ELDN 8-K
Eledon Pharmaceuticals, Inc. (ELDN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Trading |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2025, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release regarding its quarter ended June 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is furnished to comply with Item 2.02 of Form 8-K, and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 4.02 Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review.
Change of Accounting for Non-Voting Convertible Preferred Stock
In the course of preparing the Company’s unaudited condensed consolidated financial statements as of and for the three and six months ended June 30, 2025, the Company, reassessed the rights and preferences of its Series X and Series X1 non-voting convertible preferred stock, $0.001 par value (“Preferred Stock”), and concluded that, because the Preferred Stock’s rights and preferences are substantially identical to those of the Company’s common stock, $0.001 par value, the Preferred Stock should be treated as a separate class of common stock for purposes of calculating earnings per share in accordance with Accounting Standards Codification (“ASC”) 260-10, “Earnings Per Share.”
Additionally, in connection with this reassessment, the Company concluded that it had incorrectly classified the Preferred Stock as permanent equity in the consolidated balance sheets. The Preferred Stock includes a provision that, upon the occurrence of a fundamental transaction (that is defined to include a third-party tender or exchange offer) in which more than 50 percent of the common stockholders receive cash or other assets, the holders of Preferred Stock, upon any subsequent conversion, are entitled to receive the same form of consideration, even if they did not participate in the original transaction. Because this feature may result in settlement in cash or other non-equity consideration upon an event outside the Company’s control, the Preferred Stock does not meet the criteria for permanent equity classification, and management has determined it should instead be classified as temporary equity under ASC 480-10-S99-3A. The Preferred Stock is not subsequently remeasured to its redemption value because redemption is not considered probable.
The Company’s management has discussed these corrections with the Audit Committee of the Board of Directors (the “Audit Committee”). On August 11, 2025, the Company’s management and the Audit Committee concluded that the previously issued (i) audited consolidated financial statements for the fiscal years ended December 31, 2024 and December 31, 2023 included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 20, 2025 (the “2024 Form 10-K”); (ii) unaudited condensed consolidated financial statements as of and for the three months ended March 31, 2025 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 14, 2025 (the “2025 Form 10-Q”), and (iii) unaudited condensed consolidated financial statements as of and for (a) the three and nine months ended September 30, 2024 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 11, 2024, (b) the three and six months ended June 30, 2024 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 19, 2024 and (c) the three months ended March 31, 2024 included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 15, 2024 and amended by a Form 10-Q/A on August 19, 2024 (together, the “Impacted 2024 Quarterly Reports”) and, together with together the 2024 Form 10-K and the 2025 Form 10-Q, (the “Impacted Reports”) were each materially misstated and should no longer be relied upon.
The identified errors did not result in any impact on the Company's cash and short-term investment position, liquidity, or results of operations.
These identified errors will result in a restatement of the Company’s consolidated balance sheets, consolidated statements of operations and comprehensive loss, and consolidated statements of convertible preferred stock and stockholders' equity (deficit) for the years ended December 31, 2024 and December 31, 2023 and as of and for the three months ended March 31, 2024, the three and six months ended June 30, 2024, the three and nine months ended September 30, 2024 and the three months ended March 31, 2025. As a result, management and the Audit Committee determined on August 11, 2025 that the Impacted Reports require restatement and should no longer be relied upon.
In addition, any previously issued or filed earnings releases, investor presentations or other communications describing the Company’s consolidated financial statements as of and for the years ended December 31, 2024 and 2023, as of and for the three months ended March 31, 2024, the three and six months ended June 30, 2024, the three and nine months ended September 30, 2024 and the three months ended March 31, 2025 should no longer be relied on.
In connection with the restatement described above, the Company identified a material weakness in its internal control over financial reporting related to its accounting for equity instruments. Due to the material weakness, the Company has concluded, and will disclose within the applicable Impacted Reports, that its internal control over financial reporting was not effective as of December 31, 2024 and that its disclosure controls and procedures were not effective as of March 31, 2024, June 30, 2024, September 31, 2024, December 31, 2024 and March 31, 2025.
The Company has discussed the matters disclosed in this Current Report on Form 8-K with its independent registered public accounting firm, Deloitte & Touche LLP, and its predecessor registered public accounting firms, Crowe LLP and KMJ Corbin & Company LLP, and intends to file an amendment to each of the 2024 Form 10-K and the 2025 Form 10-Q to restate the Company’s consolidated financial statements included in such Impacted Reports to correct the errors related to the reclassification of the Preferred Stock as described above. The Company does not intend to file amendments to the Impacted 2024 Quarterly Reports, but instead intends to summarize the effects of the restatement with respect to the quarters ended March 31, 2024, June 30, 2024, and September 30, 2024 in the restated 2024 Form 10-K and to restate prospectively in the corresponding 2025 quarterly filings restated financial information for each of such 2024 quarterly periods, reflecting the reclassification of the Preferred Stock and the restatement of the Company’s consolidated financial statements included in the previously issued Impacted 2024 Quarterly Reports as described above.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
Description |
99.1 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Eledon Pharmaceuticals, Inc. |
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Date: |
August 14, 2025 |
By: |
/s/ David-Alexandre C. Gros, M.D. |
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Name: David Alexandre C. Gros, M.D. |
Exhibit 99.1
Eledon Pharmaceuticals Reports Second Quarter 2025 Operating and Financial Results
Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart
Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025
Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025
IRVINE, Calif., August 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.
“We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.”
Year-to-Date 2025 Business Highlights
Exhibit 99.1
Anticipated Upcoming Milestones for 2H 2025
Second Quarter 2025 Financial Results
Cash, cash equivalents and short-term investments totaled $107.6 million as of June 30, 2025 compared to $140.2 million as of December 31, 2024. The company expects current cash, cash equivalents and short-term investments to fund operations to the end of 2026.
Research and development (R&D) expenses for the second quarter of 2025 were $20.3 million, including $1.1 million of non-cash stock-based compensation expense, compared to $10.1 million, including $0.8 million of non-cash stock-based compensation expense, for the comparable period in 2024.
General and administrative expenses for the second quarter of 2025 were $4.5 million, including $1.6 million of non-cash stock-based compensation expense, compared to $4.4 million, including $2.2 million of non-cash stock-based compensation expense, for the comparable period in 2024.
Exhibit 99.1
Net loss for the second quarter of 2025 was $11.2 million, or $0.13 per basic common share, compared to a net loss of $44.9 million, or $0.92 per basic common share, for the comparable period in 2024.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, liver allograft transplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s future expectations, plans and prospects, including statements about planned clinical trials, the development of product candidates, expected timing for initiation of future clinical trials, expected timing for receipt of data from clinical trials, the company’s capital resources and ability to finance planned clinical trials, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, as well as patient enrollment; risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials; and risks associated with the impact of the ongoing coronavirus pandemic. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Exhibit 99.1
Investor Contact:
Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]
Media Contact:
Jenna Urban
CG Life
(212) 253 8881
Source: Eledon Pharmaceuticals
Exhibit 99.1
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(Unaudited)
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June 30, |
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December 31, |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,741 |
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$ |
20,549 |
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Short-term investments |
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101,829 |
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119,629 |
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Prepaid expenses and other current assets |
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3,834 |
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3,552 |
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Total current assets |
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111,404 |
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143,730 |
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Operating lease asset, net |
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773 |
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926 |
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In-process research and development |
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32,386 |
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32,386 |
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Other assets |
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346 |
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363 |
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Total assets |
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$ |
144,909 |
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$ |
177,405 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
5,831 |
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$ |
5,833 |
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Current operating lease liabilities |
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336 |
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314 |
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Accrued expenses and other liabilities |
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7,552 |
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5,430 |
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Total current liabilities |
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13,719 |
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11,577 |
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Deferred tax liabilities |
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2,183 |
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2,183 |
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Non-current operating lease liabilities |
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467 |
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640 |
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Warrant liabilities |
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22,512 |
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44,865 |
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Total liabilities |
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38,881 |
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59,265 |
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Commitments and contingencies |
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— |
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— |
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Convertible preferred stock, 5,000,000 shares authorized at June 30, 2025 and December 31, 2024: |
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Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at June 30, 2025 and December 31, 2024 |
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53,543 |
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53,543 |
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Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at June 30, 2025 and December 31, 2024 |
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2,151 |
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2,151 |
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Stockholders’ equity: |
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Common stock, $0.001 par value, 300,000,000 shares authorized at June 30, 2025 and 200,000,000 at December 31, 2024; 59,881,775 and 59,789,275 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively |
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60 |
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60 |
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Additional paid-in capital |
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423,619 |
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417,946 |
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Accumulated other comprehensive income (loss) |
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(48 |
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26 |
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Accumulated deficit |
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(373,297 |
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(355,586 |
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Total stockholders’ equity |
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50,334 |
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62,446 |
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Total liabilities, convertible preferred stock and stockholders’ equity |
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$ |
144,909 |
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$ |
177,405 |
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Exhibit 99.1
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
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For the Three Months |
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For the Six Months |
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2025 |
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2024 |
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2025 |
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2024 |
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Operating expenses |
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Research and development |
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$ |
20,276 |
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$ |
10,106 |
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$ |
33,807 |
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$ |
17,516 |
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General and administrative |
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4,457 |
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4,396 |
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8,890 |
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7,855 |
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Total operating expenses |
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24,733 |
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14,502 |
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42,697 |
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25,371 |
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Loss from operations |
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(24,733 |
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(14,502 |
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(42,697 |
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(25,371 |
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Other income, net |
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1,224 |
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869 |
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2,633 |
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1,443 |
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Change in fair value of warrant liabilities |
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12,293 |
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(31,274 |
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22,353 |
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(44,610 |
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Net loss |
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$ |
(11,216 |
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$ |
(44,907 |
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$ |
(17,711 |
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$ |
(68,538 |
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Other comprehensive loss: |
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Unrealized loss on available-for-sale securities, net |
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(30 |
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— |
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(74 |
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— |
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Comprehensive loss |
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$ |
(11,246 |
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$ |
(44,907 |
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$ |
(17,785 |
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$ |
(68,538 |
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Basic and diluted earnings per share of common stock (2024 As Restated) |
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$ |
(0.13 |
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$ |
(0.92 |
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$ |
(0.21 |
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$ |
(1.61 |
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Weighted-average common shares outstanding, basic and diluted |
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77,156,068 |
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42,278,411 |
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77,141,196 |
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36,133,906 |
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Basic and diluted earnings per share of Series X and Series X1 non-voting convertible preferred stock (2024 As Restated) |
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$ |
(7.46 |
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$ |
(51.29 |
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$ |
(11.78 |
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$ |
(89.60 |
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Weighted-average shares outstanding of Series X and Series X1 non-voting convertible preferred stock, basic and diluted (2024 As Restated) |
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114,508 |
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114,508 |
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114,508 |
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114,508 |
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