On March 11, 2021 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, reported business highlights and financial results for the year ended December 31, 2020 (Press release, Aldeyra Therapeutics, MAR 11, 2021, View Source [SID1234576476]).
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"During the past year, we have worked diligently to advance our lead investigational compound reproxalap into pivotal Phase 3 clinical trials in dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "Based on clinical results to date, we believe reproxalap has the potential to be first-line therapy for the treatment of dry eye disease and an important alternative to corticosteroids for the treatment of allergic conjunctivitis. We look forward to the potential to further validate the opportunities for reproxalap with the results of the TRANQUILITY, TRANQUILITY-2, and INVIGORATE trials, as we begin 2021 in a strong financial position, with liquidity expected to fund our current clinical development plans and operations through 2023."
Recent Highlights and Program Updates
Phase 3 INVIGORATE Allergic Conjunctivitis Trial Enrollment Completed: Aldeyra has completed patient enrollment of its randomized, double-masked, crossover design, vehicle-controlled, allergen chamber Phase 3 INVIGORATE Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis. The primary efficacy endpoint is patient-reported ocular itching score assessed on a 9-point scale. Investigator-assessed ocular redness is a key secondary endpoint. Top-line results are expected in the first half of 2021.
Phase 3 TRANQUILITY Dry Eye Disease Trial Design Finalized: In February 2021, Aldeyra announced the finalization of the design of the multi-center, randomized, double-masked, parallel-group, vehicle-controlled Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The primary endpoint is ocular redness over 90 minutes in a dry eye chamber. Tear RASP levels, Schirmer’s Test, and dry eye disease symptoms will be secondary endpoints. The protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort. Results from the run-in cohort, announced in January 2021, demonstrated statistically significant improvement of reproxalap over vehicle in eye dryness score and other dry eye disease symptoms after a single day of dosing, and, during exposure to a dry eye chamber, statistically significant improvement of reproxalap over vehicle in eye dryness symptom score, ocular discomfort score, and ocular redness. TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are on schedule to initiate enrollment in the first half of 2021. Top-line results from both trials are expected in the second half of 2021.
Phase 2 Clinical Testing of Novel Orally Administered RASP Inhibitor ADX-629 Initiated: In the fourth quarter of 2020, Aldeyra announced the initiation of Phase 2 proof-of-concept clinical trials of ADX-629, a first-in-class orally administered RASP inhibitor for the treatment of psoriasis, atopic asthma, and COVID-19. The trials are part of a systematic strategy to assess the activity of ADX-629 across different types of systemic inflammatory disease. Top-line results from the trials are expected by the end of 2021.
Enrollment of Phase 3 GUARD Proliferative Vitreoretinopathy Trial of ADX-2191 Continues: Completion of enrollment is expected in 2021 for Part 1 of the Phase 3 GUARD Trial of ADX-2191 (0.8% methotrexate intravitreal injection) for the prevention of proliferative vitreoretinopathy, a rare but serious sight-threatening retinal disease with no approved treatment.
Public Offering Completed: Aldeyra announced the closing of an underwritten public offering of 7,868,421 shares of its common stock at a price of $9.50 per share, including 1,026,315 additional shares of common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The underwritten offering generated gross proceeds of $74.7 million and net proceeds of $70.0 million after deducting underwriting discounts, commissions, and offering expenses.
Full-Year 2020 Financial Summary
Cash and cash equivalents as of December 31, 2020 were $77.9 million. Based on its current operating plan and including the net proceeds from the underwritten public offering completed in January 2021, Aldeyra believes that existing cash and cash equivalents will be sufficient to fund currently anticipated operating expenses through the end of 2023, including the completion of the Phase 3 TRANQUILITY and TRANQUILITY-2 trials in dry eye disease; the completion of the Phase 3 INVIGORATE trial in allergic conjunctivitis; the Phase 2 clinical trials of ADX-629 in psoriasis, atopic asthma, and COVID-19; and the completion of Part 1 of the adaptive Phase 3 GUARD clinical trial in proliferative vitreoretinopathy.
The net loss for full-year 2020 was $37.6 million, or $1.11 per share, compared with a net loss of $60.8 million, or $2.24 per share, for full-year 2019.
Research and Development (R&D) expenses were $24.7 million for full-year 2020 compared with $44.4 million for full-year 2019. The decrease of $19.7 million in R&D expenses primarily reflected a reduction in clinical research and development expenditures, partially offset by an increase in non-cash compensation costs related to a portion of a contingent acquisition milestone.
Acquired in-process research and development expenses were $1.8 million for full-year 2020 compared with $6.6 million for full-year 2019. The $4.8 million decrease is related to lower in-process research and development expenses associated with the 2019 acquisition of Helio Vision.
General and administrative (G&A) expenses were $10.0 million for full-year 2020 compared with $12.2 million for full-year 2019. The decrease of $2.2 million in G&A expenses primarily reflected lower personnel costs, legal costs, public company costs related to continuing compliance with the Sarbanes Oxley Act of 2002, and miscellaneous administrative costs.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its full-year 2020 financial results. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6253616. Due to the expected high demand on our conference provider, please plan to dial in to the call at least 15 minutes prior to the start time.
A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.