- Part I of Adaptive RENEW Phase 3 Clinical Trial in Dry Eye
Disease on Track for Completion in Fourth Quarter 2019
- Adaptive GUARD Phase 3 Clinical Trial of ADX-2191 in
Proliferative Vitreoretinopathy to Initiate in Fourth Quarter
2019
- Initiation of INVIGORATE Phase 3 Clinical Trial of Reproxalap
in Allergic Conjunctivitis Planned for First Half 2020
- Phase 1 Clinical Trial of Novel, Orally Administered RASP
Inhibitor ADX-629 Initiated
- Management to Host Conference Call at 8:00 a.m. ET today
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 reported financial results for the
quarter ended September 30, 2019. In addition, the company updated
investors on anticipated clinical milestones.
“Aldeyra continued to make significant progress during the
quarter in advancing our immunology platform toward the goal of
reducing the burden of disease and helping patients lead healthier
lives,” said Aldeyra President and CEO Todd C. Brady, M.D., Ph.D.
“We have reached agreement with the U.S. Food and Drug
Administration (FDA) on the primary endpoint for our pivotal
INVIGORATE Phase 3 clinical trial of reproxalap in allergic
conjunctivitis. In addition, this quarter we expect to complete
Part 1 of our adaptive RENEW Phase 3 clinical trial of reproxalap
in dry eye disease, and initiate the first part of our adaptive
GUARD Phase 3 clinical trial in proliferative vitreoretinopathy,
representing the expansion of our ocular program from the front of
the eye to the retina.”
Clinical Milestone Updates
- Dry Eye Disease: Part 1 of Adaptive RENEW Phase 3 Clinical
Trial Scheduled for Completion in the Fourth Quarter of 2019.
Part 1 of the two-part adaptive RENEW Phase 3 dry eye disease
clinical trial of topical ocular reproxalap, the company’s lead
reactive aldehyde species (RASP) inhibitor, is scheduled for
completion in the fourth quarter of 2019, at which point Aldeyra
plans to announce the endpoints, dosing regimen, and sample size
planned for Part 2 of the trial. Dry eye disease affects more than
34 million adults in the U.S., and physicians and patients
generally regard current therapeutic options as inadequate.
- Allergic Conjunctivitis: INVIGORATE Phase 3 Clinical
Trial Scheduled to Initiate in the First Half of 2020. Aldeyra
recently released expanded data from the completed allergen chamber
clinical methods trial of topical ocular reproxalap and announced
the design of the INVIGORATE Phase 3 clinical trial, which is
expected to initiate in the first half of 2020. The primary
endpoint of INVIGORATE is statistical significance versus vehicle
in ocular itch (0-4 scale) at a majority of 11 time points between
110 and 210 minutes after chamber entry. In October, the company
presented the results of the ALLEVIATE Phase 3 clinical trial in
allergic conjunctivitis at the American Academy of Ophthalmology
Annual Meeting in San Francisco. ALLEVIATE met the primary endpoint
of reduction of ocular itch versus vehicle following conjunctival
allergen challenge. Of the estimated 100 million allergic
conjunctivitis sufferers in the U.S., up to 30 million do not
respond adequately to, or are dissatisfied with,
antihistamines.
- Proliferative Vitreoretinopathy: Part 1 of the Adaptive
GUARD Phase 3 Clinical Trial Scheduled to Initiate in the Fourth
Quarter of 2019. Patient enrollment in Part 1 of the adaptive
GUARD Phase 3 Clinical Trial of ADX-2191 is expected to begin in
the fourth quarter of 2019. GUARD will compare recurrence rates
across patients treated with ADX-2191 or standard of care following
surgical repair of retinal detachment due to proliferative
vitreoretinopathy (PVR). In September, the FDA granted fast track
designation to ADX-2191 for the prevention of PVR, a rare
inflammatory disorder of the retina that leads to severe retinal
scarring and blindness. There is no approved therapy for PVR. More
than 50% of PVR cases result in severe uncorrectable vision loss,
and 76% of patients suffer from at least moderate uncorrectable
vision loss.
- Systemic Autoimmune Disease: ADX-629 Phase 1 Clinical Trial
Initiated. Patient enrollment is underway in the Phase 1
clinical trial of ADX-629, a novel orally administered RASP
inhibitor in development for the treatment of systemic autoimmune
disease and potentially other serious medical conditions.
- Post-transplant Lymphoproliferative Syndrome: Phase 2
Clinical Trial of ADX-1612 Scheduled to Initiate in the Fourth
Quarter of 2019. The Phase 2 clinical trial of ADX-1612,
Aldeyra’s lead chaperome inhibitor, is slated to start in the
fourth quarter of 2019 in patients with post-transplant
lymphoproliferative syndrome, a rare and potentially fatal
immunological disease that can occur following solid organ
transplant.
Outlook “We expect our clinical momentum to accelerate as
we move through the fourth quarter of this year and into 2020,” Dr.
Brady said. “We believe that reproxalap has the potential to be the
next novel entrant in dry eye disease and allergic conjunctivitis,
part of a spectrum of conditions estimated to affect more than four
in ten Americans. Our ocular programs represent the initial step of
our mission to develop therapies for a broad category of systemic
immune-mediated diseases.”
Quarter Ended September 30, 2019 Financial Review For the
quarter ended September 30, 2019, Aldeyra reported a net loss of
approximately $18.7 million, compared with a net loss of
approximately $10.8 million for the quarter ended September 30,
2018. Basic and diluted net loss per share was $0.69 for the
quarter ended September 30, 2019, compared with $0.52 per share for
the same period in 2018. Losses resulted from the costs of research
and development programs, as well as from general and
administrative expenses.
Research and development expenses were $16.2 million for the
quarter ended September 30, 2019, compared with $7.9 million for
the same period in 2018. The increase of $8.3 million is primarily
related to an increase in clinical and preclinical development and
manufacturing 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 $2.8 million for the
quarter ended September 30, 2019, compared with $3.1 million for
the quarter ended September 30, 2018. The decrease of $0.3 million
is primarily related to lower consulting costs.
For the quarter ended September 30, 2019, total operating
expenses were approximately $19.0 million, compared with total
operating expenses of approximately $10.9 million for the same
period in 2018.
As of September 30, 2019, cash, cash equivalents, and marketable
securities were $76.2 million, which includes $15.0 million drawn
from the company’s debt facility in September 2019.
Conference Call & Webcast Information Aldeyra will
host a conference call today at 8:00 a.m. ET to discuss its
third-quarter financial results and provide a corporate update. The
dial-in numbers are 1-866-211-4098 for domestic callers and
1-647-689-6613 for international callers. The conference ID number
for the live call will be 9487086.
A live webcast of the conference call will also be available on
the Investors Relations section of the Aldeyra Therapeutics website
at https://ir.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," "on track," "scheduled," "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
clinical 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 and Aldeyra's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2019, 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, 2019 expected to be filed in the fourth 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
September 30,2019
December 31,
(Unaudited)
2018
ASSETS Current assets:
Cash and cash equivalents
$
25,604,203
$
3,357,472
Cash equivalent - Reverse Repurchase Agreements
26,000,000
$
44,000,000
Marketable securities
24,567,074
46,242,220
Prepaid expenses and other current assets
849,087
1,169,594
Total current assets
77,020,364
94,769,286
Deferred offering costs —
86,644
Right-of-use assets
248,165
— Fixed assets, net
172,470
235,225
Total assets
$
77,440,999
$
95,091,155
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable
$
572,363
$
3,051,678
Accrued expenses
11,324,963
5,421,498
Current portion of operating lease liabilities
218,953
— Total current liabilities
12,116,279
8,473,176
Non-current liabilities:
Long-term debt
14,386,706
— Operating lease liabilities, net of current portion
58,720
— Total liabilities
26,561,705
8,473,176
Stockholders' equity:
Common stock, voting, $0.001 par value; 150,000,000 authorized
and 27,151,775 and 26,244,435 shares issued and outstanding,
respectively
27,152
26,244
Additional paid-in capital
237,047,752
225,136,127
Accumulated other comprehensive income (loss)
5,766
(9,224
)
Accumulated deficit
(186,201,376
)
(138,535,168
)
Total stockholders’ equity
50,879,294
86,617,979
Total liabilities and
stockholders’ equity
$
77,440,999
$
95,091,155
ALDEYRA THERAPEUTICS, INC. STATEMENTS OF OPERATIONS
(Unaudited) Three Months Ended September
30, Nine Months Ended September 30,
2019
2018
2019
2018
Operating expenses: Research and development
$
16,223,972
$
7,880,822
$
34,737,420
$
21,274,032
Acquired in-process research and development
(47,102
)
—
6,500,602
— General and administrative
2,839,319
3,065,912
8,940,771
7,330,142
Loss from operations
(19,016,189
)
(10,946,734
)
(50,178,793
)
(28,604,174
)
Other income (expense): Interest income
330,329
163,015
1,262,378
427,361
Interest expense
(29,154
)
(28,846
)
(59,766
)
(83,248
)
Total other income (expense), net
301,175
134,169
1,202,612
344,113
Loss before income taxes
(18,715,014
)
(10,812,565
)
(48,976,181
)
(28,260,061
)
Income tax benefit
—
—
1,309,973
— Net loss
$
(18,715,014
)
$
(10,812,565
)
$
(47,666,208
)
$
(28,260,061
)
Net loss per share - basic and diluted
$
(0.69
)
$
(0.52
)
$
(1.77
)
$
(1.40
)
Weighted average common shares outstanding - basic and
diluted
27,111,600
20,969,913
26,928,725
20,168,633
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191107005280/en/
Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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