Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — IPO Roadshow (November 2021)
28 slides from Neurosense Therapeutics's IPO roadshow presentation, Nov 10, 2021
Slide 1: Free Writing Prospectus dated November 10, 2021
1 Free Writing Prospectus dated November 10, 2021 Filed pursuant to Rule 433 Relating to the Preliminary Prospectus dated November 10, 2021 Registration Statement No. 333 - 260338
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: Offering Summary
3 Offering Summary ISSUER: NeuroSense Therapeutics Ltd. (“ NeuroSense ” or the “Company”) PROPOSED EXCHANGE / SYMBOL: NasdaqCM / NRSN, NRSNW OFFERING SIZE: $20.0 million (excluding 15% over - allotment option) OFFERING TYPE : Initial Public Offering SECURITIES OFFERED (1) : Units (1 ordinary share &
Slide 4: Investment Highlights
4 Investment Highlights NeuroSense is a Leader In Developing Novel Combination Therapies For Highly Debilitating Neurodegenerative Diseases Strong Pre - clinical Results Completed Phase IIa ALS study met primary endpoints Patent Granted, 2 Pending; Orphan Designation Granted (FDA & EMA) Novel formul
Slide 5: Experienced Leadership
5 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 6: Scientific Advisory Board
6 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 7: NeuroSense's Development Pipeline
7 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 8: ALS in Numbers
8 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 paralysi
Slide 9: The People Behind The Numbers
9 The People Behind The Numbers Oct. 2016
Slide 10: Current Treatments Show Limited Efficacy
10 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 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
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 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 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 Tra nslational Neurology, 2020 . *mSOD 1 -
Slide 15: Phase IIa Clinical Trial: PrimeC intermediate formulation
15 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 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 (matched) Exploratory Endpoint
17 * P ooled R esource O pen - A ccess ALS C linical T rials Database Of significance, all patients completing the trial have opted to continue into an extension study with PrimeC Exploratory Endpoint: PrimeC vs. PRO - ACT* (matched)
Slide 18: ALS Pathology Biomarkers
ALS Pathology Biomarkers TDP-43 TDP-43 accumulaiO®
Slide 19: NST ALS Biomarkers: Stage I and Stage II
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: 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 21: 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 22: Correlation Between Biological Activity and Clinical Outcome
22 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 23: Competitive Advantage: PrimeC is well positioned
23 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 24: Planned Development Timeline
24 Planned Development Timeline • Toxicity study completion • IND submission • Pharmacokinetic study • ALS Phase IIb study initiation • AD Pre - clinical studies completion • AD Phase I/II POC clinical study initiation • PD Pre - clinical studies completion • ALS Phase IIb Top - Line results • ALS E
Slide 25: Investment Highlights
25 Investment Highlights NeuroSense is a Leader In Developing Novel Combination Therapies For Highly Debilitating Neurodegenerative Diseases Strong Pre - clinical Results Completed Phase IIa ALS study met primary endpoints Patent Granted, 2 Pending; Orphan Designation Granted (FDA & EMA) Novel formu
Slide 26: NeuroSense Therapeutics
NeuroSense Therapeutics
Slide 27: Appendix
27 Appendix
Slide 28: Intellectual Property and Market Exclusivity Overview
28 Intellectual Property and Market Exclusivity Overview x Combination Patent: Methods for Treating ALS using Combinations of Celecoxib and Ciprofloxacin - Issued in US as US 10,980,780 , Expires in June 2038 ; Allowed in AU □ Additional patent applications relating to our combination patent are pen
NeuroSense Therapeutics — IPO Roadshow (November 2021) on 6ix