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): May 14, 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 May 14, 2018, Atossa Genetics Inc. (the “Company”) issued a press release announcing first 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 May 14, 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: May 14, 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 May 14, 2018

 

 

 

Exhibit 99.1

 

 

Atossa Genetics Announces First Quarter 2018 Financial Results

And Provides Company Update

  

SEATTLE, May 14, 2018 -- Atossa Genetics Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, today announced First Quarter ended March 31, 2018 financial results and provided an update on recent company developments.

 

Steve Quay, President and CEO, commented, “During the first part of 2018, we have continued to make significant advances driving toward the next phase of our clinical plans – including a new program in men’s breast health and receiving regulatory approval to commence our Phase 2 breast density study in Sweden. We are especially excited about engaging additional experts that will advise us on important initiatives including seeking partners in the pharmaceutical industry to accelerate the clinical development of our Endoxifen programs. This quarter, we plan to complete our Phase 1 study of topical Endoxifen in men, commence enrollment in our Phase 2 study of topical Endoxifen in women with mammographic breast density, and open our Phase 2 study of oral Endoxifen in women who are “refractory” to tamoxifen.”

 

Recent Corporate Developments

 

Atossa’s important recent developments include the following:

 

●

May 2018 - Formed strategic advisory board to accelerate growth with prominent former pharmaceutical executives from Pfizer and Boehringer Ingelheim.

●

April 2018 - Received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase 2 Study of proprietary topical Endoxifen for the treatment of women with mammographic breast density.

●

April 2018 - Received a positive interim safety review on the Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement).

●

April 2018 - Announced a reverse split of common stock at a ratio of 1-for-12 that was effective on April 20, 2018 and which led to regaining compliance with Nasdaq.

●

March 2018 - Announced that Per Hall, MD, Ph.D., Head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden had been appointed as Scientific Advisor.

●

March 2018 - Expanded the breast health program by launching a men’s’ breast health initiative with enrollment opening in a Phase 1 study of the proprietary topical Endoxifen in men.

●

February 2018 - Announced important additional findings from the Phase 1 study of Atossa’s proprietary oral Endoxifen.

 

 

Q1 2018 Financial Results  

 

We generated no revenue or cost of revenue for the three months ended March 2018. Currently we are in the research and development phase and do not market any products and services.

 

The Company recorded a net loss of $1.9 million for the three months ended March 31, 2018. Total operating expenses were approximately $1.9 million for the three months ended March 31, 2018, consisting of general and administrative (G&A) expenses of approximately $1.4 million, and research and development (R&D) expenses of approximately $0.5 million. Total operating expenses were approximately $1.7 million for the three months ended March 31, 2017, consisting of G&A expense of approximately $1.2 million and R&D expenses of $0.5 million.

 

About Atossa Genetics

 

Atossa 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.

 

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: 800 (351-3902)

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)

 

		March 31,				December 31,
		2018				2017
Assets
Current assets
Cash and cash equivalents		$	4,779,519			$	7,217,469
Restricted cash			55,000				55,000
Prepaid expenses			495,667				250,944
Research and development tax rebate receivable			395,872				358,277
Other current assets			9,316				16,344
Total current assets			5,735,374				7,898,034
Furniture and equipment, net			59,810				11,467
Intangible assets, net			70,547				75,686
Other assets			114,571				178,907
Total assets		$	5,980,302			$	8,164,094
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable		$	168,347			$	334,901
Accrued expenses			172,613				90,105
Payroll liabilities			356,427				784,867
Other current liabilities			23,323				15,534
Total current liabilities			720,710				1,225,407
Commitments and contingencies
Stockholders’ equity
Preferred stock - $.001 par value; 10,000,000 shares authorized, no shares issued or outstanding
Common stock - $.18 par value; 75,000,000 shares authorized, 2,651,952 shares issued and outstanding			477,342				477,342
Additional paid-in capital			72,082,961				71,887,674
Accumulated deficit			(67,300,711	)			(65,426,329	)
Total stockholders’ equity			5,259,592				6,938,687
Total liabilities and stockholders’ equity		$	5,980,302			$	8,164,094

 

 

ATOSSA GENETICS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

		For the Three Months Ended March 31,
			2018				2017
Operating expenses:
Research and development		$	470,976			$	544,302
General and administrative			1,403,465				1,159,289
Total operating expenses			1,874,441				1,703,591
Operating loss			(1,874,441	)			(1,703,591	)
Other income, net			59				37
Loss before income taxes			(1,874,382	)			(1,703,554	)
Income taxes
Net loss		$	(1,874,382	)		$	(1,703,554	)
Loss per common share - basic and diluted		$	(0.71	)		$	(5.40	)
Weighted average shares outstanding, basic and diluted			2,651,952				315,576