Clinical Trials and Research - Completed enrollment for the Phase 2 BESTOW clinical trial with 120 participants, four months ahead of schedule[3] - Positive initial data from the first three islet transplant recipients treated with tegoprubart, with two achieving insulin independence[4] - Anticipated milestones include reporting topline results from the Phase 2 BESTOW trial in Q4 2025 and updated interim data from Phase 1b studies in mid-2025[6] Financial Performance and Funding - Completed an oversubscribed offering, raising $85.0 million in gross proceeds, extending cash runway to the end of 2026[5] - Cash, cash equivalents, and short-term investments totaled $78.2 million as of September 30, 2024, with net proceeds from the October offering adding $79.5 million[7] - Net income for Q3 2024 was $77.0 million, primarily due to a non-cash gain of $96.4 million from changes in fair value of warrant liabilities[9] - Total current assets as of September 30, 2024, were $81.5 million, including $71.4 million in short-term investments[14] - Total liabilities as of September 30, 2024, were $38.5 million, with warrant liabilities decreasing to $24.0 million from $76.2 million in December 2023[15] Expenses and Costs - R&D expenses for Q3 2024 increased to $16.5 million, up from $7.9 million in Q3 2023, driven by clinical development and CMC expenses[7] - General and administrative expenses for Q3 2024 increased to $4.0 million, up from $3.3 million in Q3 2023, driven by professional services and operating expenses[9]

Core Insights - Eledon Pharmaceuticals has completed enrollment for the Phase 2 BESTOW trial of tegoprubart in kidney transplantation four months ahead of schedule, with topline results expected in Q4 2025 [1][3] - Initial positive data from an investigator-initiated trial at UChicago Medicine shows promising results for tegoprubart in type 1 diabetes patients following islet transplantation [1][3] - The company successfully raised $85 million in an oversubscribed underwritten offering, extending its cash runway to the end of 2026 [1][3] Recent Business Highlights - Enrollment for the Phase 2 BESTOW clinical trial reached 120 participants, four months earlier than planned, focusing on the safety and efficacy of tegoprubart for preventing organ rejection in kidney transplantation [3] - Initial data from the UChicago Medicine trial indicated that the first two subjects achieved insulin independence, with the third subject on track for similar outcomes; treatment was well tolerated with no unexpected adverse events [3] - The recent financing round raised approximately $79.5 million after expenses, with participation from both new and existing healthcare investors [3] Anticipated Upcoming Milestones - Mid-2025: Updated interim clinical data from ongoing Phase 1b and long-term safety studies of tegoprubart in kidney transplantation will be reported [4] - Q4 2025: Topline results from the Phase 2 BESTOW trial will be shared [4] - 2025: Longer-term follow-up data from the UChicago Medicine trial for pancreatic islet transplantation in type 1 diabetes subjects will be reported [4] Financial Results - As of September 30, 2024, the company reported cash, cash equivalents, and short-term investments totaling $78.2 million, which will be supplemented by the recent financing to fund operations until the end of 2026 [5] - R&D expenses for Q3 2024 were $16.5 million, a significant increase from $7.9 million in Q3 2023, primarily due to clinical development costs and increased employee compensation [6] - General and administrative expenses rose to $4.0 million in Q3 2024 from $3.3 million in the same period last year, driven by higher professional services and operating expenses [7] - The company reported a net income of $77.0 million for Q3 2024, a substantial increase from a net loss of $9.9 million in Q3 2023, largely due to a non-cash gain related to changes in the fair value of warrant liabilities [8]

Core Insights - Eledon Pharmaceuticals has completed enrollment for its phase 2 BESTOW trial, which is focused on the use of its immunosuppressive drug, tegoprubart, aimed at preventing organ rejection in kidney transplant patients [1] Company Summary - Eledon Pharmaceuticals is advancing its clinical trials with tegoprubart, which could potentially address a significant medical need in organ transplantation [1] - The company is part of the biotech sector, which is characterized by ongoing research and development efforts to innovate treatments for various health conditions [1] Industry Context - The biotech industry is increasingly focused on developing immunosuppressive therapies, particularly for organ transplant patients, highlighting the importance of successful trial outcomes [1]

Core Viewpoint - Eledon Pharmaceuticals has announced the pricing of an underwritten offering of common stock and pre-funded warrants, aiming to raise approximately $85 million to advance its pipeline and for general corporate purposes [1][3]. Group 1: Offering Details - The offering consists of 18,356,173 shares of common stock priced at $3.65 per share and pre-funded warrants for 4,931,507 shares at $3.649 each, with an exercise price of $0.001 per share [1]. - The gross proceeds from the offering are expected to be around $85 million before deducting underwriting discounts and commissions [1]. - The offering is expected to close on or about October 30, 2024, subject to customary closing conditions [1]. Group 2: Investor Participation - The financing includes participation from both new and existing investors, such as BVF Partners LP, RA Capital Management, and others [2]. - Leerink Partners is acting as the sole book-running manager for the offering, while Noble Capital Markets Inc. serves as the financial advisor [2]. Group 3: Use of Proceeds - Eledon intends to utilize the net proceeds from the offering to advance its pipeline and for working capital and general corporate purposes [3]. Group 4: Company Overview - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [6]. - The company's lead investigational product is tegoprubart, an anti-CD40L antibody with potential applications in kidney transplantation and amyotrophic lateral sclerosis (ALS) [6].

- First two out of three subjects treated with tegoprubart as part of immunosuppression regimen to prevent transplant rejection achieved insulin independence and remain insulin free, with glucose control in the normal range; Third subject was recently transplanted and is on trajectory for insulin independence - Islet engraftment in the first two subjects with tegoprubart estimated three to five times higher than engraftment in three comparable subjects receiving standard of care tacrolimus-based immunosuppr ...

IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. ("Eledon") (NASDAQ: ELDN) today announced that it has successfully completed enrollment for its Phase 2 BESTOW clinical trial, which is designed to assess the safety and efficacy of its investigational immunosuppression therapy tegoprubart for the prevention of organ rejection in patients undergoing kidney transplantation. The trial reached its target enrollment of 120 participants approximately four months earlier than original ...

Drug Development and Clinical Trials - Eledon Pharmaceuticals is focusing on the development of tegoprubart, an anti-CD40L antibody, to prevent organ rejection and treat ALS, with a strategic emphasis on kidney transplantation programs[115][118] - Interim results from the Phase 1b trial indicated a mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m² post-transplant, significantly higher than the historical average of 50 mL/min/1.73m²[127] - The Phase 1b trial reported no cases of hyperglycemia, new onset diabetes, or tremor, which are common side effects associated with standard immunosuppressive therapies[127] - Eledon received FDA clearance for the Phase 2 BESTOW trial, which will enroll 120 participants to compare the efficacy of tegoprubart against tacrolimus, focusing on graft function at 12 months[128] - In January 2023, Eledon entered a collaborative agreement with eGenesis for preclinical studies on xenotransplantation using tegoprubart[130] - Tegoprubart has received orphan designation from the FDA for preventing allograft rejection in pancreatic islet cell transplantation, indicating its potential in this area[133] - As of April 2024, the ongoing Phase 1b trial has shown that two participants maintained eGFRs above 90 mL/min/1.73m² at one year post-transplant[127] - Eledon is not funding an investigator-initiated trial at the University of Chicago but is supplying tegoprubart for a study assessing a calcineurin inhibitor-free regimen in islet cell transplantation[134] - Tegoprubart demonstrated a half-life of up to 26 days and was well-tolerated in a Phase 1 study with low anti-drug antibody responses[137] - In the Phase 2a study, 50 out of 54 subjects completed all six infusions of tegoprubart, with no drug-related serious adverse events observed[139] Financial Performance - The total operating expenses for Q2 2024 were $14.5 million, an increase of $4.1 million compared to $10.4 million in Q2 2023[152] - The net loss for Q2 2024 was $44.9 million, a decrease of $20.9 million from a net loss of $65.8 million in Q2 2023[152] - The company received $35.0 million in net proceeds from the initial closing of a private placement on May 5, 2023[145] - The 2024 Private Placement resulted in gross proceeds of $50.0 million, with net proceeds of approximately $48.1 million after deducting offering costs[148] - The total operating expenses for the six months ended June 30, 2024, were $25.4 million, an increase of $3.9 million from $21.5 million in the same period of 2023[157] - The net loss for the six months ended June 30, 2024, was $68.5 million, a decrease of $7.9 million compared to a net loss of $76.5 million for the same period in 2023[157] - Cash and cash equivalents, along with short-term investments, totaled approximately $83.6 million as of June 30, 2024, following a private placement that generated net proceeds of approximately $48.1 million[163] - Net cash used in operating activities for the six months ended June 30, 2024, was $16.5 million, compared to $18.1 million for the same period in 2023[170] - Net cash used in investing activities was $10.1 million for the six months ended June 30, 2024, significantly lower than $30.3 million in the prior year[172] - Net cash provided by financing activities for the six months ended June 30, 2024, was $48.1 million from the sale of 13.1 million shares and 8.0 million pre-funded warrants[173] - Net cash provided by financing activities for the six months ended June 30, 2023, was $33.0 million from the sale of 8.7 million shares and 6.4 million pre-funded warrants[173] Strategic Focus and Resource Allocation - The company has prioritized resources for kidney transplantation, discontinuing funding for islet cell transplantation and IgAN programs due to financial constraints[118] - The Phase 2 global study for IgAN was a 96-week trial, but all clinical development activities for IgAN were discontinued in 2023[142] - The company is unable to continue clinical development of tegoprubart for ALS without additional financing specific to the ALS program[140] - The company expects to incur significant commercialization expenses if any product candidates receive marketing approval, necessitating additional financing[165] - The company has no approved products for commercial sale and has incurred significant net losses, indicating a need for future capital raises to sustain operations[162] Market and Economic Conditions - In 2022, approximately 25,000 kidneys were transplanted in the U.S., with over 90,000 individuals waiting for a transplant, highlighting a critical shortage of available organs[121] - The global economy has experienced extreme volatility, which could negatively impact the company's ability to obtain necessary financing[149] Expense Trends - Research and development expenses increased by $2.9 million to $10.1 million for the three months ended June 30, 2024, compared to $7.2 million for the same period in 2023, driven by clinical trial materials and external research organization costs[153] - General and administrative expenses rose by $1.2 million to $4.4 million for the three months ended June 30, 2024, from $3.2 million in the prior year, primarily due to higher stock-based compensation[154] - The fair value of warrant liabilities decreased by $24.9 million to $31.3 million for the three months ended June 30, 2024, due to an increase in the company's common stock price[156]

Core Insights - Eledon Pharmaceuticals reported significant progress in its clinical trials and financial position, particularly with the Phase 2 BESTOW trial for tegoprubart in kidney transplantation [2][3] - The company completed an oversubscribed private placement raising $50 million, ensuring liquidity through December 2025 [1][7] Clinical Developments - The Phase 2 BESTOW trial has enrolled 80 participants, with expectations to complete enrollment by the end of 2024 [3][4] - Updated data from a Phase 1b trial indicated that tegoprubart was generally safe and well-tolerated, with a mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m² after day 30 post-transplant [3] - Two participants in the Phase 1b trial maintained eGFRs above 90 mL/min/1.73m² at one year post-transplant [3] Financial Overview - The company ended Q2 2024 with approximately $83.6 million in cash and cash equivalents, bolstered by the recent private placement [7] - A reclassification of certain common stock warrants as liabilities is expected, but this is a non-cash adjustment and will not impact the company's cash position [5][7] Future Milestones - Eledon anticipates completing enrollment in the Phase 2 BESTOW trial by the end of 2024 and plans to report updated interim clinical data by mid-2025 [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 001-36620 20-1000967 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.001 par value ELDN Nasdaq Global Market FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 13, 2024 Eledon ...

Core Insights - Eledon Pharmaceuticals has enrolled the 80th participant in its Phase 2 BESTOW trial for tegoprubart aimed at preventing kidney transplant rejection [1][2] - The trial has successfully enrolled two-thirds of the projected 120 participants across the United States, Europe, and Latin America, with completion expected by the end of the year [2] - The primary objective of the BESTOW trial is to evaluate graft function at 12 months post-transplant, comparing tegoprubart to tacrolimus, with better graft function linked to improved long-term survival [2][3] Company Overview - Eledon Pharmaceuticals is a clinical-stage biotechnology company focused on developing immune-modulating therapies for life-threatening conditions [4] - The lead investigational product, tegoprubart, is an anti-CD40L antibody targeting CD40 Ligand, which has significant therapeutic potential in various conditions including kidney transplantation and amyotrophic lateral sclerosis (ALS) [4] - The company is headquartered in Irvine, California, and is conducting multiple clinical trials to assess the safety and efficacy of tegoprubart [3][4]