Aldeyra Therapeutics Reports First-Quarter 2020 Financial Results and Announces New Clinical Programs
- ADX-629 Expected to Begin Phase 2 Clinical Trials in COVID-19 Respiratory Compromise, Atopic Asthma, and Psoriasis in 2020
- Type C Meeting Scheduled with FDA to Discuss Remaining NDA Requirements for Reproxalap in Dry Eye Disease
- Results from Phase 3 INVIGORATE Trial of Reproxalap in Allergic Conjunctivitis Expected in First Half of 2021
- Cash Runway Extended into 2022
-
Management to Host Conference Call at
8:00 a.m. ET Today
“Based on the success of the novel RASP inhibitor ADX-629 in Phase 1 clinical testing, we are pleased to announce a new comprehensive clinical initiative in systemic inflammatory diseases, complementing our late-stage pipeline in ocular disease,” said
New Clinical Programs in Systemic Inflammatory Diseases
Aldeyra plans to assess the activity of ADX-629 in three types of severe inflammation: cytokine release syndrome, autoimmune disease, and allergy. In preclinical models, ADX-629 treatment reduced levels of TH1, TH2, and TH17-related cytokines, suggesting potential activity across a broad array of inflammatory diseases. The timing of clinical trial initiation depends, in part, on restrictions related to COVID-19, the availability of clinical research facilities and staffing, and the ability to recruit patients.
- COVID-19 Respiratory Compromise: A Phase 2 clinical trial of ADX-629 is expected in subjects with COVID-19-associated respiratory compromise, defined as hypoxia and pulmonary radiographic involvement, immediately following admission to the hospital. Severe inflammation, characterized in part by cytokine release syndrome, leads to acute respiratory distress syndrome and other conditions that require mechanical ventilation. The clinical trial, contingent on FDA review of information submitted via the Coronavirus Treatment Acceleration Program (CTAP), is expected to begin in the third quarter of 2020.
- Autoimmune Disease: A Phase 2a clinical trial of ADX-629 in patients with psoriasis, an autoimmune condition associated with TH1 cytokines, is expected to begin in the second half of 2020.
- Allergy: A Phase 2a allergen-challenge clinical trial of ADX-629 in patients with atopic asthma, an allergic inflammatory disease associated with TH2 cytokines, is expected to begin in the second half of 2020.
Late-Stage Ocular Disease Programs
Reproxalap, a first-in-class RASP inhibitor for topical ocular administration, continues to advance towards a new drug application (NDA) filing in allergic conjunctivitis and dry eye disease. The Phase 3 GUARD Trial of ADX-2191, a novel formulation of methotrexate for intravitreal administration, in patients with proliferative vitreoretinopathy currently remains active, although enrollment has been significantly delayed due to the COVID-19 pandemic.
-
Dry Eye Disease: A Type C meeting with the
U.S. Food and Drug Administration (FDA) is scheduled for mid-2020 to discuss remaining NDA requirements for reproxalap in dry eye disease. Reproxalap has demonstrated clinically relevant improvement from baseline in two well-controlled clinical trials: Part 1 of the Phase 3 RENEW Trial announced late last year and a Phase 2 formulation trial announced earlier this year. Dry eye disease remains poorly served by available therapies, and represents one of the largest markets in ophthalmology, affecting an estimated 34 million patients inthe United States . Aldeyra plans to provide an update on dry eye disease clinical development plans following receipt and review of FDA feedback. -
Allergic Conjunctivitis: Based on delays primarily associated with an extended allergy season, results from the Phase 3 INVIGORATE Trial of reproxalap are currently expected in the first half of 2021. Based on the successful Phase 3 ALLEVIATE Trial announced in 2019, and assuming continued clinical success and positive regulatory review, reproxalap has the potential to be the first new mechanistic approach in decades for the treatment of allergic conjunctivitis. The current therapeutic landscape of allergic conjunctivitis is generally limited to antihistamines, which do not lead to satisfactory activity in up to one-third of patients, and corticosteroids, which cannot be used chronically due to potentially serious adverse events. Allergic conjunctivitis is one of most common ocular surface diseases, affecting an estimated 66 million patients in
the United States , and is often associated with dry eye disease. - Proliferative Vitreoretinopathy (PVR): Patient enrollment in Part 1 of the adaptive the Phase 3 GUARD Trial of ADX-2191 for the prevention of PVR has been significantly delayed due to lack of clinical site availability and staffing resulting from the COVID-19 pandemic. PVR is a rare but vision-threatening retinal disease associated with recurrent retinal detachments. There is no approved therapy for PVR. Aldeyra expects to update the enrollment and completion timeline by year-end, and is also exploring additional indications for ADX-2191, including primary intraocular lymphoma, a rare but serious ocular cancer that can affect the retina, uvea, optic nerve, and other ocular structures.
Financial Review for the Quarter Ended
For the quarter ended
Research and development expenses were
General and administrative expenses were
For the quarter ended
Cash, cash equivalents, and marketable securities were
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 |
|
||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents |
$ |
15,542,971 |
|
$ |
16,425,830 |
|
||
Cash equivalent - reverse repurchase agreements |
|
23,000,000 |
|
|
28,000,000 |
|
||
Marketable securities |
|
22,833,583 |
|
|
28,938,545 |
|
||
Prepaid expenses and other current assets |
|
1,375,129 |
|
|
1,804,450 |
|
||
Total current assets |
|
62,751,683 |
|
|
75,168,825 |
|
||
Right-of-use assets |
|
152,666 |
|
|
201,007 |
|
||
Fixed assets, net |
|
124,750 |
|
|
148,449 |
|
||
Total assets |
$ |
63,029,099 |
|
$ |
75,518,281 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable |
$ |
1,072,897 |
|
$ |
808,302 |
|
||
Accrued expenses |
|
3,641,724 |
|
|
11,873,122 |
|
||
Current portion of operating lease liabilities |
|
172,241 |
|
|
226,328 |
|
||
Total current liabilities |
|
4,886,862 |
|
|
12,907,752 |
|
||
Long-term debt |
|
14,669,717 |
|
|
14,528,212 |
|
||
Total liabilities |
|
19,556,579 |
|
|
27,435,964 |
|
||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock, |
— | — | ||||||
Common stock, voting, |
|
29,507 |
|
|
28,657 |
|
||
Additional paid-in capital |
|
252,615,578 |
|
|
247,409,793 |
|
||
Accumulated other comprehensive income |
|
57,594 |
|
|
5,866 |
|
||
Accumulated deficit |
|
(209,230,159 |
) |
|
(199,361,999 |
) |
||
Total stockholders’ equity |
|
43,472,520 |
|
|
48,082,317 |
|
||
Total liabilities and stockholders’ equity |
$ |
63,029,099 |
|
$ |
75,518,281 |
|
||
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(UNAUDITED) | ||||||||
Three Months Ended |
||||||||
|
2020 |
|
|
2019 |
|
|||
Operating expenses: | ||||||||
Research and development |
$ |
6,633,603 |
|
$ |
7,848,590 |
|
||
Acquired in-process research and development | — |
|
6,597,551 |
|
||||
General and administrative |
|
3,004,841 |
|
|
2,985,038 |
|
||
Loss from operations |
|
(9,638,444 |
) |
|
(17,431,179 |
) |
||
Other income (expense): | ||||||||
Interest income |
|
210,100 |
|
|
499,140 |
|
||
Interest expense |
|
(439,816 |
) |
|
(1,962 |
) |
||
Total other income (expense), net |
|
(229,716 |
) |
|
497,178 |
|
||
Loss before income taxes |
|
(9,868,160 |
) |
|
(16,934,001 |
) |
||
Income tax benefit | — |
|
1,309,973 |
|
||||
Net loss |
$ |
(9,868,160 |
) |
$ |
(15,624,028 |
) |
||
Net loss per share - basic and diluted |
$ |
(0.34 |
) |
$ |
(0.58 |
) |
||
Weighted average common shares outstanding - basic and diluted |
|
29,210,889 |
|
|
27,053,842 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005225/en/
Corporate Contact:
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor & Media Contact:
Tel: 617-542-5300
ALDX@investorrelations.com
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