- ADX-629 Expected to Begin Phase 2 Clinical Trials in COVID-19
Respiratory Compromise, Atopic Asthma, and Psoriasis in 2020
- Type C Meeting Scheduled with FDA to Discuss Remaining NDA
Requirements for Reproxalap in Dry Eye Disease
- Results from Phase 3 INVIGORATE Trial of Reproxalap in Allergic
Conjunctivitis Expected in First Half of 2021
- Cash Runway Extended into 2022
- Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
clinical-stage biotechnology company focused on the development of
novel therapies with the potential to improve the lives of patients
with immune-mediated diseases, today reported financial results for
the first quarter ended March 31, 2020, announced new clinical
trials in systemic inflammatory diseases, and provided an update on
ocular disease programs.
“Based on the success of the novel RASP inhibitor ADX-629 in
Phase 1 clinical testing, we are pleased to announce a new
comprehensive clinical initiative in systemic inflammatory
diseases, complementing our late-stage pipeline in ocular disease,”
said Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.
“Although the COVID-19 pandemic has affected clinical trial
enrollment timelines, our cash position remains strong, and we are
extending our projected cash runway guidance into 2022.”
New Clinical Programs in Systemic Inflammatory
Diseases
Aldeyra plans to assess the activity of ADX-629 in three types
of severe inflammation: cytokine release syndrome, autoimmune
disease, and allergy. In preclinical models, ADX-629 treatment
reduced levels of TH1, TH2, and TH17-related cytokines, suggesting
potential activity across a broad array of inflammatory diseases.
The timing of clinical trial initiation depends, in part, on
restrictions related to COVID-19, the availability of clinical
research facilities and staffing, and the ability to recruit
patients.
- COVID-19 Respiratory Compromise: A Phase 2 clinical
trial of ADX-629 is expected in subjects with COVID-19-associated
respiratory compromise, defined as hypoxia and pulmonary
radiographic involvement, immediately following admission to the
hospital. Severe inflammation, characterized in part by cytokine
release syndrome, leads to acute respiratory distress syndrome and
other conditions that require mechanical ventilation. The clinical
trial, contingent on FDA review of information submitted via the
Coronavirus Treatment Acceleration Program (CTAP), is expected to
begin in the third quarter of 2020.
- Autoimmune Disease: A Phase 2a clinical trial of ADX-629
in patients with psoriasis, an autoimmune condition associated with
TH1 cytokines, is expected to begin in the second half of
2020.
- Allergy: A Phase 2a allergen-challenge clinical trial of
ADX-629 in patients with atopic asthma, an allergic inflammatory
disease associated with TH2 cytokines, is expected to begin in the
second half of 2020.
Late-Stage Ocular Disease Programs
Reproxalap, a first-in-class RASP inhibitor for topical ocular
administration, continues to advance towards a new drug application
(NDA) filing in allergic conjunctivitis and dry eye disease. The
Phase 3 GUARD Trial of ADX-2191, a novel formulation of
methotrexate for intravitreal administration, in patients with
proliferative vitreoretinopathy currently remains active, although
enrollment has been significantly delayed due to the COVID-19
pandemic.
- Dry Eye Disease: A Type C meeting with the U.S. Food and
Drug Administration (FDA) is scheduled for mid-2020 to discuss
remaining NDA requirements for reproxalap in dry eye disease.
Reproxalap has demonstrated clinically relevant improvement from
baseline in two well-controlled clinical trials: Part 1 of the
Phase 3 RENEW Trial announced late last year and a Phase 2
formulation trial announced earlier this year. Dry eye disease
remains poorly served by available therapies, and represents one of
the largest markets in ophthalmology, affecting an estimated 34
million patients in the United States. Aldeyra plans to provide an
update on dry eye disease clinical development plans following
receipt and review of FDA feedback.
- Allergic Conjunctivitis: Based on delays primarily
associated with an extended allergy season, results from the Phase
3 INVIGORATE Trial of reproxalap are currently expected in the
first half of 2021. Based on the successful Phase 3 ALLEVIATE Trial
announced in 2019, and assuming continued clinical success and
positive regulatory review, reproxalap has the potential to be the
first new mechanistic approach in decades for the treatment of
allergic conjunctivitis. The current therapeutic landscape of
allergic conjunctivitis is generally limited to antihistamines,
which do not lead to satisfactory activity in up to one-third of
patients, and corticosteroids, which cannot be used chronically due
to potentially serious adverse events. Allergic conjunctivitis is
one of most common ocular surface diseases, affecting an estimated
66 million patients in the United States, and is often associated
with dry eye disease.
- Proliferative Vitreoretinopathy (PVR): Patient
enrollment in Part 1 of the adaptive the Phase 3 GUARD Trial of
ADX-2191 for the prevention of PVR has been significantly delayed
due to lack of clinical site availability and staffing resulting
from the COVID-19 pandemic. PVR is a rare but vision-threatening
retinal disease associated with recurrent retinal detachments.
There is no approved therapy for PVR. Aldeyra expects to update the
enrollment and completion timeline by year-end, and is also
exploring additional indications for ADX-2191, including primary
intraocular lymphoma, a rare but serious ocular cancer that can
affect the retina, uvea, optic nerve, and other ocular
structures.
Financial Review for the Quarter Ended March 31, 2020
For the quarter ended March 31, 2020, Aldeyra reported a net
loss of $9.9 million, compared with a net loss of $15.6 million for
the quarter ended March 31, 2019. Net loss per share was $0.34 for
the quarter ended March 31, 2020, compared with $0.58 for the same
period in 2019. Losses have resulted from the costs of Aldeyra's
clinical trials and research and development programs, as well as
from general and administrative expenses.
Research and development expenses were $6.6 million for the
quarter ended March 31, 2020, compared with $7.8 million for the
same period in 2019. The decrease of $1.2 million is primarily
related to the decreases in clinical and preclinical development
and manufacturing costs. Expenses for the 2019 period also included
$6.6 million of in-process research and development expenses
incurred in connection with the acquisition of Helio Vision.
General and administrative expenses were $3.0 million for each
of the quarters ended March 31, 2020 and 2019. Increases in
personnel related costs, including stock-based compensation, were
offset by a decrease in legal and other miscellaneous
administrative costs.
For the quarter ended March 31, 2020, total operating expenses
were $9.6 million, compared with total operating expenses of $17.4
million for the same period in 2019.
Cash, cash equivalents, and marketable securities were $61.4
million as of March 31, 2020. Based on current operating plans,
Aldeyra believes that its cash, cash equivalents, and marketable
securities as of March 31, 2020 will be sufficient to fund
currently anticipated operating expenses into 2022, including the
completion of the Phase 3 INVIGORATE Trial for reproxalap, as well
as the Phase 2 clinical trials of ADX-629 in COVID-19-associated
respiratory compromise, atopic asthma, and psoriasis; the
commencement of one or more additional clinical trials in dry eye
disease, subject to the outcome of the FDA meeting scheduled for
mid-year 2020; and the continuation of Part 1 of the adaptive Phase
3 clinical trial in PVR contingent on patient enrollment.
Conference Call & Webcast Information
Aldeyra will host a conference call today at 8:00 a.m. ET to
announce new clinical trials in systemic inflammatory diseases,
provide an update on ocular disease programs, and report
first-quarter 2020 financial results. The dial-in numbers are (866)
211-4098 for domestic callers and (647) 689-6613 for international
callers. The Conference ID number is 6982314. Due to the expected
high demand on our conference provider, please plan to dial in to
the call at least 30 minutes prior to the start time.
A live webcast of the conference call will also be available on
the investor relations page of the company’s corporate website at
https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the Aldeyra Therapeutics website for 90
days.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target
reactive aldehyde species (RASP), which are elevated in ocular and
systemic inflammatory disease, leading to elevated levels of
cytokine release via activation of a broad array of inflammatory
factors, including NF-κB, inflammasomes, and Scavenger Receptor A.
Reproxalap is being evaluated in Phase 3 clinical trials in
patients with dry eye disease and allergic conjunctivitis. The
company’s clinical pipeline also includes ADX-2191, a dihydrofolate
reductase inhibitor in Phase 3 testing for proliferative
vitreoretinopathy. 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 statements regarding Aldeyra's strategy, future
operations, expected cash runway, prospects, plans, and objectives
and Aldeyra's plans and expectations for its product candidates,
including reproxalap, ADX-629, ADX-2191 and ADX-1612. 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. As a result of the COVID-19 pandemic, clinical
site availability, staffing, and patient recruitment have been
negatively affected and the timelines to complete our clinical
trials may be delayed. 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
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 our business, results of operations and
financial position; uncertainty as to Aldeyra’s ability to
commercialize (alone or with others) 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
recent COVID-19 outbreak and subsequent public health measures,
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, 2019, which is
on file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at 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, 2020, expected to be
filed with the SEC in the second quarter of 2020.
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,
2020
2019
(Unaudited) ASSETS
Current assets: Cash and cash equivalents
$
15,542,971
$
16,425,830
Cash equivalent - reverse repurchase agreements
23,000,000
28,000,000
Marketable securities
22,833,583
28,938,545
Prepaid expenses and other current assets
1,375,129
1,804,450
Total current assets
62,751,683
75,168,825
Right-of-use assets
152,666
201,007
Fixed assets, net
124,750
148,449
Total assets
$
63,029,099
$
75,518,281
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities: Accounts payable
$
1,072,897
$
808,302
Accrued expenses
3,641,724
11,873,122
Current portion of operating lease liabilities
172,241
226,328
Total current liabilities
4,886,862
12,907,752
Long-term debt
14,669,717
14,528,212
Total liabilities
19,556,579
27,435,964
Commitments and contingencies 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
29,506,829 and 28,656,832 shares issued and outstanding,
respectively
29,507
28,657
Additional paid-in capital
252,615,578
247,409,793
Accumulated other comprehensive income
57,594
5,866
Accumulated deficit
(209,230,159
)
(199,361,999
)
Total stockholders’ equity
43,472,520
48,082,317
Total liabilities and stockholders’ equity
$
63,029,099
$
75,518,281
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED
STATEMENTS OF OPERATIONS (UNAUDITED) Three
Months Ended March 31,
2020
2019
Operating expenses: Research and development
$
6,633,603
$
7,848,590
Acquired in-process research and development —
6,597,551
General and administrative
3,004,841
2,985,038
Loss from operations
(9,638,444
)
(17,431,179
)
Other income (expense): Interest income
210,100
499,140
Interest expense
(439,816
)
(1,962
)
Total other income (expense), net
(229,716
)
497,178
Loss before income taxes
(9,868,160
)
(16,934,001
)
Income tax benefit —
1,309,973
Net loss
$
(9,868,160
)
$
(15,624,028
)
Net loss per share - basic and diluted
$
(0.34
)
$
(0.58
)
Weighted average common shares outstanding - basic and
diluted
29,210,889
27,053,842
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200507005225/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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