Aldeyra Therapeutics Announces First Quarter 2018 Financial Results
"We are pleased with our progress in the first quarter, as we continued to advance our product pipeline for the treatment of immunological diseases," stated
Recent Highlights
- Reproxalap, a novel late-stage product candidate focused on a broad spectrum of inflammatory diseases, continued to progress.
- In
January 2018 , Aldeyra initiated the enrollment of a Phase 2b clinical trial in patients with dry eye disease (DED). The trial will assess two concentrations of topical reproxalap (0.1% and 0.25%) against vehicle over 12 weeks of treatment in 300 patients with moderate DED. Consistent with Aldeyra's Phase 2a DED clinical trial, endpoints will include standard signs and symptoms characteristic of the disease. Results from the trial are expected to be announced in the second half of 2018. - In
April 2018 , Aldeyra enrolled the first patient in a Phase 3 allergic conjunctivitis clinical trial. The multi-center, double-masked, parallel-group, vehicle-controlled trial is expected to enroll 300 patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a conjunctival allergen challenge model of acute allergic conjunctivitis. The primary outcome measure will be patient-reported ocular itching. Results from the trial are expected in the second half of 2018, or early 2019. - Research collaboration initiated with Johnson & Johnson Innovation to advance immune-modulating drugs for systemic inflammatory diseases. In
February 2018 , Aldeyra entered into an agreement withJanssen Research & Development, LLC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to collaborate with Janssen on the development of novel product candidates designed to sequester pro-inflammatory reactive aldehyde species (RASP). The agreement is intended to advance existing analogs of reproxalap for the treatment of systemic inflammatory diseases. - Reproxalap and ADX-103, novel RASP scavengers, featured in a podium presentation and three posters at the 2018
Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. InMay 2018 , Aldeyra held a podium presentation on the Phase 2a clinical trial results of reproxalap in DED. In addition, Aldeyra presented a poster on the Phase 2b clinical trial results of reproxalap in allergic conjunctivitis, as well as two posters demonstrating activity of reproxalap and ADX-103 in preclinical models of pan-ocular and retinal inflammation, diabetic macular edema, and dry age-related macular degeneration. David McMullin joins Aldeyra as Senior Vice President Corporate Development and Strategy. InMay 2018 , Aldeyra hiredDavid McMullin to oversee Aldeyra's commercial planning, corporate development, and business development activities. Formerly of Shire plc, GlaxoSmithKline plc, and Novartis AG,Mr. McMullin brings extensive experience leading business development, strategic planning, commercial, and operational activities in the biopharmaceutical industry.
Quarter Ended
For the quarter ended
Research and development expenses were
General and administrative expenses were
For the quarter ended
Cash, cash equivalents, and marketable securities were
Conference Call & Webcast Information
Aldeyra will hold a conference call on
About
About Dry Eye Disease
Dry eye disease is a common and chronic inflammatory disease estimated to affect approximately 20 million people in the United States, and is characterized by insufficient moisture in the anterior surface of the eye, leading to dryness, inflammation, pain, discomfort, irritation, and, in severe cases, decreased vision. Among physicians and patients, existing therapy for dry eye disease is generally regarded as inadequate.
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.
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 strategy, future operations, future, prospects, plans, and objectives and 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 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, 2017, which is 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 March 31, 2018, expected to be filed with the SEC in the second quarter of 2018.
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
| |||||||
BALANCE SHEETS | |||||||
(UNAUDITED) | |||||||
March 31, |
December 31, | ||||||
2018 |
2017 | ||||||
ASSETS |
|||||||
Current assets: |
|||||||
Cash and cash equivalents |
$ 20,963,541 |
$ 20,023,337 | |||||
Marketable securities |
17,974,600 |
22,923,462 | |||||
Prepaid expenses and other current assets |
1,666,898 |
1,018,967 | |||||
Total current assets |
40,605,039 |
43,965,766 | |||||
Deferred offering costs |
- |
165,930 | |||||
Fixed assets, net |
170,862 |
43,262 | |||||
Total assets |
$ 40,775,901 |
$ 44,174,958 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ 1,618,889 |
$ 1,000,963 | |||||
Accrued expenses |
1,815,428 |
2,236,465 | |||||
Current portion of credit facility |
232,639 |
116,319 | |||||
Total current liabilities |
3,666,956 |
3,353,747 | |||||
Credit facility, net of current portion and debt discount |
1,107,741 |
1,220,192 | |||||
Total liabilities |
4,774,697 |
4,573,939 | |||||
Commitments and contingencies |
|||||||
Stockholders' equity: |
|||||||
Preferred stock, |
|||||||
outstanding |
- |
- | |||||
Common stock, voting, |
|||||||
and 19,137,639 shares issued and outstanding, respectively |
19,665 |
19,138 | |||||
Additional paid-in capital |
144,036,909 |
139,241,635 | |||||
Accumulated other comprehensive loss |
(16,385) |
(17,831) | |||||
Accumulated deficit |
(108,038,985) |
(99,641,923) | |||||
Total stockholders' equity |
36,001,204 |
39,601,019 | |||||
Total liabilities and stockholders' equity |
$ 40,775,901 |
$ 44,174,958 |
| |||||
STATEMENT OF OPERATIONS | |||||
(UNAUDITED) | |||||
Three Months ended | |||||
2018 |
2017 | ||||
Operating expenses: |
|||||
Research and development |
$ 6,600,106 |
$ 3,369,023 | |||
General and administrative |
1,891,303 |
1,726,878 | |||
Loss from operations |
(8,491,409) |
(5,095,901) | |||
Other income (expense): |
|||||
Interest income |
122,390 |
31,617 | |||
Interest expense |
(28,044) |
(26,837) | |||
Total other income, net |
94,346 |
4,780 | |||
Net loss |
$ (8,397,063) |
| |||
Net loss per share - basic and diluted |
$ (0.43) |
$ (0.37) | |||
Weighted average common shares outstanding - basic and diluted |
19,366,790 |
13,797,312 |
View original content:http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-first-quarter-2018-financial-results-300648099.html
SOURCE
News Provided by Acquire Media