Aldeyra Therapeutics Reports First-Quarter 2021 Financial Results and Recent Business Highlights
- Recently Announced Phase 3 INVIGORATE Clinical Trial Results Indicated Statistically Significant Activity of Reproxalap in Ocular Itching and Redness Associated with Allergic Conjunctivitis
- Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials of Reproxalap in Dry Eye Disease Expected in the Second Half of 2021
- Initial Phase 2 Clinical Trial Results for ADX-629, a Novel Orally Available Systems-Based RASP Inhibitor with Potential Broad Applicability Across Immune-Mediated Diseases, Expected in the Second Half of 2021
-
Raised Gross Proceeds of
$125 Million Before Deduction of Underwriting Discounts and Commissions, in Underwritten Public Offering -
Projected Cash Runway Through 2023, Including Potential New Drug Applications; Initial Commercialization of Reproxalap, if Approved; and
Continued Pipeline Development -
Management to Host Conference Call at
8:00 a.m. ET Today
“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
“We believe we continue to operate from a position of financial strength,”
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
For the quarter ended
Research and development (R&D) expenses were
General and administrative expenses were
For the quarter ended
Conference Call & Webcast Information
Aldeyra will host a conference call at
A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the
About
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding submission of potential New Drug Applications; the anticipated timing of results from Aldeyra’s clinical trials; and Aldeyra’s projected cash runway. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra’s ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may affect Aldeyra’s business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra’s limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra’s ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in
In addition to the risks described above and in Aldeyra's other filings with the
CONSOLIDATED BALANCE SHEETS | ||||||||||
|
|
|
||||||||
2021 |
|
2020 |
||||||||
ASSETS |
(Unaudited) |
|
|
|||||||
Current assets: | ||||||||||
Cash and cash equivalents |
$ |
88,442,379 |
|
$ |
52,858,311 |
|
||||
Cash equivalent - reverse repurchase agreements |
|
50,000,000 |
|
|
25,000,000 |
|
||||
Prepaid expenses and other current assets |
|
8,630,543 |
|
|
5,200,957 |
|
||||
Total current assets |
|
147,072,922 |
|
|
83,059,268 |
|
||||
Right-of-use assets |
|
175,619 |
|
|
233,310 |
|
||||
Fixed assets, net |
|
57,559 |
|
|
59,925 |
|
||||
Total assets |
$ |
147,306,100 |
|
$ |
83,352,503 |
|
||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable |
$ |
448,591 |
|
$ |
381,638 |
|
||||
Accrued expenses |
|
5,371,681 |
|
|
8,134,765 |
|
||||
Current portion of credit facility |
|
5,094,938 |
|
|
3,659,776 |
|
||||
Current portion of operating lease liabilities |
|
175,619 |
|
|
233,310 |
|
||||
Total current liabilities |
|
11,090,829 |
|
|
12,409,489 |
|
||||
Long-term debt, net of current portion |
|
10,140,799 |
|
|
11,434,456 |
|
||||
Total liabilities |
|
21,231,628 |
|
|
23,843,945 |
|
||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Common stock, voting, |
|
47,651 |
|
|
38,667 |
|
||||
Additional paid-in capital |
|
374,232,411 |
|
|
296,385,619 |
|
||||
Accumulated deficit |
|
(248,205,590 |
) |
|
(236,915,728 |
) |
||||
Total stockholders’ equity |
|
126,074,472 |
|
|
59,508,558 |
|
||||
Total liabilities and stockholders’ equity |
$ |
147,306,100 |
|
$ |
83,352,503 |
|
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
(UNAUDITED) | ||||||||||
Three Months Ended |
||||||||||
2021 |
|
2020 |
||||||||
Operating expenses: | ||||||||||
Research and development |
$ |
7,726,342 |
|
$ |
6,633,603 |
|
||||
General and administrative |
|
3,104,702 |
|
|
3,004,841 |
|
||||
Loss from operations |
|
(10,831,044 |
) |
|
(9,638,444 |
) |
||||
Other income (expense): | ||||||||||
Interest income |
|
23,762 |
|
|
210,100 |
|
||||
Interest expense |
|
(482,580 |
) |
|
(439,816 |
) |
||||
Total other income (expense), net |
|
(458,818 |
) |
|
(229,716 |
) |
||||
Net loss |
$ |
(11,289,862 |
) |
$ |
(9,868,160 |
) |
||||
Net loss per share - basic and diluted |
$ |
(0.25 |
) |
$ |
(0.34 |
) |
||||
Weighted average common shares outstanding - basic and diluted |
|
45,630,910 |
|
|
29,210,889 |
|
||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20210506005303/en/
Corporate:
Tel: 781-761-4904 ext. 218
jreed@aldeyra.com
Investor & Media:
Tel: 857-383-2409
ALDX@investorrelations.com
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