Completes Second Quarter with Cash and Cash Equivalents of $17.1 Million
SEATTLE, Aug. 13, 2019 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced financial results for the second quarter ended June 30, 2019 and provided an update on recent company developments.
Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO commented, "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."
Recent developments 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
Q2 2019 Financial Results
For the three and six months ended June 30, 2019 and 2018, we 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). We expect our R&D expenses to increase throughout 2019 as we commence an additional Phase 2 clinical study of oral Endoxifen, develop and manufacture our modified release tablet form of oral Endoxifen, continue our clinical trial of Fulvestrant administered via our intraductal technology and continue the development of other indications and therapeutics, including CAR-T and immunotherapies administered via our 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 $17.4 million.
About Atossa Genetics
Atossa Genetics Inc. is a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with any variation between preliminary and final clinical results, actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa including those needed to commence studies, lower than anticipated rate of patient enrollment, estimated market size of drugs under development, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, potential market sizes for Atossa's drugs under development and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form10-K and 10-Q, each as amended and supplemented from time to time.
Atossa Genetics Company Contact:
Atossa Genetics Inc.
Kyle Guse CFO and General Counsel
Office: 866 893-4927
Investor Relations Contact:
377 Oak Street
Garden City, NY 11530
Source: Atossa Genetics Inc.
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|As of |
|Cash and cash equivalents||$||17,058,527||$||10,380,493|
|Research and development tax rebate receivable||406,306||518,098|
|Other current assets||140||30,942|
|Total current assets||18,388,141||11,549,366|
|Furniture and equipment, net||44,174||54,487|
|Intangible assets, net||83,958||99,375|
|Liabilities and Stockholders' Equity|
|Stock-based compensation liability||-||1,410,025|
|Other current liabilities||19,838||39,939|
|Total current liabilities||1,032,829||2,915,436|
|Long term liabilities|
|Lease liability long term||24,027||-|
|Commitments and contingencies|
|Preferred stock - $0.001 par value; 10,000,000 shares authorized; 676 and 2,379 |
shares issued and outstanding as of June 30, 2019 and December 31, 2018, respectively
|Additional paid-in capital- Series B convertible preferred stock||675,999||2,378,997|
|Common stock - $0.18 par value; 175,000,000 shares authorized, and 9,129,563 and |
5,846,552 shares issued and outstanding, as of June 30, 2019 and December 31, 2018, respectively
|Additional paid-in capital||103,400,247||82,204,902|
|Total Stockholders' Equity||17,552,457||8,805,010|
|Total Liabilities and Stockholders' Equity||$||18,609,313||$||11,720,446|
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
|For the Three Months |
Ended June 30,
|For the Six Months |
Ended June 30,
|2019||(as restated)||2019||(as restated)|
|Research and development||$||2,611,948||$||1,467,736||$||4,063,184||$||1,938,712|
|General and administrative||4,674,121||2,674,920||7,287,214||4,078,385|
|Total operating expenses||7,286,069||4,142,656||11,350,398||6,017,097|
|Loss before income taxes||(7,262,529||)||(4,142,577||)||(11,335,836||)||(6,016,959||)|
|Deemed dividends attributable to preferred stock||-||(11,479,308||)||-||(11,479,308||)|
|Net loss applicable to common shareholders||$||(7,262,529||)||$||(15,621,885||)||$||(11,335,836||)||$||(17,496,267||)|
|Loss per common share - basic and diluted||$||(0.80||)||$||(5.08||)||$||(1.44||)||$||(6.11||)|
|Weighted average shares outstanding - basic and diluted||9,126,153||3,073,803||7,852,907||2,864,033|