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NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. These diseases encompass Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, among others.
The company's flagship product, PrimeC, is a novel extended-release oral formulation, combining ciprofloxacin and celecoxib in a specific ratio designed for synergistic effect. PrimeC aims to target several key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. The formulation has shown promising results in clinical trials, including a significant slowing of disease progression in Phase 2b studies.
In their recent PARADIGM Phase 2b clinical trial, NeuroSense demonstrated compelling data with a 37% reduction in the progression of ALS, with further subgroup analysis showing even higher efficacy in specific patient populations. This trial's success propelled the company towards preparing for a Phase 3 pivotal trial, with extensive collaboration and validation from industry experts.
NeuroSense has been active in forming strategic partnerships to enhance its research and development capabilities. Notable collaborations include agreements with Lonza for biomarker development, and Genetika+ for Alzheimer's disease drug development. These partnerships leverage cutting-edge technologies to optimize clinical outcomes and advance the company's therapeutic solutions.
Financially, NeuroSense reported an increase in R&D expenses from $6.4 million in 2022 to $7.6 million in 2023, reflecting its investment in expanding its workforce and clinical programs. Conversely, general and administrative expenses saw a decrease, contributing to an efficient allocation of resources. As of December 31, 2023, the company had a cash position of approximately $2.6 million.
With multiple ongoing projects and a robust pipeline, NeuroSense is set to play a significant role in addressing the unmet medical needs in neurodegenerative diseases. The company's dedication to advancing research and developing novel therapies positions it as a key player in biotech innovation.
For more information, visit NeuroSense's investor relations website at https://neurosense.investorroom.com/.
NeuroSense Therapeutics (NASDAQ: NRSN) reported Q1 2022 financial results, revealing a cash position of $13.74 million, up from $11.06 million in Q4 2021. The net loss increased to $2.71 million from $2.12 million in Q1 2021, primarily due to heightened general and administrative expenses. Notably, the company initiated biomarker studies for ALS and Alzheimer's, received FDA clearance for its IND application for PrimeC, and commenced a pharmacokinetic study. Looking ahead, a Phase IIb ALS clinical trial is set to begin in Q2 2022, with results anticipated in Q3.
NeuroSense Therapeutics (Nasdaq: NRSN) announces that Dr. Ferenc Tracik will present at the ALS Drug Development Summit on May 26, 2022, in Boston. The focus will be on the company's Phase IIb study, PARADIGM, that aims to evaluate the combination therapy PrimeC in treating ALS. The presentation will cover the design and findings of earlier trials, emphasizing the significance of ALS biomarkers for regulatory approval. NeuroSense is progressing towards a Phase IIb trial scheduled for Q2 2022, targeting ALS disease progression and aiming to enhance patient quality of life.
NeuroSense Therapeutics has initiated a pharmacokinetic study for its lead drug candidate PrimeC, aimed at treating amyotrophic lateral sclerosis (ALS). This study, conducted under an FDA-cleared protocol, enrolled the first healthy volunteer as of April 11, 2022. PrimeC combines the FDA-approved drugs ciprofloxacin and celecoxib to target mechanisms of ALS. The company anticipates reporting results by Q3 2022, which will inform a pivotal Phase III trial. PrimeC has received Orphan Drug Designation from both the FDA and EMA.
NeuroSense Therapeutics announced the grant of a key patent in Canada for its ALS drug, PrimeC, which combines FDA-approved drugs ciprofloxacin and celecoxib. The patent is valid through 2038 and complements similar patents issued in the U.S. and Australia. The company plans to initiate a Phase IIb trial in Q2 2022 to evaluate PrimeC's efficacy after a successful Phase IIa study. Concurrently, NeuroSense is collaborating with Massachusetts General Hospital on ALS biomarkers, with results expected in the same timeframe.
NeuroSense Therapeutics (Nasdaq: NRSN) announced new developments in its clinical program for lead drug candidate PrimeC targeting ALS. Two clinical studies are set to begin in Q2 2022, including a pharmacokinetic study and a Phase IIb multinational study, both aiming to enhance therapeutic effectiveness. The company is also expanding its intellectual property, with a key patent granted in the US and Australia. Upcoming data from studies on CogniC and StabiliC are anticipated in 2022, marking crucial milestones for NeuroSense's therapeutic pipeline.
NeuroSense Therapeutics Ltd. (NRSN) announced it has raised approximately $4 million through the exercise of warrants priced at $6 per share. This funding extends its cash runway through Q3 2023, coinciding with the planned Phase IIb study for PrimeC, targeting amyotrophic lateral sclerosis (ALS). PrimeC has previously met safety and efficacy endpoints in a Phase IIa study and has received Orphan Drug Designation from the FDA and EMA. ALS poses a significant healthcare burden affecting over 5,000 new patients annually in the U.S.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) announced FDA clearance to initiate a pharmacokinetic study of PrimeC, an oral formulation for ALS. PrimeC combines ciprofloxacin and celecoxib, targeting mechanisms of motor neuron degeneration. Having completed a successful Phase IIa study, NeuroSense is set to start a Phase IIb study in Q2 2022. The pharmacokinetic study will assess PrimeC's bioavailability in healthy subjects. The ALS treatment market is valued at $3 billion, with significant unmet needs identified, as ALS diagnoses are expected to increase by 24% by 2040.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) announced its participation in the 2022 Virtual Growth Conference on March 28-30, 2022. CEO Alon Ben-Noon will present during a fireside chat titled "NeuroSense – Novel Approach to Tackle ALS on Multiple Fronts" on March 30 at 09:30 AM EDT. The conference will feature various sectors, including biotech and healthcare, and will be hosted by Maxim Group LLC. NeuroSense focuses on developing treatments for neurodegenerative diseases, with promising results from its Phase 2a clinical study of PrimeC for ALS.
NeuroSense Therapeutics (Nasdaq: NRSN) announced the granting of a key patent in Australia for its lead ALS treatment, PrimeC, which combines ciprofloxacin and celecoxib. This patent complements the prior US patent and is valid until June 2038. The CEO highlighted the importance of this patent in enhancing their commercialization strategy. NeuroSense plans to start a Phase 2b study in May 2022 and has received Orphan Drug Designation in the US and Europe. Patent applications are also pending in various regions including Japan and Canada.
NeuroSense Therapeutics (Nasdaq: NRSN) announced that Dr. Shiran Zimri will present at the ASENT 2022 Annual Meeting on March 3, 2022, discussing PrimeC, a novel ALS therapy. PrimeC combines two FDA-approved drugs to target ALS, which currently has limited treatment options. The Phase 2a trial showed significant clinical improvements, and a Phase 2b study is planned for H1 2022. CEO Alon Ben-Noon emphasizes the importance of Dr. Zimri's presentation to ALS experts, aiming to establish PrimeC as a viable treatment.
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