Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (February 2022)
28 slides from Neurosense Therapeutics's investor presentation, Feb 15, 2022
Slide 1: NeuroSense Therapeutics
© NeuroSense Therapeutics
Slide 2: Disclaimer
2 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. All statements contained in thi
Slide 3: NST002 Trial Biomarker Analysis
NST002 Trial Biomarker Analysis *All measurements are in ng/ml Statistically Significant Results following treatment with PrimeC
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
Slide 5: NeuroSense's Story
5 Strong Pre - clinical Results Completed Phase IIa ALS study met primary endpoints Patent Granted, 2 Pending; Orphan Designation Granted (FDA & EMA) Novel formulation of approved drugs for multi - targeted approach FDA: 505 (b)( 2 ) pathway Pipeline programs for Parkinson's and Alzheimer's NeuroSen
Slide 6: Experienced Leadership
6 Experienced Leadership = CMO Ferenc Tracik, MD A Neurologist, held senior management positions at Biogen, Novartis, Teva CEO, Board Member Alon Ben - Noon Former CEO of a consulting firm, advised multiple successful biotech companies Chairman of the Board Mark Leuchtenberger Experienced as a BoD m
Slide 7: Scientific Advisory Board
7 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
Slide 8: NeuroSense's Development Pipeline
8 NeuroSense ’ s Development Pipeline ALS: Amyotrophic Lateral Sclerosis, AD: Alzheimer's Disease, PD: Parkinson ’ s Disease Complete Toxicological Study, initiation of Pharmacokinetic and Ph. IIb study in H 1 ‘ 22 and Ph. III in H 2 ‘ 23 Complete pre - clinical studies ahead of planned Ph. I/II ini
Slide 9: ALS in Numbers
9 ALS in Numbers = annual burden in the US alone = ~ 2 4 % Growth in Patients by 2040 in the US and EU = > 80 , 000 ALS Patients in NeuroSense ’ s planned target market = + 5 , 000 P eople are diagnosed with ALS each y ear (US) = ALS is an incurable neurodegenerative disease - causing complete paral
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 = Current Treatments Phase 3 Clinical trials in the past 15 years have failed, we believe, due mainly to: A Combined Therapeutic Strategy Targeting Multiple Pathways A NEW APPROACH WAS NEEDED Single Target - Aiming for only one target in complex diseases w
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 work 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 PrimeC improved locomotor and cellular deficits of ALS zebrafish models, indicating a neuroprotective effect PrimeC treatment: x Improved motor performance of both SOD 1 and TDP - 43 , widely accepted models, by 84 % and 110 % respectively x Recovered
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 Tra nslational Neurology, 2020 . *mSOD 1 -
Slide 16: Phase IIa Trial Design
16 Phase IIa Trial Design Prof. Vivian Drory NST 002 : Tel Aviv Sourasky Medical Center Phase IIa Safety Blood test, Electrocardiogram ( ECG), Urea, Vital signs, adverse events ( AE) Efficacy ALSFRS - R - Revised Amyotrophic Lateral Sclerosis Functional Rating Scale – 0 - 48 FVC - Forced Vital Capac
Slide 17: PrimeC vs. PRO-ACT Exploratory Endpoint
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 drug strength
Slide 18: Phase IIa Clinical Trial: PrimeC intermediate formulation
18 Phase IIa Clinical Trial: PrimeC intermediate formulation x Well Tolerated, No Drug Related SAEs x Reduced Functional and Respiratory Deterioration x Significant changes in ALS - related biomarkers Primary endpoint met, exploratory endpoints showed positive results with PrimeC
Slide 19: NST ALS Biomarkers
NST 002 ALS Biomarkers: Stage I : Case study experiment : Analysis of ALS pathology – healthy vs ALS blood samples Stage II : NST 002 clinical study : Assessing the Effect of PrimeC on Key Biomarkers
Slide 20: ALS Pathology Biomarkers
ALS Pathology Biomarkers TOP-43 accumuis™ & 5 3 i 4 g
Slide 21: Stage I: Case Study Results of ALS Biomarkers in Blood Samples
*All measurements of exosome protein are in ng/ml Stage I*: Case Study Results of ALS Biomarkers in Blood Samples Neuroinflammation Impaired Autophagy Lysosomal Dysfunction Iron Accumulation TDP - 43 Accumulation miRNA Dysregulation
Slide 22: Stage II: NST Trial Biomarker Analysis
Stage II*: NST 002 Trial Biomarker Analysis *All measurements are in ng/ml Neuroinflammation Lysosomal Dysfunction 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: Competitive Advantage: PrimeC is well positioned
24 x Oral administration, well tolerated x Targets multiple pathways in parallel, well - established as disease - modifying targets x Expecting accelerated path to FDA approval x Potential for competitive price point = beneficial pharmaco - economics for ALS patients, caregivers, and providers (with
Slide 25: Planned Development Timeline
25 Planned Development Timeline • Toxicity study completion • IND submission • Pharmacokinetic study • ALS Phase IIb study initiation • 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 initiat
Slide 26: High Level Gantt
26 High Level Gantt 2022 2023 Q 1 Q 2 Q 3 Q 4 Q 1 Q 2 Q 3 Q 4 Discovery R&D activities (Biomarkers, AD / PD) 90 days Tox Study PK Study Potential PoC clinical studies for AD and PD ALS Phase 2 b Clinical Trial IND Sub. PK Batch. IRB Sub. Ph 2 Batch. Top - Line Results End of Ph 2 meeting Ph 3 Initia
Slide 27: Fun Facts: Management Team of NeuroSense
28 Fun Facts: Management Team of NeuroSense Board Members are Women of Board members are US based with vast experience in Biotech public companies 66 % 50 % 70 % of NeuroSense team are Women
Slide 28: NeuroSense Therapeutics
Therapeutics
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