Full Press Release Details
Aldeyra Therapeutics Reports Third-Quarter 2019 Financial Results and Provides Updates on Anticipated
LEXINGTON, Mass., November 7, 2019 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 reported financial results for the quarter ended September 30, 2019. In addition, the company updated investors on
anticipated clinical milestones.
Aldeyra continued to make significant progress during the quarter in advancing our immunology platform toward the
goal of reducing the burden of disease and helping patients lead healthier lives, said Aldeyra President and CEO Todd C. Brady, M.D., Ph.D. We have reached agreement with the U.S. Food and Drug Administration (FDA) on the primary
endpoint for our pivotal INVIGORATE Phase 3 clinical trial of reproxalap in allergic conjunctivitis. In addition, this quarter we expect to complete Part 1 of our adaptive RENEW Phase 3 clinical trial of reproxalap in dry eye disease, and initiate
the first part of our adaptive GUARD Phase 3 clinical trial in proliferative vitreoretinopathy, representing the expansion of our ocular program from the front of the eye to the retina.
Clinical Milestone Updates
We expect our clinical momentum to accelerate as we move through the fourth quarter of this year and into 2020, Dr. Brady said. We
believe that reproxalap has the potential to be the next novel entrant in dry eye disease and allergic conjunctivitis, part of a spectrum of conditions estimated to affect more than four in ten Americans. Our ocular programs represent the initial
step of our mission to develop therapies for a broad category of systemic immune-mediated diseases.
Quarter Ended September 30, 2019
For the quarter ended September 30, 2019, Aldeyra reported a net loss of approximately $18.7 million, compared with a net
loss of approximately $10.8 million for the quarter ended September 30, 2018. Basic and diluted net loss per share was $0.69 for the quarter ended September 30, 2019, compared with $0.52 per share for the same period in 2018. Losses
resulted from the costs of research and development programs, as well as from general and administrative expenses.
Research and development expenses were
$16.2 million for the quarter ended September 30, 2019, compared with $7.9 million for the same period in 2018. The increase of $8.3 million is primarily related to an increase in clinical and preclinical development and
manufacturing costs; an increase in personnel costs; and non-cash compensation costs related to a portion of upfront acquisition consideration that is subject to vesting based on continued service.
General and administrative expenses were $2.8 million for the quarter ended September 30, 2019, compared with $3.1 million for the quarter
ended September 30, 2018. The decrease of $0.3 million is primarily related to lower consulting costs.
For the quarter ended September 30,
2019, total operating expenses were approximately $19.0 million, compared with total operating expenses of approximately $10.9 million for the same period in 2018.
As of September 30, 2019, cash, cash equivalents, and marketable securities were $76.2 million, which includes $15.0 million drawn from the
company s debt facility in September 2019.
Conference Call & Webcast Information
Aldeyra will host a conference call today at 8:00 a.m. ET to discuss its third-quarter financial results and provide a corporate update. The dial-in numbers are 1-866-211-4098 for domestic callers and 1-647-689-6613 for international callers. The conference ID number for the live call will be 9487086.
A live webcast of the conference call will also be available on the Investors Relations section of the Aldeyra Therapeutics website at
https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for one year.
Aldeyra Therapeutics
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 investigational drug product candidates are first-in-class potential treatments in
development for dry eye disease, allergic conjunctivitis, proliferative vitreoretinopathy, and Sj gren-Larsson Syndrome. The company is also developing other product candidates for retinal and systemic inflammatory diseases.
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 relating to current or future clinical development. 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, but
not limited to, may, might, will, objective, intend, should, could, can, would, expect, believe,
anticipate, project, on track, scheduled, 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
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 clinical 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, 2018 and Aldeyra s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2019, 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, 2019 expected to be filed in the fourth quarter of 2019.
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
131 Hartwell Avenue, Suite 320
ALDEYRA THERAPEUTICS, INC.
| September 30, | ||||||||
| 2019 | December 31, | |||||||
| (Unaudited) | 2018 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,604,203 | $ | 3,357,472 | ||||
| Cash equivalent - Reverse Repurchase Agreements | 26,000,000 | $ | 44,000,000 | |||||
| Marketable securities | 24,567,074 | 46,242,220 | ||||||
| Prepaid expenses and other current assets | 849,087 | 1,169,594 | ||||||
| Total current assets | 77,020,364 | 94,769,286 | ||||||
| Deferred offering costs | 86,644 | |||||||
| Right-of-use assets | 248,165 | |||||||
| Fixed assets, net | 172,470 | 235,225 | ||||||
| Total assets | $ | 77,440,999 | $ | 95,091,155 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 572,363 | $ | 3,051,678 | ||||
| Accrued expenses | 11,324,963 | 5,421,498 | ||||||
| Current portion of operating lease liabilities | 218,953 | |||||||
| Total current liabilities | 12,116,279 | 8,473,176 | ||||||
| Non-current liabilities: | ||||||||
| Long-term debt | 14,386,706 | |||||||
| Operating lease liabilities, net of current portion | 58,720 | |||||||
| Total liabilities | 26,561,705 | 8,473,176 | ||||||
| Stockholders equity: | ||||||||
| Common stock, voting, $0.001 par value; 150,000,000 authorized and 27,151,775 and 26,244,435 shares issued and outstanding, respectively | 27,152 | 26,244 | ||||||
| Additional paid-in capital | 237,047,752 | 225,136,127 | ||||||
| Accumulated other comprehensive income (loss) | 5,766 | (9,224 | ) | |||||
| Accumulated deficit | (186,201,376 | ) | (138,535,168 | ) | ||||
| Total stockholders equity | 50,879,294 | 86,617,979 | ||||||
| Total liabilities and stockholders equity | $ | 77,440,999 | $ | 95,091,155 |
ALDEYRA THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 16,223,972 | $ | 7,880,822 | $ | 34,737,420 | $ | 21,274,032 | ||||||||
| Acquired in-process research and development | (47,102 | ) | 6,500,602 | |||||||||||||
| General and administrative | 2,839,319 | 3,065,912 | 8,940,771 | 7,330,142 | ||||||||||||
| Loss from operations | (19,016,189 | ) | (10,946,734 | ) | (50,178,793 | ) | (28,604,174 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 330,329 | 163,015 | 1,262,378 | 427,361 | ||||||||||||
| Interest expense | (29,154 | ) | (28,846 | ) | (59,766 | ) | (83,248 | ) | ||||||||
| Total other income (expense), net | 301,175 | 134,169 | 1,202,612 | 344,113 | ||||||||||||
| Loss before income taxes | (18,715,014 | ) | (10,812,565 | ) | (48,976,181 | ) | (28,260,061 | ) | ||||||||
| Income tax benefit | 1,309,973 | |||||||||||||||
| Net loss | $ | (18,715,014 | ) | $ | (10,812,565 | ) | $ | (47,666,208 | ) | $ | (28,260,061 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.69 | ) | $ | (0.52 | ) | $ | (1.77 | ) | $ | (1.40 | ) | ||||
| Weighted average common shares outstanding - basic and diluted | 27,111,600 | 20,969,913 | 26,928,725 | 20,168,633 |