Sangamo Therapeutics Files 8-K

TL;DR

Sangamo filed an 8-K, something happened, details TBD.

AI Summary

Sangamo Therapeutics, Inc. filed an 8-K on September 4, 2025, to report other events. The filing does not contain specific details about the nature of these events, dollar amounts, or new agreements.

Why It Matters

This filing indicates a material event has occurred for Sangamo Therapeutics, requiring disclosure to investors, though the specifics are not yet detailed.

Risk Assessment

Risk Level: medium — The filing is a standard 8-K for 'Other Events', which can range from minor administrative changes to significant undisclosed business developments, creating uncertainty.

Key Players & Entities

• SANGAMO THERAPEUTICS, INC. (company) — Registrant
• September 4, 2025 (date) — Date of earliest event reported
• 501 Canal Blvd., Richmond, California 94804 (location) — Principal executive offices address

FAQ

Key Financial Figures

• $0.01 — ange on which registered Common Stock, $0.01 par value per share SGMO Nasdaq Capital

Filing Documents

• sgmo-20250904.htm (8-K) — 63KB
• sgmo-20250904_g1.jpg (GRAPHIC) — 196KB
• sgmo-20250904_g10.jpg (GRAPHIC) — 331KB
• sgmo-20250904_g11.jpg (GRAPHIC) — 209KB
• sgmo-20250904_g12.jpg (GRAPHIC) — 216KB
• sgmo-20250904_g2.jpg (GRAPHIC) — 261KB
• sgmo-20250904_g3.jpg (GRAPHIC) — 287KB
• sgmo-20250904_g4.jpg (GRAPHIC) — 179KB
• sgmo-20250904_g5.jpg (GRAPHIC) — 141KB
• sgmo-20250904_g6.jpg (GRAPHIC) — 229KB
• sgmo-20250904_g7.jpg (GRAPHIC) — 247KB
• sgmo-20250904_g8.jpg (GRAPHIC) — 148KB
• sgmo-20250904_g9.jpg (GRAPHIC) — 233KB
• 0001001233-25-000006.txt ( ) — 6695KB
• sgmo-20250904.xsd (EX-101.SCH) — 2KB
• sgmo-20250904_lab.xml (EX-101.LAB) — 21KB
• sgmo-20250904_pre.xml (EX-101.PRE) — 12KB
• sgmo-20250904_htm.xml (XML) — 3KB

01 Other Events

Item 8.01 Other Events. On September 4, 2025, Sangamo Therapeutics, Inc. ("Sangamo" or the "Company") announced updated clinical data from its registrational Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease, that was presented in a poster presentation at the International Congress of Inborn Errors of Metabolism 2025 ("ICIEM2025") in Kyoto, Japan, on September 4, 2025. A summary of the data is below. This announcement included data on the 33 patients treated with isaralgagene civaparvovec as of the data cutoff date of April 10, 2025. Sangamo is advancing Biologics License Application ("BLA") preparation activities for isaralgagene civaparvovec under the Accelerated Approval pathway, while continuing to engage in business development negotiations for a potential Fabry commercialization agreement. Sangamo intends to submit a BLA for isaralgagene civaparvovec as early as the first quarter of 2026, subject to its ability to secure adequate additional funding. Summary of Updated Clinical Data from Registrational Phase 1/2 STAAR Study of Isaralgagene Civaparvovec Announced on September 4, 2025 at ICIEM2025 The STAAR study is a Phase 1/2 multicenter, open-label, dose-ranging clinical study designed to assess a single infusion of isaralgagene civaparvovec in Fabry disease patients 18 years of age. Patients are infused intravenously with a single dose and followed for 52 weeks. A separate long-term follow-up study is underway to monitor the patients treated in this study for up to five years following treatment. Patients who are on stable enzyme replacement therapy ("ERT") may withdraw ERT after treatment in a controlled and monitored fashion at the discretion of the patient and the investigator. The dose escalation phase included males with classic Fabry disease. The subsequent study expansion phase, which commenced in the second half of 2022, treated females, as well

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K contains forward-looking statements regarding Sangamo's current expectations. These forward-looking statements include, without limitation: the safety and efficacy and therapeutic and commercial potential of isaralgagene civaparvovec; the potential for isaralgagene civaparvovec to qualify for the FDA's Accelerated Approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval; expectations concerning the potential BLA submission for isaralgagene civaparvovec, and the timing of such submission; Sangamo's plans to seek a commercialization partner for ST-920; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to Sangamo's lack of capital resources and need for substantial additional funding to execute its operating plan and to continue to operate as a going concern, including the risk that Sangamo will be unable to obtain substantial additional funding on acceptable terms or at all or collaboration partners necessary to advance its preclinical and clinical programs, in particular for its Fabry disease program and to otherwise operate as a going concern, in which case Sangamo may be required to cease operations entirely, liquidate all or a portion of its assets and/or seek protection under the U.S. Bankruptcy Code; the uncertain timing and unpredictable nature of clinical trial results, including the risk that the therapeutic effects observed in the latest clinical data from the Phase 1/2 STAAR study will not be durable in patients and that final clinical trial data from the study will not validate the safety and efficacy of isaralgagene civaparvovec, including that the 104-week data from such study will not

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. SANGAMO THERAPEUTICS, INC. Dated: September 4, 2025 By: /s/ SCOTT B. WILLOUGHBY Name: Scott B. Willoughby Title: Chief Legal Officer and Corporate Secretary

View Full Filing

View this 8-K filing on SEC EDGAR