Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (June 2023)
34 slides from Neurosense Therapeutics's investor presentation, Jun 8, 2023
Slide 1: Corporate Presentation June 2023
Corporate Presentation June 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 ’ s Parkinson ’ s Topline data from Phase 2b placebo - controlled clinical trial expected in Q4 2023 Commencement of Phase 2 placebo - controlled clinical trial expected in H 2
Slide 4: ALS is a dire unmet need with only three FDA approved drugs
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 Q 4 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: • M icroRNA synthesis • Iron accumulation PrimeC is a novel formulation , consisting of s
Slide 7: Potential of Combined Therapy
Potential of Combined Therapy Current Strategies: Synergistic MOAs OR Improved PK Alzheimer ’ s Donepezil + Memantine Parkinson ’ s Entacapone + levodopa/carbidopa ALS Sodium Phenybuterate + Taurursodiol SMA Onasemnogene + Nusinersen Epilepsy Lamotrigine + Valproate/Carbamazepine Successful combinat
Slide 8: PrimeC Performed Favorably in iPSC Model from ALS Patients
Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro ALS patient blood Isolated Peripheral Blood Mononuclear cells ( PBMCs) IPSCs IPSCs + / - Treatments Independent, non - sponsored research was conducted in the laboratory of Dr. Justin Ichida, at the University of Southern California Pri
Slide 9: 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 10: 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 11: 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 12: 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 13: 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 14: 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 15: Phase 2a Data: Improved Respiratory Function Decline & Attenuated Disease Progression
Phase 2 a 12 - Month Data: PrimeC (intermediate formulation) 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 * “ Combi
Slide 16: 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 17: 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 18: Phase 2a Trial 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 19: 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 enrolled 2:1 PrimeC to Placebo New formulation of PrimeC 6 - month double blind 12 - month open label extension Clinic visit eve
Slide 20: 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 21: Key Collaborations
Key Collaborations Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro
Slide 22: Milestones Achieved & Upcoming Potential Catalysts
Milestones Achieved & Upcoming Potential Catalysts Expect ALS End of Phase 2 FDA meeting Expect to initiate ALS Phase 3 clinical trial Expect Alzheimer ’ s 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 23: Experienced Leadership
VP of R& D Shiran Zimri , PhD Chief Medical Officer Ferenc Tracik , MD Founder & CEO Alon Ben - Noon Chief Operating Officer Hagit Binder Chief Financial Officer Or Eisenberg Niva Russek - Blum, PhD Chief Technology Officer VP of BD Nedira Salzman VP of Regulatory Affairs Diana Shtossel Experienced
Slide 24: Board of Directors
Revital Mandil - Levin Caren Deardorf Chairman of the Board Mark Leuchtenberger Christine Pellizzari Cary Claiborne Board of Directors Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro Alon Ben - Noon
Slide 25: 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 26: 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 27: Equity Overview – June 2023
Equity Overview – June 7 , 2023 Nasdaq: NRSN Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro Price: $ 1.95 52 - Week Range: $ 1.07 - $ 4.47 Shares Outstanding: ~ 11.8 Shares on a Fully Diluted Basis: ~ 15 M Market Cap: ~$ 23 M Cash and Deposits ( 3 / 31 / 2023 ): ~$ 4.4 M No Debt Avg
Slide 28: NRSN Highlights
NRSN Highlights Summary Top - line results from ALS Phase 2 b placebo - controlled clinical trial expected in Q 4 2023 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 si
Slide 29: Thank you!
Nasdaq: NRSN Thank you! Thank You For more information: info@neurosense - tx.com
Slide 30: The Inspiration Behind PrimeC
The Inspiration Behind PrimeC A Tribute to Shay Rishoni Shay: Oct. 2016 Shay: Dec. 2010 Shay: Mar. 2013 Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro
Slide 31: Correlation Between Biological Activity and Clinical Outcome
Correlation Between Biological Activity and Clinical Outcome The biological activity observed in TDP - 43 levels, may serve to indicate clinical outcomes , and slower deterioration in ALSFRS - R Summary Phase 2 b Phase 2 a Results Pre - clinical PrimeC Intro
Slide 32: Intellectual Property Overview
Intellectual Property Overview Patent / Application # Subject Type Jurisdiction Status Expiry Date US 10,980,780 Methods for Treating ALS using Combinations of Celecoxib and Ciprofloxacin Method for treatment United States Granted June 2038 AU 2018287021 Compositions comprising an anti - inflammator
Slide 33: Read more about us!
Read more about us! Learn more: NeuroSense YouTube Channel Journal Articles Clinical Trials Arena NeuroSense previews Phase IIb trial plans for oral ALS drug Health Professional Radio NeuroSense Therapeutics – Study of New Drug to Treat ALS The Empowered Patient Podcast Identifying Biomarkers and Ef
Slide 34: Phase 2b Endpoints to Evaluate PrimeC
Phase 2 b Endpoints to Evaluate PrimeC Safety & Tolerability Primary Efficacy Secondary Efficacy • ALSFRSr • SVC • ALSSQOL - SF • PROMIS 10 • Survival • PROOF • MMT • Adverse Events • Vital Signs • ECG • Clinical Lab Evaluations • Biomarkers • TDP - 43 • Prostagladin 2 Rationale: • Biomarker data ma
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