CORPORATE PRESENTATION

NASDAQ: ATOS

C

ORPORATE

P

RESENTATION

Some of the informaFon presented herein may contain projecFons or other forward-looking statements regarding future events or the future financial performance of the Company which the Company undertakes no obligaFon to update. These statements are based on management’s current expectaFons and are subject to risks and uncertainFes that may cause actual results to differ materially from the anFcipated or esFmated future results, including the risks and uncertainFes associated with clinical trials, acFons by the FDA, regulatory clearances, responses to regulatory maYers, the market demand for and acceptance of Atossa's products and services, performance of clinical research organizaFons and other risks detailed from Fme to Fme in Atossa's filings with the SecuriFes and Exchange Commission, including without limitaFon its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from Fme to Fme.

About Atossa Gene?cs

Atossa GeneFcs is a healthcare company focused on the development of pharmaceuFcals and delivery methods for the treatment of breast Fssue condiFons and early stage breast cancer.

Clinical Stage Pipeline - Drug Development and Delivery Programs

²  Afimoxifene Topical Gel (ATG) – Phase 2 for treatment and

prevenFon of condiFons associated with hyperplasia of the breast

²  Intraductal Microcatheters – Phase 2 to deliver fulvestrant to treat

Current Therapies:

•  Focus on cancer and systemic delivery, which can have adverse effects

•  Incidence

•  200,000 biopsy-proven ADH cases

•  60,000 DCIS cases in the U.S. per year

•  10 million women in the U.S. esFmated to be high risk

•  50% of women in the U.S. have Dense Breasts

The Unmet Need

Current Treatment Approaches:

•  Surgery for ADH, and for DCIS lumpectomy, and

perhaps radiaFon and tamoxifen

•  No approved treatment for breast density,

tamoxifen has been shown to lower density

Atossa Approach:

•  Local treatment is intended to opFmize the risk

Pharmaceu?cal Development Programs

Preclinical Phase 1 NDA Market Candidate IndicaFon

Note: Fulvestrant delivered via Atossa’s microcatheter device and ATG are under development and are not cleared or approved by the FDA for the above condi>ons or indica>ons

* Es>mated Phase 2 Phase 3 DCIS/ Breast Cancer Micro Catheters/ Fulvestrant 2017* Phase 2 to start Q1 2016

ATG _{Measured by} Hyperplasia

Breast Density

2017*

Afimoxifene Topical Gel

²  The acFve pharmaceuFcal ingredient in ATG is afimoxifene

(4-hydroxytamoxifen), an acFve metabolite of tamoxifen

²  Afimoxifene is an anF-estrogen with an affinity for the estrogen

receptor that is up to 50-fold higher compared with that of tamoxifen

²  Afimoxifene disrupts estrogen receptor signaling

²  ATG is a proprietary transdermal gel formulaFon of afimoxifene

Oral Tamoxifen: The Good and Bad

Only about 1% of eligible women will take oral Tamoxifen

Systemic Tamoxifen Administra?on

Pros Breast

• Reduces breast cancer

• Reduces breast density

Liver • Reduces cholesterol Bone • Reduces fractures Cons Eye • Increases cataracts Hypothalamus

• Increases vasomotor symptoms

Liver

• Increases thromboembolism

Uterus

• Increase endometrial cancer, fibroids,

Afimoxifene Topical Gel: Phase 2 Clinical Plan

²  Develop ATG for pre-menopausal women with fibrograndular

hyperplasia who may be at high risk of breast cancer to reduce mammographic breast density

²  Use the rights to a comprehensive preclinical pharmacology and

toxicology package on ATG

²  Manufacturing CMC package is expected to be sufficient to support

an NDA

²  The clinical development plan was reviewed by the FDA in Q4 2015

and wriYen feedback has been received

Afimoxifene Topical Gel: Trials To Date

²  A total of 16 Phase 1 and Phase 2 studies have been conducted in a

variety of breast-related indicaFons in the United States, United Kingdom, France, Poland, and Czech Republic

²  Over 350 women received ATG in clinical trials

²  Results published in peer-reviewed medical journals

J Clin Oncol 2005;23:2980-87. Clin Cancer Res 2014;20:3672-82.

Afimoxifene Topical Gel: Regulatory Pathway

²  Finalize clinical study design based on FDA input and obtain

concurrence

²  Execute clinical development program

²  Review clinical trial results with FDA for next steps

²  Key strategic features:

²  Extensive nonclinical poroolio obtained from Besins Healthcare

(this data is required for an NDA)

²  Leverage exisFng human data

²  Leverage public health concern about breast cancer

Phase 2 Neoadjuvant Study in DCIS: Oral Tamoxifen v ATG

•  Popula?on: N=27 pre- and post-menopausal [45-86]

•  SeRng: 6-10 weeks of conFnuous pre-surgery treatment

•  Randomized Treatment: 20 mg oral Tamoxifen versus 4 mg Afimoxifene Gel

•  Primary Endpoint: Change in Ki-67 labelling index

•  Secondary Endpoint:

•  Plasma and Fssue drug levels at Fme of surgery

•  Study Ins?tu?ons

•  The Robert H. Lurie Cancer Center of Northwestern University, Chicago, IL

•  IIT Research InsFtute, Chicago, IL

•  Washington University School of Medicine, St. Louis, MO

Phase 2 Neoadjuvant Study in DCIS: Oral Tamoxifen v

ATG

Treatment Breast adipose tissue (ng/g) Plasma (ng/mL)

Phase 2 Neoadjuvant Study in DCIS: Oral Tamoxifen v ATG

²  Conclusions:

²  ATG was shown to have similar biologic acFvity to oral

tamoxifen

²  ATG was shown to have comparable levels within the

breast Fssue to oral tamoxifen, with much lower plasma concentraFons

Intraductal Microcatheters – A Novel Delivery Tool

²  Patented Intraductal Microcatheters – being developed for local delivery

of a number of therapeuFcs

²  IniFal study: Phase 2 study at Columbia University for delivery of

fulvestrant in DCIS and breast cancer

²  PotenFal advantage: higher local drug exposure and lower systemic drug

Ra?onale for Development of Intraductal Fulvestrant

Atossa owns 11 U.S. and 35 foreign issued

patents for intraductal treatment of cancer and pre-cancer, including intraductal

administraFon of fulvestrant

Fulvestrant was approved by the FDA in 2002 for intramuscular treatment of metastaFc ER+ breast cancer in

postmenopausal women (marketed as Faslodex by AstraZeneca)

Intraductal Microcatheters: Clinical Development

²  Phase 2 Study to commence in Q1 2016 at Columbia University

²  30 paFents will be treated with Fulvestrant prior to mastectomy, six to

be dosed intramuscularly and the remaining 24 will be dosed via intraductal administraFon

² Builds on prior studies and commercial success of fulvestrant and prior

intraductal studies

² Sets up a proof of concept study for the establishment of a plaoorm

technology for intraductal delivery of other therapeuFcs for breast disorders

Intraductal Microcatheters: Regulatory Pathway

²  The FDA issued a “Safe to Proceed” leYer for our first

InvesFgaFonal New Drug applicaFon (IND) in Sep 2015

²  Although we do not have FDA’s input, it is our preliminary

assessment that the microcatheter intraductal fulvestrant program could qualify for designaFon under the 505(b)(2) status

²  DesignaFon under the 505(b)(2) status would allow us to seek

markeFng approval with only clinical data and without having to perform addiFonal significant clinical or pre-clinical studies

²  Since the drug has been used systemically and the safety profile

is well-defined, the 505(b)(2) path to market would be both faster and less expensive than a tradiFonal NDA program

Patent and License Por]olio

²  Exclusive worldwide license from Besins Healthcare: ATG for the

treatment of hyperplasia and opFon rights to other indicaFons

²  Issued patent covering intraductal delivery of fulvestrant via Atossa

microcatheters and pending applicaFons for the microcatheter intraductal administraFon of many anF-cancer drugs

²  147 issued U.S. patents directed to the collecFon and analysis of

specimens, devices, and the diagnosis and appropriate treatment of precancerous breast health condiFons

IND for Intraductal Delivery of Fulvestrant

Tech Transfer and Manufacture of Afimoxifene API

Completed Sale of our Lab – The NRLBH

2015 Milestones Achieved

TransiFoned from Device and DiagnosFcs Company to PharmaceuFcs Company In-Licensed ATG from Besins Healthcare

IniFate Fulvestrant/Microcatheter Phase 2 Trial Q1 2016

IniFate ATG Phase 2 Clinical Trial Q2/3 2016

Complete Manufacturing of ATG for Clinical Trials Q2/3 2016

ü  Two Phase 2 programs: ATG and fulvestrant intraductal development

drives value

ü  Favorable clinical and regulatory pathways

ü  MulF-billion dollar markets - women’s health driven

ü  Unmet medical need in men’s breast health

ü  No debt, no preferred stock

ü  Up to $25M financing facility with Aspire Capital

ü  147 Issued Patents, plus Licensed IP from Besins

ü  Experienced Management Team

Seasoned Management

Steven Quay, MD, PhD

Chairman and CEO Kyle Guse, CPA, ESQ, MBA CFO and General Counsel

ScoY Youmans COO

Janet Rose Rea, MSPH Vice President

Regulatory Affairs and Quality

Gerald Engley, PharmD Vice President

Atossa Gene?cs Inc.

(IPO November 8, 2012) NASDAQ: ATOS

Our Mission Develop pharmaceuFcals and localized delivery systems to reduce breast cancer

Debt (Sept. 30, 2015) $0

Cash (Sept. 30, 2015) $7.9M

Shares Outstanding (Sept. 30, 2015) 29M

Corporate Headquarters SeaYle, Washington

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