Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Presentation (May 2026)
29 slides from Aldeyra Therapeutics's investor presentation, May 1, 2026
Slide 1: Corporate Overview May 2026
Innovative Therapeutics for Immune-Mediated Diseases CORPORATE OVERVIEW May 2026 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2026 Exhibit 99.1
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 protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizin
Slide 4: RASP Platform Pipeline
PRECLINICAL PHASE 1 PHASE 2 PHASE 3 NDA REVIEW† RASP Platform for Immune-Mediated Diseases Reproxalap Topical ocular administration Dry Eye Disease Dry Eye Disease Allergic Conjunctivitis Allergic Conjunctivitis ADX-248 Oral administration Atopic Dermatitis Sjögren-Larsson Syndrome** Obesity/Hypertr
Slide 5: Modulating RASP – A First-in-Class, Systems-Based Therapeutic Approach
Modulating RASP – A First-in-Class, Systems-Based Therapeutic Approach Exhibit 99.1
Slide 6: RASP Represent a Novel, Potentially Broadly Applicable Pharmaceutical Target
RASP are formed by oxidation of alcohols and other metabolic processes. RASP bind thiol (Michael addition) and amine (Schiff base) residues on proteins, leading to conformational and functional changes in certain proteins that initiate pro-inflammatory signaling cascades. RASP are also precursors of
Slide 7: RASP Modulation Represents a Novel Pharmacology
RASP Modulation Represents a Novel Pharmacology RASP=reactive aldehyde species Traditional pharmacology targets specific proteins and is generally limited to two actions: on or off. . Activating or inhibiting specific proteins on a sustained basis, which rarely occurs in nature, may lead to toxicity
Slide 8: Reproxalap Activity Supported by Peer-Reviewed Publications
The Immune-Modulating Activity of Lead RASP Modulator Reproxalap is Supported by Peer-Reviewed Publications Topical ocular reproxalap is an investigational drug candidate that has not been approved by the FDA; mild and transient instillation site irritation is the most commonly reported adverse even
Slide 9: ADX-629 Activity in Phase 2 Clinical Trials
ADX-629, a Signal-Finding Orally Administered RASP Modulator, Consistently Demonstrated Activity in Phase 2 Clinical Trials ADX-629 is an investigational drug candidate. RASP=reactive aldehyde species, SEM=standard error of the mean Hepatic Inflammation: Alcohol-Associated Hepatitis Autoimmune Disea
Slide 10: Changes in Lipid Profiles with ADX-629
Statistically Significant Changes Observed in Lipid Profiles in Multiple Clinical Trials with RASP Modulator ADX-629 ADX-629 is an investigational drug candidate. AUC=area under the curve, FFA=free fatty acids, HDL=high-density lipoprotein, LDL=low-density lipoprotein, mM=millimolar, SE=linear model
Slide 11: ADX-248 Binding HNE, Orally Administered Therapy
By Binding HNE, a Pro-Inflammatory RASP, ADX-248 Potentially Represents a New Orally Administered Therapy for the Treatment of Immune-Mediated Disease ADX-248 Binding to Pro-Inflammatory RASP HNE (HNE absorbance units) Cytokine Reduction vs. Vehicle Control in LPS-Challenged Mice Epidermal Erosion S
Slide 12: ADX-248 in Preclinical Parkinson's Disease Model
ADX-248 Increased Brain Dopamine and Improved Motor Function in a Preclinical Parkinson’s Disease Model ADX-248 In Vitro Binding Neurotoxic RASP DOPAL (DOPAL absorbance units) MPTP Mouse Parkinson’s Disease Model Brain Dopamine vs. Vehicle (ng dopamine / mg protein ± SE) ADX-248 Dose (PO mg/kg) 3 10
Slide 13: ADX-246 for Dry Age-Related Macular Degeneration
By Binding the RASP Retinaldehyde, ADX-246 Potentially Represents a New Intravitreally Administered Therapy for the Treatment of Dry Age-Related Macular Degeneration (Dry AMD) Minutes Reduction in Toxic Retinaldehyde Metabolite A2E (retinal picomoles + SEM) in Abcr Knockout Mouse (Model of Dry AMD)
Slide 14: Reproxalap for Dry Eye Disease and Allergic Conjunctivitis
Reproxalap: A Novel RASP Modulator for the Treatment of Dry Eye Disease and Allergic Conjunctivitis Exhibit 99.1
Slide 15: Reproxalap: Novel Approach in Dry Eye Disease
Reproxalap Represents a Novel Potential Therapeutic Approach in Dry Eye Disease with Rapid Activity in Clinical Trials Potential advantages for patients and healthcare providers could effect a paradigm shift relative to standard of care. Dry eye disease afflicts 39 million or more adults in the Unit
Slide 16: Complete Response Letter for Reproxalap
Aldeyra Received a Complete Response Letter for Reproxalap for the Treatment of Dry Eye Disease The Complete Response Letter stated that “there is a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is r
Slide 17: Totality of Evidence Indicates Superiority over Vehicle
Aldeyra Believes That the Totality of Evidence Indicates a Clear Pattern of Superiority of Reproxalap over the Vehicle Control Vehicle is the drug product without reproxalap. Trials 012, 013, and 031 were field trials; other trials were single-day exposures (Day 1, Schirmer Test) followed by a dry e
Slide 18: Trial Endpoints: FDA vs Aldeyra Position
TRIAL PRIMARY ENDPOINT(S) P<0.05 FDA POSITION ALDEYRA POSITION 012 Symptoms Staining ✓ Co-primary not met Supportive for symptoms 013 Symptoms ✓ Endpoint met Endpoint met 019 Redness Endpoint not met Supportive for Schirmer Test (secondary P<0.0001), Schirmer Response (post-hoc P<0.0001) 023 Schirme
Slide 19: Exclusive Option Agreement with AbbVie for Reproxalap
Aldeyra Has Entered into an 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
Slide 20: Efficacy Requirements for Allergic Conjunctivitis NDA
Aldeyra Believes Efficacy Requirements Have Been Met for Potential NDA Submission of Reproxalap for Allergic Conjunctivitis† †NDA submission requirements depend, in part, on regulatory feedback. Topical ocular reproxalap is an investigational drug candidate that has not been approved by the FDA; mil
Slide 21: ADX-2191: Platform for Rare Retinal Diseases
ADX-2191: A Platform Approach for the Treatment of Rare Retinal Diseases Exhibit 99.1
Slide 22: ADX-2191 for Primary Vitreoretinal Lymphoma
ADX-2191 Has the Potential to be the First Approved Drug for Primary Vitreoretinal Lymphoma (PVRL), a Rare but Serious Retinal Cancer A rare, aggressive, high-grade cancer, PVRL arises in the vitreous and retina. Approximately 200-600 new cases of PVRL are diagnosed in the United States per year. Me
Slide 23: Phase 3 Trial Design of ADX-2191 in PVRL
Phase 3 Clinical Trial Design of ADX-2191 in Patients with PVRL Phase 3 clinical trial initiation expected H1 2026; results expected in 2026‡ Design Double-masked, 1:1 randomized, parallel-group, multicenter trial in up to 20 patients with biopsy-proven PVRL Dosing Regimen Cohort A: Monthly injectio
Slide 24: ADX-2191 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 peop
Slide 25: Phase 2 Retinitis Pigmentosa Trial Results
In the Phase 2 Retinitis Pigmentosa Clinical Trial of ADX-2191, 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 receiv
Slide 26: Planned Phase 2/3 Trial in Retinitis Pigmentosa
Planned Phase 2/3 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Design Randomized, double-masked, clinical trial Dosing High-dose (400 µg) and low-dose (200 µg) dose administered monthly for 12 months vs sham injections Size 45 retinitis pigmentosa patients with rhodopsin mutations, randomized
Slide 27: Corporate Information
Corporate Information Exhibit 99.1
Slide 28: Experienced Management Team and Board of Directors
Experienced Management Team and Board of Directors 1Acquired by Xanthus/Antisoma. 2Acquired by Schwarz/UCB. 3Acquired by Hesperion AG. 4Acquired by Shire. 5Acquired by Genzyme. Richard Douglas, Ph.D. Chairman Former SVP Corporate Development, Genzyme Ben Bronstein, M.D. Former CEO, Peptimmune5 Chip
Slide 29: Clinical and Regulatory Milestones
Dry Eye Disease (Reproxalap) Type A meeting with the FDA is expected to be held in the second quarter of 2026† Atopic Dermatitis (ADX-248) Phase 2 clinical trial initiation expected in H1 2026‡ Obesity/Hypertryglyceridemia (ADX-248) Investigational New Drug application expected to be submitted in 20
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