Sangamo Therapeutics, Inc. Q1 FY2026 earnings call

• Corporate Status & Capital Strategy

  • Sangamo's common stock transitioned to trading on the OTCQB Venture Market after receiving a Nasdaq delisting determination for non-compliance with minimum bid price requirements
  • The company intends to appeal the delisting determination at a June Nasdaq hearing, and will retain its ticker symbol SGMO on the OTCQB
  • Management is actively evaluating all strategic options to maximize asset value and pursuing multiple opportunities to secure additional capital, supported by a global investment bank
  • Business development discussions for a potential ST920 (Fabry disease program) commercialization agreement are ongoing

• ST920 (Fabry Disease Gene Therapy) Progress

  • Rolling submission of the Biologics License Application (BLA) for ST920 under the FDA's accelerated approval pathway is in progress, with the first two modules already submitted
  • The FDA recently reaffirmed the regulatory pathway: accelerated approval can be granted based on 52-week mean annualized EGFR slope data across all 32 dosed patients, and no additional confirmatory study is required. 104-week data will be submitted when seeking traditional approval
  • Three patients have now reached 5+ years of treatment follow-up, with durable, stable clinical benefit, remarkable ongoing safety, and 17 patients have remained off enzyme replacement therapy (ERT) for over 3 years
  • Detailed clinical data for ST920 was presented at the 2026 World Symposium on Fabry disease, and all presentations are posted to the company website
  • BLA submission completion is targeted for as early as summer 2026, contingent on securing additional funding

• Neurology Pipeline Progress

  • Six clinical sites are activated for the Phase I-II STANS study of ST503, an epigenetic regulator for intractable pain caused by small fiber neuropathy (SFN), and site teams are currently identifying eligible patients
  • A preclinical manuscript detailing ST503's safety and pharmacology across human neurons, mice, and non-human primates was published in Science Translational Medicine this quarter
  • For ST506, an epigenetic regulator for prion disease, CTA-enabling activities are ongoing: the GLP toxicology study is complete, with analysis in progress, and the company held a productive alignment meeting with the UK MHRA on diagnostic testing validation and non-clinical safety

• Platform & Research Highlights

  • Three Sangamo abstracts were accepted for the 2026 ASGCT (American Society of Gene and Cell Therapy) Annual Meeting, covering advances in zinc finger epigenetic regulation for NAV1.7 and prion disease, and progress in the company's modular MINT integrase technology
  • The company has achieved high levels of targeted DNA integration across multiple cell types, advancing its goal of large-scale genome engineering for large DNA sequences

No segment-specific financial performance data or absolute/percent revenue contribution figures were provided in this earnings call transcript.

No formal full-year or quarterly financial/operational guidance was provided in this call. The only forward-looking milestone update is:

• BLA submission for ST920 is anticipated to be completed as early as summer 2026, contingent on the company securing adequate additional funding

• The company's ability to complete planned development milestones, advance its pipeline, and continue operating as a going concern is entirely contingent on securing adequate additional capital
• Sangamo received a Nasdaq delisting determination for failing to meet minimum bid price requirements, and the outcome of its June appeal is uncertain
• All forward-looking statements regarding pipeline progress, regulatory outcomes, partnership discussions, and capital raising are subject to material risks and uncertainties detailed in the company's SEC filings (Form 10-K for FY2025, Form 10-Q for Q1 2026, and subsequent filings)

Q: With the last patient in the ST920 study reaching the 2-year (104-week) timepoint in April, what are the gating factors for analyzing and disclosing this data? Will disclosure wait for a 2027 medical conference, or could it come earlier after BLA submission? / A: The rolling BLA submission is more than halfway complete, and the clinical module containing 52-week data has already been submitted. The company is still completing data cleaning processes for the full 104-week dataset, and will determine the appropriate timing for disclosure and submission once cleaning is finished. Management confirmed that patient data out to 5 years shows stable, durable benefit, with ongoing excellent safety, supporting ST920's profile as a one-time curative treatment.

Q: How does the FDA's recent affirmation that 104-week data can serve as confirmatory evidence (eliminating the need for a second confirmatory trial) impact ongoing business development discussions for ST920? Are there any updates to share on those discussions? / A: Management declined to share details on active confidential business development discussions, but confirmed that potential partners view the FDA's recent clarification as a positive development for the ST920 program. The FDA's decision removes the cost and delay of a separate confirmatory trial, allowing the company to pursue accelerated approval as quickly as possible using the 52-week data, and management reaffirmed that the available longer-term durability data looks positive.