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, 2019
Atossa Genetics Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-35610 |
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26-4753208 |
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(State or other jurisdiction of |
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(Commission File Number) |
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(I.R.S. Employer |
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107 Spring Street Seattle, Washington |
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98104 |
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(Address of principal executive offices) |
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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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuance to Section 12(b) of the Act:
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Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
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Common Stock, $0.18 par value |
ATOS |
NASDAQ |
Item 2.02. Results of Operations and Financial Condition.
On August 13, 2019, Atossa Genetics Inc. (the “Company”) issued a press release announcing quarter end June 30, 2019 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 Items 2.02 and 9.01 of this 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
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Exhibit No. |
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Description |
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* * *
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.
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Date: August 13, 2019 |
Atossa Genetics Inc. |
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By: |
/s/ Kyle Guse |
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Kyle Guse |
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Chief Financial Officer, General Counsel and Secretary |
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Exhibit Index
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Exhibit No. |
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Description |
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Exhibit 99.1
Atossa Genetics Announces Second Quarter 2019 Financial Results and Provides Company Update
Completes Second Quarter with Cash and Cash Equivalents of $17.1 Million
SEATTLE, August 13, 2019 (GLOBENEWSWIRE) -- 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 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
Recent developments include the following:
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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 |
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July 2019 – Initiated a Phase 1 study of our proprietary modified-release oral Endoxifen tablet |
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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
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
kyle.guse@atossagenetics.com
Investor Relations Contact:
Scott Gordon
Core IR
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
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As of June 30, |
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As of |
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2019 |
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December 31, |
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Assets |
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(Unaudited) |
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2018 |
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Current assets |
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Cash and cash equivalents |
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$ |
17,058,527 |
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$ |
10,380,493 |
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Restricted cash |
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110,000 |
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110,000 |
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Prepaid expenses |
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813,168 |
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509,833 |
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Research and development tax rebate receivable |
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406,306 |
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518,098 |
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Other current assets |
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140 |
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30,942 |
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Total current assets |
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18,388,141 |
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11,549,366 |
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Furniture and equipment, net |
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44,174 |
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54,487 |
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Intangible assets, net |
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83,958 |
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99,375 |
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Right-of-use asset |
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75,822 |
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- |
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Other assets |
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17,218 |
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17,218 |
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Total Assets |
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$ |
18,609,313 |
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$ |
11,720,446 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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Accounts payable |
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$ |
318,266 |
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$ |
353,328 |
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Accrued expenses |
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53,485 |
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177,074 |
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Payroll liabilities |
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589,445 |
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935,070 |
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Stock-based compensation liability |
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- |
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1,410,025 |
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Lease liability |
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51,795 |
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- |
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Other current liabilities |
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19,838 |
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39,939 |
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Total current liabilities |
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1,032,829 |
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2,915,436 |
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Long term liabilities |
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Lease liability long term |
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24,027 |
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- |
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Total Liabilities |
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1,056,856 |
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2,915,436 |
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Commitments and contingencies |
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Stockholders' equity |
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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 |
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1 |
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2 |
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Additional paid-in capital- Series B convertible preferred stock |
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675,999 |
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2,378,997 |
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Common stock - $0.18 par value; 175,000,000 shares authorized, and 9,129,563 and 5,846,552 shares issued and outstanding, as of June 30, 2019 and December 31, 2018, respectively |
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1,643,309 |
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1,052,372 |
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Additional paid-in capital |
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103,400,247 |
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82,204,902 |
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Accumulated deficit |
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(88,167,099 |
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(76,831,263 |
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Total Stockholders' Equity |
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17,552,457 |
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8,805,010 |
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Total Liabilities and Stockholders' Equity |
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$ |
18,609,313 |
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$ |
11,720,446 |
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ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
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For the Three Months Ended June 30, |
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For the Six Months Ended June 30, |
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2018 |
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2018 |
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2019 |
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(as restated) |
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2019 |
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(as restated) |
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Operating expenses |
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Research and development |
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$ |
2,611,948 |
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$ |
1,467,736 |
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$ |
4,063,184 |
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$ |
1,938,712 |
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General and administrative |
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4,674,121 |
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2,674,920 |
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7,287,214 |
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4,078,385 |
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Total operating expenses |
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7,286,069 |
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4,142,656 |
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11,350,398 |
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6,017,097 |
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Operating loss |
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(7,286,069 |
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(4,142,656 |
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(11,350,398 |
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(6,017,097 |
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Other income |
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23,540 |
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79 |
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14,562 |
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138 |
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Loss before income taxes |
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(7,262,529 |
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(4,142,577 |
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(11,335,836 |
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(6,016,959 |
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Income taxes |
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- |
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- |
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- |
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- |
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Net loss |
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$ |
(7,262,529 |
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$ |
(4,142,577 |
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$ |
(11,335,836 |
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$ |
(6,016,959 |
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Deemed dividends attributable to preferred stock |
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- |
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(11,479,308 |
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- |
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(11,479,308 |
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Net loss applicable to common shareholders |
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$ |
(7,262,529 |
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$ |
(15,621,885 |
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$ |
(11,335,836 |
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$ |
(17,496,267 |
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Loss per common share - basic and diluted |
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$ |
(0.80 |
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$ |
(5.08 |
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$ |
(1.44 |
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$ |
(6.11 |
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Weighted average shares outstanding - basic and diluted |
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9,126,153 |
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3,073,803 |
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7,852,907 |
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2,864,033 |
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