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Adverum Biotechnologies, Inc. (ADVM)·Q1 2025 Earnings Summary

Executive Summary

  • ADVM reported a wider Q1 2025 net loss driven by Phase 3 start-up and clinical costs; EPS of -$2.25 missed S&P Global consensus of -$1.94 as OpEx stepped up with ARTEMIS initiation and higher G&A tied to NC facilities lien and professional services ; EPS estimate from S&P Global: -$1.94*.
  • Cash, cash equivalents and short-term investments fell to $83.1M from $125.7M in Q4, with runway guided “into the second half of 2025,” unchanged vs prior quarter’s guidance .
  • Operationally, management highlighted strong execution: ARTEMIS (first registrational intravitreal gene therapy trial in wet AMD) initiated; AQUARIUS Phase 3 still planned for 2H 2025; LUNA two‑year follow‑up data expected 4Q 2025—key 2025 catalysts .
  • No earnings call transcript was posted for Q1 2025; investor communications centered on the May 14 press release and an updated corporate presentation on May 15 .

What Went Well and What Went Wrong

What Went Well

  • First pivotal trial initiated: “We’ve kicked off 2025 with strong execution by initiating ARTEMIS… and are thrilled with the enthusiasm of retina specialists and patient interest.” – Laurent Fischer, M.D., CEO .
  • Differentiation reinforced by new data: Presented first human cell-level mapping of Ixo-vec transduction and aflibercept mRNA expression 3.5 years post-administration, supporting potential for life‑long vision preservation .
  • Clear 2025 catalyst path: AQUARIUS (global Phase 3) initiation targeted for 2H 2025 and two‑year LUNA data in 4Q 2025, giving multiple upcoming data/clinical milestones .

What Went Wrong

  • EPS miss versus consensus: Q1 2025 EPS -$2.25 vs S&P Global consensus -$1.94, reflecting higher OpEx from Phase 3 material production, bioanalytics, clinical trial costs and elevated G&A (facilities lien discharge, professional services) ; estimate -$1.94*.
  • Cash draw with Phase 3 ramp: Cash and securities declined to $83.1M from $125.7M sequentially as the company invests into pivotal development .
  • No revenue contribution to offset spend: Q4 2024 and Q1 2025 featured no license revenue line item, leaving results fully dependent on OpEx and other income .

Financial Results

Headline P&L and Liquidity (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
License Revenue ($USD Millions)$1.0 $0.0 — (no revenue line reported)
R&D Expense ($USD Millions)$20.4 $24.1 $28.7
G&A Expense ($USD Millions)$9.8 $18.5 $19.5
Total OpEx ($USD Millions)$30.2 $42.6 $48.2
Net Loss ($USD Millions)$(27.1) $(40.9) $(47.0)
Diluted EPS$(1.30) $(1.96) $(2.25)
Cash & ST Investments ($USD Millions)$153.2 $125.7 $83.1

Notes: Q1 2025 Statement of Operations presented without a revenue line; company historically records occasional license revenue .

YoY and QoQ context

  • YoY (Q1 2025 vs Q1 2024): R&D $28.7M vs $15.4M; G&A $19.5M vs $13.8M; Net loss $47.0M vs $27.1M; EPS -$2.25 vs -$1.65—all driven by Phase 3 manufacturing, bioanalytics, trial and higher facilities/pro services costs .
  • QoQ (Q1 2025 vs Q4 2024): R&D +$4.6M, G&A +$1.0M, Net loss -$47.0M vs -$40.9M; cash declined ~$42.6M, reflecting pivotal program ramp .

Estimates vs Actuals (S&P Global)

MetricQ3 2024 EstimateQ3 2024 ActualQ4 2024 EstimateQ4 2024 ActualQ1 2025 EstimateQ1 2025 Actual
EPS-$1.31*-$1.30 -$1.36*-$1.96 -$1.94*-$2.25
Revenue ($USD Millions)$0.06*$1.00 $0.00*$0.00 $0.00*— (no revenue line)

Values retrieved from S&P Global.*

KPIs and Margins: As a clinical-stage biotech with negligible revenue, gross/operating/net margin percentages are not meaningful; focus remains on OpEx cadence, cash runway, and clinical milestones .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Runway2025“Fund operations into late 2025” (Q3 2024) “Fund operations into the second half of 2025” (Q4 2024 & Q1 2025) Maintained vs Q4; wording consistent with 2H 2025
Phase 3 – ARTEMIS1H 2025Initiation planned H1 2025 Initiated; enrolling (Q1 2025) Achieved
Phase 3 – AQUARIUS2H 2025Similar timing discussed (Q4 update) Initiation planned 2H 2025 Maintained
LUNA 2‑yr follow‑up4Q 2025Planned 4Q 2025 Planned 4Q 2025 Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript found; themes derived from Q3/Q4 2024 and Q1 2025 official releases.

TopicPrevious Mentions (Q3 2024 and Q4 2024)Current Period (Q1 2025)Trend
Phase 3 executionOn track to initiate pivotal in H1 2025 ARTEMIS initiated; enrolling; AQUARIUS planned for 2H 2025 Improving
Data differentiationLUNA 52‑wk and OPTIC 4‑yr updates anticipated First human cell-level mapping; durable aflibercept expression 3.5 yrs Improving
Patient preference/complianceLUNA survey favored Ixo‑vec Continued emphasis on injection‑free preference and compliance Stable/Positive
Cash runwayInto late 2025 (Q3) Into 2H 2025 (Q4 & Q1) Stable
OpEx cadenceRising ahead of Phase 3 Higher R&D and G&A with Phase 3 and facilities items Increasing spend as planned
Regulatory momentumRMAT/PRIME/Innovation Passport reiterated Designations reiterated; pivotal underway Stable

Management Commentary

  • “We’ve kicked off 2025 with strong execution by initiating ARTEMIS, our first pivotal trial for Ixo‑vec… We look forward to starting our second registrational study, AQUARIUS, later this year.” – Laurent Fischer, M.D., CEO .
  • “New data… showcase the first human cell-level mapping of Ixo‑vec transduction and aflibercept mRNA expression, supporting its differentiated clinical profile.” .
  • “Ixo‑vec has demonstrated robust retinal transduction and sustained therapeutic levels… overwhelmingly preferred by LUNA patients over their previous frequent anti‑VEGF injections.” – Laurent Fischer, M.D. .
  • ARTEMIS design aims to enhance clinical, regulatory and commercial success by including both treatment‑naïve and previously treated patients and using NI BCVA primary endpoint with a -4.5 letter margin .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available on the company’s site or in our documents corpus; investor communications centered on the May 14 press release and a corporate presentation posted May 15, 2025 .

Estimates Context

  • EPS missed S&P Global consensus: Q1 2025 actual -$2.25 vs -$1.94*, driven by higher Phase 3‑related OpEx and G&A facilities/pro services . Values retrieved from S&P Global.*
  • Revenue estimates were de minimis: Q4 2024 $0.00* matched reported $0.00; Q1 2025 $0.00* consistent with no revenue line in the Q1 press release financials . Values retrieved from S&P Global.*

Where estimates may adjust: Street models likely to incorporate higher R&D and G&A run‑rate during pivotal execution and the updated cash trajectory through 2H 2025 .

Key Takeaways for Investors

  • Near‑term catalysts intact: ARTEMIS underway; AQUARIUS initiation targeted for 2H 2025; LUNA two‑year follow‑up in 4Q 2025—visible news flow into year‑end .
  • Q1 print was investment phase: EPS miss vs S&P Global consensus tied to deliberate spend ramp for Phase 3 materials, bioanalytics, and clinical trial execution; G&A elevated by specific facilities/pro services items . EPS estimate from S&P Global: -$1.94*.
  • Cash runway to 2H 2025: Focus on spend cadence and potential financing/partnering optionality as pivotal program advances .
  • Differentiation narrative strengthened: First human cell‑level mapping and sustained aflibercept expression support the “one‑and‑done” profile and patient preference emphasized by LUNA .
  • Pivotal design aimed at real‑world relevance: Inclusion of treatment‑naïve and experienced patients and NI BCVA endpoint designed to support clinical, regulatory, and commercial acceptance if successful .
  • Trading setup: Stock likely to trade on execution signals (ARTEMIS enrollment pacing), financing visibility/runway, and 4Q LUNA durability/safety update; watch for AQUARIUS start timing confirmation .

References:

  • Q1 2025 8‑K and press release financials and commentary
  • Q4 2024 8‑K and press release
  • Q3 2024 8‑K and press release
  • ARTEMIS initiation press release (Mar 3, 2025)
  • Company press release hub and events page for Q1 materials and absence of transcript

Values retrieved from S&P Global.*