Aldeyra Therapeutics Provides Corporate Update and Announces First Quarter 2017 Financial Results
"We are pleased to update our progress with four clinical programs, three of which are now in late-stage development," commented
Corporate Updates:
- Expected Timing of Results of Phase 2b Allergic Conjunctivitis Clinical Trial Ahead of Previous Guidance. In
April 2017 , Aldeyra announced the completion of enrollment and dosing in a Phase 2b clinical trial of topical ocular ADX-102 in allergic conjunctivitis. The trial tested 0.1% and 0.5% concentrations of topical ocular ADX-102 against saline. Each of the three groups in the trial was comprised of 50 patients with a history of allergic conjunctivitis. Consistent with clinical trials used for registration of other drugs in allergic conjunctivitis, patients in the Phase 2b trial were treated with a single dose of drug or control solution in both eyes, followed by topically administered allergens. Patient-reported ocular itching will be assessed as the primary endpoint. Results from the trial are expected to be announced inJune 2017 . - Data Timeline for Phase 2a Clinical Trial in Dry Eye Syndrome Updated to Third Quarter of 2017. The Phase 2a clinical trial in Dry Eye Syndrome will test three formulations of topical ocular ADX-102 over 28 days of dosing. Endpoints will include standard signs and symptoms characteristic of Dry Eye Syndrome. Results of the clinical trial are expected to be announced in the third quarter of 2017.
- Phase 3 Clinical Trial in Noninfectious Anterior Uveitis Initiated in
April 2017 , Consistent with Previous Guidance. The Phase 3 noninfectious anterior uveitis clinical trial is expected to enroll up to 100 patients with active disease, randomized equally to receive either 0.5% topical ocular ADX-102 or vehicle for four weeks. The primary endpoint will be the resolution of inflammation. Results of the trial are expected to be announced in the second half of 2018. - Initial Data from Phase 3 Sjögren-Larsson Syndrome (SLS) Clinical Trial Expected in the Second Half of 2018. The Phase 3 clinical trial in SLS is expected to be performed in two parts: a randomized and controlled assessment over six months of treatment, followed by a crossover design to assess change from baseline in drug-treated patients. Data from part one of the trial will be used to confirm statistical power for part two, and are expected to be available in the second half of next year. In coordination with the advancement of the SLS program to Phase 3 clinical testing, in
February 2017 , Aldeyra launched the SLS Patient Registry to unite SLS patients, caregivers, physicians, researchers, and other members of the SLS community. - Orphan Drug Designation Granted for ADX-102 in Congenital Ichthyosis, a Debilitating Condition Characteristic of Sjögren-Larsson Syndrome. In
April 2017 , Aldeyra announced that theUnited States Food and Drug Administration (FDA) granted ADX-102 orphan drug designation for the treatment of congenital ichthyosis, a severe skin disease in SLS patients.The FDA Office of Orphan Products Development designates orphan status to drugs intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people inthe United States . Receiving Orphan Drug Designation provides Aldeyra with multiple benefits, including waiver of the Prescription Drug User Fee, post-approval marketing exclusivity for seven years, research tax credits, and assistance during the marketing registration process.
First Quarter 2017 Financial Results
For the quarter ended
Research and development expenses were approximately
General and administrative expenses were
In
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 the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's plans for its product candidates. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. 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 | |||||||||
2017 | 2016 | ||||||||
(unaudited) | |||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 19,302,850 | $ | 12,015,061 | |||||
Marketable securities | 11,909,800 | 12,897,584 | |||||||
Prepaid expenses and other current assets | 260,683 | 218,682 | |||||||
Total current assets | 31,473,333 | 25,131,327 | |||||||
Fixed assets, net | 58,284 | 56,352 | |||||||
Total assets | $ | 31,531,617 | $ | 25,187,679 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 694,922 | $ | 275,441 | |||||
Accrued expenses | 1,520,322 | 1,946,251 | |||||||
Current portion of credit facility | 193,866 | 77,546 | |||||||
Total current liabilities | 2,409,110 | 2,299,238 | |||||||
Credit facility, net of current portion and debt discount | 1,127,500 | 1,238,624 | |||||||
Total liabilities | 3,536,610 | 3,537,862 | |||||||
Commitments and contingencies | |||||||||
Stockholders' equity: | |||||||||
Preferred stock, |
- |
- |
|||||||
Common stock, voting, |
15,132 |
12,576 |
|||||||
Additional paid-in capital | 110,377,077 | 98,938,446 | |||||||
Accumulated other comprehensive income (loss) | (4,747 | ) | 129 | ||||||
Accumulated deficit | (82,392,455 | ) | (77,301,334 | ) | |||||
Total stockholders' equity | 27,995,007 | 21,649,817 | |||||||
Total liabilities and stockholders' equity | $ | 31,531,617 | $ | 25,187,679 | |||||
Income Statement | |||||||||
Three Months ended |
|||||||||
2017 | 2016 | ||||||||
Operating expenses: | |||||||||
Research and development | $ | 3,369,023 | $ | 3,511,477 | |||||
General and administrative | 1,726,878 | 1,455,559 | |||||||
Loss from operations | (5,095,901 | ) | (4,967,036 | ) | |||||
Other income (expense): | |||||||||
Interest income | 31,617 | 24,719 | |||||||
Interest expense | (26,837 | ) | (25,035 | ) | |||||
Total other income (expense), net | 4,780 | (316 | ) | ||||||
Net loss | $ | (5,091,121 | ) | $ | (4,967,352 | ) | |||
Net loss per share - basic and diluted | $ | (0.37 | ) | $ | (0.51 | ) | |||
Weighted average common shares outstanding - basic and diluted | 13,797,312 | 9,712,521 | |||||||
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