Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. New Risk • Jan 09
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 33% 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 (19% average weekly change). Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (33% 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$115m net loss in 3 years). Aankondiging • 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. New Risk • Nov 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 26% This is considered a minor 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 15% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$129m net loss in 3 years). Shareholders have been diluted in the past year (26% increase in shares outstanding). New Risk • Nov 16
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$83m Forecast net loss in 3 years: US$129m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. 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 15% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$129m net loss in 3 years). Aankondiging • 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 Price Target Changed • Nov 12
Price target decreased by 14% to US$8.17 Down from US$9.50, the current price target is an average from 6 analysts. New target price is 332% above last closing price of US$1.89. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$0.83 next year compared to a net loss per share of US$0.75 last year. Aankondiging • 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 Price Target Changed • Nov 10
Price target decreased by 12% to US$9.00 Down from US$10.20, the current price target is an average from 6 analysts. New target price is 337% above last closing price of US$2.06. Stock is down 58% over the past year. The company is forecast to post a net loss per share of US$0.82 next year compared to a net loss per share of US$0.75 last year. Aankondiging • 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. Valuation Update With 7 Day Price Move • Nov 02
Investor sentiment improves as stock rises 24% After last week's 24% share price gain to US$4.32, the stock trades at a trailing P/E ratio of 17.7x. Average trailing P/E is 18x in the Biotechs industry in the US. Total returns to shareholders of 79% over the past three years. Valuation Update With 7 Day Price Move • Oct 18
Investor sentiment improves as stock rises 26% After last week's 26% share price gain to US$3.44, the stock trades at a trailing P/E ratio of 14.1x. Average trailing P/E is 16x in the Biotechs industry in the US. Total returns to shareholders of 45% over the past three years. Aankondiging • 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. New Risk • Aug 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (52% 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$124m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Aankondiging • 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. Aankondiging • 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. Price Target Changed • May 21
Price target decreased by 12% to US$9.00 Down from US$10.20, the current price target is an average from 4 analysts. New target price is 186% above last closing price of US$3.15. Stock is up 5.4% over the past year. The company is forecast to post a net loss per share of US$0.87 next year compared to a net loss per share of US$0.75 last year. Aankondiging • 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 Price Target Changed • Nov 14
Price target decreased by 20% to US$12.50 Down from US$15.60, the current price target is an average from 5 analysts. New target price is 193% above last closing price of US$4.27. Stock is up 242% over the past year. The company is forecast to post a net loss per share of US$1.16 next year compared to a net loss per share of US$4.73 last year. Aankondiging • 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 Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 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 Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$75m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Price Target Changed • May 10
Price target decreased by 10% to US$14.00 Down from US$15.60, the current price target is an average from 5 analysts. New target price is 506% above last closing price of US$2.31. Stock is down 4.1% over the past year. The company is forecast to post a net loss per share of US$1.24 next year compared to a net loss per share of US$1.64 last year. New Risk • Apr 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 25% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (80% 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$90m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$49.4m market cap). Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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. Price Target Changed • Sep 27
Price target decreased by 10% to US$16.50 Down from US$18.40, the current price target is an average from 6 analysts. New target price is 1,210% above last closing price of US$1.26. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$2.08 next year compared to a net loss per share of US$6.16 last year. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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). 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). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$30.8m market cap). Aankondiging • 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 Price Target Changed • Jan 11
Price target decreased to US$19.40 Down from US$26.80, the current price target is an average from 5 analysts. New target price is 581% above last closing price of US$2.85. Stock is down 37% over the past year. The company is forecast to post a net loss per share of US$2.61 next year compared to a net loss per share of US$2.33 last year. Price Target Changed • Apr 27
Price target decreased to US$28.80 Down from US$32.60, the current price target is an average from 4 analysts. New target price is 857% above last closing price of US$3.01. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$2.70 next year compared to a net loss per share of US$2.33 last year. Price Target Changed • Nov 15
Price target decreased to US$29.75 Down from US$32.60, the current price target is an average from 4 analysts. New target price is 435% above last closing price of US$5.56. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$2.58 next year compared to a net loss per share of US$15.72 last year. 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 (US$3.5k 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 2.1%. Recent Insider Transactions • Jun 15
Chief Financial Officer recently bought US$89k worth of stock On the 11th of June, Paul Little bought around 10k shares on-market at roughly US$8.87 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. Is New 90 Day High Low • Mar 10
New 90-day low: US$12.66 The company is down 36% from its price of US$19.79 on 09 December 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. Is New 90 Day High Low • Dec 24
New 90-day low: US$14.76 The company is down 12% from its price of US$16.74 on 24 September 2020. The American market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Price Target Changed • Dec 24
Price target raised to US$35.00 Up from US$23.70, the current price target is an average from 3 analysts. The new target price is 137% above the current share price of US$14.76. As of last close, the stock is up 34% over the past year. Is New 90 Day High Low • Oct 30
New 90-day high: US$21.42 The company is up 162% from its price of US$8.19 on 31 July 2020. The American market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.