- Results from Phase 3 TRANQUILITY-2 Trial of Reproxalap in Dry
Eye Disease Expected in Second Quarter of 2022
- Results from Part 1 of Phase 3 GUARD Trial of ADX-2191 in
Proliferative Vitreoretinopathy and Phase 2 Clinical Trial of
ADX-2191 in Retinitis Pigmentosa Expected in the Second Half of
2022
- Results from Phase 2 Clinical Trial of Oral RASP Inhibitor
ADX-629 in Ethanol Toxicity Expected in the Second Half of
2022
- Cash, Cash Equivalents, and Marketable Securities of $216.9
Million as of March 31, 2022
- Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company developing innovative therapies for the
treatment of immune-mediated diseases, today reported recent
corporate highlights and financial results for the quarter ended
March 31, 2022.
“Consistent with our planned completion this quarter of clinical
development for reproxalap in dry eye disease and the recently
announced demonstration of clinical activity of ADX-629 in three
inflammatory diseases, we are delivering on our strategy to expand
our RASP platform from the front of the eye to systemic disease,
including clinical trials in ethanol toxicity, chronic cough,
minimal change disease, and Sj�gren-Larsson Syndrome,” stated Todd
C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Additionally,
we continue to advance our intravitreal drug platform for the
treatment of rare retinal diseases, highlighted by Phase 3 clinical
trial results in proliferative vitreoretinopathy and Phase 2
clinical trial results in retinitis pigmentosa expected in the
second half of this year.”
Recent Corporate Highlights
- Completed Enrollment in the Phase 3 TRANQUILITY-2 Trial in Dry
Eye Disease. Aldeyra completed enrollment in the Phase 3
TRANQUILITY-2 Trial of 0.25% reproxalap ophthalmic solution in
patients with dry eye disease. The primary endpoints of the
TRANQUILITY-2 Trial are Schirmer test on the first day of dosing
and ocular redness on the second day of dosing during exposure to a
dry eye chamber. In a Phase 2 clinical trial and in the Phase 3
TRANQUILITY Trial announced last year, reproxalap demonstrated
statistically significant superiority over vehicle in ocular
redness and Schirmer test, respectively.
- Reported Positive Top-Line Data and Announced New
Indications for ADX-629. At its Research & Development Day
in March, Aldeyra reported positive top-line data from Phase 2
proof-of-concept trials of ADX-629, a first-in-class orally
administered RASP modulator, suggesting broad-based activity across
a number of biomarker and clinical endpoints. Accordingly, Aldeyra
announced the advancement of ADX-629 to Phase 2 clinical trials in
four new indications: ethanol toxicity, chronic cough, minimal
change disease, and Sj�gren-Larsson Syndrome.
- Initiated Phase 2 Clinical Trials of ADX-629 in Ethanol
Toxicity and Chronic Cough. Patient enrollment has begun in the
Phase 2 clinical trials of ADX-629 in ethanol toxicity and chronic
cough. Up to 10% of adults in the U.S. abuse ethanol, which when
done chronically can lead to the development of liver disease.
Chronic cough, defined as a cough that lasts eight weeks or longer
in adults, affects an estimated 13 million adults in the U.S., and
up to approximately 10% of people worldwide.
- Dry Eye Disease Clinical Data Presented at 2022 ASCRS Annual
Meeting. Edward J. Holland, M.D., Professor of Ophthalmology at
the University of Cincinnati, presented results from the run-in
cohort of the Phase 3 TRANQUILITY Trial of reproxalap in dry eye
disease at the 2022 American Society of Cataract and Refractive
Surgery (ASCRS) Annual Meeting. The TRANQUILITY run-in cohort
demonstrated statistical superiority of reproxalap over vehicle in
ocular redness during exposure to a dry eye chamber and in symptom
scores after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones
- Dry Eye Disease: Results from the Phase 3 TRANQUILITY-2
Trial of reproxalap in dry eye disease are expected in the second
quarter of 2022, followed by a planned New Drug Application (NDA)
submission to the U.S. Food and Drug Administration, pending the
outcome of TRANQUILITY-2 and enrollment in the 12-month safety
trial of reproxalap in dry eye disease patients. Aldeyra is
continuing to review data from the completed TRANQUILITY Trial to
finalize analytical plans for the TRANQUILITY-2 results.
- Allergic Conjunctivitis: Results from the Phase 3
INVIGORATE-2 allergen chamber trial of reproxalap in allergic
conjunctivitis are expected in 2023. INVIGORATE-2 is a randomized,
double-masked, crossover trial substantially similar in design to
INVIGORATE, which demonstrated statistically significant
superiority of reproxalap over vehicle for the primary endpoint of
ocular itching and the key secondary endpoint of ocular
redness.
- Retinal Disease: Results from Part 1 of the Phase 3
GUARD Trial of ADX-2191 in proliferative vitreoretinopathy, and
from the Phase 2 clinical trial of ADX-2191 in retinitis
pigmentosa, are expected in the second half of 2022.
- Systemic Disease: Results from the Phase 2 clinical
trial of ADX-629 in ethanol toxicity are expected in the second
half of 2022, and results from the Phase 2 clinical trials of
ADX-629 in chronic cough, minimal change disease, and
Sj�gren-Larsson Syndrome are expected in 2023.
First-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of March
31, 2022 were $216.9 million. Based on its current operating plan,
Aldeyra believes that existing cash, cash equivalents, and
marketable securities will be sufficient to fund currently
projected operating expenses through the end of 2023, including
potential NDA submissions; initial commercialization of reproxalap,
if approved; and continued development of Aldeyra’s product
candidates in ocular and systemic immune-mediated diseases.
Net loss for the three months ended March 31, 2022 was $16.8
million, or $0.29 per share, compared with a net loss of $11.3
million, or $0.25 per share, for the comparable period of 2021.
Losses have resulted from the costs of clinical trials and research
and development programs, as well as from general and
administrative expenses.
Research and development expenses for the three months ended
March 31, 2022 were $12.2 million, compared with $7.7 million for
the same period in 2021. The increase of $4.5 million is primarily
related to increases in clinical research and development
expenditures.
General and administrative expenses for the three months ended
March 31, 2022 were $4.2 million, compared with $3.1 million for
the same period in 2021. The increase of $1.1 million is primarily
due to increases in consulting expenditures.
Total operating expenses for the three months ended March 31,
2022 were $16.5 million, compared with total operating expenses of
$10.8 million for the same period in 2021.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to
discuss recent corporate highlights and financial results for the
quarter ended March 31, 2022. The dial-in numbers are (844)
200-6205 for domestic callers and (929) 526-1599 for international
callers. The access code is 742862. Please dial in at least
10 minutes prior to the start time.
A live webcast of the conference call can be accessed via the
Investors & Media page of Aldeyra’s website at
https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the website for 90 days.
About Aldeyra
Aldeyra develops innovative therapies designed to treat
immune-mediated diseases. Our approach is to discover
pharmaceuticals that modulate immunological systems, instead of
directly inhibiting or activating single protein targets, with the
goal of optimizing multiple pathways at once while minimizing
toxicity. Two of our lead product candidates, reproxalap and
ADX-629, target pre-cytokine, systems-based mediators of
inflammation known as RASP (reactive aldehyde species). Reproxalap
is in Phase 3 clinical trials in patients with dry eye disease and
allergic conjunctivitis. ADX-629, an orally administered RASP
modulator, is in Phase 2 clinical testing for the treatment of
systemic immune-mediated diseases. Our pipeline also includes
ADX-2191 (intravitreal methotrexate 0.8%), in development for the
prevention of proliferative vitreoretinopathy and the treatment of
retinitis pigmentosa and primary vitreoretinal lymphoma. 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, but not limited to, statements regarding submission of
potential New Drug Applications; the anticipated timing of results
from Aldeyra’s clinical trials; and Aldeyra’s projected cash
runway. 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. 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 in clinical
trials focused on the same or on different indications; the risk
that the results from earlier clinical trials, portions of clinical
trials, or pooled clinical data may not accurately predict results
of subsequent trials or the remainder of a clinical trial; 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) and
obtain reimbursement for 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 COVID-19
pandemic and subsequent public health measures, and war or other
military actions, 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, 2021, which is on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at
https://www.sec.gov/. Additional factors may be described in those
sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2022, expected to be filed with the SEC in the
second quarter of 2022.
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
March 31,
December 31,
2022
2021
ASSETS (Unaudited) Current assets: Cash and cash
equivalents
$
93,909,328
$
104,790,989
Cash equivalent - reverse repurchase agreements
65,000,000
125,000,000
Marketable securities
57,957,020
—
Prepaid expenses and other current assets
5,488,707
2,961,781
Total current assets
222,355,055
232,752,770
Right-of-use assets
296,504
351,863
Fixed assets, net
41,422
32,487
Total assets
$
222,692,981
$
233,137,120
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
2,442,830
$
1,019,702
Accrued expenses
13,675,555
10,523,353
Current portion of long-term debt
—
—
Current portion of operating lease liabilities
236,048
229,607
Total current liabilities
16,354,433
11,772,662
Operating lease liabilities, long-term
63,325
125,232
Long-term debt, net of current portion
15,586,501
15,503,703
Total liabilities
32,004,259
27,401,597
Stockholders' equity: Common stock, voting, $0.001 par
value; 150,000,000 authorized and 58,301,491 and 58,081,215 shares
issued and outstanding, respectively
58,301
58,081
Additional paid-in capital
502,172,392
500,369,444
Accumulated other comprehensive loss
(61,677
)
—
Accumulated deficit
(311,480,294
)
(294,692,002
)
Total stockholders’ equity
190,688,722
205,735,523
Total liabilities and stockholders’ equity
$
222,692,981
$
233,137,120
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED)
Three Months Ended March
31,
2022
2021
Operating expenses: Research and development
$
12,234,320
$
7,726,342
General and administrative
4,249,387
3,104,702
Loss from operations
(16,483,707
)
(10,831,044
)
Other income (expense): Interest income
101,382
23,762
Interest expense
(405,967
)
(482,580
)
Total other income (expense), net
(304,585
)
(458,818
)
Net loss
$
(16,788,292
)
$
(11,289,862
)
Net loss per share - basic and diluted
$
(0.29
)
$
(0.25
)
Weighted average common shares outstanding - basic and
diluted
58,297,861
45,630,910
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504006323/en/
Corporate Joshua Reed Aldeyra Therapeutics, Inc.
781-761-4904 ext. 218 jreed@aldeyra.com
Investors & Media Scott Solomon Sharon Merrill
Associates, Inc. 857-383-2409 ALDX@investorrelations.com
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