Eledon Pharmaceuticals, Inc. (NASDAQ: ELDN ) has been at the forefront of the revolutionary pig-to-human organ transplant story, having provided its lead immunosuppressive molecule Tegoprubart for both heart and kidney transplant experiments. It uses its immunology expertiseAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and ...

Core Insights - Eledon Pharmaceuticals has achieved significant clinical milestones for its lead product, tegoprubart, in the field of transplantation, particularly in kidney and islet cell transplants [2][5] - The company completed enrollment in the Phase 2 BESTOW trial ahead of schedule and is on track to report topline results in Q4 2025 [1][5] - Positive initial data from an investigator-initiated trial at UChicago Medicine indicates potential insulin independence in type 1 diabetes patients treated with tegoprubart [5] 2024 Key Highlights - Enrollment of 120 patients in the Phase 2 BESTOW trial was completed approximately four months earlier than planned [5] - Updated data from a Phase 1b trial showed tegoprubart to be generally safe and well tolerated, with a mean estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m post-transplant [5] - Initial data from three islet transplant recipients indicated potential insulin independence without the use of tacrolimus, the current standard of care [5] Anticipated 2025 Milestones - Summer 2025: Updated interim clinical data from ongoing Phase 1b and long-term efficacy studies of tegoprubart in kidney transplantation will be reported [5] - Q4 2025: Topline results from the Phase 2 BESTOW trial will be announced [5] - 2025: Longer-term follow-up results from the investigator-led trial at UChicago Medicine for pancreatic islet transplantation will be provided [5] Financial Overview - Eledon completed two financings totaling $135 million in gross proceeds, expected to support operations through the end of 2026 [1][5]

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[134][137] - The company reported that in the ongoing Phase 1b trial, the mean estimated glomerular filtration rate (eGFR) was 70.5 mL/min/1.73m² after day 30 post-transplant, compared to historical averages of approximately 50 mL/min/1.73m²[146] - As of April 3, 2024, two participants in the Phase 1b trial demonstrated mean eGFRs above 90 mL/min/1.73m² at one year post-transplant, indicating potential for improved long-term graft survival[146] - The Phase 2 BESTOW trial, which compares tegoprubart to tacrolimus, aims to enroll approximately 120 participants and assess graft function at 12 months post-transplant[147] - Eledon has received regulatory approvals for a Phase 1b clinical trial in multiple countries, including the U.S., Canada, the U.K., and Australia[143] - The company has entered into a collaborative research agreement with eGenesis for preclinical and clinical xenotransplantation studies using tegoprubart[150] - Tegoprubart has shown pre-clinical efficacy in non-human primate models, maintaining glucose control and improving islet cell graft survival in Type 1 diabetes studies[154] - The FDA granted orphan designation to tegoprubart for the prevention of allograft rejection in pancreatic islet cell transplantation in 2022[155] - Tegoprubart is being utilized in a trial at the University of Chicago Medicine to assess safety in islet cell transplantation for T1D patients, with the company providing the drug but not funding the trial[156] - Positive data from the trial showed that two subjects achieved insulin independence and normal HbA1c levels, while a third subject reduced insulin use by over 60% within three days post-transplant[157] - Islet engraftment in the study was three to five times higher than in subjects receiving tacrolimus-based immunosuppression, indicating improved graft survival and function with tegoprubart[157] - The Phase 2a study of tegoprubart for ALS met primary endpoints of safety and tolerability, with 50 out of 54 subjects completing all infusions[162] Financial Performance and Capital Management - Total operating expenses for Q3 2024 increased by $9.3 million to $20.5 million compared to $11.2 million in Q3 2023, driven by a significant rise in research and development expenses[185] - Research and development expenses rose by $8.6 million to $16.5 million in Q3 2024, primarily due to a $7.8 million increase in clinical development expenses with external organizations[186] - Net income for Q3 2024 was $77.0 million, a substantial increase of $86.9 million compared to a net loss of $9.9 million in Q3 2023[185] - For the nine months ended September 30, 2024, total operating expenses increased by $13.2 million to $45.9 million compared to $32.7 million in the same period of 2023[190] - The fair value of warrant liabilities increased by $107.6 million to $51.8 million for the nine months ended September 30, 2024, primarily due to the reversal of $58.7 million in warrant liabilities[194] - As of September 30, 2024, the company had cash and cash equivalents of $78.2 million and working capital of $69.0 million[195] - The company has incurred significant net losses since inception and expects to continue incurring losses for the foreseeable future, with an accumulated deficit of $311.0 million[196] - The company received net proceeds of approximately $79.5 million from a securities purchase agreement on October 29, 2024, after issuing 18,356,173 shares of common stock[201] - The company anticipates increased expenses related to ongoing clinical programs and potential commercialization efforts for its product candidates[204] - The company does not currently have approved products for sale and has never generated revenue from product sales[196] - The company used $28.3 million in cash for operating activities for the nine months ended September 30, 2024, compared to $30.4 million for the same period in 2023[209][211] - Net cash used in investing activities was $22.9 million for the nine months ended September 30, 2024, down from $55.4 million in 2023[212][213] - Net cash provided by financing activities increased to $53.4 million for the nine months ended September 30, 2024, compared to $33.0 million in 2023[209][215] - The company reported a net income of $8.4 million for the nine months ended September 30, 2024, a significant improvement from a net loss of $86.4 million in 2023[210][211] - The company plans to raise additional capital through equity offerings, debt financings, or collaborations to support ongoing clinical development and operations[206] - The company experienced a $51.8 million adjustment in cash flow due to changes in warrant liabilities and fair value of financial instruments for the nine months ended September 30, 2024[210] - The company sold 13.1 million shares of common stock in the 2024 Private Placement, generating $48.1 million in net proceeds[214] - The company is facing challenges in raising capital due to global macroeconomic trends, which may impact its financial condition and business strategies[207] - The company’s cash and cash equivalents increased by $2.1 million for the nine months ended September 30, 2024, compared to a decrease of $52.7 million in 2023[209] - The company is focused on advancing its drug product through clinical development and obtaining regulatory approval, which requires substantial additional financing[206] Strategic Focus and Program Prioritization - Eledon plans to discontinue its IgAN program and focus resources on kidney transplantation, while continuing ALS clinical development pending additional financing[137] - The company deprioritized its IgA Nephropathy program in January 2023 to focus on kidney transplantation programs, discontinuing all clinical development activities for IgAN[164][166] - The company aims to transform immunosuppression therapy by mitigating adverse events associated with current CNI-based therapies, potentially increasing organ availability for transplantation[142]

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]