SEATTLE, Nov. 13, 2018 (GLOBE NEWSWIRE) — Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage biopharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced third quarter ended September 30, 2018 financial results and provided an update on recent company developments.
Steven C. Quay, Ph.D., MD, President and CEO commented, “We continue to make great progress with our clinical programs. We successfully achieved all objectives in our Phase 1 study of topical Endoxifen in men and are looking forward to advancing that program into a Phase 2 study to address gynecomastia in men being treated for prostate cancer. We also completed enrollment in the Phase 2 study of our topical Endoxifen to treat mammographic breast density,” added Dr. Quay.
Recent Corporate Developments
Atossa’s important recent developments include the following:
- October 2018 – Completed enrollment in Phase 2 study of topical Endoxifen to treat mammographic breast density.
- September 2018 – Reported that all objectives were achieved in our Phase 1 study of topical Endoxifen in men.
- August 2018 – Contracted with a US-based additional manufacturer of Endoxifen.
- July 2018 – Announced intraductal microcatheter immunoOncology pre-clinical program.
- June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to strategic advisory board.
Q3 2018 Financial Results
For the three and nine months ended September 30, 2018 and 2017, we had no revenue and no associated cost of revenue.
Total operating expenses were approximately $3.3 million and $9.3 million for the three and nine months ended September 30, 2018, respectively, consisting of research and development (R&D) expenses of approximately $1.4 million and $3.4 million, respectively, and general and administrative (G&A) expenses of approximately $1.9 million and $6.0 million, respectively. Total operating expenses were approximately $2.1 million and $5.7 million for the three and nine months ended September 30, 2017, respectively, consisting of R&D expenses of $0.7 million and $2.1 million, respectively, and G&A expense of approximately $1.3 million and $3.5 million, respectively.
Total operating expenses for the three and nine months ended September 30, 2018 as compared to the same periods of 2017 increased approximately $1.3 million, or 61%, and increased $3.7 million, or 65%, respectively.
As of September 30, 2018, the Company had cash and cash equivalents and restricted cash of $13.0 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
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 Form 10-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
kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott Gordon
CorProminence LLC
377 Oak Street
Concourse 2
Garden City, NY 11530
Office: (516) 222-2560
scottg@corprominence.com
Source: Atossa Genetics Inc.
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
| September 30, | December 31, | |||||||
| Assets | 2018 | 2017 | ||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 12,935,587 | $ | 7,217,469 | ||||
| Restricted cash | 55,000 | 55,000 | ||||||
| Prepaid expenses | 290,331 | 250,944 | ||||||
| Research and development tax rebate receivable | 480,495 | 358,277 | ||||||
| Other current assets | 161,530 | 16,344 | ||||||
| Total current assets | 13,922,943 | 7,898,034 | ||||||
| Furniture and equipment, net | 57,804 | 11,467 | ||||||
| Intangible assets, net | 55,107 | 75,686 | ||||||
| Other assets | 88,518 | 178,907 | ||||||
| Total Assets | $ | 14,124,372 | $ | 8,164,094 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 550,704 | $ | 334,901 | ||||
| Accrued expenses | 51,673 | 90,105 | ||||||
| Payroll liabilities | 706,150 | 784,867 | ||||||
| Stock-based compensation liability | 2,180,659 | |||||||
| Other current liabilities | 66,077 | 15,534 | ||||||
| Total Current Liabilities | 3,555,263 | 1,225,407 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity | ||||||||
| Preferred stock – $0.001 par value; 10,000,000 shares authorized, consisting of Series A convertible preferred stock- $0.001 par value; 4,000 shares authorized, and 0 shares outstanding as of September 30, 2018 and December 31, 2017; Series B convertible preferred stock- $0.001 par value; 25,000 and 0 shares authorized, and 3,517 and 0 shares issued and outstanding as of September 30, 2018 and December 31, 2017, respectively |
4 | |||||||
| Additional paid-in capital- Series B convertible preferred stock | 3,516,996 | |||||||
| Common stock – $0.18 par value; 175,000,000 shares authorized, and 5,523,255 and 2,651,952 shares issued and outstanding, as of September 30, 2018 and December 31, 2017, respectively |
994,175 | 477,342 | ||||||
| Additional paid-in capital | 80,811,088 | 71,887,674 | ||||||
| Accumulated deficit | (74,753,154 | ) | (65,426,329 | ) | ||||
| Total Stockholders’ Equity | 10,569,109 | 6,938,687 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 14,124,372 | $ | 8,164,094 | ||||
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended September 30, |
For the Nine Months Ended September 30, |
|||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | $ | 1,421,851 | $ | 742,450 | $ | 3,360,563 | $ | 2,110,846 | ||||||||
| General and administrative | 1,888,119 | 1,313,477 | 5,966,504 | 3,544,935 | ||||||||||||
| Total operating expenses | 3,309,970 | 2,055,927 | 9,327,067 | 5,655,781 | ||||||||||||
| Operating loss | (3,309,970 | ) | (2,055,927 | ) | (9,327,067 | ) | (5,655,781 | ) | ||||||||
| Change in fair value of common stock warrants | (128,300 | ) | (280,747 | ) | ||||||||||||
| Warrant financing expense | (192,817 | ) | ||||||||||||||
| Other income (expense) | 104 | (283 | ) | 242 | (208 | ) | ||||||||||
| Loss before income taxes | (3,309,866 | ) | (2,184,510 | ) | (9,326,825 | ) | (6,129,553 | ) | ||||||||
| Income taxes | ||||||||||||||||
| Net loss | $ | (3,309,866 | ) | $ | (2,184,510 | ) | $ | (9,326,825 | ) | $ | (6,129,553 | ) | ||||
| Deemed Dividend attributable to preferred stock | (11,479,308 | ) | (2,568,132 | ) | ||||||||||||
| Net loss applicable to common shareholders | $ | (3,309,866 | ) | $ | (2,184,510 | ) | $ | (20,806,133 | ) | $ | (8,697,685 | ) | ||||
| Loss per common share – basic and diluted | $ | (0.64 | ) | $ | (2.11 | ) | $ | (5.71 | ) | $ | (13.23 | ) | ||||
| Weighted average shares outstanding – basic and diluted | 5,183,492 | 1,034,262 | 3,645,682 | 657,184 | ||||||||||||