Earnings release
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ab aldeyra Aldeyra Therapeutics Reports Third - Quarter 2021 Financial Results and Recent Corporate Highlights October 28 , 2021 • Company Expects to Report Top - Line Results from Phase 3 TRANQUILITY and TRANQUILITY - 2 Clinical Trials of Reproxalap in Dry Eye Disease in the Fourth Quarter of 2021 • Phase 2 Clinical Trial of ADX - 2191 in Retinitis Pigmentosa On Track to Initiate in the Fourth Quarter of 2021 • Phase 2 Clinical Trial Results of ADX - 629 in Multiple Systemic Indications Expected in the Fourth Quarter of 2021 or the First Quarter of 2022 • Cash and Cash Equivalents of $ 241.4 Million as of September 30 , 2021 ; Projected Cash Runway Through 2023 , Including Potential New Drug Applications ; Initial Commercialization of Reproxalap , if Approved ; and Continued Development of Compounds for Retinal and Systemic Diseases • Management to Host Conference Call at 8:00 a.m. ET Today LEXINGTON , Mass .-- ( BUSINESS WIRE ) -- Oct . 28 , 2021-- Aldeyra Therapeutics , Inc. ( Nasdaq : ALDX ) ( Aldeyra ) , a biotechnology company developing novel immune - modulating therapies to treat ocular and systemic diseases , today reported recent corporate highlights and financial results for the quarter ended September 30 , 2021 . " We continue to make important progress in developing safe and effective treatments for ocular and systemic diseases to improve the lives of patients who have significant unmet medical needs , " stated Todd C. Brady , M.D. , Ph.D. , President and Chief Executive Officer of Aldeyra . " Among key clinical milestones , we expect to release top - line results from the Phase 3 TRANQUILITY and TRANQUILITY - 2 dry eye disease clinical trials in the fourth quarter of this year and are on track to report top - line results from Phase 2 clinical trials of ADX - 629 in psoriasis , atopic asthma , and COVID - 19 by the end of the year or early 2022. We also look forward to the planned initiation of our Phase 2 clinical trial of ADX - 2191 in retinitis pigmentosa this quarter . " Recent Corporate Highlights and Program Updates • Top - Line Results from the Phase 3 TRANQUILITY and TRANQUILITY - 2 Trials in Dry Eye Disease Expected in the Fourth Quarter of 2021. Ocular redness is the primary endpoint of the TRANQUILITY trials , which include tear RASP levels , Schirmer's test , and dry eye disease symptoms as secondary endpoints . In addition , enrollment has completed in a multi - center , double - masked , randomized , vehicle - controlled , parallel - group Phase 2 clinical trial of reproxalap in dry eye disease . The Phase 2 trial was designed to optimize the measurement of tear RASP levels . • Phase 2 Clinical Trial of ADX - 2191 in Retinitis Pigmentosa Scheduled to Initiate in the Fourth Quarter of 2021. The primary endpoint of the trial is the safety and tolerability of ADX - 2191 in patients with retinitis pigmentosa . Secondary endpoints are visual acuity , central retinal sensitivity , dark - adapted retinal sensitivity , and retinal morphometry . • Phase 2 Clinical Trial Results from ADX - 629 , an Orally Administered RASP Inhibitor , Expected in the Fourth Quarter of 2021 or First Quarter of 2022. ADX - 629 is in proof - of - concept Phase 2 clinical trials for the treatment of psoriasis , atopic asthma , and COVID - 19 . ADX - 629 represents a first - in - class systems - based therapeutic approach for the potential treatment of many immune - mediated diseases that today are treated with single - target drugs that can lead to toxicity . • Post - Acute Ocular Tolerability Comparison of Topical Reproxalap 0.25 % and Lifitegrast 5 % in Patients with Dry Eye Disease Paper Published in Peer - Reviewed Journal . Clinical Ophthalmology published the results of a clinical trial comparing the subjective eye drop experience of patients with dry eye disease over one hour after a single dose of two formulations of reproxalap versus lifitegrast . Third - Quarter 2021 Financial Results Cash and cash equivalents as of September 30 , 2021 were $ 241.4 million . Based on Aldeyra's current operating plan , the company believes that existing cash and cash equivalents will be sufficient to fund currently projected operating expenses through the end of 2023 , including potential New Drug Application submissions ; initial commercialization of reproxalap , if approved ; and continued development of the company's product candidates in ocular and systemic immune - mediated diseases . For the quarter ended September 30 , 2021 , Aldeyra reported a net loss of $ 15.8 million , compared with a net loss of $ 8.9 million for the quarter ended September 30 , 2020. Net loss per share was $ 0.27 for the quarter ended September 30 , 2021 , compared with $ 0.23 for the same period in 2020 . Losses have resulted from the costs of clinical trials and research and development programs , as well as from general and administrative expenses . Research and development expenses were $ 12.9 million for the quarter ended September 30 , 2021 , compared with $ 6.1 million for the same period in 2020. The increase of $ 6.8 million is primarily related to increases in our clinical research and development expenditures and consulting costs , partially offset by decreases in personnel related costs , including stock - based compensation , and manufacturing activities .