Eledon Pharmaceuticals Releases Q2 2024 Preliminary Results

Eledon Pharmaceuticals, Inc. recently shared significant business updates for the second quarter of 2024. The company has reported advancements in their ongoing clinical trials and financial standing, including a notable $50 million private placement.

As of August 2024, Eledon has entered the latter part of the year with a solid financial foundation, bolstered by an oversubscribed private placement amounting to $50 million. This financial boost is expected to provide the company with adequate liquidity until December 2025. CEO David-Alexandre C. Gros, M.D., expressed optimism about the progress in their Phase 2 BESTOW trial, aimed at evaluating tegoprubart for preventing organ rejection in kidney transplantation. According to Gros, the trial is on track to complete enrollment by the end of the year, and the company remains hopeful that tegoprubart could potentially replace calcineurin inhibitors as the first-line immunosuppression treatment for kidney transplant patients.

Key developments in the second quarter of 2024 include the enrollment of the 80th participant in the Phase 2 BESTOW trial. This trial is a head-to-head comparison of tegoprubart versus tacrolimus for preventing organ rejection in kidney transplants. Additionally, Eledon presented updates from their ongoing Phase 1b open-label trial at the American Transplant Congress in June 2024. Data from 13 participants indicated that tegoprubart was generally safe and well-tolerated, with an average estimated glomerular filtration rate (eGFR) of 70.5 mL/min/1.73m2 at all recorded time points post-transplant day 30. Notably, two participants who completed over 12 months on the therapy showed mean eGFRs exceeding 90 mL/min/1.73m2 one year post-transplant.

Financially, Eledon completed a private placement financing, raising total gross proceeds of $50 million, before deducting offering-related expenses. The company concluded the second quarter with around $83.6 million in cash and cash equivalents, which includes the funds from the private placement.

Looking ahead, Eledon has set several milestones. By the end of 2024, the company aims to complete participant enrollment in the Phase 2 BESTOW trial for kidney transplantation. Mid-2025 is anticipated to bring updated interim clinical data from ongoing Phase 1b trials and long-term safety and efficacy studies of tegoprubart in kidney transplantation.

On the financial front, the company has encountered a need to reclassify certain common stock warrants and pre-funded warrants associated with their April 2023 Securities Purchase Agreement. This reclassification is a non-cash action and will reclassify these warrants as liabilities on a mark-to-market basis, without impacting the company’s cash or operations. Consequently, Eledon will restate its audited consolidated financial statements from the Annual Report and Quarterly Report filed earlier in 2024. This process has also led to a delay in filing their Form 10-Q for the period ending June 30, 2024.

Eledon Pharmaceuticals, based in Irvine, California, continues to develop immune-modulating therapies for serious health conditions. Their lead investigational product, tegoprubart, targets the CD40 Ligand (CD40L) and aims to offer a non-lymphocyte depleting, immunomodulatory treatment option for various conditions including allogeneic kidney transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS).

In summary, Eledon Pharmaceuticals has made substantial progress in their clinical trials and financial undertakings in 2024, enhancing their position and potential in the biotechnology field. The company remains committed to advancing tegoprubart as a pivotal treatment option for preventing organ rejection in kidney transplant patients.