Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Operating and Financial Results

Rhea-AI Summary

Eledon Pharmaceuticals (NASDAQ: ELDN) reported its Q4 and full year 2024 results, highlighting significant advances in organ transplantation. Their lead drug tegoprubart was successfully used in two landmark procedures: a genetically modified pig kidney transplant at Massachusetts General Hospital and islet transplants for type 1 diabetes patients at UChicago Medicine.

The company strengthened its financial position through an $85 million oversubscribed offering, extending their cash runway to end of 2026. As of December 31, 2024, cash and investments stood at $140.2 million.

For Q4 2024, R&D expenses were $17.9 million and G&A expenses were $6.8 million, with a net loss of $44.6 million ($0.64 per share). Full year 2024 resulted in a net loss of $36.2 million ($0.75 per share). The company expects topline results from their Phase 2 BESTOW trial in kidney transplantation by Q4 2025.

Positive

• Successful $85M oversubscribed offering strengthened cash position to $140.2M
• Cash runway extended through end of 2026
• Breakthrough achievements in xenotransplantation and islet transplants
• First reported cases of insulin independence without tacrolimus in islet transplants

Negative

• Increased net loss from $40.3M in 2023 to $67.1M in 2024 (excluding warrant adjustments)
• R&D expenses increased significantly to $52.0M from $30.3M year-over-year
• G&A expenses rose to $18.6M from $12.7M year-over-year

Insights

Financial Analyst

Eledon Pharmaceuticals' Q4 report signals strong clinical progress coupled with a significantly improved balance sheet position. The $85 million oversubscribed offering that priced at a premium has transformed their financial outlook, extending their cash runway through year-end 2026. With $140.2 million in cash/equivalents (compared to $78.2 million in Q3), Eledon now has substantial resources to advance its pipeline.

While operating expenses have increased substantially year-over-year – R&D rising to $52 million from $30.3 million and G&A to $18.6 million from $12.7 million – this reflects planned clinical expansion rather than operational inefficiency. The net loss excluding non-cash warrant valuation changes increased to $67.1 million from $40.3 million, reflecting this investment phase.

Eledon's tegoprubart shows exceptional commercial potential across multiple transplantation applications. Its use in groundbreaking xenotransplantation (pig-to-human kidney) and islet cell transplantation for type 1 diabetes represents potential entry into substantial addressable markets. Particularly notable is achieving insulin independence in diabetes patients without tacrolimus – a significant competitive differentiation that could drive adoption.

With multiple clinical readouts in 2025, including topline results from their Phase 2 BESTOW trial in Q4 2025, Eledon has established clear value-creating catalysts while ensuring sufficient funding to reach these milestones.

Transplantation Specialist

Tegoprubart's emerging clinical profile represents a potential paradigm shift in transplantation immunosuppression. The drug's application in Massachusetts General Hospital's xenotransplantation case is particularly significant – the patient was discharged without dialysis for the first time in two years, suggesting functional engraftment under tegoprubart-based immunosuppression.

More revolutionary are the results from UChicago Medicine showing insulin independence in type 1 diabetes patients following islet transplantation without tacrolimus. This is clinically meaningful because tacrolimus, while effective at preventing rejection, is nephrotoxic and diabetogenic – precisely the complications you want to avoid in these patients. Achieving immunosuppression without tacrolimus could dramatically improve the risk-benefit profile of islet transplantation.

The CD40L pathway that tegoprubart targets has theoretical advantages over traditional calcineurin inhibitors, potentially offering more selective immunosuppression with fewer metabolic and renal side effects. What's most impressive is tegoprubart's versatility across different transplant types and organ sources – from standard kidney allografts to xenotransplants and cellular transplants.

The anticipated data from the BESTOW trial in Q4 2025 will be crucial in establishing tegoprubart's efficacy profile in conventional kidney transplantation, but the early signals across these specialized applications suggest broad utility. If the safety profile remains acceptable, tegoprubart could become a cornerstone immunosuppressant in the transplant field.

Tegoprubart used as a key component of immunosuppression regimen in the second transplant of a genetically modified pig kidney into a human conducted at Massachusetts General Hospital

Announced positive initial data from first three subjects with type 1 diabetes treated with tegoprubart as part of immunosuppression regimen following islet transplantation in investigator-initiated trial at UChicago Medicine

Topline results from Phase 2 BESTOW trial of tegoprubart in kidney transplantation expected in fourth quarter of 2025

Proceeds from oversubscribed $85 million underwritten offering extend cash runway to end of 2026

IRVINE, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2024 operating and financial results and reviewed recent business highlights.

“We have recently made great strides in expanding our role in bringing new options in organ transplantation to patients. Tegoprubart was a cornerstone immunosuppression component in recent historic procedures including kidney xenotransplant and islet transplants in patients with type 1 diabetes,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The results from these landmark studies together with the encouraging allograft kidney transplant clinical data we have shared continue to reinforce tegoprubart’s broad potential to protect transplanted organs and cells, regardless of the transplant type and the organ source. We are entering 2025 from a position of balance sheet strength and we are on track to deliver on multiple key milestones in the coming months, including topline results from our Phase 2 BESTOW trial in the fourth quarter of 2025.”

Fourth Quarter 2024 and Recent Business Highlights

• Announced the use of tegoprubart as a lead component of the immunosuppression treatment regimen following the second transplant of a genetically modified pig kidney into a human in a study conducted at Massachusetts General Hospital. Following the successful transplant on January 25, 2025, the patient was discharged from the hospital without need for continued treatment with dialysis for the first time in over two years.
  
• Reported positive initial data for the first three islet transplant recipients treated with tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in subjects with type 1 diabetes in an investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute. The data demonstrated potentially the first in human cases of insulin independence achieved using an anti-CD40L monoclonal antibody immunosuppression therapy without the use of tacrolimus, the current standard for care for prevention of transplant rejection.
  
• Completed an oversubscribed, underwritten offering of common stock and pre-funded warrants for total gross proceeds of $85.0 million and net proceeds of approximately $79.5 million after deducting underwriting discounts, commissions, and offering expenses. The offering, which priced at a premium, included participation from both new and existing investors.
  

Anticipated Upcoming Milestones

• Summer 2025: Report updated interim clinical data from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients.
• 4Q 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
• 2025: Report updated interim clinical data from the investigator-led clinical trial with UChicago Medicine for pancreatic islet transplantation in subjects with type 1 diabetes.
  

Fourth Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments totaled $140.2 million as of December 31, 2024 compared to $78.2 million at September 30, 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 fourth quarter of 2024 were $17.9 million, including $2.7 million of non-cash stock-based compensation expense, compared to $7.1 million, including $0.3 million of non-cash stock-based compensation expense, for the comparable period in 2023.

General and administrative expenses for the fourth quarter of 2024 were $6.8 million, including $3.9 million of non-cash stock-based compensation expense, compared to $3.3 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2023.

Net loss for the fourth quarter of 2024 was $44.6 million, or $0.64 per basic share, compared with a net loss of $30.1 million, or $1.00 per basic share, for the comparable period in 2023. Both periods included a non-cash loss from changes in the fair value of warrant liabilities, totaling $20.9 million in 2024 and $20.5 million in 2023.

Full Year 2024 Financial Results

Research and development (R&D) expenses for the year ended December 31, 2024 were $52.0 million, including $4.3 million of non-cash stock-based compensation expense, compared to $30.3 million, including $1.5 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by a rise in clinical development expenses related to the Phase 1b, Phase 2 BESTOW and Phase 2 open-label extension trials for kidney transplantation, an increase in manufacturing costs for drug substance and drug product clinical trial supply, an increase in stock-based compensation expense and employee compensation and benefits related to increased headcount.

General and administrative expenses for the year ended December 31, 2024 were $18.6 million, including $8.8 million of non-cash stock-based compensation expense, compared to $12.7 million, including $5.0 million of non-cash stock-based compensation expense, for the comparable period in 2023. The increase was primarily driven by an increase in stock-based compensation expense, professional services and employee compensation and benefits.

Net loss for the year ended December 31, 2024 was $36.2 million, or $0.75 per basic share, compared with a net loss of $116.5 million, or $4.73 per basic share, in 2023. The 2024 net loss included a non-cash gain of $30.9 million from changes in the fair value of warrant liabilities, whereas the 2023 net loss included a non-cash loss of $76.2 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, the company would have recorded a net loss of $67.1 million for the year ended December 31, 2024 and a net loss of $40.3 million for the year ended December 31, 2023.

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, 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 sites, 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.

Investor Contact:

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

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
jurban@cglife.com

Source: Eledon Pharmaceuticals

ELEDON PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data)
	December 31,
	2024				2023
ASSETS
Current assets:
Cash and cash equivalents	$	20,549			$	4,612
Short-term investments		119,629				46,490
Prepaid expenses and other current assets		3,552				5,027
Total current assets		143,730				56,129
Operating lease right-of-use asset, net		926				365
In-process research and development		32,386				32,386
Other assets		363				186
Total assets	$	177,405			$	89,066
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	5,833			$	967
Current operating lease liability		314				383
Accrued expenses and other liabilities		5,430				2,545
Total current liabilities		11,577				3,895
Deferred tax liability		2,183				1,752
Non-current operating lease liability		640				—
Warrant liabilities		44,865				76,211
Total liabilities		59,265				81,858
Commitments and contingencies		—				—
Stockholders’ equity:
Preferred stock, $0.001 par value, 5,000,000 shares authorized at December 31, 2024 and 2023:
Series X1 non-voting convertible preferred stock, $0.001 par value, 515,000 shares designated; 110,086 shares issued and outstanding at December 31, 2024 and 2023		—				—
Series X non-voting convertible preferred stock, $0.001 par value, 10,000 shares designated; 4,422 shares issued and outstanding at December 31, 2024 and 2023		—				—
Common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2024 and 2023; 59,789,275 and 24,213,130 shares issued and outstanding at December 31, 2024 and 2023, respectively		60				24
Additional paid-in capital		473,640				326,586
Accumulated other comprehensive income		26				—
Accumulated deficit		(355,586	)			(319,402	)
Total stockholders’ equity		118,140				7,208
Total liabilities and stockholders’ equity	$	177,405			$	89,066

ELEDON PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data)
	Year Ended December 31,
	2024				2023
Operating expenses
Research and development	$	51,964			$	30,312
General and administrative		18,613				12,688
Total operating expenses		70,577				43,000
Other income, net		3,924				2,674
Change in fair value of warrant liabilities and fair value of financial instruments issued in excess of proceeds		30,900				(76,211	)
Loss before income taxes		(35,753	)			(116,537	)
Provision for income taxes		(431	)			—
Net loss and comprehensive loss	$	(36,184	)		$	(116,537	)
Net loss per share, basic and diluted	$	(0.75	)		$	(4.73	)
Weighted-average common shares outstanding, basic and diluted		48,543,787				24,619,197

FAQ

What were the key financial metrics for Eledon Pharmaceuticals (ELDN) in Q4 2024?

ELDN reported Q4 2024 R&D expenses of $17.9M, G&A expenses of $6.8M, and a net loss of $44.6M ($0.64 per share), with cash position of $140.2M as of December 31, 2024.

How much did Eledon Pharmaceuticals (ELDN) raise in their recent offering?

ELDN raised $85M in an oversubscribed offering, with net proceeds of $79.5M after expenses, extending their cash runway through end of 2026.

When will Eledon Pharmaceuticals (ELDN) report Phase 2 BESTOW trial results?

ELDN expects to report topline results from the Phase 2 BESTOW trial in kidney transplantation in Q4 2025.

What were the breakthrough achievements for Eledon's tegoprubart in transplantation?

Tegoprubart was successfully used in a pig kidney xenotransplant at Mass General Hospital and achieved insulin independence in type 1 diabetes patients receiving islet transplants without tacrolimus.