Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — Barclays Global Healthcare Conference 2015
23 slides from Palisade Bio's conference presentation, Mar 12, 2015
Slide 1: Barclay's Global Healthcare Conference March 12, 2015
Barclay’s Global Healthcare Conference March 12, 2015
Slide 2: Safe Harbor Statement
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 1934 , as amended . Such forward - looki
Slide 3: Neuralstem Technology
Neuralstem Technology 3 Neuralstem's technology enables the isolation, expansion and controlled differentiation of neural stem cells into mature, physiologically relevant human neurons and glial cells. Spinal Cord Hippocampus GABAergic Cholingergic Midbrain Dopaminergic • Discovered at NIH • Regiona
Slide 4: Neuralstem Overview
Neuralstem Overview Midbrain Neuralstem’s proprietary dual platform technology uses regionally specific neural stem cells for the development of CNS cell therapies and small molecule drug discovery. Neuralstem’s proprietary platform technology Transplantation Cell Therapies NSI - 566 Cell transplant
Slide 5: Neuralstem Pipeline
Neuralstem Pipeline 5 One Technology, Two Neurogenic Platforms, Multiple Indications Compound / Indication Preclinical Phase 1 Phase 1b Phase 2 Phase 2b Data Small Molecule NSI-189 US Major Depression Disorder P2 start 2Q15 NSI-189 US Cognitive Deficit in Schizoprenia PIb start mid15 Cell Therapy NS
Slide 6: Human Proof of Concept: Cell Therapy
Human Proof of Concept Safe and tolerable: • Completed 49 cell therapy transplantations world wide • No toxicity Biological Activity: • Definitive evidence of long - term cell survival via DNA fingerprinting • Synaptic integration – nursing, protecting and “bridging the gaps” Three ongoing clinical
Slide 7: NSI-566/ALS Phase I Long Term ALSFRS-R Data
NSI - 566/ALS Phase I Long Term ALSFRS - R Data 7 Phase Ib Patient Follow - up: 1200 day efficacy data • Patients 10, 11, 12, received ten lumbar and five cervical injections of 100,000 cells each • Safe and well tolerated; Average hospital stay 3 - 4 days • Proof of “Activity” – cells provide neuro
Slide 8: Lead Program: ALS Phase II 9 Month Data
NSI - 566 Lead Program: Amyotrophic Lateral Sclerosis 8 Phase II ALS 9 M onth Data Primary Endpoints x NSI - 566 cells and surgery are well tolerated x Maximum tolerate dose: 400,000 cells per injection, 20 injections for each lumbar and cervical surgery Secondary Endpoints Investigating ALSFRS - R
Slide 9: ALS Phase II Trial Design
NSI - 566 Lead Program: Amyotrophic Lateral Sclerosis 9 Phase II ALS Trial Design Phase 2 : 11 subjects entered, all cervical injections • 1 - 3 (A): 5 bilateral inj ; 200,000 cells/ inj : 2 million cells • 4 - 6 (B): 10 inj /side: 200,000 cells/ inj : 4 million cells • 7 - 9 (C): 10 inj /side: 300,
Slide 10: ALS Phase II Month Data: Responders vs Non-Responders
ALS Phase II 9 month data 10 Statistically significant between responders and non - responders - 47 % response rate to the stem cell treatment Responder measurements • ALSFRS: 7 of 15 patients had a near - zero slope of decline or positive slope • Grip Strength : 7 of 15 patients had a near - zero d
Slide 11: ALS Phase II Month Data
ALS Phase II 9 month data Non-Responders: ALSFRS-r = 315 200 0 200 400 Days Elaspsed from 1st Surgery 600
Slide 12: ALS Phase II Month Data: ALSFRS Slope
ALS Phase II 9 month data 12 • Responders ’ disease progression was - 0.007 point per day • N on - responders ’ disease progression was - 0.1 point per day • Measurement : an average slope of decline of ALSFRS Statistical Significant Reduction in ALSFRS Slope
Slide 13: ALS Phase II Month Data: Baseline Score Retained
ALS Phase II 9 month data 13 • Statistically significant difference of 93% versus 35% of the baseline score retained by the responders versus non - responders • Responders scored an average ALSFRS score of 37 • Non - responders scored an average ALSFRS score of 14
Slide 14: ALS Phase II Month Data: Seated Vital Capacity
ALS Phase II 9 month data 14 Seated Vital Capacity : responders remained within 94% of scores vs. 71% for non responders
Slide 15: ALS Phase II Control Study
ALS Phase II Control study 15 ALS Phase II Results • NSI - 566 cells and surgery are well tolerated • Identified max tolerated dose • 47% responder rates • Predictive responder profile ALS Phase II Control Study • ~ 50 patients • 9 month follow - up • L umbar and cervical injections, total 16 millio
Slide 16: Neurogenic Small Molecule Platform
Neurogenic Small Molecule Platform 16 NSI - 189: First - in - class Neurogenic Small Molecule Drug, Reversing Hippocampal Atrophy Screening human hippocampal s tem c ells Biological Activity » increase in synaptic connection » neurogenesis in the human hippocampus Major Depressive Disorder (MDD) • P
Slide 17: Stages of Neurogenesis
Stages of Neurogenesis Maturation/Function i ! Increased Cognition/Function
Slide 18: Screening Path
Screening Path 18 10,269 small molecule compounds primary screen 16 neurogenic compounds in vitro 16 tested in acute toxicity in mice 15 tested for neurogenesis in healthy, adult mice 7 orally active neurogenic leads 1 development candidate selection NSI - 189
Slide 19: NSI-189 MDD Phase Ib Clinically Meaningful Results
• SDQ combined treatment group showed statistically significant improvement (p=0.02) • Clinically meaningful reduction in depressive & cognitive symptoms (40mg, 80mg) • P ersistent efficacy over the non - dosing 8 - week follow - up period p=0.02 d=0.90 Study Day -20 0 20 40 60 80 100 Symptoms of De
Slide 20: NSI-189 MDD Phase Ib Clinically Meaningful Results (CPFQ)
p=0.01 d=0.94 Study Day -20 0 20 40 60 80 100 Cognitive and Physical Functioning Questionnaire 2.0 2.5 3.0 3.5 4.0 4.5 5.0 Placebo NS-189 NS-189 1x per day NS-189 2x per day NS-189 3x per day p<0.01 d=1.20 • Significant effect size in cognitive function improvement; improvement persisted over 8 - we
Slide 21: NSI-189 MDD Phase Ib Biomarkers
NSI - 189 MDD Phase Ib Biomarkers Quantitative EEG ( qEEG ) measurements, electrophysical biomarker : • Day 28 statistical significance • Significantly increased brain wave patterns in the hippocampal region 10 Plasma biomarkers : • Identified a rapid response • C onsistent with therapeutic effects
Slide 22: NSI-189 Program Expansion: Cognitive Deficit in Schizophrenia
NSI - 189 Program Expansion • Phase Ib to commence mid 2015 • Hippocampal atrophy well documented in this patient population • Psychotic and hallucinations are distinct from cognitive deficit • High unmet patient population; limited therapies available • 3.5 million (1%) of Americans diagnosed 22 NS
Slide 23: Neuralstem Timeline
Neuralstem Timeline 23 NSI - 189 neurogenic small molecule platform Phase II MDD commence in 2Q15 Phase Ib full data; Dr. Maurizio Fava publication Phase Ib cognitive deficit in schizophrenia commence mid2015 NSI - 566 cell therapy platform Phase II ALS full data 1H15 Phase II ALS expected commence
Neuralstem — Barclays Global Healthcare Conference 2015 on 6ix