CORPORATE PRESENTATION

Transcription

2 Forward-Looking Statements 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. 2

3 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 ductal carcinoma in-situ (DCIS) and breast cancer 3

4 The Unmet Need 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 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 benefit profile 4

5 Pharmaceu?cal Development Programs Candidate IndicaFon Pivotal Preclinical Phase 1 Phase 2 Phase 3 NDA Market ATG Hyperplasia Measured by Breast Density Phase 2 to start Q2/ * Micro Catheters/ Fulvestrant DCIS/ Breast Cancer Phase 2 to start Q * 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 5

6 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 and is protected by 10 patent families 6

7 Oral Tamoxifen: The Good and Bad 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, polyps, and vaginal discharge Only about 1% of eligible women will take oral Tamoxifen 7

8 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 Q and wriyen feedback has been received ² PaFent enrollment is targeted for Q2/

9 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: Clin Cancer Res 2014;20: Breast Cancer Res Treat 2007;106:

10 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 ² Seek opportunifes to accelerate FDA review ² Target NDA via 505(b)(2) pathway 10

11 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 Division of Cancer PrevenFon, NaFonal Cancer InsFtute, Bethesda, MD Lee et al, Clin Cancer Res 2014; 20:

12 Phase 2 Neoadjuvant Study in DCIS: Oral Tamoxifen v ATG 0-10 Oral T ATG % -53% p=0.01 from baseline p=0.03 from baseline p=0.99 between groups Treatment Breast adipose tissue (ng/g) Plasma (ng/ml) Oral T 13.4 (100%) 7.0 (100%) ATG 11.0 (82%) 0.2 (3%) Active metabolites of Oral T: endoxifen + 4-OHT Lee et al, Clin Cancer Res 2014; 20:

13 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 13

14 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 exposure vs systemically delivered agents 14

15 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) 15

16 Intraductal Microcatheters: Clinical Development ² Phase 2 Study to commence in Q 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 16

17 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 17

18 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 18

19 2015 Milestones Achieved IND for Intraductal Delivery of Fulvestrant In-Licensed ATG from Besins Healthcare TransiFoned from Device and DiagnosFcs Company to PharmaceuFcs Company Completed Sale of our Lab The NRLBH Tech Transfer and Manufacture of Afimoxifene API 19

20 2016 Milestones IniFate Fulvestrant/Microcatheter Phase 2 Trial Q Complete Manufacturing of ATG for Clinical Trials Q2/ IniFate ATG Phase 2 Clinical Trial Q2/

21 Investment/Financial Highlights 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 21

22 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 Medical Affairs and ScienFfic Development 22

23 Corporate Summary Atossa Gene?cs Inc. (IPO November 8, 2012) Our Mission NASDAQ: ATOS 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 23