Product Development - Eledon Pharmaceuticals is focused on developing AT-1501, an anti-CD40L antibody, targeting conditions such as ALS, kidney allograft rejection, islet cell allograft rejection, and IgA Nephropathy [126][129]. - The company acquired Anelixis Therapeutics in September 2020, which owned the intellectual property for AT-1501, to enhance its clinical and commercial value [127][131]. - AT-1501 has shown a half-life of up to 26 days and demonstrated low anti-drug antibody responses in Phase 1 studies [128]. - A Phase 2a clinical trial for AT-1501 in ALS began in October 2020, with plans to enroll approximately 54 subjects across 13 sites in the U.S. and Canada [135]. - In July 2021, Eledon received clearance from Health Canada to initiate a Phase 1b trial of AT-1501 for kidney transplantation, aiming to replace tacrolimus in immunosuppressive regimens [141]. - The company also received clearance in November 2020 for a Phase 2 trial of AT-1501 in islet cell transplantation for type 1 diabetes [142]. - Eledon aims to mitigate the adverse effects associated with current immunosuppressive therapies, potentially improving long-term graft survival in transplant patients [139][140]. - Eledon reported that approximately 30%-40% of IgA Nephropathy patients may reach end-stage renal disease, highlighting the need for effective treatments [145]. Financial Performance - Research and development expenses increased by $7.0 million to $7.7 million for the three months ended September 30, 2021, compared to $0.6 million for the same period in 2020 [152]. - General and administrative expenses decreased by $0.9 million to $2.8 million for the three months ended September 30, 2021, compared to $3.7 million for the same period in 2020 [153]. - Total operating expenses for the nine months ended September 30, 2021, were $27.5 million, an increase of $15.4 million compared to $12.1 million for the same period in 2020 [162]. - The net loss for the nine months ended September 30, 2021, was $25.7 million, compared to a net loss of $16.9 million for the same period in 2020, representing an increase of $8.8 million [162]. - Cash and cash equivalents as of September 30, 2021, were $94.0 million, consisting of readily available cash in bank accounts [167]. - The company recognized an income tax benefit of $0.7 million for the three months ended September 30, 2021, due to changes in deferred tax liabilities related to the Anelixis acquisition [157]. - The company incurred no restructuring expenses for the three months ended September 30, 2021, compared to $1.8 million for the same period in 2020 [154]. - The company plans to continue funding losses from operations and capital needs through cash on hand and future equity or debt financings [171]. - Net cash used in operating activities for the nine months ended September 30, 2021, was $19.7 million, compared to $5.8 million for the same period in 2020 [173]. - The company expects to incur substantial expenditures for the development and potential commercialization of its product candidates in the foreseeable future [172]. - Net cash used in operating activities for the nine months ended September 30, 2021 was $25.7 million, compared to $16.9 million for the same period in 2020 [174][175]. - Non-cash items for the nine months ended September 30, 2021 included stock-based compensation of $5.9 million and amortization of operating lease assets of $0.1 million [174]. - Cash used in operating activities for the nine months ended September 30, 2021 reflected a net increase in cash from changes in operating assets and liabilities of $1.8 million, primarily due to an increase in accounts payable and accrued expenses of $2.0 million [174]. - There was no cash provided by or used in the Company's investing activities for the nine months ended September 30, 2021 [176]. - Net cash used in financing activities for the nine months ended September 30, 2021 was $0.5 million related to offering costs accrued in connection with the sale of common stock [177]. - In contrast, net cash provided by financing activities for the nine months ended September 30, 2020 was $95.2 million from the sale of Series X1 preferred stock [178]. Operational Challenges - The COVID-19 pandemic has caused delays in studies and data collection, impacting the company's operations and financial condition [148]. - The company has suspended development of its legacy ENT assets following a failed clinical trial, focusing resources on the development of AT-1501 [131]. Regulatory and Compliance - The Company did not have any off-balance sheet arrangements as defined by SEC rules [181]. - The Company is designated as a Smaller Reporting Company and is not required to provide certain disclosures under Regulation S-K [180][182].
Eledon Pharmaceuticals(ELDN) - 2021 Q3 - Quarterly Report