Full Press Release Details
Aldeyra Therapeutics Announces Second Quarter 2017 Financial Results
Lexington, MA, August 8, 2017 Aldeyra Therapeutics, Inc. (Nasdaq:ALDX) (Aldeyra or the Company), a clinical-stage biotechnology company devoted to
treating inflammation, inborn errors of metabolism, and other diseases related to aldehydes, today announced its financial results for the quarter ended June 30, 2017.
With the release of allergic conjunctivitis Phase 2b clinical trial results in the second quarter, we were pleased to announce our third Phase 3
clinical program, commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. We are determined to continue to advance our novel aldehyde trap platform toward commercialization, with the goal of providing a novel pharmacologic
approach to patients with limited safe and effective therapeutic options for severe inflammation or inborn errors of aldehyde metabolism.
Corporate Updates and Expected Milestones:
Second Quarter 2017 Financial Results
ended June 30, 2017, Aldeyra reported a net loss of approximately $5.3 million, compared to a net loss of approximately $4.3 million for the quarter ended June 30, 2016. Basic and diluted net loss per share was $0.35 for the
quarter ended June 30, 2017, compared to basic and diluted net loss of $0.41 per share for the quarter ended June 30, 2016. 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 $3.8 million for the three months ended June 30, 2017,
compared to $2.8 million for the three months ended June 30, 2016. The increase of $1.0 million is primarily related to the increases in our external research and development expenditures, including clinical and pre-clinical activities, partially offset by a reduction in manufacturing expenses.
General and administrative expenses
were $1.5 million for the three months ended June 30, 2017, compared to $1.5 million for the three months ended June 30, 2016.
cash equivalents, and marketable securities were $25.8 million as of June 30, 2017.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Tuesday, August 8, 2017, at 8:00 a.m. eastern time to discuss the results. The
dial-in numbers are 1-877-870-4263 for domestic callers and 1-412-317-0790 for international callers. 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 August 7, 2018.
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 Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20-40% of the worldwide population, and is thought to
be mediated in part by pro-inflammatory aldehydes. Symptoms include ocular itching, excessive tear production, lid swelling, and redness. Approximately one-third of
allergic conjunctivitis patients do not adequately respond to standard-of-care therapy.
About Dry Eye Disease
Dry Eye Disease (DED) 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 DED,
aldehydes may contribute to ocular inflammation as well as the impairment of lipids (fats) that lubricate the surface of the eye. Therapy for DED is generally considered by physicians and patients to be inadequate.
About Noninfectious Anterior Uveitis
Noninfectious anterior uveitis (NAU) 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. The only approved therapy for NAU is topical corticosteroids, which can cause
serious ocular side effects, including glaucoma, cataracts, and infection.
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.
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
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, 2016 and Aldeyra s 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. 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.
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.
Tel: +1 781-761-4904 Ext. 205
MacDougall Biomedical Communications
ALDEYRA THERAPEUTICS, INC.
| June 30, 2017 | December 31, 2016 | |||||||
| (unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,609,742 | $ | 12,015,061 | ||||
| Marketable securities | 11,210,796 | 12,897,584 | ||||||
| Prepaid expenses and other current assets | 521,483 | 218,682 | ||||||
| Total current assets | 26,342,021 | 25,131,327 | ||||||
| Deferred offering costs | 77,942 | |||||||
| Fixed assets, net | 47,981 | 56,352 | ||||||
| Total assets | $ | 26,467,944 | $ | 25,187,679 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 762,681 | $ | 275,441 | ||||
| Accrued expenses | 1,038,905 | 1,946,251 | ||||||
| Current portion of credit facility | 310,185 | 77,546 | ||||||
| Total current liabilities | 2,111,771 | 2,299,238 | ||||||
| Credit facility, net of current portion and debt discount | 1,016,377 | 1,238,624 | ||||||
| Total liabilities | 3,128,148 | 3,537,862 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding | ||||||||
| Common stock, voting, $0.001 par value; 150,000,000 authorized and 15,150,176 and 12,576,325 shares issued and outstanding, respectively | 15,150 | 12,576 | ||||||
| Additional paid-in capital | 111,030,501 | 98,938,446 | ||||||
| Accumulated other comprehensive income (loss) | (4,640 | ) | 129 | |||||
| Accumulated deficit | (87,701,215 | ) | (77,301,334 | ) | ||||
| Total stockholders equity | 23,339,796 | 21,649,817 | ||||||
| Total liabilities and stockholders equity | $ | 26,467,944 | $ | 25,187,679 |
ALDEYRA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
| Three Months ended June 30, | Six Months ended June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,848,889 | $ | 2,834,523 | $ | 7,217,912 | $ | 6,346,037 | ||||||||
| General and administrative | 1,481,792 | 1,462,227 | 3,208,670 | 2,917,750 | ||||||||||||
| Loss from operations | (5,330,681 | ) | (4,296,750 | ) | (10,426,582 | ) | (9,263,787 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 48,384 | 21,951 | 80,002 | 46,671 | ||||||||||||
| Interest expense | (26,463 | ) | (27,817 | ) | (53,301 | ) | (52,853 | ) | ||||||||
| Total other income (expense), net | 21,921 | (5,866 | ) | 26,701 | (6,182 | ) | ||||||||||
| Net loss | $ | (5,308,760 | ) | $ | (4,302,616 | ) | $ | (10,399,881 | ) | $ | (9,269,969 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.35 | ) | $ | (0.41 | ) | $ | (0.72 | ) | $ | (0.91 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 15,136,399 | 10,622,411 | 14,470,555 | 10,167,466 |