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Dr. Steve Quay, Atossa Genetics (ATOS) Chairman & CEO

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“A physician recently contacted Atossa and requested our proprietary oral Endoxifen for a pre-menopausal, estrogen-receptor positive (ER+) breast cancer patient awaiting surgery. In this setting, the recommended preoperative endocrine systemic therapy is typically an aromatase inhibitor and a drug for ovarian suppression. The patient’s physician was reluctant to use this preoperative therapy as it typically induces menopause and can have other potentially serious side effects. We worked with the physician to apply to the FDA to provide “expanded access” (formerly known as compassionate use) to this patient under an Investigational New Drug (IND) application. We are very pleased to report that the FDA approved this single-patient study, and the patient is currently receiving our proprietary oral Endoxifen preoperatively. This is the same clinical setting as our Phase 2 ‘window of opportunity’ study of preoperative systemic oral Endoxifen in breast cancer patients which is open for enrollment in Australia.”

“We continue to make great progress with our clinical programs. We successfully achieved all objectives in our Phase 1 study of topical Endoxifen in men and are looking forward to advancing that program into a Phase 2 study to address gynecomastia in men being treated for prostate cancer. We also completed enrollment in the Phase 2 study of our topical Endoxifen to treat mammographic breast density.”

“Based on these positive preliminary results, we are advancing our topical Endoxifen into a Phase 2 study to reduce gynecomastia in men starting prostate cancer therapy. We anticipate retaining a clinical research organization to manage that study in the fourth quarter of 2018. In addition to advancing our mens’ program into a Phase 2 study, we also have multiple Phase 2 studies in women addressing large markets with significant unmet needs: breast cancer and a condition called mammographic breast density. We look forward to reporting progress on these programs in the fourth quarter of 2018 and into 2019.”