Sign in

You're signed outSign in or to get full access.

AT

Acrivon Therapeutics, Inc. (ACRV)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 showed continued R&D investment and clinical execution: net loss widened to $18.8M and diluted EPS was $(0.52), while cash, cash equivalents, and investments rose to $220.4M following an oversubscribed $130M private placement, extending runway into 2H 2026 .
  • Clinical narrative strengthened: management reiterated prospective validation of the AP3-based OncoSignature assay with a 50% confirmed ORR in OncoSignature-positive gynecologic cancers from the ongoing Phase 2b trial (data cut April 1), and plans to share updated data at ESMO in September .
  • ACR-2316 (dual WEE1/PKMYT1) timelines maintained: IND submission expected in Q3 2024 and Phase 1 initiation in Q4 2024; this cadence was accelerated in Q1 and maintained in Q2 .
  • Near-term stock catalysts: ESMO data disclosure and webcast in September, and initiation of ACR-2316 Phase 1 in Q4 2024; financing and runway reduce near-term balance sheet risk .

What Went Well and What Went Wrong

What Went Well

  • Prospective validation of AP3 OncoSignature: “We continue to make significant progress... building on the initial positive clinical data... which showed an overall response rate of 50% in patients... predicted sensitive to ACR-368” .
  • Operational milestones maintained: ACR-2316 Phase 1 on track for Q4 2024; IND filing in Q3 2024 as previously accelerated, indicating program readiness .
  • Balance sheet strength: oversubscribed $130M private placement and $220.4M in cash/investments at 6/30/24 extend runway into the second half of 2026 .

What Went Wrong

  • Losses and OpEx increased YoY as clinical activities and personnel costs ramped: Q2 net loss rose to $18.8M (from $13.9M YoY), R&D to $15.0M (+$4.5M YoY), and G&A to $6.4M (+$1.4M YoY) .
  • No revenue generation; company reiterates it remains pre-revenue and expects continued operating losses for the foreseeable future .
  • OncoSignature-negative cohort saw disease stabilization but no confirmed responses to date, highlighting biomarker importance and combination strategy execution need .

Financial Results

MetricQ2 2023Q1 2024Q2 2024
Net Loss ($USD Millions)$13.9 $16.5 $18.8
Diluted EPS ($USD)$(0.63) $(0.73) $(0.52)
Research & Development ($USD Millions)$10.5 $11.5 $15.0
General & Administrative ($USD Millions)$5.0 $6.2 $6.4
Total Operating Expenses ($USD Millions)$15.5 $17.7 $21.4
Other Income, net ($USD Millions)$1.6 $1.2 $2.6
Cash, Cash Equivalents & Investments ($USD Millions)N/A$110.0 (quarter-end) $220.4

Notes:

  • No revenue reported; company states it has not generated revenues to date .
  • Margins not applicable for a pre-revenue biotech.

KPIs (Clinical)

KPIQ2 2023Q1 2024Q2 2024
Confirmed ORR (OncoSignature-positive combined)N/A50% (5/10) 50% (data reiterated)
Ovarian ORR (OncoSignature-positive)N/A40% (2/5) 40% (data reiterated)
Endometrial ORR (OncoSignature-positive)N/A60% (3/5) 60% (data reiterated)
OncoSignature-negative: Stable DiseaseN/A8/16 SD 8/16 SD (data reiterated)
Median DoR (OncoSignature-positive)N/ANot reached (all responders on tx) Not reached (reiterated)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ACR-2316 IND submissionQ3 2024Q3 2024 (accelerated from Q4 2024 in Q1) Q3 2024 Maintained
ACR-2316 Phase 1 initiationQ4 2024Q4 2024 (accelerated from 1H 2025 in Q1) Q4 2024 Maintained
Cash runwayThrough 2H 2026Into 2H 2026 (pro forma Q1) Into 2H 2026 Maintained
Data disclosureSep 2024 (ESMO)“More mature ACR-368 data 1H24” (Q4 guidance) ESMO poster and webcast Sep 14, 2024 Updated timing/details

Earnings Call Themes & Trends

Note: No Q2 2024 earnings call transcript found; themes derived from Q2 press release, Q1 press release, Q4 press release, and Q2 10-Q.

TopicPrevious Mentions (Q4 2023 and Q1 2024)Current Period (Q2 2024)Trend
AP3/OncoSignature validationInitial clinical observations; plan for more mature data; 66 sites activated Reiterated 50% confirmed ORR in OncoSignature-positive patients; validation emphasized Strengthening validation
ACR-2316 timelinesIND in Q4 2024; Phase 1 1H 2025 IND Q3 2024; Phase 1 Q4 2024 maintained Accelerated and maintained
Financing & runway$127.5M YE cash/investments; runway into Q4 2025 $220.4M at 6/30/24; runway into 2H 2026; oversubscribed $130M PIPE closed Apr 11 Balance sheet improved
OncoSignature-negative strategyLDG combination arm completed Phase 1b; moving to exploratory Phase 2 8/16 SD in negative arm; continued exploration Stable disease; ongoing combo work
Regulatory designationsFast Track; Breakthrough Device for OncoSignature Reaffirmed designations Consistent positioning

Management Commentary

  • “We continue to make significant progress... planning to hold a webcast in September 2024 during the upcoming ESMO conference... building on the initial positive clinical data... which showed an overall response rate of 50%...” — Peter Blume-Jensen, CEO .
  • “We now have achieved statistically significant prospective validation of our AP3 patient selection approach via our ACR-368 OncoSignature assay...” — Peter Blume-Jensen, CEO (Q1 press release) .
  • “A novel, AP3-enabled, internally discovered dual WEE1 / PKMYT1 inhibitor... advancing towards IND in Q3, 2024, FIH in Q4, 2024” — Corporate R&D materials .

Q&A Highlights

  • No Q2 earnings call transcript available. Management emphasized OncoSignature validation, ESMO data plans, and maintained ACR-2316 timelines in press materials and corporate disclosures .
  • No explicit changes to financial guidance or tax/OpEx ranges were provided; runway and timelines reiterated .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2024 EPS and revenue was unavailable at time of retrieval; ACRV is pre-revenue and does not report product revenue .
  • Without consensus, no beat/miss assessment versus estimates can be made. If S&P Global estimates are required, note that they were unavailable at time of this analysis.

Key Takeaways for Investors

  • Biomarker-led efficacy signal: Prospective OncoSignature validation with 50% confirmed ORR across gynecologic cancers supports a potentially differentiated registration strategy; ESMO update is a key catalyst .
  • Execution on dual-path portfolio: ACR-368 registrational-intent Phase 2b continues, while ACR-2316 advances to IND/Phase 1 on an accelerated timeline, offering multiple shots on goal .
  • Strengthened liquidity: $220.4M cash/investments and runway into 2H 2026 reduce near-term financing risk and support clinical milestones .
  • Risk profile: Increasing OpEx and continued losses reflect pipeline investment; lack of responses in OncoSignature-negative arm underscores biomarker criticality and need for combination validation .
  • Trading implications (short-term): ESMO data and ACR-2316 IND/Phase 1 timing are likely to drive sentiment; any expansion of responder set or durability signals could be stock-positive .
  • Medium-term thesis: Companion diagnostic strategy with Breakthrough Device designation may enable targeted registrational pathways; success hinges on robust, durable responses and regulatory alignment .
  • Monitoring items: ESMO data quality/consistency, DoR maturation, OncoSignature-negative combo efficacy, and clarity on regulatory path and potential additional indications .