Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (March 2023)
27 slides from Neurosense Therapeutics's investor presentation, Mar 20, 2023
Slide 1: Corporate Presentation March 2023
Corporate Presentation March 2023 Nasdaq: NRSN
Slide 2: Disclaimer
Disclaimer This presentation and oral statements made regarding the subject of this presentation contain "forward - looking statements" withi n the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. Al l s tatements contained in thi
Slide 3: NeuroSense is a Leader in Developing Novel Combination Therapies for ALS
NeuroSense is a Leader in Developing Novel Combination Therapies for ALS and Other Neurodegenerative Diseases ALS Alzheimer Parkinson Topline data from Phase 2 b placebo - controlled clinical trial expected in H 2 2023 Commencement of Phase 1 / 2 placebo - controlled clinical trial expected in H 1 2
Slide 4: ALS treatment options are a dire unmet need
Treatment options for ALS is a dire unmet need with only three FDA approved drugs available : Riluzole , Edaravone , & Relyvrio All w ith a mild therapeutic effect ~ 24 % Growth in Patients by 2040 in the US and EU ( 2 ) > 80,000 ALS Patients in NeuroSense ’ s planned target market ( 2 ) + 5,000 New
Slide 5: PrimeC: Value Proposition
PrimeC: Value Proposition Novel combination therapy designed to address multiple disease targets in a synergistic manner Promising efficacy signals observed from ALS Phase 2 a clinical trial ALS Phase 2 b top - line results from placebo - controlled clinical trial expected in H 2 2023 Patent coverag
Slide 6: PrimeC: Two Compounds One Potentially Powerful Outcome
PrimeC: Two Compounds One Potentially Powerful Outcome Celecoxib - an NSAID which reduces: • N euroinflammation • G lutamate excitotoxicity • O xidative stress Ciprofloxacin - a fluoroquinolone which regulates: • microRNA synthesis • Iron accumulation PrimeC is a novel formulation , consisting of sp
Slide 7: Potential of Combined Therapy
Potential of Combined Therapy Current Strategies: Synergistic MOAs OR Improved PK Alzheimer Donepezil + Memantine Parkinson Entacapone + levodopa/carbidopa ALS Sodium Phenybuterate + Taurursodiol SMA Onasemnogene + Nusinersen Epilepsy Lamotrigine + Valproate/Carbamazepine Successful combination stra
Slide 8: PrimeC is a Combination Therapy Leveraging Both Strategies
PrimeC is a Combination Therapy Leveraging BOTH Strategies And Synergistic MOA MOA Targeting Multiple Disease Pathways Simultaneously to Combat Complex Disease Improved PK Formulation Synchronized Pharmacokinetic Profile to Enhance Efficacy Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC I
Slide 9: Improved Pharmacokinetic (PK) Profile
Improved Pharmacokinetic (PK) Profile PK proof of concept studies in rodents This finding is attributed to Celecoxib blocking exit of Ciprofloxacin in the neuron PrimeC ’ s combination ( Celecoxib + Ciprofloxacin ) remained at a higher concentration in rodent brain tissue for longer , when compared
Slide 10: PrimeC's Formulation Induces a Synchronized PK Profile
PrimeC ’ s Formulation Induces a Synchronized PK Profile A s ynchronized PK profile of the two compounds, potentially maximizes the synergy between them PK profile studies in humans Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro Synchronized concentration peak
Slide 11: Synergistic MOA
Synergistic MOA Motor Neuron Nucleus Cytoplasm PrimeC ’ s targets multiple pathways which lead to neuronal death in ALS Intracellular • MicroRNA dysregulation • TDP - 43 aggregation • Cellular recycl ing processes Extracellular • Neuroinflammation • Oxidative Stress Summary Phase 2 b Phase 2 a Resul
Slide 12: PrimeC Demonstrated a Neuroprotective Effect in ALS Zebrafish Models
PrimeC Demonstrated a Neuroprotective Effect in ALS Zebrafish Models PrimeC Results in Zebrafish , a Key Animal Model for ALS (widely accepted model) ‘ Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis ’ Annals of Clinical and Translational Neurolog
Slide 13: PrimeC Phase 2a Trial Design
PrimeC Phase 2 a Trial Design NST 002 15 patients Open - Label Intermediate formulation of PrimeC 12 - month dosing Clinic visit every 3 months Phone visit every 1.5 months Location: Tel Aviv Sourasky Medical Center Safety Blood test, electrocardiogram (ECG), urea, vital signs, adverse events (AE) E
Slide 14: Phase 2a 12-Month Data: PrimeC Improved Respiratory Function Decline
Phase 2 a 12 - Month Data: PrimeC Improved Respiratory Function Decline & Attenuated Disease Progression* ALSFRSr Score Forced vital capacity (FVC%) **In comparison to PRO - ACT matched - control : P ooled R esource O pen - A ccess ALS C linical T rials D atabase * “ Combination of ciprofloxacin/ ce
Slide 15: Phase 2a Biomarker Study Design
Phase 2 a Biomarker Study Design Service provided by: Stage II Longitudinal non - treated study The natural course of ALS was examined longitudinally over 12 months compared to an indirect placebo control group Stage I Case study experiment Cross - sectional comparison of ALS and healthy - control s
Slide 16: PrimeC Significantly Altered Key ALS Biomarkers
PrimeC Significantly Altered Key ALS Biomarkers Treated: Patients from NST 002 Phase 2 a clinical trial who received PrimeC (intermediate formulation) Non - treated: Matched patients on standard of care Neuroinflammation TDP - 43 Accumulation PrimeC PrimeC Summary Phase 2 b Phase 2 a Results Pre - c
Slide 17: Phase 2a Trial with PrimeC: Met Primary and Exploratory Endpoints
Phase 2 a Trial with PrimeC : Met Primary Endpoints & Exploratory Endpoints Positive Clinical Signal Observed These results led NeuroSense to commence a Phase 2 b clinical study, using an improved new extended - release formulation of PrimeC Significant changes in ALS - related biomarkers Well toler
Slide 18: PrimeC Phase 2b Trial Design
PrimeC Phase 2 b Trial Design Randomized, Prospective, Double - Blind, Placebo - Controlled Study Using PrimeC ’ s novel extended - release formulation NST 003 69 patients 2:1 PrimeC to Placebo New formulation of PrimeC 6 - month double blind 12 - month open label extension Clinic visit every 2 mont
Slide 19: Intellectual Property Overview
Intellectual Property Overview Our patents Methods for Treating ALS using Combinations of Celecoxib and Ciprofloxacin Compositions comprising an anti - inflammatory drug and a dicer activator for use in the treatment of neuronal diseases Methods for Treating neurodegenerative disorders using Combina
Slide 20: Key Collaborations
Key Collaborations Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro
Slide 21: Milestones Achieved & Upcoming Potential Catalysts
Milestones Achieved & Upcoming Potential Catalysts Expected ALS End of Phase 2 FDA meeting Expect to initiate ALS Phase 3 clinical trial Expected Alzheimer Phase 2 trial results ALS Phase 2 b PARADIGM study initiated FDA IND Clearance for PrimeC PK study single - dose & multi - dose completed succes
Slide 22: Experienced Leadership
VP of R& D Shiran Zimri, PhD CMO Ferenc Tracik , MD Founder & CEO Alon Ben - Noon Chairman of the Board Mark Leuchtenberger CFO Or Eisenberg Niva Russek - Blum, PhD VP Discovery & IP Generator VP of BD Nedira Salzman VP of Regulatory Affairs Diana Shtossel Experienced Leadership Summary Phase 2 b Ph
Slide 23: Scientific Advisory Board
Senior VP at the Barrow Neurological Institute Chair of the Department of Neurology Prof. Jeremy Shefner (Chair) Dr. Jinsy Andrews Associate Professor of Neurology, Division of Neuromuscular Medicine, Columbia University Director of Neuromuscular Clinical Trials Prof. Merit Cudkowicz Chief of Neurol
Slide 24: Read more about us!
Read more about us! Learn more: NeuroSense YouTube Channel Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro
Slide 25: Equity Overview – Feb. 2023
Equity Overview – Feb. 28 , 2023 Nasdaq: NRSN Price: $ 1.86 52 - Week Range: $ 1.08 - $ 8.18 Shares Outstanding: ~ 11.7 M Share on a fully diluted basis: ~ 15 M Market Cap: ~$ 22 M Cash Balance ( 9 / 30 / 22 ): ~$ 8.4 M Avg. Daily Trading Volume ( 90 day): ~ 1.5 M Analyst Coverage: Maxim Group No De
Slide 26: NRSN Highlights Summary
NRSN Highlights Summary Novel combination therapy designed to address multiple disease targets in a synergistic manner Promising efficacy signals observed from ALS Phase 2 a clinical trial Statistically significant biomarker data in Phase 2 a clinical trial which correlated to clinical signals obser
Slide 27: Thank you!
Nasdaq: NRSN Thank you! Thank You For more information: info@neurosense - tx.com
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