LEXINGTON, Mass., March 8, 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 year ended December 31, 2018 financial results.
"2018 was a landmark year for Aldeyra, highlighted by positive
results from our Phase 2b dry eye
disease clinical trial, and the subsequent acquisition of Helio
Vision in January of this year," commented Todd C. Brady, M.D., Ph.D., President and CEO of
Aldeyra. "We were pleased to add new Phase 3 clinical programs in
dry eye disease and proliferative vitreoretinopathy, complementing
our Phase 3 trials in allergic conjunctivitis, noninfectious
anterior uveitis, and Sjögren-Larsson Syndrome. We look
forward to updating investors on the progress of our late-stage
development pipeline throughout 2019, as we continue our efforts to
bring novel therapeutic options to market."
Recent Highlights and Corporate Updates
- Retinal Disease Pipeline Expanded with Acquisition of Helio
Vision. The acquisition of Helio Vision in January 2019 broadened Aldeyra's development
program in retinal disease with a Phase 3-ready product candidate,
ADX-2191, for proliferative vitreoretinopathy (PVR). PVR, a rare
inflammatory fibroproliferative disorder with no approved
treatment, leads to severe retinal scarring and blindness. ADX-2191
has received Orphan Drug Designation from the U.S. Food and Drug
Administration for the prevention of PVR. Following discussions
with regulatory authorities, Aldeyra plans to initiate an adaptive
Phase 3 clinical trial in PVR during the second half of
2019.
- Positive Results Achieved in Dry Eye Disease Phase
2b Clinical Trial. In
September 2018, Aldeyra announced
that 0.25% topical ocular reproxalap demonstrated statistical
superiority over vehicle across multiple dry eye disease symptoms
and signs. Based on the positive Phase 2b clinical results, in the first half of 2019,
Aldeyra plans to initiate Part 1 of the RENEW adaptive Phase 3
clinical trial of 0.25% topical ocular reproxalap in patients with
dry eye disease.
- Results Expected from the ALLEVIATE Phase 3 Clinical Trial
in Allergic Conjunctivitis in Early 2019. The ALLEVIATE
trial is a multi-center, double-masked, parallel-group,
vehicle-controlled, allergen-challenge Phase 3 clinical trial of
0.25% and 0.5% topical ocular reproxalap in patients with allergic
conjunctivitis. Results from the ALLEVIATE trial are expected to be
announced in early 2019.
- Results from the SOLACE Phase 3 Clinical Trial in
Noninfectious Anterior Uveitis Expected in Second Half of
2019. The SOLACE trial is 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 to be announced in the second half of
2019.
- Results from Part 1 of the RESET Phase 3 Clinical Trial in
Sjögren-Larsson Syndrome Expected in the Second Half of
2019. The RESET Trial is a 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, an orphan inborn error of metabolism.
Results from Part 1 of the RESET trial are expected to be announced
in the second half of 2019.
- Organizational Changes Highlight Preparation for
Commercialization. As Aldeyra's pipeline continues to
progress towards commercialization, in January 2019, Aldeyra announced the promotions of
David McMullin to the position of
Chief Commercial Officer and Stephen G.
Machatha, Ph.D. to the position of Senior Vice President of
Technical Operations. As the Chief Commercial Officer, Mr. McMullin
will oversee Aldeyra's strategic initiatives, commercial planning
activities, marketing, and commercial infrastructure
development. As the Senior Vice President of Technical
Operations, Dr. Machatha will lead chemistry, manufacturing and
control activities, and develop Aldeyra's commercial supply
infrastructure.
- Financing Activity in 2018 Expected to Support Operations
through 2020. In October 2018,
Aldeyra completed an underwritten public offering that raised net
proceeds of $67.6 million after
deducting underwriting discounts, commissions, and expenses. Based
on Aldeyra's current operating plan, cash and cash equivalents as
of December 31, 2018, including
proceeds from the financing, are expected to fund currently
anticipated operating expenses through 2020, including the planned
announcements of top-line data from Phase 3 clinical trials in
allergic conjunctivitis, noninfectious anterior uveitis, and
Sjögren-Larsson Syndrome (RESET Part 1); the initiation of Phase 3
clinical trials in dry eye disease and PVR; and the initiation of
multiple early-stage clinical programs.
- Clinical Programs for Systemic Immune-Mediated Disease
Expected to Begin in 2019. A Phase 2 clinical trial of ADX-1612
in post-transplant lymphoproliferative disorder and an additional
Phase 2 clinical trial of ADX-1612 in mesothelioma, pending
discussions with regulatory authorities, are expected to initiate
in 2019. A Phase 1 clinical trial of ADX-629 for the treatment of
systemic autoimmune disease is expected to begin in the second half
of 2019.
Year Ended December 31, 2018
Financial Review
Aldeyra reported a net loss of approximately $38.9 million for the year ended December 31, 2018, compared to a net loss of
approximately $22.3 million in 2017.
Basic and diluted net loss per share was $1.79 for the year ended December 31, 2018, compared to $1.40 per share in 2017. 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 approximately
$29.8 million for the year ended
December 31, 2018, compared to
approximately $16.3 million in 2017.
The increase of $13.5 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.
General and administrative expenses were approximately
$9.9 million for the year ended
December 31, 2018, compared to
approximately $6.2 million in 2017.
The increase of $3.7 million is
primarily related to an increase in legal and patent-related costs,
consulting costs, and personnel costs.
Total operating expenses were approximately $39.7 million for the year ended December 31, 2018, compared to total operating
expenses of approximately $22.5
million in 2017.
Cash, cash equivalents, and marketable securities were
$93.6 million as of December 31, 2018 which includes $67.6 million of net proceeds raised in an
October 2018 public offering of
Aldeyra's common stock.
Conference Call & Webcast
Information
Aldeyra will hold a conference call
on Friday, March 8, 2019, at
8:00 a.m. Eastern Standard 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 disorder, 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 "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, 2017 and Aldeyra's Quarterly Report
on Form 10-Q for the quarter ended September
30, 2018, both of which are 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 Annual Report on Form 10-K for the year ended
December 31, 2018, expected to be
filed with the SEC in the first 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
2018
|
|
2017
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,357,472
|
|
$
|
2,023,337
|
Cash equivalent-
reverse repurchase agreements
|
|
44,000,000
|
|
18,000,000
|
Marketable
securities
|
|
46,242,220
|
|
22,923,462
|
Prepaid expenses
and other current assets
|
|
1,169,594
|
|
1,018,967
|
Total
current assets
|
|
94,769,286
|
|
43,965,766
|
Deferred offering
costs
|
|
86,644
|
|
165,930
|
Fixed assets,
net
|
|
235,225
|
|
43,262
|
Total
assets
|
|
$
|
95,091,155
|
|
$
|
44,174,958
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
3,051,678
|
|
$
|
1,000,963
|
Accrued
expenses
|
|
5,421,498
|
|
2,236,465
|
Current portion of
credit facility
|
|
-
|
|
116,319
|
Total
current liabilities
|
|
8,473,176
|
|
3,353,747
|
|
|
|
|
|
|
|
|
Credit facility, net
of current portion and debt discount
|
|
-
|
|
1,220,192
|
Total
liabilities
|
|
8,473,176
|
|
4,573,939
|
|
|
|
|
|
|
|
|
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
26,244,435 and 19,137,639 shares issued and
|
|
|
|
|
outstanding,
respectively
|
|
26,244
|
|
19,138
|
Additional paid-in
capital
|
|
225,136,127
|
|
139,241,635
|
Accumulated other
comprehensive income (loss)
|
|
(9,224)
|
|
(17,831)
|
Accumulated
deficit
|
|
(138,535,168)
|
|
(99,641,923)
|
Total
stockholders' equity
|
|
86,617,979
|
|
39,601,019
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
95,091,155
|
|
$
|
44,174,958
|
|
|
|
|
|
|
|
|
ALDEYRA
THERAPEUTICS, INC.
|
STATEMENT OF
OPERATIONS
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
Years ended
December 31,
|
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Research and
development
|
|
$
|
29,823,007
|
|
$
|
16,302,568
|
General and
administrative
|
|
9,876,144
|
|
6,185,820
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(39,699,151)
|
|
(22,488,388)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
Interest
income
|
|
952,698
|
|
261,252
|
Interest
expense
|
|
(146,792)
|
|
(113,453)
|
|
|
|
|
|
|
|
|
Total
other income (expense), net
|
|
805,906
|
|
147,799
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(38,893,245)
|
|
$
|
(22,340,589)
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
|
(1.79)
|
|
$
|
(1.40)
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
21,685,642
|
|
15,921,884
|
|
|
|
|
|
|
|
|
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SOURCE Aldeyra Therapeutics, Inc.