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NRSN is Already Collaborating with World Renowned Names Like Mass General Hospital & Harvard Medical School

NRSN Looks to be in the Midst of Exploding Off of Recent Lows After Finding Support

CHECK OUT THE INVESTOR PRESENTATION HERE

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Hello Everyone,

I hope that you have been watching our last few profiles. Several of our more recent ones have gone on to make strong short term double digit moves. Our last one in particular was an exciting one to watch trade during the session.

We have another company that is fresh to our following.

We have never come across this ticker before but after taking a Quick Look at it, we all agree that this is a company tha you need to start your research on right away.

Pull up NRSN right away.

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company, focusing on the discovery and development of targeted innovative therapeutics for neurodegenerative diseases.

NeuroSense was founded in 2017 by Alon Ben-Noon, following a chance meeting with Shay Rishoni, an ALS patient.
During this meeting, Alon was inspired by Shay, who served as the CEO of a non-profit organization for ALS. Despite Shay not having a physical voice, therefore communicating via eye movement and computer software, the connection was instant. Shay detailed his activities in the ALS field, and described the efforts that are being made to solve the ALS puzzle, leading Alon to team up with world-renowned scientists and colleagues in order to research and develop an effective drug for ALS patients, bringing about the establishment of NeuroSense.

To date, the company has commenced with a breakthrough treatment for ALS that will halt, or significantly delay disease progression, as well as developments for Alzheimer’s and Parkinson’s diseases.

We are focused on creating a combined therapeutic strategy, targeting multiple pertinent mechanisms in these complex diseases.
Our research team and advisory board members are multidisciplinary professionals who have many years of experience with drug development and clinical programs, as well as personal connections to neurodegenerative diseases. Their collective expertise and background enable us to move in a fast and efficient manner to achieve our goals.

NeuroSense is currently conducting a phase 2b clinical trial using PrimeC in people with ALS. We also commenced research into other possible indications for the platform technology, including Alzheimer’s and Parkinson’s diseases. Additionally, our R&D team is studying the mechanisms of action and relevant biomarkers for these diseases.

NeuroSense’s novel drug, PrimeC, aims to treat ALS by regulating microRNA synthesis, reducing neuroinflammation, and influencing iron accumulation. PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS. The drug mitigates the degeneration and inflammatory response of motor neurons, and has significantly outperformed conventional treatments in a zebrafish model of ALS.

NeuroSense’s preclinical studies showed outstanding results in zebrafish models of ALS. PrimeC was shown to improve motor performance, and recover the morphology of motor neurons, neuromuscular junction structures, and microglial cells. Following these promising results, NeuroSense conducted two clinical trials which have shown that the drug is safe and tolerable, with promising clinical signs. PrimeC has received an orphan drug status from the FDA and EMA, and is currently preparing for a robust Phase 2b/3 clinical trial.

Due to the many shared pathways between neurodegenerative diseases, the hypothesis is that a disease-modifying drug for one, can lay the foundations for effective drugs for other neurodegenerative diseases. Therefore, we are working to develop a drug for Alzheimer’s based on the foundations of PrimeC. We have initiated the pre-clinical stage, testing CogniC in in-vitro models representing Alzheimer’s disease pathologies, and now initiating a phase 2 double blind placebo controlled study with 20 AD patients.

There are many shared pathways between Parkinson’s disease and ALS, such as neuroinflammation, protein aggregation, mitophagy, excitotoxicity, oxidative stress, iron accumulation, and dysregulation of miRNAs. Therefore, we are working to develop a drug for Parkinson’s based on the foundations of our drug, PrimeC, for ALS. We have initiated the pre-clinical stage, testing StabiliC in in-vivo models of Parkinson’s, assessing morphological and functional effects, exploring potential co-development with collaborators that have core focus in Parkinsons.

NRSN recently hit lows of .74 and EXPLODED off support

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NeuroSense Partners with PhaseV to Optimize Upcoming ALS Phase 3 Trial Using Advanced Causal Machine Learning

PR Newswire

Tue, May 14, 20246 min read

PhaseV's Causal Machine Learning Predicts High Probability of Success in Multiple ALS Subgroups for NeuroSense's Phase 3 Trial

CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ -- NeuroSense Therapeutics (Nasdaq: NRSN) ("NeuroSense"),  a company developing novel treatments for severe neurodegenerative diseases, today announced that it partnered with PhaseV, a pioneer in causal machine learning (ML) for clinical trial analysis and optimization, with respect to the planned Phase 3 trial of PrimeC as a treatment for amyotrophic lateral sclerosis (ALS).As part of the collaboration, PhaseV conducted an independent analysis of NeuroSense's PARADIGM Phase 2b study using a causal ML and predicts a high probability of success in multiple subgroups for the planned Phase 3 trial of PrimeC as a treatment for ALS.  The external results provide important insights that will significantly inform study design, patient enrollment and ensure cost-effectiveness."There remains a critical need for new innovative approaches to address this devastating neurodegenerative disease," said Alon Ben-Noon, CEO of NeuroSense. "Our recently announced subgroup analysis from the PARADIGM study is very encouraging and suggests the potential of PrimeC to change this reality. Through our initial collaboration with PhaseV, we gained an even greater understanding of the effect of PrimeC across multiple patient subgroups. We will apply these insights to optimize the design of our Phase 3 study with the aim of maximizing meaningful clinical results that will differentiate PrimeC in the market. We plan to continue to collaborate with PhaseV as we develop our Phase 3 trial."

NeuroSense Therapeutics recently reported positive efficacy and safety data from its Phase 2b trial (PARADIGM) with its lead drug candidate for ALS, PrimeC, and is planning on embarking on a Phase 3 pivotal trial in the next few months. In addition to PrimeC demonstrating a statistically significant 37% slowing of disease progression, as measured by the ALSFRS-R score (p=0.03), in the per-protocol population from the PARADIGM trial, it also announced a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment.  The slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38).High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately 50% of the total ALS population.

NeuroSense soon plans to submit its End of Phase 2 package to the FDA and EMA, including the updated  Phase 3 study protocol, which will be discussed in the meetings.

"Although there is an improved understanding of the underlying mechanisms of ALS, therapeutic options remain limited due to the complexity and heterogeneity of the disease," said Dr. Raviv Pryluk, CEO and Co-founder of PhaseV. "NeuroSense's ALS drug candidate PrimeC showed great promise in its Phase 2b study. Through a unique combination of causal-ML, real-world data, and advanced statistical methods, we confirmed the potential clinical benefit of PrimeC and provided actionable insights for the Phase 3 study. Our analysis predicted a high rate of success for PrimeC in the Phase 3 clinical trial for multiple recommended subgroups."

PhaseV's proprietary technology addresses the challenges of drug development by providing tools for the identification of subgroups and endpoints most likely to succeed in subsequent clinical trials. This has helped companies to better understand how their drug candidates will perform in Phase 3 clinical trials and to optimize the design of the Phase 3 trial accordingly in order to achieve meaningful and successful outcomes.

NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial

PR Newswire

Thu, Dec 14, 20236 min read

• A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) population analysis
• Neurofilament biomarker results from Biogen collaboration expected in January 2024
• Primary biomarker endpoints, TDP-43 and Prostagladin2, are expected in H1 2024
• PrimeC's meaningful effect magnitude, strong safety profile, and unique mechanism of action will be discussed with the FDA and other regulatory agencies in an End of Phase 2 meeting in H1 2024

CAMBRIDGE, Mass., Dec. 14, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today reported additional positive efficacy data from further evaluation of its Phase 2b trial (PARADIGM) with NeuroSense's lead drug candidate for amyotrophic lateral sclerosis ("ALS"), PrimeC.

Evaluation of the pre-specified Per Protocol (PP) population analysis of the recent top-line results from PARADIGM revealed a statistically significant slowing of disease progression with a 37.4% (p=0.03) difference in the gold standard ALS tracking measure, the ALS Functional Rating Scale-Revised ("ALSFRS-R"), in favor of PrimeC vs placebo, and 17.2% (p=0.39) difference in Slow Vital Capacity ("SVC"), in favor of PrimeC vs placebo. The PP analysis population includes all participants who adhered to the trial protocol and treatment plan without any major protocol deviations. The goal of a PP analysis in clinical trials is to assess the efficacy of a treatment under optimal conditions, thereby providing a clearer understanding of how well the treatment works when implemented as intended, contributing to a more comprehensive view of the trial results.  PARADIGM's PP population analysis is pre-defined in the trial's statistical analysis plan, which includes 62 patients (43 active and 19 placebo) compared to 68 patients in the Intent to Treat (ITT) population (45 active and 23 placebo).

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial. The trial's primary endpoints include: safety and tolerability, and ALS-related biomarkers TDP-43 and Prostagladin2. The trial's secondary endpoints include: clinical efficacy outcome measures, ALSFRS-R and SVC. ALSFRS-R is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. SVC is a measurement of respiratory function.While PARADIGM is powered to demonstrate statistically significant changes in the trial's primary endpoints, the highly favorable clinical results seen in the PP analysis achieved an unexpected statistical significance.The new data reported today comes on the heels of recent positive top-line safety and efficacy data of PARADIGM announced by NeuroSense. An analysis of the ITT top-line data from the 6-month double-blind segment of the trial showed clinically meaningful signs of efficacy with a 29% difference in ALSFRS-R (p=0.12) and a 13% difference in SVC (p=0.5), both in favor of PrimeC vs placebo. These data include all 68 people living with ALS enrolled in Canada, Italy, and Israel, with the exclusion of one patient who was misdiagnosed. Most patients enrolled in both the active and placebo arms of trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.  In addition, the trial met its primary endpoint of safety and tolerability with results comparable to placebo, establishing a solid safety profile for PrimeC. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date, all participants that completed the 18-month trial treatment duration requested to continue taking PrimeC, which is provided to them via an Investigator Initiated Trial.NeuroSense expects to report results from a strategic collaboration with Biogen in January 2024, evaluating the impact of PrimeC on neurofilament levels in participants enrolled in PARADIGM. Upon receipt of results, Biogen has the right of first refusal to co-develop/ commercialize PrimeC for the treatment of ALS for a limited time following the results. The Company expects to report primary biomarker endpoints of ALS hallmarks TDP-43 and Prostagladin2, to evaluate PrimeC's biological activity and target engagement, in the first half of 2024 following the completion of the analysis of participants' plasma.An End of Phase 2 meeting with the FDA and a Scientific Advice meeting with European Medicines Agency (EMA) to discuss these results and to determine the best path forward for PrimeC's development is expected in the first half of 2024."As we analyze the PARADIGM trial results, we continue to gain a better understanding of PrimeC's potential to render a significant and meaningful clinical benefit to people living with ALS. Today we are eager to share these new data with the ALS community, as we believe the PP analysis, demonstrating a statistically significant 37.4% difference in ALSFRS-R in patients treated with PrimeC vs. placebo, is an exceptional result," stated Alon Ben-Noon, NeuroSense's CEO.  "This data, in conjunction with hopefully correlative neurofilament readouts, will create a regulatory opportunity to advance PrimeC's development in a breakthrough manner toward the market."About ALSAmyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow by 24% by 2040 in the U.S. and EU.About PrimeCPrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed the 6-month double-blind portion of its Phase 2b ALS clinical trial which met its safety and tolerability endpoints, as well as showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. Additional data from the Phase 2b trial are expected H1 2024. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

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MANAGEMENT

Alon Ben-Noon

CEO & Board Member

Mr. Ben-Noon is the Co-Founder and CEO of NeuroSense Therapeutics.

Prior to the establishment of NeuroSense, Alon founded MediCan Consulting, a successful consultancy firm, with clients from diversified biotech companies, including Mediwound, Chiasma, Teva, Sol-Gel, FutuRx, NeuroDerm and others. MediCan excelled at executing efficient, accurate, and innovative drug development programs for its clients.

Dr. Ferenc Tracik

Chief Medical Officer

Dr. Ferenc Tracik, our chief medical officer has twenty years of experience in general management, medical affairs, clinical development and commercialization in the biotech industry.

Before joining the Company, he served as the Global Head Medical of Orphazyme A/S. From May 2017 until November 2020, Dr. Tracik served as VP Medical Europe, Canada and Partner Markets of Biogen Inc. From November 2013 until April 2017, Dr. Tracik served in various positions at Teva Pharmaceutical Industries Limited, including Managing Director Specialty Medicines Germany.

Dr. Tracik’s experience and expertise in therapy is extensive, and includes different disease areas such as CNS, respiratory, oncology, ophthalmology, infectious diseases, and transplantation), with a specific focus on neurodegenerative and neuro-autoimmune diseases. Before joining pharmaceutical industry Dr. Tracik worked at the university clinics of neurology at Charité Berlin and the university clinic of Innsbruck. Dr. Tracik holds a doctoral degree in human medicine from the Free University of Berlin.

Dr. Niva Russek-Blum

Chief Technology Officer

Dr. Niva Russek- Blum has over 17 years of experience in neuroscience, specifically Parkinson’s disease and ALS.

Niva established her lab in 2012, leading research as a Principle Investigator under the auspices of Ben Gurion University, focusing on neurological and immune perspectives of neurodegenerative diseases.

She established a CRO, utilizing high throughput-screening infrastructure required for the evaluation of potential therapeutics, with broad expertise in microscopy, image and behavioral analyses.

Her work was published in established journals and she has actively organized and participated in worldwide conferences. Niva is experienced in raising funds from competitive granting agencies and the private sector, collaborations with major academia and biotech/pharma entities, managing strategic planning, recruiting and mentoring students and technical staff and cooperating with TTOs.

PhD in Neurobiology, from The Weizmann Institute.

Hagit Binder

Chief Operating Officer

Ms. Hagit Binder has over 13 years of experience in the drug development industry.

Previously, Ms. Binder held VP projects and a marketing position at Nextar Chempharma solutions.

She has led projects in various therapeutic areas for both local and global companies.

In addition, she oversaw all projects, was accountable for deliverables and adherence to timelines. She maintained long term relationships with stakeholders and negotiated to ensure alignment between expectations, quality and price.

Ms. Binder holds an M.Sc. degree in Biology and M.B.A degree from Bar Ilan University.

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Sincerely,

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