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Aldeyra Therapeutics Announces Third Quarter 2018 Financial Results
Reported Positive Data from Phase 2b Clinical Trial of Topical Ocular Reproxalap in Dry Eye Disease
Announced Positive Top-Line Data from Investigator-Sponsored Phase 1/2 Clinical Trial of ADX-1612 in Malignant Mesothelioma
Raised $67.6 Million, Operations Expected to be Funded Through 2020
LEXINGTON, Mass., November 14, 2018 /PRNewswire/ Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced financial results for the third quarter ended September 30, 2018.
The third quarter was highlighted by positive results from our Phase 2b clinical trial of reproxalap in dry eye disease and an investigator-sponsored Phase 1/2 clinical trial of ADX-1612 in malignant mesothelioma, commented Todd C. Brady, M.D., Ph.D. In addition, we completed a successful financing to support a broad and diversified clinical development plan that includes Phase 3 clinical trials in dry eye disease, noninfectious anterior uveitis, allergic conjunctivitis, and Sjögren-Larsson Syndrome. We look forward to the announcement of our next major milestone, results from the ALLEVIATE Phase 3 clinical trial in allergic conjunctivitis, in early 2019.
Recent Highlights and Corporate Updates
Announced positive results from a randomized, vehicle-controlled, parallel-group, multi-center, double-masked Phase 2b clinical trial of topical ocular reproxalap in dry eye disease. In September 2018, Aldeyra announced that reproxalap was observed to be statistically superior to vehicle across multiple dry eye disease symptoms and signs in a Phase 2b clinical trial. The results demonstrated activity versus vehicle as early as two weeks, supportive of a differentiated product profile relative to current standard of care. Aldeyra plans to initiate a Phase 3 clinical trial in 2019, following discussions with regulatory authorities.
Announced positive top-line results from the MESO-2 investigator-sponsored Phase 1/2 clinical trial of ADX-1612 (ganetespib) in patients with pleural malignant mesothelioma. Results of the clinical trial were presented at the International Association for the Study of Lung Cancer (ASLC) 19th World Conference on Lung Cancer (Abstract #11921). ADX-1612, when combined with standard pemetrexed and platinum therapy, resulted in partial response rates that exceeded that of historical standard of care (pemetrexed and platinum therapy). A Phase 2 clinical trial of ADX-1612 in mesothelioma, a disease with no known cure and a poor prognosis, is expected to be initiated in 2019, pending discussion with regulatory authorities.
Strengthened balance sheet. In October 2018, Aldeyra completed an underwritten public offering that raised net proceeds of $67.6 million after deducting underwriting discounts, commissions, and estimated expenses. The proceeds are expected to fund operations through 2020, including the currently planned announcements of top-line data from Phase 3 clinical trials in allergic conjunctivitis, noninfectious anterior uveitis, Sjögren-Larsson Syndrome (Part 1), and dry eye disease.
The following information was filed by Aldeyra Therapeutics, Inc. (ALDX) on Wednesday, November 14, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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