Eledon Pharmaceuticals Reports Third Quarter 2026 Financial Results and Recent Business Highlights
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Eledon Pharmaceuticals (ELDN) reported a third-quarter 2026 net loss of $3.933 million while advancing tegoprubart studies across transplant settings. The loss narrowed from $17.459 million a year earlier, aided by a $17.025 million non-cash warrant valuation gain. Basic and diluted common-share loss was $0.03 versus $0.21. Cash, cash equivalents and short-term investments fell to $69.7 million at September 30 from $133.3 million at year-end 2025; Eledon expects funding into Q2 2027.
The company plans to start its approximately 600-patient Phase 3 LEGACY kidney transplant trial in Q4 2026. Tegoprubart received FDA Fast Track designation for preventing kidney transplant rejection and clearance to begin a planned islet transplant study in type 1 diabetes. BESTOW extension data showed kidney filtration rates of 71 versus 58 mL/min/1.73m2 with tacrolimus at month 24, a statistically significant difference.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointQ3 2026 net loss narrowed to $3.933 million from $17.459 million; common-share loss fell to $0.03 from $0.21.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 3 LEGACY is planned for Q4 2026, with approximately 600 kidney transplant patients expected.
- Moderate pointFDA cleared the investigational new drug application for a planned registrational-path islet transplant trial in type 1 diabetes.
- Moderate pointBESTOW extension kidney filtration rates were statistically significantly higher with tegoprubart at 18, 21 and 24 months.
- Moderate pointBESTOW extension no biopsy-proven acute rejection occurred with tegoprubart beyond six months, versus seven tacrolimus events.
- Moderate pointIslet study's 12 patients achieved 100% insulin independence and stable graft function through 22 months of follow-up.
12 minor points
- Minor pointQ3 2026 non-cash warrant valuation gain was $17.025 million, versus $564,000 a year earlier.
- Minor pointQ3 2026 general and administrative expenses declined to $3.911 million from $4.101 million.
- Minor pointNine-month 2026 general and administrative expenses declined to $12.534 million from $12.991 million.
- Minor pointTegoprubart received FDA Fast Track designation for preventing rejection in kidney transplantation.
- Minor pointBESTOW symptom occurrence improved at 12 months with tegoprubart, while tacrolimus patients experienced mean worsening.
- Minor pointBESTOW kidney disease symptom and problem scores improved statistically significantly with tegoprubart versus tacrolimus through 12 months.
- Minor pointIslet study reported no evidence of kidney toxicity, hypertension or neurological toxicity to date.
- Minor pointUniversity of Chicago's ongoing islet transplant study enrolled three additional subjects.
- Minor pointSeparate University of Chicago trial enrolled its first patients with type 1 diabetes and renal dysfunction.
- Minor pointCompassionate-use protocols dosed the first patients in highly sensitized kidney transplantation and islet transplantation switching from tacrolimus.
- Minor pointMassachusetts General Hospital's kidney transplant tolerance study treated its third patient with tegoprubart.
- Minor point. Forward-looking: it has not happened yet and may not happen.Eledon anticipates starting company-sponsored islet and investigator-led liver transplant studies over the next 12 months.
Negative
- Moderate pointCash, equivalents and short-term investments fell to $69.7 million from $133.3 million at year-end 2025.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Existing cash, equivalents and short-term investments are expected to fund operations into Q2 2027.
- Moderate pointQ3 2026 research and development expenses rose to $17.761 million from $14.969 million.
- Moderate pointQ3 2026 loss excluding warrant valuation changes widened to $21.0 million from $18.0 million.
- Moderate pointNine-month 2026 net loss widened to $74.588 million from $35.170 million; common-share loss rose to $0.63 from $0.42.
- Moderate pointCommon shares outstanding increased to 81,442,402 at September 30, 2026, from 75,430,033 at year-end 2025.
- Moderate pointStockholders' equity declined to $30.796 million at September 30, 2026, from $81.085 million at year-end 2025.
5 minor points
- Minor pointNine-month 2026 research and development expenses rose to $53.188 million from $48.776 million.
- Minor pointNine-month 2026 warrant valuation loss was $11.560 million, versus a $22.917 million gain a year earlier.
- Minor pointQ3 2026 other income declined to $714,000 from $1.047 million.
- Minor pointNine-month 2026 other income declined to $2.694 million from $3.680 million.
- Minor point. Forward-looking: it has not happened yet and may not happen.Kidney xenotransplantation's FDA guidance on a path to market remains pending; Eledon anticipates it within 12 months.
News Explained
At
Key Figures
- Cash, cash equivalents and short-term investments
- $69.7 million vs. $133.3 million
- As of September 30, 2026 vs. December 31, 2025
- Cash runway
- Into Q2 2027
- Expected from cash, cash equivalents and short-term investments currently on hand
- Net loss
- $3.9 million vs. $17.5 million
- Q3 2026 vs. Q3 2025; Q3 2026 included a $17.0 million non-cash warrant-liability gain
- Net loss excluding warrant-liability fair-value changes
- $21.0 million vs. $18.0 million
- Three months ended September 30, 2026 vs. September 30, 2025
- Month-24 eGFR advantage
- Approximately 13 mL/min/1.73m2
- Tegoprubart vs. tacrolimus; mean eGFR was 71 vs. 58 mL/min/1.73m2
- BPAR events beyond six months post-transplant
- 0 vs. 7
- Tegoprubart arm vs. tacrolimus arm
- Insulin independence
- 100% of 12 patients
- Islet cell transplantation; stable graft function through 22 months of follow-up
- Expected LEGACY trial enrollment
- Approximately 600 patients
- Planned Phase 3 kidney-transplant trial; primary endpoint at 52 weeks
Previous Earnings Reports
-
Reported $88.8 million in cash with runway into Q2 2027 and positive kidney-transplant data.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
estimated glomerular filtration rate (egfr) medical
biopsy-proven acute rejection (bpar) medical
investigational new drug (ind) regulatory
fast track designation regulatory
non-inferiority medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Planned global Phase 3 LEGACY trial of tegoprubart in kidney transplantation remains on track to initiate in Q4 2026
FDA cleared the Company’s IND application for a planned registrational path study of tegoprubart in islet cell transplantation for patients with type 1 diabetes
FDA Fast Track designation granted to tegoprubart for the prevention of rejection in kidney transplantation
Cash, cash equivalents and short-term investments of
IRVINE, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its third quarter 2026 operating and financial results and provided recent business highlights.
“We continue to execute across our key strategic priorities and make meaningful progress in the tegoprubart clinical program across multiple transplant types, including plans to initiate our global Phase 3 LEGACY trial in kidney transplantation by year end,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “New patient-reported outcomes data from the Phase 2 BESTOW program further strengthened the evidence supporting tegoprubart’s differentiated profile compared to today’s standard of care immunosuppression therapy, while investigator-initiated studies and compassionate-use protocols help expand our understanding of tegoprubart and its therapeutic potential in different transplant settings where significant unmet needs remain.”
Third Quarter 2026 Business Highlights
Kidney Transplantation
- New patient-reported outcomes data from the Phase 2 BESTOW clinical program were presented at the American Society of Nephrology (ASN) Kidney Week 2026 Annual Meeting in October 2026. Results demonstrated sustained improvements in quality of life and symptom burden in kidney transplant recipients treated with tegoprubart compared with tacrolimus, today’s standard of care immunosuppression therapy. Tegoprubart-treated patients demonstrated a mean improvement on the total Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) at 12 months while tacrolimus-treated patients experienced a mean worsening of symptom occurrence. Patients treated with tegoprubart also experienced a statistically significant improvement on the Kidney Disease Quality of Life Short Form (KDQOL-SF) Symptoms and Problems Scale through 12 months following transplantation compared with tacrolimus.
- Updated long-term data from the Phase 2 BESTOW extension study were presented at the International Congress of the Transplantation Society (TTS) in September 2026. Tegoprubart-treated patients maintained statistically significantly higher mean estimated glomerular filtration rate (eGFR) at 18, 21, and 24 months, with an approximately 13 mL/min/1.73m2 advantage over tacrolimus at month 24 (71 vs. 58 mL/min/1.73m2 (
95% CI: 2.6, 23.3)). There were no reported cases of biopsy-proven acute rejection (BPAR) in the tegoprubart arm beyond six months post-transplant compared with seven BPAR events in the tacrolimus arm. - The first highly sensitized kidney transplant patient was dosed with tegoprubart under a compassionate-use protocol at Duke University Medical Center. Highly sensitized patients requiring a kidney transplant face a substantial unmet need because pre-existing antibodies can significantly limit access to compatible donor organs and increase the risk of antibody-mediated rejection and graft loss post-transplant.
- The third patient was treated as part of the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH).
- Tegoprubart received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the prevention of rejection in kidney transplantation.
Islet Cell Transplantation
- The FDA cleared the Investigational New Drug (IND) application for a planned Company-sponsored, registrational path clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation.
- The first patients were enrolled in an investigator-initiated clinical trial underway at the University of Chicago Medicine Transplant Institute, evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease who are receiving an islet cell transplant.
- The first islet cell transplant recipient was dosed with tegoprubart under a compassionate-use protocol allowing patients to switch from tacrolimus-based immunosuppression therapy due to calcineurin inhibitor-related renal dysfunction.
- The University of Chicago Medicine Transplant Institute expanded its ongoing investigator-initiated study evaluating tegoprubart as the core immunosuppressant for T1D patients undergoing islet cell transplantation by enrolling three additional subjects. This will help build on previously reported study results in the 12 patients treated to date, who have achieved
100% insulin independence and demonstrated stable islet graft function through 22 months of follow-up with a favorable tolerability profile. No evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus, has been observed to date.
Anticipated Upcoming Milestones
The Company anticipates the following milestones over the next 12 months:
- Initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority of tegoprubart versus tacrolimus at 52 weeks based on a composite of BPAR, graft loss, and death.
- Initiate a Company-sponsored, registrational path study evaluating tegoprubart in T1D patients undergoing islet cell transplantation.
- Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant.
- Receive FDA regulatory guidance on the path to market for tegoprubart in kidney xenotransplantation.
Third Quarter 2026 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development (R&D) expenses for the third quarter of 2026 were
General and administrative (G&A) expenses for the third quarter of 2026 were
Net loss for the third quarter of 2026 was
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-CD40L 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. Specifically, our ability to achieve our anticipated future development and corporate milestones depends on our ability to obtain additional financing on acceptable terms. 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 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 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 Report on Form 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
| ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) | ||||||||
| September 30, 2026 | December 31, 2025 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,882 | $ | 22,808 | ||||
| Short-term investments | 62,790 | 110,528 | ||||||
| Prepaid expenses and other current assets | 4,038 | 2,352 | ||||||
| Total current assets | 73,710 | 135,688 | ||||||
| Operating lease asset, net | 358 | 613 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 185 | 322 | ||||||
| Total assets | $ | 106,639 | $ | 169,009 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,842 | $ | 3,627 | ||||
| Current operating lease liabilities | 341 | 358 | ||||||
| Accrued expenses and other liabilities | 8,519 | 14,359 | ||||||
| Total current liabilities | 11,702 | 18,344 | ||||||
| Deferred tax liabilities | 2,187 | 2,187 | ||||||
| Non-current operating lease liabilities | 35 | 283 | ||||||
| Warrant liabilities | 22,901 | 11,416 | ||||||
| Total liabilities | 36,825 | 32,230 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock, 5,000,000 shares authorized at September 30, 2026 and December 31, 2025: | ||||||||
| Series X non-voting convertible preferred stock, | 2,151 | 2,151 | ||||||
| Series X1 non-voting convertible preferred stock, | 36,867 | 53,543 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 82 | 75 | ||||||
| Additional paid-in capital | 506,631 | 482,189 | ||||||
| Accumulated other comprehensive income (loss) | (126 | ) | 24 | |||||
| Accumulated deficit | (475,791 | ) | (401,203 | ) | ||||
| Total stockholders’ equity | 30,796 | 81,085 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 106,639 | $ | 169,009 | ||||
| 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 September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 17,761 | $ | 14,969 | $ | 53,188 | $ | 48,776 | ||||||||
| General and administrative | 3,911 | 4,101 | 12,534 | 12,991 | ||||||||||||
| Total operating expenses | 21,672 | 19,070 | 65,722 | 61,767 | ||||||||||||
| Loss from operations | (21,672 | ) | (19,070 | ) | (65,722 | ) | (61,767 | ) | ||||||||
| Other income, net | 714 | 1,047 | 2,694 | 3,680 | ||||||||||||
| Change in fair value of warrant liabilities | 17,025 | 564 | (11,560 | ) | 22,917 | |||||||||||
| Net loss | $ | (3,933 | ) | $ | (17,459 | ) | $ | (74,588 | ) | $ | (35,170 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain (loss) on available-for-sale securities, net | (12 | ) | 57 | (150 | ) | (17 | ) | |||||||||
| Comprehensive loss | $ | (3,945 | ) | $ | (17,402 | ) | $ | (74,738 | ) | $ | (35,187 | ) | ||||
| Basic and diluted net loss per share of common stock | $ | (0.03 | ) | $ | (0.21 | ) | $ | (0.63 | ) | $ | (0.42 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 114,722,339 | 77,156,068 | 113,601,123 | 77,146,407 | ||||||||||||
| Basic and diluted net loss per share of Series X and Series X1 non-voting convertible preferred stock | $ | (1.83 | ) | $ | (11.61 | ) | $ | (34.84 | ) | $ | (23.40 | ) | ||||
| Weighted-average shares outstanding of Series X and Series X1 non-voting convertible preferred stock, basic and diluted | 80,222 | 114,508 | 96,076 | 114,508 | ||||||||||||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Eledon Pharmaceuticals' third-quarter 2026 financial results?
Eledon reported a $3.933 million net loss, or $0.03 per basic and diluted common share, versus $17.459 million, or $0.21 per share, a year earlier. The quarter included a $17.025 million non-cash gain from warrant valuation changes, compared with a $564,000 gain in the prior-year quarter.
When does Eledon plan to start the Phase 3 LEGACY kidney transplant trial?
Eledon plans to initiate Phase 3 LEGACY in Q4 2026. The global kidney transplantation trial is expected to enroll approximately 600 patients.
What is the primary endpoint of Eledon's Phase 3 LEGACY trial?
LEGACY's primary endpoint is non-inferiority to tacrolimus at 52 weeks, meaning tegoprubart will be tested for whether it is not worse under the trial's statistical criteria. The endpoint combines biopsy-proven acute rejection, graft loss and death.
What did Eledon's BESTOW extension show about kidney transplant rejection?
The tegoprubart arm had no reported biopsy-proven acute rejection beyond six months after transplant, compared with seven such events in the tacrolimus arm. These findings came from the Phase 2 BESTOW extension study.