Aldeyra Therapeutics Reports Third Quarter and Year to Date 2015 Financial and Operating Results
Third Quarter and Nine Months Ended
For the third quarter of 2015, Aldeyra reported a net loss attributable to common stockholders of approximately
For the nine months ended
Research and development expenses totaled approximately
For the third quarter of 2015, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2015 were approximately
As of
Operational Highlights from the Third Quarter of 2015
- Initiated enrollment in Phase II clinical trial (Clinicaltrials.gov identifier NCT02578914) of ophthalmic NS2 in patients with allergic conjunctivitis
- Announced expected completion of enrollment in allergic conjunctivitis Phase II clinical trial in the second quarter of 2016
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Reiteration of prior guidance on the expected completion of enrollment in two ongoing Phase II clinical trials:
- SLS dermatologic Phase II clinical trial expected to complete enrollment in the first quarter of 2016
- Noninfectious anterior uveitis Phase II clinical trial expected to complete enrollment in the second quarter of 2016
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Poster presentation held at the 2015
American Society of Human Genetics Annual Meeting, evidencing pre-clinical activity of NS2 in trapping succinic semi-aldehyde, the key toxic aldehyde in SSADHD, in a knock-out mouse model of SSADHD
About NS2
NS2 is an aldehyde-binding small molecule based on an innovative platform technology focused on trapping aldehydes, which are toxic and pro-inflammatory mediators of numerous diseases. By decreasing aldehyde load, NS2 may mitigate excessive inflammation and address diseases where aldehyde metabolism is impaired, including certain inborn errors of metabolism.
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. There is no
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 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 Succinic Semi-Aldehyde Dehydrogenase Deficiency
Succinic Semi-aldehyde Dehydrogenase Deficiency (SSADHD) is a rare disease caused by mutations in succinic semi-aldehyde dehydrogenase, leading to elevated levels of succinic semi-aldehyde that result in the formation of neurotoxic metabolites. SSADHD is characterized clinically by neurological compromise that includes cognitive and developmental delay, decreased muscle tone, and, in some cases, seizures. There is no
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 | $ 30,618,365 | $ 8,527,304 | |||
| Prepaid expenses and other current assets | 607,335 | 232,568 | |||
| Total current assets | 31,225,700 | 8,759,872 | |||
| Deferred offering costs | 36,236 | 14,238 | |||
| Fixed assets, net | 88,463 | 12,993 | |||
| Total assets | $ 31,350,399 | $ 8,787,103 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | $ 743,623 | $ 341,294 | |||
| Accrued expenses | 630,325 | 908,724 | |||
| Current portion of credit facility | -- | 77,546 | |||
| Total current liabilities | 1,373,948 | 1,327,564 | |||
| Credit facility, net of current portion and debt discount | 1,281,088 | 1,175,481 | |||
| Total liabilities | 2,655,036 | 2,503,045 | |||
| Commitments and contingencies | |||||
| Stockholders' equity: | |||||
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Preferred stock, |
-- | -- | |||
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Common stock, voting, |
9,712 | 5,565 | |||
| Additional paid-in capital | 82,931,679 | 52,790,090 | |||
| Accumulated deficit | (54,246,028) | (46,511,597) | |||
| Total stockholders' equity | 28,695,363 | 6,284,058 | |||
| Total liabilities and stockholders' equity | $ 31,350,399 | $ 8,787,103 | |||
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| STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (Unaudited) | |||||
| Three Months Ended | Nine Months Ended | ||||
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| 2015 | 2014 | 2015 | 2014 | ||
| Operating expenses: | |||||
| Research and development | $ 2,076,410 | $ 1,195,668 | $ 4,464,941 | $ 2,303,854 | |
| General and administrative | 1,261,196 | 772,467 | 3,188,176 | 2,555,692 | |
| Loss from operations | (3,337,606) | (1,968,135) | (7,650,117) | (4,859,546) | |
| Other income (expense): | |||||
| Change in fair value of preferred stock warrant liabilities | -- | -- | -- | 2,327,502 | |
| Interest income | -- | -- | -- | 3 | |
| Interest expense | (28,081) | (41,071) | (84,314) | (210,539) | |
| Total other income (expense), net | (28,081) | (41,071) | (84,314) | 2,116,966 | |
| Net loss and comprehensive loss | (3,365,687) | (2,009,206) | (7,734,431) | (2,742,580) | |
| Accretion of preferred stock | -- | -- | -- | (333,082) | |
| Deemed dividend | -- | -- | -- | (4,053,570) | |
| Net loss attributable to common stockholders | $ (3,365,687) | $ (2,009,206) | $ (7,734,431) | $ (7,129,232) | |
| Net loss per share attributable to common stockholders: | |||||
| Basic | $ (0.35) | $ (0.36) | $ (0.94) | $ (2.21) | |
| Diluted | $ (0.35) | $ (0.36) | $ (0.94) | $ (2.89) | |
| Weighted average common shares outstanding: | |||||
| Basic | 9,712,521 | 5,565,415 | 8,270,405 | 3,229,338 | |
| Diluted | 9,712,521 | 5,565,415 | 8,270,405 | 3,272,730 | |
CONTACT: Corporate Contact:
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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