Tegoprubart data and new orphan status headline Eledon (NASDAQ: ELDN) 2025 update

Rhea-AI Filing Summary

Eledon Pharmaceuticals reported fourth quarter and full year 2025 results and highlighted progress for its lead antibody tegoprubart in multiple transplant settings. The FDA granted Orphan Drug designation for preventing allograft rejection in liver transplantation, adding to prior orphan designations in islet cell transplantation and ALS.

In a Phase 1b kidney transplant extension study, eight patients followed for 24 months had no biopsy-proven acute rejection, graft loss, death, new-onset diabetes, or de novo donor-specific antibodies, while mean eGFR rose from 67.0 to 74.2 mL/min/1.73 m². In a UChicago islet transplant trial for type 1 diabetes, all 10 evaluable patients achieved insulin independence with most recent HbA1c below 6.0% and a mean of about 5.35%, with no rejection or typical tacrolimus-related toxicities.

For 2025, research and development expenses were $66.3 million versus $52.0 million in 2024, and general and administrative expenses were $17.0 million versus $18.6 million. Net loss was $45.6 million, or $0.52 per common share, compared to a $36.2 million loss, or $0.66 per share, in 2024. Results included non-cash gains from changes in warrant liabilities of $33.4 million in 2025 and $30.9 million in 2024.

Positive

• Strengthened clinical profile for tegoprubart: 24‑month kidney transplant data and type 1 diabetes islet transplant results showed no acute rejection, strong graft function and insulin independence, supporting tegoprubart’s potential as a next-generation immunosuppressant.
• Additional FDA Orphan Drug designation: Tegoprubart received Orphan Drug status for preventing allograft rejection in liver transplantation, adding to existing orphan designations and enhancing its regulatory and potential exclusivity position.

Negative

• None.

Insights

Biotech equity analyst

Positive tegoprubart data and new orphan status offset higher R&D spend.

Eledon Pharmaceuticals advanced tegoprubart across kidney, islet, and liver transplantation. The 24‑month kidney extension data showed sustained graft function and no acute rejection, while type 1 diabetes islet recipients achieved 100% insulin independence among evaluable patients with excellent HbA1c control.

The FDA’s Orphan Drug designation in liver transplantation strengthens the asset’s regulatory profile, complementing prior orphan designations and potentially supporting future market exclusivity. These clinical and regulatory milestones align with plans to engage the FDA on a Phase 3 kidney trial and additional investigator-led studies.

Financially, 2025 research and development expenses rose to $66.3M from $52.0M, reflecting expanded clinical and manufacturing activity, while general and administrative costs declined slightly. Net loss was $45.6M, aided by a $33.4M non-cash gain on warrant liabilities. Overall, the update emphasizes pipeline momentum more than near-term financial performance.

0001404281false00014042812026-03-192026-03-19

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): March 19, 2026

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 2.02 Results of Operations and Financial Condition.

On March 19, 2026, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 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 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press Release Issued on March 19, 2026
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 thereunto duly authorized.

			Eledon Pharmaceuticals, Inc.
Date:	March 19, 2026	By:	/s/ David-Alexandre C. Gros, M.D.
			Name: David-Alexandre C. Gros, M.D. Title: Chief Executive Officer

Exhibit 99.1

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Operating and Financial Results

Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study

Presented 24-month follow-up data from Phase 1b long-term extension study which continues to support the favorable safety and tolerability profile of tegoprubart

Tegoprubart granted Orphan Drug designation by the FDA for the prevention of allograft rejection in liver transplantation

IRVINE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2025 operating and financial results and reviewed recent business highlights.

“Over the past year, Eledon has made significant progress advancing tegoprubart, our anti-CD40L antibody, as a potential next-generation immunosuppressive therapy across multiple transplantation settings,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The over 100 patients treated across our transplantation programs to date provide a growing body of evidence that reinforces our conviction that tegoprubart can address key safety and efficacy issues with current standard-of-care transplant immunosuppression. Looking ahead, we anticipate multiple important milestones this year, including regulatory engagement to support advancement into Phase 3 development in kidney transplantation, initiation of an additional islet transplantation trial in type 1 diabetes, and the start of a clinical trial in liver transplantation.”

Fourth Quarter 2025 and Recent Corporate Developments

•Announced that tegoprubart has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of allograft rejection in liver transplantation. Tegoprubart previously received Orphan Drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS).

•Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation reported during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months.

Exhibit 99.1

•Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute. All 10 patients who were more than four weeks post-transplant achieved 100% insulin independence and a most recent hemoglobin A1C (HbA1c) below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. The study continues to generate significant patient demand with inquiries received from several hundred T1D patients.

Anticipated Upcoming Milestones

•Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment.

•Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.

•Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation.

•Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant.

•Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.

•Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction.

Full Year 2025 Financial Results

Research and development (R&D) expenses for the year ended December 31, 2025 were $66.3 million, including $4.2 million of non-cash stock-based compensation expense, compared to $52.0 million, including $4.3 million of non-cash stock-based compensation expense, for the comparable period in 2024. The increase was primarily driven by continued advancement of the tegoprubart clinical development programs, including expanded clinical trial activity and manufacturing scale-up, as well as increased personnel to support these efforts.

General and administrative expenses for the year ended December 31, 2025 were $17.0 million, including $6.2 million of non-cash stock-based compensation expense, compared to $18.6 million, including $8.8 million of non-cash stock-based compensation expense, for the comparable period

Exhibit 99.1

in 2024. The decrease was primarily driven by lower stock-based compensation expense, partially offset by higher professional services and personnel-related costs.

Net loss for the year ended December 31, 2025 was $45.6 million, or $0.52 per basic share of common stock, compared to a net loss of $36.2 million, or $0.66 per basic share of common stock, for the comparable period in 2024. The 2025 net loss included a non-cash gain of $33.4 million from changes in the fair value of warrant liabilities, while the 2024 net loss included a non-cash gain of $30.9 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $79.1 million for the year ended December 31, 2025 and $67.1 million for the year ended December 31, 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, islet cell transplantation, liver 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: our short operating history and shifts in our business strategy; our operating losses since inception; our need for additional funding to develop our lead drug candidate and our ability to secure additional funding on acceptable terms or at all; the impact of issuances of our common stock, including in the possibility of dilution or a decline in our stock price; our ability to successfully develop our product candidates; unfavorable global economic and financial market conditions; the regulatory environment of our business and our ability to obtain

Exhibit 99.1

required regulatory approvals; results of non-clinical studies and clinical trials, and risks that non-clinical studies or early clinical trials may not be predictive of results of later-stage clinical trials; delays or difficulties in enrollment of patients in clinical trials; our ability to attract and retain our executives and key employees; legislation of the pharmaceutical and healthcare industries; cybersecurity and data privacy risks; the ability of our products to achieve marketing approval; competition in our industry; our ability to obtain insurance coverage; our dependence on contract research organizations; our ability to protect our intellectual property; public health crises; our ability to maintain proper and effective internal control over financial reporting and other risks disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 19, 2026. 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 materially from the forward-looking statements contained herein, are discussed in our 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.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
stephen@gilmartinir.com

Media Contact:

Jenna Urban
Berry & Company Public Relations
(212) 253 8881
jurban@berrypr.com

Source: Eledon Pharmaceuticals

Exhibit 99.1

ELEDON PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

		December 31,
		2025				2024
ASSETS
Current assets:
Cash and cash equivalents		$	22,808			$	20,549
Short-term investments			110,528				119,629
Prepaid expenses and other current assets			2,352				3,552
Total current assets			135,688				143,730
Operating lease right-of-use asset, net			613				926
In-process research and development			32,386				32,386
Other assets			322				363
Total assets		$	169,009			$	177,405
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	3,627			$	5,833
Current operating lease liability			358				314
Accrued expenses and other liabilities			14,359				5,430
Total current liabilities			18,344				11,577
Deferred tax liability			2,187				2,183
Non-current operating lease liability			283				640
Warrant liabilities			11,416				44,865
Total liabilities			32,230				59,265
Commitments and contingencies
Convertible preferred stock, 5,000,000 shares authorized at December 31, 2025 and 2024:
Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at December 31, 2025 and 2024			2,151				2,151
Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at December 31, 2025 and 2024			53,543				53,543
Stockholders’ equity:
Common stock, $0.001 par value, 300,000,000 and 200,000,000 shares authorized at December 31, 2025 and 2024, respectively; 75,430,033 and 59,789,275 shares issued and outstanding at December 31, 2025 and 2024, respectively			75				60
Additional paid-in capital			482,189				417,946
Accumulated other comprehensive income			24				26
Accumulated deficit			(401,203	)			(355,586	)
Total stockholders’ equity			81,085				62,446
Total liabilities, convertible preferred stock and stockholders’ equity		$	169,009			$	177,405

Exhibit 99.1

ELEDON PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

		Year Ended December 31,
		2025				2024
Operating expenses
Research and development		$	66,267			$	51,964
General and administrative			16,984				18,613
Total operating expenses			83,251				70,577
Other income, net			4,220				3,924
Change in fair value of warrant liabilities			33,449				30,900
Loss before income taxes			(45,582	)			(35,753	)
Provision for income taxes			(35	)			(431	)
Net loss		$	(45,617	)		$	(36,184	)
Other comprehensive loss:
Unrealized loss on available-for-sale securities, net			(2	)			—
Comprehensive loss		$	(45,619	)		$	(36,184	)
Basic and diluted earnings per share of common stock		$	(0.52	)		$	(0.66	)
Weighted-average common shares outstanding, basic and diluted			81,836,246				48,543,787
Basic and diluted earnings per share of Series X and Series X1 non-voting convertible preferred stock		$	(28.73	)		$	(36.61	)
Weighted-average shares outstanding of Series X and Series X1 non-voting convertible preferred stock, basic and diluted			114,508				114,508

FAQ

What did Eledon Pharmaceuticals (ELDN) report for its 2025 net loss?

Eledon reported a 2025 net loss of $45.6 million, or $0.52 per share. This compares with a $36.2 million net loss, or $0.66 per share, in 2024. Both years’ results include sizable non-cash gains from changes in warrant liability fair values.

How did Eledon Pharmaceuticals (ELDN) R&D spending change in 2025?

Research and development expenses rose to $66.3 million in 2025 from $52.0 million in 2024. The increase was mainly due to advancing tegoprubart clinical programs, expanded trial activity, manufacturing scale-up, and added personnel to support these development efforts.

What new FDA designation did tegoprubart receive for Eledon (ELDN)?

Tegoprubart was granted FDA Orphan Drug designation for preventing allograft rejection in liver transplantation. This builds on earlier orphan designations in pancreatic islet cell transplantation and amyotrophic lateral sclerosis, reinforcing the drug’s potential in serious transplant-related conditions.

What were the key kidney transplant results for tegoprubart at Eledon (ELDN)?

An eight-patient Phase 1b extension showed no acute rejection, graft loss, or new-onset diabetes over 24 months. Mean eGFR improved from 67.0 to 74.2 mL/min/1.73 m², supporting tegoprubart’s favorable safety, tolerability, and graft function profile in kidney transplantation.

How did tegoprubart perform in the type 1 diabetes islet transplant study at Eledon (ELDN)?

All 10 patients more than four weeks post-transplant achieved insulin independence with HbA1c below 6.0%. The mean most recent HbA1c was about 5.35%, with no rejection, no donor-specific antibodies, and no typical tacrolimus-related toxicities observed.

What future clinical milestones does Eledon (ELDN) anticipate for tegoprubart?

Eledon expects FDA guidance on a Phase 3 kidney transplant trial and long-term data from BESTOW kidney studies. The company also plans investigator-led trials in islet cell and liver transplantation and a study focused on kidney transplant tolerance induction.

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 196.2 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA WITH EMBEDDED LINKBASES DOCUMENT 24.3 KB