Data from Phase 2 BESTOW trial demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus
Data supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection
Strengthened balance sheet with $57.5 million financing to advance transplantation programs
IRVINE, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (Nasdaq: ELDN) today reported its third quarter 2025 operating and financial results and reviewed recent business highlights.
"The results from our Phase 2 BESTOW trial demonstrated tegoprubart's excellent efficacy and safety, importantly avoiding many of the long-term toxicities commonly seen with current standard-of-care immunosuppressive therapies," said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. "Further, the proceeds from our recent financing enhance our ability to advance tegoprubart's programs in kidney transplantation, islet cell transplantation, and xenotransplantation, addressing critical unmet needs in transplant medicine."
Third Quarter 2025 and Business Highlights
-- Presented results from the Phase 2 BESTOW trial evaluating tegoprubart
for the prevention of organ rejection in patients receiving a kidney
transplant at the American Society of Nephrology's Kidney Week 2025
Annual Meeting in Houston, TX. Tegoprubart demonstrated a favorable
safety and tolerability profile, substantially reducing the metabolic,
neurologic, and cardiovascular toxicities commonly associated with
tacrolimus. Kidney function, as measured by estimated glomerular
filtration rate (eGFR), was approximately 69 mL/min/1.732 at 12-months
for participants in the tegoprubart treatment arm (n=51).
-- Based on the Phase 2 BESTOW results, Eledon plans to advance tegoprubart
into Phase 3 development following discussions with regulators on study
design and data requirements. Insights from the Phase 2 BESTOW data set
and the ongoing long-term extension study will be incorporated to
optimize the Phase 3 protocol and strengthen the regulatory package.
-- On November 13, 2025, Eledon completed an underwritten public offering of
common stock and pre-funded warrants, resulting in total gross proceeds
of $57.5 million and net proceeds of approximately $53.6 million after
deducting underwriting discounts, commissions, and estimated offering
expenses.
Anticipated Upcoming YE2025 and 2026 Milestones
-- 4Q 2025: Enroll final three patients with Type 1 diabetes in the
investigator-led clinical study at UChicago Medicine evaluating
tegoprubart in islet cell transplantation.
-- 2026: Receive U.S. Food & Drug Administration ("FDA") guidance on the
Phase 3 trial design for kidney transplantation, and subsequently
initiate a Phase 3 trial in kidney transplantation.
-- 2026: Report long-term data from the Phase 1 and Phase 2 BESTOW studies
in kidney transplantation.
-- 2026: Report data from nine patients in the investigator-led islet cell
transplantation study.
-- 2026: Receive FDA regulatory guidance on path to market for islet cell
transplantation & xenotransplantation.
Third Quarter 2025 Financial Results
Cash, cash equivalents and short-term investments totaled $93.4 million as of September 30, 2025 compared to $140.2 million as of December 31, 2024.
Research and development (R&D) expenses for the third quarter of 2025 were $15.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $16.5 million, including $0.4 million of non-cash stock-based compensation expense, for the comparable period in 2024.
General and administrative expenses for the third quarter of 2025 were $4.1 million, including $1.4 million of non-cash stock-based compensation expense, compared to $4.0 million, including $1.4 million of non-cash stock-based compensation expense, for the comparable period in 2024.
Net loss for the third quarter of 2025 was $17.5 million, or $0.21 per basic common share, compared to a net income of $77.0 million, or $1.05 per basic common share, for the comparable period in 2024. Net income in the third quarter of 2024 included a non-cash gain of $96.4 million related to changes in the fair value of warrant liabilities. Excluding this non-cash gain, Eledon would have recorded a net loss of $19.5 million for the third quarter of 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: 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 establish and maintain proper and effective internal control over financial reporting and other risks disclosed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the Securities and Exchange Commission on November 14, 2025. 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 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(Unaudited)
September 30, December 31,
2025 2024
--------------- --------------
ASSETS
Current assets:
Cash and cash equivalents $ 3,669 $ 20,549
Short-term investments 89,732 119,629
Prepaid expenses and other
current assets 2,900 3,552
----------- ----------
Total current assets 96,301 143,730
Operating lease asset, net 694 926
In-process research and development 32,386 32,386
Other assets 476 363
----------- ----------
Total assets $ 129,857 $ 177,405
=========== ==========
LIABILITIES, CONVERTIBLE PREFERRED
STOCK AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 4,627 $ 5,833
Current operating lease
liabilities 346 314
Accrued expenses and other
liabilities 9,323 5,430
----------- ----------
Total current liabilities 14,296 11,577
Deferred tax liabilities 2,183 2,183
Non-current operating lease
liabilities 376 640
Warrant liabilities 21,948 44,865
----------- ----------
Total liabilities 38,803 59,265
----------- ----------
Commitments and contingencies
Convertible preferred stock,
5,000,000 shares authorized at
September 30, 2025 and December
31, 2024:
Series X(1) non-voting
convertible preferred stock,
$0.001 par value, 515,000
shares designated; 110,086
shares issued and outstanding
at September 30, 2025 and
December 31, 2024 53,543 53,543
Series X non-voting convertible
preferred stock, $0.001 par
value, 10,000 shares
designated; 4,422 shares issued
and outstanding at September
30, 2025 and December 31, 2024 2,151 2,151
Stockholders' equity:
Common stock, $0.001 par value,
300,000,000 shares authorized
at September 30, 2025 and
200,000,000 at December 31,
2024; 59,881,775 and 59,789,275
shares issued and outstanding
at September 30, 2025 and
December 31, 2024,
respectively 60 60
Additional paid-in capital 426,047 417,946
Accumulated other comprehensive
income 9 26
Accumulated deficit (390,756) (355,586)
----------- ----------
Total stockholders' equity 35,360 62,446
----------- ----------
Total liabilities, convertible
preferred stock and stockholders'
equity $ 129,857 $ 177,405
=========== ==========
ELEDON PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
------------------------- -------------------------
2025 2024 2025 2024
----------- ----------- ----------- -----------
Operating expenses
Research and
development $ 14,969 $ 16,520 $ 48,776 $ 34,036
General and
administrative 4,101 3,990 12,991 11,845
---------- ---------- ---------- ----------
Total operating
expenses 19,070 20,510 61,767 45,881
---------- ---------- ---------- ----------
Loss from operations (19,070) (20,510) (61,767) (45,881)
Other income, net 1,047 1,042 3,680 2,485
Change in fair value of
warrant liabilities 564 96,439 22,917 51,829
Net income (loss) $ (17,459) $ 76,971 $ (35,170) $ 8,433
========== ========== ========== ==========
Other comprehensive
income (loss):
Unrealized gain
(loss) on
available-for-sale
securities, net 57 102 (17) 102
---------- ---------- ---------- ----------
Comprehensive income
(loss) $ (17,402) $ 77,073 $ (35,187) $ 8,535
========== ========== ========== ==========
Net income (loss)
attributable to common
shares - basic $ (16,130) $ 54,429 $ (32,492) $ 5,551
---------- ---------- ---------- ----------
Basic net income
(loss) per common
share $ (0.21) $ 1.05 $ (0.42) $ 0.13
========== ========== ========== ==========
Weighted-average number
of shares outstanding,
basic 77,156,068 51,945,920 77,146,407 41,443,049
Net income (loss)
attributable to common
shares - diluted $ (16,130) $ (15,703) $ (32,492) $ (53,230)
---------- ---------- ---------- ----------
Diluted net loss per
common share (2024
As Restated) $ (0.21) $ (0.28) $ (0.42) $ (1.23)
========== ========== ========== ==========
Weighted-average number
of shares outstanding
- diluted 77,156,068 55,478,342 77,146,407 43,106,746
Net income (loss)
attributable to Series
X and Series X(1)
non-voting convertible
preferred stock -
basic $ (1,330) $ 6,666 $ (2,679) $ 852
---------- ---------- ---------- ----------
Basic net income
(loss) per Series X
and Series X(1)
non-voting
convertible
preferred stock
(2024 As Restated) $ (11.61) $ 58.21 $ (23.40) $ 7.44
========== ========== ========== ==========
Weighted-average shares
outstanding of Series
X and Series X(1)
non-voting convertible
preferred stock,
basic 114,508 114,508 114,508 114,508
Net loss attributable
to Series X and Series
X(1) non-voting
convertible preferred
stock - diluted $ (1,330) $ (1,801) $ (2,679) $ (7,856)
---------- ---------- ---------- ----------
Diluted net loss per
Series X and Series
X(1) non-voting
convertible
preferred stock
(2024 As Restated) $ (11.61) $ (15.73) $ (23.40) $ (68.60)
========== ========== ========== ==========
Weighted-average shares
outstanding of Series
X and Series X(1)
non-voting convertible
preferred stock,
diluted 114,508 114,508 114,508 114,508
(END) Dow Jones Newswires
November 14, 2025 17:00 ET (22:00 GMT)
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