Aldeyra Therapeutics Announces Second Quarter 2016 Financial Results and Provides Corporate Update
"We are extremely pleased with our progress through the first half of the year with our novel aldehyde trap, NS2," said
Recent Highlights
- Reported positive results from a randomized, double-blind, vehicle controlled clinical trial in patients with Sjögren-Larsson Syndrome. Aldeyra recently reported positive data from a randomized, parallel-group, double-blind, vehicle-controlled, multi-center clinical trial of topical NS2 for the treatment of the dermatologic manifestations of Sjögren-Larsson Syndrome (SLS). Patients with SLS, a rare inborn error of aldehyde metabolism, suffer from ichthyosis, a debilitating dermatologic disease characterized by dry, thickened, scaly skin. The symptoms of SLS are thought to be related to high levels of toxic fatty aldehydes due to genetic mutations in fatty aldehyde dehydrogenase, an enzyme critical for the normal function of skin and other organs. NS2 is specifically designed to reduce levels of toxic aldehydes, and is the first therapy to be directed at the putative cause of SLS. In the clinical trial, NS2 consistently produced clinically meaningful effects in reducing the severity of ichthyosis that exceeded vehicle response.
- Reported positive results from Phase II clinical trial in patients with noninfectious anterior uveitis. In
May 2016 , Aldeyra reported positive data from a randomized, parallel-group, multi-center, investigator-masked, active-controlled Phase II clinical trial in subjects with noninfectious anterior uveitis. Forty-five patients were randomized to receive either NS2 or Pred-Forte®, a standard-of-care corticosteroid that leads to elevations of intraocular pressure in some patients, or a combination of NS2 and Pred-Forte®. Results from this study demonstrated that NS2 was as clinically effective as Pred-Forte but did not increase intraocular pressure.
- Reported positive results from Phase II clinical trial in subjects with allergic conjunctivitis. In
February 2016 , Aldeyra reported that the results of a randomized, parallel-group, single-center, double-masked, vehicle-controlled Phase II clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant and sustained activity of NS2 over vehicle in reducing ocular itching and tearing.
Second Quarter 2016 Financial Review
For the quarter ended
Research and development expenses were approximately
General and administrative expenses were approximately
During the quarter, Aldeyra sold in an underwritten public offering 2,760,000 shares of its common stock, including 360,000 shares sold in connection with the exercise in full by the underwriter of its option to purchase additional shares. The net proceeds of the offering, including the full exercise of the option, 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 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 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.
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
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BALANCE SHEETS | ||||||||
2016 (Unaudited) |
2015 |
|||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 17,607,522 | $ | 14,648,866 | ||||
Marketable securities | 14,940,912 | $ | 12,941,776 | |||||
Prepaid expenses and other current assets | 260,087 | 497,552 | ||||||
Total current assets | 32,808,521 | 28,088,194 | ||||||
Deferred offering costs | - | 36,236 | ||||||
Fixed assets, net | 75,027 | 80,334 | ||||||
Total assets | $ | 32,883,548 | $ | 28,204,764 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 823,301 | $ | 851,160 | ||||
Accrued expenses | 1,084,591 | 1,186,429 | ||||||
Accrued deferred offering costs | 155,122 | - | ||||||
Current portion of credit facility | 310,185 | 77,546 | ||||||
Total current liabilities | 2,373,199 | 2,115,135 | ||||||
Credit facility, net of current portion and debt discount | 992,625 | 1,211,310 | ||||||
Total liabilities | 3,365,824 | 3,326,445 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, |
- | - | ||||||
Common stock, voting, |
12,473 | 9,713 | ||||||
Additional paid-in capital | 97,372,402 | 83,478,851 | ||||||
Accumulated other comprehjensive income (loss), net of tax | 4,703 | (8,361 | ) | |||||
Accumulated deficit | (67,871,854 | ) | (58,601,884 | ) | ||||
Total stockholders' equity | 29,517,724 | 24,878,319 | ||||||
Total liabilities and stockholders' equity | $ | 32,883,548 | $ | 28,204,764 | ||||
STATEMENT OF OPERATIONS | ||||||||||||||||||
(unaudited) | ||||||||||||||||||
Three Months Ended |
Six Months Ended |
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2016 | 2015 | 2016 | 2015 | |||||||||||||||
Operating expenses: | ||||||||||||||||||
Research and development | $ | 2,834,523 | $ | 1,249,097 | $ | 6,346,037 | $ | 2,385,531 | ||||||||||
General and administrative | 1,462,227 | 954,879 | 2,917,750 | 1,926,980 | ||||||||||||||
Loss from operations | (4,296,750 | ) | (2,203,976 | ) | (9,263,787 | ) | (4,312,511 | ) | ||||||||||
Other income (expense): | ||||||||||||||||||
Interest income | 21,951 | - | 46,671 | - | ||||||||||||||
Interest expense | (27,817 | ) | (28,210 | ) | (52,853 | ) | (56,234 | ) | ||||||||||
Total other income (expense), net | (5,866 | ) | (28,210 | ) | (6,182 | ) | (56,234 | ) | ||||||||||
Net loss | $ | (4,302,616 | ) | $ | (2,232,186 | ) | $ | (9,269,969 | ) | $ | (4,368,745 | ) | ||||||
Net loss per share - Basic and Diluted | $ | (0.41 | ) | $ | (0.27 | ) | $ | (0.91 | ) | $ | (0.58 | ) | ||||||
Weighted average common shares outstanding - Basic and Diluted | 10,622,411 | 8,397,713 | 10,167,466 | 7,537,396 |
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