Core Insights - NeuroSense Therapeutics is participating in the 2024 International Symposium on ALS/MND, showcasing its commitment to ALS research and treatment development [1][5] - The company will present findings from its Phase 2b PARADIGM trial of PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS) [2][3] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS [1][11] - The company aims to address significant unmet medical needs in neurodegenerative diseases through innovative therapies and biomarker research [11] Clinical Trial Details - The PARADIGM trial is a Phase 2b clinical trial involving 68 participants across Canada, Italy, and Israel, designed to evaluate the efficacy of PrimeC in ALS [8] - The trial demonstrated a 29% efficacy difference in favor of PrimeC compared to placebo in the intent-to-treat population, with a statistically significant 37.4% slowing of disease progression observed in the ALS Functional Rating Scale-Revised (ALSFRS-R) [9] Treatment Insights - PrimeC is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms of ALS [10] - The drug has shown promising results in previous trials, including significant changes in ALS-related biological markers and a reduction in functional and respiratory deterioration [10] Symposium Participation - Key presentations at the symposium will include insights from leading experts in ALS research, such as Prof. Merit Cudkowicz and Dr. Cristian Lunetta, focusing on clinical outcomes and biomarker analysis from the PARADIGM trial [3][4] - The presence of NeuroSense's management team at the symposium highlights the company's leadership role in advancing ALS research [4]

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 ...

Core Insights - NeuroSense Therapeutics is seeking early commercialization approval for PrimeC in Canada following positive Phase 2b trial results, which indicate a 36% reduction in ALS disease progression and a 43% improvement in survival rates [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 [8] - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [8] Product Details - PrimeC is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [7] - The Phase 2b PARADIGM trial involved 68 participants across Canada, Italy, and Israel, with a significant majority opting to continue treatment after the trial [5][6] Clinical Trial Results - The Phase 2b trial demonstrated a statistically significant slowing of disease progression with a 37.4% difference in ALSFRS-R scores in favor of PrimeC compared to placebo [6] - The trial's double-blind segment showed a 29% efficacy difference favoring PrimeC over placebo [6] Regulatory Process - The regulatory submission for PrimeC is based on the recommendations of Canadian regulatory experts and the promising clinical findings from the PARADIGM trial [2][3] - The company plans to seek approval in additional countries following the Canadian submission [1]

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 ...

Company Overview - NeuroSense Therapeutics Ltd. is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, addressing significant unmet medical needs with limited therapeutic options available [3][4] Compliance with Nasdaq - NeuroSense has regained compliance with Nasdaq's minimum bid price requirement, achieving a closing bid price of $1.00 or more for at least 10 consecutive business days as of September 20, 2024, thus closing the prior bid price deficiency matter [1][2] Future Developments - The CEO of NeuroSense expressed optimism about advancing their treatment PrimeC, highlighting the positive momentum following Phase 2b trial results and the anticipation of initiating the Phase 3 trial in the US while continuing discussions with potential partners [3]

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 ...

Core Insights - NeuroSense Therapeutics has announced positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), indicating the potential of PrimeC as a transformative therapy for ALS, with improved survival rates by 43% and slowed disease progression by 36% [1][5] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [11] - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [11] Study Results - The 12-month study results showed a significant decrease in ferritin levels and an increase in transferrin levels, indicating improved iron metabolism and disease mitigation [3][4] - Iron levels remained stable over the 12-month dosing period, with a mean difference of 4.536 µmol/L (95% CI [1.143, 7.929], p=0.01) compared to placebo [3] Clinical Implications - The positive changes in iron metabolism correlate with improved clinical outcomes, as patients on PrimeC exhibited better functionality and survival rates compared to those on placebo [4] - The study's findings support the advancement to Phase 3 testing of PrimeC in ALS, as highlighted by Dr. Merit Cudkowicz [5] Background on ALS - ALS is an incurable neurodegenerative disease that leads to complete paralysis and death within 2-5 years from diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [6] - The disease burden in the U.S. is approximately $1 billion annually, and the number of people living with ALS is projected to grow by 24% by 2040 in the U.S. and EU [6] About PrimeC - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [10] - The drug has shown efficacy in reducing functional and respiratory deterioration and has received Orphan Drug Designation from the FDA and EMA [10] About the PARADIGM Study - The PARADIGM trial is a multinational, randomized, double-blind, placebo-controlled Phase 2b study involving 68 ALS participants across Canada, Italy, and Israel [8] - In the 6-month double-blind segment, PrimeC demonstrated a 29% efficacy difference compared to placebo, with a statistically significant slowing of disease progression observed [9]