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AP

Acumen Pharmaceuticals, Inc. (ABOS)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results were reported with full-year figures: cash, cash equivalents and marketable securities were $231.5M at year-end, and management reiterated runway into 1H 2027, while R&D ramped to support ALTITUDE-AD Phase 2 enrollment completion (542 participants) announced on March 27, 2025 .
  • EPS missed consensus in Q4 2024: actual EPS was $-0.62 vs Wall Street consensus of $-0.465, driven by higher R&D spend tied to the Phase 2 program; prior quarters also showed sequentially increasing quarterly losses as ALTITUDE-AD progressed [GetEstimates]* .
  • Strategic progress: Late-breaking publications (JPAD) strengthened Phase 1 INTERCEPT-AD data and biomarker story; subcutaneous (SC) Phase 1 topline results supported further development (well tolerated; exposure adequate), enhancing future dosing optionality .
  • Key catalysts: ALTITUDE-AD topline results expected in late 2026; SC formulation development ongoing; management highlighted strong investigator enthusiasm and efficiency gains from plasma pTau217 screening, which materially improved enrollment and reduced negative PETs .

What Went Well and What Went Wrong

What Went Well

  • Completed enrollment in ALTITUDE-AD (542 participants) earlier than plan; primary endpoint iADRS at 18 months with strong global site participation and high-quality patient selection, positioning for a late-2026 readout .
  • SC Phase 1 topline showed good tolerability (injection site reactions, all Grade 1; 62.5%) and systemic exposure sufficient for further clinical development, expanding dosing optionality for patients and providers .
  • Published Phase 1 results (INTERCEPT-AD) in JPAD, demonstrating dose/exposure-dependent target engagement of Aβ oligomers, significant plaque reduction in higher dose cohorts, and low ARIA rates, reinforcing program differentiation and MoA .

What Went Wrong

  • EPS missed consensus in Q4 2024 (actual $-0.62 vs $-0.465), reflecting the step-up in R&D expenses and operating loss as the Phase 2 trial scaled; sequential quarterly losses increased versus prior periods [GetEstimates]* .
  • Cash declined from $306.1M (12/31/2023) to $231.5M (12/31/2024) as ongoing operations and clinical trial spending intensified; net cash used in operating activities for 2024 was $86.2M .
  • No quarterly revenue contribution (pre-revenue biotech), so near-term P&L leverage unavailable; investors must anchor on clinical milestones and balance sheet runway rather than traditional earnings beats .

Financial Results

Quarterly Operating KPIs and Liquidity

MetricQ2 2024Q3 2024Q4 2024
Cash, Cash Equivalents & Marketable Securities ($M)$281.4 $258.9 $231.5
R&D Expense ($M)$19.5 $27.2 N/A (Annual reported)
G&A Expense ($M)$4.8 $5.0 N/A (Annual reported)
Net Loss ($M)$20.5 $29.8 N/A (Annual reported)
ALTITUDE-AD Enrollment (Participants)>50 sites active >75 sites active; enrollment accelerating 542 enrolled (completed)

Notes: Company reported full-year detail for Q4; quarterly R&D/G&A/Net Loss not separately disclosed for Q4 in 8-K; ALTITUDE-AD enrollment completion announced 3/27/2025 .

EPS vs Estimates (Wall Street – S&P Global)

MetricQ2 2024Q3 2024Q4 2024
Revenue Consensus Mean ($M)$0.0*$0.0*$0.0*
Primary EPS Consensus Mean ($)$-0.290*$-0.365*$-0.465*
Primary EPS Actual ($)$-0.34*$-0.50*$-0.62*

Values retrieved from S&P Global.*

Interpretation: Q4 2024 EPS came in below consensus (miss) by ~$0.155/share, consistent with higher R&D as Phase 2 advanced [GetEstimates]* .

Full-Year Comparisons (FY 2023 vs FY 2024)

MetricFY 2023FY 2024
R&D Expense ($M)$42.3 $93.8
G&A Expense ($M)$18.8 $20.2
Loss from Operations ($M)$61.1 $114.0
Net Loss ($M)$52.4 $102.3
Net Loss per Share ($)$-1.08 $-1.71
Year-End Cash, Cash Equivalents & Marketable Securities ($M)$306.1 $231.5

Segment breakdown: Not applicable (single program focus) .

KPIs: ALTITUDE-AD enrollment completed; SC formulation Phase 1 topline positive exposure/tolerability; JPAD publications reinforce Phase 1 biology .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ALTITUDE-AD Enrollment Completion1H 2025Complete enrollment in 1H 2025 Enrollment completed; 542 randomized Raised/Accelerated (achieved earlier than guided)
ALTITUDE-AD ToplineLate 2026Late 2026 (consistent) Late 2026 Maintained
SC Formulation Phase 1 ToplineQ1 2025Q1 2025 Announced; SC well tolerated; adequate exposure Achieved
Cash RunwayInto 1H 2027Into 1H 2027 Into 1H 2027 Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Enrollment & Site Momentum>50 sites; faster-than-expected enrollment >75 sites; completion targeted 1H25 Enrollment completed (542); strong investigator enthusiasm Improving
Biomarkers (pTau217 screening)Emphasized as diagnostic and enrollment aid ~50% reduction in negative PETs via pTau217 Presenting pTau217 screening efficiency at ADPD; strong adoption Increasing adoption
SC Formulation optionalityInitiated Phase 1 SC study SC PK/bioavailability planned Q1 2025 SC topline: tolerated, exposure supports development; optionality stressed Progressed to topline
Safety (ARIA profile)Low ARIA in Phase 1; ApoE4 homozygotes with no ARIA-E Reinforced low ARIA expectations; blinded reporting in Phase 2 Maintaining safety focus; Phase 2 ARIA to be disclosed at unblinding Steady emphasis
Regulatory/clinical positioningFast Track; registration-quality Phase 2 design Reinforced pivotal-quality approach; no interim looks Late-2026 topline; positioning as next-gen therapy Consistent
Market adoption dynamicsInfrastructure, diagnostics maturing Real-world Leqembi adoption insights Expect growing anti-Aβ adoption; opportunity for differentiated next-gen profiles Constructive backdrop

Management Commentary

  • “We… announced the completion of enrollment of 542 participants in [ALTITUDE-AD]… a key catalyst for our sabirnetug program” .
  • “Subcutaneous sabirnetug was well tolerated, with systemic exposure supporting the continued development of this format” .
  • “We will present… the use of a plasma pTau217 assay as a screening procedure… considerably improved enrollment efficiency and decreased patient burden and cost” .
  • “We ended 2024 with $231.5 million… expected to support… into the first half of 2027” .

Q&A Highlights

  • Preclinical AD expansion: Management is focused on ALTITUDE-AD execution now; sees mechanistic rationale for earlier populations in the future .
  • SC formulation integration: Next steps under evaluation; SC optionality to complement IV (induction/maintenance) .
  • Biomarker strategy: pTau217 as a prescreener reduces negative PETs by ~50%; may translate to clinical practice .
  • Endpoints: Preference for iADRS over CDR-SB due to lower variability; precedent noted from donanemab Phase 2 .
  • Enrollment quality: Baseline characteristics expected to resemble INTERCEPT and lecanemab-type populations (no tau requirement) .

Estimates Context

  • Q4 2024 EPS missed consensus: Actual $-0.62 vs consensus $-0.465, primarily due to elevated R&D spend as Phase 2 scaled; revenue consensus was $0 (pre-revenue) [GetEstimates]* .
  • Prior quarters also trended below consensus: Q3 2024 actual $-0.50 vs $-0.365; Q2 2024 actual $-0.34 vs $-0.290 [GetEstimates]*.
  • Implications: Street models likely need higher near-term operating loss assumptions reflecting full-year R&D inflection ($93.8M in 2024 vs $42.3M in 2023) until Phase 2 completes and program transitions .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • ALTITUDE-AD enrollment completion de-risks execution and sets up the late-2026 topline; biomarker-enabled screening improved efficiency and site enthusiasm—key narrative positives for the stock into the Phase 2 readout .
  • SC formulation topline supports continued development, adding future dosing flexibility and potential patient access advantages vs. IV-only approaches—an incremental strategic asset .
  • Balance sheet remains robust with $231.5M at year-end and runway into 1H 2027, supporting the program through topline data without near-term financing stress—important for biotech risk management .
  • Near-term P&L will remain loss-making with elevated R&D; Q4 EPS miss vs consensus underscores the priority to anchor valuation on clinical milestones rather than quarterly profitability [GetEstimates]* .
  • The competitive landscape’s growing acceptance of anti-Aβ therapies, combined with sabirnetug’s oligomer selectivity and Phase 1 safety/biomarker profile, positions ABOS as a potential next-generation entrant pending Phase 2 efficacy .
  • Watch upcoming medical meetings and publications (ADPD, JPAD follow-ups) for biomarker and screening data that could shape adoption and trial success odds .
  • Trading lens: Enrollment completion and SC topline are supportive; the next major catalyst is the Phase 2 topline in late 2026. Interim news flow (SC program design, additional biomarker data, regulatory interactions) can drive sentiment and estimate revisions along the way .