Eledon Pharmaceuticals Reports Second Quarter 2025 Operating and Financial Results
Eledon Pharmaceuticals (NASDAQ: ELDN) reported Q2 2025 financial results and clinical progress for its lead drug tegoprubart. The company highlighted positive Phase 1b data in kidney transplant patients, showing a mean 12-month eGFR of approximately 68 mL/min/1.73 m2, significantly better than the historical standard of care (~53 mL/min/1.73 m2).
Key developments include successful treatment of six islet cell transplant recipients at UChicago Medicine, with the first three achieving insulin independence, and a third patient receiving tegoprubart in kidney xenotransplantation at MGH. The company reported $107.6 million in cash as of June 30, 2025, expected to fund operations through 2026, and anticipates Phase 2 BESTOW trial results in kidney transplantation by November 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) ha annunciato i risultati finanziari del secondo trimestre 2025 e i progressi clinici del suo farmaco di punta, tegoprubart. La società ha sottolineato dati positivi di Fase 1b nei pazienti con trapianto renale, con una eGFR media a 12 mesi di circa 68 mL/min/1,73 m2, nettamente superiore allo standard storico di cura (~53 mL/min/1,73 m2).
I principali sviluppi includono il trattamento riuscito di sei riceventi di trapianto di cellule insulari presso l'UChicago Medicine, con i primi tre che hanno raggiunto l'indipendenza dall'insulina, e un terzo paziente che ha ricevuto tegoprubart in un trapianto renale xenotrapianto al MGH. La società ha dichiarato di avere 107,6 milioni di dollari in cassa al 30 giugno 2025, sufficienti a finanziare le operazioni fino al 2026, e prevede i risultati della Fase 2 BESTOW per i trapianti renali entro novembre 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) informó los resultados financieros del segundo trimestre de 2025 y los avances clínicos de su fármaco principal, tegoprubart. La compañía destacó datos positivos de la Fase 1b en pacientes con trasplante renal, mostrando una eGFR media a 12 meses de aproximadamente 68 mL/min/1,73 m2, significativamente superior al estándar histórico de atención (~53 mL/min/1,73 m2).
Entre los hitos clave figura el tratamiento exitoso de seis receptores de trasplante de islotes en UChicago Medicine, con los primeros tres alcanzando independencia de la insulina, y un tercer paciente que recibió tegoprubart en un xenotrasplante renal en MGH. La compañía reportó 107,6 millones de dólares en efectivo al 30 de junio de 2025, que se espera financien las operaciones hasta 2026, y anticipa los resultados del ensayo de Fase 2 BESTOW en trasplante renal para noviembre de 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN)는 2025년 2분기 재무 실적과 주력 약물 테고프루바트의 임상 진행 상황을 발표했습니다. 회사는 신장이식 환자에서의 긍정적인 1b상 데이터를 강조했으며, 12개월 평균 eGFR이 약 68 mL/min/1.73 m2로 과거 표준 치료(~53 mL/min/1.73 m2)보다 유의하게 우수하다고 밝혔습니다.
주요 내용으로는 UChicago Medicine에서 여섯 명의 이자 이식 수혜자를 성공적으로 치료했으며, 처음 세 명은 인슐린 독립을 달성했고, 세 번째 환자는 MGH에서 신장 이종이식에 테고프루바트를 투여받았다는 점이 포함됩니다. 회사는 2025년 6월 30일 기준 현금 1억 760만 달러를 보유하고 있어 2026년까지 운영 자금이 확보될 것으로 예상하며, 2025년 11월까지 신장 이식 관련 2상 BESTOW 시험 결과를 기대하고 있습니다.
Eledon Pharmaceuticals (NASDAQ: ELDN) a publié ses résultats financiers du deuxième trimestre 2025 et les progrès cliniques de son médicament phare, tegoprubart. La société a mis en avant des données positives de Phase 1b chez des patients transplantés rénaux, avec une eGFR moyenne à 12 mois d'environ 68 mL/min/1,73 m2, nettement supérieure à la norme historique (~53 mL/min/1,73 m2).
Parmi les avancées clés figurent le traitement réussi de six receveurs de greffe d'îlots à l'UChicago Medicine, dont les trois premiers sont devenus indépendants de l'insuline, et un troisième patient ayant reçu tegoprubart lors d'une xénogreffe rénale au MGH. La société a déclaré disposer de 107,6 millions de dollars de trésorerie au 30 juin 2025, suffisants selon elle pour financer ses activités jusqu'en 2026, et prévoit les résultats de l'essai de Phase 2 BESTOW en transplantation rénale d'ici novembre 2025.
Eledon Pharmaceuticals (NASDAQ: ELDN) veröffentlichte die Finanzergebnisse für Q2 2025 und den klinischen Fortschritt seines führenden Medikaments Tegoprubart. Das Unternehmen hob positive Phase‑1b‑Daten bei Nierentransplantationspatienten hervor, mit einer mittleren eGFR nach 12 Monaten von etwa 68 mL/min/1,73 m2, deutlich besser als der historische Standard (~53 mL/min/1,73 m2).
Zu den wichtigsten Entwicklungen zählt die erfolgreiche Behandlung von sechs Inselzelltransplantatempfängern an der UChicago Medicine, wobei die ersten drei insulinunabhängig wurden, sowie ein dritter Patient, der Tegoprubart bei einer Nierexentransplantation am MGH erhielt. Das Unternehmen meldete zum 30. Juni 2025 107,6 Millionen US-Dollar in bar, was voraussichtlich die Geschäftstätigkeit bis 2026 finanziert, und erwartet die Ergebnisse der Phase‑2 BESTOW‑Studie zur Nierentransplantation bis November 2025.
- Phase 1b trial showed superior kidney function (eGFR ~68) compared to standard of care (eGFR ~53)
- First three islet cell transplant recipients achieved insulin independence
- Strong cash position of $107.6M, funding operations through 2026
- No serious safety concerns in kidney transplant trial - no deaths, graft loss, or new-onset diabetes
- R&D expenses doubled to $20.3M in Q2 2025 vs $10.1M in Q2 2024
- Net cash position decreased from $140.2M to $107.6M over six months
- Reported net loss of $11.2M for Q2 2025
Insights
Eledon reports solid Q2 with promising kidney transplant data showing superior eGFR outcomes versus standard therapy while maintaining strong $107.6M cash position.
Eledon's Q2 results demonstrate continued clinical progress for tegoprubart across multiple transplant indications. The updated Phase 1b kidney transplant data is particularly compelling - patients maintained a mean 12-month eGFR of approximately
The safety profile continues to be favorable with no reported deaths, graft losses, tremors, sepsis, or new-onset diabetes - complications that often plague current immunosuppressive regimens. The company's multipronged strategy spanning kidney, islet cell, and liver transplantation, plus the pioneering xenotransplantation work, creates multiple paths to potential success.
Financially, Eledon reports
The upcoming Phase 2 BESTOW readout in November represents a critical near-term catalyst that could validate tegoprubart's efficacy in a larger, controlled trial setting. Additional potential value drivers include the UChicago islet cell transplant work showing insulin independence and the innovative tolerance induction program at MGH.
Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart
Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025
Cash, cash equivalents and short-term investments of
IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.
“We are proud to enter the second half of the year with strong momentum as we have achieved all of our key milestones to date including advancing tegoprubart in kidney, islet cell (type 1 diabetes), and liver allotransplantation, as well as in xenotransplantation. The positive data we recently presented at the World Transplant Congress reinforce the potential of tegoprubart to improve long-term transplant outcomes while reducing the toxic side effects often associated with the current standard of care,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “With these encouraging results in hand, we look forward to sharing topline data later this year from our Phase 2 BESTOW trial in kidney transplantation and to continuing to explore tegoprubart’s broad potential in other transplant indications.”
Year-to-Date 2025 Business Highlights
- Presented updated data at the World Transplant Congress (WTC) in August 2025 from the ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Updated data from 32 participants demonstrated that tegoprubart continues to be well tolerated with no cases of death, graft loss, drug related tremor, sepsis, or new-onset diabetes. Kidney function, as assessed by estimated glomerular filtration rate (eGFR), generally stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for participants (n=12) who remained on tegoprubart. For comparison, data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFRs of approximately 53 mL/min/1.73 m2 at 12 months after kidney transplant.
- In June 2025, a third patient was treated with tegoprubart as a cornerstone component of the immunosuppression treatment regimen following kidney xenotransplantation conducted at Massachusetts General Hospital (MGH) in collaboration with eGenesis.
- Announced the first three islet cell transplant recipients treated at the University of Chicago Medicine’s Transplant Institute in an investigator-initiated trial evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection achieved insulin independence. An additional three islet transplant recipients have now been enrolled as well, bringing the total enrollment in the trial to six patients.
- Preclinical data in liver allotransplantation utilizing tegoprubart was presented at WTC 2025 demonstrating markedly prolonged graft survival in non-human primates (NHPs) by targeting the CD40 Ligand pathway and the potential for transplant tolerance induction.
- Announced a second investigator-initiated trial at the University of Chicago Medicine’s Transplant Institute evaluating tegoprubart as part of an immunosuppression regimen for the prevention of islet transplant rejection in patients with impaired kidney function.
- Hosted an R&D Day in New York City that highlighted recent progress for the Company’s lead investigational candidate, tegoprubart, with a focus on its clinical development progress in organ and cell transplantation, including the ongoing Phase 2 BESTOW trial. The event featured members of Eledon’s executive team and leading experts in the field of transplantation. A replay of the R&D Day event can be found on Eledon’s website at https://ir.eledon.com/news-and-events/events
- In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among investors as Eledon approaches key regulatory milestones.
Anticipated Upcoming Milestones for 2H 2025
- November 2025: Report topline results from the Phase 2 BESTOW trial of tegoprubart in kidney transplantation.
- Launch an investigator-initiated trial at MGH evaluating tegoprubart as part of an immunosuppression regimen to induce donor-specific immune tolerance through mixed chimerism.
- Enroll three additional patients in the investigator-led clinical trial at UChicago Medicine in subjects with type 1 diabetes treated with tegoprubart as part of an immunosuppression regimen for the prevention of pancreatic islet transplant rejection.
Second Quarter 2025 Financial Results
Cash, cash equivalents and short-term investments totaled
Research and development (R&D) expenses for the second quarter of 2025 were
General and administrative expenses for the second quarter of 2025 were
Net loss for the second quarter of 2025 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-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: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sides, 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. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,741 | $ | 20,549 | ||||
| Short-term investments | 101,829 | 119,629 | ||||||
| Prepaid expenses and other current assets | 3,834 | 3,552 | ||||||
| Total current assets | 111,404 | 143,730 | ||||||
| Operating lease asset, net | 773 | 926 | ||||||
| In-process research and development | 32,386 | 32,386 | ||||||
| Other assets | 346 | 363 | ||||||
| Total assets | $ | 144,909 | $ | 177,405 | ||||
| LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,831 | $ | 5,833 | ||||
| Current operating lease liabilities | 336 | 314 | ||||||
| Accrued expenses and other liabilities | 7,552 | 5,430 | ||||||
| Total current liabilities | 13,719 | 11,577 | ||||||
| Deferred tax liabilities | 2,183 | 2,183 | ||||||
| Non-current operating lease liabilities | 467 | 640 | ||||||
| Warrant liabilities | 22,512 | 44,865 | ||||||
| Total liabilities | 38,881 | 59,265 | ||||||
| Commitments and contingencies | — | — | ||||||
| Convertible preferred stock, 5,000,000 shares authorized at June 30, 2025 and December 31, 2024: | ||||||||
| Series X1non-voting convertible preferred stock, | 53,543 | 53,543 | ||||||
| Series X non-voting convertible preferred stock, | 2,151 | 2,151 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 60 | 60 | ||||||
| Additional paid-in capital | 423,619 | 417,946 | ||||||
| Accumulated other comprehensive income (loss) | (48 | ) | 26 | |||||
| Accumulated deficit | (373,297 | ) | (355,586 | ) | ||||
| Total stockholders’ equity | 50,334 | 62,446 | ||||||
| Total liabilities, convertible preferred stock and stockholders’ equity | $ | 144,909 | $ | 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 Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses | ||||||||||||||||
| Research and development | $ | 20,276 | $ | 10,106 | $ | 33,807 | $ | 17,516 | ||||||||
| General and administrative | 4,457 | 4,396 | 8,890 | 7,855 | ||||||||||||
| Total operating expenses | 24,733 | 14,502 | 42,697 | 25,371 | ||||||||||||
| Loss from operations | (24,733 | ) | (14,502 | ) | (42,697 | ) | (25,371 | ) | ||||||||
| Other income, net | 1,224 | 869 | 2,633 | 1,443 | ||||||||||||
| Change in fair value of warrant liabilities | 12,293 | (31,274 | ) | 22,353 | (44,610 | ) | ||||||||||
| Net loss | $ | (11,216 | ) | $ | (44,907 | ) | $ | (17,711 | ) | $ | (68,538 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized loss on available-for-sale securities, net | (30 | ) | — | (74 | ) | — | ||||||||||
| Comprehensive loss | $ | (11,246 | ) | $ | (44,907 | ) | $ | (17,785 | ) | $ | (68,538 | ) | ||||
| Basic and diluted earnings per share of common stock (2024 As Restated) | $ | (0.13 | ) | $ | (0.92 | ) | $ | (0.21 | ) | $ | (1.61 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 77,156,068 | 42,278,411 | 77,141,196 | 36,133,906 | ||||||||||||
| Basic and diluted earnings per share of Series X and Series X1non-voting convertible preferred stock (2024 As Restated) | $ | (7.46 | ) | $ | (51.29 | ) | $ | (11.78 | ) | $ | (89.60 | ) | ||||
| Weighted-average shares outstanding of Series X and Series X1non-voting convertible preferred stock, basic and diluted (2024 As Restated) | 114,508 | 114,508 | 114,508 | 114,508 | ||||||||||||
FAQ
What were the key findings from Eledon's Phase 1b kidney transplant trial for tegoprubart?
How much cash does Eledon (ELDN) have and how long will it last?
What were Eledon's Q2 2025 financial results?
When will Eledon report Phase 2 BESTOW trial results?
What progress has Eledon made in islet cell transplantation?
