Aldeyra Therapeutics Reports Full-Year 2020 Financial Results and Recent Business Highlights
− Enrollment Completed in Phase 3 INVIGORATE Trial, with Top-Line Results Expected in the First Half of 2021
− Top-Line Results from Phase 3 TRANQUILITY and TRANQUILITY-2 Trials Expected in the Second Half of 2021
− Projected Cash Runway Through 2023, Including Potential New Drug Application Submissions for Dry Eye Disease and Allergic Conjunctivitis
− Management to Host Conference Call at
“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
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.
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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 inJanuary 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.
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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
The net loss for full-year 2020 was
Research and Development (R&D) expenses were
Acquired in-process research and development expenses were
General and administrative (G&A) expenses were
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: the timing of results from the company’s Phase 3 INVIGORATE Trial for the treatment of allergic conjunctivitis; the timing of results from the company’s Phase 3 TRANQUILITY and TRANQUILITY-2 Trials for the treatment of dry eye disease; the timing of results from the company’s Phase 2 proof-of-concept clinical trials of ADX-629; the company’s anticipated cash runway; the timing of potential New Drug Application submissions for dry eye disease and allergic conjunctivitis; and the completion of enrollment of Part 1 of the Phase 3 GUARD Trial of ADX-2191 for the treatment of proliferative vitreoretinopathy. 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; 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 | ||||||||
|
|
|
||||||
2020 |
|
2019 |
||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
52,858,311 |
|
$ |
16,425,830 |
|
||
Cash equivalent - reverse repurchase agreements |
|
25,000,000 |
|
|
28,000,000 |
|
||
Marketable securities |
|
— |
|
|
28,938,545 |
|
||
Prepaid expenses and other current assets |
|
5,200,957 |
|
|
1,804,450 |
|
||
Total current assets |
|
83,059,268 |
|
|
75,168,825 |
|
||
Fixed assets, net |
|
59,925 |
|
|
148,449 |
|
||
Right-of-use assets |
|
233,310 |
|
|
201,007 |
|
||
Total assets |
$ |
83,352,503 |
|
$ |
75,518,281 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
381,638 |
|
$ |
808,302 |
|
||
Accrued expenses |
|
8,134,765 |
|
|
11,873,122 |
|
||
Current portion of credit facility |
|
3,659,776 |
|
|
— |
|
||
Current portion of operating lease liabilities |
|
233,310 |
|
|
226,328 |
|
||
Total current liabilities |
|
12,409,489 |
|
|
12,907,752 |
|
||
Long-term debt, net of current portion |
|
11,434,456 |
|
|
14,528,212 |
|
||
Total liabilities |
|
23,843,945 |
|
|
27,435,964 |
|
||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, |
|
— |
|
|
— |
|
||
Common stock, voting, |
|
38,667 |
|
|
28,657 |
|
||
Additional paid-in capital |
|
296,385,619 |
|
|
247,409,793 |
|
||
Accumulated other comprehensive income |
|
— |
|
|
5,866 |
|
||
Accumulated deficit |
|
(236,915,728 |
) |
|
(199,361,999 |
) |
||
Total stockholders’ equity |
|
59,508,558 |
|
|
48,082,317 |
|
||
Total liabilities and stockholders’ equity |
$ |
83,352,503 |
|
$ |
75,518,281 |
|
||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
Years ended |
||||||||
2020 |
|
2019 |
||||||
Operating expenses: | ||||||||
Research and development |
$ |
24,681,301 |
|
$ |
44,351,851 |
|
||
Acquired in-process research and development |
|
1,754,265 |
|
|
6,567,754 |
|
||
General and administrative |
|
9,985,454 |
|
|
12,154,702 |
|
||
Loss from operations |
|
(36,421,020 |
) |
|
(63,074,307 |
) |
||
Other income (expense): | ||||||||
Interest income |
|
292,224 |
|
|
1,541,349 |
|
||
Interest expense |
|
(1,904,198 |
) |
|
(603,846 |
) |
||
Total other income (expense), net |
|
(1,611,974 |
) |
|
937,503 |
|
||
Loss before income taxes |
|
(38,032,994 |
) |
|
(62,136,804 |
) |
||
Income tax benefit |
|
479,265 |
|
|
1,309,973 |
|
||
Net loss |
$ |
(37,553,729 |
) |
$ |
(60,826,831 |
) |
||
Net loss per share - basic and diluted |
$ |
(1.11 |
) |
$ |
(2.24 |
) |
||
Weighted average common shares outstanding - basic and diluted |
|
33,965,955 |
|
|
27,111,840 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005317/en/
Corporate Contact:
Tel: 781-761-4904 ext. 218
jreed@aldeyra.com
Investor & Media Contact:
Tel: 857-383-2409
ALDX@investorrelations.com
Source: