Breathe BioMedical ^{Filed Terms, Nasdaq: BRTH}

We are a medical technology company focused on developing a breath test to be used as an adjunctive test to mammography screening to detect early-stage breast cancer in women with dense breast tissue. Breathe BioMedical is in the development stage of our Breast Cancer Breath Test, as an adjunct to mammography screening in women with dense breast tissue. Over the next two years we have verification and validation studies planned for the components and the Breast Cancer Breath Test, as well as a large multi-center clinical study planned to evaluate the safety and efficacy of the Breast Cancer Breath Test, subject to discussions with regulatory authorities, and build our machine learning model for breast cancer. We are currently conducting a proof-of-concept study which is discussed in detail in the Business section, under the “Breast Cancer Breath Test” heading. Data collection will be completed in 3Q2024. Data analysis will follow. We anticipate the completion of the components, the Breast Cancer Breath Test, and the verification and validation studies in 2025 with a pivotal trial in 2026 to support a marketing authorization application in the U.S. in 2027, subject to discussion with the FDA. We expect this could lead to FDA approval for our Breast Cancer Breath Test by 2027. There is no guarantee that we will meet these development milestones or be granted marketing authorization by 2027, if at all.