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 17, 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 8.01. | OTHER EVENTS |
On March 17, 2015, Aldeyra Therapeutics, Inc. issued a press release announcing that it has opened enrollment for its Phase II clinical trial of NS2 for patients with Sjögren-Larsson Syndrome and that the U.S. Food and Drug Administration has accepted the its submission of an amended protocol for its Phase II clinical study trial of NS2 in patients with noninfectious anterior uveitis.
A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
| Item 9.01. | FINANCIAL STATEMENTS AND EXHIBITS |
| (d) | Exhibits – The following exhibits are filed as part of this report: |
| 99.1 | Press Release of Aldeyra Therapeutics, Inc. |
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 17, 2015
Exhibit 99.1
Aldeyra Therapeutics Opens Enrollment in Sjögren-Larsson Syndrome Clinical Trial
and Finalizes Noninfectious Anterior Uveitis Clinical Trial Protocol
Lexington, MA, March 17, 2015 – Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that it has opened enrollment for its Phase II clinical trial of NS2 for patients with Sjögren-Larsson Syndrome.
In addition, Alderya announced that the U.S. Food and Drug Administration (FDA) has accepted its submission of an amended protocol for its Phase II clinical trial of NS2 in patients with noninfectious anterior uveitis. With the protocol finalized, Aldeyra continues to expect the trial to begin enrollment in the first half of 2015, with preliminary data expected by the end of the year.
Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, commented, “We are pleased to continue advancing our clinical trials as planned. We believe that our Sjögren-Larsson Syndrome clinical trial site, which is the top treatment center for these patients in the U.S., will enable us to initiate and complete enrollment efficiently. With regard to noninfectious anterior uveitis, our trial protocol has been finalized and we anticipate Institutional Review Board approval in the near term. We are fortunate to have engaged some of the top anterior uveitis clinical sites in the U.S. to lead this study. Overall, we believe we are well positioned as we begin Phase II testing of NS2.”
About NS2
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 excessive inflammation and address diseases where aldehydes are thought to mediate pathology.
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome (SLS) is a rare disease caused by mutations in fatty acid aldehyde dehydrogenase that lead to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease.
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis is a rare disease characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia.
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 has initiated clinical testing of NS2 for the treatment of Sjögren-Larsson Syndrome and plans to initiate clinical testing of NS2 in noninfectious anterior uveitis in the first half of 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 Institutional Review Board’s acceptance of the protocol for Aldeyra’s planned Phase II clinical trial of NS2 in noninfectious anterior uveitis, the timing of 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 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 Aldeyra’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