Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Neuroscience Innovation Forum 2018
18 slides from Palisade Bio's conference presentation, Jan 9, 2018
Slide 1: Neuroscience Innovation Forum January 7, 2018
neuralstem.com Neuroscience Innovation Forum January 7, 2018 1
Slide 2: Safe Harbor Statement
neuralstem.com Safe Harbor Statement neuralstem.com 2 Safe Harbor statements under the Private Securities Litigation Reform Act of 1995 : This presentation contains forward - looking statements as defined in Section 27 A of the Securities Act of 1933 as amended, and section 21 E of the Securities Ex
Slide 3: The Neuralstem Pipeline
neuralstem.com The Neuralstem Pipeline 7 Therapy Indication Preclinical PhaseI PhaseII PhaseIII Status Small Molecule: LeadAsset NSI - 189 Major Depressi ve Disorder (MDD) Topline Results Reported Long - term Follow - up Study(MDD) 6 Month O b s e r v a t i on Ongoing Supplementary Pr eclinical Prog
Slide 4: NSI-189 MDD Phase 2a Exploratory Study Design
neuralstem.com NSI - 189 MDD Phase 2a Exploratory Study Design Randomization (220) NSI - 189 80mg (44) NSI - 189 80mg (42) NSI - 189 40mg (44) NSI - 189 40mg (40) Placebo (132) Responder (66) Placebo (41) Non - responder (66) Placebo (22) NSI - 189 80mg (22) NSI - 189 40mg (21) Screening (350) Scree
Slide 5: Summary MDD Phase 2a Study - Safety
neuralstem.com Summary MDD Phase 2a Study -- Safety • Side effects: Fewer subjects than the placebo with symptoms and signs associated with MDD • Vital Signs: No clinically meaningful changes in body weight or BMI • ECG: No clinically significant changes • Sexual Functioning Inventory: No clinically
Slide 6: MDD Phase 2a Study Endpoints/Results
neuralstem.com 6 Stage 2 Cohen’s d Effect Size MDD Phase 2a Study Endpoints/Results
Slide 7: NSI-189 Pre-clinical Data: Insight into MOA and Broad CNS Potential
neuralstem.com NSI - 189 Pre - clinical Data Insight into MOA and Support for Broad Potential in CNS
Slide 8: Pre-clinical Overview
neuralstem.com Pre - clinical Overview Preclinical data suggests a new paradigm of reversing damage caused by disease/injury • Restores LTP of Angelman Syndrome mouse brain • Enhances short - term and long - term potentiation of normal mouse brain • Enables faster, better, durable recovery after isc
Slide 9: NSI-189 Enhances Synaptic Plasticity
neuralstem.com NSI - 189 Enhances Synaptic Plasticity • Restores LTP of Angelman Syndrome mouse brain slices. • Confirmatory model of the genetic disease. • Enhances short - and long - term potentiation of normal mouse brain slices (n=8) • Effect i ncreases with exposure time and concentration. By c
Slide 10: NSI-189 Stimulates Synaptic Remodeling
neuralstem.com 10 NSI - 189 Stimulates Synaptic Remodeling 0 0.5 1 1.5 2 2.5 3 3.5 Mean Neurologic Score Bederson Neurologic Test End of dosing 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 12 Week- Control 12 Week NSI- 189 (30mg/kg) 24 Week- Control 24 Week NSI- 189 (30mg/kg) MAP - 2 Density (pixel Intensity
Slide 11: NSI-189 Increases Motor Nerve Conduction Velocity
neuralstem.com Weeks of Diabetes 0 2 4 6 8 10 12 14 16 18 Conduction Velocity (m/s) 36 38 40 42 44 46 48 Ctl + Vehicle Diabetes + Vehicle Diabetes + NSI189 Treatment Initiated * * Type 1 Diabetes Model — Intervention Study Type 2 Diabetes Model — Prevention Study NSI - 189 Increases Motor Nerve Cond
Slide 12: NSI-189 Increases Nerve Fiber Density
neuralstem.com Number of PGP 9.5 - stained profiles in the epidermis (intra - epidermal nerve fibers: IENF) 3D reconstruction of nerve structure in the mouse cornea: A delta fibers (yellow) penetrating the Bowman’s layer and spreading into the sub - basal nerve plexus (red) NSI - 189 Increases Nerve
Slide 13: NSI-566: ALS, Stroke & Chronic Spinal Cord Injury
neuralstem.com neuralstem.com 4. NSI - 566 ALS, Stroke & Chronic Spinal Cord Injury
Slide 14: Cell Therapy: Clinical Activity Across Three Indications
neuralstem.com Cell Therapy: Clinical Activity AcrossThree Indications – ALS Phase 1 & 2: demonstrates preliminary clinical benefit against historical data – Phase I stroke completed dosing all 9 patients and currently evaluating safety – cSCI is currently evaluating 4 Phase 1 thoracic patients; Pha
Slide 15: Cell Therapy Program Overviews
neuralstem.com Cell Therapy Program Overviews MARKET CONSIDERATIONS - Orphan condition - NSI - 566 granted orphan status by FDA - Rapid accelerating disease/poor prognosis - Limited treatment options - Opportunity for RMAT designation (21 st Century Cures Act) PROGRAM OVERVIEW - Transplantation into
Slide 16: NSI-566: ALS Phase I and II vs Historical Data
neuralstem.com NSI - 566 : ALS Ph ase I and II 10 16 ALSFRS - R Ph1/2 PRO - ACT N Mean (SD) N Mean (SD) t - test Baseline 21 36·5 ± 5·4 1108 38·1 ± 4·7 0·17 6 months 18 30·6 ± 6·5 974 32·5 ± 7·6 0·25 12 months 14 30·5 ± 9 655 28·3 ± 9·3 0·37 18 months 11 31·8 ± 8·1 165 24·6 ± 10·4 0·016 24 months 11
Slide 17: NSI-566 Stroke: Phase I Clinical Benefits
neuralstem.com 17 NSI - 566 stroke: Phase I Meaningful Clinical Benefits: >10 points of improvement in Fugl - Meyer Motor Score Fugl - Meyer Motor Score Post Treatment (months, 0 - 12) Change from Baseline (+/ - SEM) Modified Rankin Scale Change from Baseline (+/ - SEM) Post Treatment (months, 0 - 1
Slide 18: Management
neuralstem.com Management Richard Daly Chief Executive Officer & acting CFO Karl Johe, Ph.D. Chief Scientific Officer Thomas Hazel, Ph.D. Senior Vice President, Research David Recker, M.D Chief Medical Officer 18 25+ years of Pharma & biotech leadership experience; start up, scale up and transformat