LEXINGTON, Mass., Nov. 9, 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 endogenous aldehyde toxicity, today announced
financial results for the quarter ended September 30, 2017.
"The announcement of clinical results in dry eye disease in the
third quarter marks the fifth positive Phase 2 clinical trial of
our lead aldehyde trap, reproxalap, formerly known as ADX-102,"
commented Todd C. Brady, M.D.,
Ph.D., President and CEO of Aldeyra. "Given the consistent clinical
activity of reproxalap across large-market and orphan diseases, we
now look to expand our pipeline with new molecules in new
indications, and, last quarter, we were pleased to announce
development of ADX-103 for retinal disease."
Third Quarter Highlights:
- Reported Positive Results from Phase 2a Clinical Trial in
Dry Eye Disease. In September
2017, Aldeyra reported positive results from a Phase 2a
clinical trial of reproxalap in dry eye disease, a common and
sub-optimally treated chronic ocular disorder. The results
demonstrated statistically and clinically significant improvement
across multiple sign and symptom endpoints, and onset of action was
observed within one week of therapy, markedly faster than standard
of care. Supportive of drug activity, reduction in levels of
pro-inflammatory aldehydes was correlated with improvement in
ocular staining scores and tear osmolarity.
- Announced New Results from Phase 2b Allergic
Conjunctivitis Clinical Trial Demonstrating Clinically Relevant
Activity of Reproxalap. Analysis of the previously reported
Phase 2b results demonstrated that patients treated with reproxalap
were more than three times more likely than vehicle-treated
patients (p<0.05) to improve in ocular itch score (range 0 to 4)
by one point, an amount consistent with U.S. Food and Drug
Administration standards for regulatory approval and clinical
relevance. Additionally, time to clinical response was more rapid
in drug groups than in the vehicle group (p<0.01). Allergic
conjunctivitis is a persistently disturbing and common ocular
disease affecting 20% or more of the worldwide population.
- Introduced Novel Aldehyde Trap ADX-103 as a Product
Candidate for the Treatment of Retinal Disease. In preclinical
retinal disease models of macular degeneration, uveitis, and
diabetic macular edema, ADX-103 (a novel aldehyde trap that is
structurally distinct from reproxalap) demonstrated consistent
activity that was at least as potent as that of reproxalap.
Additional results are expected to be released at a major
scientific meeting in 2018.
- Adoption of Reproxalap as Generic Name for ADX-102.
Reproxalap, the generic name for the first-in-class aldehyde trap,
formerly known as ADX-102, has been adopted by the United States
Adopted Names Council and the International Nonproprietary Names
Expert Group. The name incorporates a new stem for aldehyde traps,
"-alap", and recognizes aldehyde traps as a novel class of
drug.
- 2017 Research & Development Day. On
October 10, 2017, Aldeyra hosted its
Research & Development Day, which featured presentations from
key ocular inflammation opinion leaders on the therapeutic and
market potential of Aldeyra's late-stage aldehyde trap platform in
dry eye disease and allergic conjunctivitis, two closely related
ocular inflammatory conditions that, in aggregate, represent one of
the largest topical ophthalmic markets worldwide. An archived
webcast of the event can be found under the Events section of
Aldeyra's investor website.
Expected Clinical Milestones:
- Phase 3 Allergic Conjunctivitis Expected to Begin in the First
Half of 2018; Results Expected to be Announced in the Second Half
of 2018
- Phase 2b Dry Eye Disease Expected to Begin in the First Half of
2018; Results Expected to be Announced in the Second Half of
2018
- Phase 3 Noninfectious Anterior Uveitis Results Expected to be
Announced in the Second Half of 2018
- Phase 3 Sjögren-Larsson Syndrome Expected to Begin in the First
Half of 2018; Initial Results Expected to be Announced in the
Second Half of 2018
Third Quarter 2017 Financial Results
For the third quarter, Aldeyra reported a net loss of
approximately $5.0 million, compared
to a net loss of approximately $4.8
million for the quarter ended September 30, 2016. Basic and diluted net loss
per share was $0.32 for the quarter
ended September 30, 2017, compared to
basic and diluted net loss of $0.38
per share for the quarter ended September
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 $3.5 million for the three months ended
September 30, 2017, compared to
$3.4 million for the three
months ended September 30, 2016. The
increase of $0.1 million is
primarily related to the increases in external research and
development expenditures, including clinical, preclinical, and
manufacturing expenses.
General and administrative expenses were $1.5 million for the three months ended
September 30, 2017, compared to
$1.4 million for the three
months ended September 30, 2016.
Cash, cash equivalents, and marketable securities were
$47.9 million as of September 30, 2017, including $26.9 million in net proceeds from the
underwritten public offering of common stock that closed on
September 21, 2017.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Thursday, November 9, 2017, at 8:00 a.m. eastern time to discuss the
results. 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, 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,
reproxalap, formerly known as ADX-102, is an aldehyde trap in
development as topical eye drops for the treatment of ocular
inflammation. Reproxalap has now been tested in over 250 patients
in Phase 2 clinical trials in dry eye disease, allergic
conjunctivitis, and noninfectious anterior uveitis. A dermatologic
formulation of reproxalap is in late-stage clinical development for
the treatment of ichthyosis due to Sjögren-Larsson Syndrome, an
inborn error of aldehyde metabolism. Reproxalap has not been
approved for sale in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a
common inflammatory disease estimated to affect approximately 20
million people in the United
States, and is characterized by insufficient moisture and
lubrication in the anterior surface of the eye, leading to dryness,
inflammation, pain, discomfort, irritation, and in severe cases,
decreased vision. Among physicians and patients, existing therapy
for dry eye disease is generally regarded as inadequate. In
patients with dry eye disease, pro-inflammatory aldehyde mediators
may contribute to ocular inflammation. By diminishing aldehyde
levels, Aldeyra's topical ocular aldehyde trap platform represents
a novel and differentiated approach for the treatment of dry eye
disease.
About Allergic Conjunctivitis
Allergic
conjunctivitis is a common allergic disease that affects 20% or
more of the population worldwide. The disease is thought to
be mediated in part by pro-inflammatory aldehydes, and is
characterized by inflammation of the conjunctiva (a membrane
covering part of the front of the eye), resulting in ocular
itching, excessive tear production, lid swelling, and redness.
About Noninfectious Anterior
Uveitis
Noninfectious anterior uveitis 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.
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
ichthyosis (scaly, thickened, dry skin), neurological disorders,
and retinal disease. No therapy for SLS 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 and expectations for the
development of Reproxalap and ADX-103; and the potential of
Reproxalap as an agent for the treatment of dry eye disease and
allergic conjunctivitis and ADX-103 as an agent for the treatment
of retinal disease. 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; 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, 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 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.
Additional factors may be described in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, to be filed with the SEC in
the fourth quarter of 2017. 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: 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
December
31,
|
|
|
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
(unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
33,103,849
|
|
$
|
12,015,061
|
|
Marketable
securities
|
|
|
14,807,166
|
|
|
12,897,584
|
|
Prepaid expenses and
other current assets
|
|
|
1,141,727
|
|
|
218,682
|
|
|
Total current
assets
|
|
|
49,052,742
|
|
|
25,131,327
|
Deferred offering
costs
|
|
|
138,661
|
|
|
-
|
Fixed assets,
net
|
|
|
38,017
|
|
|
56,352
|
|
|
Total
assets
|
|
$
|
49,229,420
|
|
$
|
25,187,679
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
485,267
|
|
$
|
275,441
|
|
Accrued
expenses
|
|
|
1,507,458
|
|
|
1,946,251
|
|
Current portion of
credit facility
|
|
|
426,505
|
|
|
77,546
|
|
|
Total current
liabilities
|
|
|
2,419,230
|
|
|
2,299,238
|
|
|
|
|
|
|
|
|
|
Credit facility, net
of current portion and debt discount
|
|
|
905,253
|
|
|
1,238,624
|
|
|
Total
liabilities
|
|
|
3,324,483
|
|
|
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 19,117,676
|
|
|
|
|
|
|
|
and 12,576,325 shares issued and outstanding,
respectively
|
|
|
19,118
|
|
|
12,576
|
|
Additional paid-in
capital
|
|
|
138,574,234
|
|
|
98,938,446
|
|
Accumulated other
comprehensive income (loss)
|
|
|
(1,002)
|
|
|
129
|
|
Accumulated
deficit
|
|
|
(92,687,413)
|
|
|
(77,301,334)
|
|
|
Total stockholders'
equity
|
|
|
45,904,937
|
|
|
21,649,817
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
49,229,420
|
|
$
|
25,187,679
|
|
|
|
|
|
|
|
|
|
ALDEYRA THERAPEUTICS,
INC.
STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30,
|
|
|
Nine Months ended
September 30,
|
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
3,539,368
|
|
$
|
3,379,711
|
|
$
|
10,757,279
|
|
$
|
9,728,494
|
|
General and
administrative
|
|
|
1,475,904
|
|
|
1,396,734
|
|
|
4,684,574
|
|
|
4,314,483
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(5,015,272)
|
|
|
(4,776,445)
|
|
|
(15,441,853)
|
|
|
(14,042,977)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
56,651
|
|
|
27,792
|
|
|
136,652
|
|
|
74,463
|
|
Interest
expense
|
|
|
(27,578)
|
|
|
(26,654)
|
|
|
(80,878)
|
|
|
(79,507)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense), net
|
|
|
29,073
|
|
|
1,138
|
|
|
55,774
|
|
|
(5,044)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,986,199)
|
|
$
|
(4,775,307)
|
|
$
|
(15,386,079)
|
|
$
|
(14,048,021)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
|
(0.32)
|
|
$
|
(0.38)
|
|
$
|
(1.04)
|
|
$
|
(1.28)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
|
15,581,426
|
|
|
12,474,609
|
|
|
14,844,914
|
|
|
10,942,127
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original
content:http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-third-quarter-2017-financial-results-300552657.html
SOURCE Aldeyra Therapeutics, Inc.