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EO

Elevation Oncology, Inc. (ELEV)·Q2 2024 Earnings Summary

Executive Summary

  • Q2 2024 delivered a development-driven update anchored by EO-3021 clinical readout: 42.8% confirmed ORR and 71.4% DCR in Claudin 18.2-enriched gastric/GEJ subset, with a differentiated safety profile (no neutropenia or peripheral neuropathy), while net loss was $10.5M and EPS was $(0.18) .
  • Cash, cash equivalents and marketable securities increased to $110.8M, extended cash runway into 2026; company raised $44.2M YTD via ATM to support operations .
  • Strategic momentum: advancing EO-3021 into monotherapy dose expansion; initiating combination cohorts with ramucirumab (VEGFR2) and dostarlimab (PD-1) by year-end 2024; HER3-ADC development candidate nomination on track for 2H 2024 .
  • Wall Street consensus (S&P Global) for revenue/EPS was unavailable for comparison this quarter; estimate context cannot be provided due to missing CIQ mapping. Values retrieved from S&P Global are unavailable this period.
  • Near-term stock reaction catalysts: combination dosing start by YE2024 and additional monotherapy data in 1H 2025; broader pipeline visibility (HER3-ADC nomination) may add optionality .

What Went Well and What Went Wrong

What Went Well

  • EO-3021 delivered proof-of-concept with biomarker-enriched efficacy: “confirmed ORR of 42.8%” and “DCR of 71.4%” in ≥20% Claudin 18.2 IHC 2+/3% gastric/GEJ subset; management emphasized “best-in-class” potential and combinability .
  • Differentiated safety profile: “no neutropenia or peripheral neuropathy/hypoesthesia,” minimal MMAE-associated toxicities; site-specific conjugation cited as the driver of stability and safety .
  • Strengthened balance sheet and runway: cash increased to $110.8M, runway into 2026; company executed $44.2M ATM to fund development .

What Went Wrong

  • Biomarker sensitivity boundary remains unsettled: efficacy was 0% ORR in <20% Claudin 18.2 IHC 2+/3% subgroup; prospective cutoff will be set later, implying patient selection risk until defined .
  • Dose-limiting toxicities at 2.9 mg/kg (fatigue, encephalopathy, appetite-related DLTs) required stepping down to 2.0–2.5 mg/kg for expansion, limiting maximum tested dose .
  • Small, early dataset with 15 efficacy-evaluable gastric/GEJ patients; duration metrics are immature and not yet disclosed, raising questions on sustainability of responses until further data in 1H 2025 .

Financial Results

P&L Snapshot (Quarterly)

MetricQ4 2023Q1 2024Q2 2024
Research & Development ($USD Thousands)$4,691 $6,011 $6,551
General & Administrative ($USD Thousands)$3,255 $3,858 $4,412
Total Operating Expenses ($USD Thousands)$7,946 $9,869 $10,963
Loss from Operations ($USD Thousands)$(7,946) $(9,869) $(10,963)
Interest Income (Expense), net ($USD Thousands)$56 $115 $513
Net Loss ($USD Thousands)$(7,899) $(10,707) $(10,461)
Net Loss per Share (Basic & Diluted) ($USD)$(0.19) $(0.23) $(0.18)
Weighted Avg Shares (Basic & Diluted)42,416,011 47,371,882 59,018,340
Revenue ($USD Millions)n/a – not disclosed; no revenue line n/a – not disclosed; no revenue line n/a – not disclosed; no revenue line

Note: Revenue and margin metrics are not applicable for a pre-revenue development-stage company in these releases .

Balance Sheet Snapshot

MetricQ4 2023 (Dec 31, 2023)Q1 2024 (Mar 31, 2024)Q2 2024 (Jun 30, 2024)
Cash, Cash Equivalents & Marketable Securities ($USD Thousands)$83,107 $104,051 $110,849
Working Capital ($USD Thousands)$83,819 $105,553 $110,806
Total Assets ($USD Thousands)$89,091 $108,961 $114,597
Long-term Debt, net of discount ($USD Thousands)$30,137 $30,809 $30,916
Total Stockholders’ Equity ($USD Thousands)$54,809 $75,818 $80,918

Clinical KPIs (EO-3021 Phase 1 – Dose Escalation, data cutoff June 10, 2024)

KPIBiomarker GroupValueNotes
Objective Response Rate (ORR)Claudin 18.2 ≥20% at IHC 2+/3+42.8% (3 confirmed PRs) Responses all in enriched cohort; one PR confirmed post-cutoff
Disease Control Rate (DCR)Claudin 18.2 ≥20% at IHC 2+/3+71.4% (incl. 2 SD) —
ORRClaudin 18.2 <20% at IHC 2+/3+0% —
DCRClaudin 18.2 <20% at IHC 2+/3+50% (4 SD) —
Safety – Neutropenia/Peripheral NeuropathyAll EO-3021-treated patients (n=32)None observed Minimal MMAE-associated tox reported
DLTs at 2.9 mg/kgDose escalation4 DLTs → select 2.0/2.5 mg/kg for expansion Fatigue, encephalopathy, appetite-related

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto Q4 2025 Into 2026 Raised (Q1) then Maintained (Q2)
EO-3021 – Initial data2024Update mid-2024; initial safety/efficacy mid-3Q 2024 Delivered Aug 6, 2024 Achieved
EO-3021 – Combination cohorts2024Details in 1H 2024 Initiate dosing by YE 2024 Formalized timing
EO-3021 – Additional data2025Additional data 1H 2025 Additional monotherapy data 1H 2025 Maintained
HER3-ADC – Dev candidate2024Nominate in 2024 On-track for 2H 2024 Narrowed window

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q4 2023; Q-1: Q1 2024)Current Period (Q2 2024)Trend
Clinical efficacy (EO-3021) & biomarker strategyExpanded global trial; update mid-2024 42.8% ORR in ≥20% Claudin 18.2 subset; 0% ORR in <20%; prospective cutoff to be set Clear enrichment; moving toward biomarker-driven selection
Safety profile (MMAE tox)Emphasis on ADC differentiation No neutropenia/peripheral neuropathy; manageable GI AEs with prophylaxis Differentiated vs peers; supports combination strategies
Combination plans (ramucirumab, dostarlimab)Plan to share details 1H 2024 Dosing initiation by YE 2024; rationale for VEGFR2/PD-1 combos Execution timeline set
Regional expansion (Japan)First patient dosed in Japan (Feb 2024) Continued enrollment; global PI commentary from Japan Global dataset broadening
Financing & runwayATM proceeds; runway Q4 2025 Cash to $110.8M; runway into 2026 Strengthened liquidity
R&D execution (HER3-ADC)AACR preclinical data; 2024 nomination On track for 2H 2024 nomination Program advancing as planned

Management Commentary

  • “Today, we announced promising initial data from our Phase 1 trial…support EO-3021’s potential as a best-in-class Claudin 18.2 antibody drug conjugate…encouraging anti-tumor activity…as well as a differentiated safety profile” — Joseph Ferra, CEO .
  • “Treatment with 3021 was generally well tolerated with no reported adverse events of neutropenia or peripheral neuropathy…we are working quickly to advance a robust clinical development program…both as monotherapy and in combination” — Joseph Ferra, CEO .
  • “We are encouraged to see the benefits of EO-3021’s site-specific conjugation translate clinically, with minimal MMAE-associated toxicities…data suggest that EO-3021 is a potential best-in-class Claudin 18.2 ADC” — Valerie M. Jansen, CMO .

Q&A Highlights

  • Biomarker cutoff strategy: Management presented data stratified at ≥20% Claudin 18.2 IHC 2+/3% and indicated a prospective cutoff will be defined with more data; external PI cited ~70% concordance pre/post chemo for Claudin 18.2 expression, supporting a relatively wide target population .
  • Combination safety and overlap: Differentiated safety (no heme tox/neutropenia) viewed as enabling combos with ramucirumab and PD-1 without overlapping tox; contrast drawn versus other Claudin 18.2 ADC programs .
  • Duration of response: Too early for medians; one PR at 1 mg/kg ongoing since Aug 2023; PI anecdotal responses >4–5 months in heavily pretreated patients .
  • Trial flow/assay comparability: 15 evaluable of 26 gastric/GEJ due to scan/IHC timing; assays/clones and thresholds remain an area of standardization as more data accrue .
  • Line-of-therapy differentiation: Monotherapy expansion in ≥2L; ramucirumab combo in 2L; dostarlimab combo in 1L; treating physicians to guide cohort selection .

Estimates Context

  • S&P Global Wall Street consensus for Q2 2024 EPS and revenue was unavailable due to missing CIQ mapping; therefore, comparison vs estimates cannot be provided this quarter. Values retrieved from S&P Global are unavailable this period.

Key Takeaways for Investors

  • EO-3021 has early, biomarker-enriched efficacy and a clean safety profile, positioning it well for both monotherapy and combinations; upcoming expansion and combo dosing milestones are key near-term catalysts .
  • The absence of neutropenia/peripheral neuropathy mitigates typical MMAE ADC constraints, potentially broadening combinability and differentiation vs peers; watch for safety consistency in expansion cohorts .
  • Patient selection is central: responses clustered in ≥20% Claudin 18.2; a prospective cutoff/CDx path will drive future adoption, trial success, and market sizing; monitor biomarker strategy disclosures .
  • Liquidity is solid with $110.8M cash and runway into 2026, reducing financing overhang while enabling robust clinical execution across EO-3021 and HER3-ADC .
  • Data set is early and small; durability and breadth will be scrutinized in 1H 2025 readouts; manage expectations around DoR/PFS and expansion cohort heterogeneity .
  • Competitive landscape in Claudin 18.2 is active (ADC/mAb/TCE/CAR-T); EO-3021’s safety/combination profile could be a differentiator in real-world regimens if efficacy scales in expansion .
  • Medium-term thesis hinges on converting early signal into robust, reproducible outcomes with a clear biomarker/CDx; near-term trading skew tied to combo start by YE2024 and interim expansion updates in 1H 2025 .

Notes on Sources:

  • Q2 2024 8-K and press release (financials and clinical highlights): .
  • Clinical data press release (dose escalation details): .
  • Special call transcript (prepared remarks and Q&A): –.
  • Prior quarters (Q1 2024 and Q4 2023) financials and milestones: – .