Aldeyra Therapeutics Reports Full-Year 2022 Financial Results and Recent Corporate Highlights
Aldeyra Therapeutics (Nasdaq: ALDX) reported significant developments and financial results for 2022, with key highlights including the Priority Review Designation for ADX-2191 to treat primary vitreoretinal lymphoma, with a PDUFA date set for June 21, 2023. The NDA for reproxalap to treat dry eye disease has a PDUFA date of November 23, 2023. Financially, cash and marketable securities totaled $174.3 million as of December 31, 2022. Despite a net loss of $62 million for the year, Aldeyra believes its current financial resources will fund operations into the second half of 2024, supporting ongoing clinical trials and potential commercial launches.
- Priority Review Designation granted for ADX-2191 for primary vitreoretinal lymphoma.
- NDA for reproxalap under FDA review with promising results from clinical trials.
- Cash position of $174.3 million supports operations into 2024.
- Net loss of $62 million for 2022, indicating ongoing financial strain.
-
NDA Priority Review PDUFA Date for ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma is
June 21, 2023 -
NDA PDUFA Date for Reproxalap for the Treatment of Dry Eye Disease is
November 23, 2023 - Top-Line Results from the Phase 3 INVIGORATE-2 Trial of Reproxalap in Allergic Conjunctivitis Expected in the First Half of 2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa Expected in the First Half of 2023
- Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the First Half of 2023
-
Cash, Cash Equivalents, and
Marketable Securities of$174.3 Million December 31, 2022 -
Management to Host Conference Call at
8:00 a.m. ET Today
“Now with Priority Review Designation for the treatment of primary vitreoretinal lymphoma, ADX‑2191 joins reproxalap as the second investigational drug candidate at Aldeyra under NDA review at the
Recent Corporate Highlights
-
Priority Review Designation Granted for NDA of ADX-2191 for the Treatment of Primary Vitreoretinal Lymphoma: The New Drug Application (NDA) submission of ADX‑2191 (methotrexate injection, USP), an investigational drug candidate, is supported by a combination of published literature on the safety and efficacy of intravitreal methotrexate for the treatment of primary vitreoretinal lymphoma and safety data from the recently completed Phase 3 GUARD Trial of ADX‑2191 for the prevention of proliferative vitreoretinopathy. During the Phase 3 GUARD Trial, no safety signals were observed, and ADX‑2191 was well tolerated; there were no observed treatment-emergent serious adverse events. The most common adverse event associated with ADX‑2191 treatment was punctate keratitis, a frequently observed side effect of intravitreal methotrexate, that was most commonly mild in severity. The
U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) date ofJune 21, 2023 . The FDA noted that no potential filing review issues had been identified. -
FDA Accepted for Review NDA of Reproxalap for the Treatment of Signs and Symptoms of Dry Eye Disease: The NDA submission of topical ocular reproxalap, a first-in-class investigational new drug candidate, is supported by previously announced safety and efficacy results from five adequate and well-controlled clinical trials encompassing data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA includes activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. The FDA assigned a PDUFA date of
November 23, 2023 . The FDA noted that no potential filing review issues had been identified, and that an advisory committee meeting was not currently planned. - Positive Top-Line Results Announced from the 12-Month Safety Clinical Trial of Reproxalap in Dry Eye Disease: Treatment-related serious adverse events in ocular safety were not observed in any patient. Ocular safety events were similar across reproxalap and vehicle treatment groups. Consistent with prior experience with reproxalap and other topical ocular medications, the most common adverse event in reproxalap-treated patients was mild and transient instillation site irritation. In a post-hoc analysis, reproxalap was statistically superior to vehicle in improvement from baseline in distance visual acuity, potentially representing the first demonstration of improvement in distance visual acuity with a topically administered therapy.
- Positive Top-Line Results Announced from the Phase 2 Clinical Trial of ADX-629 in Acute Alcoholic Hepatitis: ADX‑629, a first-in-class orally administered investigational RASP modulator, demonstrated target engagement and improvement in the signs of alcohol intoxication in a sequence-randomized, double-masked, placebo-controlled crossover Phase 2 clinical trial. Relative to placebo, ADX‑629 reduced dermal flushing (P=0.0007); increased Romberg test balance time (P=0.02); and lowered levels of total cholesterol (P=0.02), LDL (P=0.047), and the ethanol RASP metabolite acetaldehyde (P=0.03) following acute exposure to alcohol. Both ADX-629 and placebo were well tolerated, and no safety concerns were noted.
- Phase 2 Clinical Trials Initiated for ADX-629 in Systemic Immune-Mediated Diseases: Aldeyra initiated Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629 for the treatment of atopic dermatitis, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome.
Upcoming Planned Clinical and Regulatory Milestones
-
Results from the Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis: Top-line results from the Phase 3 clinical trial of reproxalap in patients with allergic conjunctivitis are expected in the first half of 2023. The Phase 3 INVIGORATE Trial in allergic conjunctivitis, announced in
April 2021 , met the primary endpoint and all secondary endpoints. - 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, a rare group of sight-threatening retinal diseases with no approved therapy, are expected in the first half of 2023.
- Results from Phase 2 Clinical Trials of ADX‑629: Top-line results from the Phase 2 clinical trial of ADX‑629 in chronic cough are expected in the first half of 2023. Additionally, top-line results from Phase 2 clinical trials of ADX‑629 in atopic dermatitis (Part 1), idiopathic nephrotic syndrome (Part 1), and Sjögren-Larsson Syndrome are expected in the second half of 2023.
- Type C Meeting with the FDA for ADX-2191 in Proliferative Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting with the FDA mid-2023 to discuss the completion of clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy.
- Initiation of Clinical Trials of Next-Generation RASP-Modulator Drug Candidates for Systemic Immune-Mediated Diseases and Geographic Atrophy: Pending completion of Investigational New Drug requirements, a Phase 1 clinical trial of orally administered ADX‑246 for the treatment of systemic immune-mediated diseases, and a Phase 1/2 clinical trial of intravitreally injected ADX‑248 for the treatment of geographic atrophy, a sight-threatening retinal disease, are expected to initiate in the second half of 2023 or early 2024.
Full-Year 2022 Financial Results
Cash, cash equivalents, and marketable securities as of
Net loss for the year ended
Research and development expenses for the year ended
General and administrative expenses for the year ended
Total operating expenses for the year 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
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 likelihood and timing of the FDA’s potential approval of the NDAs for reproxalap and ADX-2191 by the respective PDUFA dates, or at any other time, and the adequacy of the data included in the NDA submissions; the expectation around any potential future request by the FDA to hold an advisory committee meeting related to the NDAs; the anticipated timing of enrollment and results from Aldeyra’s clinical trials; expectations regarding the results of scheduled and planned pre-NDA meetings; the post-hoc analysis of the 12-month safety clinical trial and the potential to demonstrate distance visual acuity improvement in adults, expectations regarding evidence of acuity improvements and differentiation of reproxalap, if approved for sale, from other therapeutic options; 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,” “contemplates,” “likely,” “potential,” “continue,” “ongoing,” “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, funding, 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; delay in or failure to obtain regulatory approval of Aldeyra's product candidates, including as a result of the FDA not accepting Aldeyra’s regulatory filings, requiring additional clinical trials or data prior to review or approval of such filings; 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 different indications; 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 Aldeyra’s business, results of operations, and financial position; 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 future revenue, the timing of future 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 commercialization, marketing and manufacturing capabilities and strategy; 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; 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; regulatory developments in
In addition to the risks described above and in Aldeyra's other filings with the
| CONSOLIDATED BALANCE SHEETS | ||||||||
|
|
|
||||||
2022 |
|
2021 |
||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ |
144,419,364 |
|
$ |
104,790,989 |
|
||
| Cash equivalent - reverse repurchase agreements |
|
— |
|
|
125,000,000 |
|
||
| Marketable securities |
|
29,881,520 |
|
|
— |
|
||
| Prepaid expenses and other current assets |
|
6,722,229 |
|
|
2,961,781 |
|
||
| Total current assets |
|
181,023,113 |
|
|
232,752,770 |
|
||
| Right-of-use assets |
|
249,265 |
|
|
351,863 |
|
||
| Fixed assets, net |
|
19,279 |
|
|
32,487 |
|
||
| Total assets | $ |
181,291,657 |
|
$ |
233,137,120 |
|
||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ |
133,625 |
|
$ |
1,019,702 |
|
||
| Accrued expenses |
|
14,065,885 |
|
|
10,523,353 |
|
||
| Current portion of long-term debt |
|
911,763 |
|
|
— |
|
||
| Current portion of operating lease liabilities |
|
249,265 |
|
|
229,607 |
|
||
| Total current liabilities |
|
15,360,538 |
|
|
11,772,662 |
|
||
| Operating lease liabilities, long-term |
|
— |
|
|
125,232 |
|
||
| Long-term debt, net of current portion |
|
14,923,090 |
|
|
15,503,703 |
|
||
| Total liabilities |
|
30,283,628 |
|
|
27,401,597 |
|
||
| Stockholders' equity: | ||||||||
| Preferred stock, |
|
— |
|
|
— |
|
||
| Common stock, voting, |
|
58,560 |
|
|
58,081 |
|
||
| Additional paid-in capital |
|
507,770,045 |
|
|
500,369,444 |
|
||
| Accumulated other comprehensive loss |
|
(103,938 |
) |
|
— |
|
||
| Accumulated deficit |
|
(356,716,638 |
) |
|
(294,692,002 |
) |
||
| Total stockholders’ equity |
|
151,008,029 |
|
|
205,735,523 |
|
||
| Total liabilities and stockholders’ equity | $ |
181,291,657 |
|
$ |
233,137,120 |
|
||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
Years ended |
||||||||
2022 |
|
2021 |
||||||
| Operating expenses: | ||||||||
| Research and development | $ |
47,306,066 |
|
$ |
44,936,532 |
|
||
| General and administrative |
|
15,373,921 |
|
|
11,283,004 |
|
||
| Loss from operations |
|
(62,679,987 |
) |
|
(56,219,536 |
) |
||
| Other income (expense): | ||||||||
| Interest income |
|
2,349,449 |
|
|
185,363 |
|
||
| Interest expense |
|
(1,694,098 |
) |
|
(1,742,101 |
) |
||
| Total other income (expense), net |
|
655,351 |
|
|
(1,556,738 |
) |
||
| Net loss | $ |
(62,024,636 |
) |
$ |
(57,776,274 |
) |
||
| Net loss per share - basic and diluted | $ |
(1.06 |
) |
$ |
(1.07 |
) |
||
| Weighted average common shares outstanding - basic and diluted |
|
58,405,897 |
|
|
54,042,103 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20230308005858/en/
Investors & Media:
(857) 383-2409
ALDX@investorrelations.com
Source:
FAQ
What are the key dates for Aldeyra Therapeutics' NDA submissions in 2023?
What is the net loss for Aldeyra Therapeutics for the year 2022?
What is the current cash position of Aldeyra Therapeutics?
What clinical trials are underway for Aldeyra's drug candidates?
What were the results of the Phase 3 GUARD Trial for ADX-2191?
