Slide 1: Corporate Presentation July 27, 2016
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
Slide 2: Forward-Looking Statements
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 a
Slide 3: About Atossa Genetics
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.
Slide 4: Our Programs
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
Slide 5: Breast Cancer Timeline and Treatment Points
Suspicious Lump Biopsy Surgery* and/or Radiation/ Chemotherapy Diagnosis Breast Cancer Timeline Tamoxifen (5 years) Intraductal Fulvestrant Oral Endoxifen Neoadjuvant Adjuvant * Mastecomy or lumpectomy
Slide 6: Program Pipeline
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
Slide 7: The Unmet Need
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 Curren
Slide 8: Neoadjuvant: Intraductal Microcatheters
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 h
Slide 9: Intraductal Fulvestrant - Clinical Trial Study Design
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 F
Slide 10: Intraductal Fulvestrant - Regulatory Pathway
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 Ma
Slide 11: Adjuvant Solution: Oral Endoxifen
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
Slide 12: Tamoxifen is a Pro-Drug with Many Metabolites
Tamoxifen is a Pro - Drug with Many Metabolites 12
Slide 13: Only Three Have Cancer Inhibition Activity
Only Three Have Cancer Inhibition Activity… 13
Slide 14: Major Tamoxifen Metabolites
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
Slide 15: Low Plasma Endoxifen Predicts Recurrence
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 Rec
Slide 16: Endoxifen - Clinical Trial Design
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)
Slide 17: 2016 Value Creation Points
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
Slide 18: Investment/Financial Highlights
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 coverin
Slide 19: Seasoned Management
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
Slide 20: Corporate Summary
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, Was
Slide 21: WWW . ATOSSAGENETICS . COM ©2016, A TOSSA G ENETICS , I NC .
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