Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Investor Presentation (March 2018)
23 slides from Palisade Bio's investor presentation, Mar 16, 2018
Slide 1: Corporate Overview March, 2018
neuralstem.com Corporate Overview March, 2018 1
Slide 2: Safe Harbor Statement
neuralstem.com Safe Harbor Statement 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 Exchange Act of 1
Slide 3: Topics
neuralstem.com 01 Highlights 03 NSI - 189: Major Depressive Disorder Overview Clinical Results Preclinical Programs 05 Financials 02 Platform/Pipeline 04 NSI - 566: ALS, Stroke, cSCI Overview Clinical Results 06 Management Topics
Slide 4: Highlights: Lead Programs
neuralstem.com 1. Highlights : Lead Programs 4 NSI - 189: MDD – Novel neurogenic small molecule approach – Positive, randomized placebo - controlled Phase 1b in MDD – Phase II Exploratory Study in Major Depressive Disorder (MDD) • Key metrics: – Montgomery - Asberg Depression Rating Scale (MADRS) pr
Slide 5: Pipeline
neuralstem.com 2. Pipeline 7 Therapy Indication Preclinical PhaseI PhaseII PhaseIII Status Small Molecule 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 Program for Signal Generati
Slide 6: NSI-189: A New Chemical Entity for Major Depressive Disorder and Other Debilitating CNS Conditions
neuralstem.com neuralstem.com 3. NSI - 18 9 : A New Chemical Entity for Major Depressive Disorder and Other Debilitating CNS Conditions
Slide 7: 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 8: MDD Phase 2a Study Endpoints/Results
neuralstem.com MDD Phase 2a Study Endpoints/Results 8 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 9: Stage Cohen's d Effect Size
neuralstem.com Stage 2 Cohen’s d Effect Size 9
Slide 10: 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 11: 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 12: Pre-clinical Overview
neuralstem.com Pre - clinical Overview • Restores LTP of Angelman Syndrome mouse brain • Enhances short - term and long - term potentiation of normal mouse brain • Enables faster, better, durable recovery after ischemic stroke in rat, that corresponds with increased neurogenesis and synaptic remodel
Slide 13: NSI-189 Enhances LTP Magnitude
neuralstem.com NSI - 189 Enhances LTP Magnitude • 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 courtes
Slide 14: NSI-566: ALS, Stroke & Chronic Spinal Cord Injury
neuralstem.com neuralstem.com 4. NSI - 566 ALS, Stroke & Chronic Spinal Cord Injury
Slide 15: Cell Therapy: Targeting Paralysis Across Three Indications
neuralstem.com Cell Therapy: Targeting Paralysis Across Three Indications – ALS Phase 1 & 2 (n=30) : demonstrates preliminary clinical benefit against historical data . Ready for Ph2b/3 study – cStroke Phase I (n=9) : demonstrates preliminary clinical benefit from baseline. Ready for Phase 2b/3 stud
Slide 16: NSI-566: Targeting Paralysis – Program Overviews
neuralstem.com NSI - 566: Targeting Paralysis – 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 -
Slide 17: NSI-566: ALS Phase I and II Follow-Up vs Historical Data
neuralstem.com NSI - 566 : ALS Ph ase I and II -- 2 - Year Follow - Up vs Historical Data 10 17 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
Slide 18: NSI-566: Subacute SCI – Restorative effect in monkey model
neuralstem.com NSI - 566: Subacute SCI -- Restorative effect in monkey model 18 Graft a c d e b Lateral white matter Dorsal horn Segment T1 e Rosenzweig et al., Nat Med. 2018 Feb 26. doi : 10.1038/nm.4502
Slide 19: NSI-566: Chronic SCI – Phase I Safety Trial Subject #4
neuralstem.com NSI - 566: Chronic SCI -- Phase I Safety Trial 19 Subject #4 • 25 y/o male, injury 416 days prior to stem cell treatment • Baseline: T5 Neurological AIS A Complete Muscle Location 12 - Week Visit: EMG Voluntary Muscle Unit Potentials 6 - Month Visit: EMG Voluntary Muscle Unit Potentia
Slide 20: NSI-566: Chronic Stroke – Phase I Data
neuralstem.com 20 NSI - 566 : Chronic Stroke -- Phase I Data at 12 Months 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)
Slide 21: NSI-566: CMC — Ready for commercialization
neuralstem.com NSI - 566: CMC — Ready for commercialization Chemically defined culture system – No serum, no feeder cells, no un defined raw material – Fully tested for potential pathogens – Multi - tiered cGMP cell banks Efficient expansion – A stable, multipotent stem cell line, no genetic manipul
Slide 22: Financials
neuralstem.com 5. Financials 22
Slide 23: Management
neuralstem.com 6. 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 23 25+ years of Pharma & biotech leadership experience; start up, scale up and transfor