Sangamo Therapeutics, Inc (SGMO) 10K Annual Reports & 10Q SEC Filings

– Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and fourth quarter and full year 2022 financial results.

“2022 was a year of important clinical and non-clinical milestones across our pipeline. We strengthened that momentum today by releasing compelling data from our Phase 1/2 Fabry disease study, supporting a potential best-in-class product profile,” said Sandy Macrae, Chief Executive Officer of Sangamo. “In 2023, wise resource allocation is our top priority, as we focus on advancing our wholly owned Fabry program, CAR-Treg portfolio and epigenetic regulation programs in the central nervous system, alongside progression of our Zinc Finger platform and AAV delivery capabilities. We look forward to sharing additional pipeline and delivery milestones in 2023 as we continue to strive to deliver for patients in need.”

Fourth Quarter Updates and Recent Business Highlights

Fabry disease – Reported compelling updated preliminary Phase 1/2 data showing extended clinical benefit; reported kidney biopsy data demonstrating 78% globotriaosylceramide (Gb3) substrate clearance at 6-months; Phase 3 trial anticipated to start by end of 2023.

•Presented updated preliminary data as of the October 20, 2022 cutoff date from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, our wholly owned gene therapy product candidate for the treatment of Fabry disease at the 19th Annual WORLDSymposium.

•Sustained, elevated expression of alpha-galactosidase A (α-Gal A) activity observed in 13 patients for over two years for the longest treated patient as of the November 15, 2022 supplemental cutoff date.

•No prophylactic corticosteroids or other immune modulating agents have been administered.

•All five patients who began the dose escalation phase on enzyme replacement therapy (ERT) had been successfully withdrawn from ERT and remain off ERT today.

•Announced first available kidney biopsy data demonstrating 78% Gb3 substrate clearance at 6-months and 77% reduction in urine podocyte loss in a treated patient with high baseline plasma globotriaosylsphingosine (lyso-Gb3) levels.

•Reported a clinically meaningful and statistically significant increase in mean general health scores measured across all patients treated in dose escalation phase, as measured by the SF-36 General Health Survey.

•As of the October 20, 2022 cutoff date, naïve and pseudo-naïve patients treated in the dose expansion and escalation phases with baseline lyso-Gb3 levels above 80 ng/mL experienced a 40-65% reduction. For the first time, and at the highest dose, a 54% reduction in lyso-Gb3 levels was observed where baseline levels started below 25 ng/mL.

•As of the October 20, 2022 cutoff date, isaralgagene civaparvovec remained generally well tolerated with no treatment-related adverse events greater than Grade 2 and no treatment-related serious adverse events.

•Since the October 20, 2022 cutoff date, four additional patients have been dosed in the expansion phase to achieve a total of 17, and a further two patients have been withdrawn from ERT.

•Dosing of remaining patients in the expansion phase of the Phase 1/2 STAAR study is ongoing, with a total of 20 sites active and recruiting. We expect dosing to conclude by the end of 2023.

•Preparations for a potential Phase 3 trial actively progress, with a trial start anticipated by the end of 2023, depending on regulatory interactions. Dosing of the first patient is expected to start as early as the first part of 2024.

The following information was filed by Sangamo Therapeutics, Inc (SGMO) on Wednesday, February 22, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Sangamo Therapeutics, Inc provided additional information to their SEC Filing as exhibits

Exhibit 4.1: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.53: Material Contract

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: SGMO
CIK: 1001233
Form Type: 10-K Annual Report
Accession Number: 0001628280-23-004666
Submitted to the SEC: Wed Feb 22 2023 9:45:41 PM EST
Accepted by the SEC: Thu Feb 23 2023
Period: Saturday, December 31, 2022
Industry: Biological Products No Disgnostic Substances

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Sangamo Therapeutics, Inc (SGMO) SEC Filing 10-K Annual Report for the fiscal year ending Saturday, December 31, 2022

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