NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) announced it has regained compliance with Nasdaq's minimum stockholders' equity requirement, allowing its shares to continue trading on the Nasdaq Capital Market. The decision, confirmed in a formal notice received January 3, 2025, follows NeuroSense's successful efforts to improve its balance sheet through strategic financing and liability reduction.
Financial Restructuring and Nasdaq Compliance
Since its Nasdaq hearing on August 1, 2024, NeuroSense has focused on strengthening its financial footing. A key step was the closing of a $5 million financing in December 2024, which significantly contributed to exceeding the required $2.5 million in stockholders' equity. Alon Ben-Noon, CEO of NeuroSense, emphasized that regaining compliance is a "significant milestone" reflecting the company's commitment to financial stability and growth.
As part of the compliance terms, NeuroSense will be subject to a mandatory panel monitor for one year. Failure to maintain the equity requirement during this period could lead to delisting, though the company would have the opportunity to request another hearing.
Advancing PrimeC for ALS Treatment
NeuroSense is focusing on advancing PrimeC, a novel oral formulation combining ciprofloxacin and celecoxib, into a pivotal Phase 3 trial for amyotrophic lateral sclerosis (ALS). The decision to move forward with Phase 3 is supported by promising results from the Phase 2b PARADIGM study (NCT05357950), a multinational, randomized, double-blind, placebo-controlled trial.
The PARADIGM trial involved 68 participants with ALS across Canada, Italy, and Israel. During the initial six months, 45 participants received PrimeC, while 23 received a placebo. This was followed by a 12-month open-label extension where all participants received PrimeC, with both participants and clinical staff blinded to the initial treatment assignments. Data indicated that PrimeC, when used with the standard-of-care Riluzole, slowed disease progression beyond what Riluzole alone could achieve.
PrimeC's Mechanism and Regulatory Status
PrimeC is designed to target key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. It has already received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
ALS: An Unmet Medical Need
ALS is a progressive neurodegenerative disease characterized by complete paralysis and death within 2-5 years of diagnosis. In the U.S. alone, over 5,000 people are diagnosed with ALS annually, contributing to a $1 billion annual disease burden. The prevalence of ALS is projected to increase by 24% by 2040 in the U.S. and EU, highlighting the urgent need for effective treatments.
