Results of Operations and Financial Condition.
On November 7, 2019, Aldeyra Therapeutics, Inc. (Aldeyra) issued a press release and is holding a conference call regarding its financial
results for the quarter ended September 30, 2019. The press release also included a corporate update. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
by reference herein.
Various statements to be made during the conference call are forward-looking statements under the securities laws,
including, but not limited to, statements regarding Aldeyras plans and expectations for its product candidates. 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 early stage of development and may not ever have any products that generate significant revenue. All of Aldeyras 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 Aldeyras forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyras 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 Aldeyras continuing review and quality control analysis of clinical data; Aldeyras ability to design clinical trials with protocols and
endpoints acceptable to applicable regulatory authorities; the delay in or failure to obtain regulatory approval of Aldeyras product candidates; Aldeyras ability to maintain regulatory approval of Aldeyras 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 our product candidates; the scope, progress, expansion, and costs of developing and commercializing Aldeyras product candidates; uncertainty as to Aldeyras ability to commercialize (alone or with others)
Aldeyras product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyras product candidates and the ability to serve those markets; Aldeyras expectations regarding
Aldeyras expenses and revenue, the sufficiency or use of Aldeyras cash resources and needs for additional financing; the rate and degree of market acceptance of any of Aldeyras product candidates; Aldeyras expectations
regarding competition; Aldeyras anticipated growth strategies; Aldeyras ability to attract or retain key personnel; Aldeyras limited sales and marketing infrastructure; Aldeyras ability to establish and maintain development
partnerships; Aldeyras ability to successfully integrate acquisitions into its business; Aldeyras expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign
countries; Aldeyras ability to obtain and maintain intellectual property protection for Aldeyras product candidates; the anticipated trends and challenges in Aldeyras business and the market in which it operates; and other factors
that are described in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Aldeyras Annual Report on Form
10-K for the year ended December 31, 2018 and Aldeyras 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 SECs website at www.sec.gov. Additional factors may be described in those sections of Aldeyras Quarterly Report on Form 10-Q for the
quarter ended September 30, 2019, expected to be filed with the SEC in the fourth quarter of 2019.
In addition to the risks described above and in
Aldeyras other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyras results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The
information conveyed on the conference call is provided only as of the date of the call, and Aldeyra undertakes no obligation to update any forward-looking statements presented on the call on account of new information, future events, or otherwise,
except as required by law.
The information in Item 2.02 of this Current Report on Form 8-K and the Exhibit
attached hereto shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended (the Securities Act), or the Exchange Act, except as expressly set forth by specific reference in such a filing.