Eledon Pharmaceuticals(US:ELDN)2025-11-14 22:05Drug 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].