- Part 1 of Adaptive Phase 3 RENEW Trial in Dry Eye Disease
Expected to be Completed in Fourth Quarter 2019
- Meeting with FDA Scheduled in Fourth Quarter 2019 to Confirm
Design of Second Phase 3 Trial in Allergic Conjunctivitis
- Initiation of the Adaptive Phase 3 GUARD Trial of ADX-2191 in
Proliferative Vitreoretinopathy Planned for Fourth Quarter
2019
- Part 1 of Adaptive Phase 3 RESET Trial in Sj�gren-Larsson
Syndrome Completed
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 June 30,
2019 financial results and provided a corporate update.
“With Part 1 of our first Phase 3 trial in dry eye disease
expected to be completed later this year, Aldeyra continues to
advance reproxalap, the lead product candidate in our novel RASP
inhibitor platform, towards commercialization,” commented Todd C.
Brady, M.D., Ph.D., President and CEO of Aldeyra. “In addition, in
the fourth quarter of 2019, we expect to confirm the design of our
second Phase 3 trial of reproxalap in allergic conjunctivitis and
initiate Phase 3 clinical testing of ADX-2191 in our first retinal
indication, proliferative vitreoretinopathy, a rare and potentially
blinding inflammatory disorder with no approved therapies.”
Recent Highlights and Corporate Updates
- Dry Eye Disease – Part 1 of the Adaptive Phase 3 RENEW Trial
Expected to be Completed in Fourth Quarter of 2019. Aldeyra
announced completion of enrollment in Part 1 of the two-part
adaptive Phase 3 RENEW Trial of topical ocular reproxalap in dry
eye disease. Following completion of Part 1 of RENEW, expected in
the fourth quarter of 2019, Aldeyra plans to report the endpoints,
dosing regimen, and sample size for Part 2 of the trial. Top-line
results of the RENEW Trial are expected to be announced following
completion of Part 2.
- Allergic Conjunctivitis – FDA Meeting Scheduled for Fourth
Quarter to Confirm Design of Second Phase 3 Clinical Trial. In
March 2019, Aldeyra reported positive top-line results from the
Phase 3 ALLEVIATE Trial of topical ocular reproxalap in allergic
conjunctivitis, and plans to present full results of ALLEVIATE at
the American Academy of Ophthalmology 2019 Annual Meeting in
October 2019. In addition, in June of 2019, Aldeyra announced
results of topical ocular reproxalap in an allergen chamber trial,
which demonstrated that ocular itching and redness in
reproxalap-treated patients were statistically lower than that of
vehicle-treated patients. A meeting with the U.S. Food and Drug
Administration (FDA) has been scheduled in the fourth quarter of
2019 to confirm the design of a second Phase 3 trial.
- Proliferative Vitreoretinopathy – the Adaptive Phase 3 GUARD
Clinical Trial of ADX-2191 Expected to Initiate in the Fourth
Quarter of 2019. Later this year, Aldeyra expects to initiate
the adaptive Phase 3 GUARD Trial of ADX-2191 for the prevention of
proliferative vitreoretinopathy (PVR). The trial will compare
recurrence rates across patients treated with ADX-2191 or standard
of care following surgical repair of retinal detachment due to PVR.
PVR is expected to be the first indication in Aldeyra’s retinal
disease platform to begin clinical testing.
- Sj�gren-Larsson Syndrome – Part 1 of the Phase 3 RESET Trial
Completed. In Part 1 of the two-part adaptive Phase 3 RESET
trial in Sj�gren-Larsson Syndrome, investigator-assessed dermal
scaling scores in the six patients treated with 1% reproxalap
topical dermatologic formulation were statistically lower than
pre-treatment values over six months of therapy, an improvement
that was numerically greater than that observed in the three
patients treated with vehicle, when adjusted for baseline score.
Prior to initiating subsequent clinical testing, Aldeyra plans to
discuss the RESET Part 1 results with regulatory authorities. The
RESET Trial is a randomized, multi-center, double-masked Phase 3
clinical trial of 1% topical dermal reproxalap for the treatment of
ichthyosis, a severe skin disease associated with Sj�gren-Larsson
Syndrome.
- Programs in Systemic Immune-Mediated Diseases Expected to
Begin Clinical Testing in 2019. As Aldeyra expands to the
development of therapies for the treatment of systemic
immune-mediated disease, 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 and
metabolic disease remain on track to be initiated in the second
half of 2019.
Quarter Ended June 30, 2019 Financial Review For the
quarter ended June 30, 2019, Aldeyra reported a net loss of
approximately $13.3 million, compared to a net loss of
approximately $9.1 million for the quarter ended June 30, 2018.
Basic and diluted net loss per share was $0.49 for the quarter
ended June 30, 2019, compared to $0.46 per share for the same
period in 2018. Losses have resulted from the costs of research and
development programs, as well as from general and administrative
expenses.
Research and development expenses were $10.7 million for the
quarter ended June 30, 2019, compared to $6.8 million for the same
period in 2018. The increase of $3.9 million is primarily related
to an increase in manufacturing, preclinical, and clinical
development costs; an increase in personnel costs; and non-cash
compensation costs related to a portion of upfront acquisition
consideration that is subject to vesting based on continued
service.
General and administrative expenses were $3.1 million for the
quarter ended June 30, 2019, compared to $2.4 million for the
quarter ended June 30, 2018. The increase of $0.7 million is
primarily related to an increase in personnel costs.
For the quarter ended June 30, 2019, total operating expenses
were approximately $13.7 million, compared to total operating
expenses of approximately $9.2 million for the same period in
2018.
Cash, cash equivalents, and marketable securities were $69.5
million as of June 30, 2019.
Conference Call & Webcast Information Aldeyra will
hold a conference call on Thursday, August 8, 2019, at 8:00 a.m.
Eastern Time. The dial-in numbers are 1-877-211-4098 for domestic
callers and 1-647-689-6613 for international callers. The
conference ID number for the live call will be 9329328. 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 investigational drug
product candidates are first-in-class potential treatments in
development for dry eye disease, allergic conjunctivitis,
proliferative vitreoretinopathy, and Sj�gren-Larsson Syndrome. The
company is also developing other product candidates for retinal and
systemic inflammatory diseases.
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 relating to current or future clinical
development. 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 June 30, 2019 expected to be filed
in the third 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.
ALDEYRA THERAPEUTICS, INC. BALANCE SHEETS
June 30,
2019
December 31,
(Unaudited)
2018
ASSETS Current assets: Cash and cash equivalents
$
7,399,564
$
3,357,472
Cash equivalent - Reverse Repurchase Agreements
32,000,000
$
44,000,000
Marketable securities
30,057,408
46,242,220
Prepaid expenses and other current assets
3,398,930
1,169,594
Total current assets
72,855,902
94,769,286
Deferred offering costs —
86,644
Debt issuance costs
492,448
— Right-of-use assets
294,173
— Fixed assets, net
196,491
235,225
Total assets
$
73,839,014
$
95,091,155
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
2,773,987
$
3,051,678
Accrued expenses
3,403,789
5,421,498
Current portion of operating lease liabilities
211,744
— Total current liabilities
6,389,520
8,473,176
Operating lease liabilities, long-term
116,124
— Total liabilities
6,505,644
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 26,986,936 and
26,244,435 shares issued and outstanding, respectively
26,987
26,244
Additional paid-in capital
234,779,291
225,136,127
Accumulated other comprehensive income (loss)
13,453
(9,224
)
Accumulated deficit
(167,486,361
)
(138,535,168
)
Total stockholders’ equity
67,333,370
86,617,979
Total liabilities and stockholders’ equity
$
73,839,014
$
95,091,155
ALDEYRA THERAPEUTICS, INC. STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Operating expenses: Research and development
$
10,664,858
$
6,792,974
$
18,513,448
$
13,393,080
Acquired in-process research and development
(49,848
)
—
6,547,703
— General and administrative
3,116,414
2,373,059
6,101,452
4,264,360
Loss from operations
(13,731,424
)
(9,166,033
)
(31,162,603
)
(17,657,440
)
Other income (expense): Interest income
432,908
141,956
932,049
264,346
Interest expense
(28,649
)
(26,358
)
(30,612
)
(54,402
)
Total other income (expense), net
404,259
115,598
901,437
209,944
Loss before income taxes
(13,327,165
)
(9,050,435
)
(30,261,166
)
(17,447,496
)
Income tax benefit
—
—
1,309,973
— Net loss
$
(13,327,165
)
$
(9,050,435
)
$
(28,951,193
)
$
(17,447,496
)
Net loss per share - basic and diluted
$
(0.49
)
$
(0.46
)
$
(1.08
)
$
(0.88
)
Weighted average common shares outstanding - basic and
diluted
26,985,454
19,761,352
26,836,292
19,761,352
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190808005197/en/
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
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