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- **Fabry Disease Breakthrough:** ST-920 demonstrates durable kidney and cardiac benefits with 4.5-year follow-up data, FDA reaffirms accelerated approval pathway, and BLA submission planned for Q1 2026.
- **Neurology Pipeline Momentum:** ST-503 enrollment begins for chronic pain, ST-506 advances toward CTA for prion disease, and STAC-BBB capsid shows promise in preclinical studies.
- **Financial Resilience:** $6M Pfizer license fee extends cash runway to Q1 2026, with focus on securing a commercialization partner and exploring capital options.
- **Patient-Centric Innovation:** Gene therapy for Fabry disease and epigenetic regulators for chronic pain address unmet needs, supported by strong preclinical and clinical data.

**【CEO Opening Remarks】**
- Highlighted promising data from the registrational STAAR study in Fabry disease, showing a mean annualized eGFR slope of 1.7 at 2 years and stable cardiac morphology.
- Announced FDA reaffirmation of the accelerated approval pathway using eGFR slope as the primary endpoint, with BLA submission planned for Q1 2026.
- Reported initiation of patient enrollment in the Phase I/II STAND study for chronic neuropathic pain and advancement of the prion disease program toward CTA submission in mid-2026.

**【CDO Program Updates】**
- **Fabry Disease (ST-920):** Presented detailed clinical data showing durable kidney and cardiac benefits, with 3 patients achieving 4.5 years of follow-up. FDA meeting minutes confirmed the adequacy of the safety package and clinical data for BLA submission.
- **Neurology Pipeline:**
  - ST-503: Activated 2 clinical sites for the STAND study, targeting small fiber neuropathy. Preclinical data demonstrated potent pain relief and safety in nonhuman primates.
  - ST-506: Presented preclinical data showing significant prion reduction and survival extension in animal models, with CTA submission planned for mid-2026.

**【CFO Financial Update】**
- Cash runway extended to Q1 2026, supported by a $6 million license fee from Pfizer and ATM stock sales.
- Emphasized priority on securing a Fabry commercialization partner and exploring non-dilutive funding options.

**【CEO Closing Remarks】**
- Reiterated confidence in ST-920's potential to transform Fabry disease treatment, citing patient testimonials and the uniqueness of gene therapy compared to ERT.
- Highlighted the strategic importance of the neurology pipeline, with ST-503 and ST-506 representing distinct delivery mechanisms and therapeutic opportunities.
- Acknowledged the scientific milestone of CAR-Treg dosing in kidney transplantation and the need for long-term funding solutions.

**【Q&A Highlights】**
- **Regulatory Clarity:** FDA reaffirmed the use of eGFR slope for accelerated approval and provided CMC guidance, supporting BLA readiness.
- **Partnership Progress:** FDA interactions and clinical data clarity are being shared with potential partners, with no remaining regulatory uncertainties.
- **STAND Study Challenges:** Recruitment is proceeding as planned, with broad patient interest and site expansion to 10 locations.
- **Capsid and MINT Platform:** Ongoing discussions with partners (e.g., Genentech, Astellas) for STAC-BBB capsid and MINT technology, with minimal spend allocated to MINT advancement.

Sangamo Therapeutics, Inc. (SGMO) Q3 2025 Earnings Call Transcript

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