Aldeyra Therapeutics Announces First Quarter 2019 Financial Results and Provides Corporate Update
- Reported Positive Results from Phase 3 ALLEVIATE Trial in Allergic Conjunctivitis
- Initiated Adaptive Phase 3 RENEW Trial in Dry Eye Disease
- Last Patient Dosed in Phase 3 SOLACE Trial in Noninfectious Anterior Uveitis
- Completion of Part 1 of the Phase 3 RESET Trial in Sjögren-Larsson Syndrome Expected in Second Half of 2019
- Initiation of Adaptive Phase 3 Clinical Trial in Proliferative Vitreoretinopathy Expected in Second Half of 2019
"With the announcement of positive results from the Phase 3 ALLEVIATE Trial, the initiation of the Phase 3 RENEW Trial, and the completion of dosing in the Phase 3 SOLACE Trial, our progress in 2019 has been remarkable," commented
Recent Highlights and Corporate Updates
- Reported Positive Results from the Phase 3 ALLEVIATE Trial in Allergic Conjunctivitis. The double-masked, randomized, vehicle-controlled, multi-center, parallel-group conjunctival allergen challenge ALLEVIATE Trial assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solutions compared to vehicle in 318 patients with seasonal allergic conjunctivitis. The primary endpoint of ocular itch score area under the curve was achieved for both concentrations (p < 0.0001 and p = 0.0025, respectively). The key secondary endpoint of clinically relevant two-point ocular itch score improvement was also achieved for both concentrations (p = 0.0005 and p = 0.0169, respectively). 0.25% reproxalap is expected to advance to additional Phase 3 clinical testing contingent upon successful completion of ongoing environmental allergen exposure method development studies and subsequent discussion with regulatory authorities.
- Initiated Adaptive Phase 3 RENEW Trial in Dry Eye Disease, and Presented Phase 2b Dry Eye Disease Clinical Trial Results at the 2019
Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. InSeptember 2018 , and at ARVO inMay 2019 , Aldeyra reported results from topical ocular reproxalap in a Phase 2b dry eye disease clinical trial, which demonstrated statistically significant superiority of 0.25% reproxalap over vehicle in ocular dryness symptom score and fluorescein nasal region ocular staining in pre-specified moderate to severe patients (p = 0.0048 and p = 0.0007, respectively). InApril 2019 , the first patient was enrolled in the Phase 3 RENEW trial, an adaptive, two-part, Phase 3 clinical trial of topical ocular 0.25% reproxalap. Following the completion of the first part of RENEW, assuming the results support advancement to further testing, Aldeyra expects to report the endpoints, dosing regimen, and sample size for the second part of the trial. Aldeyra expects to report full clinical results following the completion of RENEW.
- Dosed Last Patient in the Phase 3 SOLACE Trial in Noninfectious Anterior Uveitis. In
April 2019 , dosing was completed in the SOLACE Trial, a randomized, multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial of 0.5% topical ocular reproxalap in patients with noninfectious anterior uveitis, a serious ocular inflammatory disease that can lead to loss of vision. Results from the SOLACE Trial are expected in the second half of 2019.
- Completion of Part 1 of the Phase 3 RESET Trial in Sjögren-Larsson Syndrome Expected in the Second Half of 2019. The RESET Trial is an adaptive, two-part, pivotal, randomized, multi-center, double-masked Phase 3 clinical trial of 1% topical dermal reproxalap for the treatment of ichthyosis associated with Sjögren-Larsson Syndrome. Following the completion of RESET Part 1, assuming the results support advancement to further testing, Aldeyra expects to report the endpoints, dosing regimen, and sample size for RESET Part 2. Aldeyra expects to report full clinical results following the completion of RESET.
- Phase 3 Adaptive Clinical Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected to Initiate in the Second Half of 2019. In
January 2019 , Aldeyra expanded its pipeline in retinal disease with the addition ADX-2191 for the treatment of proliferative vitreoretinopathy, a rare inflammatory disorder that leads to severe retinal scarring and blindness. An adaptive, two-part Phase 3 clinical trial is expected to begin in the second half of 2019. Following the completion of the initial part of the trial, expected in 2020, and assuming the results support advancement to further testing, Aldeyra expects to report the endpoints, dosing regimen, and sample size for the remainder of the trial. Aldeyra expects to report full clinical results following the completion of the trial.
- Programs in Systemic Immune-Mediated Diseases Expected to Begin Clinical Testing in 2019. A Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative disorder and a Phase 1 clinical trial of ADX-629 for the treatment of systemic autoimmune disease are expected to initiate in the second half of 2019.
Quarter Ended
For the quarter ended
Research and development expenses were
In connection with the
General and administrative expenses were
For the quarter ended
Cash, cash equivalents, and marketable securities were
Conference Call & Webcast Information
Aldeyra will hold a conference call on
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, future financial position, projected costs and expenses, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including plans to initiate further clinical testing. 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," "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 trials involving Aldeyra's product candidates; 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; 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
Corporate Contact:
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Westwicke, an
Tel: 339-970-2843
Chris.brinzey@westwicke.com
ALDEYRA THERAPEUTICS, INC. |
||||||
BALANCE SHEETS |
||||||
(UNAUDITED) |
||||||
March 31, |
December 31, |
|||||
2019 |
2018 |
|||||
ASSETS |
||||||
Current assets: |
||||||
Cash and cash equivalents |
$ 5,297,555 |
$ 3,357,472 |
||||
Cash equivalent - Reverse Repurchase Agreements |
39,000,000 |
$ 44,000,000 |
||||
Marketable securities |
37,826,635 |
46,242,220 |
||||
Prepaid expenses and other current assets |
4,872,067 |
1,169,594 |
||||
Total current assets |
86,996,257 |
94,769,286 |
||||
Deferred offering costs |
— |
86,644 |
||||
Debt issuance costs |
538,038 |
— |
||||
Right-of-use assets |
377,920 |
— |
||||
Fixed assets, net |
215,908 |
235,225 |
||||
Total assets |
$ 88,128,123 |
$ 95,091,155 |
||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||
Current liabilities: |
||||||
Accounts payable |
$ 4,013,362 |
$ 3,051,678 |
||||
Accrued expenses |
5,257,071 |
5,421,498 |
||||
Current portion of operating lease liabilities |
221,112 |
— |
||||
Total current liabilities |
9,491,545 |
8,473,176 |
||||
Operating lease liabilities, long-term |
156,808 |
— |
||||
Total liabilities |
9,648,353 |
8,473,176 |
||||
Commitments and contingencies (Notes 14 and 15) |
||||||
Stockholders' equity: |
||||||
Preferred stock, $0.001 par value, 15,000,000 shares authorized, none |
— |
— |
||||
Common stock, voting, $0.001 par value; 150,000,000 authorized |
26,910 |
26,244 |
||||
Additional paid-in capital |
232,605,244 |
225,136,127 |
||||
Accumulated other comprehensive income (loss) |
6,812 |
(9,224) |
||||
Accumulated deficit |
(154,159,196) |
(138,535,168) |
||||
Total stockholders' equity |
78,479,770 |
86,617,979 |
||||
Total liabilities and stockholders' equity |
$ 88,128,123 |
$ 95,091,155 |
||||
ALDEYRA THERAPEUTICS, INC. |
||||||
STATEMENT OF OPERATIONS |
||||||
(UNAUDITED) |
||||||
Three Months Ended March 31, |
||||||
2019 |
2018 |
|||||
Operating expenses: |
||||||
Research and development |
$ 7,848,590 |
$ 6,600,106 |
||||
Acquired in-process research and development |
6,597,551 |
— |
||||
General and administrative |
2,985,038 |
1,891,303 |
||||
Loss from operations |
(17,431,179) |
(8,491,409) |
||||
Other income (expense): |
||||||
Interest income |
499,140 |
122,390 |
||||
Interest expense |
(1,962) |
(28,044) |
||||
Total other income (expense), net |
497,178 |
94,346 |
||||
Loss before income taxes |
(16,934,001) |
(8,397,063) |
||||
Income tax benefit |
1,309,973 |
— |
||||
Net loss |
$ (15,624,028) |
$ (8,397,063) |
||||
Net loss per share - basic and diluted |
$ (0.58) |
$ (0.43) |
||||
Weighted average common shares outstanding - basic and diluted |
27,053,842 |
19,366,790 |
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