Aldeyra Therapeutics Announces Third Quarter 2018 Financial Results
- Reported Positive Data from Phase 2b Clinical Trial of Topical Ocular Reproxalap in Dry Eye Disease
- Announced Positive Top-Line Data from Investigator-Sponsored Phase 1/2 Clinical Trial of ADX-1612 in Malignant Mesothelioma
- Raised $67.6 Million, Operations Expected to be Funded Through 2020
"The third quarter was highlighted by positive results from our Phase 2b clinical trial of reproxalap in dry eye disease and an investigator-sponsored Phase 1/2 clinical trial of ADX-1612 in malignant mesothelioma," commented
Recent Highlights and Corporate Updates
- Announced positive results from a randomized, vehicle-controlled, parallel-group, multi-center, double-masked Phase 2b clinical trial of topical ocular reproxalap in dry eye disease. In
September 2018 , Aldeyra announced that reproxalap was observed to be statistically superior to vehicle across multiple dry eye disease symptoms and signs in a Phase 2b clinical trial. The results demonstrated activity versus vehicle as early as two weeks, supportive of a differentiated product profile relative to current standard of care. Aldeyra plans to initiate a Phase 3 clinical trial in 2019, following discussions with regulatory authorities.
- Announced positive top-line results from the MESO-2 investigator-sponsored Phase 1/2 clinical trial of ADX-1612 (ganetespib) in patients with pleural malignant mesothelioma. Results of the clinical trial were presented at the
International Association for the Study of Lung Cancer (ASLC) 19thWorld Conference on Lung Cancer (Abstract #11921). ADX-1612, when combined with standard pemetrexed and platinum therapy, resulted in partial response rates that exceeded that of historical standard of care (pemetrexed and platinum therapy). A Phase 2 clinical trial of ADX-1612 in mesothelioma, a disease with no known cure and a poor prognosis, is expected to be initiated in 2019, pending discussion with regulatory authorities.
- Strengthened balance sheet. In
October 2018 , Aldeyra completed an underwritten public offering that raised net proceeds of$67.6 million after deducting underwriting discounts, commissions, and estimated expenses. The proceeds are expected to fund operations through 2020, including the currently planned announcements of top-line data from Phase 3 clinical trials in allergic conjunctivitis, noninfectious anterior uveitis, Sjögren-Larsson Syndrome (Part 1), and dry eye disease.
Upcoming Milestones and Events
- Phase 3 results from the ALLEVIATE Trial, a randomized, multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial of topical ocular reproxalap in an allergen challenge model of allergic conjunctivitis, expected in early 2019
- Phase 3 results from the SOLACE Trial, a randomized, multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial of topical ocular reproxalap in noninfectious anterior uveitis, expected in the second half of 2019
- Results from the first part of the RESET Trial, a two-part, pivotal, randomized, multi-center, double-masked Phase 3 clinical trial of topical dermal reproxalap for the treatment of ichthyosis (scaly, thickened, dry skin) associated with Sjögren-Larsson Syndrome, expected in the second half of 2019
- Initiation of a Phase 3 clinical trial of topical ocular reproxalap in dry eye disease expected in 2019
- Phase 1 clinical trial of ADX-629, for the treatment of systemic autoimmune disease, expected to be initiated in 2019
- Investigator-sponsored Phase 2 clinical trial of ADX-1612 in ovarian cancer (EUDARIO) expected to be initiated in 2018
- Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative syndrome expected to be initiated in 2019
- Phase 2 clinical trial of ADX-1612 in mesothelioma expected to be initiated in 2019, pending discussion with regulatory authorities
Quarter Ended
For the quarter ended
Research and development expenses were
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, 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 "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, the ability to obtain and maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; 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 ability to establish and maintain development partnerships; 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 Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
ALDEYRA THERAPEUTICS, INC. |
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BALANCE SHEETS |
|||||||
(UNAUDITED) |
|||||||
September 30, |
December 31, |
||||||
2018 |
2017 |
||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ 7,008,652 |
$ 2,023,337 |
|||||
Cash equivalent- reverse repurchase agreements |
11,000,000 |
18,000,000 |
|||||
Marketable securities |
17,133,925 |
22,923,462 |
|||||
Prepaid expenses and other current assets |
1,702,533 |
1,018,967 |
|||||
Total current assets |
36,845,110 |
43,965,766 |
|||||
Deferred offering costs |
43,000 |
165,930 |
|||||
Fixed assets, net |
243,483 |
43,262 |
|||||
Total assets |
$ 37,131,593 |
$ 44,174,958 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ 3,442,370 |
$ 1,000,963 |
|||||
Accrued expenses |
3,746,037 |
2,236,465 |
|||||
Current portion of credit facility |
465,278 |
116,319 |
|||||
Total current liabilities |
7,653,685 |
3,353,747 |
|||||
Credit facility, net of current portion and debt discount |
882,841 |
1,220,192 |
|||||
Total liabilities |
8,536,526 |
4,573,939 |
|||||
Commitments and contingencies |
|||||||
Stockholders' equity: |
|||||||
Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and |
|||||||
outstanding |
- |
- |
|||||
Common stock, voting, $0.001 par value; 150,000,000 authorized and 20,989,302 |
|||||||
and 19,137,639 shares issued and outstanding, respectively |
20,989 |
19,138 |
|||||
Additional paid-in capital |
156,481,258 |
139,241,635 |
|||||
Accumulated other comprehensive income (loss) |
(5,196) |
(17,831) |
|||||
Accumulated deficit |
(127,901,984) |
(99,641,923) |
|||||
Total stockholders' equity |
28,595,067 |
39,601,019 |
|||||
Total liabilities and stockholders' equity |
$ 37,131,593 |
$ 44,174,958 |
ALDEYRA THERAPEUTICS, INC. |
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STATEMENT OF OPERATIONS |
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(UNAUDITED) |
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Three Months ended September 30, |
Nine Months ended September 30, |
||||||||
2018 |
2017 |
2018 |
2017 |
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Operating expenses: |
|||||||||
Research and development |
$ 7,880,822 |
$ 3,539,368 |
$ 21,274,032 |
$ 10,757,279 |
|||||
General and administrative |
3,065,912 |
1,475,904 |
7,330,142 |
4,684,574 |
|||||
Loss from operations |
(10,946,734) |
(5,015,272) |
(28,604,174) |
(15,441,853) |
|||||
Other income (expense): |
|||||||||
Interest income |
163,015 |
56,651 |
427,361 |
136,652 |
|||||
Interest expense |
(28,846) |
(27,578) |
(83,248) |
(80,878) |
|||||
Total other income (expense), net |
134,169 |
29,073 |
344,113 |
55,774 |
|||||
Net loss |
$ (10,812,565) |
$ (4,986,199) |
$ (28,260,061) |
$ (15,386,079) |
|||||
Net loss per share - basic and diluted |
$ (0.52) |
$ (0.32) |
$ (1.40) |
$ (1.04) |
|||||
Weighted average common shares outstanding - basic and diluted |
20,969,913 |
15,581,426 |
20,168,633 |
14,844,914 |
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