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Silexion Therapeutics Corp (SLXN)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 was an operationally steady quarter focused on pipeline execution and balance-sheet strengthening: net loss was $1.7M and EPS was $0.26, with cash rising to $6.2M following equity financings and warrant exercises .
  • R&D execution advanced meaningfully: SIL204 demonstrated anti-tumor (~70% and ~80% reductions) and anti-metastatic activity in orthotopic models; extended systemic exposure (>56 days); and chemotherapy synergy—important de-risking data ahead of planned first-in-human initiation in H1 2026 .
  • Expense mix shifted: G&A rose (public company costs, headcount), while R&D declined (lower subcontractor/consultant spend), consistent with post-de-SPAC scale-up and financing-related activities .
  • No explicit financial guidance or revenue was provided; Street consensus for Q1 2025 EPS and revenue was unavailable via S&P Global, limiting beat/miss framing; near-term stock catalysts are tied to preclinical updates and the Catalent collaboration for formulation and clinical manufacturing .

What Went Well and What Went Wrong

What Went Well

  • SIL204 delivered breakthrough orthotopic pancreatic cancer data: subcutaneous, systemic administration reduced primary tumor burden (~70% in AsPC‑1 KRAS G12D; ~80% in BxPC‑3) and metastases to multiple organs, signaling potential to address both primary and metastatic disease .
  • Durable exposure and synergy: a single systemic dose maintained effective levels for >56 days; preclinical data showed synergistic activity with first‑line chemotherapy agents in pancreatic cancer—supporting combination strategies .
  • Balance sheet strengthened: ~$5.0M gross from a public offering, ~$0.9M from warrant exercises, and ~$3.3M from a warrant inducement; retirement of a $1.25M promissory note improved capital structure and liquidity .
  • Quote: “Our latest orthotopic model data demonstrated SIL204’s ability to significantly reduce both primary tumor burden and metastatic spread…representing a potential paradigm shift” — Ilan Hadar, Chairman & CEO .

What Went Wrong

  • Continued losses and no commercial revenue: net loss of $1.7M; company remains pre‑revenue and flagged substantial doubt about going concern in audited FY 2024 disclosures, necessitating continued access to capital .
  • G&A materially higher vs. prior year due to public company costs and headcount growth; this compresses runway absent additional financing .
  • Nasdaq listing deficiency letter (Oct 29, 2024) on minimum bid price highlights market/listing risk until compliance is regained (window to Apr 28, 2025) .

Financial Results

Core P&L and EPS

MetricQ1 2024Q3 2024Q1 2025
Revenues ($USD Millions)— (no commercial revenues) — (no commercial revenues) — (no commercial revenues)
Total Operating Expenses ($USD Millions)$1.25 $8.04 $1.65
Research & Development ($USD Millions)$0.96 $0.54 $0.59
General & Administrative ($USD Millions)$0.29 $4.82 $1.06
Financial Expenses, net ($USD Millions)$0.17 $0.07 $0.09
Net Loss ($USD Millions)$1.42 $0.81 $1.74
Diluted EPS ($USD)$12.29 (post split) $0.78 $0.26

Notes:

  • Sequential Q4 2024 quarterly P&L detail was not furnished in the FY 2024 8‑K press release; comparisons use Q3 2024 as the latest quarterly reference available .
  • Expense drivers: G&A up on public company costs and headcount; R&D down on lower subcontractor/consultant spend .

Liquidity

MetricQ3 2024Q4 2024 (FY)Q1 2025
Cash & Equivalents ($USD Millions)$1.97 (Sep 30, 2024) $1.19 (Dec 31, 2024) $6.15 (Mar 31, 2025)
Total Liabilities ($USD Millions)$7.67 (Sep 30, 2024) $6.85 (Dec 31, 2024) $5.72 (Mar 31, 2025)
Shareholders’ Equity ($USD Millions)$(4.58) (Sep 30, 2024) $(3.99) (Dec 31, 2024) $2.59 (Mar 31, 2025)

Segment Breakdown

SegmentDescriptionQ1 2025 Expense ($USD Millions)
R&D (single reportable segment)Company operates one R&D segment during startup phase $0.59

Pipeline and Operating KPIs

KPIQ1 2025 Detail
SIL204 orthotopic efficacy~70% reduction (AsPC‑1 KRAS G12D) and ~80% (BxPC‑3) in tumor cell numbers; reduced metastases to liver, intestine, spleen, stomach
Systemic exposure durationSingle systemic dose maintained effective levels >56 days
Chemotherapy synergySynergistic activity with first‑line chemotherapy agents in pancreatic cancer
Catalent collaborationStrategic collaboration for formulation development and clinical manufacturing (Limoges, France)
Capital raised~$5.0M gross offering + ~$0.9M warrant exercises + ~$3.3M warrant inducement; $1.25M promissory note retired
Cash and cash equivalents$6.2M at March 31, 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SIL204 first-in-human initiationH1 2026“Plans to initiate Phase 2/3 clinical trials by H1 2026” (preclinical prep/toxicology) “Clinical trials planned to be initiated in the first half of 2026” Maintained
SIL204 development approach2025+Focus on systemic program preparations (toxicology) Expanded dual‑route plan: systemic (metastases) + intratumoral (primary tumors) Raised/expanded scope
Manufacturing/formulation2025Not disclosedCollaboration with Catalent for formulation and clinical manufacturing New
Financial guidance (revenue, OpEx, margins, tax)2025Not providedNot providedMaintained (no formal guidance)

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available; themes below reflect press releases and 8‑K disclosures.

TopicQ‑2 (Q3 2024)Q‑1 (Q4 2024)Current (Q1 2025)Trend
R&D executionSIL‑204 anti‑tumor effects; prep for toxicology; plan for H1 2026 trials Continued preclinical progress; early 2025 orthotopic results highlighted in FY update Orthotopic anti‑metastatic efficacy; dual‑route strategy unveiled Strengthening
Partnerships/manufacturingNone notedNone notedCatalent collaboration announced Increasing strategic engagement
Financing/runwayELOC raised ~$0.6M net; total ~$2.5M to date ~$3.1M ELOC in 2024; ~$9.1M gross raised in early 2025 post‑reporting Offering + warrants + inducement totaling ~$9.2M gross in/around Q1; note retired Improved liquidity
Regulatory/listingDe‑SPAC; listing completed Nasdaq minimum bid deficiency letter; remediation window to Apr 28, 2025 Not updated in Q1 2025 8‑KOngoing risk
Macro/security (Israel war)Risk disclosed; minimal operational impact expected Continued disclosure; no material impact Continued monitoring; no material impact Unchanged

Management Commentary

  • CEO prepared remarks: “SIL204’s ability to significantly reduce both primary tumor burden and metastatic spread…[and] expanded dual‑route development strategy…positioning us to potentially address both primary tumors and metastases…well‑positioned to advance our pipeline toward clinical development.” — Ilan Hadar, Chairman & CEO .
  • CFO (FY context): “Recent successful financings…reinforce our ability to support ongoing and upcoming development initiatives…With a strengthened financial foundation, we remain focused on executing our strategic objectives and driving long‑term growth.” — Mirit Horenshtein Hadar, CFO .

Q&A Highlights

No Q1 2025 earnings call transcript was available; therefore, no Q&A themes or clarifications were furnished in primary documents [ListDocuments returned none for transcripts].

Estimates Context

  • Wall Street consensus (S&P Global Capital IQ) for Q1 2025 EPS and revenue was unavailable for SLXN at the time of query; as a pre‑revenue clinical‑stage company, estimate coverage may be limited [GetEstimates returned no data]. Values retrieved from S&P Global.*

Where estimates may need to adjust:

  • The orthotopic anti‑metastatic efficacy, extended exposure, and Catalent collaboration could be incremental positives for probability of success and timing assumptions embedded in medium‑term models, but formal Street numbers were not available to quantify changes .

Key Takeaways for Investors

  • SIL204 orthotopic anti‑metastatic efficacy plus >56‑day exposure materially de‑risks the program entering toxicology and IND‑enabling work; supports dual‑route clinical strategy for both primary and metastatic disease .
  • Liquidity improved: ~$9.2M gross across offering, warrant exercises, and inducement, plus retirement of $1.25M note; cash rose to $6.2M at quarter‑end—providing near‑term funding for R&D and CMC activities .
  • Expense profile is normalizing post‑de‑SPAC: G&A elevated from public company costs and financing activities; R&D down due to reduced subcontractor/consultant spend—watch operating discipline as CMC and tox costs ramp .
  • No formal financial guidance and no revenues; trading narrative will hinge on preclinical readouts, CMC progress with Catalent, and clarity on the H1 2026 clinical start .
  • Listing risk persists until minimum bid deficiency is cured (window extended to late April 2025 per Nasdaq letter) .
  • For near‑term positioning, catalysts include additional SIL204 preclinical/CMC updates and any regulatory process milestones; mid‑term thesis centers on KRAS‑targeted RNAi in pancreatic/colorectal settings with potentially complementary systemic and intratumoral approaches .
Sources:
Q1 2025 8-K press release and financials: **[2022416_0001178913-25-001763_exihibt_99-1.htm:1]** **[2022416_0001178913-25-001763_exihibt_99-1.htm:2]** **[2022416_0001178913-25-001763_exihibt_99-1.htm:4]** **[2022416_0001178913-25-001763_exihibt_99-1.htm:5]** **[2022416_0001178913-25-001763_zk2533189.htm:1]** **[2022416_0001178913-25-001763_zk2533189.htm:2]**
Q3 2024 8-K press release and financials: **[2022416_0001178913-24-003695_exhibit_99-1.htm:0]** **[2022416_0001178913-24-003695_exhibit_99-1.htm:1]** **[2022416_0001178913-24-003695_exhibit_99-1.htm:3]** **[2022416_0001178913-24-003695_exhibit_99-1.htm:4]**
FY 2024 8-K press release and financials: **[2022416_0001178913-25-000889_exhibit_99-1.htm:1]** **[2022416_0001178913-25-000889_exhibit_99-1.htm:2]** **[2022416_0001178913-25-000889_exhibit_99-1.htm:3]** **[2022416_0001178913-25-000889_exhibit_99-1.htm:5]** **[2022416_0001178913-25-000889_exhibit_99-1.htm:6]** **[2022416_0001178913-25-000889_zk2532884.htm:1]** **[2022416_0001178913-25-000889_zk2532884.htm:2]**
Updated unaudited and audited financial statements (reverse split; segment; going concern; Nasdaq letter): **[2022416_0001178913-25-000102_exhibit_99-1.htm:11]** **[2022416_0001178913-25-000102_exhibit_99-1.htm:12]** **[2022416_0001178913-25-000102_exhibit_99-1.htm:26]** **[2022416_0001178913-25-000102_exhibit_99-2.htm:8]** **[2022416_0001178913-25-000102_exhibit_99-2.htm:14]**
Estimates: GetEstimates (no data returned). Values retrieved from S&P Global.*