Eledon Pharmaceuticals Announces Recent Business Highlights and Third Quarter 2025 Financial Results
Eledon Pharmaceuticals (Nasdaq: ELDN) reported Q3 2025 results and business highlights on Nov 14, 2025. Key points: Phase 2 BESTOW data showed tegoprubart with a favorable safety profile and an eGFR of approximately 69 mL/min/1.73m2 at 12 months in the treatment arm (n=51), supporting plans to advance to Phase 3 after regulator discussions. The company completed an underwritten public offering on Nov 13, 2025, raising $57.5 million gross (net ≈ $53.6M) to fund transplantation programs. Cash and short-term investments were $93.4 million as of Sept 30, 2025. Anticipated 2026 milestones include FDA guidance and initiation of a Phase 3 kidney transplant trial.
Eledon Pharmaceuticals (Nasdaq: ELDN) ha comunicato risultati del Q3 2025 e i punti salienti dell'attività il 14 novembre 2025. Punti chiave: i dati della fase 2 BESTOW hanno mostrato che il tegoprubart ha un profilo di sicurezza favorevole e una eGFR di circa 69 mL/min/1,73 m^2 a 12 mesi nel braccio di trattamento (n=51), a sostegno dei piani per proseguire con Fase 3 dopo le discussioni con i regolatori. L'azienda ha completato un'offerta pubblica sottoscritta il 13 novembre 2025, raccogliendo $57,5 milioni lordi (net ≈ $53,6M) per finanziare i programmi di trapianto. La liquidità e gli investimenti a breve termine ammontavano a $93,4 milioni al 30 settembre 2025. Le tappe previste per il 2026 includono linee guida della FDA e l'avvio di uno studio di Fase 3 sul trapianto renale.
Eledon Pharmaceuticals (Nasdaq: ELDN) informó los resultados del tercer trimestre de 2025 y los aspectos destacados del negocio el 14 de noviembre de 2025. Puntos clave: los datos de Fase 2 BESTOW mostraron que tegoprubart tiene un perfil de seguridad favorable y una eGFR de aproximadamente 69 mL/min/1.73m^2 a los 12 meses en el brazo de tratamiento (n=51), respaldando los planes para avanzar a Fase 3 tras las discusiones con el regulador. La compañía completó una oferta pública suscrita el 13 de noviembre de 2025, que obtuvo $57.5 millones brutos (net ≈ $53.6M) para financiar programas de trasplante. El efectivo y las inversiones a corto plazo eran de $93.4 millones al 30 de septiembre de 2025. Los hitos previstos para 2026 incluyen orientación de la FDA e inicio de un ensayo de Fase 3 de trasplante de riñón.
Eledon Pharmaceuticals (Nasdaq: ELDN)는 2025년 11월 14일 2025년 3분기 실적 및 비즈니스 하이라이트를 발표했습니다. 주요 내용: 2상 BESTOW 데이터는 텍로뽀랍트 tegoprubart가 우수한 안전성 프로파일을 보였고 치료군(n=51)에서 12개월 시점 eGFR가 약 69 mL/min/1.73m^2였으며(Regulator와의 논의 후 3상으로의 진행 계획을 뒷받침했습니다. 회사는 2025년 11월 13일에 공모를 완료하여 총 $57.5 million의 실현(순수익 ≈ $53.6M)을 확보해 이식 프로그램을 위한 자금을 조달했습니다. 현금 및 단기투자는 2025년 9월 30일 기준 $93.4 million이었습니다. 2026년의 예상 마일스톤에는 FDA 가이드라인과 신장 이식의 3상 시작이 포함됩니다.
Eledon Pharmaceuticals (Nasdaq: ELDN) a publié les résultats du T3 2025 et les points saillants de l'activité le 14 novembre 2025. Points clés : les données de la Phase 2 BESTOW ont montré que le tegoprubart présente un profil de sécurité favorable et une eGFR d'environ 69 mL/min/1,73 m^2 à 12 mois dans le bras de traitement (n=51), ce qui soutient les plans de passer à la Phase 3 après les discussions avec les autorités de régulation. L'entreprise a terminé une offre publique souscrite le 13 novembre 2025, levant $57,5 millions bruts (net ≈ $53,6 M) pour financer les programmes de transplantation. La trésorerie et les investissements à court terme s'élevaient à $93,4 millions au 30 septembre 2025. Les jalons prévus pour 2026 incluent des orientations de la FDA et le lancement d'un essai de Phase 3 sur la transplantation rénale.
Eledon Pharmaceuticals (Nasdaq: ELDN) hat am 14. November 2025 die Ergebnisse des Q3 2025 und die wichtigsten Geschäftspunkte bekannt gegeben. Kernpunkte: Daten der Phase 2 BESTOW zeigten, dass Tegoprubart ein günstiges Sicherheitsprofil aufweist und eine eGFR von ca. 69 mL/min/1,73 m^2 nach 12 Monaten im Behandlungsarm (n=51) vorliegt, was Pläne unterstützt, nach Gesprächen mit den Regulierungsbehörden in die Phase 3 vorzudringen. Das Unternehmen schloss am 13. November 2025 eine underwriting Public Offering ab und nahm $57,5 Mio. Brutto (net ≈ $53,6 Mio.) zur Finanzierung von Transplantationsprogrammen ein. Barbestand und kurzfristige Anlagen beliefen sich zum 30. September 2025 auf $93,4 Mio.. Erwartete Meilensteine für 2026 umfassen FDA-Richtlinien und den Beginn einer Phase-3-Studie zur Nierentransplantation.
إيلِدون فارماسيوتيكالز (ناسداك: ELDN) أصدرت نتائج ربِع السنة الثالث 2025 ونقاط بارزة عن الأعمال في 14 نوفمبر 2025. النقاط الرئيسية: أظهرت بيانات المرحلة 2 BESTOW أن tegoprubart لديه ملف سلامة مفضل وeGFR يقارب 69 mL/min/1.73m^2 عند 12 شهراً في الذراع العلاجي (n=51)، مما يدعم الخطط للمضي قدمًا إلى المرحلة 3 بعد مناقشات مع الجهات التنظيمية. أكملت الشركة عرضاً عاماً مُكتتباً في 13 نوفمبر 2025، بجمع $57.5 مليون إجمالي (صافي ≈ $53.6M) لتمويل برامج الزرع. النقد والاستثمارات قصيرة الأجل بلغت $93.4 مليون حتى 30 سبتمبر 2025. الأهداف الموعودة لعام 2026 تشمل توجيهات FDA وبداية تجربة المرحلة 3 لزرع الكلى.
- Completed public offering raising $57.5 million gross
- Phase 2 BESTOW eGFR ≈ 69 mL/min/1.73m2 at 12 months
- Plans to initiate Phase 3 kidney transplant trial in 2026
- Cash and short-term investments down to $93.4 million (Sept 30, 2025)
- Net loss of $17.5 million in Q3 2025
Insights
Phase 2 BESTOW shows a favorable safety signal and company secured financing to fund Phase 3 planning.
Eledon showed that tegoprubart had a favorable safety and tolerability profile in the Phase 2 BESTOW trial and reported an approximate 12‑month eGFR of 69 mL/min/1.732 in the treatment arm (n=51). The company plans to discuss Phase 3 design with regulators and advance into Phase 3 after those discussions, and it completed an underwritten public offering that generated gross proceeds of
The business impact rests on two concrete pillars: the clinical safety signal and the new capital. The safety and tolerability findings, if confirmed by regulators, support a regulatory pathway toward a Phase 3 kidney transplantation trial. The financing materially increases runway for development but does not on its own validate Phase 3 success; successful regulatory alignment and confirmatory data remain required.
Watch for three near‑term, monitorable items: receipt of FDA guidance on Phase 3 trial design in
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
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
Research and development (R&D) expenses for the third quarter of 2025 were
General and administrative expenses for the third quarter of 2025 were
Net loss for the third 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: 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, 2025 | December 31, 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 X1 non-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 | 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 Ended September 30, | For the Nine Months 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 X1 non-voting convertible preferred stock - basic | $ | (1,330 | ) | $ | 6,666 | $ | (2,679 | ) | $ | 852 | ||||||
| Basic net income (loss) per Series X and Series X1 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 X1 non-voting convertible preferred stock, basic | 114,508 | 114,508 | 114,508 | 114,508 | ||||||||||||
| Net loss attributable to Series X and Series X1 non-voting convertible preferred stock - diluted | $ | (1,330 | ) | $ | (1,801 | ) | $ | (2,679 | ) | $ | (7,856 | ) | ||||
| Diluted net loss per Series X and Series X1 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 X1 non-voting convertible preferred stock, diluted | 114,508 | 114,508 | 114,508 | 114,508 | ||||||||||||
FAQ
What did ELDN report about tegoprubart in the Phase 2 BESTOW trial on Nov 14, 2025?
How much did Eledon raise in the Nov 13, 2025 offering for ELDN?
What is Eledon’s cash position reported for Q3 2025 for ELDN shareholders?
When does Eledon expect to begin a Phase 3 kidney transplant trial for ELDN?
What were Eledon’s Q3 2025 R&D and net loss figures relevant to ELDN investors?
