Aldeyra Therapeutics Reports Full Year 2016 Financial Results
"2016 was a productive year for Aldeyra, highlighted by positive data from our late-stage clinical programs in allergic conjunctivitis, noninfectious anterior uveitis, and Sjögren-Larsson Syndrome," commented
Key 2016 Clinical Program Highlights and Upcoming Events
- Topical Dermatologic ADX-102 in Sjögren-Larsson Syndrome. In
August 2016 , Aldeyra announced positive results from a randomized, double-blind, vehicle-controlled Phase 2 clinical trial of ADX-102 in SLS patients. ADX-102 was statistically superior to vehicle and demonstrated clinically relevant activity in diminishing the severity of ichthyosis, a serious dermatologic disease that afflicts patients with Sjögren-Larsson Syndrome. Following an End of Phase 2 meeting held with theU.S. Food and Drug Administration (FDA), Aldeyra expects to initiate a Phase 3 trial in the second half of 2017. - Topical Ocular ADX-102 in Noninfectious Anterior Uveitis. In
May 2016 , Aldeyra announced positive results from a randomized, parallel-group, investigator-masked, active-controlled Phase 2 clinical trial of ADX-102 in Noninfectious Anterior Uveitis patients. ADX-102 reduced inflammatory cell count in the anterior chamber of the eye to a degree similar to that of standard-of-care corticosteroid therapy (which may lead to cataracts and glaucoma in some patients), but without the intraocular pressure elevations that were observed in subjects treated with corticosteroids. Following meetings held with theFDA , Aldeyra expects to initiate a vehicle-controlled Phase 3 clinical trial in the second quarter of 2017. - Topical Ocular ADX-102 in Allergic Conjunctivitis. In
February 2016 , Aldeyra announced positive results from a randomized, parallel-group, double-masked, vehicle-controlled Phase 2a clinical trial of ADX-102 in allergic conjunctivitis patients. ADX-102 demonstrated statistically and clinically significant activity over vehicle in reducing ocular itching and tearing. Following a meeting held with theFDA , Aldeyra initiated enrollment inFebruary 2017 of a saline-controlled Phase 2b clinical trial. Results from the trial are expected to be reported in the second half of 2017. - Topical Ocular ADX-102 and Topical Ocular ADX-103 in Dry Eye Syndrome. In
November 2016 , Aldeyra announced the addition of a Phase 2a clinical program in Dry Eye Syndrome, a common and painful ocular disease caused by inflammation and insufficient lipids (fats) in tears. By diminishing inflammation and protecting lipids from aldehyde-mediated damage, Aldeyra's aldehyde trap platform may represent a novel, dual-acting, approach for the treatment of Dry Eye Syndrome. Aldeyra plans to initiate a Phase 2a clinical trial of topical ocular ADX-102 in the second quarter of 2017. Contingent on preclinical results, regulatory feedback, and other factors, Aldeyra may also subsequently initiate a Phase 2a clinical trial of ADX-103. Results from the ADX-102 trial are expected to be reported in the second half of 2017.
Year Ended
For the year ended
Research and development expenses were
General and administrative expenses were
In 2016, total operating expenses were approximately
Conference Call & Webcast Information
Aldeyra 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, in severe cases, 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 | 2015 | |||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 12,015,061 | $ | 14,648,866 | ||||||
Marketable securities | 12,897,584 | 12,941,776 | ||||||||
Prepaid expenses and other current assets | 218,682 | 497,552 | ||||||||
Total current assets | 25,131,327 | 28,088,194 | ||||||||
Deferred offering costs | - | 36,236 | ||||||||
Fixed assets, net | 56,352 | 80,334 | ||||||||
Total assets | $ | 25,187,679 | $ | 28,204,764 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 275,441 | $ | 851,160 | ||||||
Accrued expenses | 1,946,251 | 1,186,429 | ||||||||
Current portion of credit facility | 77,546 | 77,546 | ||||||||
Total current liabilities | 2,299,238 | 2,115,135 | ||||||||
Credit facility, net of current portion and debt discount | 1,238,624 | 1,211,310 | ||||||||
Total liabilities | 3,537,862 | 3,326,445 | ||||||||
Commitments and contingencies | ||||||||||
Stockholders' equity: | ||||||||||
Preferred stock, |
- | - | ||||||||
Common stock, voting, |
12,576 | 9,713 | ||||||||
Additional paid-in capital | 98,938,446 | 83,478,851 | ||||||||
Accumulated other comprehensive income (loss) | 129 | (8,361 | ) | |||||||
Accumulated deficit | (77,301,334 | ) | (58,601,884 | ) | ||||||
Total stockholders' equity | 21,649,817 | 24,878,319 | ||||||||
Total liabilities and stockholders' equity | $ | 25,187,679 | $ | 28,204,764 |
STATEMENTS OF OPERATIONS | ||||||||||
Years ended |
||||||||||
2016 | 2015 | |||||||||
Operating expenses: | ||||||||||
Research and development | $ | 13,175,670 | $ | 7,574,398 | ||||||
General and administrative | 5,520,308 | 4,414,709 | ||||||||
Loss from operations | (18,695,978 | ) | (11,989,107 | ) | ||||||
Other income (expense): | ||||||||||
Interest income | 102,037 | 11,126 | ||||||||
Interest expense | (105,509 | ) | (112,306 | ) | ||||||
Total other expense, net | (3,472 | ) | (101,180 | ) | ||||||
Net loss | (18,699,450 | ) | (12,090,287 | ) | ||||||
Net loss per share - basic and diluted | $ | (1.65 | ) | $ | (1.40 | ) | ||||
Weighted average common shares outstanding - basic and diluted | 11,352,230 | 8,633,897 |
Corporate Contact:
Tel: +1 781-761-4904 Ext. 205
Email Contact
Investor Contact:
Tel: 339-970-2843
Email Contact
Media Contact:
781-591-3443
Email Contact
Source:
News Provided by Acquire Media