Aldeyra Therapeutics Announces Third Quarter 2016 Financial Results
"We are extremely pleased with the progress we have made this year with our novel aldehyde trap, ADX-102," said
Recent Highlights
- 2016 Research & Development Day. On
September 11, 2016 , Aldeyra hosted a Research & Development Day featuring presentations by key ocular inflammation and metabolic disease opinion leaders on the therapeutic potential of Aldeyra's aldehyde trap platform. A webcast of the event can be found under the Events section of Aldeyra's investor website. - Clinical Pipeline Advancement. Following positive data from Phase II clinical trials in Sjögren-Larsson Syndrome, noninfectious anterior uveitis, and allergic conjunctivitis, Aldeyra announced plans to initiate three late-stage clinical trials in addition to a clinical program in dry eye syndrome:
- Phase III vehicle-controlled trial in noninfectious anterior uveitis, expected to be initiated in the first half of 2017
- Phase III clinical trial in Sjögren-Larsson Syndrome ichthyosis, expected to be initiated in the second half of 2017 following
U.S. Food and Drug Administration (FDA) andEuropean Medicines Agency (EMA) regulatory feedback - Phase IIb clinical trial in allergic conjunctivitis, expected to be initiated in the first half of 2017
- Phase IIa clinical trial in dry eye syndrome, expected to be initiated in the first half of 2017
- Phase III vehicle-controlled trial in noninfectious anterior uveitis, expected to be initiated in the first half of 2017
- Organizational Update. In
September 2016 , Aldeyra announced the appointment ofRichard H. Douglas to its Board of Directors.Dr. Douglas is the former Senior Vice President, Corporate Development at Genzyme Corporation where he led Genzyme's Corporate Development team, until the acquisition of Genzyme by Sanofi (now Sanofi Genzyme), in numerous acquisitions, licenses, financings, joint ventures, and strategic alliances.
Third Quarter 2016 Financial Review
For the quarter ended
Research and development expenses were approximately
General and administrative expenses were approximately
Cash, cash equivalents and marketable securities were approximately
Conference Call and Webcast Information
The Company will hold a conference call on
After the live webcast, the event will remain archived on the
About
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome is a rare inborn error of aldehyde metabolism caused by mutations in fatty acid aldehyde dehydrogenase, leading to elevated toxic fatty aldehyde levels that are thought to contribute to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. There is no therapy for SLS that has been approved by the
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis is a rare, potentially blinding disease that may be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation in the front of the eye, pain, impaired vision, and photophobia.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that is thought to be mediated in part by pro-inflammatory aldehydes, and is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in ocular itching, excessive tear production, lid swelling and redness.
About Dry Eye Syndrome
Dry eye syndrome is a common inflammatory disease characterized by insufficient moisture and lubrication in the anterior surface of the eye. Symptoms may include ocular irritation, burning or stinging, and severe cases may lead to decreased vision. In patients with dry eye syndrome, aldehydes may contribute to ocular inflammation as well as the impairment of lipids (fats) that lubricate the surface of the eye.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra's plans for its product candidates. 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. 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; the ability to obtain and maintain regulatory approval to conduct clinical trials and to commercialize 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 for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency 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
BALANCE SHEETS | ||||||||||
2016 | ||||||||||
(Unaudited) | 2015 | |||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 14,568,508 | $ | 14,648,866 | ||||||
Marketable securities | 14,307,073 | 12,941,776 | ||||||||
Prepaid expenses and other current assets | 250,206 | 497,552 | ||||||||
Total current assets | 29,125,787 | 28,088,194 | ||||||||
Deferred offering costs | - | 36,236 | ||||||||
Fixed assets, net | 65,690 | 80,334 | ||||||||
Total assets | $ | 29,191,477 | $ | 28,204,764 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 733,560 | $ | 851,160 | ||||||
Accrued expenses | 1,476,592 | 1,186,429 | ||||||||
Current portion of credit facility | 426,505 | 77,546 | ||||||||
Total current liabilities | 2,636,657 | 2,115,135 | ||||||||
Credit facility, net of current portion and debt discount | 883,282 | 1,211,310 | ||||||||
Total liabilities | 3,519,939 | 3,326,445 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Preferred stock, |
||||||||||
outstanding as of |
- | - | ||||||||
Common stock, voting, |
||||||||||
shares issued and outstanding as of |
||||||||||
issued and outstanding as of |
12,569 | 9,713 | ||||||||
Additional paid-in capital | 98,302,346 | 83,478,851 | ||||||||
Accumulated other comprehensive income (loss), net of tax | 6,528 | (8,361 | ) | |||||||
Accumulated deficit | (72,649,905 | ) | (58,601,884 | ) | ||||||
Total stockholders' equity | 25,671,538 | 24,878,319 | ||||||||
Total liabilities and stockholders' equity | $ | 29,191,477 | $ | 28,204,764 | ||||||
STATEMENT OF OPERATIONS | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||
2016 | 2015 | 2016 | 2015 | |||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | $ | 3,379,711 | $ | 2,076,410 | $ | 9,728,494 | $ | 4,461,941 | ||||||||||
General and administrative | 1,396,734 | 1,261,196 | 4,314,483 | 3,188,176 | ||||||||||||||
Loss from operations | (4,776,445 | ) | (3,337,606 | ) | (14,042,977 | ) | (7,650,117 | ) | ||||||||||
Other income (expense): | ||||||||||||||||||
Interest income | 27,792 | - | 74,463 | - | ||||||||||||||
Interest expense | (26,654 | ) | (28,081 | ) | (79,507 | ) | (84,314 | ) | ||||||||||
Total other income (expense), net | 1,138 | (28,081 | ) | (5,044 | ) | (84,314 | ) | |||||||||||
Net loss | $ | (4,775,307 | ) | $ | (3,365,687 | ) | $ | (14,048,021 | ) | $ | (7,734,431 | ) | ||||||
Net loss per share - basic and diluted | $ | (0.38 | ) | $ | (0.35 | ) | $ | (1.28 | ) | $ | (0.94 | ) | ||||||
Weighted average common shares outstanding - basic and diluted | 12,474,609 | 9,712,521 | 10,942,127 | 8,270,405 | ||||||||||||||
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Tel: +1 781-761-4904 Ext. 205
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Tel: 339-970-2843
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781-591-3443
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Source: Aldeyra
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