ELDN

If we are unable to raise such capital, or if we are unable to do so on acceptable terms, we will be forced to significantly alter our business strategy, substantially curtail our current operations, or liquidate and cease operations altogether. • Future issuances of our common stock, including common stock that may be issuable pursuant to outstanding warrants or other convertible securities, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall. • Our product candidates are in the early stages of clinical development and may not be successfully developed.
If we are unable to successfully develop and commercialize these or any other product candidate, or if we experience significant delays in doing so, our business will be materially harmed. • Public health crises, including pandemics or epidemics could adversely affect our business. • Unfavorable global economic conditions could have a material adverse effect on our business. • Adverse conditions in the financial markets, including bank failures, could adversely affect our liquidity and financial performance. • Drug development involves a lengthy and expensive process with an uncertain outcome, including failure to demonstrate safety and efficacy to the satisfaction of the U.S.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development, formulation and commercialization of our product candidates. • The results of non-clinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, and there is a risk that additional non-clinical and/or clinical safety studies will be required by the FDA or similar regulatory authorities outside the United States or that subsequent studies will not match results seen in prior studies. • Delays or difficulties in the enrollment of patients in clinical trials could delay or prevent our receipt of necessary regulatory approvals and increase expenses for the development of our product candidates. • Our ability to conduct clinical trials in some jurisdictions outside of the United States may be adversely affected' • If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates. • Our future success depends on our ability to retain executives and key employees and to attract, retain and motivate qualified personnel in the future. • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, or the approvals may be for a narrow indication, we may not be able to commercialize our product candidates, and our ability to generate revenue may be materially impaired. • Legislation regulating the pharmaceutical and healthcare industries may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain. • Our internal computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, disruptions, or incidents, which could result in a material disruption of our development programs or loss of data and have a material adverse effect on our reputation, business, financial condition or results of operations. • The compromise of privacy, security, integrity or confidentiality of sensitive information related to our business or failure to comply with confidentiality and data privacy obligations could have a material adverse effect on our business. • Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success. • If our current product candidates, or a future product candidate receives marketing approval and we, or others, later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the product could be compromised. • We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do. • The insurance coverage and reimbursement status of newly-approved products is uncertain.
As a result, the outcomes of the activities performed by these organizations will be, to a certain extent, beyond our control. • If we are unable to obtain and maintain intellectual property protection for our technology and products or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired. • Public health crises, including pandemics or epidemics, could adversely affect our business. • Our stock price could be volatile, and the market price of our common stock may drop unexpectedly. • If we fail to maintain effective internal controls, we may conclude that our internal control over financial reporting is not effective, which could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner. • Provisions in our corporate charter and under Delaware law could make an acquisition of the Company more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Our lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40L, a well-validated biological target that we believe has broad therapeutic potential.
We are first focusing on kidney transplantation as this is the most common type of solid organ transplantation in the U.S. with an estimated 270,000 Americans living with a transplanted kidney.
Approximately 90,000 people in the U.S. are on a waiting list where they typically wait an average 3-5 years for a kidney transplant while about 5,000 people in the U.S. in need of a kidney transplant die each year waiting for a suitable kidney.
We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023, June 2024 and August 2025.
At the time of the August 2025 update, which reported data as of July 2025, 32 patients undergoing kidney transplantation have been enrolled in the Phase 1b study.
Updated data showed that kidney function, as assessed by eGFR, stabilized after the first month post-transplant and remained in the range of approximately 68 mL/min/1.73 m2 through 12 months for patients (n = 12) who remained on tegoprubart.
Kidney function in the intention-to-treat population (n=15) was approximately 63 mL/min/1.73 m2 at 12 months.
Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean eGFR of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant.
In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival.
Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score.
Based on data collected as of July 2025, abbreviated iBox scores were -3.75 in the intention-to-treat population and -4.11 in the on-treatment population, which compare favorably to a -2.98 historical mean for calcineurin inhibitors.
A difference in abbreviated iBox score of -0.40 at 12 months is considered predictive of a 4-5% difference in 5-year graft survival suggesting that tegoprubart may have a predicted 5-year allograft survival rate of over 96%.
As of July 2025, there were six (18.8%) rejection episodes, and 75% of patients who experienced a rejection had received low-dose rabbit antithymocyte globulin induction.
All rejection episodes were successfully treated.
Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1.73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR of approximately 34 mL/min/1.73 m² at 12 months.
The BESTOW study is a multi-center, two-arm, active comparator, head-to-head superiority clinical study, with approximately 120 participants undergoing kidney transplantation in the U.S. and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus.
Secondary objectives are the assessment of graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant.
The first subject in the BESTOW study was dosed in August 2023 and the last patient was dosed on September 4, 2025.
On November 6, 2025, we announced topline efficacy and safety data from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of kidney transplant rejection.
Safety and efficacy results supported the potential for tegoprubart to provide effective immunosuppression with a favorable safety and tolerability profile compared to tacrolimus.
Safety findings underscore tegoprubart’s potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy.
Notably, new-onset diabetes developed in approximately 17% of patients receiving tacrolimus versus 2% receiving tegoprubart.
Tremor was markedly higher in the tacrolimus group (25.0% vs. 1.6%) and cardiovascular effects, including hypertension (25.0% vs. 15.9%), hypertensive crisis (7.8% vs. 1.6%), and heart failure (4.7% vs. 0%) all favored tegoprubart.
Delayed graft function occurred less often with tegoprubart and required shorter dialysis (14.3% vs. 25%; 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 versus tacrolimus.
Sepsis or bacteremia occurred more frequently in the tacrolimus arm (17.2% vs. 4.8%) and viral infection rates (CMV, BK, EBV, fungal) were similar across groups, with no cases of Post-Transplant Lymphoproliferative Disorder or Progressive Multifocal Leukoencephalopathy.
Additionally, overall rates of serious adverse events were comparable between treatment arms.
From an efficacy standpoint, tegoprubart achieved an eGFR of approximately 69 mL/min/1.73 m² (n=51) at 12 months compared to 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 one of the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention.
Subgroup analyses showed higher eGFRs in nearly all tegoprubart subgroups compared to 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 compared to 68 mL/min/1.73 m² for tacrolimus.
The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint historically recognized by the FDA.
Efficacy failure composite endpoint was 22% in the tegoprubart group versus 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart versus tacrolimus, using a 20% non-inferiority margin.
We believe 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% for 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 to 50 mL/min/1.73 m² in those who switched to tacrolimus.
Additionally, there was one case of donor-specific antibodies in the tegoprubart arm versus two in the tacrolimus arm.

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Gone since FY2024

If we are unable to raise such capital, or if we are unable to do so on acceptable terms, we will be forced to significantly alter our business strategy, substantially curtail our current operations, or liquidate and cease operations altogether. • Issuances of our common stock, including common stock that may be issuable pursuant to outstanding warrants or other convertible securities as well as shares and warrants issued or issuable in connection with our recent private placement transactions, could result in significant dilution and could cause our stock price to fall. • Our product candidates are in the early stages of clinical development and may not be successfully developed.
If we are unable to successfully develop and commercialize these or any other product candidate, or if we experience significant delays in doing so, our business will be materially harmed. • Unfavorable global economic conditions could have a material adverse effect on our business. • Adverse conditions in the financial markets, including bank failures, could adversely affect our liquidity and financial performance. • Drug development involves a lengthy and expensive process with an uncertain outcome, including failure to demonstrate safety and efficacy to the satisfaction of the U.S.
We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development, formulation and commercialization of our product candidates. • The results of non-clinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials, and there is a risk that additional non-clinical and/or clinical safety studies will be required by the FDA or similar regulatory authorities outside the United States or that subsequent studies will not match results seen in prior studies. • Delays or difficulties in the enrollment of patients in clinical trials could delay or prevent our receipt of necessary regulatory approvals and increase expenses for the development of our product candidates. • If serious adverse events or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates. • Our future success depends on our ability to retain executives and key employees and to attract, retain and motivate qualified personnel in the future. • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, or the approvals may be for a narrow indication, we may not be able to commercialize our product candidates, and our ability to generate revenue may be materially impaired. • Legislation regulating the pharmaceutical and healthcare industries may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain. • Our internal computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, disruptions, or incidents, which could result in a material disruption of our development programs or loss of data and have a material adverse effect on our reputation, business, financial condition or results of operations. • The compromise of privacy, security, integrity or confidentiality of sensitive information related to our business or failure to comply with confidentiality and data privacy obligations could have a material adverse effect on our business. • Even if any of our product candidates receives marketing approval, we may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success. • If our current product candidates, or a future product candidate receives marketing approval and we, or others, later discover that the product is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the product could be compromised. • We face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do. • The insurance coverage and reimbursement status of newly-approved products is uncertain.
As a result, the outcomes of the activities performed by these organizations will be, to a certain extent, beyond our control. • If we are unable to obtain and maintain intellectual property protection for our technology and products or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired. • Public health crises, including pandemics or epidemics, could adversely affect our business. • Our stock price could be volatile, and the market price of our common stock may drop unexpectedly. • We have previously identified and remediated a material weakness in our internal control over financial reporting.
If we fail to maintain effective internal controls, we may conclude that our internal control over financial reporting is not effective, which could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner. • Provisions in our corporate charter and under Delaware law could make an acquisition of the Company more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Our lead compound in development is tegoprubart, an IgG1, anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that we believe has broad therapeutic potential.
We are first focusing on kidney transplantation as this is the most common type of solid organ transplantation in the U.S. with an estimated 260,000 Americans living with a transplanted kidney.
Approximately 100,000 people in the U.S. are on a waiting list where they typically wait an average 3-5 years for a kidney transplant while about 5,000 people in the U.S. in need of a kidney transplant die each year waiting for a suitable kidney.
We reported interim safety and efficacy results from the Phase 1b clinical trial in March 2023, and provided updated data in November 2023 and June 2024.
At the time of the June 2024 update, which reported data as of April 3, 2024, results from the 13 participants in the Phase 1b trial support tegoprubart’s potential to protect organs from rejection while improving renal function in patients undergoing kidney transplantation.
As mentioned above, data from historical studies using standard of care, calcineurin inhibitor-based, immunosuppression therapy typically report aggregate mean estimated eGFRs of approximately 53 mL/min/1.73m² during the first year after kidney transplant.
In the ongoing Phase 1b trial, as of April 3, 2024, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant.
Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant.
The interim results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation.
As of April 3, 2024, three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively.
There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy.
There have been no cases of graft loss or death.
The BESTOW study is a multi-center, two-arm, active comparator, head-to-head superiority clinical study, and will enroll approximately 120 participants undergoing kidney transplantation in the U.S. and other countries to evaluate the safety, pharmacokinetics, and efficacy of tegoprubart compared to the calcineurin inhibitor tacrolimus.
Secondary objectives will include assessment of graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant.
The first subject in the BESTOW study was dosed in August 2023.
On September 4, 2024, we announced the completion of enrollment in the BESTOW study.
In January 2024, we announced that tegoprubart would be utilized in an investigator-initiated trial, conducted at the University of Chicago Medicine's Transplantation Institute.
This pilot study is assessing the safety of using a monoclonal antibody against CD40 ligand to achieve a calcineurin inhibitor-free immunosuppression regimen in patients with T1D mellitus undergoing islet cell transplantation.
The Company is not funding this trial but is providing tegoprubart for use in the study.
On October 29, 2024, positive data were reported for the first three islet transplant recipients in the study, potentially demonstrating the first human cases of insulin independence achieved using an anti-CD40L monoclonal antibody therapy without the use of tacrolimus.
The first two subjects achieved insulin independence and normal hemoglobin A1C (HbA1c) levels, a measure of average blood glucose, post-transplant.
The third subject, decreased insulin use by more than 60% three days following the procedure and continues on insulin independence trajectory typically observed one-to-two months post-transplant.
Subjects in the study received islet transplants combined with induction therapy and for chronic maintenance therapy, mycophenolate mofetil plus tegoprubart given every third week by intravenous infusion.
The first two subjects achieved insulin independence and presented stable islet graft function at approximately three months and six months post-transplant, respectively.
Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than three comparable subjects who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart results is less toxic to transplanted islet cells resulting in improved graft survival and function.
Treatment was generally well tolerated in all subjects with no unexpected adverse events or hypoglycemic episodes.
After initial islet transplant, the first participant reduced insulin requirements by over 60% and normalized blood glucose control.
As of October 29, 2024, the first patient had achieved insulin independence within approximately a week after a second islet transplantation procedure.
We own and have exclusive rights to six active patent families, of which three families are exclusively licensed and the rest are wholly-owned by Eledon.
The first exclusively-licensed family is directed to methods for treating amyotrophic lateral sclerosis with antibodies and includes two issued United States patents and 14 issued foreign patents (Japan, Hong Kong, Belgium, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, the Netherlands, Sweden, and Switzerland).
The second exclusively-licensed family is directed to tegoprubart, with 13 pending applications, and issued patents including four issued United States patents and 23 issued foreign patents (Australia, Belgium, Switzerland, China, Germany, Denmark, France, Great Britain, Hong Kong, Ireland, Israel, India, Italy, Japan, South Korea, Mexico, the Netherlands, New Zealand, Russia, Sweden, Singapore).
The third exclusively-licensed family is directed to tegoprubart, with 17 pending applications, including one pending United States patent application, and issued patents, including one issued United States patent and four issued foreign patents (China, Hong Kong, Mexico, Russia).
We have recently nationalized two of our Eledon-owned patent families in the United States, Europe, Australia, Canada, China, Japan, South Korea, Mexico, and Singapore, and one of our Eledon-owned patent families is at the Patent Cooperation Treaty stage.
Absent any term adjustments or extensions, any patents to issue from the pending applications in these patent families would expire in May 2043, and November 2044, respectively.
Subsequent to our acquisition of Anelixis, we undertook a strategic review of the legacy ENT assets.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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