Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (March 2022)
28 slides from Neurosense Therapeutics's investor presentation, Mar 15, 2022
Slide 1: Corporate Presentation March 2022
1 Corporate Presentation March 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
3 S t r ong Pr e - clini c al Results Compl e t e d Ph a se I I a A LS study m e t pri m a r y endpoints Pa t e nt G ra nte d , 2 Pending; Orphan Designation G ra nte d (FD A & EMA) N o v e l f ormul a t ion of F D A approv e d drugs f or m ulti - t a rg e t e d approach FDA: 50 5 ( b ) ( 2 ) pathwa
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 A n Inno v ative A ppro a ch Gene Therapy Str a tegy Antisense M olecular Str a tegy Antibodies Chemica l Strategy Sma l l molecu l es Cel l B a s ed St r ate g y Cel l an d Gene therapies Combine d Thera p e u ti c Strategy Targeting M ult i pl e Pathways ALS Drug s in Tria ls
Slide 6: Experienced Leadership
6 Experienced Leadership H e a d o f Scie n tif ic Progra m Shira n Zimr i , PhD C MO Fere n c Tr a cik , MD C EO , Board M e mber Alo n B e n - Noon C h airm a n of t h e Board M a rk Le u chtenberger C FO O r Eisenberg Niva R usse k - B l u m , PhD VP Disco v e ry & IP G e n e rator VP B D Ne d ir
Slide 7: Scientific Advisory Board
7 Scientific Adviso r y Boa r d P r of. Jerem y S h e f ne r ( Cha i r) • Senior VP at the Barrow Neurological Institute • C h a i r o f t h e D e p a r t m e n t o f N e ur olog y Dr. Jins y A n d rews • As s o c i a t e P r o fe sso r o f N e ur olog y , D i v i s i o n of Neuromuscular Medicine,
Slide 8: NeuroSense's Development Pipeline
8 NeuroS e ns e ’ s De v el o p men t Pipel ine ALS: Amyotrophic Lateral Sclerosis, AD: Alzheimer's Disease, PD: Parkinson’s Disease • C omple t e Toxicological Stud y • Init i at e Pharma co k i n e ti c S tu d y • Init i at e Phase I I b in H 1 ‘ 22 • Init i at e P h a s e I I I in H 2 ‘ 23 • C om
Slide 9: ALS in Numbers
9 AL S in Nu m bers ~24% Gr o wt h i n P a tien ts b y 2 0 40 i n the U S a nd EU ALS i s a n incur a bl e n e urodegen e rative dise a s e ca u sin g c o mpl e te paralysis and ultimately death within 2 - 5 years from diagnosis >$1B A n n u a l burden i n the U S a lone + 5 , 00 0 1 P eo p l e a re
Slide 10: The People Behind The Numbers
10 The People Behind T he Num b ers Oct. 2016
Slide 11: Current Treatments Show Limited Efficacy
11 Current Treatments Show Limited Efficacy Phase 3 C l ini c a l tri a l s i n th e past 1 5 yea r s have failed , w e belie v e , due mai nl y to: A N E W APPROA C H WA S N E E DED A Combined Therapeutic Strategy Targeting Multiple Pathways Single Target - Aiming for only one target in complex di
Slide 12: NeuroSense's Lead Candidate: PrimeC
12 NeuroSense ' s Lea d Cand i date : P r imeC Two Compoun ds - One Po t ent i al ly Po w erfu l Outcome N e u r oSense ’ s F l a g ship Tr e a t ment A novel formulation , consisting of specific doses of two FDA - approved drugs, Ciprofloxacin & Celecoxib, designed to work synergistically on more t
Slide 13: PrimeC – Mechanism of Action
13 Prim e C – Mechan i sm o f A c tion 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, regulati
Slide 14: Pre-Clinical Results in a Key Animal Model
14 P r e - Clinic al Results in a K e y A nima l Model 1. Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neurology, 2020. Pr i m e C im p rove d loco m o tor and cel l ular def i cits of ALS zebrafish models,
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 . I m p r o ved mot o r perf o rm a nc e 2 . Rec o ve r e d ne u r o na l struct u re Efficacy of Ciprofloxacin/Celecoxib combination in zebrafish models of amyotrophic lateral sclerosis, Annals of Clinical and Translational Neuro
Slide 16: Phase IIa Trial Design
16 Phase IIa Trial Design P r o f . V i v ia n D r or y Phas e IIa NS T 00 2 : Te l A v i v Sour a s k y Me d i c a l Ce n ter Safety Blood test, electrocardiogram ( E C G), u r e a , vital sig n s, a dv e rs e e v e n ts (AE) Efficacy AL S FR S - R - Revis ed A LS F u n ction a l R a tin g S c a le
Slide 17: PrimeC Reduced the Rate of Decline
17 * P oo l e d R e so u r ce O pe n - A cc es s ALS C l inical T r ials D ata base All patients completing the trial have opted to continue into an extension study with PrimeC Exploratory Endpoint: PrimeC vs. PRO - ACT* (matched) The tr i al w a s co n d u cted with an i n t erm e diate fo r mu l a
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 Si g ni f icant changes i n AL S - re l ate d bi o mark e rs x Well Tolerated, No Drug Related SAEs
Slide 19: Phase IIa ALS Biomarkers
Phase IIa AL S Bioma r ker s : 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
Slide 20: ALS Pathology
ALS Pathology Biomarkers "P43 TP.43 accumules™ & 5 3 i 4 %
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 Im paired Aut o pha g y L yso s omal D y sfunct ion T D P - 4 3 Acc u m u lat ion m i RN A D y s r egu lat ion Ir o n Acc u m u lat ion Ne u r o infl a mma tion
Slide 22: Stage II: Phase IIa Trial Biomarker Analysis
Stage II*: Phase IIa Trial Biomarker Analysis *All measurem e n t s a r e in n g/ml Ne u r o infl a mma tion Im paired Aut o pha g y T D P - 4 3 Acc u m u lat ion L yso s omal D y sfunct ion
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
24 Planned Development Timeline • Pharmacokinetic study • ALS Phase IIb study initiation Expected: • 9 0 d a y T o xicity s tudy c o m p le ti o n • • AD Pre - clinical studies completion PD Pre - clinical studies completion • ALS Phase IIb Top - Line results • ALS End of Phase II meeting • ALS Phas
Slide 25: High Level Gantt
25 Hig h Leve l Gantt Q 1 Q 2 2022 Q 3 Q 4 Q 1 Q 2 2023 Q 3 Q 4 Dis c o ve r y R & D a ctivi tie s (Bi o markers A D / PD) 90 day s T o x St u dy PK Study Po t e n tia l Po C c l inic a l st u die s f o r A D a n d PD PK B a t c h . I N D Su b. I RB Sub. Ph I I Bat c h. T op - L in e E n d o f P h I
Slide 26: NRSN – Highlights Summary
26 NRS N – Highlight s Su m mary x Novel formulation addresses multiple targets in a synergistic manner x Promising Phase 2a efficacy results x Statistically significant biomarkers data which corelates to meaningful clinical effect x Patents granted and additional IP coverage (valid till 2038) x Fun
Slide 27: Fun Facts: Management Team
27 Fu n Facts : Managemen t Team 66% o f B o a r d m e mbers a r e US based w i t h v a st experienc e in B i otech p u b l ic c o m p a nies 50% o f N e u ro S e n se B o a rd M e m bers a r e Women < 70% o f N e u r o Sens e t e a m a re Women
Slide 28: Thank You!
28 THAN K YOU! For more information: www.NeuroSense - tx.com i n f o@Neu r oSen s e - tx . c om
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