Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (July 2022)
31 slides from Neurosense Therapeutics's investor presentation, Jul 5, 2022
Slide 1: Corporate Presentation July 2022
1 Corporate Presentation July 2022 Nasdaq: NRSN
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 co nta ined in t
Slide 3: Leader in Developing 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 Neur
Slide 4: Phase IIa NST002 Trial Biomarker Analysis Statistically Significant Results Following Treatment with PrimeC
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 • 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 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 H 1 ‘ 22 • Initiate Phase III in H 2 ‘ 23 • Complete Pre - clinical Studies Ahead of P
Slide 9: ALS in Numbers
9 ALS in Numbers = A nnual 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 paraly
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 - Mu
Slide 16: Phase IIa Trial Design
16 Phase 2 a 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 ALS Functional Rating Scale – 0 - 48 FVC - Forced Vital Capacity Biomarkers Examination
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 x Reduced Functional and Respiratory Deterioration x Significant changes in ALS - related biomarkers x Well Tolerated, No Drug Related SAEs Primary endpoint met, exploratory endpoints showed positive results with PrimeC
Slide 19: Phase IIa ALS Biomarkers
Phase IIa ALS Biomarkers: Stage I : Analysis of ALS pathology - healthy vs ALS blood samples Stage II : NST 002 clinical trial : Assessing the Effect of PrimeC on Key Biomarkers
Slide 20: Phase IIa Trial Biomarker Analysis Statistically Significant Results
Phase IIa NST 002 Trial Biomarker Analysis Statistically Significant Results Following Treatment with PrimeC PrimeC ’ s effect on Biomarkers may lead to: 1 . Patient Stratification 2 . Precision medicine In collaboration with Massachusetts General Hospital
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 Neuroinflammation Impaired Autophagy Lysosomal Dysfunction Iron Accumulation TDP - 43 Accumulation miRNA Dysregulation
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 Lysosomal Dysfunction Neuroinflammation Impaired Autophagy TDP - 43 Accumulation Lysosomal Dysfunction
Slide 23: Phase IIb Study in ALS
NST 003 – Phase II b 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 Pl
Slide 24: Phase IIb Endpoints
NST 003 – 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 25: Shifting the Paradigm
if PARADIGM SHIFTING THE PARADIGM CQ Neumsense
Slide 26: Planned Development Timeline
26 Planned Development Timeline • AD Pre - clinical studies completion • PD Pre - clinical studies completion • Expected: • Complete Phase IIb clinical trial enrollment • ALS Phase IIb Top - Line results • ALS End of Phase II meeting • ALS Phase III initiation H 1 / 2022 H 2 / 2022 H 1 / 2023 H 2 /
Slide 27: High Level Gantt
27 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 PhaseIIb Clinical Trial IND Sub. PK Batch. IRB Sub. Ph II Batch. Top - Line Results End of Ph II meeting Ph III Init
Slide 28: Intellectual Property Overview
28 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 29: NRSN – Highlights Summary
29 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 Fu
Slide 30: Fun Facts: Management Team of NeuroSense
30 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 % ʕ 70 % of NeuroSense team are Women
Slide 31: Thank You!
31 THANK YOU! For more information: www.NeuroSense - tx.com info@NeuroSense - tx.com
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