Aldeyra Therapeutics Reports Full Year 2015 Financial Results
"We are pleased with the progression of our clinical development in 2015. Specifically, we initiated three Phase II clinical trials of our lead product candidate, NS2, in different indications," commented
Year Ended
For the year ended
Research and development expenses were
General and administrative expenses were
In 2015, total operating expenses were approximately
Cash, cash equivalents and marketable securities were
Conference Call & Webcast Information
The Company will hold a conference call on
After the live webcast, the event will remain archived on the Company's website for one year. In addition, a telephonic replay of the call will be available until
About
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 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 Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome is a rare disease caused by mutations in fatty acid aldehyde dehydrogenase, leading to elevated fatty aldehyde levels that are thought to contribute to severe ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. There is no
About Succinic Semi-Aldehyde Dehydrogenase Deficiency
Succinic Semi-Aldehyde Dehydrogenase Deficiency is a rare disease caused by mutations in succinic semi-aldehyde dehydrogenase, leading to elevated levels of succinic semi-aldehyde that are then converted to neurotoxic metabolites. SSADHD is characterized clinically by neurological compromise that includes autism, cognitive and developmental delay, decreased muscle tone, and, in some cases, seizures. There is no
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 and its financial guidance. 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 | ||||||||||||
| | |||||||||||
2015 | 2014 | |||||||||||
ASSETS | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 14,648,866 | $ | 8,527,304 | ||||||||
Marketable securities | 12,941,776 | - | ||||||||||
Prepaid expenses and other current assets | 497,552 | 232,568 | ||||||||||
Total current assets | 28,088,194 | 8,759,872 | ||||||||||
Deferred offering costs | 36,236 | 14,238 | ||||||||||
Fixed assets, net | 80,334 | 12,993 | ||||||||||
Total assets | $ | 28,204,764 | $ | 8,787,103 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | $ | 851,160 | $ | 341,294 | ||||||||
Accrued expenses | 1,186,429 | 908,724 | ||||||||||
Current portion of credit facility | 77,546 | 77,546 | ||||||||||
Total current liabilities | 2,115,135 | 1,327,564 | ||||||||||
Credit facility, net of current portion and debt discount | 1,211,310 | 1,175,481 | ||||||||||
Total liabilities | 3,326,445 | 2,503,045 | ||||||||||
Commitments and contingencies | ||||||||||||
Stockholders' equity: | ||||||||||||
Preferred stock, | ||||||||||||
outstanding | - | - | ||||||||||
Common stock, voting, | ||||||||||||
and 5,565,415 shares issued and outstanding, respectively | 9,713 | 5,565 | ||||||||||
Additional paid-in capital | 83,478,851 | 52,790,090 | ||||||||||
Accumulated other comprehensive loss, net of tax | (8,361 | ) | - | |||||||||
Accumulated deficit | (58,601,884 | ) | (46,511,597 | ) | ||||||||
Total stockholders' equity | 24,878,319 | 6,284,058 | ||||||||||
Total liabilities and stockholders' equity | $ | 28,204,764 | $ | 8,787,103 | ||||||||
STATEMENTS OF OPERATIONS | |||||||||||
Years ended | |||||||||||
2015 | 2014 | ||||||||||
Operating expenses: | |||||||||||
Research and development | $ | 7,574,398 | $ | 3,707,544 | |||||||
General and administrative | 4,414,709 | 3,563,046 | |||||||||
Loss from operations | (11,989,107 | ) | (7,270,590 | ) | |||||||
Other income (expense): | |||||||||||
Change in fair value of preferred stock warrant liabilities | - | 2,327,502 | |||||||||
Interest income | 11,126 | 3 | |||||||||
Interest expense | (112,306 | ) | (244,174 | ) | |||||||
Total other income (expense), net | (101,180 | ) | 2,083,331 | ||||||||
Net loss | (12,090,287 | ) | (5,187,259 | ) | |||||||
Accretion of preferred stock | - | (333,082 | ) | ||||||||
Deemed dividend | - | (4,053,570 | ) | ||||||||
Net loss attributable to common stockholders | $ | (12,090,287 | ) | $ | (9,573,911 | ) | |||||
Net loss per share attributable to common stockholders: | |||||||||||
Basic | $ | (1.40 | ) | $ | (2.51 | ) | |||||
Diluted | $ | (1.40 | ) | $ | (3.09 | ) | |||||
Weighted average common shares outstanding: | |||||||||||
Basic | 8,633,897 | 3,818,157 | |||||||||
Diluted | 8,633,897 | 3,850,612 | |||||||||
Corporate Contact:Source:Stephen Tulipano Aldeyra Therapeutics, Inc. Tel: +1 781-761-4904 Ext. 205 stulipano@aldeyra.com Investor Contact:David Burke The Ruth Group Tel: +1 646-536-7009 dburke@theruthgroup.com
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