- NDA Priority Review PDUFA Date for ADX-2191 for the Treatment
of Primary Vitreoretinal Lymphoma is June 21, 2023
- NDA PDUFA Date for Reproxalap for the Treatment of Dry Eye
Disease is November 23, 2023
- Top-Line Results from the Phase 3 INVIGORATE-2 Trial of
Reproxalap in Allergic Conjunctivitis Expected in the First Half of
2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in
Retinitis Pigmentosa Expected in the First Half of 2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in
Chronic Cough Expected in the First Half of 2023
- Cash, Cash Equivalents, and Marketable Securities of $174.3
Million as of December 31, 2022
- Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated diseases,
today reported recent corporate highlights and financial results
for the year ended December 31, 2022.
“Now with Priority Review Designation for the treatment of
primary vitreoretinal lymphoma, ADX‑2191 joins reproxalap as the
second investigational drug candidate at Aldeyra under NDA review
at the U.S. Food and Drug Administration,” stated Todd C. Brady,
M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “In
addition to potential approvals and supplemental NDA submissions,
2023 promises to be a catalyst-rich year for Aldeyra, as we
continue to advance an industry-leading pipeline of novel RASP
modulators for the treatment of systemic and retinal
immune-mediated diseases.”
Recent Corporate Highlights
- Priority Review Designation Granted for NDA of ADX-2191 for
the Treatment of Primary Vitreoretinal Lymphoma: The New Drug
Application (NDA) submission of ADX‑2191 (methotrexate injection,
USP), an investigational drug candidate, is supported by a
combination of published literature on the safety and efficacy of
intravitreal methotrexate for the treatment of primary
vitreoretinal lymphoma and safety data from the recently completed
Phase 3 GUARD Trial of ADX‑2191 for the prevention of proliferative
vitreoretinopathy. During the Phase 3 GUARD Trial, no safety
signals were observed, and ADX‑2191 was well tolerated; there were
no observed treatment-emergent serious adverse events. The most
common adverse event associated with ADX‑2191 treatment was
punctate keratitis, a frequently observed side effect of
intravitreal methotrexate, that was most commonly mild in severity.
The U.S. Food and Drug Administration (FDA) assigned a Prescription
Drug User Fee Act (PDUFA) date of June 21, 2023. The FDA noted that
no potential filing review issues had been identified.
- FDA Accepted for Review NDA of Reproxalap for the Treatment
of Signs and Symptoms of Dry Eye Disease: The NDA submission of
topical ocular reproxalap, a first-in-class investigational new
drug candidate, is supported by previously announced safety and
efficacy results from five adequate and well-controlled clinical
trials encompassing data for ocular dryness symptom score, ocular
redness, Schirmer test, and Schirmer test ≥10 mm responder
analysis. The NDA includes 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. The FDA
assigned a PDUFA date of November 23, 2023. The FDA noted that no
potential filing review issues had been identified, and that an
advisory committee meeting was not currently planned.
- Positive Top-Line Results Announced from the 12-Month Safety
Clinical Trial of Reproxalap in Dry Eye Disease:
Treatment-related serious adverse events in ocular safety were not
observed in any patient. Ocular safety events were similar across
reproxalap and vehicle treatment groups. Consistent with prior
experience with reproxalap and other topical ocular medications,
the most common adverse event in reproxalap-treated patients was
mild and transient instillation site irritation. In a post-hoc
analysis, reproxalap was statistically superior to vehicle in
improvement from baseline in distance visual acuity, potentially
representing the first demonstration of improvement in distance
visual acuity with a topically administered therapy.
- Positive Top-Line Results Announced from the Phase 2
Clinical Trial of ADX-629 in Acute Alcoholic Hepatitis:
ADX‑629, a first-in-class orally administered investigational RASP
modulator, demonstrated target engagement and improvement in the
signs of alcohol intoxication in a sequence-randomized,
double-masked, placebo-controlled crossover Phase 2 clinical trial.
Relative to placebo, ADX‑629 reduced dermal flushing (P=0.0007);
increased Romberg test balance time (P=0.02); and lowered levels of
total cholesterol (P=0.02), LDL (P=0.047), and the ethanol RASP
metabolite acetaldehyde (P=0.03) following acute exposure to
alcohol. Both ADX-629 and placebo were well tolerated, and no
safety concerns were noted.
- Phase 2 Clinical Trials Initiated for ADX-629 in Systemic
Immune-Mediated Diseases: Aldeyra initiated Phase 2 clinical
trials evaluating the safety and efficacy of ADX‑629 for the
treatment of atopic dermatitis, idiopathic nephrotic syndrome, and
Sj�gren-Larsson Syndrome.
Upcoming Planned Clinical and Regulatory Milestones
- Results from the Phase 3 INVIGORATE‑2 Trial of
Reproxalap in Allergic Conjunctivitis: Top-line results from
the Phase 3 clinical trial of reproxalap in patients with
allergic conjunctivitis are expected in the first half
of 2023. The Phase 3 INVIGORATE Trial in allergic
conjunctivitis, announced in April 2021, met the primary
endpoint and all secondary endpoints.
- 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, a
rare group of sight-threatening retinal diseases with no approved
therapy, are expected in the first half of 2023.
- Results from Phase 2 Clinical Trials of ADX‑629:
Top-line results from the Phase 2 clinical trial of ADX‑629 in
chronic cough are expected in the first half of 2023. Additionally,
top-line results from Phase 2 clinical trials of ADX‑629 in atopic
dermatitis (Part 1), idiopathic nephrotic syndrome (Part 1), and
Sj�gren-Larsson Syndrome are expected in the second half of
2023.
- Type C Meeting with the FDA for ADX-2191 in Proliferative
Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting
with the FDA mid-2023 to discuss the completion of clinical
development of ADX-2191 for the prevention of proliferative
vitreoretinopathy.
- Initiation of Clinical Trials of Next-Generation
RASP-Modulator Drug Candidates for Systemic Immune-Mediated
Diseases and Geographic Atrophy: Pending completion of
Investigational New Drug requirements, a Phase 1 clinical trial of
orally administered ADX‑246 for the treatment of systemic
immune-mediated diseases, and a Phase 1/2 clinical trial of
intravitreally injected ADX‑248 for the treatment of geographic
atrophy, a sight-threatening retinal disease, are expected to
initiate in the second half of 2023 or early 2024.
Full-Year 2022 Financial Results
Cash, cash equivalents, and marketable securities as of December
31, 2022 were $174.3 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 into the second half of 2024,
including the initial commercialization and launch plans for
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 year ended December 31, 2022 was $62.0 million,
or $1.06 per share, compared with a net loss of $57.8 million, or
$1.07 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 year ended December
31, 2022 were $47.3 million, compared with $44.9 million for the
same period in 2021. The increase of $2.4 million is primarily
related to an increase in our drug product manufacturing
expenditures, personnel costs, consulting expenditures, and
external preclinical development costs, partially offset by a
decrease in our external clinical development costs.
General and administrative expenses for the year ended December
31, 2022 were $15.4 million, compared with $11.3 million for the
same period in 2021. The increase of $4.1 million was primarily
related to higher consulting expenditures and personnel costs.
Total operating expenses for the year ended December 31, 2022
were $62.7 million, compared with total operating expenses of $56.2
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
year ended December 31, 2022. The dial-in numbers are (833)
470-1428 for domestic callers and (404) 975-4839 for international
callers. The access code is 202679. 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 biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
diseases. Our approach is to develop 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 product candidates
include RASP (reactive aldehyde species) modulators ADX‑629,
ADX‑246, ADX‑248, and chemically related molecules for the
potential treatment of systemic and retinal immune-mediated
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of primary vitreoretinal lymphoma (under U.S. Food and
Drug Administration New Drug Application review), proliferative
vitreoretinopathy, and other rare sight-threatening retinal
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 likelihood
and timing of the FDA’s potential approval of the NDAs for
reproxalap and ADX-2191 by the respective PDUFA dates, or at any
other time, and the adequacy of the data included in the NDA
submissions; the expectation around any potential future request by
the FDA to hold an advisory committee meeting related to the NDAs;
the anticipated timing of enrollment and results from Aldeyra’s
clinical trials; expectations regarding the results of scheduled
and planned pre-NDA meetings; the post-hoc analysis of the 12-month
safety clinical trial and the potential to demonstrate distance
visual acuity improvement in adults, expectations regarding
evidence of acuity improvements and differentiation of reproxalap,
if approved for sale, from other therapeutic options; 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, funding, 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 in clinical trials focused on the same or
different indications; 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 future revenue, the timing of
future 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 commercialization, marketing and manufacturing
capabilities and strategy; 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 September 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 Annual
Report on Form 10-K for the year ended December 31, 2022, expected
to be filed with the SEC in the first quarter of 2023.
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
December 31,
December 31,
2022
2021
ASSETS Current assets: Cash and cash equivalents
$
144,419,364
$
104,790,989
Cash equivalent - reverse repurchase agreements
—
125,000,000
Marketable securities
29,881,520
—
Prepaid expenses and other current assets
6,722,229
2,961,781
Total current assets
181,023,113
232,752,770
Right-of-use assets
249,265
351,863
Fixed assets, net
19,279
32,487
Total assets
$
181,291,657
$
233,137,120
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
133,625
$
1,019,702
Accrued expenses
14,065,885
10,523,353
Current portion of long-term debt
911,763
—
Current portion of operating lease liabilities
249,265
229,607
Total current liabilities
15,360,538
11,772,662
Operating lease liabilities, long-term
—
125,232
Long-term debt, net of current portion
14,923,090
15,503,703
Total liabilities
30,283,628
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
507,770,045
500,369,444
Accumulated other comprehensive loss
(103,938
)
—
Accumulated deficit
(356,716,638
)
(294,692,002
)
Total stockholders’ equity
151,008,029
205,735,523
Total liabilities and stockholders’ equity
$
181,291,657
$
233,137,120
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS
Years ended December
31,
2022
2021
Operating expenses: Research and development
$
47,306,066
$
44,936,532
General and administrative
15,373,921
11,283,004
Loss from operations
(62,679,987
)
(56,219,536
)
Other income (expense): Interest income
2,349,449
185,363
Interest expense
(1,694,098
)
(1,742,101
)
Total other income (expense), net
655,351
(1,556,738
)
Net loss
$
(62,024,636
)
$
(57,776,274
)
Net loss per share - basic and diluted
$
(1.06
)
$
(1.07
)
Weighted average common shares outstanding - basic and
diluted
58,405,897
54,042,103
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230308005858/en/
Investors & Media: Scott Solomon Sharon Merrill
Associates, Inc. (857) 383-2409 ALDX@investorrelations.com
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