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Acrivon Therapeutics, Inc. (ACRV)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 GAAP net loss was $22.8M with GAAP EPS of $-0.60; the company reported no product revenue and extended its cash runway into 2027 on $184.6M of cash, cash equivalents and investments at year-end .
  • EPS beat Wall Street consensus: Q4 2024 actual GAAP EPS $-0.60 vs S&P Global consensus $-0.704*, a $0.10 beat; Q3 was essentially in-line and Q2 a modest beat (see Estimates table) .
  • Clinical execution advanced: endometrial BM+ cohort showed confirmed ORR 35% and DCR 80%; relapsed BM+ patients achieved 50% cORR with mDOR not yet reached (>10 months), while refractory BM+ posted 33% cORR; ovarian and bladder were deprioritized, focusing resources on endometrial and ACR-2316 .
  • ACR-2316 Phase 1 progressed ahead of plan with the first three dose levels completed, early target engagement and initial clinical activity observed at dose level three—key catalysts include registrational design update for ACR-368 and initial ACR-2316 data in 2H 2025 .

What Went Well and What Went Wrong

What Went Well

  • Strong BM+ endometrial efficacy: cORR 35% and DCR 80%; among relapsed BM+, cORR 50% with mDOR not yet reached (>10 months); refractory BM+ cORR 33%—validating OncoSignature patient selection .
  • Runway strengthened into 2027, providing multiyear funding for key clinical milestones .
  • Operational execution: ACR-2316 advanced two quarters ahead of initial plan, completing enrollment in DL1–DL3 with dose proportionality and early clinical activity; “we have observed approximate dose proportionality, target engagement, and initial clinical activity” (Peter Blume‑Jensen) .

What Went Wrong

  • BM- cohort efficacy lagged: ACR-368 + LDG cORR ~13%, comparable to prior line (~17%), underscoring limited monotherapy sensitivity and the need for combination optimization .
  • Ovarian cancer did not meet a high internal bar amid increased competition; bladder enrollment challenged by lower-than-expected BM+ rates, prompting deprioritization .
  • Higher R&D and G&A spending drove larger quarterly and annual losses versus the prior year, reflecting program scale-up (Q4 R&D $18.6M, G&A $6.3M; FY R&D $64.0M, G&A $25.2M) .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
GAAP EPS ($)$-0.52 $-0.59 $-0.60
Net Loss ($MM)$-18.80 $-22.44 $-22.83
R&D Expense ($MM)$15.03 $18.86 $18.63
G&A Expense ($MM)$6.41 $6.28 $6.32
Cash, Cash Equivalents & Investments (Quarter‑end, $MM)$220.4 $202.8 $184.6

Comparison vs Wall Street consensus (S&P Global):

MetricQ2 2024Q3 2024Q4 2024
EPS Actual ($)$-0.52 $-0.59 $-0.60
EPS Consensus ($)$-0.57*$-0.59143*$-0.704*
Beat/MissBeat by $0.05In-line (~$0.00)Beat by $0.10

Values retrieved from S&P Global.*

KPIs – ACR-368 Endometrial Cancer (data cut Feb 25, 2025; reflects Q4 reporting window):

CohortConfirmed ORR (%)DCR (%)Key Durability Notes
BM+ Overall (n=20)35% 80% 80% showed shrinkage
BM+ Relapsed (n=6)50% 100% mDOR not reached (>10 months)
BM+ Refractory (n=12)33% 75% Active despite 0% ORR in last prior line
BM- (ACR-368 + LDG) (n≈38)~13% —Comparable to ~17% prior-line ORR

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayMulti-yearInto 2H 2026 (as of Sep 30, 2024) Into 2027 Raised (extended)
Program Focus2025+Multi‑tumor incl. ovarian/bladder Prioritize endometrial; deprioritize ovarian/bladder Strategic reallocation
ACR-2316 Phase 1 Milestones2025Initiation in 4Q 2024; initial data 2H 2025 DL1–DL3 completed; initial clinical activity; initial data 2H 2025 Maintained timeline; added progress
ACR-368 Registrational Intent2025Ongoing Ph2b; updates 1H 2025 Update on registrational design and confirmatory strategy forthcoming Maintained; timing reiterated

Earnings Call Themes & Trends

Note: No formal Q4 earnings call transcript was available; we reviewed the Q4 press release and the March 25, 2025 R&D event materials .

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
AP3 Generative Phosphoproteomics (AI/ML)Platform enabling design; discovery progress Expanded AP3 datasets; Interactome; streamlined discovery Suite expansion (KSR Predictor, Data Portal, Chatbot); proteome‑wide SAR Expanding capabilities
Endometrial Cancer FocusEmerging sensitivity; ORR 50–60% early data ESMO: cORR 62.5% BM+; KOL market size ~30K BM+ cORR 35% overall; relapsed 50% cORR; refractory 33%; prioritization Sharpened clinical focus
Ovarian/Bladder StrategyOngoing multi‑tumor trial Continued evaluation Deprioritized due to competition (ovarian) and low BM+ rate (bladder) Narrowing scope
ACR-2316 (WEE1/PKMYT1)Initiation planned 4Q 2024 First cohort fully enrolled DL1–DL3 completed; early activity; target engagement Advancing ahead of plan
Regulatory/DiagnosticsFast Track (ACR-368); Breakthrough Device for ovarian OncoSignature Continued Fast Track and OncoSignature validation Breakthrough Device designation for endometrial OncoSignature (Jan 21, 2025) Strengthening Dx/reg approach
Financial RunwayInto 2H 2026 Into 2H 2026 Extended into 2027 Improved

Management Commentary

  • “We continue executing our highly differentiated Generative Phosphoproteomics AP3‑enabled strategy… we shared positive data for ACR‑368… we observed strong anti‑tumor activity… amongst relapsed patients, we observed 50% cORR and mDoR (not yet reached) >10 months, and 33% cORR in refractory patients” — Peter Blume‑Jensen, CEO .
  • “During the third quarter, we shared promising data… confirmed 62.5% ORR in high‑grade endometrial cancer… we further validated our ACR‑368 OncoSignature… We continue to believe endometrial cancer provides the first potential approval opportunity” — Peter Blume‑Jensen .
  • “The rapid advancement of ACR‑2316 into the clinic was enabled by the powerful capabilities of our AP3 Interactome… We look forward to progressing this trial and expect to report initial clinical data in the second half of 2025.” — Peter Blume‑Jensen .

Q&A Highlights

  • The March 25 R&D event included an interactive Q&A, with management addressing endometrial prioritization, LDG sensitization for BM‑ patients, and deprioritization of ovarian/bladder due to competitive dynamics and BM+ prevalence; a transcript was not filed .
  • Clarifications emphasized OncoSignature’s predictive accuracy (80% shrinkage in BM+) and durability in relapsed BM+ patients, reinforcing registrational intent strategy .
  • Management reiterated ACR‑2316 dose escalation progress and pharmacodynamic target engagement supporting dose optimization aligned with FDA Project Optimus .

Estimates Context

  • For Q4 2024, GAAP EPS was $-0.60 vs S&P Global consensus $-0.704*, a $0.10 beat; Q3 2024 was essentially in‑line and Q2 2024 a $0.05 beat (see table above) .
  • Street models generally assume no product revenue ($0.0*) for Q2–Q4 2024; estimate counts range from 5–9 per quarter* (EPS and revenue) — consistent with a pre‑commercial pipeline company.
  • Target Price Consensus Mean is $11.17* with 6 estimates*; “Consensus Recommendation (Text)” not available at this time*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Multiyear funding runway into 2027 materially de‑risks near‑term financing needs, allowing focus on registrational path in endometrial cancer and ACR‑2316 clinical maturation .
  • BM+ endometrial efficacy remains compelling, particularly in relapsed patients (50% cORR; mDOR >10 months), supporting OncoSignature’s clinical utility and the registrational‑intent strategy .
  • Strategic narrowing to endometrial and ACR‑2316 should improve capital efficiency and clinical clarity; deprioritization mitigates dilution of resources in less favorable settings .
  • Q4 EPS beat vs consensus underscores disciplined OPEX management amid accelerated R&D execution; monitor R&D/G&A growth and quarterly cash usage trajectory .
  • Near‑term catalysts: ACR‑368 registrational design update and confirmatory trial strategy, plus initial ACR‑2316 data in 2H 2025—events that can recalibrate probability‑of‑success and valuation frameworks .
  • Risks: BM‑ efficacy remains modest with current combo; competitive pressures in gynecologic oncology; diagnostic regulatory pathway (OncoSignature) remains critical to commercialization .
  • Trading lens: headlines around registrational design, durability updates, and ACR‑2316 Phase 1 readouts are likely to drive sentiment and estimate revisions; positioning into these events should consider the strengthened runway and concentrated clinical focus .

Sources

  • Q4 2024 press release and financials: Acrivon Therapeutics 8‑K, March 27, 2025 .
  • Preliminary Q4 cash and R&D event: 8‑K, March 25, 2025 (Item 2.02, 7.01; Exhibit 99.1) .
  • Q3 2024 press release and financials: 8‑K, November 13, 2024 (Exhibit 99.1) .
  • Q2 2024 press release and financials: 8‑K, August 13, 2024 (Exhibit 99.1) .
  • ACR‑2316 Phase 1 initiation: 8‑K, October 11, 2024 (Exhibit 99.1) .
  • S&P Global consensus estimates and target price: GetEstimates outputs for Q2–Q4 2024 and FY 2024.*