Seattle’s Atossa Genetics (ATOS) Published Q2 Financial Results & Company Update

By John Heerdink LinkedIn

Seattle-based Atossa Genetics Inc. (ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today published their financial results for Q2, 2019 and provided an update on recent company developments.

“During the quarter we were very pleased to have achieved our primary endpoint in our Phase 2 trial of topical Endoxifen to reduce mammographic breast density (MBD). We are now focusing our efforts on the oral formulation of Endoxifen and are developing a modified-release oral tablet which is being tested in a Phase 1 study and that we plan to use in a Phase 2 study to reduce MBD. The Phase 2 study is scheduled to start in the fourth quarter and should be completed by mid-2020. We completed the quarter with $17.1 million in cash, which will enable us to continue to make clinical progress with our programs,” stated Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President, and CEO

Atossa offered recent developments that include the following:

  • July 2019 – Provided update on expanded access program, which now allows physicians and patients to visit the company website to obtain information on compassionate use access
  • July 2019 – Initiated a Phase 1 study of our proprietary modified-release oral Endoxifen tablet
  • June 2019 – Successfully reached the primary endpoint of MBD reduction using the topical formulation of Endoxifen in a Phase 2 study

Atossa published the following Q2 2019 Financial Results:

  • For the three and six months ended June 30, 201,9 and 2018, they have no source of sustainable revenue and no associated cost of revenue.
  • Total operating expenses were approximately $7,286,000 and $11,350,000 for the three and six months ended June 30, 2019, respectively, consisting of research and development (R&D) expenses of approximately $2,612,000 and $4,063,000 respectively, and general and administrative (G&A) expense of approximately $4,674,000 and $7,287,000, respectively.
  • Total operating expenses were approximately $4,143,000 and $6,017,000 for the three and six months ended June 30, 2018, respectively, consisting of research and development expenses of approximately $1,468,000 and $1,939,000, respectively, and general and administrative expenses of approximately $2,675,000 and $4,078,000, respectively.
  • R&D expenses for the three months ended June 30, 2019, were approximately $2,612,000, an increase of approximately $1,144,000 or 78% from total R&D expenses for the three months ended June 30, 2018, of approximately $1,468,000. R&D expenses for the six months ended June 30, 2019, were approximately $4,063,000, an increase of approximately $2,124,000 or 110% from total R&D expenses for the six months ended June 30, 2018, of approximately $1,939,000. The increase in R&D expenses for the period ended June 30, 2019, is mainly attributed to an increase in stock-based compensation expense (non-cash).
  • They expect R&D expenses to increase throughout 2019 as they commence an additional Phase 2 clinical study of oral Endoxifen, develop and manufacture the modified-release tablet form of oral Endoxifen, continue their 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 $4,674,000 for the three months ended June 30, 2019, an increase of approximately $1,999,000, or 75% from the total G&A expenses for the three months ended June 30, 2018, of approximately $2,675,000. G&A expenses were approximately $7,287,000 for the six months ended June 30, 2019, an increase of approximately $3,209,000, or 79% from the total G&A expenses for the six months ended June 30, 2018, of approximately $4,078,000. 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 period ended June 30, 2019, is mainly attributed to an increase in stock-based compensation expense (non-cash). Additionally, payroll expenses have increased resulting from salary increases over the prior year.
  • As of June 30, 2019, Atossa had approximately $17.1 million in cash and cash equivalents and working capital of approximately $17.4 million.

Atossa Genetics Announces Second Quarter 2019 Financial Results and Provides Company Update

SEATTLE, Aug. 13, 2019 — Atossa Genetics Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast…

finance.yahoo.com

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