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SANGAMO THERAPEUTICS, INC (SGMO)·Q3 2025 Earnings Summary

Executive Summary

  • Revenue collapsed to $0.58M and diluted EPS was -$0.11; both were far below Wall Street consensus for revenue of $34.4M* and EPS of -$0.0418*; the miss was driven by the absence of collaboration revenue that boosted Q3 2024 results. Bold miss; consensus was based on S&P Global.
  • Total GAAP operating expenses were $36.1M; non-GAAP operating expenses were $33.0M, down year-over-year on leaner staffing and lower licensing/patent costs, partially offset by BLA readiness for Fabry.
  • Cash and cash equivalents were $29.6M; management expects runway into Q1 2026 after a $6M Pfizer license payment in October and ATM proceeds since quarter-end.
  • FDA reaffirmed use of eGFR slope as endpoint for accelerated approval of ST-920 (Fabry); BLA submission targeted as early as Q1 2026; patient enrollment began for the STAND pain study, with first dosing expected in the coming months.
  • Near-term stock catalysts: a Fabry commercialization partnership, initial dosing in STAND (pain), and continued regulatory clarity; all are explicitly prioritized by management.

What Went Well and What Went Wrong

What Went Well

  • FDA meeting minutes reiterated agreement to use eGFR slope for accelerated approval, providing regulatory clarity ahead of the anticipated BLA filing. “The FDA reaffirmed its October 2024 agreement to use eGFR slope as an endpoint to support an accelerated approval pathway.”
  • Clinical momentum: registrational STAAR data show positive mean annualized eGFR slopes at 52 weeks (1.965) and 104 weeks (1.747), supportive subgroup consistency, stable cardiac function, and durable α-Gal A expression up to 4.5 years.
  • Operational progress in neurology: STAND pain study sites activated, enrollment underway; first patient dosing expected in the coming months; MHRA alignment on prion program CMC strategy.

Quote (CEO): “We continued to advance our clinical and pre-clinical pipeline this quarter… the announcement of detailed clinical data from our registrational STAAR study in Fabry disease, alongside our recent FDA meeting, marked important steps forward on the path to an anticipated regulatory submission.”

What Went Wrong

  • Severe revenue decline versus prior year due to lack of collaboration revenue recognized in Q3 2024; Q3 2025 revenue fell to $0.58M vs $49.41M YoY.
  • Return to net loss: Q3 net loss was -$34.93M vs net income of $10.67M in Q3 2024; diluted EPS fell to -$0.11 vs $0.04.
  • Funding risk persists: filings and forward-looking disclosures emphasize need for substantial additional financing and going-concern risks if a Fabry commercialization agreement or other non-dilutive capital is not secured.

Financial Results

Income Statement and EPS vs prior year and prior quarter

MetricQ3 2024Q2 2025Q3 2025
Revenue ($USD Millions)$49.412 $18.306 $0.581
Net (Loss) Income ($USD Millions)$10.672 $(19.986) $(34.930)
Diluted EPS ($USD)$0.04 $(0.08) $(0.11)
Total Operating Expenses ($USD Millions)$38.781 $36.161 $36.134

Liquidity (quarter-end)

MetricQ2 2025Q3 2025
Cash and Cash Equivalents ($USD Millions)$38.344 $29.616

Non-GAAP Operating Expenses

MetricQ3 2024Q3 2025
Non-GAAP Operating Expenses ($USD Millions)$34.2 $33.0

Trailing 3 Quarters (trend snapshot)

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$6.437*$18.306 $0.581
Net (Loss) Income ($USD Millions)$(30.597)*$(19.986) $(34.930)
Diluted EPS ($USD)$(0.139)*$(0.078)*$(0.110)*
Total Operating Expenses ($USD Millions)$34.865*$36.161 $36.134

Values with asterisk retrieved from S&P Global.

Key Clinical KPIs (Fabry STAAR study)

KPIValueNotes
Mean annualized eGFR slope at 52 weeks (32 patients)+1.965 mL/min/1.73m²/year Positive across all dosed patients
Mean annualized eGFR slope at 104 weeks (19 patients)+1.747 mL/min/1.73m²/year Positive in 2-year follow-up subset
ERT withdrawal18/18 off ERT at cutoff (one resumed post-cutoff) Lyso-Gb3 generally stable post-withdrawal
Cardiac function/morphologyStable across measures over ≥1 year LVMI, GLS, T1/T2, volumes stable
α-Gal A activity durabilityUp to 4.5 years in longest treated patient

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Operating Expenses (GAAP)FY 2025~$135–$155M ~$135–$155M Maintained
Total Operating Expenses (Non-GAAP)FY 2025~$125–$145M; excludes ~$7M SBC, ~$3M D&A ~$125–$145M; excludes ~$7M SBC, ~$3M D&A Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Fabry (ST-920) regulatory pathFDA Type B CMC clarity; plan to file on 52-week eGFR; strong durability and QoL signals FDA reaffirmed eGFR slope endpoint for accelerated approval; BLA as early as Q1 2026 Continued de-risking; timeline holding
Pain (ST-503) STAND studySite initiation; dosing targeted fall 2025; early efficacy in late 2026 First two sites activated; enrollment begun; first dose in coming months; up to 10 sites planned Operational momentum
Prion (ST-506)MHRA alignment on nonclinical safety/design; GLP tox prep; CTA mid-2026 MHRA alignment on CMC; updated animal data show survival extension and brain delivery Advancing toward CTA
Capsid (STAC-BBB) partnershipsLilly license $18M upfront; ongoing BD discussions Partners (Genentech, Astellas, Lilly) “pleased”; active discussions continue External validation sustained
Funding/BDEquity raise as bridge; Fabry commercialization BD ongoing $6M Pfizer license fee; runway into Q1 2026; BD focus remains priority Runway extended; BD urgency unchanged

Management Commentary

  • “The FDA reaffirmed its October 2024 agreement to use eGFR slope as an endpoint to support an accelerated approval pathway.” (Sandy Macrae, CEO)
  • “We continue to prepare for our anticipated BLA submission under the accelerated approval pathway planned for as early as the first quarter of 2026.” (Nathalie Dubois-Stringfellow, CDO)
  • “We are excited now to be recruiting and enrolling patients in the phase I/II STAND study in chronic neuropathic pain… expect to dose the first patient in the coming months.” (Nathalie Dubois-Stringfellow)
  • “Cash equivalents, including the license fee received from Pfizer and proceeds from sales of common stock under our at the market program since September 30th, will be sufficient to fund our planned operations into the first quarter of 2026.” (Prathyusha Duraibabu)
  • “The certainty of the eGFR slope remains… CMC and manufacturing route is clear and the manufacturing process is underway and locked and loaded.” (Sandy Macrae)

Q&A Highlights

  • Business development and partnership status: management emphasized that FDA clarity on clinical and CMC can only help BD negotiations; partners will see meeting minutes as part of diligence.
  • Pre-BLA interactions: RMAT has allowed ongoing dialogue; a pre-BLA meeting may not be required if all questions are answered; clarity achieved on clinical, safety, and CMC.
  • STAND (pain) trial operational readiness: two sites activated; broadened to SFN (not just idiopathic) to aid recruitment; endpoints include PI-NRS pain scale with blinded monitoring; up to 10 sites.
  • STAC-BBB and MINT platform interest: continued discussions with potential partners; existing partners “pleased”; MINT advancing with minimal spend, de-risking design.
  • Priority review voucher: not yet discussed with FDA; management evaluating implications.

Estimates Context

MetricConsensus (Q3 2025)Actual (Q3 2025)Surprise
Revenue ($USD Millions)$34.400*$0.581 Miss: -$33.819 (-98.3%)
Diluted EPS ($USD)-$0.0418*-$0.11 Miss: -$0.0682

Values with asterisk retrieved from S&P Global.

Context: The miss was driven by the absence of collaboration revenue recognized in Q3 2024 (Genentech), which materially reduced year-over-year comparisons and likely confounded consensus expectations.

Where estimates may need to adjust: Models should reflect minimal near-term collaboration/licensing revenue, BLA preparation spend, and timeline to STAND dosing/early data; emphasize non-GAAP opex trend and funding milestones.

Key Takeaways for Investors

  • The regulatory path for ST-920 (Fabry) remains clear with FDA reaffirmation of eGFR slope for accelerated approval; BLA submission targeted for Q1 2026.
  • Q3 headline numbers were weak due to no collaboration revenue; focus should shift to pipeline/regulatory catalysts over near-term revenue prints.
  • Non-GAAP opex remains controlled; expect continued spend tied to BLA readiness and STAND trial ramp.
  • Runway into Q1 2026 hinges on supplemental capital and BD; watch for a Fabry commercialization deal as the most material near-term catalyst.
  • STAND dosing in the coming months introduces a new clinical catalyst path in chronic pain (Nav1.7 target); initial proof-of-efficacy expected in late 2026.
  • Continued external validation of STAC-BBB capsid (Genentech, Astellas, Lilly) and interest in MINT provide optionality for non-dilutive capital.
  • Trading lens: expect the stock to be sensitive to BD headlines, regulatory updates (pre-BLA steps), and first-patient dosing in STAND; Q4/Q1 news flow could drive volatility.