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

Rhea-AI Filing Summary

Eledon Pharmaceuticals reported first quarter 2026 results and progress for its lead antibody tegoprubart. In an investigator-led islet transplant study, all 10 patients who were more than four weeks post-transplant achieved 100% insulin independence with no graft rejection or typical tacrolimus-related toxicities. Tegoprubart also received FDA Orphan Drug designation for preventing allograft rejection in liver transplantation.

In kidney transplantation, 24‑month Phase 1b extension data in eight patients showed no biopsy‑proven acute rejection, graft loss, death, new-onset diabetes, or de novo donor‑specific antibodies, and mean eGFR improved from 67.0 to 74.2 mL/min/1.73 m². Cash, cash equivalents and short‑term investments were $111.1 million as of March 31, 2026, which the company believes will fund operations into the second quarter of 2027.

R&D expenses were $17.2 million versus $13.5 million a year earlier, while G&A was $4.0 million versus $4.4 million. Net loss was $39.0 million, or $0.33 per common share, compared with $6.5 million, or $0.08 per share, mainly due to a $19.0 million non‑cash loss from warrant liabilities versus a $10.1 million non‑cash gain in 2025; excluding these, net loss was $20.1 million versus $16.6 million.

Insights

Biotech earnings and clinical-stage strategy analyst

Strong tegoprubart data and Orphan status offset a warrant-driven loss.

Eledon highlighted encouraging early efficacy and safety signals for tegoprubart. All 10 evaluable islet transplant patients achieved insulin independence without rejection or common tacrolimus toxicities, and 24‑month kidney data showed stable or improving graft function with no acute rejection or graft loss. FDA Orphan Drug designation in liver transplantation adds regulatory support.

Financially, the business remains development-stage with no product revenue. The reported $39.0M Q1 2026 net loss versus $6.5M in 2025 is largely explained by a swing in the fair value of warrant liabilities from a $10.1M gain to a $19.0M loss. On an adjusted view excluding these non‑cash items, the loss widened more modestly, reflecting higher R&D as trials advance.

Cash, cash equivalents and short‑term investments of $111.1M as of March 31, 2026 are expected to fund operations into Q2 2027. Multiple planned 2026 milestones, including Phase 3 design guidance in kidney transplantation and additional data readouts, mean subsequent disclosures and trial updates will be important for understanding tegoprubart’s path through late‑stage development.

8-K Event Classification

2 items: 2.02, 9.01

2 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Cash and investments: $111.1M Net loss: $39.0M Adjusted net loss: $20.1M +5 more

8 metrics

Cash and investments $111.1M Cash, cash equivalents and short-term investments as of March 31, 2026

Net loss $39.0M Net loss for the quarter ended March 31, 2026

Adjusted net loss $20.1M Net loss excluding fair value changes in warrant liabilities, Q1 2026

R&D expense $17.2M Research and development expenses in Q1 2026

Non-cash warrant impact $19.0M loss Change in fair value of warrant liabilities in Q1 2026

Islet transplant insulin independence 10 patients All 10 patients >4 weeks post-transplant achieved insulin independence with tegoprubart

Kidney eGFR improvement 67.0 to 74.2 mL/min/1.73 m² Mean eGFR from 12 to 24 months in Phase 1b kidney extension

Common shares outstanding 75,851,722 shares Common stock issued and outstanding as of March 31, 2026

Key Terms

Orphan Drug designation, allograft rejection, islet transplantation, warrant liabilities, +2 more

6 terms

Orphan Drug designation regulatory

"The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation."

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

allograft rejection medical

"FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation."

Allograft rejection is the immune system’s attack on a transplanted tissue or organ from another person, where the recipient’s defenses recognize the graft as foreign and try to destroy it. Investors should care because rejection affects the success of transplant procedures and related therapies, drives demand for immunosuppressive drugs and diagnostics, and is a key clinical or regulatory endpoint that can determine a product’s market potential—think of it as a security team mistakenly ejecting an invited guest, undermining the event.

islet transplantation medical

"high-risk type 1 diabetes undergoing allogenic islet transplantation."

Islet transplantation is a medical procedure that moves clusters of insulin-producing cells (islets) from a donor into a patient to restore the body’s natural ability to regulate blood sugar. For investors, it matters because successful, scalable islet therapies can create new markets for biotech drugs, cell processing services and medical devices, change long-term treatment costs and reimbursement patterns, and trigger regulatory milestones that affect company value.

warrant liabilities financial

"Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities"

Warrant liabilities are the financial obligations a company records when it grants warrants—special rights allowing someone to buy shares at a set price in the future. If the warrants are expected to be exercised, they are treated as a liability because the company might need to deliver shares or cash later. This matters to investors because it affects the company’s reported financial health and the potential dilution of existing shares.

Phase 3 trial clinical

"Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation"

A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.

xenotransplantation medical

"to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS)."

Transplanting organs, tissues, or cells from one species into a human, most often using genetically modified animals as donors. Investors watch this area because successful xenotransplantation could create large new markets for treating organ failure but also faces steep scientific, regulatory, ethical and reimbursement hurdles—think of fitting a part from a different-model car: if it works it can extend life and value, but compatibility and approval risks are high.

Earnings Snapshot

Net loss: $39.0M · Guidance included

Q1 2026

Net loss $39.0M

Net loss per common share $0.33

R&D expense $17.2M

G&A expense $4.0M

Cash and investments $111.1M

Guidance

The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027.

Understanding 8-K Material Events →

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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): May 13, 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 May 13, 2026, Eledon Pharmaceuticals, Inc. (the “Company”) issued a press release regarding its quarter ended March 31, 2026. 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 May 13, 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:	May 13, 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 First Quarter 2026 Financial Results and Recent Business Highlights

100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study

FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation

Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026

IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights.

“In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding potential paths to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.”

First Quarter 2026 and Business Highlights

•In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care.

•The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation.

•Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of

Exhibit 99.1

Transplant Surgeons Winter Symposium in January 2026. Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation 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.

2026 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 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation.

•Receive FDA regulatory guidance on the 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.

First Quarter 2026 Financial Results

Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026, compared to $133.3 million as of December 31, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027.

Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million, including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million, including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025.

General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million, including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025.

Net loss for the first quarter of 2026 was $39.0 million, or $0.33 per basic common share, compared to a net loss of $6.5 million, or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 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 $20.1 million for the three months ended March 31, 2026, and $16.6 million for the three months ended March 31, 2025.

Exhibit 99.1

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; X

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 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

Exhibit 99.1

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

CG Life

(212) 253 8881

jurban@cglife.com

Exhibit 99.1

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)

(Unaudited)

		March 31, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents		$	6,152			$	22,808
Short-term investments			104,937				110,528
Prepaid expenses and other current assets			2,485				2,352
Total current assets			113,574				135,688
Operating lease asset, net			530				613
In-process research and development			32,386				32,386
Other assets			177				322
Total assets		$	146,667			$	169,009
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	6,585			$	3,627
Current operating lease liabilities			369				358
Accrued expenses and other liabilities			6,504				14,359
Total current liabilities			13,458				18,344
Deferred tax liabilities			2,187				2,187
Non-current operating lease liabilities			186				283
Warrant liabilities			30,378				11,416
Total liabilities			46,209				32,230
Commitments and contingencies
Convertible preferred stock, 5,000,000 shares authorized at March 31, 2026 and December 31, 2025:
Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at March 31, 2026 and December 31, 2025			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 March 31, 2026 and December 31, 2025			53,543				53,543
Stockholders’ equity:
Common stock, $0.001 par value, 300,000,000 shares authorized at March 31, 2026 and December 31, 2025; 75,851,722 and 75,430,033 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively			76				75
Additional paid-in capital			484,988				482,189
Accumulated other comprehensive income (loss)			(72	)			24
Accumulated deficit			(440,228	)			(401,203	)
Total stockholders’ equity			44,764				81,085
Total liabilities, convertible preferred stock and stockholders’ equity		$	146,667			$	169,009

Exhibit 99.1

ELEDON PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

		For the Three Months Ended March 31,
		2026				2025
Operating expenses
Research and development		$	17,197			$	13,531
General and administrative			3,984				4,433
Total operating expenses			21,181				17,964
Loss from operations			(21,181	)			(17,964	)
Other income, net			1,118				1,409
Change in fair value of warrant liabilities			(18,962	)			10,060
Net loss		$	(39,025	)		$	(6,495	)
Other comprehensive loss:
Unrealized loss on available-for-sale securities, net			(96	)			(44	)
Comprehensive loss		$	(39,121	)		$	(6,539	)
Basic and diluted earnings per share of common stock		$	(0.33	)		$	(0.08	)
Weighted-average common shares outstanding, basic and diluted			112,424,211				77,126,763
Basic and diluted earnings per share of Series X and Series X1 non-voting convertible preferred stock		$	(18.25	)		$	(4.32	)
Weighted-average shares outstanding of Series X and Series X1 non-voting convertible preferred stock, basic and diluted			114,508				114,508

Filing Exhibits & Attachments

2 documents

Press Releases

• EX-99.1 EX-99.1 199.6 KB

Other Documents

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