Slide 1: Corporate Presentation May 16, 2018
1 NASDAQ: ATOS WWW . ATOSSAGENETICS . COM ©2018 A TOSSA G ENETICS , I NC . A LL R IGHTS R ESERVED . C ORPORATE P RESENTATION M AY 16, 2018 Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated May 16, 2018 Relating to Prospectus dated May 10, 2018 Registration Statement No. 333 - 223949
Slide 2: Forward-looking statements and offering disclaimer
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 an
Slide 3: Corporate Summary
Corporate Summary Issuer: Atossa Genetics Inc. (NASDAQ: ATOS) Our Mission: Develop novel pharmaceuticals and delivery systems to treat breast cancer and other breast conditions Debt Mar. 31, 2018: None Cash Mar. 31, 2018: $4.8 million Capital Structure Mar. 31, 2018: 2.65M common shares; no preferre
Slide 4: Seasoned Management
Steven Quay, MD, PhD Chairman, CEO and President Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet R. Rea, MSPH, RAC SVP Regulatory, Quality and Clinical Affairs Seasoned Management 4
Slide 5: Corporate Summary
Corporate Summary Issuer: Atossa Genetics Inc. (NASDAQ: ATOS) Our Mission: Develop novel pharmaceuticals and delivery systems to treat breast cancer and other breast conditions Debt Mar. 31, 2018: None Cash Mar. 31, 2018: $4.8 million Capital Structure Mar. 31, 2018: 2.65M common shares; no preferre
Slide 6: Drug Programs
Drug Programs Using our Proprietary Endoxifen : • Topical Endoxifen Mammographic breast density (MBD) reduction Gynecomastia (male) • Oral Endoxifen - Adjuvant therapy in breast cancer patients Drug Programs 6
Slide 7: Drug Delivery Programs
Programs Using Proprietary Microcatheter Technology: • Microcatheters for Transpapillary CAR - T Delivery (TRAP CAR - T) - R&D program • Intraductal Microcatheters for Drug Delivery - Phase 2 study underway Drug Delivery Programs 7
Slide 8: Breast Cancer Timeline
Suspicious Lump Biopsy Surgery and Radiation/ Chemotherapy Diagnosis Tamoxifen (5 - 10 years) Intraductal : - Fulvestrant - TRAP CAR - T Oral Endoxifen Neoadjuvant Phase Adjuvant Phase Prevention Window Topical Endoxifen Mammographic Breast Density Breast Cancer Timeline 8
Slide 9: Program Pipeline
Pivotal Preclinical Phase 1 NDA* Market Drug/Device Program * Estimated FDA or Ex - US submission Phase 2 Phase 3 TRAP CAR - T Microcatheters Ph. 2 Underway Fulvestrant - DCIS and BC R&D 2020 2021 Ph. 2 start in 1H ‘18 MBD Refractory t o Tamoxifen Ph. 2 start in 1H ‘18 Topical Endoxifen Oral Endoxif
Slide 10: Large Market Opportunities
(1) Nat’l Cancer Inst.: Prevalence of Mammographically Dense Breasts in the United States (Retrieved from https ://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200066/ ) (2) Mayo Clinic (retrieved from: https:// www.mayoclinic.org /diseases - conditions/ gynecomastia /symptoms - causes/syc - 20351793 ) (3)
Slide 11: Intraductal Microcatheters and Endoxifen Opportunities
Intraductal Microcatheters • Provides alternative to systemic delivery, which can have: - Systemic adverse effects - Limited tumor drug level • ATOS microcatheter technology may: - Increase drug to tumor ratio - Improve efficacy - Reduce toxicity - CAR - T cells may follow lymphatic migration of can
Slide 12: Endoxifen - Overview
• Most active metabolite of tamoxifen • Tamoxifen has been widely studied • Tamoxifen is a pro - drug • Up to 50% of patients can’t make enough E ndoxifen (1) Tamoxifen Endoxifen (1) Breast Care (Basel): Clinical Relevance of CYP2D6 Genetics for Tamoxifen Response in Breast Cancer ( Retrieved from:
Slide 13: MBD Can Mask Tumors
Source: http ://woodtv.com/2015/05/11/are - you - dense - know - your - numbers / MBD Can Mask Tumors 13
Slide 14: MBD Correlates with Cancer Incidence
Source: http ://slideplayer.com/slide/1557508 / MBD Correlates with Cancer Incidence 14
Slide 15: Endoxifen - Phase 1 Clinical Trial
• Female Phase 1: Completed Q3 2017 • Pharmacokinetics; safety and tolerability • Placebo controlled, double - blinded • 49 female volunteers • Oral (single and repeat dose) and topical (28 - day repeat dose) arms at varying dose levels Endoxifen – Phase 1 Clinical Trial 15
Slide 16: Endoxifen - Phase 1 Results
• Safety : no clinically significant safety signals and no clinically significant adverse events. • Tolerability: tolerated at each dose level through out the study. • Pharmacokinetics : • Topical - crossed the skin barrier when applied daily to the breast, as demonstrated by low but measurable Endo
Slide 17: Topical Endoxifen for Men
• Underserved markets in Gynecomastia • Gynecomastia (breast enlargement and pain): – Affects 25% of men ages 50 - 69 (1), approx. 10m men – Causes: androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti - anxiety medications; cancer treatments (chemotherapy), and some
Slide 18: Topical Endoxifen Phase Study - Male Cohort
Topical Endoxifen Phase 1 Study - Male Cohort Dose Level Number of Participants (mg/breast) (Total mg) (Z) - Endoxifen Placebo 1 1 2 6 2 2 3 6 6 2 3 5 10 6 2 18
Slide 19: Oral Endoxifen - Potentially Faster Therapy
Atossa Oral Endoxifen May Solve the “Tamoxifen Delay ” Endoxifen Source Time to Steady State Oral Tamoxifen (daily) Approx. 50 to 200 days (1) Atossa Oral Endoxifen (daily) 7 days (1) https ://www.ncbi.nlm.nih.gov/pmc/articles/PMC3357105/ Oral Endoxifen – Potentially Faster Therapy 19
Slide 20: Pharmacokinetics Summary - Oral Study
Single Dose Pharmacokinetics Time, hours Potential Therapeutic Level Time to maximum Endoxifen level is less than 8 hours Pharmacokinetics Summary – Oral Study 20
Slide 21: Oral Tamoxifen Pharmacokinetics
Oral Tamoxifen Yields Much Slower Blood Levels of Endoxifen 50 to >200 days to reach endoxifen steady - state levels Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3357105/ The difference is metabolizer status Oral Tamoxifen Pharmacokinetics 21
Slide 22: Endoxifen / Tamoxifen - Treatment Timeline
29 Days +29 Days This is 25 th percentile on breast cancer growth rate in women 50 - 59, as measured by mammography (1) (1) https://breast - cancer - research.biomedcentral.com/articles/10.1186/bcr2092 Oral Endoxifen Oral Tamoxifen Endoxifen / Tamoxifen – Treatment Timeline 22
Slide 23: Oral Endoxifen - Refractory Clinical Trial
Entry Criteria: ER + breast cancer patients on tamoxifen Measure Endoxifen Levels >35 nM Endoxifen Continue on tamoxifen ≤35 nM Endoxifen Add Oral Endoxifen (4 mg/day) Oral Endoxifen – Refractory Clinical Trial 23
Slide 24: Endoxifen Regulatory Pathway
Program 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 • Multi - year market exclusivity possible Endoxifen Regulatory Pathway 24
Slide 25: Intraductal Microcatheters
• Potential advantages - higher local drug/CAR - T exposure; lower systemic concentrations (lower toxicity) vs systemically delivered agents; potential for lymphatic migration of T - cells • Recent Activity - Kite Pharma acquisition by Gilead; Juno acquired by Celgene ; FDA approved Novartis's Kymri
Slide 26: Fulvestrant - Clinical Trial Study
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: Bio - Marker Expression FACT - ES: Side Effects Tissue and Blood Levels of Fulvestrant Intramuscular Administration Intraducta
Slide 27: Local Delivery of CAR-T for Breast Cancer
Local Delivery of CAR - T for Breast Cancer • Safety : Reduced risk of systemic complications • Efficacy : Delivery of CAR - T cells to the site of the cancer cells. Greater CAR - T to cancer cell ratio. • Dose : Fewer cells would be required • Reduced cost • Increased access (due to production, cos
Slide 28: Microcatheters - TRAP CAR-T
Source: NIH Step 1 : Remove blood and genetically modify T - cells to kill cancer Step 2 : Atossa’s Transpapillary (TRAP) microcatheters deliver CAR modified T - cells to breast ducts containing cancer cells Microcatheters – TRAP CAR - T 28
Slide 29: Upcoming Milestones
TRAP CAR - T - Seeking partners Topical Endoxifen : (1) 2Q 2018 – Open Phase 2 study for MBD (Sweden) (2) 2Q 2018 – Complete enrollment in Phase 1 study in men Oral Endoxifen : 2Q 2018 – Open Phase 2 study in patients refractory to Tamoxifen Upcoming Milestones 29
Slide 30: For More Information
30 NASDAQ: ATOS WWW . ATOSSAGENETICS . COM ©2018, 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