UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 13, 2018
Atossa Genetics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35610 | 26-4753208 | ||
| (State
or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S.
Employer Identification No.) |
107 Spring Street Seattle, Washington |
98104 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (206) 325-6086
Not
Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On August 13, 2018, Atossa Genetics Inc. (the “Company”) issued a press release announcing second quarter 2018 financial results and a company update. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The
information in the report, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall
not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether
made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated August 13, 2018 | |
* * *
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: August 13, 2018 | Atossa Genetics Inc. |
|||
| By: | /s/ Kyle Guse | |||
| Kyle Guse | ||||
| Chief Financial Officer, General Counsel and Secretary | ||||
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release, dated August 13, 2018 | |
Exhibit 99.1
Atossa Genetics Announces Second Quarter 2018 Financial Results
And Provides Company Update
SEATTLE, August 13, 2018 -- 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 second quarter ended June 30, 2018 financial results and provided an update on recent company developments.
Steve Quay, President and CEO commented, “We have made tremendous progress with our clinical programs. We opened enrollment in two phase 2 clinical studies: one study using our proprietary topical Endoxifen for breast density reduction, and another study using our proprietary oral Endoxifen for reducing breast cancer tumor cell activity in the “window of opportunity” between diagnosis of breast cancer and surgery. We also completed dosing and patient visits in our phase 1 study of topical Endoxifen in men. Our intraductal microcatheter immunoOncology pre-clinical program was launched and we contracted with an additional manufacturer for Endoxifen. We have had a very busy and productive first six months of 2018 as we continue the momentum in the advancement of our clinical programs. We are looking forward to announcing preliminary results from our phase 1 study of topical Endoxifen in men by September 30, 2018,” added Dr. Quay.
Recent Corporate Developments
Atossa’s important recent developments include the following:
| ● | August 2018 - Contracted with a US-based additional manufacturer of Endoxifen. |
| ● | July 2018 - Announced intraductal microcatheter immunoOncology pre-clinical program. |
| ● | July 2018 - Opened enrollment in phase 2 study of oral Endoxifen to treat breast cancer. |
| ● | June 2018 – Opened phase 2 study of topical Endoxifen to treat mammographic breast density. |
| ● | June 2018 - Completed all dosing and clinical visits in its phase 1 study of topical Endoxifen in men. |
| ● | June 2018 – Appointed two additional prominent industry executives from Pfizer and the Belgium-based Flemish Institute of Biotechnology to strategic advisory board. |
| ● | May 2018 – Announced $13.4 million in gross proceeds from rights offering. |
| ● | May 2018 - Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim. |
| ● | April 2018 - Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men. |
Q2 2018 Financial Results
For the three and six months ended June 30, 2018 and 2017, we had no revenue and no associated cost of revenue.
Total operating expenses were approximately $4.1 million and $6.0 million for the three and six months ended June 30, 2018, respectively, consisting of general and administrative (G&A) expenses of approximately $2.7 million and $4.1 million, respectively; and research and development (R&D) expenses of approximately $1.5 million and $1.9 million, respectively. For the previous year, total operating expenses were approximately $1.9 million and $3.6 million for the three and six months ended June 30, 2017, respectively, consisting of G&A expense of approximately $1.1 million and $2.2 million, respectively, and R&D expenses of $0.8 million and $1.4 million, respectively.
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)
| June 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 15,236,736 | $ | 7,217,469 | ||||
| Restricted cash | 55,000 | 55,000 | ||||||
| Prepaid expenses | 440,389 | 250,944 | ||||||
| Research and development tax rebate receivable | 626,011 | 358,277 | ||||||
| Other current assets | 50,035 | 16,344 | ||||||
| Total current assets | 16,408,171 | 7,898,034 | ||||||
| Furniture and equipment, net | 60,926 | 11,467 | ||||||
| Intangible assets, net | 59,882 | 75,686 | ||||||
| Other assets | 48,867 | 178,907 | ||||||
| Total assets | $ | 16,577,846 | $ | 8,164,094 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 191,217 | $ | 334,901 | ||||
| Accrued expenses | 286,713 | 90,105 | ||||||
| Payroll liabilities | 952,657 | 784,867 | ||||||
| Stock-based compensation liability | 1,557,163 | |||||||
| Other current liabilities | 23,331 | 15,534 | ||||||
| Total current liabilities | 3,011,081 | 1,225,407 | ||||||
| Commitments and contingencies (note 11) | ||||||||
| 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 June 30, 2018 and December 31, 2017; Series B convertible preferred stock- $0.001 par value; 25,000 and 0 shares authorized, and 5,802 and 0 shares issued and outstanding, as of June 30, 2018 and December 31, 2017, respectively | 6 | |||||||
| Additional paid-in capital-Series B convertible preferred stock | 5,234,116 | |||||||
| Common stock - $0.18 par value; 175,000,000 shares authorized, 4,874,099 and 2,651,952 shares issued and outstanding, as of June 30, 2018 and December 31, 2017, respectively | 877,329 | 477,342 | ||||||
| Additional paid-in capital | 78,898,602 | 71,887,674 | ||||||
| Accumulated deficit | (71,443,288 | ) | (65,426,329 | ) | ||||
| Total stockholders’ equity | 13,566,765 | 6,938,687 | ||||||
| Total liabilities and stockholders’ equity | $ | 16,577,846 | $ | 8,164,094 | ||||
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,467,736 | $ | 824,094 | $ | 1,938,712 | $ | 1,368,396 | ||||||||
| General and administrative | 2,674,920 | 1,072,169 | 4,078,385 | 2,231,458 | ||||||||||||
| Total operating expenses | 4,142,656 | 1,896,263 | 6,017,097 | 3,599,854 | ||||||||||||
| Operating loss | (4,142,656 | ) | (1,896,263 | ) | (6,017,097 | ) | (3,599,854 | ) | ||||||||
| Change in fair value of common stock warrants | (152,447 | ) | (152,447 | ) | ||||||||||||
| Warrant financing expense | (192,817 | ) | (192,817 | ) | ||||||||||||
| Other income | 79 | 38 | 138 | 75 | ||||||||||||
| Loss before income taxes | (4,142,577 | ) | (2,241,489 | ) | (6,016,959 | ) | (3,945,043 | ) | ||||||||
| Income taxes | ||||||||||||||||
| Net loss | $ | (4,142,577 | ) | $ | (2,241,489 | ) | $ | (6,016,959 | ) | $ | (3,945,043 | ) | ||||
| Deemed dividends attributable to preferred stock | (4,782,100 | ) | (2,568,132 | ) | (4,782,100 | ) | (2,568,132 | ) | ||||||||
| Net loss applicable to common stockholders | $ | (8,924,677 | ) | $ | (4,809,621 | ) | $ | (10,799,059 | ) | $ | (6,513,175 | ) | ||||
| Loss per common share - basic and diluted | $ | (2.90 | ) | $ | (7.72 | ) | $ | (3.77 | ) | $ | (13.85 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 3,073,803 | 623,004 | 2,864,033 | 470,139 | ||||||||||||