Full Press Release Details
Aldeyra Therapeutics Announces First Quarter 2018 Financial Results
LEXINGTON, Mass., May 15, 2018 /PRNewswire/ Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company
devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced financial results for the first quarter ended March 31, 2018.
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 Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. Our research collaboration with Johnson & Johnson Innovation to develop novel drug candidates for systemic inflammatory diseases, the initiation of
late-stage clinical testing in dry eye disease and allergic conjunctivitis, and the poster presentations of our ocular inflammation programs, all highlight the promise of our platform across a number of product candidates and indications. We look
forward to multiple milestones over the next year, including Phase 2b and Phase 3 clinical results in dry eye disease and allergic conjunctivitis, respectively.
Quarter Ended March 31, 2018 Financial Review
For the quarter ended March 31, 2018, Aldeyra reported a net loss of approximately $8.4 million, compared to a net loss of approximately $5.1 million for
the quarter ended March 31, 2017. Basic and diluted net loss per share was $0.43 for the quarter ended March 31, 2018, compared to $0.37 per share for the same period in 2017. 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 $6.6 million
for the quarter ended March 31, 2018, compared to $3.4 million for the same period in 2017. The increase of $3.2 million is primarily related to the increase in research and development expenditures, including manufacturing, preclinical, and
clinical development costs, and an increase in personnel costs.
General and administrative expenses were $1.9 million for the quarter ended
March 31, 2018, compared to $1.7 million for the quarter ended 2017. The increase of $0.2 million is primarily related to an increase in legal and patent-related costs, rent, consulting costs, and personnel costs.
For the quarter ended March 31, 2018, total operating expenses were approximately $8.5 million, compared to total operating expenses of approximately
$5.1 million for the same period in 2017.
Cash, cash equivalents, and marketable securities were $38.9 million as of March 31, 2018.
Conference Call & Webcast Information
will hold a conference call on Tuesday, May 15, 2018, at 8:00 a.m. Eastern Daylight Time to discuss the results. The dial-in numbers are 1-877-266-8979 for domestic callers and 1-412-317-5231 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
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated 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 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.
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 205
MacDougall Biomedical Communications
ALDEYRA THERAPEUTICS, INC.
| March 31, 2018 | December 31, 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, $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 19,664,921 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 |
ALDEYRA THERAPEUTICS, INC.
STATEMENT OF OPERATIONS
| Three Months ended March 31, | ||||||||
| 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 | ) | $ | (5,091,121 | ) | ||
| 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 |