Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Jefferies 2019 Healthcare Conference
35 slides from Aldeyra Therapeutics's conference presentation, Jun 6, 2019
Slide 1: Innovating Transformative Therapies
Innovating Transformative Therapies JEFFERIES 2019 HEALTHCARE CONFERENCE Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019 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 the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended
Slide 3: Our Mission
Our Mission Developing Next-Generation Medicines to Improve the Lives of Patients with Immune-Mediated Diseases Suffer from some form of immune-mediated disease, and incidence is increasing Disease control elusive despite existing therapies, and thus novel approaches are needed Source: Lerner, Jerem
Slide 4: Deep and Innovative Pipeline Focused on Immune-Mediated Diseases
Deep and Innovative Pipeline Focused on Immune-Mediated Diseases Ocular Inflammation Ocular Diseases Indication Compound Disease Area Preclinical Phase 1 Phase 2 Phase 3 Next Anticipated Milestone = Positive Phase 2/3 clinical trial data reported in 2016-2019 Trial initiations contingent on funding,
Slide 5: Our Lead Programs May Offer Potential Benefits Over Standard of Care
Reproxalap: Phase 3 Reproxalap: Phase 3 Drug Candidate and Dev. Stage Reproxalap: Phase 3 ADX-2191: Phase 3 Reproxalap: Phase 3 Pricing Benchmarks† $500-550 per month (dry eye disease pricing) $1,500 per regimen (to treat one flare) $30,000 per course (avg. cost of surgeries) $200,000 - $400,000 per
Slide 6: Ocular Disease Area: Dry Eye Disease
DRY EYE DISEASE ALLERGIC CONJUNCTIVITIS NONINFECTIOUS ANTERIOR UVEITIS PROLIFERATIVE VITREORETINOPATHY Ocular Disease Area Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 7: Reproxalap in DED
Reproxalap in DED Early and consistent symptom and sign improvements in Phase 2b clinical trial Broad symptom and sign improvements in Phase 2b clinical trial Dry Eye Disease: Persistently Disturbing Disease with Inadequate Therapy Dry Eye Disease Women are twice as likely to suffer from DED than me
Slide 8: Dry Eye Disease Symptom and Sign Endpoints Achieved in Phase 2b Clinical Trial
Dry Eye Disease Symptom and Sign Endpoints Achieved in Phase 2b Clinical Trial Mean Change from Baseline OD & 4-Symptom Questionnaire: Dryness (0-5) Baseline Score > 3 (N=69|69) Fluorescein Staining: Nasal (0-4) Baseline Score > 2 (N=62|56) Primary Symptom Endpoint for Phase 3 Primary Sign Endpoint
Slide 9: Broad Pattern of Drug Activity Across Dry Eye Disease Symptoms and Signs
Dry Eye Disease Symptoms Broad Pattern of Drug Activity Across Dry Eye Disease Symptoms and Signs Supports Differentiated Product Profile Improvement Effect Size at Week 12 Dry Eye Disease Signs Improvement Effect size = Change from Baseline / Standard Deviation at Baseline Source: Reproxalap DED Ph
Slide 10: Dry Eye Disease Clinical Program
Dry Eye Disease Clinical Program Adaptive Phase 3 Dry Eye Disease Clinical Program Adaptive Phase 3 Program RENEW Phase 3 (Part 1) RENEW Phase 3 (Part 2) Confirmatory DED Phase 3 NDA Initiated April 2019 DED Safety Study Adaptive design, co-primary endpoints, and innovative analysis strategy confirm
Slide 11: RENEW Trial Design in Dry Eye Disease
RENEW Trial Design in Dry Eye Disease Adaptive Phase 3 (Part 1) Clinical Trial Initiated April 2019 Primary objective: Evaluate efficacy of reproxalap ophthalmic solution (0.25%) vs. vehicle to confirm dosing regimen and sample size for Part 2 Inclusion/exclusion criteria: Same as used for Phase 2b
Slide 12: Ocular Disease Area: Allergic Conjunctivitis
DRY EYE DISEASE ALLERGIC CONJUNCTIVITIS NONINFECTIOUS ANTERIOR UVEITIS PROLIFERATIVE VITREORETINOPATHY Ocular Disease Area Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 13: Allergic Conjunctivitis: A Common Disease with Unmet Medical Need
~2% of AC patients have severe symptoms and may be corticosteroid-dependent 2% Underserved Patient Population Antihistamines are not effective in an estimated 24% of treated AC patients 24% Many AC patients make significant sacrifices due to lack of drug activity AC can result in acute, intermittent
Slide 14: Novel Mechanism of Action Versus Antihistamines
Novel Mechanism of Action has the Potential to Provide Differentiated Activity Versus Antihistamines Reproxalap has the potential to be uniquely effective in post-histaminic allergy, which affects all allergic conjunctivitis patients Histaminic Phase Post-Histaminic Phase (Cells, cytokines, and othe
Slide 15: Reproxalap Greater and More Durable Responses in ALLEVIATE Phase 3
Reproxalap Showed Greater and More Durable Clinical Responses vs. Vehicle Group in ALLEVIATE Phase 3 Clinical Trial Source: ALLEVIATE allergic conjunctivitis Phase 3 clinical trial results; Ocular itch scale 0 (no itch) to 4 (incapacitating itch) Area Under the Curve: Ocular Itch Score (0-4) 10 to 6
Slide 16: Reproxalap Results in Allergen Chamber Clinical Trial
Reproxalap Showed Greater and More Durable Clinical Responses vs. Vehicle in Allergen Chamber Clinical Trial 16 Source: Aldeyra Therapeutics methodology development clinical trial (ClinicalTrials.gov #NCT03709121); n=66 Ocular Itch Score (0-100) During 3.5 Hours of Allergen Exposure Ocular Redness S
Slide 17: Allergic Conjunctivitis Clinical Program
Allergic Conjunctivitis Phase 3 Clinical Program Design Elements AC Safety Study Additional AC Phase 3 Allergic Conjunctivitis Clinical Program Type C FDA Meeting AC = Allergic conjunctivitis CAC = Conjunctival Allergen Challenge NDA ALLEVIATE Phase 3 (CAC) Results March 2019 Contingent on funding,
Slide 18: Ocular Disease Area: Noninfectious Anterior Uveitis
DRY EYE DISEASE ALLERGIC CONJUNCTIVITIS NONINFECTIOUS ANTERIOR UVEITIS PROLIFERATIVE VITREORETINOPATHY Ocular Disease Area Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 19: Noninfectious Anterior Uveitis
Noninfectious Anterior Uveitis Reproxalap Noninfectious anterior uveitis: A Serious Inflammatory Disease With Inadequate Current Therapy Source: Aldeyra internal estimates based on primary and secondary market research; published literature NAU = Noninfectious anterior uveitis SOC = Standard of Care
Slide 20: Reproxalap Reduced Inflammation in NAU Phase 2 Trial
Reproxalap Reduced Inflammation in Noninfectious Anterior Uveitis Phase 2 Clinical Trial Reproxalap was statistically non-inferior to corticosteroid in a noninfectious anterior uveitis Phase 2 clinical trial Source: Reproxalap NAU Phase 2b clinical trial results Proportion Cured (Grade 0 = no inflam
Slide 21: Reproxalap Did Not Increase Intraocular Pressure
Reproxalap Did Not Increase Intraocular Pressure in Noninfectious Anterior Uveitis Phase 2 Clinical Trial Increase in intraocular pressure, which may lead to glaucoma, is a major corticosteroid toxicity that is not apparent with reproxalap Source: Reproxalap NAU Phase 2b clinical trial results Mean
Slide 22: SOLACE Trial Design in Noninfectious Anterior Uveitis
SOLACE Trial Design in Noninfectious Anterior Uveitis Phase 3 Clinical Trial Initiated April 2017 Primary objective: Evaluate efficacy of reproxalap ophthalmic solution (0.5%) on anterior chamber cell count (ACC) vs. vehicle Inclusion highlights: Acute endogenous NAU with onset of symptoms within th
Slide 23: Ocular Disease Area: Proliferative Vitreoretinopathy
DRY EYE DISEASE ALLERGIC CONJUNCTIVITIS NONINFECTIOUS ANTERIOR UVEITIS PROLIFERATIVE VITREORETINOPATHY Ocular Disease Area Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 24: Proliferative Vitreoretinopathy: ADX-2191
Proliferative vitreoretinopathy ADX-2191 Proliferative vitreoretinopathy: A Rare Sight-Threatening Retinal Disease With No Approved Therapies Source: Aldeyra internal estimates based on primary and secondary market research; published literature NAU = Noninfectious anterior uveitis SOC = Standard of
Slide 25: ADX-2191 Reduced Recurrent Retinal Detachment in Phase 1b
ADX-2191 Reduced Recurrent Retinal Detachment in Investigator Sponsored Phase 1b Clinical Trial and in Additional In-Practice Use *Timing of open globe injury as shown is estimated. Typically 6-8 weeks prior to reattachment & initiation of ADX-2191. There is no assurance that prior results, such as
Slide 26: ADX-2191 Adaptive Phase 3 PVR Trial Design
ADX-2191: Adaptive Phase 3 (Part 1) Proliferative Vitreoretinopathy Clinical Trial Design* Primary objective: Evaluate efficacy of intravitreal ADX-2191 injections for prevention of recurrent retinal detachment due to proliferative vitreoretinopathy (PVR) Design: Multi-center, non-masked, randomized
Slide 27: Systemic Disease Area: Sjögren-Larsson Syndrome
Systemic Disease Area SJÖGREN-LARSSON SYNDROME Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 28: Sjögren-Larsson Syndrome: A Rare RASP-Mediated Disease
Sjögren-Larsson Syndrome Reproxalap Sjögren-Larsson Syndrome: A Rare RASP-Mediated Disease with No Approved Therapy 28 Source: Aldeyra internal estimates based on primary and secondary market research; published literature RASP = Reactive Aldehyde Species SLS = Sjögren-Larsson Syndrome Severe sympto
Slide 29: Reproxalap Activity in Phase 2 Clinical Trial
Reproxalap Demonstrated Clinically Relevant and Consistent Activity in Phase 2 Clinical Trial Over two months of treatment, ichthyosis improved consistently from moderate to mild disease Source: Reproxalap SLS Phase 2 clinical trial results (6 patients per arm) Investigator Assessment of Ichthyosis
Slide 30: RESET Trial Design in Sjögren-Larsson Syndrome
RESET Trial Design in Sjögren-Larsson Syndrome Phase 3 Part 1 Clinical Trial Initiated July 2018 Primary objective: Evaluate efficacy of reproxalap topical dermal cream (1%) for the treatment of SLS associated ichthyosis Inclusion/exclusion highlights: Genetically confirmed diagnosis of SLS and at l
Slide 31: Building The Future
Building The Future Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
Slide 32: Our Value Proposition
$ Our Value Proposition Deep and Innovative Pipeline focused on immune-mediated diseases Near-Term Development Catalysts support path to commercialization Solid Track Record of development success Solid Cash Position Large Market Potential of late-stage pipeline Cash, cash equivalents and marketable
Slide 33: Experienced Management Team and Board of Directors
Marty Joyce, M.B.A. Former CFO of Serono USA Jesse Treu, Ph.D. Domain Associates Gary Phillips, M.D. CEO OrphoMed Experienced Management Team and Board of Directors 33 Management Team Board of Directors Todd Brady, M.D., Ph.D. President, CEO, & Director Joshua Reed, M.B.A. Chief Financial Officer Da
Slide 34: Expected Development Milestones
Expected Development Milestones:* Novel Approaches to Address Immune-Mediated Disease *Contingent on funding, regulatory review, clinical results and other factors Positive reproxalap ALLEVIATE Phase 3 clinical trial results March 2019 Ocular Diseases: Anticipated Milestones Systemic Diseases: Antic
Slide 35: Innovating Transformative Therapies
Innovating Transformative Therapies JEFFERIES 2019 HEALTHCARE CONFERENCE Nasdaq: ALDX ©Aldeyra Therapeutics, Inc. 2019 June 2019
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