Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Presentation (February 2024)
19 slides from Aldeyra Therapeutics's investor presentation, Feb 13, 2024
Slide 1: Innovative Therapeutics for Immune-Mediated Diseases: Corporate Overview
Innovative Therapeuticsfor Immune-Mediated Diseases CORPORATE OVERVIEW February 2024 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2023
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation contains 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, including statements regarding Aldeyra’s possible or assumed
Slide 3: Aldeyra's Mission and Approach
ALDEYRA’S MISSION is to discover innovative therapies that improve the lives of patients who suffer from immune-mediated diseases. OUR APPROACH is to develop pharmaceuticals that modulate immunological systems, instead of directly inhibiting or activating single protein targets, with the goal of opt
Slide 4: Well-Capitalized Biotechnology Company with a Broad Immunology Pipeline
Aldeyra Is a Well-Capitalized Biotechnology Companywith a Broad Immunology Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA REVIEW† RASP PLATFORM FOR OCULAR AND SYSTEMIC IMMUNE-MEDIATED DISEASES Reproxalap (ophthalmic solution) Dry Eye Disease Dry Eye Disease Allergic Conjunctivitis Allergic Conjunc
Slide 5: Modulating RASP – A First-in-Class, Systems-Based Therapeutic Approach
Modulating RASP – A First-in-Class,Systems-Based Therapeutic Approach
Slide 6: Leading Developer of RASP Modulators Supported by Late-Stage Trials
Aldeyra is the Leading Developer of RASP Modulators: A Novel Approach Supported by Late-Stage Trials Broad-Based Symptom Reduction †Treatment difference of induction-maintenance dosing, defined as the difference between the changes from baseline for the evaluated drug minus vehicle (least squares me
Slide 7: Reproxalap Supported by Peer-Reviewed Publications
The Activity of Lead RASP Modulator Reproxalap is Supported by Marquee Peer-Reviewed Publications Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 2,400 patients with no observed safety concerns; mild and transient instillation site irritation is
Slide 8: ADX-629 Has Demonstrated Activity in Phase 2 Clinical Trials
ADX-629, a First-in-Class Orally Administered RASP Modulator, Has Demonstrated Activity in Phase 2 Clinical Trials ADX-629 is an investigational drug candidate. SEM = standard error of measurement. P = 0.001 P = 0.0003 P = 0.0008 Allergic Inflammation: Asthma Autoimmune Disease: Atopic Dermatitis Au
Slide 9: ADX-629 Data Suggest Potential for ADX-246 and ADX-248
ADX-629 Data Suggest Potential for Next-Generation Investigational RASP Modulators ADX-246 and ADX-248 ADX-246 Oral Administration … designed to treat immune-mediated systemic diseases thought to be caused or exacerbated by pro-inflammatory RASP. Pre-clinical studies of ADX-246 demonstrated high aff
Slide 10: RASP Platform Validated by Reproxalap in Dry Eye Disease
The RASP Platform is Validated by Reproxalap, a Novel Potential Therapeutic Approach in Dry Eye Disease Potential advantages for patients and healthcare providers could effect a paradigm shift relative to standard of care. †Company estimates and Am J Ophthalmol. 2014;157(4):799-806. NDA = New Drug A
Slide 11: Complete Response Letter from the FDA for the Reproxalap NDA
Aldeyra Received a Complete Response Letter from the FDA for the Reproxalap NDA for the Treatment of Dry Eye Disease An additional trial is required to demonstrate activity in symptoms. Based on Special Protocol Assessment (SPA) feedback received from the FDA in December 2023, Aldeyra has amended th
Slide 12: Exclusive Option Agreement with AbbVie for Reproxalap
Exclusive Option Agreement with AbbVie Inc.for License to Develop and Commercialize Reproxalap Option for AbbVie to obtain: Co-exclusive license to develop, manufacture, and commercialize reproxalap in the U.S. Exclusive license to develop, manufacture, and commercialize outside the U.S. Financial t
Slide 13: Efficacy Requirements for Potential NDA Submission in Allergic Conjunctivitis
Aldeyra Believes Efficacy Requirements Have Been Met for Potential NDA Submission of Reproxalap for Allergic Conjunctivitis† †NDA submission requirements depend, in part, on clinical results, enrollment, and regulatory feedback. Source: INVIGORATE and INVIGORATE-2 clinical trial results. Topical ocu
Slide 14: ADX-2191: A Novel Approach for the Treatment of Retinitis Pigmentosa
ADX-2191: A Novel Approach for the Treatment of Retinitis Pigmentosa
Slide 15: ADX-2191 Potential First Approved Drug for Retinitis Pigmentosa
ADX-2191 Has the Potential to be the First Approved Drug for Retinitis Pigmentosa, a Clinical Group of Rare Genetic Eye Diseases Retinitis pigmentosa refers to a group of inherited retinal diseases characterized by cell death and loss of vision. Retinitis pigmentosa affects more than 1 million peopl
Slide 16: Retinal Sensitivity Improved from Baseline in Phase 2 Retinitis Pigmentosa Trial
In the Phase 2 Retinitis Pigmentosa Clinical Trial, Retinal Sensitivity Improved from Baseline Phase 2 clinical trial was performed in eight retinitis pigmentosa patients with rhodopsin misfolding mutations: four patients received monthly injections for three months; four patients received twice-mon
Slide 17: Corporate Information
fee) aldeyra Corporate Information
Slide 18: Experienced Management Team and Board of Directors
Experienced Management Team and Board of Directors 1. Acquired by Xanthus/Antisoma. 2. Acquired by Schwarz/UCB. 3. Acquired by Ligand. 4. Acquired by Merck. 5. Acquired by Alexion. 6. Acquired by Genzyme. Richard Douglas, Ph.D. Chairman Former SVP Corporate Development at Genzyme Ben Bronstein, M.D.
Slide 19: Clinical and Regulatory Milestones
Atopic DermatitisPhase 1 clinical trial initiation expected in H1 2024‡ Metabolic DiseasePre-clinical program initiated Retinitis PigmentosaType C Meeting with FDA expected in first quarter of 2024 to discuss pivotal clinical testing† Dry Age-Related Macular Degeneration/Geographic AtrophyIND expect
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