- Pre-NDA (New Drug Application) Meeting with the U.S. Food and
Drug Administration (FDA) Scheduled for the Third Quarter of 2022
to Discuss NDA Submission of Reproxalap for the Treatment of Dry
Eye Disease
- Pre-NDA Meeting with the FDA Planned for the Second Half of
2022 to Discuss NDA Submission of ADX-2191 for the Treatment of
Primary Vitreoretinal Lymphoma
- Top-line Results from Phase 3 GUARD Trial of ADX-2191 in
Proliferative Vitreoretinopathy Expected in the Second Half of
2022
- Top-line Results from Phase 2 Clinical Trial of Oral RASP
Modulator ADX-629 in Acute Alcoholic Hepatitis Expected in the
Second Half of 2022
- Cash, Cash Equivalents, and Marketable Securities of $196.7
Million as of June 30, 2022
- Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
clinical-stage biotechnology company developing innovative
therapies designed to treat immune-mediated diseases, today
reported recent corporate highlights and financial results for the
quarter ended June 30, 2022.
“The second half of 2022 is highlighted by planned new drug
applications in dry eye disease and primary vitreoretinal lymphoma,
two diseases that are currently sub-optimally treated,” stated Todd
C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “In addition,
we look forward to announcing the results of the Phase 3 GUARD
trial of ADX-2191 in proliferative vitreoretinopathy later this
year, as well as the Phase 2 results of the oral RASP modulator
ADX-629 in a challenge model of acute alcoholic hepatitis.”
Recent Corporate Highlights
- Positive Results from the Dry Eye Disease Chamber Crossover
Clinical Trial: Reproxalap was statistically superior to
vehicle for each of the two prespecified primary endpoints, ocular
redness in a dry eye chamber (P=0.0004) and Schirmer test
(P=0.0005), a measure of tear production, after a single day of
dosing. The secondary endpoint of Schirmer test ≥10 mm responder
analysis, which was multiplicity-controlled and has been reported
to correlate with symptomatic improvement in dry eye disease,1 was
also achieved (P=0.0361). Rapid and statistically significant
reductions in patient-reported ocular discomfort and dryness were
observed in the dry eye disease chamber.
- Positive Results from the Phase 3 TRANQUILITY-2 Trial in Dry
Eye Disease: Reproxalap was statistically superior to vehicle
for each of the two prespecified primary endpoints, Schirmer test
(P=0.0001) and Schirmer test ≥10 mm responder analysis
(P<0.0001) after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones
- NDA Submission of Reproxalap in Dry Eye Disease: Pending
discussions with the FDA and enrollment in the 12-month safety
trial of reproxalap in patients with dry eye disease, Aldeyra
intends to submit an NDA with data on ocular dryness symptom score,
ocular redness, Schirmer test, and Schirmer test ≥10 mm responder
analysis, encompassing results across five adequate and
well-controlled completed clinical trials. A pre-NDA meeting with
the FDA to discuss the regulatory package has been scheduled for
the third quarter of 2022.
- Pre-NDA Meeting for ADX-2191 in Primary Vitreoretinal
Lymphoma: Aldeyra plans to conduct a pre-NDA meeting with the
FDA in the second half of 2022 to discuss ADX-2191 for the
treatment of primary vitreoretinal lymphoma. Pending discussion
with the FDA, an NDA submission is planned for the second half of
2022.
- Results from the Phase 3 GUARD Trial of ADX-2191 in
Proliferative Vitreoretinopathy: Top-line results from Part 1
of the Phase 3 GUARD trial of ADX-2191 in patients with
proliferative vitreoretinopathy are expected in the second half of
2022.
- Results from the Phase 2 Clinical Trial of ADX-2191 in
Retinitis Pigmentosa: Top-line results from the Phase 2
clinical trial of ADX-2191 in patients with retinitis pigmentosa
are expected in the first half of 2023.
- Results from Phase 2 Clinical Trials of ADX-629 in Systemic
Immune-Mediated Diseases: In the second half of this year,
Aldeyra expects to report top-line results from a Phase 2 clinical
trial in acute alcoholic hepatitis, and to initiate Phase 2
clinical trials in Sj�gren-Larsson Syndrome and minimal change
disease. Top-line results from the ongoing Phase 2 clinical trial
of ADX-629 in chronic cough are anticipated in the first half of
2023.
Second-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of June 30,
2022 were $196.7 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
planned NDA submissions and initial commercialization of reproxalap
and ADX-2191, if approved, and continued development of Aldeyra’s
product candidates in ocular and systemic immune-mediated
diseases.
Net loss for the three months ended June 30, 2022 was $17.8
million, or $0.30 per share, compared with a net loss of $14.9
million, or $0.28 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
June 30, 2022 were $14.6 million, compared with $11.5 million for
the same period in 2021. The increase of $3.1 million is primarily
related to increases in external clinical and preclinical
development costs, and drug product manufacturing expenditures.
General and administrative expenses for the three months ended
June 30, 2022 were $3.1 million, compared with $3.1 million for the
same period in 2021.
Total operating expenses for the three months ended June 30,
2022 were $17.7 million, compared with total operating expenses of
$14.5 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 June 30, 2022. The dial-in numbers are (844) 200‑6205
for domestic callers and (929) 526‑1599 for international callers.
The access code is 908644. 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 the Aldeyra website at
https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the website for 90 days.
About Aldeyra
Aldeyra is a clinical-stage biotechnology company developing
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 late-stage 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 the timing of
planned NDA submissions; the anticipated timing of enrollment and
results from Aldeyra’s clinical trials; expectations regarding the
results of scheduled and planned pre-NDA meetings, including the
FDA’s acceptance of Aldeyra’s post-hoc review of data, the FDA’s
agreement with Aldeyra’s methods of analyzing data and the FDA’s
agreement that data from the crossover clinical trial can be used
to support the safety or efficacy of reproxalap; 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, enrollment 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 or post-hoc review and
quality control analysis of clinical data, Aldeyra's ability to
design clinical trials with protocols, data analysis methodologies,
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, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2022, which are 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 set forth in those sections of Aldeyra's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2022, expected to be filed
with the SEC in the third 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.
1 Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL.
Reliability and validity of the Ocular Surface Disease Index. Arch
Ophthalmol. 2000;118(5):615-21.
ALDEYRA THERAPEUTICS,
INC.
CONSOLIDATED BALANCE
SHEETS
June 30,
December 31,
2022
2021
ASSETS
(Unaudited)
Current assets: Cash and cash equivalents
$
42,012,015
$
104,790,989
Cash equivalent - reverse repurchase agreements
79,000,000
125,000,000
Marketable securities
75,677,040
—
Prepaid expenses and other current assets
4,052,355
2,961,781
Total current assets
200,741,410
232,752,770
Right-of-use assets
239,873
351,863
Fixed assets, net
34,041
32,487
Total assets
$
201,015,324
$
233,137,120
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
264,225
$
1,019,702
Accrued expenses
10,810,155
10,523,353
Current portion of long-term debt
4,925,765
—
Current portion of operating lease liabilities
242,636
229,607
Total current liabilities
16,242,781
11,772,662
Operating lease liabilities, long-term
—
125,232
Long-term debt, net of current portion
10,743,535
15,503,703
Total liabilities
26,986,316
27,401,597
Stockholders' equity: Preferred stock, $0.001 par value,
15,000,000 shares authorized, none issued and outstanding
—
—
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
503,517,715
500,369,444
Accumulated other comprehensive loss
(285,763
)
—
Accumulated deficit
(329,261,245
)
(294,692,002
)
Total stockholders’ equity
174,029,008
205,735,523
Total liabilities and stockholders’ equity
$
201,015,324
$
233,137,120
ALDEYRA THERAPEUTICS,
INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS
(UNAUDITED)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Operating expenses: Research and development
$
14,570,654
$
11,474,446
$
26,804,975
$
19,200,788
General and administrative
3,144,280
3,068,652
7,393,667
6,173,355
Loss from operations
(17,714,934
)
(14,543,098
)
(34,198,642
)
(25,374,143
)
Other income (expense): Interest income
344,378
39,665
445,760
63,427
Interest expense
(410,395
)
(433,477
)
(816,361
)
(916,056
)
Total other income (expense), net
(66,017
)
(393,812
)
(370,601
)
(852,629
)
Net loss
$
(17,780,951
)
$
(14,936,910
)
$
(34,569,243
)
$
(26,226,772
)
Net loss per share - basic and diluted
$
(0.30
)
$
(0.28
)
$
(0.59
)
$
(0.52
)
Weighted average common shares outstanding - basic and
diluted
58,301,491
54,280,393
58,299,686
49,979,545
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220804005996/en/
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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