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Silexion Therapeutics Corp (SLXN)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 net loss widened to $2.50M versus $1.50M in Q2 2024, driven by higher public-company G&A and increased R&D; loss per share was $4.32 with 579,523 weighted-average shares .
  • Cash and equivalents were $3.47M at June 30, 2025, down from $6.15M at March 31, 2025, reflecting operating spend; total shareholders’ equity improved to $0.12M from $(3.99)M at year-end 2024 .
  • Strategic progress: Catalent collaboration for SIL204 formulation/manufacturing, maintenance of Nasdaq listing post 1-for-15 reverse split, and expanded preclinical efficacy across pancreatic, colorectal, and lung cancers (including KRAS Q61H up to 97% inhibition) .
  • Clinical timeline reaffirmed: regulatory submissions planned to Israel MoH in Q4 2025 and EU in Q1 2026; Phase 2/3 initiation targeted for 1H 2026; narrative remains a development-catalyst story rather than revenue/EPS beats/misses .
  • Stock-reaction catalysts: pan‑KRAS efficacy data breadth, listing-compliance clarity, and nearer-term regulatory milestones; funding actions (post‑quarter warrant exercise) modestly extend runway but dilution risk remains a watchpoint .

What Went Well and What Went Wrong

What Went Well

  • Expanded SIL204 efficacy beyond pancreatic into colorectal and lung, with ~90% inhibition in GP2D colorectal cells and up to 94% in pancreatic; first evidence vs KRAS Q61H mutation up to 97% inhibition supports a pan‑KRAS profile .
  • Strategic collaboration with Catalent to optimize systemic and intratumoral formulations and support clinical manufacturing—key for execution against the dual-route development plan .
  • Management tone confident on platform potential: “SIL204’s impressive efficacy across pancreatic, colorectal, and lung cancers… positioned as a potentially transformative pan‑KRAS therapeutic” — Ilan Hadar, CEO .

What Went Wrong

  • Operating expenses rose 64% YoY to $2.28M and G&A more than doubled to $1.3M, reflecting public‑company costs; net loss increased 66.7% YoY to $2.50M .
  • Cash declined QoQ to $3.47M, tightening near‑term liquidity; while equity turned positive by Q2, the company still works toward achieving the $2.5M shareholders’ equity compliance threshold .
  • Going‑concern language highlighted in FY 2024 filings underscores dependency on external capital to fund development until clinical inflection points are reached .

Financial Results

P&L vs Prior Periods and Prior Year

MetricQ2 2024Q1 2025Q2 2025
Total Operating Expenses ($USD Millions)$1.39 $1.65 $2.28
R&D Expense ($USD Millions)$0.80 $0.59 $1.00
G&A Expense ($USD Millions)$0.60 $1.06 $1.30
Financial Expenses, net ($USD Millions)$0.10 $0.09 $0.22
Net Loss ($USD Millions)$1.50 $1.74 $2.50
Loss per Share (Basic & Diluted) ($USD)$197.80 $0.26 $4.32
Weighted Avg Shares (000s)7.4 6,779.2 579.5

Note: Share and per-share amounts reflect reverse splits noted in filings .

Balance Sheet Snapshot

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash and Equivalents ($USD Millions)$1.19 $6.15 $3.47
Total Assets ($USD Millions)$2.86 $8.31 $5.80
Total Liabilities ($USD Millions)$6.85 $5.72 $5.68
Shareholders’ Equity ($USD Millions)$(3.99) $2.59 $0.12

KPIs (Program and R&D)

KPIQ2 2024Q1 2025Q2 2025
Pancreatic cancer inhibition (KRAS G12D)n/a~70–80% in orthotopic models (AsPC‑1, BxPC‑3) Up to 94% inhibition in pancreatic cells
Colorectal cancer (GP2D, KRAS G12D)n/an/a~90% inhibition; dose-dependent down to nanomolar
Lung cancer (A427, KRAS G12D)n/an/aSignificant dose-dependent inhibition
New KRAS coverage (Q61H)n/an/aUp to 97% inhibition (pancreatic cells)
Development strategyLODER Phase 2 data (ORR 56%) contextual Dual-route plan announced (systemic + intratumoral) Dual-route reaffirmed; Catalent collaboration to execute

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
Phase 2/3 initiation (SIL204, LAPC)Program timingInitiate clinical trials in 1H 2026 Initiate clinical trials in 1H 2026 Maintained
Regulatory submission (Israel MoH)Q4 2025“Second half of 2025” (general) Q4 2025 (specific) Refined/Specified
Regulatory submission (EU)Q1 2026“First half of 2026” (general) Q1 2026 (specific) Refined/Specified
Delivery strategyOngoingDual-route (systemic + intratumoral) planned Dual-route reiterated; Catalent collaboration supports execution Maintained
Listing status / equity thresholdOngoingWorking toward Nasdaq compliance Nasdaq maintained post 1‑for‑15 reverse split; target $2.5M equity threshold Improved compliance clarity

No financial guidance (revenue/margins/tax rate/dividends) was provided in Q2 2025 materials .

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was found after targeted searches; themes below reflect press releases and 8‑K disclosures rather than live Q&A [SearchDocuments: no results] .

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
R&D execution (pan‑KRAS efficacy)Orthotopic pancreatic models show reduced primary tumor and metastases Adds colorectal and lung efficacy; Q61H inhibition up to 97% Strengthening
Clinical/regulatory timelinesPreparing toxicology; 1H 2026 trial start Israel MoH Q4 2025; EU Q1 2026; 1H 2026 trial start reaffirmed On track
Partnerships/manufacturingn/a (pre‑Q2)Catalent collaboration for formulation/CMC Positive
Financing/liquidityELOC and early-2025 financings; equity deficit at YE 2024 Post‑quarter $1.8M warrant exercise; equity positive but below target Mixed (runway vs dilution)
Listing complianceSPAC transition; compliance work Nasdaq listing maintained; 1‑for‑15 reverse split Improved clarity

Management Commentary

  • “Our preclinical data now demonstrates SIL204’s impressive efficacy across pancreatic, colorectal, and lung cancers… including the newly validated Q61H and G13D variants, SIL204 is positioned as a potentially transformative pan‑KRAS therapeutic.” — Ilan Hadar, CEO .
  • “Catalent’s expertise in complex formulation development will be instrumental as we work toward our goal of initiating human clinical trials in the first half of 2026.” — Ilan Hadar, CEO .
  • “Our latest orthotopic model data… represent a potential paradigm shift in treating KRAS‑driven cancers… we unveiled our expanded dual‑route development strategy for SIL204.” — Ilan Hadar, CEO (Q1 update) .

Q&A Highlights

  • Q2 2025 earnings call transcript was not available across SEC/press distribution and third-party transcript aggregators at time of review; therefore, no Q&A highlights or clarifications can be provided [SearchDocuments: no results] .
  • Narrative clarity on timelines and program scope is taken from 8‑K/press releases; any guidance details would be refined at future calls .

Estimates Context

  • Wall Street consensus (S&P Global) for Q2 2025 EPS and revenue was unavailable for SLXN at time of retrieval; as a pre‑revenue biotech, earnings comparisons to sell‑side models are not meaningful this quarter [GetEstimates: empty].
  • Implication: Estimate revisions will likely focus on opex pace/runway and timeline confidence rather than revenue/EPS models; watch for changes to cash burn assumptions and required financing cadence .
MetricQ2 2025
Revenue Consensus MeanN/A*
Primary EPS Consensus MeanN/A*
Primary EPS – # of EstimatesN/A*
Revenue – # of EstimatesN/A*

*Values retrieved from S&P Global.

Key Takeaways for Investors

  • Execution momentum: breadth of pan‑KRAS efficacy and Q61H coverage strengthens platform differentiation ahead of regulatory submissions in late‑2025/early‑2026 .
  • Path to clinic: Catalent collaboration de‑risks formulation/CMC steps necessary for dual‑route administration, supporting the 1H 2026 clinical start .
  • Liquidity watch: cash fell to $3.47M in Q2; post‑quarter $1.8M warrant proceeds help, but further capital will likely be needed before Phase 2/3 initiation .
  • Cost profile: G&A scaling with public‑company operations and R&D ramp drive higher opex; near‑term focus on disciplined spend to preserve runway .
  • Compliance trajectory: listing maintained via reverse split; shareholders’ equity improved to $0.12M but remains below the $2.5M threshold target—monitor equity actions and balance sheet .
  • No revenue/estimate anchor: with no reported revenue and no S&P Global consensus available, trading catalysts remain clinical/regulatory rather than fundamental beats/misses [GetEstimates: empty].
  • Tactical setup: upcoming Israel/EU submissions and any additional human cell‑line data readouts can drive sentiment; financing terms/dilution will be a key swing factor for medium‑term risk‑reward .