Gross Proceeds of Approximately $19.5 Million
from At-the-Market Offering Program Sufficient to Extend Operations
Through the End of 2022, Including Potential New Drug Application
(NDA) Approvals for Reproxalap in Dry Eye Disease and Allergic
Conjunctivitis, Based on Current Operating Plans
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 block sales of an aggregate of 4,580,361
shares of common stock to Perceptive Advisors, LLC and Avidity
Partners Management LP, two leading healthcare-focused investment
funds, under Aldeyra’s previously announced at-the-market offering
program. The shares were sold for a price of $4.25 per share.
Aggregate gross proceeds, before deducting commissions, were
approximately $19.5 million. The sales completed Aldeyra’s
previously disclosed at-the-market offering program and no further
sales will be made under this program. Jefferies, LLC served as
sales agent under the at-the-market offering program.
Aldeyra anticipates using the net proceeds from the sales for
the continued development of the company’s lead compound reproxalap
and other product candidates, as well as for debt maintenance,
working capital, and other general corporate purposes. Based on
current operating plans, cash, cash equivalents, and marketable
securities are sufficient to fund operations through the end of
2022, including potential NDA approvals for reproxalap, a
first-in-class topical ocular reactive aldehyde species (RASP)
inhibitor, in dry eye disease and allergic conjunctivitis, assuming
positive clinical trial results, and planned NDA submissions,
acceptances, and approvals. Use of proceeds are also expected to
include the continuation of Part 1 of the Phase 3 GUARD Trial for
proliferative vitreoretinopathy, a rare retinal disease with no
approved therapy, and Phase 2 clinical testing of ADX-629, an
orally administered RASP inhibitor, in inflammatory diseases.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the company's common stock nor
shall there be any sale of such common stock in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target
reactive aldehyde species (RASP), which are elevated in ocular and
systemic inflammatory disease, leading to elevated levels of
cytokine release via activation of a broad array of inflammatory
factors, including NF-κB, inflammasomes, and Scavenger Receptor A.
Reproxalap is being evaluated in Phase 3 clinical trials in
patients with dry eye disease and allergic conjunctivitis. The
company’s clinical pipeline also includes ADX-2191, a dihydrofolate
reductase inhibitor in Phase 3 testing for proliferative
vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2
testing for COVID-19 and ovarian cancer. For more information,
visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook,
and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements regarding the anticipated use of proceeds from
the financing that is the subject of this release; the sufficiency
of the company’s cash, cash equivalents and marketable securities;
and potential clinical outcomes from the company’s trials in dry
eye disease and allergic conjunctivitis. 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 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. As a
result of the COVID-19 pandemic, clinical site availability,
staffing, and patient recruitment have been negatively affected and
the timelines to complete our clinical trials may be delayed.
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; the current and potential future impact of the
COVID-19 pandemic on our business, results of operations and
financial position; 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;
political, economic, legal, social and health risks, including the
recent COVID-19 outbreak and subsequent public health measures,
that may affect Aldeyra’s business or the global economy; 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, 2019 and
Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March
31, 2020, 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 set forth in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
expected to be filed with the SEC in the third quarter of 2020.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200714005323/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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