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Elicio Therapeutics, Inc. (ELTX)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 showed disciplined OpEx control and narrower losses: net loss was $10.1M (vs. $18.8M YoY) and EPS was ($0.60) vs. ($1.39) in Q3’24, aided by lower clinical trial costs as AMPLIFY-7P patients progressed through the trial . EPS missed the single-analyst consensus of ($0.48) by $0.12* .*
  • Key clinical update: event-driven primary DFS analysis for the randomized Phase 2 AMPLIFY-7P trial shifted to 1H26, as fewer disease progressions and deaths than projected have occurred—management believes this may reflect a favorable DFS impact (blinded study) .
  • Immune response data remain robust: ELI-002 7P induced mutant KRAS-specific T cell responses in 99% of evaluable patients (89/90), with 86% antigen response; 86.8% (66/76) showed cytotoxic responses, with 75% CD8+ and 75% CD4+ responses across diverse HLA backgrounds .
  • Liquidity extended: $11.1M gross raised via ATM since the start of Q3; cash of $20.6M at 9/30/25 supports operations through Q2 2026, beyond the anticipated Phase 2 DFS analysis .

What Went Well and What Went Wrong

What Went Well

  • Strong immunogenicity across KRAS epitopes and HLA diversity: 99% KRAS-specific T cell responses (89/90), 86% antigen response rate; 86.8% cytotoxic responses; 75% CD8+ and 75% CD4+ responses, reinforcing platform breadth .
  • Positive external validation and safety oversight: IDMC recommended continuation of the randomized Phase 2 without modifications and confirmed favorable safety (August update) .
  • Operating discipline and runway extension: Q3 R&D fell to $5.0M (from $7.2M YoY) driving net loss improvement, while $11.1M ATM proceeds extended cash runway through Q2 2026 .
  • Management tone: “We are encouraged to see fewer disease progressions and deaths… This may reflect a favorable impact on DFS… [and] our current cash position will allow us to reach this critical catalyst and beyond” — Robert Connelly, CEO .

What Went Wrong

  • Timing push to 1H26 for primary DFS analysis, a delay from prior expectation (Q4’25), largely due to fewer-than-expected events in the event-driven design .
  • EPS missed consensus by $0.12 as reported EPS of ($0.60) compared with the single-analyst estimate of ($0.48)* .*
  • Continued pre-revenue profile with operating losses; net loss was $10.1M in Q3 despite cost reductions .

Financial Results

Quarterly P&L and Cash (QoQ)

MetricQ1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$7.778 $7.006 $5.039
G&A Expense ($USD Millions)$2.958 $3.085 $3.006
Total Operating Expenses ($USD Millions)$10.736 $10.091 $8.045
Net Loss ($USD Millions)$11.209 $10.561 $10.083
EPS (Basic & Diluted) ($)($0.87) ($0.66) ($0.60)
Cash & Cash Equivalents (Period-End) ($USD Millions)$18.351 $22.088 $20.611

EPS YoY

MetricQ3 2024Q3 2025
EPS (Basic & Diluted) ($)($1.39) ($0.60)

Estimates Comparison (Q3 2025)

MetricConsensusActual
EPS ($)($0.48)*($0.60)
Revenue ($USD Millions)$0.00*Not disclosed in release (pre-revenue focus)

Values marked with * retrieved from S&P Global.

Clinical KPIs

KPICurrent Period (Q3 2025)
mKRAS-specific T cell response rate99% (89/90)
Antigen response rate86%
Cytotoxic mKRAS-specific T cell responses86.8% (66/76)
CD8+ T cell induction75% (57/76)
CD4+ T cell induction75% (57/76)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2 AMPLIFY-7P primary DFS analysis timingEvent-drivenFinal analysis expected Q4 2025 Primary DFS analysis anticipated 1H 2026 Delayed
Cash runwayAs of Q1 2025Into Q4 2025 Maintained at time
Cash runwayAs of Q2 2025Into Q1 2026 Extended
Cash runwayAs of Q3 2025Through Q2 2026 Extended again
Liquidity actionsSince start of Q3 2025N/A~$11.1M gross raised via ATM Strengthened balance sheet

Earnings Call Themes & Trends

Note: We searched for an earnings call transcript for Q3 2025 but did not find one in our document set; therefore, themes are drawn from press releases.

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q3 2025)Trend
Clinical efficacy signalsIDMC continued Phase 2 without modifications; viewed as preliminary efficacy signal Fewer progressions/deaths than projected may indicate favorable DFS; blinded remains Improving signal profile
Regulatory pathAlignment with FDA on Phase 3 key elements (dose, schedule, population, DFS endpoint) in Q1 ; plan to request EoP2 post final DFS Will request EoP2 upon event-driven primary DFS analysis now in 1H26 Steady, timeline shifted
SafetyIDMC confirmed favorable safety Prior IDMC confirmation reaffirmed Consistent
Immunogenicity breadthPlatform overview/KOL event 99% KRAS-specific T cell responses; broad HLA coverage Strengthening dataset
Financing/runwayQ1 runway into Q4’25 ; $10M financing in Q2 extended into Q1’26 ~$11.1M ATM in Q3; runway through Q2’26 Strengthened
External collaborations—Planned MSK-led Phase 1 neoadjuvant (ELI-002 7P + mFOLFIRINOX ± anti-PD-1), funded by Lustgarten; starts 1H’26 Expanding footprint

Management Commentary

  • “We are encouraged to see fewer disease progressions and deaths… This may reflect a favorable impact on DFS… we are updating our guidance for the timing of the event-driven primary DFS endpoint analysis to the first half of 2026. Importantly, we believe our current cash position will allow us to reach this critical catalyst and beyond” — Robert Connelly, CEO .
  • “We… received the IDMC’s positive recommendation to continue the AMPLIFY-7P study to final analysis without modification… With final DFS data expected in the fourth quarter of this year, we are focused on advancing clinical preparations for a potential pivotal Phase 3 trial” (Q2 context) . Note: final DFS timing subsequently moved to 1H26 .
  • “We believe ELI-002 represents a potentially transformative approach… and the upcoming randomized interim data readout in PDAC will be a critical validating opportunity for our AMP platform” (Q1 context) .

Q&A Highlights

  • No Q3 2025 earnings call transcript was available in our document set; consequently, Q&A highlights and any guidance clarifications from a live call are not available.

Estimates Context

  • EPS: Actual ($0.60) vs. consensus ($0.48)* — result was a modest miss of $0.12, driven within a development-stage profile where OpEx timing and non-cash items can influence quarter-to-quarter EPS .*
  • Revenue: Consensus modeled $0.0*, and the company did not disclose product revenue in the release, consistent with its clinical-stage status .
    Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • The DFS primary analysis delay to 1H26 is event-driven and linked to fewer-than-expected progressions/deaths, which management believes may favor DFS; this shifts the pivotal/EoP2 cadence but may reflect emerging benefit in a blinded setting .
  • Immunogenicity results remain a core bull point (99% KRAS-specific T cell responses; strong cytotoxic and CD4/CD8 induction across HLA), strengthening the platform narrative ahead of DFS .
  • Runway now extends through Q2 2026 after ~$11.1M ATM proceeds in Q3 and $20.6M cash at quarter-end, reducing near-term financing overhang through the DFS catalyst .
  • Cost discipline is evident: R&D stepped down to $5.0M in Q3 as the trial progressed, improving losses vs. prior year despite the pre-revenue model .
  • Near-term catalyst path: 1H26 Phase 2 DFS readout followed by an End-of-Phase 2 meeting to finalize Phase 3; pre-work with FDA on design elements de-risks the transition to pivotal .
  • External validation/expansion: Planned MSK-led neoadjuvant study (funded by Lustgarten) could broaden ELI-002’s clinical footprint and generate combination data in 2026 .
  • Trading setup: Expect sentiment to hinge on interim clinical signals (IDMC decisions, immunogenicity durability) versus the extended DFS timeline; funding runway through the analysis reduces balance sheet risk into the binary readout .