797*
Revenue Actual ($USD)$0.00 $0.00 N/A
Revenue Consensus Mean ($USD)$1,777,470*$1,670*$0*

Values retrieved from S&P Global.*

Notes:

  • Margins are not meaningful due to zero/immaterial revenue in recent quarters .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Burn (Decrease in cash, cash equivalents & investments)FY 2025~$170M (Q4 2024) ~$150M (Q1 2025 reaffirmed Q2 2025) Lowered
GAAP Operating ExpensesFY 2025~$250M incl. ~$50M SBC (Q4 2024) ~$230M incl. ~$45M SBC (Q1 2025 reaffirmed Q2 2025) Lowered
Cash RunwayMulti‑yearInto 2H 2026 (Q4 2024) Into 2H 2027 (Q1 2025 reaffirmed Q2 2025) Extended

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
ALPHA3 design & lymphodepletionSite activation; LD selection mid‑2025; MRD‑guided, ~240 pts; DSMB interim 1H 2026 Shift of LD selection/futility to 1H 2026; ~50 sites; Canada expansion; >250 consents for MRD screening Selected standard FC; two‑arm randomized vs observation; >50 sites; futility 1H 2026 Streamlined design; de‑risking; operational focus
Safety/regulatoryRMAT for ALLO‑316; platform ambitions Emphasis on real‑world site readiness FCA arm closed after ALLO‑647–related Grade 5 event; standard FC adopted; ALLO‑647 removed from open programs Safety-driven protocol change; regulatory alignment
Dagger® platform validationRobust expansion/persistence with ALLO‑316; manageable safety ASCO oral planned; translational findings in Phase 1b ASCO Phase 1b update; durable responses; strong kinetics with standard LD; FDA alignment on pivotal design Strengthening validation; pivotal planning
Autoimmune (ALLO‑329)IND cleared; mid‑2025 start; POC ~YE 2025 Mid‑2025 start; POC moved to 1H 2026 with biomarker+clinical package RESOLUTION initiated; first update planned 1H 2026; includes cyclophosphamide‑only and no‑LD arms Program initiated; broader adoption thesis
Financial disciplineCash runway into 2H 2026; FY25 cash burn ~$170M, OpEx ~$250M Runway extended into 2H 2027; FY25 cash burn ~$150M, OpEx ~$230M Runway into 2H 2027 reaffirmed Improved efficiency maintained

Management Commentary

  • “This quarter marked a significant inflection point for Allogene as we advance the streamlined ALPHA3 trial toward its next key milestone, initiate clinical enrollment in our first autoimmune indications with ALLO‑329, and aligned with the FDA on a pivotal path forward for ALLO‑316 in solid tumors.” — David Chang, President & CEO .
  • “We are executing on a strategy that is grounded in science, shaped by real‑world insights, and supported by a platform purpose‑built to scale.” — David Chang .
  • “The loss of a patient is always deeply saddening… This event… compelled us to make a decisive choice… The ability to administer cema‑cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review…” — David Chang .

Q&A Highlights

  • EPS beat and liquidity reaffirmation: EPS of -$0.22 reported on certain transcript services vs consensus -$0.268; management reiterated cash runway into 2H 2027 and highlighted streamlined ALPHA3 design and FDA alignment on ALLO‑316 .
  • Timeline clarity: MRD‑focused futility analysis for ALPHA3 remains scheduled for 1H 2026 with MRD conversion rates to be disclosed at that time .
  • Strategic pivot on lymphodepletion: Closure of FCA arm and removal of ALLO‑647 from active programs were addressed as safety‑driven changes to simplify execution and de‑risk the pivotal path .

Note: We attempted to read the full Q2 2025 earnings call transcript via the document tool, but the transcript document (ID 6) returned a database inconsistency error. We supplemented with reputable transcript sources and summaries and provided full URLs for verification .

Estimates Context

  • EPS: Actual -$0.23 vs consensus -$0.26797; beat driven by disciplined OpEx (R&D down ~$10M QoQ and ~$10M YoY; G&A down YoY) and higher net interest income . Values retrieved from S&P Global.*
  • Revenue: Consensus near $0 in Q2 2025; company continues to report no collaboration revenue in Q1 and Q2 prior year; Q2 2025 revenue not disclosed in press release . Values retrieved from S&P Global.*

Key Takeaways for Investors

  • The EPS beat alongside reaffirmed lower OpEx and extended runway reflects effective cost realignment; watch for continued OpEx discipline to support catalysts through 2026–2027 .
  • ALPHA3’s move to standard FC and closure of FCA arm reduces safety risk and could accelerate enrollment; MRD conversion futility in 1H 2026 is the next binary event .
  • Dagger platform is gaining external credibility in solid tumors (ALLO‑316) under standard lymphodepletion; FDA alignment on pivotal design enhances partnering optionality .
  • Autoimmune entry with ALLO‑329 and a no‑lymphodepletion arm broadens the addressable opportunity and could be a meaningful valuation lever if early data in 1H 2026 are positive .
  • Near‑term trading: stock may react to safety de‑risking and platform clarity; further upside likely tied to incremental ALPHA3 enrollment updates and any early MRD signals .
  • Medium‑term thesis: MRD‑guided earlier‑line use in LBCL and scalable allogeneic manufacturing provide structural advantages vs autologous CAR Ts if efficacy is confirmed and safety remains manageable .

Appendix: Additional Relevant Q2 2025 Period Documents

  • Q2 2025 8‑K earnings press release with financials and program update .
  • Aug 1, 2025 press release on FC lymphodepletion selection and FCA arm closure .
  • June 1, 2025 ASCO Phase 1b ALLO‑316 press release .
  • Prior quarters for trend analysis: Q1 2025 8‑K earnings press release ; Q4 2024 press release .

Values retrieved from S&P Global.*