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): July 27, 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)
2300 Eastlake Ave. East, Suite 200, Seattle, WA 98102
(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 8.01 Other Events.
A copy of the corporate presentation of Atossa Genetics Inc. provided to investors on July 27, 2016 is attached to this Current Report on Form 8-K as Exhibit 99.1 and incorporated into this Item 8.01 by this reference. The corporate presentation was previously posted to the Company’s web site in compliance with Regulation FD.
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 related to the potential future sale of shares of the Company’s common stock and price for such sales under the Purchase Agreement. 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 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
Exhibit Number |
Description | |
| 99.1 |
Corporate presentation dated July 27, 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. | ||
| Date: July 27, 2016 |
By: /s/ Kyle Guse Its: Chief Financial Officer |
Exhibit 99.1
1 NASDAQ: ATOS WWW . ATOSSAGENETICS . COM ©2016, A TOSSA G ENETICS , I NC . A LL R IGHTS R ESERVED . C ORPORATE P RESENTATION J ULY 27, 2016
2 Some of the information presented herein may contain projections or other forward - looking statements regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update . These statements are based on management’s current expectations and 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 clinical trials, actions by the FDA, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of A tossa's products and services, performance of clinical research organizations and other risks detailed from time to time in A tossa's filings with the S ecurities and Exchange C ommission, including without limitation its most recent annual report on form 10 - K, subsequent quarterly reports on F orms 10 - Q and Forms 8 - K, each as amended and supplemented from time to time . Forward - Looking Statements
About Atossa Genetics 3 Atossa Genetics is a healthcare company focused on developing novel pharmaceuticals and delivery methods to treat breast conditions including breast cancer.
Our Programs 4 Drug Development and Delivery Programs Intraductal Microcatheters Ongoing Phase 2 study at Columbia University to deliver fulvestrant for neoadjuvant treatment of ductal carcinoma in - situ (DCIS) and estrogen receptor positive (ER+) breast cancer Oral Endoxifen – Preparing for Phase 2 – adjuvant therapy for breast cancer patients who are refractory to tamoxifen
Suspicious Lump Biopsy Surgery* and/or Radiation/ Chemotherapy Diagnosis Breast Cancer Timeline Tamoxifen (5 years) Intraductal Fulvestrant Oral Endoxifen Neoadjuvant Adjuvant * Mastecomy or lumpectomy
Program Pipeline 6 Pivota l Preclinical Phase 1 NDA* Market Candidate Indication * Estimated FDA submission Phase 2 Phase 3 DCIS/ ER+ Breast Cancer Micro Catheters/ Fulvestrant 2017 Oral Endoxifen Tamoxifen Refractory Prep. for Phase 2 Phase 2 Underway 2018 2018 2019
Adjuvent Oral Endoxifen 1 million women take tamoxifen in the U.S. annually 50% of patients taking tamoxifen may be refractory – meaning they make inadequate Endoxifen and have an increased rate of recurrence Potential market: >$2.0 billion The Unmet Need 7 Neoadjuvent Intruductal Fulvestrant Current therapies: use systemic delivery, which can have adverse effects and potentially limited tumor tissue concentration U.S. annual incidence: 235,000 breast cancers and 60,000 DCIS Potential market: intramuscular Fulvestrant is $14,000 per dose; $700M expanding market
Neoadjuvant: Intraductal Microcatheters 8 • Being developed for transpapillary, local delivery of therapeutics • Ongoing Phase 2 study at Columbia University for delivery of fulvestrant in patients with DCIS or ER+ breast cancer • Advantages: paradigm shift towards local treatment with potentially higher local drug exposure and lower systemic concentrations vs systemically delivered agents • 1 issued and 3 pending patent app’s (US and PCT) for intraductal drug delivery • Fulvestrant is FDA approved for intramuscular admin (AstraZeneca)
9 Intraductal Fulvestrant - Clinical Trial Study Design Thirty women with ER + DCIS or Invasive Breast Cancer 6 24 Drug Administered 30 - 45 days B efore S urgery Assessments Efficacy Safety Pharmacokinetic Pathological Response, Ki - 67 Expression FACT - ES Tolerability Tissue and Blood Levels of Fulvestrant Intramuscular Administration Intraductal Administration
Intraductal Fulvestrant - Regulatory Pathway 10 The FDA issued a “Safe to Proceed” letter in Q4 2015 A combination drug/device could qualify for designation under the 505(b)(2) status. Advantages: A single clinical study of safety and efficacy Limited additional clinical or pre - clinical studies Market exclusivity possible
11 • Significance of unmet need: >500,000 are tamoxifen refractory and have increased risk of recurrence (see chart at right; Journal of Clinical Oncology Vol. 25, No. 33, Schroth et al.) • IP: Composition of Matter and Methods of Treatment applications have been filed • E xisting data: Abundant pre - clinical and clinical data support approach • Speed to market: Potential for rapid approval • Potential competition: No known current commercial clinical development underway • Regulatory pathway: 505(b)(2) pathway potential Adjuvant Solution: Oral Endoxifen
Tamoxifen is a Pro - Drug with Many Metabolites 12
Only Three Have Cancer Inhibition Activity… 13
Major Tamoxifen Metabolites 14 Compound Plasma Level (nM) IC 50 Estrogen Receptor Effect (nM) PL/IC 50 Endoxifen 29.1 3 9.7 4 - OH - Tamoxifen 5.8 7 0.8 (8%) 3 - OH - Tamoxifen 0.7 94 <0.01 (0.1%) Murdter et al, Clin Pharmacol Therap. 2011 May
Low Plasma Endoxifen P redicts R ecurrence 15 CYP2D6 EM Mean (n=586) Dezentje ´ et. al. Breast Cancer Res Treat (2015) 153:583 – 590. 35 % increased Recurrence Rate Pre/Post - Menopausal (n=1370 ) Madlensky et. al. Clin Pharmacol Ther . (2011) 89:718 – 725 . 1.6 - 1.9 Increased Hazards Ratio for Recurrence Pre - Menopausal Only (n=587) Saladores et. al. The Pharmacogenomics Journal (2015) 15, 84 – 94
Endoxifen - Clinical Trial Design 16 Entry Criteria: Pre - menopausal ER + breast cancer patients on tamoxifen Perform Test to Measure Endoxifen >TBD nM Endoxifen Continue on tamoxifen (20 mg/day) ≤TBD nM Endoxifen Add Oral Endoxifen (1 - 2 mg/day)
Ongoing Microcatheter / Fulvestrant Phase 2 Trial Oral Endoxifen Progress Provides Significant Near Term Opportunity Secured Financing Facility with Aspire Capital – Up to $10M over 30 Months 2016 Value Creation Points 17
x Drug Development Programs: intraductal fulvestrant in Phase 2 and a Phase 2 planned for oral endoxifen x Favorable clinical and regulatory pathways x Multi - billion dollar markets x No debt, no preferred stock x Up to $10M financing facility with Aspire Capital x Patent applications filed covering composition and methods x Experienced m anagement team 18 Investment/Financial Highlights
19 Seasoned Management Steven Quay, MD, PhD Chairman and CEO Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet Rose Rea, MSPH VP Regulatory, Quality and Clinical Affairs
Atossa Genetics Inc. (IPO November 8, 2012) NASDAQ: ATOS Our Mission Develop novel pharmaceuticals and delivery systems to treat breast conditions including breast cancer Debt (March 31, 2016 ) NONE Cash (March 31, 2016) $3.2M Shares Outstanding (May 31, 2016) 39M Corporate Headquarters Seattle, Washington Corporate Summary 20
21 NASDAQ: ATOS WWW . ATOSSAGENETICS . COM ©2016, A TOSSA G ENETICS , I NC . A LL R IGHTS R ESERVED . F OR M ORE I NFORMATION : K YLE G USE , CFO AND G ENERAL C OUNSEL KYLE . GUSE @ ATOSSAGENETICS . COM