Page 1

Eledon Pharmaceuticals Eledon Pharmaceuticals Reports Second Quarter 2021 Operating and Financial Results August 12 , 2021 Received approval from Health Canada to initiate a clinical trial of AT - 1501 in kidney transplantation ; company expects to initiate trial in Q4 with initial data in late 2022 Reached agreement with the FDA to conduct a preclinical renal transplant study evaluating AT - 1501 monotherapy in four non - human primates ; launched academic collaboration to conduct the study with data expected mid - 2022 Announces plans to develop AT - 1501 as a therapy for IgA nephropathy ( IgAN ) , the fourth potential indication for clinical development of AT - 1501 ; company expects to initiate Phase 2 by year - end 2021 Conference call today at 4:30 PM ET IRVINE , Calif . , Aug. 12 , 2021 ( GLOBE NEWSWIRE ) -- Eledon Pharmaceuticals , Inc. , ( " Eledon " ) ( NASDAQ : ELDN ) , a clinical stage biopharmaceutical company focused on developing targeted medicines for persons living with autoimmune disease , requiring an organ or cell - based transplant , or living with amyotrophic lateral sclerosis ( ALS ) , today reported its second quarter 2021 operating and financial results . " We have made significant progress since the announcement in April of our updated development strategy for AT - 1501 in renal transplantation , " stated David - Alexandre C. Gros , M.D. , Chief Executive Officer of Eledon . “ Enrollment in our ALS study is progressing well and we anticipate completing enrollment in the 4th quarter . Separately , we received a No Objection Letter from Health Canada in response to our Clinical Trial Application proposing to initiate a clinical trial evaluating AT - 1501 , in 6 to 12 subjects , replacing tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation . We believe that replacing tacrolimus as an agent in renal transplantation can reduce immunosuppressive side effects and improve long - term graft survival . We look forward to reporting initial clinical data from the study late next year . In addition , we plan to initiate a preclinical renal transplant study evaluating AT - 1501 monotherapy in four non - human primates , as requested by the U.S. Food and Drug Administration , with data expected in mid - 2022 . " " In addition to our progress in ALS and renal transplant , we have selected IgA nephropathy as the fourth indication for the clinical development of AT - 1501 , " said Steven Perrin , Ph.D. , President and Chief Scientific Officer of Eledon . " There is strong scientific rationale for this indication , as blocking CD40 ligand has been shown in preclinical studies to slow disease progression and improve renal function in animal models of autoimmune nephritis . We look forward to initiating a Phase 2 trial for this fourth indication in the coming months . " Second Quarter 2021 and Recent Corporate Developments • Completion of enrollment in third of four cohorts in the Phase 2 study of AT - 1501 in ALS expected shortly with full enrollment of the trial expected to be completed by year end 2021 . • Received clearance from Health Canada in response to Clinical Trial Application to initiate a clinical trial of AT - 1501 for the prevention of kidney transplant rejection . • Reached agreement on the design of an FDA - requested preclinical renal transplant study in non - human primates ( n = 4 ) evaluating AT - 1501 monotherapy and launched academic collaboration to conduct the study . • Announced selection of IgA nephropathy ( IgAN ) as fourth indication for clinical development of AT - 1501 . • Presented two posters and two oral presentations at the American Society of Transplantation annual meeting held in June . • Appointed leading immunology and rheumatology expert Dr. Jan Hillson to its Board of Directors . Upcoming Anticipated Milestones • Presentation at the International Pancreas and Islet Transplantation World Congress annual meeting , which is being held virtually October 20-23 , 2021 . • Q4 2021 : initiation of non - human primate renal transplant study of AT - 1501 monotherapy . • Q4 2021 : initiation of clinical trial of AT - 1501 for the prevention of kidney transplant rejection . • Q4 2021 : initiation of clinical trial of AT - 1501 in IgAN . • H1 2022 : topline data from Phase 2 trial of AT - 1501 in ALS . • H1 2022 : initial data from Phase 2 trial of AT - 1501 in islet cell transplantation . • Mid - 2022 : completion of non - human primate renal transplant study of AT - 1501 monotherapy .