Atossa Therapeutics, Inc. · NASDAQ:ATOS
Atossa Therapeutics — Atossa Genetics — Investor Presentation (February 2018)
31 slides from Atossa Therapeutics's investor presentation, Feb 21, 2018
Slide 1: Corporate Presentation February 21, 2018
1 NASDAQ: ATOS WWW . ATOSSAGENETICS . COM ©2018 A TOSSA G ENETICS , I NC . A LL R IGHTS R ESERVED . C ORPORATE P RESENTATION F EBRUARY 21, 2018
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 an
Slide 3: Atossa Genetics (NASDAQ: ATOS)
Atossa Genetics (NASDAQ: ATOS) 3 - Clinical - stage company - Novel pharmaceuticals - Novel drug delivery methods - Breast cancer & other breast conditions
Slide 4: Our Drug and Delivery Programs
Our Drug and Delivery Programs 4 Drug Programs Using our Proprietary Endoxifen: • Topical Endoxifen • For mammographic breast density (MBD) reduction • All Phase 1 objectives met • 1 H 2018: Phase 2 study for MBD in Sweden • Oral Endoxifen • For “ tamoxifen - refractory” patients • All Phase 1 objec
Slide 5: Our Drug and Delivery Programs, Cont.
Our Drug and Delivery Programs, Cont. 5 Two Programs Using Proprietary Microcatheter Technology: • Microcatheters for Transpapillary CAR - T Delivery (TRAP CAR - T) – In R&D phase with goals of reducing toxicity, improving efficacy and the potential of T - cells migrating along the lymphatic pathway
Slide 6: Breast Cancer Timeline and Treatment Windows
Suspicious Lump Biopsy Surgery and Radiation/ Chemotherapy Diagnosis Breast Cancer Timeline Tamoxifen (5 years) Intraductal : - Fulvestrant - TRAP CAR - T Oral Endoxifen Neoadjuvant Phase Adjuvant Phase 6 Prevention Window Topical Endoxifen Mammographic Breast Density
Slide 7: Program Pipeline
Program Pipeline 7 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 Microcatheters Fulvestrant - DCIS and BC R&D 2019 2020 Ph. 2 start in 1H ‘18 Breast Density Refractory t o Tamoxifen Ph. 2 s
Slide 8: Large Market Opportunities
Large Market Opportunities 8 Intraductal Fulvestrant : $800M U.S. market in DCIS pre - surgery and replacement to surgery (4) TRAP CAR - T: TBD U.S. Market Triple neg. – 37k patients/yr.; can’t use hormone therapy (3) The Need: Breast Cancer Statistics • 250,000 cancers and 60,000 DCIS in U.S. in 20
Slide 9: The Unmet Need
The Unmet Need 9 Intraductal Microcatheters • Provides alternative to Systemic delivery, which has: - 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 migr
Slide 10: Endoxifen – Rationale for Development
Endoxifen – Rationale for Development 10 • Develop TWO formulations for two large unmet medical needs: – Topical to reduce density: less than 5% of patients at increased risk of breast cancer will take oral t amoxifen because of actual or perceived side effects (1) – Oral: up to 50% of patients taki
Slide 11: Why Endoxifen?
• Low levels of circulating Endoxifen during tamoxifen adjuvant therapy correlate to an increased risk of recurrent or new breast cancers • Identified as an independent risk factor • Known and unknown causes for low endoxifen levels during tamoxifen therapy • Most active tamoxifen metabolite • It ma
Slide 12: Endoxifen - Overview
Endoxifen - Overview 12 • 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 C
Slide 13: MBD Can Mask Tumors
MBD Can Mask Tumors Source: http ://woodtv.com/2015/05/11/are - you - dense - know - your - numbers / 13
Slide 14: MBD Correlates with Cancer Incidence
MBD Correlates with Cancer Incidence http://slideplayer.com/slide/1557508 / 14
Slide 15: Endoxifen – Phase 1 Clinical Trial
Endoxifen – Phase 1 Clinical Trial 15 • Study started in Q2 2017 in Australia; completed Q3 2017 • Pharmacokinetics; safety and tolerability • Placebo controlled, double - blinded • 48 female volunteers • Oral and topical arms at varying dose levels • Single, 28 day repeat dose
Slide 16: Endoxifen – Preliminary Phase 1 Results
Endoxifen – Preliminary Phase 1 Results 16 All objectives in both topical and o ral arms successfully met: • Safety: no clinically significant safety signals and no clinically significant adverse events. • Tolerability: tolerated at each dose level through out the study. • Pharmacokinetics : • Topic
Slide 17: Oral Endoxifen – Potentially Faster Therapy
Oral Endoxifen – Potentially Faster Therapy 17 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/
Slide 18: Oral Endoxifen
Oral Endoxifen 18 Oral Endoxifen may solve the “Tamoxifen Delay” • Low Endoxifen levels in breast cancer patients who take oral tamoxifen correlate with an increased risk of developing new tumors or recurrence • Steady - state of Endoxifen in the serum as a metabolite from daily oral tamoxifen occur
Slide 19: Single Dose Pharmacokinetics Summary – Oral Study
Single Dose Pharmacokinetics Time, hours Pharmacokinetics Summary – Oral Study 19 Potential Therapeutic Level Time to maximum Endoxifen level is less than 8 hours
Slide 20: Oral Tamoxifen Yields Much Slower Blood Levels of Endoxifen
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 20 Oral Tamoxifen Pharmacokinetics
Slide 21: Endoxifen / Tamoxifen – Treatment Timeline
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 28
Slide 22: Oral Endoxifen – Refractory Clinical Trial Design
Oral Endoxifen – Refractory Clinical Trial Design 22 Entry Criteria: Pre - menopausal ER + breast cancer patients on tamoxifen Measure Endoxifen Levels >TBD nM Endoxifen Continue on tamoxifen (20 mg/day) ≤TBD nM Endoxifen Add Oral Endoxifen (2 or 4 mg/day)
Slide 23: Endoxifen Regulatory Pathway
Endoxifen Regulatory Pathway 23 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
Slide 24: Intraductal Microcatheters
Intraductal Microcatheters 24 • Potential advantages: higher local drug/CAR - T exposure; lower systemic concentrations (lower toxicity) vs systemically delivered agents; potential for lymphatic migration of T - cells • 1 issued and 3 pending patent app’s (US and PCT) for intraductal delivery of dru
Slide 25: Intraductal Microcatheters – Fulvestrant Phase 2
Intraductal Microcatheters 25 • Phase 2 study for delivery of fulvestrant in patients with DCIS or breast cancer (initiated at Columbia; transferred to Montefiore) • Advantages: potentially higher local drug exposure and lower systemic concentrations vs systemically delivered agents • Fulvestrant is
Slide 26: Microcatheter Fulvestrant - Clinical Trial Study Design
26 Microcatheter 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: Bio - Marker Expression FACT - ES: Side Effects Tissue and Blood Le
Slide 27: Microcatheters – TRAP CAR-T
Microcatheters – TRAP CAR - T 27 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
Slide 28: Upcoming Milestones
TRAP CAR - T - Seeking partners Topical Endoxifen : 1H 2018 - Phase 2 study for MBD with Karolinska Institute Investigator (Sweden) Oral Endoxifen : 1H 2018 - Phase 2 study in patients refractory to Tamoxifen (AUS) Upcoming Milestones 28
Slide 29: Seasoned Management
29 Seasoned Management Steven Quay, MD, PhD Chairman, CEO and President Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet R. Rea, MSPH, RAC Sr. VP Regulatory, Quality and Clinical Affairs
Slide 30: Corporate Summary
Atossa Genetics Inc. NASDAQ: ATOS Our Mission Develop novel pharmaceuticals and delivery systems to treat breast cancer and other breast conditions Long - Term Debt (1) (Sept. 30, 2017) None Cash (pro forma Sept. 30 , 2017 incl. Oct. offering ) $7.8m Capital Structure (Dec. 20 , 2017) 26.5M common s
Slide 31: For More Information
31 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
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