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Verve Therapeutics, Inc. (VERV)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 delivered steady execution: seven participants dosed across two cohorts in Heart-2 (VERVE-102) with no serious adverse events or clinically significant lab abnormalities; first participant dosed in Pulse-1 (VERVE-201) .
  • Financials: collaboration revenue rose to $6.9M (+120% YoY), net loss was $50.1M, and diluted EPS was $(0.59); cash, equivalents, and marketable securities ended at $539.9M, with runway “through 2026” .
  • Guidance maintained: initial Heart-2 data still targeted for 1H 2025; Phase 2 for PCSK9 program planned for 2H 2025; ANGPTL3 program progressed from “on track” to first patient dosed (achievement) .
  • Consensus estimates were unavailable via S&P Global due to a CIQ mapping issue; relative to a pre-revenue biotech profile, collaboration revenue and EPS tracked in line with internal execution milestones rather than street targets [GetEstimates error].
  • Near-term stock catalysts: clinical tolerability and geographic expansion (Israel, New Zealand CTAs), plus upcoming initial data in 1H 2025; medium-term, Phase 2 initiation for PCSK9 in 2H 2025 .

What Went Well and What Went Wrong

What Went Well

  • “VERVE-102 has been well-tolerated, with no serious adverse events and no clinically significant laboratory abnormalities observed.” This supports continued dose escalation in Heart-2 and underpins the PCSK9 program’s risk profile .
  • First participant dosed with VERVE-201 in Pulse-1, moving ANGPTL3 from preclinical/on-track into human dosing; regulatory clearances in Australia, Canada, and the U.K. broaden execution footprint .
  • Cash runway reiterated “through 2026,” providing funding visibility across planned 2025 milestones; execution consistent across consecutive quarters .

What Went Wrong

  • Heart-1 (VERVE-101) remains paused during Heart-2 dose escalation as nonclinical work continues to support LNP as the primary driver of prior lab abnormalities; prolongs timeline for VERVE-101 .
  • Operating expenses increased YoY (R&D +14.1%, G&A +18.4%), widening operating loss and net loss YoY (from $45.8M to $50.1M), reflecting heavier clinical activity and stock-based compensation .
  • Street comparison not possible this quarter due to S&P Global mapping error; lack of consensus benchmarking can temper near-term investor confidence in “beat/miss” framing [GetEstimates error].

Financial Results

Quarterly Trend (Q1 → Q2 → Q3 2024)

MetricQ1 2024Q2 2024Q3 2024
Collaboration Revenue ($USD Millions)$5.695 $6.692 $6.865
Net Loss ($USD Millions)$48.736 $49.805 $50.133
Diluted EPS ($USD)$(0.59) $(0.59) $(0.59)
R&D Expense ($USD Millions)$48.376 $50.984 $49.938
G&A Expense ($USD Millions)$14.163 $14.547 $13.837
Cash & Equivalents ($USD Millions)$606.367 $575.948 $539.920

YoY Comparison (Q3 2024 vs Q3 2023)

MetricQ3 2023Q3 2024YoY Change
Collaboration Revenue ($USD Millions)$3.117 $6.865 +120% (from $3.117 to $6.865)
R&D Expense ($USD Millions)$43.765 $49.938 +14% (from $43.765 to $49.938)
G&A Expense ($USD Millions)$11.686 $13.837 +18% (from $11.686 to $13.837)
Net Loss ($USD Millions)$45.758 $50.133 +10% (from $45.758 to $50.133)
Diluted EPS ($USD)$(0.72) $(0.59) +$0.13 (loss per share improved)

Actuals vs Wall Street Consensus (S&P Global)

MetricQ3 2024 ActualS&P Global ConsensusSurprise
Collaboration Revenue ($USD Millions)$6.865 N/A (Unavailable via S&P Global due to CIQ mapping issue)N/A
Diluted EPS ($USD)$(0.59) N/A (Unavailable via S&P Global due to CIQ mapping issue)N/A

KPIs (Clinical and Operating)

KPIQ1 2024Q2 2024Q3 2024Notes/Trend
Heart-2 (VERVE-102) participants dosedFirst patient dosed Enrollment ongoing (count not disclosed) Seven participants dosed; 0.3 and 0.45 mg/kg cohorts Dose escalation progressing; tolerability supports continuation
Heart-2 safetyN/AN/ANo SAEs; no clinically significant lab abnormalities Reinforces safety profile for PCSK9 program
CTAs/regulatory clearances (Heart-2)U.K., Canada cleared Australia cleared Israel and New Zealand cleared; enrollment ongoing AU/CA/UK Geographic expansion accelerates enrollment
Heart-1 (VERVE-101) statusPaused; LNP suspected driver Preliminary data support LNP driver Nonclinical studies support LNP as primary driver; trial remains paused during Heart-2 Risk mitigation continues; prioritizing VERVE-102
ANGPTL3 (VERVE-201)On track H2’24 initiation On track H2’24 initiation First participant dosed Program transitioned to clinical dosing
Cash runwayInto late 2026 Into late 2026 Through 2026 Funding window consistent, slight wording change

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayThrough 2026“Into late 2026” (Q1/Q2) “Through 2026” (Q3) Maintained (wording narrowed)
Heart-2 initial data (VERVE-102)1H 20251H 2025 1H 2025 Maintained
PCSK9 Phase 2 initiation2H 20252H 2025 2H 2025 Maintained
VERVE-201 Phase 1b initiation2H 2024On track for 2H 2024 First participant dosed Achieved
Heart-1 (VERVE-101) statusOngoingPaused; investigating LNP driver Paused; nonclinical data support LNP as driver; remains paused during Heart-2 Maintained with added evidence
Heart-2 geographiesOngoingUK/Canada; Australia cleared Added Israel, New Zealand; enrollment ongoing AU/CA/UK Raised (expanded)

Earnings Call Themes & Trends

No earnings call transcript found for Q3 2024 in the document catalog; therefore, themes are drawn from the Q3 press release and prior quarter releases [ListDocuments result; 0 earnings-call-transcript].

TopicPrevious Mentions (Q1 2024 and Q2 2024)Current Period (Q3 2024)Trend
R&D execution (PCSK9)Q1: First Heart-2 patient dosed ; Q2: enrollment ongoing and expanding Seven dosed; well-tolerated; advancing dose escalation Positive progression
Delivery technology (GalNAc-LNP)Described in VERVE-102 and VERVE-201 programs Emphasized as enabling ASGPR/LDLR access Stable narrative, continued emphasis
Safety (Heart-1 LNP)Paused; LNP suspected Preliminary nonclinical support LNP driver Nonclinical studies support LNP as primary driver; Heart-1 paused
ANGPTL3 programOn track H2’24 initiation First patient dosed; clears in AU/CA/UK Milestone achieved
Regulatory/geographiesUK/CA (Q1); Australia CTA (Q2) Added Israel/New Zealand; enrollment ongoing AU/CA/UK Broader footprint
Capital and runway$606.4M; into late 2026 (Q1) ; $575.9M; into late 2026 (Q2) $539.9M; through 2026 Controlled cash burn; runway consistent

Management Commentary

  • “We continue to execute on the Heart-2 clinical trial and are pleased to share that as of October 29, 2024, seven participants have been dosed. VERVE-102 has been well-tolerated, with no serious adverse events and no clinically significant laboratory abnormalities observed.” — Sekar Kathiresan, M.D., CEO .
  • “We are excited to announce that the first participant in the Pulse-1 Phase 1b clinical trial for our ANGPTL3 product candidate, VERVE-201, was recently dosed.” — Sekar Kathiresan, M.D., CEO .
  • “With cash runway through 2026, we are well-positioned to execute additional important milestones across our pipeline and advance our early-stage programs, including our program targeting LPA.” — Sekar Kathiresan, M.D., CEO .

Q&A Highlights

No Q3 2024 earnings call transcript was available in the document catalog; therefore, Q&A highlights and tone shifts cannot be assessed this quarter [ListDocuments result; 0 earnings-call-transcript].

Estimates Context

  • S&P Global consensus for Q3 2024 EPS and revenue was unavailable due to a CIQ mapping issue (tool error), preventing formal beat/miss analysis vs Street expectations [GetEstimates error].
  • In the absence of Street benchmarks, investors should focus on execution milestones (participant dosing, safety/tolerability, geographic expansion) that underpin future valuation drivers heading into the planned initial data in 1H 2025 .

Key Takeaways for Investors

  • Heart-2 (VERVE-102) execution on track: seven participants dosed across two cohorts with favorable tolerability profile; supports continued dose escalation and PCSK9 program momentum heading into initial data in 1H 2025 .
  • ANGPTL3 (VERVE-201) achieved first human dosing; a second clinical pillar alongside PCSK9 increases program diversification and optionality into 2025 .
  • Operating cadence consistent: collaboration revenue growth (+120% YoY) offsets a small fraction of elevated R&D/G&A, net loss stable QoQ; cash runway “through 2026” supports major upcoming milestones without near-term financing .
  • Heart-1 remains paused with strengthening evidence the LNP was the primary driver of lab abnormalities; prioritization of VERVE-102’s GalNAc-LNP delivery may de-risk the platform’s clinical path .
  • Watch for geographic/regulatory expansion (Israel/New Zealand) to aid enrollment velocity and data generation; 2025 remains the pivotal data year .
  • Trading implications: lack of Street consensus this quarter reduces headline beat/miss catalysts; near-term stock moves likely tied to incremental clinical/regulatory updates and safety/tolerability disclosures [GetEstimates error] .
  • Medium-term thesis: If PCSK9/ANGPTL3 deliver durable LDL-C/protein reductions with clean safety, Verve’s “once-and-done” paradigm could reshape cardiovascular risk management; Phase 2 initiation in 2H 2025 is a critical inflection .