LEXINGTON, Mass., Aug. 8, 2017 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra or the Company), a
clinical-stage biotechnology company devoted to treating
inflammation, inborn errors of metabolism, and other diseases
related to aldehydes, today announced its financial results for the
quarter ended June 30, 2017.
"With the release of allergic conjunctivitis Phase 2b clinical
trial results in the second quarter, we were pleased to announce
our third Phase 3 clinical program," commented Todd C. Brady, M.D., Ph.D., President and CEO of
Aldeyra. "We are determined to continue to advance our novel
aldehyde trap platform toward commercialization, with the goal of
providing a novel pharmacologic approach to patients with limited
safe and effective therapeutic options for severe inflammation or
inborn errors of aldehyde metabolism."
Corporate Updates and Expected Milestones:
- Phase 3 Clinical Testing of ADX-102 in Allergic
Conjunctivitis Planned Following End of Phase 2 Meeting with
Regulatory Authorities. Based on the results of Aldeyra's Phase
2b clinical trial in allergic conjunctivitis reported in
June 2017, Aldeyra plans to begin
Phase 3 clinical testing of ADX-102 following an End of Phase 2
Meeting with regulatory authorities in the second half of 2017. The
randomized, dose-ranging, parallel-group, double-masked,
saline-controlled, multi-center Phase 2b clinical trial of topical
ocular ADX-102 in 154 allergic conjunctivitis patients demonstrated
statistically significant improvement in ocular itch relative to
control. Consistent with Phase 2a clinical results, the sustained
clinical activity of ADX-102 in the Phase 2b clinical trial was
distinct from the activity of antihistamines, a commonly used
therapy that is only partially effective in many allergic
conjunctivitis patients. Aldeyra believes that the differentiated
mechanism of action of ADX-102 could apply to millions of allergic
conjunctivitis patients in the United
States.
- Data from Phase 2a Clinical Trial in Dry Eye Disease (DED)
Expected to be Announced in September
2017. The Phase 2a clinical trial is a single-center,
double-blind, randomized trial testing three formulations of
topical ocular ADX-102 (ADX-102 0.5% ophthalmic solution, ADX-102
0.1% ophthalmic solution, and ADX-102 0.5% ophthalmic lipid
solution) over 28 days of treatment. Endpoints will include
standard signs and symptoms characteristic of DED, a bothersome and
generally poorly treated inflammatory condition that represents one
of the largest ophthalmic markets worldwide.
- Noninfectious Anterior Uveitis (NAU) Phase 3 Clinical
Results Expected to be Announced in the Second Half of 2018. In
April 2017, Aldeyra initiated a
randomized, parallel-group, double-masked, vehicle-controlled,
multi-center Phase 3 clinical trial of ADX-102 0.5% ophthalmic
solution in up to 100 patients with active NAU. The primary
endpoint is resolution of inflammation as measured by inflammatory
cell count in the anterior chamber of the eye, the same endpoint
assessed in the positive Phase 2 clinical trial of ADX-102
announced last year. NAU is a potentially blinding inflammatory
ocular disease that is typically treated with topical
corticosteroids, which can result in glaucoma, cataracts, and other
serious ocular toxicities.
- Initial Results from Phase 3 Trial in Sjögren-Larsson
Syndrome (SLS) Expected in the Second Half of 2018. The Phase 3
clinical trial in SLS, an inborn error of aldehyde metabolism
characterized by severe skin and neurological disease, is expected
to be performed in two parts: a randomized and controlled
assessment over six months of treatment, followed by a crossover
design to evaluate change from baseline in drug-treated patients.
Data from the first part of the trial will be used to confirm
statistical power for the second part. In coordination with the
start of the Phase 3 clinical trial, Aldeyra has launched the SLS
Patient Registry with the intention of increasing the Company's
profile among SLS patients, caregivers, physicians, researchers,
and other members of the SLS community. The results from part one
of the Phase 3 SLS trial are expected in the second half 2018.
There is no FDA-approved therapy for the treatment of SLS.
- Novel Data on the Anti-Inflammatory Mechanism and Activity
of ADX-102 Presented at the World Congress on Inflammation 2017
Annual Meeting. In July 2017,
Aldeyra presented the differentiated effects of ADX-102 on the
down-regulation of inflammatory cell migration and activation in a
mouse model of endotoxin-induced lung injury. The data demonstrate
that the anti-inflammatory effects of ADX-102 differ from that of
corticosteroids, building on existing evidence that aldehyde
sequestration represents a novel anti-inflammatory therapeutic
approach.
Second Quarter 2017 Financial Results
For the quarter ended June 30,
2017, Aldeyra reported a net loss of approximately
$5.3 million, compared to a net loss
of approximately $4.3 million for the
quarter ended June 30, 2016. Basic
and diluted net loss per share was $0.35 for the quarter ended June 30, 2017, compared to basic and diluted net
loss of $0.41 per share for the
quarter ended June 30, 2016. 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 $3.8 million for the three months ended
June 30, 2017, compared to
$2.8 million for the three
months ended June 30, 2016. The increase of $1.0 million is primarily related to the
increases in our external research and development expenditures,
including clinical and pre-clinical activities, partially offset by
a reduction in manufacturing expenses.
General and administrative expenses were $1.5 million for the three months ended
June 30, 2017, compared to
$1.5 million for the three
months ended June 30, 2016.
Cash, cash equivalents, and marketable securities were
$25.8 million as of June 30, 2017.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Tuesday, August 8, 2017, at 8:00 a.m. eastern time to discuss the
results. The dial-in numbers are 1-877-870-4263 for domestic
callers and 1-412-317-0790 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. In addition, a
telephonic replay of the call will be available until August 7, 2018.
About Aldeyra
Therapeutics
Aldeyra Therapeutics, Inc. is a
biotechnology company devoted to improving lives by inventing,
developing and commercializing products that treat diseases thought
to be related to endogenous aldehydes, a naturally occurring class
of pro-inflammatory and toxic molecules. Aldeyra's lead product
candidate, ADX-102, is an aldehyde trap in development for ocular
inflammation, as well as for Sjögren-Larsson Syndrome and Succinic
Semi-Aldehyde Dehydrogenase Deficiency, two inborn errors of
aldehyde metabolism. ADX-102 has not been approved for sale in the
U.S. or elsewhere.
About Allergic Conjunctivitis
Allergic
conjunctivitis is a common allergic disease that affects 20-40% of
the worldwide population, and is thought to be mediated in part by
pro-inflammatory aldehydes. Symptoms include ocular itching,
excessive tear production, lid swelling, and redness.
Approximately one-third of allergic conjunctivitis patients do not
adequately respond to standard-of-care therapy.
About Dry Eye Disease
Dry Eye Disease (DED) is
a common inflammatory disease characterized by insufficient
moisture and lubrication in the anterior surface of the eye.
Symptoms may include ocular irritation, burning or stinging, and,
in severe cases, decreased vision. In patients with DED, aldehydes
may contribute to ocular inflammation as well as the impairment of
lipids (fats) that lubricate the surface of the
eye. Therapy for DED is generally considered
by physicians and patients to be inadequate.
About Noninfectious Anterior
Uveitis
Noninfectious anterior uveitis (NAU) is a rare,
potentially blinding disease that may be mediated in part by
pro-inflammatory aldehydes, and is characterized by inflammation in
the front of the eye, pain, impaired vision, and photophobia.
The only approved therapy for NAU is topical corticosteroids, which
can cause serious ocular side effects, including glaucoma,
cataracts, and infection.
About Sjögren-Larsson Syndrome
Sjögren-Larsson
Syndrome is a rare inborn error of aldehyde metabolism caused by
mutations in fatty acid aldehyde dehydrogenase, leading to elevated
toxic fatty aldehyde levels that are thought to contribute to
severe ichthyosis (scaly, thickened, dry skin), neurological
disorders, and retinal disease. There is no therapy for SLS that
has been approved by the U.S. Food and Drug Administration.
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 plans for its product candidates. 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. 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;
the ability to obtain and maintain regulatory approval to conduct
clinical trials and to commercialize Aldeyra's product candidates,
and the labeling for any approved products; the scope, progress,
expansion, and costs of developing and commercializing Aldeyra's
product candidates; the size and growth of the potential markets
for Aldeyra's product candidates and the ability to serve those
markets; Aldeyra's expectations regarding Aldeyra's expenses and
revenue, the sufficiency 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
ability to establish and maintain development partnerships;
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,
2016 and Aldeyra's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2017 which are
on file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at www.sec.gov. 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.
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:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 Ext. 205
stulipano@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
Tel: 781-591-3443
cduong@macbiocom.com
ALDEYRA THERAPEUTICS,
INC.
|
BALANCE
SHEETS
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
2017
|
|
2016
|
|
|
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
14,609,742
|
|
$
12,015,061
|
|
Marketable
securities
|
|
11,210,796
|
|
12,897,584
|
|
Prepaid expenses and
other current assets
|
|
521,483
|
|
218,682
|
|
Total current
assets
|
|
26,342,021
|
|
25,131,327
|
Deferred offering
costs
|
|
77,942
|
|
-
|
Fixed assets,
net
|
|
47,981
|
|
56,352
|
|
Total assets
|
|
$
26,467,944
|
|
$
25,187,679
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
762,681
|
|
$
275,441
|
|
Accrued
expenses
|
|
1,038,905
|
|
1,946,251
|
|
Current portion of
credit facility
|
|
310,185
|
|
77,546
|
|
Total current
liabilities
|
|
2,111,771
|
|
2,299,238
|
|
|
|
|
|
|
|
|
Credit facility, net
of current portion and debt discount
|
|
1,016,377
|
|
1,238,624
|
|
Total
liabilities
|
|
3,128,148
|
|
3,537,862
|
|
|
|
|
|
|
|
|
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 15,150,176
|
|
|
|
|
and 12,576,325 shares issued and outstanding,
respectively
|
|
15,150
|
|
12,576
|
|
Additional paid-in
capital
|
|
111,030,501
|
|
98,938,446
|
|
Accumulated other
comprehensive income (loss)
|
|
(4,640)
|
|
129
|
|
Accumulated
deficit
|
|
(87,701,215)
|
|
(77,301,334)
|
|
Total stockholders'
equity
|
|
23,339,796
|
|
21,649,817
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
26,467,944
|
|
$
25,187,679
|
ALDEYRA THERAPEUTICS,
INC.
|
STATEMENTS OF
OPERATIONS
|
(UNAUDITED)
|
|
|
|
|
Three Months ended
June 30,
|
|
Six Months ended
June 30,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
3,848,889
|
|
$
2,834,523
|
|
$
7,217,912
|
|
$
6,346,037
|
|
General and
administrative
|
|
1,481,792
|
|
1,462,227
|
|
3,208,670
|
|
2,917,750
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(5,330,681)
|
|
(4,296,750)
|
|
(10,426,582)
|
|
(9,263,787)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
48,384
|
|
21,951
|
|
80,002
|
|
46,671
|
|
Interest
expense
|
|
(26,463)
|
|
(27,817)
|
|
(53,301)
|
|
(52,853)
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
21,921
|
|
(5,866)
|
|
26,701
|
|
(6,182)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(5,308,760)
|
|
$
(4,302,616)
|
|
$
(10,399,881)
|
|
$
(9,269,969)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
(0.35)
|
|
$
(0.41)
|
|
$
(0.72)
|
|
$
(0.91)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
15,136,399
|
|
10,622,411
|
|
14,470,555
|
|
10,167,466
|
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SOURCE Aldeyra Therapeutics, Inc.