Atossa Genetics (ATOS) is a clinical-stage pharmaceutical company focused on developing novel, proprietary therapeutics and delivery methods for the treatment of breast cancer and other breast conditions. The company currently have three programs underway: two using its proprietary endoxifen (oral and topical formulations) and the other using its patented microcatheter technology. The company's proprietary oral and topical forms of endoxifen are the subject of a comprehensive Phase 1 clinical study in healthy women in Australia. The company's patented microcatheter technology is in a Phase 2 clinical study that is also currently enrolling patients.

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. Tamoxifen has been widely used for over 30 years to both treat and prevent breast cancer. Additional research has shown that it is the metabolites of tamoxifen, of which endoxifen is the most active that have potential therapeutic value.

Atossa Genetics is developing both oral and a topical formulation of endoxifen, which are now in a Phase 1 dose-finding clinical study being conducted by a leading Clinical Research Organization in Australia. The study is a placebo-controlled, repeat dose study of 48 healthy female volunteers. The primary end point is to assess the pharmacokinetics of both formulations of endoxifen over 28 days. The secondary endpoint is to assess safety and tolerability. Atossa Genetics has completed enrollment in both the oral and topical arms of this study. Subject to positive results from this study, the company plan to advance to one or more Phase 2 clinical studies in the second half of 2017.

Summary of Programs

Oral Endoxifen. The company believe that up to 50% of the one million patients taking tamoxifen in the United States each year are refractory, meaning that they have inadequate endoxifen levels (for any number of reasons including low levels of a liver enzyme) and they have an increased risk for breast cancer recurrence. Subject to favorable results from its Phase 1 study, Atossa Genetics is planning to begin a Phase 2 study of oral endoxifen in the second half of 2017 for these patients who are refractory to tamoxifen. Atossa Genetics is also evaluating oral endoxifen in the neo-adjuvant setting, meaning it would be used, to treat breast cancer before surgery to remove the cancerous tumor.

Topical Endoxifen. The company's topical formulation is being developed for women with a condition called high breast density, which has been shown in studies to result in a higher risk of developing breast cancer. Subject to favorable results from its Phase 1 study, Atossa Genetics is planning to begin a Phase 2 study of topical endoxifen for women with high breast density. The goal of this program is to reduce high breast density, which should result in the lowering of the risk of breast cancer. Topical endoxifen is also being evaluated for its potential in other breast conditions.

Microcatheter Technology. The company's third program uses its patented microcatheter technology to deliver drugs through the nipple directly to the site of the cancer. The goals of this delivery method are to increase the amount of the drug getting to the targeted area while reducing the side effects caused by delivering the drug through the blood stream.

The company believe its patented intraductal microcatheter technology may be useful in delivering a number of drugs directly to the breast tissue. The initial drug Atossa Genetics is studying using its microcatheters is fulvestrant. Fulvestrant is FDA-approved for metastatic breast cancer. It is administered as a monthly intramuscular injection of two injections, typically into the buttocks. In 2012, a published study documented that the single dose cost of intramuscular fulvestrant was approximately $12,000.

The company own one issued patent and several pending applications directed to the treatment of breast conditions, including cancer, by the intraductal administration of therapeutics, including fulvestrant.

Atossa Genetics is currently conducting a Phase 2 study using its microcatheter technology to deliver fulvestrant at Montefiore Medical Center. This trial is a Phase 2 study in women with ductal carcinoma in situ (DCIS) or Stage 1 or 2 breast cancer (invasive ductal carcinoma) scheduled for mastectomy or lumpectomy within 30 to 45 days. This study is assessing the safety, tolerability, cellular activity and distribution of fulvestrant when delivered directly into breast milk ducts of these patients compared to those who receive the same drug by injection. Of the 30 patients required for full enrollment, six will receive the standard intramuscular injection of fulvestrant and 24 will receive fulvestrant with its microcatheter device.

The primary endpoint of the clinical trial is to compare the safety, tolerability and distribution of fulvestrant between the two routes of administration (intramuscular injection or through its microcatheters). The secondary endpoint of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimens. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. The company cannot provide an estimate of the date by which enrollment will be completed in this study.

The company's key objectives are to advance its programs through Phase 2 trials and then evaluate further development independently or with partners.