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]

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]

Company Overview - NeuroSense Therapeutics Ltd. is a late-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, which represent significant unmet medical needs with limited therapeutic options available [5] Financing Details - NeuroSense has entered into a definitive agreement for a $500,000 private placement of ordinary shares, issuing 333,334 shares at a purchase price of $1.50 per share, which is a 40% premium to the closing price on September 3, 2025 [2][3] - The private placement is expected to close on September 8, 2025, subject to customary conditions, and the proceeds will be used for general corporate purposes and working capital [2] Management Commentary - The CEO of NeuroSense stated that this investment serves as a short-term bridge to advance the company's activities and prepare for the next stage of growth, emphasizing that this is the third financing with private investors at a premium to market [3]

Financial Performance - The company reported a net loss of $4,709,000 for the six months ended June 30, 2025, compared to a net loss of $6,261,000 for the same period in 2024, indicating an improvement of about 24.8%[3] - Research and development expenses decreased from $3,733,000 in the six months ended June 30, 2024, to $2,503,000 in the same period of 2025, a reduction of approximately 33.1%[3] - Cash and cash equivalents at the end of the period decreased to $666,000 from $3,378,000 at the beginning of the period, a decline of approximately 80.3%[7] - Shareholders' equity turned from a positive $2,583,000 as of December 31, 2024, to a deficit of $519,000 as of June 30, 2025[2] Assets and Liabilities - Total current assets decreased from $4,402,000 as of December 31, 2024, to $1,556,000 as of June 30, 2025, representing a decline of approximately 64.7%[2] - The total liabilities increased from $1,992,000 as of December 31, 2024, to $2,203,000 as of June 30, 2025, reflecting an increase of about 10.6%[2] Shareholder Activity - The weighted average number of shares outstanding increased from 16,773,806 in 2024 to 25,402,649 in 2025, an increase of approximately 51.7%[3] - The Company entered into a Capital on Demand Sales Agreement with JonesTrading, allowing for the sale of ordinary shares with an aggregate offering price of up to $2,556 thousand, with $1,410 thousand already sold as of February 21, 2025[16] - During the six-month period ended June 30, 2025, the Company sold 708,952 ordinary shares at an average gross sales price of $1.45 per share, generating aggregate gross proceeds of $1,031 thousand[16] - Under the Standby Equity Purchase Agreement with Yorkville, the Company can sell up to $30.0 million of ordinary shares over 36 months, with 175,000 shares sold at an average gross price of $1.85 per share, resulting in gross proceeds of $323 thousand during the same period[17] - The Company granted 295,512 RSUs to consultants and service providers, with a fair value estimated at $275 thousand[18] - The Company issued 180,000 ordinary shares following the exercise of vested RSUs during the six-month period ended June 30, 2025[20] - The Company issued 14,000 ordinary shares following the exercise of options during the six-month period ended June 30, 2025[20] Compensation and Expenses - The share-based compensation expense for research and development was $18 thousand for the six months ended June 30, 2025, compared to $154 thousand for the same period in 2024[21] - The total share-based compensation expense for general and administrative purposes was $288 thousand for the six months ended June 30, 2025, compared to $152 thousand for the same period in 2024[21] - The options granted to employees have an exercise price of $0.93 per share and vest quarterly over three years[19] - The expected volatility for the options granted was 92.06%, with a risk-free interest rate of 4.38%[19] Business Focus - The company has no products approved for sale and has generated no sales or revenues to date, indicating a pre-revenue status[9] - The company anticipates needing additional cash to fund its mid and long-term development program, highlighting the need for external financing[9] - The company is focused on developing treatments for neurodegenerative diseases, with its lead product candidate being PrimeC, a combination of two FDA-approved drugs[8]

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]