Eledon Pharma Files 2023 Annual Report Amendment

TL;DR

Eledon Pharma amended its 2023 10-K, check for updated financials and agreements.

AI Summary

Eledon Pharmaceuticals, Inc. filed an amendment (10-K/A) to its annual report for the fiscal year ending December 31, 2023. The filing includes information on various financial activities and agreements, such as a Securities Purchase Agreement Third Closing on April 28, 2023, and a license agreement with ALSTherapyDevelopmentFoundationInc. The company, formerly Novus Therapeutics, Inc. and Tokai Pharmaceuticals Inc., is based in Irvine, CA.

Why It Matters

This amendment provides updated financial and operational details for Eledon Pharmaceuticals, Inc., which is crucial for investors and stakeholders to assess the company's performance and future prospects.

Risk Assessment

Risk Level: medium — As a pharmaceutical company, Eledon is subject to inherent risks in drug development, regulatory approvals, and market competition, which are amplified by the nature of an amendment filing that may contain previously undisclosed or revised information.

Key Numbers

• 20231231 — Fiscal Year End (The period covered by the annual report.)
• 20240819 — Filing Date (The date the amendment was filed with the SEC.)

Key Players & Entities

• Eledon Pharmaceuticals, Inc. (company) — Filer
• 20231231 (date) — Fiscal Year End
• Novus Therapeutics, Inc. (company) — Former Company Name
• Tokai Pharmaceuticals Inc (company) — Former Company Name
• 20170511 (date) — Date of Name Change
• 20070622 (date) — Date of Name Change
• 19800 MACARTHUR BLVD. SUITE 250 (address) — Business Address
• IRVINE, CA 92612 (address) — Business Address
• 949-238-8090 (phone_number) — Business Phone
• Securities Purchase Agreement Third Closing (agreement) — Financial Activity

FAQ

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/A) — 2991KB
• eldn-ex23_1.htm (EX-23.1) — 6KB
• eldn-ex31_5.htm (EX-31.5) — 16KB
• eldn-ex31_6.htm (EX-31.6) — 16KB
• eldn-ex32_3.htm (EX-32.3) — 8KB
• eldn-ex32_4.htm (EX-32.4) — 8KB
• img116206746_0.jpg (GRAPHIC) — 848KB
• img116206746_1.jpg (GRAPHIC) — 329KB
• img116206746_2.jpg (GRAPHIC) — 139KB
• img116206746_3.jpg (GRAPHIC) — 117KB
• 0000950170-24-098575.txt ( ) — 15611KB
• eldn-20231231.xsd (EX-101.SCH) — 1458KB
• eldn-20231231_htm.xml (XML) — 2647KB

Risk Factors

Item 1A. Risk Factors

Management's discussion and analysis of financial condition and results of operations

Item 7. Management's discussion and analysis of financial condition and results of operations.

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data

Controls and Procedures

Item 9A. Controls and Procedures The information required by Items 10, 11, 12, 13 and 14 of Part III of this Report is incorporated by reference to Amendment No. 1, which was filed with the Securities and Exchange Commission on April 26, 2024. The information contained in Amendment No. 1 is not impacted by the Restatement. In addition, in accordance with Rule 12b-15 under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), Item 15 of Part IV of the Original Report is being amended and restated solely to include as exhibits the certifications of our principal executive officer and principal financial officer required by Rule 13a-14(a) under the Exchange Act and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350). Except as otherwise expressly noted herein, this Amendment No. 2 does not amend, modify or update any other information set forth in the Original Report. Furthermore, this Amendment No. 2 does not change any previously reported financial results, except as necessary to reflect the Restatement, nor does it reflect events occurring after the filing date of the Original Report. Information not affected by this Amendment No. 2 remains unchanged and reflects the disclosures made at the time the Original Report was filed. Accordingly, this Amendment No. 2 should be read in conjunction with our filings made with the SEC subsequent to the filing of the Original Report, including any amendment to those filings. 3 Table of Contents INDE X Page Number PART I ITEM 1.

Business

Business 8 ITEM 1A.

Risk Factors

Risk Factors 26 ITEM 1B. Unresolved Staff Comments 48 ITEM 1C. Cybersecurity 48 ITEM 2.

Properties

Properties 49 ITEM 3.

Legal Proceedings

Legal Proceedings 49 ITEM 4. Mine Safety Disclosures 49 PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 50 ITEM 6. Reserved 50 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 51 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 58 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 58 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 59 ITEM 9A.

Controls and Procedures

Controls and Procedures 59 ITEM 9B. Other Information 60 ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspection 60 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 61 ITEM 11.

Executive Compensation

Executive Compensation 61 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 61 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 61 ITEM 14. Principal Accountant Fees and Services 61 PART IV ITEM 15. Exhibits and Financial Statement Schedules 62 ITEM 16. Form 10-K Summary 68

Signatures

Signatures 69 Index to Financial Statements F- 1 4 Table of Contents Special Note Regarding Forward-Looking Statements This Annual Report on Form 10-K as amended by Amendment No. 1 and this Amendment No 2. (together, the "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 result of various factors, including the factors listed under "Risk Factor Summary" below. These risks and uncertainties, as well as other risks a

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

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View this 10-K/A filing on SEC EDGAR