Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (January 2018)
28 slides from Palisade Bio's investor presentation, Jan 9, 2018
Slide 1: Corporate Overview January, 2018
neuralstem.com Corporate Overview January, 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: Topics
neuralstem.com 01 Highlights 03 NSI - 189: Major Depressive Disorder Overview Clinical Results Preclinical Programs 05 Execution 07 Financials 02 Platform/Pipeline 04 NSI - 566: ALS, Stroke, cSCI Overview Clinical Results 06 Scientific Advisory Board 08 Management Topics
Slide 4: Key Highlights
neuralstem.com 1. Key Highlights neuralstem.com 4 Lead Program – Novel neurogenic small molecule approach – NSI - 189: Positive, randomized placebo - controlled Phase 1b in MDD – Phase II Exploratory Study in Major Depressive Disorder (MDD) • Key metrics: – Montgomery - Asberg Depression Rating Scal
Slide 5: The Neuralstem Platform/Pipeline
neuralstem.com Neuralstem 5 A self - sustaining CNS therapeutics company Unique lines of human, regionally specific neural stem cells Proprietary technology and therapeutic solutions to address serious CNS d iseases A world without debilitating CNS conditions Research ( Screening & Novel Molecules )
Slide 6: The Neuralstem Platform/Pipeline
neuralstem.com 2. The Neuralstem Platform/ 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 e
Slide 7: NSI-189: A New Chemical Entity for Major Depressive Disorder and Other CNS Conditions
neuralstem.com neuralstem.com 3. NSI - 18 9 : A New Chemical Entity for Major Depressive Disorder and Other Debilitating CNS Conditions
Slide 8: Major Depressive Disorder: Overview
neuralstem.com • Mono Therapy • SSRI/SNRI (generic) First Line Therapy • Rx switch • Adjunctive therapy. i.e., • Non - SSRI/SNRI • Anti anxiolytics Level 2 • Rx Switch • Adjunctive therapy, i.e., • Second generation anti - psychs • Mood stabilizers Level 3 • Highly resistant depression • Rx Switch t
Slide 9: NSI-189 Clinical Development Approach: A Functionally-Driven Development Strategy
neuralstem.com NSI - 189 demonstrates PRO - COGNITIVE activity in MDD and in the Angelman preclinical model; potential additional indications in cognitive impairment. NSI - 189 demonstrates ANTI - DEPRESSANT activity in MDD patients; additional opportunities in bipolar disorder, and the depression s
Slide 10: NSI-189's Activities and Potential Benefits & Indications
neuralstem.com NSI - 189’s Activities and Potential Benefits & Indications 1 2 • Neurogenesis: – reversal of stress - induced damage • treatment - resistant depression • Rapid, long - lasting, synaptic plasticity: – improvement of working memory, executive functioning • cognitive impairment in schiz
Slide 11: NSI-189: Phase 2 Exploratory MDD Trial Design
neuralstem.com NSI - 189: Phase 2 Exploratory MDD Trial Design Study Objectives – Primary: Montgomery - Asberg Depression Rating Scale (MADRS) – Secondary*: SDQ, HAM - D17, CGI - S, CPFQ, SFI – Exploratory: Cogscreen Battery, Cogstate Brief Battery Innovative Study Design – Randomized, double blind,
Slide 12: NSI-189 P2 MDD Exploratory Study Design
neuralstem.com NSI - 189 P2 MDD 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) Screening:
Slide 13: MDD Phase 2a Study Endpoints/Results
neuralstem.com MDD Phase 2a Study Endpoints/Results 13 Endpoint V al i d a t e d / FDA Accepted 40mg stat sig ( c o m b i n e d) Cohen’s d (stage 2) 80mg stat sig (combined) Cohen’s d (stage 2) MADRS (Primary) Yes/Yes No 0.25 No 0.19 HAMD - 17 Yes/Yes No 0.33 No 0.38 QIDS - SR (patient reported) Yes
Slide 14: Stage Cohen's d Effect Size
neuralstem.com Stage 2 Cohen’s d Effect Size 14
Slide 15: 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 16: NSI-189 Pre-clinical Data: Insight into MOA and Support for Broad Potential in CNS
neuralstem.com NSI - 189 Pre - clinical Data Insight into MOA and Support for Broad Potential in CNS
Slide 17: 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 is
Slide 18: NSI-189 Enhances LTP Magnitude
neuralstem.com NSI - 189 Enhances LTP Magnitude 1 • 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 court
Slide 19: NSI-566: ALS, Stroke & Chronic Spinal Cord Injury
neuralstem.com neuralstem.com 4. NSI - 566 ALS, Stroke & Chronic Spinal Cord Injury
Slide 20: Cell Therapy: Activity Across Three Indications
neuralstem.com Cell Therapy: 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; Phase 1 tria
Slide 21: 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 - O pportunity for RMAT designation (21 st Century Cures Act) PROGRAM OVERVIEW - Transplantation int
Slide 22: NSI-566: ALS Phase I and II, 2-Year Follow-Up vs Historical Data
neuralstem.com NSI - 566 : ALS Ph ase I and II, 2 - Year Follow - Up vs Historical Data 10 22 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
Slide 23: Meaningful Clinical Benefits: NSI-566 Stroke Phase I Interim Data
neuralstem.com 23 Meaningful Clinical Benefits: >10 points of improvement in Fugl - Meyer Motor Score NSI - 566 stroke: Phase I interim data Fugl - Meyer Motor Score Post Treatment (months, 0 - 12) Change from Baseline (+/ - SEM) Modified Rankin Scale Change from Baseline (+/ - SEM) Post Treatment (
Slide 24: Neuralstem's Technical Expertise/Differentiation
neuralstem.com Neuralstem’s Technical Expertise/Differentiation Chemically defined culture system – No serum, no feeder cells, no particulates, no un defined raw material – Fully tested for potential pathogens; validated SOPs Efficient expansion – Multi - tiered cell banks for maximum efficiency – S
Slide 25: Execution: 2016-2018 Milestones
neuralstem.com x Jan : Refocused clinical strategy x Feb : Rich Daly joins as CEO x May: x Initiation of P2 MDD study x $9M institutional raise x Jun : Corporate Reorganization to align with updated strategy x Rich Daly appointed Chairman, Board of Directors x Dec : Closing of Tianjin Pharmaceutical
Slide 26: Scientific Advisory Board
neuralstem.com 6. Scientific Advisory Board Comprised of World Class Psychiatric, Clinical and Regulatory Experts Dr. Maurizio Fava Harvard, MGH, Executive Vice Chair, Dept. of Psychiatry Principal Investigator: NSI - 189 Phase 2 MDD clinical trial Dr. Michael Thase Univ. of Pennsylvania, Chief. Div
Slide 27: Financials
neuralstem.com 7. Financials 27
Slide 28: Management
neuralstem.com 8. 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 28 25+ years of Pharma & biotech leadership experience; start up, scale up and transfor