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Enliven Therapeutics, Inc. (ELVN)·Q1 2024 Earnings Summary

Executive Summary

  • Enliven reported Q1 2024 net loss of $22.7M and EPS of $0.54; operating expenses rose on R&D investment, while cash and marketable securities increased to $320.5M, extending runway into late 2026 .
  • The quarter’s key catalyst was positive proof‑of‑concept data for ELVN‑001 in CML: initial 12‑week cumulative MMR of 44% (7/16) in response‑evaluable patients, with activity in asciminib‑resistant and TKI‑resistant cohorts; ELVN‑001 was well tolerated with no grade ≥3 non‑hematologic TRAEs and no dose reductions .
  • ELVN‑002 combination program advanced with first site activated to evaluate ELVN‑002 plus trastuzumab in HER2+ cancers; first patient dosing expected in Q2 2024, consistent with prior guidance .
  • No earnings call transcript or S&P Global consensus estimates were available at the time of analysis; estimate comparisons cannot be made. This limits immediate “beat/miss” narrative, but the clinical data and extended runway are the dominant stock catalysts .

What Went Well and What Went Wrong

What Went Well

  • Positive ELVN‑001 proof‑of‑concept in CML: “We are thrilled by the initial ELVN‑001 data, particularly the tolerability profile and evidence of activity in heavily pre‑treated patients, including in patients with asciminib‑resistant chronic myeloid leukemia” — Sam Kintz, CEO .
  • ELVN‑002 progression: First site activated for Herceptin combination in HER2+ MBC/CRC; initial monotherapy signs of activity in HER2+ and HER2‑mutant tumors, including patients progressed on Enhertu and those with brain metastases; >10x target coverage at predicted optimal dose .
  • Balance sheet strength and financing: Cash/marketable securities of $320.5M and a $90M PIPE announced, extending cash runway into late 2026 (vs early 2026 previously) .

What Went Wrong

  • Higher operating expense base: R&D of $20.0M (+68% YoY) and G&A of $6.0M (+33% YoY) drove total operating expenses up to $26.0M, increasing quarterly net loss to $22.7M (vs $14.7M YoY) .
  • Estimate benchmarking gap: No Street consensus available via S&P Global at time of analysis; inability to frame results vs expectations impedes near‑term “beat/miss” assessment (procedural limitation) .
  • Earnings call transparency: No earnings call transcript found for Q1 2024, limiting insights into management Q&A tone and clarifications .

Financial Results

Income Statement and EPS

MetricQ1 2023Q3 2023Q4 2023Q1 2024
Net Loss ($USD Millions)$14.724 $20.769 $19.370 $22.738
Net Loss per Share ($)$0.80 $0.51 $0.47 $0.54
R&D Expense ($USD Millions)$11.880 $19.606 $17.905 $19.970
G&A Expense ($USD Millions)$4.538 $4.642 $4.824 $6.017
Total Operating Expenses ($USD Millions)$16.418 $24.248 $22.729 $25.987

Notes:

  • Revenue and margin metrics not applicable; company reported no product revenues and disclosed operating expenses and net loss only .

Balance Sheet Highlights

MetricDec 31, 2023Mar 31, 2024
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$253.148 $320.504
Total Assets ($USD Millions)$271.867 $342.777
Total Liabilities ($USD Millions)$25.961 $25.065
Stockholders’ Equity ($USD Millions)$245.906 $317.712

Clinical KPIs (ELVN‑001 and ELVN‑002)

KPIQ3 2023Q4 2023Q1 2024
ELVN‑001: Cumulative MMR rate by Week 12 (response‑evaluable)N/A N/A (POC expected Q2 2024) 44% (7/16)
ELVN‑001: TolerabilityN/A N/A No Grade ≥3 non‑hematologic TRAEs; no dose reductions
ELVN‑002: Clinical activity signalsN/A N/A (IND cleared for combo) Investigator‑reported responses incl. Enhertu‑progressed and brain mets
ELVN‑002: PK/Target coverageN/A N/A >10x target coverage at predicted optimal monotherapy dose

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto early 2026 Into late 2026 Raised/Extended
ELVN‑001: Phase 1b dataset scope2025Not specifiedPhase 1b data expected in 2025; ~60–100 pts across lines with significant follow‑up New detail
ELVN‑002: Herceptin combo first patient dosingQ2 2024Mid‑2024 expected First patient dosing expected in Q2 2024 Maintained/Confirmed
ELVN‑001: Initial PoC disclosureQ2 2024Q2 2024 expected Achieved with initial data disclosed and 44% MMR at 12 weeks Achieved

Earnings Call Themes & Trends

No earnings call transcript was found for Q1 2024; thematic tracking relies on consecutive press releases.

TopicQ3 2023 (Prev. Mentions)Q4 2023 (Prev. Mentions)Q1 2024 (Current Period)Trend
R&D ExecutionAdvancing ELVN‑001 and ELVN‑002; initial PoC expected in 2024 ELVN‑001 PoC in Q2 2024; ELVN‑002 IND for combo cleared ELVN‑001 PoC positive; ELVN‑002 site activated for combo Improving; milestones hit
Regulatory/INDsPipeline advancing; early‑stage programs ELVN‑002 combo IND cleared Combination trial site activated Progressing
Clinical Data (Efficacy)No efficacy disclosed No efficacy disclosed ELVN‑001 44% MMR; ELVN‑002 investigator‑reported responses Turning positive
Safety/TolerabilityNot discussed Not discussed ELVN‑001 well tolerated; no ≥Grade 3 non‑hematologic TRAEs Positive
Capital & Runway$263.5M cash at Q3; runway early 2026 $253.1M cash at FY; runway early 2026 $320.5M cash; runway late 2026; $90M PIPE Strengthening

Management Commentary

  • “The first quarter of 2024 was a pivotal quarter for Enliven. We released positive proof of concept data from our Phase 1 clinical trial of ELVN‑001, which was a significant milestone for the Company” — Sam Kintz, CEO .
  • “We also continued to advance our trials of ELVN‑002, including the activation of the first site to evaluate ELVN‑002 in combination with trastuzumab… which we believe is an area of significant unmet need” — Sam Kintz .
  • Financing and runway: PIPE financing of $90M from new and existing investors; runway extended into late 2026, supporting milestones for ELVN‑001/002 .

Q&A Highlights

  • No Q1 2024 earnings call transcript was located; Q&A themes and clarifications are unavailable for this quarter .

Estimates Context

  • Street consensus via S&P Global for Q1 2024 EPS and revenue was unavailable at the time of analysis due to access limitations; therefore, results cannot be compared to consensus. If estimates become available, focus should be on EPS trajectory and cash burn vs expectations given elevated R&D .
  • Estimates unavailable via S&P Global at the time of writing; comparisons to consensus could not be performed.

Key Takeaways for Investors

  • ELVN‑001’s initial PoC in CML is a meaningful de‑risking event with favorable 12‑week MMR and tolerability; continued data flow (Phase 1b in 2025) can sustain momentum .
  • ELVN‑002’s combo program is moving into execution with Q2 2024 first patient dosing; early monotherapy signals and CNS penetration position it competitively in HER2+ disease, including post‑Enhertu settings .
  • Operating spend is rising in line with clinical execution (R&D up 68% YoY); monitor cash burn vs milestones with extended runway into late 2026 supported by $320.5M cash and $90M PIPE .
  • Lack of Street estimates and call transcript limits near‑term “beat/miss” framing; trading likely keys off clinical readouts and funding runway rather than quarterly P&L .
  • Watch upcoming catalysts: ELVN‑002 first patient dosing (Q2 2024), incremental ELVN‑001 updates en route to Phase 1b dataset, and any HER2 combination efficacy signals .
  • Balance sheet improved QoQ; equity base strengthened, liabilities stable—supports multi‑program execution without near‑term financing risk .
  • Near‑term trade: sentiment sensitive to additional ELVN‑001 efficacy durability and ELVN‑002 combination data flow; medium‑term thesis rests on differentiated profiles against current standards (asciminib resistance in CML; post‑Enhertu HER2+) .

Appendix: Source Documents

  • Q1 2024 8‑K and press release (Item 2.02; EX‑99.1) .
  • Q4 2023 8‑K and press release (Item 2.02; EX‑99.1) .
  • Q3 2023 8‑K and press release (Item 2.02; EX‑99.1) .