Enliven Therapeutics, Inc. (ELVN)·Q2 2024 Earnings Summary

Executive Summary

• Q2 2024 showed continued pipeline execution: first patient dosed in ELVN-001 Phase 1b (relapsed/refractory/intolerant CML) and first patients dosed in ELVN-002 combination trials in HER2+ MBC/CRC, reinforcing multi-program momentum .
• Operating expenses increased year over year (R&D $18.8M vs $15.2M; G&A $5.8M vs $5.0M), driving net loss of $20.0M vs $16.7M YoY; diluted EPS was -$0.41, flat YoY .
• Cash, cash equivalents and marketable securities were $312.4M as of June 30, 2024, with stated cash runway into late 2026; Q2 cash includes $10M milestone payment received from Cardurion and subsequently remitted (less permitted deductions) to legacy stockholders in August 2024 .
• Near-term catalysts: updated ELVN-001 Phase 1a data abstract accepted for ESH-iCMLf Conference (Sept 27–29), and management guides to additional Phase 1 data in 2025 across ~60–100 patients .

What Went Well and What Went Wrong

What Went Well

• ELVN-001 program advanced: “Dosed the first patient in the Phase 1b arm of the clinical trial” in relapsed/refractory/intolerant CML, with updated data slated in 2025 across ~60–100 patients .
• ELVN-002 combination strategy initiated: first patient dosed in Phase 1a combination trial with trastuzumab (+/- chemo) in HER2+ MBC/CRC; initial combination data expected in 2025 .
• Management tone constructive on execution: “The second quarter of 2024 marked another period of significant progress for both of our parallel lead programs, ELVN-001 and ELVN-002” — CEO Sam Kintz .

What Went Wrong

• Higher operating spend: R&D rose to $18.8M (from $15.2M), G&A rose to $5.8M (from $5.0M), increasing total operating expenses to $24.6M (from $20.1M) YoY .
• Continued losses: net loss widened to $20.0M vs $16.7M YoY; operating loss was -$24.6M vs -$20.1M YoY .
• Risk backdrop unchanged: forward-looking statement section highlights limited operating history, clinical execution risks, capital needs, and reliance on third parties, underscoring program and financing risks typical of clinical-stage biotechs .

Financial Results

P&L and EPS comparison (YoY, QoQ, Current)

Notes: ELVN did not report product revenues in these press releases; margins such as gross margin/EBITDA margin are not applicable based on disclosed data .

Balance Sheet and Liquidity

Other items: Cash balance includes $10M milestone received from Cardurion and remitted in August 2024 (less permitted deductions) to legacy stockholders . Management states cash runway into late 2026 .

Segment Breakdown and KPIs

• Segment reporting: Not applicable; company is clinical-stage with no commercial segments disclosed .
• Clinical KPIs:
  • ELVN-001 Phase 1a proof-of-concept: cumulative MMR rate of 44% (7/16) at 12 weeks among response-evaluable patients; favorable tolerability; announced May 14 press release linked to April 11 data .
  • ELVN-001 progression: first patient dosed in Phase 1b; abstract accepted for ESH-iCMLf Sept conference .
  • ELVN-002: first patient dosed in Phase 1a combination (trastuzumab +/- chemo) in HER2+ MBC/CRC; exploratory arm dosed with Kadcyla in HER2+ MBC; initial 2025 data guided .

Guidance Changes

No revenue, margin, OpEx guidance ranges were issued; only cash runway and program timelines were disclosed .

Earnings Call Themes & Trends

Transcript unavailable in the catalog; themes inferred from quarterly press releases.

Management Commentary

• CEO (Q2 2024): “The second quarter of 2024 marked another period of significant progress for both of our parallel lead programs, ELVN-001 and ELVN-002… We began dosing patients in the Phase 1b arm for ELVN-001 and in two combination trials for ELVN-002.” — Sam Kintz .
• CMO (Q1 2024, ELVN-001 PoC): “ELVN-001… demonstrated activity in a heavily pre-treated patient population… with a preliminary safety profile consistent with its highly selective design.” — Helen Collins, M.D. .
• Investigator (ELVN-001 PoC): “ELVN-001 looks promising… activity in heavily pre-treated patients, including post-asciminib patients.” — Fabian Lang, M.D. .

Q&A Highlights

• An earnings call transcript for Q2 2024 was not available in the document catalog, and no Q&A content was identified in the filings or company press materials reviewed .
• The company did host a KOL event related to ELVN-001 data on April 11, 2024, but this was not an earnings call Q&A; no transcript was included in the 8-K materials .

Estimates Context

• Wall Street consensus (S&P Global) for Q2 2024 EPS and revenue could not be retrieved due to access limits; therefore, comparisons to consensus are unavailable at this time. Values retrieved from S&P Global were unavailable due to data access limits.*

Key Takeaways for Investors

• Dual-lead program execution is tracking: ELVN-001 transitioned into Phase 1b dosing; ELVN-002 initiated combinations, supporting a multi-asset clinical strategy and upcoming 2025 data readouts .
• Liquidity remains robust with $312.4M cash and runway into late 2026, supporting clinical milestones without near-term financing needs per company commentary .
• Spend is rising as trials scale: YoY increases in R&D and G&A drove a wider operating loss; monitor cadence of upcoming data vs expense trajectory .
• Near-term catalysts include ESH-iCMLf abstract for ELVN-001 in September and broader 2025 Phase 1 data (60–100 patients), potential to shape perceptions of best-in-class profile in CML .
• No product revenue and continued net losses underscore binary clinical and regulatory risk; forward-looking statements reiterate risks around execution, funding, and reliance on third parties .
• For trading, watch data flow and conference disclosures; positive clinical updates historically correlate with sentiment shifts in clinical-stage biotech equities .

Sources: Q2 2024 8-K and attached press release ; Q1 2024 8-K and press release ; Q4/FY 2023 8-K and press release ; April 11, 2024 8-K and press release .