8-K

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)

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))

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:

Title of each class	Trading symbol(s)	Name of each exchange on which registered
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

Exhibit No.	Description
99.1	Press Release, dated August 13, 2019

* * *

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, 2019	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, 2019

EX-99.1

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:

● 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

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

	As of June 30,				As of
	2019			December 31,
Assets	(Unaudited)			2018
Current assets
Cash and cash equivalents	$	17,058,527		$	10,380,493
Restricted cash		110,000			110,000
Prepaid expenses		813,168			509,833
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
Right-of-use asset		75,822			-
Other assets		17,218			17,218
Total Assets	$	18,609,313		$	11,720,446
Liabilities and Stockholders' Equity
Current liabilities
Accounts payable	$	318,266		$	353,328
Accrued expenses		53,485			177,074
Payroll liabilities		589,445			935,070
Stock-based compensation liability		-			1,410,025
Lease liability		51,795			-
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			-
Total Liabilities		1,056,856			2,915,436
Commitments and contingencies
Stockholders' equity
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		1			2
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		1,643,309			1,052,372
Additional paid-in capital		103,400,247			82,204,902
Accumulated deficit		(88,167,099	)		(76,831,263	)
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

(UNAUDITED)

	For the Three Months Ended June 30,						For the Six Months Ended June 30,
				2018							2018
	2019			(as restated)				2019			(as restated)
Operating expenses
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
Operating loss		(7,286,069	)		(4,142,656	)			(11,350,398	)		(6,017,097	)
Other income		23,540			79				14,562			138
Loss before income taxes		(7,262,529	)		(4,142,577	)			(11,335,836	)		(6,016,959	)
Income taxes		-			-				-			-
Net loss	$	(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