Seattle based Atossa Genetics Inc. (NASDAQ: ATOS) is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions.
On Monday after the market close Atossa announced their financial results for the quarter ended March 31, 2019, and provided an update on recent company developments.
Atossa offered the following Q1 2019 Corporate Developments:
- April 2019 – Completed dosing of Phase 2 topical Endoxifen breast density trial
- April 2019 – Completed the first phase of a preclinical study using proprietary intraductal delivery technology. The company is now advancing to the next preclinical phase, which involves the intraductal administration of immune modulating formulations. These results will form the basis for advancing the intraductal delivery program into humans and to ultimately deliver immunotherapy to treat breast cancer using Atossa’s proprietary intraductal delivery technology
- March 2019 – FDA approval of oral Endoxifen for expanded access as post-mastectomy treatment for a U.S. breast cancer patient
- March 2019 – Atossa received $11.3 million from the exercise of warrants that were previously outstanding
- February 2019 – Atossa provided breast cancer prevention recommendations to the United States Preventative Services Task Force
- February 2019 – Atossa reports results from expanded access program for a U.S. breast cancer patient taking oral Endoxifen: sizeable reduction in cancer cell biological activity; no safety or tolerability issues
- January 2019 – Successfully completed and provided final results from male Phase 1 study of topical Endoxifen; no clinically significant safety nor tolerability issues and acceptable pharmacokinetics
Atossa offered the following Q1 2019 Financial Results:
- As of March 31, 2019, Atossa had approximately $19.6 million in cash and cash equivalents and working capital of approximately $19.3 million.
- For the quarter ended March 31, 2019, the company reported no revenue and no associated cost of revenue.
- Total operating expenses were approximately $4,064,000 for the three months ended March 31, 2019, which is an increase of approximately $2,190,000 or 117 percent, from the three months ended March 31, 2018. Operating expenses for the three months ended March 31, 2019 consisted of research and development (R&D) expenses of approximately $1,451,000 and general and administrative (G&A) expenses of approximately $2,613,000. Operating expenses for the same period in 2018 consisted of R&D expenses of approximately $471,000, and G&A expenses of approximately $1,403,000.
- R&D expenses for the three months ended March 31, 2019, were approximately $1,451,000, an increase of approximately $980,000 or 208 percent from total R&D expenses for the three months ended March 31, 2018 of approximately $471,000. The increase in R&D expense is attributed to salaries, stock-based compensation, and clinical trial expenses associated with our Endoxifen program. Stock-based compensation expense increased approximately $668,000 in 2019 resulting from the cancellation of stock options. There were no option cancellations in the comparable period in 2018. Atossa expects their R&D expenses to increase throughout 2019 as they commence additional Phase 2 clinical studies of Endoxifen, continue the clinical trial of Fulvestrant administered via their intraductal technology and continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via their intraductal technologies.
- G&A expenses were approximately $2,613,000 for the three months ended March 31, 2019, an increase of approximately $1,210,000, or 86 percent from the total G&A expenses for the three months ended March 31, 2018, of approximately $1,403,000. G&A expenses consist primarily of personnel and related benefit costs, facilities, professional services, insurance, and public company related expenses. The increase in G&A expenses for the quarter ended March 31, 2019, is mainly attributed to an increase in stock-based compensation expense due to the cancellation of 2018 options of approximately $1,074,000, payroll expenses resulting from salary increases, and increased legal and professional consulting expenses over the prior year.
Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO commented, “As we anticipated, we completed dosing in the topical Endoxifen breast density study in April and we look forward to announcing initial top-line results later this quarter. Further, as previously reported, the FDA approved an ‘Expanded Access’ program for use of our oral Endoxifen to treat a breast cancer patient prior to her surgery and in March 2019 we received a second approval for this patient to continue treatment post-surgery. We are planning a Phase 2 clinical study using our oral Endoxifen to reduce breast density and we look forward to providing updates on the launch of that study and progress with our other programs.”
Visit the Atossa Genetics (ATOS) page at Vista Partners to keep up with their progress and to learn more daily!