On May 6, 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 financial results for the quarter ended March 31, 2021 and provided recent business highlights (Press release, Aldeyra Therapeutics, MAY 6, 2021, View Source [SID1234579428]).
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"We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in anterior ocular inflammatory disease," stated President and CEO Todd C. Brady, M.D., Ph.D. "We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.
"We believe we continue to operate from a position of financial strength," Dr. Brady stated. "With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need."
Recent Highlights and Program Updates
Primary, Key Secondary, and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial: In the first-ever Phase 3 clinical trial of a novel investigational product in an allergen chamber, 0.25% reproxalap ophthalmic solution (reproxalap) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching (p<0.0001), the key secondary endpoint of ocular redness (p<0.0001), and the secondary endpoints of ocular tearing and total ocular severity score (each p<0.0001). The results of INVIGORATE, the second positive Phase 3 trial for reproxalap in allergic conjunctivitis, indicate potential clinical utility before and during exposure to moderate to high levels of pollen.
Phase 3 TRANQUILITY and TRANQUILITY-2 Dry Eye Disease Trial Results Expected in Second Half of 2021: Patient enrollment has begun in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap. The primary endpoint of the trial is ocular redness, which was statistically lower (p=0.03) for reproxalap relative to vehicle in the TRANQUILITY run-in cohort results announced in January 2021. Tear RASP (reactive aldehyde species) levels will also be assessed. Approximately 150 dry eye disease patients are expected to be enrolled per arm. Reproxalap will be administered four times the day prior to entry into the dry eye chamber, just before entry into the chamber, and 45 minutes after chamber entry. Enrollment in TRANQUILITY is ongoing, and enrollment in the confirmatory TRANQUILITY-2 Trial is expected to begin in the second quarter of 2021. Aldeyra plans to report top-line results from both trials in the second half of this year.
Phase 2 Clinical Trial Results from ADX-629, an Orally Available RASP Inhibitor, Expected Second Half of 2021: Initial Phase 2 clinical results from ADX-629, a novel orally available RASP inhibitor currently undergoing testing in asthma, psoriasis, and COVID-19, are expected in the second half of 2021. ADX-629 represents a first-in-class systems-based therapeutic approach for an orally administered RASP inhibitor, the potential applicability of which could extend to a myriad of immune-mediated diseases that today are treated with single-target drugs that can lead to serious toxicity.
Public Offering Completed: Aldeyra sold 10,000,000 shares of its common stock at a public offering price of $12.50 per share in an underwritten public offering. The offering generated gross proceeds of $125.0 million and net proceeds of $117.3 million after deducting underwriting discounts, commissions, and estimated offering expenses.
First-Quarter 2021 Financial Summary
Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on Aldeyra’s current operating plan, the company believes that existing cash and cash equivalents, as of March 31, 2021, together with the net proceeds from the sale of common stock in the underwritten public offering in May 2021, will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submission for reproxalap; initial commercialization of reproxalap, if approved; and continued early and late-stage development of the company’s product candidates in ocular and systemic immune-mediated diseases.
For the quarter ended March 31, 2021, Aldeyra reported a net loss of $11.3 million, compared with a net loss of $9.9 million for the quarter ended March 31, 2020. Net loss per share was $0.25 for the quarter ended March 31, 2021, compared with $0.34 for the same period in 2020. Losses have resulted from the costs of Aldeyra’s clinical trials and research and development programs, as well as from general and administrative expenses.
Research and development (R&D) expenses were $7.7 million for the quarter ended March 31, 2021, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to clinical development and manufacturing costs, partially offset by lower personnel related costs and a decrease in preclinical costs.
General and administrative expenses were $3.1 million for the quarter ended March 31, 2021, compared with $3.0 million for the quarter ended March 31, 2020.
For the quarter ended March 31, 2021, total operating expenses were $10.8 million, compared with total operating expenses of $9.6 million for the same period in 2020.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its first-quarter 2021 financial results and recent highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. Due to the expected high demand on our conference call 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.