Full Press Release Details
Aldeyra Therapeutics Announces Year-End 2018 Financial Results
LEXINGTON, Mass., March 8, 2019 /PRNewswire/ -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology
company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced year ended December 31, 2018 financial results.
2018 was a landmark year for Aldeyra, highlighted by positive results from our Phase 2b dry eye disease clinical trial, and the subsequent acquisition of Helio
Vision in January of this year, commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. We were pleased to add new Phase 3 clinical programs in dry eye disease and proliferative vitreoretinopathy, complementing our Phase 3
trials in allergic conjunctivitis, noninfectious anterior uveitis, and Sj gren-Larsson Syndrome. We look forward to updating investors on the progress of our late-stage development pipeline throughout 2019, as we continue our efforts to
bring novel therapeutic options to market.
Recent Highlights and Corporate Updates
Year Ended December 31, 2018 Financial Review
Aldeyra reported a net loss of approximately $38.9 million for the year ended December 31, 2018, compared to
a net loss of approximately $22.3 million in 2017. Basic and diluted net loss per share was $1.79 for the year ended December 31, 2018, compared to $1.40 per share 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 approximately
$29.8 million for the year ended December 31, 2018, compared to approximately $16.3 million in 2017. The increase of $13.5 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 approximately
$9.9 million for the year ended December 31, 2018, compared to approximately $6.2 million in 2017. The increase of $3.7 million is primarily related to an increase in legal and patent-related costs, consulting costs, and
Total operating expenses were approximately $39.7 million for the year ended December 31, 2018, compared to total operating expenses of
approximately $22.5 million in 2017.
Cash, cash equivalents, and marketable securities were $93.6 million as of December 31, 2018 which includes
$67.6 million of net proceeds raised in an October 2018 public offering of Aldeyra s common stock.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Friday, March 8, 2019, at 8:00 a.m. Eastern Standard Time. 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 year.
Aldeyra Therapeutics is a biotechnology company devoted to developing and commercializing 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,
allergic conjunctivitis, noninfectious anterior uveitis, and Sj gren-Larsson Syndrome. The company is also developing other product candidates for proliferative vitreoretinopathy and other retinal diseases, post-transplant lymphoproliferative
disorder, autoimmune disease, metabolic disease, and cancer. None of Aldeyra s product candidates have been approved for sale in the U.S. or elsewhere.
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 financial position, projected costs and expenses, prospects, plans, and
objectives and Aldeyra s plans and expectations for its product candidates, including plans to initiate further clinical testing. 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, delay in or failure to obtain regulatory approval of
Aldeyra s product candidates, the ability to maintain regulatory approval of Aldeyra s product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of
effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving Aldeyra s product candidates; the scope, progress, expansion, and costs of developing and
commercializing Aldeyra s product candidates; uncertainty as to Aldeyra s ability to commercialize (alone or with others) Aldeyra s product candidates following regulatory approval, if any; 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 limited sales and marketing infrastructure; Aldeyra s ability to establish and maintain development partnerships; Aldeyra s ability to successfully integrate acquisitions into its business; 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 and Aldeyra s Quarterly Report on Form
10-Q for the quarter ended September 30, 2018, both of 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
described in those sections of Aldeyra s Annual Report on Form 10-K for the year ended December 31, 2018, expected to be filed with the SEC in the first quarter of 2019.
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. 218
Westwicke, an ICR Company
ALDEYRA THERAPEUTICS, INC.
| December 31, 2018 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,357,472 | $ | 2,023,337 | ||||
| Cash equivalent- reverse repurchase agreements | 44,000,000 | 18,000,000 | ||||||
| Marketable securities | 46,242,220 | 22,923,462 | ||||||
| Prepaid expenses and other current assets | 1,169,594 | 1,018,967 | ||||||
| Total current assets | 94,769,286 | 43,965,766 | ||||||
| Deferred offering costs | 86,644 | 165,930 | ||||||
| Fixed assets, net | 235,225 | 43,262 | ||||||
| Total assets | $ | 95,091,155 | $ | 44,174,958 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,051,678 | $ | 1,000,963 | ||||
| Accrued expenses | 5,421,498 | 2,236,465 | ||||||
| Current portion of credit facility | - | 116,319 | ||||||
| Total current liabilities | 8,473,176 | 3,353,747 | ||||||
| Credit facility, net of current portion and debt discount | - | 1,220,192 | ||||||
| Total liabilities | 8,473,176 | 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 26,244,435 and 19,137,639 shares issued and outstanding, respectively | 26,244 | 19,138 | ||||||
| Additional paid-in capital | 225,136,127 | 139,241,635 | ||||||
| Accumulated other comprehensive income (loss) | (9,224 | ) | (17,831 | ) | ||||
| Accumulated deficit | (138,535,168 | ) | (99,641,923 | ) | ||||
| Total stockholders equity | 86,617,979 | 39,601,019 | ||||||
| Total liabilities and stockholders equity | $ | 95,091,155 | $ | 44,174,958 |
ALDEYRA THERAPEUTICS, INC.
STATEMENT OF OPERATIONS
| Years ended December 31, | ||||||||
| 2018 | 2017 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 29,823,007 | $ | 16,302,568 | ||||
| General and administrative | 9,876,144 | 6,185,820 | ||||||
| Loss from operations | (39,699,151 | ) | (22,488,388 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 952,698 | 261,252 | ||||||
| Interest expense | (146,792 | ) | (113,453 | ) | ||||
| Total other income (expense), net | 805,906 | 147,799 | ||||||
| Net loss | $ | (38,893,245 | ) | $ | (22,340,589 | ) | ||
| Net loss per share - basic and diluted | $ | (1.79 | ) | $ | (1.40 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 21,685,642 | 15,921,884 |