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Elicio Therapeutics, Inc. (ELTX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was steady operationally: ELTX reiterated its AMPLIFY-7P randomized Phase 2 interim DFS analysis for Q3 2025, highlighted FDA alignment on key Phase 3 design elements for ELI-002, and ended the quarter with $18.4M cash, guiding runway into Q4 2025 .
  • Financials tracked expectations for a clinical-stage biotech with no product revenue: net loss improved year/year to $11.2M and EPS was $(0.87), slightly below S&P Global consensus EPS of $(0.83) (miss by $0.04)* .
  • Management strengthened the balance sheet with a $10.0M registered direct offering in January, supporting the cash runway into the upcoming interim readout .
  • Stock reaction catalysts revolve around the AMPLIFY-7P interim DFS analysis in Q3 2025 and subsequent Phase 3 protocol finalization in H2 2025 .

What Went Well and What Went Wrong

What Went Well

  • Clear regulatory path: ELTX achieved alignment with FDA on key Phase 3 design elements (dose, schedule, population, DFS primary endpoint), reducing regulatory uncertainty heading into late-stage development .
  • Adequate funding runway: $18.4M quarter-end cash with guidance that cash supports operations into Q4 2025, beyond the Phase 2 interim DFS analysis .
  • Strategic and leadership reinforcement: Appointment of Preetam Shah, Ph.D., MBA, as Chief Strategy and Financial Officer to advance registrational strategy and financing optionality .

Management quotes:

  • “We believe ELI-002 represents a potentially transformative approach… the upcoming randomized interim data readout in PDAC will be a critical validating opportunity for our AMP platform.” — Robert Connelly, CEO .

What Went Wrong

  • Slight EPS miss vs. S&P Global Street: Q1 EPS of $(0.87) vs. $(0.83) consensus (miss $0.04)*, reflecting ongoing R&D/G&A investment ahead of interim analysis .
  • Timeline slippage vs. mid-2024 expectations: Interim DFS timing moved from H1 2025 (messaged in Q3 2024) to Q3 2025, reflecting event-driven accrual realities .
  • Continued dependence on external capital: The January 2025 $10.0M offering underscores funding dependency until pivotal data and potential partnerships occur .

Financial Results

ELTX does not report product revenue; primary P&L drivers are R&D and G&A.

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$0.00*$0.00*$0.00*
Net Loss ($USD Millions)$18.8 $14.00*$11.21
Diluted EPS ($)$(1.39) $(1.03)*$(0.87)
Total Operating Expenses ($USD Millions)$10.34 $13.48*$10.74
Cash & Cash Equivalents ($USD Millions)$26.0 $17.62*$18.35

Estimates vs. Actuals (Q1 2025)

MetricActualS&P Global ConsensusSurprise
EPS ($)$(0.87) $(0.83)*Miss $(0.04)
Revenue ($USD Millions)$0.00*$0.00*In line

Notes: Items marked with * are values retrieved from S&P Global.

Additional detail (Q1 2025, YoY):

  • R&D: $7.8M vs. $7.6M (+$0.2M), driven by AMPLIFY-7P Phase 2 trial costs .
  • G&A: $3.0M vs. $2.7M (+$0.3M), primarily compensation and benefits .
  • Net loss: $(11.2)M vs. $(11.8)M YoY; includes $0.5M non-cash other expense from warrant liability revaluation .

Segment breakdown/KPIs: Not applicable; ELTX is pre-revenue with no reportable segments. Clinical KPIs focus on trial timelines and regulatory milestones.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
AMPLIFY-7P Phase 2 Interim DFS Analysis2025H1 2025 (Q3’24 press release) Q3 2025 Lowered/Delayed
AMPLIFY-7P Phase 2 Interim DFS Analysis2025Q3 2025 (3/31/25 FY update) Q3 2025 Maintained
Phase 3 Protocol Finalization (ELI-002 in resected mKRAS PDAC)H2 2025H2 2025 (3/31/25 FY update) H2 2025 Maintained
FDA Alignment on Phase 3 ElementsN/AAlignment reached as of Q1 2025 FY update Alignment reiterated Maintained
Cash RunwayThroughInto Q4 2025 (3/31/25 FY update) Into Q4 2025 Maintained

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available in our sources; themes are synthesized from company releases.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory/Phase 3 planningFocus on Phase 2 progress; no Phase 3 alignment disclosed Completed enrollment; planning for Phase 3 clarified in FY update FDA alignment on Phase 3 dose/schedule/patient/DFS endpoint reiterated Increasing regulatory clarity
R&D execution (AMPLIFY-7P)Enrollment expected to complete Q4 2024; interim DFS in H1 2025 Enrollment completed; interim DFS shifted to Q3 2025 Interim DFS in Q3 2025 reaffirmed Timeline slipped, now stable
Cash/financingCash into Q2 2025; later Q3’24 noted into Q2 2025 Cash $17.6M at YE 2024; strengthened via financings, runway into Q4 2025 $18.4M cash at Q1-end; runway into Q4 2025 Runway extended
Product performance (ELI-002)Phase 1 data at SITC showed robust T-cell responses/antigen spreading; potential DFS benefit Continued development; finalizing Phase 2 interim plan Emphasis on PDAC interim readout as key validation for AMP platform Building toward pivotal signal
Pipeline expansionELI-007 (BRAF), ELI-008 (p53) advancing toward clinic in H1 2025 Continued focus; updates planned via FY communications No new timing in Q1 release beyond core PDAC focus Neutral

Management Commentary

  • “The upcoming randomized interim data readout in PDAC will be a critical validating opportunity for our AMP platform.” — Robert Connelly, CEO .
  • “Importantly, our current cash runway extends into the fourth quarter of 2025, beyond the anticipated AMPLIFY-7P Phase 2 interim analysis.” — Robert Connelly, CEO .
    Key messages: maintain focus on PDAC Phase 2 interim DFS readout, leverage FDA alignment to accelerate Phase 3 readiness, and preserve flexibility with reinforced liquidity .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available in our document set; no Q&A items to report.

Estimates Context

  • Q1 2025 EPS of $(0.87) was slightly below S&P Global consensus of $(0.83), a modest miss likely driven by normal quarter-to-quarter expense variability during Phase 2 execution* .
  • Revenue was in line at $0.00, consistent with pre-revenue biotech status*.

Where estimates may adjust:

  • Post-Q1, Street models are likely to focus on operating burn and cash runway to the Q3 2025 interim DFS; a significant positive interim signal could drive upward adjustments to probability-weighted pipeline value and funding assumptions.

Notes: Items marked with * are values retrieved from S&P Global.

Key Takeaways for Investors

  • The Q3 2025 AMPLIFY-7P interim DFS readout is the defining near-term catalyst; strong DFS separation could reset the stock and accelerate Phase 3 initiation .
  • FDA alignment on Phase 3 design elements lowers regulatory risk and shortens the path from a positive interim to a pivotal start .
  • Liquidity is sufficient into Q4 2025 post-January $10M financing, bridging beyond the interim readout and giving flexibility on timing of any incremental capital .
  • Q1 EPS modestly missed S&P Global consensus, but P&L remains dominated by planned R&D, with no revenue; focus should remain on clinical and regulatory milestones* .
  • Watch for protocol finalization of Phase 3 in H2 2025; clarity there is essential for partnering and funding strategy .
  • Medium-term thesis hinges on ELI-002’s ability to deliver a DFS benefit in PDAC and support expansion to other mKRAS tumors, validating the AMP platform .
  • Trading stance: positioning into the Q3 interim readout is binary; consider risk-managed exposure ahead of the event and be prepared for secondary financing scenarios contingent on data outcomes .

Sources and documents read in full:

  • Q1 2025 8-K 2.02 press release and financial statements .
  • Prior quarter 8-K press releases: Q3 2024 ; Q2 2024 .
  • FY 2024 press release (3/31/25) .
  • January 30, 2025 financing press release .

Notes: Items marked with * are values retrieved from S&P Global.