Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Investor Presentation (November 2025)
30 slides from Aldeyra Therapeutics's investor presentation, Nov 13, 2025
Slide 1: 2025 Research & Development Webcast: Corporate Overview
2025 Research & Development Webcast CORPORATE OVERVIEW November 13, 2025 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2025 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: Well-Capitalized Biotechnology Company with a Broad Immunology 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 4: Modulating RASP – A First-in-Class, Systems-Based Therapeutic Approach
Modulating RASP – A First-in-Class, Systems-Based Therapeutic Approach
Slide 5: 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 6: 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 toxicit
Slide 7: Results from a Phase 2 Proof-of-Concept Trial of ADX-629 in Alcohol-Associated Hepatitis
Results from a Phase 2 Proof-of-Concept Trial of ADX-629, a Signal-Finding RASP Modulator, in Alcohol-Associated Hepatitis
Slide 8: Development of ADX-629 Concluded with Positive Results in Alcohol-Associated Hepatitis
Development of ADX-629, a Signal-Finding, First-Generation RASP Modulator, Concluded with Positive Results in Alcohol-Associated Hepatitis ADX-629 is a first-generation RASP modulator that was tested in proof-of-concept Phase 2 clinical trials across a number of immune-mediated diseases, including:
Slide 9: ADX-629 Consistently Demonstrated Activity in Phase 2 Clinical Trials
ADX-629 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 Disease: Atopic Dermatitis Autoimmune Disease: Psoriasis I
Slide 10: Statistically Significant Changes in Lipid Profiles with ADX-629
Statistically Significant Changes Observed in Lipid Profiles in Multiple Clinical Trials with 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 standard error
Slide 11: ADX-629 Reduced C-Reactive Protein in Phase 2 Trial
ADX-629 Reduced Levels of the Inflammation Marker C-Reactive Protein in Phase 2 Clinical Trial in Alcohol-Associated Hepatitis ADX-629 is an investigational drug candidate. SEM=standard error of the mean. C-Reactive Protein has been associated with adverse cardiovascular outcomes, poor prognosis, an
Slide 12: Activity of Next-Generation RASP Modulators in Preclinical Disease Models
Activity of Next-Generation RASP Modulators in Preclinical Disease Models
Slide 13: ADX-246 Potentially a New Intravitreal Therapy for Dry AMD
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: ADX-248 Potentially a New Oral Therapy for Immune-Mediated Disease
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 (absorbance units) Cytokine Reduction vs. Vehicle Control in LPS-Challenged Mice Epidermal Erosion Score
Slide 15: RASP Are Associated with Human Neuroinflammatory Diseases
RASP Are Associated with Human Neuroinflammatory Diseases that Affect the Central Nervous System Parkinson’s Disease Multiple Sclerosis Amyotrophic Lateral Sclerosis (ALS) Environmental toxins that promote Parkinson’s disease also increase RASP. The RASP DOPAL cross-links α-synuclein and leads to do
Slide 16: ADX-629 Reduced Disease Severity in a Mouse Model of Multiple Sclerosis
EAE Disease Model Inducible mouse model of MS Characterized by increasing paralysis Widely accepted model of neuron demyelination Study Design Legacy RASP Modulator ADX-629 Significantly Reduced Disease Severity in a Mouse Model of Multiple Sclerosis ADX-629 is an investigational drug candidate. EAE
Slide 17: ADX-248 Binds RASP Associated with CNS/Neuroinflammatory Diseases
ADX-248 Binds RASP Associated with CNS/Neuroinflammatory Diseases ADX-248 binds DOPAL and HNE, neurotoxic RASP associated with neuroinflammatory diseases. ADX-248 is an investigational drug candidate. DOPAL=3, 4-dihydroxyphenylacetaldehyde, HNE=4-hydroxynonenal, , RASP=reactive aldehyde species, CNS
Slide 18: ADX-248 Improved Rotarod Performance and Grip Strength in Mouse MPTP Model
ADX-248 Significantly Improved Rotarod Performance and Grip Strength in the Mouse MPTP Parkinson’s Disease Model Study Design MPTP Parkinson’s Model Dopaminergic neuron loss Parkinson’s-like disease symptoms Widely accepted preclinical model Rotarod Performance vs. Vehicle (time to fall, seconds ± S
Slide 19: ADX-248 Increased Brain Dopamine and Dopaminergic Neuron Cell Area
ADX-248 Significantly Increased Brain Dopamine and Dopaminergic Neuron Cell Area in the Mouse MPTP Parkinson's Disease Model Brain Dopamine vs. Vehicle (ng dopamine / mg protein ± SE) ADX-248 (PO mg/kg) 3 10 20 P=0.05 P=0.001 P=0.03 ADX-248 (PO mg/kg) 3 10 20 Substantia Nigra Dopaminergic Neuron Cel
Slide 20: ADX-248 Improved Wire Hang Time in Rat 6-OHDA Model
ADX-248 Significantly Improved Wire Hang Time in the Rat 6-OHDA Parkinson’s Disease Model ADX-248 (PO mg/kg) 3 10 20 Grip Strength vs. Vehicle (gram force ± SE) ADX-248 is an investigational drug candidate. 6-OHDA= 6-hydroxydopamine, BID=twice daily, SE= mixed model for repeated measures standard er
Slide 21: ADX-248 Improved Grip Strength and Rotarod in Mouse SOD1-G93A ALS Model
ADX-248 Significantly Improved Grip Strength and Rotarod Performance in the Mouse SOD1-G93A Amyotrophic Lateral Sclerosis Disease Model ADX-248 (PO mg/kg) Rotarod Performance vs. Vehicle (time to fall, seconds ± SE) 3 10 20 P=0.005 P=0.02 ADX-248 is an investigational drug candidate. SOD1=superoxide
Slide 22: Key Messages: ADX-248 Activity in Multiple Preclinical Neuroinflammatory Models
Key Messages ADX-248 Pharmacology Sequestered DOPAL and HNE, RASP associated with neuronal cell death Improved neuromotor function in Parkinson’s and ALS disease models Increased brain dopamine levels and TH+ cell area in the mouse MPTP Parkinson’s disease model ADX-248 Exposure & Safety Mouse in vi
Slide 23: ADX-248 Preclinical Benefit Observed at Doses Predicted to Be Safe and Achievable
ADX-248 Preclinical Benefit Observed at Doses Predicted to be Safe and Achievable Based on Ongoing Phase 1 Clinical Trial Preclinical Dose (PO mg/kg, BID) Human Equivalent Dose (PO mg, QD) 3 15 10 50 20 100 10x safety margin* expected for 100 mg human dose ADX-248 Phase 1 dose escalation in healthy
Slide 24: Reproxalap: A Novel RASP Modulator for the Treatment of Dry Eye Disease
Reproxalap: A Novel RASP Modulator for the Treatment of Dry Eye Disease
Slide 25: Reproxalap Represents a Novel Potential Approach in Dry Eye Disease
Reproxalap Represents a Novel Potential Therapeutic Approach in Dry Eye Disease with Rapid Activity Observed 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
Slide 26: Dry Eye Chamber Trial Achieved the Primary Endpoint of Ocular Discomfort
The Phase 3 Dry Eye Chamber Trial Achieved the Primary Endpoint of Ocular Discomfort †Regulatory review and discussion timelines are flexible and subject to change based on the regulator's workload, governmental shutdown, and other potential review issues. P value derived from primary endpoint mixed
Slide 27: Reproxalap Vendors Recently Inspected by the U.S. FDA
Reproxalap Drug Substance and Drug Product Vendors Have Recently Been Inspected by the U.S. Food and Drug Administration In 2025, the U.S. Food and Drug Administration (FDA) performed routine cGMP inspections of manufacturing sites associated with the production of reproxalap. The reproxalap drug pr
Slide 28: Exclusive Option Agreement with AbbVie for Reproxalap License
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 29: Milestones
foe) aldeyra Milestones
Slide 30: Clinical and Regulatory Milestones
Dry Eye Disease (Reproxalap) New Drug Application PDUFA date December 16, 2025† 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 2026 Dry Age-Related Macular Dege
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