On August 5, 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 June 30, 2022 (Press release, Aldeyra Therapeutics, AUG 5, 2022, View Source [SID1234617683]).
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"The second half of 2022 is highlighted by planned new drug applications in dry eye disease and primary vitreoretinal lymphoma, two diseases that are currently sub-optimally treated," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "In addition, we look forward to announcing the results of the Phase 3 GUARD trial of ADX-2191 in proliferative vitreoretinopathy later this year, as well as the Phase 2 results of the oral RASP modulator ADX-629 in a challenge model of acute alcoholic hepatitis."
Recent Corporate Highlights
Positive Results from the Dry Eye Disease Chamber Crossover Clinical Trial: Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber (P=0.0004) and Schirmer test (P=0.0005), a measure of tear production, after a single day of dosing. The secondary endpoint of Schirmer test ≥10 mm responder analysis, which was multiplicity-controlled and has been reported to correlate with symptomatic improvement in dry eye disease,1 was also achieved (P=0.0361). Rapid and statistically significant reductions in patient-reported ocular discomfort and dryness were observed in the dry eye disease chamber.
Positive Results from the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease: Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, Schirmer test (P=0.0001) and Schirmer test ≥10 mm responder analysis (P<0.0001) after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones
NDA Submission of Reproxalap in Dry Eye Disease: Pending discussions with the FDA and enrollment in the 12-month safety trial of reproxalap in patients with dry eye disease, Aldeyra intends to submit an NDA with data on ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis, encompassing results across five adequate and well-controlled completed clinical trials. A pre-NDA meeting with the FDA to discuss the regulatory package has been scheduled for the third quarter of 2022.
Pre-NDA Meeting for ADX-2191 in Primary Vitreoretinal Lymphoma: Aldeyra plans to conduct a pre-NDA meeting with the FDA in the second half of 2022 to discuss ADX-2191 for the treatment of primary vitreoretinal lymphoma. Pending discussion with the FDA, an NDA submission is planned for the second half of 2022.
Results from the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy: Top-line results from Part 1 of the Phase 3 GUARD trial of ADX-2191 in patients with proliferative vitreoretinopathy are expected in the second half of 2022.
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: In the second half 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.
Second-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of June 30, 2022 were $196.7 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 planned NDA submissions and initial commercialization of reproxalap and ADX-2191, if approved, and continued development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.
Net loss for the three months ended June 30, 2022 was $17.8 million, or $0.30 per share, compared with a net loss of $14.9 million, or $0.28 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 June 30, 2022 were $14.6 million, compared with $11.5 million for the same period in 2021. The increase of $3.1 million is primarily related to increases in external clinical and preclinical development costs, and drug product manufacturing expenditures.
General and administrative expenses for the three months ended June 30, 2022 were $3.1 million, compared with $3.1 million for the same period in 2021.
Total operating expenses for the three months ended June 30, 2022 were $17.7 million, compared with total operating expenses of $14.5 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 June 30, 2022. The dial-in numbers are (844) 200‑6205 for domestic callers and (929) 526‑1599 for international callers. The access code is 908644. 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.