GUIDED THERAPEUTICS INC

Except as noted below, there have been no material changes from the risk factors previously disclosed in the Company’s most recent Annual Report on Form 10-K as filed with the SEC on March 31, 2025.

In October 2025, a partial shutdown of the U.S. federal government began, resulting in reduced staffing and limited operations at certain agencies, including the U.S. Food and Drug Administration (“FDA”). The Company is currently pursuing FDA clearance for the LuViva Advanced Cervical Scan, and a prolonged shutdown could delay the timing of regulatory reviews and approvals, which in turn could adversely affect product commercialization timelines, revenue opportunities, and cash flow forecasts. The duration and potential impacts of the shutdown are uncertain and could vary depending on the extent of agency operations and the resolution of the federal budget process.

Regarding the Chinese market, the ability of SMI to timely achieve NMPA approval and be able to successfully market LuViva in China is a risk factor of increasing magnitude, given repeated delays over the past year. While SMI has been able to bring new partners to the table which has resulted in increased sales to China in the past year, full NMPA approval will be necessary to achieve significant sales over the long term.