- New Drug Application (NDA) Submission of Reproxalap for the
Treatment of Dry Eye Disease on Schedule for the Fourth Quarter of
2022
- Pre-NDA Meeting with the U.S. Food and Drug Administration
(FDA) Scheduled for the Fourth Quarter of 2022 to Discuss NDA
Submission of ADX-2191 for the Treatment of Primary Vitreoretinal
Lymphoma
- Top-Line Results from the Phase 2 Clinical Trial of Oral RASP
Modulator ADX-629 in Acute Alcoholic Hepatitis Expected by the End
of 2022
- Type C Meeting with the FDA Planned for the First Half of 2023
to Discuss Completion of Clinical Development of ADX-2191 for the
Treatment of Proliferative Vitreoretinopathy
- Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in
Retinitis Pigmentosa Expected in the First Half of 2023
- Cash, Cash Equivalents, and Marketable Securities Exceeding
$185 Million as of September 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 September 30, 2022.
“Now with two product candidates that could generate revenue as
soon as next year, Aldeyra remains a leader in the development of
systems-based therapeutic approaches for the treatment of diseases
characterized by inflammation,” stated Todd C. Brady, M.D., Ph.D.,
President and CEO of Aldeyra.
Recent Corporate Highlights
- Pre-NDA Meeting with the FDA for Reproxalap in Dry Eye
Disease: Following the receipt of official minutes from its
pre-NDA meeting with the FDA, Aldeyra remains on schedule to submit
an NDA requesting marketing approval of the novel RASP modulator
reproxalap in the fourth quarter of 2022. With results from five
adequate and well-controlled completed clinical trials, Aldeyra
intends to submit the NDA with data for ocular dryness symptom
score, ocular redness, Schirmer test, and Schirmer test ≥10 mm
responder analysis. The NDA efficacy package is expected to include
activity ranging from within minutes of drug administration to up
to 12 weeks of treatment, crossover and parallel-group clinical
trial designs, and assessment in dry eye chamber challenge and
natural environment settings. In addition to efficacy data, Aldeyra
plans to submit up to 12 months of reproxalap safety data. Topical
ocular reproxalap has been studied in more than 2,000 patients with
no observed clinically significant safety concerns; mild and
transient instillation site irritation is the most commonly
reported adverse event in clinical trials.
- Results from the Phase 3 GUARD Trial of ADX-2191 in
Proliferative Vitreoretinopathy: ADX-2191 was statistically
superior to historical control1 for the prevention of retinal
detachment due to proliferative vitreoretinopathy over six months
(P=0.024). Although not statistically powered for secondary or
exploratory endpoints, the results of the GUARD Trial demonstrated
numerical superiority of ADX-2191 over routine surgical care in
reducing the dichotomous endpoints of retinal detachment rate over
six months, hypotony (low intraocular pressure), complete retinal
attachment by six months, macular attachment by six months, and
epiretinal membrane formation (overall P=0.047). The most common
adverse event associated with ADX-2191 treatment was punctate
keratitis, a well-known side effect of intravitreal methotrexate,
that was most commonly mild in severity. Across all other
treatment-emergent adverse events occurring in at least 10% of
patients in either treatment arm, relative to patients treated with
routine surgical care, ADX-2191-treated patients had numerically
fewer side effects, including pain, cystoid macular edema, corneal
edema, macular fibrosis, corneal epithelial defects, anterior
uveitis, ocular hypertension, and post-operative inflammation
(overall P=0.0002).
Additional Upcoming Planned Clinical and Regulatory
Milestones
- Pre-NDA Meeting with the FDA for ADX-2191 in Primary
Vitreoretinal Lymphoma: Aldeyra has scheduled a pre-NDA meeting
with the FDA in the fourth quarter of 2022 to discuss ADX-2191 for
the treatment of primary vitreoretinal lymphoma. Pending the
results of the pre-NDA meeting, NDA submission may occur as soon as
the end of 2022.
- Type C meeting with the FDA for ADX-2191 in Proliferative
Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting
with the FDA in the first half of 2023 to discuss the completion of
clinical development of ADX-2191 for the prevention of
proliferative vitreoretinopathy.
- 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: By the end 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.
Third-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of
September 30, 2022 were $185.3 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 NDA submissions and initial commercialization of
reproxalap and ADX-2191, if approved; and continued early and
late-stage development of Aldeyra’s product candidates in ocular
and systemic immune-mediated diseases.
Net loss for the three months ended September 30, 2022 was $14.6
million, or $0.25 per share, compared with a net loss of $15.8
million, or $0.27 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
September 30, 2022 were $11.5 million, compared with $12.9 million
for the same period in 2021. The decrease of $1.4 million is
primarily related to a decrease in external clinical development
costs, offset by an increase in Aldeyra's external preclinical
development costs, drug product manufacturing expenditures,
personnel costs, and consulting expenditures.
General and administrative expenses for the three months ended
September 30, 2022 were $3.2 million, compared with $2.5 million
for the same period in 2021. The increase of $0.7 million was
primarily related to higher personnel costs and consulting
expenditures.
Total operating expenses for the three months ended September
30, 2022 were $14.8 million, compared with total operating expenses
of $15.4 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 September 30, 2022. The dial-in numbers are (844)
200-6205 for domestic callers and (929) 526-1599 for international
callers. The access code is 048610. 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 Therapeutics 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. Our pre-commercial
product candidates are reproxalap, a potential treatment for dry
eye disease and allergic conjunctivitis, and ADX-2191, a potential
treatment for primary vitreoretinal lymphoma, proliferative
vitreoretinopathy, and other rare sight-threatening retinal
diseases. In addition, we are developing other product candidates,
including ADX-629 and chemically related molecules, for the
potential treatment of systemic and retinal immune-mediated
diseases. 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,”
“contemplates,” “likely,” “potential,” “continue,” “ongoing,”
“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; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates, including as a result of
the FDA not accepting Aldeyra’s regulatory filings, requiring
additional clinical trials or data prior to review or approval of
such filings; 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; 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) 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; 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;
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; 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 June 30, 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 September 30, 2022, expected to be filed with the SEC in the
fourth 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
September 30,
December 31,
2022
2021
ASSETS
(Unaudited)
Current assets: Cash and cash equivalents
$
107,150,541
$
104,790,989
Cash equivalent - reverse repurchase agreements
21,500,000
125,000,000
Marketable securities
56,678,860
—
Prepaid expenses and other current assets
4,153,721
2,961,781
Total current assets
189,483,122
232,752,770
Right-of-use assets
181,943
351,863
Fixed assets, net
26,660
32,487
Total assets
$
189,691,725
$
233,137,120
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
1,306,926
$
1,019,702
Accrued expenses
10,254,451
10,523,353
Current portion of long-term debt
12,449,058
—
Current portion of operating lease liabilities
184,599
229,607
Total current liabilities
24,195,034
11,772,662
Operating lease liabilities, long-term
—
125,232
Long-term debt, net of current portion
3,303,042
15,503,703
Total liabilities
27,498,076
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
58,560,078 and 58,081,215 shares issued and outstanding,
respectively
58,560
58,081
Additional paid-in capital
506,235,298
500,369,444
Accumulated other comprehensive loss
(285,733
)
—
Accumulated deficit
(343,814,476
)
(294,692,002
)
Total stockholders’ equity
162,193,649
205,735,523
Total liabilities and stockholders’ equity
$
189,691,725
$
233,137,120
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS
OF OPERATIONS (UNAUDITED)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Operating expenses: Research and development
$
11,539,620
$
12,894,344
$
38,344,594
$
32,095,132
General and administrative
3,244,936
2,546,807
10,638,602
8,720,161
Loss from operations
(14,784,556
)
(15,441,151
)
(48,983,196
)
(40,815,293
)
Other income (expense): Interest income
648,242
59,306
1,094,001
122,732
Interest expense
(416,917
)
(413,110
)
(1,233,279
)
(1,329,166
)
Total other income (expense), net
231,325
(353,804
)
(139,278
)
(1,206,434
)
Net loss
$
(14,553,231
)
$
(15,794,955
)
$
(49,122,474
)
$
(42,021,727
)
Net loss per share - basic and diluted
$
(0.25
)
$
(0.27
)
$
(0.84
)
$
(0.80
)
Weighted average common shares outstanding - basic and
diluted
58,457,863
58,019,099
58,352,991
52,688,846
1 Ophthalmology 124(6):757-767, 2017; Archives of Ophthalmology
25(9):1161-7, 2007.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109006044/en/
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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