Alzheimer's Clinical and Biomarker Outcomes Expected in Q1 2026 CAMBRIDGE, Mass., Jan. 8, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that Prof. Steven E. Arnold, a world-renowned Alzheimer's disease expert and Professor of Neurology at Harvard Medical School, has joined the Company's Scientific Advisory Board. Prof. Arnold brings decades of exp ...

Clinical and Biomarker Outcomes Expected to Be Reported in Q1 2026 CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's disease. The safety analysis indicated a f ...

NeuroSense Therapeutics Update Summary Company Overview - **Company**: NeuroSense Therapeutics (NasdaqCM:NRSN) - **Focus**: Development of therapies for neurodegenerative diseases, particularly ALS and Alzheimer's disease Key Topics Discussed 1. **ALS Phase III Study (PARADIGM)** - The pivotal PARADIGM trial is set to initiate in mid-2026, focusing on ALS treatment with PrimeC [3][4] - The study aims to confirm previous findings and support future success with PrimeC [4] - The primary endpoint is the ALS Functional Rating Scale (ALS-FRS) adjusted for survival after 12 months [18] - The study is designed to enroll approximately 300 participants across the US, Europe, and Israel [10] 2. **Regulatory Progress** - Recent FDA clearance allows the initiation of the PARADIGM study [11] - A pre-New Drug Submission (NDS) meeting with Health Canada is scheduled for April 2026 to align on submission strategy [11][31] - New data, including long-term survival and additional biomarkers, will be submitted to Health Canada [38] 3. **Alzheimer's Disease Program** - The proof of concept phase II program for Alzheimer's disease has completed database lock, with top-line results expected in Q1 2026 [5][12] - The study aims to assess PrimeC's potential to address unmet needs in Alzheimer's [5] 4. **Partnership Discussions** - Ongoing discussions with a large pharmaceutical company have resulted in a binding term sheet [14] - The company is also engaging with additional potential partners to maintain strategic optionality [15][22] - The partnership strategy aims to maximize long-term value for shareholders [15][34] Financial and Operational Insights - NeuroSense is actively seeking financing options to support the phase III study [20][39] - The company has received interest from leading venture capitalists and is exploring multiple pathways for funding [20] - The phase III study is powered to over 95% to detect the anticipated treatment effect [10] Clinical Insights - PrimeC, the flagship therapy, is a fixed-dose combination of two FDA-approved drugs designed to target chronic inflammation, iron accumulation, and microRNA dysregulation [6][10] - The PARADIGM study has shown a 58% reduction in the risk of death and a 64% reduction in ALS complication-free survival among participants who started treatment with PrimeC [9] - Biomarkers are being integrated into the phase III study to enhance clinical credibility and regulatory confidence [48] Future Milestones - Anticipated top-line data from the PARADIGM study is expected in 2028, with potential for earlier results due to the adaptive design [50] - Key value inflection points include the initiation of the phase III study, results from the Alzheimer's program, and partnership developments [25] Conclusion - NeuroSense is committed to advancing its programs with scientific rigor and creating value for shareholders, with a focus on executing important milestones ahead [51]

Core Insights - NeuroSense Therapeutics is resuming regulatory advancement for its drug candidate PrimeC in Canada for the treatment of amyotrophic lateral sclerosis (ALS) following a productive discussion with Health Canada [1][2][3] Company Overview - NeuroSense Therapeutics is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease [6] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [6] Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib [5] - The drug is designed to target multiple mechanisms contributing to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation, potentially inhibiting the progression of ALS and Alzheimer's disease [5] Regulatory Progress - Health Canada has outlined the remaining requirements for NeuroSense, confirming that the company's proposed next steps align with the Agency's expectations [2] - NeuroSense is preparing for a pre-New Drug Submission (NDS) meeting with Health Canada, anticipated in April 2026, with a potential NDS submission expected by mid-2026 [2][3] ALS Overview - 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. [4] - The annual disease burden of ALS in the U.S. is approximately $1 billion, and the number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU [4]

Core Insights - NeuroSense Therapeutics has received FDA authorization to initiate a pivotal Phase 3 clinical trial for its lead drug candidate, PrimeC, aimed at treating amyotrophic lateral sclerosis (ALS) [1][2][3] Company Overview - NeuroSense is a late-clinical stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's disease, and Parkinson's disease [7] - The company aims to address significant unmet medical needs in the neurodegenerative disease space, where effective therapeutic options are limited [7] Clinical Trial Details - The Phase 3 trial, named PARAGON, will include 300 ALS patients randomized in a 2:1 ratio (PrimeC : Placebo) and is designed to achieve over 95% power to meet its primary endpoint [2][3] - The trial will be conducted in the U.S. and EU, featuring a double-blind, 12-month placebo-controlled design with an open-label extension to assess safety and efficacy [3] - An adaptive design will allow for interim analyses to optimize sample size and evaluate early efficacy and futility boundaries [3] Drug Candidate Information - PrimeC is an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib, targeting mechanisms involved in ALS and Alzheimer's disease [6] - The drug aims to inhibit the progression of ALS and Alzheimer's by addressing motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation [6] ALS Background - ALS is an incurable neurodegenerative disease leading to complete paralysis and death within 2-5 years of diagnosis, with over 5,000 new cases diagnosed annually in the U.S. [5] - The annual disease burden of ALS in the U.S. is approximately $1 billion, and the number of individuals living with ALS is projected to increase by 24% by 2040 in the U.S. and EU [5]

Core Insights - NeuroSense Therapeutics is hosting an investor update meeting on December 8, 2025, to discuss its near-term milestones and objectives [1] Company Overview - NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's disease [2] - The company aims to address significant unmet medical needs in neurodegenerative diseases by developing combined therapies that target multiple pathways [2] Upcoming Developments - The company plans to initiate the Phase 3 PARAGON study for ALS and submit a Notice of Compliance with conditions (NOC/c) in Canada [5] - Updates will also include the status of a binding term sheet executed in December 2024 and the RoAD Phase 2 program for Alzheimer's disease [5]

Company Summaries - Robin Energy Ltd. (NASDAQ:RBNE) experienced a significant stock price decrease of approximately 39.56%, now trading at $1.39, potentially due to its announcement of a public offering of 5.77 million shares at $1.30 per share, aiming to raise about $7.5 million, expected to close around September 12, 2025 [1][7] - Lexaria Bioscience Corp. (LEXXW) saw a 33.05% drop in its stock price to $0.06, influenced by the volatile nature of the biotech sector, possibly due to regulatory news or clinical trial results [2][7] - Ethzilla Corp. (ETHZW) experienced a 32.6% decline in stock price to $0.06, highlighting the impact of the volatile cryptocurrency market on digital asset management companies [3][7] - NeuroSense Therapeutics Ltd. (NRSNW) witnessed a 30.18% decline in its stock price to $0.37, with sensitivity to news related to its lead product candidate, PrimeC, and other pipeline developments [4] - Sentage Holdings Inc. (NASDAQ:SNTG) saw its stock price fall by 28.04% to $2.9, potentially impacted by regulatory changes in China's financial sector and broader economic factors affecting the Chinese market [5] Industry Insights - The movements in stock prices underscore the diverse range of factors influencing them, from industry-specific developments to broader economic trends [6] - The biotech sector is characterized by volatility, with companies' valuations heavily dependent on their pipelines' progress and potential market opportunities [2] - The cryptocurrency market's volatility significantly affects companies like Ethzilla, which focus on digital asset management and yield generation strategies [3]

Core Insights - NeuroSense Therapeutics announced positive initial results from the RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease, demonstrating improvements in brain-cell connectivity and health with a favorable safety profile [1][5][9] Company Overview - NeuroSense Therapeutics is a late-stage clinical biotechnology company focused on developing treatments for severe neurodegenerative diseases, including Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and Parkinson's disease [11] - The company aims to address significant unmet medical needs in neurodegenerative diseases through combined therapies targeting multiple pathways [11] Clinical Trial Details - The RoAD Phase 2 trial is a randomized, double-blind, placebo-controlled study enrolling mild-to-moderate Alzheimer's disease patients, designed to evaluate the safety, efficacy, and biological activity of PrimeC over 12 months [2][6] - Initial results provide a patient-specific view of how PrimeC may affect disease-relevant human neurons, reinforcing the mechanistic rationale for the treatment [3] Technology and Methodology - NeuroKaire's proprietary technology generates brain cells from patients' blood, reprogramming them into induced pluripotent stem cells (iPSCs) and differentiating them into mature human cortical neurons [4] - Advanced imaging and AI-driven analytics are used to quantify neuronal structure and generate profiles related to neuroplasticity, connectivity, and cell health [4] Drug Candidate Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib, targeting mechanisms contributing to neuron degeneration and inflammation [8] - The treatment has shown enhanced neuroplasticity, a critical feature for brain health and memory retention, with no treatment-related toxicity observed [9] Future Directions - NeuroSense and NeuroKaire will continue to evaluate PrimeC's cellular effects alongside clinical outcomes from the RoAD trial, with top-line data expected after study completion [6]

Core Insights - NeuroSense Therapeutics is advancing its investigational therapy PrimeC for ALS and preparing for a pivotal Phase 3 trial [2][3] - The first half of 2025 has been transformational for the company, regaining Nasdaq compliance and generating additional long-term data from its Phase 2b study [3][5] Corporate Highlights for H1 2025 - Nasdaq compliance was restored after a $5 million private placement in December 2024, strengthening the balance sheet [5] - New analyses from the Phase 2b PARADIGM study showed PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and complication-free survival by 79% [6] - Manufacturing capabilities for PrimeC were successfully scaled to commercial levels, ensuring supply chain readiness [8] Financial Results for H1 2025 - Research and development expenses decreased by 32.9% to $2,503 thousand compared to $3,733 thousand in the same period of 2024 [12] - General and administrative expenses slightly decreased by 4.4% to $2,189 thousand [12] - The net loss for the first half of 2025 was $4,709 thousand, down from $6,261 thousand in the first half of 2024 [12] Future Plans - NeuroSense plans to submit a new request for Notice of Compliance with conditions (NOC/c) in Canada, supported by additional data [11] - A multinational Phase 3 study of PrimeC is expected to commence in the second half of 2025 following positive regulatory feedback from the FDA [11] - Discussions are ongoing with a global pharmaceutical partner to advance the development and commercialization of PrimeC [11]

Core Insights - NeuroSense Therapeutics is a late-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, particularly ALS [12] - The company is set to unveil new insights regarding its investigational therapy PrimeC and its regulatory progress in Canada during a live broadcast event hosted by Aaron Lazar [1][2] Company Overview - NeuroSense Therapeutics is dedicated to discovering and developing therapies for neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's, which represent significant unmet medical needs [12] - The company employs a strategy of developing combined therapies that target multiple pathways associated with these diseases [12] Product Development - PrimeC, NeuroSense's lead drug candidate, is an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, aimed at addressing key mechanisms of ALS [11] - The Phase 2a clinical trial for PrimeC has met safety and efficacy endpoints, showing potential in reducing functional and respiratory deterioration and demonstrating biological activity through significant changes in ALS-related biomarkers [11] Regulatory Milestones - PrimeC has received Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency, indicating its potential to address a rare disease with limited treatment options [11] - The upcoming live event will discuss NeuroSense's regulatory path in Canada and the latest developments regarding its binding term sheet with a pharmaceutical partner [2]