More information about ATOSSA THERAPEUTICS INC.

Atossa Genetics is a clinical-stage drug company developing novel, proprietary therapeutics and delivery methods for breast cancer and other breast conditions. We believe our innovative therapies and delivery methods can transform breast cancer treatment– with the goals of preventing breast cancer from developing in the first place to increasing the odds of surviving for those who do develop this deadly disease. For example, we are developing a new drug called endoxifen, which can be applied directly to the breast like a lotion, and we are developing a new way to deliver therapies, such as “CAR-T” cells, through our microcatheters to target the site of the breast cancer. Approximately one in eight women will be diagnosed with breast cancer during their lifetime. Every two minutes an American woman is diagnosed with breast cancer; 40,000 die each year. The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017. Although tamoxifen has been widely used for over 30 years for breast cancer, recent research has shown that it is the metabolites of tamoxifen, of which endoxifen is the most active, that have potential therapeutic value. Our lead compound is endoxifen. We are taking a unique two-pronged approach to breast cancer: Prevention as well as treatment. The best way to treat a disease is to prevent it in the first place. We are developing endoxifen “lotion” that applied to each breast, to treat a condition known as high breast density. Endoxifen goes directly through the skin into the breast tissue. Third-party studies have shown that high breast density correlates with the risk of developing breast cancer in some women. Breast density is diagnosed by mammography and approximately 10 million women have high density in the U.S. Thirty states currently require patients to be told if their breasts are dense. Although tamoxifen has been demonstrated to reduce density and the incidence of breast cancer it can have serious side effects because, as a drug taken orally, it is delivered “systemically” meaning it travels throughout the body to other areas where the drug is not needed. Although tamoxifen has been widely used since its initial approval in 1977 for breast cancer, recent research has shown that it is the metabolites of tamoxifen, of which endoxifen is the most active, that have therapeutic value. Studies with tamoxifen suggest that breast density can be reduced in a relatively short period of time. The goal of our topical endoxifen program is to reduce high breast density. My biggest worry is that my breast cancer will return. We are also developing an oral formulation of endoxifen for breast cancer survivors who are otherwise recommended to take tamoxifen, the most commonly recommended FDA-approved drug to reduce the risk of cancer recurrence. Tamoxifen, however, does not work for up to 50% of these patients. Studies have shown that increasing the levels of endoxifen in breast cancer patients reduces the risk of future recurrence. The goal of this program is to reduce the number of patients who may get breast cancer again, even after initial treatment. Why am I receiving a needle injection – my cancer is in the breast, not the buttock. We are also developing a new way to deliver pharmaceuticals and genetically modified, or “CAR-T” cells – through microcatheters (small tubes that can be inserted with anesthetic, through the nipple) so that therapeutics can be targeted to the tissue where breast cancer actually grows. The goal of the microcatheter programs is to provide treatment directly to the cancer when it is in the breast. Our proprietary oral and topical forms of endoxifen were the subject of a 2017 comprehensive Phase 1 clinical study in healthy women in Australia. All objectives from the topical arm of this study were successfully met and we reported results from the oral arm of this study on October 25, 2017. Our patented microcatheter technology is in a Phase 2 clinical study using a drug called fulvestrant that is also currently enrolling patients