Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Day (September 2016)
24 slides from Aldeyra Therapeutics's investor day presentation, Sep 26, 2016
Slide 1: Research and Development Day
A Novel Pharmaceutical Platform Focused on Inflammation and Rare Inborn Errors of Metabolism Research and Development Day September 26, 2016 Exhibit 99.1
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or as
Slide 3: Agenda
Agenda Aldeyra R&D Highlights Todd Brady, M.D., Ph.D., CEO David Clark, M.D., CMO Aldehydes: A Novel Target in Human Disease Brian Day, Ph.D., Professor, Department of Medicine, Colorado School of Public Health Ocular Inflammation: A Steroid-Sparing Approach John Sheppard, M.D., Professor of Ophthal
Slide 4: R&D Highlights
R&D Highlights Todd Brady, M.D., Ph.D. Chief Executive Officer, President & Director Aldeyra Therapeutics
Slide 5: Research and Development Update
Research and Development Update Aldeyra is now a Phase III company: two different clinical programs expected to start in 2017 Aldeyra’s program in allergic conjunctivitis expected to advance to Phase IIb in 2017 Clinical data in inflammation and an inborn error of aldehyde metabolism are first-in-cl
Slide 6: A Robust Pipeline with Recent Clinical Success
A Robust Pipeline with Recent Clinical Success Discovery Formulation Pre-Clinical Phase I Phase II Phase III Sjögren-Larsson Syndrome (ADX-102 Dermatologic) Sjögren-Larsson Syndrome (ADX-102 Systemic) SSADH Deficiency (ADX-102 Systemic) Noninfectious Anterior Uveitis (ADX-102 Ocular) Allergic Conjun
Slide 7: A Clinically Validated Therapeutic Platform with Multiple Potential Value Drivers
A Clinically Validated Therapeutic Platform with Multiple Potential Value Drivers Aldehyde trapping represents a novel and clinically validated potential therapeutic platform intended for the treatment of inflammation and inborn errors of aldehyde metabolism. Positive Phase II data Q1 2016 Positive
Slide 8: Review of ADX-102 Data in Ocular Inflammation
Review of ADX-102 Data in Ocular Inflammation David J. Clark, M.D., M.R.C.P., A.F.P.M. Chief Medical Officer Aldeyra Therapeutics
Slide 9: ADX-102 Reduced Inflammation in Noninfectious Anterior Uveitis
ADX-102 Reduced Inflammation in Noninfectious Anterior Uveitis Mean (±SD) Change from Baseline in Anterior Chamber Cell Grade over Time (mITT Population*, Last Observation Carried Forward) *Modified intent-to-treat population excludes one patient that was found to have history of ovarian cancer with
Slide 10: ADX-102 Did Not Increase Intraocular Pressure in Noninfectious Anterior Uveitis
ADX-102 Did Not Increase Intraocular Pressure in Noninfectious Anterior Uveitis Increase in intraocular pressure, which may lead to glaucoma, is a major toxicity of corticosteroids that was not apparent with ADX-102. Mean (±SD) Change from Baseline in Intraocular Pressure (mmHg) over Time (Safety Po
Slide 11: ADX-102 Reduced Itching and Tearing in Allergic Conjunctivitis After a Single Dose
ADX-102 Reduced Itching and Tearing in Allergic Conjunctivitis After a Single Dose ADX-102 achieved reductions in ocular itching and tearing that were clinically relevant and statistically greater than vehicle in this Phase II clinical trial. Mean ± SEM Change in Score from Baseline Ocular Itching O
Slide 12: Highlights of Clinical Trials Expected to Start in 2017
Highlights of Clinical Trials Expected to Start in 2017 Phase III noninfectious anterior uveitis Vehicle-controlled, up to 45 subjects per arm Data expected in 2018 H2* Phase IIb allergic conjunctivitis Dose-ranging (two doses + modified vehicle), up to 50 subjects per arm Data expected in 2017 H2*
Slide 13: Significant Unmet Medical Need for Non-Steroidal Therapy
Significant Unmet Medical Need for Non-Steroidal Therapy VKC AKC Topical Corticosteroid Use In Ophthalmology Dry Eye/MGD Allergic Conjunctivitis Refractive Surgery Post-Cataract Ocular Rosacea Blepharitis Iritis Cyclitis Corneal Trauma Ocular GVHD Persistent Corneal Erosion Uveitis Scleritis Corneal
Slide 14: ADX-102: A Potential First or Second-Line Approach in Ocular Inflammation
ADX-102: A Potential First or Second-Line Approach in Ocular Inflammation Disease Severity Allergic Conjunctivitis Noninfectious Anterior Uveitis ~60M US Population ~1M US Population ~150,000 US Population ADX-102 ADX-102 + Corticosteroid Corticosteroid Anti-histamines ADX-102 Cortico -steroid
Slide 15: Steroid Toxicity Expected to Allow for Premium Pricing of Novel Drugs in Ocular Inflammation
Steroid Toxicity Expected to Allow for Premium Pricing of Novel Drugs in Ocular Inflammation Generic Steroid Branded Steroid Est. ADX-102 Range† Pricing Range per Course of Therapy $100$300$1000 Potential Side Effects of Therapy Corticosteroids Cataracts, glaucoma, corneal ulceration, ocular infecti
Slide 16: Review of ADX-102 Data in SLS
Review of ADX-102 Data in SLS David J. Clark, M.D., M.R.C.P., A.F.P.M. Chief Medical Officer Aldeyra Therapeutics
Slide 17: Statistically Significant Reduction in Ichthyosis Severity Score
Statistically Significant Reduction in Ichthyosis Severity Score Central Reader Digital Photography Assessment Reduction from Baseline in Composite Ichthyosis Severity Score ± SEM at 8 Weeks p<0.05* *p values are subject to change based on quality control analysis In a Phase II clinical trial, ADX-1
Slide 18: Every Treated Subject Improved in a Phase II Clinical Trial
Every Treated Subject Improved in a Phase II Clinical Trial Central Reader Digital Photography Assessment of ADX-102-Treated Subjects Composite Ichthyosis Severity Score at 8 Weeks p<0.001* *p values are subject to change based on quality control analysis
Slide 19: Clinical Development Plans
Clinical Development Plans* Phase III Sjögren-Larsson Syndrome Dermatologic, Expected initiation 2017 H1 Pivotal design pending FDA/EMA feedback, estimated 20-30 subjects ADX-102 systemic lead oral formulation selected; IND filing planned for 2017 H2 Inborn errors of aldehyde metabolism: Sjögren-Lar
Slide 20: Lifelong Therapy for Sjögren-Larsson Syndrome
Lifelong Therapy for Sjögren-Larsson Syndrome Estimated 0.4 births/100,000 (about 1000 patients in US)† Total US SLS market: ~$200M *Managed Care Qualitative Market Research of NS2 as a Potential Topically Applied Treatment for the Dermatologic Aspects of Sjögren-Larsson Syndrome, CPD Research & Con
Slide 21: Summary
Summary Todd Brady, M.D., Ph.D. Chief Executive Officer, President & Director Aldeyra Therapeutics
Slide 22: Target Indications with Significant Markets
Target Indications with Significant Markets Disease Unmet Medical Need Clinical Data Estimated US Patients Potential Pricing† Allergic Conjunctivitis Steroid toxicity (glaucoma, cataracts, other) Positive Phase IIa data Q1 2016 1,000,000 Steroid-dependent $1,000/course Noninfectious Anterior Uveitis
Slide 23: Research and Development Summary
Research and Development Summary Aldeyra is now a Phase III company: two different clinical programs expected to start in 2017 Aldeyra’s program in allergic conjunctivitis expected to advance to Phase IIb in 2017 Clinical data in inflammation and an inborn error of aldehyde metabolism are first-in-c
Slide 24: Questions
Questions OaALDEYRA THERAPEUTICS”