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 31, 2016
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 |
On March 31, 2016, David J. Clark, M.D., Chief Medical Officer of Aldeyra Therapeutics, Inc. (“Aldeyra”) will be making a presentation during the 2016 SSADH Symposium in Boston, Massachusetts at 12:15 p.m. ET. The presentation will include information and data regarding Aldeyra’s Succinic Semi-Aldehyde Dehydrogenase (SSADH) Deficiency development program. SSADH Deficiency is an inborn error of aldehyde metabolism characterized by motor planning dysfunction, speech impairment, intellectual disability, and autism. The slides that will be used for such presentation are furnished as Exhibit 99.1 to this Form 8-K.
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 9.01. | FINANCIAL STATEMENTS AND EXHIBITS. |
(d) Exhibits.
| Exhibit |
Description | |
| 99.1 | Presentation Slides | |
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 31, 2016
 A Novel Therapy for SSADH:
An Aldehyde Trap for an Aldehyde-Mediated Disease
March 2016 Exhibit 99.1 |
 Disclaimers and Forward-Looking
Statements 2 • 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
possible or assumed future results of operations and expenses, business strategies and plans, research and development plans or expectations, trends, market sizing, competitive position, industry
environment and potential growth opportunities, among other things..
Forward-looking statements include all statements that are not
historical facts and, in some cases, can be identified by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,”
“could,” “can,” “would,” “expect,”
“believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan”
or similar expressions and the negatives of those terms. • Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra’s actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. 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 of commencement, enrollment and completion of
Aldeyra’s clinical trials; 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
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 its expenses and revenue, the sufficiency or use of Aldeyra’s cash resources and needs for
additional financing; the rate and degree of market acceptance of
any of Aldeyra’s product candidates; Aldeyra’s expectations regarding competition; Aldeyra’s anticipated growth strategies; Aldeyra’s ability to attract or retain key personnel;
Aldeyra’s ability to establish and maintain development
partnerships; Aldeyra’s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra’s ability to obtain and maintain
intellectual property protection for its product candidates; the
anticipated trends and challenges in Aldeyra’s business and the market in which it operates; the use or sufficiency of Aldeyra’s cash or cash equivalents; 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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 March
31, 2016, and Aldeyra undertakes no obligation to update any
forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
- - |
 Aldehydes Are Toxic Destruction of fats, proteins, sugars Formation of toxic metabolites such as -hydroxybutyric acid (GHB) Inflammation Aldehydes |
 Symptoms of SSADH Deficiency
Believed to be Due to Aldehydes
Genetic Mutations in SSADH Autism, Cognitive Delay, Decreased Muscle Tone, Seizures Destruction of fats, proteins, sugars Formation of GHB, D-2- hydroxyglutarate (D-2-HG) Inflammation SSA |
 An
Aldehyde Trap Could Diminish the Symptoms of SSADH
Deficiency Genetic
Mutations in SSADH |
 Aldehyde Traps: A Novel Therapeutic Approach 6 Aldeyra’s lead aldehyde trap, NS2, appears to have minimal pharmacology, with no known
effects on receptors, enzymes and other proteins. In clinical trials to
date, NS2 has been observed to be safe and well-tolerated.
Aldeyra is not aware of any similar technology. Aldeyra’s
lead aldehyde trap, NS2, appears to have minimal pharmacology, with no known effects on receptors, enzymes and other proteins. In clinical trials to date, NS2 has been
observed to be safe and well-tolerated. Aldeyra is not aware of any similar
technology. •
Aldeyra’s compounds rapidly trap
free aldehydes
• Trapped aldehydes are transported to the lysosome • Drug-aldehyde adducts are metabolized within hours Aldehyde Binding Adduct Transport Cellular Disposal |
 An
Aldehyde Trap is Proven to Reduce Inflammation in Humans
Ocular Itching
Ocular Tearing
Vehicle NS2 Visit 4 Minutes Post-Challenge 7 * * * * * * * *p<0.05; p values are subject to change based on quality control analysis Phase IIa Allergic Conjunctivitis Clinical Trial (February, 2016) -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 0 50 100 150 200 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 50 100 150 200 0 |
 Aldeyra
is Clinically Testing Aldehyde Traps in Several Diseases
Discovery Formulation
Pre-Clinical Phase I Phase II Phase III Allergic Conjunctivitis (NS2 Ocular) Noninfectious Anterior Uveitis (NS2 Ocular) Sjögren-Larsson Syndrome (NS2 Dermatologic) Sjögren-Larsson Syndrome (NS2 Systemic) SSADH Deficiency (NS2 Systemic) Autoimmune Crisis (NS2 Systemic) Various (NSX Series & Other) 8 |
 Our
Lead Candidate, NS2, Traps the Toxic Aldehyde in SSADH
Deficiency By trapping SSA, NS2 may prevent the formation of
pathologic metabolites that are thought to be responsible for the
severe neurological complications of SSADH Deficiency. By
trapping SSA, NS2 may prevent the formation of pathologic metabolites that are thought to be responsible for the severe neurological complications of SSADH Deficiency.
Data presented at the 2015 American Society of Human Genetics Annual
Meeting Ainslie, Vogel, Cullen, Young, Brady and Gibson, 2015
Washington State University and Aldeyra
Therapeutics NS2 administered as a single dose to SSADH knock-out mice |
 NS2 May Reduce GHB and D2HG
Levels in SSADH KO Mice
Ainslie, Vogel, Cullen, Young, Brady and Gibson, 2015
Washington State University and Aldeyra
Therapeutics t test (**p<0.01) |
 Next
Steps in the Development of NS2 for SSADH Deficiency
1. Generate additional preclinical data supporting the use of NS2 in SSADH
patients •
Identify endpoints to assess clinical efficacy of NS2
2. Natural History Study • Understand levels of metabolites and clinical endpoints in patients • Use data to confirm endpoints for Phase II study in SSADH 3. Healthy Volunteer Safety Study • Confirm safety and pharmacological activity of systemic NS2 in adults 4. Phase II study in SSADH patients • Metabolites and clinical endpoints • Progress to longer duration dosing evaluating disease modification |
 Hope
for the Future 12
“In 2016, we expect to build on our accomplishments from last year by initiating clinical development of aldehyde traps that are administered systemically. We are excited to continue to advance NS2 and other aldehyde traps as a novel therapeutic approach for inflammatory disease and inborn errors of aldehyde metabolism.” Aldeyra Therapeutics Reports Full Year 2015 Financial Results Press Release, March 30, 2016 |