Aldeyra Therapeutics Reports Second-Quarter 2022 Financial Results and Recent Corporate Highlights
Aldeyra Therapeutics (Nasdaq: ALDX) reported significant progress in Q2 2022, with cash reserves of $196.7 million expected to support operations into 2023. Key upcoming milestones include pre-NDA meetings with the FDA for reproxalap, aimed at treating dry eye disease, and ADX-2191 for primary vitreoretinal lymphoma. Positive results from clinical trials of reproxalap indicated statistical superiority in reducing ocular discomfort. However, the company reported a net loss of $17.8 million for the quarter, an increase from the prior year, primarily due to rising R&D expenses.
- Cash and marketable securities of $196.7 million as of June 30, 2022, sufficient to fund operations through 2023.
- Reproxalap showed statistically significant improvements in ocular redness and tear production in clinical trials.
- Upcoming NDA submissions for reproxalap and ADX-2191 indicate progress in regulatory pathways.
- Net loss of $17.8 million for Q2 2022, compared to $14.9 million in Q2 2021.
- R&D expenses increased by $3.1 million due to higher external clinical development costs.
-
Pre-NDA (New Drug Application) Meeting with the
U.S. Food and Drug Administration (FDA) Scheduled for the Third Quarter of 2022 to Discuss NDA Submission of Reproxalap for the Treatment of Dry Eye Disease - Pre-NDA Meeting with the FDA Planned for the Second Half of 2022 to Discuss NDA Submission of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma
- Top-line Results from Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected in the Second Half of 2022
- Top-line Results from Phase 2 Clinical Trial of Oral RASP Modulator ADX-629 in Acute Alcoholic Hepatitis Expected in the Second Half of 2022
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Cash, Cash Equivalents, and
Marketable Securities of as of$196.7 Million June 30, 2022 -
Management to Host Conference Call at
8:00 a.m. ET Today
“The second half of 2022 is highlighted by planned new drug applications in dry eye disease and primary vitreoretinal lymphoma, two diseases that are currently sub-optimally treated,” stated
Recent Corporate Highlights
- Positive Results from the Dry Eye Disease Chamber Crossover Clinical Trial: Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, ocular redness in a dry eye chamber (P=0.0004) and Schirmer test (P=0.0005), a measure of tear production, after a single day of dosing. The secondary endpoint of Schirmer test ≥10 mm responder analysis, which was multiplicity-controlled and has been reported to correlate with symptomatic improvement in dry eye disease,1 was also achieved (P=0.0361). Rapid and statistically significant reductions in patient-reported ocular discomfort and dryness were observed in the dry eye disease chamber.
- Positive Results from the Phase 3 TRANQUILITY-2 Trial in Dry Eye Disease: Reproxalap was statistically superior to vehicle for each of the two prespecified primary endpoints, Schirmer test (P=0.0001) and Schirmer test ≥10 mm responder analysis (P<0.0001) after a single day of dosing.
Upcoming Planned Clinical and Regulatory Milestones
- NDA Submission of Reproxalap in Dry Eye Disease: Pending discussions with the FDA and enrollment in the 12-month safety trial of reproxalap in patients with dry eye disease, Aldeyra intends to submit an NDA with data on ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis, encompassing results across five adequate and well-controlled completed clinical trials. A pre-NDA meeting with the FDA to discuss the regulatory package has been scheduled for the third quarter of 2022.
- Pre-NDA Meeting for ADX-2191 in Primary Vitreoretinal Lymphoma: Aldeyra plans to conduct a pre-NDA meeting with the FDA in the second half of 2022 to discuss ADX-2191 for the treatment of primary vitreoretinal lymphoma. Pending discussion with the FDA, an NDA submission is planned for the second half of 2022.
- Results from the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy: Top-line results from Part 1 of the Phase 3 GUARD trial of ADX-2191 in patients with proliferative vitreoretinopathy are expected in the second half of 2022.
- Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa: Top-line results from the Phase 2 clinical trial of ADX-2191 in patients with retinitis pigmentosa are expected in the first half of 2023.
- Results from Phase 2 Clinical Trials of ADX-629 in Systemic Immune-Mediated Diseases: In the second half of this year, Aldeyra expects to report top-line results from a Phase 2 clinical trial in acute alcoholic hepatitis, and to initiate Phase 2 clinical trials in Sjögren-Larsson Syndrome and minimal change disease. Top-line results from the ongoing Phase 2 clinical trial of ADX-629 in chronic cough are anticipated in the first half of 2023.
Second-Quarter 2022 Financial Results
Cash, cash equivalents, and marketable securities as of
Net loss for the three months ended
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
Total operating expenses for the three months ended
Conference Call & Webcast Information
Aldeyra will host a conference call at
A live webcast of the conference call can be accessed via the Investors & Media page of the Aldeyra website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the website for 90 days.
About Aldeyra
Aldeyra is a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases. Our approach is to discover pharmaceuticals that modulate immunological systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Two of our lead product candidates, reproxalap and ADX-629, target pre-cytokine, systems-based mediators of inflammation known as RASP (reactive aldehyde species). Reproxalap is in late-stage clinical trials in patients with dry eye disease and allergic conjunctivitis. ADX-629, an orally administered RASP modulator, is in Phase 2 clinical testing for the treatment of systemic immune-mediated diseases. Our pipeline also includes ADX-2191 (intravitreal methotrexate
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing of planned NDA submissions; the anticipated timing of enrollment and results from Aldeyra’s clinical trials; expectations regarding the results of scheduled and planned pre-NDA meetings, including the FDA’s acceptance of Aldeyra’s post-hoc review of data, the FDA’s agreement with Aldeyra’s methods of analyzing data and the FDA’s agreement that data from the crossover clinical trial can be used to support the safety or efficacy of reproxalap; and Aldeyra’s projected cash runway. 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, enrollment 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 or post-hoc review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols, data analysis methodologies, 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 in clinical trials focused on the same or on different indications; the risk that the results from earlier clinical trials, portions of clinical trials, or pooled clinical data may not accurately predict results of subsequent trials or the remainder of a clinical trial; 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) and obtain reimbursement for 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 COVID-19 pandemic and subsequent public health measures, and war or other military actions, 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
1 Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000;118(5):615-21.
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||||||||
CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
|||||||
2022 |
2021 |
|||||||
ASSETS | (Unaudited) |
|||||||
Current assets: | ||||||||
Cash and cash equivalents | $ |
42,012,015 |
|
$ |
104,790,989 |
|
||
Cash equivalent - reverse repurchase agreements |
|
79,000,000 |
|
|
125,000,000 |
|
||
Marketable securities |
|
75,677,040 |
|
|
— |
|
||
Prepaid expenses and other current assets |
|
4,052,355 |
|
|
2,961,781 |
|
||
Total current assets |
|
200,741,410 |
|
|
232,752,770 |
|
||
Right-of-use assets |
|
239,873 |
|
|
351,863 |
|
||
Fixed assets, net |
|
34,041 |
|
|
32,487 |
|
||
Total assets | $ |
201,015,324 |
|
$ |
233,137,120 |
|
||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ |
264,225 |
|
$ |
1,019,702 |
|
||
Accrued expenses |
|
10,810,155 |
|
|
10,523,353 |
|
||
Current portion of long-term debt |
|
4,925,765 |
|
|
— |
|
||
Current portion of operating lease liabilities |
|
242,636 |
|
|
229,607 |
|
||
Total current liabilities |
|
16,242,781 |
|
|
11,772,662 |
|
||
Operating lease liabilities, long-term |
|
— |
|
|
125,232 |
|
||
Long-term debt, net of current portion |
|
10,743,535 |
|
|
15,503,703 |
|
||
Total liabilities |
|
26,986,316 |
|
|
27,401,597 |
|
||
Stockholders' equity: | ||||||||
Preferred stock, |
|
— |
|
|
— |
|
||
Common stock, voting, |
|
58,301 |
|
|
58,081 |
|
||
Additional paid-in capital |
|
503,517,715 |
|
|
500,369,444 |
|
||
Accumulated other comprehensive loss |
|
(285,763 |
) |
|
— |
|
||
Accumulated deficit |
|
(329,261,245 |
) |
|
(294,692,002 |
) |
||
Total stockholders’ equity |
|
174,029,008 |
|
|
205,735,523 |
|
||
Total liabilities and stockholders’ equity | $ |
201,015,324 |
|
$ |
233,137,120 |
|
||
|
|||||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||||||
(UNAUDITED) |
|||||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||||
2022 |
2021 |
2022 |
2021 |
||||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | $ |
14,570,654 |
|
$ |
11,474,446 |
|
$ |
26,804,975 |
|
$ |
19,200,788 |
|
|||||
General and administrative |
|
3,144,280 |
|
|
3,068,652 |
|
|
7,393,667 |
|
|
6,173,355 |
|
|||||
Loss from operations |
|
(17,714,934 |
) |
|
(14,543,098 |
) |
|
(34,198,642 |
) |
|
(25,374,143 |
) |
|||||
Other income (expense): | |||||||||||||||||
Interest income |
|
344,378 |
|
|
39,665 |
|
|
445,760 |
|
|
63,427 |
|
|||||
Interest expense |
|
(410,395 |
) |
|
(433,477 |
) |
|
(816,361 |
) |
|
(916,056 |
) |
|||||
Total other income (expense), net |
|
(66,017 |
) |
|
(393,812 |
) |
|
(370,601 |
) |
|
(852,629 |
) |
|||||
Net loss | $ |
(17,780,951 |
) |
$ |
(14,936,910 |
) |
$ |
(34,569,243 |
) |
$ |
(26,226,772 |
) |
|||||
Net loss per share - basic and diluted | $ |
(0.30 |
) |
$ |
(0.28 |
) |
$ |
(0.59 |
) |
$ |
(0.52 |
) |
|||||
Weighted average common shares outstanding - basic and diluted |
|
58,301,491 |
|
|
54,280,393 |
|
|
58,299,686 |
|
|
49,979,545 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220804005996/en/
Investor & Media Contact:
Tel: (857) 383-2409
ALDX@investorrelations.com
Source:
FAQ
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