Announcement • Jun 05
Eledon Pharmaceuticals Presents Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes Eledon Pharmaceuticals, Inc. announced that updated results from an investigator-initiated trial being conducted at the University of Chicago Medicine Transplant Institute will be presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana. Details of the oral presentation are as follows: Presentation Title: Anti-CD40L to Induce Graft Survival and Function in Islet Allotransplantation. Session: Immune Modulatory Strategies for Next-Generation Cell Therapies. Date: Sunday, June 7, 2026. Time: 2:30 p.m. – 3:00 p.m. CT. Room: 343 (Level 3). The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver transplantation and amyotrophic lateral sclerosis (ALS). Announcement • Apr 22
Eledon Pharmaceuticals, Inc., Annual General Meeting, Jun 18, 2026 Eledon Pharmaceuticals, Inc., Annual General Meeting, Jun 18, 2026. Location: 19800 macarthur boulevard, suite 250, california., irvine United States Announcement • Mar 16
Eledon Pharmaceuticals Announces Updated Data From Investigator-Initiated Islet Transplant Trial Of Tegoprubart In Patients With Type 1 Diabetes At UChicago Medicine Eledon Pharmaceuticals, Inc. announced updated results from an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute and presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the Advanced Technologies and Treatments for Diabetes (ATTD) conference, held March 11-14, 2026 in Barcelona, Spain. The investigator-initiated pilot study enrolled 12 adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation at UChicago Medicine. Patients had a median duration of diabetes of approximately 33 years and mean hemoglobin A1C (“HbA1C”) of approximately 8.0% prior to transplantation. Participants received tegoprubart, Eledon’s anti-CD40L monoclonal antibody, as part of a calcineurin inhibitor-free immunosuppression regimen. The data demonstrated rapid improvement in glycemic control following islet transplantation, with stable islet graft function observed across the cohort. All 10 patients who were more than four weeks post-transplant achieved both insulin independence and a most recent HbA1c below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors. This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease. Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection. Announcement • Mar 10
Eledon Pharmaceuticals, Inc. Announces Orphan Drug Designation Granted to Tegoprubart for the Prevention of Allograft Rejection in Liver Transplantation Eledon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Tegoprubart has previously received orphan drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS). Orphan Drug Designation is intended to support the development of therapies for rare diseases, defined as conditions affecting fewer than 200,000 people in the United States or fewer than 5 in 10,000 individuals in the European Union. These designations provide sponsors with a range of incentives intended to encourage the development of medicines for diseases with high unmet medical needs. Announcement • Jan 23
Eledon Pharmaceuticals Presents Long-Term Phase 1B Data for Tegoprubart in Kidney Transplant Patients At the American Society of Transplant Surgeons Winter Symposium Eledon Pharmaceuticals, Inc. announced that it will present 24-month follow-up data from eight patients enrolled in the Phase 1b trial long-term extension evaluating tegoprubart in kidney transplantation at the American Society of Transplant Surgeons Winter Symposium, taking place January 23-25, 2026, in Scottsdale, Arizona. There were no episodes of biopsy-proven acute rejection, graft loss, death, new-onset diabetes mellitus, or de Novo donor-specific antibody formation during the study period. Mean estimated glomerular filtration rate (eGFR) increased over the measurement period, from 67.0 mL/min/1.73 m2 at 12 months to 74.2 mL/min/1. 73 m2 at 24 months. Announcement • Nov 20
Eledon Pharmaceuticals, Inc. Reports Preliminary Data from First Six Patients with Type 1 Diabetes Treated with Tegoprubart as the Core Immunosuppressant Following Islet Transplantation in Investigator-Initiated Trial at U Chicago Medicine Eledon Pharmaceuticals, Inc. announced preliminary results from an investigator-initiated trial conducted at the University of Chicago Medicine's Transplant Institute and presented at the Rachmiel Levine-Arthur Riggs Diabetes Research Symposium, held November 14-17, 2025 at City of Hope in Los Angeles, California. The ongoing trial, which has been extended to include a total of 12 subjects, is evaluating tegoprubart, Eledon's investigational anti-CD40 Ligand (anti-CD40L) antibody, as the core of a tacrolimus-free immunosuppression drug regimen for the prevention of islet transplant rejection in individuals with type 1 diabetes (T1D). The results, presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, provide updated preliminary data on the first six subjects in the trial, demonstrating the ability of tegoprubart to prevent the rejection of transplanted islet cells in the absence of calcineurin inhibition resulting in sustained insulin-free management of hemoglobin A1C (HbA1c) in patients with T1D. This clinical trial is funded by Breakthrough T1D (formerly JDRF), with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression Drug regimen to prevent islet transplant rejection in individuals With T1D and chronic kidney disease. Post-procedure, subjects remain on immunosuppression therapy to prevent transplant rejection. Announcement • Nov 13
Eledon Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $49.986448 million. Eledon Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $49.986448 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,152,485
Price\Range: $1.65
Discount Per Security: $0.099
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 15,151,515
Price\Range: $1.649
Discount Per Security: $0.099 Announcement • Nov 12
Eledon Pharmaceuticals, Inc. has filed a Follow-on Equity Offering. Eledon Pharmaceuticals, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Nov 07
Eledon Pharmaceuticals, Inc. Presents Phase 2 Bestow Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation At the American Society of Nephrology's Kidney Week 2025 Annual Meeting Eledon Pharmaceuticals, Inc. announced results from its Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a de novo kidney transplant. Results from the Phase 2 BESTOW clinical trial were presented as a late breaking oral presentation titled "Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTow Trial," at the American Society of Nephrology's Kidney Week 2025 Annual Meeting in Houston, TX. The study's primary efficacy endpoint was the change in eGFR at 12 months post-transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR), patient and graft survival, composite efficacy failure, iBox score, donor-specific antibodies (DSAs), delayed graft function (DGF), and new-onset diabetes after transplantation (NODAT). Safety findings underscore tegoprubart's potential to maintain effective immunosuppression while minimizing the metabolic, neurologic, and cardiovascular toxicities characteristic of tacrolimus-based therapy. eGFR on tegoprubart treatment was 69 mL/min/1.73 m2 (n=51) at 12 months vs. 66 mL/min/1. 73 m2 for tacrolimus (n=56). Although the primary endpoint did not reach statistical significance, tegoprubart maintained strong renal function, delivering what the Company believes is the highest mean eGFR level reported to date in kidney transplant clinical trials evaluating rejection prevention. Subgroup analyses demonstrated higher eGFRs in nearly all tegoprubart subgroups compared with tacrolimus, particularly among living-related donor recipients (72 mL/min/1.74 m2 vs. 62 mL/min/1.72 m2) and high Kidney Donor Profile Index (KDPI > 35) transplants (62 mL/min/1.83 m2 vs. 53 mL/min/1.1.73 m2). The efficacy failure composite endpoint, comprising death, graft loss and biopsy proven acute rejection, is the approval endpoint currently recognized by the U.S. Food and Drug Administration. Announcement • Oct 17
Eledon Pharmaceuticals to Present Results from Phase 2 Bestow Trial of Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology Kidney Week 2025 Annual Meeting Eledon Pharmaceuticals, Inc. announced an oral presentation will be featured at the American Society of Nephrology's upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025. The oral presentation will highlightline results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation. Announcement • Aug 07
Eledon Pharmaceuticals, Inc. Presents Updated Data from Ongoing Phase 1b Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation Eledon Pharmaceuticals, Inc. announced updated data from the Company's ongoing open-label Phase 1b trial evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the oral presentation, titled "Tegoprubart, an Anti-CD40L Antibody, for the Prevention of Rejection in Kidney Transplantation: An Ongoing Phase 1b Study," were presented at the World Transplant Congress (WTC) taking place in San Francisco, CA. Data from historical studies using the standard of care, calcineurin inhibitor-based immunosuppression therapy, typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 53 mL/min/1.73 m2 during the first year after kidney transplant. In addition, preliminary abbreviated iBox data was presented suggesting that tegoprubart may improve 5-year graft survival. Abbreviated iBox, a composite biomarker panel developed by the Paris Transplant Group, incorporates kidney function (eGFR, proteinuria) and immunologic response (donor-specific antibodies) parameters into a single prognostic score. Of the patients who experienced a rejection episode and completed a year in the study, three who remained on tegoprubart had a mean eGFR of approximately 73 mL/min/1. 73 m2 at 12 months, indicating full recovery of kidney function, while the two patients who switched to standard of care tacrolimus had a mean eGFR the mean eGFR of approximately 34 mL/min/1.73 m2 at 12 months. Announcement • Jul 09
Sernova Biotherapeutics Announces Collaboration with Eledon Pharmaceuticals to Advance A Potential Functional Cure for Type 1 Diabetes Sernova Biotherapeutics announced a Collaborative Research Agreement with Eledon Pharmaceuticals, Inc. to evaluate Eledon's immunosuppressive agent tegoprubart (AT-1501) in Sernova's ongoing Phase 1/2 clinical trial of its Cell Pouch Bio-hybrid Organ in patients with type 1 diabetes (T1D). Under the terms of the agreement, Eledon will supply tegoprubart, an investigational anti-CD40L antibody being evaluated for its potential to prevent transplant rejection in islet cell, kidney and xeno transplantation, will be used in place of tacrolimus in the upcoming Cohort C of Sernova's Phase 1/2 clinical trial. Tacrolimus is currently a standard immunosuppressive drug used in organ transplantation to prevent rejection. However, its potential toxicity, particularly toward insulin-producing beta cells, and its side effect profile limit its suitability as an optimal immunosuppressive agent for islet cell therapy in T1D. In an investigator-initiated study led by Dr. Piotr Witkowski, a leading expert in islet transplantation at the University of Chicago, T1D patients received islet transplants along with tegoprubart to prevent rejection. Islet engraftment, measured by graft function standardized to the number of islets infused, was three to five times higher than in comparable subjects outside this study who received tacrolimus-based immunosuppression, suggesting treatment with tegoprubart better protects transplanted islets resulting in improved graft survival and function. Treatment was generally well tolerated in all subjects with no unexpected adverse events or severe hypoglycemic episodes. This collaboration highlights the shared commitment of both companies to address the unmet needs of individuals living with T1D. By combining their expertise and leveraging complementary technologies, Sernova and Eledon aim to deliver a therapeutic solution that offers a durable and effective alternative to daily insulin injections and current immunosuppressive protocols. Announcement • Apr 15
Eledon Pharmaceuticals, Inc., Annual General Meeting, Jun 10, 2025 Eledon Pharmaceuticals, Inc., Annual General Meeting, Jun 10, 2025. Location: at 19800 macarthur boulevard, suite 250, california, irvine United States New Risk • Nov 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-US$8.5m). Earnings are forecast to decline by an average of 4.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (147% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$91m net loss in 3 years). Announcement • Sep 21
Eledon Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $75 million. Eledon Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Announcement • Aug 15
Eledon Pharmaceuticals, Inc. announced delayed 10-Q filing On 08/14/2024, Eledon Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Jul 29
Eledon Pharmaceuticals, Inc. Provides Enrollment Update for Phase 2 Bestow Trial Assessing Tegoprubart for the Prevention of Organ Rejection Eledon Pharmaceuticals, Inc. announced that it has enrolled the 80th participant in its ongoing Phase 2 BESTOW trial assessing tegoprubart for the prevention of rejection in kidney transplantation. This progress underscores the urgency and need for innovative solutions in preventing kidney transplant rejection. The study's primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival. Eledon is currently conducting a Phase 2 trial (BESTOW; NCT05983770), a Phase 1b trial (NCT05027906), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegop Rubart for the prevention of organ rejection in patients receiving a kidney transplant. Announcement • Jun 05
Eledon Pharmaceuticals, Inc. Presents Updated Data from Ongoing Phase 1B Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation Eledon Pharmaceuticals, Inc. presented updated data from the Company’s ongoing open-label Phase 1b trial and open-label extension study evaluating tegoprubart for the prevention of organ rejection in kidney transplant patients. Results from the poster, titled “Biomarkers of Inflammation and eGFR in an Ongoing Phase 1B Study of an Anti-CD40L Antibody Tegoprubart, for the Prevention of Rejection in Kidney Transplant,” were presented at the American Transplant Congress (ATC) taking place in Philadelphia, PA from June 1-5, 2024. As of the April 2024 cutoff date, updated data from the 13 participants in the ongoing Phase 1b trial support tegoprubart’s potential to protect organ function in patients undergoing kidney transplantation. Data from historical studies using standard of care, calcineurin inhibitor-based immunosuppression therapy typically report aggregate mean estimated glomerular filtration rates (eGFRs) of approximately 50 mL/min/1.73m2 during the first year after kidney transplant. In the ongoing Phase 1b trial, mean eGFR was above 60 mL/min/1.73m² at each reported time points after day 30, with an overall mean eGFR of 70.5 mL/min/1.73m² for all the reported time points after day 30 post-transplant. Two participants completed 12 months on therapy post-transplant, and both demonstrated mean eGFRs above 90 mL/min/1.73m² at one-year post-transplant. Results demonstrated that tegoprubart is generally safe and well tolerated in patients undergoing de novo kidney transplantation. Three subjects have discontinued the study due to hair loss and fatigue, viral infection, and rejection, respectively. There have been no cases of hyperglycemia, new onset diabetes, or tremor, all of which are side effects often associated with standard of care immunosuppression therapy. There have been no cases of graft loss or death. Eledon is currently conducting a Phase 1b trial (NCT05027906), a Phase 2 trial (BESTOW; NCT05983770), and a long-term safety and efficacy extension study (NCT06126380) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. Announcement • Jun 02
Eledon Pharmaceuticals, Inc., Annual General Meeting, Jul 10, 2024 Eledon Pharmaceuticals, Inc., Annual General Meeting, Jul 10, 2024. Location: 19800 macarthur boulevard, suite 250, california, irvine United States New Risk • May 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 71% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (71% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$75m net loss in 3 years). Announcement • Mar 26
Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection Eledon Pharmaceuticals, Inc. announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation. Announcement • Nov 03
Eledon Pharmaceuticals, Inc. Reports Updated Data from Ongoing Phase 1B Trial Evaluating Tegoprubart for Prevention of Rejection in Kidney Transplantation Eledon Pharmaceuticals, Inc. reported results from the Company's ongoing Phase 1b open-label trial evaluating tegoprubart for the prevention of rejection in patients undergoing de novo kidney transplantation. Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting taking place in Philadelphia, PA from November 2-5, 2023. Aggregate mean estimated glomerular filtration rate (eGFR) -- a measure of kidney function -- was above 70 mL/min/1.73m(2) at all reported time points after day 90. Historical studies have reported average eGFRs generally in the low 50 mL/min/1. 73m(2) range during the first year after kidney transplant using standard of care. One participant has completed the study with an eGFR of 91 at one year (day 374) and is now enrolled in a Phase 2 open-label extension (OLE) study, which will evaluate the long-term safety, pharmacokinetics, and efficacy of tegoprubart in participants who have completed one year of treatment in either the ongoing Phase 1b or Phase 2 BESTOW study. The Phase 1b open-label study has enrolled 11 participants who underwent kidney transplantation in Canada, Australia, and the United Kingdom. The webcast will be archived on the website following the completion of the call. Announcement • Oct 24
Eledon Pharmaceuticals, Inc. Appoints of Eliezer Katz as Chief Medical Officer Eledon Pharmaceuticals, Inc. announced the appointment of Eliezer Katz, M.D., FACS as Chief Medical Officer with responsibility for leading the company’s clinical development programs. Dr. Katz is an experienced transplant surgeon with significant clinical development experience. Most recently, he was Chief Medical Officer at eGenesis where he helped lead the clinical development of eGenesis’ xenotransplantation programs. Prior to eGenesis, Dr. Katz was Vice President of Clinical Development first at Viela Bio and then at Horizon Therapeutics following its acquisition of Vielo Bio. At Horizon and Viela Bio, Dr. Katz led the clinical development of inebilizumab in multiple autoimmune indications and oversaw the regulatory submission and approval of UPLIZNA(inebilizumab) to treat neuromyelitis optica spectrum disorder in adults. Prior to Viela Bio, Dr. Katz served as Senior Director of Clinical Development at MedImmune Inc. where he oversaw the clinical development of three different biologics. Prior to MedImmune, Dr. Katz served as Senior Director of Transplantation with the Medicine Development Group at Pfizer. At Pfizer, he oversaw multiple research programs with rapamycin, an anti-rejection drug, and was instrumental in the regulatory submission and FDA approval of rapamycin as a treatment for lymphangioleiomyomatosis (LAM), a rare and fatal lung disease. Before joining industry, Dr. Katz spent two decades as a transplant surgeon. He was director of the abdominal transplantation division at Integris Baptist Medical Center in Oklahoma City, and an associate professor of surgery and the director of the liver transplantation division at the University of Massachusetts Medical Center, Worcester, MA.Dr. Katz spearheaded liver transplantation advances at these institutions and was actively involved with policy making in organ donation and allocation. Dr. Katz earned his M.D. at Hadassah Hebrew University Medical School in Jerusalem. Board Change • Oct 13
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. Director Jim Robinson was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Oct 05
Eledon Pharmaceuticals Appoints Allan Douglas Kirk to Board of Directors Eledon Pharmaceuticals, Inc. announced the appointment of Allan Douglas Kirk, M.D., Ph.D., to its Board of Directors. Dr. Kirk is internationally recognized for his work in organ transplantation, with a specialized focus on kidney transplants and transplant immunology. He is currently Chairman of the Department of Surgery and Surgeon-in-Chief at Duke University School of Medicine. He is also the David C. Sabiston, Jr. Professor of Surgery, a Professor of Integrative Immunobiology, and a Professor of Pediatrics at Duke. Dr. Kirk served as the inaugural Chief of the Transplantation Branch for the National Institute of Diabetes and Digestive and Kidney Diseases and has been a principal investigator for multiple clinical trials, including the first-in-human experience with novel immunosuppressive agents. Dr. Kirk has helped pioneer the use of co-stimulation pathway blockade to prevent organ rejection in transplant patients. He has a special interest in immune management of transplant recipients, including therapies that influence T cell co-stimulation pathways and adjuvant therapies that facilitate co-stimulation blockade to prevent the rejection of transplanted organs without undue suppression of protective immunity. His research is directed toward understanding transplant rejection and translating this understanding into improved therapies for transplant recipients. He has co-authored hundreds of peer-reviewed journal publications. Dr. Kirk is a member of the Duke Transplant Center and is a core faculty member of the Duke Innovation & Entrepreneurship program. He also previously served as Editor-in-Chief for the American Journal of Transplantation. Dr. Kirk earned an M.D. from Duke University School of Medicine, a Ph.D. from Duke University and a B.S. from Old Dominion University. Announcement • Sep 13
Eledon Pharmaceuticals, Inc. Appoints James Robinson to Its Board of Directors, Effective October 1, 2023 Eledon Pharmaceuticals, Inc. announced the appointment of James Robinson to its Board of Directors effective October 1, 2023. Mr. Robinson is a seasoned biopharmaceutical executive with over 30 years of experience in the industry, most recently serving as Chief Executive Officer and Director of Urovant Sciences until its merger with Sumitomo Pharma America on July 1, 2023. As Chief Executive Officer and Director of Urovant Sciences, Mr. Robinson guided the company through FDA approval of its first drug, a successful product launch, and its acquisition and take-private transaction by Sumitomo Dainippon Pharma. Prior to Urovant, he was President and Chief Operating Officer of Paragon Biosciences. Before his time at Paragon, Mr. Robinson served as President and COO of Alkermes, leading operations that generated more than $1 billion in annual revenue. Prior to Alkermes, Mr. Robinson spent over 12 years at Astellas Pharma, one of the leaders in the field of solid organ transplant, where he served as President of the Americas and was responsible for approximately $4 billion in revenue generation. Mr. Robinson currently serves on the Board of Directors of UroGen Pharma (Nasdaq: URGN). He previously served on the Board of Directors for Neos Therapeutics and for AGTC before the company was sold to Syncona. Mr. Robinson also previously served on the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA), where he served as Chairman of PhRMA s State Committee. He earned a Bachelor of Science in marketing from DePaul University. Announcement • Sep 06
Eledon Pharmaceuticals, Inc. Announces First Participant Dosed in Phase 2 Bestow Trial Evaluating Tegoprubart for the Prevention of Rejection in Kidney Transplantation Eledon Pharmaceuticals, Inc. announced the first participant has been dosed in the Company's Phase 2 BESTOW trial evaluating tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. BESTOW, a multicenter, two-arm, active comparator clinical study, will enroll approximately 120 participants undergoing kidney transplantation in the United States and other countries to evaluate the safety, pharmacokinetics, and efficacy of the anti-CD40 ligand antibody tegoprubart compared to the calcineurin inhibitor tacrolimus. The study's primary objective is to assess graft function at 12 months post-transplant, as measured by estimated glomerular filtration rate (eGFR), in participants treated with tegoprubart compared to tacrolimus. Secondary objectives will include graft survival, biopsy-proven acute rejection, and the incidence of new onset diabetes mellitus after transplant. Eledon will also be using the iBox Scoring System, a composite endpoint of kidney graft function using clinical, histological, and serum biomarkers for the early prediction of graft failure, as an exploratory endpoint. Eledon previously reported results from the first three participants dosed in the Company's ongoing Phase 1b trial. Results showed no incidence of acute rejection and strong graft function observed in all three participants, with mean eGFRs above historical averages with standard of care at measured timepoints out to 31 weeks. The trial currently has enrolled 11 participants to date and will continue in parallel with the Phase 2 BESTOW trial. Eledon expects to report additional data from the ongoing Phase 1b study during the American Society of Nephrology's Kidney Week 2023, taking place November 2-5, 2023 in Philadelphia. Announcement • Aug 17
Eledon Pharmaceuticals, Inc. Announces Dosing of 10th Patient in Ongoing Phase 1b Trial Evaluating Tegoprubart in Patients Undergoing Kidney Transplantation Eledon Pharmaceuticals, Inc. announced the dosing of the 10th patient in the company’s ongoing Phase 1b trial evaluating tegoprubart in patients undergoing kidney transplantation and will report interim clinical data from this study at the American Society of Nephrology (ASN) Kidney Week Annual Meeting in November 2023. With the dosing of the 10th patient, the Company has now completed the first of two clinical development milestones related to the second tranche closing; the other clinical development milestone related to the second tranche closing is the dosing of the 12th patient in the Phase 2 BESTOW study that is expected to begin enrollment in the 3rd quarter of this year. New Risk • Jul 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$30m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 9.1% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (64% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$88m net loss in 3 years). Market cap is less than US$100m (€28.3m market cap, or US$30.8m). Announcement • May 05
Eledon Pharmaceuticals, Inc. to Report Q1, 2023 Results on May 11, 2023 Eledon Pharmaceuticals, Inc. announced that they will report Q1, 2023 results After-Market on May 11, 2023 Announcement • Nov 04
Eledon Pharmaceuticals, Inc. to Report Q3, 2022 Results on Nov 14, 2022 Eledon Pharmaceuticals, Inc. announced that they will report Q3, 2022 results After-Market on Nov 14, 2022 Announcement • Sep 07
Eledon Pharmaceuticals, Inc. Receives FDA Clearance of IND Application to Evaluate Tegoprubart in IgA Nephropathy Eledon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN). Eledon plans to open U.S. sites under this IND as part of its ongoing global Phase 2a clinical trial evaluating tegoprubart for the treatment of IgAN. Including the U.S., the trial has now received regulatory clearances in 10 countries with plans to expand the study in up to 2 additional countries, including China. Multiple patients in the Phase 2a study have begun receiving treatment with tegoprubart. The global multicenter, open-label study is enrolling up to 21 patients in each of two dose cohorts with confirmed diagnosis of IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. The study will evaluate the safety and efficacy of tegoprubart, with the primary endpoint being change from baseline in urine protein (assessed as urine protein to creatinine ratio) after 24 weeks of therapy. Dosing will continue through 96 weeks, and change from baseline in eGFR slope will be assessed at 96 weeks. Preclinical evidence has demonstrated that blocking CD40L signaling can improve proteinuria, reduce autoantibodies, decrease immune cell infiltration into the kidneys, and improve survival. Announcement • Aug 05
Eledon Pharmaceuticals, Inc. to Report Q2, 2022 Results on Aug 11, 2022 Eledon Pharmaceuticals, Inc. announced that they will report Q2, 2022 results After-Market on Aug 11, 2022 Announcement • Aug 02
Eledon Pharmaceuticals Receives FDA Clearance of IND Application to Evaluate Tegoprubart for the Prevention of Rejection in Kidney Transplant Recipients Eledon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant. The IND-opening phase 2 study will be a multicenter, open-label, 2-arm, active comparator safety, pharmacokinetic, and efficacy study that will enroll approximately 120 participants (60/arm) undergoing kidney transplant. Participants will receive tegoprubart or the active comparator, tacrolimus, as part of an immunosuppressive regimen including corticosteroids and mycophenolate mofetil (MMF) or mycophenolate sodium (MPS). The study's primary objective is to assess superiority of graft function at 12 months post-transplant in tegoprubart-treated participants compared with tacrolimus-treated participants. The primary endpoint will compare the mean estimated glomerular filtration rate (eGFR) at 12 months for tegoprubart vs. current standard of care. Better graft function as assessed by eGFR has been associated with improved long-term patient and graft survival. Secondary objectives include safety, incidence of new onset diabetes, and participant and graft survival. More than 23,000 people undergo a kidney transplant in the United States every year. Nationwide, only about a quarter of persons on the transplant waitlist will receive a deceased donor kidney transplant within 5 years, in part because approximately 10% of yearly kidney transplants are re-transplants. Tegoprubart seeks to reduce drug-associated morbidity and improve graft survival associated with current standard of care regimens including calcineurin inhibitors (CNIs). Announcement • Jul 19
Eledon Pharmaceuticals Announces the First Patient Dosed in Phase 1B Trial Evaluating Tegoprubart in Kidney Transplantation Eledon Pharmaceuticals, Inc. reported that the first patient has been dosed in a Phase 1b study to evaluate tegoprubart in patients undergoing kidney transplantation. This open-label study, which has received clearance in Canada and the United Kingdom, is enrolling up to 12 patients who will undergo kidney transplantation. The patients will receive tegoprubart in combination with rabbit anti-thymocyte globulin (rATG) induction, and mycophenolate mofetil and an oral steroid taper as maintenance therapy. The study will evaluate the safety, pharmacokinetics, and efficacy of tegoprubart, including incidence of biopsy-proven acute rejection, immune cell infiltrate of graft biopsy, and biomarker measures of kidney injury and rejection risk. More than 20,000 people a year undergo a kidney transplant in the United States, and another 90,000 people will wait an average of 3-5 years for a transplant. Re-transplants represent up to 15% of yearly transplant surgeries and thus decreasing the need for re-transplantation would lead to greater organ availability for new patients. In addition, tegoprubart seeks to address the challenges with current immunosuppressive calcineurin inhibitor (CNI)-based regimens, associated with up to an approximately 30% incidence of new onset diabetes post-transplant, as well as hypertension, kidney-toxicity and neuro-toxicity. Announcement • Jun 01
Eledon Announces Positive Topline Results from Phase 2a Trial of Tegoprubart Demonstrating Safety, Target Engagement, and Biomarker Response in Patients Living with Amyotrophic Lateral Sclerosis Eledon Pharmaceuticals, Inc. announced topline results from a Phase 2a clinical trial of tegoprubart (formerly AT-1501) in patients with amyotrophic lateral sclerosis. Tegoprubart is an investigational humanized monoclonal antibody that inhibits CD40 Ligand (CD40L), a membrane protein linked to increased peripheral immune responses and neuroinflammation in ALS. The 12-week trial included 54 patients with ALS at 13 treatment sites in the United States and Canada. The primary objectives of the study were to assess the safety and tolerability of multiple doses of tegoprubart in four sequential, ascending dose cohorts (1, 2, 4, and 8 mg/kg). Secondary outcome measures included pharmacokinetic assessment of multiple intravenous doses of tegoprubart on target engagement and on pro-inflammatory biomarkers associated with ALS. Each subject served as their own control, with changes being compared to baseline. Tegoprubart successfully met the primary endpoints of safety and tolerability. Adverse events were equally distributed across dose levels. Tegoprubart was well-tolerated, and no drug-related serious adverse events were observed. Anti-drug antibodies (ADAs) were present in less than 5% of samples. All ADAs were of low titer and did not impact tegoprubart drug levels. Tegoprubart target engagement was demonstrated at the 4 and 8 mg /kg dosing levels using CD40L and CXCL13 biomarkers related to T cell and B cell function, respectively. A pro-inflammatory ALS signature was identified, consisting of 32 different inflammatory biomarkers in the tested population, including TNF-a, MCP1, EN-RAGE, C-Reactive Protein (CRP), and IL-6. IL-1 was not significantly detected in the study patient population. Dose dependent, significant reductions were observed in up to 23 of these biomarkers, including TNF-a, MCP1, EN-RAGE, and CRP. Other pro-inflammatory biomarkers significantly reduced included biomarkers also associated with IgA nephropathy and kidney transplant rejection, such as IgA, IgE, IgM, C3, CXCL9, and CXCL10. While the study was neither primarily designed nor powered to assess the effect of tegoprubart on ALS Functional Rating Scale (“ALSFRS”), both target engagement and level of pro-inflammatory biomarker reduction were associated with a trend in the slowing of disease progression as measured by ALSFRS slope when compared to a cohort from the ALS PRO-ACT database. Announcement • May 10
Eledon Pharmaceuticals, Inc. Announces First Patient Dosed in Phase 2a Trial Evaluating Tegoprubart in IgA Nephropathy Eledon Pharmaceuticals, Inc. reported that the first patient has been dosed in a Phase 2a study evaluating tegoprubart in patients with IgA Nephropathy (IgAN). IgAN, the most common primary glomerulonephritis, is characterized by gradual, progressive kidney function deterioration which can potentially lead to End-Stage Renal Disease (“ESRD”), dialysis, renal transplant, and death. Leakage of blood proteins into the urine, or proteinuria, is a clinical sign of IgAN, and the severity of proteinuria predicts the rate of progression to ESRD. In addition, reducing proteinuria has been shown to delay progression to ESRD. Current standard of care with ACEi/ARB therapies and budesonide are effective in a subset of patients with IgAN but many patients will continue to have progressive disease and be at risk of ESRD. This multicenter, open-label study is enrolling up to 21 patients in each of two dose cohorts with confirmed diagnosis of IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. The study will evaluate the safety and efficacy of tegoprubart, with the primary endpoint being change from baseline in urine protein after 24 weeks of therapy. Dosing will continue through 96 weeks, and change from baseline in eGFR slope will be assessed at 96 weeks. Preclinical evidence has demonstrated that blocking CD40L signaling can improve proteinuria, reduce autoantibodies, decrease immune cell infiltration into the kidneys, and improve survival. Announcement • May 06
Eledon Pharmaceuticals, Inc. to Report Q1, 2022 Results on May 12, 2022 Eledon Pharmaceuticals, Inc. announced that they will report Q1, 2022 results After-Market on May 12, 2022 Executive Departure • Aug 04
Senior VP of Administration & Principal Accounting Officer Jon Kuwahara has left the company On the 31st of July, Jon Kuwahara was replaced as CEO by David-Alexander Gros after less than a year in the role. As of March 2021, Jon still personally held only 331.00 shares (€2.8k worth at the time). A total of 2 executives have left over the last 12 months. The current median tenure of the management team is less than a year, which is considered inexperienced in the Simply Wall St Risk Model. Under Jon's leadership, the company delivered a total shareholder return of 6.3%. Recent Insider Transactions • Jun 15
Chief Financial Officer recently bought €73k worth of stock On the 11th of June, Paul Little bought around 10k shares on-market at roughly €7.33 per share. This was the largest purchase by an insider in the last 3 months. This was Paul's only on-market trade for the last 12 months. Announcement • Apr 28
Eledon Pharmaceuticals, Inc. Announces Update on Development Strategy for AT-1501 in Renal Transplantation Eledon Pharmaceuticals, Inc. announced an updated development strategy for AT-1501 in renal transplantation. As part of ongoing discussions with the U.S. Food and Drug Administration (FDA) regarding the AT-1501 renal transplant program, the FDA requested that Eledon provide AT-1501 specific, renal transplant data in non-human primates prior to initiating a Phase 2 trial in renal transplantation in the United States. As a result, Eledon plans to initiate an evaluation of AT-1501 in a standard non-human primate model of renal transplantation which is expected to be completed by late 2022. In parallel, the company will continue to explore potentially conducting a renal transplantation clinical trial outside the United States. The FDA request and this shift in development strategy is specific to the previously planned Phase 2 trial in renal transplantation; the company’s other ongoing development programs are continuing in both the United States and Canada as previously communicated. No significant drug-related safety signals with AT-1501 have been identified to date, and this change in development strategy is not due to any specific event in or data from the company’s ongoing trials of AT-1501. Is New 90 Day High Low • Mar 10
New 90-day low: €10.50 The company is down 35% from its price of €16.20 on 10 December 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 3.0% over the same period. Announcement • Jan 06
Eledon Pharmaceuticals, Inc.(NasdaqCM:ELDN) dropped from NASDAQ Composite Index Novus Therapeutics, Inc. has been removed from NASDAQ Composite Index . Is New 90 Day High Low • Dec 24
New 90-day low: €12.50 The company is down 14% from its price of €14.58 on 25 September 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Dec 10
Novus Therapeutics, Inc. Appoints June Lee to the Board of Directors Novus Therapeutics, Inc. announced the appointment of June Lee, M.D., to the company’s Board of Directors. Dr. Lee is a physician-scientist recognized for her ability to integrate emerging advances in science with business strategy. Most recently, she was Chief Development Officer and Chief Operating Officer of MyoKardia, Inc. Announcement • Nov 11
Novus Therapeutics, Inc. to Report Q3, 2020 Results on Nov 16, 2020 Novus Therapeutics, Inc. announced that they will report Q3, 2020 results at 5:00 PM, Eastern Standard Time on Nov 16, 2020 Announcement • Nov 03
Novus Therapeutics Announces First Patient Enrolled in Phase 2a Clinical Trial of Anti-CD40L Antibody AT-1501 in Amyotrophic Lateral Sclerosis Novus Therapeutics, Inc. announced that the first subject has been enrolled in the Phase 2a clinical trial evaluating AT-1501, the company’s lead product candidate, in adults with amyotrophic lateral sclerosis (ALS). AT-1501 blocks the activation of the CD40L pathway, which has been shown to improve muscle function, slow disease progression, and improve survival in a pre-clinical animal model of ALS. AT-1501 previously received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ALS. The AT-1501 Phase 2a trial in ALS is a 12-week, open label, dose escalating, safety and biomarker study. The endpoints of the study are safety and tolerability, and changes in pro-inflammatory biomarkers as well as neurofilament light chain. Exploratory clinical endpoints will also be assessed. Novus Therapeutics has completed a Phase 1a/1b single ascending dose trial in healthy volunteers and adults living with ALS. In that trial, AT-1501 was well tolerated at all doses tested and demonstrated a good safety profile. AT-1501 also demonstrated linear dose proportionality across the dose range and a half-life of up to 26 days. Is New 90 Day High Low • Nov 01
New 90-day high: €21.50 The company is up 243% from its price of €6.26 on 03 August 2020. The German market is down 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Sep 26
Novus Therapeutics, Inc. announced that it has received $108.15 million in funding from a group of investors On September 25, 2020, Novus Therapeutics, Inc. (NasdaqCM:NVUS) closed the transaction. The company received $108,144,151 from 35 investors pursuant to exemption provided under Regulation D. Announcement • Sep 21
Novus Therapeutics, Inc. announced that it expects to receive $108.15 million in funding from a group of investors Novus Therapeutics, Inc. (NasdaqCM:NVUS) announced that it has entered into a stock purchase agreement for a private placement of approximately 217,200 shares of series X1 preferred stock at a price of approximately $497.928177 for an aggregate purchase price of approximately $108,150,000 led by existing investor BVF Partners LP on September 14, 2020. The transaction will include participation from certain institutional and accredited investors, including Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P., Biotechnology Value Trading Fund OS LP, and MSI BVF SPV, LLC, funds managed by BVF Partners LP for a total of 46,693 shares, Cormorant Global Healthcare Master Fund, LP, a fund managed by Cormorant Asset Management, LLC for 35,145 shares, Logos Global Master Fund, LP, a fund managed by Logos Global Management, L.P. for 20,083 shares, and other investors. Subject to stockholder approval, each preferred stock, at the option of the holder, will be convertible into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. The preferred shares will convert to common shares at a price of $0.5 per share on an as-converted-to-common basis. The company will issue shares pursuant to Section 4(a)(2) of the Securities Act and/or Regulation D. Announcement • Sep 05
Novus Therapeutics, Inc. Announces Resignation of Gregory Flesher as Chief Executive Officer Novus Therapeutics, Inc. accepted the resignation of Gregory Flesher as the Company's Chief Executive Officer and a member of the Board.