Aldeyra Therapeutics Announces Year End 2017 Financial Results
"2017 was a productive year for Aldeyra, highlighted by favorable clinical results in dry eye disease and allergic conjunctivitis, initiation of a Phase 3 clinical trial in noninfectious anterior uveitis, and receipt of orphan drug designation for reproxalap in Sjögren-Larsson Syndrome," commented
Key 2017 Highlights and Upcoming Events
- Reported favorable Phase 2a clinical data in dry eye disease and initiated enrollment of Phase 2b clinical trial. In
September 2017 , Aldeyra reported positive results from a randomized, dose-ranging, parallel-group, double-masked Phase 2a clinical trial of topical ocular reproxalap in dry eye disease patients. Reproxalap demonstrated statistically and clinically significant improvement across multiple sign and symptom scores. Improvements in dry eye disease signs and symptoms were evident within one week of therapy and effect sizes increased over the duration of therapy, supportive of rapid drug activity relative to standard of care. Aldeyra enrolled its first patient into a Phase 2b clinical trial of reproxalap in dry eye disease inJanuary 2018 , and expects to report results in the second half of 2018. - Planned initiation of Phase 3 clinical trial in allergic conjunctivitis. Based on an End of Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) following favorable results from Aldeyra's Phase 2b clinical trial in allergic conjunctivitis, Aldeyra plans to begin a Phase 3 allergic conjunctivitis clinical trial of topical ocular reproxalap in the first half of 2018. Results of the Phase 3 clinical trial are expected in the second half of 2018, or early 2019. - Presented Phase 2 clinical results in noninfectious anterior uveitis (NAU) at ophthalmic medical conferences and initiated Phase 3 clinical trial. In
May 2017 , Dr.John Sheppard , an internationally recognized expert in anterior ocular inflammation, presented the results of Aldeyra's Phase 2 clinical trial of topical ocular reproxalap in NAU as an Emerging Treatments paper at theAssociation for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting. Data from the trial demonstrated activity comparable to Pred Forte®, a standard-of-care topical ocular corticosteroid, in reducing anterior chamber inflammatory cell count in patients with active NAU, without increasing intraocular pressure, a major side effect of corticosteroids. InNovember 2017 ,Dr. Sheppard presented additional analyses of Aldeyra's Phase 2 clinical trial at theAmerican Uveitis Society held at theAmerican Academy of Ophthalmology 2017 Annual Meeting. The results of the analyses demonstrated formal statistical non-inferiority of 0.5% reproxalap ophthalmic solution to Pred Forte® in reducing anterior chamber inflammatory cell count. The results also demonstrated that the combination of reproxalap and sub-therapeutic (twice-daily) Pred Forte® administration was also statistically non-inferior to Pred Forte® monotherapy (four-times-daily).
InApril 2017 , Aldeyra initiated a Phase 3 clinical trial of topical ocular reproxalap in patients with NAU. Results of the trial are expected to be announced in 2019. - Planned initiation of Phase 3 clinical trial in Sjögren-Larsson Syndrome (SLS) and receipt of Orphan Drug Designation. Based on an End of Phase 2 meeting with the
FDA following favorable results from a Phase 2 clinical trial in SLS, Aldeyra plans to initiate a global, double-blind, two-part Phase 3 clinical trial of topical dermatologic reproxalap in the first half of 2018. Additionally, inApril 2017 , theFDA granted reproxalap orphan drug designation for the treatment of congenital ichthyosis, a severe skin disease characteristic of SLS. There are no FDA-approved therapies specifically indicated for the treatment of SLS, and reproxalap is believed to be the only potential SLS therapy in clinical development. Results from part one of the Phase 3 clinical trial are expected to be announced in 2019.
Year Ended
For the year ended
Research and development expenses were
General and administrative expenses were
In 2017, total operating expenses were approximately
Cash, cash equivalents, and marketable securities were
Conference Call & Webcast Information
Aldeyra will hold a conference call on
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with inflammatory diseases. Aldeyra's lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. Aldeyra is leveraging its experience in ocular inflammation to develop other product candidates for systemic inflammatory disease. None of Aldeyra's product candidates have been approved for sale in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a common and chronic inflammatory disease estimated to affect approximately 20 million people in the
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The disease 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. Antihistamines are commonly used to treat allergic conjunctivitis, but use is limited by lack of durable activity and ocular dryness.
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. Topical corticosteroid therapy is the only approved therapy for the resolution of inflammation associated with noninfectious anterior uveitis, but can lead to serious ocular complications, including glaucoma, infections, and cataracts.
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 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 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. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. 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 of 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 and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use 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
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
| ||||
BALANCE SHEETS | ||||
(UNAUDITED) | ||||
December 31, |
December 31, | |||
2017 |
2016 | |||
ASSETS |
||||
Current assets: |
||||
Cash and cash equivalents |
$ 20,023,337 |
$ 12,015,061 | ||
Marketable securities |
22,923,462 |
12,897,584 | ||
Prepaid expenses and other current assets |
1,018,967 |
218,682 | ||
Total current assets |
43,965,766 |
25,131,327 | ||
Deferred offering costs |
165,930 |
- | ||
Fixed assets, net |
43,262 |
56,352 | ||
Total assets |
$ 44,174,958 |
$ 25,187,679 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||
Current liabilities: |
||||
Accounts payable |
$ 1,000,963 |
$ 275,441 | ||
Accrued expenses |
2,236,465 |
1,946,251 | ||
Current portion of credit facility |
116,319 |
77,546 | ||
Total current liabilities |
3,353,747 |
2,299,238 | ||
Credit facility, net of current portion and debt discount |
1,220,192 |
1,238,624 | ||
Total liabilities |
4,573,939 |
3,537,862 | ||
Stockholders' equity: |
||||
Preferred stock, |
- | - | ||
Common stock, voting, |
19,138 | 12,576 | ||
Additional paid-in capital |
139,241,635 |
98,938,446 | ||
Accumulated other comprehensive income (loss) |
(17,831) |
129 | ||
Accumulated deficit |
(99,641,923) |
(77,301,334) | ||
Total stockholders' equity |
39,601,019 |
21,649,817 | ||
Total liabilities and stockholders' equity |
$ 44,174,958 |
$ 25,187,679 | ||
| ||||
STATEMENTS OF OPERATIONS | ||||
(UNAUDITED) | ||||
Years ended | ||||
2017 |
2016 | |||
Operating expenses: |
||||
Research and development |
$ 16,302,568 |
$ 13,175,670 | ||
General and administrative |
6,185,820 |
5,520,308 | ||
Loss from operations |
(22,488,388) |
(18,695,978) | ||
Other income (expense): |
||||
Interest income |
261,252 |
102,037 | ||
Interest expense |
(113,454) |
(105,509) | ||
Total other income (expense), net |
147,798 |
(3,472) | ||
Net loss |
$ (22,340,589) |
$ (18,699,450) | ||
Net loss per share - basic and diluted |
$ (1.40) |
$ (1.65) | ||
Weighted average common shares outstanding - basic and diluted |
15,921,884 |
11,352,230 |
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