Executive Summary

ELEV delivered an R&D-driven quarter with net loss of $12.9M and EPS of $(0.22); cash, cash equivalents and marketable securities were $103.1M, with runway into 2026 .
Clinical momentum continued: FDA Fast Track designation for EO-3021 (CLDN18.2 ADC), Phase 1 monotherapy moved into dose expansion, and combination cohorts with ramucirumab (VEGFR2) and dostarlimab (PD-1) were set to begin dosing in 4Q24; additional monotherapy data expected 1H25 .
Initial EO-3021 data (Aug-6) showed 42.8% confirmed ORR and 71.4% DCR in CLDN18.2-enriched gastric/GEJ tumors, with minimal MMAE-associated toxicities (no neutropenia or peripheral neuropathy), supporting a more “combinable” profile vs peers .
Relative to third-party Street tracking, EPS missed by $0.02 (actual $(0.22) vs. consensus $(0.20)); S&P Global consensus was unavailable for this micro-cap OTC biotech in our data pipeline .

What Went Well and What Went Wrong

What Went Well
- Fast Track designation for EO-3021 in CLDN18.2+ gastric/GEJ cancer, potentially expediting development and review pathways .
- Differentiated clinical profile: 42.8% confirmed ORR and 71.4% DCR in CLDN18.2-enriched subset (≥20% tumor cells at IHC 2+/3+), with minimal MMAE-associated toxicities (no neutropenia/peripheral neuropathy) supporting combination potential .
- Management execution and runway: advanced to monotherapy dose expansion; combination cohorts to start in 4Q24; cash runway into 2026. “We are well-positioned to explore the full promise of EO-3021 including its better combinability…” — CEO Joseph Ferra .
What Went Wrong
- Operating expenses rose sequentially as clinical programs ramped (R&D $9.4M in Q3 vs. $6.6M in Q2), widening net loss QoQ ($12.9M vs. $10.5M) .
- Lack of revenue/gross margin (early-stage pipeline); results hinge on clinical milestones and financing environment .
- S&P Global EPS consensus unavailable, complicating standardized beat/miss benchmarking; third-party aggregates showed a modest EPS miss (actual $(0.22) vs. $(0.20)) .

Financial Results

Income statement and per-share metrics (USD $000s except per-share). Periods shown oldest → newest.

Metric	Q3 2023	Q2 2024	Q3 2024
Research & Development ($)	$7,422	$6,551	$9,388
General & Administrative ($)	$3,498	$4,412	$3,841
Total Operating Expenses ($)	$10,920	$10,963	$13,229
Loss from Operations ($)	$(10,920)	$(10,963)	$(13,229)
Interest Income (Expense), net ($)	$295	$513	$360
Net Loss ($)	$(10,636)	$(10,461)	$(12,881)
Net Loss per Share ($)	$(0.23)	$(0.18)	$(0.22)
Weighted Avg. Shares (basic & diluted)	46,842,489	59,018,340	59,108,724

Balance sheet (USD $000s). Periods oldest → newest.

Metric	12/31/2023	6/30/2024	9/30/2024
Cash, Cash Equivalents & Marketable Securities ($)	$83,107	$110,849	$103,070
Working Capital ($)	$83,819	$110,806	$99,397
Total Assets ($)	$89,091	$114,597	$106,302
Long-term Debt, net ($)	$30,137	$30,916	$31,021
Total Stockholders’ Equity ($)	$54,809	$80,918	$69,355

KPIs and liquidity

KPI	Q1 2024	Q2 2024	Q3 2024
Cash Runway	Into 2026	Into 2026	Into 2026
Cash, Cash Equivalents & Marketable Securities ($000s)	$104,051	$110,849	$103,070
Net Loss ($000s)	$(10,707)	$(10,461)	$(12,881)

Notes: Management raised $44.2M via ATM in 1H24, bolstering the balance sheet .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Multi-year	Into 2026 (Q1, Q2)	Into 2026 (Q3)	Maintained
EO-3021 Monotherapy Data Timing	2025	Additional data 1H25 (Q2)	Additional data 1H25 (Q3)	Maintained
EO-3021 Combo Dosing Start	4Q 2024	Initiate dosing by YE24 (Q2)	Initiate dosing in 4Q24 (Q3)	Maintained
HER3-ADC Development Candidate	4Q 2024	Nominate DC 2H24 (Q2)	Nominate DC 4Q24 (Q3)	Narrowed window (maintained within 2H24)

Earnings Call Themes & Trends

Note: A Q3 earnings call transcript was not available in our corpus; Elevation held a special clinical data call on Aug-6 (Q2). We reference that transcript for thematic continuity -.

Topic	Previous Mentions (Q1 & Q2)	Current Period (Q3)	Trend
EO-3021 efficacy/safety	Planned initial data mid-3Q24; cash runway extended	Reinforced 42.8% ORR/71.4% DCR in CLDN18.2-enriched; minimal MMAE tox; dose expansion underway	Positive momentum, moving to expansion/combos
Biomarker strategy (CLDN18.2 threshold)	Anticipated enrichment strategy	Prospective cutoff under evaluation; initial bifurcation at ≥20% IHC 2+/3+ showed responses	Clarifying threshold; data-driven enrichment
Combination strategy	Announced combo plans with ramucirumab and dostarlimab	Combo dosing to start 4Q24; preclinical combo data at ESMO-IO 2024	Advancing as planned
Regulatory	—	FDA Fast Track designation for EO-3021 (GC/GEJ)	De-risking milestone
R&D execution	Enrollment ongoing Q1; initial data Q2	Dose expansion initiated; additional data 1H25	On-track execution
HER3-ADC	Preclinical PoC at AACR; DC nomination 2H24	DC nomination in 4Q24	Progressing to DC

Management Commentary

“We continue to make significant progress with EO-3021… we are advancing EO-3021 in both the monotherapy and combination settings… we initiated the dose expansion portion of the Phase 1 trial… look forward to reporting additional data in the first half of 2025.” — Joseph Ferra, CEO .
“The favorable initial data highlights EO-3021’s unique potential as a more combinable Claudin 18.2 ADC with competitive anti-tumor activity… initiating the combination portion of our Phase 1 trial in Q4 2024.” — Joseph Ferra, CEO .
“EO-3021 was designed to maximize efficacy while minimizing the potential for free MMAE… we are encouraged to see… minimal MMAE-associated toxicities… suggesting EO-3021 is a potential best-in-class Claudin 18.2 ADC.” — Valerie M. Jansen, CMO (Aug-6 call) .

Q&A Highlights

Biomarker cutoff and enrichment: Management is evaluating a prospective CLDN18.2 cutoff after seeing clear efficacy bifurcation at ≥20% IHC 2+/3+. Investigators note ~70% concordance in expression pre/post-chemotherapy; threshold optimization needs more data .
Safety and combinability: Minimal MMAE-associated toxicities support combinations with ramucirumab and dostarlimab; clinicians report manageable GI AEs with antiemetic prophylaxis and no discontinuations for GI toxicity in their experience; ocular AEs were mild; no myelosuppression or worsening neuropathy observed in their patients to date .
Trial design and patient flow: Monotherapy expansion targets patients with ≥1 prior line; combinations target second-line (ramucirumab) and first-line (dostarlimab), with minimal overlap; enrolling physicians will guide cohort assignment .
Duration of response: Too early for medians; one PR at 1 mg/kg ongoing since Aug-2023; investigator anecdotes suggest several ongoing responders at 4–5 months+ in a heavily pretreated population .

Estimates Context

S&P Global consensus estimates were unavailable for ELEV Q3 2024 in our data pipeline.
Third-party aggregators indicate Q3 2024 EPS actual of $(0.22) vs. consensus of $(0.20), a miss of $0.02; revenue not applicable for this R&D-stage company .
Implications: Modest EPS variances are primarily a function of timing of R&D and G&A; as the program advances into expansion and combos, OpEx forecasts may drift higher near term before normalizing around clinical cadence .

Key Takeaways for Investors

Clinical de-risking: Fast Track designation and initial efficacy/safety data support a differentiated ADC profile with attractive combinability—an investable point of differentiation vs. MMAE-based peers with heme tox/neuropathy .
Execution on catalysts: Dose expansion is underway; combo dosing with ramucirumab/dostarlimab slated for 4Q24; additional monotherapy data in 1H25; HER3-ADC DC nomination in 4Q24—events likely to drive stock volatility .
Balance sheet: $103.1M in cash and equivalents funds operations into 2026, reducing near-term financing risk despite R&D ramp .
Biomarker path: Prospective CLDN18.2 threshold selection is a key near-term update; strong enrichment-response relationship should inform registrational design and commercial positioning .
Risk/reward: No revenue; outcomes hinge on Phase 1/2 evolution, combination data, and path to pivotal; watch for safety durability in combos and DoR as the dataset matures .
Trading lens: Near-term moves tied to combo initiation confirmations, ESMO-IO preclinical combination data, and any incremental monotherapy updates; modest EPS misses are less meaningful than clinical inflections for this stage .

Appendices

Other relevant Q3 period press releases and context

FDA Fast Track designation for EO-3021 (Sept-23, 2024) .
Corporate participation at H.C. Wainwright conference (Sept-3, 2024) .
Q2 results and initial EO-3021 clinical data (Aug-6, 2024) .

Document sources used

Q3 2024 earnings press release and metrics .
8-K referencing Q3 press release .
Prior quarters: Q2 press release & 8-K ; Q1 press release & 8-K .
Special call transcript (Aug-6) for clinical/Q&A themes -.
Third-party EPS tracking for context (S&P Global unavailable) .

Elevation Oncology, Inc. (ELEV)·Q3 2024 Earnings Summary