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Sagimet Biosciences Inc. (SGMT)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 was steady operationally: net loss was $12.9M with diluted EPS of -$0.40, and cash, cash equivalents and marketable securities ended at $125.5M . EPS modestly beat S&P Global consensus (-$0.416*) as operating expenses declined year over year .
  • Development execution progressed: the Phase 1 PK drug–drug interaction trial of denifanstat + resmetirom is ongoing (enrolled ~40 healthy adults) with topline data expected 1H 2026; TVB‑3567 first‑in‑human acne study continues .
  • China acne pathway advanced via license partner Ascletis: pre‑NDA consultation completed with NMPA, with plans to submit an NDA for denifanstat (ASC40) for moderate‑to‑severe acne .
  • Cash runway: management’s 10‑Q indicates ≥12 months of liquidity from the filing date ; the November investor presentation frames cash “expected to fund current operations for 2 years” .
  • Near‑term stock catalysts: Ascletis’ China NDA submission outcome; 1H 2026 PK combo readout; continued MASH Phase 3 funding clarity; manufacturing IP license work streams following a $2.5M upfront to a CMO .

What Went Well and What Went Wrong

What Went Well

  • Initiated and progressed the once‑daily denifanstat/resmetirom combination trial; CEO emphasized the intent to move to PoC studies in F4 MASH if PK data are positive: “We plan to use this data, if positive, to advance the combination to proof‑of‑concept studies in MASH patients with F4 fibrosis” .
  • China acne program de‑risking: Ascletis completed pre‑NDA consultation and plans to submit an NDA for acne, after Phase 3 met all efficacy endpoints and was well tolerated .
  • Cost discipline YoY: R&D fell 23% and total operating expenses fell 15% vs Q3 2024, improving net loss YoY (-$12.9M vs -$14.6M) .

What Went Wrong

  • Manufacturing/non‑clinical costs rose 81% YoY in Q3, driven largely by a $2.5M up‑front license fee tied to a CMO term sheet for API manufacturing IP .
  • Other income fell 38% YoY due to lower cash balances/yields, slightly worsening bottom‑line support .
  • No product revenue yet; Phase 3 MASH trials remain contingent on additional financing, posing execution risk for monotherapy registration timing .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.0 (no product revenue) $0.0 (no product revenue) $0.0 (no product revenue)
Net Loss ($USD Millions)$(18.176) $(10.386) $(12.908)
Diluted EPS ($USD)$(0.56) $(0.32) $(0.40)
Total Operating Expenses ($USD Millions)$19.865 $11.925 $14.334
R&D Expense ($USD Millions)$15.342 $7.248 $9.730
G&A Expense ($USD Millions)$4.523 $4.677 $4.604
Other Income ($USD Millions)$1.689 $1.539 $1.426
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$144.569 $135.466 $125.499

Notes:

  • Margins (gross, EBITDA, net) are not applicable given no product revenue .
  • Operating metrics are GAAP; the company did not provide non‑GAAP adjustments .

Segment breakdown (company reports one segment):

SegmentDescription
Therapeutics developmentSingle reportable segment encompassing MASH, acne and oncology programs

Selected KPIs

KPIQ1 2025Q2 2025Q3 2025
Stock‑based compensation ($USD Millions)$1.472 $1.598 $1.688
Weighted‑average shares (Basic & Diluted)32,195,345 32,195,366 32,464,893

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Denifanstat + resmetirom Phase 1 PK trial1H 2026 toplinePlanned 2H 2025 start; data 1H 2026 Ongoing; topline data expected 1H 2026 Maintained timeline; status advanced to ongoing
TVB‑3567 Phase 1 (acne)2026 next stepFirst‑in‑human initiated June 2025; goal to start Phase 2 in 2026 Phase 1 ongoing; anticipate Phase 2 in 2026 (post regulatory consult) Maintained
China acne NDA (Ascletis)2025–2026No prior formal pre‑NDA updatePre‑NDA consultation completed; plans to submit NDA New milestone introduced
Cash runwayLiquidity horizon“Through 2027” (Aug investor deck) “Expected to fund current operations for 2 years” (Nov deck) ; ≥12 months per 10‑Q Messaging updated in deck; statutory ≥12 months unchanged in 10‑Q

Earnings Call Themes & Trends

(No Q3 2025 earnings call transcript was available; themes derived from press release, investor deck, and 10‑Q.)

TopicPrevious Mentions (Q1 & Q2 2025)Current Period (Q3 2025)Trend
Combination therapy (denifanstat + resmetirom)Planned Phase 1 PK in 2H 2025; preclinical synergy presented at EASL Phase 1 PK ongoing; topline 1H 2026 Advancing per plan
Precision/AI pathology (qFibrosis)AI‑based fibrosis analyses in FASCINATE‑2; responders identified; zonal improvements Additional AI/digital pathology references; spatial computational histology baseline predictors Consistent reinforcement
Regulatory (China acne)Ascletis Phase 3 met all endpoints; topline disclosed June Pre‑NDA consult completed; NDA planned Progress to filing
R&D execution (TVB‑3567 acne)IND cleared; FIH initiated June 2025 FIH ongoing; plan Phase 2 in 2026 On track
Manufacturing/supplyStandard CRO/CMO reliance noted CMO term sheet; $2.5M upfront for manufacturing IP Building manufacturing capability/IP
Macro/tariffsUS tariff risk highlighted (April measures) No new explicit changes in Q3 filing; risk remains Ongoing macro watch

Management Commentary

  • CEO: “We have initiated a Phase 1 PK trial evaluating the compatibility of a once‑daily combination of denifanstat and resmetirom... We plan to use this data, if positive, to advance the combination to proof‑of‑concept studies in MASH patients with F4 fibrosis” .
  • China acne: Ascletis completed pre‑NDA consultation and plans NDA submission; Sagimet presented Ascletis’ Phase 3 data at clinical conferences .
  • Organization: Marie O’Farrell promoted to Chief Scientific Officer; Liz Rozek promoted to Chief Legal & Administrative Officer (effective Nov 1) .

Q&A Highlights

No earnings call transcript was available for Q3 2025; thus, no Q&A themes to report [ListDocuments/Search showed no “earnings-call-transcript” for Q3].

Estimates Context

MetricQ1 2025Q2 2025Q3 2025
Primary EPS Consensus Mean-0.687*-0.496*-0.416*
Actual EPS ($)-0.56 -0.32 -0.40
Revenue Consensus Mean ($MM)0.0*0.0*0.0*
Actual Revenue ($MM)0.0 (no product revenue) 0.0 (no product revenue) 0.0 (no product revenue)
Primary EPS – # of Estimates7*9*5*
Revenue – # of Estimates6*8*8*

Values retrieved from S&P Global.*

  • EPS: Sagimet beat consensus in all three quarters (less negative than estimates), with Q3 at -$0.40 vs -$0.416*.
  • Revenue: In‑line at $0 given clinical‑stage status and lack of product revenue .

Key Takeaways for Investors

  • Execution continues across MASH and acne: Phase 1 PK combo trial is underway with data in 1H 2026; TVB‑3567 acne program is progressing toward a 2026 Phase 2 start .
  • China acne commercial option maturing: Ascletis’ pre‑NDA consult and planned NDA submission could create earlier ex‑US value recognition if approved .
  • EPS beats reflect disciplined OpEx and interest income, but rising manufacturing/IP investments (CMO license) can add near‑term cost volatility .
  • Liquidity is adequate near term (≥12 months by 10‑Q), with investor‑deck framing as ~2‑year runway; funding clarity for Phase 3 MASH monotherapy remains a key medium‑term thesis driver .
  • Watch for: China NDA outcome/formal submission timing, PoC design in F4 MASH following PK data, and any updates on US Phase 3 MASH funding strategy (potential partnerships or capital markets) .
  • Macro supply chain: tariff risk and expanded CMO arrangements may influence manufacturing costs and working capital needs; monitor disclosures on cost structure .
  • Hair thinning AE management remains addressed via dose pauses/titration; safety profile continues to compare favorably vs placebo across studies, supporting broader development .