SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 7, 2020
ALDEYRA THERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction
131 Hartwell Avenue, Suite 320
Lexington, MA 02421
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (781) 761-4904
(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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange
on which registered
|Common Stock, $0.001 par value per share||ALDX||The Nasdaq Stock Market, LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
|Item 8.01.|| |
On July 7, 2020, Aldeyra Therapeutics, Inc. (the Company) issued a press release (the Press Release) providing an update on its development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease. The Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Aldeyra Therapeutics, Inc. Press Release dated July 7, 2020.|
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.
|Dated: July 7, 2020|| |
ALDEYRA THERAPEUTICS, INC.
|Name: Joshua Reed|
|Title: Chief Financial Officer|
Aldeyra Therapeutics Announces New Drug Application (NDA) Development
Plans for Dry Eye Disease
Top-Line Results from First of Two Planned Clinical Trials Based on Tear RASP Levels Expected by the End of 2020
New Drug Application Submission for Reproxalap in Dry Eye Disease Expected by the End of 2021
Based on Current Operating Plans, Current Cash Expected to Support Operations into 2022, Consistent with Prior Guidance
LEXINGTON, Mass., July 7, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease. Based on U.S. Food and Drug Administration (FDA) meeting minutes, Aldeyra intends to initiate two clinical trials to assess the activity of reproxalap in reducing tear levels of RASP, pro-inflammatory mediators recently accepted by the FDA as an objective sign of dry eye disease.
Top-line results from the first of the RASP trials are expected by the end of 2020, pending potential disruptions due to the COVID-19 pandemic. In addition, a safety trial in dry eye disease patients is expected to be initiated in the fourth quarter of 2020. NDA submission is expected in late 2021.
Aldeyras written meeting minutes with the FDA confirming the use of RASP as an objective sign for the treatment of dry eye disease is a positive step in the regulatory science of novel treatments for ocular surface disease, stated Gary D. Novack, Ph.D., Professor of Ophthalmology at the School of Medicine at University of California, Davis, President of PharmaLogic Development, Inc., and Chair of the Tear Film and Ocular Surface Society DEWS (Dry Eye Workshop) II Clinical Trial Design Group. RASP assessment is a measurement of the mechanism of action of reproxalap, and represents a potentially important biomarker-based approach. This announcement comes in a context where we have few biomarkers in pharmacotherapy for ocular diseases, and no regulatory-based biomarkers in the treatment of ocular surface disease.
Assessment of RASP in the two planned trials is expected after single and multiple doses of drug over two days. Investigational new drug reproxalap covalently binds RASP via a series of reactions that occur rapidly in vitro, and statistically reduced RASP levels in the tears of dry eye patients in a Phase 2a clinical trial.
Aldeyra also reiterated financial guidance that, based on current operating plans, cash, cash equivalents, and marketable securities are sufficient to support operations into 2022, including completion of the two planned RASP trials and the companys second Phase 3 clinical trial in allergic conjunctivitis, the INVIGORATE Trial.
With only one drug approved in the United States for the treatment of the symptoms and signs of dry eye disease, the need for therapeutic options with new mechanisms of action is substantial, stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. Reproxalap is a first-in-class investigational RASP inhibitor that, in the Phase 3 RENEW-1 Trial, demonstrated potential rapid and broad symptom control we believe is an important commercial differentiator.
RASP (reactive aldehyde species) are pre-cytokine pro-inflammatory mediators that are elevated in the tears of patients with dry eye disease,1 and correlate with dry eye disease symptoms and signs.2 RASP covalently bind to cellular biomolecules, altering molecular function and activating numerous pro-inflammatory pathways implicated in human disease.
Reproxalap is a novel investigational small-molecule immune-modulating covalent inhibitor of RASP in development as a topically administered ophthalmic solution for dry eye disease and allergic conjunctivitis. The mechanism of action of reproxalap has been validated with the demonstration of statistically significant and clinically relevant activity in multiple late-phase clinical trials.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the companys lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease, leading to elevated levels of cytokine release via activation of a broad array of inflammatory factors, including NF-KB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The companys clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyras strategy, future operations, prospects, and development plans to support a New Drug Application for reproxalap in dry eye disease and expectations regarding FDA acceptance and review of such NDA and the sign and symptom requirements. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, may, might, will, objective, intend, should, could, can, would, expect, believe, anticipate, project, on track, scheduled, 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. All of Aldeyras development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete our clinical trials may be delayed. Important factors that could cause actual results to differ materially from those reflected in Aldeyras forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyras clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyras continuing review and quality control analysis of clinical data, Aldeyras ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyras product candidates; the ability to maintain regulatory approval of Aldeyras product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyras product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyras product candidates; the current and potential future impact of the COVID-19 pandemic on our business, results of operations and financial position; uncertainty as to Aldeyras ability to commercialize (alone or with others) Aldeyras product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyras product candidates and the ability to serve those markets; Aldeyras expectations regarding Aldeyras expenses and revenue, the sufficiency or use of Aldeyras cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyras business or the global economy; the rate and degree of market acceptance of any of Aldeyras product candidates; Aldeyras expectations regarding competition; Aldeyras anticipated growth strategies; Aldeyras ability to attract or retain key personnel; Aldeyras limited sales and marketing infrastructure; Aldeyras ability to establish and maintain development partnerships; Aldeyras ability to successfully integrate acquisitions into its business; Aldeyras expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyras ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyras business and the market in which it operates; and other factors that are described in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Aldeyras Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyras Quarterly
Report on Form 10-Q for the quarter ended March 31, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SECs website at www.sec.gov. Additional factors may be set forth in those sections of Aldeyras Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, expected to be filed with the SEC in the third quarter of 2020.
In addition to the risks described above and in Aldeyras other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyras 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.
Augustin et al., Oxidative reactions in the tear fluid of patients suffering from dry eyes, Graefes Archive for Clinical and Experimental Ophthalmology, 233(11):694-698 (1995).
Choi W., et al. Expression of Lipid Peroxidation Markers in the Tear Film and Ocular Surface of Patients with Non-Sjogren Syndrome: Potential Biomarkers for Dry Eye Disease. Curr Eye Res. 2016, 41(9):1143-9; Reproxalap preclinical and Phase 2a in dry eye disease clinical trial results on file.
Investor & Media Contact:
Aldeyra Therapeutics, Inc.
Sharon Merrill Associates, Inc.
Tel: 781-761-4904 ext. 218