Aldeyra Therapeutics Announces Year End 2017 Financial Results

Aldeyra Therapeutics Announces Year End 2017 Financial Results

LEXINGTON, Mass., Mar. 29, 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 inflammatory diseases, today announced financial results for the year ended December 31, 2017.

2017 was a productive year for Aldeyra, highlighted by favorable clinical results in dry eye disease and allergic conjunctivitis, initiation of a Phase

3 clinical trial in noninfectious anterior uveitis, and receipt of orphan drug designation for reproxalap in Sj gren-Larsson Syndrome, commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. Our progress has continued in

2018, having recently enrolled the first patient into our Phase 2b dry eye disease clinical trial, and with the signing of our development partnership with Janssen Research & Development, a Johnson & Johnson company. We look

forward to sharing important milestones across multiple pipeline programs in 2018.

Key 2017 Highlights and Upcoming Events

In April 2017, Aldeyra initiated a Phase 3 clinical trial of topical ocular reproxalap in patients with NAU. Results of

the trial are expected to be announced in 2019.

Year Ended December 31, 2017 Financial Review

For the year ended December 31, 2017, Aldeyra reported a net loss of approximately $22.3 million, compared to a net loss of approximately

$18.7 million for the year ended December 31, 2016. Basic and diluted net loss per share was $1.40 for the year ended December 31, 2017, compared to $1.65 per share for the same period in 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 $16.3 million for the year ended December 31, 2017, compared to $13.2 million for the same period in 2016. The increase of $3.1 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

$6.2 million for the year ended December 31, 2017, compared to $5.5 million for the year ended 2016. The increase of $0.7 million is primarily related to an increase in legal costs, rent, consulting costs, and personnel costs.

In 2017, total operating expenses were approximately $22.5 million for the year, compared to total operating expenses of approximately

$18.7 million in 2016.

Cash, cash equivalents, and marketable securities were $42.9 million as of December 31, 2017, including

$26.9 million in net proceeds from the underwritten public offering of common stock that closed on September 21, 2017.

Call & Webcast Information

Aldeyra will hold a conference call on Thursday, March 29, 2018, at 8:00 a.m. eastern 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 year.

About Aldeyra Therapeutics

Therapeutics is developing next-generation medicines to improve the lives of patients with inflammatory 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.

About Noninfectious Anterior Uveitis

Noninfectious anterior uveitis 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. Topical corticosteroid therapy is the only approved therapy for the resolution of inflammation associated with noninfectious anterior

uveitis, but can lead to serious ocular complications, including glaucoma, infections, and cataracts.

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

ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. No therapy for SLS 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 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended

September 30, 2017, 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, 2017, expected to be filed with the SEC in the first 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. 205

MacDougall Biomedical Communications

ALDEYRA THERAPEUTICS, INC.

ALDEYRA THERAPEUTICS, INC.

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