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Silexion Therapeutics Corp (SLXN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was execution-focused: net loss narrowed to $3.3M (vs $11.9M YoY) on sharply lower non-cash comp; EPS was ($2.88) vs ($274.25) YoY . Cash rose to $9.2M, aided by ~$9.5M gross financings; shareholders’ equity reached $7.0M, restoring Nasdaq compliance .
  • Scientific momentum continued: SIL204 showed broad pan-KRAS activity (83.5%–99.7% inhibition) across five cancer types with first gastric cancer data; lung and colorectal activity reinforced breadth; additional Q3 CRO selection de-risks trial startup .
  • Development timeline maintained: regulatory submissions targeted for Israel (Q4 2025) and EU (Q1 2026); Phase 2/3 initiation anticipated in H1 2026; manufacturing/formulation partnership with Catalent supports readiness .
  • Liquidity runway: management estimates current cash funds operations until end of Q2 2026; however, going-concern language remains given ongoing losses and expected future financing needs .

What Went Well and What Went Wrong

  • What Went Well

    • Pan-KRAS preclinical validation strengthened: up to 99.7% inhibition in human cell lines; first evidence in gastric cancer; activity across KRAS G12D/V/R/C, G13D/C, Q61H, G12A .
    • EU/Israel execution path: CRO (AMS) selected with deep oncology experience; scope includes regulatory strategy, design, data management for upcoming Phase 2/3 .
    • Balance sheet improvement and Nasdaq compliance: cash and equivalents rose to $9.2M; shareholders’ equity $7.0M; Nasdaq confirmed compliance with bid price and equity standards (monitor through Sep-2026) .
    • Management tone: “entering the next phase of development with great confidence,” citing financing and CRO selection supporting H1’26 trial start .
  • What Went Wrong

    • Continuing losses and burn: net loss $3.3M in Q3; operating cash outflow ~$2.84M in Q3; pre-revenue profile persists .
    • Going concern remains: substantial doubt about ability to continue as a going concern without additional financing despite improved liquidity .
    • Capital structure risk: dispute from Moringa Sponsor on note conversion introduces potential legal/financing overhang .

Financial Results

Quarterly trend (oldest → newest)

MetricQ1 2025Q2 2025Q3 2025
Revenues ($M)$0.0 $0.0 $0.0
R&D Expense ($M)$0.59 $1.02 $2.16
G&A Expense ($M)$1.06 $1.27 $1.14
Total Operating Expenses ($M)$1.65 $2.28 $3.29
Net Loss ($M)$(1.74) $(2.50) $(3.26)
Diluted EPS ($)$(0.26) $(4.32) $(2.88)
Cash & Equivalents ($M, end-period)$6.15 $3.47 $9.24
Operating Cash Flow (CFO) ($M)n/an/a$(2.84)

YoY comparison (Q3 2025 vs Q3 2024)

MetricQ3 2024Q3 2025YoY Change
Revenues ($M)$0.0 $0.0 Flat
R&D Expense ($M)$3.22 $2.16 Improved (lower spend)
G&A Expense ($M)$4.82 $1.14 Improved (lower spend)
Total Operating Expenses ($M)$8.04 $3.29 Improved
Net Loss ($M)$(11.86) $(3.26) Improved
Diluted EPS ($)$(274.25) $(2.88) Improved

KPIs

KPIQ1 2025Q2 2025Q3 2025
Shareholders’ Equity ($M)$2.59 $0.12 $6.98
Shares Outstanding (period end)8,691,971* 579,536 3,126,642
Nasdaq Compliance StatusHearings panel favorable decision Jul 7; reverse split Jul 29 Compliance confirmed Sep 23; 1-year monitor

*Share counts reflect reverse splits per period footnotes .

Estimates vs Actuals (S&P Global)

  • No S&P Global consensus EPS or revenue estimates were available for Q1–Q3 2025 for SLXN; therefore, no comparisons to Wall Street consensus can be provided (values unavailable via S&P Global) [GetEstimates].

Guidance Changes

Metric/ItemPeriodPrevious GuidanceCurrent Update (Q3)Change
Regulatory submission – Israel MoHQ4 2025File in Q4 2025 Reiterated Q4 2025 Maintained
Regulatory submission – EU (Germany/EU)Q1 2026File in Q1 2026 Reiterated Q1 2026 Maintained
Phase 2/3 trial initiation (SIL204)H1 2026H1 2026 H1 2026 Maintained
Cash runwayThrough Q2 2026Not disclosed priorEstimated sufficient to end of Q2 2026 New disclosure
Listing/compliance2025Reverse split to regain bid compliance Compliance confirmed; monitor to Sep 2026 Improved status

Earnings Call Themes & Trends

Note: No Q3 2025 earnings call transcript was available. Thematic evolution from company disclosures:

TopicQ1 2025 (May PR)Q2 2025 (Aug PR)Q3 2025 (Nov PR)Trend
Pan-KRAS breadthOrthotopic models: primary/metastases reduction; dual-route strategy unveiled Expanded to lung/colorectal; Q61H coverage up to 97% Broad human cell-line data (83.5–99.7%); first gastric cancer Broadening/strengthening
Trial readinessH1’26 start targeted; Catalent collaboration On track; toxicology progressing CRO selected; regulatory filings timetable reaffirmed Operational de-risking
Financing/liquidity~$9.2M gross raised Q1; cash $6.2M Cash $3.5M; reverse split to aid listing; warrant inducement ~$9.5M raised in Q3; cash $9.2M; ATM and shelf in place; compliance regained Improved liquidity/access
Listing statusHearings panel favorable, reverse split Compliance confirmed; panel monitor to Sep 2026 Improved but monitored
Risk languageGoing concern still present Unchanged risk

Management Commentary

  • CEO: “The third quarter marked a period of strong scientific progress and continued operational momentum... the successful completion of additional financing further strengthen our readiness to initiate Phase 2/3 clinical trials in the first half of 2026.”
  • CFO: “$9.5 million of financings... increased our cash position and shareholders’ equity, contributing to maintaining our Nasdaq listing.”
  • CSO on systemic data: “These findings provide additional validation... subcutaneously delivered SIL204 to reach metastatic sites throughout the body” (liver, peritoneum, lung) with significant reductions in tumor burden at clinically relevant doses .
  • CEO on pan-KRAS potency: “High levels of inhibition... across different KRAS mutations substantially strengthens SIL204’s potential as a pan-KRAS therapeutic candidate” .

Q&A Highlights

No earnings call transcript was furnished for Q3 2025. Clarifications from filings and press releases:

  • Cash runway: management estimates funding until end of Q2 2026, but going-concern language remains due to expected future financing needs .
  • Regulatory/clinical timeline unchanged: Israel filing Q4 2025; EU Q1 2026; Phase 2/3 initiation H1 2026 .
  • Listing status: compliance regained; mandatory Nasdaq panel monitor through Sep 23, 2026 .
  • Capital access: ATM facility ($13.17M capacity) under effective shelf (S-3) established Sep 2025 .

Estimates Context

  • S&P Global consensus estimates for EPS and Revenue were not available for SLXN for Q1–Q3 2025; as a result, we cannot present beat/miss analysis against Wall Street consensus (values unavailable via S&P Global) [GetEstimates].

Key Takeaways for Investors

  • Execution is on track: regulatory filings (Israel/EU) and H1’26 Phase 2/3 start reaffirmed; CRO partner in place to support operational readiness .
  • Scientific breadth expanded: robust pan-KRAS inhibition across multiple mutations and tumor types, including first gastric cancer data, bolsters platform narrative ahead of clinical entry .
  • Balance sheet stabilized but not de-risked: cash to Q2 2026 and regained listing compliance; ATM and shelf provide financing avenues, yet going-concern language underscores ongoing capital dependence .
  • P&L optics improved YoY: sizable reductions in non-cash share-based comp and operating costs narrowed quarterly loss/elevated EPS from extreme prior-year levels; still pre-revenue .
  • Potential overhang: sponsor note conversion dispute introduces legal/financing uncertainty to monitor .
  • Near-term catalysts: Israel MoH submission (Q4 2025), EU submission (Q1 2026), any additional preclinical readouts supporting indication breadth, and financing/access-to-capital milestones .

Supporting documents: Q3 2025 8-K earnings PR -; 10-Q (Q3 2025) -; Q2/Q1 earnings 8-Ks -, -; additional PRs (clinical/ops/financing) - - - - - - - -.