Full Press Release Details
Financial Results and Provides Company Update
March 8, 2018 (GLOBE NEWSWIRE) -- Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel
therapeutics and delivery methods for breast cancer and other breast conditions, today announces 2017 financial results and provides
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," continued Dr. Quay.
important recent developments include the following:
2018 potential milestones include:
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.
and Cost of Revenue: For the years ended December 31, 2017 and 2016, we have no source of sustainable revenue and no associated
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 our Acueity intangible assets of $461,715.
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 deceased headcount,
rent and exit costs incurred in 2016. At the beginning of 2016, our strategy shifted away from commercialization of medical devices
towards focusing exclusively on development of our pharmaceutical and microcatheter candidates.
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 our Endoxifen program for which manufacturing commenced at the beginning of 2017 and
the clinical studies commenced in mid-2017. We expect our R&D expenses to increase throughout 2018 as we commence Phase 2
clinical studies of Endoxifen, continue the clinical trial of fulvestrant administered via our microcatheters and as we continue
the development of other indications and therapeutics, including CAR-T and immunotherapies administered via our intraductal microcatheters.
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.
Genetics Inc., is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer
and other breast conditions. For more information, please visit www.atossagenetics.com.
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, lower than anticipated rate of patient enrollment, preliminary and final results
of clinical studies, 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,
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 Form 10-K and 10-Q, each as amended and supplemented from time to time.
Genetics Company Contact:
CFO and General Counsel
Garden City, NY 11530
Office: 516.222.2560
| As of December 31, | ||||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,217,469 | $ | 3,027,962 | ||||
| Restricted cash | 55,000 | 55,000 | ||||||
| Prepaid expenses | 250,944 | 171,601 | ||||||
| Research and development tax rebate receivable | 358,277 | |||||||
| Other current assets | 16,344 | |||||||
| Total current assets | 7,898,034 | 3,254,563 | ||||||
| Furniture and equipment, net | 11,467 | 55,119 | ||||||
| Intangible assets, net | 75,686 | 640,440 | ||||||
| Other assets | 178,907 | 194,250 | ||||||
| Total assets | $ | 8,164,094 | $ | 4,144,372 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 334,901 | $ | 254,320 | ||||
| Accrued expenses | 90,105 | 16,964 | ||||||
| Payroll liabilities | 784,867 | 769,899 | ||||||
| Other current liabilities | 15,534 | 6,083 | ||||||
| Total current liabilities | 1,225,407 | 1,047,266 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock - $.001 par value; 10,000,000 shares authorized, no shares issued and outstanding | ||||||||
| Common stock - $.015 par value; 75,000,000 shares authorized, 31,822,741 and 3,786,913 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 477,342 | 56,804 | ||||||
| Additional paid-in capital | 71,887,674 | 60,344,050 | ||||||
| Accumulated deficit | (65,426,329 | ) | (57,303,748 | ) | ||||
| Total stockholders' equity | 6,938,687 | 3,097,106 | ||||||
| Total liabilities and stockholders' equity | $ | 8,164,094 | $ | 4,144,372 |
STATEMENTS OF OPERATIONS
| For the Years Ended December 31, | ||||||||
| 2017 | 2016 | |||||||
| Operating expenses: | ||||||||
| Research and development expenses | $ | 2,328,087 | $ | 770,427 | ||||
| General and administrative expenses | 4,859,369 | 6,479,193 | ||||||
| Impairment of intangible assets | 461,715 | 718,970 | ||||||
| Total operating expenses | 7,649,171 | 7,968,590 | ||||||
| Operating loss | (7,649,171 | ) | (7,968,590 | ) | ||||
| Change in fair value of common stock warrants | (280,747 | ) | ||||||
| Warrant financing expense | (192,817 | ) | ||||||
| Other income, net | 154 | 1,599,705 | ||||||
| Loss before income taxes | (8,122,581 | ) | (6,368,885 | ) | ||||
| Income taxes | ||||||||
| Net loss | (8,122,581 | ) | (6,368,885 | ) | ||||
| Deemed dividend attributable to Series A preferred stock | (2,568,132 | ) | ||||||
| Net loss attributable to common stockholders | $ | (10,690,713 | ) | $ | (6,368,885 | ) | ||
| Loss per common share - basic and diluted | $ | (0.91 | ) | $ | (2.16 | ) | ||
| Weighted average shares outstanding, basic and diluted | 11,697,273 | 2,947,282 |