Aldeyra Therapeutics, Inc. - FORM 8-K - EX-99.1 - EXHIBIT 99.1

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8-K - FORM 8-K - Aldeyra Therapeutics, Inc.	d879909d8k.htm
EX-99.2 - EXHIBIT 99.2 - Aldeyra Therapeutics, Inc.	d879909dex992.htm

A Novel Pharmaceutical Platform

Focused on Trapping Aldehydes

March 2015

Exhibit 99.1

XXXXX

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

statements

terms

such

"may,"

"might,"

"will,"

"objective,"

"intend,"

"should,"

"could,"

"can,"

"would,"

"expect,"

"believe,"

"anticipate,"

"project," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended

to identify forward-looking statements.

•

Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and

uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue.

Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include,

among others, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the

ability

obtain

and

maintain

regulatory

approval

conduct

clinical

trials

and

commercialize

Aldeyra's

product

candidates,

and

the

labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product

candidates; the size and growth of the potential markets for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's

expectations regarding Aldeyra's expenses and revenue, the sufficiency of Aldeyra's cash resources and needs for additional financing;

Aldeyra's ability to attract or retain key personnel; and other factors that are described in the "Risk Factors" and "Management's

Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Quarterly Report on Form 10-Q for the

quarter ended September 30, 2014 which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's

website at www.sec.gov.

•

In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could

affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements.

The information in this presentation is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any

forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by

law.

Management and Directors

•

Todd Brady, M.D., Ph.D. –

President, CEO, and

Director

–

18 years of pharmaceutical business and

clinical development

–

Domain Associates, Phenome Sciences,

(acquired by Xanthus/Antisoma), Aderis

Pharmaceuticals (acquired by Schwarz/UCB)

•

Scott Young –

Chief Operating Officer

–

28 years of pharmaceutical clinical

development

–

Genzyme, Genetics Institute, Oxigene,

Repligen

•

Steve Tulipano, CPA –

Chief Financial Officer

–

27 years of financial experience

–

Biogen, Javelin Pharmaceuticals

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

Serono

USA

Jesse

Treu,

Ph.D.

–

Domain

Associates

Todd

Brady

–

CEO

Aldeyra

Therapeutics

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 compound, IP extends to late 2020s worldwide and to 2033 in US, assuming

Hatch-Waxman extension

Fidelity, Perceptive, DAFNA, Sphera, Knoll, Johnson & Johnson Development

Corporation, Domain Associates, and other top-tier funds

Markets for orphan indications alone are substantial, and positive data may suggest

efficacy in a broad array of mass-market diseases

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, cardiovascular

and endocrinologic diseases

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.

Aldeyra’s compounds rapidly

trap free aldehydes

Trapped aldehydes are

transported to the lysosome

Drug and aldehydes are

metabolized within hours

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.

Mice treated with NS2 or

vehicle 30 minutes prior to

endotoxin exposure;

cytokines measured two

hours after endotoxin

exposure

p<0.01

***

p<0.001

***

Data presented at the American Academy of Asthma Allergy and Immunology 2015

Annual Meeting

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 Administration

Murine Model of Allergic Dermatitis (Oxazolone)

24.5 hours after NS2 Administration

Single dose of NS2 has early and potent anti-inflammatory effect that reduces

swelling in two different models of skin inflammation

Data presented at the American Academy of Asthma Allergy and Immunology 2015

Annual Meeting

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

Vehicle

NS2

p=0.01

Day

6 21 36

p=0.1

Vehicle

None

Minimal

Mild

Marked

Moderate

Severe

Hamster cheek pouch radiation-induced oral mucositis

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

SLS

Mutants

SLS Mutants +

NS2

NS2 prevents aldehyde-mediated damage of lipid that is critical to dermal moisture

barrier and ocular tear integrity

p<0.01

Data to be presented at the Society for Inherited Metabolic Disorders

2015 Annual Meeting, March 28

NS2 Traps Aldehydes Generated by

Dry Conditions in Human Tissue

NS2 may reduce aldehyde-mediated damage in diseases characterized by dry 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

Dermatologic

Normal Tissue

Dry Tissue

p < 0.05

Human Ocular Tissue

Human Skin Tissue

Data presented at the Society for Investigative Dermatology

2014 Annual Meeting

NS2 Summary of Efficacy:

Multiple Mechanisms of Action

The same biological mechanisms may apply to many orphan and prevalent diseases.

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 0.25% & 0.5% qid

o

Eye drops were well tolerated in all treatment groups

o

No plasma exposure detected by LC-MS/MS (<5 ng/ml)

NS2 is safe and tolerable in healthy volunteers at doses up to four

times per day over seven days .

Noninfectious Anterior Uveitis: A

Rare Inflammatory Ocular Disease

Aldehydes are inflammatory mediators of ocular diseases, and can

lead to

degradation of tear quality

Anticipated Clinical Trial

Design for Uveitis

Formulation

Control

Total Patients

Treatment Time

Endpoints

Eye Drop

Active 1:1:1

(NS2, Steroid, NS2 + Sub-

Therapeutic Steroid)

45 Patients

6 weeks

Inflammation Markers,

Symptoms

Noninfectious

Anterior Uveitis

Sjögren-Larsson Syndrome (SLS):

Orphan Disease with No Therapy

Therapeutic aldehyde trap

would be analogous to an

enzyme replacement 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 SLS patients in Europe.

Anticipated Clinical Trial Design For

Sjögren-Larsson Syndrome

Formulation

Control

Total Patients

Treatment Time

Endpoints

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 investigational review

board approval

–

Study start and data in 2015, per earlier guidance

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

There is no FDA-approved therapy for Sjögren-

Larsson Syndrome

Therapies for acute anterior uveitis are

associated with significant side effects

Orphan Topical: Attractive Pricing,

Large Market

Total US SLS market: ~$200M

Payer research

confirms similar or

higher pricing for a

topical SLS therapy

Intellectual Property Portfolio:

Composition of Matter into the 2030s

*Pending in Brazil, India

Formulation

Composition

Method

Valuation Comparables

Orphan disease biotechnology and late-stage specialty pharmaceutical companies

are highly valued.

Company

Stage

Diseases in

Phase II or III

Clinical Trials

Valuation

Aldeyra Therapeutics (ALDX)

Phase II

$64M

Anacor (ANAC)

Phase II/III

$1.9B

GW Pharmaceuticals (GWPH)

Phase II/III

$1.6B

Ultragenyx (RARE)

Phase II

$1.7B

Insmed (INSM)

Phase II/III

$921M

Intercept (ICPT)

Phase III

$4.7B

Data as of 2/27/15

(1) Pending FDA review of submitted filings, among other contingencies.

(1)

2015 Medical Conferences

Conference

Date

Location

Data

February 20-24

Houston, TX

Cytokine Reduction, Contact

Dermatitis, and Allergic

Dermatitis

March 28-31

Salt Lake, UT

SLS Lipid Protection

May 3-7

Denver, CO

Ocular Inflammation and

Ocular Fibrosis

Significant data to be presented at upcoming medical conferences

which will highlight

the safety and efficacy of NS2 in both ocular and dermal indications

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 orphan indications alone are substantial, and positive data may suggest efficacy

in a broad array of mass-market diseases

For lead compound, IP extends to late 2020s worldwide and to 2033 in US, assuming

Hatch-Waxman extension

Fidelity, Perceptive, DAFNA, Sphera, Knoll, Johnson & Johnson Development Corporation,

Domain Associates, and other top-tier funds

Attached files

Aldeyra Therapeutics, Inc. Reports

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