Aldeyra Therapeutics Announces Third Quarter 2018 Financial Results
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
$37,131,593 $44,174,958
Total assets
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
View original content:http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-third-quarter-2018-financial-results-300749773.html
SOURCE Aldeyra Therapeutics, Inc.
