- Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in
Retinitis Pigmentosa Expected in the Second Quarter of 2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in
Chronic Cough Expected in the Second Quarter of 2023
- Top-Line Results from the Phase 3 INVIGORATE-2 Trial of
Reproxalap in Allergic Conjunctivitis Expected in the Second
Quarter of 2023
- 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
- Cash and Cash Equivalents of $165.0 Million as of March 31,
2023
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 quarter ended March 31, 2023.
“Aldeyra continues to build a robust pipeline of novel drug
candidates for the treatment of immune-mediated diseases,” stated
Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer
of Aldeyra. “Multiple regulatory and clinical catalysts are planned
for the coming quarters, including PDUFA dates for ADX-2191 and
reproxalap, top-line results from our Phase 2 clinical trials in
retinitis pigmentosa and chronic cough, and top-line results from
our Phase 3 INVIGORATE-2 trial in allergic conjunctivitis.”
Recent Corporate Highlights
- Enrollment Completed in the Phase 2 Clinical Trial of
ADX‑2191 in Retinitis Pigmentosa: The open-label, single-center
Phase 2 clinical trial enrolled a total of eight retinitis
pigmentosa patients with rhodopsin gene mutations, including the
P23H gene mutation. Patients receive either monthly or
twice-monthly intravitreal doses of ADX‑2191 for three months. The
primary endpoint of the trial is safety. Secondary endpoints
include change from baseline in visual acuity; retinal function, as
assessed by foveal microperimetry, electroretinography, and dark
adaptation; and retinal morphology, as assessed by optical
coherence tomography. ADX-2191, an investigational drug candidate,
is a novel intravitreal formulation of methotrexate, which in
preclinical models of retinitis pigmentosa facilitates the
clearance of misfolded rhodopsin, a critical visual cycle protein
susceptible to genetic mutation.1 Top-line results from the Phase 2
clinical trial are expected in the second quarter of 2023.
- Enrollment Completed in the Phase 2 Clinical Trial of
ADX-629 in Chronic Cough: The multicenter, randomized,
double-blind, placebo-controlled, two-period Phase 2 crossover
trial enrolled 51 patients with refractory or unexplained chronic
cough, which is often defined as a cough that persists for more
than eight weeks. Patients were randomized to receive ADX-629 or
placebo twice daily for two weeks, followed by a two-week washout
period prior to crossing over to two weeks of treatment with
ADX-629 or placebo, whichever was not received in the first period.
The primary endpoint of the trial is safety. Secondary endpoints
include awake cough frequency, 24-hour cough frequency,
patient-reported cough severity, quality of life, and patient and
clinician global impression of change. ADX-629, an investigational
new drug candidate, is a novel, orally administered RASP (reactive
aldehyde species) modulator for the potential treatment of systemic
immune-mediated diseases. RASP were observed in a preliminary
observational study to be elevated in the bronchioalveolar lavage
fluid of patients with chronic cough,2 and may contribute to
neurosensory dysfunction as well as inflammation. Top-line results
from the Phase 2 clinical trial are expected in the second quarter
of 2023.
- First Patient Enrolled in the Phase 2 Clinical Trial of
ADX-629 in Atopic Dermatitis: The multicenter, adaptive,
two-part Phase 2 clinical trial will evaluate the safety and
efficacy of ADX‑629 alone and in combination with standard of care
in adults with mild, moderate, or severe atopic dermatitis. In Part
1, approximately 10 patients will receive open-label ADX‑629 twice
daily for three months. Outcomes will include improvement in
Investigator Global Assessment and Eczema Area and Severity Index
scores. In patients with atopic dermatitis, the pro-inflammatory
RASP malondialdehyde is elevated compared to levels observed in
healthy controls.3 Top-line results from Part 1 are expected in the
second half of 2023. Pending the results of Part 1, Part 2 will
randomize patients to receive either ADX‑629 or placebo treatment
twice daily for three months.
- Enrollment Completed in the Phase 3 INVIGORATE-2 Clinical
Trial of Reproxalap in Allergic Conjunctivitis: The randomized,
double-masked, crossover, vehicle-controlled Phase 3 clinical trial
enrolled 131 seasonal allergic conjunctivitis patients who were
evaluated for 3.5 hours in an allergen chamber designed to simulate
real-world pollen exposure. Consistent with pivotal trials of
approved allergic conjunctivitis products, the primary endpoint of
INVIGORATE-2 is patient-reported ocular itching. The protocol of
INVIGORATE-2 is substantially identical to that of the Phase 3
INVIGORATE clinical trial and a Phase 2 clinical trial,4 both of
which achieved the ocular itching endpoint (P<0.001).
Reproxalap, an investigational new drug candidate, is a
first-in-class small-molecule modulator of RASP, which are elevated
in ocular and systemic inflammatory disease. Top-line results from
the Phase 3 INVIGORATE-2 clinical trial are expected in second
quarter of 2023.
Additional Planned Clinical and Regulatory Milestones
- Results from Phase 2 Clinical Trials of ADX-629:
Top-line results from Phase 2 clinical trials of ADX‑629 in
idiopathic nephrotic syndrome (Part 1) and Sj�gren-Larsson Syndrome
are expected in the second half of 2023. Idiopathic nephrotic
syndrome is a rare inflammatory kidney disease characterized by
inflammation. Sj�gren-Larsson Syndrome is an inborn error of
metabolism characterized by mutations in an enzyme that metabolizes
RASP.
- Type C Meeting with the FDA for ADX-2191 in Proliferative
Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting
with the U.S. Food and Drug Administration in the second half of
2023 to discuss the completion of clinical development of ADX‑2191
for the prevention of proliferative vitreoretinopathy, a rare
sight-threatening disease that occurs following retinal
detachment.
- 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.
First-Quarter 2023 Financial Results
Cash and cash equivalents as of March 31, 2023 were $165.0
million. Based on its current operating plan, Aldeyra believes that
existing cash and cash equivalents 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 three months ended March 31, 2023 was $15.6
million, or $0.27 per share, compared with a net loss of $16.8
million, or $0.29 per share, for the comparable period of 2022.
Research and development expenses for the three months ended
March 31, 2023 were $11.2 million, compared with $12.2 million for
the same period in 2022. The decrease of $1.0 million was primarily
related to a decrease in external clinical development costs,
offset by an increase in personnel costs, drug product
manufacturing expenditures, external preclinical development costs,
and consulting expenditures.
General and administrative expenses for the three months ended
March 31, 2023 were $5.6 million, compared with $4.2 million for
the same period in 2022. The increase of $1.4 million was primarily
related to higher personnel costs and legal expenditures, offset by
a decrease in consulting expenditures.
Total operating expenses for the three months ended March 31,
2023 were $16.8 million, compared with total operating expenses of
$16.5 million for the same period in 2022.
Beginning with this announcement of first quarter 2023 financial
results, Aldeyra will no longer conduct quarterly conference calls
to discuss financial results. Aldeyra plans to continue hosting
conference calls, as appropriate, to report the results of certain
clinical trials and other material information concerning
regulatory and clinical developments.
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 Priority 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 expected
timing of top-line results from the Phase 2 clinical trials of
ADX-2191 in retinitis pigmentosa and ADX-629 in chronic cough; the
timing of top-line results from the Phase 3 INVIGORATE-2 Trial of
reproxalap for the treatment of allergic conjunctivitis; the
likelihood and timing of the FDA’s potential approval of the NDAs
for ADX-2191 and reproxalap by the respective PDUFA dates, or at
any other time, and the adequacy of the data included in the NDA
submissions; the timing of a Type C meeting with the FDA to discuss
the completion of clinical development of ADX 2191 for the
prevention of proliferative vitreoretinopathy; 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, 2022, 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, 2023, expected to be filed
with the SEC in the second 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.
________________ 1 Neural Regen Res. 17(1): 110-112, 2022. FASEB
J. 34(8): 10146-10167, 2020. 2 Date on file. 3 Heliyon 28;7(3):
e06621, 2021. J Clin Diagn Res. 7(12): 2683-5, 2013. 4 Clin
Ophthalmol. 16: 15-23, 2022.
ALDEYRA THERAPEUTICS,
INC.
CONSOLIDATED BALANCE SHEETS
March 31,
December 31,
2023
2022
ASSETS
(Unaudited)
Current assets: Cash and cash equivalents
$
165,028,105
$
144,419,364
Marketable securities
—
29,881,520
Prepaid expenses and other current assets
2,989,115
6,722,229
Total current assets
168,017,220
181,023,113
Right-of-use assets
189,033
249,265
Fixed assets, net
12,539
19,279
Total assets
$
168,218,792
$
181,291,657
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
429,685
$
133,625
Accrued expenses
14,433,679
14,065,885
Current portion of long-term debt
954,325
911,763
Operating lease liabilities
190,202
249,265
Total current liabilities
16,007,891
15,360,538
Long-term debt, net of current portion
14,967,688
14,923,090
Total liabilities
30,975,579
30,283,628
Stockholders' equity: Preferred stock, $0.001 par value,
15,000,000 shares authorized, none issued and outstanding
—
—
Common stock, $0.001 par value; 150,000,000 authorized and
58,791,603 and 58,560,078 shares issued and outstanding,
respectively
58,792
58,560
Additional paid-in capital
509,516,738
507,770,045
Accumulated other comprehensive loss
—
(103,938
)
Accumulated deficit
(372,332,317
)
(356,716,638
)
Total stockholders’ equity
137,243,213
151,008,029
Total liabilities and stockholders’ equity
$
168,218,792
$
181,291,657
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF
OPERATIONS (UNAUDITED)
Three Months Ended March
31,
2023
2022
Operating expenses: Research and development
$
11,235,861
$
12,234,320
General and administrative
5,567,416
4,249,387
Loss from operations
(16,803,277
)
(16,483,707
)
Other income (expense): Interest income
1,678,885
101,382
Interest expense
(491,287
)
(405,967
)
Total other income (expense), net
1,187,598
(304,585
)
Net loss
$
(15,615,679
)
$
(16,788,292
)
Net loss per share - basic and diluted
$
(0.27
)
$
(0.29
)
Weighted average common shares outstanding - basic and
diluted
58,791,603
58,297,861
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230503006049/en/
Investor & Media Contact: Scott Solomon
Sharon Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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