Eledon Pharmaceuticals Files 2023 Annual Report on Form 10-K

TL;DR

<b>Eledon Pharmaceuticals (ELDN) has filed its 2023 10-K, detailing past corporate names, various financing agreements, and warrant structures.</b>

AI Summary

Eledon Pharmaceuticals, Inc. (ELDN) filed a Annual Report (10-K) with the SEC on March 28, 2024. Eledon Pharmaceuticals, Inc. (ELDN) filed its 2023 Form 10-K on March 28, 2024. The company was formerly known as Novus Therapeutics, Inc. and Tokai Pharmaceuticals Inc. Key agreements mentioned include the ALSTherapyDevelopmentFoundationIncLicenseAgreement and Securities Purchase Agreements with accredited investors. The filing details various warrant types, including CommonAndPreferredWarrants, PreFundedWarrants, and CommonStockWarrants. Financial data points include GeneralAndAdministrativeExpense and AdditionalPaidInCapital for fiscal years ending December 31, 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking Eledon Pharmaceuticals, Inc., this filing contains several important signals. The 10-K provides a historical overview of the company's identity, which may be relevant for investors tracking its evolution. Details on securities purchase agreements and warrant exchanges offer insight into the company's capital-raising activities and potential future dilution.

Risk Assessment

Risk Level: medium — Eledon Pharmaceuticals, Inc. shows moderate risk based on this filing. The company has a history of name changes and complex warrant structures, indicating potential financial complexities and past restructuring efforts.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Eledon Pharmaceuticals' current financial health and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-28 — Filing Date (Date of submission)
• 0000950170-24-038091 — Accession Number (Unique identifier for the filing)
• 2834 — SIC Code (Pharmaceutical Preparations)

Key Players & Entities

• Eledon Pharmaceuticals, Inc. (company) — Filer name
• Novus Therapeutics, Inc. (company) — Former company name
• Tokai Pharmaceuticals Inc (company) — Former company name
• ALSTherapyDevelopmentFoundationIncLicenseAgreement (company) — License agreement
• Armistice Capital Master Fund Ltd (company) — Counterparty in securities purchase agreement
• 2023-12-31 (date) — Fiscal year end
• 2024-03-28 (date) — Filing date

FAQ

Risk Factors

• Complex Capital Structure and Warrants [high — financial]: The company has issued various series of preferred stock and warrants, including common stock warrants, pre-funded warrants, and Series X1 convertible preferred stock, which could lead to significant future dilution.
• Dependence on Key Personnel and Agreements [medium — operational]: The company's success may depend on the continued service of key personnel and the successful execution of agreements such as the ALSTherapyDevelopmentFoundationIncLicenseAgreement.
• History of Name Changes and Restructuring [medium — financial]: Eledon Pharmaceuticals has undergone multiple name changes (formerly Novus Therapeutics, Inc. and Tokai Pharmaceuticals Inc.), suggesting a history of restructuring or strategic shifts.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-28: 10-K Filing Date — Date Eledon Pharmaceuticals submitted its annual report.

Key Financial Figures

• $0.001 — nge on Which Registered Common Stock, $0.001 par value ELDN Nasdaq Capital Marke

Filing Documents

• eldn-20231231.htm (10-K) — 2449KB
• eldn-ex10_22.htm (EX-10.22) — 44KB
• eldn-ex10_23.htm (EX-10.23) — 24KB
• eldn-ex23_1.htm (EX-23.1) — 5KB
• eldn-ex31_1.htm (EX-31.1) — 15KB
• eldn-ex31_2.htm (EX-31.2) — 15KB
• eldn-ex32_1.htm (EX-32.1) — 8KB
• eldn-ex32_2.htm (EX-32.2) — 8KB
• eldn-ex97_1.htm (EX-97.1) — 23KB
• img116206746_0.jpg (GRAPHIC) — 848KB
• img116206746_1.jpg (GRAPHIC) — 329KB
• img116206746_2.jpg (GRAPHIC) — 139KB
• img116206746_3.jpg (GRAPHIC) — 117KB
• 0000950170-24-038091.txt (&nbsp;) — 12569KB
• eldn-20231231.xsd (EX-101.SCH) — 1300KB
• eldn-20231231_htm.xml (XML) — 1521KB

Business

Business 6 ITEM 1A.

Risk Factors

Risk Factors 24 ITEM 1B. Unresolved Staff Comments 46 ITEM 1C. Cybersecurity 46 ITEM 2.

Properties

Properties 47 ITEM 3.

Legal Proceedings

Legal Proceedings 47 ITEM 4. Mine Safety Disclosures 47 PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 48 ITEM 6. Reserved 48 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 49 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 55 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 55 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 56 ITEM 9A.

Controls and Procedures

Controls and Procedures 56 ITEM 9B. Other Information 56 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 57 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 58 ITEM 11.

Executive Compensation

Executive Compensation 58 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 58 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 58 ITEM 14. Principal Accountant Fees and Services 58 PART IV ITEM 15. Exhibits and Financial Statement Schedules 59 ITEM 16. Form 10-K Summary 62

Signatures

Signatures 63 Index to Financial Statements F- 1 2 Table of Contents In this Annual Report on Form 10-K, Annual Report, unless the context requires otherwise, "Eledon", the "Company", "we", "our", and "us" means Eledon Pharmaceuticals, Inc. (formerly Novus Therapeutics, Inc.) and all wholly owned subsidiaries. Special Note Regarding Forward-Looking Statements This Annual Report on Form 10-K contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, which statements involve substantial risks and uncertainties. Any statements other than statements of historical or current fact in this Annual Report on Form 10-K are forward looking statements. In some instances, you can identify forward-looking statements by the use of words such as "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," "could," "may," and similar expressions, although not all forward-looking statements include such identifying words. Forward-looking statements include, but are not limited to statements regarding: our product development plans, expectations for and the timing of commencement, enrollment, completion, data, and release of results of clinical trials for our product candidates; our estimates regarding expenses, capital requirements and needs for additional financing; our strategies with respect to our preclinical and clinical development programs, including our expectations regarding the production of clinical quantities of our product candidates; our plans, strategy and timing to obtain and maintain regulatory approvals of our product candidates; our expectations regarding competitive conditions for our product candidates; our review of strategic alternatives and the outcome of such review; and our expectations about our future financial performance or condition. Actual results may differ materially from those indicated by such forward-looking statements as a r

B usiness

Item 1. B usiness. Overview We are a clinical stage biotechnology company using our immunology expertise in targeting the CD40 Ligand ("CD40L" or "CD154") pathway to develop therapies to protect transplanted organs and prevent rejection, and to treat amyotrophic lateral sclerosis ("ALS"). Our lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that we believe has broad therapeutic potential. Tegoprubart is engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches. The CD40L/CD40 pathway is recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as macrophages and dendritic cells, as well as B cells. By blocking CD40L and not the CD40 receptor, tegoprubart inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4+ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which may play a therapeutic role in autoimmune diseases and in the prevention of allograft rejection after solid organ transplantation. Figure 1: Mechanism overview of CD40L inflammatory signaling and tegoprubart site of action Figure 1: Interaction of CD40 with CD40L on immune cells mediates activation of the co-stimulatory immune pathway, controlling "cross talk" between the adaptive and innate immune systems. Blocking CD40L shifts polarization away from pro-inflammatory signaling to T-cell anergy, apoptosis, and polarization to a "T-reg" environment. (Source: Adapted from Kant et al., Principles

View Full Filing

View this 10-K filing on SEC EDGAR