LEXINGTON, Mass., Nov. 14, 2018 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology
company devoted to development of next-generation medicines to
improve the lives of patients with immune-mediated diseases, today
announced financial results for the third quarter ended
September 30, 2018.
"The third quarter was highlighted by positive results from our
Phase 2b clinical trial of reproxalap
in dry eye disease and an investigator-sponsored Phase 1/2 clinical
trial of ADX-1612 in malignant mesothelioma," commented
Todd C. Brady, M.D., Ph.D. "In
addition, we completed a successful financing to support a broad
and diversified clinical development plan that includes Phase 3
clinical trials in dry eye disease, noninfectious anterior uveitis,
allergic conjunctivitis, and Sjögren-Larsson Syndrome. We look
forward to the announcement of our next major milestone, results
from the ALLEVIATE Phase 3 clinical trial in allergic
conjunctivitis, in early 2019."
Recent Highlights and Corporate Updates
- Announced positive results from a randomized,
vehicle-controlled, parallel-group, multi-center, double-masked
Phase 2b clinical trial of topical
ocular reproxalap in dry eye disease. In September 2018, Aldeyra announced that reproxalap
was observed to be statistically superior to vehicle across
multiple dry eye disease symptoms and signs in a Phase 2b clinical trial. The results demonstrated
activity versus vehicle as early as two weeks, supportive of a
differentiated product profile relative to current standard of
care. Aldeyra plans to initiate a Phase 3 clinical trial in 2019,
following discussions with regulatory authorities.
- Announced positive top-line results from the MESO-2
investigator-sponsored Phase 1/2 clinical trial of ADX-1612
(ganetespib) in patients with pleural malignant mesothelioma.
Results of the clinical trial were presented at the International
Association for the Study of Lung Cancer (ASLC) 19th World
Conference on Lung Cancer (Abstract #11921). ADX-1612, when
combined with standard pemetrexed and platinum therapy, resulted in
partial response rates that exceeded that of historical standard of
care (pemetrexed and platinum therapy). A Phase 2 clinical trial of
ADX-1612 in mesothelioma, a disease with no known cure and a poor
prognosis, is expected to be initiated in 2019, pending discussion
with regulatory authorities.
- Strengthened balance sheet. In October 2018, Aldeyra completed an underwritten
public offering that raised net proceeds of $67.6 million after deducting underwriting
discounts, commissions, and estimated expenses. The proceeds are
expected to fund operations through 2020, including the currently
planned announcements of top-line data from Phase 3 clinical trials
in allergic conjunctivitis, noninfectious anterior uveitis,
Sjögren-Larsson Syndrome (Part 1), and dry eye disease.
Upcoming Milestones and Events
- Phase 3 results from the ALLEVIATE Trial, a randomized,
multi-center, double-masked, parallel-group, vehicle-controlled
Phase 3 clinical trial of topical ocular reproxalap in an allergen
challenge model of allergic conjunctivitis, expected in early
2019
- Phase 3 results from the SOLACE Trial, a randomized,
multi-center, double-masked, parallel-group, vehicle-controlled
Phase 3 clinical trial of topical ocular reproxalap in
noninfectious anterior uveitis, expected in the second half of
2019
- Results from the first part of the RESET Trial, a two-part,
pivotal, randomized, multi-center, double-masked Phase 3 clinical
trial of topical dermal reproxalap for the treatment of ichthyosis
(scaly, thickened, dry skin) associated with Sjögren-Larsson
Syndrome, expected in the second half of 2019
- Initiation of a Phase 3 clinical trial of topical ocular
reproxalap in dry eye disease expected in 2019
- Phase 1 clinical trial of ADX-629, for the treatment of
systemic autoimmune disease, expected to be initiated in 2019
- Investigator-sponsored Phase 2 clinical trial of ADX-1612 in
ovarian cancer (EUDARIO) expected to be initiated in 2018
- Phase 2 clinical trial of ADX-1612 in post-transplant
lymphoproliferative syndrome expected to be initiated in 2019
- Phase 2 clinical trial of ADX-1612 in mesothelioma expected to
be initiated in 2019, pending discussion with regulatory
authorities
Quarter Ended September 30,
2018 Financial Review
For the quarter ended September 30,
2018, Aldeyra reported a net loss of approximately
$10.8 million, compared to a net loss
of approximately $5.0 million for the
quarter ended September 30, 2017.
Basic and diluted net loss per share was $0.52 for the quarter ended September 30, 2018, compared to $0.32 per share for the same period 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 $7.9 million for the quarter ended September 30, 2018, compared to $3.5 million for the same period in 2017. The
increase of $4.4 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 $3.1 million for the quarter ended September 30, 2018, compared to $1.5 million for the quarter ended September 30, 2017. The increase of $1.6 million is primarily related to an increase
in legal and patent-related costs, consulting costs, and personnel
costs.
For the quarter ended September 30,
2018, total operating expenses were approximately
$10.9 million, compared to total
operating expenses of approximately $5.0
million for the same period in 2017.
Cash, cash equivalents, and marketable securities were
$35.1 million as of September 30, 2018. In October 2018, $67.6
million of net proceeds was raised in a public offering of
Aldeyra's common stock.
Conference Call & Webcast Information
Aldeyra will hold a conference call on Wednesday, November 14, 2018, 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 developing 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 and other forms of ocular
inflammation. The company is also developing other product
candidates for autoimmune disease, post-transplant
lymphoproliferative disease, retinal inflammation, 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, 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, the ability to obtain and
maintain regulatory approval of 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
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 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, 2017 and Aldeyra's Quarterly Report
on Form 10-Q for the quarter ended June 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 Quarterly Report on Form 10-Q for the quarter
ended September 30,2018, expected to
be filed with the SEC in the fourth quarter of 2018.
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 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
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
|
2018
|
|
2017
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
7,008,652
|
|
$
2,023,337
|
|
Cash equivalent-
reverse repurchase agreements
|
|
11,000,000
|
|
18,000,000
|
|
Marketable
securities
|
|
17,133,925
|
|
22,923,462
|
|
Prepaid expenses and
other current assets
|
|
1,702,533
|
|
1,018,967
|
|
Total current
assets
|
|
36,845,110
|
|
43,965,766
|
Deferred offering
costs
|
|
43,000
|
|
165,930
|
Fixed assets,
net
|
|
243,483
|
|
43,262
|
Total assets
|
|
$
37,131,593
|
|
$
44,174,958
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
3,442,370
|
|
$
1,000,963
|
|
Accrued
expenses
|
|
3,746,037
|
|
2,236,465
|
|
Current portion of
credit facility
|
|
465,278
|
|
116,319
|
|
Total current
liabilities
|
|
7,653,685
|
|
3,353,747
|
|
|
|
|
|
Credit facility, net
of current portion and debt discount
|
|
882,841
|
|
1,220,192
|
|
Total
liabilities
|
|
8,536,526
|
|
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 20,989,302
|
|
|
|
|
|
and 19,137,639 shares issued and outstanding,
respectively
|
|
20,989
|
|
19,138
|
|
Additional paid-in
capital
|
|
156,481,258
|
|
139,241,635
|
|
Accumulated other
comprehensive income (loss)
|
|
(5,196)
|
|
(17,831)
|
|
Accumulated
deficit
|
|
(127,901,984)
|
|
(99,641,923)
|
Total stockholders' equity
|
|
28,595,067
|
|
39,601,019
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
37,131,593
|
|
$
44,174,958
|
ALDEYRA
THERAPEUTICS, INC.
|
STATEMENT OF
OPERATIONS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended
September 30,
|
|
Nine Months ended
September 30,
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
7,880,822
|
|
$
3,539,368
|
|
$
21,274,032
|
|
$
10,757,279
|
|
General and
administrative
|
|
3,065,912
|
|
1,475,904
|
|
7,330,142
|
|
4,684,574
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(10,946,734)
|
|
(5,015,272)
|
|
(28,604,174)
|
|
(15,441,853)
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
163,015
|
|
56,651
|
|
427,361
|
|
136,652
|
|
Interest
expense
|
|
(28,846)
|
|
(27,578)
|
|
(83,248)
|
|
(80,878)
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
134,169
|
|
29,073
|
|
344,113
|
|
55,774
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(10,812,565)
|
|
$
(4,986,199)
|
|
$
(28,260,061)
|
|
$
(15,386,079)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
|
$
(0.52)
|
|
$
(0.32)
|
|
$
(1.40)
|
|
$
(1.04)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding - basic and diluted
|
|
20,969,913
|
|
15,581,426
|
|
20,168,633
|
|
14,844,914
|
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SOURCE Aldeyra Therapeutics, Inc.