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Sagimet Biosciences Inc. (SGMT)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 GAAP net loss was $18.2M and diluted EPS was -$0.56; EPS beat Wall Street consensus (-$0.69) as operating loss was smaller than modeled and interest income provided a partial offset . Consensus EPS sourced from S&P Global data; see Estimates Context section below.*
  • Cash, cash equivalents and marketable securities were $144.6M, supporting operations for at least the next 12 months per management’s current plan .
  • Strategic updates: Phase 1 PK/tolerability trial of denifanstat + resmetirom planned to initiate in 2H 2025 with data readout in 1H 2026; TVB-3567 IND cleared with first-in-human acne trial initiation planned for 2H 2025 .
  • Phase 3 in F2/F3 MASH remains operationally ready but deferred until sufficient funding; near‑term catalysts include Ascletis’ China acne Phase 3 topline in 2Q 2025 and initiation of the denifanstat+resmetirom combo study .

What Went Well and What Went Wrong

What Went Well

  • EPS beat: -$0.56 vs consensus -$0.69, reflecting lower-than-modeled net loss this quarter; interest income of $1.69M provided offset . Consensus EPS from S&P Global.*
  • Strong cash on hand: $144.6M cash, cash equivalents and marketable securities at quarter-end .
  • Pipeline momentum: CEO emphasized conviction in FASN inhibition and announced plan to initiate Phase 1 denifanstat + resmetirom in 2H 2025 — “We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.”

What Went Wrong

  • Operating expenses scaled sharply YoY (+127% to $19.9M), driven by Phase 3 startup activities, widening net loss YoY (+174% to $18.2M) .
  • Phase 3 in non‑cirrhotic MASH not starting until funding is secured; funding dependency increases program timing risk .
  • Other income declined YoY (-$0.45M) on lower investable balances; macro risk from newly announced tariffs could pressure future manufacturing costs .

Financial Results

Income Statement and Cash Summary (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
License Revenue ($USD Millions)$2.00 $0.00 $0.00
Research & Development ($USD Millions)$12.65 $14.22 $15.34
General & Administrative ($USD Millions)$4.25 $3.98 $4.52
Total Operating Expenses ($USD Millions)$16.90 $18.20 $19.87
Net Loss ($USD Millions)$(14.62) $(16.20) $(18.18)
Diluted EPS ($USD)$(0.45) $(0.50) $(0.56)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$170.0 $158.7 $144.6

Year-over-Year (Q1 2024 vs Q1 2025)

MetricQ1 2024Q1 2025
Research & Development ($USD Millions)$5.26 $15.34
General & Administrative ($USD Millions)$3.51 $4.52
Total Operating Expenses ($USD Millions)$8.77 $19.87
Net Loss ($USD Millions)$(6.63) $(18.18)
Diluted EPS ($USD)$(0.23) $(0.56)
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$176.8 $144.6

Estimates vs Actual EPS (oldest → newest)

MetricQ3 2024Q4 2024Q1 2025
Consensus EPS (S&P Global)*$(0.4045)*$(0.5853)*$(0.6874)*
Actual EPS ($USD)$(0.45) $(0.50) $(0.56)
Result vs ConsensusMissBeatBeat

Note: Values marked with * are S&P Global Wall Street consensus estimates retrieved via GetEstimates.

KPIs

KPIQ3 2024Q4 2024Q1 2025
Other Income ($USD Millions)$1.10 $1.99 $1.69
Weighted-Avg Shares (Millions)32.14 32.20 32.20

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Denifanstat + Resmetirom Phase 1 (initiation)2H 2025Planned 2H 2025 Planned 2H 2025 Maintained
Denifanstat + Resmetirom Phase 1 (data readout)1H 20261H 2026 1H 2026 Maintained
TVB-3567 Phase 1 (initiation)2H 2025IND planned 2025 IND cleared; 2H 2025 initiation planned Raised (progressed)
Denifanstat Phase 3 in F2/F3 MASH (start)4Q 2024Initiation by end of 2024 Operationally ready; deferred until sufficient funding Lowered/Delayed
Cash runwayRolling 12–18 monthsThrough 2025 (as of Q3’24) ≥12 months from Q1’25 filing issuance Maintained/Updated framing
Ascletis China Acne Phase 3 topline2Q 20252Q 2025 2Q 2025 Maintained

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript was found; themes reflect press releases/10‑Q and prior earnings materials.

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Regulatory (BTD, End-of-Phase 2)FDA BTD and End-of-Phase 2 completed; Phase 3 design outlined Phase 3 operationally ready but contingent on funding Progress constrained by funding
Combination Therapy (Resmetirom)Preclinical synergy presented; Phase 1 PK/DI planningPhase 1 denifanstat+resmetirom initiation planned 2H 2025; data in 1H 2026 Advancing
Acne ProgramAscletis Phase 3 enrollment completed; topline expected 2Q 2025 Timeline reiterated; TVB-3567 IND cleared; FIH planned 2H 2025 Accelerating
R&D Execution and OpexR&D scaling for Phase 3 preparation R&D +192% YoY driven by Phase 3 startup; G&A +29% YoY Elevated investment
AI/Digital PathologyAI-based fibrosis analyses highlighted Continued emphasis on AI-based fibrosis assessment Consistent
Macro/TariffsNot highlightedNew tariff risk noted; potential manufacturing cost headwinds Emerging risk factor

Management Commentary

  • “Building on our presentation of compelling preclinical data at 2024 EASL… we anticipate initiating a Phase 1 clinical trial to evaluate the PK and tolerability of a combination of denifanstat and resmetirom in the second half of 2025… We remain strongly convinced of the significant therapeutic potential associated with FASN inhibition across multiple disease states.” — David Happel, CEO .
  • “The clearance of the TVB-3567 IND marks a significant milestone… Based on both its mechanism of action and strong preclinical profile, we believe TVB-3567 has the potential to offer a differentiated treatment option for acne.” — David Happel, CEO .
  • Phase 3 readiness and funding: “While Sagimet is operationally ready to dose patients in Phase 3 trials… it does not intend to initiate these trials until such time as it has sufficient funding to do so.” .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; no Q&A session to summarize.

Estimates Context

  • Q1 2025 EPS was -$0.56 vs consensus -$0.69; a beat driven by lower-than-expected net loss and interest income offset . EPS consensus from S&P Global.*
  • Revenue consensus remained $0 across recent quarters, consistent with pre-commercial status and absence of product revenue; Q3 2024 had license revenue of $2.0M . Consensus revenue from S&P Global.*
  • Prior quarters: Q4 2024 EPS -$0.50 vs -$0.59 (beat); Q3 2024 EPS -$0.45 vs -$0.40 (miss). Consensus EPS values via S&P Global.*

Key Takeaways for Investors

  • EPS beat with -$0.56 vs -$0.69 consensus indicates tighter expense execution than modeled and interest income support; watch opex trajectory as Phase 3 prep continues .*
  • Funding is the pivotal gating factor for Phase 3 in MASH; expect program timing updates alongside capital markets activity or partnerships .
  • Near-term catalysts: Ascletis China acne Phase 3 topline in 2Q 2025, initiation of denifanstat+resmetirom Phase 1 in 2H 2025, and TVB-3567 first-in-human start in 2H 2025 .
  • Cash, cash equivalents and marketable securities of $144.6M provide ≥12 months runway; monitor burn as combo trial and acne FIH commence .
  • R&D investment is scaling (+192% YoY) as programs advance; opex discipline will be key to sustaining runway without dilutive financing .
  • AI-enabled pathology continues to feature in fibrosis assessment; reinforces mechanistic differentiation messaging in MASH .
  • New tariff risks could increase manufacturing costs; supply chain strategy and CMO choices warrant ongoing diligence .

Footnote: S&P Global Wall Street consensus estimates used for EPS and revenue comparisons (values marked with *).