Core Viewpoint - NeuroSense Therapeutics is advancing its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS) following a productive Type C meeting with the FDA, which is a significant step towards commencing a Phase 3 clinical study in mid-2025 [1][2][4]. Company Developments - The FDA provided positive feedback on the trial design for the planned Phase 3 study, which is crucial for meeting regulatory expectations and potentially securing drug approval [2][4]. - NeuroSense plans to submit a final protocol to the FDA in the first half of 2025, aiming to enroll approximately 300 patients in a randomized, double-blind, placebo-controlled Phase 3 study [3][4]. - The Phase 3 study will evaluate the efficacy and safety of PrimeC, with participants transitioning to an open-label extension after 12 months of treatment [3][4]. Clinical Trial Insights - The completed Phase 2b PARADIGM study demonstrated PrimeC's significant impact on slowing disease progression and increasing survival rates in ALS patients [1][5]. - The PARADIGM trial involved 68 participants across multiple countries, with a design that included a 12-month open-label extension [7][8]. - Most participants in the trial were concurrently treated with Riluzole, indicating that PrimeC may offer benefits beyond the current standard of care [9]. Product Information - PrimeC is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, targeting multiple mechanisms of ALS [10][11]. - The drug has received Orphan Drug Designation from both the FDA and the European Medicines Agency, highlighting its potential in addressing an urgent medical need [11]. Industry Context - ALS is an incurable neurodegenerative disease with a significant annual disease burden of $1 billion in the U.S., and the number of diagnosed cases is expected to grow by 24% by 2040 [6].

Core Insights - NeuroSense Therapeutics announced statistically significant positive results from the 18-month PARADIGM study, showing that PrimeC slowed disease progression in ALS patients by 33% and improved survival rates by 58% compared to placebo [1][8]. 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 [11]. - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [11]. Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to ALS progression [9][10]. - The drug has shown efficacy in reducing functional and respiratory deterioration and has received Orphan Drug Designation from the FDA and EMA [10]. Study Details - The PARADIGM study is a Phase 2b clinical trial involving 68 participants across Canada, Italy, and Israel, designed to evaluate the efficacy of PrimeC in ALS [7]. - The study demonstrated a 36% improvement in ALS Functional Rating Scale-Revised (ALSFRS-R) scores at the 12-month readout, marking the best results in ALS clinical research to date [8]. Future Developments - Results from the PARADIGM study will be presented at the 2024 International Symposium on ALS/MND, with insights from Prof. Merit Cudkowicz, a leading figure in ALS research [2]. - The company plans to provide updates on its meeting with the FDA in the coming days [4].

Core Viewpoint - NeuroSense Therapeutics Ltd. has entered into a definitive agreement for a private placement to raise $5,000,000 through the sale of ordinary shares and warrants, aimed at supporting its development of treatments for severe neurodegenerative diseases [1][2]. Group 1: Private Placement Details - The company will sell a total of 4,000,000 ordinary shares and 8,000,000 warrants, with a combined purchase price of $1.25 per share, which is 25% above the closing price on November 29, 2024 [2]. - The warrants will have a term of five years and an exercise price of $1.25 per share [2]. - The proceeds from the private placement will be delivered in two tranches and are expected to be used for general corporate and working capital purposes [3]. Group 2: Company Overview - NeuroSense Therapeutics is focused on developing treatments for debilitating neurodegenerative diseases such as ALS, Alzheimer's, and Parkinson's disease, which represent significant unmet medical needs [6]. - The company aims to develop combined therapies targeting multiple pathways associated with these diseases, based on strong scientific research and a large panel of related biomarkers [6].

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 ...