8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 2, 2015

ALDEYRA THERAPEUTICS, INC.

(Exact name of Registrant as specified in its charter)

Delaware	001-36332	20-1968197
(State or other Jurisdiction of Incorporation)	(Commission File No.)	(IRS Employer Identification No.)

131 Hartwell Avenue, Suite 320

Lexington, MA 02421

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (781) 761-4904

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 REGULATION FD DISCLOSURE

Aldeyra Therapeutics, Inc. (the “Company” or “Aldeyra”) will be making a presentation regarding the Company and the status of its clinical programs at the Cowen and Company 35th Annual Healthcare Conference, which will be webcasted live on Monday, March 2, 2015 at 4:50 p.m. ET. The live webcast will be available on the Investors’ section of Alderya’s website at www.aldeyra.com. An archived version of the webcast will be available for 14 days following the presentation. The slides that will be used for such presentation are furnished as Exhibit 99.1 to this Form 8-K.

Various statements to be made during the presentation, including statements in the slides furnished as Exhibit 99.1 to this Form 8-K, are “forward-looking statements” under the securities laws, including, but not limited to, statements regarding Aldeyra’s plans for its product candidates. In some cases, you can identify forward-looking statements by terms such as “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 FDA’s acceptance of the modified protocol for Alderya’s planned Phase II clinical trial of an ophthalmic formulation of NS2 to treat acute noninfectious uveitis, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to 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. Additional information will also be set forth in those sections of Alderya’s Annual Report on Form 10-K for the year ended December 31, 2014, which will be filed with the SEC in the first quarter of 2015. There can be no assurance that the actual results or developments anticipated by Aldeyra will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Aldeyra. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Aldeyra or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Aldeyra cautions investors not to rely too heavily on the forward-looking statements Aldeyra makes or that are made on its behalf. The information in the slides attached as Exhibit 99.1 to this Form 8-K will be provided only as of the date on which such slides are presented, and the Company undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements contained in such slides from and after the date of such presentation whether as a result of new information, future events or otherwise.

The information in Item 7.01 of this Current Report on Form 8-K and the slides attached as Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. OTHER EVENTS

On March 2, 2015, Aldeyra issued a press release providing an update regarding its planned clinical trials of the Aldeyra’s lead compound, NS2, in noninfectious anterior uveitis and Sjögren-Larsson Syndrome and announcing that the company will provide an update on its clinical programs at the Cowen and Company 35th Annual Healthcare Conference. A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein.

Item 9.01. FINANCIAL STATEMENTS AND EXHIBITS

(d) Exhibits – The following exhibits are filed as part of this report:

99.1	Presentation slides
99.2	Press Release of Aldeyra Therapeutics, Inc. dated March 2, 2015

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ALDEYRA THERAPEUTICS, INC.
By:	/s/ Todd C. Brady, M.D., Ph.D.
	Name:	Todd C. Brady, M.D., Ph.D.
	Title:	President and Chief Executive Officer

Dated: March 2, 2015

EX-99.1

A Novel Pharmaceutical Platform

Focused on Trapping Aldehydes

March 2015

Exhibit 99.1

XXXXX

X

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

by

terms

such

as

"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

to

obtain

and

maintain

regulatory

approval

to

conduct

clinical

trials

and

to

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.

2

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

3

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

of

Serono

USA

Jesse

Treu,

Ph.D.

–

Domain

Associates

Todd

Brady

–

CEO

Aldeyra

Therapeutics

Investment Highlights

4

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

5

Aldehyde Traps:

A Novel Therapeutic Approach

6

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

7

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

8

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

9

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

NS

2

Vehicle

None

Minimal

Mild

Marked

Moderate

Severe

Hamster cheek pouch radiation-induced oral mucositis

10

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

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

11

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

0

5

10

15

20

25

30

0

2

4

6

8

10

12

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

12

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)

13

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

14

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

15

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

16

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

17

Clinical Trial Updates

18

•

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

19

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

20

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

21

*Pending in Brazil, India

Formulation

Composition

Method

Valuation Comparables

22

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

2

$64M

Anacor (ANAC)

Phase II/III

4

$1.9B

GW Pharmaceuticals (GWPH)

Phase II/III

5

$1.6B

Ultragenyx (RARE)

Phase II

2

$1.7B

Insmed (INSM)

Phase II/III

3

$921M

Intercept (ICPT)

Phase III

4

$4.7B

Data as of 2/27/15

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

(1)

2015 Medical Conferences

23

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

24

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

EX-99.2

Exhibit 99.2

                

Aldeyra Therapeutics Provides Update on NS2 Clinical Program

Lexington, MA, March 2, 2015 Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today provided an update on its planned clinical trial programs in noninfectious anterior uveitis and Sjögren-Larsson Syndrome, as part of its webcast presentation at the Cowen and Company 35^th Annual Healthcare Conference on Monday, March 2, 2015 at 4:50 p.m. ET.

Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, “As we work to finalize the clinical trial protocol in both noninfectious anterior uveitis and Sjögren-Larsson Syndrome, we have remained in close contact with the FDA. Based on their requirements, we have amended and submitted an updated trial protocol for noninfectious anterior uveitis with regard to the severity of patients and the frequency of dosing. We believe that the updated protocol will satisfy these requirements and, pending FDA and IRB review, we remain on track to generate data from both of our clinical programs in 2015.”

The U.S. Food and Drug Administration (FDA) has notified Aldeyra that, before initiation of Aldeyra’s planned Phase II clinical study of NS2 in patients with noninfectious anterior uveitis, the protocol submitted as part of the company’s Investigational New Drug Application requires amending. Aldeyra has submitted an amended protocol that the Company believes will be acceptable to the FDA. Specifically, in the amended protocol, a minority subset of the most severe uveitis patients are excluded from enrollment, and the frequency of dosing was reduced to treat less severe disease and match the dosing frequency employed in the Phase I study. Consistent with earlier guidance, and subject to FDA review of the modified protocol, the trial is expected to begin enrollment in the first half of 2015, with preliminary data available by the end of the year.

The company’s Phase II clinical trial of a dermatologic formulation of NS2 to treat ichthyosis and other skin manifestations of Sjögren-Larsson Syndrome is expected to begin enrollment pending final Institutional Review Board (IRB) approval. Consistent with earlier guidance, final data from the trial are expected in the second half of 2015.

NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping free aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate pathologic inflammation and address other diseases where aldehydes are thought to mediate pathology.

To access the webcast of Aldeyra’s presentation, please visit the Investors section of the Company’s website at www.aldeyra.com. An archived version of the webcast will be available for 14 days following the presentation.

About Aldeyra Therapeutics

Aldeyra Therapeutics, Inc., is a biotechnology company focused primarily on the development of products to treat diseases thought to be related to endogenous free aldehydes, a naturally occurring class of toxic molecules. The company has developed NS2, a product candidate designed to trap free aldehydes. Aldeyra plans to initiate Phase II clinical studies of NS2 in Sjögren-Larsson Syndrome and noninfectious anterior uveitis in 2015. NS2 has not been approved for sale in the U.S. or elsewhere. www.aldeyra.com

Safe Harbor Statement

This release 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 by terms such as “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 FDA’s acceptance of the modified protocol for Alderya’s planned Phase II clinical trial of an ophthalmic formulation of NS2 to treat acute noninfectious uveitis, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; the ability to obtain and maintain regulatory approval to conduct clinical trials and to 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. Additional information will also be set forth in those sections of Alderya’s Annual Report on Form 10-K for the year ended December 31, 2014, which will be filed with the SEC in the first quarter of 2015.

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 release 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.

Corporate Contact:

Stephen Tulipano

Aldeyra Therapeutics, Inc.

Tel: +1 781-761-4904 Ext. 205

stulipano@aldeyra.com

Investor Contact:

David Burke

The Ruth Group

Tel: +1 646-536-7009

dburke@theruthgroup.com