Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [2] - The lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, which has broad therapeutic potential [2] - The company is conducting preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [2] Upcoming Events - David-Alexandre C. Gros, M.D., CEO of Eledon, will participate in a fireside chat at the Cantor Global Healthcare Conference on September 5, 2025, at 9:10 a.m. ET [1] - A webcast replay of the fireside chat will be available on the company's website following the live session [1]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20-%20Unaudited) Unaudited financials for Q2 2025 show decreased assets, continued operating losses, and a restatement of prior period financials - The company restated 2024 financial statements due to reclassification of Series X and X1 preferred stock and a change in EPS calculation method[31](index=31&type=chunk)[32](index=32&type=chunk)[134](index=134&type=chunk) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $5,741 | $20,549 | | Short-term investments | $101,829 | $119,629 | | **Total Assets** | **$144,909** | **$177,405** | | Warrant liabilities | $22,512 | $44,865 | | **Total Liabilities** | **$38,881** | **$59,265** | | Convertible preferred stock | $55,694 | $55,694 | | **Total Stockholders' Equity** | **$50,334** | **$62,446** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $20,276 | $10,106 | $33,807 | $17,516 | | General and administrative | $4,457 | $4,396 | $8,890 | $7,855 | | Loss from operations | $(24,733) | $(14,502) | $(42,697) | $(25,371) | | Change in fair value of warrant liabilities | $12,293 | $(31,274) | $22,353 | $(44,610) | | **Net loss** | **$(11,216)** | **$(44,907)** | **$(17,711)** | **$(68,538)** | | Basic and diluted EPS (common stock) | $(0.13) | $(0.92) | $(0.21) | $(1.61) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(33,773) | $(16,515) | | Net cash provided by (used in) investing activities | $18,850 | $(10,130) | | Net cash provided by financing activities | $115 | $48,072 | | **Net change in cash and cash equivalents** | **$(14,808)** | **$21,427** | | Cash and cash equivalents at end of period | $5,741 | $26,039 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - Existing cash, cash equivalents, and marketable securities are deemed sufficient to fund operations for at least the next **12 months** from the filing date[44](index=44&type=chunk) - As of June 30, 2025, non-cancelable manufacturing purchase obligations total **$6.6 million**[69](index=69&type=chunk) - Milestone payment obligations to ALS TDI include **$6.0 million** for the first licensed product, plus potential one-time payments of **$15.0 million** and **$30.0 million** upon reaching annual net sales of **$500.0 million** and **$1.0 billion**, respectively[82](index=82&type=chunk)[84](index=84&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A covers the company's focus on tegoprubart for kidney transplantation, increased R&D, and liquidity for the next 12 months [Overview and Strategy](index=35&type=section&id=Overview%20and%20Strategy) - Eledon is a clinical-stage biotech company focused on its lead compound, **tegoprubart**, an anti-CD40L antibody for organ transplant rejection and ALS[139](index=139&type=chunk) - The company prioritizes kidney transplantation programs, discontinuing islet cell and IgAN programs, while the ALS program requires additional financing[142](index=142&type=chunk) [Clinical Development of Tegoprubart](index=36&type=section&id=Clinical%20Development%20of%20Tegoprubart) - Phase 1b kidney transplant trial showed mean eGFR above **60 mL/min/1.73m²** after day 30, with an overall mean of **70.5 mL/min/1.73m²**, favorable compared to historical **53 mL/min/1.73m²**[152](index=152&type=chunk) - Enrollment for the Phase 2 BESTOW kidney transplant study concluded in September 2024, with topline results expected in **November 2025**[153](index=153&type=chunk) - In an islet cell transplant trial, the first three patients treated with tegoprubart achieved insulin independence and stable graft function without tacrolimus[163](index=163&type=chunk) [Results of Operations](index=45&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $20,276 | $10,106 | $33,807 | $17,516 | | General & Administrative | $4,457 | $4,396 | $8,890 | $7,855 | | **Loss from Operations** | **$(24,733)** | **$(14,502)** | **$(42,697)** | **$(25,371)** | | **Net Loss** | **$(11,216)** | **$(44,907)** | **$(17,711)** | **$(68,538)** | - Increased R&D expenses for Q2 and H1 2025 were primarily due to higher external CRO costs for kidney transplantation trials and increased manufacturing expenses[194](index=194&type=chunk)[201](index=201&type=chunk) - Net loss decreased significantly for Q2 and H1 2025, primarily due to a positive change in the fair value of warrant liabilities, reflecting a decline in stock price[197](index=197&type=chunk)[204](index=204&type=chunk) [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the company held **$107.6 million** in cash, cash equivalents, and short-term investments, with **$97.7 million** in working capital[206](index=206&type=chunk) - Existing cash resources are deemed sufficient to meet anticipated cash needs for at least the next **12 months** from the report's filing date[209](index=209&type=chunk) - Insufficient liquidity exists to fund continued clinical development of tegoprubart for ALS without additional financing[209](index=209&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a Smaller Reporting Company, Eledon Pharmaceuticals, Inc. is exempt from providing market risk disclosures - The company, as a Smaller Reporting Company, is not required to provide the disclosures for this Item[220](index=220&type=chunk) [Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2025, due to a material weakness in internal control over financial reporting - Disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness in internal control over financial reporting[222](index=222&type=chunk) - The material weakness led to the restatement of financial statements for the quarter ended June 30, 2024, within this Form 10-Q[222](index=222&type=chunk) - Remediation efforts to address the identified material weakness are ongoing[223](index=223&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material legal proceedings - The company and its subsidiaries are not party to any material legal proceedings[227](index=227&type=chunk) [Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include operating losses, critical need for additional funding, drug development uncertainties, competition, and internal control weaknesses - The company has a history of significant operating losses, totaling **$17.7 million** for the six months ended June 30, 2025, and may never achieve profitability[231](index=231&type=chunk) - Additional funding is critical to complete lead drug candidate development; without it, the company may alter or cease operations, especially for the ALS program[233](index=233&type=chunk) - Substantial competition exists from major pharmaceutical companies like Novartis, Sanofi, UCB, and Amgen, possessing significantly greater resources[300](index=300&type=chunk) - A material weakness in internal control over financial reporting could adversely affect financial reporting accuracy and timing, and the company's stock price[341](index=341&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=78&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the current reporting period [Other Information](index=78&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 trading plans during Q2 2025 - No officers or directors adopted or terminated any Rule 10b5-1 trading plans during the quarter ended June 30, 2025[349](index=349&type=chunk)

[Eledon Pharmaceuticals Second Quarter 2025 Results](index=1&type=section&id=Eledon%20Pharmaceuticals%20Second%20Quarter%202025%20Results) [Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) The company reports positive clinical trial momentum for its lead candidate, tegoprubart, in various transplant applications - The company is on track to report topline results from its Phase 2 BESTOW trial in kidney transplantation in **November 2025**[1](index=1&type=chunk) - CEO David-Alexandre C. Gros highlighted positive data reinforcing tegoprubart's potential to **improve long-term transplant outcomes**[2](index=2&type=chunk) [Year-to-Date 2025 Business Highlights](index=1&type=section&id=Year-to-Date%202025%20Business%20Highlights) - Updated Phase 1b data showed tegoprubart was well-tolerated, with kidney function (eGFR) at 12 months of approximately **68 mL/min/1.73 m2**, compared to the standard of care at **53 mL/min/1.73 m2**[3](index=3&type=chunk) - A third patient was treated with tegoprubart in a **kidney xenotransplantation** at Massachusetts General Hospital (MGH)[3](index=3&type=chunk) - The first three islet cell transplant recipients achieved **insulin independence** with a tegoprubart-based regimen[3](index=3&type=chunk)[4](index=4&type=chunk) - In June 2025, Eledon was added to the **Russell 3000® and Russell 2000® Indexes**, increasing investor visibility[8](index=8&type=chunk) [Anticipated Upcoming Milestones for 2H 2025](index=2&type=section&id=Anticipated%20Upcoming%20Milestones%20for%202H%202025) - Report topline results from the **Phase 2 BESTOW trial** in kidney transplantation in November 2025[8](index=8&type=chunk) - Launch an investigator-initiated trial at MGH to evaluate tegoprubart for inducing **donor-specific immune tolerance**[8](index=8&type=chunk) - Enroll three additional patients in the investigator-led clinical trial for **pancreatic islet transplant rejection**[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a strong cash position sufficient to fund operations to late 2026, alongside a narrowed net loss [Financial Position (Balance Sheet)](index=5&type=section&id=Financial%20Position%20(Balance%20Sheet)) - Cash, cash equivalents, and short-term investments totaled **$107.6 million** as of June 30, 2025, expected to fund operations to the **end of 2026**[5](index=5&type=chunk) Condensed Consolidated Balance Sheet Summary (in thousands) | Metric | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $5,741 | $20,549 | | **Short-term investments** | $101,829 | $119,629 | | **Total Assets** | $144,909 | $177,405 | | **Total Liabilities** | $38,881 | $59,265 | | **Total Stockholders' Equity** | $50,334 | $62,446 | [Financial Performance (Income Statement)](index=2&type=section&id=Financial%20Performance%20(Income%20Statement)) Q2 2025 vs Q2 2024 Operating Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Research and development (R&D)** | $20,276 | $10,106 | | **General and administrative** | $4,457 | $4,396 | Q2 2025 vs Q2 2024 Net Loss (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Change in fair value of warrant liabilities** | $12,293 | ($31,274) | | **Net loss** | ($11,216) | ($44,907) | | **Net loss per basic common share** | ($0.13) | ($0.92) | [About Eledon Pharmaceuticals](index=3&type=section&id=About%20Eledon%20Pharmaceuticals) Eledon is a clinical-stage biotechnology company developing its lead anti-CD40L antibody, tegoprubart, for various transplant and ALS indications - Eledon is a clinical-stage biotechnology company developing **immune-modulating therapies** for life-threatening conditions[10](index=10&type=chunk) - The company's lead product is **tegoprubart**, an anti-CD40L antibody targeting a well-validated biological pathway[10](index=10&type=chunk) - Tegoprubart is under investigation for use in **kidney, liver, and xenotransplantation**, as well as for amyotrophic lateral sclerosis (ALS)[10](index=10&type=chunk)

Core Insights - Eledon Pharmaceuticals reported positive data from an ongoing Phase 1b trial of tegoprubart, showing a mean 12-month estimated glomerular filtration rate (eGFR) of approximately 68 mL/min/1.73 m for kidney transplant patients, significantly higher than the historical mean of 53 mL/min/1.73 m with standard care [1][3] - The company is on track to release topline results from the Phase 2 BESTOW trial in kidney transplantation in November 2025 [1][10] - Eledon has a cash position of $107.6 million as of June 30, 2025, which is expected to fund operations through the end of 2026 [1][5] Business Highlights - Eledon achieved key milestones in advancing tegoprubart for kidney, islet cell, and liver transplantation, as well as xenotransplantation [2] - Updated data presented at the World Transplant Congress indicated that tegoprubart was well tolerated with no severe adverse events reported [3] - The company announced the first three islet cell transplant recipients treated with tegoprubart at the University of Chicago, achieving insulin independence [3] Financial Results - Research and development expenses for Q2 2025 were $20.3 million, up from $10.1 million in Q2 2024 [6] - General and administrative expenses for Q2 2025 were $4.5 million, slightly higher than $4.4 million in Q2 2024 [7] - The net loss for Q2 2025 was $11.2 million, a significant reduction from a net loss of $44.9 million in Q2 2024 [7][16] Upcoming Milestones - The company plans to report topline results from the Phase 2 BESTOW trial in November 2025 [10] - Eledon will launch an investigator-initiated trial at Massachusetts General Hospital to evaluate tegoprubart for inducing donor-specific immune tolerance [10]

Summary of Eledon Pharmaceuticals (ELDN) Update / Briefing August 06, 2025 Company Overview - **Company**: Eledon Pharmaceuticals (ELDN) - **Focus**: Development of tegoprovart for kidney transplantation Key Industry Insights - **Industry**: Kidney transplantation and immunosuppression therapies - **Event**: Presentation of updated Phase 1b trial results at the World Transplant Congress Core Points and Arguments 1. **Phase 1b Trial Results**: Eledon presented updated results from the Phase 1b trial of tegoprovart, which is being evaluated as a cornerstone immunosuppression therapy in de novo kidney transplantation [3][6][8] 2. **Safety and Efficacy**: The trial demonstrated good safety and tolerability for tegoprovart, with twelve-month eGFR (estimated Glomerular Filtration Rate) results indicating good kidney function [8][26] 3. **Rejection Episodes**: A total of six rejection episodes were reported, with a 19% incidence rate. Most rejections occurred in patients receiving lower doses of ATG (antithymocyte globulin) induction therapy [21][24] 4. **Long-term Predictive Endpoints**: The trial included the abbreviated IBOX score, which is being developed as a surrogate endpoint to predict five-year graft survival. The IBOX score showed strong predictive capabilities [31][35] 5. **Regulatory Considerations**: Eledon is in discussions with regulatory bodies regarding the use of IBOX as a potential endpoint for future clinical trials, with expectations for feedback in the second half of the following year [31][59] Additional Important Content 1. **Patient Demographics**: The study included 32 patients with a mean age of 52.9 years, with 75% being living donors. Notably, 56% of patients had an HLA mismatch of more than five, indicating a higher immunological risk [15][16][94] 2. **Infection Rates**: The trial reported manageable infection rates, with no cases of graft loss. The infections were controllable, and the study aims to explore lower dosing to potentially improve safety outcomes [90][91] 3. **Impact of Improved Graft Survival**: A hypothetical 5% improvement in five-year graft survival could significantly reduce the number of patients dying while waiting for a kidney transplant, potentially allowing for 1,500 additional kidneys to be available each year [41][43] 4. **Future Studies**: Eledon is preparing for the Phase II BISTOLE study, with results expected to be presented in the fourth quarter of the year [44] Conclusion Eledon Pharmaceuticals is making significant strides in the development of tegoprovart for kidney transplantation, with promising Phase 1b trial results indicating good safety and efficacy. The company is focused on regulatory discussions regarding the IBOX score as a predictive endpoint for long-term graft survival, which could have a substantial impact on patient outcomes in the field of kidney transplantation.

Core Viewpoint - Eledon Pharmaceuticals is set to present updated clinical data on tegoprubart for kidney transplantation at the World Transplant Congress on August 6, 2025, with a conference call scheduled for the same day [1]. Group 1: Company Overview - Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [3]. - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting the CD40 Ligand, which has significant therapeutic potential [3]. - The company is conducting studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [3]. Group 2: Clinical Study Details - The ongoing open-label Phase 1b study evaluates tegoprubart for preventing rejection in approximately 30 kidney transplant recipients [1]. - The updated clinical data will be presented at the World Transplant Congress in San Francisco, CA [1]. Group 3: Conference Call Information - A conference call and webcast will take place on August 6, 2025, at 4:30 p.m. ET to discuss the updated clinical data [1]. - Domestic callers can join by dialing 1-800-717-1738, while international callers can use 1-646-307-1865, with the conference ID being 34575 [2].

Core Insights - Eledon Pharmaceuticals is set to present updated clinical data on tegoprubart for kidney transplantation at the World Transplant Congress in August 2025 [1] - The presentation will include results from approximately 30 kidney transplant recipients and will be delivered by Dr. John Gill from the University of British Columbia [1][2] - Eledon will also sponsor a satellite symposium discussing kidney transplant success, featuring notable faculty from various prestigious institutions [3] Presentation Details - The oral presentation titled "Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study" is scheduled for August 6, 2025, from 10:00 a.m. to 11:15 a.m. PT [2] - A poster session will present new preclinical data on tegoprubart's use in liver transplantation, led by Dr. Andrew Adams from the University of Minnesota [4] Company Overview - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for severe conditions [4] - The lead product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which plays a significant role in immune cell activation [4] - The company is conducting studies in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [4]

Group 1: Eledon Pharmaceuticals, Inc. (ELDN) - Eledon Pharmaceuticals is a clinical stage biotechnology company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 23.8% over the last 60 days [1] - Eledon's shares gained 22.2% over the past month, outperforming the S&P 500's advance of 3.8% [1] - The company has a Momentum Score of A [1] Group 2: KDDI Corporation (KDDIY) - KDDI Corporation is a Japanese telecommunications services company with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 39.7% over the last 60 days [2] - KDDI's shares gained 5.9% over the last six months, slightly outperforming the S&P 500's advance of 5.2% [2] - The company has a Momentum Score of B [2] Group 3: Penguin Solutions, Inc. (PENG) - Penguin Solutions is a designer and developer of enterprise solutions with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased by 14.2% over the last 60 days [3] - Penguin's shares gained 41.2% over the last three months, significantly outperforming the S&P 500's advance of 16% [3] - The company has a Momentum Score of A [3]

Group 1 - Wipro Limited (WIT) has seen a 7.1% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - KNOT Offshore Partners LP (KNOP) has experienced a significant 44.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Penguin Solutions, Inc. (PENG) has recorded a 14.2% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Eledon Pharmaceuticals, Inc. (ELDN) has seen a 23.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - KDDI Corporation (KDDIY) has experienced a 39.7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [3]

Summary of Elodon R&D Day Conference Call Company Overview - **Company**: Elodon - **Lead Asset**: Tegoprobart - **Focus**: Solid organ transplantation, particularly kidney, liver, and islet cell transplants, as well as xenotransplantation [1][6][10] Key Industry Insights - **Market Opportunity**: The transplantation market is described as a "proven blockbuster market" with a significant need for innovation, particularly in immunosuppressants [8][12] - **Current Standard of Care**: Calcineurin inhibitors (CNIs), such as tacrolimus, have been the standard for decades but have limitations in long-term graft survival and patient quality of life [12][42] - **Need for New Therapies**: There is a critical need for therapies that can extend the functional life of transplanted organs beyond the current average of about ten years [13][39] Core Scientific Insights - **Mechanism of Action**: Tegoprobart targets the CD40 ligand pathway, which is crucial for modulating immune responses and preventing transplant rejection [17][20] - **Clinical Data**: Preclinical studies indicate that blocking the CD40 ligand is the most effective method for preventing transplant rejection across various organ types [30][32] - **Long-term Outcomes**: The focus is shifting from short-term rejection rates to long-term graft survival, with a need for therapies that minimize side effects associated with current immunosuppressants [55][56] Regulatory Developments - **New Endpoints**: Introduction of the IBOX surrogate endpoint, which combines existing biomarkers to predict long-term graft survival at one year post-transplant [59][60] - **Validation of IBOX**: The IBOX has shown strong predictive capabilities for five-year graft loss, with C statistics ranging from 0.72 to 0.84 across multiple validation datasets [67][68] Financial and Strategic Considerations - **Funding Needs**: The company is seeking non-dilutive financing to advance its programs, particularly in ALS, which is currently on hold [10][11] - **Commercial Potential**: The kidney transplantation market alone is projected to be a large blockbuster opportunity, with unique commercial dynamics due to reimbursement structures [13][14] Additional Insights - **Patient Demographics**: The aging population and rising rates of obesity are expected to increase the number of patients requiring transplants, further highlighting the need for effective therapies [37][38] - **Healthcare Burden**: The financial burden on healthcare systems, particularly Medicare, is significant due to the high costs associated with dialysis and transplant procedures [36][37] Conclusion - Elodon is positioned to address significant unmet needs in the transplantation market through innovative therapies like Tegoprobart, with a focus on improving long-term outcomes and reducing the side effects associated with current treatments. The introduction of new regulatory endpoints like IBOX may facilitate the approval of these therapies and enhance their market potential.