Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (August 2022)
30 slides from Neurosense Therapeutics's investor presentation, Aug 9, 2022
Slide 1: Corporate Presentation August 2022
1 Corporate Presentation August 2022 Nasdaq: NRSN
Slide 2: Disclaimer
Trademarks in this presentation are the property of their respective owners and used for informational and educational purposes only. 2 Disclaimer This presentation and oral statements made regarding the subject of this presentation contain "forward - looking statements" within the meaning of the U.
Slide 3: NeuroSense is a Leader in Developing Novel Combination Therapies for Neurodegenerative Diseases
3 NeuroSense is a Leader in Developing Novel Combination Therapies for Highly Debilitating Neurodegenerative Diseases Inspiration Inception Innovation Strong ALS Pre - clinical Results ; Significant ALS novel biomarker data Commenced ALS Phase IIb after successful completion of Phase IIa Patent Gran
Slide 4: An Innovative Approach
4 An Innovative Approach Gene Therapy Strategy Antisense Molecular Strategy Antibodies Chemical Strategy Small molecules Cell Based Strategy Cell and Gene therapies Combined Therapeutic Strategy Targeting Multiple Pathways ALS Drugs in Trials
Slide 5: Experienced Leadership
5 Experienced Leadership Head of Scientific Program Shiran Zimri, PhD CMO Ferenc Tracik, MD CEO, Board Member Alon Ben - Noon Chairman of the Board Mark Leuchtenberger CFO Or Eisenberg Niva Russek - Blum, PhD VP Discovery & IP Generator VP BD Nedira Salzman Head of Regulatory Affairs Diana Shtossel
Slide 6: Scientific Advisory Board
6 Scientific Advisory Board Prof. Jeremy Shefner (Chair) • Senior VP at the Barrow Neurological Institute • Chair of the Department of Neurology Dr. Jinsy Andrews • Associate Professor of Neurology, Division of Neuromuscular Medicine, Columbia University • Director of Neuromuscular Clinical Trials P
Slide 7: NeuroSense's Development Pipeline
7 NeuroSense’s Development Pipeline ALS: Amyotrophic Lateral Sclerosis, AD: Alzheimer's Disease, PD: Parkinson’s Disease • PK Study Data Q3 2022 • Topline Data Phase IIb Q2 2023 • Initiate Phase III in H2 2023 • Complete Pre - clinical Studies Ahead of Planned Phase I/II • Complete Pre - Clinical St
Slide 8: ALS in Numbers
8 ALS in Numbers Growth in Patients by 2040 in the US and EU >80 , 000 ALS Patients in NeuroSense’s planned target market +5 , 000 People are diagnosed with ALS each year (US) ALS is an incurable neurodegenerative disease causing complete paralysis and ultimately death within 2 - 5 years from diagno
Slide 9: The People Behind The Numbers
9 The People Behind The Numbers Shay: Oct. 2016
Slide 10: Current Treatments Show Limited Efficacy
10 Current Treatments Show Limited Efficacy Phase 3 Clinical trials in the past 15 years have failed, we believe, due mainly to: A NEW APPROACH WAS NEEDED A Combined Therapeutic Strategy Targeting Multiple Pathways Single Target - Aiming for only one target in complex diseases with multiple mechanis
Slide 11: NeuroSense's Lead Candidate: PrimeC
11 NeuroSense's Lead Candidate: PrimeC Two Compounds - One Potentially Powerful Outcome NeuroSense’s Flagship Treatment A novel formulation , consisting of specific doses of two FDA - approved drugs, Ciprofloxacin & Celecoxib, designed to work synergistically on more than one target : • Regulating m
Slide 12: PrimeC – Mechanism of Action
12 PrimeC – Mechanism of Action PrimeC is a novel formulation of : Celecoxib - an NSAID that inhibits COX - 2 enzyme, reducing inflammatory processes, glutamate excitotoxicity and oxidative stress, among others Ciprofloxacin - a fluoroquinolone family member, inducing Dicer activity, regulating micr
Slide 13: Pre-Clinical Results in a Key Animal Model
13 Pre - Clinical Results in a Key Animal Model PrimeC treatment: x Improved motor performance of both SOD1 and TDP - 43, widely accepted models, by 84% and 110% respectively x Recovered impaired motor neurons morphology x Recovered abnormal neuromuscular junction structure x Preserved the ramified
Slide 14: Pre-Clinical Results in Zebrafish, a Key Animal Model for ALS
14 Pre - Clinical Results in Zebrafish, a Key Animal Model for ALS: 1. Improved motor performance 2. Recovered neuronal structure Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neurology, 2020 *mSOD1 - Mutati
Slide 15: Phase 2a Trial Design
15 Phase 2a Trial Design Prof. Vivian Drory NST002: Tel Aviv Sourasky Medical Center Safety Blood test, electrocardiogram (ECG), urea, vital signs, adverse events (AE) Efficacy ALSFRS - R - Revised ALS Functional Rating Scale – 0 - 48 FVC - Forced Vital Capacity Biomarkers Examination of key element
Slide 16: PrimeC Reduced the Rate of Decline
16 * P ooled R esource O pen - A ccess ALS C linical T rials Database All patients completing the trial have opted to continue into an extension study with PrimeC Exploratory Endpoint: PrimeC vs. PRO - ACT* (matched) The trial was conducted with an intermediate formulation and dose PrimeC Reduced th
Slide 17: Phase IIa Clinical Trial: PrimeC intermediate formulation
17 Phase IIa Clinical Trial: PrimeC intermediate formulation Primary endpoint met, exploratory endpoints showed positive results with PrimeC x Reduced Functional and Respiratory Deterioration x Significant changes in ALS - related biomarkers x Well Tolerated, No Drug Related SAEs
Slide 18: NST002 ALS Biomarkers
NST002 ALS Biomarkers: Stage I: Case study experiment: Analysis of ALS pathology – healthy vs ALS blood samples Stage II: NST002 clinical study: Assessing the Effect of PrimeC on Key Biomarkers Stage III: Longitudinal non - treated study: Reinforcing the characterization of NRSN cassette of biomarke
Slide 19: Phase IIa NST002 Trial Biomarker Analysis
Phase IIa NST002 Trial Biomarker Analysis Statistically Significant Results Following Treatment with PrimeC PrimeC’s effect on Biomarkers may lead to: 1. Patient Stratification 2. Precision medicine
Slide 20: Characterization of Novel ALS Biomarkers in Blood Samples
All measurements of exosome protein are in ng/ml Characterization of Novel ALS Biomarkers in Blood Samples Impaired Autophagy Lysosomal Dysfunction TDP - 43 Accumulation miRNA Dysregulation Iron Accumulation Neuroinflammation
Slide 21: Significantly Alters Key ALS Biomarkers
Significantly Alters Key ALS Biomarkers Neuroinflammation TDP - 43 Accumulation Treated: Patients from NRSN Phase IIa clinical trial who received PrimeC Non - treated: Matched patients on standard of care
Slide 22: NST003 – Phase IIb Study in ALS
NST003 – Phase IIb Study in ALS Clinical Visit N = 69 2 : 1 0 Months 6 2 4 Clinical Visit Clinical Visit BL Visit OLE A Phase IIb, Randomized, Prospective, Double - Blind, Placebo - Controlled Study, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects with ALS PrimeC PrimeC Only Plac
Slide 23: NST003 – Endpoints
NST003 – Endpoints Safety & Tolerability Primary Efficacy Secondary Efficacy x ALSFRS - R x SVC x ALSSQOL - SF x PROMIS 10 x Survival x PROOF x MMT x Advese Events x Vital Signs x ECG x Clinical Lab Evaluations
Slide 24: US Italy Israel
US Italy Israel
Slide 25: Planned Development Timeline
Planned Development Timeline • AD Pre - clinical studies completion • PD Pre - clinical studies completion • Commenced multi - dose PK study • Expected: • Complete ALS Phase IIb clinical trial enrollment • ALS Phase IIb clinical trial top - line results • ALS End of Phase II meeting • ALS Phase III
Slide 26: High Level Gantt
26 High Level Gantt Q1 Q2 2022 Q3 Q4 Q1 Q2 2023 Q3 Q4 Discovery R&D activities (Biomarkers AD / PD) 90 days Tox Study PK Study Potential PoC clinical studies for AD and PD PK Batch. IND Sub. Ph II Batch. IRB Sub. Top - Line End of Ph II Results meeting Ph III Initiation ALS PhaseIIb Clinical Trial P
Slide 27: Intellectual Property Overview
27 Intellectual Property Overview Patent / Application # US 10,980,780 Subject Methods for Treating ALS using Combinations of Celecoxib and Ciprofloxacin Type Method for treatment Jurisdiction United States Status Granted Expiry Date June 2038 AU 2018287021 Compositions comprising an anti - inflamma
Slide 28: NRSN – Highlights Summary
28 NRSN – Highlights Summary x Novel formulation addresses multiple targets in a synergistic manner x Promising Phase IIa efficacy results x Statistically significant biomarker data which correlates to a meaningful clinical effect x Patents granted and additional IP coverage (valid until 2038) x Fun
Slide 29: Fun Facts: Management Team
29 Fun Facts: Management Team 66% of Board members are US based with vast experience in Biotech public companies 50% of NeuroSense Board Members are Women >70% of NeuroSense team are Women
Slide 30: Thank You!
30 THANK YOU! For more information: www.NeuroSense - tx.com info@NeuroSense - tx.com
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