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U.S. 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): December 9, 2016

 

 

Atossa Genetics Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or jurisdiction of incorporation or organization)

 

001-35610

(Commission File Number)

 

26-4753208

(I.R.S. Employer Identification Number)

 

107 Spring Street, Seattle, WA 98104

(Address of principal executive offices (Zip Code)

 

Registrant's telephone number: (206) 325-6086

 

                                             N/A                                             

(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 (see General Instruction A.2. below):

 

¨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

(17CFR 240.14d-2(b))

 

¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act

(17CFR 240.13e-4(c))

 

 
 

 

Item 8.01Other Events.

 

On December 9, 2016, from 5 p.m. to 7 p.m., a poster was presented at The San Antonio Breast Cancer Symposium featuring Atossa Genetic Inc.’s (the “Company”) clinical study titled “OT3-02-08: Open Label, phase 2 safety, efficacy, and pharmacokinetic study of pre-surgical intramuscular and intraductal fulvestrant in women with invasive breast cancer or DCIS undergoing mastectomy or lumpectomy.” A copy of the presentation is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 8.01 by this reference.

 

This Current Report on Form 8-K contains “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements about the Company’s ongoing Phase 2 clinical study. The words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. While the Company believes its plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. The Company’s actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, including the information discussed under the captions “Item 1 Business,” “Item 1A. Risk Factors” and “Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as the Company’s various other filings with the SEC including reports on Forms 10-Q and 8-K. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company assumes no obligation to update any forward-looking statement.

 

 

 

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

Number

   Description
   
99.1  

Poster presentation presented December 9, 2016*

_________________

*Filed herewith.

 

Signature(s)

 

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.

 

 

   

ATOSSA GENETICS INC.

 

/s/ Kyle Guse

 

Date: December 9, 2016  

By: Kyle Guse

Its: General Counsel and Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

OT3 - 02 - 08: Open label, phase 2 safety, efficacy, and pharmacokinetic study of pre - surgical intramuscular and intraductal fulvestrant in wom en with invasive breast cancer or DCIS undergoing mastectomy or lumpectomy Sheldon Marc Feldman M.D. FACS; Chief, Division of Breast Surgery; Vivian L. Milstein Associate Professor of Clinical Surger y; Columbia University; New York, NY A. Gomberwalla a A. Alonso a , J.R. Rea b , S. Quay b , L. Remmel b , METHODS BACKGROUND Breast cancer (BC) is the leading cause of cancer in women in the United States and the second leading cause of cancer - related death. Currently available options for prevention are oophorectomy, bilateral mastectomy, or medical therapy, such as tamoxifen, raloxifene or aromatase inhibitors. None of these options for prevention are without significant side effects with low patient uptake. This study proposes fulvestrant 1 instilled directly into the breast via the nipple orifices as intraductal therapy. Providing a local therapy into the ducts could reduce the morbidity associated with prevention while potentially targeting the carcinoma cell better. Building on prior studies with cytotoxic agents 2,3 , this study utilizes the pure anti - estrogen fulvestrant to be injected in up to 5 ducts to determine its effect on BC or DCIS as well as the safety of this method of administration. . This study is currently open for enrollment. © 2016, Atossa Genetics, Inc. Primary Objective To study the safety and tolerability of intraductal administration of fulvestrant (Faslodex) in women with Stage 1 or 2 invasive ductal carcinoma or DCIS, prior to mastectomy or lumpectomy. Secondary Objectives To determine the pathological effects, specifically changes in Ki67, ER/PgR expression between the pre - fulvestrant biopsy and the post - fulvestrant surgical specimen. The study will also collect an abbreviated pharmacokinetic (PK) profile between standard intramuscular administration (500 mg) and intraductal instillation of single - dose (500 mg maximum) fulvestrant. OBJECTIVES RESULTS and CONCLUSIONS As this study is currently open for enrollment, there are no results or conclusions at this time. Printed by This is an open - label, non - randomized pharmacokinetic study of pre - surgical fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified upon admission to the institution for surgical management of Stage 1 or 2 invasive ductal carcinoma or DCIS, specifically mastectomy or lumpectomy. Diagnostic and surgical biopsy samples are examined, specifically for changes in Ki67, ER/PgR expression between the pre - fulvestrant biopsy and the post - fulvestrant surgical specimen. Fulvestrant levels will be determined in a serial manner from all patients. Patients receive their dose of fulvestrant (either IM or ID) 30 to 45 days prior to surgery (lumpectomy or mastectomy). IM - 6 patients receive fulvestrant as 2 - 250 mg injections into the buttocks. ID – 24 patients receive 500 mg of fulvestrant through up to 5 ducts. Dye (Figures 2, 3) is used to mark the dosed ducts when a mastectomy is performed. Figure 1: Duct and lobule system Figure 2: Dye - infused milk ducts Figure 3: Histograph of dye - infused milk duct Figures courtesy of Susan Love MD MBA Dr Susan Love Research Foundation a Columbia University Medical Center, New York, NY b Atossa Genetics, Seattle, WA 1 Fasolex ® Prescribing Information (AstraZeneca) 2 Stearns V et al ., Science Translational Medicine 2011;3 (106): 106ra108 3 Love SM et al ., Cancer Prevention Research 2012;6:51 - 58