ELDN

IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction First patients dosed under compassionate use of tegoprubart in highly sensitized patients with pre-existing antibodies receiving a kidney transplant Company on track to initiate global Phase 3 LEGACY trial of tegoprubart in kidney transplantation in Q4 2026 IRVINE, Calif., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced significant progress across multiple tegoprubart development programs in kidney allotransplantation and islet cell transplantation. The Company also reaffirmed that it remains on track to initiate LEGACY, its global Phase 3 clinical trial evaluating its investigational novel immunosuppression therapy tegoprubart, an anti-CD40L antibody, in patients undergoing kidney transplantation, in the fourth quarter of 2026. “The progress announced today reflects the growing breadth and momentum of tegoprubart’s clinical development across multiple transplant settings as we work to redefine transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “We remain on track to initiate our global Phase 3 LEGACY trial in kidney transplantation in the fourth quarter of 2026, while the submission of an IND for our first Company-sponsored islet cell transplantation study represents an important regulatory milestone for the tegoprubart program. In parallel, investigator-initiated studies and compassionate-use experience are expanding the clinical evaluation of tegoprubart into transplant populations with significant unmet needs, including in patients experiencing calcineurin inhibitor-related toxicities and in highly sensitized kidney transplant recipients who face elevated immunologic risk. These new programs are expected to generate important clinical insights and data updates over the next 12 months.” Islet Cell Transplantation IND submitted for Eledon-sponsored islet cell transplantation study in type 1 diabetes. Eledon has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a planned Company-sponsored, registrational clinical trial evaluating tegoprubart for the prevention of allograft rejection in type 1 diabetes (T1D) patients undergoing pancreatic islet cell transplantation. The planned study would be Eledon’s first Company-sponsored clinical trial in islet cell transplantation and represents an important step in the Company’s registrational pathway for tegoprubart in this patient population. First patients enrolled in a new investigator-initiated study involving islet cell transplant recipients with T1D and chronic kidney disease. The first patients have been enrolled in an investigator-initiated clinical trial evaluating tegoprubart for the prevention of allograft rejection in patients with T1D and renal dysfunction from chronic kidney disease receiving an islet cell transplant. The study, underway at the University of Chicago Medicine Transplant Institute, evaluates a calcineurin inhibitor–free, tegoprubart-based immunosuppression regimen in patients who are especially susceptible to tacrolimus toxicity, including kidney damage, which has long constrained the use of islet cell transplantation. First islet cell transplant recipient dosed with tegoprubart following conversion from tacrolimus. The first islet cell transplant recipient has been dosed with tegoprubart under a compassionate-use protocol allowing them to switch from their previous tacrolimus-based immunosuppression therapy due to calcineurin inhibitor–related renal dysfunction. This compassionate use of tegoprubart may address an important unmet need among transplant recipients who require lifelong immunosuppression therapy to preserve graft function but experience renal complications often associated with calcineurin inhibitors such as tacrolimus, today’s standard of care. Ongoing UChicago Medicine investigator-initiated study in participants with T1D undergoing islet cell transplantation expanded by three patients. UChicago Medicine is adding three additional patients in its ongoing investigator-initiated islet cell transplantation study evaluating tegoprubart as the core immunosuppressant, expanding the study beyond the 12 patients treated to date. This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease, and a hemoglobin A1c (HbA1c) level below 7.0% following islet cell transplantation and treatment with tegoprubart. Stable islet graft function was observed across all 12 study participants through a maximum reported follow-up of 22 months. Tegoprubart demonstrated a favorable tolerability profile, with no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are side effects often associated with calcineurin inhibitors such as tacrolimus. Kidney Transplantation Phase 3 LEGACY clinical trial on track to initiate in Q4 2026. Following its successful End-of-Phase 2 meeting with the FDA, Eledon remains on track to initiate its global Phase 3 trial of tegoprubart in kidney transplantation (LEGACY) in the fourth quarter of 2026. The LEGACY trial is expected to enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss, and death. First highly sensitized kidney transplant patient dosed under compassionate use. The first highly sensitized kidney transplant patient has been 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 compassionate use of tegoprubart in this setting will help expand our clinical insights and understanding of tegoprubart’s potential in a particularly challenging patient population. Third patient treated in investigator-initiated kidney transplant tolerance study. A third patient has been treated in the investigator-initiated study evaluating tegoprubart for kidney transplant tolerance induction at Massachusetts General Hospital (MGH). Tolerance induction has the potential to eliminate the need for patients to require lifelong immunosuppression therapy. 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; 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. 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 as 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 JasperGilmartin Group(858) 525 [email protected] Media Contact: Jenna UrbanCG Life(212) 253 [email protected] Source: Eledon Pharmaceuticals

Successful End-of-Phase 2 meeting with FDA supports advancement of tegoprubart into a global Phase 3 kidney transplantation trial, on track to initiate in late 2026 Long-term Phase 2 BESTOW data presented at ATC 2026 demonstrated sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus Updated islet cell transplantation data presented at ADA 2026 showed 100% insulin independence in all 12 patients with type 1 diabetes Cash, cash equivalents and short-term investments of $88.8 million as of June 30, 2026 IRVINE, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its second quarter 2026 operating and financial results and provided recent business highlights. “During the first half of the year, we made meaningful progress establishing the regulatory framework for our planned Phase 3 kidney transplantation program, which we expect to initiate later this year,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The continued strength of our clinical data, including sustained long-term kidney function in BESTOW and the compelling results from the UChicago Medicine islet cell transplantation study, reinforces the potential of tegoprubart to improve outcomes across multiple transplant settings. We look forward to advancing our Phase 3 program and expanding the clinical evidence for tegoprubart across additional transplant indications.” Second Quarter 2026 Business Highlights Kidney Transplantation Completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration, establishing the regulatory framework for the planned Phase 3 trial of tegoprubart in kidney transplantation. The global trial is on track to initiate in late 2026 and enroll approximately 600 patients, with a primary endpoint of non-inferiority versus tacrolimus at 52 weeks based on a composite of biopsy-proven acute rejection (BPAR), graft loss and death. Presented new long-term data from the Phase 2 BESTOW clinical program at the American Transplant Congress (ATC) in June 2026, demonstrating sustained higher kidney function in kidney transplant patients treated with tegoprubart compared with tacrolimus, the current standard-of-care immunosuppression therapy. At 18 months, the eGFR curves showed a statistically significant separation (p<0.05), with mean eGFR approximately 12 mL/min/1.73 m² higher for tegoprubart compared with tacrolimus (approximately 74 vs. 61 mL/min/1.73 m²). No BPAR events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm. Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden. Long-term data from the BESTOW extension trial also demonstrated favorable long-term safety and tolerability. Treated the first two patients in an investigator-initiated study of kidney transplant tolerance induction at Massachusetts General Hospital. Entered into a strategic partnership with Natera, Inc., a global leader in cell-free DNA testing and precision medicine, to incorporate Natera’s Prospera kidney transplant assessment test as the exclusive donor-derived cell-free DNA (dd-cfDNA) monitoring assay in Eledon’s planned Phase 3 kidney transplantation trial. Islet Cell Transplantation Presented updated data from the University of Chicago Medicine investigator-initiated islet cell transplantation study at ADA 2026. All 12 patients with T1D achieved insulin independence and HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4% and no severe hypoglycemic episodes post-transplant. Tegoprubart demonstrated stable islet graft function through a maximum follow-up of 22 months and was generally well tolerated, with no evidence of nephrotoxicity, hypertension or neurotoxicity. Anticipated Upcoming Milestones The Company anticipates the following milestones in 2026 and over the next 12 months: Initiate Phase 3 clinical trial evaluating tegoprubart in kidney transplantation in late 2026. Support the initiation of an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant in 2026. Initiate company-sponsored, registration path study evaluating tegoprubart in islet cell transplantation. Support the initiation of 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 xenotransplantation. Second Quarter 2026 Financial Results Cash, cash equivalents and short-term investments totaled $88.8 million as of June 30, 2026, compared to $133.3 million as of December 31, 2025. The Company expects current cash, cash equivalents and short-term investments to fund operations into the second quarter of 2027. Research and development (R&D) expenses for the second quarter of 2026 were $18.2 million, including $2.1 million of non-cash stock-based compensation expense, compared to $20.3 million for the comparable period in 2025, including $1.1 million of non-cash stock-based compensation expense. General and administrative (G&A) expenses for the second quarter of 2026 were $4.6 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.5 million for the comparable period in 2025, including $1.6 million of non-cash stock-based compensation expense. Net loss for the second quarter of 2026 was $31.6 million, or $0.27 per basic common share, compared to a net loss of $11.2 million, or $0.13 per basic common share, for the comparable period in 2025. Net loss in the second quarter of 2026 included a non-cash loss of $9.6 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $12.3 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $22.0 million for the three months ended June 30, 2026, and $23.5 million for the three months ended June 30, 2025. 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. 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 as 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 JasperGilmartin Group(858) 525 [email protected] Media Contact: Jenna UrbanCG Life(212) 253 [email protected]

Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm Patient-reported outcomes at 52 weeks favored tegoprubart, with statistically significant improvements versus tacrolimus on two validated measures of symptom burden Conference call and webcast to be held today at 8:00 a.m. ET IRVINE, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced new long-term data from its Phase 2 BESTOW clinical program evaluating tegoprubart in patients undergoing kidney transplantation, presented in oral and poster presentations at the American Transplant Congress (ATC) taking place June 20-24, 2026, in Boston, Massachusetts. The presentations highlight updated results from the Phase 2 BESTOW trial and new long-term follow-up data from the Phase 2 BESTOW extension study. “These long-term data further strengthen our belief that tegoprubart has the potential to redefine the standard of care in transplant immunomodulation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “A statistically significant kidney function benefit at 18 months, no observed BPAR events after six months in tegoprubart-treated patients, favorable long-term safety and tolerability, and improved patient-reported outcomes collectively reinforce tegoprubart’s emerging, differentiated clinical profile as we prepare to advance into Phase 3 development.” “For kidney transplant recipients, success is measured not only by preventing rejection, but by preserving kidney function and maintaining quality of life over the long term,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “These data are especially encouraging because tegoprubart was associated with sustained kidney function and improvements in patient-reported measures of symptom burden compared with tacrolimus. Providing an effective alternative to tacrolimus-based immunosuppression remains one of the most important unmet needs in kidney transplantation, particularly because lifelong immunosuppression can affect both long-term graft survival and how patients feel and function every day.” Efficacy Results Among patients who completed 12 months of treatment in the BESTOW study, 96% (49/51) of tegoprubart-treated patients and 86% (48/56) of tacrolimus-treated patients entered the BESTOW long-term extension study. As of the data cutoff, mean follow-up was 21 months, with: 89 patients followed through 18 months, 20 patients followed through 24 months, and the longest-followed ongoing patient followed for approximately 33 months. Kidney graft function, as assessed by estimated glomerular filtration rate (eGFR), stabilized after the first month of treatment and remained higher in tegoprubart-treated patients than in tacrolimus-treated patients at each reported time point. At month 18, tegoprubart-treated patients demonstrated a statistically significant approximately 12 mL/min/1.73 m² higher mean eGFR compared with tacrolimus-treated patients (74 vs. 61 mL/min/1.73 m²; p<0.05). No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months of treatment. In the tacrolimus arm, seven of 11 total BPAR events (approximately 64% of BPAR events) occurred after six months, including two events after 12 months: one new case of active antibody-mediated rejection (aAMR) and one recurrent case of active T-cell-mediated rejection with aAMR. Patient-reported outcome measures demonstrated lower symptom burden among tegoprubart-treated patients compared with tacrolimus-treated patients at 52 weeks, with statistically significant improvements on the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R; treatment difference: -12.2; 95% CI: -19.7, -4.6; p<0.05) and the KDQOL-36 Symptoms and Problems domain (treatment difference: 5.7; 95% CI: 1.0, 10.5; p<0.05). In an exploratory analysis of patients who experienced rejection post-transplant, those who remained on tegoprubart maintained higher mean eGFR than tacrolimus-treated patients who experienced rejection, with the observed difference increasing from approximately 15 mL/min/1.73 m² at 12 months to approximately 25 mL/min/1.73 m² at 21 months. Long-term follow-up from the Phase 1b study for patients treated at the 20 mg/kg dose of tegoprubart was consistent with the Phase 2 BESTOW results, with no BPAR episodes observed after six months in tegoprubart-treated patients. In the Phase 1b study, long-term data was available for 16 patients; eight patients have been followed through 24 months, and the longest-followed ongoing patient has been on tegoprubart for approximately 3.5 years. Safety Results In the BESTOW long-term extension study, key central nervous system and kidney-related adverse events were observed more frequently in the tacrolimus arm than in the tegoprubart arm, including headache (12% vs. 2%), extremity pain (10% vs. 0%), fall or loss of balance (6% vs. 0%), and acute kidney injury (6% vs. 2%), respectively. Diarrhea was observed more frequently in the tacrolimus arm than in the tegoprubart arm during long-term follow-up (21% vs. 10%, respectively). This pattern was consistent with the first-year BESTOW results, in which diarrhea was reported in 34% of tacrolimus-treated patients vs. in 22% of tegoprubart-treated patients. No graft loss, no progressive multifocal leukoencephalopathy (PML), no post-transplant lymphoproliferative disorder (PTLD), no BK or CMV nephropathy/disease, and no new malignancies were reported in the BESTOW long-term extension study. No new proteinuria was reported on the tegoprubart arm. One death occurred in the tegoprubart arm and was not attributed to study drug. Next Steps Following a successful FDA End-of-Phase 2 meeting, Eledon has established the regulatory framework for its Phase 3 kidney transplantation program and plans to initiate Phase 3 clinical development of tegoprubart in late 2026. The Phase 3 primary endpoint is expected to be non-inferiority versus tacrolimus at 52 weeks on a composite of BPAR, graft loss and death. The Phase 3 study will also incorporate key learnings from the Phase 2 BESTOW trial and ongoing long-term extension study, including evidence of sustained kidney function benefit, favorable rejection outcomes, and improved patient-reported outcomes. Investor Conference Call Information Eledon will hold a conference call today, June 22, 2026 at 8:00 a.m. Eastern Time to discuss the long-term data from the Phase 2 BESTOW and the Phase 1b kidney transplant clinical trials, as well as to discuss recently presented data from the on-going islet cell transplant investigator sponsored study. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 84665. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call. Full details of the ATC oral presentation are below: Title: Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy in Preventing Kidney Transplant RejectionPresenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health FairviewAbstract Publication Number: 585Session Title: Emerging Discoveries Oral Abstract Session - Kidney: Biomarkers -3Session Date and Time: Monday, June 22, 2026, from 11:15 a.m. - 12:15 p.m. ETSession Room: 253BC (Level 2)Presentation Time: 12:03 p.m. - 12:15 p.m. ET 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, 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. 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 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 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 JasperGilmartin Group(858) 525 [email protected] Media Contact: Jenna UrbanCG Life(212) 253 [email protected] Source: Eledon Pharmaceuticals

While Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) has gained 125.83% year-to-date, analysts continue to see 134.60% upside, helping it secure a spot on our list of the hot biotech stocks under $5 to buy. Updated clinical data presented at a major diabetes conference added weight to the case that Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN)’s lead drug could reshape how islet cell transplantation is managed in type 1 diabetes. On June 08, 2026, Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) announced updated results from an investigator-initiated trial evaluating tegoprubart, its anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The data were presented at the American Diabetes Association 86th Scientific Sessions in New Orleans. All 12 patients treated in the study achieved insulin independence and showed rapid improvement in glycemic control following transplantation. Stable islet graft function was observed over a median follow-up of eight months and a maximum of 22 months. All patients also recorded a most recent HbA1c below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4%. No severe hypoglycemic episodes were reported post-transplant, compared to recurrent severe events in all patients before the procedure. Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart regimen than in historical patients treated with tacrolimus at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. No evidence of nephrotoxicity, hypertension, or neurotoxicity was observed, side effects commonly associated with tacrolimus. Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) said it looks forward to working with the FDA toward regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year. Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) is a clinical-stage biotechnology company that targets the CD40L pathway to develop ALS treatments and therapies to prevent organ transplant rejection. The company’s lead candidate, tegoprubart, is an anti-CD40L IgG1 antibody. While we acknowledge the potential of ELDN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 33 Stocks That Should Double in 3 Years and 15 Stocks That Will Make You Rich in 10 Years. Disclosure: None. Follow Insider Monkey on Google News.

100% insulin independence achieved in 10 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study FDA Orphan Drug designation granted to tegoprubart for the prevention of allograft rejection in liver transplantation Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026 IRVINE, Calif., May 13, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its first quarter 2026 operating and financial results and provided recent business highlights. “In the first quarter of 2026, we achieved significant milestones in our tegoprubart program, including important data updates in kidney and islet cell transplantation and FDA Orphan Drug designation for tegoprubart in liver transplantation,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “Looking ahead, we expect multiple catalysts in 2026, including regulatory engagements supporting the advancement of tegoprubart into Phase 3 development in kidney transplantation and discussions regarding a potential path to market in islet cell transplantation. We also plan to initiate several new clinical trials, including an investigator sponsored study in liver transplantation, and share new kidney transplant data from our Phase 2 BESTOW long-term extension study, building on encouraging 24-month Phase 1b results that demonstrated a durable safety profile and improved graft function.” First Quarter 2026 Business Highlights In March 2026, announced updated results from an ongoing investigator-led trial at the University of Chicago Medicine Transplant Institute evaluating tegoprubart in 12 adults with high-risk type 1 diabetes undergoing allogenic islet transplantation. All 10 patients who are more than four weeks post-transplant achieved 100% insulin independence. There were no signs of graft rejection or de novo donor-specific HLA antibodies and no evidence of nephrotoxicity, hypertension, or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, the current standard of care. The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Presented 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium in January 2026. Results showed there were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m2 at 12 months to 74.2 mL/min/1.73 m2 at 24 months. 2026 Anticipated Upcoming Milestones Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment. Report long-term data from Phase 1b and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation. Receive FDA regulatory guidance on the path to market for tegoprubart in islet cell transplantation and xenotransplantation. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant. Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction. First Quarter 2026 Financial Results Cash, cash equivalents and short-term investments totaled $111.1 million as of March 31, 2026, compared to $133.3 million as of December 31, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations into 2Q 2027. Research and development (R&D) expenses for the first quarter of 2026 were $17.2 million, including $1.1 million of non-cash stock-based compensation expense, compared to $13.5 million, including $1.0 million of non-cash stock-based compensation expense, for the comparable period in 2025. General and administrative (G&A) expenses for the first quarter of 2026 were $4.0 million, including $1.1 million of non-cash stock-based compensation expense, compared to $4.4 million, including $1.8 million of non-cash stock-based compensation expense, for the comparable period in 2025. Net loss for the first quarter of 2026 was $39.0 million, or $0.33 per basic common share, compared to a net loss of $6.5 million, or $0.08 per basic common share, for the comparable period in 2025. Net loss in the first quarter of 2026 included a non-cash loss of $19.0 million from changes in the fair value of warrant liabilities, while the 2025 net loss included a non-cash gain of $10.1 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $20.1 million for the three months ended March 31, 2026, and $16.6 million for the three months ended March 31, 2025. 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, 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. 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 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 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 [email protected] Media Contact: Jenna Urban CG Life (212) 253 8881 [email protected]

NewcelX and Eledon Pharmaceuticals are collaborating to advance one of the few scalable approaches to a potential functional cure in Type 1 Diabetes, NCEL-101, as the flagship program and key long-term value driver toward IND-enabling milestones Substantially debt free, NewcelX recently closed a financing of up to approximately $3.4 million, including $1.35 million in cash and approximately $2 million of potential additional proceeds from the exercise of warrants, and has access to up to a $25 million Equity Line of Credit Strengthened scientific leadership with appointment of Julien Boisdron, MD, Chief Medical Officer of a Swiss Big Pharma, to Scientific Advisory Board Aims to significantly accelerate development progress of NCEL-101 and rest of clinical pipeline in 2026 ZURICH, Switzerland, April 30, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (Nasdaq: NCEL),– NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced reporting its financial results for the period ended December 31, 2025 and corporate highlights. “2025 was a transformative year for NewcelX, marked by completion of the merger, strengthening of our balance sheet and advancement of NCEL-101 together with our partner Eledon Pharmaceuticals (Nasdaq: ELDN) as our flagship program and key long-term shareholder value driver,” said Ronen Twito, Executive Chairman and Chief Executive Officer of NewcelX. “We believe our scalable stem cell-derived islet platform, combined with targeted immune protection, represents one of the few differentiated approaches aimed at a potential functional cure for Type 1 Diabetes. With our first post-merger annual results, strengthened capital structure and growing scientific validation, we expect 2026 to be a year of significantly accelerated execution.” Corporate and Program Highlights Advanced development of NCEL-101, Company’s flagship stem cell-derived islet therapy for Type 1 Diabetes. Continued IND-enabling development activities, including regulatory preparation and preclinical planning. Progress in manufacturing readiness, including clinical batches manufacturing preparations with CDMO, Pluri Inc., supporting continued development. Further development of clinical pipeline with advancement of a differentiated approach combining stem cell-derived islets with tegoprubart for targeted immune protection. Strengthened scientific advisory board with appointment of Julien Boisdron, MD, Chief Medical Officer of a Swiss Big Pharma, whose experience in diabetes innovation and translational medicine is expected to support advancement of NCEL-101. Clinical Pipeline Development and Platform Value Beyond NCEL-101, the Company continued advancing its broader pipeline, including AstroRx® for ALS and DOXA for narcolepsy and additional CNS indications, while exploring strategic development and collaboration opportunities for these programs. The Company believes prior development work in AstroRx®, including GMP cell manufacturing development, translational activities and regulatory interactions with the U.S. Food and Drug Administration, has provided foundational validation of the Company’s ability to develop, manufacture and advance cell therapies toward the clinic, and contributed important know-how now supporting advancement of NCEL-101 in Type 1 Diabetes. This accumulated experience in cell therapy development, manufacturing and regulatory execution supports NewcelX’s multi-asset strategy and may also create potential non-dilutive partnering opportunities across the broader portfolio. Strengthened Balance Sheet In April 2026, the Company completed a $1.35 million private placement, with approximately $2.0 million in additional potential proceeds from future exercise of warrants, representing a financing transaction totaling up to approximately $3.4 million. The Company also maintains access to its $25 million Equity Line of Credit. As of year-end, the Company’s balance sheet was substantially free of debt and financial liabilities other than ordinary working capital obligations. Financial Highlights for the Period Ended December 31, 2025 Cash and cash equivalents as of December 31, 2025 were $2.2 million. Net loss for 2025 was $8.3 million, including $5.7 million in non-cash accounting-related finance expenses, primarily associated with fair value remeasurement of derivative liabilities related to convertible instruments converted prior to merger completion and not expected to recur. Net cash used in operating activities was $2.8 million, reflecting increased investment in NCEL-101 development activities, including manufacturing, as well as payments to service providers related to merger obligations. Outlook for 2026 The Company expects 2026 to be a year of accelerated execution, including: Advancing NCEL-101 toward key IND-enabling milestones Expanding strategic development collaborations Pursuing additional financing and partnership opportunities Accelerating development activities following establishment of an integrated post-merger operating platform “With a strengthened capital structure, clean balance sheet and expected acceleration in development, we believe our scalable stem cell-derived islet platform, combined with targeted immune protection, represents one of the few differentiated approaches aimed at a potential functional cure for Type 1 Diabetes. At the same time, capabilities built through AstroRx® and our broader pipeline strengthen our platform and our ability to execute across multiple programs,” added Ronen Twito NewcelX Chief Executive Officer. A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission https://www.sec.gov/ and posted on the Company’s investor relations website at https://newcelx.com/investors/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected]. About NewcelX NewcelX is an innovative biopharmaceutical company focused on developing transformative stem-cell-derived therapies for Type 1 Diabetes. Built on a validated human pluripotent stem cell (hPSC) platform, the company’s lead program, NCEL-101, is designed to restore functional insulin production through scalable, off-the-shelf cell replacement. NewcelX is advancing a comprehensive therapeutic approach for Type 1 Diabetes integrating cell therapy, immune protection, and translational science to address critical unmet medical needs. Social Media: LinkedIn, Facebook, X, Instagram Website: www.newcelx.com Forward-Looking Statements This press release contains expressed or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. For example, NewcelX is using forward-looking statements when it discusses its business strategy and product pipeline including the development of a potential functional cure for Type 1 Diabetes, expectations regarding accelerated execution and the potential for non-dilutive partnering opportunities. These forward-looking statements and their implications are based on the current expectations of the management of NewcelX and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; our ability to drive revenue growth, enhance research and development capabilities, and improve financial performance is subject to uncertainties; that our financial position raises substantial doubt about our ability to continue as a going concern; our ability to maintain listing and effectively comply with the listing requirements of the Nasdaq; changes in technology and market requirements; potential delays or obstacles in launching or completing clinical trials, including our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; competitive companies, technologies and our industry; the development and commercialization, if any, of any other product candidates that we may seek to develop; products that may not be approved by regulatory agencies; technologies that may not be validated or accepted by the scientific community; the inability to retain or attract key employees; unforeseen scientific difficulties with products in development; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; higher-than-expected product costs; results in the laboratory that do not translate to clinical success; insufficient patent protection; possible adverse safety outcomes; our ability to establish and maintain strategic partnerships and other corporate collaborations; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; delays in developing or introducing new technologies, products, or applications; competitive pressures that could reduce market share or pricing; the overall global political and economic environment in the countries in which we operate; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel.. Except as otherwise required by law, NewcelX does not undertake any obligation to publicly release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission ("SEC") and available at www.sec.gov, as well as in subsequent filings made by NewcelX. Investor & Media Contacts Sarah Bazak, Investors relations [email protected]

Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart following islet transplantation in UChicago Medicine-led study Presented 24-month follow-up data from Phase 1b long-term extension study which continues to support the favorable safety and tolerability profile of tegoprubart Tegoprubart granted Orphan Drug designation by the FDA for the prevention of allograft rejection in liver transplantation IRVINE, Calif., March 19, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2025 operating and financial results and reviewed recent business highlights. “Over the past year, Eledon has made significant progress advancing tegoprubart, our anti-CD40L antibody, as a potential next-generation immunosuppressive therapy across multiple transplantation settings,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “The over 100 patients treated across our transplantation programs to date provide a growing body of evidence that reinforces our conviction that tegoprubart can address key safety and efficacy issues with current standard-of-care transplant immunosuppression. Looking ahead, we anticipate multiple important milestones this year, including regulatory engagement to support advancement into Phase 3 development in kidney transplantation, initiation of an additional islet transplantation trial in type 1 diabetes, and the start of a clinical trial in liver transplantation.” Fourth Quarter 2025 and Recent Corporate Developments Announced that tegoprubart has been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA) for the prevention of allograft rejection in liver transplantation. Tegoprubart previously received Orphan Drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS). Presented 24-month follow-up data from eight patients enrolled in the Phase 1b long-term extension trial evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium. The data continue to support the favorable safety and tolerability profile of tegoprubart with no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de novo donor-specific antibody formation reported during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m² at 12 months to 74.2 mL/min/1.73 m² at 24 months. Reported updated results from 12 patients with type 1 diabetes treated with tegoprubart as the core immunosuppressant following islet transplantation in an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute. All 10 patients who were more than four weeks post-transplant achieved 100% insulin independence and a most recent hemoglobin A1C (HbA1c) below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. The study continues to generate significant patient demand with inquiries received from several hundred T1D patients. Anticipated Upcoming Milestones Receive FDA guidance on the Phase 3 trial design assessing tegoprubart in kidney transplantation, followed by initiation of the Phase 3 trial pending regulatory alignment. Report long-term data from Phase 1 and Phase 2 BESTOW studies evaluating tegoprubart in kidney transplantation. Receive FDA regulatory guidance on path to market for tegoprubart in islet cell transplantation and xenotransplantation. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients with renal dysfunction receiving an islet cell transplant. Initiate an investigator-led study evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo liver transplant. Initiate an investigator-led study evaluating tegoprubart for kidney transplant tolerance induction. Full Year 2025 Financial Results Research and development (R&D) expenses for the year ended December 31, 2025 were $66.3 million, including $4.2 million of non-cash stock-based compensation expense, compared to $52.0 million, including $4.3 million of non-cash stock-based compensation expense, for the comparable period in 2024. The increase was primarily driven by continued advancement of the tegoprubart clinical development programs, including expanded clinical trial activity and manufacturing scale-up, as well as increased personnel to support these efforts. General and administrative expenses for the year ended December 31, 2025 were $17.0 million, including $6.2 million of non-cash stock-based compensation expense, compared to $18.6 million, including $8.8 million of non-cash stock-based compensation expense, for the comparable period in 2024. The decrease was primarily driven by lower stock-based compensation expense, partially offset by higher professional services and personnel-related costs. Net loss for the year ended December 31, 2025 was $45.6 million, or $0.52 per basic share of common stock, compared to a net loss of $36.2 million, or $0.66 per basic share of common stock, for the comparable period in 2024. The 2025 net loss included a non-cash gain of $33.4 million from changes in the fair value of warrant liabilities, while the 2024 net loss included a non-cash gain of $30.9 million from such changes. Excluding the non-cash items related to changes in the fair value of warrant liabilities, Eledon would have recorded a net loss of $79.1 million for the year ended December 31, 2025 and $67.1 million for the year ended December 31, 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, 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; 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 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 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 [email protected] Media Contact: Jenna Urban Berry & Company Public Relations (212) 253 8881 [email protected] Source: Eledon Pharmaceuticals

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 [email protected] Media Contact: Jenna Urban CG Life (212) 253 8881 [email protected] Source: Eledon Pharmaceuticals ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) (Unaudited) ELEDON PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share data) (Unaudited)

Eledon Pharmaceuticals (ELDN) just shared results from its Phase 2 BESTOW trial on tegoprubart for kidney transplant rejection. While the main goal was not fully met, the data points to meaningful preservation of kidney function. See our latest analysis for Eledon Pharmaceuticals. Shares of Eledon Pharmaceuticals have taken a steep dive recently, with the share price dropping over 49% in a single day and more than 52% over the past week following news from the Phase 2 trial. This latest setback has added to what has been a tough 12 months for long-term holders, reflected in a 57% decline in total shareholder return, though the company’s advancement toward Phase 3 keeps the door open for a potential turnaround if clinical results improve and market sentiment shifts. If the ups and downs of biotech spark your curiosity, now is a good time to see what else is happening across the industry. See the full list for free. With the share price in freefall but analyst targets suggesting substantial upside, it is worth asking: are investors overlooking possible long-term value here, or is the market already factoring in all that future growth? Compared to its peers and the broader market, Eledon Pharmaceuticals is trading at a price-to-earnings ratio of 8.4x. This compares to the US market average of 18.1x and the US Biotechs industry average of 17x, making the current price appear undervalued by these benchmarks. The price-to-earnings (P/E) ratio indicates how much investors are willing to pay per dollar of earnings. In the biotech sector, this figure provides a snapshot of market confidence in a company’s ability to generate profits, especially after achieving profitability. Eledon’s P/E ratio is significantly below both the industry and peer averages. This suggests that either the market is not fully pricing in its profitability or has concerns about its growth prospects. Both the peer group average (16.9x) and the estimated fair P/E (10.7x) are materially higher, highlighting that the stock could see upward multiple expansion if sentiment shifts or fundamentals improve. Explore the SWS fair ratio for Eledon Pharmaceuticals Result: Price-to-Earnings of 8.4x (UNDERVALUED) However, further setbacks in clinical trials or continued weak financial results could easily undermine any momentum and keep investor confidence subdued. Find out about the key risks to this Eledon Pharmaceuticals narrative. If you would rather dive into the numbers and form your own perspective, it takes less than three minutes to develop your personal view. Do it your way. A great starting point for your Eledon Pharmaceuticals research is our analysis highlighting 4 key rewards and 3 important warning signs that could impact your investment decision. Stop waiting for the perfect stock. Get ahead of the market by checking out powerful opportunities other investors are acting on now. Boost your income potential and see which companies are paying out with above-average yields using these 16 dividend stocks with yields > 3%. Leap into the AI boom by evaluating these 25 AI penny stocks that are reshaping industries with advanced automation and smart technology. Capitalize on hidden values and spot real market bargains through these 875 undervalued stocks based on cash flows based on actual cash flows. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include ELDN. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Data from patients who remained on tegoprubart for a year post transplant showed an overall mean 12-month estimated glomerular filtration rate (eGFR) of approximately 69 mL/min/1.73 m² Tegoprubart demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection Conference call to be held Friday, November 7 at 8:00 a.m. ET IRVINE, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented today as a late breaking oral presentation titled “Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial,” at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting in Houston, TX. “The Phase 2 BESTOW data results demonstrate tegoprubart’s potential to maintain excellent kidney function while reducing the chronic metabolic, neurologic, and cardiovascular toxicities that burden patients on tacrolimus,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “By pairing strong immunosuppressive efficacy with a differentiated safety profile, including dramatically lower rates of new-onset diabetes, tremor, and dialysis-requiring delayed graft function, tegoprubart represents a promising next-generation option for kidney transplant immunosuppression as we advance into Phase 3.” “There remains a significant unmet need for safer alternatives to traditional tacrolimus-based immunosuppression regimens—options that can reduce harmful side effects without compromising efficacy. The Phase 2 results presented at ASN Kidney Week highlight the potential of tegoprubart to deliver strong graft function after kidney transplantation, while avoiding the long-term toxicities often associated with current standard of care,” said Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief, Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota. “It’s been more than a decade since we’ve seen true innovation in transplant immunosuppression. These data offer real hope that patients may soon have a transformative therapy that improves their health outcomes and overall quality of life.” Study Design The 12-month, randomized, head-to-head, Phase 2 study enrolled 127 kidney transplant recipients (63 receiving tegoprubart and 64 receiving tacrolimus) across 44 global sites. The study directly compared tegoprubart-based immunosuppression with a tacrolimus-based regimen. All patients also received rabbit antithymocyte globulin (rATG) induction and maintenance therapy with mycophenolate mofetil (MMF/MPA) and corticosteroids. The study’s primary efficacy endpoint was the change in eGFR at 12 months post-transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR), patient and graft survival, composite efficacy failure, iBox score, donor-specific antibodies (DSAs), delayed graft function (DGF), and new-onset diabetes after transplantation (NODAT). Safety Results Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy. Metabolic effects: New-onset diabetes developed in approximately 1 in 6 patients receiving tacrolimus versus 1 in 47 receiving tegoprubart. Neurologic effects: Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%). Cardiovascular effects: Hypertension (15.9% vs. 25.0%), hypertensive crisis (1.6% vs. 7.8%), and heart failure (0% vs. 4.7%) all favored tegoprubart. Renal recovery: Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days), suggesting potential reductions of 115 days on dialysis post-transplant per 100 deceased donor kidney recipients on tegoprubart vs. tacrolimus. Infections: Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%). Viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder (PTLD) or Progressive Multifocal Leukoencephalopathy (PML). Overall rates of serious adverse events were comparable between treatment arms. Efficacy Results eGFR on tegoprubart treatment was 69 mL/min/1.73 m² (n=51) at 12 months vs. 66 mL/min/1.73 m² for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention. Subgroup analyses demonstrated higher eGFRs in nearly all tegoprubart subgroups compared with tacrolimus, particularly among living-related donor recipients (~72 mL/min/1.73 m² vs. 62 mL/min/1.73 m²) and high Kidney Donor Profile Index (KDPI > 35) transplants (~62 mL/min/1.73 m² vs. 53 mL/min/1.73 m²). In the deceased donor subgroup, tegoprubart achieved a mean eGFR of approximately 68 mL/min/1.73 m² at 12 months. The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Efficacy failure composite endpoint was 22% in the tegoprubart group vs. 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart vs. tacrolimus, using a 20% non-inferiority margin. The Company believes these results, if replicated in a Phase 3 study, would be sufficient to support tegoprubart’s approvability. The rate of acute rejection in all biopsies was 20.6% in the tegoprubart group compared with 14.1% in the tacrolimus group. Among patients in the tegoprubart group who experienced acute rejection and remained on treatment through month 12, mean eGFR was 73 mL/min/1.73 m², compared with 50 mL/min/1.73 m² in those who switched to tacrolimus. There was 1 case of donor-specific antibodies (DSA) in the tegoprubart arm vs. 2 in the tacrolimus arm. Next Steps Based on these 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. Estimated cash, cash equivalents and short-term investments totaled approximately $93.4 million as of September 30, 2025. The company expects current cash, cash equivalents and short-term investments to fund operations to late 2026. Conference Call Eledon will hold a conference call on November 7, 2025, at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call and a copy of the presentation for the conference call will be posted on the Company’s website at https://ir.eledon.com/investor-relations prior to the conference call. Full details of the oral presentation are below: Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Session Title: Late-Breaking Research Orals - 1 Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT Eledon is also conducting an ongoing open label Phase 1b study (NCT05027906) and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Participants who complete 12 months of treatment in the Phase 1b and Phase 2 BESTOW trials are eligible to enroll into the long-term extension study. 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 Statement Regarding Preliminary Financial Information The cash, cash equivalents and short-term investments presented in this press release is unaudited and preliminary and is subject to completion of financial closing procedures, including the completion of management’s review. The preliminary financial information is based on information currently available to management, and may vary from the amounts that will be reported in Eledon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 that the Company will file with the U.S. Securities and Exchange Commission. 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 ongoing, planned and future clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with kidney transplantation, submissions to regulators, our expected cash, cash equivalents and short-term investments 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 uncertainties relating to the completion of our quarter-end closing procedures for our financial statements for the quarter ended September 30, 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 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 [email protected] Media Contact: Jenna Urban CG Life (212) 253 8881 [email protected] Source: Eledon Pharmaceuticals

Conference call and webcast to discuss results to be held on November 7, 2025 at 8:00 a.m. ET IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the American Society of Nephrology’s upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025. The oral presentation will highlight topline results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation. Details of the oral presentation are below: Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview Abstract Publication Number: TH-OR089 Session Title: Late-Breaking Research Orals - 1 Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT Session Room: Grand Ballroom C (Convention Center) Presentation Time: 5:30 p.m. to 5:42 p.m. CT Conference Call Eledon will hold a conference call on November 7, 2025 at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company's website at www.eledon.com. The webcast will be archived on the website following the completion of the call. 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 Investor Contact: Stephen Jasper Gilmartin Group (858) 525 2047 [email protected] Media Contact: Jenna Urban CG Life (212) 253 8881 [email protected] Source: Eledon Pharmaceuticals

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 $107.6 million as of June 30, 2025 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 $107.6 million as of June 30, 2025 compared to $140.2 million as of December 31, 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 second quarter of 2025 were $20.3 million, including $1.1 million of non-cash stock-based compensation expense, compared to $10.1 million, including $0.8 million of non-cash stock-based compensation expense, for the comparable period in 2024. General and administrative expenses for the second quarter of 2025 were $4.5 million, including $1.6 million of non-cash stock-based compensation expense, compared to $4.4 million, including $2.2 million of non-cash stock-based compensation expense, for the comparable period in 2024. Net loss for the second quarter of 2025 was $11.2 million, or $0.13 per basic common share, compared to a net loss of $44.9 million, or $0.92 per basic common share, for the comparable period in 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: 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 [email protected] Media Contact: Jenna Urban CG Life (212) 253 8881 [email protected] Source: Eledon Pharmaceuticals