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Elicio Therapeutics, Inc. (ELTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 was operationally steady with lower R&D YoY, an IDMC greenlight to continue AMPLIFY-7P to final analysis, and cash runway extended into Q1 2026 following a $10M note financing; net loss was $10.6M (EPS -$0.66) versus -$7.2M in Q2 2024, with the delta driven primarily by warrant liability fair value changes and non-operating items .
  • EPS modestly beat consensus (actual -$0.66 vs. -$0.69 consensus, +$0.03); revenue remains $0 as expected for a clinical-stage biotech without commercial products (consensus $0) (S&P Global data).*
  • Key catalyst: event-driven primary DFS analysis for AMPLIFY-7P now targeted for Q4 2025, with Phase 3 preparations underway and prior FDA alignment on key design elements .
  • Risk balance: management reiterated “substantial doubt” about going concern absent additional financing, even as cash of $22.1M supports operations into Q1 2026 on the current plan .

What Went Well and What Went Wrong

What Went Well

  • IDMC recommended continuing the randomized Phase 2 AMPLIFY-7P trial in PDAC without modification after a pre-specified interim review, confirming favorable safety and indicating preliminary signs of efficacy; final DFS analysis is targeted for Q4 2025 .
  • Operating discipline: R&D expense declined to $7.0M from $8.2M YoY, primarily due to lower clinical trial manufacturing as ELI-002 7P advanced .
  • Cash runway extended into Q1 2026, supported by a $10M senior secured promissory note and associated warrant issuance in June 2025 .

Quote: “We were pleased to receive the IDMC’s positive recommendation to continue the AMPLIFY-7P study to final analysis… 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.” — Robert Connelly, CEO .

What Went Wrong

  • Net loss widened YoY to $10.6M (from $7.2M) as other non-operating items (e.g., warrant liability remeasurement) moved against the company; Q2 included $0.9M loss from warrant fair value changes and $0.4M grant income .
  • G&A increased YoY to $3.1M from $2.7M, tied to higher professional fees related to June’s financing .
  • Going concern flagged: despite extended runway, management disclosed substantial doubt about continuing as a going concern without additional capital beyond the current plan .

Financial Results

MetricQ2 2024 (oldest)Q1 2025Q2 2025 (newest)
R&D Expense ($M)$8.18 $7.78 $7.01
G&A Expense ($M)$2.74 $2.96 $3.09
Total Operating Expenses ($M)$10.92 $10.74 $10.09
Net Loss ($M)$(7.23) $(11.21) $(10.56)
Diluted EPS$(0.64) $(0.87) $(0.66)

Estimates vs. Actuals (S&P Global):

MetricQ2 2025 ConsensusQ2 2025 Actual
EPS$(0.69)*$(0.66)
Revenue ($M)$0.00*$0.00
  • Note: YoY Opex decreased on lower manufacturing; EPS improved sequentially (Q1 to Q2), aided by lower opex and $0.4M grant income, partly offset by warrant remeasurement losses .

KPIs

KPIQ1 2025Q2 2025
Cash & Cash Equivalents ($M)$18.35 $22.09
Cash Runway (Mgmt Guidance)Into Q4 2025 Into Q1 2026
Weighted Avg Shares (basic+prefunded)12.95M 16.06M
Grant Income ($M)$0.42

Segment reporting: single reportable segment (immunotherapy R&D) .

Guidance Changes

MetricPeriodPrior GuidanceCurrent GuidanceChange
AMPLIFY-7P Phase 2 analysis timingInterim (IDMC) / Final DFSInterim in Q3 2025; potential final H2 2025 IDMC positive; Final DFS in Q4 2025 Updated milestone; positive IDMC outcome
Regulatory next stepsPost-Phase 2Phase 3 design alignment reached with FDA Plan End-of-Phase 2 meeting post-final DFS to finalize Phase 3 strategy Advanced toward pivotal path
Cash runwayLiquidityInto Q4 2025 Into Q1 2026 (post $10M financing) Raised

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript located; analysis uses press releases and 10-Q narrative.

TopicPrevious Mentions (Q3 2024, Q1 2025)Current Period (Q2 2025)Trend
Regulatory/Phase 3 pathwayFDA alignment on Phase 3 design elements (dose, schedule, population, DFS endpoint) reiterated Q1 2025 Plan End-of-Phase 2 meeting after final DFS to finalize Phase 3 Continued progress toward pivotal
Clinical efficacy/safety signalsStrong T-cell and translational data presented; DFS correlations in early studies (SITC/AACR) IDMC positive recommendation to continue without modification; favorable safety confirmed Strengthening narrative
Financing/runwayCash into Q2–Q4 2025 depending on quarter $10M senior secured note; runway into Q1 2026 Improved liquidity
R&D execution/costsR&D stable YoY in 2024; manufacturing spend elevated then tapering R&D down YoY on lower manufacturing as program advances Efficiency improving
Going concern riskNoted historically due to development-stage profileSubstantial doubt reiterated despite extended runway Ongoing financing risk

Management Commentary

  • Prepared remarks emphasized the IDMC outcome and Phase 3 readiness: “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.” — Robert Connelly, CEO .
  • On interim outcome interpretation: “We believe [the IDMC recommendation] indicates preliminary signals of efficacy from ELI-002 7P” .
  • Liquidity: “We secured $10 million in additional financing to extend our cash runway into the first quarter of 2026, beyond the anticipated final DFS analysis” .

Other relevant Q2 period press releases:

  • IDMC positive recommendation (Aug 5, 2025) .
  • Q2 earnings press release (Aug 7, 2025) .

Q&A Highlights

  • No earnings call transcript was available for Q2 2025; no Q&A themes could be extracted. Supporting materials consisted of the earnings press release and the 10-Q filing .

Estimates Context

  • EPS: Actual -$0.66 vs. consensus -$0.69; beat by $0.03. Revenue: $0 vs. $0 consensus (S&P Global; 2 covering estimates).*
  • Implications: Modest EPS beat likely reflects lower operating expenses and $0.4M grant income partially offset by non-cash warrant liability remeasurement; revenue remains non-applicable at this stage .

Key Takeaways for Investors

  • Near-term binary catalyst: event-driven primary DFS readout for AMPLIFY-7P in Q4 2025; positive IDMC signal and safety confirmation de-risk execution into final analysis .
  • Pivotal readiness: prior FDA alignment on Phase 3 design and planned End-of-Phase 2 meeting post-DFS could accelerate the path to a registrational program if data are supportive .
  • Liquidity risk remains: despite a $10M note financing and runway into Q1 2026, management disclosed substantial doubt about going concern absent additional financing; capital strategy is a key watch item .
  • Operating discipline: R&D trending lower YoY on manufacturing efficiencies while G&A reflects financing activities; focus remains on advancing ELI-002 7P .
  • Stock set-up: outcome of the Q4 2025 DFS analysis is the dominant driver; interim IDMC outcome is favorable but not determinative—event rates and DFS magnitude versus observation will drive narrative.
  • Non-cash items (warrant remeasurement) add EPS volatility; core cash burn and Opex trends are better indicators of underlying trajectory .
  • Monitoring list: trial event accrual pace, any updates to DFS timing, additional financing actions (ATM usage, partnerships), and any interim translational data correlative to DFS.

Sources:

  • Q2 2025 8-K press release and exhibits .
  • Q2 2025 Form 10-Q (financials, liquidity, warrants, debt, and MD&A) .
  • Q1 2025 8-K press release (prior quarter trend and guidance) .
  • Q3 2024 8-K press release (historical context) .
  • Other press releases (Q2 period): IDMC recommendation (Aug 5, 2025) ; Q2 earnings release (Aug 7, 2025) .

*Values retrieved from S&P Global (consensus estimates).