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Enliven Therapeutics, Inc. (ELVN)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 results: Net loss of $23.2M and diluted net loss per share of $0.46; R&D $20.7M, G&A $6.2M; cash, cash equivalents and marketable securities were $313.4M with runway into mid-2027 .
  • Pipeline execution continues: ELVN-001 momentum accelerated post ESH‑iCMLf; FDA orphan drug designation; company preparing for potential pivotal start in 2026; ELVN-002 combo trials enrolling with first Phase 1b CRC dosing; data updates expected mid‑2025 (ELVN‑001) and 2H25 (ELVN‑002) .
  • QoQ trend: Total operating expenses modestly lower vs Q3 ($26.9M vs $27.1M), net loss roughly flat; period‑end cash rose to $313.4M from $291.8M at 9/30/24, extending runway from late 2026 to mid‑2027 .
  • Near‑term stock catalysts: mid‑2025 ELVN‑001 Phase 1 update and 2H25 ELVN‑002 monotherapy/combination readouts; potential 2026 pivotal start for ELVN‑001 .

What Went Well and What Went Wrong

What Went Well

  • Liquidity and runway: Cash, cash equivalents and marketable securities of $313.4M provide visibility into mid‑2027, enhancing funding certainty for planned studies .
  • ELVN‑001 momentum/positioning: “The momentum of ELVN‑001 has accelerated since the data presentation at the ESH‑iCMLf conference… preparing for the potential start of a pivotal trial for ELVN‑001 in 2026.” — CEO Sam Kintz .
  • ELVN‑002 progress: Continued enrollment across monotherapy and combination arms; dosing initiated in Phase 1b CRC cohort; multiple 2025 data catalysts outlined .

What Went Wrong

  • Operating intensity and losses increased YoY: Q4 R&D up to $20.7M (from $17.9M), G&A to $6.2M (from $4.8M), and net loss to $23.2M (from $19.4M) vs Q4 2023 .
  • Pre‑revenue profile persists: No product revenue disclosed; statements begin with operating expenses, keeping P&L leverage deferred to future milestones .
  • Limited quantitative guidance: Company reiterated cash runway and timing of data, but provided no numerical ranges for revenue, margins, or OpEx beyond historicals, leaving model sensitivity to program timelines and trial cadence .

Financial Results

Quarterly P&L and Liquidity (oldest → newest)

Metric ($USD Millions, except per-share/shares)Q2 2024Q3 2024Q4 2024
R&D Expense$18.8 $21.3 $20.7
G&A Expense$5.8 $5.8 $6.2
Total Operating Expenses$24.6 $27.1 $26.9
Other Income (Expense), net$4.7 $3.9 $3.7
Net Loss$(20.0) $(23.2) $(23.2)
Net Loss per Share (basic/diluted)$(0.41) $(0.48) $(0.46)
Cash, Cash Equivalents & Marketable Securities (period end)$312.4 $291.8 $313.4
Wtd-Avg Shares Outstanding (basic/diluted, Millions)48.1 48.3 49.9

Q4 2024 vs Q4 2023

Metric ($USD Millions, except per-share)Q4 2023Q4 2024
R&D Expense$17.9 $20.7
G&A Expense$4.8 $6.2
Total Operating Expenses$22.7 $26.9
Other Income (Expense), net$3.4 $3.7
Net Loss$(19.4) $(23.2)
Net Loss per Share$(0.47) $(0.46)
Cash, Cash Equivalents & Marketable Securities (12/31)$253.1 $313.4
  • Segment breakdown: Not applicable; Enliven is a clinical‑stage biotech without commercial segments .
  • KPIs (clinical): ELVN‑001 Phase 1 cumulative MMR rate of 44.4% (8/18) by 24 weeks as of 6/25/2024 update; additional data planned in 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayCompany-levelInto late 2026 Into mid‑2027 Raised/extended
ELVN‑001 data timingProgram milestone“Additional Phase 1 data in 2025” “Updated Phase 1 data mid‑2025” Refined timing
ELVN‑002 data timingProgram milestone“Phase 1 monotherapy and initial combo data in 2025” “Monotherapy and combination data in 2H 2025” Refined timing

Note: No revenue, margin, OpEx, OI&E, or tax guidance ranges were provided; disclosures focused on runway and clinical milestones .

Earnings Call Themes & Trends

No earnings call transcript was available in the document corpus; third‑party sites list ELVN transcripts behind access controls, but we could not retrieve a Q4 2024 transcript to review .

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
R&D execution (ELVN‑001)Dosed first Phase 1b patient; abstract accepted for ESH‑iCMLf; additional 2025 data planned Positive updated Phase 1 data; cumulative MMR 44.4% at 24 weeks; strong enrollment momentum Momentum accelerated post ESH‑iCMLf; planning for potential pivotal start in 2026; updated Phase 1 data mid‑2025 Improving
R&D execution (ELVN‑002)Initiated combinations with trastuzumab ± chemo and Kadcyla; 2025 data expected Continued progress; plan to report 2025 data Continued enrollment; Phase 1b CRC dosing begun; data in 2H25 Steady progress
Regulatory——FDA orphan drug designation for ELVN‑001 in CML (noted in business update) Positive
Liquidity/runway$312.4M cash; runway late 2026 $291.8M cash; runway late 2026 $313.4M cash; runway mid‑2027 Extended
Non‑GAAP/marginsNot provided Not provided Not provided Unchanged

Management Commentary

  • “We continue to hear significant enthusiasm and excitement from investigators on both of our programs. The momentum of ELVN‑001 has accelerated since the data presentation at the ESH‑iCMLf conference… 2025 is a big year for Enliven… preparing for the potential start of a pivotal trial for ELVN‑001 in 2026.” — Sam Kintz, Co‑founder & CEO .
  • Strategic focus remains on clinical execution for ELVN‑001 and ELVN‑002 with clearly staged 2025 data catalysts and runway support into mid‑2027 .

Q&A Highlights

  • We found no accessible Q4 2024 earnings call transcript in our document set. Third‑party pages list ELVN transcripts, but we could not retrieve the Q4 2024 call to extract Q&A details or tone shifts .
  • Accordingly, any guidance clarifications or analyst focus areas are not available. Management commentary herein reflects the press release/8‑K only .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 could not be retrieved at this time due to access limits, so we cannot assess beats/misses vs consensus. We recommend updating this section once S&P Global access is available to capture EPS and any R&D/OpEx expectations and recalibration needs.
  • As a pre‑revenue clinical‑stage company, reported results consist primarily of operating expenses and net loss; no non‑GAAP financial adjustments were presented .

Key Takeaways for Investors

  • Funding visibility: $313.4M in cash and equivalents with runway into mid‑2027 reduces financing overhang and supports near‑term clinical catalysts .
  • ELVN‑001 pathfinding: Post‑ESH‑iCMLf momentum and mid‑2025 update are key stock catalysts; 2026 potential pivotal start, if confirmed, would be a material de‑risking event for the program .
  • ELVN‑002 optionality: 2H25 monotherapy and combination data could broaden the story into HER2+ tumors, including CRC and MBC, adding multi‑asset upside .
  • Cost trajectory: YoY increases in R&D and G&A drove a wider net loss; QoQ OpEx modestly declined in Q4, with net loss roughly flat — monitor spend cadence vs trial expansion .
  • Lack of quantitative guidance: With no OpEx or EPS guidance ranges, investor models will hinge on trial enrollment pace and data timing; revisit following mid‑2025 update .
  • Next steps: Track ELVN‑001 mid‑2025 dataset quality and durability; assess any pivot‑enabling endpoints or regulatory interactions disclosed thereafter; monitor ELVN‑002 combo safety/early activity in 2H25 readouts .

Sources: Q4 press release and attached financial statements (also furnished via 8‑K) ; Q3 press release ; Q2 8‑K .