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Elicio Therapeutics, Inc. (ELTX)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was pre-revenue and focused on clinical execution; EPS of -$1.02 missed S&P Global consensus of -$0.875 as R&D spending ramped for the randomized Phase 2 AMPLIFY-7P trial in PDAC, though sequential EPS improved vs. Q3 (-$1.39) (estimates from S&P Global; see tables) *.
  • Clinical catalysts strengthened: enrollment in the 135-patient Phase 2 AMPLIFY-7P study was completed on Dec 3, 2024, and the company later aligned with FDA on key Phase 3 design elements; the DFS event‑driven interim analysis shifted from H1 2025 to Q3 2025 (depending on event accrual) .
  • Liquidity improved: cash and cash equivalents were $17.6M at 12/31/24, and with a January 2025 $10M raise, Elicio expects runway into Q4 2025, beyond the Phase 2 interim analysis (incremental to the Q3 guidance of runway into Q2 2025) .
  • Stock reaction catalyst: upcoming Phase 2 DFS interim readout (event‑driven) and subsequent Phase 3 initiation planning are the key inflection points for 2025-2026 .

What Went Well and What Went Wrong

  • What Went Well

    • Completed enrollment of the randomized Phase 2 AMPLIFY-7P trial (135 PDAC patients) ahead of the interim readout; “speed of study enrollment exceeded our expectations,” per CMO Christopher Haqq, M.D., Ph.D. .
    • FDA alignment achieved on key elements of a registrational Phase 3 design for ELI‑002 (dose, schedule, patient population, DFS endpoint) .
    • Strengthened balance sheet: cash was $17.6M at year-end 2024 and a $10M January 2025 financing extended runway into Q4 2025, beyond the interim .

  • What Went Wrong

    • EPS missed consensus in Q4 2024 (actual -$1.02 vs -$0.875) amid elevated operating costs supporting late-stage clinical execution (S&P Global; see tables) *.
    • Timing push: the interim DFS analysis timeline shifted from H1 2025 (signaled in Q3 communication) to Q3 2025 (event‑driven) .
    • Full‑year R&D increased to support the Phase 2 trial (FY24 R&D $33.7M vs $23.8M), underscoring ongoing spend needs ahead of pivotal plans .

Financial Results

  • Notes:
    • ELTX is pre-revenue. Q4 2024 EPS comparison is primary focus.
    • Some values are drawn from S&P Global (asterisked) due to absence of quarter-specific detail in filings/PR; see footnote.
MetricQ4 2023Q2 2024Q3 2024Q4 2024
EPS Actual ($)-3.78*-0.64 -1.39 -1.02*
EPS Consensus ($)-1.03*-0.96*-0.73*-0.875*
EPS Surprise ($)-2.75*+0.32*-0.66*-0.145*
Operating Expense KPIQ2 2024Q3 2024Q4 2024
Total Operating Expenses ($M)10.924 10.344 13.476*
Liquidity KPIQ2 2024Q3 2024Q4 2024
Cash & Cash Equivalents ($M)3.425 26.0 17.6

Footnote: Asterisked estimate/actual values and Q4 operating expense are retrieved from S&P Global. Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AMPLIFY-7P DFS interim analysis timingPhase 2 (event‑driven)H1 2025 (pre‑planned interim incl. DFS) Q3 2025 (depending on event accrual) Delayed
Phase 2 enrollment135 pts randomizedComplete in Q4 2024 Completed Dec 3, 2024 Achieved
Cash runwayCorporateInto Q2 2025, beyond interim Into Q4 2025, beyond interim (incl. Jan 2025 $10M raise) Extended
Phase 3 regulatory pathELI‑002 (PDAC)Not specifiedAligned with FDA on key Phase 3 design elements (dose, schedule, population, DFS) New disclosure

Earnings Call Themes & Trends

Note: No Q4 2024 earnings call transcript was located in filings; company communications for Q4 centered on the 8‑K press release and corporate updates .

TopicPrevious Mentions (Q-2 = Q2’24)Previous Mentions (Q-1 = Q3’24)Current Period (Q4’24)Trend
Phase 2 AMPLIFY-7P progressRobust early 7P immunogenicity; enrollment to complete Q4’24; interim in Q1’25 Enrollment on track; interim in H1’25 Enrollment completed Dec 3; interim in Q3’25 (event‑driven) Timing pushed; dataset maturing
Regulatory path (Phase 3)Not detailedNot detailedFDA alignment on Phase 3 design elements (ELI‑002, PDAC) Visibility improving
Balance sheet/runwayFunded into Q2’25; July and Aug 2024 financings noted Runway into Q2’25 beyond interim Runway into Q4’25 post $10M Jan 2025 raise Stronger
Clinical data updates (Phase 1/1a)ASCO 7P: 100% T‑cell response; translational correlates SITC & ESMO‑IO: durable T cells; antigen spreading; RFS/OS update Reinforced in FY PR summary; emphasis on DFS correlation with T‑cell response Consistent, supportive
Pipeline beyond PDACELI‑007/008 preclinical progress Plans to advance in 1H’25 Continued positioning; Phase 3 planning for ELI‑002 PDAC first Focus on PDAC pivotal path first

Management Commentary

  • “We made substantial progress in 2024… including completing enrollment in our first randomized Phase 2 clinical trial. We believe that ELI‑002 could play a transformational role in preventing the recurrence of difficult‑to‑treat KRAS‑mutant cancers.” — Robert Connelly, CEO .
  • “The speed of study enrollment exceeded our expectations… We are now eagerly looking forward to the pre‑planned interim data analysis as we continue working to bring this potentially transformative vaccine to cancer patients.” — Christopher Haqq, M.D., Ph.D., EVP, Head of R&D and CMO (on Phase 2 AMPLIFY‑7P) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was filed; corporate messaging emphasized:
    • Interim DFS timing and event-driven nature (now Q3 2025) .
    • FDA alignment on Phase 3 design (key de‑risking step prior to pivotal) .
    • Cash runway extended into Q4 2025 after January financing .

Estimates Context

  • Q4 2024: EPS actual -$1.02 vs consensus -$0.875 (miss); sequential improvement vs Q3 (-$1.39) and better YoY vs Q4 2023 (-$3.78). Elicio remains pre-revenue; consensus revenue was $0.0 [tables; S&P Global]. Values retrieved from S&P Global.*

  • Where estimates may adjust:

    • Expense cadence: FY24 R&D rose to $33.7M as Phase 2 progressed; investors may calibrate expense run-rate into 2025 as interim timing pushed to Q3 2025 .
    • Key driver is binary/interim result, not near-term revenue; EPS estimates likely remain expense‑led until pivotal clarity.

Key Takeaways for Investors

  • Near-term catalyst: Phase 2 AMPLIFY‑7P DFS interim in Q3 2025 (event‑driven); positive signal could unlock pivotal Phase 3 start and rerating .
  • Execution milestone achieved: Phase 2 enrollment completed (Dec 3, 2024), de‑risking operational element ahead of interim .
  • Regulatory visibility improved: FDA alignment on Phase 3 design elements reduces pathway ambiguity for ELI‑002 in resected mKRAS PDAC .
  • Liquidity extended: Runway into Q4 2025 limits near‑term financing overhang through interim readout .
  • EPS miss vs consensus reflects R&D ramp; sequential EPS improved vs Q3; focus stays on clinical data, not revenue/EPS optics (S&P Global; see tables). Values retrieved from S&P Global.*
  • Narrative shift: Interim timing push (H1 → Q3 2025) is event‑driven; slower event accrual can be consistent with potential benefit, but remains unblinded until analysis—stay tuned for interim .
  • Trading setup: Stock likely moves on interim DFS outcome and subsequent FDA interactions; consider positioning around event timing and liquidity runway.

Sources

  • Q4/FY 2024 8‑K (Item 2.02; PR furnished as Ex. 99.1) .
  • FY2024 press release (March 31, 2025) with financials and guidance updates .
  • Enrollment completion PR (Dec 3, 2024) .
  • Q3 2024 results PR (Nov 13, 2024) .
  • Q2 2024 results PR (Aug 13, 2024) .

Footnote: Asterisked estimate/actual values are from S&P Global consensus and actuals feeds. Values retrieved from S&P Global.*