Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Presentation (March 2015)
24 slides from Aldeyra Therapeutics's investor presentation, Mar 2, 2015
Slide 1: A Novel Pharmaceutical Platform Focused on Trapping Aldehydes
A Novel Pharmaceutical Platform Focused on Trapping Aldehydes March 2015 Exhibit 99.1 XXXXX X
Slide 2: Forward-Looking Statements
Forward-Looking Statements • This presentation contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra's plans for its product candidates. In some cases, you can identify forward-looking statemen
Slide 3: Management and Directors
Board of Directors Boyd Clarke – former CEO Aviron (acquired by MedImmune) Gary Phillips, M.D. – Chief Strategy Officer Mallinckrodt Pharmaceuticals Ben Bronstein, M.D. – former CEO Peptimmune (acquired by Genzyme) Neal Walker, D.O. – CEO Aclaris Therapeutics Marty Joyce – former CFO of Serono USA J
Slide 4: Investment Highlights
Investment Highlights Orphan and mass-market diseases in which toxic aldehydes are implicated Lead compound in two topical indications: one dermal and one ocular Phase II/III results for Sjögren Larsson Syndrome (SLS) in 2015 Phase II trial initiated for acute anterior uveitis in 2015 For lead compo
Slide 5: Aldehydes Are Mediators of Disease
Aldehydes Are Mediators of Disease • Toxic mediators of numerous diseases • Modify cellular constituents, lead to indigestible aggregates, and are pro- inflammatory • Dehydrogenases attempt to eliminate free aldehydes • High levels are implicated in autoimmune, inflammatory, neurological, cardiovasc
Slide 6: Aldehyde Traps: A Novel Therapeutic Approach
Aldeyra’s lead aldehyde trap, NS2, appears to have minimal pharmacology; it does not seem to affect receptors or proteins. No similar technology believed to be available. Aldehyde Traps: A Novel Therapeutic Approach Aldeyra’s compounds rapidly trap free aldehydes Trapped aldehydes are transported to
Slide 7: Trapping Aldehydes Generates a Broad Anti-Inflammatory Response
In an endotoxin model of cytokine generation in mice, NS2 administration significantly reduced levels of a broad array of pro-inflammatory cytokines. Trapping Aldehydes Generates a Broad Anti-Inflammatory Response Mice treated with NS2 or vehicle 30 minutes prior to endotoxin exposure; cytokines mea
Slide 8: NS2 Decreases Dermal Inflammation in Animal Models
Single dose of NS2 has early and potent anti-inflammatory effect that reduces swelling in two different models of skin inflammation NS2 Decreases Dermal Inflammation in Animal Models ** Vehicle NS2 Vehicle NS2 * * p<0.05 ** p<0.01 Murine Model of Contact Dermatitis (PMA) 6.5 hours after NS2 Administ
Slide 9: NS2 Speeds Healing and Reduces Scarring of Lesions in Animal Models
NS2 speeds lesion healing and reduces scarring in a model of skin and eye disease NS2 Speeds Healing and Reduces Scarring of Lesions in Animal Models Vehicle NS2 p=0.01 Day 21 36 p=0.1 NS Vehicle None Minimal Mild Marked Moderate Severe Hamster cheek pouch radiation-induced oral mucositis
Slide 10: NS2 Protects a Key Lipid Relevant to Skin and Eye Disease in Cell Systems
NS2 prevents aldehyde-mediated damage of lipid that is critical to dermal moisture barrier and ocular tear integrity NS2 Protects a Key Lipid Relevant to Skin and Eye Disease in Cell Systems Aldehyde- Damaged Lipid Control Aldehyde NS2+Aldehyde Human Skin Cells Aldehyde- Damaged Lipid Normal Cells S
Slide 11: NS2 Traps Aldehydes Generated by Dry Conditions in Human Tissue
NS2 may reduce aldehyde-mediated damage in diseases characterized by dry tissue NS2 Traps Aldehydes Generated by Dry Conditions in Human Tissue Malondialdehyde concentration in human tissues after 72 hours of NS2 Dry Tissue + NS2 Eye Drop Normal Tissue Dry Tissue p < 0.01 Dry Tissue + NS2 Dermatolog
Slide 12: NS2 Summary of Efficacy: Multiple Mechanisms of Action
The same biological mechanisms may apply to many orphan and prevalent diseases. NS2 Summary of Efficacy: Multiple Mechanisms of Action
Slide 13: Positive NS2 Eye Drop Phase I Results
NS2 is safe and tolerable in healthy volunteers at doses up to four times per day over seven days . Positive NS2 Eye Drop Phase I Results o 48 healthy volunteers o Double-blinded and placebo controlled o Two treatment stages for two drug concentrations: Single day 0.25% & 0.5% bid & qid Seven day 0.
Slide 14: Noninfectious Anterior Uveitis: A Rare Inflammatory Ocular Disease
Aldehydes are inflammatory mediators of ocular diseases, and can lead to degradation of tear quality Noninfectious Anterior Uveitis: A Rare Inflammatory Ocular Disease
Slide 15: Anticipated Clinical Trial Design for Uveitis
Eye Drop Active 1:1:1 (NS2, Steroid, NS2 + Sub- Therapeutic Steroid) 45 Patients 6 weeks Inflammation Markers, Symptoms Anticipated Clinical Trial Design for Uveitis Formulation Control Total Patients Treatment Time Endpoints Noninfectious Anterior Uveitis
Slide 16: Sjögren-Larsson Syndrome (SLS): Orphan Disease with No Therapy
Therapeutic aldehyde trap would be analogous to an enzyme replacement therapy Sjögren-Larsson Syndrome (SLS): Orphan Disease with No Therapy (1) Extrapolating from a Swedish estimate, it is generally assumed that there are approximately 1,000 SLS patients in the United States and a greater number of
Slide 17: Anticipated Clinical Trial Design For Sjögren-Larsson Syndrome
Anticipated Clinical Trial Design For Sjögren-Larsson Syndrome Formulation Control Total Patients Treatment Time Endpoints
Slide 18: Clinical Trial Updates
Clinical Trial Updates • Noninfectious Anterior Uveitis – Prior to study initiation, FDA requires protocol amendment, which has been submitted – Pending FDA review of amended protocol, study start and data in 2015, per earlier guidance • Sjögren-Larsson Syndrome – Study initiation pending final inve
Slide 19: Unmet Medical Need for Our Clinical Indications
Market demand is substantial for a novel therapy that is safe and effective in the indications that we intend to develop Unmet Medical Need for Our Clinical Indications There is no FDA-approved therapy for Sjögren- Larsson Syndrome Therapies for acute anterior uveitis are associated with significant
Slide 20: Orphan Topical: Attractive Pricing, Large Market
Total US SLS market: ~$200M Orphan Topical: Attractive Pricing, Large Market Payer research confirms similar or higher pricing for a topical SLS therapy
Slide 21: Intellectual Property Portfolio: Composition of Matter into the 2030s
Intellectual Property Portfolio: Composition of Matter into the 2030s *Pending in Brazil, India Formulation Composition Method
Slide 22: Valuation Comparables
Company Stage Diseases in Phase II or III Clinical Trials Valuation Valuation Comparables Orphan disease biotechnology and late-stage specialty pharmaceutical companies are highly valued. Aldeyra Therapeutics (ALDX) Phase II $64M Anacor (ANAC) Phase II/III $1.9B GW Pharmaceuticals (GWPH) Phase II/II
Slide 23: 2015 Medical Conferences
Conference Date Location Data Significant data to be presented at upcoming medical conferences which will highlight the safety and efficacy of NS2 in both ocular and dermal indications 2015 Medical Conferences February 20-24 Houston, TX Cytokine Reduction, Contact Dermatitis, and Allergic Dermatitis
Slide 24: Investment Highlights
Investment Highlights Orphan and mass-market diseases in which toxic aldehydes are implicated Lead compound in two topical indications: one dermal and one ocular Phase II/III results for Sjögren Larsson Syndrome (SLS) in 2015 Phase II trial initiated for acute anterior uveitis in 2015 Markets for or
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