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Eledon Pharmaceuticals Eledon Pharmaceuticals Reports Third Quarter 2021 Operating and Financial Results November 11 , 2021 Nearing full enrollment in ALS Phase 2 Study ; topline data expected 1H 2022 Received Investigational New Drug ( " IND " ) clearance from the FDA for AT - 1501 in islet cell transplantation in the U.S. Announced renal transplantation research collaboration with CareDx , Inc. Initiated AT - 1501 monotherapy non - human primate renal transplant study ; topline data expected 1H 2022 Conference call today at 4:30 PM ET IRVINE , Calif . , Nov. 11 , 2021 ( GLOBE NEWSWIRE ) -- Eledon Pharmaceuticals , Inc. ( " Eledon " ) ( NASDAQ : ELDN ) , a clinical stage biopharmaceutical company focused on developing targeted medicines for persons requiring an organ or cell - based transplant , living with autoimmune disease , or living with amyotrophic lateral sclerosis ( ALS ) , today reported its third quarter 2021 operating and financial results . " We made significant progress across our three therapeutic areas : transplantation focusing on kidney and islet cell transplantation , autoimmunity focused on IgA Nephropathy ( IgAN ) , and neurodegeneration focusing on ALS , " stated David - Alexandre C. Gros , M.D. , Chief Executive Officer . " In ALS , we completed enrollment in the first three cohorts of our phase 2 study and anticipate completing enrollment in the fourth and final cohort by year - end . In renal transplantation , we are in the process of opening our first clinical site in Canada and our non - human primate study in the U.S. is well underway . We recently announced IgAN as the next indication for development of AT - 1501 and are still on track to initiate a Phase 2 trial by the end of this year . Finally , we received IND clearance for AT - 1501 to initiate a clinical trial for the prevention of islet cell rejection in the U.S. We remain focused on continued execution across our three therapeutic areas in 2021 and building momentum as we prepare for multiple data readouts in 2022. " " In addition , we recently announced our research collaboration with CareDx , the leader in precision medicine for transplant patients and caregivers , " said Steven Perrin , Ph.D. , President and Chief Scientific Officer of Eledon . " This multi - year and multi - trial collaboration provides us with access to CareDx's best - in - class technologies for our renal transplantation studies . Our partner's extensive experience with biomarkers and predictive algorithms will allow us to gather important insights on the potential for product differentiation and long - term allograft survival rates as we advance AT - 1501 through clinical development . " Third Quarter 2021 and Recent Corporate Developments • Received a " No Objection ” Letter from Health Canada , allowing Eledon to initiate a Canadian clinical trial of AT - 1501 for the prevention of kidney transplant rejection . • Announced selection of IgAN as next indication for clinical development of AT - 1501 ; initiation of Phase 2 study expected by year - end . • Completed enrollment of the first three cohorts of a Phase 2 study of AT - 1501 in ALS ; fourth and final cohort enrollment is nearing completion with full enrollment expected by year - end . • Initiated preclinical renal transplant study evaluating AT - 1501 monotherapy in at least four non - human primates . • Announced renal transplant research collaboration with CareDx providing Eledon access to CareDx's best - in - class biomarker and predictive algorithm technologies . • Received IND clearance from the U.S. Food & Drug Administration for AT - 1501 in islet cell transplantation in the United States . • Presented data at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium and the International Pancreas and Islet Transplantation World Congress . Upcoming Anticipated Milestones • Q4 2021 : initiation of Phase 1b clinical trial of AT - 1501 in kidney transplantation . • Q4 2021 : initiation of Phase 2 clinical trial of AT - 1501 in IgAN . • 1H 2022 : topline data from Phase 2 trial of AT - 1501 in ALS . • 1H 2022 : completion of non - human primate study with AT - 1501 . • 2H 2022 : initial data from Phase 1b trial of AT - 1501 in kidney transplantation . • 2H 2022 : initial data from Phase 2 trial of AT - 1501 in IgAN . • 2022 : initial data from Phase 2 trial of AT - 1501 in islet cell transplantation . Financial Results for the Three Months Ended September 30 , 2021