Full Press Release Details
Aldeyra Therapeutics Announces Third Quarter 2018 Financial Results
Reported Positive Data from Phase 2b Clinical Trial of Topical Ocular Reproxalap in Dry Eye Disease
Announced Positive Top-Line Data from Investigator-Sponsored Phase 1/2 Clinical Trial of ADX-1612 in Malignant Mesothelioma
Raised $67.6 Million, Operations Expected to be Funded Through
LEXINGTON, Mass., November 14, 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 third quarter ended
The third quarter was highlighted by positive results from our Phase 2b clinical trial of reproxalap in dry eye disease
and an investigator-sponsored Phase 1/2 clinical trial of ADX-1612 in malignant mesothelioma, commented Todd C. Brady, M.D., Ph.D. In addition, we completed a successful financing to support a
broad and diversified clinical development plan that includes Phase 3 clinical trials in dry eye disease, noninfectious anterior uveitis, allergic conjunctivitis, and Sj gren-Larsson Syndrome. We look forward to the announcement of our next
major milestone, results from the ALLEVIATE Phase 3 clinical trial in allergic conjunctivitis, in early 2019.
Recent Highlights and Corporate
Upcoming Milestones and Events
Quarter Ended September 30, 2018 Financial Review
For the quarter ended September 30, 2018, Aldeyra reported a net loss of approximately $10.8 million, compared to a net loss of approximately
$5.0 million for the quarter ended September 30, 2017. Basic and diluted net loss per share was $0.52 for the quarter ended September 30, 2018, compared to $0.32 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.
development expenses were $7.9 million for the quarter ended September 30, 2018, compared to $3.5 million for the same period in 2017. The increase of $4.4 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 $3.1 million for the quarter ended September 30, 2018, compared to $1.5 million for the quarter ended September 30, 2017. The increase of $1.6 million is primarily related to an increase in legal and
patent-related costs, consulting costs, and personnel costs.
For the quarter ended September 30, 2018, total operating expenses were approximately
$10.9 million, compared to total operating expenses of approximately $5.0 million for the same period in 2017.
Cash, cash equivalents, and
marketable securities were $35.1 million as of September 30, 2018. In October 2018, $67.6 million of net proceeds was raised in a public offering of Aldeyra s common stock.
Conference Call & Webcast Information
will hold a conference call on Wednesday, November 14, 2018, 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.
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. The company is also developing
other product candidates for autoimmune disease, post-transplant lymphoproliferative disease, retinal inflammation, 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, 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, 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 and Aldeyra s Quarterly Report on Form 10-Q for the quarter ended June 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, expected to be filed with the SEC in the fourth quarter of 2018.
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
MacDougall Biomedical Communications
ALDEYRA THERAPEUTICS, INC.
| September 30, 2018 | December 31, 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,008,652 | $ | 2,023,337 | ||||
| Cash equivalent- reverse repurchase agreements | 11,000,000 | 18,000,000 | ||||||
| Marketable securities | 17,133,925 | 22,923,462 | ||||||
| Prepaid expenses and other current assets | 1,702,533 | 1,018,967 | ||||||
| Total current assets | 36,845,110 | 43,965,766 | ||||||
| Deferred offering costs | 43,000 | 165,930 | ||||||
| Fixed assets, net | 243,483 | 43,262 | ||||||
| Total assets | $ | 37,131,593 | $ | 44,174,958 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,442,370 | $ | 1,000,963 | ||||
| Accrued expenses | 3,746,037 | 2,236,465 | ||||||
| Current portion of credit facility | 465,278 | 116,319 | ||||||
| Total current liabilities | 7,653,685 | 3,353,747 | ||||||
| Credit facility, net of current portion and debt discount | 882,841 | 1,220,192 | ||||||
| Total liabilities | 8,536,526 | 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 20,989,302 and 19,137,639 shares issued and outstanding, respectively | 20,989 | 19,138 | ||||||
| Additional paid-in capital | 156,481,258 | 139,241,635 | ||||||
| Accumulated other comprehensive income (loss) | (5,196 | ) | (17,831 | ) | ||||
| Accumulated deficit | (127,901,984 | ) | (99,641,923 | ) | ||||
| Total stockholders equity | 28,595,067 | 39,601,019 | ||||||
| Total liabilities and stockholders equity | $ | 37,131,593 | $ | 44,174,958 |
ALDEYRA THERAPEUTICS, INC.
STATEMENT OF OPERATIONS
| Three Months ended September 30, | Nine Months ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 7,880,822 | $ | 3,539,368 | $ | 21,274,032 | $ | 10,757,279 | ||||||||
| General and administrative | 3,065,912 | 1,475,904 | 7,330,142 | 4,684,574 | ||||||||||||
| Loss from operations | (10,946,734 | ) | (5,015,272 | ) | (28,604,174 | ) | (15,441,853 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 163,015 | 56,651 | 427,361 | 136,652 | ||||||||||||
| Interest expense | (28,846 | ) | (27,578 | ) | (83,248 | ) | (80,878 | ) | ||||||||
| Total other income (expense), net | 134,169 | 29,073 | 344,113 | 55,774 | ||||||||||||
| Net loss | $ | (10,812,565 | ) | $ | (4,986,199 | ) | $ | (28,260,061 | ) | $ | (15,386,079 | ) | ||||
| Net loss per share basic and diluted | $ | (0.52 | ) | $ | (0.32 | ) | $ | (1.40 | ) | $ | (1.04 | ) | ||||
| Weighted average common shares outstanding basic and diluted | 20,969,913 | 15,581,426 | 20,168,633 | 14,844,914 |