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[8-K] Eledon Pharmaceuticals, Inc. Reports Material Event

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Form Type
8-K
Rhea-AI Filing Summary

Date: August 6, 2025.

Eledon Pharmaceuticals, Inc. (ELDN) disclosed updated data from its ongoing Phase 1b open-label trial of tegoprubart for the prevention of organ rejection in kidney transplant patients. The results were presented at the World Transplant Congress in San Francisco, CA. The company issued a press release (attached as Exhibit 99.1) and hosted a conference call on the same date. The presentation for the call will be posted on the company investor site at https://ir.eledon.com/investor-relations prior to the call.

The filing notes that the Item 7.01 disclosure and Exhibit 99.1 are not deemed "filed" under Section 18 of the Exchange Act and are not incorporated by reference into Securities Act or Exchange Act filings unless expressly stated.

Positive
  • Updated Phase 1b data disclosed for tegoprubart presented at a major scientific meeting (World Transplant Congress).
  • Investor access facilitated via press release, conference call, and presentation posted on the company investor relations website.
Negative
  • No substantive clinical or numerical data are included in the 8-K text; investors must consult Exhibit 99.1 and the presentation for details.
  • No financial metrics or guidance are provided in this filing, limiting immediate assessment of investor impact.

Insights

TL;DR: Company presented updated Phase 1b tegoprubart data at a major conference; filing provides notice but no clinical detail within the 8-K.

The 8-K serves as a regulatory disclosure that updated Phase 1b data were presented at the World Transplant Congress and that a press release (Exhibit 99.1) and presentation were made available. The filing itself contains no efficacy, safety, patient counts, endpoints, or numerical outcomes. Investors and clinicians must review the attached press release and the presentation on the investor site for substantive clinical details.

TL;DR: Routine Regulation FD disclosure; provides investor access but does not include material financial or numeric trial results in the filing.

The 8-K documents Reg FD disclosure and logistics: a press release issued Aug 6, 2025 (Exhibit 99.1), a conference call, and a posted presentation. The filing explicitly states the materials are not "filed" under Section 18, limiting legal incorporation. Without numeric or financial metrics in the 8-K, the document is a notice of publication and event rather than a source of analyzable results for valuation or near-term financial impact.

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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

Date of Report (Date of earliest event reported): August 06, 2025

 

 

Eledon Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-36620

20-1000967

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

19800 MacArthur Blvd.

Suite 250

 

Irvine, California

 

92612

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 949 238-8090

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 par value

 

ELDN

 

Nasdaq Global Market

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 7.01 Regulation FD Disclosure.

On August 6, 2025, Eledon Pharmaceuticals Inc. (the “Company” or “Eledon”) issued a press release announcing updated data from the Company's ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results were presented at the World Transplant Congress taking place in San Francisco, CA. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Also, on August 6, 2025 and as previously disclosed, the Company is hosting a conference call to discuss the updated Phase 1b clinical data. A copy of the presentation for the conference call will be posted on the Company’s website at https://ir.eledon.com/investor-relations prior to the conference call.

The information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) 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, or be deemed, incorporated by reference in any filings under the Securities Act of 1933, as amended (the “Securities Act”), unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or incorporates it by reference into a filing under the Securities Act or the Exchange Act.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

 

99.1

Press Release Issued on August 6, 2025

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.

 

 

 

Eledon Pharmaceuticals, Inc.

 

 

 

 

Date:

August 6, 2025

By:

/s/ David-Alexandre C. Gros, M.D

 

 

 

Name: David-Alexandre C. Gros, M.D.
Title: Chief Executive Officer
 

 


FAQ

What did Eledon (ELDN) report on August 6, 2025?

Eledon issued a press release and hosted a conference call announcing updated Phase 1b data for tegoprubart presented at the World Transplant Congress.

Where were the updated Phase 1b results presented?

At the World Transplant Congress in San Francisco, CA.

Is the press release included in the 8-K filing?

Yes; the press release issued on August 6, 2025 is attached as Exhibit 99.1.

Where can I find the presentation for the conference call?

The presentation will be posted on Eledon’s investor relations website at https://ir.eledon.com/investor-relations prior to the conference call.

Is the information in Item 7.01 considered "filed" under the Exchange Act?

No; the filing states the Item 7.01 disclosure (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Exchange Act.
Eledon Pharmaceuticals Inc

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