Aldeyra Therapeutics Announces Third-Quarter 2020 Financial Results and Provides Corporate Update
− Initiation of Phase 3 Objective Sign Trial in Dry Eye Disease Planned for the Fourth Quarter 2020
− Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma, and Psoriasis Expected to Initiate in the Fourth Quarter of 2020
− Top-line Results from the Phase 3 INVIGORATE Clinical Trial in Allergic Conjunctivitis Expected in the First Half of 2021
− Cash, Cash Equivalents, and
− Management to Host Conference Call at
“Our novel RASP inhibitor reproxalap continues to progress toward New Drug Application (NDA) submissions for dry eye disease and allergic conjunctivitis, two of the largest markets in ophthalmology,” stated
“We concluded the third quarter in a strong financial position, with cash, cash equivalents, and marketable securities of
Recent Highlights
-
American Academy of Ophthalmology 2020: Aldeyra announced the presentation of new clinical utility data from the Phase 2 allergen chamber clinical trial of reproxalap in allergic conjunctivitis. The data will be presented in a poster at theAmerican Academy of Ophthalmology 2020 Virtual Annual Meeting fromNovember 11 through November 15, 2020 . -
Phase 2 Clinical Trial Data Published in
Journal of Ocular Pharmacology and Therapeutics : The peer-reviewedJournal of Ocular Pharmacology and Therapeutics published the positive results of a randomized, corticosteroid-controlled Phase 2 clinical trial of reproxalap in patients with noninfectious anterior uveitis, a sight-threatening ocular inflammatory condition typically treated with topical corticosteroids. -
Regulatory Clearance for Phase 2 Clinical Trial in COVID-19: In
September 2020 , Aldeyra announced receipt of a Study May Proceed letter from theU.S. Food and Drug Administration to begin a Phase 2 clinical trial evaluating ADX-629, a novel orally available RASP inhibitor, for the treatment of adult patients hospitalized for COVID-19.
Clinical-Stage Pipeline Updates
- Reproxalap – A Novel Topical Ocular RASP Inhibitor for the Treatment of Dry Eye Disease and Allergic Conjunctivitis: Aldeyra plans to initiate a Phase 3 clinical trial in the fourth quarter of 2020 to assess the activity of reproxalap in objective signs of dry eye disease, including tear RASP levels, after single and multiple doses of drug. The trial initiation timing is subject to the finalization of trial design, assay development, and potential disruptions due to the COVID-19 pandemic. Enrollment is ongoing in the Phase 3 INVIGORATE Trial of reproxalap for the treatment of patients with allergic conjunctivitis. INVIGORATE is a randomized, double-masked, crossover, vehicle-controlled clinical trial to assess the efficacy and safety of reproxalap compared to vehicle using an allergen chamber. Consistent with prior allergic conjunctivitis trials, the primary endpoint will be subject-reported ocular itching score, as agreed with FDA. Aldeyra expects top-line results in the first half of 2021. NDA submission in dry eye disease and allergic conjunctivitis is expected by the end of 2021, assuming positive clinical trial results and regulatory review.
-
ADX-629 – A Novel Orally Available RASP Inhibitor for the Treatment of Systemic Inflammatory Diseases: Phase 2 clinical testing of ADX-629 for the treatment of COVID-19, atopic asthma, and psoriasis is expected to begin by the end of this year.
- ADX-2191 – 0.8% Methotrexate Intravitreal Injection for Rare Proliferative Ocular Diseases: Completion of enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR), a rare but serious sight-threatening retinal disease with no approved treatment, is expected in 2021.
Financial Results for the Quarter Ended
For the quarter ended
Research and development expenses were
General and administrative expenses were
For the quarter ended
As of
Conference Call & Webcast Information
Aldeyra will host a conference call today at
A live webcast of the conference call will also be available on the investor relations page of the company’s corporate 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 statements regarding Aldeyra's strategy, future operations, expected cash runway, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including reproxalap, ADX-629, ADX-2191, and ADX-1612. 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.
As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete Aldeyra’s clinical trials may be delayed. 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 trials involving Aldeyra's product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; the current and potential future impact of the COVID-19 pandemic on Aldeyra's business, results of operations and financial position; 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 | ||||||||
|
|
|
||||||
2020 |
|
2019 |
||||||
ASSETS |
(Unaudited) |
|
|
|||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
71,175,507 |
|
$ |
16,425,830 |
|
||
Cash equivalent - reverse repurchase agreements |
|
15,000,000 |
|
28,000,000 |
|
|||
Marketable securities |
|
— |
|
|
28,938,545 |
|
||
Prepaid expenses and other current assets |
|
2,017,273 |
|
|
1,804,450 |
|
||
Total current assets |
|
88,192,780 |
|
|
75,168,825 |
|
||
Right-of-use assets |
|
52,195 |
|
|
201,007 |
|
||
Fixed assets, net |
|
79,455 |
|
|
148,449 |
|
||
Total assets |
$ |
88,324,430 |
|
$ |
75,518,281 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
123,900 |
|
$ |
808,302 |
|
||
Accrued expenses |
|
4,018,635 |
|
|
11,873,122 |
|
||
Current portion of credit facility |
|
2,259,417 |
|
|
— |
|
||
Current portion of operating lease liabilities |
|
58,720 |
|
|
226,328 |
|
||
Total current liabilities |
|
6,460,672 |
|
|
12,907,752 |
|
||
Long-term debt |
|
12,693,311 |
|
|
14,528,212 |
|
||
Total liabilities |
|
19,153,983 |
|
|
27,435,964 |
|
||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Common stock, voting, and 38,631,709 and 28,656,832 shares issued and outstanding, respectively |
|
38,632 |
|
|
28,657 |
|
||
Additional paid-in capital |
|
294,755,363 |
|
|
247,409,793 |
|
||
Accumulated other comprehensive income |
|
— |
|
|
5,866 |
|
||
Accumulated deficit |
|
(225,623,548 |
) |
|
(199,361,999 |
) |
||
Total stockholders’ equity |
|
69,170,447 |
|
|
48,082,317 |
|
||
Total liabilities and stockholders’ equity |
$ |
88,324,430 |
|
$ |
75,518,281 |
|
||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(UNAUDITED) | |||||||||||||||||
Three Months Ended |
|
|
Nine Months Ended |
||||||||||||||
2020 |
|
2019 |
|
|
2020 |
|
2019 |
||||||||||
Operating expenses: | |||||||||||||||||
Research and development |
$ |
6,133,580 |
|
$ |
16,223,972 |
|
$ |
17,653,058 |
|
$ |
34,737,420 |
|
|||||
Acquired in-process research and development |
|
— |
|
|
(47,102 |
) |
|
— |
|
|
6,500,602 |
|
|||||
General and administrative |
|
2,255,617 |
|
|
2,839,319 |
|
|
7,480,461 |
|
|
8,940,771 |
|
|||||
Loss from operations |
|
(8,389,197 |
) |
|
(19,016,189 |
) |
|
(25,133,519 |
) |
|
(50,178,793 |
) |
|||||
Other income (expense): | |||||||||||||||||
Interest income |
|
5,215 |
|
|
330,329 |
|
|
287,025 |
|
|
1,262,378 |
|
|||||
Interest expense |
|
(489,191 |
) |
|
(29,154 |
) |
|
(1,415,055 |
) |
|
(59,766 |
) |
|||||
Total other income (expense), net |
|
(483,976 |
) |
|
301,175 |
|
|
(1,128,030 |
) |
|
1,202,612 |
|
|||||
Loss before income taxes |
|
(8,873,173 |
) |
|
(18,715,014 |
) |
|
(26,261,549 |
) |
|
(48,976,181 |
) |
|||||
Income tax benefit |
|
— |
|
|
— |
|
|
— |
|
|
1,309,973 |
|
|||||
Net loss |
$ |
(8,873,173 |
) |
$ |
(18,715,014 |
) |
$ |
(26,261,549 |
) |
$ |
(47,666,208 |
) |
|||||
Net loss per share - basic and diluted |
$ |
(0.23 |
) |
$ |
(0.69 |
) |
$ |
(0.81 |
) |
$ |
(1.77 |
) |
|||||
Weighted average common shares outstanding - basic and diluted |
|
37,796,946 |
|
|
27,111,600 |
|
|
32,395,217 |
|
|
26,928,725 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105005234/en/
Corporate:
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor & Media:
Tel: 617-542-5300
ALDX@investorrelations.com
Source: