Full Press Release Details
Aldeyra Therapeutics Announces Third Quarter 2016 Financial Results
On Track to Initiate Two Phase II and Two Phase III Trials in 2017
LEXINGTON, MA (Marketwired) 11/14/2016 Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology
company focused on the development of products to treat diseases related to aldehydes, today reported third quarter 2016 financial results.
extremely pleased with the progress we have made this year with our novel aldehyde trap, ADX-102, said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. We have reported favorable Phase II clinical data in three
diseases, which include ocular inflammation and inborn errors of metabolism. In addition, we expect to initiate a new clinical program in dry eye syndrome, a common disease where existing treatments have shown limited efficacy. Dr. Brady
continued, In aggregate, the clinical trial results announced this year validate ADX-102 and the aldehyde trap platform as a potentially important therapeutic approach in inflammation and inborn errors of aldehyde metabolism. We look forward
to continuing the development of ADX-102 and other aldehyde traps in these and other clinical indications with unmet medical need.
Third Quarter 2016 Financial Review
For the quarter ended September 30, 2016, Aldeyra reported a net loss of approximately $4.8 million compared to a net loss of
approximately $3.4 million for the quarter ended September 30, 2015. Basic and diluted net loss per share was $0.38 for the quarter ended September 30, 2016, compared to basic and diluted net loss
of $0.35 per share for the quarter ended September 30, 2015. Losses have resulted from the costs of Aldeyra s clinical trials and research and development programs, as well as from general and administrative expenses.
Research and development expenses were approximately $3.4 million for the quarter ended September 30, 2016, compared to
approximately $2.1 million for the quarter ended September 30, 2015. The increase of approximately $1.3 million is primarily related to the increase in Aldeyra s external research and development expenditures, including
preclinical, manufacturing, and clinical development activities, and an increase in personnel costs, including stock-based compensation due to an increase in headcount.
General and administrative expenses were approximately $1.4 million for the quarter ended September 30, 2016, compared to
approximately $1.3 million for the quarter ended September 30, 2015. The increase of approximately $100,000 was primarily related to an increase in legal and personnel costs, including stock-based compensation due to an increase in
Cash, cash equivalents and marketable securities were approximately $28.9 million at September 30, 2016.
Conference Call and Webcast Information
Company will hold a conference call on Monday, November 14, 2016 at 8:00 a.m. EST to discuss the results and operational updates. The dial-in numbers are 1-888-740-6116 for domestic callers and 1-913-312-0958 for international
callers. The conference ID number for both is 2931479. A live webcast of the conference call will also be available on the investor relations page of the Aldeyra Therapeutics corporate website at www.aldeyra.com.
After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for one year. In addition, a telephonic replay of the
call will be available until November 13, 2017. The replay dial-in numbers are 1-888-203-1112 for domestic callers and 1-719-457-0820 for international callers. Please use event passcode 2931479.
About Aldeyra Therapeutics
Aldeyra Therapeutics, Inc. is a biotechnology company devoted to improving lives by inventing, developing and commercializing products that treat diseases
thought to be related to endogenous aldehydes, a naturally occurring class of pro-inflammatory and toxic molecules. Aldeyra s lead product candidate, ADX-102, is an aldehyde trap in development for ocular inflammation, as well as for
Sj gren-Larsson Syndrome and Succinic Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of aldehyde metabolism. ADX-102 has not been approved for sale in the U.S. or elsewhere.
About Sj gren-Larsson Syndrome
Sj gren-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 U.S. Food and Drug Administration.
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 severe cases may lead to 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 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,
2015 and Aldeyra s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, 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 set forth in Aldeyra s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, to be filed with the SEC in the fourth quarter of 2016.
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.
ALDEYRA THERAPEUTICS, INC.
| September 30, | December 31, | |||||||
| 2016 (Unaudited) | 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $14,568,508 | $14,648,866 | ||||||
| Marketable securities | 14,307,073 | 12,941,776 | ||||||
| Prepaid expenses and other current assets | 250,206 | 497,552 | ||||||
| Total current assets | 29,125,787 | 28,088,194 | ||||||
| Deferred offering costs | 36,236 | |||||||
| Fixed assets, net | 65,690 | 80,334 | ||||||
| Total assets | $29,191,477 | $28,204,764 | ||||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $733,560 | $851,160 | ||||||
| Accrued expenses | 1,476,592 | 1,186,429 | ||||||
| Current portion of credit facility | 426,505 | 77,546 | ||||||
| Total current liabilities | 2,636,657 | 2,115,135 | ||||||
| Credit facility, net of current portion and debt discount | 883,282 | 1,211,310 | ||||||
| Total liabilities | 3,519,939 | 3,326,445 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding as of September 30, 2016 and December 31, 2015 | ||||||||
| Common stock, voting, $0.001 par value; 150,000,000 authorized and 12,568,563 shares issued and outstanding as of September 30, 2016 and 9,712,521 shares issued and outstanding as of December 31, 2015 | 12,569 | 9,713 | ||||||
| Additional paid-in capital | 98,302,346 | 83,478,851 | ||||||
| Accumulated other comprehensive income (loss), net of tax | 6,528 | (8,361) | ||||||
| Accumulated deficit | (72,649,905) | (58,601,884) | ||||||
| Total stockholders equity | 25,671,538 | 24,878,319 | ||||||
| Total liabilities and stockholders equity | $29,191,477 | $28,204,764 |
ALDEYRA THERAPEUTICS, INC.
STATEMENT OF OPERATIONS
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,379,711 | $ | 2,076,410 | $ | 9,728,494 | $ | 4,461,941 | ||||||||
| General and administrative | 1,396,734 | 1,261,196 | 4,314,483 | 3,188,176 | ||||||||||||
| Loss from operations | (4,776,445 | ) | (3,337,606 | ) | (14,042,977 | ) | (7,650,117 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 27,792 | 74,463 | ||||||||||||||
| Interest expense | (26,654 | ) | (28,081 | ) | (79,507 | ) | (84,314 | ) | ||||||||
| Total other income (expense), net | 1,138 | (28,081 | ) | (5,044 | ) | (84,314 | ) | |||||||||
| Net loss | $ | (4,775,307 | ) | $ | (3,365,687 | ) | $ | (14,048,021 | ) | $ | (7,734,431 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.38 | ) | $ | (0.35 | ) | $ | (1.28 | ) | $ | (0.94 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 12,474,609 | 9,712,521 | 10,942,127 | 8,270,405 |
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904
MacDougall Biomedical Communications