Atossa Therapeutics, Inc. · NASDAQ:ATOS
Atossa Therapeutics — Atossa Genetics — Corporate Update (September 2018)
25 slides from Atossa Therapeutics's corporate update, Sep 13, 2018
Slide 1: Preliminary Topical Endoxifen Male Phase 1 Results All Objectives Successfully Met
Preliminary Topical Endoxifen Male Phase 1 Results All Objectives Successfully Met September 13, 2018 1 107 Spring St. Seattle WA 98104
Slide 2: Forward-Looking Statements
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 managemen
Slide 3: Discussion Topics
DISCUSSION TOPICS • Atossa Genetics Overview • Endoxifen • Phase 1 Study • Preliminary Safety Summary • Preliminary Tolerability Summary • Preliminary Pharmacokinetic Summary • Next Steps 107 Spring St. Seattle WA 98104 3
Slide 4: Atossa Genetics Overview
Atossa Genetics Overview 107 Spring St. Seattle WA 98104 4
Slide 5: Atossa Genetics
Atossa Genetics: • Clinical - stage • Novel drugs & delivery methods • Breast cancer & other breast conditions • Headquartered in Seattle, WA 107 Spring St. Seattle WA 98104 5
Slide 6: Senior 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 6 Senior Management
Slide 7: Corporate Summary
Company: Atossa Genetics Inc. (NASDAQ: ATOS) Our Mission: Develop novel pharmaceuticals and delivery systems to treat breast cancer and other breast conditions Debt June 30, 2018: None Cash June 30, 2018: $15.2M Capital Structure Sept. 5, 2018: 5.5M shares common stock 1.0M shares preferred stock, a
Slide 8: Clinical Program Summary
Clinical Program Summary ● Phase 2 study to determine if oral Endoxifen reduces tumor activity in early stage breast cancer patients in the “window of opportunity” between diagnosis of breast cancer and surgery (now enrolling in Australia) ● Phase 2 study to determine if topical Endoxifen reduces ma
Slide 9: Near-Term Milestones
Near - Term Milestones ● Q4 2018: Complete enrollment in Phase 2 study to reduce MBD ● Q4 2018: Retain CRO for Phase 2 study of topical Endoxifen to treat gynecomastia in prostate cancer patients ● Q4 2018: Retain CRO for Phase 2 study of oral Endoxifen for patients who are “refractory” to Tamoxifen
Slide 10: Endoxifen
Endoxifen 107 Spring St. Seattle WA 98104 10
Slide 11: Phase 1 Study - Men
107 Spring St. Seattle WA 98104 11 Phase 1 Study - Men
Slide 12: Preliminary Phase 1 Topical Results
Preliminary Phase 1 Topical Results • Study objectives achieved • Demonstrated: - No Safety Issues - No Tolerability Issues - Topical Endoxifen not detected in the blood stream Supports continued development 107 Spring St. Seattle WA 98104 12
Slide 13: Preliminary Study Conclusions
Preliminary Study Conclusions • All study objectives successfully achieved • Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen. • Tolerability: Topical Endoxifen was well tolerated at each dose level a
Slide 14: Topical Design Summary
Topical Design Summary Cohort Dose Number of Participants mg per Breast Total mg (Z) - Endoxifen Placebo 1 1 2 6 2 2 3 6 6 2 3 5 10 6 2 107 Spring St. Seattle WA 98104 14 x Healthy males, 18 to 65 years of age x Body Mass Index of 18 to 32 x No chronic or acute disease x Daily administration diaries
Slide 15: Safety Summary
Safety Summary 107 Spring St. Seattle WA 98104 15
Slide 16: Safety Summary
Safety Summary • No safety signals observed in weekly assessments of/in: • Blood chemistry • Coagulation parameters • Hematology parameters • Urinalysis • Vital Signs • Heart • Physical Examinations 107 Spring St. Seattle WA 98104 16
Slide 17: Adverse Events
Adverse Events • There were no Serious Adverse Events • No significant treatment - emergent Adverse Events related to study drug 107 Spring St. Seattle WA 98104 17
Slide 18: Tolerability Summary
Tolerability Summary 107 Spring St. Seattle WA 98104 18
Slide 19: Local Tolerability By Instances
Local Tolerability By Instances • A daily self - assessment of local tolerance was performed • 24 subjects for 28 days for a total of 672 daily assessments • Redness, Burning, Pain, Itching and Irritation were assessed each day • Scoring was None, Mild, Moderate or Severe for all five parameters 107
Slide 20: Overall Tolerability Scoring: Based on Instance
Overall Tolerability Scoring: Based on Instance None Mild Moderate Severe Not Done 107 Spring St. Seattle WA 98104 20 None 97.2% Mild 2.5% Moderate 0.3% Severe 0.0%
Slide 21: Parameter by Instance
Parameter by Instance Parameter Percent Reporting None Redness 96% Burning 98% Pain 99% Itching 95% Irritation 97% 107 Spring St. Seattle WA 98104 21 One subject reported itching, irritation, redness and burning, and accounted for over 50% of the reports skin reactions
Slide 22: In-person Interview Results for Side-effects
In - person Interview Results for Side - effects There were sporadic reports of weight change (gain or loss), breast tenderness and headache A participant who received placebo reported the highest frequency of side - effects and itching, irritation, redness and burning 107 Spring St. Seattle WA 9810
Slide 23: Pharmacokinetic Summary
107 Spring St. Seattle WA 98104 23 Pharmacokinetic Summary Endoxifen blood levels below detection limit of assay
Slide 24: Next Steps in Gynecomastia
Next Steps in Gynecomastia • Q4 2018: Report final data • Q4 2018: Retain CRO for male Phase 2 study of topical Endoxifen to reduce/prevent gynecomastia and maintain and/or improve quality of life 107 Spring St. Seattle WA 98104 24
Slide 25: NASDAQ: ATOS 107 Spring St. Seattle WA 98104 25
NASDAQ: ATOS 107 Spring St. Seattle WA 98104 25