Atossa Therapeutics, Inc. · NASDAQ:ATOS
Atossa Therapeutics — Atossa Genetics — Corporate Update (February 2018)
31 slides from Atossa Therapeutics's corporate update, Feb 1, 2018
Slide 1: Endoxifen Clinical Update
Endoxifen Clinical Update February 1, 2018 107 Spring Street • Seattle, WA 98104 USA
Slide 2: Forward-looking Statements
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 and
Slide 3: Additional Data Announced Today: Oral Endoxifen May Solve the Tamoxifen Delay
Additional Data Announced Today 3 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 4: Oral Endoxifen may solve the Tamoxifen Delay
Additional Data Announced Today 4 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
Slide 5: Discussion Topics
Discussion Topics • Atossa Genetics Overview • Endoxifen Clinical Update • Upcoming Milestones 5
Slide 6: Atossa Genetics Overview
Atossa Genetics Overview @Atossa GENETICS 6
Slide 7: About Atossa
About Atossa (NASDAQ: ATOS) 7 - Clinical - stage company - Novel pharmaceuticals - Novel drug delivery methods - Breast cancer & other breast conditions
Slide 8: Recent capitalization improvements
Corporate Update 8 Recent capitalization improvements: • Cash at Sept. 30, 2017: $2.8M • Capital raise Dec. 20, 2017: $1.4M • Capital raise Oct. 30, 2017: $5.5M • Warrants from Apr. 2017 financing: all exercised
Slide 9: Our Drug and Delivery Programs
Our Drug and Delivery Programs 9 Drug Programs Using our Proprietary Endoxifen: • Topical Endoxifen - For mammographic breast density (MBD) reduction • Oral Endoxifen - For “tamoxifen - refractory” patients
Slide 10: Our Drug and Delivery Programs, Cont.
Our Drug and Delivery Programs, Cont. 10 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 pathw
Slide 11: The Unmet Need
The Unmet Need 11 Intraductal Microcatheters ATOS microcatheter technology may: • Increase drug to tumor ratio • Improve efficacy • Reduce toxicity • CAR - T cells may follow lymphatic migration of cancer Topical Endoxifen for MBD • No FDA approved treatment • 10 million women (1) Oral Endoxifen for
Slide 12: Breast Cancer Timeline
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 Prevention Window Topical Endoxifen High Density via Mammography 12
Slide 13: Oral Endoxifen
Oral Endoxifen @Atossa GENETICS 13
Slide 14: Tamoxifen Metabolites
Altered availability of active tamoxifen metabolites regulated by drug - metabolizing enzymes such as CYP2D6 can cause tamoxifen resistance Endoxifen is the primary metabolite responsible for the overall effectiveness of tamoxifen Compound Plasma Level (nM) IC 50 Estrogen Receptor Effect (nM) PL/IC
Slide 15: Endoxifen - Overview
Endoxifen - Overview 15 • Most active metabolite of tamoxifen • Tamoxifen has been widely studied • Tamoxifen is a pro - drug • Up to 50% of patients can’t make enough Endoxifen (1) Tamoxifen Endoxifen (1) Breast Care (Basel): Clinical Relevance of CYP2D6 Genetics for Tamoxifen Response in Breast Ca
Slide 16: Low Endoxifen correlates with increased risk of breast cancer
Endoxifen 16 Low Endoxifen correlates with increased risk of breast cancer • 1. J Natl Cancer Inst 2011;103:744 – 752 2. Cuzick J, et al. J Natl Cancer Inst 2004 3. https:// www.ncbi.nlm.nih.gov / pmc /articles/PMC3081375/
Slide 17: 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 18: Emerging Unmet Medical Need
• Tamoxifen Treatment Delay – 100% of patients get no treatment effect when just starting tamoxifen • Tamoxifen Refractory Patients – Up to 50% of patients fail to achieve therapeutic endoxifen blood levels ever • Approximately 30 nM is therapeutic threshold – Only option is aromatase inhibitors • S
Slide 19: Large Market Opportunities
Large Market Opportunities 19 Intraductal Fulvestrant : $800M U.S. market in DCIS pre - surgery and replacement to surgery (Defined Health 1/17) TRAP CAR - T: TBD U.S. Market Triple neg. – 37k patients/yr.; can’t use hormone therapy The Need: Breast Cancer Statistics • 250,000+ cancers and 60,000 DC
Slide 20: Phase Study
Phase 1 Study @Atossa 20 NETICS
Slide 21: Final Study Conclusions
All study objectives successfully achieved – Safety: There were no clinically significant safety signals and no clinically significant or serious adverse events in participants receiving oral Endoxifen . – Tolerability: Oral Endoxifen was well tolerated at each dose level throughout the study . – Ph
Slide 22: Final Study Conclusion (cont.)
Final Study Conclusion (cont.) 22 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 23: Additional Data Announced Today
Additional Data Announced Today 23 Atossa 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 d
Slide 24: Pharmacokinetics Summary
Pharmacokinetics Summary 24 Oral Endoxifen yielded blood levels that met or exceeded the published therapeutic levels in the adjuvant setting in breast cancer patients. Both the extent and the rate of endoxifen delivery to the systemic circulation is therapeutically attractive
Slide 25: Single Dose Pharmacokinetics Summary – Oral Study
Single Dose Pharmacokinetics Time, hours Pharmacokinetics Summary – Oral Study 25 Potential Therapeutic Level Time to maximum Endoxifen level is less than 8 hours
Slide 26: 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 26 Oral Tamoxifen Pharmacokinetics
Slide 27: Why Are Rapid Blood Levels Important?
Why Are Rapid Blood Levels Important? 27 Oral Endoxifen Pharmacokinetics
Slide 28: 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 29: Upcoming Milestones
TRAP CAR - T - Seeking partners Topical Endoxifen: Phase 2 study of MBD to open in Q1 ‘18 with Karolinska Institute Investigator in Stockholm Oral Endoxifen : Phase 2 study for patients refractory to Tamoxifen is planned to open in Q1 ‘18 Upcoming Milestones 29
Slide 30: Seasoned Management
30 Seasoned Management Steven Quay, MD, PhD Chairman, CEO and President Kyle Guse, CPA, ESQ, MBA CFO and General Counsel Janet Rose Rea, MSPH, RAC Sr. VP Regulatory, Quality and Clinical Affairs
Slide 31: @ Atossa
@ Atossa GENETICS NASDAQ: ATOS