SGMO News & Events

Sangamo Therapeutics announced advancement of the rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920. Following initiation of the rolling submission in December 2025, Sangamo has now submitted the preclinical and clinical modules to the FDA for review. Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire BLA to be submitted at once. In addition, the antibody assay companion diagnostic, which is designed to screen patients for eligibility with isaralgagene civaparvovec, has been submitted to, and accepted by, the FDA's Center for Devices and Radiological Health seeking Premarket Approval.

Sangamo Therapeutics announced the pricing of an underwritten offering consisting of 35,190,292 shares of its common stock and pre-funded warrants to purchase 17,787,033 shares of its common stock, together with accompanying warrants to purchase 52,977,325 shares of its common stock. The combined offering price of each share of common stock and accompanying warrant is $0.4719. The combined offering price of each pre-funded warrant and accompanying warrant is $0.4619. The common stock and pre-funded warrants are being sold in combination with an accompanying warrant to purchase one share of common stock issued for each share of common stock or pre-funded warrant sold. The accompanying warrant has an exercise price of $0.4719 per share, will become exercisable six months from the date of issuance and will expire five and a half years from the date of issuance. In addition, Sangamo agreed to reduce the exercise price on outstanding warrants to purchase 23,809,523 shares of common stock held by an investor from $1.00 to $0.4719 and extend the term of such warrants to five and a half years from the date of issuance of the securities in the offering, with such warrants to become exercisable six months from the date of issuance of the securities in the offering. All of the securities in the offering are to be sold by Sangamo. The offering is expected to close on or about February 4, subject to the satisfaction of customary closing conditions. The gross proceeds to Sangamo from this underwritten offering, before deducting the underwriting discount and other estimated offering expenses, are expected to be approximately $25M. Cantor and Wells Fargo Securities are acting as joint book-running managers for the offering.

In a regulatory filing, Sangamo announced that on February 2, the employment of Prathyusha Duraibabu, the company's principal financial officer, terminated. Effective February 3, Nikunj Jain, Sangamo's Vice President, Finance and Corporate Controller and principal accounting officer, has been appointed to the position of Interim CFO and will serve as the company's principal financial officer.