Seattle based Atossa Genetics Inc. is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.
Today Atossa announced the following recent developments:
Successful Phase 1 Study
All objectives of Atossa’s recent Phase 1 study of its proprietary oral and topical formulations of Endoxifen were successfully met: there were no clinically significant safety signals and no clinically significant adverse events and both the oral and topical Endoxifen were well tolerated. In the topical arm of the study, low but measurable Endoxifen levels were detected in the blood in a dose-dependent fashion. In the oral arm of the study, participants exhibited dose-dependent Endoxifen levels that met or exceeded the published therapeutic level. The median time for patients in the study to reach the steady-state serum levels of Endoxifen while taking daily doses of Atossa’s oral Endoxifen was 7 days. Published literature indicates that it takes approximately 50-200 days for patients to reach steady-state Endoxifen levels when taking daily doses of oral tamoxifen.
TRAP CAR-T Program
In October 2017, they announced that they are developing a novel method to deliver CAR-T cells into the ducts of the breast for the potential targeted treatment of breast cancer. This approach uses their proprietary intraductal microcatheter technology for the potential transpapillary, or “TRAP,” delivery of either T-cells that have been genetically modified to attack breast cancer cells or various immunotherapies.
They believe this method has several potential advantages including the reduction of toxicity by limiting systemic exposure of the T-cells or immunotherapy; improved efficacy by placing the T-cells or immunotherapy in direct contact with the target ductal epithelial cells that are undergoing malignant transformation; and, lymphatic migration of the CAR-T cells or immunotherapy potentially extending their cytotoxic actions into the regional lymph system, which could limit tumor cell dissemination. Their approach is in the R&D stage and is currently not FDA approved.
Expansion of Scientific Advisory Board
At the end of 2017, they added Dr. Carl Novina to our Scientific Advisory Board. Together with Dr. Jack Cuzick, they now have a world-renowned group advising on the scientific and medical aspects of their programs.
Capital Raising Activity
In 2017, they made significant improvements to their balance sheet by raising approximately $12 million in capital, which strengthened their balance sheet and improved their stockholder base with the addition of institutional biotech-focused investors.
Atossa also provided the following 2018 potential milestones:
First half of 2018 – opening the Phase 2 Study of topical Endoxifen to treat MBD at Stockholm South General Hospital in Sweden (which they plan to complete in 2018)
First half of 2018 – opening the Phase 2 Study of oral Endoxifen to treat patients who are not responding to Tamoxifen (which they plan to complete in 2018).
Second half of 2018 – commencing one or more studies to demonstrate safety and efficacy of administering TRAP CAR-T or another immunotherapy with their microcatheters.
Throughout 2018 – Identifying additional opportunities for their Endoxifen formulations; and Continuing our Phase 2 study administering Fulvestrant with their microcatheters.
Dr. Steve Quay, President and CEO, commented, “In the later part of 2017, we completed a Phase 1 Study of our proprietary oral and topical Endoxifen formulations, and we were pleased to report that all study objectives were met. We are now looking forward to opening enrollment in two Phase 2 studies. One will use our oral Endoxifen to treat breast cancer patients who are not responding to tamoxifen. Tamoxifen is the current FDA-approved standard of care for the approximately one million breast cancer survivors to prevent a recurrence and new cancer. The second study will use our topical Endoxifen to determine if it can reduce a condition called mammographic breast density, or MBD. Mammographic Breast Density is an independent risk factor for developing breast cancer. It affects approximately 10 million women in the U.S. We are also planning to commence an additional study with topical Endoxifen as well as a study using our intraductal microcatheters to deliver CAR-T or other immunotherapy.”
Atossa provided the following 2017 Financial Results:
Revenue and Cost of Revenue: For the years ended December 31, 2017 and 2016, they have no source of sustainable revenue and no associated cost of revenue.
Operating Expenses: Total operating expenses were $7,649,171 for the year ended December 31, 2017, which is a decrease of $319,419 or 4.0%, from the year ended December 31, 2016. Operating expenses for 2017 consisted of general and administrative (G&A) expenses of $4,859,369, R&D expenses of $2,328,087, and impairment of their Acueity intangible assets of $461,715.
General and Administrative Expenses: G&A expenses were $4,859,369 for the year ended December 31, 2017, a decrease of $1,619,824, or 25.0% from the total G&A expenses for the year ended December 31, 2016, of $6,479,193. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The 2017 decrease in G&A expense was primarily attributable to a reduction in payroll expenses resulting from decreased headcount, rent and exit costs incurred in 2016. At the beginning of 2016, their strategy shifted away from the commercialization of medical devices towards focusing exclusively on the development of their pharmaceutical and microcatheter candidates.
Research and Development Expenses: R&D expenses for the year ended December 31, 2017, were $2,328,087, an increase of $1,557,660, or 202% from R&D expenses in 2016 of $770,427. The increase in R&D expenses is attributed to salaries, manufacturing, and clinical trial expenses associated with their Endoxifen program for which manufacturing commenced at the beginning of 2017 and the clinical studies commenced in mid-2017. They expect their R&D expenses to increase throughout 2018 as they commence Phase 2 clinical studies of Endoxifen, continue the clinical trial of fulvestrant administered via their microcatheters and as they continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via their intraductal microcatheters.
Cash and Cash Equivalents: As of December 31, 2017, the Company had approximately $7.2 million in cash and cash equivalents and working capital of approximately $6.7 million.
To learn more about Atossa Genetics (ATOS) and to track its ongoing progress, please visit the Vista Partners Atossa Genetics Coverage Page.
Atossa Genetics Announces 2017 Financial Results and Provides Company Update
SEATTLE, March 08, 2018– Atossa Genetics Inc., a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, today announces …..