Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (May 2022)
29 slides from Neurosense Therapeutics's investor presentation, May 2, 2022
Slide 1: Corporate Presentation May 2022
1 Corporate Presentation May 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: Leader in Novel Combination Therapies for Neurodegenerative Diseases
3 Strong Pre - clinical Results Completed Phase IIa ALS study met primary endpoints Patent Granted, 2 Pending; Orphan Designation Granted (FDA & EMA) Novel formulation of FDA approved drugs for multi - targeted approach FDA: 505(b)(2) pathway Pipeline programs for Parkinson's and Alzheimer's NeuroSe
Slide 4: Phase IIa NST002 Trial Biomarker Analysis Statistically Significant Results
Phase IIa NST002 Trial Biomarker Analysis Statistically Significant Results Following Treatment with PrimeC
Slide 5: An Innovative Approach
5 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 6: Experienced Leadership
6 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 ALS Program Avital Pushett
Slide 7: Scientific Advisory Board
7 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 8: NeuroSense's Development Pipeline
8 NeuroSense’s Development Pipeline ALS: Amyotrophic Lateral Sclerosis, AD: Alzheimer's Disease, PD: Parkinson’s Disease • C omplete Toxicological Study • Initiate Pharmacokinetic Study • Initiate Phase IIb in H1 ‘ 22 • Initiate Phase III in H2 ‘ 23 • Complete Pre - clinical Studies Ahead of Planned
Slide 9: ALS in Numbers
9 ALS in Numbers ~24% Growth in Patients by 2040 in the US and EU ALS is an incurable neurodegenerative disease causing complete paralysis and ultimately death within 2 - 5 years from diagnosis >$1B Annual burden in the US alone +5 , 000 1 People are diagnosed with ALS each year (US) >80 , 000 2 ALS
Slide 10: The People Behind The Numbers
10 The People Behind The Numbers Oct. 2016
Slide 11: Current Treatments Show Limited Efficacy
11 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 12: NeuroSense's Lead Candidate: PrimeC
12 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 w o rk synergistically on more than one target : • Regulating
Slide 13: PrimeC – Mechanism of Action
13 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 14: Pre-Clinical Results in a Key Animal Model
14 Pre - Clinical Results in a Key Animal Model 1. Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neurology, 2020. PrimeC improved locomotor and cellular deficits of ALS zebrafish models, indicating a neuropr
Slide 15: Pre-Clinical Results in Zebrafish, a Key Animal Model for ALS
15 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 16: Phase IIa Trial Design
16 Phase IIa Trial Design Prof. Vivian Drory Phase IIa 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
Slide 17: PrimeC Reduced the Rate of Decline
17 * 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 18: Phase IIa Clinical Trial: PrimeC Intermediate Formulation
18 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 19: Phase IIa ALS Biomarkers
Phase IIa ALS Biomarkers: Stage I: Analysis of ALS pathology - healthy vs ALS blood samples Stage II: NST002 clinical trial: Assessing the Effect of PrimeC on Key Biomarkers
Slide 20: 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 3. Increased likelihood of FDA approval 4. Expedited approval process In collaboration with Massachus
Slide 21: Stage I: Characterization of Novel ALS Biomarkers in Blood Samples
*All measurements of exosome protein are in ng/ml Stage I*: Characterization of Novel ALS Biomarkers in Blood Samples Impaired Autophagy Lysosomal Dysfunction TDP - 43 Accumulation miRNA Dysregulation Iron Accumulation Neuroinflammation
Slide 22: Stage II: Significant Effect in Phase IIa Trial Biomarker
Stage II*: Significant Effect in Phase IIa Trial Biomarker *All measurements are in ng/ml Neuroinflammation Impaired Autophagy TDP - 43 Accumulation Lysosomal Dysfunction
Slide 23: Correlation Between Biological Activity and Clinical Outcome
23 The biological activity observed in TDP - 43 levels may serve to indicate clinical outcomes, as can be seen from the relative correlation between the reduction in TDP - 43 levels and slower deterioration in ALSFRS - R . Correlation Between Biological Activity and Clinical Outcome
Slide 24: Planned Development Timeline
Planned Development Timeline AD Pre - clinical studies completion PD Pre - clinical studies completion • ALS Phase IIb Top - Line results • ALS End of Phase II meeting • ALS Phase III initiation H1 / 2022 H2 / 2022 H1 / 2023 H2 / 2023 Expected: • 90 day Toxicity study completion • • ALS Phase IIb st
Slide 25: High Level Gantt
25 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 26: Intellectual Property Overview
26 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 - inflamma
Slide 27: NRSN – Highlights Summary
27 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 28: Fun Facts: Management Team
28 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 29: Thank You!
29 THANK YOU! For more information: www.NeuroSense - tx.com info@NeuroSense - tx.com
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