Atossa is a pure play pharmaceutical company focused on the development of novel therapeutics and delivery methods aimed at both treating breast cancer as well as preventing breast cancer.
The current standard of care for most breast cancer patients is a 5-10 year regimen of an FDA-approved drug called Tamoxifen. Unfortunately, not all patients benefit from Tamoxifen and it can have serious side effects. The company is developing a new drug called Endoxifen, which is the most active metabolite of Tamoxifen.The company is also developing our proprietary intraductal microcatheters with the potential ability to deliver drugs and Chimeric Antigen Receptor Therapy, or CAR-T, cells directly to the site of breast cancer.
Unfortunately there is a large addressable market for breast cancer therapies.
The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. 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.
The company is developing our products for large market opportunities. A study conducted by Defined Health, a leading market research firm, estimates that the potential market for Endoxifen exceeds $1 billion in annual sales and the potential market for our intraductal microcatheters to delivery therapeutics exceeds $800 million as a treatment and replacement for surgery.
CAR-T has been the subject of much attention recently. In October 2017, pioneer CAR-T company Kite Pharma was acquired for $11.9 billion by Gilead and in August 2017 Novartis received the first FDA approval in the CAR-T field for Kymriah for the treatment of B-cell Acute Lymphoblastic Leukemia. Other companies in the clinical-stage in the field of CAR-T include Blue Bird Corporation, and Juno Therapeutics, which trades on Nasdaq with a multi-billion dollar market capitalization.
This has been an extraordinarily productive year for Atossa. In may the company announced that it has received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), a common condition in patients being treated for prostate cancer. Later that same month, the company raised $13.4 million in a rights offering.
Then in June, the company announced that it has opened its Phase 2 study of proprietary topical Endoxifen on mammographic breast density, or MBD, reduction.
With more than half of the year behind us, Atossa, still has some upcoming milestones, which could help drive shareholder value if achieved. Specifically, the company is expected to begin one or more studies administering TRAP CAR-T with the company’s microcatheters, and there will be continuing Phase 2 data on the studies administering Fluvestrant with Atossa’s microcatheters.