Outlook Therapeutics, Inc. · NASDAQ:OTLK
Outlook Therapeutics — Corporate Update (August 2021)
21 slides from Outlook Therapeutics's corporate update, Aug 3, 2021
Slide 1: ONS-5010: NORSE TWO Top-Line Results
ONS - 5010: NORSE TWO Top - Line Results August 3, 2021 NASDAQ: OTLK outlooktherapeutics.com
Slide 2: Forward-looking statements
This presentation contains forward - looking statements about Outlook Therapeutics, Inc . (“Outlook Therapeutics” or the “Company”) based on management’s current expectations, which are subject to known and unknown uncertainties and risks . Words such as “anticipated,” “initiate,” “expect,” “intend,
Slide 3: Call Agenda
Call Agenda • Introduction and Opening Remarks • NORSE TWO: Study Design and Demographics • NORSE TWO Top - line Efficacy and Safety Results • Wet AMD Market Overview • Commercial Strategy • Next Steps 3
Slide 4: Executing on Pathway Towards Potential FDA Approval in Wet AMD
Executing on Pathway Towards Potential FDA Approval in Wet AMD 4 Open - Label Safety Study Supports BLA Requirements x Completed Clinical Experience Trial 1 st Registration Trial x Positive Results U.S. BLA Filing Targeted Calendar Q1 2022 Pivotal Trial 2 nd Registration Trial x Positive Top - line
Slide 5: Pivotal Trial: 2nd Registration Trial Highlights
5 Pivotal Trial 2 nd Registration Trial Trial Highlights: • Randomized masked controlled trial • ONS - 5010 (bevacizumab - vikg ) vs LUCENTIS® (ranibizumab) • 228 patients enrolled • Trial conducted in the United States • Trial arms included >95% treatment - naïve patients • Safety & efficacy data s
Slide 6: Terry Dagnon, Chief Operating Officer
Terry Dagnon Chief Operating Officer 6
Slide 7: NORSE TWO Pivotal Trial Design
NORSE TWO Pivotal Trial Design 7 ONS - 5010 (bevacizumab - vikg ) administered monthly X 12 LUCENTIS dosing arm (PIER dosing) – Three initial monthly injections followed by fixed quarterly dosing Primary endpoint difference in proportion of subjects gaining 15 letters of BCVA at Day 330 Randomized m
Slide 8: Study Disposition and Demographic Characteristics
Study Disposition 8 Demographic Characteristics Statistic ONS - 5010 (bevacizumab - vikg ) LUCENTIS® ( ranibizumab) Overall Number of Subjects Screened n 378 Randomized n 113 115 228 Received at Least 1 Dose n (%) 113 (100.0) 115 (100.0) 228 (100.0) Completed Study n (%) 103 (91.2) 96 (83.5) 199 (87
Slide 9: Positive Efficacy Data
Positive Efficacy Data 9 Unprecedented 41% ONS - 5010 with 3 - Line Gainers 1 Statistically Significant Difference Across Both Primary and Key Secondary Endpoints ONS - 5010 (bevacizumab - vikg ) LUCENTIS® ( ranibizumab) p - value Primary Endpoint: Difference in subjects who gained at least 15 lette
Slide 10: Safety Results: Consistent with NORSE ONE and NORSE THREE
Safety Results: Consistent with Previously Reported Results from NORSE ONE and NORSE THREE 10 In All Three Studies Only One Subject has Reported Ocular Inflammation Characteristic Statistic ONS - 5010 (Masked Data) (N=113) Ranibizumab (N=115) Overall (Masked Data) (N=228) At Least 1 TEAE n (%) 83 (7
Slide 11: C. Russell Trenary III, President & Chief Executive Officer
11 C. Russell Trenary III President & Chief Executive Officer
Slide 12: Summary of NORSE TWO Results
Summary of NORSE TWO Results x NORSE TWO demonstrated statistical significance across primary and key secondary endpoints x In NORSE TWO ONS - 5010 was demonstrated to be safe and well tolerated x NORSE TWO is the final step needed in clinical evaluation of ONS - 5010 x Confidence as we move forward
Slide 13: Targeting Large and Growing Ophthalmic Markets
Targeting Large and Growing Ophthalmic Markets 13 83% 12% 5% wAMD DR/DME RVO 73% 24% 3% wAMD DR/DME RVO 2020 9MM Anti - VEGF Revenue Share (USD) $13.1B 2030 9MM Anti - VEGF Revenue Share (USD) Sources: Guidehouse Triangulation of Global Data, Market Scope and Investor Forecasts (2020);*9MM is US, EU
Slide 14: Unapproved Bevacizumab Represents 50% of U.S. Wet AMD Market
Unapproved Bevacizumab Represents 50% of U.S. Wet AMD Market 14 Anti - VEGF U.S. Market Share in Wet AMD 1 50% 12% 1% 1% 36% Used Off - Label Expected Drivers to Compete Across All Ophthalmic Anti - VEGF Therapeutics, if Approved by FDA 1 2 Provide cost - effective FDA approved ophthalmic bevacizuma
Slide 15: Commercial Planning Activities Underway
Commercial Planning Activities Underway 15 If ONS - 5010 (bevacizumab - vikg ) is FDA approved and has a cost - effective profile, Outlook Therapeutics expects ONS - 5010 to be widely adopted by payors and clinicians worldwide and to become the first - line drug of choice for payor - mandated “step
Slide 16: Manufacturing and Regulatory Progress Towards Commercialization
Manufacturing and Regulatory Progress Towards Commercialization 16 Manufacturing Best - in - class cGMP manufacturing partners Pre - Filled Syringes Supply agreement for a best - in - class pre - filled ophthalmic syringe Regulatory Achieved requirements agreed upon with the FDA
Slide 17: Next Steps
Next Steps • On target for U.S. FDA BLA submission in calendar Q1 2022 • Accelerate pre - commercial activities to support potential launch - Manufacturing - Distribution - Sales force planning - Physician and payor advisory boards - Key opinion leader support 17
Slide 18: Goal: Enhance the Standard of Care in Treating Retinal Disorders
Goal: 18 Enhance the Standard of Care in Treating Retinal Disorders
Slide 19: Q&A
19 Q&A
Slide 20: Thank you!
Thank you! 20 Employees Patients Investigators Partners Investors CROs
Slide 21: Thank you! Investor Relations
Thank you! NASDAQ: OTLK outlooktherapeutics.com Investor Relations JTC Team 833.475.8247 otlk@jtcir.com
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