NeuroSense Management's Q1 2024 Update and Financial Results

NeuroSense Therapeutics Ltd., a biotechnology firm focusing on treatments for neurodegenerative diseases, announced promising results from its Phase 2b PARADIGM clinical trial. The trial demonstrated that PrimeC, the company's lead drug candidate, significantly slowed the progression of amyotrophic lateral sclerosis (ALS) by 43% compared to a placebo. The pre-specified per protocol (PP) population analysis revealed a notable difference in ALSFRS-R scores favoring PrimeC, with a 5.04-point difference.

Key updates from the company include the anticipated release of 12-month clinical results, including survival data, by June 2024. NeuroSense also plans to meet with the FDA in the third quarter of 2024 to discuss the path forward for a Phase 3 clinical trial in the United States. Preparations for this trial are already underway, with the protocol submission expected by the end of 2024.

Alon Ben-Noon, CEO of NeuroSense, expressed optimism about the ongoing results from the PARADIGM trial. The company intends to share additional biomarker data, including iron, ferritin, and transferrin, alongside the 12-month clinical outcomes. NeuroSense is also in discussions with potential partners to advance its clinical programs efficiently.

Financially, NeuroSense reported research and development expenses of $1.88 million for the first quarter of 2024, consistent with the previous year. These expenses are expected to remain steady through the rest of the year due to the ongoing Phase 2b ALS clinical study and a Phase 2 study for Alzheimer's Disease (AD). General and administrative expenses were $1.11 million for the same period, also stable compared to the previous year. The company's cash position as of March 31, 2024, was $0.74 million, excluding approximately $4.5 million raised through financing in April 2024.

Following the first quarter, NeuroSense transitioned its accounting method from IFRS to U.S. GAAP. The company's unaudited consolidated financial results for the first quarter of 2024 have been reissued under U.S. GAAP and filed with the Securities and Exchange Commission.

The PARADIGM trial, a multinational, randomized, double-blind, placebo-controlled Phase 2b study, involved 68 ALS patients from Canada, Italy, and Israel. The trial showed promising efficacy signals, with a 29% difference in ALSFRS-R scores and a 13% difference in SVC favoring PrimeC in the intent-to-treat (ITT) population analysis. In the PP analysis, a 37.4% difference in ALSFRS-R scores was observed, indicating a significant slowing of disease progression. Most trial participants were treated with Riluzole, the standard ALS medication, suggesting PrimeC's effectiveness extends beyond existing treatments.

PrimeC, NeuroSense's lead candidate, is an extended-release oral formulation combining ciprofloxacin and celecoxib. It targets multiple ALS mechanisms, including motor neuron degeneration, inflammation, iron accumulation, and RNA regulation, potentially inhibiting disease progression. PrimeC previously demonstrated safety and efficacy in a Phase 2a trial, showing reduced functional and respiratory deterioration and significant changes in ALS-related biomarkers. The drug has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency.

NeuroSense Therapeutics, Ltd. is dedicated to developing treatments for debilitating neurodegenerative diseases like ALS, Alzheimer's, and Parkinson's disease. The company aims to address these complex diseases by targeting multiple pathways based on robust scientific research.