LEXINGTON, Mass., May 9, 2019 /PRNewswire/ -- Aldeyra Therapeutics,
Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to
developing and commercializing next-generation medicines to improve
the lives of patients with immune-mediated diseases, today
announced quarter ended March 31,
2019 financial results and provided a corporate update.
"With the announcement of positive results from the Phase 3
ALLEVIATE Trial, the initiation of the Phase 3 RENEW Trial, and the
completion of dosing in the Phase 3 SOLACE Trial, our progress in
2019 has been remarkable," commented Todd
C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "We
look forward to announcing results from the SOLACE Trial and
completing Part 1 of the Phase 3 RESET Trial later this year, as we
continue to advance our innovative pipeline towards
commercialization across a variety of serious diseases."
Recent Highlights and Corporate Updates
- Reported Positive Results from the Phase 3 ALLEVIATE Trial
in Allergic Conjunctivitis. The double-masked,
randomized, vehicle-controlled, multi-center, parallel-group
conjunctival allergen challenge ALLEVIATE Trial assessed the
efficacy and safety of 0.25% and 0.5% concentrations of reproxalap
topical ophthalmic solutions compared to vehicle in 318 patients
with seasonal allergic conjunctivitis. The primary endpoint
of ocular itch score area under the curve was achieved for both
concentrations (p < 0.0001 and p = 0.0025,
respectively). The key secondary endpoint of clinically
relevant two-point ocular itch score improvement was also achieved
for both concentrations (p = 0.0005 and
p = 0.0169, respectively). 0.25% reproxalap is expected
to advance to additional Phase 3 clinical testing contingent upon
successful completion of ongoing environmental allergen exposure
method development studies and subsequent discussion with
regulatory authorities.
- Initiated Adaptive Phase 3 RENEW Trial in Dry Eye Disease,
and Presented Phase 2b Dry Eye
Disease Clinical Trial Results at the 2019 Association for Research
in Vision and Ophthalmology (ARVO) Annual Meeting. In
September 2018, and at ARVO in
May 2019, Aldeyra reported results
from topical ocular reproxalap in a Phase 2b dry eye disease clinical trial, which
demonstrated statistically significant superiority of 0.25%
reproxalap over vehicle in ocular dryness symptom score and
fluorescein nasal region ocular staining in pre-specified moderate
to severe patients (p = 0.0048 and p = 0.0007,
respectively). In April 2019,
the first patient was enrolled in the Phase 3 RENEW trial, an
adaptive, two-part, Phase 3 clinical trial of topical ocular 0.25%
reproxalap. Following the completion of the first part of RENEW,
assuming the results support advancement to further testing,
Aldeyra expects to report the endpoints, dosing regimen, and sample
size for the second part of the trial. Aldeyra expects to report
full clinical results following the completion of RENEW.
- Dosed Last Patient in the Phase 3 SOLACE Trial in
Noninfectious Anterior Uveitis. In April 2019, dosing was completed in the SOLACE
Trial, a randomized, multi-center, double-masked, parallel-group,
vehicle-controlled Phase 3 clinical trial of 0.5% topical ocular
reproxalap in patients with noninfectious anterior uveitis, a
serious ocular inflammatory disease that can lead to loss of
vision. Results from the SOLACE Trial are expected in the second
half of 2019.
- Completion of Part 1 of the Phase 3 RESET Trial in
Sjögren-Larsson Syndrome Expected in the Second Half of
2019. The RESET Trial is an adaptive, two-part, pivotal,
randomized, multi-center, double-masked Phase 3 clinical trial of
1% topical dermal reproxalap for the treatment of ichthyosis
associated with Sjögren-Larsson Syndrome. Following the
completion of RESET Part 1, assuming the results support
advancement to further testing, Aldeyra expects to report the
endpoints, dosing regimen, and sample size for RESET Part 2.
Aldeyra expects to report full clinical results following the
completion of RESET.
- Phase 3 Adaptive Clinical Trial of ADX-2191 in Proliferative
Vitreoretinopathy Expected to Initiate in the Second Half of
2019. In January 2019,
Aldeyra expanded its pipeline in retinal disease with the addition
ADX-2191 for the treatment of proliferative vitreoretinopathy, a
rare inflammatory disorder that leads to severe retinal scarring
and blindness. An adaptive, two-part Phase 3 clinical trial
is expected to begin in the second half of 2019. Following the
completion of the initial part of the trial, expected in 2020, and
assuming the results support advancement to further testing,
Aldeyra expects to report the endpoints, dosing regimen, and sample
size for the remainder of the trial. Aldeyra expects to report full
clinical results following the completion of the trial.
- Programs in Systemic Immune-Mediated Diseases Expected to
Begin Clinical Testing in 2019. A Phase 2
clinical trial of ADX-1612 in post-transplant lymphoproliferative
disorder and a Phase 1 clinical trial of ADX-629 for the treatment
of systemic autoimmune disease are expected to initiate in the
second half of 2019.
Quarter Ended March 31, 2019
Financial Review
For the quarter ended March 31, 2019, Aldeyra reported a net loss of
approximately $15.6 million, compared
to a net loss of approximately $8.4
million for the quarter ended March
31, 2018. Basic and diluted net loss per share was
$0.58 for the quarter ended
March 31, 2019, compared to
$0.43 per share for the same period
in 2018. Losses have resulted from the costs of research and
development programs; non-cash charges in connection with Aldeyra's
January 2019 stock-for-stock
acquisition of Helio Vision, Inc. (Helio); and general and
administrative expenses.
Research and development expenses were $7.8 million for the quarter ended March 31, 2019, compared to $6.6 million for the same period in 2018. The
increase of $1.2 million is primarily
related to the increase in research and development expenditures,
including manufacturing, preclinical, and clinical development
costs; and an increase in personnel costs; and non-cash
compensation costs related to a portion of the upfront
consideration paid to the founders of Helio.
In connection with the Helio acquisition, in-process research
and development expenses were $6.6
million for the quarter ended March
31, 2019. There was no such expense for the three months
ended March 31, 2018. The acquired
in-process research and development expensed during the quarter was
comprised of a non-cash charge related to the fair value of
consideration issued to the Helio non-founders, a cash charge
related to Helio acquisition transaction expenses, and a non-cash
charge related to the deferred tax liability arising from the
accounting differences for book and tax purposes resulting from the
acquisition.
General and administrative expenses were $3.0 million for the quarter ended March 31, 2019, compared to $1.9 million for the quarter ended March 31, 2018. The increase of $1.1 million is primarily related to an increase
in personnel, legal, and patent-related costs.
For the quarter ended March 31,
2019, total operating expenses were approximately
$17.4 million, compared to total
operating expenses of approximately $8.5
million for the same period in 2018.
Cash, cash equivalents, and marketable securities were
$82.1 million as of March 31, 2019. In March 2019, Aldeyra entered into a Loan and
Security Agreement, which provides up to $60 million in
non-dilutive financing. The facility advances capital at Aldeyra's
option based upon certain funding conditions. Aldeyra elected
not to draw the initial term loan advance, which expired on
April 15, 2019. An additional
term loan advance of $15.0 million is
expected to be available, and may be drawn at Aldeyra's option,
through September 30, 2019.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Thursday, May 9, 2019, at 8:00 a.m. Eastern Time. The dial-in numbers are
1-877-266-8979 for domestic callers and 1-412-317-5231 for
international callers. A live webcast of the conference call will
also be available on the investor relations page of the Aldeyra
Therapeutics corporate website at www.aldeyra.com. After the
live webcast, the event will remain archived on the Aldeyra
Therapeutics website for one year.
About Aldeyra Therapeutics
Aldeyra
Therapeutics is a biotechnology company devoted to developing and
commercializing next-generation medicines to improve the lives of
patients with immune-mediated diseases. Aldeyra's lead product
candidate, reproxalap, is a first-in-class treatment in late-stage
development for dry eye disease, allergic conjunctivitis,
noninfectious anterior uveitis, and Sjögren-Larsson Syndrome. The
company is also developing other product candidates for
proliferative vitreoretinopathy and other retinal diseases,
post-transplant lymphoproliferative disease, autoimmune disease,
metabolic disease, and cancer. None of Aldeyra's product candidates
have been approved for sale in the U.S. or elsewhere.
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, future financial
position, projected costs and expenses, prospects, plans, and
objectives and Aldeyra's plans and expectations for its product
candidates, including plans to initiate further clinical testing.
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," "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.
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; 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; 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, 2018, 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, 2019 expected
to be filed in the second quarter of 2019.
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.
Corporate Contact:
David
McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Chris
Brinzey
Westwicke, an ICR Company
Tel: 339-970-2843
Chris.brinzey@westwicke.com
ALDEYRA
THERAPEUTICS, INC.
|
BALANCE
SHEETS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
|
2019
|
|
2018
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
5,297,555
|
|
$
3,357,472
|
|
|
Cash equivalent -
Reverse Repurchase Agreements
|
|
39,000,000
|
|
$
44,000,000
|
|
|
Marketable
securities
|
|
37,826,635
|
|
46,242,220
|
|
|
Prepaid expenses and
other current assets
|
|
4,872,067
|
|
1,169,594
|
|
|
Total current
assets
|
|
86,996,257
|
|
94,769,286
|
|
|
Deferred offering
costs
|
|
—
|
|
86,644
|
|
|
Debt issuance
costs
|
|
538,038
|
|
—
|
|
|
Right-of-use
assets
|
|
377,920
|
|
—
|
|
|
Fixed assets,
net
|
|
215,908
|
|
235,225
|
|
|
Total
assets
|
|
$
88,128,123
|
|
$
95,091,155
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
|
$
4,013,362
|
|
$
3,051,678
|
|
|
Accrued
expenses
|
|
5,257,071
|
|
5,421,498
|
|
|
Current portion of
operating lease liabilities
|
|
221,112
|
|
—
|
|
|
Total current
liabilities
|
|
9,491,545
|
|
8,473,176
|
|
|
Operating lease
liabilities, long-term
|
|
156,808
|
|
—
|
|
|
Total
liabilities
|
|
9,648,353
|
|
8,473,176
|
|
|
Commitments and
contingencies (Notes 14 and 15)
|
|
|
|
|
|
|
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 26,910,355 and 26,244,435 shares issued and
outstanding, respectively
|
|
26,910
|
|
26,244
|
|
|
Additional paid-in
capital
|
|
232,605,244
|
|
225,136,127
|
|
|
Accumulated other
comprehensive income (loss)
|
|
6,812
|
|
(9,224)
|
|
|
Accumulated
deficit
|
|
(154,159,196)
|
|
(138,535,168)
|
|
|
Total stockholders'
equity
|
|
78,479,770
|
|
86,617,979
|
|
|
Total liabilities and
stockholders' equity
|
|
$
88,128,123
|
|
$
95,091,155
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALDEYRA
THERAPEUTICS, INC.
|
|
|
STATEMENT OF
OPERATIONS
|
|
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
7,848,590
|
|
$
6,600,106
|
|
|
Acquired in-process
research and development
|
|
6,597,551
|
|
—
|
|
|
General and
administrative
|
|
2,985,038
|
|
1,891,303
|
|
|
Loss from
operations
|
|
(17,431,179)
|
|
(8,491,409)
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest
income
|
|
499,140
|
|
122,390
|
|
|
Interest
expense
|
|
(1,962)
|
|
(28,044)
|
|
|
Total other income
(expense), net
|
|
497,178
|
|
94,346
|
|
|
Loss before income
taxes
|
|
(16,934,001)
|
|
(8,397,063)
|
|
|
Income tax
benefit
|
|
1,309,973
|
|
—
|
|
|
Net loss
|
|
$
(15,624,028)
|
|
$
(8,397,063)
|
|
|
Net loss per share -
basic and diluted
|
|
$
(0.58)
|
|
$
(0.43)
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
27,053,842
|
|
19,366,790
|
|
|
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SOURCE Aldeyra Therapeutics, Inc.