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Enliven Therapeutics, Inc. (ELVN)·Q3 2024 Earnings Summary

Executive Summary

  • Q3 2024 delivered continued pipeline momentum: ELVN-001 achieved a cumulative MMR rate of 44.4% (8/18) by 24 weeks with no dose reductions at ≥40 mg, and ELVN-002 combination trials in HER2+ MBC/CRC continued enrolling; cash runway guided “into late 2026” was maintained .
  • Financials: Net loss was $23.156M and EPS was $(0.48), with R&D at $21.258M and G&A at $5.810M; cash, cash equivalents and marketable securities were $291.834M as of September 30, 2024 .
  • Strategic context: Management highlighted accelerated approval of Scemblix in 1L CML as potentially paving the way for a larger 2L+ opportunity for ELVN-001, framing a favorable market setup ahead of 2025 data readouts .
  • Estimates: S&P Global consensus EPS/revenue for Q3 2024 was unavailable at time of analysis; ELVN did not report product revenue in the quarter (condensed statements presented operating expenses and net loss only) .

What Went Well and What Went Wrong

What Went Well

  • ELVN-001 efficacy and tolerability: cumulative MMR 44.4% by 24 weeks (8/18), no dose reductions at ≥40 mg; management states results compare favorably to precedent Phase 1 trials in a more heavily pre-treated population .
  • ELVN-002 execution: continued enrollment in Phase 1 combination trials with trastuzumab ± chemotherapeutic agents for HER2+ MBC/CRC; ongoing monotherapy and Kadcyla® exploratory arm progress .
  • CEO tone and strategic framing: “thrilled by the progress… strong enrollment and momentum,” and Scemblix 1L accelerated approval seen as a tailwind for ELVN-001’s 2L+ opportunity .

What Went Wrong

  • Operating spend increased: R&D rose to $21.258M (+8% YoY), G&A to $5.810M (+26% YoY), widening net loss to $23.156M (+12% YoY) .
  • Sequential cash decline: cash/equivalents/marketable securities decreased to $291.834M (from $312.390M in Q2 and $320.504M in Q1); Q2’s milestone-related CVR remittance to pre-merger stockholders was noted, and operating spend remained elevated .
  • No Q3 earnings call transcript available in the document set, limiting visibility into Q&A specifics and near-term guidance nuances [List: 0 transcripts].

Financial Results

Income Statement Highlights (oldest → newest)

MetricQ3 2023Q1 2024Q2 2024Q3 2024
Net Loss ($USD Millions)$20.769 $22.738 $19.950 $23.156
EPS, Basic & Diluted ($USD)$(0.51) $(0.54) $(0.41) $(0.48)
R&D Expenses ($USD Millions)$19.606 $19.970 $18.826 $21.258
G&A Expenses ($USD Millions)$4.642 $6.017 $5.777 $5.810
Other Income (Expense), net ($USD Millions)$3.479 $3.249 $4.653 $3.912
Weighted Avg Shares (000s)41,031 42,046 48,075 48,267

Balance Sheet Liquidity

MetricQ1 2024Q2 2024Q3 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$320.504 $312.390 $291.834

KPIs and Pipeline

KPIQ1 2024Q2 2024Q3 2024
ELVN-001 cumulative MMR rate44% (7/16) at 12 weeks Abstract accepted for updated Phase 1a data (ESH-iCMLf) 44.4% (8/18) at 24 weeks
ELVN-001 tolerabilityNo Grade ≥3 non-hematologic TRAEs; no dose reductions —No dose reductions ≥40 mg; well-tolerated
ELVN-002 combination progressFirst site activation for trastuzumab ± chemo First patients dosed in trastuzumab± chemo and Kadcyla® arms Continued enrollment in MBC/CRC combos
Cash runwayInto late 2026 Into late 2026 Into late 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto late 2026 Into late 2026 Maintained
ELVN-001 Clinical Data Timing2025Phase 1 data expected 2025 Additional Phase 1 data in 2025 Maintained
ELVN-002 Clinical Data Timing2025Phase 1 mono and initial combo data in 2025 Phase 1 data in 2025 Maintained
ELVN-002 Combo Trial Status2024First patients dosed (trastuzumab± chemo, Kadcyla®) Continued enrollment in MBC/CRC combos Progressed

Earnings Call Themes & Trends

Note: No Q3 2024 earnings call transcript was available in the document set; themes reflect management communications via press releases.

TopicQ1 2024Q2 2024Q3 2024Trend
ELVN-001 efficacy44% MMR at 12 weeks; activity in asciminib-resistant CML Phase 1b dosing initiated 44.4% MMR at 24 weeks; favorable vs precedent Phase 1 TKIs Improving (based on Q1→Q3 updates)
ELVN-001 safetyNo Grade ≥3 non-hematologic TRAEs; no dose reductions —No dose reductions ≥40 mg; well-tolerated Stable/Positive
Competitive landscape (CML)——Scemblix 1L accelerated approval seen as enabling larger 2L+ opportunity for ELVN-001 Constructive
ELVN-002 combinationsSite activation for trastuzumab ± chemo First patients dosed; Kadcyla® arm initiated Continued enrollment in MBC/CRC combos Advancing
Cash runwayInto late 2026 Into late 2026 Into late 2026 Maintained

Management Commentary

  • “We are thrilled by the progress that we made in the third quarter of 2024… strong enrollment and momentum for the program… [Scemblix] accelerated approval in 1L CML… creating a potentially large, 2L+ opportunity for ELVN-001.” — Sam Kintz, Co-founder & CEO .
  • “The second quarter of 2024 marked another period of significant progress for both of our parallel lead programs, ELVN-001 and ELVN-002.” — Sam Kintz .
  • “The first quarter of 2024 was a pivotal quarter… positive proof of concept data from our Phase 1 clinical trial of ELVN-001…” — Sam Kintz .

Q&A Highlights

  • No Q3 2024 earnings call transcript was available in the document set; Q&A themes and any guidance clarifications could not be assessed [List: 0 transcripts].

Estimates Context

  • S&P Global consensus EPS/revenue estimates for Q3 2024 were unavailable due to data access limitations at time of analysis. ELVN did not report product revenue in Q3 (condensed statements presented operating expenses and net loss only) .
  • Where consensus numbers are required for model updates, we recommend refreshing S&P Global access and re-checking “Primary EPS Consensus Mean” and “Revenue Consensus Mean” for Q3 2024 and forward periods (values to be sourced from S&P Global when available).

Key Takeaways for Investors

  • Pipeline momentum remains strong: ELVN-001 showed durable responses (44.4% cumulative MMR at 24 weeks) with favorable tolerability, supporting continued development and potential differentiation in heavily pre-treated CML .
  • Strategic tailwind: Scemblix’s 1L accelerated approval may expand the 2L+ market opportunity for ELVN-001, an explicit positive framing from management for medium-term positioning .
  • ELVN-002 breadth: Multiple HER2+ combination trials (trastuzumab ± chemo, Kadcyla®) are enrolling in MBC and CRC, creating multiple 2025 data catalysts across modalities and settings .
  • Balance sheet supports execution: $291.834M cash/equivalents/marketable securities at Q3 with runway guided into late 2026, enabling sustained clinical progress without near-term financing pressure .
  • Spending profile: Elevated R&D and G&A reflect program scale-up; monitor expense trajectory and other income to gauge net loss path (Q3 net loss $23.156M; EPS $(0.48)) ahead of 2025 readouts .
  • Near-term catalysts: Continued enrollment updates, potential conference presentations, and preparatory steps toward 2025 data for ELVN-001 and ELVN-002; investor visibility supported by upcoming events (e.g., Jefferies London Healthcare fireside chat) .
  • Action for the trading desk: Stock reaction likely tied to clinical updates and competitive read-throughs; watch for additional ELVN-001 data in 2025, HER2 combo signals, and any regulatory developments that further validate 2L+ CML positioning .