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Acrivon Therapeutics, Inc. (ACRV)·Q1 2024 Earnings Summary

Executive Summary

  • Pre-revenue quarter; OpEx rose year over year while net loss widened to $(16.5)M (EPS $(0.73)) on higher R&D and G&A; cash and securities were $110M at 3/31 pre-PIPE .
  • The April R&D event delivered a major clinical catalyst: prospective validation of AP3 patient selection in ACR-368 with a 50% confirmed ORR (5/10) in OncoSignature-positive ovarian/endometrial patients vs 0% (0/16) in negatives (p=0.0038); all responders on treatment, median DoR not reached .
  • Balance sheet materially strengthened via an oversubscribed $130M private placement; pro forma cash and securities ~$234M and runway extended into 2H 2026, up from prior Q4 2025 .
  • Development timelines accelerated: ACR-2316 (dual WEE1/PKMYT1) IND moved up to Q3’24 with first-in-human now anticipated Q4’24 (from prior Q4’24/H1’25) .

What Went Well and What Went Wrong

  • What Went Well

    • Prospective clinical validation of AP3/OncoSignature selection for ACR-368 with 50% confirmed ORR in OncoSignature-positive ovarian and endometrial cancers; 0% in negatives; all responders ongoing; p=0.0038 .
    • CEO on platform progress: “Within the first few months of 2024, we have demonstrated significant progress across our AP3 platform and our clinical and preclinical pipeline… statistically significant prospective validation” .
    • Financing and runway: oversubscribed $130M private placement at a premium; pro forma cash/securities ~$234M; runway into 2H 2026 .

  • What Went Wrong

    • Continued operating losses as development scales; net loss widened to $(16.5)M vs $(12.8)M YoY; EPS $(0.73) vs $(0.58) .
    • R&D and G&A grew YoY (R&D $11.5M vs $9.8M; G&A $6.2M vs $4.6M), reflecting clinical progression and public company costs .
    • OncoSignature-negative arm still without confirmed responses; LDG combo shows disease stabilization (8/16 SD) but no PRs to date at locked thresholds .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Research & Development Expense ($M)$10.267 $15.478 $11.473
General & Administrative Expense ($M)$5.870 $5.575 $6.195
Total Operating Expenses ($M)$16.137 $21.053 $17.668
Loss from Operations ($M)$(16.137) $(21.053) $(17.668)
Interest/Other Income, net ($M)$1.671 $1.801 $1.182 (interest $1.446; other $(0.264))
Net Loss ($M)$(14.466) $(19.252) $(16.486)
Net Loss per Share (basic/diluted)$(0.66) $(0.86) $(0.73)
Cash & Cash Equivalents ($M) (period-end)$29.859 $36.015 $24.607
Short-term Investments ($M) (period-end)$112.231 $91.443 $85.368

KPIs

KPIQ3 2023Q4 2023Q1 2024
Cash, Cash Equivalents & Marketable Securities ($M)$142.1 $127.5 $110.0
Pro Forma Cash & Securities ($M)——~$234.0 (incl. April PIPE)
Operating Cash Used (Quarter) ($M)——$(17.083)
Weighted Avg Shares (basic/diluted) (M)22.081 22.335 22.591

Note: No product revenue reported (company remains pre-revenue) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayAs of Q4 2023 vs Q1 2024Funded into Q4 2025 Funded into 2H 2026 (pro forma) Raised/extended
ACR-2316 IND filing2024Q4 2024 Q3 2024 Accelerated
ACR-2316 First-in-human start2024–2025H1 2025 Q4 2024 Accelerated
ACR-368 data updates1H 2024; 2H 2024Present more mature data 1H 2024 Initial positive data presented April 24; further pipeline/corporate updates in 2H 2024 Achieved initial data; next updates scheduled

Earnings Call Themes & Trends

TopicQ3 2023 (prior-2)Q4 2023 (prior-1)Q1 2024 (current)Trend
AP3/OncoSignature patient selectionInitial clinical observations; strong preclinical validation; plan for major H1’24 update Continued enrollment; Phase 1b LDG arm completed; expansion planned Prospective validation; 50% ORR in OncoSignature+; 0% in negatives; p=0.0038 Strengthening clinical evidence
ACR-368 + low-dose gemcitabine (LDG) in negativesEarly imaging activity in negatives on combo during dose escalation Phase 1b combo complete; moving to exploratory Phase 2 8/16 SD at RP2D combo; no PRs to date at locked thresholds Progressing but response depth pending
ACR-2316 (dual WEE1/PKMYT1)IND targeted Q4’24 IND Q4’24 reiterated IND pulled up to Q3’24; FIH now Q4’24 Accelerating timeline
Regulatory/diagnosticsFast Track (ACR-368); AP3 CDx development background Breakthrough Device for OncoSignature highlighted Continued use of OncoSignature; prospective validation Building regulatory/dx position
Balance sheet/liquidity$142.1M cash & secs; runway into H2’25 $127.5M; runway into Q4’25 $130M PIPE; pro forma ~$234M; runway 2H’26 Improved runway

Management Commentary

  • “We now have achieved statistically significant prospective validation of our AP3 patient selection approach via our ACR-368 OncoSignature assay… initial combined overall confirmed response rate of 50 percent…” — Peter Blume‑Jensen, CEO .
  • “For the first time, we share statistically significant prospective validation… A 50% confirmed ORR… We are extremely gratified… also for patients with endometrial cancer, a new tumor type identified… by our AP3 platform” — Peter Blume‑Jensen (R&D event) .
  • “ACR-2316… IND timeline accelerated with filing now expected in Q3 2024… potential first‑in‑class asset designed for superior single‑agent activity” — Kristina Masson, EVP .

Q&A Highlights

  • No Q1 2024 earnings call transcript was available. The company hosted a Corporate R&D webcast with a live Q&A session, but no transcript was furnished; a replay link was provided on the investor site .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2024 EPS and revenue was unavailable for ACRV at the time of analysis (limited coverage). As a pre-revenue biotech, no revenue comparison to estimates is applicable .

Key Takeaways for Investors

  • Clinical de‑risking: Prospective OncoSignature validation with 50% ORR in ACR-368 OncoSignature‑positive ovarian/endometrial patients is a meaningful efficacy signal with strong patient-selection biology; all responders remain on therapy, DoR not reached .
  • Near‑term catalysts: Additional ACR-368 updates and broader pipeline/AP3 updates expected in 2H 2024; first‑in‑human for ACR‑2316 targeted for Q4 2024 after an accelerated Q3 IND .
  • Runway extended: Post-PIPE pro forma ~$234M cash/securities funds operations into 2H 2026, reducing financing overhang through key data milestones .
  • Execution focus: Watch conversion of LDG combo disease stabilization in negatives into objective responses and durability metrics as exploration continues .
  • Operating spend trending with pipeline: R&D/G&A growth reflects advancing programs; expect continued OpEx as ACR‑2316 enters clinic .
  • Regulatory/diagnostic moat: Breakthrough Device for OncoSignature and Fast Track designations support a potential precision-oncology path; continued validation may enhance competitive positioning .
  • Risk frame: No product revenue, ongoing losses, and clinical execution risk persist; but strengthened balance sheet and validated selection biomarker improve risk-adjusted outlook .

Appendix: Additional Q1 2024 Business Updates

  • Private placement financing: $130M gross proceeds via PIPE (shares and pre-funded warrants), at $8.50/$8.499; use of proceeds for ACR-368/ACR-2316 and AP3 platform .
  • Manufacturing readiness: ACR-368 API and drug product campaign completed; 21.9 kg GMP API on hand (>100k doses) .