Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, to prevent organ rejection and treat ALS, with a strategic emphasis on kidney transplantation programs [141][144]. - Interim results from the Phase 1b trial indicated that mean estimated glomerular filtration rate (eGFR) was 70.5 mL/min/1.73m² post-transplant, significantly higher than the historical average of 53 mL/min/1.73m² for standard care [154]. - As of July 2025, 32 patients were enrolled in the Phase 1b study, with eGFR stabilizing around 68 mL/min/1.73m² at 12 months for those on tegoprubart, compared to 63 mL/min/1.73m² in the intention-to-treat population [155]. - The Phase 2 BESTOW trial, which began dosing in August 2023, aims to evaluate tegoprubart against tacrolimus in approximately 120 participants, focusing on graft function and safety [156]. - Safety data from the BESTOW trial indicated that new-onset diabetes occurred in 1 in 47 patients receiving tegoprubart, compared to 1 in 6 for tacrolimus, demonstrating a favorable safety profile [157]. - Tegoprubart showed a significant reduction in tremor incidence (1.6% vs. 25.0%) and cardiovascular effects compared to tacrolimus, suggesting improved tolerability [157]. - Tegoprubart achieved a mean eGFR of approximately 69 mL/min/1.73 m² at 12 months, compared to 66 mL/min/1.73 m² for tacrolimus, indicating strong renal function [158]. - The efficacy failure composite endpoint was 22% in the tegoprubart group versus 17% in the tacrolimus group, demonstrating non-inferiority for tegoprubart [158]. - In a Phase 2 open-label extension study, the first participant was enrolled in October 2023 to evaluate long-term safety and efficacy of tegoprubart [159]. - Tegoprubart has been utilized in four xenotransplantation procedures, with two kidney transplant recipients remaining alive and one maintaining kidney function [162]. - The FDA granted orphan designation to tegoprubart for the prevention of allograft rejection in pancreatic islet cell transplantation in 2022 [167]. - In a pilot study, the first two subjects achieved insulin independence post-transplant, with islet engraftment three to five times higher than those receiving tacrolimus-based immunosuppression [169]. - Tegoprubart demonstrated low anti-drug antibody responses in a Phase 2a study, with no drug-related serious adverse events observed [175]. - The company deprioritized its IgAN program in 2023, discontinuing all clinical development activities related to it [177]. - Eledon acquired Anelixis Therapeutics in September 2020, gaining control over the intellectual property related to tegoprubart [145]. Financial Performance and Funding - The company reported a net loss of $17.46 million for the three months ended September 30, 2025, compared to a net income of $76.97 million in the same period in 2024, a variance of $94.43 million [203]. - For the three months ended September 30, 2025, total operating expenses were $19.07 million, a decrease of $1.44 million compared to $20.51 million in the same period in 2024 [203]. - Research and development expenses for the three months ended September 30, 2025, were $14.97 million, down from $16.52 million in 2024, reflecting a decrease of $1.55 million [203]. - The company has no approved products for commercial sale and has incurred significant net losses since inception, with an accumulated deficit of $390.8 million as of September 30, 2025 [217]. - The company expects to require additional financing to fund operations and advance drug products through clinical development [223]. - For the nine months ended September 30, 2025, the company reported a net cash used in operating activities of $48.3 million, compared to $28.3 million for the same period in 2024, reflecting an increase in net loss from $8.4 million to $35.2 million [225][226][227]. - The company experienced a net cash provided by investing activities of $31.2 million for the nine months ended September 30, 2025, primarily from $123.2 million in proceeds from the maturity of available-for-sale short-term investments [228]. - Financing activities for the nine months ended September 30, 2025, generated only $0.1 million from the exercise of stock options, a significant decrease compared to $53.4 million in net proceeds from the 2024 Private Placement in 2024 [231][232]. - The company entered into an Open Market Sale Agreement on September 20, 2024, to sell shares of common stock with aggregate sales proceeds of up to $75.0 million [188]. - The 2023 Securities Purchase Agreement involved the issuance of 15,151,518 shares of common stock and warrants in a private placement [179]. - The company received gross proceeds of $35.0 million from the initial closing on May 5, 2023, with net proceeds of approximately $33.0 million after expenses [181]. - The second closing on July 8, 2024, generated gross proceeds of $2.1 million, resulting in net proceeds of approximately $2.0 million [182]. - The third closing on September 30 and October 1, 2024, resulted in gross proceeds of $4.0 million, with net proceeds of approximately $3.8 million [183]. - The 2024 Private Placement yielded gross proceeds of $50.0 million, with net proceeds of approximately $48.1 million after offering costs [186]. - The 2024 Underwritten Offering closed on October 30, 2024, generating gross proceeds of $85 million and net proceeds of approximately $79.5 million after expenses [191]. - Total operating expenses for the nine months ended September 30, 2025, increased by $15.886 million to $61.767 million, up from $45.881 million in 2024 [210]. - Net income (loss) for the nine months ended September 30, 2025, was a loss of $35.170 million, compared to a net income of $8.433 million in 2024, reflecting a variance of $43.603 million [210]. - The fair value of warrant liabilities decreased by $22.9 million, from $44.9 million as of December 31, 2024, to $21.9 million as of September 30, 2025 [214]. - Cash and cash equivalents and short-term investments totaled $93.4 million as of September 30, 2025, with working capital of $82.0 million [216]. - Research and development expenses for the nine months ended September 30, 2025, increased by $14.740 million to $48.776 million, compared to $34.036 million in 2024 [211]. - General and administrative expenses increased by $1.146 million to $12.991 million for the nine months ended September 30, 2025, compared to $11.845 million in 2024 [212]. - Other income, net, increased by $1.195 million to $3.680 million for the nine months ended September 30, 2025, compared to $2.485 million in 2024 [210]. Capital Raising and Ownership Dilution - The company may face challenges in raising capital due to potential limitations in financial and credit markets, which could negatively impact its business plans and strategies [224]. - The issuance of shares in various private placements has diluted the ownership interests of existing stockholders, which may continue with future capital raises [224]. - The company is considering the extent of acquiring or in-licensing other product candidates and technologies as part of its future strategy [229].

Core Insights - Eledon Pharmaceuticals reported favorable results from the Phase 2 BESTOW trial for tegoprubart, indicating a potential new standard for kidney transplant rejection prevention [1][2] - The company strengthened its financial position with a $57.5 million financing to support its transplantation programs [1][2] Business Highlights - The Phase 2 BESTOW trial demonstrated tegoprubart's efficacy and safety, significantly reducing toxicities associated with tacrolimus [2][7] - Eledon plans to advance tegoprubart into Phase 3 development after discussions with regulators regarding study design and data requirements [7] - The company aims to address unmet needs in transplant medicine, including kidney and islet cell transplantation, as well as xenotransplantation [2] Financial Results - As of September 30, 2025, Eledon's cash, cash equivalents, and short-term investments totaled $93.4 million, down from $140.2 million at the end of 2024 [5] - Research and development expenses for Q3 2025 were $15.0 million, a decrease from $16.5 million in Q3 2024 [5] - General and administrative expenses were $4.1 million in Q3 2025, slightly up from $4.0 million in Q3 2024 [6] - The net loss for Q3 2025 was $17.5 million, compared to a net income of $77.0 million in Q3 2024, which included a non-cash gain related to warrant liabilities [8][15] Upcoming Milestones - In Q4 2025, Eledon plans to enroll the final three patients in a clinical study evaluating tegoprubart for islet cell transplantation [7] - In 2026, the company expects to receive FDA guidance on the Phase 3 trial design for kidney transplantation and initiate the trial [7] - Long-term data from the Phase 1 and Phase 2 BESTOW studies will be reported in 2026, along with data from the islet cell transplantation study [7]

Eledon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart, an anti-CD40 ligand antibody aimed at preventing transplant rejection across various organ types including kidney, heart, and liver [3][4] Core Insights and Arguments - **Current Market Context**: Tacrolimus, a long-standing immunosuppressant, has significant side effects including nephrotoxicity, cardiovascular issues, and metabolic toxicities, which Eledon aims to address with tegoprubart [5][6] - **Clinical Trials**: Eledon is conducting multiple clinical trials, with a primary focus on kidney transplants, which account for approximately 25,000 procedures annually in both the U.S. and Europe [9] - **BESTOW Study**: A phase 2 trial designed to compare tegoprubart against tacrolimus, with a primary endpoint focused on kidney function. The study enrolled 120 patients across various countries [13][14] - **Data Results**: The phase 2 study showed promising results, with tegoprubart demonstrating better kidney function compared to tacrolimus in several subgroups, despite missing the primary endpoint by three points [15][16][18] - **Safety Profile**: Tegoprubart exhibited a significantly better safety profile compared to tacrolimus, with lower incidences of diabetes, hypertension, and neurological issues [19][26] Additional Important Points - **Market Reaction**: Despite positive feedback from the medical community, the investment market reacted negatively, possibly due to a misunderstanding of the study's primary endpoint expectations [24][26] - **Future Steps**: Eledon plans to transition to a phase 3 study for kidney transplants, with regulatory discussions ongoing regarding endpoints and study design [22][41] - **Islet Cell and Xenotransplant Programs**: Eledon is also exploring islet cell transplants and xenotransplantation, with ongoing studies showing promising early results [33][36] - **Competitive Landscape**: Eledon is currently the only company focusing on CD40 ligand inhibition for transplant rejection prevention, while competitors are targeting larger autoimmune indications [39] Financial Position - **Cash Reserves**: As of September, Eledon reported approximately $90 million in cash, with plans to extend the runway to Q1 2027 through an ongoing capital raise [40][41]

Core Points - Eledon Pharmaceuticals announced a public offering of 15,152,485 shares of common stock at a price of $1.65 per share, along with pre-funded warrants for an additional 15,151,515 shares at $1.649 each, aiming for gross proceeds of approximately $50 million [1][2] - The offering is expected to close on or about November 13, 2025, subject to customary closing conditions [1] - The net proceeds will be used to support clinical development of product candidates and advance pipeline programs, as well as for general corporate purposes [2] Offering Details - The offering is made under a registration statement on Form S-3, previously filed with the SEC [3] - A preliminary prospectus supplement was filed with the SEC on November 12, 2025, with a final prospectus supplement to follow [3] Company Overview - Eledon Pharmaceuticals is a clinical stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [5] - The lead product candidate is tegoprubart, an anti-CD40L antibody targeting CD40 Ligand, which has potential applications in kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5]

Core Viewpoint - Eledon Pharmaceuticals has initiated an underwritten public offering of its common stock and pre-funded warrants, with the intention to use the proceeds for clinical development and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes common stock and pre-funded warrants, with a 30-day option for underwriters to purchase an additional 15% of the total shares sold [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1]. Group 2: Use of Proceeds - Eledon plans to utilize the net proceeds from the offering to support the clinical development of its product candidates and advance its pipeline programs, along with general corporate purposes [2]. Group 3: Company Background - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions, with its lead product being tegoprubart, an anti-CD40L antibody [5]. - The company is conducting studies in areas such as kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS) [5].

Group 1 - Eledon presented Phase II BESTOW data, highlighting the progress in their development of tegoprubart [2][3] - The call included key executives from Eledon, including the CEO, President, CFO, CMO, and Chief Regulatory Officer, indicating a strong leadership presence [2] - Dr. Andrew Adams, a notable figure in transplantation, participated in the presentation, suggesting the significance of the data shared [2]

Core Insights - Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) stock is experiencing a significant decline following the announcement of Phase 2 trial results for its drug tegoprubart, which is aimed at preventing organ rejection in kidney transplant patients [1][7] Trial Results - The Phase 2 BESTOW trial showed that tegoprubart did not provide significant improvements in estimated glomerular filtration rates (eGFR) compared to the standard immunosuppressant tacrolimus [2][5] - After 12 months, tegoprubart demonstrated an eGFR of 69 mL/min/1.73 m², while tacrolimus had a rate of 66 mL/min/1.73 m² [3] - In living-related donor recipient patients, tegoprubart's eGFR was higher at 72 mL/min/1.73 m², while patients with a high Kidney Donor Profile Index (KDPI > 35) had an eGFR of 62 mL/min/1.73 m² [4] Efficacy and Safety - The composite endpoint of efficacy failure for tegoprubart was non-inferior to tacrolimus, with rates of 22% for tegoprubart compared to 17% for tacrolimus [5] - Delayed graft function was less frequent with tegoprubart, requiring shorter dialysis (14.3% vs. 25.0%; 4.6 days vs. 6.1 days) [6] - Sepsis or bacteremia occurred more frequently in the tacrolimus group (17.2% vs. 4.8%) [6] Future Development - Despite not meeting the primary efficacy endpoint, the company plans to advance tegoprubart into Phase 3 development after discussions with regulators regarding study design and data requirements [6] - Eledon has approximately $93.4 million in cash and short-term investments, which is expected to sustain operations into late 2026 [7]

Eledon Pharmaceuticals Conference Call Summary Company Overview - **Company**: Eledon Pharmaceuticals (NasdaqCM:ELDN) - **Focus**: Development of tegoprubart for transplantation, particularly kidney transplants Key Points and Arguments Industry Context - **Transplantation Landscape**: The success in transplantation has been linked to the development of immunosuppressive drugs to prevent organ rejection. However, existing drugs like tacrolimus have limitations, including toxicity and complexity of use [2][5][6]. Tegoprubart Development - **Tegoprubart's Role**: Eledon aims for tegoprubart to be a cornerstone maintenance chronic immunosuppressive medicine across all transplant types, including kidney, islet cell, and potentially xenotransplantation [3][4]. - **Clinical Trials**: The company is conducting multiple studies, including a phase 2 trial (Bistot study) comparing tegoprubart to tacrolimus, the current standard of care [9][10]. Bistot Study Results - **Study Design**: The Bistot trial compared tacrolimus with tegoprubart in kidney transplant patients, focusing on eGFR (estimated Glomerular Filtration Rate) as a primary endpoint [9][10]. - **Efficacy**: Tegoprubart showed a mean eGFR of 69 mL/min compared to 66 mL/min for tacrolimus, indicating numerical superiority but not statistical significance [11][17]. - **Safety Profile**: Tegoprubart demonstrated a favorable safety profile, with significant reductions in side effects commonly associated with tacrolimus, such as new-onset diabetes, tremors, and hypertension [12][28][33]. Unmet Needs in Transplantation - **Current Limitations**: Tacrolimus, while effective, has a narrow therapeutic index and is associated with various toxicities, leading to complications such as kidney injury and increased cardiovascular risk [6][7][8]. - **Need for New Treatments**: There is a pressing need for new immunosuppressive agents that can reduce toxicity and improve long-term outcomes for kidney transplant patients [8][12]. Future Directions - **Phase 3 Study Plans**: Eledon plans to approach the FDA for a phase 3 study design based on the non-inferiority endpoint, with potential for additional superiority claims based on long-term outcomes [42][43]. - **Financial Position**: The company reported $93.4 million in cash, sufficient to fund operations into late 2026, with several upcoming milestones [35][61]. Additional Insights - **Patient Management**: The ability to maintain patients on tegoprubart during rejection episodes without switching to tacrolimus may lead to better long-term kidney function [50][55]. - **KDPI Scores**: The study revealed unexpected findings regarding the quality of donor kidneys, with higher quality kidneys (KDPI < 35) performing better with tacrolimus, raising questions about the long-term implications of drug choice [62]. Conclusion - **Overall Outlook**: Eledon is optimistic about the potential of tegoprubart to improve kidney transplant outcomes and is preparing for further studies to validate its efficacy and safety [34][36].

Phase 2 BESTOW Clinical Trial Results November 7, 2025 Forward -Looking Statements This presentation contains forward ‐looking statements that involves substantial risks and uncertainties. Any statements about the company's future expectations, plans and prospects, including statements about its strategy, future operations, development of its product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," "estimates," "intends," "predicts," "projects," "targets," ...

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Motorsport Games Inc. (MSGM) has seen a substantial increase of 122%, trading at $4.88 [3] - Globus Medical, Inc. (GMED) is up 27%, currently priced at $78.75 [3] - JFrog Ltd. (FROG) has risen by 26%, trading at $59.60 [3] - FIGS, Inc. (FIGS) is up 19%, with a trading price of $8.97 [3] - Organogenesis Holdings Inc. (ORGO) has increased by 18%, trading at $4.59 [3] - PureCycle Technologies, Inc. (PCT) is up 17%, currently priced at $11.31 [3] - Expedia Group, Inc. (EXPE) has risen by 16%, trading at $255.10 [3] - 10x Genomics, Inc. (TXG) is up 13%, currently priced at $14.72 [3] - Abacus Global Management, Inc. (ABL) has increased by 12%, trading at $5.95 [3] - GigaCloud Technology Inc. (GCT) is up 9%, currently priced at $27.80 [3] Premarket Losers - Davis Commodities Limited (DTCK) has experienced a significant decline of 65%, trading at $2.23 [4] - Eledon Pharmaceuticals, Inc. (ELDN) is down 46%, currently priced at $2.19 [4] - Treace Medical Concepts, Inc. (TMCI) has decreased by 35%, trading at $4.00 [4] - Energys Group Limited (ENGS) is down 30%, currently priced at $2.77 [4] - Intellia Therapeutics, Inc. (NTLA) has seen a decline of 27%, trading at $8.89 [4] - Fox Factory Holding Corp. (FOXF) is down 24%, currently priced at $16.60 [4] - Opendoor Technologies Inc. (OPEN) has decreased by 24%, trading at $4.94 [4] - AirSculpt Technologies, Inc. (AIRS) is down 21%, currently priced at $8.27 [4] - Power Solutions International, Inc. (PSIX) has seen a decline of 20%, trading at $64.25 [4] - ClearPoint Neuro, Inc. (CLPT) is down 17%, currently priced at $15.00 [4]