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Acrivon Therapeutics, Inc. (ACRV)·Q3 2024 Earnings Summary

Executive Summary

  • Acrivon reported Q3 2024 net loss of $22.4M (EPS -$0.59) as R&D spending stepped up on ACR-368 Phase 2b and the initiation of ACR-2316 Phase 1; cash and securities were $202.8M with runway into 2H 2026 .
  • Clinically, updated ESMO data in endometrial cancer showed a confirmed ORR of 62.5% in OncoSignature-positive patients and prospective validation of AP3-driven patient selection (p=0.009), strengthening the registrational intent for ACR-368 .
  • Pipeline execution accelerated: ACR-2316 Phase 1 began dosing two quarters ahead of original timelines, with the first dose-escalation cohort enrollment completed; initial data are expected in 2H 2025 .
  • Street consensus (S&P Global) could not be retrieved at this time due to API rate limits; as a result, beat/miss vs estimates cannot be assessed. Values from S&P Global were unavailable.

What Went Well and What Went Wrong

What Went Well

  • Prospective biomarker validation and efficacy: “confirmed 62.5% ORR … and further validated our ACR-368 OncoSignature prospective patient selection with a p-value = 0.009,” positioning endometrial cancer as the first approval opportunity for ACR-368 .
  • Pipeline speed: “Began dosing patients, two quarters ahead of original timelines, in the Phase 1 monotherapy clinical trial of ACR-2316,” and completed planned enrollment of the first dose-escalation cohort, underscoring execution and AP3-enabled design efficiency .
  • Balance sheet visibility: Cash, cash equivalents, and marketable securities of $202.8M with funding runway into 2H 2026 supports planned clinical milestones without near-term financing pressure .

What Went Wrong

  • Operating expense intensity rose: R&D increased to $18.9M (from $10.3M YoY) and total OpEx to $25.1M (from $16.1M YoY), driving a wider quarterly net loss vs prior year as trials scale and personnel expand .
  • Sequential cash draw: Cash and marketable securities declined to $202.8M from $220.4M in Q2 as operating investment increased, albeit runway remains intact into 2H 2026 .
  • No formal Q3 earnings call transcript available; investors rely on the 8-K/press release and September investor event materials for qualitative color, limiting traditional Q&A visibility for this quarter .

Financial Results

Key P&L and balance metrics (USD Millions except per-share and shares; columns oldest → newest):

MetricQ1 2024Q2 2024Q3 2024
Research & Development ($M)$11.47 $15.03 $18.86
General & Administrative ($M)$6.20 $6.41 $6.28
Total Operating Expenses ($M)$17.67 $21.44 $25.14
Interest Income ($M)$1.45 $2.69 $2.70
Net Loss ($M)$(16.49) $(18.80) $(22.44)
Net Loss per Share (Basic & Diluted)$(0.73) $(0.52) $(0.59)
Weighted Avg. Shares (Basic & Diluted)22,590,804 36,132,616 38,105,131

Liquidity (USD Millions):

MetricQ1 2024Q2 2024Q3 2024
Cash, Cash Equivalents & Marketable Securities ($M)$110.0 $220.4 $202.8
Cash Runway CommentaryInto 2H 2026 Into 2H 2026 Into 2H 2026

Notes: No product revenue is reported; the company remains in clinical stage and reports operating expenses and other income lines rather than sales and gross margin .

Clinical KPIs and biomarker validation:

KPIQ1 2024Q2 2024Q3 2024
ACR-368 ORR (prospective OncoSignature-positive, gynecological)50% confirmed ORR across ovarian + endometrial (n=10 BM+) 50% confirmed ORR reiteration; 60% in endometrial subset noted 62.5% confirmed ORR in endometrial BM+; 95% CI 30.4–86.5
Prospective OncoSignature Separationp=0.0038 (BM+ vs BM-) p=0.0038 (BM+ vs BM-) p=0.009 (BM+ vs BM-)
mDOR status (endometrial)Not yet reached (early) Maturing; not reached Not yet reached; ~6 months at cut; all responders on therapy at cut

Segment breakdown: Not applicable (no commercial revenue) .

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent GuidanceChange
ACR-2316 Phase 1 initiation4Q 2024Initiate Phase 1 in 4Q 2024 Began dosing; first cohort enrollment completed (ahead of timelines) Accelerated execution vs plan
ACR-2316 initial data2H 2025Not previously specifiedInitial Phase 1 data expected 2H 2025 New timing disclosed
ACR-368 updates1H 2025Ongoing program; ESMO update in Sep-24 Program updates from registrational-intent Phase 2b in 1H 2025 Milestone window specified
Cash runwayMulti-yearInto 2H 2026 Into 2H 2026 reaffirmed Maintained

Earnings Call Themes & Trends

No formal Q3 2024 earnings call transcript was published; qualitative trends are synthesized from the Q3 press release, ESMO press releases, and investor event materials.

TopicPrevious Mentions (Q1 & Q2 2024)Current Period (Q3 2024)Trend
ACR-368 efficacy in gynecologic cancersInitial confirmed 50% ORR in BM+ gynecologic patients; early prospective biomarker validation p=0.0038 Endometrial BM+ ORR 62.5%; prospective validation p=0.009; mDOR not reached (~6 months) Strengthening efficacy and validation
AP3/OncoSignature validationProspective validation emerging; separation of responders BM+ vs BM- Statistically significant segregation maintained; continued AP3-driven indication selection Reinforced platform credibility
ACR-2316 executionIND targeted 3Q 2024; plan to initiate 4Q 2024 First-in-human dosing achieved two quarters ahead of original timelines; first cohort completed Accelerated development
Funding runwayInto 2H 2026, supported by $130M private placement (Apr-24) Runway reaffirmed into 2H 2026 Stable
Safety/tolerabilityLimited, transient, mechanism-based hematologic AEs reported; absence of severe non-hematologic AEs typical of ADCs/chemo emphasized Consistent profile maintained Supportive safety profile persists

Management Commentary

  • “During the third quarter, we shared promising data from our Phase 2b study of ACR-368, demonstrating a confirmed 62.5% ORR in patients with high-grade endometrial cancer… We continue to believe endometrial cancer provides the first potential approval opportunity for ACR-368.” — Peter Blume-Jensen, CEO .
  • On AP3 platform leverage and speed: “ACR-2316… advanced in 15 months from initial lead to Phase 1 trial initiation, uniquely enabled by AP3” .
  • On market need: KOL research highlighted significant unmet need in high-grade, recurrent endometrial cancer post PD-1 + chemo; second-line chemo ORR benchmark ~14.7% and median PFS 3.8 months (Makker et al., 2022), underscoring potential differentiation of ACR-368 .

Q&A Highlights

  • No Q3 earnings call transcript was posted. The company held an investor event around ESMO (Sep 14, 2024) to discuss updated ACR-368 data and ACR-2316 progression; webcast and materials are available on the IR site .
  • Key discussion points from releases and event: endometrial cohort efficacy, biomarker validation, accelerated ACR-2316 start, and runway to key 2025 milestones .

Estimates Context

  • Consensus estimates (S&P Global) could not be retrieved due to API rate limits at the time of analysis, so beat/miss vs Street could not be assessed. Values from S&P Global were unavailable.
  • Given no recognized product revenue and clinical-stage status, investor focus remains on OpEx pacing vs cash runway and milestone timing rather than near-term revenue/EPS “beats.” Q3 OpEx trend and reaffirmed runway imply adequate capital for 2025 catalysts .

Key Takeaways for Investors

  • Clinical de-risking in endometrial cancer: 62.5% confirmed ORR in BM+ patients with prospective biomarker validation (p=0.009) supports the registrational intent and positions endometrial cancer as the first potential approval setting for ACR-368 .
  • Platform value: Reproducible, prospective OncoSignature selection across quarters validates AP3 as a differentiating engine for indication finding and patient selection .
  • Execution momentum: ACR-2316 moved into human dosing ahead of schedule with first cohort enrollment completed; initial Phase 1 data guided for 2H 2025, adding a second near-term clinical catalyst .
  • Runway in line with plan: $202.8M in cash/securities at 9/30/24 with runway into 2H 2026 enables continued investment through multiple readouts without immediate financing needs .
  • Watch for next catalysts: 1H 2025 program updates for ACR-368 and 2H 2025 initial ACR-2316 data; any additional efficacy, durability, or safety signals and regulatory feedback could be stock-moving .
  • Expense cadence: Rising R&D tied to clinical execution widened net loss; monitor OpEx trajectory vs milestone delivery to gauge burn-rate discipline .
  • Stock reaction drivers: Continued strength in endometrial data (e.g., durability) and clarity on confirmatory trial design/label path for ACR-368, plus early ACR-2316 signals, are likely to dominate narrative and sentiment .

Sources

  • Q3 2024 8-K and Exhibit 99.1 press release: financials, cash runway, clinical updates .
  • Prior quarters’ 8-Ks/press releases for trend analysis .
  • Company news releases and ESMO updates (Q3 timeframe): Sep 9 and Sep 14, 2024 .