− Initiation of Phase 3 Objective Sign Trial in Dry Eye Disease
Planned for the Fourth Quarter 2020
− Phase 2 Clinical Trials of ADX-629 in COVID-19, Atopic Asthma,
and Psoriasis Expected to Initiate in the Fourth Quarter of
2020
− Top-line Results from the Phase 3 INVIGORATE Clinical Trial in
Allergic Conjunctivitis Expected in the First Half of 2021
− Cash, Cash Equivalents, and Marketable Securities of $86.2
Million as of September 30, 2020, Expected to Support Operations
Through 2022
− Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), 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, today announced financial results
for the third quarter of 2020 and provided a corporate update.
“Our novel RASP inhibitor reproxalap continues to progress
toward New Drug Application (NDA) submissions for dry eye disease
and allergic conjunctivitis, two of the largest markets in
ophthalmology,” stated Todd C. Brady, M.D., Ph.D., President and
CEO of Aldeyra. “Among a number of key clinical milestones planned
for the fourth quarter of 2020, we expect to initiate a pivotal
Phase 3 objective sign clinical trial of reproxalap for the
treatment of dry eye disease, and Phase 2 clinical trials of
ADX-629 in COVID-19, atopic asthma, and psoriasis.”
“We concluded the third quarter in a strong financial position,
with cash, cash equivalents, and marketable securities of $86.2
million as of September 30,” Dr. Brady continued. “Based on our
current operating plans, we expect to have sufficient capital to
fund operations through 2022, including NDA submissions for
reproxalap in dry eye disease and allergic conjunctivitis, assuming
positive clinical trial results and regulatory review.”
Recent Highlights
- American Academy of Ophthalmology 2020: Aldeyra
announced the presentation of new clinical utility data from the
Phase 2 allergen chamber clinical trial of reproxalap in allergic
conjunctivitis. The data will be presented in a poster at the
American Academy of Ophthalmology 2020 Virtual Annual Meeting from
November 11 through November 15, 2020.
- Phase 2 Clinical Trial Data Published in Journal of Ocular
Pharmacology and Therapeutics: The peer-reviewed Journal of
Ocular Pharmacology and Therapeutics published the positive results
of a randomized, corticosteroid-controlled Phase 2 clinical trial
of reproxalap in patients with noninfectious anterior uveitis, a
sight-threatening ocular inflammatory condition typically treated
with topical corticosteroids.
- Regulatory Clearance for Phase 2 Clinical Trial in
COVID-19: In September 2020, Aldeyra announced receipt of a
Study May Proceed letter from the U.S. Food and Drug Administration
to begin a Phase 2 clinical trial evaluating ADX-629, a novel
orally available RASP inhibitor, for the treatment of adult
patients hospitalized for COVID-19.
Clinical-Stage Pipeline Updates
- Reproxalap – A Novel Topical Ocular RASP Inhibitor for the
Treatment of Dry Eye Disease and Allergic Conjunctivitis:
Aldeyra plans to initiate a Phase 3 clinical trial in the fourth
quarter of 2020 to assess the activity of reproxalap in objective
signs of dry eye disease, including tear RASP levels, after single
and multiple doses of drug. The trial initiation timing is subject
to the finalization of trial design, assay development, and
potential disruptions due to the COVID-19 pandemic. Enrollment is
ongoing in the Phase 3 INVIGORATE Trial of reproxalap for the
treatment of patients with allergic conjunctivitis. INVIGORATE is a
randomized, double-masked, crossover, vehicle-controlled clinical
trial to assess the efficacy and safety of reproxalap compared to
vehicle using an allergen chamber. Consistent with prior allergic
conjunctivitis trials, the primary endpoint will be
subject-reported ocular itching score, as agreed with FDA. Aldeyra
expects top-line results in the first half of 2021. NDA submission
in dry eye disease and allergic conjunctivitis is expected by the
end of 2021, assuming positive clinical trial results and
regulatory review.
- ADX-629 – A Novel Orally Available RASP
Inhibitor for the Treatment of Systemic Inflammatory Diseases:
Phase 2 clinical testing of ADX-629 for the treatment of COVID-19,
atopic asthma, and psoriasis is expected to begin by the end of
this year.
- ADX-2191 – 0.8% Methotrexate Intravitreal Injection for Rare
Proliferative Ocular Diseases: Completion of enrollment in Part
1 of the Phase 3 GUARD Trial of ADX-2191 for the prevention of
proliferative vitreoretinopathy (PVR), a rare but serious
sight-threatening retinal disease with no approved treatment, is
expected in 2021.
Financial Results for the Quarter Ended September 30,
2020
For the quarter ended September 30, 2020, Aldeyra reported a net
loss of $8.9 million, compared with a net loss of $18.7 million for
the quarter ended September 30, 2019. Net loss per share was $0.23
for the quarter ended September 30, 2020, compared with $0.69 for
the same period in 2019. 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 $6.1 million for the
quarter ended September 30, 2020, compared with $16.2 million for
the same period in 2019. The decrease of $10.1 million is primarily
related to decreases in clinical research and development
expenditures and lower personnel related costs, partially offset by
increases in manufacturing and preclinical development costs.
General and administrative expenses were $2.3 million for the
quarter ended September 30, 2020, compared with $2.8 million for
the same period in 2019. The decrease of $0.5 million is due to
decreases in personnel related costs and other miscellaneous
administrative costs.
For the quarter ended September 30, 2020, total operating
expenses were $8.4 million, compared with total operating expenses
of $19.0 million for the same period in 2019.
As of September 30, 2020, cash, cash equivalents, and marketable
securities were $86.2 million. Based on current operating plans,
Aldeyra’s cash, cash equivalents, and marketable securities as of
September 30, 2020 are expected to be sufficient to fund operations
through the end of 2022, including potential NDA submissions for
reproxalap in dry eye disease and allergic conjunctivitis, assuming
positive clinical trial results and regulatory review. Use of
Aldeyra’s cash, cash equivalents, and marketable securities is also
expected to include the continuation of Part 1 of the Phase 3 GUARD
Trial in PVR and Phase 2 clinical testing of ADX-629.
Conference Call & Webcast Information
Aldeyra will host a conference call today at 8:00 a.m. ET to
discuss its third-quarter 2020 financial results. The dial-in
numbers are (866) 211-4098 for domestic callers and (647) 689-6613
for international callers. The Conference ID number is 5472726. Due
to the expected high demand on our conference provider, please plan
to dial in to the call at least 15 minutes prior to the start
time.
A live webcast of the conference call will also be available on
the investor relations page of the company’s corporate website at
https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the Aldeyra Therapeutics website for 90
days.
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 and result in 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 development 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 Aldeyra's strategy, future
operations, expected cash runway, prospects, plans, and objectives
and Aldeyra's plans and expectations for its product candidates,
including reproxalap, ADX-629, ADX-2191, and ADX-1612. 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 Aldeyra’s
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 Aldeyra's 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 June
30, 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 September 30,
2020, expected to be filed with the SEC in the fourth 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.
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED BALANCE
SHEETS
September 30,
December 31,
2020
2019
ASSETS
(Unaudited)
Current assets: Cash and cash equivalents
$
71,175,507
$
16,425,830
Cash equivalent - reverse repurchase agreements
15,000,000
28,000,000
Marketable securities
—
28,938,545
Prepaid expenses and other current assets
2,017,273
1,804,450
Total current assets
88,192,780
75,168,825
Right-of-use assets
52,195
201,007
Fixed assets, net
79,455
148,449
Total assets
$
88,324,430
$
75,518,281
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
123,900
$
808,302
Accrued expenses
4,018,635
11,873,122
Current portion of credit facility
2,259,417
—
Current portion of operating lease liabilities
58,720
226,328
Total current liabilities
6,460,672
12,907,752
Long-term debt
12,693,311
14,528,212
Total liabilities
19,153,983
27,435,964
Commitments and contingencies Stockholders' equity: Common
stock, voting, $0.001 par value; 150,000,000 authorizedand
38,631,709 and 28,656,832 shares issued and outstanding,
respectively
38,632
28,657
Additional paid-in capital
294,755,363
247,409,793
Accumulated other comprehensive income
—
5,866
Accumulated deficit
(225,623,548
)
(199,361,999
)
Total stockholders’ equity
69,170,447
48,082,317
Total liabilities and stockholders’ equity
$
88,324,430
$
75,518,281
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS
OF OPERATIONS (UNAUDITED)
Three Months Ended September
30,
Nine Months Ended September
30,
2020
2019
2020
2019
Operating expenses: Research and development
$
6,133,580
$
16,223,972
$
17,653,058
$
34,737,420
Acquired in-process research and development
—
(47,102
)
—
6,500,602
General and administrative
2,255,617
2,839,319
7,480,461
8,940,771
Loss from operations
(8,389,197
)
(19,016,189
)
(25,133,519
)
(50,178,793
)
Other income (expense): Interest income
5,215
330,329
287,025
1,262,378
Interest expense
(489,191
)
(29,154
)
(1,415,055
)
(59,766
)
Total other income (expense), net
(483,976
)
301,175
(1,128,030
)
1,202,612
Loss before income taxes
(8,873,173
)
(18,715,014
)
(26,261,549
)
(48,976,181
)
Income tax benefit
—
—
—
1,309,973
Net loss
$
(8,873,173
)
$
(18,715,014
)
$
(26,261,549
)
$
(47,666,208
)
Net loss per share - basic and diluted
$
(0.23
)
$
(0.69
)
$
(0.81
)
$
(1.77
)
Weighted average common shares outstanding - basic and
diluted
37,796,946
27,111,600
32,395,217
26,928,725
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201105005234/en/
Corporate: David McMullin Aldeyra Therapeutics, Inc. Tel:
781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media: Scott Solomon Sharon Merrill
Associates, Inc. Tel: 617-542-5300 ALDX@investorrelations.com
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