Aldeyra Therapeutics Announces Third Quarter 2017 Financial Results
"The announcement of clinical results in dry eye disease in the third quarter marks the fifth positive Phase 2 clinical trial of our lead aldehyde trap, reproxalap, formerly known as ADX-102," commented
Third Quarter Highlights:
- Reported Positive Results from Phase 2a Clinical Trial in Dry Eye Disease. In
September 2017 , Aldeyra reported positive results from a Phase 2a clinical trial of reproxalap in dry eye disease, a common and sub-optimally treated chronic ocular disorder. The results demonstrated statistically and clinically significant improvement across multiple sign and symptom endpoints, and onset of action was observed within one week of therapy, markedly faster than standard of care. Supportive of drug activity, reduction in levels of pro-inflammatory aldehydes was correlated with improvement in ocular staining scores and tear osmolarity. - Announced New Results from Phase 2b Allergic Conjunctivitis Clinical Trial Demonstrating Clinically Relevant Activity of Reproxalap. Analysis of the previously reported Phase 2b results demonstrated that patients treated with reproxalap were more than three times more likely than vehicle-treated patients (p < 0.05) to improve in ocular itch score (range 0 to 4) by one point, an amount consistent with
U.S. Food and Drug Administration standards for regulatory approval and clinical relevance. Additionally, time to clinical response was more rapid in drug groups than in the vehicle group (p < 0.01). Allergic conjunctivitis is a persistently disturbing and common ocular disease affecting 20% or more of the worldwide population. - Introduced Novel Aldehyde Trap ADX-103 as a Product Candidate for the Treatment of Retinal Disease. In preclinical retinal disease models of macular degeneration, uveitis, and diabetic macular edema, ADX-103 (a novel aldehyde trap that is structurally distinct from reproxalap) demonstrated consistent activity that was at least as potent as that of reproxalap. Additional results are expected to be released at a major scientific meeting in 2018.
- Adoption of Reproxalap as Generic Name for ADX-102. Reproxalap, the generic name for the first-in-class aldehyde trap, formerly known as ADX-102, has been adopted by the
United States Adopted Names Council and theInternational Nonproprietary Names Expert Group . The name incorporates a new stem for aldehyde traps, "-alap", and recognizes aldehyde traps as a novel class of drug. - 2017 Research & Development Day. On
October 10, 2017 , Aldeyra hosted its Research & Development Day, which featured presentations from key ocular inflammation opinion leaders on the therapeutic and market potential of Aldeyra's late-stage aldehyde trap platform in dry eye disease and allergic conjunctivitis, two closely related ocular inflammatory conditions that, in aggregate, represent one of the largest topical ophthalmic markets worldwide. An archived webcast of the event can be found under the Events section of Aldeyra's investor website.
Expected Clinical Milestones:
- Phase 3 Allergic Conjunctivitis Expected to Begin in the First Half of 2018; Results Expected to be Announced in the Second Half of 2018
- Phase 2b Dry Eye Disease Expected to Begin in the First Half of 2018; Results Expected to be Announced in the Second Half of 2018
- Phase 3 Noninfectious Anterior Uveitis Results Expected to be Announced in the Second Half of 2018
- Phase 3 Sjögren-Larsson Syndrome Expected to Begin in the First Half of 2018; Initial Results Expected to be Announced in the Second Half of 2018
Third Quarter 2017 Financial Results
For the third quarter, Aldeyra reported a net loss of approximately
Research and development expenses were
General and administrative expenses were
Cash, cash equivalents, and marketable securities were
Conference Call & Webcast Information
Aldeyra will hold a conference call on
About Aldeyra Therapeutics
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to affect approximately 20 million people in
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The disease 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 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 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 ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. No therapy for SLS has been approved by the
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 and expectations for the development of Reproxalap and ADX-103; and the potential of Reproxalap as an agent for the treatment of dry eye disease and allergic conjunctivitis and ADX-103 as an agent for the treatment of retinal disease. 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; updated or refined data based on Aldeyra's continuing review and quality control analysis of
clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities, 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 the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, which are on file with the Securities and Exchange Commission(SEC) and available on the SEC's website at www.sec.gov. Additional factors may be described in
those sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter ended
In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
Corporate Contact:
Tel: 781-761-4904 ext. 205
stulipano@aldeyra.com
Investor Contact:
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
| ||||||||
September 30, |
December 31, | |||||||
2017 |
2016 | |||||||
(unaudited) |
||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ |
33,103,849 |
$ |
12,015,061 | ||||
Marketable securities |
14,807,166 |
12,897,584 | ||||||
Prepaid expenses and other current assets |
1,141,727 |
218,682 | ||||||
Total current assets |
49,052,742 |
25,131,327 | ||||||
Deferred offering costs |
138,661 |
- | ||||||
Fixed assets, net |
38,017 |
56,352 | ||||||
Total assets |
$ |
49,229,420 |
$ |
25,187,679 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ |
485,267 |
$ |
275,441 | ||||
Accrued expenses |
1,507,458 |
1,946,251 | ||||||
Current portion of credit facility |
426,505 |
77,546 | ||||||
Total current liabilities |
2,419,230 |
2,299,238 | ||||||
Credit facility, net of current portion and debt discount |
905,253 |
1,238,624 | ||||||
Total liabilities |
3,324,483 |
3,537,862 | ||||||
Commitments and contingencies |
||||||||
Stockholders' equity: |
||||||||
Preferred stock, |
||||||||
outstanding |
- |
- | ||||||
Common stock, voting, |
||||||||
and 12,576,325 shares issued and outstanding, respectively |
19,118 |
12,576 | ||||||
Additional paid-in capital |
138,574,234 |
98,938,446 | ||||||
Accumulated other comprehensive income (loss) |
(1,002) |
129 | ||||||
Accumulated deficit |
(92,687,413) |
(77,301,334) | ||||||
Total stockholders' equity |
45,904,937 |
21,649,817 | ||||||
Total liabilities and stockholders' equity |
$ |
49,229,420 |
$ |
25,187,679 | ||||
| |||||||||||||||||||
Three Months ended |
Nine Months ended | ||||||||||||||||||
2017 |
2016 |
2017 |
2016 | ||||||||||||||||
Operating expenses: |
|||||||||||||||||||
Research and development |
$ |
3,539,368 |
$ |
3,379,711 |
$ |
10,757,279 |
$ |
9,728,494 | |||||||||||
General and administrative |
1,475,904 |
1,396,734 |
4,684,574 |
4,314,483 | |||||||||||||||
Loss from operations |
(5,015,272) |
(4,776,445) |
(15,441,853) |
(14,042,977) | |||||||||||||||
Other income (expense): |
|||||||||||||||||||
Interest income |
56,651 |
27,792 |
136,652 |
74,463 | |||||||||||||||
Interest expense |
(27,578) |
(26,654) |
(80,878) |
(79,507) | |||||||||||||||
Total other income (expense), net |
29,073 |
1,138 |
55,774 |
(5,044) | |||||||||||||||
Net loss |
$ |
(4,986,199) |
$ |
(4,775,307) |
$ |
(15,386,079) |
$ |
(14,048,021) | |||||||||||
Net loss per share - basic and diluted |
$ |
(0.32) |
$ |
(0.38) |
$ |
(1.04) |
$ |
(1.28) | |||||||||||
Weighted average common shares outstanding - basic and diluted |
15,581,426 |
12,474,609 |
14,844,914 |
10,942,127 | |||||||||||||||
View original content:http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-third-quarter-2017-financial-results-300552657.html
SOURCE
News Provided by Acquire Media