On November 10, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, reported recent corporate highlights and financial results for the quarter ended September 30, 2022 (Press release, Aldeyra Therapeutics, NOV 10, 2022, View Source [SID1234623748]).
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"Now with two product candidates that could generate revenue as soon as next year, Aldeyra remains a leader in the development of systems-based therapeutic approaches for the treatment of diseases characterized by inflammation," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
Recent Corporate Highlights
Pre-NDA Meeting with the FDA for Reproxalap in Dry Eye Disease: Following the receipt of official minutes from its pre-NDA meeting with the FDA, Aldeyra remains on schedule to submit an NDA requesting marketing approval of the novel RASP modulator reproxalap in the fourth quarter of 2022. With results from five adequate and well-controlled completed clinical trials, Aldeyra intends to submit the NDA with data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. In addition to efficacy data, Aldeyra plans to submit up to 12 months of reproxalap safety data. Topical ocular reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
Results from the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy: ADX-2191 was statistically superior to historical control1 for the prevention of retinal detachment due to proliferative vitreoretinopathy over six months (P=0.024). Although not statistically powered for secondary or exploratory endpoints, the results of the GUARD Trial demonstrated numerical superiority of ADX-2191 over routine surgical care in reducing the dichotomous endpoints of retinal detachment rate over six months, hypotony (low intraocular pressure), complete retinal attachment by six months, macular attachment by six months, and epiretinal membrane formation (overall P=0.047). The most common adverse event associated with ADX-2191 treatment was punctate keratitis, a well-known side effect of intravitreal methotrexate, that was most commonly mild in severity. Across all other treatment-emergent adverse events occurring in at least 10% of patients in either treatment arm, relative to patients treated with routine surgical care, ADX-2191-treated patients had numerically fewer side effects, including pain, cystoid macular edema, corneal edema, macular fibrosis, corneal epithelial defects, anterior uveitis, ocular hypertension, and post-operative inflammation (overall P=0.0002).
Additional Upcoming Planned Clinical and Regulatory Milestones
Pre-NDA Meeting with the FDA for ADX-2191 in Primary Vitreoretinal Lymphoma: Aldeyra has scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2022 to discuss ADX-2191 for the treatment of primary vitreoretinal lymphoma. Pending the results of the pre-NDA meeting, NDA submission may occur as soon as the end of 2022.
Type C meeting with the FDA for ADX-2191 in Proliferative Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting with the FDA in the first half of 2023 to discuss the completion of clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy.
Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa: Top-line results from the Phase 2 clinical trial of ADX-2191 in patients with retinitis pigmentosa are expected in the first half of 2023.
Results from Phase 2 Clinical Trials of ADX-629 in Systemic Immune-Mediated Diseases: By the end of this year, Aldeyra expects to report top-line results from a Phase 2 clinical trial in acute alcoholic hepatitis, and to initiate Phase 2 clinical trials in Sjögren-Larsson Syndrome and minimal change disease. Top-line results from the ongoing Phase 2 clinical trial of ADX-629 in chronic cough are anticipated in the first half of 2023.
Third-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of September 30, 2022 were $185.3 million. Based on its current operating plan, Aldeyra believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including NDA submissions and initial commercialization of reproxalap and ADX-2191, if approved; and continued early and late-stage development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.
Net loss for the three months ended September 30, 2022 was $14.6 million, or $0.25 per share, compared with a net loss of $15.8 million, or $0.27 per share, for the comparable period of 2021. 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 for the three months ended September 30, 2022 were $11.5 million, compared with $12.9 million for the same period in 2021. The decrease of $1.4 million is primarily related to a decrease in external clinical development costs, offset by an increase in Aldeyra’s external preclinical development costs, drug product manufacturing expenditures, personnel costs, and consulting expenditures.
General and administrative expenses for the three months ended September 30, 2022 were $3.2 million, compared with $2.5 million for the same period in 2021. The increase of $0.7 million was primarily related to higher personnel costs and consulting expenditures.
Total operating expenses for the three months ended September 30, 2022 were $14.8 million, compared with total operating expenses of $15.4 million for the same period in 2021.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss recent corporate highlights and financial results for the quarter ended September 30, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 048610. Please dial in at least 10 minutes prior to the start time.
A live webcast of the conference call can be accessed via the Investors & Media page of the Aldeyra website at View Source After the live webcast, the event will remain archived on the website for 90 days.