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Apogee Therapeutics, Inc. (APGE)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 net loss was $55.3M as R&D and G&A stepped up to drive multiple clinical catalysts; cash, cash equivalents and marketable securities were $681.4M, supporting runway into Q1 2028 .
  • EPS beat consensus: Primary EPS actual was -$0.95 vs Wall Street -$1.26 consensus, while revenue remained non-material for this pre-commercial stage company; estimates context below.*
  • Operationally, management highlighted progress across APG777 (AD) with the Phase 2 APEX Part A 16-week readout expected mid-2025, initiation of APG777 in mild-to-moderate asthma, and positive APG808 Phase 1b interim data demonstrating robust FeNO suppression with sustained effect to 12 weeks .
  • Near-term catalysts include APG777 mid-2025 Part A data, APG808 advancement in asthma, and initiation of APG279 (APG777+APG990) head-to-head vs DUPIXENT in AD later in 2025, framing the stock’s catalyst path and narrative on potential dosing/efficacy differentiation .

What Went Well and What Went Wrong

What Went Well

  • APG808 Phase 1b interim data showed rapid, robust FeNO suppression (max -53%; sustained -50% at 12 weeks) and favorable safety, supporting potential 2-month+ maintenance dosing; management framed this as “a significant milestone” validating design for potentially best-in-class PK-driven dosing .
  • APG777 program execution: APEX Part A fully enrolled, Part B actively enrolling; mid-2025 16-week Part A data on track. First patient dosed in APG777 asthma Phase 1b (readout 1H 2026), reinforcing multi-indication expansion momentum .
  • Cash runway remains strong: $681.4M cash/securities at Q1-end, guiding funding into Q1 2028, enabling execution across AD and respiratory programs without near-term financing overhang .

What Went Wrong

  • Elevated operating expenses: R&D rose to $46.4M from $28.7M YoY and G&A to $16.7M from $9.5M YoY, widening quarterly net loss to $55.3M (vs $32.1M YoY) as the company scales clinical development and headcount .
  • No commercial revenue; results are driven solely by Opex and interest income, keeping fundamental valuation tethered to clinical milestones rather than earnings quality or margins .
  • Timelines for certain programs are extended out (e.g., APG279 readout in 2H 2026, APG333 HV data 2H 2025), which can increase period-to-period binary risk and strengthen dependency on upcoming APG777 Part A outcomes .

Financial Results

Headline Operating Metrics (quarterly)

Metric ($USD Millions)Q1 2024Q3 2024Q1 2025
R&D Expense$28.7 $45.7 $46.4
G&A Expense$9.5 $13.0 $16.7
Net Loss$(32.1) $(49.0) $(55.3)
Cash, Cash Equivalents & Marketable Securitiesn/a$753.8 $681.4

EPS vs Estimates

MetricQ3 2024Q4 2024Q1 2025
Primary EPS Consensus Mean-$0.77*-$1.03*-$1.26*
Primary EPS Actual-$0.86*-$1.20*-$0.95*
Surprise-$0.09 vs est (miss)*-$0.17 vs est (miss)*+$0.31 vs est (beat)*

Values retrieved from S&P Global.*

Revenue vs Estimates

MetricQ3 2024Q4 2024Q1 2025
Revenue Consensus Mean$0.00*$0.00*$0.00*
Revenue Actualn/an/an/a

Values retrieved from S&P Global.*
Note: APGE is pre-commercial; financial statements do not present product revenue lines for Q1 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
APG777 APEX Part A topline (16-week)Mid-2025Mid-2025 Mid-2025 Maintained
APG777 APEX Part B enrollment2025–2026Initiate ahead of schedule (Feb 2025) Actively enrolling; Part B data 2H 2026 Maintained/clarified timing
APG777 asthma Phase 1b1H 2026 readoutInitiate 1H 2025 First patient dosed; readout 1H 2026 Achieved initiation; timeline clarified
APG279 (APG777+APG990) Phase 1b vs DUPIXENT (AD)Initiation 2025; interim 2H 2026Initiation 2025; interim 2H 2026 Initiation 2025; interim 2H 2026 Maintained
APG333 Phase 1 in HV2025; data 2H 2025Initiate late 2024/early 2025 Trial underway; data 2H 2025 Timeline clarified; on track
APG808 asthma Phase 1b1H 2025 data1H 2025 interim data expected Positive interim data reported May 12, 2025 Achieved
Cash runwayFunding horizonInto Q1 2028 Into Q1 2028 Maintained
EoE Phase 2 (APG777)20262026 2026 Maintained

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not found in our document catalog after targeted searches (earnings-call-transcript filter, APGE, QDF=5; 2025-04-01 to 2025-06-30). We read all available press materials in full and incorporated prior quarters for thematic trend analysis.

TopicPrevious Mentions (Q-2: Q3 2024; Q-1: Q4 2024)Current Period (Q1 2025)Trend
R&D execution cadenceQ3: Multiple programs advancing; strong cash, runway into 2028 . Q4: Over-enrolled APG777 Part A; Part B initiated; APG990 interim Phase 1 positive .Continued execution: APG777 Part A on track mid-2025; Part B enrolling; APG777 asthma Phase 1b first patient dosed; APG808 Phase 1b interim data positive .Strengthening
Combination strategy (APG279)Q3: 2025 initiation planned . Q4: Supported by APG990 interim results and combo tox; 2025 initiation; 2H 2026 interim readout .Plans maintained; combination positioned for head-to-head vs DUPIXENT in AD .Stable
Dosing differentiation narrativeQ3/Q4: Extended half-life designs; potential Q3M/Q6M dosing for APG777/APG990 .Market research suggests strong preference for APG777’s potential quarterly dosing among physicians/patients .Building commercial case
Respiratory portfolio (TSLP, IL-4Rα, IL-13)Q3/Q4: APG333 nomination/initiation plans; APG808 Phase 1 on track; combo potential in respiratory .APG333 HV trial underway (data 2H 2025); APG808 interim clinical signal supports less frequent dosing .Advancing
Cash runway & fundingQ3/Q4: Runway into 2028; strong cash position .$681.4M cash/securities; runway into Q1 2028 .Stable

Management Commentary

  • CEO framing: “2025 is poised to be a transformational year for Apogee… strong execution in the first quarter… advancing therapies with the goal of reshaping the standard of care for patients living with I&I diseases,” highlighting APEX progress and APG808 interim data .
  • Commercial positioning: “APG777’s potential quarterly dosing is highly preferred by both physicians and patients… AD biologic market is expanding rapidly… we believe APG777 is well positioned to transform the AD treatment landscape” — Jeff Hartness, CCO .
  • APG808 significance: “APG808 demonstrated a favorable safety profile and encouraging initial efficacy… could substantially improve clinical outcomes for patients with asthma… enable dosing as infrequently as every two months or longer” — Michael Henderson, CEO .

Q&A Highlights

  • A Q1 2025 earnings call transcript could not be located in our filings/document catalog despite targeted searches (APGE earnings-call-transcript filter, 2025-04-01 to 2025-06-30). No Q&A highlights are available from primary-source transcripts in this dataset.

Estimates Context

  • EPS: Q1 2025 Primary EPS actual -$0.95 beat consensus -$1.26 by +$0.31; prior quarters: Q4 2024 -$1.20 vs -$1.03 (miss), Q3 2024 -$0.86 vs -$0.77 (miss).*
  • Revenue: Consensus $0.00; actual revenue not reported for this pre-commercial quarter.*
  • Implication: The Q1 EPS beat likely reflects higher interest income and disciplined Opex pacing relative to sell-side expectations amid step-ups in R&D/G&A . Values retrieved from S&P Global.*

Key Takeaways for Investors

  • APG777’s mid-2025 Part A readout is the pivotal near-term catalyst; quarterly dosing preference data adds commercial weight to a potential efficacy-confirming update .
  • Positive APG808 Phase 1b signal de-risks respiratory strategy and supports a less-frequent dosing profile, broadening the platform’s differentiation beyond AD .
  • The combination thesis (APG279 vs DUPIXENT) remains intact for 2025 initiation and 2H 2026 interim data, a key medium-term efficacy/dosing showdown .
  • Cash runway into Q1 2028 limits capital risk and supports multi-catalyst execution, anchoring the medium-term story through several readouts .
  • Near-term trading: Stock likely sensitive to APG777 APEX Part A topline and any interim APG777 asthma updates; traders should watch company event timing and any incremental clinical disclosures .
  • Estimate adjustments: Following Q1 EPS beat, models may modestly raise interest income and reassess Opex cadence; revenue assumptions remain de minimis pre-commercial.*
  • Risk monitor: Binary readouts (APG777 Part A, APG279 head-to-head trajectory) and timeline slippage risk; dilution risk mitigated near-term by runway but re-evaluated post 2026 catalysts .

Values retrieved from S&P Global.*