Core Viewpoint - NeuroSense Therapeutics is advancing its lead product PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS), with a Type C meeting scheduled with the FDA to finalize the Phase 3 clinical trial design and New Drug Application (NDA) readiness [1][2][3] Company Overview - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's disease [11] - The company aims to address significant unmet medical needs in these areas, where effective therapeutic options are limited [11] Product Development - PrimeC has demonstrated promising results in clinical trials, showing a statistically significant reduction in disease progression and improved survival rates by 43% compared to placebo [5][9] - The drug is a novel extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms of ALS [10] - NeuroSense completed a Phase 2a clinical trial for PrimeC, meeting safety and efficacy endpoints, and received Orphan Drug Designation from the FDA and the European Medicines Agency [10] Regulatory Strategy - The FDA Type C meeting on November 6, 2024, will focus on the Phase 3 trial design and NDA submission strategy [2] - NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026, estimating a market opportunity of $100 million to $150 million in annual revenue in Canada [4][6] Clinical Trial Insights - The PARADIGM trial, a Phase 2b study, included 68 participants and showed a 37.4% difference in ALS Functional Rating Scale-Revised (ALSFRS-R) scores in favor of PrimeC compared to placebo [9][8] - A significant majority (96%) of trial participants opted to continue treatment with PrimeC after the double-blind portion of the trial [8] Market Context - ALS is an incurable neurodegenerative disease with a significant annual disease burden of $1 billion in the U.S., with over 5,000 new diagnoses each year [6] - The number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU, highlighting the urgent need for effective treatments [6]

Dossier submission planned for Q2 2025; regulatory decision expected by Q1 2026 Estimated potential market opportunity: peak of $100M to $150M in annual revenue Company aims to expand approval efforts to additional global markets CAMBRIDGE, Mass., Oct. 15, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, provided a further update on its plans to file for early commer ...

The preparations for the regulatory submission for early commercialization in Canada follows the positive Phase 2b trial results which show PrimeC reduces ALS disease progression by 36% and improves survival rates by 43% Company plans to seek approval in additional countries CAMBRIDGE, Mass., Oct. 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ('NeuroSense'), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it ...

CAMBRIDGE, Mass., Oct. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the acceptance of two abstracts focusing on the company's lead drug candidate, PrimeC, for the treatment of Amyotrophic Lateral Sclerosis (ALS). These abstracts will be presented at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Consortium Meeting, taking pl ...

Exhibit 99.1 Condensed Interim Unaudited balance sheets U.S. dollars in thousands | --- | --- | --- | --- | --- | |--------|-------|-------|------------|----------------| | | | | | | | | | | June 30, | December 31, | | Assets | | | 2024 | 2023 | Date of approval of the interim financial statements: September 30, 2024 NeuroSense Therapeutics Ltd. | --- | --- | --- | |-------------------------------------------------------------------------------------------------------------------------|----------|---------- ...

The Company's intellectual property now covers the combination, formulation, and method of use of PrimeC Patent protection extends through 2042, adding four additional years to PrimeC's IP umbrella CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the issuance of a pivotal patent by the United States Patent and Trademark Off ...

CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has received notice from The Nasdaq Stock Market LLC ("Nasdaq") informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Rule") for continued listing. To regain compliance with the Rule, the Company's ordinary shares were require ...

CAMBRIDGE, Mass., Aug. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares and warrants in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 800,000 ordinary shares and warrants to purchase an aggregate of ...

12-month data demonstrated regulation of iron levels, which aligns with improved ALS survival and disease mitigation Previous results showed PrimeC slowed disease progression by 36% and improved survival rates, highlighting its potential as a transformative ALS therapy CAMBRIDGE, Mass., Aug. 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces positive 12-mo ...

Logo:https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg SOURCE NeuroSense Previously, NeuroSense reported that PrimeC significantly slowed disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Per-Protocol analysis revealed even greater benefits, with a 40% (p=0.003) improvement in ALSFRS-R scores and a 63% increase in survival rates, representing a distinguished advancement in outcomes for a controlled 12-month ALS study. Other positive clin ...