Aldeyra Therapeutics Announces Second-Quarter 2020 Financial Results and Provides Corporate Update
− 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
“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
“We also have enhanced our financial flexibility with recent common stock sales to
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 theEuropean 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
For the quarter ended
Research and development expenses were
General and administrative expenses were
For the quarter ended
As of
Conference Call & Webcast Information
Aldeyra will host a conference call today at
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
About
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
In addition to the risks described above and in Aldeyra's other filings with the
CONSOLIDATED BALANCE SHEETS | ||||||||||
|
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, and 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 |
|
||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
(UNAUDITED) | |||||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||
|
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:
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor & Media Contact:
Tel: 617-542-5300
ALDX@investorrelations.com
Source: