Palisade Bio, Inc. · NASDAQ:PALI
Palisade Bio — Neuralstem — 28th Annual Roth Conference 2016
19 slides from Palisade Bio's conference presentation, Mar 16, 2016
Slide 1: 28th Annual Roth Conference, March 15, 2016
March 15, 2016 28 th Annual Roth Conference
Slide 2: March 2016 28th Annual Roth Conference
March 2016 28 th Annual Roth Conference
Slide 3: Safe Harbor Statement
NEURALSTEM, INC. 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 1
Slide 4: Proprietary Neural Stem Cell Technology
Proprietary Neural Stem Cell Technology 3 Neural Stem cell CNS platform Small Molecule Screening Safe, Novel MOA Multiple Targets New Chemical Entity Cell Therapy High unmet medical need Outsourced Funding/Partnering Lead Candidate: NSI - 189 Phase II MDD Lead Candidate: NSI - 566 ALS (orphan), Stro
Slide 5: Pipeline
Pipeline Compound / Indication Preclinical Phase | Phase II Phase Ill Small Molecule NSI-189_ US Phase II start Major Depression Disorder 1Q16 NSI-189 4 ongoing Exploratory Cell Therapy (outsourced funding) NSI-566 US Phase II Amyotrophic Lateral Sclerosis Completion NSI-566_ US Phase | data Chronic
Slide 6: Clinical Corporate Goals
Clinical Corporate Goals 5 • MDD Ph II Trial, Data 2H 2017 • Exploration of additional safety studies NSI - 189 • Partnerships for continuing clinical development • Expedite regulatory pathways NSI - 566 • Expansion of clinical & regulatory personnel • Business development initiatives Corporate
Slide 7: Scientific Advisory Board
NSI - 189 Scientific Advisory Board 6 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. Division of Mood and Anxiety Disorders Treatment and Research Program Dr. Mark
Slide 8: Screening Path to NSI-189 Development Candidate
7 10,269 Small Molecule Compounds through High Content Screen 16 Neurogenic Compounds in vitro 7 Orally Active Neurogenic Leads ( 3 Structural Classes) 16 Tested for Acute Toxicity in Mice 15 Tested for Neurogenesis in Healthy, Adult Mice 1 Development Candidate Selected NSI - 189 Screening Path to
Slide 9: Target Product Profile
NSI - 189 Target Product Profile 8 Indication Monotherapy and Adjunctive treatment of Major Depressive Disorder (MDD), with improvement of cognition Efficacy • Primary: MADRS • Key secondary: Onset of effect, s ustained effect, cognitive symptom improvement Superiority vs. active comparator at day 2
Slide 10: Clinical Results from Phase Ib: Study Design
Cohort 1 N=8 (6 drug, 2 placebo) 40 mg QD Cohort 2 N=8 (6 drug, 2 placebo) 40 mg BID Cohort 3 N=8 (6 drug, 2 placebo) 40 mg TID Acute treatment: 28 days Follow up: Days 35, 42, 49, 56, 70, 84 (End - of - study) Clinical Results from NSI - 189 Phase Ib NSI - 189 Phase Ib double - blind, randomized, p
Slide 11: Clinical Results from MDD Phase Ib
Clinical Results from NSI - 189 MDD Phase Ib 10 p=0.02 d=0.90 Study Day -20 0 20 40 60 80 100 Symptoms of Depression Questionnaire 2.0 2.2 2.4 2.6 2.8 3.0 3.2 3.4 3.6 3.8 Placebo NS-189 NS-189 1x per day NS-189 2x per day NS-189 3x per day p=0.03 d=1.10 Day 84 Day 28 Symptoms of Depression Questionn
Slide 12: Clinical Results from MDD Phase Ib: Cognitive Function
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 Day 28 Day 84 Clinical Results from NSI - 189 MDD Phase Ib 11 All: A Phase 1B, Randomized, Dou
Slide 13: Phase Ib: Minimal Adverse Events
Phase Ib : Minimal Adverse Events 12
Slide 14: qEEG Biomarker Results from MDD Phase Ib
Topographs of High Frequency alpha (10 - 12 Hz): Day 28 from Baseline Left posterior temporal (T5) (t=2.45, p=0.02) Left parietal regions (P3) (t=3.31, p=0.004) qEEG Biomarker Results from NSI - 189 MDD Phase Ib Quantitative EEG ( qEEG ) biomarker : • Increases coherence activity between prefrontal
Slide 15: Biomarker Results from MDD Phase Ib
Biomarker Results from NSI - 189 MDD Phase Ib Blood biomarker panel : • Blood panel analysis correlates to MADRS r esponse rate • MDD panel was developed based on SSRIs activity profile • Rapid and persistent efficacy 14 Response Rate Partial Responder (<14) +Responders ( ≥ 50%) Responder ( ≥ 50%) R
Slide 16: Phase II MDD Trial Milestones
NSI - 189 Phase II MDD Trial 15 Milestones: • First Patient enrolled 2Q16 • Phase 2 Data 2H17 Study Objectives • Primary: Montgomery - Asberg Depression Rating Scale (MADRS ) • Secondary: SDQ , HAMD17, CGI - S, CPFQ, SFI, Cogscreen Battery, Cogstate Brief Battery Principal Investigator: Maurizio Fav
Slide 17: Phase II MDD Trial Innovative Study Design
NSI - 189 Phase II MDD Trial 16 • Three arm: 40mg BID, 40mg QD, & placebo (n=220 randomized ) • H igher quality MDD trial sites (n=12 ) • Independent , remote, confirmation of MADRS diagnosis by MGH • P lacebo - reducing prescreen process • Potential registration study if successful in either active
Slide 18: Building the Case for MOA
Building the Case for MOA 17 No appreciable binding activity against 52 neurotransmitter related receptors/ion channels/ enzymes No binding or functional activities against 900 Other kinases (DISCOVERX KinomeScan ) NSI - 189 Binding Activities ≥ 50% at 10µM Target IC50 (µM) Dopamine Transporter (h)
Slide 19: Milestones
18 Milestones NSI - 189 Phase 2 MDD initiation • First Patient enrolled 2Q16 • Phase 2 Data 2H17 NSI - 189 Exploratory Studies • Company update on secondary trial 1H16 Business Development • Ongoing partnering discussions