Neurosense Therapeutics Ltd. · NASDAQ:NRSN
Neurosense Therapeutics — Investor Presentation (September 2023)
25 slides from Neurosense Therapeutics's investor presentation, Sep 12, 2023
Slide 1: Investor Webinar September 2023
Investor Webinar September 2023 Nasdaq: NRSN
Slide 2: Forward-Looking Statements
Forward - Looking Statements This presentation and oral statements made regarding the subject of this presentation contain "forward - looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements c
Slide 3: NeuroSense Highlights
NeuroSense Highlights Developing novel therapies for neurodegenerative diseases of high unmet need Multiple near - term catalysts including Phase 2 b topline results for ALS (1) expected in Q4 2023 Existing partnership with big pharma and fully funded through Q2 2024 zed 1. ALS - Amyotrophic Lateral
Slide 4: Focused Pipeline
Focused Pipeline Diseases with Limited Treatment Options and High Commercial Opportunity ALS Alzheimer’s Parkinson’s Topline data from Phase 2b placebo - controlled clinical trial expected in Q4 2023 Commencement of Phase 2 placebo - controlled clinical trial expected in H2 2023 Exploring potential
Slide 5: PrimeC: At a Glance
PrimeC: At a Glance Novel combination therapy of approved products optimized for PK and synergistic effects to address ALS and potentially other disease targets Differentiated efficacy and excellent safety profile observed from ALS Phase 2a clinical trial ALS Phase 2b top - line results from placebo
Slide 6: ALS patients and market opportunity
>80,000 ALS Patients in NeuroSense’s planned target market (2) ~24% Growth in Patients by 2040 in the US and EU (2) +5,000 New cases of ALS each year (US) (1) ~$3B Annual Market Opportunity (3) 1. ALS - Amyotrophic Lateral Sclerosis, Johns Hopkins Medicine 2. Projected increase in amyotrophic latera
Slide 7: PrimeC: Two Compounds One Potentially Powerful Outcome
PrimeC: Two Compounds One Potentially Powerful Outcome PrimeC is a novel formulation , consisting of specific doses of two FDA - approved drugs, designed to work synergistically on more than one target in ALS Celecoxib - an NSAID which reduces: • Neuroinflammation • Glutamate excitotoxicity • Oxidat
Slide 8: Improved Pharmacokinetic (PK) Profile
Improved Pharmacokinetic (PK) Profile This finding is attributed to Celecoxib blocking exit of Ciprofloxacin in the neuron PrimeC’s combination ( Celecoxib + Ciprofloxacin ) remained at a higher concentration in rodent brain tissue for longer , when compared to administration of Ciprofloxacin alone
Slide 9: PrimeC's Formulation Induces a Synchronized PK Profile
PrimeC’s Formulation Induces a Synchronized PK Profile A synchronized PK profile of the two compounds, potentially maximizes the synergy between them PK profile studies in humans Synchronized concentration peak Phase 2a Results Intro PrimeC Pre - clinical Phase 2b Summary
Slide 10: Elucidating the Synergistic Effects of PrimeC
Elucidating the Synergistic effects of PrimeC via Cutting Edge Methodologies via Brain Tissue From ALS Patients and Stem Cells ALS patient blood Isolated Peripheral Blood Mononuclear cells (PBMCs) IPSCs IPSCs + / - Treatments Dr. Justin Ichida, University of Southern California Dr. Ghazaleh Sadri -
Slide 11: PrimeC Performed Favorably in iPSC Model
Independent, non - sponsored research was conducted in the laboratory of Dr. Justin Ichida, University of Southern California PrimeC Performed Favorably * = p<0.05, *** = p<0.001 *** *** *** * * In induced Pluripotent Stem Cell (iPSC) Model Generated from People Living with ALS Candidate compounds o
Slide 12: Phase 2a Trial with PrimeC: Met Primary and Exploratory Endpoints
Phase 2a Trial with PrimeC: Met Primary Endpoints & Exploratory Endpoints Positive Clinical Signal Observed These results led NeuroSense to commence a Phase 2b clinical study, using an improved new extended - release formulation of PrimeC Significant changes in ALS - related biomarkers Well tolerate
Slide 13: Phase 2a Efficacy Data Results
Phase 2a 12 - Month Efficacy Data Results: PrimeC (intermediate formulation) Improved Respiratory Function Decline & Attenuated Disease Progression* ALSFRSr Score Forced vital capacity (FVC%) **In comparison to PRO - ACT matched - control : P ooled R esource O pen - A ccess ALS C linical T rials D a
Slide 14: PrimeC Phase 2b Trial Design
PrimeC Phase 2b Trial Design Randomized, Prospective, Double - Blind, Placebo - Controlled Study Using PrimeC’s novel extended - release formulation NST003 69 patients enrolled 2:1 PrimeC to Placebo New formulation of PrimeC 6 - month double blind 12 - month open label extension Clinic visit every 2
Slide 15: Double-Blind Phase 2b enrollment and timeline
Double - Blind PrimeC 2 : 1 Placebo First Patient In May 2022 Israel First Patient In March 2023 Torino 2022 2023 First Patient In March 2023 Milan First Patient In April 2023 Canada Nov2023 PrimeC Only OLE 2024 Last patient Out DB Top Line Results Double Blind Summary Phase 2b Phase 2a Results Pre
Slide 16: Pioneering Approach to ALS Biomarker Research
Pioneering Approach to ALS Biomarker Research NeuroSense is collaborating with leading KOLs and industry on the PARADIGM trial to elucidate PrimeC’s MOA via novel methodologies Summary Phase 2a Results Pre - clinical Identification of Novel Biomarkers Neurofilaments Neuronal Derived Exosomes Interpl
Slide 17: AD Studies Reveal Potential Effect of Combination Therapy
AD Studies Reveal Potential Effect of NeuroSense’s Combination Therapy Biomarkers tested in Neuronal Derived Exosomes comparing non - treated Healthy vs. AD patients, to elucidate the potential target engagement of CogniC Biomarker data were analyzed using a Mann - Whitney U test comparing AD sample
Slide 18: AD Phase 2 Trial Design
AD Phase 2 Trial Design Randomized, Prospective, Double - Blind, Placebo - Controlled Study 20 patients with mild to moderate AD 1:1 PrimeC to Placebo CogniC - intermediate formulation (= PrimeC - ER) 12 - month dosing Clinic visit every 3 months Single - center Target Engagement Biomarkers Secondar
Slide 19: PD Studies Reveal Potential Effect of Combination Therapy
• AGO2 is a protein - coding gene essential for miRNA function, involved in the regulation of α Syn biogenesis • Depletion of AGO 2 leads to α Syn accumulation . The dysregulation of α Syn through dysfunction of AGO 2 can have detrimental effects in the brain, resulting in PD . 1 • A significant dif
Slide 20: Milestones Achieved & Upcoming Potential Catalysts
Milestones Achieved & Upcoming Potential Catalysts Expect ALS End of Phase 2 Meeting with the FDA and EMA Expect to initiate ALS Phase 3 clinical trial Initiated ALS Phase 2b PARADIGM study Received FDA IND Clearance for PrimeC Completed PK study single - dose & multi - dose successfully Completed I
Slide 21: Scientific Advisory Board
of Neurology Prof. Jeremy Shefner (Chair) Senior VP at the Barrow Neurological Institute Chair of the Department Dr. Jinsy Andrews Associate Professor of Neurology, Division of Neuromuscular Medicine, Columbia University Director of Neuromuscular Clinical Trials Prof. Merit Cudkowicz Chief of Neurol
Slide 22: Key Collaborations
Key Collaborations Intro PrimeC Summary Pre - clinical Phase 2a Results Phase 2b
Slide 23: Proven Success of Combined Therapy
Proven Success of Combined Therapy Successful combination strategies in neurology: Alzheimer’s Donepezil + Memantine Parkinson’s Entacapone + levodopa/carbidopa ALS Sodium Phenybuterate + Taurursodiol SMA Onasemnogene + Nusinersen Epilepsy Lamotrigine + Valproate/Carbamazepine Case Study: Amylyx (NA
Slide 24: NeuroSense Summary
NeuroSense Summary Novel combination therapy designed to address multiple disease targets in a synergistic manner Promising efficacy and biomarker results with an excellent safety profile observed from 12 - month ALS Phase 2a clinical trial Top - line results from ALS Phase 2b placebo - controlled c
Slide 25: Q&A
Nasdaq: NRSN Q&A For more information: info@neurosense - tx.com
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