Aldeyra Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Aldeyra Therapeutics, Inc. has filed its annual report detailing its 2023 financial performance and operations.</b>

AI Summary

Aldeyra Therapeutics, Inc. (ALDX) filed a Annual Report (10-K) with the SEC on March 7, 2024. Aldeyra Therapeutics, Inc. filed its 2023 Form 10-K on March 7, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business address is 131 Hartwell Avenue, Suite 320, Lexington, MA 02421. Aldeyra Therapeutics was formerly known as Neuron Systems Inc. and Aldexa Therapeutics, Inc. The company is incorporated in Delaware.

Why It Matters

For investors and stakeholders tracking Aldeyra Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Aldeyra's financial health, operational activities, and strategic direction for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's progress, risks, and future prospects in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Aldeyra Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory hurdles, clinical trial risks, and market competition, as evidenced by the nature of 10-K filings for companies in this sector.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to understand Aldeyra Therapeutics' current financial position and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-07 — Filing Date (As of date)
• 131 Hartwell Avenue, Suite 320 — Business Address (Street 1 and Street 2)
• Lexington, MA 02421 — Business Address (City, State, and Zip)
• 781-761-4904 — Business Phone (Phone number)

Key Players & Entities

• Aldeyra Therapeutics, Inc. (company) — Filer name
• Lexington, MA (location) — Business address city and state
• 2023-12-31 (date) — Fiscal year end
• 2024-03-07 (date) — Filing date
• Neuron Systems Inc (company) — Former company name
• Aldexa Therapeutics, Inc. (company) — Former company name

FAQ

Industry Context

Aldeyra Therapeutics operates within the pharmaceutical industry, focusing on the development of novel therapies. This sector is characterized by extensive research and development, rigorous clinical trials, and complex regulatory pathways.

Regulatory Implications

As a pharmaceutical company, Aldeyra Therapeutics is subject to the oversight of regulatory bodies such as the U.S. Food and Drug Administration (FDA). Compliance with regulations governing drug development, testing, and marketing is critical.

What Investors Should Do

1. Analyze the financial statements for revenue, expenses, and cash flow.
2. Review the 'Risk Factors' section for potential challenges and uncertainties.
3. Examine management's discussion and analysis for strategic insights.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-07: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the initial filing data extracted from the provided text, and no prior filing data is available for comparison.

Key Financial Figures

• $0.001 — nge on which registered Common Stock, $0.001 par value per share ALDX The Nasdaq
• $1 million — has paid us a non-refundable payment of $1 million in consideration of the Option (the Opt
• $5 million — y paying us a non-refundable payment of $5 million (the Option Extension Fee). As a result
• $100 million — ration Agreement, AbbVie would pay us a $100 million upfront cash payment, less the Option P
• $300 million — eligible to receive up to approximately $300 million in regulatory and commercial milestone

Filing Documents

• aldx-20231231.htm (10-K) — 2278KB
• aldx-ex10_14.htm (EX-10.14) — 45KB
• aldx-ex10_26.htm (EX-10.26) — 1126KB
• aldx-ex21_1.htm (EX-21.1) — 7KB
• aldx-ex23_1.htm (EX-23.1) — 3KB
• aldx-ex31_1.htm (EX-31.1) — 12KB
• aldx-ex31_2.htm (EX-31.2) — 12KB
• aldx-ex32_1.htm (EX-32.1) — 13KB
• aldx-ex97.htm (EX-97) — 48KB
• img129990092_0.jpg (GRAPHIC) — 128KB
• img129990092_1.jpg (GRAPHIC) — 92KB
• img129990092_2.jpg (GRAPHIC) — 47KB
• img129990092_3.jpg (GRAPHIC) — 28KB
• img129990092_4.jpg (GRAPHIC) — 27KB
• img129990092_5.jpg (GRAPHIC) — 72KB
• img129990092_6.jpg (GRAPHIC) — 31KB
• 0000950170-24-027933.txt (&nbsp;) — 11103KB
• aldx-20231231.xsd (EX-101.SCH) — 1288KB
• aldx-20231231_htm.xml (XML) — 1316KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 31 Item 1B. Unresolved Staff Comments 85 Item 1C. Cybersecurity 85 Item 2.

Properties

Properties 86 Item 3.

Legal Proceedings

Legal Proceedings 86 Item 4. Mine Safety Disclosures 86 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 87 Item 6. [Reserved] 87 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 88 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 97 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 97 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 97 Item 9A.

Controls and Procedures

Controls and Procedures 98 Item 9B. Other Information 99 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 99 Part III Item 10. Directors, Executive Officers and Corporate Governance 100 Item 11.

Executive Compensation

Executive Compensation 100 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 100 Item 13. Certain Relationships and Related Transactions, and Director Independence 101 Item 14. Principal Accounting Fees and Services 101 Part IV Item 15. Exhibits, Financial Statements Schedules 102 Item 16 Form 10-K Summary 105

Signatures

Signatures 106 Index to Financial Statements 107 2 SPECIAL NOTE REGARDING FO RWARD-LOOKING STATEMENTS Various statements throughout this report are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this report regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are subject to risks and uncertainties and are based on information currently available to our management. Words such as, but not limited to, "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "contemplates," "predict," "project," "target," "likely," "potential," "continue," "ongoing," "design," "might," "objective," "will," "would," "should," "could," or the negative of these terms and similar expressions or words, identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The events and circumstances reflected in our forward-looking statements may not occur and actual results could differ materially from those projected in our forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to: our plans to develop and commercialize reproxalap and any other product candidates, if approved; delay in or failure to obtain regulatory approval of reproxalap or any of our other product candidates, including as a result of the U.S. Food and Drug Administration (FDA) not accepting our regulatory filings or requiring additional clinical trials or data prior to review or ap

B USINESS

ITEM 1. B USINESS Overview We are a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. We are developing a novel pharmaceutical platform targeting a class of toxic endogenous small molecules known as RASP (reactive aldehyde species) that are associated with many inflammatory, metabolic, and neurodegenerative diseases. Our RASP modulator product pipeline includes ADX-629, a novel orally administered RASP modulator in clinical development for moderate alcohol-associated hepatitis and Sjgren-Larsson Syndrome. Our preclinical RASP platform includes ADX-246, ADX-248, and other drug candidates in development for systemic inflammatory, metabolic and retinal diseases. The validity of the RASP platform is supported by reproxalap, our first-in-class product candidate in late-stage development for the treatment of dry eye disease. Reproxalap has demonstrated broad-based, rapid-onset activity and consistent safety across a number of Phase 2 and Phase 3 clinical trials. We have additional product candidates in development, including ADX-2191, which is in clinical development for the treatment of retinitis pigmentosa, a rare retinal disease characterized by inflammation and vision loss. ADX-2191 has received Orphan Drug Designation for the treatment of retinitis pigmentosa. Our pipeline, as of the date of filing this annual report on Form 10K is illustrated below. Product Candidate Development Pipeline On October 31, 2023 (the Option Agreement Effective Date), we entered into an exclusive option agreement (the Option Agreement) with AbbVie Inc. (AbbVie), pursuant to which we granted AbbVie an exclusive option (the Option) to obtain (a) a co-exclusive license in the United States to facilitate a collaboration with us to develop, manufacture and commercialize reproxalap in the United States, (b) an exclusive license to develop, manufacture and commercialize reproxalap outside the United States, (c) a right of firs

View Full Filing

View this 10-K filing on SEC EDGAR