− Based on FDA Agreement that RASP is an Objective Sign of Dry
Eye Disease, Assessment of Tear RASP Levels in Dry Eye Disease
Patients Expected to Begin in the Fourth Quarter of 2020
− New Drug Application (NDA) Submission for Reproxalap in Dry
Eye Disease Expected by the End of 2021
− Current Cash Expected to Support Operations Through 2022,
Including Potential Approvals for Dry Eye Disease and Allergic
Conjunctivitis
− Management to Host Conference Call at 8:00 a.m. ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
clinical-stage biotechnology company focused on the development of
novel therapies with the potential to improve the lives of patients
with immune-mediated diseases, today announced financial results
for the second quarter of 2020 and provided a corporate update.
“We continue to make important progress in advancing a number of
clinical-stage programs focused on the development of reproxalap
and ADX-629, our first-in-class reactive aldehyde species (RASP)
inhibitors,” stated Todd C. Brady, M.D., Ph.D., President and CEO
of Aldeyra. “Following a successful meeting with the US Food and
Drug Administration (FDA) in June, we are on track to initiate
clinical trials assessing levels of RASP, a pro-inflammatory
mediator, in the tears of patients with dry eye disease. Clinical
development of ADX-629, an orally available RASP inhibitor, in
COVID-19, psoriasis, and atopic asthma is expected to begin during
the second half of this year.”
“We also have enhanced our financial flexibility with recent
common stock sales to Perceptive Advisors and Avidity Partners,
transactions that generated gross proceeds of approximately $19.5
million and completed our previously announced at-the-market
offering program,” Dr. Brady continued. “We now expect to be able
to fund operations through 2022, including potential approvals for
reproxalap in dry eye disease and allergic conjunctivitis.”
Recent Highlights
- Use of RASP as an Objective Sign for Treatment of Dry Eye
Disease: In June 2020, Aldeyra announced agreement with the FDA
for the use of RASP as an objective sign for the treatment of dry
eye disease, marking the first new objective sign for the disease
in more than a decade.
- IND Submission for ADX-629: Aldeyra completed an
Investigational New Drug (IND) submission under the FDA’s
Coronavirus Accelerated Treatment Program to initiate a Phase 2
clinical trial of ADX-629 in patients with COVID-19.
- Orphan Medicinal Product Designation for ADX-2191: The
European Commission designated ADX-2191 as an orphan medicinal
product for the treatment of retinal detachment. ADX-2191, a novel
and proprietary intravitreal formulation of methotrexate, is being
evaluated in the Phase 3 GUARD Trial for prevention of recurrent
retinal detachment due to proliferative vitreoretinopathy (PVR),
the leading cause of failure of retinal detachment surgery. Drugs
that receive the orphan medicinal product designation in the
European Union (EU) are entitled to protocol assistance, research
funding, and, upon approval, 10 years of EU market
exclusivity.
Clinical-Stage Pipeline Updates
- Reproxalap – A Novel Topical Ocular RASP Inhibitor for the
Treatment of Dry Eye Disease and Allergic Conjunctivitis: In
the fourth quarter of this year, Aldeyra intends to initiate
clinical testing to assess the activity of topical ocular
reproxalap in reducing tear levels of RASP and other objective
signs of dry eye disease, subject to finalization of trial design,
RASP assay development, and potential disruptions due to the
COVID-19 pandemic. In addition, a safety trial in dry eye disease
patients is expected to be initiated in the fourth quarter of 2020.
NDA submission is expected by the end of 2021, assuming positive
clinical trial results and regulatory review. Top-line results from
the Phase 3 INVIGORATE allergen chamber trial, the second Phase 3
trial of reproxalap in allergic conjunctivitis, are expected in the
first half of 2021.
- ADX-629 – A Novel Orally Available RASP
Inhibitor for the Treatment of Systemic Inflammatory Diseases:
An IND for Phase 2 clinical testing of ADX-629 in patients with
COVID-19 has been filed with the FDA. Additionally, in the fourth
quarter of this year, the company expects to initiate Phase 2a
clinical trials of ADX-629 in patients with psoriasis and atopic
asthma.
- ADX-2191 – An Intravitreal Methotrexate
Injectable for Rare Proliferative Ocular Diseases: Aldeyra has
filed for Orphan Drug Designation (ODD) with the FDA for ADX-2191
for the treatment of primary vitreoretinal lymphoma, a rare,
aggressive, high-grade cancer that arises in the vitreous and
retina. Additionally, an update on enrollment in the Phase 3 GUARD
trial of ADX-2191 for the prevention of PVR, a rare but serious
sight-threatening retinal disease with no approved treatment, is
expected by the end of this year.
- ADX-1612 – A Protein Chaperome Inhibitor for
Systemic Disease: Enrollment has been completed in the
investigator-sponsored Phase 2 EUDARIO Trial of ADX-1612 in ovarian
cancer. Regarding the ADX-1612 COVID-19 program, consistent with
FDA feedback, additional preclinical antiviral testing of ADX-1612
against SARS-CoV-2, the virus that causes COVID-19, will be
performed by the National Institute of Allergy and Infectious
Diseases, which has accepted the company’s request to evaluate
ADX-1612 in in vivo models. Aldeyra expects to provide an update on
the ADX-1612 COVID-19 program by the end of 2020.
Financial Results for the Quarter Ended June 30, 2020
For the quarter ended June 30, 2020, Aldeyra reported a net loss
of $7.5 million, compared with a net loss of $13.3 million for the
quarter ended June 30, 2019. Net loss per share was $0.25 for the
quarter ended June 30, 2020, compared with $0.49 for the same
period in 2019. 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 $4.9 million for the
quarter ended June 30, 2020, compared with $10.7 million for the
same period in 2019. The decrease of $5.8 million is primarily
related to the decreases in clinical and preclinical development,
manufacturing, and personnel costs.
General and administrative expenses were $2.2 million for the
quarter ended June 30, 2020, compared with $3.1 million for the
same period in 2019. The decrease of $0.9 million is due to
decreases in personnel related costs, including stock-based
compensation, and other miscellaneous administrative costs.
For the quarter ended June 30, 2020, total operating expenses
were $7.1 million, compared with total operating expenses of $13.7
million for the same period in 2019.
As of June 30, 2020, cash, cash equivalents, and marketable
securities were $66.2 million. Subsequent to June 30, 2020, $25.2
million in cash was received from at-the-market offering program
sales to Perceptive Advisors, Avidity Partners, and other
investors. Based on current operating plans, cash, cash
equivalents, and marketable securities as of June 30, 2020, plus
the additional at-the-market offering program proceeds, are
expected to be sufficient to fund operations through the end of
2022, including potential NDA approvals for reproxalap in dry eye
disease and allergic conjunctivitis, assuming positive clinical
trial results, and planned NDA submissions, acceptances, and
approvals. Use of Aldeyra’s cash, cash equivalents, and marketable
securities are also expected to include the continuation of Part 1
of the Phase 3 GUARD Trial in PVR, and Phase 2 clinical testing of
ADX-629, an orally administered RASP inhibitor, in inflammatory
diseases.
Conference Call & Webcast Information
Aldeyra will host a conference call today at 8:00 a.m. ET to
discuss its second-quarter 2020 financial results. The dial-in
numbers are (866) 211-4098 for domestic callers and (647) 689-6613
for international callers. The Conference ID number is 9297174. Due
to the expected high demand on our conference provider, please plan
to dial in to the call at least 15 minutes prior to the start
time.
A live webcast of the conference call will also be available on
the investor relations page of the company’s corporate website at
https://ir.aldeyra.com. After the live webcast, the event will
remain archived on the Aldeyra Therapeutics website for 90
days.
About Aldeyra Therapeutics
Aldeyra Therapeutics is a clinical-stage biotechnology company
focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of
the company’s lead compounds, reproxalap and ADX-629, target
reactive aldehyde species (RASP), which are elevated in ocular and
systemic inflammatory disease and result in cytokine release via
activation of a broad array of inflammatory factors, including
NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being
evaluated in Phase 3 clinical trials in patients with dry eye
disease and allergic conjunctivitis. The company’s clinical
pipeline also includes ADX-2191, a dihydrofolate reductase
inhibitor in Phase 3 testing for proliferative vitreoretinopathy,
and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19
and ovarian cancer. For more information, visit
https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and
Twitter.
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, expected cash runway, prospects, plans, and objectives
and Aldeyra's plans and expectations for its product candidates,
including reproxalap, ADX-629, ADX-2191, and ADX-1612. 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.
As a result of the COVID-19 pandemic, clinical site
availability, staffing, and patient recruitment have been
negatively affected and the timelines to complete our clinical
trials may be delayed. 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; the current and potential future impact of the
COVID-19 pandemic on our business, results of operations and
financial position; 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;
political, economic, legal, social and health risks, including the
recent COVID-19 outbreak and subsequent public health measures,
that may affect Aldeyra’s business or the global economy; 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, 2019 and
Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March
31, 2020, 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 set forth in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020,
expected to be filed with the SEC in the third quarter of 2020.
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. CONSOLIDATED BALANCE
SHEETS June 30, December 31,
2020
2019
ASSETS (Unaudited) Current assets: Cash and cash
equivalents
$
50,688,834
$
16,425,830
Cash equivalent - reverse repurchase agreements
10,000,000
$
28,000,000
Marketable securities
5,500,975
28,938,545
Prepaid expenses and other current assets
5,232,717
1,804,450
Total current assets
71,422,526
75,168,825
Right-of-use assets
103,074
201,007
Fixed assets, net
101,695
148,449
Total assets
$
71,627,295
$
75,518,281
LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable
$
216,689
$
808,302
Accrued expenses
3,693,594
11,873,122
Current portion of credit facility
894,042
—
Current portion of operating lease liabilities
116,124
226,328
Total current liabilities
4,920,449
12,907,752
Long-term debt
13,917,180
14,528,212
Total liabilities
18,837,629
27,435,964
Commitments and contingencies Stockholders' equity: Common
stock, voting, $0.001 par value; 150,000,000 authorizedand
32,997,346 and 28,656,832 shares issued and outstanding,
respectively
32,997
28,657
Additional paid-in capital
269,502,290
247,409,793
Accumulated other comprehensive income
4,754
5,866
Accumulated deficit
(216,750,375
)
(199,361,999
)
Total stockholders’ equity
52,789,666
48,082,317
Total liabilities and stockholders’ equity
$
71,627,295
$
75,518,281
ALDEYRA THERAPEUTICS, INC. CONSOLIDATED STATEMENTS
OF OPERATIONS (UNAUDITED) Three Months
Ended June 30, Six Months Ended June 30,
2020
2019
2020
2019
Operating expenses: Research and development
$
4,885,875
$
10,664,858
$
11,519,478
$
18,513,448
Acquired in-process research and development
—
(49,848
)
—
6,547,703
General and administrative
2,220,003
3,116,414
5,224,844
6,101,452
Loss from operations
(7,105,878
)
(13,731,424
)
(16,744,322
)
(31,162,603
)
Other income (expense): Interest income
71,710
432,908
281,809
932,049
Interest expense
(486,048
)
(28,649
)
(925,863
)
(30,612
)
Total other income (expense), net
(414,338
)
404,259
(644,054
)
901,437
Loss before income taxes
(7,520,216
)
(13,327,165
)
(17,388,376
)
(30,261,166
)
Income tax benefit
—
—
—
1,309,973
Net loss
$
(7,520,216
)
$
(13,327,165
)
$
(17,388,376
)
$
(28,951,193
)
Net loss per share - basic and diluted
$
(0.25
)
$
(0.49
)
$
(0.59
)
$
(1.08
)
Weighted average common shares outstanding - basic and
diluted
30,118,456
26,985,454
29,586,148
26,836,292
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200806005469/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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