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 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 May 13, 2019, Atossa Genetics Inc. (the “Company”) issued a press release announcing quarter end March 31, 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 May 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: May 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 May 13, 2019

 

 

 

 

 

ex_144532.htm

 

Exhibit 99.1

 

Atossa Genetics Announces First Quarter 2019 Financial Results and Provides Company Update

 

Completes First Quarter with Cash and Cash Equivalents of $19.6 Million

 

 

SEATTLE, May 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 quarter ended March 31, 2019 and provided an update on recent company developments.

 

Steven C. Quay, M.D., Ph.D., Atossa Genetics’ President and CEO commented, "As we anticipated, we completed dosing in the topical Endoxifen breast density study in April and we look forward to announcing initial top-line results later this quarter. Further, as previously reported, the FDA approved an ‘Expanded Access’ program for use of our oral Endoxifen to treat a breast cancer patient prior to her surgery and in March 2019 we received a second approval for this patient to continue treatment post-surgery. We are planning a Phase 2 clinical study using our oral Endoxifen to reduce breast density and we look forward to providing updates on the launch of that study and progress with our other programs."

 

Q1 2019 Corporate Developments 

 

Developments during the first quarter include the following:

 

 

April 2019 – Completed dosing of Phase 2 topical Endoxifen breast density trial

 

April 2019 – Completed the first phase of a preclinical study using proprietary intraductal delivery technology. The company is now advancing to the next preclinical phase, which involves the intraductal administration of immune modulating formulations. These results will form the basis for advancing the intraductal delivery program into humans and to ultimately deliver immunotherapy to treat breast cancer using Atossa's proprietary intraductal delivery technology

 

March 2019 – FDA approval of oral Endoxifen for expanded access as post-mastectomy treatment for a U.S. breast cancer patient

 

March 2019 – Atossa received $11.3 million from the exercise of warrants that were previously outstanding

 

February 2019 – Atossa provided breast cancer prevention recommendations to the United States Preventative Services Task Force

 

February 2019 – Atossa reports results from expanded access program for a U.S. breast cancer patient taking oral Endoxifen: sizeable reduction in cancer cell biological activity; no safety or tolerability issues

 

January 2019 – Successfully completed and provided final results from male Phase 1 study of topical Endoxifen; no clinically significant safety nor tolerability issues and acceptable pharmacokinetics

 

Q1 2019 Financial Results 

 

For the quarter ended March 31, 2019 the company reported no revenue and no associated cost of revenue.

 

Total operating expenses were approximately $4,064,000 for the three months ended March 31, 2019, which is an increase of approximately $2,190,000 or 117 percent, from the three months ended March 31, 2018. Operating expenses for the three months ended March 31, 2019 consisted of research and development (R&D) expenses of approximately $1,451,000 and general and administrative (G&A) expenses of approximately $2,613,000. Operating expenses for the same period in 2018 consisted of R&D expenses of approximately $471,000, and G&A expenses of approximately $1,403,000.

    

R&D expenses for the three months ended March 31, 2019, were approximately $1,451,000, an increase of approximately $980,000 or 208 percent from total R&D expenses for the three months ended March 31, 2018 of approximately $471,000. The increase in R&D expense is attributed to salaries, stock-based compensation, and clinical trial expenses associated with our Endoxifen program. Stock-based compensation expense increased approximately $668,000 in 2019 resulting from the cancellation of stock options. There were no option cancellations in the comparable period in 2018. We expect our R&D expenses to increase throughout 2019 as we commence additional Phase 2 clinical studies of Endoxifen, continue the 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 $2,613,000 for the three months ended March 31, 2019, an increase of approximately $1,210,000, or 86 percent from the total G&A expenses for the three months ended March 31, 2018, of approximately $1,403,000. 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 quarter ended March 31, 2019, is mainly attributed to an increase in stock-based compensation expense due to the cancellation of 2018 options of approximately $1,074,000, payroll expenses resulting from salary increases, and increased legal and professional consulting expenses over the prior year.

 

As of March 31, 2019, Atossa had approximately $19.6 million in cash and cash equivalents and working capital of approximately $19.3 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 March 31,

 

 

 

 

 

 

2019

 

 

 As of December 31,

 

Assets

 

(Unaudited)

 

 

 

2018 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

19,568,247

 

 

$

10,380,493

 

Restricted cash

 

 

110,000

 

 

 

110,000

 

Prepaid expenses

 

 

835,468

 

 

 

509,833

 

Research and development tax rebate receivable

 

 

237,856

 

 

 

518,098

 

Other current assets

 

 

27,957

 

 

 

30,942

 

Total current assets

 

 

20,779,528

 

 

 

11,549,366

 

 

 

 

 

 

 

 

 

 

Furniture and equipment, net

 

 

48,212

 

 

 

54,487

 

Intangible assets, net

 

 

91,667

 

 

 

99,375

 

Right-of-use asset

 

 

88,103

 

 

 

 

 

Other assets

 

 

17,218

 

 

 

17,218

 

Total Assets

 

$

21,024,728

 

 

$

11,720,446

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

463,970

 

 

$

353,328

 

Accrued expenses

 

 

74,844

 

 

 

177,074

 

Payroll liabilities

 

 

891,758

 

 

 

935,070

 

Stock-based compensation liability

 

 

 

 

 

 

1,410,025

 

Lease liability

 

 

50,706

 

 

 

 

 

Other current liabilities

 

 

9,863

 

 

 

39,939

 

Total current liabilities

 

 

1,491,141

 

 

 

2,915,436

 

Long term liabilities

 

 

 

 

 

 

 

 

Lease liability long term

 

 

37,397

 

 

 

 

 

Total Liabilities

 

 

1,528,538

 

 

 

2,915,436

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

 

 

Preferred stock - $0.001 par value; 10,000,000 shares authorized; 702 and 2,379 shares issued and outstanding as of March 31, 2019 and December 31, 2018, respectively

 

 

1

 

 

 

2

 

Additional paid-in capital- Series B convertible preferred stock

 

 

701,999

 

 

 

2,378,997

 

Common stock - $0.18 par value; 175,000,000 shares authorized, and 9,122,171 and 5,846,552 shares issued and outstanding, as of March 31, 2019 and December 31, 2018, respectively

 

 

1,641,979

 

 

 

1,052,372

 

Additional paid-in capital

 

 

98,056,781

 

 

 

82,204,902

 

Accumulated deficit

 

 

(80,904,570

)

 

 

(76,831,263

)

Total Stockholders' Equity

 

 

19,496,190

 

 

 

8,805,010

 

 

 

 

 

 

 

 

 

 

Total Liabilities and Stockholders' Equity

 

$

21,024,728

 

 

$

11,720,446

 

 

 

 

 

 

 

 

 

 

 

ATOSSA GENETICS INC. 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

 

 

For the Three Months Ended March 31,

 

 

 

2019

 

 

2018

 

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

Research and development

 

$

1,451,236

 

 

$

470,976

 

General and administrative

 

 

2,613,093

 

 

 

1,403,465

 

Total operating expenses

 

 

4,064,329

 

 

 

1,874,441

 

Operating loss

 

 

(4,064,329

)

 

 

(1,874,441

)

Other income (expense)

 

 

(8,978

)

 

 

59

 

Loss before income taxes

 

 

(4,073,307

)

 

 

(1,874,382

)

Income taxes

 

 

 

 

 

 

 

 

Net loss

 

$

(4,073,307

)

 

$

(1,874,382

)

Loss per common share - basic and diluted

 

$

(0.62

)

 

$

(8.48

)

Weighted average shares outstanding - basic and diluted

 

 

6,565,514

 

 

 

220,996