Aldeyra Therapeutics Reports Second Quarter and Year to Date 2015 Financial Results and Provides Development Updates
"As we move forward, we are continuing to advance the development of new aldehyde trap compounds as well as a systemic formulation of NS2. We are pleased to announce that we expect to begin clinical testing of systemically administered NS2 in 2016."
Second Quarter and Six Months Ended
For the second quarter of 2015, Aldeyra reported a net loss attributable to common stockholders of approximately
For the six months ended
Research and development expenses totaled approximately
For the second quarter of 2015, general and administrative expenses were approximately
Total operating expenses for the second quarter of 2015 were approximately
As of
Development Highlights and Update
Aldeyra filed a Clinical Trial Authorization with
Aldeyra continued progress on the design and synthesis of new aldehyde trap compounds, as well as a systemic formulation of NS2 that is expected to begin clinical testing in 2016. Potential clinical indications for the systemic formulation include SLS, Succinic Semi-aldehyde Dehydrogenase Deficiency, and autoimmune crises.
During the second quarter of 2015, novel data on the effects of NS2 in an animal model of radiation mucositis and fibrosis was accepted and presented at the 2015
About NS2
NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping free aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate excessive inflammation and address diseases where aldehydes are thought to mediate pathology.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common 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 excessive tear production in addition to ocular swelling, redness, and itching.
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome (SLS) 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.
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis is a rare 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 Succinic Semi-Aldehyde Dehydrogenase Deficiency
Succinic Semi-aldehyde Dehydrogenase (SSADH) Deficiency is a rare disease caused by mutations in SSADH, leading to elevated levels of succinic semi-aldehyde that are then converted to neurotoxic metabolites. SSADH Deficiency is characterized clinically by neurological compromise that includes cognitive and developmental delay, decreased muscle tone, and, in some cases, seizures.
About
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
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BALANCE SHEETS (Unaudited) | ||
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December 31, | |
2015 | 2014 | |
ASSETS | ||
Current assets: | ||
Cash and cash equivalents | $ 33,569,784 | $ 8,527,304 |
Prepaid expenses and other current assets | 266,850 | 232,568 |
Total current assets | 33,836,634 | 8,759,872 |
Deferred offering costs | -- | 14,238 |
Fixed assets, net | 40,868 | 12,993 |
Total assets | $ 33,877,502 | $ 8,787,103 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current liabilities: | ||
Accounts payable | $ 629,346 | $ 341,294 |
Accrued expenses | 451,641 | 908,724 |
Current portion of credit facility | 310,185 | 77,546 |
Total current liabilities | 1,391,172 | 1,327,564 |
Credit facility, net of current portion and debt discount | 961,549 | 1,175,481 |
Total liabilities | 2,352,721 | 2,503,045 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Preferred stock, |
-- | -- |
Common stock, voting, |
9,712 | 5,565 |
Additional paid-in capital | 82,395,410 | 52,790,090 |
Accumulated deficit | (50,880,341) | (46,511,597) |
Total stockholders' equity | 31,524,781 | 6,284,058 |
Total liabilities and stockholders' equity | $ 33,877,502 | $ 8,787,103 |
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STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (Unaudited) | ||||
Three Months Ended | Six Months Ended | |||
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2015 | 2014 | 2015 | 2014 | |
Operating expenses: | ||||
Research and development | $ 1,249,097 | $ 663,908 | $ 2,385,531 | $ 1,108,186 |
General and administrative | 954,879 | 982,579 | 1,926,980 | 1,783,225 |
Loss from operations | (2,203,976) | (1,646,487) | (4,312,511) | (2,891,411) |
Other income (expense): | ||||
Change in fair value of preferred stock warrant liabilities | -- | 567,588 | -- | 2,327,502 |
Interest income | -- | -- | -- | 3 |
Interest expense | (28,210) | (56,246) | (56,234) | (169,467) |
Total other income (expense), net | (28,210) | 511,342 | (56,234) | 2,158,038 |
Net loss and comprehensive loss | (2,232,186) | (1,135,145) | (4,368,745) | (733,373) |
Accretion of preferred stock | -- | (141,513) | -- | (333,082) |
Deemed dividend | -- | (4,053,570) | -- | (4,053,570) |
Net loss attributable to common stockholders | $ (2,232,186) | $ (5,330,228) | $ (4,368,745) | $ (5,120,025) |
Net loss per share attributable to common stockholders: | ||||
Basic | $ (0.27) | $ (1.43) | $ (0.58) | $ (2.51) |
Diluted | $ (0.27) | $ (1.56) | $ (0.58) | $ (3.53) |
Weighted average common shares outstanding: | ||||
Basic | 8,397,713 | 3,737,675 | 7,537,396 | 2,041,941 |
Diluted | 8,397,713 | 3,769,360 | 7,537,396 | 2,107,389 |
CONTACT: 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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